Jan 2006

Infection Control plus OSHA

12 Homestudy Credit Hours

Mary Oeding, R.D.H., M Ed. Anthony S. Mennito, D.M.D.

Foundations in Continuing Dental Education is an ADA CERP Recognized provider.

Foundations in Continuing Education PO Box 342 Herndon, VA 20172 Website: www.fice.com Email: CEsupport@fice.com 800-522-1207 : 703-935-2190 fax

Answer Sheet - Infection Control plus OSHA - 12 hrs

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Instructions
Read the course material and enter your test answers on the one-page answer sheet included with this book. You earn course credit for every test answer sheet with at least 70% correct answers. We notify failing students within 7 days and give them an opportunity to take a new test. The first retest is no charge; subsequent tests cost $25.00 each. To claim your credits, return your answers by: Taking the test online (only if you have not purchased the coursebook separately, you will need to provide credit card information at the time you submit your exam online for scoring). Writing your answers on the one-page answer sheet included with this book, then fax or mail them to: Foundations In Continuing Education P.O. Box 342 Herndon, VA 20194 Phone: 800-522-1207 Fax: 866-233-9267 We grade all tests in a timely manner, so if you do not receive your certificate within five days, please send an email to cesupport@fice.com. There is no time limit for return of your answer sheet. Completion dates are taken from the test answer sheet envelope postmark or the finish date recorded in the computer when you do an online exam, and must be in the licensing cycle you wish to use the credits. If you are dissatisfied with the course for any reason, please return the printed materials within 30 days of purchase and we will refund your full tuition. Shipping charges are nonrefundable. If someone else would like to use this material after you are done, he or she may register with us and take advantage of the sharing discount workbook tuition charge. Courses downloaded from the Internet can be shared at the same tuition rate as currently available on our website. Please call us if you need an extra answer sheet or download one from our website. There is no sharing discount for online exams. Keep in mind several States have specific requirements on subject matter as well as credits earned through different educational methods for license renewal. You are responsible to know of these limitations. The author and FICE have made every effort to include information in this course that is factual and conforms to accepted standards of care. This course is not to be used as a sole reference for treatment decisions. It is your responsibility to understand your legal obligations and license requirements when treating patients. FICE is not responsible for the misuse of information presented in this course. The material in this course cannot be reproduced or transmitted in any way without the written consent of FICE.

Table of Contents
Instructions .............................................................................................................. 4 Table of Contents..................................................................................................... 5 Objectives................................................................................................................. 7 Introduction .............................................................................................................. 8
Introduction ......................................................................................................................... 8 Definitions ........................................................................................................................... 8 Types of Microorganisms .................................................................................................... 9 Chemical Agents that Kill Microorganisms .......................................................................... 9 Classification of Common Dental Items ............................................................................ 10 Tuberculosis...................................................................................................................... 11 AIDS.................................................................................................................................. 12 Hepatitis ............................................................................................................................ 14 Introduction ....................................................................................................................... 16 Handwashing .................................................................................................................... 16 Gloves ............................................................................................................................... 16 Gowns ............................................................................................................................... 17 Masks................................................................................................................................ 18 Protective Eyewear ........................................................................................................... 18 Surface Covers ................................................................................................................. 19 Surface Cleaning............................................................................................................... 19 Spilled Blood ..................................................................................................................... 19 Disposal of Contaminated Wastes .................................................................................... 19 Needles ............................................................................................................................. 19 Introduction ....................................................................................................................... 21 Iodophor Solutions ............................................................................................................ 22 Complex Phenolics ........................................................................................................... 23 Alcohol-Quaternary Ammonium Compounds.................................................................... 23 Sodium Hypochlorite (Bleach)........................................................................................... 23 Unacceptable Solutions .................................................................................................... 24 Sterilants and High Level Disinfectants............................................................................. 24 Preprocedural Mouthrinsing .............................................................................................. 25 Introduction ....................................................................................................................... 29 Presoaking ........................................................................................................................ 29 Precleaning ....................................................................................................................... 29 Corrosion Control and Lubrication .................................................................................... 30 Packaging ......................................................................................................................... 30 Backflow Prevention.......................................................................................................... 30 High-Speed Handpiece Asepsis ....................................................................................... 30 Slow Speed Handpieces, Contra Angles, and Prophy Angles .......................................... 33 Air/Water Syringes and Ultrasonic Scaler ......................................................................... 33 Lasers, Curing Lights, Electrocautery Devices ................................................................. 33 Disposable Items............................................................................................................... 33 Saliva Ejector and High Speed Evacuation System.......................................................... 33 X-ray Equipment and Film................................................................................................. 34

Etiology and Transmission of TB, HIV, and Hepatitis B ..................................... 11

Personal Protective Attire ..................................................................................... 16

Surfaces and Waste Disposal ............................................................................... 19

Chemical Disinfectants ......................................................................................... 21

Steps in Instrument Processing ........................................................................... 29

Methods of Sterilization ........................................................................................ 35

Introduction ....................................................................................................................... 35 Sterilization Monitoring...................................................................................................... 36 Sterilization Failure............................................................................................................ 37 Glutaraldehyde as a Sterilant............................................................................................ 37 OPA................................................................................................................................... 38 Introduction ....................................................................................................................... 39 Introduction ....................................................................................................................... 40 Boil-Water Advisories........................................................................................................ 41 Introduction ....................................................................................................................... 43 The Acer Case .................................................................................................................. 43 Sharpe vs. Breglio............................................................................................................. 44 The Bragdon Case ............................................................................................................ 44 Introduction ....................................................................................................................... 46 The Bloodborne Pathogens Standard............................................................................... 46 Federal OSHA Training..................................................................................................... 47 Employee Medical Records .............................................................................................. 49 The Hazard Communication Standard.............................................................................. 49 MSDS................................................................................................................................ 49 Container Labels ............................................................................................................... 50 OSHA Ergonomics Standard ............................................................................................ 50 Fire and Emergency Plan.................................................................................................. 51 More Information on OSHA............................................................................................... 51

Impression Materials ......................................................................................................... 34

The Dental Laboratory........................................................................................... 39 Waterlines............................................................................................................... 40 Ethical and Legal Considerations Regarding AIDS and HIV .............................. 43

OSHA ...................................................................................................................... 46

Sample OSHA Documentation.............................................................................. 53 Summary Checklists.............................................................................................. 64

Introduction ....................................................................................................................... 64 Dental Laboratories........................................................................................................... 65 Timetable Checklist........................................................................................................... 65 Supplies ............................................................................................................................ 66 Cleaning Materials ............................................................................................................ 66 Federal OSHA Checklist ................................................................................................... 66 The Absolute Bottom Line .............................................................................................. 67

Test ......................................................................................................................... 69 Bibliography and Suggested Reading List .......................................................... 77 Appendices ............................................................................................................ 91
OSHA Bloodborne Pathogens Standard.......................................................................... 91 1910.1200 - Hazard Communication. ............................................................................... 98 CPL 2-2.44D - Enforcement Procedures ........................................................................ 106 CDC Guidelines for Reducing TB Transmission in Dental Care Settings ....................... 125 ADA Statement on Dental Unit Waterlines...................................................................... 127 ADA Statement on Saliva Ejectors.................................................................................. 128

Internet Resources .............................................................................................. 129 Endnotes .............................................................................................................. 132

Objectives
Upon completion of this course, the student should be able to: List and define important terms in Infection Control. Describe diseases like Tuberculosis, Hepatitis B, and AIDS. Give the rationale for immunization against the Hepatitis B Virus. List the common forms of barrier techniques and the rationale for each. Describe correct aseptic technique for dental procedures. List the steps in correct instrument processing to achieve sterility. Describe an ideal chemical disinfectant. Describe the most commonly used sterilization methods, and list the pros and cons of each. Explain good sterile technique to be used in a dental laboratory. Explain the main points from the OSHA Bloodborne Pathogens Standard. Explain the Hazard Communication Standard. Write an office Exposure Control Plan specific to an individual practice including all items of record keeping required by OSHA.

Introduction
Introduction
Fundamental infection control techniques date back to the mid-1800's. Dr. Lister used carbolic acid, (a phenolic) on instruments, in wounds, and as a handwash. Barrier products, aseptic techniques, and hospital-quality sterilization and disinfection are commonplace in dental offices today. Another development in dentistry is the formation of the Occupational Safety and Health Administration (OSHA) regulations for dental offices. The OSHA Standard on Occupational Exposure to Bloodborne Pathogens was originally written and implemented in 1991. OSHA has the authority from Congress to make regulations and laws concerning the safety of the employee in the workplace. OSHA inspectors are able to enter workplaces to review their compliance documentation and injury prevention protocol. Violations are punishable by financial penalties.

Definitions
Consider the following definitions from The Webster's New World Dictionary: Clean: free from dirt and impurities; unsoiled Sterile: free from living microorganisms Disinfect: to destroy the harmful bacteria, viruses, etc., in; sterilize Unfortunately, this is not an acceptable definition of "disinfect." Disinfection is not the same as sterilization. For the precise needs of the dental environment: An item is clean if debris, dirt, or visible blood is removed from the surface. Cleaning alone does not remove all the microorganisms, but it is an important first step in correct sterile procedure. True sterilization involves killing all microorganisms including hardy bacterial spores on a surface or instrument. Disinfection lies somewhere in between these two. Disinfection may kill all kinds of disease-producing microorganisms but cannot kill bacterial spores.

The following terms will be used throughout this course i: Universal Precautions: The infection control procedures and barrier techniques are determined by the exposure to blood and blood-contaminated products, and are used on all patients, regardless of their disease state. The procedures are designed to prevent transmission of HIV, HBV, and other bloodborne pathogens in health care settings. Sterilization: Destruction or removal of all forms of life, including viruses, bacteria, fungi, and spores. Disinfection: Destruction of most forms of microorganisms, but not bacterial and mycotic spores, which are highly resistant. Sanitization: Using chemicals or procedures that reduce the microbial flora to a safe public health level. Asepsis: Using techniques designed to keep all microorganisms out of the working field and from spreading to other areas. Cleaning Agent: A surfactant used to remove debris on surfaces prior to disinfection. Disinfectant: A chemical that can be applied on an inanimate object or surface that kills microorganisms.

Antiseptic: A chemical that can be applied on living tissues to kill or inhibit microorganism activity. Cidal agents: Chemicals that completely kill microorganisms. Static agents: Chemicals that inhibit the growth of microorganisms without killing them. Cross-infection: Passage of disease from one person to another. Cross-contamination: Passage of microorganisms from one person or inanimate object to another. The basic aim of infection control is to reduce the number of pathogenic (disease causing) microbes in the field of operation to a level where the body's normal resistance can prevent infection. The major components of infection control are: aseptic technique patient screening and evaluation personal protection instrument sterilization environmental surface disinfection equipment asepsis laboratory asepsis

Modes of transmission of disease are: direct contact with an infectious lesion, blood, or saliva; indirect transmission from a contaminated object (gloves, dirty instruments); and aerosolization of infected blood, saliva, and/or nasopharyngeal secretion droplets.

Types of Microorganisms
The following list of microorganisms is organized from most difficult to kill on surfaces or instruments to easiest to kill on surfaces or instruments. Bacterial spores (endospores): The most difficult to kill. Dormant forms of bacteria that are encapsulated in a tough shell. Mycobacterium Tuberculosis: One of the most difficult organisms to kill, may be carried in aerosols. Small non-lipid viruses: The AIDS virus is this type. Fungi: Can cause a variety of diseases. Medium sized lipid viruses: Hepatitis B is this type of virus. Vegetative bacteria: Causes diseases like syphilis and cholera. Streptococcus pyogenes causes more diseases than any other organism even though this type of bacteria is the easiest to kill.

Chemical Agents that Kill Microorganisms

Chemical sterilizer: Most effective method. Kills all microorganisms in a certain amount of time, usually 10 hours. High-level disinfectant: Kills microorganisms except spores, with prolonged contact may kill endospores. Intermediate disinfectants: Kills M. Tuberculosis and all other microorganisms but not endospores. Low-level disinfectants: Kills certain viruses and vegetative bacteria, but not M. Tuberculosis or non-lipid viruses and fungi.

Classification of Common Dental Items

Anything that penetrates tissue or bone or touches broken skin including: needles, hand instruments, surgical instruments, probes, burs, scalers, ultrasonic scaler tips, curettes, and endodontic instruments must be sterile, and if reusable, sterilized after each use. Anything handled during a procedure but does not penetrate the mucous membrane, and anything within the range of droplets from the air/water syringe, high-speed drill, or the patient coughing ideally should be sterilized and must be disinfected at a high level if they cannot be sterilized. Anything else in the operatory that does not come in contact with the patient's mucosa, like walls, floor, cabinets must be disinfected at (at least) a low level.

1 2 3

Treatment Zone Sterile or high level disinfectant used after every patient. Instruments, bracket table, ultrasonic scaler tips, impression trays, handpieces, suction and evacuation tips, air/water syringe tip, gloved hands of operator.

Treatment Fringe, Spatter Zone High level disinfectant used after every patient. Chair, switches, handles, cuspidor, counters, amalgamator, bracket table supports, light, handpiece hoses, evacuation hoses, controls on ultrasonic scaler, cabinet facings, protective eyewear, x-ray viewer, sink. Other Surfaces in the Room Intermediate to low level disinfectant, clean regularly. Walls, floors, door handles, drawers, pictures, chair base, rheostat, pens, inside cabinets, bathrooms.

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Etiology and Transmission of TB, HIV, and Hepatitis B

Tuberculosis
Tuberculosis is an infection of the lungs caused by Mycobacterium tuberculosis. Prolonged exposure to the disease is usually required for infection. The dental teams relatively brief interaction reduces the risk of transmission during treatment. Some strains of the disease are resistant to the standard drug treatment regimens. High risk groups for tuberculosis include patients: who have had close contact with someone with active tuberculosis, with HIV or AIDS infection, with lymphoma, who are using immunosuppressive drugs, who have diabetes, who are older and have multiple medically compromising conditions, who are immigrants from areas with high TB prevalence, who are residents or employees at long-term care facilities like nursing homes or correctional institutions, who are living in high population, low economic, and medically underserved areas, who are alcoholic, who have had recent tuberculin skin test conversion, with any history of intravenous drug abuse, or have a history of silicosis, gastrectomy, or jejunoileal bypass.
Decision Tree for Dental Management of TB Patients
Patients with history of TB Patients with +PPD Patients with TB symptoms

Defer dental treatment. Physician consult Refer if necessary to rule out active tuberculosis

History of TB adequately treated

AFB negative sputum

False +PPD

AFB positive sputum

+PPD with abnormal chest x-ray

Patient is NONINFECTIOUS Outpatient dental treatment in a conventional manner wihtout special precautions

Anti-TB drugs supervised for nine to 12 months

Patient is INFECTIOUS Emergency treatment only in hospital Defer elective dental treatment until AFB negative sputum.

Faecher, Thomas, Bender, Tuberculosis: a growing concern for dentistry. JADA 124:100 1993 Reprinted by permission of ADA Publishing Co., Inc.

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Signs and symptoms of Pulmonary TB include productive cough, rales, fever, malaise, night sweats, and weight loss. The patient will show a positive tuberculin skin test (+PPD) within 6 to 12 weeks. Chest radiographs will reveal infiltrates or cavitation of the apical-posterior segments of the upper lobes of the lung. Most adults with a properly functioning immune system are able to resist a tuberculosis infection. More than 90% of current TB cases occur in people who have been previously infected with the disease (reactivation rather than new onset). The CDC recommends the following protocol for treating dental patients with tuberculosis ii: 1. 2. 3. 4. Ask patients about TB symptoms and history of TB. Refer patients with symptoms of active TB to a physician for evaluation. Postpone elective dental treatment until diagnostic tests rule out active tuberculosis. Implement isolation protocol in a medical center if emergency dental care is required. Dental care providers must use HEPA-filter masks during treatment. Limit treatment to relieve immediate pain. 5. Refer any dental health care worker with TB symptoms to a physician for evaluation. The worker may return to practice after diagnostic tests rule out active tuberculosis or once therapy has eliminated infectivity.

AIDS
Acquired immune deficiency syndrome (AIDS) was identified and reported in the Morbidity and Mortality Weekly Report (MMWR) for the first time on June 5, 1991. iii. It is caused by a retrovirus, called human immunodeficiency virus (HIV). This virus suppresses human T-cells that are critical in the immune system. Patients are susceptible to diseases that are harmless to a person with a normal immune system. The patient may be completely asymptomatic for quite some time (even up to 7 years). Both a symptomatic AIDS patient and an asymptomatic HIV positive patient are equally infectious. Dr. Robert Siliciano from Johns Hopkins University conducted research with the blood of 50 Baltimore AIDS patients to measure the virus' resistance to treatment. What HIV has done is tap into the most fundamental aspect of the immune system, and that is its immunological memory, he said. Siliciano said the virus lies silent inside resting memory T cells, whose job is to store a record of the germs they encounter to keep the body ready for return battles. Inside these sleeping cells, HIV lies dormant but dangerous. The cells die off very slowly. Based on data from his Baltimore patients, Siliciano estimated that it would take 73 years for the cells to die off-and he can imagine no way to speed the process. Scientists now say this latently infected reservoir is the single biggest obstacle to curing AIDS. iv Signs and symptoms of HIV infection include: persistent generalized lymphadenopathy, fever of more than one month, involuntary weight loss more that 10% of baseline body weight, diarrhea lasting more than one month, or any combination of these. This disease is called AIDS when the patient acquires what is known as an AIDS defining illness (Pneumocystis pneumonia, Kaposi's Sarcoma and recurrent Bacterial Pneumonia are examples) or when their T-Cell count drops below 200 or 14% of their total lymphocyte count. Many patients who test positive for HIV infection may have been carrying the disease undiagnosed for a long time. It is currently not a legal requirement for anyone to disclose his or her HIV status in a health history. Many times patients do not disclose this information for

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fear of being denied treatment or discriminated against. Dentists should be aware of lesions present in the mouth that may indicate that the patient be tested for HIV. These include:
Fungal infections Pseudomembranous Candidiasis Hyperplastic Candidiasis Histoplasmosis Geotrichosis Bacterial infection HIV-necrotizing gingivitis HIV-periodontitis Klebsiella pneumoniae Exacerbation of apical periodontitis Focal epithelial hyperplasia Viral infections Herpes simplex virus Epstein-Barr virus Varicella Verruca vulgaris Neoplasms Kaposi's sarcoma Non-Hodgkin's lymphoma Unknown etiology Recurrent aphthous ulceration Idiopathic thrombocytopenia Progressive necrotizing ulceration Melanotic hyperpigmentation Delayed wound healing Erythematous Candidiasis Angular chelitis Cryptococcosis HIV-gingivitis Mycobacterium avium Enterobacter cloacae Submandibular cellulitis Cytomegalovirus Herpes zoster Human papillomarvirus Codyloma acuminatum Squamous cell carcinoma Toxic epidermolysis Xerostoia Salivary gland enlargement Toxic epidermolysis

Most of the initial adult AIDS cases were homosexual or bisexual men or intravenous drug users. Today, everyone is at equal risk for contraction of the disease regardless of sexuality. It is estimated that over 1 million people are infected in the U.S. alone. Lifestyle choices such as number of sexual partners, IV drug use, and failure to practice safe sex dramatically increase the risk of contraction. HIV is transmitted through sexual contact, direct exposure to infected blood or blood components, and perinatally from mother to neonate. Blood, semen, vaginal secretions, and possibly breast milk have been linked to the disease transmission. HIV has been isolated from saliva, but the CDC has removed it from the list of body fluids requiring universal precautions, except in the dental setting where saliva is usually contaminated with blood. There is no cure or vaccine for AIDS. Therapies include drugs used to inhibit the multiplication of the virus, drugs that boost the immune system, and drugs to combat the opportunistic diseases that usually are the causes of death in AIDS patients. The current data from the CDC indicates that the average risk of acquiring HIV from a needlestick contaminated with HIV infected blood is .3% or 1 in 300. Immediate (within 24 hrs) treatment with antiretroviral drugs is recommended for these situations in order to further reduce the likelihood of contraction. The course for these drugs is usually 4 weeks. AIDS statistics are continuously updated on the CDC website www.cdc.gov.

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Hepatitis
Viral Hepatitis is categorized in three types: Infectious: A; Serum: B and D; and Non-A, Non-B: C, E

Hepatitis A and E are spread through food or water contaminated by infected human feces. Hepatitis B, C, and D are spread through percutaneous or permucosal contact with infected body fluids or blood. Hepatitis E is rare in the US and not encountered in the dental setting very often. The hepatitis B virus (HBV) is transmitted either through percutaneous modes (IV drug abuse or prick wounds), by sexual contact, from mother to fetus or infant, and nonpercutaneous modes (transfer of infectious body secretions like saliva, blood, and crevicular fluid to mucous membranes or open wounds in the skin). Approximately 80% of all HBV infections are undiagnosed. The hepatitis B virus damages liver cells and can be found in high numbers in the blood of an infected individual. The symptoms of hepatitis B infection include: anorexia, malaise, nausea, vomiting, abdominal pain, and jaundice in varying combinations. Other symptoms may be skin rashes, arthralgias, and arthritis. If left untreated, the patient may become a carrier or develop cirrhosis, acute hepatitis, or primary liver cancer. The greatest concentration of HBV in an infected patient's mouth is in the gingival sulcus. Inflammation may be present in this area due to gingivitis. Probing or scaling will result in easy, profuse bleeding. The dental hygienist is at high risk for infection because of the bleeding associated with routine prophylaxis. Other risky procedures include packing cord for crown impressions, oral surgery, needle sticks, injuries from contaminated sharps, blood and saliva contamination of cuts and cracks on the skin, and spraying of blood and saliva onto mucous membranes. Hepatitis C is a bloodborne disease transmitted through intravenous drug abuse, blood transfusion, from mother to child at birth, or occupational exposure. 80% of infected individuals have no signs or symptoms. Symptoms include jaundice, fatigue, dark urine, abdominal pain, loss of appetite, and nausea. The cause of infection is unknown in as many as 50% of hepatitis C cases. Approximately 50% of those infected become chronic carriers. The hepatitis D virus needs part of the hepatitis B virus to complete its life cycle. The infection can only be present in someone who was infected with hepatitis B, so it is considered a complication of hepatitis B. It is also a bloodborne disease with routes of transmission similar to hepatitis B. Hepatitis A and E are not an occupational risk to dental workers because transmission is primarily via the fecal-oral route. Hepatitis B Vaccine Dental Professionals are at a high risk of contracting hepatitis B from their patients. The American Dental Association, The Centers for Disease Control, and OSHA v all recommend that dental professionals be vaccinated against hepatitis B. OSHA requires employers to

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pay for the vaccine, and make it available to the employee within 10 working days of being assigned to duties that may result in exposure. The plasma-derived hepatitis B vaccine, "Heptavax-B" was introduced in the United States in 1982. 96% of young, healthy adults seroconvert and have the correct antibody levels to prevent infection by the end of the series. Two vaccines are currently available: Recombivax HB (Merck Sharp & Dohme) and Engerix B (SmithKline). They are made using recombinant DNA technology, and results in 99% of healthy adults seroconverting. Anyone who is hypersensitive to yeast should consult their personal physician before being immunized with these products. The standard protocol for administration of the HBV vaccine is three doses in the deltoid muscle. The first dose should be given at baseline, the second, one month later, and the third 6 months later. If an unvaccinated person is exposed to HBV, a single dose of hepatitis B immunoglobulin is given within 24 hours of exposure and the first of the normal 3 doses of vaccine within 7 days. If someone is exposed while in the middle of their series, one dose of immunoglobin is given immediately and then the series continues as scheduled. Anyone who has been vaccinated and then is exposed to HBV should have his or her blood tested. If they have a low antibody response, they should be given a booster dose of the vaccine and a dose of hepatitis B immunoglobin. People who are exposed to HBV but have been unresponsive to the vaccine should have a dose of hepatitis B immunoglobin immediately, then another one month later. Everyone should have a blood test after completing the vaccine series to confirm its effectiveness. Currently, the CDC does not recommend boosters. OSHA requires that employers make a Hepatitis B vaccination available to all employees who have potential contact to blood. Even though the vaccine protects healthcare workers from hepatitis B; it is not a replacement for good sterile procedure and barrier techniques.

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Personal Protective Attire

Introduction
Dental care professionals are exposed to bacteria, viruses, fungi, and other diseaseproducing microbes during the normal course of their day. Universal precautions dictate that personal protective attire choices are based on the procedure rather than the patients health history. If the patient is an infectious disease carrier and spatter is expected, gown, booties, and head covering should be worn. HIV is not considered highly infectious, so barrier protection that might be considered out of the ordinary could be considered discriminatory. Gloves, eyewear, masks, face shields, and protective apparel are classified as medical devices and are regulated by the FDA. vii

Handwashing
Dental care workers should wash their hands thoroughly with an antimicrobial handwash at the beginning of the day and between patients. Also, wash after removing gloves and before touching anything. Spend plenty of time when washing hands. Make sure to work a liquid soap between the webs of the fingers, cleaning the tips of the fingers around fingernails, and rubbing the backs of the hands and the thumbs. Bars of soap can become contaminated so liquid soap in a dispenser is recommended. Do not use scrubbing brushes on hands because they can cause abrasions to the skin. Remember to disinfectant on the handles of the sink and the pump of the soap container after every patient. Dampness under gloves can cause irritation. Dry hands thoroughly with disposable paper towels. Any member of the dental team who has an exudative lesion or weeping dermatitis should avoid direct patient contact and refrain from handling equipment until the wound is completely healed.

Gloves
Washing hands thoroughly with antimicrobial soaps can disinfect the hands, but will not make them sterile. Gloves should be worn when expecting contact with blood, body fluids, or secretions. Properly fitting gloves should be snug but not restrictive, and should cover the cuffs of a long sleeved gown. Discard gloves and wash hands after each use. Gloves that are washed may develop small holes and are not suitable to be reused on patients. Do not touch your face, nose, or mouth with contaminated gloves. For most dental procedures, single- use non-sterile rubber gloves are acceptable. It is recommended that sterile surgical gloves be worn for surgical extractions and more invasive procedures. Sterile gloves will theoretically limit contamination of the surgical site. Also, since the FDA more strictly regulates the production of these gloves, they may offer increased piece of mind to the practitioner. The chemicals in disinfectants can cause defects in the material of latex gloves, so it is better to use heavy utility gloves when using or mixing chemicals. Do not use petroleum or

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oil-based lotions before donning gloves because it can damage the gloves and reduce their effectiveness. Store gloves according to manufacturers directions to assure the longest shelf life. If gloves are torn, cut, or punctured they must be changed as soon as it is safely possible. Wash hands thoroughly and replace the gloves before continuing with the procedure. Any cuts should be covered with a Band-Aid. Use an antibacterial ointment underneath if indicated. Slip one layer of gauze between the Band-Aid the glove to help keep the BandAid from becoming moist from the gloves, or being contaminated by the powder inside the gloves. Inexpensive plastic gloves used for handling food can be put over the gloves during treatment to enter data in charts or to retrieve an item out of a drawer. These gloves may not be used alone as a hand barrier or for intraoral patient care. vi Gloves are available as ambidextrous or right-left-specific. The ambidextrous gloves are less expensive, but right-left-specific gloves are more comfortable on hands and wrists. vii Some health care workers have reported allergies to the latex or the powder used in gloves. The three types of skin reactions to latex are: irritation contact dermatitis, delayed contact dermatitis (rash), and immediate allergic urticaria (hives). Repeated exposure to latex increases chances of an allergic episode. Most dental professionals wear gloves 8 to 10 hours daily, 4 to 5 days a week. Histories of allergies, asthma, and eczema have been linked to latex glove reactions. A physician should treat any dermatitis and the dental professional should not be exposed to the latex until the condition is completely healed. Some dermatitis problems may result from moisture accumulating under gloves. Cotton glove liners are available to provide a barrier between the skin and the latex. Dental professionals who exhibit skin rash, itching, or wheezing should seek the care of a physician for diagnosis. Patients with spina bifida are particularly vulnerable to life-threatening latex reactions. Patients who have undergone repeated surgery with prolonged contact with rubber tubes or post-surgical drains, and those with history of other allergies are most likely to have reactions to rubber gloves or the rubber dam. For these patients it would be advisable to wear a non-latex glove (vinyl or other non-synthetic polymer). Wear heavy utility gloves when cleaning, disinfecting, handling contaminated instruments or trash, mixing chemicals, and changing ultrasonic solutions. Spray utility gloves with a disinfectant and leave to dry after every use. If the glove is punctured or damaged, it should be discarded.

Gowns
Wear fluid resistant gowns or laboratory coats when spatter of blood or other body fluids is possible. The garment should be fluid-resistant, high-necked, and provide coverage to the knees. Change gowns when they are visibly soiled or at least daily. Protective attire should be removed and placed in laundry or disposal bags after use. These protective garments should not be worn outside the office. OSHA requires the employer to launder or dispose of contaminated garments either in the office or by hiring a service. Wash uniforms in hot soapy water and bleach. Machine dry at least at 100F. An easy cost analysis will reveal the

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most economical protective apparel choice for the office. Compare the costs of bulk purchases of disposable gowns and disposal requirements with the purchase and installation of a washer and dryer or medical laundry service.

Masks
Wear surgical masks or chin-length plastic face shields to protect the face, mouth, and nasal cavity when spatter of blood and other body fluids is expected. Masks should be well constructed. The pleated, soft type of mask has a higher filtration than the cup style. A tight seal at the bridge of the nose will minimize eyewear fogging. Use a mask with at least a filtration of 95% of particles 3 to 5 microns in diameter.vi Microbes pass more easily through moisture, so change the mask if it becomes wet or visibly soiled. Some professionals use a new mask with each patient. Others change masks after an hour of use. Depending on the procedure, a mask may be worn longer if it is not wet or soiled, but do not use the same mask for the whole day. Be careful not to touch the mask with soiled gloves if it is to be reused.

Protective Eyewear
Debris can be irritating to the eye, and microorganisms can enter the body through the eyes mucous membrane. Wear protective eyewear to shield your eyes from spatter of contaminated material. Goggle-type wrap around styles or face shields are recommended. Face shields used during air-abrasion deflects aluminum oxide particles from the lenses of magnifying eyewear. vii Protective eyewear also reminds the health care worker not to touch their eyes during procedures and when mixing chemicals. Disinfect protective eyewear and face shields after each use. The patient can wear protective eyewear. Some offices use sunglasses to reduce the glare of the overhead light and to protect the patient's eyes from spatter. Disinfect patient eyewear after each use.

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Surfaces and Waste Disposal

Surface Covers
Many surfaces in the dental operatory become contaminated, but they are too difficult to clean or cannot be autoclaved. Cover items like chair buttons, control buttons on the air/water syringe, switches on the unit, light handles, hoses, and handpiece and air/water syringe holders with plastic wrap, aluminum foil, or other material impervious to water. Replace with fresh covers after each patient. It is faster and easier to remove and throw away these coverings after dismissing the patient than to clean and disinfect the area. Make sure not to contaminate the underlying surface by touching it or carelessly removing the covers.

Surface Cleaning
Some surfaces like countertops are disinfected after each patient. Preclean surfaces before disinfection with a detergent cleaner. Disinfectants that have detergent properties can be used for this step and for disinfecting. This minimizes the amount of overall product necessary. Carefully follow the manufacturer's directions on the disinfectant product label. Use water to dilute concentrates, not alcohol or any other chemical. Wear utility gloves, a mask, protective eyewear, and protective clothing during surface cleaning and disinfection to reduce chances of direct contamination of the skin, mucous membranes, or eyes. Generously spray the cleaner onto the surface and wipe or scrub with paper towels or a brush. If possible, rinse over a sink. After precleaning, spray enough disinfectant to stay moist and leave undisturbed for 10 minutes, or the time specified in the directions. (Spray Wipe - Spray)

Spilled Blood
Absorb any spilled blood with paper toweling, saturate with bleach and place in appropriate containers. Always wear utility gloves when cleaning up spilled blood.

Disposal of Contaminated Wastes

Local ordinances vary from area to area in regards to waste management. Check with local authorities for specific regulations. Any disposable items (masks, gloves, paper covers, paper towels, gauze, surface covers, gowns, etc.,) that are contaminated with blood or body fluids should be carefully handled with utility gloves and placed in a sturdy plastic red bag. In some states, liquid wastes (like blood and suctioned fluids) can be carefully poured down a drain that is connected to a sanitary sewer system. Put sharps (like needles and scalpel blades) in a puncture-resistant container and dispose of according to local regulations. Anesthetic cartridges may contain aspirated blood or fluids, so they should be disposed of in the sharps container. There are special regulations regarding the disposal of infectious medical wastes like tissues and culture media. In several states, regulated wastes must be transported by a waste hauler, and a log must be kept for 3 years with the receipts from each pick up.

Needles
OHSA has very strict guidelines pertaining to handling and disposing of sharps in the dental office. First, every office is required to have an exposure control plan. This will help minimize the risk of exposure and clearly outline steps to be taken should an exposure occur. Use a new, sterile disposable needle and fresh carpule of anesthetic for every patient requiring local anesthesia. Handle needles and sharp instruments like scalpels and

19

scalers very carefully because they easily puncture gloves and injure skin. Recap needles using a safe method or place them uncapped in a "sterile field" away from the bracket table until the procedure is complete. If recapping, do not hold the cap with your hand, use a recapping device or "scoop up" the cap without touching it. One safe recapping method uses forceps to steady the cap. Contaminated needles must be disposed of as soon as possible after use. They should be placed in color coded, puncture resistant, leakproof containers until they can be properly processed. For the comprehensive listing of the Blood Borne Pathogen Standards, visit the following website: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=1 0051 Continue to watch for new needle safety technology.

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Chemical Disinfectants
Introduction Decision Factors: Surface Cleaning and Disinfection
James A. Cottone, DMD, MS University of Texas Health Science Center at San Antonio Dental School I. Efficacy: A. Assumptions: 1. EPA registered a) Hospital-level disinfectant:

Staphylococcus aureus Salmonella choleraesuis Pseudomonas aeruginosa

Tuberculocidal: 1. 10 minutes or less C. Virucidal: 1. Lipophilic virus (HIV) 2. Hydrophilic virus (Polio, Coxsackie, Rhinovirus, Rotavirus) 3. 10 minutes or less D. Efficacy verified: 1. Multiple: studies, different investigators, agency recommendations II. Choices: A. Cleaning ability: Water-based (good) vs. alcohol-based (usually poorer) B. Application method: Pump spray (preferable) vs. aerosol spray (less preferable) C. Minimize disadvantages: 1. Chlorines-Corrosive; damages clothes, plastics, rubber; usually prepared daily 2. iodophors- removable stains, prepare daily 3. Synthetic phenols- film accumulation, damages plastics and rubber III. Available Products: A. Water-based: a) Pump Spray (1) Concentrate: Chlorines (Bleach, Exspor) (dilute before use) Iodophors (Iodofive) Synthetic phenols (OmniII, ProPhene, Vital Defense-D, Top-Cide, Asepti-phene 128) (2) Pre-diluted: Chlorines (Dispatch) Synthetic phenols (ProSpray) none b) Aerosol Spray: B. Alcohol-based a) Pump Spray: (Coe Spray-The Pump, Novospray) b) Aerosol Spray: (1) Accusol Aerosol (Lysol IC Disinfectant Spray) (2) Standard aerosol (Citrace, Lysol IC Disinfectant Spray, Asepti-Steryl) October 4, 1995 Reprinted by permission, OSAP Foundation

B.

Disinfection will kill disease-producing microorganisms, but not bacterial spores. Office disinfection procedures employ a liquid chemical at room temperature to kill microorganisms. If the chemical used is not sporicidal, it is called a disinfectant (for example, iodophors, synthetic phenolics, phenols, alcohol/phenolics, sodium hypochlorite, lowconcentration glutaraldehyde) and will not completely sterilize the surface. Liquid glutaraldehydes (at concentration levels for immersion sterilization) are not acceptable as surface disinfectants because of dangerous vapors and odors. Properly diluted iodophor, sodium hypochlorite, and complex phenol preparations have been shown to be superior in comparison with other disinfectants for initial precleaning.

21

An ideal disinfectant should: have a wide spectrum of antibacterial activity; be tuberculocidal, effective against hepatitis B, and HIV; be fast acting; be effective in the presence of bioburden and debris; compatible with soaps and other chemicals; non-corrosive, non-staining, non-toxic; have a residual effect; be odorless, economical, and easy to use. i registered with the EPA

Each dental office must take its own needs into account when selecting an appropriate surface disinfectant. Is it easy to use, economical, and compatible with the materials in the office? Is it tuberculocidal within a reasonable period of time at room temperature? What are the disposal requirements and will it cause allergic reactions in patients or staff? If it needs to be diluted, can it mix with common tap water or will you need to purchase distilled water? When comparing product costs, remember to take into account shelf life and mixing time. vii

Iodophor Solutions
Iodophors are probably the most commonly used surface disinfectants. They have a low toxicity, no offensive odor, and are not irritating to the skin. However, they do not produce a residual effect on the treated surface. Iodophors are rated by the EPA as a tuberculocidal hospital disinfectant. Some solutions are poor detergents, so the surface must be precleaned with another product. Other manufacturers recommend their formula for both precleaning and disinfecting. The residual effect is cumulative with each treatment. A more effective, longer lasting disinfection action will result if allowed to dry completely. Follow the manufacturer's directions for mixing and contact time. Pros EPA licensed broad spectrum, tuberculocidal economical few side effects disinfection in 3 to 30 minutes, depending on the bioburden (number of microorganisms) surfectant carrier keeps area moist during action residual biocidal action even after dry

Cons not a sterilant may be corrosive to some metals inactivated by hard water and alcohol unstable at high temperatures loses activity with age requires prolonged exposure to be sporicidal may discolor light colored surfaces

22

Complex Phenolics
Some complex or synthetic phenols are excellent for surface disinfection. They have a good detergent effect, so the same solution can be used for precleaning and disinfection. Pros EPA licensed broad spectrum, tuberculocidal good detergent for precleaning economical residual biocidal action even after dry

Cons not a sterilant disinfection in 10 minutes must be mixed weekly follow dilution directions carefully

Alcohol-Quaternary Ammonium Compounds

Alcohol combined with quaternary ammonium compounds enhances the antimicrobial spectrum. Alcohol-quats are appropriate disinfectants. viii Pros EPA licensed broad spectrum, tuberculocidal

Cons not a sterilant sensitive to organic material and anionic detergents.

Sodium Hypochlorite (Bleach)

Bleach should be mixed with water in a dilution of 1 to 10 or 21:100 of a 5.25% solution. Use a 1:100 solution when blood and debris are present. Make a fresh solution every day and wear heavy utility gloves. A bleach and water mixture is not recommended as a surface disinfectant after every patient because of its odor and corrosive nature. It is a good solution for applying to contaminated paper products before their disposal. Any instruments that may have been sprayed with bleach should be rinsed well before soaking in a detergent/disinfectant. Pros effective as a hard surface disinfectant low cost easily purchased broad spectrum, tuberculocidal

23

Cons corrosive to many metals toxic if swallowed irritating to eyes and hands odor

Unacceptable Solutions
Quaternary Ammonium Compounds The Council for Dental Therapeutics of The American Dental Association has declared all older quaternary ammonium compounds unacceptable for use in dentistry. They are not tuberculocidal, sporicidal, or virucidal and will not kill all gram-negative bacteria. They are inactivated by soap, hard water, and organic debris. Alcohol Alcohol (both types: ethyl and isopropyl) is ineffective against bacterial spores, irregular in killing viruses, evaporates rapidly, has no residual effect, and is inactivated by organic matter. Alcohol is not EPA approved for instrument or surface disinfection.

