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CLINICAL LABORATORIES:
• Facilities that perform chemical and microscopic examinations of
various body fluids like blood and tissues.
• Found in a variety of settings both in government and private
hospitals or free standing( non- hospital) laboratories such as found
in clinics, group practices, physician’s offices, veterinary offices,
government agencies and military institutions.
• Large in size, offering sophisticated services and employing many
medical technologist and technicians or it maybe a small facility
having only few employees.
• Type of clinical laboratory:
• Small size hospital (< 100 beds) – routine procedures, more
complicated or infrequently requested tests may be sent to reference
labs.
• Medium size hospital( 100-300 beds) routine procedures including
complicated procedures.
• Laboratories in large size hospitals ( over 300 beds) –large volumes
of work and perform complex tests.
PATHOLOGIST:
MEDICAL TECHNOLOGIST:
• Dr. Pio de Roda instructed Dr. Sta. Ana to prepare a formal syllabus
of training program.
• June 1960, the permit for the internship program was issued.
• June 14,1961- full recognition of the 4th year BS Medical
Technology course was given.
• Dr. Horacio Ylagan and Dr. Serafin Juliano thru the authority of Dr.
Lauro H. Panganiban(Dean IM) and Dr, Jesus Nolasco(sec.IM)
applied for the offering the BS Med tech course. The Bureau of
Education approved the program in July 5, 1962, the first batch
graduated in 1963.
ORGANIZATIONAL STRUCTURE:
• Chief executive officer and board of trustees (CEO)
• Chief Operating Officer ( COO)
• Chief Financial Officer ( CFO)
• Chief Information Officer (CIO)
• Chief Technology Officer (CTO)
PRESIDENT / CEO
Vice President
Human Resources
Vice President
Central Services
Vice president
Finance
Vice president
Clinical Services
Vice president
Nursing
Department Chairman
(Laboratory Director)
Department Manager
Support Services
Laboratory Medicine
Directors
Anatomical Pathology
Point of
Care testing
Molecular
diagnostics
Histology
Supervisor -----Central
processing
-----phlebotomy
Autopsy
Service Chemistry -----Clerical
Coagulation Services
Hematology -----Laboratory
Immunology Information
Services
Microbiology
Toxicology
• Leaders and managers of the clinical laboratory must be certain that all legal
operating regulations have been met and all persons working in the laboratory
setting are fully aware of the importance of compliance with these regulations.
HEMATOLOGY:
• Study of blood
• Formed elements of blood –blood cells- erythrocytes (red blood cells, RBC),
leucocytes ( white blood cells, WBC) and thrombocytes ( platelets)
• CBC –complete blood count- includes- RBC count, WBC count, platelet count,
hemoglobin concentration, hematocrit and percentage differential of WBC’s
present.
• useful in diagnosis of anemia- too few RBC-too little hemoglobin
• leukemia- too many WBC or abnormal WBC/ infectious process.
• Test – hematology lab- automated instrument
• Automated cell counter- WBC differential analysis, separation of the types of
WBC.
• Cell counts- body fluids.
• Microscopic assessment – stained blood film-CBC
• Reticulocyte count and Eryhtrocyte sedimentation rate (ESR)
• Bone marrow examination
URINALYSIS:
• For the detection of disease related to the kidney and urinary tract.
• 3 components:
• physical characteristics of urine specimen( color, clarity, specific gravity)
• screening for chemical constituents (pH, glucose, ketone bodies, protein, blood
bilirubin, urobilinogen, nitrites, leucocyte esterase)
• microscopic examination of urinary sediment (metabolic diseases – diabetes
mellitus, kidney disease and infectious diseases of urinary bladder or kidney.
CLINICAL CHEMISTRY:
• Quantitative analytical procedures on body fluids- serum and plasma-.
• Common test:
• Glucose- to diagnose and monitor diabetes mellitus
• Cholesterol- lipid status
• Electrolytes- affect many metabolic process of the body- osmotic pressure and
water distribution in body compartments, maintenance of pH, regulation of
function of the heart, oxidation- reduction process.
• Drug therapy and drug levels – toxicology
MICROBIOLOGY
• Microorganisms that can cause disease are identified.(Pathogens)
• Specimen in micro lab for culture include swabs from throat and wounds,
sputum, vaginal excretions, urine and blood.
• Differential testing- inoculation and incubation of classic culture plate to
observation of microorganism’s growth characteristics; Gram staining
techniques to separate gram positive and gram negative organisms.