Sterilants and High Level Disinfectants

The FDA has approved the following products with General Claims for Processing Reusable Medical and Dental Devices. ix
Advanced Sterilization Products: Cidex OPA Solution High Level Disinfectant, (0.55% ortho-phthaldehyde) K991487 High Level Disinfection Claim - 12 minutes at 20 C, maximum reuse of 14 days Sporicidin International: Sporicidin Sterilizing and Disinfecting Solution (0.95% glut and 1.64% phenol/phenate), K983194 Sterilant Claim - 12 hours at 25 C, maximum reuse of 7 days High Level Disinfection Claim 20 minutes at 25 C, maximum reuse of 7 days Johnson & Johnson Medical Products, Inc: CidexTM Activated Dialdehyde Solution (2.4% glut), K924434 Sterilant claim - 10 hours immersion at 25 C, maximum of 1 4 days reuse High Level Disinfection claim - 45 minutes at 25 C, maximum of 14 days reuse Cidex Formula 7TM Long-Life Activated Dialdehyde solution (2.5% glut), K924334 sterilant claim 10 hours at 20 - 25 C, maximum reuse of 28 days High Level Disinfection claim - 90 minutes at 25 C, maximum reuse of 28 days Cidex PlusTM 28 Day Solution (3.4% glut), K923744 Sterilant claim - 10 hours at 20 - 25 C, maximum reuse of 28 days High Level Disinfection claim - 20 minutes at 25 C , maximum reuse of 28 days Metrex Research, Inc. Metricide Activated Dialdehyde Solution (2.6% Glut), K930284 Sterilant Claim - 10 hours at 25 C, maximum reuse of 14 days High Level Disinfection Claim - 45 minutes at 25 C, maximum reuse of 14 days Metricide Plus 30 Long-Life Activated Dialdehyde Solution (3.4% Glut), K931592 Sterilant Claim - 10 hours at 25 C, maximum reuse of 28 days High Level Disinfection Claim - 90 minutes at 25 C, maximum reuse of 28 days Metricide 28 day Long-Life Activated Dialdehyde Solution (2.5% glut), K931052 Sterilant Claim 10 hours at 25 C, maximum reuse of 28 days High Level Disinfection Claim - 90 minutes at 25 C, maximum reuse of 28 days Cottrell Limited Procide 14 N.S. (2.4% glut), K932922 Sterilant Claim - 10 hours at 20 C, maximum reuse of 14 days High Level Disinfection Claim - 45 minutes at 20 C, maximum reuse of 14 days

24

OmnicideTM Long Life Activated Dialdehyde Solution ( 2.4% glut), K932922 Sterilant Claim - 10 hours at 20 C, maximum reuse of 28 days High Level Disinfection Claim - 45 minutes at 20 C, maximum reuse of 28 days OmnicideTM Plus (3.4% glut), K932922 Sterilant Claim - 10 hours at 20 C, maximum reuse of 28 days High Level Disinfection Claim 45 minutes at 20 C, maximum reuse of 28 days EndoSpor plus Sterilizing and Disinfecting Solution (7.35% hydrogen peroxide and 0.23% peracetic acid), K972708 Sterilant Claim: 180 minutes at 20 C, maximum reuse life of 14 days High Level Disinfection Claim: 15 minutes at 20 C, maximum reuse life of 14 days Note: Due to the lack of test strips for monitoring the concentrations of the active ingredients, the reuse period is limited to 14 days. Wave Energy Systems Wavicide - 01 (2.5% glut), K914749 Sterilant Claim - 10 hours at 22 C, maximum reuse of 30 days High Level Disinfection Claim - 45 minutes at 22 C, maximum reuse of 30 days STERIS Corporation STERIS 20TM Sterilant (0.2% peracetic acid), K875280 Sterilant Claim - 12 minutes between 5056 C, single use only. Only cleared for use with the STERIS System 1TM Processor. Minntech Corporation PeractTM 20 Liquid Sterilant/Disinfectant (0.08% peroxyacetic acid and 1.0% hydrogen peroxide) K960513 Sterilant Claim - 8 hours at 20 C, maximum reuse of 14 days High level Disinfection Claim - 25 minutes at 20 C, maximum reuse of 14 days. Reckitt & Colman Inc. SporoxTM Sterilizing & Disinfection Solution (7.5% hydrogen peroxide), K970230 Sterilant Claim 6 hours at 20 C, maximum reuse life of 21 days High Level Disinfection Claim - 30 minutes at 20 C, maximum reuse life of 21 days MedSci, Inc. MedSci 3% Glutaraldehyde (3% glut), K974062 Sterilant Claim - 10 hours at 25 C, maximum reuse of 28 days High Level Disinfection Claim - 25 minutes at 25 C, maximum reuse of 28 days Cetylite Industries, Inc. Cetylcide-G Concentrate and Diluent Concentrate (3.2% glut), K974188 Sterilant Claim - 10 hours at 20 C, maximum reuse of 28 days High Level Disinfection Claim - 40 minutes at 20 C, maximum reuse of 28 days MediVators, Incorporated Rapicide High Level Disinfectant and Sterilant, (2.5% glutaraldehyde) K993042 For use in a legally marketed automated endoscope reprocessor only. Sterilant Claim - 7 hours 40 minutes at 35 C, maximum reuse life of 28 days High Level Disinfection Claim 5.0 minutes at 35 C, maximum reuse life of 28 days

Preprocedural Mouthrinsing
It is an excellent idea to use a pre-procedural mouth rinse with residual activity to reduce the microbial levels in the patients mouth. There is no mouthwash currently available that would make a perfect preprocedural mouthrinse. Chlorhexidine gluconate seems to be the best currently available wide spectrum mouthrinse. Studies show a 0.12 percent chlorhexidine gluconate (CHG) preoperative rinse clinically reduces the incidence of alveolar osteitis in extraction patients by 60%. The American Heart Association recommends chlorhexidine rinses as an adjunct to antibiotic prophylaxis, especially if the patient is of high risk or has poor oral hygiene. The 0.12 % CHG has a wide spectrum of antimicrobial effects including reductions of:

25

65 to 85% of aerobes, 42 to 80% of anaerobes, 44 to 78% streptococci, and 85 to 97% actinomyces.

Repeated rinsing will not shift the normal oral flora. Opportunistic microbial species do not tend to grow. It has a significant and sustained effect on the salivary bacterial load. It also has a virucidal effect on herpes simplex virus, cytomegalovirus, influenza A., parainfluenza, and hepatitis B viruses. Much of the research for CHG shows that it reduces the patient's chances of developing an infection during the procedure rather than reducing cross-infection to health care workers. CHG helps to control the onset of opportunistic infections in compromised patients who have bone marrow transplants, cancer, or HIV infection. x

26

Chemical Agents for Surface Disinfection Reference Chart

CHEMICAL CLASSIFICATION Advantages Disadvantages PRODUCTS Dilution TB Time TB Temperature Hydrophilic Virus Kill** Total Time for Surface Disinfection 10 min 10 min 2 min For more information Contact Example of Active Name EPA Reg Ingredient as listed on # product label Do not use for environmental Surface disinfection. Rapid evaporation rate. Diminished activity with bioburden Rapid acting; Broad Specrum; Economical (Bleach) Discard diluted soutions daily; Diminished activity by organic matter; Corrosive Sodium hypochlorite; chlorine dioxide Bleach (5.25%) Clorox Dipatch (0.55%) N/A 5813-1 56392-7

Alcohols Chlorines

1:100 1:100 None

10 min 10 min 2 min

20 C 20 C 20-25 C

Yes Yes Yes

Clorox Caltech

Iodophors

Broad Spectrum; Few Reactions; Residual biocidal activity

Unstable at high temperatures; Dilution & contact time critical; Discard daily; Discoloration of some surfaces; Inactivated by hard water.

Butoxpolypropoxypolyethoxyethanol iodine complex

IodoFive Biocide Iodophor Disinfect Asepti-IDC

4959-16 4959-16 4959-16 303-63

1:213 1:213 1:213 1:256

10 min 10 min 10 min 10 min

20 C 20 C 20 C 20 C

Yes Yes Yes Yes

10 min 10 min 10 min 10 min

Cottrell, Ltd Biotrol Smart Practice Huntington

Continues on next page

IMPORTANT INFORMATION All products to be used as disinfectants on precleaned surfaces must be EPA-registered. Listing does not imply endorsement, recommendation or warranty. Other products available. Purchasers are legally required to consult the package insert for changes in formulation and recommended product uses. Check compatibility of material before use on dental/medical equipment. This chart is a publication of the Organization for Safety & Asepsis Procedures (OSAP). OSAP assumes no liability for actions taken based on the information herein.

27

Continued from previous page

CHEMICAL CLASSIFICATION Advantages Sythetic Phenolics Broad spectrum; Residual biocidal activity Disadvantages Discard daily for most diluted solutions; Degrades certain plastic over time; Difficult to rinse; Film accumulation Example of Active Ingredient as listed on product label WATER-BASED Dual Phenolics Phenylphenol and benzylchlorophenol or tertiary amylphenol PRODUCTS Name Omni II ProPhene Vital Defense-D ProSpray Birex se Lysol IC Disinfect Cleaner Lysol IC Disinfect. Dual Phenol Germicidal Cleaner BiArrest-2 Tri-Cide Dencide Asepti-phene128 PUMP CoeSpray Asepti-phene RTU AEROSOL Lysol IC Disinfect. Asepti-Steryl Dicide Disinf Spray Citrace Medicide/ADC Disinfect. Deodorant Cavicide DisCide TB Precise QTB GC Spray-Cide SaniTex Plus Asepticare TB Microstat 2 EPA Reg # 46851-1 46851-1 46851-1 46851-5 1043-92 675-46 675-43 67813-3 67813-1 11725-7 63281-4 303-223 334-417 334-417 777-53 706-69 706-69 46392-2 334-214 46781-6 1839-83 1839-83 1130-15 1130-15 1130-13 70369-1 Dilution 1:32 1:32 1:32 none 1:256 1:128 1:200 1:256 1:256 1:256 1:256 1:128 none none none none none none none None None None None None None 2 tablets per quart TB Time 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 6 min 6 min 10 min 5 min TB Temperature 20 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C 25 C 25 C 20-25 C 25 C 20 C 20 C 20 C 20 C 20 C 20 C 20 C Hydrophilic Virus Kill** Yes Yes Yes Yes No*** No*** No*** No*** No Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Total Time for Surface Disinfection 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 10 min 5 min For more information Contact Cottrell Cottrell Block Cottrell, Ltd Biotrol Reckitt Colman Reckitt Colman Smart Practice Infection Control Technology Health-Sonics Dentsply Huntington GC America Huntington Reckitt Colman Huntigton Palmero Caltech ADC Kerr Palmero Caltech GC America CrossTex Huntington Septodont

Tri-Phenolics Phenylphelol Benzylchlorophenol Tertiary amylphenol ALCOHOL-BASED Tertiary amylphenol And/or phenylphenol plus ethyl alcohol or isoporopyl alcohol

Dual or Synergized Quarternaries (do not use older generations of quats a s surface disinfectants) Sodium Bromide and Chlorine

Broad Spectrum; Contains detergent for cleaning; Few reactions Broad spectrum; Reduced storage (tablets)

Easily inactivated by anionic detergents and organic matter; Deleterious to some materials May not be used for immersion (hard surfaces only); Chlorine smell

Diisobutylphenoxyethyo xyethyl dimethyl benzyl ammonium chloride; isopropanol

Sodium bromide; sodium dichloroisocyanurate dihydrate

*Temperature: 20 C = 68F; 25 C = 77F **Studies by Klein and DeForest suggest that hydrophilic are more resistant than lipophilic viruses and therefore represent a better gauge of a disinfectants virucidal efficacy. Hydrophilic viruses include various strains of Polio, Coxsackie, Thinovirus and Rotavirus. ***Demonstrates activity toward Adeno virus (resistance level between hydrophilic and lipophilic.) October 1998. Office Safety & Asepsis Procedures (OSAP) Research Foundation. P.O. Box 6297 Annapolis, MD 21401 www.osap.org (410) 798-5665 Used by permission.

28

Steps in Instrument Processing

Introduction
Correct processing will sterilize instruments with minimal risk of injury to the staff and the least amount of damage to the instruments.

Presoaking
Soak contaminated instruments in a mild detergent to prevent blood, saliva, and debris from drying on the instruments. Presoaking for longer than a few hours may cause corrosion of some instruments. If possible, use the ultrasonic cleaner basket set in a pan of presoak, so the instruments can be directly immersed in the ultrasonic cleaner without additional handling. Always wear heavy utility gloves, protective eyewear, a mask, and protective clothing when handling contaminated instruments.

Precleaning
Preclean debris and blood from instruments and surfaces after the presoak and before a sterilization cycle because this bioburden will prevent chemicals or heat from contacting the instruments. Clean instruments by hand or by submerging in an ultrasonic cleaner. If hand scrubbing is the only option, wear heavy utility gloves, a mask, protective eyewear, and protective clothing. Be especially careful of spatter during hand scrubbing, and keep sterile instruments away from the scrubbing area. If safe, try to scrub instruments while submersed in a sink of water and use careful, light motions. Always rinse and dry instruments. Ultrasonic cleaners are very effective and greatly reduce the risk of puncture injury to the health care worker. Arrange the cleaning area so the ultrasonic cleaner is on one side, a sink in the middle, and sterilizer on the other side. Use solutions designed specifically to aid in cavitation. These solutions are generally not disinfectants, so the instruments will emerge free from bioburden but still contaminated. Match the cleaning activity with the type of instruments being cleaned (e.g., a light purpose cleaner for lightly soiled instruments, heavy duty for more heavily soiled instruments.) Place the instruments in the basket before submersion to avoid spatter and keep them off the bottom of the ultrasonic cleaner. Use bur blocks, and be careful of overloading sharp instruments that may be dulled by contact with other items. Check manufacturer directions for burs because some cannot be cleaned ultrasonically. Make sure the lid is securely in place before turning the unit on. Instruments should be free of debris before removing them from the ultrasonic cleaner. Increase ultrasonic cleaning time for instruments contained in plastic or resin type cassettes. Visually inspect the tips of instruments to make sure the bioburden is removed. Use heavy utility gloves for handling instruments from the ultrasonic since they are still contaminated. Instruments must be rinsed and dried before sterilization. Wet instruments may corrode in chemical vapor sterilizers and cause paper wraps to burst making the packaged instruments open to air and contamination after the sterilization process.

29

Always follow the manufacturer's directions for use, care, and cleaning of ultrasonic devices. Change solutions in the ultrasonic cleaner daily. Use heavy utility gloves, mask, protective eyewear, and protective clothing when changing the solution. The inside of the chamber should be disinfected, rinsed, and dried. Then fill the container with fresh solution. Occasionally test the ultrasonic by suspending a piece of aluminum foil in the chamber and cavitate for 10 minutes. There should be a peppering effect on the foil from the ultrasonic action. Keep the foil pieces for comparison.

Corrosion Control and Lubrication

Rust inhibitors are available to protect non-stainless instruments in steam autoclaves. If the manufacturer recommends lubrication before sterilization, be sure to remove excess lubricant so it does not bleed on the bags.

Packaging
Always use the correct type of instrument packaging for the sterilizing system you use. Wraps that may work fine in a dry heat sterilizer (like closed metal or glass, and aluminum foil) can prevent penetration by steam or chemicals in other types. Sterility will not be achieved if the sterilizing agent does not contact the surface of the instruments for the correct amount of time. Plastics may melt in dry heat, causing damage to the sterilizing unit and the instruments. When using paper, make sure it is strong enough to hold the sharp tips of instruments within the bag to avoid contamination and possible injury. Use transparent materials or mark the contents clearly on the paper to avoid opening packages needlessly. Use self-sealing bags, autoclave tape, heat-sealing, or double fold the open end of the bags to contain the instruments. Staples and paper clips rust easily and are not reliable for sealing bags. Use containers of some type because loose instruments will become easily contaminated between the sterilizer and the operatory, especially if stored in a drawer then sorted out later. Bag instruments in sets to be used on individual patients and open them in front of the patient.

Backflow Prevention
A majority of state and local health departments require backflow prevention devices in dental offices. Agencies are concerned about the potential for aspiration of oral fluids through the high high-speed handpiece or the air/water syringe. Risk of aspiration is nearly impossible because the instruments are not immersed in the oral fluids. Any incident would be precipitated by a pause in the water flow, which would signal the dental professional to discontinue the procedure. xi

High-Speed Handpiece Asepsis

The American Dental Association, the Food and Drug Administration, and the Center for Disease Control recommend heat sterilization for handpieces and prophy angles between each patient with an acceptable method that assures internal as well as external sterility. They also stress running the handpiece waterline after use for 20 to 30 seconds to flush the internal lines. The Food and Drug Administration also recommends that air/water syringes, and ultrasonic scaler tips be sterilized between each patient. Most States now have laws that require heat sterilization of all reusable hand instruments, handpieces, and prophy angles. If you do not have the directions and information regarding a handpiece's tolerance to heat or the recommended sterilization and lubrication regimen, contact the manufacturer with the model number and request a written copy.

30

Always follow the handpiece manufacturer's directions for proper maintenance, cleaning, sterilization, disinfection, and compatibility with chemical agents. Each handpiece is different. Some must be lubricated before, after, or before and after sterilization. Some don't need lubrication at all.

31

HANDPIECE STERILIZATION/ASEPSIS MANUFACTURER RECOMMENDED PROCEDURES

Brand Ultrasonic Cleaning Cleaning/ Lubrication Type Lubrication Time Max Temp Dry Heat

Adec (Adec brand) yes# Spray B&A Adec (W&H) No Assistina Syst. B 503-538-7478 800-884-3507 Bien Air NO Grease B&A 718-263-7866 Air Bearing Byro/cleaner B (cleaner only) Dabi-Atlante NO Cleaner/Lube B&A 800-884-3507 Luckman Corp. NO Encore cleaner B&A Encore 215-659-1664 KaVo/all No KaVo spray only B 312-885-3855 800-347-3289 Kinetics/all Yes Spray B 203-743-0080 Lares NO Spray B&A 916-345-1767 800-347-3289 Midwest YES+ HS=pump B&A++ 708-640-4800 LS= drop oil 800-800-7202 NSK/all NO NSK oil B&A 708-843-7664 Star NO HS=spray B 800-275-3320 LS=drop oil B NOTE: * B&A=Before and After Sterilization # Non-chlorine containing solution or solution corrosive to aluminum ## Also, do not sterilize in alcohol autoclaves

250 F/121C 250F/132 C

NO NO

270 F/132C 275 F/135C 260 F/127C

NO## NO Yes

275F/135 C

NO

250 F/121C 275 F/135C

NO Yes~

275 F/135C

NO

275 F/135C 275 F/135C

NO NO

Rapid Dry Heat sterilization only Use distilled water only. Kinetics has their own proprietary high level disinfection system clean fiberoptic surfaces w/ isopropyl alcohol immediately after cooling from sterilizer ~ Later Lares can be rapid dry heat sterilized. PLEASE CHECK WITH LARES (WILL discolor HP & dim fiberoptics)

+ Ultrasonic air turbines and low speed attachments for Lifecycle cleaner only. ++ Before=Lifecycle cleaner. After=Spray-A-Day lube
Star LS (Lube Free) turbines require no lubrication (cleaner OK for troubleshooting) LUBE Star & attachments. Dr. Young UTHSCSA (210) 567-3450 From OSAP October 3, 1995 Reprinted by permission of OSAP

32

Slow Speed Handpieces, Contra Angles, and Prophy Angles

As with High Speed Handpieces, Low Speed Handpieces and their components should be sterilized between each patient. Follow manufacturers directions for cleaning, lubricating and sterilizing. Use heat sterilizable or disposable prophy angles and contra angles. If treating an immunocompromised patient, a sterile angle is recommended. Some disposables can be autoclaved prior to first use, check manufacturers directions. Never reuse a disposable prophy angle.

Air/Water Syringes and Ultrasonic Scaler

Units that dispense water into the patient's mouth should be flushed for 30 seconds into a vacuum line between each patient. The tips of both air/water syringes and ultrasonic scaler tips should be removable and sterilized if possible. Plastic disposable tips are available for the air/water syringes.

Lasers, Curing Lights, Electrocautery Devices

Follow manufacturers directions for all devices. Use barrier protection when possible, and preclean removable tips before sterilization.

Disposable Items
Throw away all items designed by the manufacturers to be disposable after a single use. Don't try to disinfect or reuse items like disposable air/water syringes, plastic prophy angles, saliva ejector tips, prophy cups or brushes and paper products.

Saliva Ejector and High Speed Evacuation System

The saliva ejector tip is disposable and should be thrown away after every patient. However, if the interior of the vacuum line is not disinfected, it is contaminated with microorganisms and debris. Many health care workers incorrectly instruct the patients to close their lips around the ejector tip, which causes a suck back effect. A study of saliva ejectors by Watson and Whitehouse published in 1993 xii clearly demonstrated this phenomenon. They thoroughly disinfected suction lines with a bleach/water solution, and then added red disclosing solution. Patients were suctioned with the mouth open and no red dye was found in the oral cavity. The same patients were then told to make a seal around the tip, and red dye was seen coming back up the clear ejector, with a significant number of patients receiving red dye into their mouths (evidenced by the patient expectorating into a white tissue). Out of 97 tests using 15 different dental units at 9 different locations, 20 cases of red dye aspiration into participants' mouths were documented. Several times the red dye was observed to come up the clear saliva ejector towards the patient's mouth, but these were not counted as positive results. Since many offices do not decontaminate their suction lines after every patient, it is likely that some patients will aspirate bacteria and even debris from infected suction lines if they seal off the saliva ejector. More effective methods of preventing accidental suck back are currently being investigated (like safety valves and changing the construction of the saliva ejector). Patients should be directed not to close their mouths around the suction tips. Flush the high speed evacuation system after every patient with a 2% glutaraldehyde or any other non-foaming agent recommended by the manufacturer for disinfecting the lines. At the end of the day, flush with a disinfectant that will remain in the vacuum system overnight to

33

help reduce the number of microorganisms. Handle evacuation system traps with utility gloves, empty into the toilet, and clean the traps with a high-level disinfectant every day.

X-ray Equipment and Film

Cover or disinfect collimating tubes between each patient. Once the film is inserted into the patient's mouth it is considered contaminated. Use disposable gloves in the darkroom to open the packets. Remove the films from the packets without touching them, and collect contaminated packets on a disposable paper towel. When all films are out of the packets, discard the towel and the packets and remove the gloves. After washing hands, process the films as usual, and the darkroom equipment will not be contaminated. The film packets could also be decontaminated by wiping them with bleach before taking them into the darkroom.

Impression Materials
There is a deficit in the general knowledge regarding disinfection of impressions in the dental office. Due to the diversity of impression materials used today, there is no clear-cut protocol for their disinfection. Each material has different properties that may be affected by the disinfection process. Furthermore, studies have shown a lack of communication between dental offices and labs in regard to disinfection of impressions. This is an area that needs to be addressed. The CDC recommends that when an impression is sent to the lab, information should be included pertaining to the manner of impression disinfection (e.g., type of disinfectant used and time of exposure). Cleaning and disinfecting of an impression should be done as soon as possible after removal from the patients mouth. The Organization of Safety and Asepsis Procedures (OSAP) recommends the following:
Cleaning and disinfecting impressions before pouring in stone is an important aspect of laboratory asepsis. Different materials require different handling techniques. In general, impressions should be gently scrubbed with a camel hair brush (i.e., artists brush, one-half inch bristle) and a liquid detergent to remove bioburden. Scrubbing gently with dental stone sprinkled into the impression will remove stubborn materials. Always consult the impression material manufacturer or instructions for use for advice on using compatible disinfectants. Hydrocolloid and polyether impression materials generally are sprayed to saturate for the required time with an intermediate level disinfectant and placed in a plastic bag or sealed container to prevent evaporation of the agent. More stable silicone (vinyl polysiloxane) or rubber-based impression material typically may be immersed for disinfection(1).

Studies have shown that when submersing elastomer impression materials (polyether, polysulfide, addition silicone and condensation silicone) in either 5.25% NaOCl for 10 minutes or 2% Glutaraldehyde for 30 minutes, there is no negative effect on dimensional accuracy. Any disinfection procedure should be, at worst, tuberculocidal. It is possible to adequately disinfect alginate impressions in only 10 minutes, thereby preserving their dimensional stability. As impression material technology is rapidly changing, it is wise to contact the manufacturer concerning proper disinfection of any new type of material.

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Methods of Sterilization
Introduction
METHOD Steam autoclave STANDARD STERILIZING CONDITIONS* 20-30 min at 250 F 3-10 min at 273 F ADVANTAGES Time efficient; Good penetration; Sterilize waterbased liquid PRECAUTIONS SPORE-TESTING

Do not use closed containers; Bacillus May damage plastic and rubber stearothermophilus items; non-stainless steel metal strips, vials, or items corrode; Use of hard water ampules. may leave deposits Unsaturated 20 min at 270 F Time efficient; No Do not use closed containers; Bacillus chemical (20-40 psi) corrosion; Items dry quickly May damage plastic and rubber stearothermophilus vapor after cycle items; Must use special solution; strips Predry instruments or dip in special solution; Provide adequate ventilation; cannot sterilize liquids. Dry heat oven 60-120 min at 320 F No corrosion; Can use Longer sterilization time; cannot Bacillus subtilis strips Dry heat closed containers; Large sterilize liquids; May damage capacity per cost; items are plastic and rubber items; Do not dry after cycle open door before end of cycle Rapid Heat 12 min at 375 F (for No corrosion; Short cycle; Predry instruments; Cannot Bacillus subtilis strips Transfer wrapped items) 6 min items are dry after cycle. sterilize liquids; May damage at 375 F (for plastic and rubber items; Do not unwrapped items open door before end of cycle; Small capacity per cost; Unwrapped items quickly contaminated after cycle. * These conditions do not include warm-up time and they may vary depending upon the nature and volume of the load. Sterilizing conditions in your office sterilizer should be defined by results of routine spore-testing.
C.H. Miller. Sterilization and disinfection: what every dentist needs to know., JADA vol 123:46 1992 Reprinted by permission of ADA Publishing Co., Inc.

The Centers for Disease Control and the American Dental Association recommend sterilization of any instruments, burs, and handpieces that come into contact with oral tissue, or penetrate soft tissue or bone after each use. An adequate sterilization procedure must kill all microorganisms present on the item being sterilized. A process cannot be called sterilization unless it kills all bacterial spores, the most difficult of microorganisms to kill. The four main sterilizing methods used in dentistry today are steam heat autoclave, unsaturated chemical vapor, dry heat, and rapid heat transfer. The effectiveness of these types of sterilizers can be tested with commercial spore testing. Precleaned instruments submerged in glutaraldehyde solution at 2.0 percent or 3.2 percent concentration for 10 hours will also kill bacterial spores, but there is no test to verify the results. Currently, no single system will work for all the items used in a dental office. Most offices use at least two: usually a steam autoclave and glutaraldehyde chemical sterilization. The best and safest approach to preventing disease transmission from patient to patient via the instruments is to sterilize all reusable instruments that are contaminated with blood or saliva instead of sterilizing some and disinfecting others. Many states have laws that require the sterilization of all reusable dental instruments.

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Sterilizers must be used correctly to achieve sterilization with every load of instruments. Examples of common mistakes include: overloading of sterilizer chamber; lack of separation between packs or trays in the chamber; incorrect packaging material for method of sterilization; excessive layering of wrap, inhibiting penetration; closed container not penetrated by steam or chemical vapor; insufficient time and/or temperature; dry heat sterilizer door opened to add more items without starting sterilization time over; sterilizer timer malfunction; sterilizer malfunction; and improper cleaning of items to be sterilized.i

When purchasing a sterilizer, take into account the needs of the office as well as the quality of support from the manufacturer. Any sterilizer purchased should be FDA approved for use in a dental office.

Sterilization Monitoring
A two-part system of sterilization monitoring using both biological and chemical indicators helps assure patient safety and sterilizer effectiveness. Biological monitoring (also called spore tests) ensures correct use of heat sterilizers (including operation, packaging, loading and timing) by demonstrating the sterilizers ability to kill live spore samples. The spore test should be specific for the type of sterilizer used. The test should be placed in the same type of container normally used for instruments, then run through a normal cycle with other instruments. The time, temperature, and pressure are recorded. The test is then sent back to the lab along with a control strip that has not been sterilized. Spores should grow on the control sample but not on the test. Spore survival in the test sample indicates sterilization failure and inactivation of spores is verification of successful sterilization. The laboratory notifies the office of the results. Weekly spore testing is required by the Centers for Disease Control, the American Dental Association, the Association for Advancement of Medical Instrumentation, and the OSAP Research Foundation. There are many spore-testing services for steam, dry heat, unsaturated chemical vapor and ethylene oxide gas sterilizers. They send the appropriate biological indicator strips, instructions, and return envelopes. They call immediately for failures, and send written reports for each test. Different companies may also have special advice on how to correct malfunctions, newsletters, and certificates for participation. Incubator and test units can be purchased for in-office testing of steam sterilizers. The results must be carefully analyzed and recorded. Keep reports of spore tests. Records of negative results (complete inactivation of spores) establish a pattern of compliance and successful sterile procedures on a consistent basis. xiii The records should include: the sterilizer identification number, date, duration and temperature of sterilization cycle,

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description of the general contents of the load, operators name, results of biologic monitoring, repair and preventive maintenance measures, and a space for notes. xiii

Along with weekly spore testing, tests should be performed when any new variable is introduced into the sterilization process; For example, if a new packaging material is used, if a new sterilizer is purchased, after a sterilizer has been repaired or after any change in sterilizer loading procedure. After purchase of a new sterilizer, it should be immediately tested and the results used as a baseline test. Chemical monitoring using special sterilizing bags, tapes, or strips offers an immediate indicator that the packages have been exposed to heat, steam, or chemical vapor. Two types of chemical indicators are: rapid-change (like tape that changes color immediately when exposed to temperatures of 250F) and slow-change or integrator (usually a strip or tab that changes color with a combination of physical conditions like heat and time).

Every package or cassette of instruments should have a visible chemical indicator so with a quick glance everyone will know if the instruments are ready to use. It is important to note that this is not a replacement for weekly spore tests.

Sterilization Failure
If monitoring indicates a failure in the sterilization process, you should: Take the sterilizer out of service, Repackage and sterilize all unused instruments in a properly operating sterilizer. Review sterilization procedures to identify operator error. If operator error is identified, retest the sterilizer. If the spore test indicates failure, replace or send the sterilizer in for repair. If the spore test is negative (indicating successful sterilization) put the sterilizer back into use. Spore test the replacement or repaired sterilizer before using it for the first time. xiii

Glutaraldehyde as a Sterilant
Always wear gloves, masks, protective eyewear and protective clothing when preparing, using, or discarding glutaraldehyde. It is very harmful to skin, mucous membranes, and eyes. Follow the manufacturer's label directions to prepare and activate properly. Mark the container of activated solutions with the date of mixing to accurately assess shelf life. Mark used containers or pans with the word "Glutaraldehyde," the brand name, and the date of expiration. Monitors are available commercially to test the concentration of glutaraldehyde, but do not assure sterility of instruments. Preclean, rinse, and dry instruments to prevent dilution of the sterilant. Completely submerge the instruments for proper contact time, usually 10 hours for sterilization. All glutaraldehyde solution should be discarded and replaced with fresh solution when indicated. After correct processing time, thoroughly rinse

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the instruments with water. Use sterile water if the item may penetrate tissue during use. The instruments must be handled aseptically to prevent contamination from hands, aerosols, and dust before placement at chairside. Use sterile forceps to handle items and put them in bags or covers. Glutaraldehyde sterilants are indicated for immersion use only and are not recommended for use as a surface disinfectant. It should be kept in a closed container and in a well ventilated room because repeated exposure to the fumes can cause breathing difficulties and dizziness. Some instruments will dull or corrode if soaked in glutaraldehyde for too long. Remember to start timing the sterile cycle after the addition of the last instrument is added to the solution, because each new addition contaminates the whole batch.

OPA
Due to the toxic nature of glutaraldehyde, there has been a recent shift in use to a product called orthophthalaldehyde or OPA. Orthophthalaldehyde 0.55% received FDA approval in 1999 as a chemical sterilant. It is superior to glutaraldehyde in several ways. First off, it is non-irritating to the eyes and nose, which is a very important distinction. It is also stable over a larger range of pHs than glutaraldehyde and therefore does not require activation. A drawback of this product is that it will stain clothing and the skin so personal protective equipment should be used at all times when handling OPA.

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The Dental Laboratory

Introduction
Even though the patient never sets foot in the dental laboratory, the cases, if not properly disinfected, carry microorganisms that can contaminate the lab. The lab should set up a receiving area separate from the production area for all incoming cases. The countertop should be disinfected daily with an acceptable disinfectant according to the directions on the bottle. Unless the technicians are certain that the case has been disinfected properly, they should disinfect each case as it is received. Case containers should be disinfected also. Anyone receiving cases before their disinfection should wear a uniform or laboratory coat, a mask, protective eyewear, and disposable gloves. Utility gloves and other standard protective attire should be used when working with disinfectant chemicals. All equipment and surfaces in the production area should be disinfected daily. Ragwheels should be cleaned and autoclaved after each case. Dispense pumice in small individual amounts for each case, and discard all excess. Mix 5 parts sodium hypochlorite (bleach) with 100 parts distilled water and three parts soap with the pumice to provide a disinfectant effect. Instruments, attachments, and materials used on new prostheses should be kept separate from the ones used on an appliance that has contacted a patient's mouth. Disinfect cases before returning to the dental office. The dentist and laboratory should communicate with each other about proper infection control regarding all lab cases.

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Waterlines
Introduction
Water from dental unit water lines (DUWL) usually contains higher levels of bacteria than municipal water supplies, yet no widespread health problems have been associated with this water. Concern over DUWL contamination has been fueled by an increase in awareness of infection control issues, media reports of contaminated water from dental units, and case reports associating illness with dental water contamination. Water from dental handpieces, sonic and ultrasonic scalers, and air water syringes continues to be the target of a program to reduce pathogens delivered to the patient during treatment. Dental unit water contains approximately the same types of bacteria found in drinking water, but in a higher concentration. Municipal water is normally maintained with below 500 colony forming units of heterotrophic bacteria per milliliter of water (CFU/mL). Several studies show water from dental handpieces and air-water syringes contaminated at levels exceeding 100,000 CFU/mLs. xiv The ADA has recommended a goal of 200 CFU/mL. The microorganisms in DUWL are bacteria, protozoa, and fungi. These microorganisms are found in the water as well as attached to the inside walls of the waterline (biofilm). Microbes enter the tubing from incoming water and a very small proportion from dental patients during treatment. These microbes adhere to the walls of the tubing and begin to multiply. The microbes produce a slime layer and more microbes from the water attach to the slime. The flow of the water can dislodge the microbes from the slime layer and release them into the flowing water. The tubing is constantly replenished with more microbes, stagnation of the water facilitates growth of the slime layer, and the small diameter of the tubing results in a large surface-area-to-volume ratio. xv Water heating systems in dental units are designed to heat the water to human body temperature. This may increase the numbers of microorganisms adapted to growth in human hosts and encourage bacterial growth in the waterlines. xvi Water heating systems should not be used. Waterlines should be flushed after each patient to remove material that may have been retracted during the procedure. Flushing will also dislodge some of the biofilm. Sterile coolant and irrigating solutions should be used for surgical dental procedures involving bone and incision of mucosa. Water with less than 200 CFU/mL of heterotrophic mesophillic bacteria is acceptable for non-surgical procedures including those involving the sulcus or initial access into dental pulp. xvii The US Food and Drug Administration (as specified in Section 510(k) of the Federal Food, Drug, and Cosmetic Act) classify dental water treatment and delivery systems as medical devices. They are subject to pre-market standards and must have a 510(k) clearance. Any chemical germicides used must be EPA registered and produce water that must: be compatible with dental restorative materials, not exceed 200 CFU/mL of heterotrophic mesophillic bacteria, and not contain toxic or carcinogenic chemicals. xvii

Separate water reservoir systems in cooperation with chemical treatment are safe and effective.xvii Technologies for waterline treatment include: independent reservoirs, chemical

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treatment (either continuous or intermittent), filtration, sterile water delivery systems, and combined approaches. A universal treatment protocol has not been published because dental units and water systems vary. Practitioners should consult their dental unit manufacturer for safe, acceptable methods of providing treatment water with fewer than 200 CFU/mL of heterotrophic mesophillic bacteria. Dental professionals should: 1. Review scientific literature to understand the nature and risks of DUWL contamination as well as learn recent discoveries in technology, 2. Contact the manufacturer of their current dental units and devices that use water to receive recommendations on maintaining the quality of water delivered during dental treatment, and 3. When purchasing new equipment or retrofitting devices, select dental units and products that economically and reliably maintain water quality. xvii Water unfit to drink (or swim in) is unfit for therapeutic use in dentistry. ADAs 200 CFU/mL goal is achievable now. Prudence dictates reasonable action to protect dental professionals and dental patients. xviii

Boil-Water Advisories xix

OSAP (based on CDC recommendations) suggests the following procedures for dental offices during boil-water advisories. Use these instructions along with specific instructions issued by state or local health departments during these advisories. While a boil-water advisory is in effect: Do not deliver water from the public water system through the dental unit, ultrasonic scaler, or other dental equipment that uses the public water system until the boilwater advisory is canceled. Do not allow patients to use water from the public water system for rinsing. Use water from alternative sources, such as bottled or distilled water. Dental workers should not use water from the public water supply for hand washing. Instead, use antimicrobial-containing products that do not require water for use, such as alcohol-based hand rubs, until the boil-water notice is canceled. Use products that have been reviewed and cleared for marketing by the U.S. Food and Drug Administration (FDA). When the boil-water advisory is canceled: Flush incoming public water system water lines. All faucets in the dental setting should be turned on completely for at least 30 minutes, including water lines to dental equipment that uses the public water system. After the incoming public water system water lines are flushed, disinfect dental unit water lines according to manufacturer recommendations. Alternative water sources, such as separate water reservoirs that have been cleared for marketing by the FDA, can be used during a boil-water advisory. However, if the alternative water source were to flow through a dental unit previously connected to the affected public

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water supply, first flush and disinfect the dental unit water lines according to the manufacturer's instructions.

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Ethical and Legal Considerations Regarding AIDS and HIV

Introduction
All patients should be treated with compassion and dignity, regardless of their HIV status. There is little known risk of contacting AIDS through dental procedures if the recommended infection control procedures are followed carefully. The ADA Council on Ethics, Bylaws and Judicial Affairs presented the following advisory opinion about patient selection: "A dentist has the general obligation to provide care to those in need. A decision not to provide treatment to an individual because the individual has AIDS or is HIV seropositive, based solely on that fact, is unethical. Decisions with regard to the type of dental treatment provided or referrals made or suggested, in such instances, should be made on the same basis as they are made with other patients, that is, whether the individual dentist believes he or she has need of another's skills, knowledge, equipment or experience and whether the dentist believes, after consultation with the patient's physician if appropriate, the patient's health status would be significantly compromised by the provision of dental treatment." Currently, it is illegal to refuse to treat a patient because they are HIV positive. If the individual is a patient of record, it is considered abandonment if the dentist refuses them treatment. If a dentist or auxiliary is carrying an infectious disease, especially HIV or hepatitis B, he or she is obliged to take the precautions necessary to ensure that the disease is not transmitted to the patients. The laws are changing rapidly in this area, so the dentist or auxiliary who is a carrier of a disease should consult with their physician and lawyer to find out if there are any current laws that might restrict their practice or force them to advise patients of their disease state.

The Acer Case

In July of 1990, The Centers for Disease Control published the only documented cases of transmission of HIV from an infected health care worker to patients during invasive dental procedures. Five patients of Dr. Acer of Florida have been diagnosed as HIV positive. Each patient had undergone invasive dental procedures, and all reported that the dentist wore a mask and gloves. Epidemiological and molecular biological investigations confirmed that the infection was transmitted from the dentist. The precise mode of transmission is still a mystery. All the patients had dental care from the dentist after he was diagnosed HIV positive. Opportunities existed for needlestick injuries or cuts with other sharp instruments. Treatment records do not indicate any unusual circumstances involving any of the procedures, and the dentist denied any needlestick injuries since his HIV positive diagnosis. None of the patients had confirmed exposures to HIV other than the dental treatment by Dr. Acer. The dentist's practice opened in 1981. His first reported positive HIV test was documented in 1986, but the date of onset of his HIV is unknown. The invasive procedures were performed between September of 1987 and July of 1989. Transmission occurred relatively late in the course of the dentist's infection. Cross-infection by dental instruments has been ruled out because none of the patients had appointments on the same day. Intentional transmission of HIV may be another theory, but no evidence exists to support this, through interviews with family, staff, and others. The virus was passed through direct patient exposure to the dentist's blood, but the exact route of transmission remains unknown.

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Sharpe vs. Breglio

The Hampshire County Superior Court in Massachusetts decided a landmark case regarding contraction of AIDS in the Dental Office. Mr. Sharpe contended that he contracted AIDS by unsterilized dental equipment at Dr. Breglios office. Dr. John Molinari, a recognized expert in Infection Control, testified that it was remotely possible that the virus was transmitted through the dental equipment. He added that the Tcell evidence suggests that the virus was contracted years earlier. A surprise witness testified that Mr. Sharpe frequented private membership sex clubs in New York and she witnessed him with several sexual partners. The jury was not convinced that the high-speed hand piece was the mode of transmission for the virus. The case (concluded February 16, 1996) confirms the necessity of heat sterilizing dental equipment (including dental hand pieces), and gives additional documentation that the virus is not spread by dental visits. xx

The Bragdon Case

Ms. Sidney Abbott sought dental care from Dr. Randon Bragdon on Sept 16, 1994. She indicated that she had AIDS on her medical information sheet. During the examination, Dr. Bragdon found a carious lesion on a mandibular molar. He informed her that he would need to fill the tooth in a hospital because of his infectious disease policy and she would be responsible for the additional costs. Ms. Abbott sued. A federal judge and then the 1st U.S. Circuit Court of Appeals found that Bragdon had violated federal law in refusing to treat her in his office. The 1st Circuit court said, Had the patient required more invasive treatment or had the dentist proffered stronger evidence of a direct threat, the result may well have differed. Bragdon appealed to the nations highest court. xxi The Supreme Court delivered a decision in June, 1998 that HIV infected individuals are protected under the Americans with Disabilities Act. The Americans With Disabilities Act requires that a major life activity be impaired in order to be covered. Sydney Abbott claimed that her HIV status forced her to decide not to have children, and the judges agreed that reproduction is a major life activity. This ruling does not necessarily mean every HIVpositive person is covered by the act, but they most likely will be able to demonstrate they are covered by the AWDA in some way. The AWDA bans discrimination against disabled people, but there is an exception whereby care providers are not required to treat an infected person if the condition poses a significant safety risk. The Supreme Court directed the U.S. Court of Appeals for the First Circuit (the court that found Dr. Bragdon had illegally discriminated against Ms. Abbott by refusing to treat her) to further investigate the question of risk involved in the case. According to Justice Anthony M. Kennedy, the Supreme Court could not decide on the matter since it should be limited to objective, scientific information. xxii The American Dental Association released a statement on September 29, 1998 reaffirming that patients with HIV may be safely treated in a dental office. ADA policy based on current scientific information states: "Current scientific and epidemiological evidence indicates that there is little risk of transmission of infectious disease through dental treatment if recommended infection procedures are routinely followed. Patients with HIV infection may be safely treated in private dental offices when appropriate infection control procedures are

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employed." In addition, a decision not to provide treatment to an individual based solely on their AIDS or HIV seropositive status is unethical. xxiii

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OSHA
Introduction
The Occupational Safety and Health Administration (a division of the US Department of Labor) was developed to write rules to help protect workers from chemical, physical, or infectious hazards in the workplace. Some States have their own OSHA programs and some States cooperate with regional branches.

The Bloodborne Pathogens Standard

The standard is based on the theory that universal precautions will protect workers from infection with bloodborne pathogens. OSHA addresses engineering controls, work practice controls, personal protective equipment, housekeeping, and disposal of regulated waste. The following are the main points to the Federal OSHA Bloodborne Pathogen Standard: All employers are required to have a written exposure control plan identifying workers with occupational exposure to blood and other potentially infectious materials. It must be specific for the facility and appropriate for dental office procedures. xxvThe plan specifies how employees will be protected and trained. The plan must include the employer's protocol for job classifications along with exposure risks, engineering and work practice controls, barrier techniques, sterilization and disinfection, hepatitis B vaccination, handling office accidents, post-exposure evaluation and follow up, communications of hazards to employees, and record keeping.

The plan must be accessible to employees, and it must be reviewed and updated at least each year. Include notes in your plan that clearly indicate you have reviewed it and considered new technology for improving workplace safety. xxv Puncture-resistant containers for used needles, handwashing when gloves are changed, and "appropriate" personal protective equipment are required. Home laundering of gowns and other protective clothing is prohibited. All sharps injuries must be logged. During an inspection, OSHA officers would look for patterns of injuries and what types of engineering controls were put into use to prevent future injuries of the same type. Employers should clearly document any use of alternative devices or controls put into practice after an exposure incident. Employers are responsible to provide confidential medical evaluation and management for all employees who report an exposure incident. Document the injury including specific information on the treatment and follow up to ensure the accident has less likelihood of happening again. xxv Recapping of sharps is prohibited unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical procedure. In such cases (for example, when an anesthetic is being administered on the same patient more than once),

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only a one-handed technique or mechanical device can be used. In a May 2000 letter, OSHA told the American Dental Association that it continues to believe that needles and sharps pose the same significant risk of harm to dental employees that have been shown in other health care professions. It is up to the employer (dentist) to determine what engineering controls can be utilized in his or her workplace to reduce or eliminate exposure to needlesticks for workers and whether or not they would be effective for the unique situations dentists often face.At least once a year, dentists must review and update their exposure control plans. Safer devices are continually becoming available. Dentists will be expected to check with vendors, review their literature and try prospective devices. xxiv Employees must wear gloves and gowns when there is a reasonable chance of skin contact with blood, saliva, or body tissue. Disposable gloves may not be washed for reuse. Employees must wear masks and protective eyewear or face shields when splashes, spray, spatter, or droplets of blood, body tissue, or saliva may be generated and eye, nose, or mouth contamination can reasonably be anticipated. Protective eyewear must include solid side shields. Employers must ensure that employees wear personal protective equipment when necessary. The employer is responsible for purchasing these items. Needle safety devices used must have FDA (Food and Drug Administration) approval. Safety features should be fixed and provide a barrier between the hands and the needle after use. The workers hands must remain behind the needle. The safety feature should be part of the device, not an accessory. It should be in effect before disassembly and stay in effect after disposal. The feature should be simple and require little or no training for correct use. xxv Sharps containers must be labeled, easily accessible and as close as possible to work stations where sharps are used. Employers must offer the hepatitis B vaccine without charge to employees after they are trained and within 10 days of assignment to a position with occupational exposure. Workers may decline the vaccine by signing a form to that effect, but they retain the right to employer-provided vaccinations if they change their minds. The vaccination must be offered at no charge to the employee (with no out-of-pocket expense including time to travel to get the vaccination). Prevaccination testing is not required, but the US Public Health Service (PHS) recommends postvaccination titer testing for employees at risk of sharps injuries. Hepatitis B surface antigen testing is recommended one to two months after completion of the three dose series. If the test is negative, the PHS recommends a second series of vaccinations. If the employee still does not respond to the series, they should be medically evaluated. Periodic antibody tests and routine boosters for employees responding to the series are not currently recommended. Infectious waste such as blood and body fluid; items that release blood, body fluid, or saliva when compressed; items caked with dried blood, body fluid, or saliva if they are capable of releasing these fluids when handled; sharps; and pathological waste must be disposed of properly. These waste materials must be placed in special, labeled containers, and disposed of according to local laws.

Federal OSHA Training

Employers must provide training for all employees with occupational exposure to hazardous

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materials. Training must be provided during working hours and at no cost to the employee. The agenda for the training meeting includes: 1. A copy of the Bloodborne Pathogens Standard and an explanation of it's contents; 2. An explanation of the epidemiology of bloodborne diseases, their symptoms and modes of transmission; 3. An explanation of the office's exposure control plan and how the employees can get copies; 4. Information about personal protective equipment: gloves, masks, gowns, and eyewear or face shields. They must clearly state what type of equipment is available, where it is stored, when and how to use it, and how it is to be removed, handled, cleaned or destroyed after its use; 5. Explanations of specific tasks that may involve occupational exposure including how to recognize these tasks and minimize the chance for injury; 6. Information about the hepatitis B vaccine, including administration, safety, efficacy, and that it is paid for by the employer; 7. Information on how to handle any accidents, specifically, who to contact and what to do; 8. Information on the office procedures for reporting and follow-up for injuries from contaminated sharps; 9. Explanation of the biohazard labels and material safety data sheets; and 10. An opportunity for the employees to ask questions.

OSHA requires that a qualified instructor train every employee regarding OSHA standards. The trainer must be knowledgeable enough about the OSHA regulations to answer questions asked by the staff. Some offices designate members of their staff to learn about the standard then conduct the training. Others hire outside consultants. Ask consultants about their qualifications and compare the materials the consultants provide to the Bloodborne Pathogens Standard. The consultant should become familiar with the routines and products used in the individual office so the instruction will be specific. Remember to conduct instruction on a regular basis to train new employees and address changes in protocol or technology. Outside seminars on OSHA are informative and important, but the office must schedule a time for individual discussion with a knowledgeable trainer for a completely specific training experience. Records of the training meetings must be kept for three years and should include: date of training summary of class qualifications and name of trainer names and job titles of all attendees signature of employees

During an inspection, OSHA investigator may interview employees about their knowledge of the Bloodborne Pathogens Standard, so it is important that everyone on staff understands the whole plan.

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Employee Medical Records

Employee Medical Records must contain the name and social security number of the employee; a copy of the hepatitis vaccine report or the declination form signed by the employee; and any examinations, information, medical tests, or post-exposure reports from an occupational injury. The records are confidential, and must be maintained for the length of employment plus 30 years. A written consent from the employee is required to disclose any of the information contained in this record.

The Hazard Communication Standard

OSHAs Hazard Communication Standard is called the employee right to know law and explains regulations about informing employees about the safe use of hazardous chemicals in their workplace. xxvi OSHA requires chemical manufacturers to provide material safety data sheets (MSDS) with all hazardous chemicals. Hazardous chemicals include any chemical that a worker may be exposed to during normal working duties and in any emergency situation. The employer must train all employees regarding the hazardous materials, the labels and warnings, use and location of MSDS, and any procedures for emergencies. Employers are required to write and maintain a Hazard Communication Program specifically designed for their office. The employees must be trained in all aspects of this plan. The following is a checklist that includes all the important aspects of a written hazard communication plan:

Provide a copy of the Hazard Communications Standard to each employee Designate individual(s) responsible for developing, implementing, and monitoring the hazard communication program. Develop an inventory list of all hazardous substances used in the office. Collect accurate and current Material Safety Data Sheets for each item on the list. If an MSDS is unavailable from the supplier of the product, send a copy of your request letter to: Division Of Occupational Safety and Health, Right-to-Know Unit, 1625 Shattuck Avenue, Berkeley, CA 94709. Label any secondary containers with the name of the hazardous substance, hazard warning, and the name and address of the manufacturer or importer. Describe how the labeling, MSDS, and employee information and training requirements will be met, along with a plan of how to make employees aware of hazards they may encounter while performing routine or non-routine tasks. Location and details of the written hazard communication program. (How to read and understand MSDS and labels). Operations where hazardous substances are present. Physical and health hazards as provided on the MSDS. How to detect presence of hazardous substances (i.e.: appearance and odor). Protective measures such as work practices, personal protective equipment and emergency procedures. Written documentation of employee training. Develop a plan for an on-going Hazard Communication Program that will continue to train new employees, keep up to date with MSDS for new chemicals being used, and to retrain employees when new chemicals are introduced.

MSDS
Material Safety Data Sheets (MSDS) are required for each hazardous substance or mixture used in the office. They should be available from the manufacturer when the substance is purchased. All MSDSs should contain the following information (From Cal/OSHA Booklet Employer's Guide to The California Hazard Communication Regulation 1986):

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1. Trade name (product identity, same as used on the label) 2. Chemical and common name and CAS numbers of each hazardous ingredient. 3. The physical and chemical properties such as vapor pressure, flashpoint and solubility of the chemicals. 4. The physical hazards such as fire, explosion, and dangerous chemical reactions. 5. The specific acute (short term) and chronic (long term) health hazards, including the signs and symptoms of illness and medical conditions (use simple or lay terms) that may be aggravated by exposure. 6. The potential routes of entry of the hazardous substance(s) into the body. 7. The permissible exposure limits published and/or recommended limits for the hazardous substance(s) (OSHA Permissible Exposure Limit (PEL) and the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV) listings) and any other limit recommended by the manufacturer. 8. If the hazardous substance(s) is listed as a carcinogen by the National Toxology Program (NTP) the International Agency for Research on Cancer (IARC) or the Occupational Safety and Health Administration (OSHA). 9. The precautions necessary for safe handling, use and storage, including the protective measures for repair and maintenance of equipment. 10. The known control measures, including engineering, work practices and personal protective equipment necessary to protect against the hazards. 11. Emergency and spill clean-up procedures. 12. First aid procedures. 13. The date of preparation of the MSDS or the date of last change in contents. 14. The name, address, and phone number of the party responsible for preparing the MSDS.

Manufacturers must update the MSDS within three months of learning that new hazard data is available for the MSDS. The training for the employees must include: 1. 2. 3. 4. Identification of hazardous materials. Physical and health hazards present in the specific facility. Correct use of personal protective devices. Any other information which may be important for that particular setting.(Including the written hazard communication plan)

Container Labels
The manufacturer of hazardous chemicals must label all containers before shipping. The labels must be in English and include: The identity of the hazardous chemical, Appropriate hazard warnings, and The name and address of the chemical manufacturer. xxvi

You must label any secondary containers of hazardous chemicals with the identity of the contents and its hazard warning(s). Many distributors provide adhesive labels for chemicals commonly used in secondary containers.

OSHA Ergonomics Standard

On November 14, 2000, OSHA published a document called The Final Ergonomics Program Standard. (Full text available at www.osha-slc.gov/ergonomics-

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tandard/regulatory/regtext.html) The standards goal was to reduce the number and severity of musculoskeletal disorders caused by risks at the workplace. The first stage of compliance was to be completed by October 14, 2001. xxvii On March 20, 2001 President Bush repealed the rule, saying it posed overwhelming compliance challenges for businesses. At the time of publication of this course, Labor Secretary Elaine Chao is tasked with drafting regulations that will be more economically feasible for both large and small businesses. Workers can begin to take personal responsibility for preventing these types of injuries by applying some of the principles for reducing their likelihood of developing injuries from repetitive tasks contained in the original standard until the new Standard is released. The original wording of the standard is available at www.osha-slc.gov/ergonomics-standard/archive-index.html. Updates to the Ergonomics Standard will be published on the OSHA website.

Fire and Emergency Plan

OSHA regulates the creation and maintenance of a Dental Office Fire and Emergency Plan. This plan includes instructions and procedures that employees would follow in case of an emergency in the office. This plan mainly deals with education and prevention of hazards associated with certain jobs in a dental office. Some of the highlights include:

Knowing emergency numbers. Knowing where emergency exits are. Location of fire extinguishers. Knowing which chemicals in the office are flammable (e.g., nitrous oxide, oxygen). Individual training that includes signed forms stating when the training was completed.

More Information on OSHA

For more information about OSHA compliance, contact the American Dental Association or www.osha.gov. Printed documents are available from: Superintendent of Documents U.S. Government Printing Office Washington, DC 20402 (202) 512-1800 (202) 512-2250 fax The Appendix contains a complete copy of the Federal OSHA Bloodborne Pathogens Standard, OSHAs Hazard Communication Standard, CFR 29.1910.1200; and CPL 2-2.44D Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens. (The second document updates but does not replace CFR 29.) Read both documents in their entirety so you can be sure to appropriately implement the regulations to your specific practice setting. Regional OSHA Offices
I. II. III. Boston (617) 565-7164 Massachusetts, Maine, New Hampshire, Rhode Island New York (212) 337-2378 New Jersey, New York, Puerto Rico Philadelphia (215) 596-1201 District of Columbia, Delaware, Pennsylvania, West Virginia

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IV. Atlanta (404) 347-3573 Alabama, Florida, Georgia, Mississippi V. Chicago (312) 353-2220 Illinois, Ohio, Wisconsin VI. Dallas (214) 767-4731 Arkansas, Louisiana, Oklahoma, Texas VII. Kansas City (816) 426-5861 Kansas, Missouri, Nebraska VIII. Denver (303) 844-3061 Colorado, Montana, North Dakota, South Dakota IX. San Francisco (415) 744-6670 American Samoa, Guam, Trust Territories of the Pacific X. Seattle (206) 553-5930 Idaho

States with OSHA-Approved Programs

Alaska: Arizona: California: Connecticut: Hawaii: Indiana: Iowa: Kentucky: Maryland Michigan Nevada New Mexico New York No. Carolina Oregon Puerto Rico So. Carolina Tennessee Utah Vermont Virgin Islands Virginia Washington Wyoming Juneau Phoenix San Francisco Wethersfield Honolulu Indianapolis Des Moines Frankfort Baltimore Lansing Carson City Santa Fe Albany Raleigh Salem Hato Rey Columbia Nashville Salt Lake City Montpelier St. Croix Richmond Olympia Cheyenne (907) 465-2700 (602) 542-5795 (415) 703-4590 (203) 566-5123 (808) 548-3150 (317) 232-2665 (515) 281-3447 (502) 564-3070 (301) 333-4179 (517) 373-9600 (702) 687-3032 (505) 827-2850 (518) 457-2741 (919) 733-7166 (503) 378-3272 (809) 754-2119 (803) 734-9594 (615) 741-2582 (801) 530-6900 (802) 828-2765 (809) 773-1994 (804) 786-2376 (206) 753-6307 (307) 777-7786

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Sample OSHA Documentation

Exposure Control Plan The following Sample Exposure Control Plan is intended to serve as an employer guide to the OSHA Bloodborne Pathogens standard. The intent of this model is to provide small employers with an easy-to-use format for developing a written exposure control plan. Each employer will need to adjust or adapt the model for his or her specific use. It should include information specific to the office so it can be identified as unique to that practice. Keep all documents in one place and neatly organized. Review it yearly and at staff changes to make sure it is up to date.
SECTION 1: TITLE PAGE
xxviii

EXPOSURE CONTROL PLAN (ECP) FOR: (Name of Office) (Full Address) (Phone Number)
SECTION 2: INTRODUCTION The (Facility Name) is committed to providing a safe and healthful work environment for our entire staff. In pursuit of this endeavor, the following exposure control plan (ECP) is provided to eliminate or minimize occupational exposure to bloodborne pathogens in accordance with OSHA Standard 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." The ECP is a key document to assist our firm in implementing and ensuring compliance with the standard, thereby protecting our employees. This ECP includes: Determination of employee exposure Implementation of various methods of exposure control, including: Universal precautions Engineering and work practice controls Personal protective equipment Housekeeping Hepatitis B vaccination Post-exposure evaluation and follow-up Communication of hazards to employees and training Recordkeeping Procedures for evaluating circumstances surrounding an exposure incident The methods of implementation of these elements of the standard are discussed in the subsequent pages of this ECP. Employees covered by the bloodborne pathogens standard receive an explanation of this ECP during their initial training session. It will also be reviewed in their annual refresher training. All employees have an opportunity to review this plan at any time during their work shifts by contacting (Name of responsible person or department). The person Responsible for maintaining this plan is: (Name of responsible person or department) He/She is responsible to: keep this plan in a designated location, hold training meetings for other employees regarding exposure control, and hold employees accountable to compliance with the regulations. He/she will maintain, review, and update the ECP at least annually, and whenever necessary to include new or modified tasks and procedures. If requested, we will provide an employee with a copy of the ECP free of charge and within 15 days of the request. Those employees who are determined to have occupational exposure to blood or other potentially infectious materials (OPIM) must comply with the procedures and work practices outlined in this ECP. (Name of responsible person or department) will maintain and provide all necessary personal protective equipment (PPE), engineering controls (e.g., sharps containers), labels, and red bags as required by the standard. (Name of responsible person or department) will ensure that adequate supplies of the aforementioned equipment

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are available in the appropriate sizes. Contact location/phone number: Engineering controls and work practice controls will be used to prevent or minimize exposure to bloodborne pathogens. The specific engineering controls and work practice controls used are listed below: * (For example: sharps containers in each operatory) * * Sharps disposal containers are inspected and maintained or replaced by (Name of responsible person or department) every (list frequency) or whenever necessary to prevent overfilling. This facility identifies the need for changes in engineering control and work practices through (Examples: Review of OSHA records, employee interviews, committee activities, etc.) We evaluate need procedures or new products by (Describe the process) The following staff are involved in this process: (Describe how employees will be involved) (Name of responsible person or department) will ensure effective implementation of these recommendations. Personal Protective Equipment (PPE) PPE is provided to our employees at no cost to them. Training is provided by (Name of responsible person or department) in the use of the appropriate PPE for the tasks or procedures employees will perform. The types of PPE available to employees are as follows: (Ex., gloves, eye protection, etc.)

PPE is located (List location) and may be obtained through (Name of responsible person or department) (Specify how employees are to obtain PPE, and who is responsible for ensuring that it is available.) All employees using PPE must observe the following precautions: Wash hands immediately or as soon as feasible after removal of gloves or other PPE. Remove PPE after it becomes contaminated, and before leaving the work area. Used PPE may be disposed of in ____________ (List appropriate containers for storage, laundering, decontamination, or disposal.) Wear appropriate gloves when it can be reasonably anticipated that there may be hand contact with blood or OPIM, and when handling or touching contaminated items or surfaces; replace gloves if torn, punctured, contaminated, or if their ability to function as a barrier is compromised. Utility gloves may be decontaminated for reuse if their integrity is not compromised; discard utility gloves if they show signs of cracking, peeling, tearing, puncturing, or deterioration. Never wash or decontaminate disposable gloves for reuse. Wear appropriate face and eye protection when splashes, sprays, spatters, or droplets of blood or OPIM pose a hazard to the eye, nose, or mouth. Remove immediately or as soon as feasible any garment contaminated by blood or OPIM, in such a way as to avoid contact with the outer surface.

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The procedure for handling used PPE is as follows: (may refer to specific agency procedure by title or number and last date of review)

(For example, how and where to decontaminate face shields, eye protection, resuscitation equipment) Housekeeping Regulated waste is placed in containers which are closable, constructed to contain all contents and prevent leakage, appropriately labeled or color-coded (see Labels), and closed prior to removal to prevent spillage or protrusion of contents during handling. The procedure for handling sharps disposal containers is: (may refer to specific agency procedure by title or number and last date of review)

The procedure for handling other regulated waste is: (may refer to specific agency procedure by title or number and last date of review)

Contaminated sharps are discarded immediately or as soon as possible in containers that are closable, punctureresistant, leakproof on sides and bottoms, and labeled or color-coded appropriately. Sharps disposal containers are available at (must be easily accessible and as close as feasible to the immediate area where sharps are used). Bins and pails are cleaned and decontaminated as soon as feasible after visible contamination. Broken glassware which may be contaminated is picked up using mechanical means, such as a brush and dust pan. Laundry The following contaminated articles will be laundered by this company:

Laundering will be performed by (Name of responsible person or department) at (time and/or location). The following laundering requirements must be met: handle contaminated laundry as little as possible, with minimal agitation place wet contaminated laundry in leak-proof, labeled or color-coded containers before transport. Use (red bags or bags purpose.) wear the following PPE when handling and/or sorting contaminated laundry: (List appropriate PPE) Labels The following labeling method(s) is used in this facility: LABEL TYPE (size, color, etc.) EQUIPMENT TO BE LABELED (e.g., specimens, contaminated laundry, etc.) (red bag, biohazard label, etc.) ___________________________ __________________________ ___________________________ (Name of responsible person or department) will ensure warning labels are affixed or red bags are used as required if regulated waste or contaminated equipment is brought into the facility. Employees are to notify (Name of responsible person or department) if they discover regulated waste containers, refrigerators containing blood or OPIM, contaminated equipment, etc. without proper labels. (Name of responsible person or department) will be responsible for ensuring that all medical actions required are performed and that appropriate employee health and OSHA records are maintained. Contact location/phone number: ________________________

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(Name of responsible person or department) will be responsible for training, documentation of training, and making the written ECP available to employees, OSHA, and NIOSH representatives. Contact location/phone number: _____________________________ The designated location for this plan is: This plan was last updated: SECTION 3: EMPLOYEE EXPOSURE DETERMINATION FORMS Tasks in which the employees have exposure to blood or another potentially hazardous material should be in Category 1. Those who perform tasks where there is some occupational exposure belong in Category 2. Those who never are exposed during their normal tasks are in Category 3. Make each item specific for the office. Category 1 Tasks: The following is a list of all job classifications at our establishment in which all employees have occupational exposure: Dental Assisting, Cleaning Instruments Dental Hygiene Functions, Root planing

Category 2 Tasks The following is a list of job classifications in which some employees at our establishment have occupational exposure. Included is a list of tasks and procedures, or groups of closely related tasks and procedures, in which occupational exposure may occur for these individuals: Office worker who occasionally takes x-rays

Category 3 Tasks: Front desk receptionist who does not assist.

The employees should be named in order of their risk category: Category 1 Employees: Name First Day of Work

Last Day of Work

Category 2 Employees: Name

First Day of Work

Last Day of Work

Category 3 Employees: Name

First Day of Work

Last Day of Work

Part-time, temporary, contract and per diem employees are covered by the standard. How the provisions of the standard will be met for these employees should be described in the ECP. SECTION 4: LIST ALL HAZARDOUS CHEMICALS USED IN THE WORKPLACE Collect MSDS for all hazardous chemicals used in the office. See list of requirements in MSDS section to make sure all information is included. Sample MSDS Request Letter: Date: Name of Distributor of Chemical:

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RE: MSDS for (Name of Product) Please send a copy of the Material Safety Data Sheet (MSDS) for the above product. We need the MSDA to comply with the Federal Hazard Communication Program. Please send the MSDS to: Name of person in charge C/O Name of Dental Office Full Address If this product does not require an MSDS, please contact (Name of person in charge) Thank you,

SECTION 5: STANDARD OF CARE IN THE OFFICE Place a document similar to the checklist at the end of the course to describe general office protocol for cleaning, use of Personal Protective Equipment, handling of sharps. Universal Precautions All employees will utilize universal precautions. SECTION 6: EXPOSURE INCIDENT REPORTS Post-Exposure Evaluation and Follow-up Should an exposure incident occur, contact (Name of responsible person) at the following number: _____________________________. An immediately available confidential medical evaluation and follow-up will be conducted by (Licensed health care professional). Following the initial first aid (clean the wound, flush eyes or other mucous membrane, etc.), the following activities will be performed: Document the routes of exposure and how the exposure occurred. Identify and document the source individual (unless the employer can establish that identification is infeasible or prohibited by state or local law). Obtain consent and make arrangements to have the source individual tested as soon as possible to determine HIV, HCV, and HBV infectivity; document that the source individual's test results were conveyed to the employee's health care provider. If the source individual is already known to be HIV, HCV and/or HBV positive, new testing need not be performed. Assure that the exposed employee is provided with the source individual's test results and with information about applicable disclosure laws and regulations concerning the identity and infectious status of the source individual (e.g., laws protecting confidentiality). After obtaining consent, collect exposed employee's blood as soon as feasible after exposure incident, and test blood for HBV and HIV serological status If the employee does not give consent for HIV serological testing during collection of blood for baseline testing, preserve the baseline blood sample for at least 90 days; if the exposed employee elects to have the baseline sample tested during this waiting period, perform testing as soon as feasible. Administration of Post-Exposure Evaluation and Follow-up (Name of responsible person or department) ensures that health care professional(s) responsible for employee's hepatitis B vaccination and post-exposure evaluation and follow-up are given a copy of OSHA's bloodborne pathogens standard. (Name of responsible person or department) ensures that the health care professional evaluating an employee after an exposure incident receives the following: * a description of the employee's job duties relevant to the exposure incident * route(s) of exposure * circumstances of exposure

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* if possible, results of the source individual's blood test * relevant employee medical records, including vaccination status (Name of responsible person or department) provides the employee with a copy of the evaluating health care professional's written opinion within 15 days after completion of the evaluation. Place all completed OSHA Forms 101 and 200. Include a documentation of the incident and all referral forms sent to medical evaluators. Make a form for accident/exposure investigations containing the following information: Name of Dental Office, Date, Name of Members of Investigation Team, Employees Name, ID Number, sex, age, Job Description, Risk Category, Accident Date, Accident Time, Date Reported to Supervisor, Nature of Incident, Nature of Injury, Referral to a Medical Facility or Doctor, Date and Time of employee returning to work, a complete statement by the employee, witness names, witness interviews, photographs of injury, diagram of injury, Preventative action recommendations, date corrective actions completed, name of responsible manager, Accident cost analysis including lost time, temp help, cleanup, repair, discussion, investigation, and compliance. Have ready a Source of Exposure Consent Form saying: I understand that a health care worker has been exposed to my blood or other tissues which may be potentially infections, and I understand that a test for HBV (hepatitis B) and HIV (AIDS) is necessary. I consent to this test by my personal physician and I will allow the results to be sent to the health care workers physician. The fees for theses tests will be paid by the Workers Compensation Insurance of the health care worker and I will not be responsible for the fees. Patient Signature Witness Date Have ready a Patient Referral form with the following information: Date To From , Dear Dr. (name of patient), your patient of record, was involved in an occupational exposure incident on (date). According to section (f)(3)(iii) of OSHAs Bloodborne Pathogen Standard, an attempt must be made to establish the source patients HBV and HIV status. This patient has consented to testing and understands that you will provide pre-test and post-test counseling. If the patient declines testing or refuses permission to release the results of the test please notify this physician as well. (Employees Physician) Physician: Address: Phone: Thank you, Have ready this Employee consent form: I understand that a baseline blood test for HBV and HIV is recommended as part of a post-exposure evaluation and follow-up. I consent to this test and it will remain a confidential part of my medical records. The physician will give pre- and post-test counseling and will provide my employer with a written report containing recommendations on hepatitis B vaccination, when I am informed of the test results, and the medical conditions resulting from this exposure incident that may require further treatment. This report to my employer will remain in my medical record at work for 30 years. Employee signature date witness Have ready an Employee Referral form with the following information: From: To: Date:

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Dear Dr.

was involved in an occupational (Name of employee), who is employed at exposure incident on (date). According to section (f)(3)(iii) of the OSHA Bloodborne Pathogens Standard, a baseline test for HBV and HIV is recommended at this time. This employee has consented to testing, and has been told that you will provide pre- and post-test counseling, OSHA requires us to keep a report from you containing the following information in this employees file for 30 years: If a hepatitis B vaccination is indicated, If the employee is already vaccinated against HBV, If the employee has been informed of the test results, If the employee has been informed of any future medical treatment necessary as a result of this incident. Any other findings will remain part of your confidential records. Thank you, Procedures for Evaluating the Circumstances Surrounding an Exposure Incident (Name of responsible person or department) will review the circumstances of all exposure incidents to determine: * engineering controls in use at the time * work practices followed * a description of the device being used * protective equipment or clothing that was used at the time of the exposure incident (gloves, eye shields, etc.) * location of the incident (O.R., E.R., patient room, etc.) * procedure being performed when the incident occurred * employee's training If it is determined that revisions need to be made, (Responsible person or department) will ensure that appropriate changes are made to this ECP. (Changes may include an evaluation of safer devices, adding employees to the exposure determination list, etc.) SECTION 7: LOGS Have a chart with the following information: Date, Time of Sterilization Cycle, Temperature, Pressure, Heat strip use, and results of the biological monitoring. Keep all reports from the Monitoring service. Keep these records for at least 3 years. Have a chart with the following information: Name of Dental Office, name of employer, address, telephone. Infectious waste statistics like date generated, date disposal service notified, and date of pickup. Sharps container statistics like date container sealed, date disposal service notified, and date of pickup. Have a chart detailing the training for employees. Include the following information: Training records are completed for each employee upon completion of training. These documents will be kept for at least three years at (Name of responsible person or location of records). The training records include: * the dates of the training sessions * the contents or a summary of the training sessions * the names and qualifications of persons conducting the training the names and job titles of all persons attending the training sessions * Employee training records are provided upon request to the employee or the employee's authorized representative within 15 working days. Such requests should be addressed to (Name of Responsible person or department) SECTION 8: EMPLOYEE MEDICAL RECORDS Medical records are maintained for each employee with occupational exposure in accordance with 29 CFR 1910.20, "Access to Employee Exposure and Medical Records."

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(Name of Responsible person or department) is responsible for maintenance of the required medical records. These confidential records are kept at (List location) for at least the duration of employment plus 30 years. Include information such as: Employee name, employee number or social security number, home address, home phone number, first day of work, last day of work, occupational risk category, records of hepatitis B vaccines and boosters, or signed declination form (see Hepatitis B Vaccination section) Employee medical records are provided upon request of the employee or to anyone having written consent of the employee within 15 working days. Such requests should be sent to (Name of responsible person or department and address) OSHA Recordkeeping An exposure incident is evaluated to determine if the case meets OSHA's Recordkeeping Requirements (29 CFR 1904). This determination and the recording activities are done by (Name of responsible person or department). Hepatitis B Vaccination (Name of responsible person or department) will provide training to employees on hepatitis B vaccinations, addressing the safety, benefits, efficacy, methods of administration, and availability. The hepatitis B vaccination series is available at no cost after training and within 10 days of initial assignment to employees identified in the exposure determination section of this plan. Vaccination is encouraged unless: 1) documentation exists that the employee has previously received the series, 2) antibody testing reveals that the employee is immune, or 3) medical evaluation shows that vaccination is contraindicated. However, if an employee chooses to decline vaccination, the employee must sign a declination form: I understand that, due to my occupational exposure to blood or other potentially infectious materials, I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis b vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B. a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis B vaccine3, I can receive the vaccination series at no charge to me. Employees who decline may request and obtain the vaccination at a later date at no cost. Documentation of refusal of the vaccination is kept at (List location or person responsible for this recordkeeping). Vaccination will be provided by (List Health care Professional who is responsible for this part of the plan) at (location). Following hepatitis B vaccinations, the health care professional's Written Opinion will be limited to whether the employee requires the hepatitis vaccine, and whether the vaccine was administered. Keep any exposure incident reports with this record as well. Employee Training All employees who have occupational exposure to bloodborne pathogens receive training conducted by (Name of responsible person or department). (Attach a brief description of their qualifications.) All employees who have occupational exposure to bloodborne pathogens receive training on the epidemiology, symptoms, and transmission of bloodborne pathogen diseases. In addition, the training program covers, at a minimum, the following elements: a copy and explanation of the standard an explanation of our ECP and how to obtain a copy an explanation of methods to recognize tasks and other activities that may involve exposure to blood and OPIM, including what constitutes an exposure incident an explanation of the use and limitations of engineering controls, work practices, and PPE an explanation of the types, uses, location, removal, handling, decontamination, and disposal of PPE an explanation of the basis for PPE selection information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine will be offered free of charge

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information on the appropriate actions to take and persons to contact in an emergency involving blood or OPIM an explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident an explanation of the signs and labels and/or color coding required by the standard and used at this facility an opportunity for interactive questions and answers with the person conducting the training session. Training materials for this facility are available at ___________________________.

Engineering Control Evaluation Form The following is a sample form that may be used in evaluating safer engineering controls. Forms like this are not specifically required by the bloodborne pathogens standard, but they may be useful as guidance documents. Employers are responsible for setting the evaluation criteria for the devices used in their facilities in accordance with the standard.

Questionnaire For Evaluating Sharps Disposal Container Performance

xxix

INSTRUCTIONS: Product evaluators should inspect and operate containers to be evaluated in side-by-side comparisons. Representative sharps (syringes, IV sets, blades, biopsy needles, pipettes, etc.) should be used to test candidate products. Actual use conditions should be simulated, if possible. Prior to inserting test sharps, attempt to reopen sealed containers and attempt to spill or remove contents from unsealed containers if this is a functional requirement. Evaluation facilitators should provide product manufacturer literature and visual instructions and should demonstrate proper operation of each of the containers. Use of this guideline requires knowledge that the ideal product may not exist and that this evaluation tool was based on common product designs available at the time.
PLEASE CIRCLE YOUR RESPONSE FUNCTIONALITY Container is stable when placed on horizontal surface and when used as described in the product labeling for use in trays, holders, or enclosures Container provides for puncture, leak, and impact resistance Container, labels, warning devices, and brackets are durable Container is autoclavable, if necessary Container is available in various sizes and capacities Container is available with auxiliary safety features (e.g., restricted access to sharps in the container), if required Closure mechanism will not allow needlestick injury Closure mechanism provides secure seal Design minimizes needle-tip flipback Design promotes clinical performance (e.g., will not compromise sterile field or increase injury or infection control hazards) Design resists easy reopening after sealing for final disposal or autoclaving Inlet design defeats waste removal when open Inlet design prevents spillage of contents (physical or liquid) while sharps disposal container is in use in the intended upright position Containers designed to be reopenable have removable lids design with tight closure that facilitates ease of removal with grip safety and comfort Mounting brackets are rugged and designed for ease of service and decontamination ACCESSIBILITY agree . . . . . disagree 1 2 3 4 5 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 5 5

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Container available in various opening sizes and shapes Containers are supplied in sufficient quantity Container has an entanglement-free opening/access way Container opening/access way and current fill status visible to user prior to placing sharps into container Internal design/molding of container does not impede ease of use Handles, if present, located above full-fill level Handles, if present, facilitate safe vertical transport and are located away from opening/access way and potentially soiled surfaces Fixed locations place container within arm's reach of point of waste generation Fixed locations allow for installation of the container below horizontal vision level If necessary, in high patient or visitor traffic areas, container should provide for security against tampering VISIBILITY Color or warning label implies danger. A warning indicator (i.e., color or warning label) is readily visible to the user prior to user placing sharps into container Overfill level provided and current fill status is readily visible to the user prior to use placing sharps into container Sharps disposal container complies with OSHA requirements Disposal opening/access way is visible prior to user placing sharps into container Security, mounting, aesthetic, and safety features do not distort visibility of the opening/access way or fill status indicator ACCOMMODATION

agree . . . . . disagree 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 1 1 1 1 1 2 2 2 2 2 2 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5

agree . . . . . disagree 1 2 3 4 5 1 2 3 4 5 1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4 5 5 5 5

agree . . . . . disagree No sharp edges in construction or materials 1 2 3 4 5 Safety features do not impede free access 1 2 3 4 5 Promotes patient and user satisfaction (i.e., aesthetic to extent possible) 1 2 3 4 5 Is simple to operate 1 2 3 4 5 Any emissions from final disposal comply with pollution regulations 1 2 3 4 5 Easy to assemble, if required 1 2 3 4 5 Components of containers that require assembly are easy to store prior to use 1 2 3 4 5 Use allows onehanded disposal 1 2 3 4 5 Product available in special designs for environments with specific needs (e.g., 1 2 3 4 5 laboratories, emergency rooms, emergency medical services, pediatrics, correctional facilities) Mounting system durable, secure, safe, cleanable, and, where appropriate, lockable 1 2 3 4 5 Mounting systems allow height adjustments 1 2 3 4 5 Design promotes task confidence 1 2 3 4 5 Cost effectiveness 1 2 3 4 5 OTHER COMMENTS What design or performance requirements are missing from the product you evaluated that are really needed to safely or more comfortably conduct your job or sharps related task?

Additional Evaluator Concerns and Comments:

This product selection questionnaire was developed by the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health in conjunction with NIOSH Educational Resource Centers; The Johns Hopkins University, Baltimore; the University of Texas, Houston; the University of California, Berkeley; and the Mount Sinai School of Medicine, New York City.

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Guidelines for the Use of Safety Features Evaluation Sheets

xxx

Coordinators: Determine which products are to be evaluated and provide at least four or more test samples for each individual evaluating the product. (Each evaluator should have enough samples to disassemble and examine the design thoroughly.) Set up a testing station for each type of device which allows testers to evaluate products in a simulated patient procedure. Provide training dummies (injection pads, oranges, etc.) as necessary. Provide visual instructions and demonstrate proper use of each device. Review the instructions and rating system with each evaluator. Encourage each evaluator to comment on the sheets and prioritize the questions at the end of the evaluation. This will provide a useful decision making tool and will help alert you to specific areas of concern which may not have been covered by the questionnaire. Evaluators: Re-enact all steps of intended or possible procedures performed with the device being tested. Attempt to misuse the device and circumvent or disable the safety feature. Answer each question, including the short answer section at the end. If you do not understand a question, please write comments directly on the sheets. NOTE: Certain assumptions have been made in the development of these forms based on information about currently available products. We recognize the likelihood that the ideal product may not exist.
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Safety Feature Evaluation Form: Safety Dental Syringes

Date: _______ Department: ____________ Occupation: ________________________ Product: _______________________ Number of times used: ___________________ Please circle the most appropriate answer for each question. Not applicable (N/A) may be used if the question does not apply to this particular product. agree . . . . . disagree 1. The safety feature can be activated using a one-handed technique 1 2 3 4 5 N/A 2. The safety feature does not obstruct vision of the tip of the sharp and the intraoral 1 2 3 4 5 N/A injection site. 3. Use of this product requires you to use the safety feature 1 2 3 4 5 N/A 4. This product does not require more time to use than a non-safety device 1 2 3 4 5 N/A 5. The safety feature works well with a wide variety of hand sizes 1 2 3 4 5 N/A 6. The device is easy to handle while wearing gloves 1 2 3 4 5 N/A 7. The device is easy to handle when wet 1 2 3 4 5 N/A 8. This device accepts standard anesthetic carpules and does not hinder carpule changing 1 2 3 4 5 N/A 9. The safety feature does not restrict visibility of carpule contents intraorally 1 2 3 4 5 N/A 10. This device accepts standard dental needles of all common lengths and gauges, and 1 2 3 4 5 N/A does not interfere with needle changing 11. The device provides a better alternative to traditional recapping 1 2 3 4 5 N/A 12. Sterilization of this device is as easy as a standard dental syringe 1 2 3 4 5 N/A 13. For syringes with integral needles only: The needle on this syringe will not break 1 2 3 4 5 N/A while bending and repositioning in the tissue 14. This device is no more difficult to break down after use for sterilization than a 1 2 3 4 5 N/A standard dental syringe 15. The safety feature operates reliably 1 2 3 4 5 N/A 16. The exposed sharp is permanently blunted or covered after use and prior to disposal 1 2 3 4 5 N/A 17. There is a clear and unmistakable change (either visible or audible) that occurs when 1 2 3 4 5 N/A the safety feature is activated 18. The user does not need extensive training to operate the product correctly 1 2 3 4 5 N/A 19. The design of the device allows for easy removal of the needle from the syringe 1 2 3 4 5 N/A 20. The design of the device allows for easy removal of the carpule from the syringe 1 2 3 4 5 N/A

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Summary Checklists
Introduction
In outline form, here are the main points of infection control for the dental office: Before the patient is seated for treatment:

All health care workers in direct contact with patients should be immunized against the hepatitis B virus. Each patient should fill out a thorough medical health history form and this should be updated at each appointment. Prostheses and appliances to be delivered to the patients should be disinfected before fitting. Disposable coverings should be placed prior to seating patient in operatory, and all surfaces should be disinfected. Take a few seconds to look over the setup to see if anything is missing.

During patient treatment:

Treat all patients as potentially infectious. Use protective wear and barrier techniques when in contact with body fluids or mucous membranes: gloves, mask, protective eyewear, and gowns, lab coats, or uniforms. X-ray films that are contaminated should be opened for processing in the darkroom with gloves, being careful not to touch the film. Then, remove the gloves to place film in the developer. Conduct procedures with the minimum amount of droplets, spatters, and aerosols. Use a rubber dam when appropriate. Use a high-volume aspirator. Use gloves correctly to protect hands. Wash hands before and after gloving. Change gloves in between each patient. Change gloves that are torn, cut, or punctured. Avoid injury to hands by being careful with sharp items, placing disposable needles in an appropriate receptacle, and recapping needles using a recommended technique. Try not to leave the treatment room if at all possible during a procedure. Use an overglove if answering the phone, writing or going into a drawer. Don't touch your face or hair. At end of treatment: discard mask and gloves, wash hands, and remove gown. Make notes in chart and dismiss patient.

After the patient leaves:

Wear heavy rubber gloves while disinfecting surfaces and handling instruments. Clear off all instruments that can be soaked and put them in a container. Clean all debris from instruments. Sterilize instruments that penetrate soft tissue or bone. Also sterilize, when possible, all instruments that come in contact with oral mucous membranes, body fluids, or any contaminated secretions of patients. High level of disinfectant must be used if item is heat sensitive or oddly sized. Run air/water syringe, ultrasonic scaler, and/or handpiece for 30 seconds to flush lines. Clean suction lines with disinfectant by aspirating an acceptable, non-foaming solution. Dispose of all disposable items after one use. Clean and sterilize handpieces if possible; follow manufacturer's directions. Use caution when handling sharps, especially disposable needles and scalpels. Place them in a punctureresistant container before disposal. Decontaminate all environmental surfaces. Use absorbent paper toweling and a detergent type disinfectant to preclean surface and remove debris. Dispose of towels appropriately. Spray area liberally with disinfectant and leave wet for the time indicated by the directions. Dispose of and replace any protective coverings on switches, light handles, x-ray unit head. Decontaminate all outgoing materials such as impressions, bite registrations, and appliances being sent to a laboratory. Use only small individual amounts of pumice in a disposable container for each patient, and discard any unused portion. Appropriately dispose of wastes. Any blood, suctioned fluids, or other liquid waste should be poured in a drain connected to a sanitary sewer system. Solid wastes contaminated with blood or saliva, including tissue, extracted teeth, and bloody (dripping) gauze should be sealed in a sturdy impervious bag and disposed of according to local government regulations. Wash hands after removing gloves.

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Dental Laboratories
Incoming Cases

Wear appropriate protective gear including lab coats or uniforms, masks, and appropriate gloves (utility type when working with chemicals, disposable type when handling infected cases). Have a specific receiving area where all cases are placed before being taken to the production area. Properly disinfect each case when it is received. (If impressions cannot be disinfected without distorting, pour up and then disinfect the model). Disinfect case containers. Disinfect countertops and work areas daily by precleaning and then spraying with a suitable disinfectant, following the manufacturer's directions. Any solid waste contaminated with blood or saliva should be placed in sturdy bags and disposed of according to local regulations.

Production Area

Use appropriate protective wear, safety glasses and masks. Clean and disinfect work surfaces daily. Have different sets of instruments, attachments, and materials: one for new cases and others for cases that have already been in a patient's mouth. Use small, individual amounts of pumice for each case and discard any remaining. Clean and disinfect brushes and other equipment used on contaminated prostheses. Clean and autoclave ragwheels.

Outgoing cases

Disinfect all outgoing cases. Communicate clearly with the dental office about infection control procedures the laboratory uses and what must be done to each case in the dental office.

Timetable Checklist
Daily
Clean and disinfect floors, work surfaces, door knobs, sink handles, drawer pulls, and anything else that may have been touched but not disinfected after each patient. Clean sterilizing area, disinfect brushes, and wipe down heat sterilizers.

Weekly
Clean and disinfect lower areas of walls, front office areas, phones, and other areas not disinfected daily. Check stock and supplies to make certain you have an adequate amount of barrier products, chemicals, solutions, and supplies for the next week. Check the expiration date on all chemicals like glutaraldehyde. Test heat sterilizer with biological test strips.

Monthly
Clean out drawers and storage spaces, disinfect with a product that has a long lasting effect.