• Rapid testing method- immunologic tests –monoclonal antibodies to identify
streptococcal organism causing pharyngitis or “ strep “ throat.
• Identify appropriate antibiotic for treatment of offending pathogen
Pathogen is tested by using a panel of antibiotics of various types and dosages to
determine the susceptibility of the organism to various antibiotics
• Regulations and standards are designed to protect staff working in the lab,
health care personnel, patients treated in health care facilities and society.-
Federal regulations.
• Regulatory mandates have been issued externally- Clinical Laboratory
Improvement Amendments of 1988 (CLIA).
• regulate chemical waste disposal, use of hazardous chemicals, issues of
laboratory safety personnel, handling of biohazard.
• Laboratory that wants to receive payment for its services from Medicare or
Medicaid must be Licensed under the Public Health Service Act.
• Any facility performing quantitative , qualitative or screening test procedures
or examination on materials derived from the human body is regulated by
CLIA ’88-
Hospital lab; physician office lab,; nursing home facilities; clinics; industrial
lab, pharmacies, fitness centers; independent laboratories.
Reference Laboratories:
• Can perform complex tests for many customers, giving good turn around times.
• Should be managed by professionals who recognize the importance of
providing quality results and information about the utilization of results when
needed.
PATHOLOGIST
• anatomic pathologist- licensed physician trained- 4-5 years after graduating
from medical school to examine ( grossly and microscopically) all the
surgically removed specimens from patients- frozen sections, tissue samples
and autopsy specimen; examination of pap smears and other cytologic and
histologic test.
• Clinical pathologist- licensed physician , additional training in clinical
pathology or laboratory medicine.
• Services – examination of surgical specimen- done by anatomic pathologist.
• Accuracy- describes how close a test result is to the true value. Reference
samples and standards with known values are needed to check accuracy.
• calibration – comparison of an instrument measurement or reading to a known
physical constant.
• Control – represent a specimen that is similar in composition to the patient
whole blood or plasma. Value of control specimen is known. Control specimen
are tested exactly the same way as the patient specimen and are tested or in
conjunction with the unknown specimen.
• Precision- describes how close the test results are to one another when repeated
analyses of same material are performed.
• refers to the reproducibility of test results.
• Standards- are highly purified substance of a known composition, a standard
may differ from a control in its overall composition and the way it is handled in
the test.
• best way to measure accuracy, used to establish reference points in the
construction of graph or to calculate a result
PROFICIENCY TESTING:
• Acdg to CLIA’88- laboratory must establish and follow written quality control
procedures for monitoring and evaluating the quality of analytical process of
each method, to ensure the accuracy and reliability of patient test results and
reports.
• Proficiency testing- is a means by which quality control between laboratories is
maintained.
• Provisions of CLIA’88 require enrollment in an external PT program for
laboratories performing moderately complex or highly complex test.
CONFIDENTIALITY:
• Any results obtained for specimens from patients must be kept strictly
confidential.
• The Health Insurance Portability and Accountability act enacted in 1996
requires the privacy of patient information.
• Only authorized persons should have access to the information about a patient.
And any release of the information to non- health care persons such as
insurance personnel, lawyers or friends of the patient can be done only when
authorized by the patient.
CHAIN OF CUSTODY
• Laboratory results that could potentially be used in a court of law, such as a
trial or judicial hearing must be handled in a specific manner.
• For evidence to be admissible, each step of the analysis, beginning with the
moment the specimen is collected and transported to the laboratory, to the
analysis itself and reporting of results, must be documented, this process is
known as maintaining the Chain of custody.
• Specimens that provide alcohol levels, specimens collected from rape victims,
specimen for paternity testing and specimen submitted from medical
examiner’s cases are usual types requiring chain of custody documentation.
LABELLING
• OSHA recommends that all chemically hazardous contents and severity of the
material, as well as bear a hazard symbol.
• Substance can be classified as hazardous by the Department of Transportation
(DOT), Environmental Protection Agency ( EPA), or National Fire Protection
program(NFPA). Labels of chemicals in the original containers must not be
removed or altered.
• For chemicals not in original container, the labeling for all substances with a
rating of 2 or greater( scale 0-4, 4= greater risk) acdg to hazard identification
developed by NFPA, must include the following:
• Identity of hazardous chemical, Route of body entry, health hazard, physical
hazard, target affected organ.
Hazard identification system / Diamond Shaped Symbols
Red- Flammability
• laboratories develop, implement and comply with a plan that ensures the
protective safety of laboratory staff to potential infectious blood borne
pathogens.
• Manage and handle medical waste in a safe and effective manner.
• Government regulations require that all employees who handle hazardous
material must be trained to use and handle these materials.
• CDC also recommends safety precautions concerning the handling of all
patients specimens, known as Standard Precautions formerly “Universal
Precautions”
• CLSI issued guidelines for the laboratory worker in regard to protection from
blood borne diseases spread through contact with patient specimen.
BIOHAZARD:
• Potential risk – direct infection or though the environment. Infection can occur
during the process of specimen collection or from handling , transporting or
testing the specimen.
UNIVERSAL PRECAUTIONS :
* Method of controlling infection in which all blood and body fluids are treated
as infected with Hepatitis B, HIV, tissue producing blood borne pathogen.
1. Use a PROTECTIVE BARRIER, gloves, when handling blood and body fluids.
Wear a gown or laboratory coat and change when contaminated. Cover all
cuts and abrasions with adhesive tape or bandage.
1. Use Pasteur pipette or other devices for transferring fluid samples. Do not
pour from one tube to another, because a drop or two may contaminate the
outer surface of the tube.
1. Minimize spills and spatters. If they should occur, absorb the liquid with
disposable, absorbent material, clean with detergent and disinfect with a
hypochlorite solution.
1. Blood and most other body fluids including semen, vaginal secretions,
pericardial fluid, peritoneal fluid, synovial fluid ,pleural fluid, amniotic fluid,
saliva, tears, (CSF) cerebrous spinal fluid, and breast milk of all patients
maybe considered potentially infectious for HIV, HBV.Unfixed tissues, organs
or blood slides may also be considered potentially infectious.
1. Wash hands after removal of gloves, after any contact with blood or body
fluids and between patients. Practice of washing and reusing gloves between
patients is discouraged.
17.No precaution labels are used on any patient specimens because of the
fact that all specimen are considered infectious and handled
accordingly.
Techniques common to all phlebotomy procedures.
1.Correct patient identification is critical.
3.Blood specimen obtained should be labeled with patient’s first and last name,
hospital identification number, patient location, time and date and Phlebotomist
initials.
To be consistent with Laboratory guidelines and Universal precaution, Gloves
must be worn at all times while performing phlebotomy techniques to protect the
technologist from acquiring blood-borne infection.
5. All sharp objects such as lancets and needles must be disposed of in special
puncture- resistant disposable needle containers labeled as biohazardous. Needles
should not be ebent, broken or resheated before disposal.
82 % Unknown
working with agent
being in the laboratory
handling infected animal
Trained Investigators
Technical assistant
Animal caretaker
Graduate students
13.7% Maintenance
Janitors
Dishwashers
BIOHAZARD
- are infectious agents or biological materials that present a risk to the health of
humans or animals .The risk can be direct through infection or indirect through
damage to the environment.
Infectious agents have the ability to replicate and to give rise to large numbers of
organisms when small numbers are released from a controlled situation.
BIOSAFETY LEVELS:
BSL 1: Involves agents of no known or minimal potential hazard to lab personnel
or environment work is usually done on open bench top.
Carefully pour freshly prepared 1:10 dilution of household bleach around the
edges of the spill and into the spill.
UNIVERSAL PRECAUTIONS:
Pathological waste- stored with disinfectants- must be autoclaved or incinerated.
Infectious agents- ( from cultures, surgery, disposable towels, gowns and
gloves.)metal bin storage is required. Autoclaved and incinerated.
Handwashing:
• be performed after contact with patient and laboratory specimens.
• Should be used as an adjunct to, not a substitute for hand washing.
• Hands should be washed with soap and water or by hand antisepsis with an
alcohol based hand rub:
• after completing lab work and before leaving the laboratory
• After removing gloves. Association for Professionals in Infection control and
Epidemiology reports extreme variability in quality of gloves, with leakage 4%
to 63% of vinyl gloves and 3% to 52% of latex gloves.
• Before eating , drinking , applying makeup and changing contact lens and
before and after using the bathroom
• Before all activities that involve hand contact with mucous membranes or
breaks in skin.
• Immediately after accidental skin contact with blood, body fluids or tissues.
CHEMICAL HAZARDS:
• Proper storage and use of chemicals are essential to avoid a potential fire
hazard and other health hazards resulting from inhalation of toxic vapors or
from skin contact.
• Fire and explosions are a concern when flammable solvents are used.
• These materials should always be stored in special OSHA- approved metal
storage cabinets that are properly ventilated
• Organic solvents should be used in fume hood.