Annually
Review cross-infection control system. Have an OSHA training meeting. Check that your hepatitis B vaccine is up to date (usually needs a booster every 5 years). Communicate with the laboratory regarding infection control of incoming/outgoing cases.

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Supplies
What are the products claims? Do they fit well with the needs of the practice? Does the product meet or exceed regulatory requirements? Does it meet the current standards of care and guidelines for infection control? Is it easy to use? Are instructions clear, easy to follow and compatible with the conditions of use in the practice? Are any special precautions required when using the product, and if so, are they reasonable? Is the product cost-effective? What are the disposal requirements? Are the products components compatible with the materials found in the practice? vii Is the product acceptable to staff and patients?

Cleaning Materials

Antibacterial Handwash Container with a lid for collecting, presoaking, and transporting instruments from the room to the sterilizing area Rigid container for sharps disposal Properly functioning heat sterilizer Glutaraldehyde for submersion sterilant Chemical detergent precleaner Chemical disinfectant (best if it is detergent like, then one product can be used for both precleaning and disinfecting) Wire instrument cleaning brush Ultrasonic cleaner Disposable, individual units of items like pumice Barrier Protection Supplies Disposable gloves: latex and vinyl Face masks or face shield Clean uniform Disposable or washable fluid-resistant gown Heavy utility gloves for clean up and mixing of chemicals Disposable covers for surfaces and switches Patient bibs Rubber dam Safety device for recapping needles

Federal OSHA Checklist

OSHA Poster (Form 2203or the newer version: Form 3165) in an area where employees can see it. Bloodborne Pathogens Standard accessible to all employees. Universal precautions practiced and understood by all exposed employees. Written exposure plan including: exposure determination listing of all jobs that involve some occupational exposure listing of tasks and procedures where the exposure occurs. Engineering and work practice controls used routinely: High-speed evacuation, rubber dam, correct needle recapping, self-sheathing needles, etc. Handwashing facilities that are readily accessible. Employees instructed to wash hands after removing gloves. Employees instructed to wash hands, skin, or mucous membranes after exposure to blood or other potentially infectious materials. Employees recap or remove needles according to safe guidelines (one handed technique or forceps). No eating, drinking, smoking, applying cosmetics or lip balm, or handling contact lenses in areas where occupational exposure is likely. No food or drink stored in areas where blood or other potentially infectious materials are present. Specimens placed in labeled and color-coded container which will not leak during collection, handling, processing, storage, transport, or shipping. Equipment decontaminated before servicing or shipment. Any contaminated equipment should be labeled. Hepatitis B vaccine is available to all employees with occupational exposure at no cost to them. Anyone not wishing to be vaccinated must sign the declination form. Employer provides, repairs, and replaces personal protective equipment. Employer launders or disposes of personal protective equipment. Any garment penetrated by blood or other infectious materials is removed as soon as feasible.

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Personal protective equipment is not worn out of the work area. Used and soiled protective equipment is in an appropriate designated area prior to storage, washing, decontamination or disposal. Gloves are worn when contacting blood or saliva. Disposable gloves are disposed of after each use. Utility gloves may be decontaminated for reuse but are disposed of when punctured, cracked, or peeling. Masks and goggles, glasses with solid side shields, or chin length face shield must be worn whenever splashes, spray, spatter, or droplets may be generated. Gowns, lab coats, clinic jackets, etc., worn in exposure situations. Type depends upon task and degree of exposure anticipated. Workplace maintained in a clean and sanitary condition with a written schedule for cleaning and method of decontamination. Equipment and surfaces cleaned and decontaminated following exposure to blood and saliva. Equipment and surface barriers removed and replaced between patients. Sharps disposed of immediately or as soon as feasible in containers that are closable, puncture resistant, leakproof, labeled and color-coded. Blood or saliva-soaked disposables placed in labeled and color-coded containers that are closable, prevent leakage, closed before removal. OSHA Forms 101 and 200 for recording occupational injury or illness. Kept for 5 years. Post-exposure and evaluation and follow-up program. Reporting, documentation, and follow-up requirements followed. Yearly review of exposure incidents. Employee medical records maintained for length of employment plus 30 years. Sterilization log maintained. Training program provided to employees with occupational exposure at no cost to the employee and during working hours. Training provided at the time of initial assignment and at least annually thereafter. Additional training provided when tasks or procedures change or new tasks or procedures are instituted. Training records maintained for 3 years from the date on which the training occurred. Waste disposal log maintained for 3 years.

The Absolute Bottom Line

Be vaccinated against hepatitis B. Treat all patients as if they were infectious. Have patients use an antiseptic mouthrinse before invasive procedures. Use an antiseptic handwash. Wear a disposable mask or faceshield. Wear disposable latex gloves any time you touch mucous membranes. Wear protective eyewear. Wear a disposable gown or lab coat when spatter is expected. Wear clinical attire at all times. Use a rubber dam when appropriate. Put needles and other sharps in a puncture resistant container. Use sterilizable handpieces. Use an ultrasonic cleaner instead of hand scrubbing instruments. Package instruments correctly for sterilization. Use a heat sterilizer. As a general rule of thumb, it an instrument goes into a patients mouth, it needs to be either discarded or sterilized before being used on another patient. Monitor the sterilizer with appropriate spore tests weekly. Use glutaraldehyde for items that cannot be heat sterilized for the appropriate time recommended. Use an appropriate surface precleaner. Use an appropriate surface disinfectant for the time recommended by the manufacturer. Use surface covers. Have an adequate waste disposal system according to local regulations. Put your OSHA poster up where employees can read it. Have a regular OSHA training class.

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Review scientific literature for technology at least annually to find safer devices to use in your practice. Keep your dental unit water cleaner than 200 CFU/mL for regular procedures and use sterile water for surgical procedures.

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Test
Please mark only one best answer to the following questions on the one page answer sheet. Return the answers by mailing or faxing the answer sheet or entering your answers on the form available on our website at www.fice.com. This test contains 50 questions. Please mark your answers in spaces numbered 1 through 50 on your answer sheet. 1. In the dental environment, disinfection means: a. to sterilize. b. destruction of several forms of disease-producing microorganisms, but not bacterial spores. c. destruction of all forms of life including viruses, bacteria, fungi, and spores. d. none of the above. 2. Universal precautions means that the infection control procedures and barrier techniques are determined by the exposure to blood and blood-contaminated products, and are used on all patients, regardless of their disease state. a. True b. False 3. The greatest concentration of the hepatitis B virus in the mouth is in: a. the tongue b. the anterior palate c. the gingival sulcus d. the enamel structure 4. Which of the following can damage latex gloves? a. oil or petroleum based hand cream b. disinfecting chemicals c. antimicrobial hand wash d. a sharp instrument e. all of the above 5. OSHA requires employers to launder or dispose of lab coats or gowns. a. True b. False 6. Protective eyewear or face shields should: a. have openings at the sides to allow for ventilation. b. be designed to shield the eyes from contaminated material. c. be disposable. d. be sterilizable.

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7. Local ordinances for contaminated waste disposal: a. are federally mandated by the FDA. b. are the same as disposal for uncontaminated waste. c. vary from area to area in regards to waste management so professionals must check with local authorities for specific regulations. d. all of the above. 8. A preprocedural chlorhexidine gluconate rinse may be indicated: a. prior to oral surgery to reduce the patients chances of developing an infection. b. as an adjunct to antibiotic prophylaxis if the patient has poor oral hygiene, c. for patients who are compromised because of HIV infection or cancer. d. all of the above 9. Properly diluted iodophor is rated by the EPA as a tuberculocidal disinfectant. a. True b. False 10. Sodium hypochlorite (bleach) is recommended: a. as a surface disinfectant after every patient b. as a surface disinfectant after a high-risk patient c. as a sterilizing soak for metal instruments. d. as a solution to apply to contaminated paper products before their disposal 11. Isopropyl alcohol (used alone) is unacceptable as a surface disinfectant because: a. it has a residual effect. b. it is approved by the EPA. c. it is ineffective against bacterial spores. d. it is effective against bacterial spores. 12. Older quaternary ammonium compounds are approved by The Council for Dental Therapeutics of The American Dental Association. a. True b. False 13. Presoaking contaminated instruments in a mild detergent is beneficial because: a. it will sterilize the instruments. b. presoaking will protect the instruments from damage. c. it is required by law. d. presoaking takes the place of hand scrubbing or using an ultrasonic. e. it will prevent blood, saliva, and debris from drying on the instruments.

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14. When handling contaminated instruments, wear: a. heavy utility gloves. b. protective eyewear. c. a mask. d. protective clothing. e. all of the above 15. Ultrasonic cleaners are a safer way of precleaning instruments than hand scrubbing. a. True b. False 16. When packaging instruments: a. use the correct type of instrument packaging for the sterilizing system you use. b. make sure the packaging is strong enough to hold the sharp tips of instruments within the bag to avoid contamination and possible injury. c. use containers of some type because loose instruments will become easily contaminated after removal from the sterilizer. d. bag instruments in sets to be used on individual patients and open them in front of the patient. e. all of the above 17. Autoclavable handpieces should be sterilized after each use. a. True b. False 18. Disposable items should not be disinfected and reused, they should be thrown away after each use. a. True b. False 19. To disinfect high speed evacuation systems: a. flush after every patient with a 2% glutaraldehyde or any other non-foaming agent recommended by the manufacturer for disinfecting the lines. b. at the end of the day, flush with a disinfectant that will remain in the vacuum system overnight to help reduce the number of microorganisms. c. handle evacuation system traps with utility gloves. d. clean the traps with a high-level disinfectant every day. e. all of the above 20. Disinfect impressions by rinsing with hot tap water before casting with die stone or sending out to the laboratory. a. True b. False

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21. Common mistakes of sterilizer use include: a. use of ultrasonic cleaners to preclean the instruments. b. using only one layer of wrap for good penetration. c. overloading sterilizer chamber. d. completely drying instruments before packaging. 22. The American Dental Association recommends sterilizers should be spore tested: a. daily. b. weekly. c. yearly. d. when instruments start looking dirty after a cycle. 23. In addition to the date, operator name, description of the general contents of the load, and maintenance, spore test records should include: a. sterilizer identification number. b. duration and temperature of sterilization cycle. c. results of biologic monitoring. d. all of the above. 24. The first step to take if a monitoring service indicates that the sterilizer failed the spore test is: a. repeat the spore test. b. order a new unit and use a tuberculocidal disinfectant spray on all instruments until the new one arrives. c. take the sterilizer out of service. d. use the same unit but run all loads twice. 25. Glutaraldehyde is recommended for immersion use only and is not recommended for use as a surface disinfectant. a. True b. False 26. If the Dental Laboratory technicians are not sure that an impression (or case) has been disinfected, they should: a. send it back to the dental office for disinfection. b. disinfect it as it is received. c. work with it as it is. d. autoclave it. 27. The Dental Laboratory should disinfect outgoing cases before delivery. a. True b. False

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28. The Written Exposure Plan required by OSHA should include: a. the names of workers who have occupational exposure to blood and other potentially infectious materials. b. how these employees will be protected and trained. c. the employer's protocol for barrier techniques, sterilization, disinfection, and hepatitis B vaccination. d. handling of office accidents, post-exposure evaluation and follow-up, communications of hazards to employees and record keeping. e. all of the above. 29. Water with less than CFU/mL of heterotrophic mesophillic bacteria is acceptable for non-surgical procedures including those involving the sulcus or initial access into dental pulp: a. 2. b. 20. c. 200 d. 20,000. 30. The US Food and Drug Administration classifies dental water treatment and delivery systems as medical devices. a. True b. False 31. Any chemical germicides used to treat dental unit waterlines must be EPA registered and produce water that must: a. be compatible with dental restorative materials. b. not exceed 20,000 CFU/mL of heterotrophic mesophillic bacteria. c. contain toxic or carcinogenic chemicals. d. all of the above. 32. In the case Sharpe vs. Breglio confirms: a. it is illegal to refuse to treat a patient because of their HIV status. b. HIV was not transmitted from Dr. Acer to his patients. c. the Supreme Court decision that HIV infected individuals are protected under the Americans with Disabilities Act. d. the necessity of heat sterilizing dental equipment (including dental hand pieces), and gives additional documentation that the virus is not spread by dental visits. 33. In the Bloodborne Pathogens Standard, OSHA addresses: a. engineering controls. b. work practice controls. c. personal protective equipment. d. housekeeping and disposal of regulated waste. e. all of the above.

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34. Employers are required to have an unwritten verbal agreement with workers who are occupational exposed to blood and other potentially infectious materials. a. True b. False 35. A written exposure control plan identifying workers with occupational exposure to blood and other potentially infectious materials must be specific for the facility and appropriate for dental office procedures. a. True b. False 36. Employers are responsible to provide confidential medical evaluation and management for all employees who report an exposure incident. a. True b. False 37. The employee is responsible for purchasing protective equipment if their jobs may expose them to blood, body tissue, or saliva. a. True b. False 38. Sharps containers must be: a. blue, hidden from view of the patient, and centrally located. b. labeled, easily accessible and as close as possible to work stations where sharps are used. c. a fixed part of the dental syringe and will provide a barrier between the hands and the needle immediately after its use. d. unmarked and easy to open. 39. Employers must offer the hepatitis B vaccine without charge to employees within 1 year of assignment to a position with occupational exposure. a. True b. False 40. Workers may decline the vaccine by signing a form to that effect, but they retain the right to employer-provided vaccinations if they change their minds. a. True b. False 41. The agenda for an OSHA training meeting must include: a. a copy of the Bloodborne Pathogens Standard. b. doughnuts and coffee. c. time for each employee to fill out an MSDS form.

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d. a playact of a dental surgery and proper disposal of an extracted tooth. e. expensive training materials to be distributed to each employee. 42. OSHA requires the instructor for annual office OSHA meetings to know enough about the OSHA regulations to answer questions asked by the staff. a. True b. False 43. Records of OSHA training meetings must be kept for a. 3 b. 30 44. Records of the training meetings should include: a. date of training b. summary of class c. qualifications and name of trainer and names and job titles of all attendees d. all of the above 45. Employee medical records must be maintained for: a. the length of employment b. the length of employment plus 30 years c. 30 years d. for the lifetime of the employer 46. MSDS sheets should be available from the: a. American Dental Association. b. U.S. Food and Drug Administration. c. Centers for Disease Control. d. manufacturer of the product. 47. Manufacturers must update the MSDS within three months of learning that new hazard data is available for the MSDS. a. True b. False 48. Manufacturers of hazardous chemicals must label all containers before shipping with the identity of the contents, its hazard warning(s), and the name and address of the chemical manufacturer. a. True b. False 49. Secondary containers of hazardous chemicals must: a. be made of transparent plastic. b. include hazard warnings in English, Spanish, Japanese, and Greek. years.

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c. be labeled with its contents and hazard warnings. d. indicate the name of the person in the facility responsible for maintaining the MSDS log. 50. The OSHA Ergonomics Standard published in November 2000 is in effect today and employers are held responsible by OSHA to train their employees about any risk of injuries from repetitive tasks. a. True. b. False (end of test)

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Bibliography and Suggested Reading List

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Appendices
OSHA Bloodborne Pathogens Standard
Federal Register December 6, 1991 Vol. 56. No. 235 XI. The Standard General Industry Part 1910 of title 29 of the Code of Federal Regulations is amended as follows: PART 1910-[AMENDED] Subpart Z-[Amended] 1. The general authority citation for subpart Z of 29 CFR part 1910 continues to read as follows and a new citation for ? 1910.1030 is added: Authority: Secs. 6 and 8, Occupational Safety and Health Act, 29 U.S.C. 655, 657, Secretary of Labor's Orders Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), or 83 (48 FR 35736), as applicable: and 29 CFR part 1911. * * * * * Section 1910.1030 also issued under 29 U.S.C. 653. * * * * * 2. Section 1910.1030 is added to read as follows: 1910.1030 Bloodborne Pathogens. (a) Scope and Application. This section applies to all occupational exposure to blood or other potentially infectious materials as defined by paragraph (b) of this section. (b) Definitions. For purposes of this section, the following shall apply: Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and health, or designated representative. Blood means human blood, human blood components, and products made from human blood. Bloodborne Pathogens means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus, [HBV] and human immunodeficiency virus [HIV]. Clinical Laboratory means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials. Contaminated means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. Contaminated Laundry means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps. Contaminated Sharps means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. Decontamination means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal. Director means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designated representative. Engineering Controls means controls (e.g., sharps disposal containers, self-sheathing needles) that isolate or remove the bloodborne pathogens hazard from the workplace. Exposure Incident means a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties. Handwashing Facilities means a facility providing an adequate supply of running potable water, soap and single use towels or hot air drying machines. Licensed Healthcare Professional is a person whose legally permitted scope of practice allows him or her to independently perform the activities required by paragraph (f) Hepatitis B Vaccination and Post-exposure Evaluation and Follow-up. HBV means hepatitis B virus. HIV means human immunodeficiency virus. Occupational Exposure means reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties. Other Potentially Infectious Materials means (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV- containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. Parenteral means piercing mucous membranes or the skin barrier through such events as needlesticks, human bites, cuts, and abrasions.

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Personal Protective Equipment is specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes, (e.g. uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment. Production Facility means a facility engaged in industrial-scale, large-volume or high concentration production of HIV or HBV. Regulated Waste means liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials. Research Laboratory means a laboratory producing or using research-laboratory-scale amounts of HIV for HBV. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in production facilities. Source Individual means any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Examples include, but are not limited to, hospital and clinic patients; clients in institutions for the developmentally disabled; trauma victims; clients of drug and alcohol treatment facilities; residents of hospices and nursing homes; human remains; and individuals who donate or sell blood or blood components. Sterilize means the use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. Universal Precautions is an approach to infection control. According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens. Work Practice Controls means controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique). (c) Exposure control- (1) Exposure Control Plan. (i) Each employer having an employee(s) with occupational exposure as defined by paragraph (b) of this section shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure. (ii) The Exposure Control Plan shall contain at least the following elements; (A) The exposure determination required by paragraph (c)(2), (B) The schedule and method of implementation for paragraphs (d) Methods of Compliance, (e) HIV and HBV Research Laboratories and Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up, (g) Communication of Hazards to Employees, and (h) Recordkeeping, of this standard, and (C) The procedure for the evaluation of circumstances surrounding exposure incidents as required by paragraph (f)(3)(i) of this standard. (iii) Each employer shall ensure that a copy of the Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure. (v) The Exposure Control Plan shall be made available to the Assistant Secretary and the Director upon request for examination and copying. (2) Exposure determination. (i) Each employer who has an employee(s) with occupational exposure as defined by paragraph (b) of this section shall prepare an exposure determination. This exposure determination shall contain the following: (A) A list of all job classifications in which all employees in those job classifications have occupational exposure; (B) A list of job classifications in which some employees have occupational exposure, and (C) A list of all tasks and procedures or groups of closely related tasks and procedures in which occupational exposure occurs and that are performed by employees in job classifications listed in accordance with the provisions of paragraph (c)(2)(i)(B) of this standard. (ii) This exposure determination shall be made without regard to the use of personal protective equipment. (d) Methods of compliance- (1) General- Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids shall be considered potentially infectious materials. (2) Engineering and work practice controls. (i) Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, personal protective equipment shall also be used. (ii) Engineering controls shall be examined and maintained or replaced on a regular schedule to ensure their effectiveness. (iii) Employers shall provide handwashing facilities which are readily accessible to employees. (iv) When provision of handwashing facilities is not feasible, the employer shall provide either an appropriate antiseptic hand cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes. When antiseptic hand cleansers or towelettes are used, hands shall be washed with soap and running water as soon as feasible. (v) Employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment. (vi) Employers shall ensure that employees wash hands and any other skin with soap and water immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials. (vii) Contaminated needles and other contaminated sharps shall not be bent, recapped, or removed except as noted in paragraphs (d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of contaminated needles is prohibited. (A) Contaminated needles and other contaminated sharps shall not be recapped or removed unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical procedure. (B) Such recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique. (viii) Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in an appropriate containers until properly reprocessed. These containers shall be: (A) Puncture resistant; (B) Labeled or color-coded in accordance with this standard; (C) Leakproof on the sides and bottom; and (D) In accordance with the requirements set forth in paragraph (d)(4)(ii)(E) for reusable sharps. (ix) Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is reasonable likelihood of occupational exposure. (x) Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present. (xi) All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances.

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(xii) Mouth pipetting/suctioning of blood or other potentially infectious materials is prohibited. (viii) Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. (A) The container for storage, transport, or shipping shall be labeled or color-coded according to paragraph (g)(1)(i) and closed prior to being stored, transported, or shipped. When a facility utilizes Universal Precautions in the handling of all specimens, the labeling/ colorcoding of specimens is not necessary provided containers are recognizable as containing specimens. This exemption only applies while such specimens/containers remain within the facility. Labeling or color-coding in accordance with paragraph (g)(1)(i) is required when such specimens/ containers leave the facility. (B) If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or color-coded according to the requirements of this standard. (C) If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which is puncture-resistant in addition to the above characteristics. (xiv) Equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible. (A) A readily observable label in accordance with paragraph (g)(1)(i)(H) shall be attached to the equipment stating which portions remain contaminated. (B) The employer shall ensure that this information is conveyed to all affected employees, the servicing representative, and/or the manufacturer, as appropriate, prior to handling, servicing, or shipping so that appropriate precautions will be taken. (3) Personal protective equipment(i) Provision. When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used. (ii) Use. The employer shall ensure that the employee uses appropriate personal protective equipment unless the employer shows that the employee temporarily and briefly declined to use personal protective equipment when, under rare and extraordinary circumstances, it was the employee's professional judgment that in the specific instance its use would have prevented the delivery of health care or public safety services or would have posed an increased hazard to the safety of the worker or co-worker. When the employee makes this judgment, the circumstances shall be investigated and documented in order to determine whether changes can be instituted to prevent such occurrences in the future. (iii) Accessibility. The employer shall ensure that appropriate personal protective equipment in the appropriate sizes is readily accessible at the worksite or is issued to employees. Hypoallergenic gloves, glove liners, powderless gloves, or other similar alternatives shall be readily accessible to those employees who are allergic to the gloves normally provided. (iv) Cleaning, Laundering, and Disposal. The employer shall clean, launder, and dispose of personal protective equipment required by paragraphs (d) and (e) of this standard, at no cost to the employee. (v) Repair and Replacement. The employer shall repair or replace personal protective equipment as needed to maintain its effectiveness, at no cost to the employee. (vi) If a garment(s) is penetrated by blood or other potentially infectious materials, the garment(s) shall be removed immediately or as soon as feasible. (vii) All personal protective equipment shall be removed prior to leaving the work area. (viii) When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination or disposal. (ix) Gloves. Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures except as specified in paragraph (d)(3)(ix)(D); and when handling or touching contaminated items or surfaces. (A) Disposable (single use) gloves such as surgical or examination gloves, shall be replaced as soon as practical when contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised. (B) Disposable (single use) gloves shall not be washed or decontaminated for re-use. (C) Utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised, however, they must be discarded if they are cracked, peeling, torn, punctured, or exhibit other signs of deterioration or when their ability to function as a barrier is compromised. (D) If an employer in a volunteer blood donation center judges that routine gloving for all phlebotomies is not necessary then the employer shall: (1) Periodically reevaluate this policy; (2) Make gloves available to all employees who wish to use them for phlebotomy; (3) Not discourage the use of gloves for phlebotomy; and (4) Require that gloves be used for phlebotomy in the following circumstances: (i) When the employee has cuts, scratches, or other breaks in his or her skin; (ii) When the employee judges that hand contamination with blood may occur, for example, when performing phlebotomy on an uncooperative source individual; and (iii) When the employee is receiving training in phlebotomy. (x) Masks, Eye Protection, and Face Shields. Masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated. (xi) Gowns, Aprons, and Other Protective Body Clothing. Appropriate protective clothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer garments shall be worn in occupational exposure situations. The type and characteristics will depend upon the task and degree of exposure anticipated. (xii) Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated (e.g., autopsies, orthopaedic surgery).

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(4) Housekeeping. (i) General. Employers shall ensure that the worksite is maintained in a clean and sanitary condition. The employer shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area. (ii) All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials. (A) Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning. (B) Protective coverings, such as plastic wrap, aluminum foil, or imperviously-backed absorbent paper used to cover equipment and environmental surfaces, shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the workshift if they may have become contaminated during the shift. (C) All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials shall be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination. (D) Broken glassware which may be contaminated shall not be picked up directly with the hands. It shall be cleaned up using mechanical means, such as a brush and dust pan, tongs, or forceps. (E) Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed. (iii) Regulated Waste. (A) Contaminated Sharps Discarding and Containment. (1) Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: (i) Closable; (ii) Puncture resistant; (iii) Leakproof on sides and bottom; and (iv) Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard. (2) During use, containers for contaminated sharps shall be: (i) Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found (e.g., laundries); (ii) Maintained upright throughout use; and (iii) Replaced routinely and not be allowed to overfill. (3) When moving containers of contaminated sharps form the area of use, the containers shall be: (i) Closed immediately prior to removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping; (ii) Placed in a secondary container if leakage is possible. The second container shall be: (A) Closable; (B) Constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping; and (C) Labeled or color-coded according to paragraph (g)(1)(i) of this standard. (4) Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury. (B) Other Regulated Waste Containment. (1) Regulated waste shall be placed in containers which are: (i) Closable; (ii) Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping; (iii) Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard; and (iv) Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping. (2) If outside contamination of the regulated waste container occurs, it shall be placed in a second container. The second container shall be: (i) Closable; (ii) Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping; (iii) Labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard; and (iv) Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping. (C) Disposal of all regulated waste shall be in accordance with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories. (iv) Laundry. (A) Contaminated laundry shall be handled as little as possible with a minimum of agitation. (1) Contaminated laundry shall be bagged or containerized at the location where it was used and shall not be sorted or rinsed in the location of use. (2) Contaminated laundry shall be placed and transported in bags or containers labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard. When a facility utilizes Universal Precautions in the handling of all soaked laundry, alternative labeling or colorcoding is sufficient if it permits all employees to recognize the containers as requiring compliance with Universal Precautions. (3) Whenever contaminated laundry is wet and presents a reasonable likelihood of soak-through of or leakage from the bag or container, the laundry shall be placed and transported in bags or containers which prevent soak-through and/or leakage of fluids to the exterior. (B) The employer shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment. (C) When a facility ships contaminated laundry off-site to a second facility which does not utilize Universal Precautions in the handling of all laundry, the facility generating the contaminated laundry must place such laundry in bags or containers which are labeled or color-coded in accordance with paragraph (g)(1)(i). (e) HIV and HBV Research Laboratories and Production Facilities. (1) This paragraph applies to research laboratories and production facilities engaged in the culture, production, concentration, experimentation, and manipulation of HIV and HBV. It does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, or organs. These requirements apply in addition to the other requirements of the standard.

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(2) Research laboratories and production facilities shall meet the following criteria: (i) Standard microbiological practices. All regulated waste shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens. (ii) Special practices. (A) Laboratory doors shall be kept closed when work involving HIV or HBV is in progress. (B) Contaminated materials that are to be decontaminated at a site away from the work area shall be placed in a durable, leakproof, labeled or color-coded container that is closed before being removed from the work area. (C) Access to the work area shall be limited to authorized persons. Written policies and procedures shall be established whereby only persons who have been advised of the potential biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work areas and animal rooms. (3) Whether potentially infectious materials or infected animals are present in the work area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors. The hazard warning sign shall comply with paragraph (g)(1)(ii) of this standard. (E) All activities involving other potentially infectious materials shall be conducted in biological safety cabinets or other physicalcontainment devices within the containment module. No work with these other potentially infectious materials shall be conducted on the open bench. (F) Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animal rooms. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being laundered. (G) Special care shall be taken to avoid skin contact with other potentially infectious materials. Gloves shall be worn when handling infected animals and when making hand contact with other potentially infectious materials is unavoidable. (H) Before disposal all waste from work areas and from animal rooms shall either be incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens. (I) Vacuum lines shall be protected with liquid disinfectant traps and high-efficiency particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as necessary. (J) Hypodermic needles and syringes shall be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles. Only needle-locking syringes or disposable syringe-needle units (i.e., the needle is integral to the syringe) shall be used for the injection or aspiration of other potentially infectious materials. Extreme caution shall be used when handling needles and syringes. A needle shall not be bent , sheared, replaced in the sheath or guard, or removed from the syringe following use. The needle and syringe shall be promptly placed in a puncture-resistant container and autoclaved or decontaminated before reuse or disposal. (K) All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials. (L) A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or other responsible person. (M) A biosafety manual shall be prepared or adopted and periodically reviewed and updated at least annually or more often if necessary. Personnel shall be advised of potential hazards, shall be required to read instructions on practices and procedures, and shall be required to follow them. (iii) Containment equipment. (A) Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations of personal protection or physical containment devices, such as special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols. (B) Biological safety cabinets shall be certified when installed, whenever they are moved and at least annually. (HIV and HBV research laboratories shall beet the following criteria: (i) Each laboratory shall contain a facility for hand washing and an eye wash facility which is easily available within the work area. (ii) An autoclave for decontamination of regulated waste shall be available. (4) HIV and HBV production facilities shall meet the following criteria: (i) The work areas shall be separated from areas that are open to unrestricted traffic flow within the building. Passage through two sets of doors shall be the basic requirement for entry into the work area from access corridors or other contiguous areas. Physical separation of the high-containment work area from access corridors or other areas or activities may also be provided by a double-doors clothes-change room (showers may be included), airlock, or other access facility that requires passing through two sets of doors before entering the work area. (ii) The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination. (iii) Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area. (iv) Access doors to the work area or containment module shall be self-closing. (v) An autoclave for decontamination of regulated waste shall be available within or as near as possible to the work area. (vi) A ducted exhaust-air ventilation system shall be provided, This system shall create directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (i.e., into the work area). (5) Training Requirements. Additional training requirements for employees in HIV and HBV research laboratories and HIV and HBV production facilities are specified in paragraph (g)(2)(ix). (f) Hepatitis B vaccination and post-exposure and follow-up (1) General (i) The employer shall make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and post-exposure evaluation and follow-up to all employees who have had an exposure incident. (ii) The employer shall ensure that all medical evaluations and procedures including the hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis, are: (A) Made available at no cost to the employee; (B) Made available to the employee at a reasonable time and place; (C) Performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare professional; and

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(D) Provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by this paragraph (f). (iii) The employer shall ensure that all laboratory tests are conducted by an accredited laboratory at no cost to the employee. (2) Hepatitis B Vaccination. (i) Hepatitis B vaccination shall be made available after the employee has received the training required in paragraph (g)(2)(vii)(I) and within 10 working days of initial assignment to all employees who have occupational exposure unless the employee has previously received the complete hepatitis B vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. (ii) The employer shall not make participation in a prescreening program a prerequisite for receiving hepatitis B vaccination. (iii) If the employee initially declines hepatitis B vaccination but at a later date while still covered under the standard decides to accept the vaccination, the employer shall make available hepatitis B vaccination at that time. (iv) The employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign the statement in appendix A. (v) If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available in accordance with section (f)(1)(ii). (3) Post-exposure Evaluation and Follow-up. Following a report of an exposure incident, the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up, including at least the following elements: (i) Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred; (ii) Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law; (A) The source individual's blood shall be tested as soon as feasible and after consent is obtained in order to determine HBV and HIV infectivity. If consent is not obtained, the employer shall establish that legally required consent cannot be obtained. When the source individual's consent is not required by law, the source individual's blood, if available, shall be tested and results documented. (B) When the source individual is already known to be infected with HBV or HIV, testing for the source individual's known HBV or HIV status need not be repeated. (c) Results of the source individual's testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual. (iii) Collection and testing of blood for HBV and HIV serological status; (A) The exposed employee's blood shall be collected as soon as feasible and tested after consent is obtained. (B) If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible. (iv) Post-exposure prophylaxis, when medically indicated, as recommended by the U.S. Public Health Service; (v) Counseling; and (vi) Evaluation of reported illnesses. (4) Information Provided to the Healthcare Professional. (i) The employer shall ensure that the healthcare professional responsible for the employee's Hepatitis B vaccination is provided a copy of this regulation. (ii) The employer shall ensure that the healthcare professional evaluating an employee after an exposure incident is provided the following information: (A) A copy of this regulation; (B) A description of the exposed employee's duties as they relate to the exposure incident; (C) Documentation of the route(s) of exposure and circumstances under which require further evaluation or treatment. (iii) All other findings or diagnoses shall remain confidential and shall not be included in the written report. (6) Medical recordkeeping. Medical records required by this standard shall be maintained in accordance with paragraph (h)(1) of this section. (g) Communication of hazards to employees(1) Labels and signs. (i) Labels (A) Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials, except as provided in paragraph (g)(1)(i)(E),(F) and (G).Labels required by this section shall include the following legend;

BIOHAZARD (C) These labels shall be fluorescent orange or orange-red or predominantly so, with lettering or symbols in a contrasting color. (D) Labels required must be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal. (E) Red bags or red containers may be substituted for labels.

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(F) Containers of blood, blood components, or blood products that are labeled as to their contents and have been released for transfusion or other clinical use are exempted from the labeling requirements of paragraph (g). (G) Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment, or disposal are exempted from the labeling requirement. (H) Labels required for contaminated equipment shall be in accordance with this paragraph and shall also state which portions of the equipment remain contaminated. (I) Regulated waste that has been decontaminated need not be labeled or color-coded. (ii) Signs. (A) The employer shall post signs at the entrance to work areas specified in paragraph (e), HIV and HBV Research Laboratory and Production Facilities, which shall bear the following legend:

BIOHAZARD

(Name of the Infectious Agent) (Special requirements for entering the area) (Name, telephone number of the laboratory director or other responsible person.) (B) These signs shall be fluorescent orange-red or predominantly so, with lettering or symbols in a contrasting color. (2) Information and Training. (i) Employers shall ensure that all employees with occupational exposure participate in a training program which must be provided at no cost to the employee and during working hours. (ii) Training shall be provided as follows: (A) At the time of initial assignment to tasks where occupational exposure may take place; (B) Within 90 days after the effective date of the standard; and (C) At least annually thereafter. (iii) For employees who have received training on bloodborne pathogens in the year preceding the effective date of the standard, only training with respect to the provisions of the standard which were not included need be provided. (iv) Annual training for all employees shall be provided within one year of their previous training. (v) Employers shall provide additional training when changes such as modification of tasks or procedures or institution of new tasks or procedures affect the employee's occupational exposure. The additional training may be limited to addressing the new exposures created. (vi) Material appropriate in content and vocabulary to educational level, literacy, and language of employees shall be used. (vii) The training program shall contain at a minimum the following elements: (A)An accessible copy of the regulatory text of this standard and an explanation of its contents; (B) A general explanation of the epidemiology and symptoms of bloodborne diseases; (C) An explanation of the modes of transmission of bloodborne pathogens; (D) An explanation of the employer's exposure control plan and the means by which the employee can obtain a copy of the written plan; (E) An explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials; (F) An explanation of the use and limitations of methods that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protective equipment; (G) Information on the types, proper use, location, removal, handling, decontamination and disposal of personal protective equipment; (I) Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine and vaccination will be offered free of charge; (J) Information on the appropriate actions to take and persons to contact in an emergency involving blood or other potentially infectious materials; (K) An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available; (L) Information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident; (M) An explanation of the signs and labels and/or color coding required by paragraph (g)(1); and (N) An opportunity for interactive questions and answers with the person conducting the training session. (viii) The person conducting the training shall be knowledgeable in the subject matter covered by the elements contained i the training program as it relates to the workplace that the training will address. (ix) Additional Initial Training for Employees in HIV and HBV Laboratories and Production Facilities. Employees in HIV or HBV research laboratories and HIV or HBV production facilities shall receive the following initial training in addition to the above training requirements.

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(A) The employer shall assure that employees demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or HBV. (B) The employer shall assure that employees have prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV. (C) The employer shall provide a training program to employees who have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed. The employer shall assure that employees participate in work activities involving infectious agents only after proficiency has been demonstrated. (h) Recordkeeping(1) Medical Records. (i) The employer shall establish and maintain an accurate record for each employee with occupational exposure, in accordance with 29 CFR 1910.20. (ii) This record shall include: (A) The name and social security number of the employee; (B) A copy of the employee's hepatitis B vaccination status including the dates of all the hepatitis B vaccinations and any medical records relative to the employee's ability to receive vaccination as required by paragraph (f)(2); (C) A copy of all results of examinations, medical testing, and follow-up procedures as required by paragraph (f)(3); (D) The employer's copy of the healthcare professional's written opinion as required by paragraph (f)(5); and (e) A copy of the information provided to the healthcare professional as required by paragraphs (f)(4)(ii)(B)(C) and (D). (iii) Confidentiality. The employer shall ensure that employee medical records required by paragraph (h)(1) are: (A) Kept confidential; and (B) Are not disclosed or reported without the employee's express written consent to any person within or outside the workplace except as required by this section or as may be required by law. (iv) The employer shall maintain the records required by paragraph (h) for at least the duration of employment plus 30 years in accordance with 29 CFR 1910.20. (2) Training Records. (i) Training records shall include the following information: (A) The dates of the training sessions; (B) The contents or a summary of the training sessions; (C) The names and qualifications of persons conducting the training; and (C) The names and job titles of all persons attending the training sessions. (ii) Training records shall be maintained for 3 years from the date on which the training occurred. (3) Availability. (i) The employer shall ensure that all records required to be maintained by this section shall be made available upon request to the Assistant Secretary and the Director for examination and copying. (ii) Employee training records required by this paragraph shall be provided upon request for examination and copying to employees, to employee representatives, to the Director, and to the Assistant Secretary in accordance with 29 CFR 1910.20. (iii) Employee medical records required by this paragraph shall be provided upon request for examination and copying to the subject employee, to anyone having written consent of the subject employee, to the Director, and to the Assistant Secretary in accordance with 29 CFR 1910.20. (4) Transfer of Records. (i) The employer shall comply with the requirements involving transfer of records set forth in 29 CFR 1910.20(h). (ii) If the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the employer shall notify the Director, at least three months prior to their disposal and transmit them to the Director, if required by the Director to do so, within that three month period. (i) Dates(1) Effective Date. The standard shall become effective on March 6, 1992. (2) The Exposure Control Plan required by paragraph (c)(2) of his section shall be completed on or before May 5, 1992. (3) Paragraph (g)(2) Information and Training and (h) Recordkeeping shall take effect on or before June 4, 1992. (4) Paragraphs (d)(2) Engineering and Work Practice Controls, (d)(3) Personal Protective Equipment, (d)(4) Housekeeping, (e) HIV and HBV Research Laboratories and Production Facilities, (f) Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up, and (g)(1) Labels and signs, shall take effect July 6, 1992. Appendix A to Section 1910.1030-Hepatitis B Vaccine Declination (Mandatory) I understand that due to my occupational exposure to blood or the potentially infectious materials I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me. [FR Doc. 91-28886 Filed 12-2-91; 8:45 am] Billing Code 4510-026-M

1910.1200 - Hazard Communication.

Standard Number: 1910.1200 Standard Title: Hazard Communication. SubPart Number: Z SubPart Title: Toxic and Hazardous Substances Produced by USDOL OSHA - Directorate of Safety Standards & Directorate of Health Standards

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Maintained by USDOL OSHA - OCIS (a) "Purpose." (1) The purpose of this section is to ensure that the hazards of all chemicals produced or imported are evaluated, and that information concerning their hazards is transmitted to employers and employees. This transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, material safety data sheets and employee training. (2) This occupational safety and health standard is intended to address comprehensively the issue of evaluating the potential hazards of chemicals, and communicating information concerning hazards and appropriate protective measures to employees, and to preempt any legal requirements of a state, or political subdivision of a state, pertaining to this subject. Evaluating the potential hazards of chemicals, and communicating information concerning hazards and appropriate protective measures to employees, may include, for example, but is not limited to, provisions for: developing and maintaining a written hazard communication program for the workplace, including lists of hazardous chemicals present; labeling of containers of chemicals in the workplace, as well as of containers of chemicals being shipped to other workplaces; preparation and distribution of material safety data sheets to employees and downstream employers; and development and implementation of employee training programs regarding hazards of chemicals and protective measures. Under section 18 of the Act, no state or political subdivision of a state may adopt or enforce, through any court or agency, any requirement relating to the issue addressed by this Federal standard, except pursuant to a Federally-approved state plan. ..1910.1200(b) (b) "Scope and application." (1) This section requires chemical manufacturers or importers to assess the hazards of chemicals which they produce or import, and all employers to provide information to their employees about the hazardous chemicals to which they are exposed, by means of a hazard communication program, labels and other forms of warning, material safety data sheets, and information and training. In addition, this section requires distributors to transmit the required information to employers. (Employers who do not produce or import chemicals need only focus on those parts of this rule that deal with establishing a workplace program and communicating information to their workers. Appendix E of this section is a general guide for such employers to help them determine their compliance obligations under the rule.) (2) This section applies to any chemical which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency. (3) This section applies to laboratories only as follows: (i) Employers shall ensure that labels on incoming containers of hazardous chemicals are not removed or defaced; ..1910.1200(b)(3)(ii) (ii) Employers shall maintain any material safety data sheets that are received with incoming shipments of hazardous chemicals, and ensure that they are readily accessible during each workshift to laboratory employees when they are in their work areas; (iii) Employers shall ensure that laboratory employees are provided information and training in accordance with paragraph (h) of this section, except for the location and availability of the written hazard communication program under paragraph (h)(2)(iii) of this section; and, (iv) Laboratory employers that ship hazardous chemicals are considered to be either a chemical manufacturer or a distributor under this rule, and thus must ensure that any containers of hazardous chemicals leaving the laboratory are labeled in accordance with paragraph (f)(1) of this section, and that a material safety data sheet is provided to distributors and other employers in accordance with paragraphs (g)(6) and (g)(7) of this section. (4) In work operations where employees only handle chemicals in sealed containers which are not opened under normal conditions of use (such as are found in marine cargo handling, warehousing, or retail sales), this section applies to these operations only as follows: ..1910.1200(b)(4)(i) (i) Employers shall ensure that labels on incoming containers of hazardous chemicals are not removed or defaced; (ii) Employers shall maintain copies of any material safety data sheets that are received with incoming shipments of the sealed containers of hazardous chemicals, shall obtain a material safety data sheet as soon as possible for sealed containers of hazardous chemicals received without a material safety data sheet if an employee requests the material safety data sheet, and shall ensure that the material safety data sheets are readily accessible during each work shift to employees when they are in their work area(s); and, (iii) Employers shall ensure that employees are provided with information and training in accordance with paragraph (h) of this section (except for the location and availability of the written hazard communication program under paragraph (h)(2)(iii) of this section), to the extent necessary to protect them in the event of a spill or leak of a hazardous chemical from a sealed container. (5) This section does not require labeling of the following chemicals: (i) Any pesticide as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when subject to the labeling requirements of that Act and labeling regulations issued under that Act by the Environmental Protection Agency; ..1910.1200(b)(5)(ii) (ii) Any chemical substance or mixture as such terms are defined in the Toxic Substances Control Act (15 U.S.C. 2601 et seq.), when subject to the labeling requirements of that Act and labeling regulations issued under that Act by the Environmental Protection Agency; (iii) Any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture; (iv) Any distilled spirits (beverage alcohols), wine, or malt beverage intended for nonindustrial use, as such terms are defined in the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) and regulations issued under that Act, when subject to the labeling requirements of that Act and labeling regulations issued under that Act by the Bureau of Alcohol, Tobacco, and Firearms; ..1910.1200(b)(5)(v) (v) Any consumer product or hazardous substance as those terms are defined in the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) respectively, when subject to a consumer product safety standard or labeling requirement of those Acts, or regulations issued under those Acts by the Consumer Product Safety Commission; and, (vi) Agricultural or vegetable seed treated with pesticides and labeled in accordance with the Federal Seed Act (7 U.S.C. 1551 et seq.) and the labeling regulations issued under that Act by the Department of Agriculture. (6) This section does not apply to: (i) Any hazardous waste as such term is defined by the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C. 6901 et seq.), when subject to regulations issued under that Act by the Environmental Protection Agency;

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(ii) Any hazardous substance as such term is defined by the Comprehensive Environmental Response, Compensation and Liability ACT (CERCLA) (42 U.S.C. 9601 et seq.) when the hazardous substance is the focus of remedial or removal action being conducted under CERCLA in accordance with the Environmental Protection Agency regulations. ..1910.1200(b)(6)(iii) (iii) Tobacco or tobacco products; (iv) Wood or wood products, including lumber which will not be processed, where the chemical manufacturer or importer can establish that the only hazard they pose to employees is the potential for flammability or combustibility (wood or wood products which have been treated with a hazardous chemical covered by this standard, and wood which may be subsequently sawed or cut, generating dust, are not exempted); (v) Articles (as that term is defined in paragraph (c) of this section); (vi) Food or alcoholic beverages which are sold, used, or prepared in a retail establishment (such as a grocery store, restaurant, or drinking place), and foods intended for personal consumption by employees while in the workplace; (vii) Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, final form for direct administration to the patient (e.g., tablets or pills); drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment (e.g., over-the-counter drugs); and drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies); ..1910.1200(b)(6)(viii) (viii) Cosmetics which are packaged for sale to consumers in a retail establishment, and cosmetics intended for personal consumption by employees while in the workplace; (ix) Any consumer product or hazardous substance, as those terms are defined in the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) respectively, where the employer can show that it is used in the workplace for the purpose intended by the chemical manufacturer or importer of the product, and the use results in a duration and frequency of exposure which is not greater than the range of exposures that could reasonably be experienced by consumers when used for the purpose intended; (x) Nuisance particulates where the chemical manufacturer or importer can establish that they do not pose any physical or health hazard covered under this section; (xi) Ionizing and nonionizing radiation; and, (xii) Biological hazards. (c) "Definitions." "Article" means a manufactured item other than a fluid or particle: (i)which is formed to a specific shape or design during manufacture; (ii)which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical (as determined under paragraph (d) of this section), and does not pose a physical hazard or health risk to employees. "Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee. "Chemical" means any element, chemical compound or mixture of elements and/or compounds. "Chemical manufacturer" means an employer with a workplace where chemical(s) are produced for use or distribution. "Chemical name" means the scientific designation of a chemical in accordance with the nomenclature system developed by the International Union of Pure and Applied Chemistry (IUPAC) or the Chemical Abstracts Service (CAS) rules of nomenclature, or a name which will clearly identify the chemical for the purpose of conducting a hazard evaluation. "Combustible liquid" means any liquid having a flashpoint at or above 100 deg. F (37.8 deg. C), but below 200 deg. F (93.3 deg. C), except any mixture having components with flashpoints of 200 deg. F (93.3 deg. C), or higher, the total volume of which make up 99 percent or more of the total volume of the mixture. "Commercial account" means an arrangement whereby a retail distributor sells hazardous chemicals to an employer, generally in large quantities over time and/or at costs that are below the regular retail price. "Common name" means any designation or identification such as code name, code number, trade name, brand name or generic name used to identify a chemical other than by its chemical name. "Compressed gas" means: (i) A gas or mixture of gases having, in a container, an absolute pressure exceeding 40 psi at 70 deg. F (21.1 deg. C); or (ii) A gas or mixture of gases having, in a container, an absolute pressure exceeding 104 psi at 130 deg. F (54.4 deg. C) regardless of the pressure at 70 deg. F (21.1 deg.C); or (iii) A liquid having a vapor pressure exceeding 40 psi at 100 deg. F (37.8 deg. C) as determined by ASTM D-323-72. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical. For purposes of this section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "Designated representative" means any individual or organization to whom an employee gives written authorization to exercise such employee's rights under this section. A recognized or certified collective bargaining agent shall be treated automatically as a designated representative without regard to written employee authorization. "Director" means the Director, National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee. "Distributor" means a business, other than a chemical manufacturer or importer, which supplies hazardous chemicals to other distributors or to employers. "Employee" means a worker who may be exposed to hazardous chemicals under normal operating conditions or in foreseeable emergencies. Workers such as office workers or bank tellers who encounter hazardous chemicals only in non-routine, isolated instances are not covered. "Employer" means a person engaged in a business where chemicals are either used, distributed, or are produced for use or distribution, including a contractor or subcontractor. "Explosive" means a chemical that causes a sudden, almost instantaneous release of pressure, gas, and heat when subjected to sudden shock, pressure, or high temperature. "Exposure or exposed" means that an employee is subjected in the course of employment to a chemical that is a physical or health hazard, and includes potential (e.g. accidental or possible) exposure. "Subjected" in terms of health hazards includes any route of entry (e.g. inhalation, ingestion, skin contact or absorption.) "Flammable" means a chemical that falls into one of the following categories: (i) "Aerosol, flammable" means an aerosol that, when tested by the method described in 16 CFR 1500.45, yields a flame projection exceeding 18 inches at full valve opening, or a flashback (a flame extending back to the valve) at any degree of valve opening; (ii) "Gas, flammable" means: (A) A gas that, at ambient temperature and pressure, forms a flammable mixture with air at a concentration of thirteen (13) percent by volume or less; or (B) A gas that, at ambient temperature and pressure, forms a range of flammable mixtures with air wider than twelve (12) percent by volume, regardless of the lower limit; (iii) "Liquid, flammable" means any liquid having a flashpoint below 100 deg. F (37.8 deg. C), except any mixture having components with flashpoints of 100 deg. F (37.8 deg. C) or higher, the total of which make up 99 percent or more of the total volume of the mixture. (iv) "Solid, flammable" means a solid, other than a blasting agent or explosive as defined in 1910.109(a), that is liable to cause fire through friction, absorption of moisture, spontaneous chemical change, or retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious hazard. A chemical shall be considered to be a flammable solid if, when tested by the method described in 16 CFR 1500.44, it ignites and burns with a self-sustained flame at a rate greater than one-tenth of an inch per second along its major axis. "Flashpoint" means

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the minimum temperature at which a liquid gives off a vapor in sufficient concentration to ignite when tested as follows: (i) Tagliabue Closed Tester (See American National Standard Method of Test for Flash Point by Tag Closed Tester, Z11.24-1979 (ASTM D 56-79)) for liquids with a viscosity of less than 45 Saybolt Universal Seconds (SUS) at 100 deg. F (37.8 deg. C), that do not contain suspended solids and do not have a tendency to form a surface film under test; or (ii) Pensky-Martens Closed Tester (see American National Standard Method of Test for Flash Point by Pensky-Martens Closed Tester, Z11.7-1979 (ASTM D 93-79)) for liquids with a viscosity equal to or greater than 45 SUS at 100 deg. F (37.8 deg. C), or that contain suspended solids, or that have a tendency to form a surface film under test; or (iii) Setaflash Closed Tester (see American National Standard Method of Test for Flash Point by Setaflash Closed Tester (ASTM D 3278-78)). Organic peroxides, which undergo autoaccelerating thermal decomposition, are excluded from any of the flashpoint determination methods specified above. "Foreseeable emergency" means any potential occurrence such as, but not limited to, equipment failure, rupture of containers, or failure of control equipment which could result in an uncontrolled release of a hazardous chemical into the workplace. "Hazardous chemical" means any chemical which is a physical hazard or a health hazard. "Hazard warning" means any words, pictures, symbols, or combination thereof appearing on a label or other appropriate form of warning which convey the specific physical and health hazard(s), including target organ effects, of the chemical(s) in the container(s). (See the definitions for "physical hazard" and "health hazard" to determine the hazards which must be covered.) "Health hazard" means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term "health hazard" includes chemicals which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes. Appendix A provides further definitions and explanations of the scope of health hazards covered by this section, and Appendix B describes the criteria to be used to determine whether or not a chemical is to be considered hazardous for purposes of this standard. "Identity" means any chemical or common name which is indicated on the material safety data sheet (MSDS) for the chemical. The identity used shall permit cross-references to be made among the required list of hazardous chemicals, the label and the MSDS. "Immediate use" means that the hazardous chemical will be under the control of and used only by the person who transfers it from a labeled container and only within the work shift in which it is transferred. "Importer" means the first business with employees within the Customs Territory of the United States which receives hazardous chemicals produced in other countries for the purpose of supplying them to distributors or employers within the United States. "Label" means any written, printed, or graphic material displayed on or affixed to containers of hazardous chemicals. "Material safety data sheet (MSDS)" means written or printed material concerning a hazardous chemical which is prepared in accordance with paragraph (g) of this section. "Mixture" means any combination of two or more chemicals if the combination is not, in whole or in part, the result of a chemical reaction. "Organic peroxide" means an organic compound that contains the bivalent -O-O-structure and which may be considered to be a structural derivative of hydrogen peroxide where one or both of the hydrogen atoms has been replaced by an organic radical. "Oxidizer" means a chemical other than a blasting agent or explosive as defined in 1910.109(a), that initiates or promotes combustion in other materials, thereby causing fire either of itself or through the release of oxygen or other gases. "Physical hazard" means a chemical for which there is scientifically valid evidence that it is a combustible liquid, a compressed gas, explosive, flammable, an organic peroxide, an oxidizer, pyrophoric, unstable (reactive) or water-reactive. "Produce" means to manufacture, process, formulate, blend, extract, generate, emit, or repackage. "Pyrophoric" means a chemical that will ignite spontaneously in air at a temperature of 130 deg. F (54.4 deg. C) or below. "Responsible party" means someone who can provide additional information on the hazardous chemical and appropriate emergency procedures, if necessary. "Specific chemical identity" means the chemical name, Chemical Abstracts Service (CAS) Registry Number, or any other information that reveals the precise chemical designation of the substance. "Trade secret" means any confidential formula, pattern, process, device, information or compilation of information that is used in an employer's business, and that gives the employer an opportunity to obtain an advantage over competitors who do not know or use it. Appendix D sets out the criteria to be used in evaluating trade secrets. "Unstable (reactive)" means a chemical which in the pure state, or as produced or transported, will vigorously polymerize, decompose, condense, or will become self-reactive under conditions of shocks, pressure or temperature. "Use" means to package, handle, react, emit, extract, generate as a byproduct, or transfer. "Water-reactive" means a chemical that reacts with water to release a gas that is either flammable or presents a health hazard. "Work area" means a room or defined space in a workplace where hazardous chemicals are produced or used, and where employees are present. "Workplace" means an establishment, job site, or project, at one geographical location containing one or more work areas. 1910.1200(d) (d) "Hazard determination." (1) Chemical manufacturers and importers shall evaluate chemicals produced in their workplaces or imported by them to determine if they are hazardous. Employers are not required to evaluate chemicals unless they choose not to rely on the evaluation performed by the chemical manufacturer or importer for the chemical to satisfy this requirement. (2) Chemical manufacturers, importers or employers evaluating chemicals shall identify and consider the available scientific evidence concerning such hazards. For health hazards, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the definitions of health hazards in this section. Appendix A shall be consulted for the scope of health hazards covered, and Appendix B shall be consulted for the criteria to be followed with respect to the completeness of the evaluation, and the data to be reported. (3) The chemical manufacturer, importer or employer evaluating chemicals shall treat the following sources as establishing that the chemicals listed in them are hazardous: ..1910.1200(d)(3)(i) (i) 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration (OSHA); or, (ii) "Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment," American Conference of Governmental Industrial Hygienists (ACGIH) (latest edition). The chemical manufacturer, importer, or employer is still responsible for evaluating the hazards associated with the chemicals in these source lists in accordance with the requirements of this standard. (4) Chemical manufacturers, importers and employers evaluating chemicals shall treat the following sources as establishing that a chemical is a carcinogen or potential carcinogen for hazard communication purposes: (i) National Toxicology Program (NTP), "Annual Report on Carcinogens" (latest edition); (ii) International Agency for Research on Cancer (IARC) "Monographs" (latest editions); or (iii) 29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, Occupational Safety and Health Administration. Note: The "Registry of Toxic Effects of Chemical Substances" published by the National Institute for Occupational Safety and Health indicates whether a chemical has been found by NTP or IARC to be a potential carcinogen. 1910.1200(d)(5) (5) The chemical manufacturer, importer or employer shall determine the hazards of mixtures of chemicals as follows:

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(i) If a mixture has been tested as a whole to determine its hazards, the results of such testing shall be used to determine whether the mixture is hazardous; (ii) If a mixture has not been tested as a whole to determine whether the mixture is a health hazard, the mixture shall be assumed to present the same health hazards as do the components which comprise one percent (by weight or volume) or greater of the mixture, except that the mixture shall be assumed to present a carcinogenic hazard if it contains a component in concentrations of 0.1 percent or greater which is considered to be a carcinogen under paragraph (d)(4) of this section; (iii) If a mixture has not been tested as a whole to determine whether the mixture is a physical hazard, the chemical manufacturer, importer, or employer may use whatever scientifically valid data is available to evaluate the physical hazard potential of the mixture; and, (iv) If the chemical manufacturer, importer, or employer has evidence to indicate that a component present in the mixture in concentrations of less than one percent (or in the case of carcinogens, less than 0.1 percent) could be released in concentrations which would exceed an established OSHA permissible exposure limit or ACGIH Threshold Limit Value, or could present a health risk to employees in those concentrations, the mixture shall be assumed to present the same hazard. ..1910.1200(d)(6) (6) Chemical manufacturers, importers, or employers evaluating chemicals shall describe in writing the procedures they use to determine the hazards of the chemical they evaluate. The written procedures are to be made available, upon request, to employees, their designated representatives, the Assistant Secretary and the Director. The written description may be incorporated into the written hazard communication program required under paragraph (e) of this section. (e) "Written hazard communication program." (1) Employers shall develop, implement, and maintain at each workplace, a written hazard communication program which at least describes how the criteria specified in paragraphs (f), (g), and (h) of this section for labels and other forms of warning, material safety data sheets, and employee information and training will be met, and which also includes the following: (i) A list of the hazardous chemicals known to be present using an identity that is referenced on the appropriate material safety data sheet (the list may be compiled for the workplace as a whole or for individual work areas); and, (ii) The methods the employer will use to inform employees of the hazards of non-routine tasks (for example, the cleaning of reactor vessels), and the hazards associated with chemicals contained in unlabeled pipes in their work areas. ..1910.1200(e)(2) (2) "Multi-employer workplaces." Employers who produce, use, or store hazardous chemicals at a workplace in such a way that the employees of other employer(s) may be exposed (for example, employees of a construction contractor working on-site) shall additionally ensure that the hazard communication programs developed and implemented under this paragraph (e) include the following: (i) The methods the employer will use to provide the other employer(s) on-site access to material safety data sheets for each hazardous chemical the other employer(s)' employees may be exposed to while working; (ii) The methods the employer will use to inform the other employer(s) of any precautionary measures that need to be taken to protect employees during the workplace's normal operating conditions and in foreseeable emergencies; and, (iii) The methods the employer will use to inform the other employer(s) of the labeling system used in the workplace. (3) The employer may rely on an existing hazard communication program to comply with these requirements, provided that it meets the criteria established in this paragraph (e). ..1910.1200(e)(4) (4) The employer shall make the written hazard communication program available, upon request, to employees, their designated representatives, the Assistant Secretary and the Director, in accordance with the requirements of 29 CFR 1910.20 (e). (5) Where employees must travel between workplaces during a workshift, i.e., their work is carried out at more than one geographical location, the written hazard communication program may be kept at the primary workplace facility. (f) "Labels and other forms of warning." (1) The chemical manufacturer, importer, or distributor shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged or marked with the following information: (i) Identity of the hazardous chemical(s); (ii) Appropriate hazard warnings; and (iii) Name and address of the chemical manufacturer, importer, or other responsible party. (2)(i) For solid metal (such as a steel beam or a metal casting), solid wood, or plastic items that are not exempted as articles due to their downstream use, or shipments of whole grain, the required label may be transmitted to the customer at the time of the initial shipment, and need not be included with subsequent shipments to the same employer unless the information on the label changes; ..1910.1200(f)(2)(ii) (ii) The label may be transmitted with the initial shipment itself, or with the material safety data sheet that is to be provided prior to or at the time of the first shipment; and, (iii) This exception to requiring labels on every container of hazardous chemicals is only for the solid material itself, and does not apply to hazardous chemicals used in conjunction with, or known to be present with, the material and to which employees handling the items in transit may be exposed (for example, cutting fluids or pesticides in grains). (3) Chemical manufacturers, importers, or distributors shall ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged, or marked in accordance with this section in a manner which does not conflict with the requirements of the Hazardous Materials Transportation Act (49 U.S.C. 1801 et seq.) and regulations issued under that Act by the Department of Transportation. (4) If the hazardous chemical is regulated by OSHA in a substance-specific health standard, the chemical manufacturer, importer, distributor or employer shall ensure that the labels or other forms of warning used are in accordance with the requirements of that standard. ..1910.1200(f)(5) (5) Except as provided in paragraphs (f)(6) and (f)(7) of this section, the employer shall ensure that each container of hazardous chemicals in the workplace is labeled, tagged or marked with the following information: (i) Identity of the hazardous chemical(s) contained therein; and, (ii) Appropriate hazard warnings, or alternatively, words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical. (6) The employer may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of affixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys the information required by paragraph (f)(5) of this section to be on a label. The written materials shall be readily accessible to the employees in their work area throughout each work shift. ..1910.1200(f)(7)

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(7) The employer is not required to label portable containers into which hazardous chemicals are transferred from labeled containers, and which are intended only for the immediate use of the employee who performs the transfer. For purposes of this section, drugs which are dispensed by a pharmacy to a health care provider for direct administration to a patient are exempted from labeling. (8) The employer shall not remove or deface existing labels on incoming containers of hazardous chemicals, unless the container is immediately marked with the required information. (9) The employer shall ensure that labels or other forms of warning are legible, in English, and prominently displayed on the container, or readily available in the work area throughout each work shift. Employers having employees who speak other languages may add the information in their language to the material presented, as long as the information is presented in English as well. (10) The chemical manufacturer, importer, distributor or employer need not affix new labels to comply with this section if existing labels already convey the required information. ..1910.1200(f)(11) (11) Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within three months of becoming aware of the new information. Labels on containers of hazardous chemicals shipped after that time shall contain the new information. If the chemical is not currently produced or imported, the chemical manufacturer, importers, distributor, or employer shall add the information to the label before the chemical is shipped or introduced into the workplace again. (g) "Material safety data sheets." (1) Chemical manufacturers and importers shall obtain or develop a material safety data sheet for each hazardous chemical they produce or import. Employers shall have a material safety data sheet in the workplace for each hazardous chemical which they use. (2) Each material safety data sheet shall be in English (although the employer may maintain copies in other languages as well), and shall contain at least the following information: (i) The identity used on the label, and, except as provided for in paragraph (i) of this section on trade secrets: ..1910.1200(g)(2)(i)(A) (A) If the hazardous chemical is a single substance, its chemical and common name(s); (B) If the hazardous chemical is a mixture which has been tested as a whole to determine its hazards, the chemical and common name(s) of the ingredients which contribute to these known hazards, and the common name(s) of the mixture itself; or, (C) If the hazardous chemical is a mixture which has not been tested as a whole: {1} The chemical and common name(s) of all ingredients which have been determined to be health hazards, and which comprise 1% or greater of the composition, except that chemicals identified as carcinogens under paragraph (d) of this section shall be listed if the concentrations are 0.1% or greater; and, {2} The chemical and common name(s) of all ingredients which have been determined to be health hazards, and which comprise less than 1% (0.1% for carcinogens) of the mixture, if there is evidence that the ingredient(s) could be released from the mixture in concentrations which would exceed an established OSHA permissible exposure limit or ACGIH Threshold Limit Value, or could present a health risk to employees; and, ..1910.1200(g)(2)(i)(C){3} {3} The chemical and common name(s) of all ingredients which have been determined to present a physical hazard when present in the mixture; (ii) Physical and chemical characteristics of the hazardous chemical (such as vapor pressure, flash point); (iii) The physical hazards of the hazardous chemical, including the potential for fire, explosion, and reactivity; (iv) The health hazards of the hazardous chemical, including signs and symptoms of exposure, and any medical conditions which are generally recognized as being aggravated by exposure to the chemical; (v) The primary route(s) of entry; (vi) The OSHA permissible exposure limit, ACGIH Threshold Limit Value, and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the material safety data sheet, where available; (vii) Whether the hazardous chemical is listed in the National Toxicology Program (NTP) Annual Report on Carcinogens (latest edition) or has been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest editions), or by OSHA; ..1910.1200(g)(2)(viii) (viii) Any generally applicable precautions for safe handling and use which are known to the chemical manufacturer, importer or employer preparing the material safety data sheet, including appropriate hygienic practices, protective measures during repair and maintenance of contaminated equipment, and procedures for clean-up of spills and leaks; (ix) Any generally applicable control measures which are known to the chemical manufacturer, importer or employer preparing the material safety data sheet, such as appropriate engineering controls, work practices, or personal protective equipment; (x) Emergency and first aid procedures; (xi) The date of preparation of the material safety data sheet or the last change to it; and, (xii) The name, address and telephone number of the chemical manufacturer, importer, employer or other responsible party preparing or distributing the material safety data sheet, who can provide additional information on the hazardous chemical and appropriate emergency procedures, if necessary. (3) If no relevant information is found for any given category on the material safety data sheet, the chemical manufacturer, importer or employer preparing the material safety data sheet shall mark it to indicate that no applicable information was found. ..1910.1200(g)(4) (4) Where complex mixtures have similar hazards and contents (i.e. the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture), the chemical manufacturer, importer or employer may prepare one material safety data sheet to apply to all of these similar mixtures. (5) The chemical manufacturer, importer or employer preparing the material safety data sheet shall ensure that the information recorded accurately reflects the scientific evidence used in making the hazard determination. If the chemical manufacturer, importer or employer preparing the material safety data sheet becomes newly aware of any significant information regarding the hazards of a chemical, or ways to protect against the hazards, this new information shall be added to the material safety data sheet within three months. If the chemical is not currently being produced or imported the chemical manufacturer or importer shall add the information to the material safety data sheet before the chemical is introduced into the workplace again.

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(6)(i) Chemical manufacturers or importers shall ensure that distributors and employers are provided an appropriate material safety data sheet with their initial shipment, and with the first shipment after a material safety data sheet is updated; ..1910.1200(g)(6)(ii) (ii) The chemical manufacturer or importer shall either provide material safety data sheets with the shipped containers or send them to the distributor or employer prior to or at the time of the shipment; (iii) If the material safety data sheet is not provided with a shipment that has been labeled as a hazardous chemical, the distributor or employer shall obtain one from the chemical manufacturer or importer as soon as possible; and, (iv) The chemical manufacturer or importer shall also provide distributors or employers with a material safety data sheet upon request. (7)(i) Distributors shall ensure that material safety data sheets, and updated information, are provided to other distributors and employers with their initial shipment and with the first shipment after a material safety data sheet is updated; (ii) The distributor shall either provide material safety data sheets with the shipped containers, or send them to the other distributor or employer prior to or at the time of the shipment; (iii) Retail distributors selling hazardous chemicals to employers having a commercial account shall provide a material safety data sheet to such employers upon request, and shall post a sign or otherwise inform them that a material safety data sheet is available; ..1910.1200(g)(7)(iv) (iv) Wholesale distributors selling hazardous chemicals to employers over-the-counter may also provide material safety data sheets upon the request of the employer at the time of the over-the-counter purchase, and shall post a sign or otherwise inform such employers that a material safety data sheet is available; (v) If an employer without a commercial account purchases a hazardous chemical from a retail distributor not required to have material safety data sheets on file (i.e., the retail distributor does not have commercial accounts and does not use the materials), the retail distributor shall provide the employer, upon request, with the name, address, and telephone number of the chemical manufacturer, importer, or distributor from which a material safety data sheet can be obtained; (vi) Wholesale distributors shall also provide material safety data sheets to employers or other distributors upon request; and, (vii) Chemical manufacturers, importers, and distributors need not provide material safety data sheets to retail distributors that have informed them that the retail distributor does not sell the product to commercial accounts or open the sealed container to use it in their own workplaces. ..1910.1200(g)(8) (8) The employer shall maintain in the workplace copies of the required material safety data sheets for each hazardous chemical, and shall ensure that they are readily accessible during each work shift to employees when they are in their work area(s). (Electronic access, microfiche, and other alternatives to maintaining paper copies of the material safety data sheets are permitted as long as no barriers to immediate employee access in each workplace are created by such options.) (9) Where employees must travel between workplaces during a workshift, i.e., their work is carried out at more than one geographical location, the material safety data sheets may be kept at the primary workplace facility. In this situation, the employer shall ensure that employees can immediately obtain the required information in an emergency. (10) Material safety data sheets may be kept in any form, including operating procedures, and may be designed to cover groups of hazardous chemicals in a work area where it may be more appropriate to address the hazards of a process rather than individual hazardous chemicals. However, the employer shall ensure that in all cases the required information is provided for each hazardous chemical, and is readily accessible during each work shift to employees when they are in their work area(s). ..1910.1200(g)(11) (11) Material safety data sheets shall also be made readily available, upon request, to designated representatives and to the Assistant Secretary, in accordance with the requirements of 29 CFR 1910.20(e). The Director shall also be given access to material safety data sheets in the same manner. (h) "Employee information and training." (1) Employers shall provide employees with effective information and training on hazardous chemicals in their work area at the time of their initial assignment, and whenever a new physical or health hazard the employees have not previously been trained about is introduced into their work area. Information and training may be designed to cover categories of hazards (e.g., flammability, carcinogenicity) or specific chemicals. Chemical-specific information must always be available through labels and material safety data sheets. (2) "Information." Employees shall be informed of: {i} The requirements of this section; {ii} Any operations in their work area where hazardous chemicals are present; and, {iii} The location and availability of the written hazard communication program, including the required list(s) of hazardous chemicals, and material safety data sheets required by this section. ..1910.1200(h)(3) (3) "Training." Employee training shall include at least: {i} Methods and observations that may be used to detect the presence or release of a hazardous chemical in the work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc.); {ii} The physical and health hazards of the chemicals in the work area; {iii} The measures employees can take to protect themselves from these hazards, including specific procedures the employer has implemented to protect employees from exposure to hazardous chemicals, such as appropriate work practices, emergency procedures, and personal protective equipment to be used; and, {iv} The details of the hazard communication program developed by the employer, including an explanation of the labeling system and the material safety data sheet, and how employees can obtain and use the appropriate hazard information. (i) "Trade secrets." (1) The chemical manufacturer, importer, or employer may withhold the specific chemical identity, including the chemical name and other specific identification of a hazardous chemical, from the material safety data sheet, provided that: ..1910.1200(i)(1)(i) (i) The claim that the information withheld is a trade secret can be supported; (ii) Information contained in the material safety data sheet concerning the properties and effects of the hazardous chemical is disclosed; (iii) The material safety data sheet indicates that the specific chemical identity is being withheld as a trade secret; and, (iv) The specific chemical identity is made available to health professionals, employees, and designated representatives in accordance with the applicable provisions of this paragraph.

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(2) Where a treating physician or nurse determines that a medical emergency exists and the specific chemical identity of a hazardous chemical is necessary for emergency or first-aid treatment, the chemical manufacturer, importer, or employer shall immediately disclose the specific chemical identity of a trade secret chemical to that treating physician or nurse, regardless of the existence of a written statement of need or a confidentiality agreement. The chemical manufacturer, importer, or employer may require a written statement of need and confidentiality agreement, in accordance with the provisions of paragraphs (i)(3) and (4) of this section, as soon as circumstances permit. ..1910.1200(i)(3) (3) In non-emergency situations, a chemical manufacturer, importer, or employer shall, upon request, disclose a specific chemical identity, otherwise permitted to be withheld under paragraph (i)(1) of this section, to a health professional (i.e. physician, industrial hygienist, toxicologist, epidemiologist, or occupational health nurse) providing medical or other occupational health services to exposed employee(s), and to employees or designated representatives, if: (i) The request is in writing; (ii) The request describes with reasonable detail one or more of the following occupational health needs for the information: (A) To assess the hazards of the chemicals to which employees will be exposed; (B) To conduct or assess sampling of the workplace atmosphere to determine employee exposure levels; (C) To conduct pre-assignment or periodic medical surveillance of exposed employees; (D) To provide medical treatment to exposed employees; (E) To select or assess appropriate personal protective equipment for exposed employees; ..1910.1200(i)(3)(ii)(F) (F) To design or assess engineering controls or other protective measures for exposed employees; and, (G) To conduct studies to determine the health effects of exposure. (iii) The request explains in detail why the disclosure of the specific chemical identity is essential and that, in lieu thereof, the disclosure of the following information to the health professional, employee, or designated representative, would not satisfy the purposes described in paragraph (i)(3)(ii) of this section: (A) The properties and effects of the chemical; (B) Measures for controlling workers' exposure to the chemical; (C) Methods of monitoring and analyzing worker exposure to the chemical; and, (D) Methods of diagnosing and treating harmful exposures to the chemical; (iv) The request includes a description of the procedures to be used to maintain the confidentiality of the disclosed information; and, (v) The health professional, and the employer or contractor of the services of the health professional (i.e. downstream employer, labor organization, or individual employee), employee, or designated representative, agree in a written confidentiality agreement that the health professional, employee, or designated representative, will not use the trade secret information for any purpose other than the health need(s) asserted and agree not to release the information under any circumstances other than to OSHA, as provided in paragraph (i)(6) of this section, except as authorized by the terms of the agreement or by the chemical manufacturer, importer, or employer. ..1910.1200(i)(4) (4) The confidentiality agreement authorized by paragraph (i)(3)(iv) of this section: (i) May restrict the use of the information to the health purposes indicated in the written statement of need; (ii) May provide for appropriate legal remedies in the event of a breach of the agreement, including stipulation of a reasonable pre-estimate of likely damages; and, (iii) May not include requirements for the posting of a penalty bond. (5) Nothing in this standard is meant to preclude the parties from pursuing non-contractual remedies to the extent permitted by law. (6) If the health professional, employee, or designated representative receiving the trade secret information decides that there is a need to disclose it to OSHA, the chemical manufacturer, importer, or employer who provided the information shall be informed by the health professional, employee, or designated representative prior to, or at the same time as, such disclosure. (7) If the chemical manufacturer, importer, or employer denies a written request for disclosure of a specific chemical identity, the denial must: ..1910.1200(i)(7)(i) (i) Be provided to the health professional, employee, or designated representative, within thirty days of the request; (ii) Be in writing; (iii) Include evidence to support the claim that the specific chemical identity is a trade secret; (iv) State the specific reasons why the request is being denied; and, (v) Explain in detail how alternative information may satisfy the specific medical or occupational health need without revealing the specific chemical identity. (8) The health professional, employee, or designated representative whose request for information is denied under paragraph (i)(3) of this section may refer the request and the written denial of the request to OSHA for consideration. (9) When a health professional, employee, or designated representative refers the denial to OSHA under paragraph (i)(8) of this section, OSHA shall consider the evidence to determine if: (i) The chemical manufacturer, importer, or employer has supported the claim that the specific chemical identity is a trade secret; ..1910.1200(i)(9)(ii) (ii) The health professional, employee, or designated representative has supported the claim that there is a medical or occupational health need for the information; and, (iii) The health professional, employee or designated representative has demonstrated adequate means to protect the confidentiality. (10)(i) If OSHA determines that the specific chemical identity requested under paragraph (i)(3) of this section is not a "bona fide" trade secret, or that it is a trade secret, but the requesting health professional, employee, or designated representative has a legitimate medical or occupational health need for the information, has executed a written confidentiality agreement, and has shown adequate means to protect the confidentiality of the information, the chemical manufacturer, importer, or employer will be subject to citation by OSHA. (ii) If a chemical manufacturer, importer, or employer demonstrates to OSHA that the execution of a confidentiality agreement would not provide sufficient protection against the potential harm from the unauthorized disclosure of a trade secret specific chemical identity, the Assistant Secretary may issue such orders or impose such additional limitations or conditions upon the disclosure of the requested chemical information as may be appropriate to assure that the occupational health services are provided without an undue risk of harm to the chemical manufacturer, importer, or employer. ..1910.1200(i)(11)

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(11) If a citation for a failure to release specific chemical identity information is contested by the chemical manufacturer, importer, or employer, the matter will be adjudicated before the Occupational Safety and Health Review Commission in accordance with the Act's enforcement scheme and the applicable Commission rules of procedure. In accordance with the Commission rules, when a chemical manufacturer, importer, or employer continues to withhold the information during the contest, the Administrative Law Judge may review the citation and supporting documentation "in camera" or issue appropriate orders to protect the confidentiality of such matters. (12) Notwithstanding the existence of a trade secret claim, a chemical manufacturer, importer, or employer shall, upon request, disclose to the Assistant Secretary any information which this section requires the chemical manufacturer, importer, or employer to make available. Where there is a trade secret claim, such claim shall be made no later than at the time the information is provided to the Assistant Secretary so that suitable determinations of trade secret status can be made and the necessary protections can be implemented. ..1910.1200(i)(13) (13) Nothing in this paragraph shall be construed as requiring the disclosure under any circumstances of process or percentage of mixture information which is a trade secret. (j) "Effective dates." Chemical manufacturers, importers, distributors, and employers shall be in compliance with all provisions of this section by March 11, 1994. Note: The effective date of the clarification that the exemption of wood and wood products from the Hazard Communication standard in paragraph (b)(6)(iv) only applies to wood and wood products including lumber which will not be processed, where the manufacturer or importer can establish that the only hazard they pose to employees is the potential for flammability or combustibility, and that the exemption does not apply to wood or wood products which have been treated with a hazardous chemical covered by this standard, and wood which may be subsequently sawed or cut generating dust has been stayed from March 11, 1994 to August 11, 1994. [59 FR 17479, April 13, 1994; 59 FR 65947, Dec. 22, 1994; 61 FR 5507, Feb. 13, 1996]

CPL 2-2.44D - Enforcement Procedures

for the Occupational Exposure to Bloodborne Pathogens Nov. 5, 1999
I. Purpose. This instruction establishes policies and provides clarifications to ensure uniform inspection procedures are followed when conducting inspections to enforce the Occupational Exposure to Bloodborne Pathogens Standard. II. Scope. This instruction applies OSHA-wide. III.Cancellation. This instruction cancels OSHA Instruction CPL 2-2.44C, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Standard, 29 CFR 1910.1030, February 13, 1992. IV. References A. OSHA Instruction, CPL 2.103, Field Inspection Reference Manual (FIRM), September 26, 1994. B. OSHA Instruction CPL 2.111, Citation Policy for Paperwork and Written Program Violations., November 27, 1995. C. OSHA Instruction, CPL 2-2.30, Authorization of Review of Medical Opinions, November 14, 1980. D. OSHA Instruction, CPL 2-2.32, January 19, 1981, Authorization of Review of Specific Medical Information. E. OSHA Instruction, CPL 2-2.33, February 8, 1982, Rules of Agency Practice and Procedure Concerning OSHA Access to Employee Medical Records-Procedures Governing Enforcement Activities. F. OSHA Instruction, CPL 2-2.46, January 5, 1989, Authorization and Procedures for Reviewing Medical Records. G. OSHA Instruction, PER 8-2.4, March 31, 1989, CSHO Pre-Employment Medical Examinations. H. Centers for Disease Control Morbidity and Mortality Weekly Report: "Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis." May 15, 1998; Vol. 47, No. RR-7. I. Centers for Disease Control Morbidity and Mortality Weekly Report: "Recommendations for Follow-Up of Health-Care Workers After Occupational Exposure to Hepatitis C Virus". July 4, 1997; Vol. 46, No. 26. J. Record Summary of the Request for Information (RFI) on Occupational Exposure to Bloodborne Pathogens due to Percutaneous Injury. May 20, 1999. K. Safer Needle Devices: Protecting Health Care Workers , Directorate of Technical Support, Office of Occupational Health Nursing, October 1997. L. Needlestick Injuries Among Health Care Workers: A Literature Review, Directorate of Technical Support, Office of Occupational Health Nursing, July, 1998. M.International HealthCare Worker Safety Center, #407, Health Sciences Center, University of Virginia, Charlottesville, VA 22908, EPINet, Exposure Prevention Information Network, E-mail: epinet@virginia.edu. N. DHHS, Public Health Service, "FDA Safety Alert: Needlestick and Other Risks from Hypodermic Needles on Secondary IV Administration Sets - Piggyback and Intermittent IV", April 16, 1992. O. Glass Capillary Tubes: Joint Safety Advisory About Potential Risks, OSHA/NIOSH/FDA, February, 1999 and Memorandum dated February 18, 1999, from Steve Witt to the Regional Administrators. P. NIOSH, "Selecting, Evaluating, and Using Sharps Disposal Containers", DHHS (NIOSH) Publication No. 97-111, January 1998. Q. Centers for Disease Control, MMWR, October 16, 1998/Vol.47/No. RR-19 "Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease." R. Centers for Disease Control, American Journal of Infection Control, June 1998, Vol. 26, "Guideline for Infection Control in Health Care Personnel, 1998." (www.cdc.gov/ncidod/hip/Guide/guide.htm) S. Centers for Disease Control, MMWR, December 26, 1997, Vol.46, No.RR-18, Immunization of Health-Care Workers: Recommendations T. 29 CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens; Final Rule, Federal Register/Vol.56, No.235/ December 6, 1991. U. Training for Development of Innovative Control Technology Project, "Safety Feature Evaluation Forms".

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V. Action. OSHA Regional Administrators and Area Directors should use the guidelines in this instruction to ensure uniform enforcement of the Bloodborne Pathogens Standard. The Directorate of Compliance Programs will provide support necessary to assist the Regional Administrators and Area Directors in enforcing the Bloodborne Pathogens Standard. VI. Federal Program Change: This instruction describes a Federal Program Change for which State adoption is not required. NOTE: In order to effectively enforce safety and health standards, guidance to compliance staff is necessary. Therefore, although adoption of this instruction is not required, States are expected to have standards, enforcement policies and procedures which are at least as effective as those of Federal OSHA. VII. Background. In September 1986, OSHA was petitioned by various unions representing healthcare employees to develop an emergency temporary standard to protect employees from occupational exposure to bloodborne diseases. The agency decided to pursue the development of a Section 6(b) standard and published a proposed rule on May 30, 1989. A. The agency also concluded that the risk of contracting the hepatitis B virus (HBV) and human immunodeficiency virus (HIV) among members of various occupations within the healthcare sector required an immediate response and therefore issued OSHA Instruction CPL 2-2.44, January 19, 1988. That instruction was superseded by CPL 2-2.44A, August 15, 1988; subsequently, CPL 2-2.44B was issued February 27, 1990. B. On December 6, 1991, the agency issued its final regulation on occupational exposure to bloodborne pathogens (29 CFR 1910.1030). Based on a review of the information in the rulemaking record, OSHA has determined that employees face a significant health risk as the result of occupational exposure to blood and other potentially infectious materials (OPIM) because they may contain bloodborne pathogens. These pathogens include but are not limited to HBV, which causes hepatitis B; HIV, which causes acquired immunodeficiency syndrome (AIDS); hepatitis C virus; human T-lymphotrophic virus Type 1; and pathogens causing malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, CreutzfeldtJakob disease, and viral hemorrhagic fever. The agency further concludes that these hazards can be minimized or eliminated by using a combination of engineering and work practice controls, personal protective clothing and equipment, training, medical surveillance, hepatitis B vaccination, signs and labels, and other provisions. Both the standard and CPL 2-2.44C became effective on March 6, 1992. VIII. Inspection Scheduling, and Scope. A. Inspection scheduling should be conducted in accordance with the procedures outlined in the FIRM (CPL 2.103), Chapter II, Inspection Procedures. B. All inspections, programmed or unprogrammed, should include, if appropriate, a review of the employer's exposure control plan and employee interviews to assess compliance with the standard. C. Expansion of an inspection to areas involving the hazard of occupational exposure to blood or other potentially infectious materials (including on site healthcare units and emergency response or first aid personnel) should be performed when: 1. The exposure control plan or employee interviews indicate deficiencies in complying with OSHA requirements, as set forth in 29 CFR 1910.1030 or this instruction. 2. Relevant formal employee complaints are received which are specifically related to occupational exposure to blood or OPIM. 3. A fatality/catastrophe inspection is conducted as the result of occupational exposure to blood or OPIM. IX. General Inspection Procedures. The procedures given in the FIRM, Chapter II, should be followed except as modified in the following sections: A. Where appropriate, the facility administrator, as well as the directors of infection control, employee (occupational) health, training and education, and environmental services (housekeeping) will be included in the opening conference or interviewed early in the inspection. B. The facility's file of "incident reports" that document the circumstances of exposure incidents in accordance with the provisions in the exposure control plan, or a first aid log of injuries (e.g., needlesticks), should be reviewed. The compliance officer should ask for any other additional records that track bloodborne incidents. The compliance officer should review the most recent Part 1904 - Recording and Reporting Occupational Injuries and Illnesses regulations prior to citing recordkeeping violations. Compliance Officers are reminded that the publication of the final recordkeeping standard may affect certain recording requirements that will impact their bloodborne inspections. C. Compliance officers should take necessary precautions to avoid direct contact with blood or OPIM and should not participate in activities that will require them to come into contact with blood or OPIM. The CSHO should avoid direct contact with needles or other sharp instruments potentially contaminated with blood or OPIM. To evaluate such activities, compliance officers normally should establish the existence of hazards and adequacy of work practices through employee interviews and should observe them at a safe distance. D. On occasions when entry into potentially hazardous areas is judged necessary, the compliance officer should be properly equipped as required by the facility as well as by his/her own professional judgment, after consultation with the supervisor, who should refer to OSHA's exposure control plan for further guidance. E. Compliance officers should use appropriate caution when entering patient care areas of the facility. When such visits are judged necessary for determining actual conditions in the facility, the privacy of patients must be respected. Photos or videos are normally not necessary and in no event should identifiable photos be taken without the patient's consent. X. Recording of Exposure Incidents. For recordkeeping purposes, an occupational bloodborne pathogens exposure incident (e.g., needlestick, laceration, or splash) should be classified as an injury since it is usually the result of an instantaneous event or exposure. The compliance officer should review the most current Part 1904, to determine when injuries must be recorded. XI. Multi-Employer and Related Worksites. There are a number of different types of multi-employer worksites. This paragraph addresses a few typical situations but does not address all the circumstances that occur. In addition, this paragraph deals with situations in which employees are sent out to sites that are not multi-employer worksites. Where these guidelines do not address a particular question, see Chapter III C6. of the FIRM, dealing with multi-employer worksites. A. Employment Agencies. An employment agency refers job applicants to potential employers but does not put these workers on the payroll or otherwise establish an employment relationship with them; thus, the employment agency is not the employer of these workers. These agencies shall not be cited for violations affecting the workers they refer. The company that uses these workers, e.g., a hospital, is the employer of these workers and shall be cited for all violations affecting them. B. Personnel Services. Personnel services firms employ medical care staff and service employees who are assigned to work at hospitals and other healthcare facilities that contract with the firm. Typically, the employees are on the payroll of the personnel services firm, but the healthcare facility exercises day-to-day supervision over them. In these circumstances, due to the

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concerns expressed by the court in American Dental Association v. Martin, 984 F.2d 823, 829-30 (7th Cir. 1993) (dictum about medical personnel services) the personnel services firm should be cited for violations of the bloodborne pathogens standard only in the following categories: (1) hepatitis B vaccinations; (2) post-exposure evaluation and follow-up; (3) recordkeeping under paragraph (h) of the standard; (4) generic training; (5) violations occurring at the healthcare facility about which the personnel services firm actually knew and where the firm failed to take reasonable steps to have the host employer (the employer using the workers, e.g., a hospital) correct the violation (see FIRM multi-employer worksite guidelines); and (6) pervasive serious violations occurring at the healthcare facility about which the personnel service firm could have known with the exercise of reasonable diligence. When the host employer exercises day-to-day supervision over the personnel service workers, they are the employees of the host employer, as well as of the personnel service, and thus the host employer must comply with all provisions of the standard with respect to these workers. With respect to Hepatitis B vaccination, post-exposure evaluation and follow-up, recordkeeping, and generic training, the host employer's obligation is to take reasonable measures to assure that the personnel service firm has complied with these provisions. C. Home Health Services. The American Dental Association v. Martin decision upheld the bloodborne pathogens standard but restricted its application in the home health services industry. These are companies whose employees provide home health services in private homes. The court held that OSHA had not adequately considered feasibility problems for such employers, where employees work at sites that the employer does not control. As a result, OSHA may not cite those employers for sitedependent provisions of the standard when the hazard is site-specific. In implementing this decision, OSHA determined that the employer will not be held responsible for the following site-specific violations: housekeeping requirements, such as the maintenance of a clean and sanitary worksite and the handling and disposal of regulated waste; ensuring the use of personal protective equipment; and ensuring that specific work practices are followed (e.g., handwashing with running water) and ensuring the use of engineering controls. The employer will be held responsible for all non-site-specific requirements of the standard, including the non-site specific requirements of the exposure control plan, hepatitis B vaccinations, post exposure evaluation and follow-up, recordkeeping, and the generic training requirements. OSHA will also cite employers for failure to supply appropriate personal protective equipment to employees. D. Physicians and Healthcare professionals who have established an independent practice. In applying the provisions of the standard in situations involving physicians, the status of the physician is important. Physicians may be employers or employees. Physicians who are unincorporated sole proprietors or partners in a bona fide partnership are employers for purposes of the OSH Act and may be cited if they employ at least one employee (such as a technician or secretary). Such physician-employers may be cited if they create or control bloodborne pathogens hazards that expose employees at hospitals or other sites where they have staff privileges may be cited in accordance with the multi-employer worksite guidelines of the FIRM. Because the physicians in these situations are not themselves employees, citations may not be based on the exposure of such physicians to the hazards of bloodborne diseases. Physicians may be employed by a hospital or other healthcare facility or may be members of a professional corporation and conduct some of their activities at host employer sites where they have staff privileges. In general, professional corporations are the employers of their physician-members and must comply with the hepatitis B vaccination, post-exposure-evaluation and follow up, recordkeeping, and generic training provisions with respect to these physicians when they work at host employer sites. The host employer is not responsible for these provisions with respect to physicians with staff privileges, but in appropriate circumstances, may be cited under other provisions of the standard in accordance with the multi-employer worksite guidelines of the FIRM. The professional corporation may also be cited under other provisions of the standard for the exposure of its physicians and other workers at a host employer site in accordance with the multi-employer worksite guidelines of the FIRM. E. Independent Contractors. These are companies that provide a service, such as radiology or housekeeping, to host employers. They provide supervisory personnel, as well as rank-and-file workers, to carry out the service. These companies and the host employers are responsible for complying with all provisions of the standard in accordance with the multi-employer worksite guidelines of the FIRM. XII. Federal Agency Facilities. Agencies of the Federal Government are covered by this instruction. XIII. Clarification of the Standard on Occupational Exposure to Bloodborne Pathogens, 29 CFR 1910.1030. The guidance that follows relates to specific provisions of 29 CFR 1910.1030 and is provided to assist compliance officers in conducting inspections where the standard may be applicable: A. Scope and Application - 29 CFR 1910.1030(a). This paragraph defines the range of employees covered by the standard. 1. Since there is no population that is risk free for HIV, HBV or other bloodborne disease infection, any employee who has occupational exposure to blood or other potentially infectious material will be included within the scope of this standard. 2. Although a list is included below of a number of job classifications that may be associated with tasks that have occupational exposure to blood and other potentially infectious materials, the scope of this standard is not limited to employees in these jobs. The hazard of exposure to infectious materials affects employees in many types of employment and is not restricted to the healthcare industry. At the same time, employees in the following jobs are not automatically covered unless they have the potential for occupational exposure: Physicians, physician's assistants, nurses, nurse practitioners, and other healthcare employees in clinics and physicians' offices; employees of clinical and diagnostic laboratories; housekeepers in healthcare and other facilities; personnel in hospital laundries or commercial laundries that service healthcare or public safety institutions; tissue bank personnel; employees in blood banks and plasma centers who collect, transport, and test blood; freestanding clinic employees (e.g., hemodialysis clinics, urgent care clinics, health maintenance organization (HMO) clinics, and family planning clinics); employees in clinics in industrial, educational, and correctional facilities (e.g., those who collect blood, and clean and dress wounds); employees designated to provide emergency first aid; dentists, dental hygienists, dental assistants and dental laboratory technicians; staff of institutions for the developmentally disabled; hospice employees; home healthcare workers; staff of nursing homes and longterm care facilities; employees of funeral homes and mortuaries; HIV and HBV research laboratory and production facility workers; employees handling regulated waste; custodial workers required to clean up contaminated sharps or spills of blood or OPIM; medical equipment service and repair personnel; emergency medical technicians, paramedics, and other emergency medical service providers; fire fighters, law enforcement personnel, and correctional officers (employees in the private sector,

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the Federal Government, or a State or local government in a State that has an OSHA-approved State plan); maintenance workers, such as plumbers, in healthcare facilities and employees of substance abuse clinics. 3. INSPECTION GUIDELINES. The scope paragraph of this standard states that it "applies to all occupational exposure to blood or other potentially infectious materials as defined by paragraph (b)." The compliance officer must take careful note of the definition of "occupational exposure" in paragraph (b) in determining if an employee is covered by this standard. a. Part-time, temporary, and healthcare workers known as "per diem" employees are covered by this standard. b. OSHA jurisdiction extends only to employees in the workplace. It does not extend to students if they are not considered employees, to state, county, or municipal employees, to health care professionals who are sole practitioners or partners, and to the self-employed. c. If an employee is trained in first aid and identified by the employer as responsible for rendering medical assistance as part of his/her job duties, that employee is covered by the standard. See the citation policy for paragraph (f)(2) of the standard below regarding designated first aid providers, who administer first aid as a collateral duty to their routine work assignments. An employee who routinely provides first aid to fellow employees with the knowledge of the employer may also fall, de facto, under this designation even if the employer has not officially designated this employee as a first aid provider. d. Exposure to bloodborne pathogens in shipyard operations is covered under 29 CFR 1915.1030, which states that its requirements are identical to those in 29 CFR 1910.1030. e. Other Industries: The bloodborne pathogens standard does not apply to the construction, agriculture, marine terminal and longshoring industries. OSHA has not, however, stated that these industries are free from the hazards of bloodborne pathogens. For industries not covered by the bloodborne pathogens standard, Section 5(a)(1) of the OSH Act provides that "each employer shall furnish to each of his employees employment and a place of employment which is free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees." The General Duty Clause should not be used to cite for violations of the bloodborne pathogens rule, but may be used to cite for failure to provide a workplace free from exposure to bloodborne pathogens. Section 5(a)(1) citations must meet the requirements outlined in the FIRM, OSHA Instruction CPL 2.103, Chapter III. Failure to implement all or any part of 29 CFR 1910.1030 should not be, in itself, the basis for a citation. Accordingly, 29 CFR 1910.1030 should not be specifically referenced in a citation. B. Definitions - 29 CFR 1910.1030(b). The following provides further clarifications of some definitions found in this paragraph: 1. "Blood": The term "human blood components" includes plasma, platelets, and serosanguinous fluids (e.g., exudates from wounds). Also included are medications derived from blood, such as immune globulins, albumin, and factors 8 and 9. (See letter of interpretation, 5/5/98) 2. "Bloodborne Pathogens": While HBV and HIV are specifically identified in the standard, the term includes any pathogenic microorganism that is present in human blood or OPIM and can infect and cause disease in persons who are exposed to blood containing the pathogen. Pathogenic microorganisms can also cause diseases such as hepatitis C, malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob disease, adult T-cell leukemia/lymphoma (caused by HTLV-I), HTLV-I associated myelopathy, diseases associated with HTLV-II, and viral hemorrhagic fever. NOTE: According to the Centers for Disease Control and Prevention (CDC), hepatitis C virus (HCV) infection is the most common chronic bloodborne infection in the United States. (MMWR: Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease, October 16, 1998/Vol.47/No. RR-19.) HCV is a viral infection of the liver that is transmitted primarily by exposure to blood. Currently there is no vaccine effective against HCV. See discussion of paragraph (f)(3) below. 3. "Exposure Incident": "Non-intact skin" includes skin with dermatitis, hangnails, cuts, abrasions, chafing, acne, etc 4. "Engineering controls" means controls that isolate or remove the bloodborne pathogens hazard from the workplace. Examples include needleless devices, shielded needle devices, blunt needles, plastic capillary tubes. 5. "Occupational Exposure": The term "reasonably anticipated contact" includes the potential for contact as well as actual contact with blood or OPIM. Lack of history of blood exposures among designated first aid personnel of a particular manufacturing site, for instance, does not preclude coverage. "Reasonably anticipated contact" includes, among others, contact with blood or OPIM (including regulated waste) as well as incidents of needlesticks. For example, a compliance officer may document incidents in which an employee observes uncapped needles or contacts other regulated waste in order to substantiate "occupational exposure." NOTE: This definition does not cover "Good Samaritan" acts which result in exposure to blood or other potentially infectious materials from voluntarily assisting a fellow employee, although OSHA encourages employers to offer follow-up procedures to these employees in such cases. 6. "Other Potentially Infectious Materials" (OPIM): Coverage under this definition also extends to blood and tissues of experimental animals who are infected with HIV or HBV. 7. "Parenteral": This definition includes human bites that break the skin, which are most likely to occur in violent situations such as may be encountered by prison personnel and police and in emergency rooms or psychiatric wards. C. Exposure Control Plan - 29 CFR 1910.1030(c). This paragraph requires the employer to identify those tasks and procedures in which occupational exposure may occur and to identify the positions whose duties include those tasks and procedures identified as having occupational exposure. The exposure control plan required by paragraph (c)(1) is a key provision of the standard because it requires the employer to identify the individuals who will receive the training, protective equipment, vaccination, and other protections of the standard. 1. INSPECTION AND CITATION GUIDELINES. The Compliance Officer should review the facility's written exposure control plan. While the plan may be part of a larger document, such as one addressing all health and safety hazards in the workplace, in order for the plan to be accessible to employees, it must be a cohesive entity by itself or there must be a guiding document which states the overall policy goals and references the elements of existing separate policies that comprise the plan. The Compliance Officer should determine whether the plan is reviewed annually and updated to reflect significant modifications in tasks or procedures which may result in occupational exposure as required in paragraph (c)(1)(iv). The location of the plan may be adapted to the circumstances of a particular workplace, provided that the employee can access a copy at the workplace, during the workshift (e.g., if the plan is maintained solely on computer, employees must be trained to operate the computer). In accordance with 29 CFR 1910.1020, a hard copy of the exposure control plan must be made available to the employee within 15 working days of the employee's request.

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If a facility is lacking an exposure control plan and the other requirements of the standard have not been implemented, the other relevant paragraphs of the standard should be cited in addition to paragraph (c). These should normally be classified as serious violations. 2. Paragraphs (c)(1)(ii)(A) and (c)(2)(i). The exposure determination requires employers to identify and document: a. Those job classifications in which all employees have occupational exposure, and/or b. Those job classifications in which some employees have occupational exposure. (1)In the latter case, the specific tasks and procedures, or groups of closely related tasks and procedures, which are associated with occupational exposure must be delineated. For example, only some of the employees in a hospital laundry room might be assigned the task of handling contaminated laundry. (2)The tasks and procedures that are grouped must be related; i.e., they must share a common activity such as "vascular access procedures," "handling of contaminated sharps," or "handling of deceased persons," etc. NOTE: If a job classification, task, or procedure involving occupational exposure is omitted from the list, but all employees in the job or performing the task or procedure have been included in all other aspects of the plan (e.g., vaccinations, training, etc.), it is to be considered an other-than-serious violation. c. The exposure determination must have been made without taking into consideration the use of personal protective clothing or equipment. 3. Paragraph (c)(1)(ii)(B). While the primary purpose of the exposure control plan is to identify those employees who have occupational exposure and to commit the employer to a timetable for implementation of the standard's requirements, paragraphs (d)-(h) of the standard must also be addressed in a manner appropriate to the circumstances of the particular workplace. An annotated copy of the final standard may be adequate for small facilities. Larger facilities could develop a broad facility-wide program incorporating provisions from the standard that apply to their establishments. 4. Paragraph (c)(1)(ii)(C). The exposure control plan must include the procedure for evaluating the circumstances surrounding exposure incidents, in accordance with paragraph (f)(3)(i). CITATION GUIDELINES: If the employer failed to include procedures for the documentation of exposure incidents in the exposure control plan, a citation for paragraph (c)(1)(ii)(C), should be issued. If procedures are included in the plan but not implemented, then paragraph (f)(3)(i) should be cited. 5. Paragraph (c)(1)(iv) requires the exposure control plan to be reviewed and updated at least annually (every 12 months) and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee positions with occupational exposure. According to the preamble to the standard, the requirement to review and update the plan means that the plan must reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens. [56 Fed. Reg. 64109-10 (1991).] A periodic review ensures that the exposure control plan remains current with the latest information and scientific knowledge pertaining to bloodborne pathogens. The exposure control plan must document consideration and implementation of appropriate commercially available and effective engineering controls designed to eliminate or minimize exposure. NOTE: While the exact number of injuries sustained annually in the United States is unknown, current estimates vary between 590,000 and 800,000 injuries annually. This compliance instruction clarifies the agency's position regarding the implementation of effective engineering controls to reduce needlesticks and other sharps injuries. Effective engineering controls include the safer medical devices used to prevent percutaneous injuries before, during, or after use through safer design features. When the Final Rule was published in December 1991, the variety of engineering controls was limited although some were available. At that time adequate data and information on effective engineering controls and their effectiveness were not available. The preamble to the Final Rule in 1991 stated that "with regard to percutaneous incidents, such as needlestick injuries, evidence indicated that most injuries were preventable . . . 75 percent of all exposure incidents are caused by disposable syringes . . . and could be prevented by using syringes which incorporate resheathing or retracting designs." [56 Fed. Reg./64057(1991)] Since publication of the standard, there has been a substantial increase in the number and assortment of effective engineering controls available to employers. There is now a large body of research and data available to OSHA and to the public concerning the effectiveness of these engineering controls. According to OSHA's Record Summary of the Request for Information on Occupational Exposure to Bloodborne Pathogens Due to Percutaneous Injury ("Record Summary") issued on May 20, 1999, www.osha-slc.gov/html/ndlreport052099.html, use of effective engineering controls such as safer medical devices appear to be steadily increasing in some applications. Nearly every healthcare facility responding to the RFI noted a reduction in injuries after use of effective engineering controls. Most IV line access is now accomplished using safer devices. Engineering controls are an effective and feasible method of hazard control in many instances. NOTE: The Exposure Control Plan must include the procedure for evaluation of circumstances surrounding exposure incidents. See discussion of paragraph (f)(3)(i). CITATION GUIDELINES: The employer must review and update the plan, as necessary, to reflect changes in technology, such as the use of effective engineering controls, that can eliminate or minimize exposures. If the employer did not review and update its exposure control plan at least annually, paragraph (c)(1)(iv) should be cited. See Appendix D for a Sample Exposure Control Program. D. Methods of Compliance - 29 CFR 1910.1030(d). Paragraph (d) sets forth the method by which employers must protect their employees from the hazards of bloodborne pathogens and comply with this standard through the use of universal precautions, engineering controls, work practice controls, personal protective equipment, proper housekeeping and handling of regulated waste. 1. Universal Precautions - Paragraph (d)(1). Universal precautions are OSHA's required methods of control to protect employees from exposure to all human blood and OPIM. The term "universal precautions" refers to a concept of bloodborne disease control which requires that all human blood and OPIM be treated as if known to be infectious for HIV, HBV, HCV or other bloodborne pathogens, regardless of the perceived "low risk" status of a patient or patient population. Alternative concepts in infection control are called Body Substance Isolation (BSI) and Standard Precautions. These methods define all body fluids and substances as infectious. These methods incorporate not only the fluids and materials covered by this standard but expands coverage to include all body fluids and substances. These concepts are acceptable alternatives to universal precautions, provided that facilities utilizing them adhere to all other provisions of this standard.

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CITATION GUIDELINES. If the employer has a policy of treating the blood or OPIM of some patients as potentially infectious and the blood or OPIM of others (e.g., the elderly or children) as not infectious, a violation of this provision exists. 2. Engineering Controls and Work Practices - Paragraph (d)(2)(i). This paragraph requires the employer to institute engineering and work practice controls as the primary means of eliminating or minimizing employee exposure. It conforms to OSHA's traditional adherence to a hierarchy of controls [See 56 Fed. Reg. 64114-15 (1991)]. OSHA has always required employers to use engineering and work practice controls. Thus the employer must use engineering and work practice controls that eliminate occupational exposure or reduce it to the lowest feasible extent. It is OSHA's view that preventing exposures requires a comprehensive program, including engineering controls (e.g., needleless devices, shielded needle devices, and plastic capillary tubes) and proper work practices (e.g., no-hands procedures in handling contaminated sharps, eliminating hand-tohand instrument passing in the operating room). If engineering and work practice controls do not eliminate exposure, the use of personal protective equipment (e.g., eye protection) is required. The employer must also make changes to its Exposure Control Plan to include these engineering controls. [See discussion of paragraph (c)(1)(iv) above.] Safer medical devices are generally of two types: needleless systems (e.g., needleless IV connectors) and sharps with engineered sharps injury protection (e.g., self-sheathing needles on syringes). Substitution methods such as the use of plastic (instead of glass) capillary tubes are also available. Appendix B (Safety Evaluation Forms) and Appendix C (Web Site Resource List) have been provided to assist in the evaluation of these devices. OSHA encourages employers to involve employees in the selection of effective engineering controls to improve employee acceptance of the newer devices and to improve the quality of the selection process. NOTE: Where engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used. Significant improvements in technology are most evident in the growing market of safer medical devices that minimize, control or prevent exposure incidents. OSHA does not advocate the use of one particular device over another. The FDA is responsible for clearing medical devices for marketing, although this "clearance" alone is not enough to guarantee the device will be effective in the workplace. The employer must rely on further evidence to ensure its effectiveness in the situations it will be used . There are specific design features for recessed needle systems that the Food and Drug Administration (FDA Safety Alert, April 16, 1992 and Draft Supplementary Guidance on the Content of Premarket Notification 510(K) Submissions for Medical Devices with Sharps Injury Prevention Features, March 1995) has published and agrees are important in preventing percutaneous injury. These design features have the following characteristics: a. A fixed safety feature provides a barrier between the hands and the needle after use; the safety feature should allow or require the worker's hands to remain behind the needle at all times; b. The safety feature is an integral part of the device and not an accessory; c. The safety feature is in effect before disassembly and remains in effect after disposal to protect users and trash handlers, and for environmental safety; d. The safety feature is as simple as possible, and requiring little or no training to use effectively. OSHA has changed the language of the compliance instruction to clarify the agency's position regarding the use of engineering and work practice controls in light of the increased use and acknowledged feasibility of effective engineering controls, as discussed in the Record Summary. See the discussion of paragraph (c)(1)(iv). Furthermore, the preamble to the standard supports this change in the instruction. It states that the exposure control plan is to be updated to reflect new technology to control occupational exposure to bloodborne pathogens [56 Fed. Reg. 64109-10 (1991)]. INSPECTION GUIDELINES. The Compliance Officer should determine through interviews or observation of work involving exposure to blood or OPIM whether sufficient engineering controls and work practices are used. While it is generally accepted that an exposure incident can occur at any time or place, a review of the facility records can better direct the Compliance Officer to areas that are more likely to be sites of exposure incidents. Data from The Uniform Needlestick and Sharp Object Injury Report, 77 Hospitals, 1993-1995 ( Exposure Prevention Information Network EPINet at www.med.virginia.edu/~epinet/soio.html) show that injuries occurred, in order of frequency, in patient rooms, operating rooms, emergency departments, and intensive/critical care units. The report indicates that nurses (RN's and LPN's) were injured more often than any other type of healthcare worker. Furthermore, the report finds that an overwhelming majority (93%) of the injuries were caused by items that were not a "safe design with a shielded, recessed, or retractable needle." The Compliance Officer should determine if there were occasions where injuries were incurred during the same procedure, using the same equipment, in the same location or among similar employees (e.g., housekeepers) and determine whether engineering or work practices have been implemented to prevent or minimize future injuries. The Compliance Officer should investigate whether the employer has instituted alternative engineering controls and work practices to eliminate or minimize employee exposure in areas where exposure incidents have been documented. CITATION GUIDELINES. Paragraph (d)(2)(i) should be cited for failure to use engineering/work practice controls as discussed above. The Compliance Officer should carefully evaluate the exposure control measures, such as effective engineering controls, that are in use at the facility. Part of this evaluation should include whether other devices that are commercially available were reviewed or considered by the employer and whether there is evidence that other engineering controls would reduce exposures. Such evidence might include CDC studies of efficacy, pilot tests by the employer, or data available in published studies. The Record Summary indicates that employers are using safer equipment and devices, e.g., over 87% of the respondents who provided information on device usage now use needleless or shielded needle IV line access. Other popular devices include blunt suture needles, safer syringes, and safer phlebotomy devices. This is not an exhaustive list of effective engineering controls that are available. Appendix B provides some examples of forms an employer might use for evaluation of engineering controls. Compliance with this paragraph should take into consideration that the availability or use of an engineering control is not enough to guarantee that an employee cannot be injured. Employee acceptance and employee training are required for the engineering control to be effective. The Compliance Officer should evaluate the training in accordance with paragraph (g)(2)(vii). A citation for the appropriate paragraph of (g)(2)(vii) should be grouped with paragraph (d)(2)(i), if the Compliance Officer determines that inadequate training caused the failure to use such controls. Examples of effective engineering controls can be found in several resources linked on OSHA's Needlestick Injuries page, www.osha-slc.gov/SLTC/needlestick/index.html. Citations for paragraph (d)(2)(i) should be issued when these criteria are met: If a combination of engineering and work practice controls used by the employer does not eliminate or minimize exposure, the employer shall be cited for failing to use engineering and work practice controls.

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When the compliance officer finds that an employer is using an engineering control, but believes another device would be clearly more effective than the one in use, the compliance officer should document how the device was being used and how it was selected by the employer and/or employee. The compliance officer should consult with the Regional Bloodborne Pathogens Coordinator to determine if a violation of (d)(2)(i) exists. The citation should describe that the employer failed to use engineering controls or work practices that would "eliminate or minimize exposures." [e.g., failed to identify opportunities for change based upon their evaluation of circumstances surrounding exposure incidents (f)(3)(i); failed to evaluate feasible alternatives; failed to incorporate the changes based on an annual review of the exposure control plan] Paragraph (d)(2)(i) should not be cited where another provision of the standard mandates a specific engineering or work practice control (e.g., paragraph (d)(4)(iii)(A) for sharps containers and paragraph (d)(2)(vii) for the prohibition of recapping). 3. Paragraph (d)(2)(ii). This paragraph requires that engineering controls be examined and maintained or replaced on a regular schedule to ensure their effectiveness. Regularly scheduled inspections are required to confirm, for instance, that engineering controls such as safer devices continue to function effectively, that protective shields have not been removed or broken, and that physical, mechanical or replacement-dependent controls are functioning as intended. CITATION GUIDELINES. It is the employer's responsibility to regularly examine and repair and/or replace engineering controls as often as necessary to ensure that each control is maintained and that it provides the protection intended. If the Compliance Officer finds that there is no system for regular checking of the engineering controls or that regular checking is not done, paragraph (d)(2)(ii) should be cited. 4. Paragraphs (d)(2)(iii) through (d)(2)(vi). These paragraphs require employers to provide handwashing facilities which are readily accessible to employees. Handwashing with soap and at least tepid running water must be performed as soon as feasible, particularly in cases of gross contamination, to adequately flush contaminated material from the skin. a. Paragraph (d)(2)(iv). This paragraph allows the use of alternative handwashing methods as an interim measure when soap and water are not a feasible means of washing the hands or other parts of the body. In such cases, the employer must provide either antiseptic hand cleaner and clean cloth/paper towels, or antiseptic towelettes. When these types of alternatives are used, employees must wash their hands (or other affected area) with soap and running water as soon as feasible thereafter. The Compliance Officer may see these types of alternative washing methods used by ambulance-based paramedics and emergency medical technicians (EMT's), fire fighters, police, and mobile blood collection personnel who are exposed to blood or OPIM but have no means of washing up with running water at the site of the exposure (e.g., a crime scene, traffic accident, fire). b. Paragraph (d)(2)(v). This paragraph requires employers to ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other PPE. There is no requirement for handwashing upon leaving the work area unless contact with blood or OPIM has occurred or gloves/PPE have been removed. CITATION GUIDELINES. If the compliance officer finds that required handwashing facilities are not being provided, paragraph (d)(2)(iii) should be cited unless the employer demonstrates that handwashing facilities are not feasible. If infeasibility is demonstrated, paragraph (d)(2)(iv) should be cited when the required alternatives are not used. If handwashing is not performed by the employees after exposures or removal of gloves, paragraphs (d)(2)(iv), (v), or (vi) should be cited. A citation for one or more of these paragraphs may be grouped with the pertinent training paragraphs of (g)(2) if employees have not been adequately trained in handwashing procedures. At a fixed establishment, if employees need to perform handwashing, they must have a location for washing available at a reasonable distance from their normal work area. If an employee must thread his/her way through doorways and/or stairs to wash with appropriate frequency so that there is a reasonable chance of resultant environmental surface contamination, a violation of paragraph (d)(2)(iii) exists. 5. Paragraph (d)(2)(vii). Shearing or breaking of contaminated sharps is completely prohibited by this paragraph. Bending, recapping, or removing contaminated needles is prohibited as a general practice. Needles are expected to be used and immediately discarded, un-recapped, into accessible sharps containers. Certain circumstances may exist, however, in which recapping, bending, or removing needles is necessary (e.g., administering incremental doses of a medication such as an anesthetic to the same patient). a. In these procedures, if the employer can demonstrate that such action is required by a specific medical procedure, recapping must be performed by some method other than the traditional two-handed procedure, e.g., by means of a mechanical device or forceps. b. Similarly, if the employer can demonstrate that no alternative, such as immediately discarding used needles into an accessible and appropriate sharps container, is feasible, recapping is also allowed. c. The use of the properly performed one-hand scoop method (in which the hand holding the sharp is used to scoop up the cap from a flat surface) for recapping is a recognized and acceptable method; however, the scoop method must be performed in a safe manner and must also be limited to situations in which recapping is necessary. d. An acceptable means of demonstrating that no alternative to bending, recapping, or removing contaminated needles is feasible or that such action is required by a specific medical procedure would be a written justification (supported by reliable evidence) included as part of the exposure control plan. This justification must state the basis for the employer's determination that no alternative is feasible or must specify that a particular medical procedure requires, for example, the bending of the needle and the use of forceps to accomplish this. 6. Paragraph (d)(2)(viii). Since reusable sharps, such as large bore needles, scalpels, and saws, pose the same percutaneous exposure hazard as disposable sharps, they must be contained in a manner that eliminates or minimizes the hazard until they are reprocessed. Therefore, the containers for reusable sharps must meet the same requirements as containers for disposable sharps, with the exception that they are not required to be closable since it is anticipated that containers used for collecting and holding reusable sharps will, themselves, be reused. 7. Paragraphs (d)(2)(ix) and (x). These paragraphs are intended primarily to eliminate or minimize indirect transmission of bloodborne pathogens from contaminated environmental surfaces. Hand cream is not considered a "cosmetic" and is permitted. It should be noted that some petroleum-based hand creams can adversely affect glove integrity, and the hand washing requirements of paragraph (d)(2)(v) and (d)(2)(vi) must be followed. NOTE: The term "work area" means the area where work involving exposure or potential exposure to blood or OPIM exists, along with the potential contamination of surfaces. Employees are permitted to eat and drink in an ambulance cab, for

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example, as long as the employer has implemented procedures to permit employees to wash up and change contaminated clothing prior to entering the ambulance cab, and to ensure that patients and contaminated material remain behind the separating partition. INSPECTION GUIDELINES. In addition to direct contamination of food or drink by blood or OPIM, the Compliance Officer must keep in mind that containers of food and beverage may also become contaminated, resulting in unsuspected contamination of the hands. The purpose of this paragraph is to prevent food and drink from being contaminated by the leakage/spilling of specimen containers, contact with contaminated items, or the performance of activities (e.g., laboratory analysis) that could generate splashes, sprays, or droplets of blood or OPIM, for example. CITATION GUIDELINES. Deficiencies of paragraphs (d)(2)(iv) through (x) should be cited in conjunction with the appropriate paragraph of (g)(2) if inadequate training exists. 8. Paragraph (d)(2)(xi). The intent of this paragraph is not only to decrease the chances of direct employee exposure through spraying or splashing of infectious materials onto employees, but also to reduce contamination of surfaces in the general work area. Surgical power tools, lasers, and electrocautery devices may generate aerosols as well as be a source for splashing and spattering. Some of these devices include labeling recommendations such as local exhaust ventilation. The employer is responsible for appropriate operation of these devices, including controls recommended by the manufacturer. Typically, reasonably anticipated spattering or generation of droplets would necessitate use of eye protection and mask or a face shield to prevent contamination of the mucous membranes of the eyes, nose, and mouth. CITATION GUIDELINES. The use of sprays, brushes, and high pressure in equipment lines is particularly hazardous. A citation should normally be issued for paragraph (d)(2)(xi) if cleaning procedures cause unnecessary splashing, spraying, spattering, or generation of droplets of blood or OPIM. 9. Paragraph (d)(2)(xii). While this paragraph prohibits mouth pipetting/suctioning, the agency allows a recognized emergency care method of clearing an infant's airways called "DeLee suctioning" in the following situation: in an emergency; when no other method is available, and a trap which prevents suctioned fluid from reaching the employee's mouth is inserted in-line between the infant and the employee. 10. Paragraphs (d)(2)(xiii)-(d)(2)(xiii)(C). These paragraphs deal with the containerization and labeling of specimens with the intent to eliminate or minimize the possibility of inadvertent employee contact with blood or OPIM which have leaked out of the container, contaminated exterior surfaces of the container, and/or surrounding surfaces. The labeling requirement warns employees that these substances are present so that proper handling precautions can be taken. The labeling exemption listed in paragraph (d)(2)(xiii)(A) applies to facilities which handle all specimens (not just those specimens which contain blood or OPIM) with universal precautions. This exemption applies only while these specimens remain within the facility. All employees who will have contact with the specimens must be trained to handle all specimens with universal precautions. If the specimens leave the facility (e.g., during transport, shipment, or disposal) a label or red colorcoding is required. Extracted teeth which are being discarded or used as specimens are subject to the containerization and labeling provisions of the standard. However, OSHA does not issue citations to dentists and doctors for non-employee exposures. Extracted teeth, gall stones and kidney stones may be given to the patients. In these situations, the teeth and stones are not subject to the containerization and labeling provisions of the standard. The use of pneumatic tube systems for transport of small materials in hospitals now includes transmittal of laboratory specimens and other more fragile items. The primary concern in the transportation of clinical specimens in a pneumatic tube system is leakage of the specimen into the carrier and potentially into the system tubing. Some systems have virtually eliminated breakage as a cause of leakage by means of padded inserts for carriers and soft delivery of the carrier. Leakage generally results from improper packaging and/or the use of primary containers that do not prevent leakage during transport. All employees who might potentially open a carrier must be trained to regard the contents as biohazardous in nature. Employees who open biohazard carriers must wear gloves in accordance with paragraph (d)(3) when removing specimens from the tube system carrier, because it may be contaminated with leakage. They must be trained in decontamination of the carrier and, if need be, the tube system in accordance with paragraph (g)(2). All precautions and standards for manual transport of specimens also apply to the automated transport of specimens (e.g., containerization and tagging/labeling). INSPECTION GUIDELINES. The Compliance Officer must observe or document work practices to determine whether a secondary container is being used when necessary. If a bloody glove contaminates the outside of a primary container while the employee is placing a specimen, the employee would need to use a secondary container. Also, primary containers which may be punctured by their contents, including such items as pointed bone slivers, must be placed in a puncture-resistant secondary container. 11. Paragraph (d)(2)(xiv). When it is not possible to decontaminate equipment prior to servicing or shipping (e.g., highly technical or sensitive equipment and/or limited access to contaminated parts), at least partial decontamination, such as flushing lines and wiping the exterior, must be accomplished. INSPECTION AND CITATION GUIDELINES. The Compliance Officer should ensure that the employer's program makes provision for the required equipment labels. A label must be attached to equipment stating which portions of the equipment remain contaminated in order to inform downstream servicing/repair employees of the hazard and precautions they need to take. Before citing paragraph (d)(2)(xiv), the Compliance Officer should document that equipment is being shipped and/or serviced. Compliance Officers should observe or document work practices used when employees are decontaminating equipment. When decontaminating reusable equipment that is heavily soiled, the employee will have to perform some prewashing before proceeding with decontamination because most disinfectants/sterilants cannot sufficiently penetrate the organic material that may remain on such heavily soiled equipment. 12. Personal Protective Equipment - Paragraph (d)(3). When there is occupational exposure, PPE must be provided at no cost to the employee to prevent blood or OPIM from passing through to, or contacting, the employees' work or street clothes, undergarments, skin, eyes, mouth, or other mucous membranes. 13. Paragraph (d)(3)(i). The type and amount of PPE must be chosen to protect against contact with blood or OPIM based upon the type of exposure and quantity of these substances reasonably anticipated to be encountered during the performance of a task or procedure.

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INSPECTION AND CITATION GUIDELINES. The financial responsibility for purchasing and providing PPE rests with the employer. The employer is not obligated under this standard to provide general work clothes to employees, but is responsible for providing PPE. If laboratory coats or uniforms are intended to protect the employee's body from contamination, they are to be provided by the employer at no cost to the employee. Laboratory coats, uniforms and the like that are used as PPE must be laundered by the employer and not sent home with the employee for cleaning. Scrubs are usually worn in a manner similar to street clothing, and normally should be covered by appropriate gowns, aprons or laboratory coats when splashes to skin or clothes are reasonably anticipated. If a pullover scrub (as opposed to scrubs with snap closures) becomes minimally contaminated, employees should be trained in accordance with paragraph (g)(2)(vii)(G) to remove the pullover scrub in such a way as to avoid contact with the outer surface, e.g., rolling up the garment as it is pulled toward the head for removal. However, if the amount of blood exposure is such that the blood penetrates the scrub and contaminates the inner surface, not only is it impossible to remove the scrub without exposure to blood, but the penetration itself would constitute skin exposure. Even though wearing scrubs for protection against exposures of this magnitude is inappropriate, it may also be prudent to train employees on the proper methods to remove grossly contaminated scrubs and prevent exposure to the face. A gown which is frequently ripped or falls apart under normal use would not be considered "appropriate PPE." Resuscitator devices are to be readily available and accessible to employees who can reasonably be expected to perform resuscitation procedures. Emergency ventilation devices also fall under the scope of PPE and hence must be provided by the employer for use in resuscitation (e.g., masks, mouthpieces, resuscitation bags, shields/overlay barriers). Improper use of these devices should be cited as a violation of paragraph (d)(3)(ii). In addition, paragraph (g)(2)(vii)(G), which requires employees to be trained in the types, proper use, location, etc., of the PPE should be cited if inadequate training exists. Improper use includes failure to follow the manufacturer's instructions and/or accepted medical practice. NOTE: The American Society for Testing and Materials (ASTM) has several complete testing and evaluation methods which can be used for assessing the resistance of materials used for PPE for medical use. (ASTM-F1819-98, ASTM-F-1671-97b, and ASTM-F1670-97) 14. Paragraph (d)(3)(ii). This paragraph requires the use of PPE. It also provides for a limited exemption from the use of PPE, based on situations in which use of PPE would prevent the proper delivery of healthcare or public safety services, or would pose an increased hazard to the personal safety of the worker or coworker. The following represent examples of when such a situation could occur: a. A sudden change in patient status occurs such as when an apparently stable patient unexpectedly begins to hemorrhage profusely, putting the patient's life in immediate jeopardy; b. A fire fighter rescues an individual who is not breathing from a burning building and discovers that his/her resuscitation equipment is lost/damaged and he/she must administer CPR; c. A bleeding suspect unexpectedly attacks a police officer with a knife, threatening the safety of the officer and/or coworkers. NOTE: An employee's decision not to use PPE is to be made on a case-by-case basis and must have been prompted by legitimate and truly extenuating circumstances. In such cases, no citation should be issued when the employee temporarily and briefly abandons use of PPE. This does not relieve the employer of the responsibility to ensure that PPE is readily accessible at all times. The employer must investigate and document why PPE was not used in each case and evaluate the circumstances surrounding the incident to reduce the likelihood of a future (unprotected) incident. CITATION GUIDELINES. Paragraph (d)(3)(ii) should be cited if PPE is not being used properly. Improper use would include wearing the wrong PPE (e.g., wearing a laboratory coat when a rubber apron is needed) or wearing the wrong size glove. In addition, paragraph (g)(2)(vii)(G) should also be cited if the employees have not been adequately trained. Unless all elements of the exemption, including the documentation requirement, are met, the employer should not receive the benefit of this exemption and paragraph (d)(3) (ii) should be cited. 15. Paragraph (d)(3)(iii). This paragraph requires that the employer provide PPE in appropriate sizes and accessible locations. In addition, "hypoallergenic" gloves (see Note below), glove liners, powderless gloves, or other similar alternatives must be readily available and accessible at no cost to those employees who are allergic to the gloves normally provided. Similar alternatives must supply appropriate barrier protection and must be approved by the FDA for use as a medical glove. The compliance officer should review the employer's program and, through employee interviews and inspection of places where PPE is kept, ensure that these provisions have been met. NOTE: In accordance with a notice published in the Federal Register, Volume 62, No. 189, effective September 30, 1998, the FDA now requires labeling statements for medical devices which contain natural rubber and prohibits the use of the word "hypoallergenic" to describe such products. Additional information on the incidence of hypersensitivity reactions to natural rubber latex can be found in the following documents: NIOSH Alert, Preventing Allergic Reactions to Natural Rubber Latex in the Workplace (Publication No. 97-135) published in June 1997; Directorate of Technical Support, Technical Information Bulletin: Potential for Allergy to Natural Rubber Latex Gloves and other Natural Rubber Products, www.oshaslc.gov/html/hotfoias/tib/TIB19990412.html. CITATION GUIDELINES. If PPE is not provided at no cost to the employee, the Compliance Officer should cite paragraph (d)(3)(i). If PPE is not being used properly or the wrong PPE is used (e.g., wearing a laboratory coat when a rubber apron is needed) or wearing the wrong size PPE, paragraph (d)(3)(ii) should be cited. If PPE is not available in appropriate sizes or readily accessible, the Compliance Officer should cite paragraph (d)(3)(iii). For example, the clothing of paramedics out on an emergency call may become blood soaked. If they are unable to change before the next emergency call because a second set of clothing is located at the ambulance's home base, and the ambulance does not return to base for prolonged periods, a violation of paragraph (d)(3)(iii) would exist. If it is common practice that PPE is not utilized during certain situations or procedures where exposure to blood or OPIM is anticipated, then a violation of paragraph (d)(3)(ii) would exist. If inaccessibility of PPE exists, paragraph (d)(3)(iii) should also be cited. 16. Paragraph (d)(3)(iv). It is the employer's responsibility not only to provide PPE, but to clean, maintain, and/or dispose of it. Home laundering is not permitted since the employer cannot guarantee that proper handling or laundering procedures are being followed. While many employees have traditionally provided and laundered their own uniforms or laboratory coats or the like, if the item's intended function is to act as PPE, then it is the employer's responsibility to provide, clean, repair, replace, and/or dispose of it.

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Home laundering by employees is not permitted since the standard requires that the laundering be performed by the employer at no cost to the employee. Home laundering is unacceptable because the employer cannot ensure that proper handling or laundering procedures are being followed and because contamination could migrate to the homes of employees. If the employee wishes to choose, wear, and maintain his/her own uniform or laboratory coat, then he/she would need to don additional employer-handled and employer-controlled PPE when performing tasks where it is reasonable to anticipate exposure to blood or OPIM. CITATION GUIDELINES. If PPE is not cleaned, laundered, and disposed of by the employer, or if the employer cleans the PPE but there is a charge to the employee, then paragraph (d)(3)(iv) should be cited. If PPE is not repaired and/or replaced by the employer at no cost to the employee, then paragraph (d)(3)(v) should be cited. If a garment is not removed as soon as possible when penetrated by blood or OPIM, the Compliance Officer should cite paragraph (d)(3)(vi). If the PPE is not changed, and additional PPE was available, paragraph (g)(2)(vii)(G) may also be cited if employees have not been adequately trained. 17. Paragraph (d)(3)(vii). To minimize migration of contamination beyond the work area, employees must wash up and change any contaminated clothing before leaving a work area. Then, for example, they may enter designated lunchrooms or break rooms. INSPECTION AND CITATION GUIDELINES. While "work areas" must be determined on a case-by-case basis, a work area is generally considered to be an area where work involving occupational exposure occurs or where the contamination of surfaces may occur. The standard would not require employees to change PPE when traveling, for example, from one hospital laboratory area to another, provided the connecting hallway is also considered to be a work area. The Compliance Officer should evaluate on a case-by-case basis whether the employee received adequate training in accordance with paragraph (g)(2)(vii)(F) to ensure that no surface contamination occurs during the employee's movement. A violation would exist for the following: An employee wearing contaminated gloves exits from a pathology laboratory to use a public telephone located in a public hallway of the hospital. Under such circumstances, it can be reasonably anticipated that another employee, without benefit of gloves or knowledge of the potential surface contamination, could use the phone and unwittingly become contaminated. 18. Paragraph (d)(3)(ix)(A)-(C). These paragraphs discuss the use of gloves. Gloves of appropriate sizes must be made available in accordance with paragraph (d)(3)(iii). Studies have shown that gloves provide a barrier, but that neither vinyl nor latex procedure gloves are completely impermeable. Thus, hand washing after glove removal is required. Disposable gloves must be replaced as soon as practical or as soon as feasible when contaminated. While disposable gloves must be replaced as soon as practical when contaminated, obviously some critical procedures (i.e., surgery, delivery) cannot be interrupted to change gloves. The key words to evaluate are "practical" and "feasible." Disinfecting agents may cause deterioration of the glove material; washing with surfactants could result in "wicking" or enhanced penetration of liquids into the glove via undetected pores, thereby transporting blood or other potentially infectious materials into contact with the hand. For this reason, disposable (single use) gloves may not be washed and reused. The Compliance Officer should note that certain solutions, such as iodine, may cause discoloration of gloves without affecting their integrity and function. At a minimum, gloves must be used where there is reasonable anticipation of employee hand contact with blood, OPIM, mucous membranes, or non-intact skin; when performing vascular access procedures; or when handling or touching contaminated surfaces or items. Gloves are usually not necessary when administering intramuscular or subcutaneous injections as long as bleeding that could result in hand contact with blood or OPIM is not anticipated. Plastic film food handling gloves ("cafeteria" or "baggie" gloves) are not considered to be appropriate for use in exposurerelated tasks. They would not fit the employee as required by paragraph (d)(3)(iii) of the standard. 19. Paragraph (d)(3)(ix)(D). The exemption regarding the use of gloves during phlebotomy procedures applies only to employees of volunteer donor blood collection centers, and does not apply to phlebotomy conducted in other settings such as plasmapheresis centers or hospitals. INSPECTION GUIDELINES. Where an employer in a volunteer donor blood collection center does not require routine gloving for all phlebotomies, the Compliance Officer should document that the employer has fulfilled the requirements of paragraphs (d)(3)(ix)(D)(1) through (d)(3) (ix)(D)(4)(iii), and that employees have received the training necessary to make an informed decision on the wearing of gloves. CITATION GUIDELINES. Paragraph (d)(3)(ix)(D) should not be cited. Rather, the other paragraphs of (d)(3) should be cited if such an employer violates them and if the employer has not demonstrated fulfillment of all the requirements of the exemptions. 20. Paragraph (d)(3)(x). This paragraph requires protection for the mucous membranes of the face and upper respiratory tract from exposure. Depending on the degree and type of anticipated exposure, protection for the face would consist of a surgical mask in conjunction with goggles or eye glasses with solid side shields or, alternatively, a chin length face shield. The employer would not necessarily have to provide prescription eyewear for employees. He/she could provide and mandate the use of side shields, goggles, and/or protective face shields, and provide proper training in decontamination procedures. During microsurgery, when it is not reasonably anticipated that there would be any splattering, a surgeon would not be required to wear eye protection while observing surgery through the microscope. 21. Paragraphs (d)(3)(xi)-(xii). Requirements for the use of protective body clothing, such as gowns, aprons, laboratory coats, clinic jackets, surgical caps, or shoe covers, and the degree to which such PPE must resist penetration, are performance based. The employer must evaluate the task and the type of exposure expected and, based on the determination, select the "appropriate" personal protective clothing in accordance with paragraph (d)(3)(i). For example, laboratory coats or gowns with long sleeves must be used for procedures in which exposure of the forearm to blood or OPIM is reasonably anticipated to occur. INSPECTION GUIDELINES. The Compliance Officer will need to evaluate the task being performed and the degree of anticipated exposure by direct observation, employee interview, or review of written standard operating procedures. 22. Housekeeping (d)(4). The term "worksite" in this paragraph refers not only to permanent fixed facilities such as hospitals, dental/medical offices, clinics, etc., but also covers temporary non-fixed workplaces. Examples of such facilities include but are not limited to ambulances, bloodmobiles, temporary blood collection centers, and any other non-fixed worksites which have a reasonable possibility of becoming contaminated with blood or OPIM.

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Paragraph (d)(4)(i). Cleaning schedules and methods will vary according to the factors outlined in this paragraph. While extraordinary attempts to disinfect or sterilize environmental surfaces such as walls or floors are rarely indicated, routine cleaning and removal of soil are required. The employer must determine and implement an appropriate written schedule of cleaning and decontamination based upon the location within the facility (e.g., surgical operatory versus patient room), type of surface to be cleaned (e.g., hard-surfaced flooring versus carpeting), type of soil present (e.g., gross contamination versus minor splattering), and tasks and procedures being performed (e.g., laboratory analyses versus routine patient care). The particular disinfectant used, as well as the frequency with which it is used, will depend upon the circumstances in which the housekeeping task occurs. 23. Paragraph (d)(4)(ii). Since environmental contamination is an effective method of disease transmission for HBV (the CDC states that HBV can survive for at least one week in dried blood on environmental surfaces or contaminated needles and instruments), paragraph (d)(4)(ii) provides the minimum requirements for the cleaning and decontamination of equipment and environmental and working surfaces that come into contact with blood or OPIM. Under paragraph (d)(4)(ii)(A), cleaning of contaminated work surfaces after completion of procedures is required to ensure that employees are not unwittingly exposed to blood or OPIM remaining on a surface from previous procedures. This paragraph requires contaminated work surfaces to be cleaned with an "appropriate disinfectant." Appropriate disinfectants include a diluted bleach solution and EPA-registered tuberculocides (List B), sterilants (List A), or products registered against HIV/HBV(List D). The lists of these EPA Registered Products are available from the National Antimicrobial Information Network at (800) 447-6349 or its web site at ace.orst.edu/info/nain/lists.htm. List D includes primarily quaternary ammonia products that EPA has approved as effective against HIV and HBV. OSHA allows the use of these products provided the surfaces have not become contaminated with agents or volumes of or concentrations of agents for which higher level disinfection is recommended. NOTE: The lists contain the primary registrants' products only. The same formulation is repackaged and renamed and distributed by other companies. These renamed products will not appear on the list, but their EPA Registration number must appear on the label. INSPECTION GUIDELINES. Compliance Officers should check the product label for EPA registration and/or consult the Environmental Protection Agency (EPA) lists of registered sterilants (representing the highest level of antimicrobial activity that destroys all viruses), tuberculocidal disinfectants (effective against tuberculosis bacteria and the specific viruses named on the product label as well as the hepatitis B virus), and antimicrobials with HIV/HBV efficacy claims for verification that the disinfectant used is appropriate. The employer must follow the label instructions regarding the amount of disinfectant and the length of time it must remain wet on the surface. Since the effectiveness of a disinfectant is governed by strict adherence to the instructions on the label, Compliance Officers should also interview employees to ensure that the disinfectants are being used according to the manufacturer's instructions. If employees have not been trained in the proper use of the disinfectant, a violation of the appropriate paragraph in (g)(2)(vii) should be cited. NOTE: Fresh solutions of diluted household bleach made up daily (every 24 hours) are also considered appropriate for disinfection of environmental surfaces and for decontamination of sites following initial cleanup (i.e., wiping up) of spills of blood or other potentially infectious materials. Contact time for bleach is generally considered to be the time it takes the product to air dry. Solutions of bleach should not be stored in glass containers, but in material such as the plastic in which the bleach, the consumer product, is packaged in. Household bleach (5.25 sodium hypochlorite) diluted to the appropriate strength for the clean up job at hand is also an effective disinfectant, although bleach may cause damage to some medical instruments and therefore cannot be used in all cases. In addition, gross contamination must be cleaned up first with a soap and water solution, to ensure the disinfectant is completely effective. Where procedures are performed on a continual basis throughout a shift or a day, as may be the case with a clinical laboratory technician performing blood analyses, it is not the agency's intent for the work surface to be decontaminated before the technician can proceed to the next analysis; rather the intention is for contaminated work surfaces to be decontaminated after the procedures are completed which, in the above example, would include a set of analyses. The completion of procedures might also occur when the employee is going to leave the work area for a period of time. Decontamination is not automatically required after each patient care procedure, but is required only after procedures resulting in surface contamination. There may be some instances in which "immediate" decontamination of overt contamination and spills may not be practical as in, for example, an operating table during surgery. The work surface decontamination is to be performed at the end of the work shift if the work surface may have become contaminated since the last cleaning by, for example, setting down contaminated instruments or specimens on the work surface. This requirement is based upon the existence of a contaminated work surface rather than a particular worksite location. It does not, for example, encompass desks, countertops, and so forth that remain uncontaminated. The use of protective coverings described in paragraph (d)(4)(ii)(B) is an acceptable alternative for protecting items and surfaces against contamination and is particularly useful in situations in which a piece of equipment would be difficult to decontaminate but could be protected by a cover. If this option is chosen, the covering must be removed and replaced at the stated minimum intervals, i.e., as soon as feasible following overt contamination or at the end of a workshift if it may have become contaminated during the shift. More stringent decontamination rules, such as cleaning equipment or changing coverings between patients, may be prudent infection control policy but do not fall under OSHA's mandate to safeguard employee (not patient) health. 24. Paragraph (d)(4)(ii)(C) requires both the inspection and decontamination, on a regularly scheduled basis, of cans, bins, pails, and so forth which are intended for reuse. Since these containers may be used in a manner which presents the potential for their becoming contaminated with blood or OPIM, they must be cleaned immediately or as soon as feasible upon visible contamination. For example, a reusable metal trash can could have been lined with a disposable plastic regulated waste bag which leaks and contaminates the can. In addition, regular decontamination will prevent the can from leaking, spilling, or contaminating the outside of successive bags. Disinfection of these containers is not necessary to ensure their safety for their intended use; it may be possible to achieve their proper decontamination by means of a soap and water wash. Since contaminated broken glass (e.g., glass capillary tubes, lab specimen dishes, phlebotomy tubes) is capable of inflicting percutaneous injury and direct inoculation of bloodborne pathogens into the bloodstream, paragraph (d)(4)(ii)(D) stipulates that

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broken glassware which may be contaminated must not be picked up directly with the hands. The tools which are used in cleanup (e.g., forceps) must be properly decontaminated or discarded after use and the broken glass placed in a sharps container, and employees must be given specific information and training with respect to this task in accordance with the requirements of paragraph (g)(2). Vacuum cleaners are not appropriate for cleanup of contaminated broken glass. 25. Paragraph (d)(4)(ii)(E) prohibits employers from allowing employees to place their hands into containers whose contents include reusable sharps contaminated with blood or OPIM. The intent is to prevent conditions of use in which the contents cannot be seen and safely handled. For example, employees must not reach into sinks filled with soapy water into which sharp instruments have been placed; appropriate controls in such a circumstance would include the use of strainer type baskets to hold the instruments and forceps to remove the items. The final standard recognizes that proper decontamination of reusable equipment, such as glassware or hand instruments, cannot be achieved in the presence of organic debris (e.g., blood) because it interferes with the efficacy of the disinfecting/sterilizing process, and the number of products which can successfully penetrate a heavy bioburden is limited. Violations of paragraphs (d)(4)(ii) and (d)(4)(ii)(A)-(E) may result from a failure to adequately train employees in proper housekeeping procedures. If the Compliance Officer determines this is the case, violations should be grouped with the appropriate paragraph(s) of paragraph (g)(2). 26. Regulated Waste (d)(4)(iii). This paragraph requires regulated waste to be properly contained and disposed of, so as not to become a source of transmission of disease to employees. To eliminate the implication that OSHA has determined the "infectivity" of certain medical wastes, the bloodborne pathogens standard uses the term "regulated waste" to refer to the following categories of waste which require special handling, at a minimum: liquid or semi-liquid blood or OPIM; items contaminated with blood or OPIM and which would release these substances in a liquid or semi-liquid state if compressed; items that are caked with dried blood or OPIM and are capable of releasing these materials during handling; contaminated sharps; pathological and microbiological wastes containing blood or OPIM. INSPECTION AND CITATION GUIDELINES. The compliance officer should not use the actual volume of blood to determine whether or not a particular material is to be considered regulated waste, since 10 ml of blood on a disposable bed sheet would appear as a spot (not regulated waste) while the same amount of blood on a cotton ball would likely cause saturation and dripping (regulated waste). Similarly, an item may adequately contain these materials when in a static state yet liberate them when compacted in the waste container. Instead, the compliance officer should the potential for the generation of bulk blood should be considered (e.g., through dripping or flaking off of material that may contain either blood or OPIM). Under no circumstances should a bag of waste be squeezed or shaken to determine this. The compliance officer should exercise professional judgment to make a determination based on visual factors such as a pool of liquid in the bottom of the container or dried blood flaking or falling off during handling, or based on employee interviews. NOTES: The Compliance Officer should keep in mind that, while OSHA specifies certain features of the regulated waste containers, including appropriate tagging, the ultimate disposal method (landfilling, incinerating, and so forth) for medical waste falls under the purview of the EPA and possibly State and local regulations. Lacking information to the contrary, the Compliance Officer should consider a used needle to be contaminated. 27. Paragraph (d)(4)(iii)(A)(1). The construction of the sharps containers must meet at least four criteria, two of which will be easily discernible. The Compliance Officer should examine a container, preferably empty, to check that it is closable and color-coded or labeled. Sharps containers are made from a variety of products, from cardboard to plastic. As long as they meet the criteria for a sharps container, the Compliance Officer should consider them to be acceptable no matter what the composition. If questions arise, the Compliance Officer should consult the manufacturer's literature or contact the manufacturer directly to determine if the container is leakproof on the sides and bottom, as well as puncture resistant. The NIOSH publication, "Selecting, Evaluating and Using Sharps Disposal Containers" is also a good resource. If the container is considered puncture resistant by the manufacturer, but there is evidence, through observation or employee statements, that sharps have been protruding through a container, paragraph (d)(4)(iii)(A)(1)(ii) should be cited. The sharps container should not create additional hazards. Some sharps containers have unwinders that are used to separate needles from reusable syringes or from reusable vacutainer holders. The design of the sharps container and the location of the unwinder must allow the needle removal to be accomplished in a safe, one-handed manner. If this situation is encountered, the Compliance Officer should determine if the circumstances warrant needle removal. If they do not, paragraph (d)(2)(vii)(A), which prohibits needle removal unless no alternative is feasible or it is required by a specific medical procedure, should be cited. If needle removal must be accomplished, the employee must be trained in the correct procedure as required by paragraph (g)(2)(vii)(F). The needle sheath is not to be considered a "waste container" because it is viewed as a temporary measure. Self-sheathing needle products must be disposed of in a sharps container which conforms to the requirements of paragraph (d)(4)(iii)(A)(1). Duct tape may be used to secure a sharps container lid, but tape is not acceptable if it serves as the lid itself. 28. Paragraph (d)(4)(iii)(A)(2)(i). The Compliance Officer should ensure that the sharps container is as close as feasible to where sharps are used or can be reasonably anticipated to be found. If an employee must travel to a remote location to discard a sharp, it will increase the possibility of an accidental needlestick and increase the chances that needles and sharps will be improperly discarded and create potential hazards for other staff members. Areas such as correctional facilities, psychiatric units, pediatric units, or residential homes may have difficulty placing containers in the immediate use area. Alternatives include using containers which are lockable or which are designed to prevent removal of syringes while maintaining easy accessibility for discarding. Containers may also be locked onto a mobile cart if one is used by healthcare workers in these units, or they may be brought to the site and removed by the employee upon leaving. The determination of whether or not the container is as close as feasible should be made on a case-by-case basis. After interviewing employees, if the Compliance Officer believes there is a better location for the container, management should be given the opportunity to explain the reasons for the present location of the container. The acceptability of the new site should also be discussed. The Compliance Officer should then decide if a violation of this paragraph exists. Laundries must also have sharps containers easily accessible because of the high incidence of needles being mixed with laundry. Facilities that handle shipments of waste which may contain contaminated sharps must also have sharps containers available in the event a package accidentally opens and releases sharps.

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29. Paragraph (d)(4)(iii)(A)(2)(iii). The Compliance Officer should ensure that sharps containers are being replaced routinely to prevent overfilling. The Record Summary states that overfilling of sharps containers is an often reported problem. Overfilling is often associated with containers that were too small to accommodate the volume of sharps, limited ability to see the contents in order to determine the remaining capacity, and lax procedures for container maintenance. Examples of methods by which sharps containers can be examined to determine a need for replacement, are the use of sharps containers which have a transparent window or are placed at a height which allows employees to see if the container needs to be replaced. Overfilling of sharps containers should be cited under paragraph (d)(4)(iii)(A)(2)(iii). A citation for inadequate training on work practices, paragraph (g)(2)(vii)(F), should be grouped with the citation for this paragraph if the overfilled containers are present because of lack of training. NOTE: The Exposure Prevention Information Network (EPINet) study Uniform Needlestick and Sharp Object Injury Report (77 Hospitals, 1993-1995) reports that 717 injuries occurred in this time period when an employee was putting an item into a disposal container. The Compliance Officer should closely inspect sharps disposal containers at the site to ensure containers are not overfilled. Additional information on sharps disposal containers is available in the NIOSH publication, Selecting, Evaluating and Using Sharps Disposal Containers, January 1998, DHHS (NIOSH) Publication No. 97-111. 30. Paragraphs (d)(4)(iii)(A)(3)(i) and (ii). If work practice violations of these paragraphs exist (e.g., not closing the container prior to movement or not placing the container in a secondary container if leakage is possible), the citations should be grouped with paragraph (g)(2)(vii)(F) if employees have not received adequate training. 31. Paragraph (d)(4)(iii)(A)(3)(ii)(B). It is reasonable to presume that some sharps containers will contain residual liquids. If the container cannot be sealed to prevent leakage, it must be placed in a secondary container. 32. Paragraph (d)(4)(iii)(A)(4). A reusable sharps container system for disposable sharps will be acceptable if it does not expose employees to the risk of percutaneous injury. No system involving the manual opening, emptying, or cleaning of the containers will be allowed. The only acceptable system is a fully automated container cleaning system that eliminates employee exposure to sharps. 33. Paragraph (d)(4)(iii)(B). While this paragraph requires that regulated waste containers be closable, simply being closed does not ensure that waste will be contained. Waste-containing bags may break and spill their contents, including liquid blood, while, for example, being loaded onto incinerator hoppers, thus contaminating both the employees and the work area. Also, small medical offices which generate only a small volume of regulated waste may place that waste in a large holding container until the container is filled. In such a case, the design of the container must be such that it is able to retain the waste over an extended period of time between pickups by a specialized waste service. The Compliance Officer should, therefore, check for visual signs of leakage of fluids during handling, storage, transport, or shipping. Any failures to comply with the container construction requirements would be cited under this paragraph. If the compliance officer determines that the employee was not properly trained to recognize the problem or use the containers correctly, a citation for the appropriate paragraph of paragraph (g)(2) should be grouped with violations of paragraph (d). 34. Paragraphs (d)(4)(iii)(B)(1)(iii) and (2)(iii). Regulated waste containers are required to be labeled with the biohazard symbol or color-coded to warn employees who may have contact with the containers of the potential hazard posed by their contents. Even if a facility considers all of its waste to be regulated waste, the waste containers must still bear the required label or colorcoding in order to protect new employees, employees who would not normally come into contact with wastes, and employees from outside the facility. This requirement is in contrast to the labeling alternative allowed when laundries use universal precautions for the handling of all soiled laundry. Regulated waste that has been decontaminated need not be labeled or color-coded. The compliance officer in such a case should verify that the employer's exposure control plan states the decontamination procedures to be followed. In order to ensure that the decontamination process is successful, the employer must monitor factors such as the content, volume, density, configuration, and organic content of the load of waste. The temperature needed for incineration is sufficient to decontaminate regulated waste. Autoclave efficiency can be verified by means of biological or chemical indicators. While most disposal bags used will contain an indicative color strip, if this is not the case a review may be made of the documentation kept for the sterilizer. Such documentation should include (1) date, time, and operator of each run, (2) type and approximate amount of waste tracked, (3) post-treatment reading of temperature-sensitive tape, (4) dates and results of calibration of the sterilizer, and (5) results of routine spore testing. Although these paragraphs contain label requirements, failure to label can also be cited under paragraph (g)(1)(i). 35. Paragraph (d)(4)(iii)(B)(2). A second container is required to be used when outside contamination of the first waste container occurs. This provision does not require routine double-bagging but rather requires double-bagging in such circumstances as a waste container being splashed with blood during surgery or autopsy, when a container has been handled by an employee with bloody gloves, or when a waste bag leaks blood or OPIM onto an adjacent bag. 36. Laundry - Paragraph (d)(4)(iv). This paragraph reduces employee exposure to bloodborne pathogens by reducing the amount of manual handling of contaminated laundry. Restricting the sorting to the laundry area will also reduce contamination of additional surfaces. INSPECTION AND CITATION GUIDELINES. Paragraphs (d)(4)(iv)(A) and (A)(1) limit the handling of laundry to removal and bagging or containerization. The compliance officer should check the laundry collection program as well as the training of the employees assigned to these tasks. 37. Paragraph (d)(4)(iv)(A)(2). The employer has been given the choice, by this paragraph, to either: label or color-code according to paragraph (g)(1)(i), or to utilize universal precautions in the handling of all soiled (i.e., used) laundry. If universal precautions are used for handling all soiled laundry, the employer may use an alternative color or label for the bags/containers, as long as all employees are trained to recognize them as containing soiled laundry which requires the use of universal precautions. Training violations would be cited under the appropriate paragraph of (g)(2)(vii). 38. Paragraph (d)(4)(iv)(A)(3). The material for the bags or containers used in laundry collection must prevent soak-through or leakage of fluids to the exterior, if the contaminated laundry is wet and presents a reasonable likelihood of soak-through or leakage. Not all contaminated laundry must be placed in such bags or containers; only laundry wet enough to leak or soak through and expose workers handling the bags/containers to blood or OPIM, or contaminate other surfaces should be considered contaminated laundry. 39. Paragraph (d)(4)(iv)(B). Employees having direct contact with contaminated laundry must wear protective gloves (e.g., utility gloves) and any other appropriate personal protective equipment, in order to prevent or reduce contact exposure to blood

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or OPIM. Any other personal protective equipment required must be determined on a case-by-case basis. Gowns, aprons, eyewear, and masks may be necessary to prevent employee exposure. 40. Paragraph (d)(4)(iv)(C). The employer generating the laundry must have determined if the facility to which it is shipped utilizes universal precautions in the handling of all laundry. If not, all bags or containers of contaminated laundry must be labeled or color-coded in accordance with paragraph (g)(1)(i). In this instance, if the employer generating the laundry chooses to color-code rather than label, the color of the bag must be red. INSPECTION AND CITATION GUIDELINES. The compliance officer should check the employer's program to determine if laundry is shipped to another facility for cleaning and should evaluate the methods used to ship contaminated laundry (CL) to a facility that does not utilize universal precautions in the handling of all soiled laundry. The following are unacceptable shipment methods and constitute violations of this paragraph: The CL is not shipped labeled or in a red bag, paragraph (d)(4)(iv)(C) would be cited and grouped with the applicable subparagraph of paragraph (g)(1)(i); The CL is shipped with an improper label, paragraph (d)(4)(iv)(C) would be cited and grouped with the applicable subparagraphs of paragraphs (g)(1)(i) (B), (C) and/or (D); The CL is shipped in a bag color-coded for in-house use (in a color other than red), paragraph (d)(4)(iv)(C) would be cited and grouped with citations for paragraph (g)(1)(i)(E). CDC has published "Guidelines for Laundry in Health Care Facilities" Current recommendations for the laundering of contaminated linen stipulate only that normal laundering methods be used according to the manufacturer's recommendations. E. HIV and HBV Research Laboratories and Production Facilities 29 CFR 1910.1030(e). This paragraph includes additional requirements that must be met by research laboratories and production facilities engaged in the culture, production, concentration, and manipulation of HIV and HBV. Research laboratory" means a laboratory which produces or uses research laboratory scale amounts of HIV or HBV. Although research laboratories may not have the volume found in production facilities, they deal with solutions containing higher viral titers than those normally found in patients' blood. Academic research laboratories are included in this definition. Laboratories that conduct research on blood and other body fluids unrelated to HIV or HBV, or that use unconcentrated blood or blood components as the source of HIV or HBV, are not considered research laboratories for the purpose of this paragraph. "Production facilities" are those engaged in industrial scale, large volume, or high concentration production of HIV or HBV. NOTE: Employers in such facilities remain responsible for complying with the entire standard. Requirements stated elsewhere in the standard are not repeated here. These requirements are based largely on information from published guidelines of the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). (Resource: "Biosafety in Microbiological and Biomedical Laboratories.") INSPECTION AND CITATION GUIDELINES. The compliance officer should review the covered facility's plan, interview a sufficient number of employees, and observe work practices as necessary to determine if the requirements of this paragraph are met. Care should be taken to ensure the compliance officer understands the special practices and precautions in place at the facility so that the compliance officer is not placed at risk. Specific requirements include: 1. Paragraph (e)(2)(i). The term "regulated waste" refers to the OSHA definition as found in paragraph (b) of this standard. The purpose of decontaminating regulated waste is to prevent the accidental exposure of other employees to the concentrated virus. 2. Paragraphs (e)(2)(ii)(A) through (M). Paragraphs (A), (C), and (D) require employers to limit access to the laboratory and warn of the hazards associated with bloodborne pathogens. The must review the written policies and procedures to determine if they are adequate to ensure that access to the work areas and animal rooms is limited to authorized persons. Interviews with employees should be used to determine if the policies are followed. 3. Paragraph (e)(2)(ii)(E). The "other physical containment device" must be sufficient to ensure that virus containing material will be kept away from the worker's mucous membranes, unprotected skin, and breathing zone. 4. Paragraphs (e)(2)(ii)(H) and (I). These paragraphs are designed to prevent the spread of contamination to other work areas. Paragraph (I) allows for an alternative to a HEPA filter as long as it is of equivalent or superior efficiency. HEPA filters may be ineffective in humid atmospheres. The employer must also have made provisions for routine maintenance and/or replacement of all filters and traps. If the compliance officer suspects that the engineering controls are failing to prevent the spread of the virus, the manufacturer should be contacted to establish the limits and required maintenance of the filters and traps. 5. Paragraph (e)(2)(ii)(J). The compliance officer should determine if the use of needles and syringes is kept to a minimum and that they are properly handled as required, paying particular attention to establishing if the puncture-resistant containers are properly autoclaved or decontaminated before being discarded, reused, or incinerated. 6. Paragraph (e)(2)(ii)(M). This paragraph ensures that any necessary additional procedures are developed to protect employees in situations unique to a research/production facility. The biosafety manual required by this paragraph must be reviewed and updated annually or more often if necessary. The facility will thus be required to review its procedures and determine if they are adequate to protect workers. 7. Paragraph (e)(2)(iii). Specific containment equipment is required by this paragraph to minimize or eliminate exposure to the viruses. If the compliance officer determines that biological safety cabinets (BSC) have been chosen as the means of containment, they must be certified (Class I, Class II, or Class III, as appropriate) when installed or moved, and at least annually. The compliance officer should check that a dated tag is affixed to the BSC indicating who performed the certification. Alternatively, a certification report attesting to a minimum inward face velocity of at least 75 linear feet per minute and the integrity of the HEPA filters should be reviewed by the compliance officer. The report must be dated and signed by the trained technician performing the measurements and integrity tests. In the alternative, appropriate combinations of PPE or physical containment devices (examples listed in the standard) will be accepted. 8. Paragraphs (e)(3)(i) and (e)(4)(iii). The hand washing facility must be supplied with at least tepid water, soap, and hand towels. The eyewash must supply a sufficient quantity of water to completely flush the eyes. A 15-minute supply of continuous

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free-flowing water is acceptable. The hands must be free to hold the eyelids open to aid in the complete flushing of the eyes. Portable facilities are acceptable only if they meet these requirements. 9. Paragraph (e)(4) covers additional requirements for production facilities only. The requirement in paragraph (e)(4)(v) minimizes the potential for accidental exposure of other employees from the transport of culture fluids, plastic ware, and other contaminated equipment. 10. Training Requirements (e)(5). The additional training requirements are specified in paragraph (g)(2)(ix). Any violations found would be cited under that paragraph of the standard. F. Hepatitis B Vaccination and Post Exposure Evaluation and Follow-up 29 CFR 1910.1030(f). This paragraph provides a means to protect employees from infection caused by the hepatitis B virus by requiring employers to make the hepatitis B vaccination available to employees with occupational exposure to blood or OPIM. It also ensures that employees receive appropriate medical follow-up after each specific exposure incident. 1. General - Paragraph (f)(1). This paragraph refers to the hepatitis B vaccination as both the hepatitis B vaccine and vaccination series. These are to be made available to all occupationally exposed employees. In addition, a post-exposure evaluation and follow-up procedures are to be made available to all employees who experience an exposure incident. While it is OSHA's intent to have the employer remove, as much as possible, obstacles to the employee's acceptance of the vaccine, the term "made available" emphasizes that the employee has the option to decline participation in the vaccination and follow-up programs. INSPECTION GUIDELINES. The compliance officer should examine the employer's program to determine if the vaccination series and post-exposure follow-up procedures meet the requirements of paragraph (f)(1)(ii). 2. Paragraph (f)(1)(ii)(A). The term "no cost to the employee" means, among other things, no "out of pocket" expense to the employee. The employer may not permit the employee to use his/her healthcare insurance to pay for the series unless the employer pays all of the cost of the health insurance and unless there is no cost to the employee in the form of deductibles, copayments, or other expenses. Even partial employee contribution to the insurance premium means the employee could be affected by a rise in the total premium caused by insurance company reaction to widespread hepatitis B vaccinations and is therefore unacceptable. Likewise, any use of a spouse or other family member's insurance plan to provide vaccination would not be considered "at no cost" to the employee. The employer may not institute a program in which the employee pays the original cost of the vaccine and is reimbursed by the employer if she/he remains employed for a specified period of time. An "amortization contract" which requires employees to reimburse the employer for the cost of the vaccination should they leave his/her employ prior to a specified period of time is similarly prohibited. A waiver of liability with respect to acceptance of the vaccine is also prohibited. 3. Paragraph (f)(1)(ii)(B). The term "reasonable time and place" requires the medical procedures and evaluations to be convenient to the employee. They must normally be offered during employees' scheduled work hours. If participation requires travel away from the worksite, the employer must bear the cost. 4. Paragraph (f)(1)(ii)(C). The Compliance Officer can contact the National Council of State Boards of Nursing, Inc. at the Board of Nursing Contact Information web site at www.ncsbn.org to obtain the most current lists of addresses and phone numbers for each State Board of Nursing, to determine if the State Board of Nursing allows licensed healthcare professionals other than physicians to carry out the procedures and evaluations required by paragraph (f). The National Commission on Certification of Physicians' Assistants can clarify the role of physician assistants in these procedures. They can be reached at (770) 399-9971. 5. Paragraph (f)(1)(ii)(D). This paragraph takes into consideration the changing nature of medical treatment relating to Hepatitis B. The CDC is the U.S. Public Health Service (USPHS) agency responsible for issuing guidelines and making recommendations regarding infectious agents. OSHA requires use of the CDC guidelines current at the time of the evaluation or procedure. Copies of the current guidelines and other CDC documents can be obtained on CDC's web site, www.cdc.gov. The hepatitis B vaccination must be given in the standard dose and through the standard route of administration as recommended in the USPHS/CDC guidelines. The most current CDC guideline regarding Hepatitis B is Immunization of HealthCare Workers: Recommendations of ACIP and HICPAC in Vol. 46, No RR-18, published in the 12/26/1997 MMWR. (See Appendix C for the web site address) It recommends that employees who have ongoing contact with patients or blood and are at on going risk for injuries with sharp instruments or needlesticks be tested for antibody to Hepatitis B surface antigen, one to two months after the completion of the three-dose vaccination series. Employees who do not respond to the primary vaccination series must be revaccinated with a second three-dose vaccine series and retested. Non-responders must be medically evaluated. INSPECTION GUIDELINES: It is important that the compliance officer investigate thoroughly whether the employer knows of the contents of the CDC guidelines. Evidence may include an interview with the employer, employer's attendance at conferences or seminars where in service training about the CDC guidelines was provided, knowledge of interactive webpages associated with the CDC, actual copies of the MMWR, and/or employee interviews where knowledge of the MMWR has been made evident. CITATION GUIDELINES: Paragraph (f)(1)(ii)(D) should be cited if the employer failed to provide vaccinations, evaluations, or follow-up procedures for Hepatitis B in accordance with the CDC recommendations that were current at the time these procedures took place. Any additional requirements (such as obtaining a written healthcare professional's opinion) specified in paragraph (f) must also be met. 6. Paragraph (f)(1)(iii) requires that all laboratory tests be conducted by an accredited laboratory. The Compliance Officer must determine by means of employer documentation (e.g., certificate) that the laboratory is accredited by a national accrediting body (e.g., American Association of Blood Labs, College of American Pathologists, Joint Commission on Accreditation of Healthcare Organizations, etc.) or equivalent State agency which participates in a recognized quality assurance program. 7. Hepatitis B Vaccination - Paragraph (f)(2). The Compliance Officer should determine whether or not all occupationally exposed employees have had the hepatitis B vaccination series made available to them after the training required by paragraph (g)(2)(vii)(I) and within 10 working days of their initial assignment. The term "made available" includes the healthcare professional's evaluation and arranging for the administration of the first dose of the hepatitis B vaccination series to begin within the 10 days. This includes all employees with occupational exposure, regardless of how often the exposure may occur.

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Part-time and temporary employees are included in this coverage. The vaccine does not have to be made available if the employer documents the exemption(s) set forth in paragraph (f)(2). It does not have to be administered if the employer can produce the signature of the employee on the mandatory declination form (See Appendix A of 29 CFR 1910.1030.) 8. Paragraph (f)(2)(i) states the circumstances under which an employer is exempted from making the vaccination available. If, (a) the complete hepatitis B vaccination series was previously received (three vaccines or in the case of a non-responder, six), or (b) antibody testing shows the employee to be immune, or (c) the vaccine cannot be given for medical reasons, the series does not have to be made available. If the employer claims one of these exemptions, it must be documented in the employee's medical record in accordance with paragraph (h)(1)(ii)(B). Current USPHS guidelines recommend post-vaccination screening for antibody to HBsAg (anti-HBs) for certain healthcare workers. See discussion of (f)(1)(ii)(D). Periodic antibody tests thereafter are not currently recommended. CITATION POLICY. Citations should not be issued when designated first aid providers who have occupational exposure are not offered the pre-exposure hepatitis B vaccine if the following conditions exist: a. The primary job assignment of such a designated first aid provider is not the rendering of first aid or other medical assistance, and b. Any first aid rendered by such person is rendered only as a collateral duty, responding solely to injuries resulting from workplace incidents, generally at the location where the incident occurred. NOTE: This provision does not apply to designated first aid providers who render assistance on a regular basis, for example, at a first aid station, clinic, dispensary or other location where injured employees routinely go for assistance; nor does it apply to any healthcare, emergency, or public safety personnel who are expected to render first aid in the course of their work. c. The employer's exposure control plan must specifically address the provision of the hepatitis B vaccine to all unvaccinated first aid providers who render assistance in any situation involving the presence of blood or OPIM (regardless of whether an actual "exposure incident" as defined by the standard occurred) and the provision of appropriate post-exposure evaluation, prophylaxis, and follow-up for those employees who experience an "exposure incident." The plan must include: d. Provision for a reporting procedure that ensures that all first aid incidents involving the presence of blood or OPIM will be reported to the employer before the end of the work shift during which the incident occurred. The report must include the names of all first aid providers who rendered assistance, regardless of whether personal protective equipment was used and must describe the first aid incident, including time and date. The description must include a determination of whether or not, in addition to the presence of blood or other potentially infectious materials, an "exposure incident," as defined by the standard, occurred. This determination is necessary in order to ensure that the proper post-exposure evaluation, prophylaxis, and followup procedures required by paragraph (f)(3) of the standard are made available immediately, whenever there has been an "exposure incident" as defined by the standard. e. A report that lists all such first aid incidents, that is readily available, upon request, to all employees and to the Assistant Secretary. f. Provision for the bloodborne pathogens training program for designated first aiders to include the specifics of this reporting procedure. g. Provision for the full hepatitis B vaccination series to be made available as soon as possible, but in no event later than 24 hours, to all unvaccinated first aid providers who have rendered assistance in any situation involving the presence of blood or OPIM, regardless of whether or not a specific "exposure incident," as defined by the standard, has occurred. h. Unless all the requirements of this de minimis policy are met, paragraph (f)(2)(i) should be cited for failure to provide the hepatitis B vaccine. NOTE: For industries not covered by 1910.1030 or 1915.1030, failure to provide appropriate evaluation of first aid incidents (including the determination of whether an exposure incident occurred) and adequate follow-up of exposure incidents (including the provision of the hepatitis B vaccine series free of charge) should be considered for a possible 5(a)(1) citation. 9. Paragraph (f)(2)(ii). Prevaccination screening for antibody status cannot be required of an employee, although if an employer wishes, he/she can make it available at no cost to employees. An employee may decline the prescreening, and the employer must still make the vaccination series available to the employee. 10. Paragraph (f)(2)(iii). The signing of the hepatitis B vaccine declination form by the employee, at the time the vaccination is made available, does not relieve the employer from the requirement to provide the vaccine at a later date if the employee so chooses. 11. Paragraph (f)(2)(iv). Although the declination form set forth in 29 CFR 1910.1030, Appendix A, need not be reproduced verbatim, any modifications to that language shall be made for the sole purpose of improving employee comprehension. The standard does not make reference to consent forms. Medical informed consent forms, when they are a part of the healthcare professional's standard medical practice, are acceptable. However, any waiver of liability violates paragraph f(1)(ii)(A), which requires that the vaccine be provided at no cost. Consent forms which require the employee to release his or her test results to the employer violate the confidentiality requirements in paragraph (f)(5)(iii). Consent forms which are used by the employer for training or documentation purposes would violate paragraph (g)(2)(vii)(I) if the hazards of the vaccine are clearly exaggerated. 12. Paragraph (f)(2)(v). At the time of this publication, the provision of routine boosters of the hepatitis B vaccine is still being assessed. There is no requirement to provide boosters unless the USPHS recommends it at a later date. 13. Post-Exposure Evaluation and Follow-up paragraph (f)(3). This paragraph requires the employer to make immediately available a confidential medical evaluation and follow-up to an employee reporting an exposure incident. Bloodborne pathogens are defined by the standard (see the Definitions paragraph of this Directive), to include more than just HIV and HBV. The standard applies to any pathogenic microorganism present in human blood that can cause disease in humans. Paragraph (f)(3) is not specific to HIV and HBV. This paragraph requires that the employer provide post-exposure evaluation and follow-up to employees for bloodborne pathogens, such as hepatitis C (HCV), as recommended by the CDC. The current CDC recommendation for HCV is found in Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease, October 16, 1998/Vol. 47/No. RR-19 www.cdc.gov/epo/mmwr/preview/mmwrhtml/00055154.htm. In addition, the most current HIV post-exposure follow-up recommendations for an exposure incident made applicable by the bloodborne pathogens standard, at paragraph (f)(3)(iv) are found in the CDC Morbidity and Mortality Weekly Report: "Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure

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Prophylaxis," May 15, 1998/Vol. 47/ No. RR-7. www.cdc.gov/epo/mmwr/preview/mmwrhtml/00052722.htm (See Appendix C for the web site address) NOTE: Employees who do not fall within the scope of this standard may still experience a specific exposure incident at work that is unrelated to the performance of their job duties. An example is "Good Samaritan" assistance, voluntarily performed, to an injured co-worker or a member of the public. In such a case, OSHA strongly encourages employers of these employees to offer them the follow-up procedures set forth in this paragraph. INSPECTION GUIDELINES. The compliance officer should determine if the employer's plan ensures immediate and confidential post-exposure and follow-up procedures in accordance with the current CDC guidelines. As advised in paragraph (f)(1)(ii)(D), the compliance officer should document the employer's awareness of CDC guidelines. At sites where an exposure incident has occurred it should be determined if the procedures were properly followed through interviews, incident report reviews, and, if necessary, medical records reviews. CITATION GUIDELINES: The word "immediately" is used in the standard to emphasize the importance of prompt medical evaluation and prophylaxis. An exact time was not given in the standard because the time limit on the effectiveness of postexposure prophylactic measures can vary depending on the infection of concern. OSHA requires the post-exposure evaluation and follow-up to be given as soon as possible after exposure. Where medical practice is an issue, and the compliance officer believes that access to care was delayed or denied or the employer was not following accepted post-exposure procedures, the Regional Bloodborne Pathogens Coordinator shall be contacted. A health care professional in the Directorate of Technical Support will be consulted if necessary. The employer must have established a system that maintains the confidentiality of the employee's identity and test results. If the employer has contracted with a clinic or other healthcare facility to provide the followup programs, the confidentiality requirements must be part of the contract. The boundary between employer and healthcare professional may be blurred in a medical setting in which, for example, the physician is both the employer and the evaluating healthcare professional or where the employer's certified medical laboratory analyzes the serological samples. In such cases, the compliance officer should ensure that requirements for consent and confidentiality have been followed. The medical information is to be confined to the medical department and not to be discussed with or revealed to others (e.g., the personnel department, supervisors, or other healthcare professionals who do not need the information to comply with the standard). The employer should be cited for violating paragraph (f)(3) provisions (except (iv)) for not providing a confidential medical evaluation and follow-up, e.g., testing. Failure to provide post-exposure prophylaxis should be cited under (f)(3)(iv). 14. Paragraph (f)(3)(i). Documentation of the circumstances surrounding an exposure incident will help the employer and the Compliance Officer determine, for example, if PPE is being used or if training is lacking. Percutaneous injuries are primarily associated with the following activities: disposing of needles; administering injections; drawing blood, including use of capillary tubes; recapping needles; and handling trash and dirty linens. Following an exposure incident, such as a needlestick or other sharps injury, employers are required to document, at a minimum, "the route(s) of exposure, and the circumstances under which the exposure incident occurred," as per paragraph (f)(3)(i). The documentation of circumstances surrounding an incident by the employer allows identification and correction of hazards. To be useful, the documentation must contain sufficient detail about the incident. There should be information about the following: engineering controls in use at the time, work practices followed, a description of the device in use, protective equipment or clothing that was used at the time of the exposure incident, location, procedure being performed when the incident occurred, and the employee's training. Additional information might also include a comparison of similar occurrences and recommendations to avoid future incidents, although this information is not mandatory. The Compliance Officer should request copies of the employer's documentation on exposure incidents to determine if they are in compliance with paragraphs (c)(1)(ii)(C) and (f)(3)(i). INSPECTION AND CITATION GUIDELINES. The goal of the employer should be to implement a method or device that prevents exposure incidents from recurring. Evaluating the circumstances around an exposure incident as required by paragraph (f)(3)(i) provides the employer with data necessary to make effective decisions about engineering controls and work practices that will reduce the risk of exposure. The compliance officer should review the documentation of incidents available in the facility. The compliance officer should request the Exposure Control Plan and review the procedures for evaluating the circumstances surrounding exposure incidents. 15. Paragraph (f)(3)(ii). This paragraph requires the employer to identify the source individual in an exposure incident, unless this is infeasible. The employer must document in writing the identity of, or infeasibility of identifying, the source individual. Examples of when it may not be feasible to identify the source individual include incidents of needlesticks caused by unmarked syringes left in laundry or those involving blood samples which are not properly labeled, as well as incidents occurring where State or local laws prohibit such identification. 16. Paragraph (f)(3)(ii)(A). This paragraph requires testing of the source individual's blood after consent is obtained. The employer must ask for consent from the source individual or anyone legally authorized to give consent on his/her behalf. If legally-required consent is not obtained, the employer must establish this. This fact should be documented in writing, unless there is other clear evidence that consent could not be obtained. The compliance officer should ensure that the employer's plan includes this provision. For those jurisdictions that do not require consent of the individual, available blood may be used for testing rather than redrawing a specimen. The term "if available" applies to blood samples that have already been drawn from the source individual. OSHA does not require redrawing of blood specifically for HBV and HIV testing without the consent of the source individual. 17. Paragraph (f)(3)(ii)(C). This paragraph does not authorize the employer to be informed of the results of source individual or exposed employee testing. However, the results of the source individual's testing must be made available to the exposed employee in accordance with applicable State and Federal laws and regulations concerning medical privacy and confidentiality. 18. Paragraph (f)(3)(iii). The Compliance Officer must determine if the employer's program offers covered employees all of the listed requirements in the event of an exposure incident. Counseling and evaluation of reported illnesses are not dependent on the employee's electing to have baseline HBV and HIV serological testing. 19. Paragraph (f)(3)(iii)(A). The consent of the employee must be obtained before the collection and testing of his or her blood. 20. Paragraph (f)(3)(iii)(B). This paragraph allows employees the opportunity for future testing without the need for an immediate decision. Employees involved in an exposure incident have at least 90 days following baseline blood collection to decide if they wish to have their blood tested for HIV.

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To the employee, HIV testing may present adverse ramifications, e.g., confidentiality, employment, prejudice, or lack of medical information. Therefore, the 90-day time frame allows for the opportunity to obtain knowledge about baseline serologic testing after exposure incidents, and to participate in further discussion, education or counseling. This opportunity will, instead of placing a demand on the employee to make an immediate decision, encourage employees to consent to blood collection at the time of exposure. Employers are required to preserve the blood the employee consented to have drawn, if it was not tested for HIV initially, for at least the 90-day period. Compliance officers should check that if the employer contracts for post-exposure follow-up, the contractor has been informed of the 90- day requirement. 21. Paragraph (f)(3)(iv). Employers must follow the current guidelines at the time of exposure to determine if post-exposure prophylaxis is medically indicated. See paragraph (f)(3) above. CITATION GUIDELINES: Failure to offer post-exposure HIV prophylaxis under the current CDC guidelines should be cited as a violation of paragraph (f)(3)(iv). The guidelines leave decisions about prophylaxis up to the healthcare professional. However, in unusual circumstances involving gross misapplication of the CDC guidelines by the healthcare professional, the employer may be cited. In such cases consultation with the National office is appropriate. 22. Information Provided to the Healthcare Professional - Paragraph (f)(4). This paragraph requires the employer to provide information to the healthcare professional responsible for the employee's hepatitis B vaccination and post-exposure incident follow-up. INSPECTION GUIDELINES. The Compliance officer must determine if the employer's plan includes providing a copy of this standard to the healthcare professional responsible for the employee's hepatitis B vaccination. In the case of an exposure incident, the plan must provide for the transmission of the information required by paragraphs (f)(4)(ii)(A)-(C) and (E) to the healthcare professional. The information required by paragraph (f)(4)(ii)(D) must be provided only if available. The employer does not have a specific right to know the actual results of the source individual's blood testing, but must ensure that the information is provided to the evaluating healthcare professional. If the evaluating healthcare professional is also the employer, the information must still be in the employee's record and be made available at the time of a post-exposure incident. All applicable laws and standards of confidentiality apply in this situation. 23. Healthcare Professional's Written Opinion - Paragraph (f)(5). The employer is required to obtain a written opinion and provide it to the employee within 15 working days of completion of the original evaluation. Employer access to the healthcare professional's written opinion is specifically allowed. 24. Paragraph (f)(5)(i) limits the healthcare professional's written opinion to very specific information regarding the employee's hepatitis B vaccine status, including indication for vaccine and whether such vaccination was initiated (i.e., the first shot had been given.) 25. Paragraph (f)(5)(ii) requires documentation that a post-exposure evaluation was performed and that the exposed employee was informed of the results as well as any medical conditions resulting from exposure which require further evaluation and treatment. G. Employee Information and Training - Paragraph(g). Paragraph (g) ensures that employees receive sufficient warning through labels, signs, and training to eliminate or minimize their exposure to bloodborne pathogens. 1. Labels, paragraph (g)(1). Labels must be provided on containers of regulated waste, on refrigerators and freezers that are used to store blood or OPIM, and on containers used to store, transport, or ship blood or OPIM. This requirement alerts employees to possible exposure since the nature of the material or contents will not always be readily identifiable as blood or OPIM. NOTE: The labeling requirements do not preempt either the U.S. Postal Service labeling requirements (39 CFR Part III) or the Department of Transportation's Hazardous Materials Regulations (49 CFR Parts 171, 180). DOT labeling is required on some transport containers (i.e., those containing "known infectious substances"). It is not required on all containers for which 29 CFR 1910.1030 requires the biohazard label. Where there is an overlap between the OSHAmandated label and the DOT-required label, the DOT label will be considered acceptable on the outside of the transport container, provided that the OSHA-mandated label appears on any internal containers which may be present. Containers serving as collection receptacles within a facility must bear the OSHA label since these are not covered by the DOT requirements. INSPECTION AND CITATION GUIDELINES. The Compliance Officer should determine that the warning labels in the facility are used as required by paragraphs (g)(1)(i)(A) through (D) and include the term "BIOHAZARD." 2. Paragraphs (g)(1)(i)(E) through (G). These paragraphs list exemptions from the labeling requirements which are additional to those exemptions listed for specimens in paragraph (d)(2)(xiii)(A) and for laundry in paragraph (d)(4)(iv)(A)(2). Blood and blood products bearing an identifying label as specified by the Food and Drug Administration, which have been screened for HBV and HIV antibodies and released for transfusion or other clinical uses, are exempted from the labeling requirements. When blood is being drawn or laboratory procedures are being performed on blood samples, then the individual containers housing the blood or OPIM do not have to be labeled, provided the larger container into which they are placed for storage, transport, shipment, or disposal (e.g., a test tube rack) is labeled. 3. Paragraph (g)(1)(i)(I). Regulated waste that has been decontaminated by incineration, autoclaving, or chemical means, prior to disposal is not required to bear the BIOHAZARD warning label. Failure to ensure adequate decontamination procedures prior to removal of the hazard label should be cited under paragraph (g)(1)(i)(A), since the material would still be regulated waste. 4. Information and Training - Paragraph (g)(2). All employees with occupational exposure must receive initial and annual training on the hazards associated with blood and OPIM, and the protective measures to be taken to minimize the risk of occupational exposure. Retraining must take place when changes in procedures or tasks occur which affect occupational exposure. While the provisions for employee training are performance oriented, with flexibility allowed to tailor the program to, for example, the employee's background and responsibilities, the categories of information listed in paragraph (g)(2)(vii) must be covered, at a minimum. These requirements include some site-specific information. INSPECTION GUIDELINES. The Compliance Officer should verify that the training is provided at the time of initial employment and at least annually thereafter as well as whenever a change in an employee's responsibilities, procedures, or work situation is such that an employee's occupational exposure is affected. "At the time of initial assignment to tasks where occupational exposure may take place" means that employees must be trained prior to being placed in positions where occupational

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exposure may occur. The annual retraining for these employees must be provided within one year of their original training. This refresher training must cover topics listed in the standard to the extent needed and must emphasize new information or procedures. It does not need to be an exact repetition of the previous annual training. Part-time and temporary employees, and healthcare employees, known as "per diem" employees, are covered and are also to be trained on company time. The Compliance Officer should interview a representative number of employees from different work areas to determine that the training (including written material, oral presentations, films, videos, computer programs, or audiotapes) was presented in a manner that was appropriate to the employee's education, literacy level, and language. If an employee is only proficient in a foreign language, the trainer or an interpreter must convey the information in that foreign language. 5. Paragraphs (g)(2)(vii)(B) and (C). These paragraphs require that HIV and HBV and other bloodborne diseases be described. The employer must convey the idea that a number of bloodborne diseases other than HIV and HBV exist, such as hepatitis C (HCV) and syphilis. At the same time, the employer need not cover such uncommon diseases as Creutzfeldt-Jakob disease unless it is appropriate, for example, for employees working in a research facility with that particular virus. HCV is the most common chronic bloodborne infection in the United States. Persons who are chronically infected with HCV may not be aware of their infection because they may not be clinically ill. The infection may lead to chronic liver disease that develops slowly, often taking two or more decades before it is recognized. It is important that training include information on the transmission and symptoms of HCV. 6. Paragraph (g)(2)(vii)(F). This paragraph requires that training include an explanation of the use and limitations of methods that will prevent or reduce exposure, including appropriate engineering controls, work practices, and personal protective equipment. This requirement is very important, because the development of safer engineering controls introduces a variety of new techniques and practices to the work environment. Manufacturers market passive safety features, active devices, integrated safety designs, and accessory safety devices. The Record Summary respondents "repeatedly" emphasized the necessity of effective training and education whenever new engineering controls are implemented. Training must include instruction in any new techniques and practices. "Hands-on" training is particularly useful. Employee participation in the selection of new devices, which plays a major part in their acceptance and correct use, is encouraged but not required. (See above discussion in paragraphs (c)(1)(iv) and (d)(2) on engineering and work practice controls.) 7. Paragraph (g)(2)(vii)(J). The word "emergency" in this paragraph refers to blood or OPIM exposure outside the normal scope of work. This does not refer to hospital emergency rooms or emergency medical technicians' work. 8. Paragraph (g)(2)(vii)(N). This paragraph requires that there be an opportunity for interactive questions and answers with the person conducting the training session. During training, it is critical that trainees have an opportunity to ask and receive answers to questions where material is unfamiliar to them. Frequently, a trainee may be unable to go further with the training or to understand related training content until a response is received. Training the employees solely by means of a film or video without the opportunity for a discussion period would constitute a violation of this paragraph. Similarly, a generic computer program, even an interactive one, is not considered appropriate unless the employer supplements such training with the site-specific information required (e.g., the location of the exposure control plan and the procedures to be followed if an exposure incident occurs) and a person is accessible for interaction. Trainees must have direct access to a qualified trainer during training. OSHA's requirement can be met if trainees have direct access to a trainer by way of a telephone hot line. The use of an electronic mail system to answer employee questions is not considered direct access to a qualified trainer, unless the trainer is available to answer e-mailed questions at the time the questions arise. 9. Paragraph (g)(2)(viii). The person conducting the training is required to be knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace that the training will address. In addition to demonstrating expertise in the area of the occupational hazard of bloodborne pathogens, the trainer must be familiar with the manner in which the elements in the training program relate to the particular workplace. The Compliance Officer should verify the competency of the trainer based on the completion of specialized courses, degree programs, or work experience, if he/she determines that deficiencies in training exist. Possible trainers include a variety of healthcare professionals such as infection control practitioners, nurse practitioners, registered nurses, occupational health professionals, physician's assistants, and emergency medical technicians. Non-healthcare professionals, such as but not limited to, industrial hygienists, epidemiologists, or professional trainers, may conduct the training provided they are knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace. One way, but not the only way, knowledge can be demonstrated is the fact that the person received specialized training. In some workplaces, such as dental or physicians' offices, the individual employer may conduct the training, provided he or she is familiar with bloodborne pathogen exposure control and the subject matter required by paragraphs (g)(2)(vii)(A) through (N). 10. Paragraphs (g)(2)(ix)(A)-(C). "Standard microbiological practices" as used in these paragraphs refer to procedures outlined in "Biosafety in Microbiological and Biomedical Laboratories." The requirement that "proficiency" be demonstrated means that employees who are experienced laboratory workers may not need to be retrained in accordance with these paragraphs. Education such as a graduate degree in the study of viral diseases, or another closely related subject area with a period of related laboratory research experience, would also constitute "proficiency." The employer is responsible for evaluating the employee's proficiency and for documenting the mechanism used to determine proficiency. H. Recordkeeping 29 CFR 1910.1030(h). Records are required to be kept for each employee covered by this standard for training, as well as for medical records. 1. Medical records required by paragraph (h)(1) will be of particular importance to the healthcare professional in determining vaccination status and recommendation for treatment in the event of an exposure incident. Although the employer is required to establish and maintain medical records, he/she may contract for the services of a healthcare professional located offsite and that person or company may retain the records. The requirements of 29 CFR 1910.1020 apply. In particular, 29 CFR 1910.1020(d)(1)(i)(C) provides that the medical records of employees who have worked for less than one (1) year need not be retained beyond the term of employment if they are provided to the employee upon termination of employment.

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NOTE: While paragraph (h)(1)(iii) requires that medical records are to be kept confidential, paragraph (h)(1)(iii)(B) stipulates that disclosure is permitted when required by this standard or other Federal, State, or local law. INSPECTION GUIDELINES. All medical records required to be kept by this standard are also required to be made available to OSHA. The Compliance Officer must protect the confidentiality of these records. If they are copied for the case file, the provisions of 29 CFR 1913.10 must be followed. The Compliance Officer should review the employer's recordkeeping program to ensure that the required information is collected, and provision has been made to ensure the confidentiality of the medical records in accordance with 29 CFR 1910.1020. While 29 CFR 1910.1020(a) makes allowances for its provisions being carried out on behalf of the employer, paragraph 1910.1020(b)(3) states that "each employer must ensure that the preservation and access requirements are complied with regardless of the manner in which the records are made or maintained." If the employer has contracted with a responsible third party to maintain the required records, the employer should only be cited for deficiencies of which she/he knew or could have known with the exercise of reasonable diligence. 2. Paragraph (h)(2) requires accurate recordkeeping of training sessions, including titles of the employees who attend. The records are necessary to assist the employer and OSHA in determining whether the training program adequately addresses the risks involved in each job. Additionally, this information is helpful in tracking the relationship between exposure incidents (e.g., needlesticks) and various jobs and the corresponding level of training. Training records may be stored onsite where the actual documents will be easily accessible for review. In order to ensure that the employee training is complete, all the components of the program required by paragraph (g)(2)(vii) must be covered. Training records are not considered to be confidential. Training records may be stored onsite where the actual documents are readily accessible. They must be retained for 3 years from the training date. XIV. Interface With Other Standards. A. The hazard communication standard, 29 CFR 1910.1200, applies only to the hazards of chemicals in the workplace and does not apply to biological hazards such as bloodborne diseases. B. Records concerning employee exposure to bloodborne pathogens and records about HIV and/or HBV status are both considered employee medical records within the meaning of 29 CFR 1910.1020. Under 29 CFR 1913.10 (b)(4) the Compliance Officer may review these records on site for verification of compliance with the medical surveillance requirements. If requested this review shall be conducted under the observation of the medical record holder (or other employer designated healthcare professional). The compliance officer should not record or take offsite any information from the medical record other than documentation of the fact of compliance or noncompliance. Generally, compliance/noncompliance verification requires no additional action (i.e., in-depth review, copying, and/or removal of confidential medical information from the worksite) on behalf of the compliance officer. If additional or more detailed information is required for clarification or to support a suspected violation, the compliance officer is advised to seek a medical access order (MAO) from the director (Medical Records Officer), Office of Occupational Medicine. Also, when a compliance officer anticipates (or if it is known) that there may be a problem in gaining access to confidential medical information/medical records or the employer denies access during the course of the inspection, the compliance officer is advised to obtain an administrative subpoena (from the regional solicitor) in addition to the MAO before looking at any confidential medical information or medical record. C. Generally, the respiratory protection standard, 29 CFR 1910.134, does not apply. However, placing or storing respirators in areas where they could be contaminated by body fluids constitutes a violation of 29 CFR 1910 .134(h)(2)(i) (or 29 CFR 1910 .139(b)(6), if the respirator is used for protection against tuberculosis.) D. The Hazardous Waste Operations and Emergency Response (HAZWOPER) standard, 29 CFR 1910.120, covers four groups of employees: workers at uncontrolled hazardous waste remediation sites; workers at Resource Conservation and Recovery Act (RCRA) permitted hazardous waste treatment, storage and disposal facilities; workers performing corrective actions involving cleanup operations at RCRA sites; and those workers expected to respond to emergencies caused by the uncontrolled release of a hazardous substance. 1. The definition of hazardous substance includes any biological agent or infectious material which may cause disease or death. There are potential scenarios where the bloodborne and HAZWOPER standards may interface, such as: workers involved in cleanup operations at hazardous waste sites involving infectious waste; workers at RCRA permitted incinerators that burn infectious waste; workers at RCRA permitted incinerators that burn infectious waste and that are involved in cleanup operations; and workers responding to an emergency caused by the uncontrolled release of infectious material, e.g., a transportation accident. 2. Employers of employees engaged in these types of activities must comply with the requirements in 29 CFR 1910.120 as well as the bloodborne pathogens standard. If there is a conflict or overlap, the provision that is more protective of employee safety and health applies. This directive provides guidance for enforcement of the Bloodborne Pathogens Standard. The agency's application of this policy in any particular matter will, however, depend upon all relevant circumstances. For purposes of providing information and guidance, this directive also restates, clarifies, or explains the provisions of the standard. OSHA's restatement, clarification or explanation of the requirements of the standard does not amend the standard or create new legal duties, obligations or defenses.

CDC Guidelines for Reducing TB Transmission in Dental Care Settings

The CDC recommends the following for reducing the risk of TB transmission in the dental office, depending on the facilitys level of risk: In general, the symptoms for which patients seek treatment in a dental care setting are not likely to be caused by infectious TB. Unless a patient requiring dental care coincidentally has TB, it is unlikely that infections TB will be encountered in the dental setting. Furthermore, generation of droplet nuclei containing M. tuberculosis during dental procedures has not been demonstrated. Therefore, the risk for transmission of M. tuberculosis in most dental settings is probably quite low. Nevertheless, during dental procedures, patients and dental workers share the same air for varying periods of time. Coughing may be stimulated occasionally by oral manipulations,

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although no specific dental procedures have been classified as cough inducing. In some instances, the population served by a dental care facility, or the HCWs in the facility, may be at relatively high risk for TB. Because the potential exists for transmission of M. tuberculosis in dental settings, the following recommendations should be followed: A risk assessment [Section II.B] should be done periodically, and TB infection-control policies for each dental setting should be based on the risk assessment. The policies should include provisions for detection and referral of patients who may have undiagnosed active TB, management of patients with active TB relative to provision of urgent dental care; and employer-sponsored HCW education, counseling and screening. While taking patients initial medical histories and at periodic updates, dental HCWs should routinely ask all patients whether they have a history of TB and symptoms suggestive of TB. Patients with a medical history or symptoms suggestive of undiagnosed active TB should be referred promptly for medical evaluation of possible infectiousness. Such patients should not remain in the dental care facility any longer than required to arrange a referral. While in the dental care facility, they should wear surgical masks and should be instructed to cover their mouths and noses when coughing or sneezing. Elective dental treatment should be deferred until a physician confirms that the patient does not have infectious TB. If the patient is diagnosed as having active TB, elective dental treatment should be deferred until the patient until the patient is no longer infectious. If urgent dental care must be provided for a patient who has, or is strongly suspected of having, infectious TB, such care should be provided in facilities that can provide TB isolation (Sections II.E and G) Dental HCWs should use respiratory protection while performing procedures on such patient. Any dental HCW who has a persistent cough (i.e., a cough lasting 3 weeks), especially in the presence of other signs or symptoms compatible with active TB e.g., weight loss, night sweats, bloody sputum, anorexia, and fever), should be evaluated promptly for TB. The HCW should not return to the workplace until a diagnosis of TB has been excluded or until the HCW is noninfectious. In dental-care facilities that provide care to populations at high risk for active TB, it may be appropriate to use engineering controls similar to those used in general-use areas (e.g., waiting rooms) of medical facilities that have a similar risk profile.

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ADA Statement on Dental Unit Waterlines

Preface to ADA Statement on Dental Unit Waterlines The issue of biofilm in dental unit waterlines has been actively addressed by the ADA Division of Science. In the past two years, workshops have been held that reviewed current research in this area -- in particular, methods to prevent or control biofilm formation in dental unit waterlines. Most recently, an expert panel was brought together to focus on what the goal should be for dental unit water quality and to identify critical research and development needs. The panel developed a statement addressing these areas, which was subsequently adopted by the ADA Council on Scientific Affairs. In turn, the Council recommended that the statement be adopted by the ADA Board of Trustees. The Board approved a resolution adopting the statement as the position of the Association on December 13, 1995. The complete statement follows. American Dental Association Statement on Dental Unit Waterlines Adopted by the American Dental Association Board of Trustees, December 13, 1995, and ADA Council on Scientific Affairs, September 28, 1995 Background: Organized dentistry has traditionally assumed responsibility for assessing and improving the quality of dental care provided to patients. The widespread adoption of enhanced infection control methodologies by dental practitioners is just one example of the profession's commitment to high quality patient care. The Council is sensitive to heavy regulatory burden imposed on dentists in recent years by various federal, state and local government agencies. In some cases, the regulations have been based on limited science. The Council reaffirms its strong belief that both the profession and the public are served when recommendations affecting dental practice are based on sound science and take into account their cost in light of their expected benefit. The recommendations that follow are made in light of these considerations. Through its continued monitoring of scientific literature, the Council has become aware that the microbiologic quality of water used in dental treatment could be improved. Although there is no evidence of a public health risk due to this phenomenon, steps should be taken to improve the quality of water used in patient care as soon as feasible. The profession, the dental industry, and the research community all have an important role to play in this process. Dental unit waterlines (the tubes that connect the high-speed handpiece, air/water syringe and ultrasonic scaler to the water supply) have been shown to harbor a wide variety of microorganisms including bacteria, fungi, and protozoans. These microorganisms colonize and replicate on the interior surfaces of the waterline tubing, inevitably resulting in adherent heterogeneous microbial accumulations termed "biofilms." Biofilms, once formed, serve as a reservoir significantly amplifying the numbers of freefloating microorganisms in the water exiting the waterlines. It has been suggested that heating dental unit water to increase patient comfort, as is the practice in some dental offices, may further augment biofilm formation. In unmaintained dental unit waterline systems, these microbial accumulations can contribute to occasional objectionable odors and visible particles of biofilm material exiting the system. Water Quality Improvement: Dental unit water systems currently designed for general dental practice are incapable of delivering water of an optimal microbiologic quality. The Council recommends an ambitious and aggressive course to encourage industry and the research community to improve the design of dental equipment so that by the year 2000, water delivered to patients during nonsurgical dental procedures consistently contains no more than 200 colony forming units per milliliter (cfu/ml) of aerobic mesophilic heterotrophic bacteria at any point in time in the unfiltered output of the dental unit; this is equivalent to an existing quality assurance standard for dialysate fluid that ensures the fluid delivery systems in hemodialysis units have not been colonized by indigenous waterborne organisms. Manufacturers of dental equipment are encouraged to develop accessory components that can be retrofitted to dental units currently in use, whatever the water source (public or independent), to aid in achieving this goal. Further, the ADA should urge industry to ensure that all dental units manufactured and marketed in the U.S.A. in the future have the capability to be equipped with a separate water reservoir independent of the public water supply. In this way, dentists not only will have better control over the quality of the source water used in patient care, but also will be able to avoid interruptions in dental care when "boil water" notices are issued by local health authorities. At the present time, commercially available options for improving dental unit water quality are limited and will involve some additional expense. They include the use of: Independent water reservoirs Chemical treatment regimens Daily draining and air purging regimens Point-of-use filters Preliminary data suggest that some combination of the above strategies will be necessary to control biofilm formation and to achieve the desired level of water quality. To date, however, there are insufficient data to establish the effectiveness of available methods. Industry and independent researchers should be strongly encouraged to explore as wide a range as

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possible of alternatives and adjuncts to the above listed options. Dental practitioners should always consult with the manufacturer of their dental units before initiating any waterline treatment protocol. Water Quality Monitoring: Simple and inexpensive methods to estimate the number of free-floating heterotrophic bacteria in dental unit water need to be developed to test the effectiveness of control measures. A well-designed water quality indicator (WQI) should be self-contained and easy to use in-office; accurately detect a wide concentration range and type of aerobic mesophilic heterotrophic waterborne bacteria within a reasonable incubation time at room temperature; and be relatively inexpensive to use. The Council is aware that technology meeting these criteria is already available and could possibly be adapted for use in dentistry with minimal developmental cost. Training and Education: The ADA should enhance its efforts to educate dental practitioners regarding microbial contamination and biofilm formation in dental unit waterlines, and the need for improvement in the quality of water delivered to patients. Additionally, manufacturers should maintain an active approach in training and educating the profession in the proper use and maintenance of their systems. Critical Research and Development Needs Identified by the Council: 1.Research is needed to define the natural history of biofilms, specifically to more clearly determine the relationship of the numbers and types of microorganisms in the fixed population (sessile) to their free-floating (planktonic) counterparts. 2.Improved, research-based, methods need to be developed to effectively eliminate existing biofilm and prevent or control formation of new biofilm in dental unit waterlines. 3.Alternative devices for monitoring the microbial quality of water used during dental care should be developed that are simple, reliable, and cost-effective. In summary, the Council recognizes that the scientific literature supports the need for improvement in dental unit water quality. The Council will continue to work with industry and the research community to address research and development needs that will allow the delivery of water of an optimal microbiological quality to the dental patient. The Council recommends dissemination of this information to dentists as part of the ADA's on-going service to the profession and the public. Copyright 1995 American Dental Association. Reprinted by permission of ADA Publishing Co., Inc.

ADA Statement on Saliva Ejectors

A recent study published in the Journal of the American Dental Association raised the issue of possible cross contamination among dental patients as a result of backflow from the saliva ejector when, and if, the patient's lips form a seal around the ejector tip. The plastic tip suctions excess saliva from the patient's mouth during dental procedures. As part of the Association's ongoing commitment to monitoring infection control developments, its Council on Scientific Affairs is reviewing the issue at its scheduled meeting in February. If called for, the Council will recommend updated guidance to dentists on this issue. Current infection control recommendations call for the disposal of saliva ejector tips after use on each patient. The dental profession has undertaken stringent infection control measures to help ensure patient safety. While the ADA and Centers for Disease Control and Prevention are not aware of any adverse health effects associated with the saliva ejector, dentists may wish to remind patients not to close their lips around the saliva ejector tip during use. Copyright 1996 American Dental Association. Reprinted by permission of ADA Publishing Co., Inc.

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Internet Resources
ADA Infection Control Recommendations http://www.ada.org/prof/resources/topics/icontrol/index.asp ADA Statement on Dental Unit Waterlines http://www.ada.org/prof/resources/positions/statements/lines.asp ALERT: Allergy to Latex Education and Resource Team, Inc. http://www.latexallergyresources.org/ Appendix - First-Line Drugs for HIV Postexposure Prophylaxis (PEP). Publication date 05/15/1998. www.cdc.gov/epo/mmwr/preview/mmwrhtml/00052801.htm CDC Prevention Guidelines http://wonder.cdc.gov/wonder/prevguid/p0000018/P0000018.asp CDC Prevention Guidelines Database http://wonder.cdc.gov/wonder/prevguid/prevguid.html Provides access to the CDC Prevention Guidelines Database, which is a compilation of all of the official guidelines and recommendations published by the CDC for the prevention of diseases, disabilities, and injuries. Information on how to find a specific CDC Prevention Guideline. CDC: Hoaxes - www.cdc.gov/hoax_rumors.htm CDC: Infection Control in Dentistry - Airborne www.cdc.gov/nccdphp/oh/icair.htm CDC: Infection Control in Dentistry - Bloodborne www.cdc.gov/nccdphp/oh/icbbp.htm CDC: Infection Control in Dentistry - Waterborne www.cdc.gov/nccdphp/oh/icwater.htm Center for Biofilm Engineering, Montana State University. Interdisciplinary glossary www.erc.Montana.edu/Res-Lib99-SW/glossary/Gterms.html Centers for Disease Control and Prevention www.cdc.gov/ OR: www.crawford.com/cgi-bin/kidofwais.pl Centers for Disease Control and Prevention (CDC) www.cdc.gov/nip/vacsafe/ The National Immunization Program (NIP) of the CDC information on vaccine safety. Centers for Disease Control Morbidity and Mortality Weekly Report: "Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis." May 15, 1998; Vol. 47, No. RR-7. The Adobe Acrobat pdf version contains the text of the report. ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4707.pdf OR www.cdc.gov/epo/mmwr/preview/mmwrhtml/00052722.htm www.cdc.gov/epo/mmwr/preview/mmwrhtml/00052801.htm Centers for Disease Control Morbidity and Mortality Weekly Report: "Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease." October 16, 1998/Vol.47/No. RR-19. The Adobe Acrobat pdf version contains the text of the report. www.cdc.gov/epo/mmwr/preview/mmwrhtml/00055154.htm or ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4719.pdf Centers for Disease Control Morbidity and Mortality Weekly Report: "Immunization of Health-Care Workers. Recommendations of the Advisory Committee on Immunization Practices (APIC) and the Hospital Infection Control Practices Advisory Committee (HICPAC)." December 26, 1997, Vol.46, No.RR-18. www.cdc.gov/epo/mmwr/preview/ind97_rr.html or ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4618.pdf CPL 2.103 Field Inspection Reference Manual CPL 2.251 Scheduling System for Programme Inspections CPL 2-0.124 Multi-Employer Citation Policy Effective Engineering Controls ECRI designated as an Evidence-based Practice Center by the Agency for Health Care Policy and Research, is a nonprofit international health services research organization. This web site discusses the June 1998 issue of ECRI's Health Devices, which evaluated 19 needlestick-prevention devices, and provides information on how to obtain the document. http://www.ecri.org/Products_and_Services/Products/Special_Reports/Sharps_Safety_and_Needl estick_Prevention.aspx/ssnp_press_release_111501.aspx ECRI, Environmental Protection Agency www.epa.gov/ FDA Clearances: www.fda.gov/ode/germlab.html Federal Register www.access.gpo.gov/su_docs/aces/aaces002.html/ Food and Drug Administration (FDA) information on how the FDA ensures vaccine safety. www.fda.gov/fdac/features/095_vacc.html. Information on the Vaccine Adverse Event Reporting

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System (VAERS), a cooperative program for vaccine safety of the FDA and CDC. www.fda.gov/cber/vaers/vaers.htm Food and Drug Administration (FDA) Safety Alert: Needlestick and Other Risks from Hypodermic Needles on Secondary IV Administration Sets - Piggyback and Intermittent IV Warns of the risk of needlestick injuries from the use of hypodermic needles as a connection between two pieces of intravenous (IV) equipment. Describes characteristics of devices which have the potential to decrease the risk of needlestick injuries. www.fda.gov/cdrh/safety.html Glutaraldehyde Information: www.metrex.com/techinfo.html Guideline for infection control in health care personnel, 1998. www.cdc.gov/ncidod/hip/GUIDE/InfectControl98.pdf Hazardous Waste Management www.metrokc.gov/lhwmp/cesqg/index.html HIV Dent www.hivdent.org Immunization Action Coalition (IAC) www.immunize.org/ The IAC is a nonprofit organization working to increase immunization rates and prevent disease. Vaccine Information Statements, free print materials, and other hepatitis and immunization sites. Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC). Publication date 12/26/1997. Provides recommendations for Hepatitis B. www.cdc.gov/epo/mmwr/preview/mmwrhtml/00050577.htm Infectious Diseases Society of America (IDSA) www.idsociety.org/vaccine/index.html The Vaccine Initiative is a project of the IDSA and the Pediatric Infectious Diseases Society. information on vaccination and vaccination-related issues. Institute for Vaccine Safety, Johns Hopkins School of Public Health www.vaccinesafety.edu/ International Health Care Worker Safety Center at the University of Virginia www.med.virginia.edu/~epinet International Health Care Worker Safety Center, University of Virginia a list of safety devices with manufacturers and specific product names.www.people.virginia.edu/~epinet/products.html Latex Allergy: www.latex.org/in_the_news.html www.elastyren.com/info/question.html allergy.mcg.edu/physicians/ltxhome.html www.logicnet.com/alan.macleod/allergy.htm www.latex.org/literature_library.html Medscape Infectious Diseases www.medscape.com/ Morbidity and Mortality Weekly Report (MMWR) www2.cdc.gov/mmwr/mmwr.html Provides access to the MMWR, a series which is prepared by the CDC. Contains comprehensive information on policy statements for prevention and treatment that are within the CDC's scope of responsibility, for example, recommendations from the Advisory Committee on Immunization Practices (ACIP). National Institute for Occupational Safety and Health (NIOSH) Sharps Disposal Containers information on selecting, evaluating, and using sharps disposal containers.www.cdc.gov/niosh/sharps1.html National Institute of Health www.nih.gov/ OR: www.fedworld.gov/ OR: golgi.harvard.edu/biopages/medicine.html OR: www.cis.ohio-state.edu/hypertext/faq/usenet National Institutes of Health (NIH) www.niaid.nih.gov/publications/vaccine/undvacc.htm a 40 page brochure "Understanding Vaccines." National Library of Medicine www.nlm.nih.gov/ (National Institute of Health) OR: www.med.harvard.edu/bwhrad/ OR: www.excite.com/subject/health-and-medicine/ Occupational Safety and Health Administration (OSHA) Needlestick Injuries recent news, recognition, evaluation, controls, compliance, and links to information on effective engineering controls. www.osha-slc.gov/SLTC/needlestick/index.html OSAP (Office Safety & Asepsis Procedures Research Foundation): Home Page www.osap.org OSAP: Infection Control in Dentistry Guidelines www.osap.org/o-guide1.htm OSAP: List of FDA-cleared products for Waterline Quality Improvement www.osap.org OSHA Bloodborne Pathogens Rule www.osha-slc.gov/fedreg_osha/fed_19911206.html

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OSHA Directives: www.osha.gov OSHA e-Compliance Assistance Tools www.osha-slc.gov/dts/osta/oshasoft/ecats.html OSHA Enforcement Procedures and Scheduling for Occupational Exposure to TB www.oshaslc.gov/oshadoc/directive_data/direct_19960209.html OSHA Hazard Communications www.osha-slc.gov/fedreg_osha_data/fed_19940209.html OSHA Technical Manual www.osha-slc.gov/dts/osta/otm/otm_toc.html OSHA: Bloodborne Pathogens Rule www.osha-slc.gov/fedreg_osha/fed_19911206.html OSHA: Enforcement Procedures and Scheduling for Occupational Exposure to TB www.oshaslc.gov/oshadoc/directive_data/direct_19960209.html OSHA: Hazard Communications www.osha-slc.gov/fedreg_osha_data/fed_19940209.html OSHA: Worker complaints www.osha.bov/as/opa/worker/index.html Post-Exposure Evaluation and Follow-Up Requirements: Dental Employer Obligations Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis. Publication date 05/15/1998. www.cdc.gov/epo/mmwr/preview/mmwrhtml/00052722.htm Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease. Publication date 10/16/1998. www.cdc.gov/epo/mmwr/preview/mmwrhtml/00055154.htm Safety Sharp Device Contracts safety sharp devices on contract with the US Department of Veterans Affairs (VA). www.va.gov/vasafety/osh-issues/needlesafety/safetysharpcontracts.htm SHARPS Injury Control Program Established by Senate Bill 2005 to study sharps injuries in hospitals, skilled nursing facilities, and home health agencies in California. A Beta version of Safety Enhanced Device Database Listing by Manufacturer. www.ohb.org/sharps.htm Training for Development of Innovative Control Technologies (TDICT) Project "Safety Feature Evaluation Forms" for specific devices. www.tdict.org/criteria.html United States Air Force Dental Investigation Service The Year 2000 USAF Dental Iinfection Control Guidelines www.brooks.af.mil/dis/icguidelines/index.htm United States Food and Drug Administration www.fda.gov World Health Organization www.who.org World Health Organization vaccine safety home page which offers links to vaccine safety-related information. www.who.int/gpv-safety/

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Endnotes

Miller, C.H.; Palenik, C.J. Infection Control and Management of Hazardous Materials for the Dental Team. Mosby 1994. ii Centers for Disease Control and Prevention Guidelines for preventing the transmission of Mycobacterium tuberculosis in Health Care Facilities, 1994. iii http://www.cdc.gov/hiv/pubs/mmwr/mmwr05jun81.pdf iv "Can AIDS Be Cured? Research Suggests a Disappointing Answer: Probably Not" Wall Street Journal (04.30.01) Associated Press. In The PreventioNews Mailing List maintained by the National Prevention Information Network (NPIN), part of the Centers for Disease Control and Prevention's National Center for HIV, STD and TB Prevention. April 30, 2001. v ADA, CDC, OSHA. vi OSAP Dental Infection Control and Office Safety Resource Guide 1999. vii OSAP Monthly Focus #1, 2001 viii OSAP Monthly Focus #6, 1998 ix US Food and Drug Administration-Center for Devices and Radiological Health Office Of Device Evaluation Division Of Dental, Infection Control and General Hospital Devices Website x Molinari, J.A.; Molinari, G.E. "Is mouthrinsing before dental procedures worthwhile?" JADA 1992; 123(3): 75-80. xi ADA Statement on Backflow Prevention and the Dental Office Adopted by the American Dental Association Board of Trustees, April 24, 1996, and ADA Council on Scientific Affairs, April 21, 1996 xii Watson, C.M.; Whitehouse, R.L.S. "Possibility of cross-contamination between dental patients by means of the saliva ejector." JADA 1993; 124(4): 77-80. xiii OSAP Monthly Focus #3, 2000. xiv Santiago, J et al Mictobial contamination of dental unit waterlines: Short and long term effects of flushing. Gen Dent 1994. 42(6): 528-544. xv Bednarsh, H. et al Check your dental unit water IQ. Access Vol. 10, No.9, 1997 xvi OSAP Monthly Focus #12, 1999. xvii OSAP Position Paper on dental unit waterlines. 2000. xviii Colonel Shannon E. Mills, DDS. Dental Waterline Update 2000.June 17, 2000 OSAP Annual Symposium. xix OSAP Website: www.osap.org Suggested Procedures for Dental Offices During Boil-Water Advisories xx Donn, J. Jury rejects mans claim he contracted AIDS from dentist. Feb. 17, 1996. Patriot Ledger xxi Associated Press High Court to hear HIV bias case New York Times 11/25/97 xxii Greenhouse, Linda Justices, 6-3, Bar Veto of Line Items in Bills; See H.I.V. as Disability New York Times 6/26/98 P. A1. xxiii ADA Statement on Bragdon Case Brief. www.ada.org xxiv ADA News, Vol. 31, No. 11, June 5, 2000: 8 in OSAP Report Spring/Summer 2000 13(2). xxv Bednarsh, H. OSHA Issues new compliance directive. Access March 2000. xxvi OSAP Monthly Focus #2, 2000. xxvii OSAP Monthly Focus #2, 2001. xxviii Based on information from www.osha.gov and Appendix material from CPL 2-2.44D Enforcement Procedures for the Occupational Exposure to Blood-borne Pathogens Nov. 5, 1999 xxix Downloaded from www.osha.gov xxx Downloaded from www.osha.gov. Training for Development of Innovative Control Technology Project June Fisher, M.D. June1993, revised August 1998 Trauma Foundation, Bldg #1, Room #300 San Francisco General Hospital 1001 Potrero Avenue San Francisco, CA 94110 xxxi Downloaded from www.osha.gov. Training for Development of Innovative Control Technology Project June Fisher, M.D. June1993, revised August 1998

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