Governing Agencies - U.S. Food and Drug Administration - AABB- American Association of Blood Banks - College of American Pathologist DONOR SCREENING - Medical history - Physical examination 1. Will a donation of approximately 450ml of whole blood at this time be harmful to the donor? 2. Could blood drawn from this donor at this time potentially transmit a disease to the recipient? - Serologic testing
Registration - Outlined in the AABB Standards - Must confirm donor identity and link the donor to existing donor records - Photographic identification Drivers license Passport School ID - To prevent ineligible donor: Every donor must be checked against a permanent record - List of information in the registration process:
Name (first, last, MI) Date and time of donation Address Telephone Gender Age or date of birth o Minimum age o For allogenic donation: Between 16-17 years old Depend on individual state requirements No upper age limit o For autologous donation: No age restriction Each blood donor-patient must be evaluated by the blood bank medical director
Consent to donate Donors should be informed of the procedure and its potential risks Must also be given educational materials informing the signs and symptoms associated with HIV infection and AIDS Statement documenting that the donor have given consent to the donation. Typically done at the end of the donor history questionnaire
Additional information The name of the patient for whom the blood is intended (directed donation) Race of the donor - for unique phenotypes CMV status
Medical History Questionnaire - Obtains accurate medical history of the donor - Ensure protection of the donor and the benefit to the recipient - A standardized medical history questionnaire was developed by representatives from: AABB FDA Blood and plasma industry - Questionnaire was designed to be: Self-administered o Must be reviewed before completing the screening process and prior to blood collection Can be administered by trained donor historian - Interviewer should be familiar with the questions - Interview should be conducted in a secluded area of blood center or donor site - Questions are designed to a simple yes or no but elaborated if indicated - Currently approved version of the Donor History Questionnaire (DHQ) can be downloaded from the FDA website.
Medical History Questions 1. Are you feeling healthy and well today? - Donor should be in good health without obvious signs or symptoms of colds, flu, or other illness.
2. Are you currently taking an antibiotic or taking any other medication for an infection? - Antibiotics for infection - Prophylaxis after dental surgery - Deferred temporarily until treatment completed
3. Are you now taking or have you ever taken any medications on the Medication Deferral List? - Developed along with DHQ
CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 2
CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 3
4. Have you read the educational materials?
CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 4
5. In the past 48 hours, have you taken aspirin or anything with aspirin in it? - Piroxicam, aspirin - May not be suitable donor for platelet apheresis - Inhibit platelet function - No restriction for whole blood donation
6. In the past 6 weeks, have you been pregnant or are you pregnant now? - Female donors: 6-week deferral - 1 st -trimester or 2 nd trimester or miscarriage is not a cause for deferral - Pregnant woman received a transfusion: 12 month deferral
7. In the past 8 weeks, have you donated blood, platelets or plasma? In the past 16 weeks, have you donated a double unit of red cells using an apheresis machine? - Time interval for allogeneic whole blood donations: 8 weeks or 56 days - Apheresis donation (platelets, leukocytes, granulocytes): at least 48 hours - Infrequent plasma apheresis: 4-week deferral - Double red cell unit apheresis: 16 weeks
8. In the past 8 weeks, have you had any vaccinations or other shots? Have you had contact with someone who had a smallpox vaccination? - Live attenuated or bacterial vaccine (measles/rubeola, mumps, oral polio, typhoid, yellow fever): 2-week deferral - Live attenuated vaccine for German measles/rubella or chickenpox: 4-week deferral - Toxoids or killed or synthetic viral, bacterial, or rickettsial vaccines with no deferral if symptom-free and afebrile: Diphtheria Hepatitis A Hepatitis B Influenza Lyme disease Pneumococcal polysaccharide Polio injection (Salk) Anthrax Cholera Pertussis Plague Paratyphoid Rabies Rocky Mountain spotted fever Tetanus Typhoid injection - Smallpox vaccination: deferred for 14-21 days or until the scab has fallen off - Close contact (defined by FDA): exposure to vaccination site or bandages, clothing, towes, or bedding that have been in contact with the vaccination site - Vaccinia virus infection symptoms (new rash or skin sores since the time of contact) from the vaccine
9. In the past 12 months, have you had a blood transfusion; a transplant such as organ, tissue, or bone marrow; or a graft such as bone or skin? - 12-month deferral
10. In the past 12 months, have you come in contact with someone elses blood or had an accidental needle- stick injury? Had a tattoo? Had ear or body piercing? - 12-month deferral - Exposure of blood in contact with an open wound, any broken skin, or mucous membranes (nose, mouth, eyes) - Skin-penetrating injuries from instruments, equipment, needles that are non-sterile and contaminated with blood or body fluids - Includes tattoos, permanent makeup, ear and body piercing
11. In the past 12 months, have you had a sexual contact with anyone who has HIV/AIDS or has had a positive test for HIV/AIDS? - 12-month deferral
12. In the past12 months, have you had sexual contact with a prostitute or anyone else who takes money or drugs or other payment for sex? - 12-month deferral
13. In the past 12months, have you had sex with anyone who has ever used a needle to take drugs or steroids or anything not prescribed by their doctor? In the past 12 months, have you ever had sex with anyone who has hemophilia or has used clotting factor concentrates? - Sex with any person who is past or present IV drug user: 12-month deferral - Sex with persons with hemophilia or related blood disorder who has received factor concentrates: 12-month deferral
14. Female donors: have you had sexual contact with a male who has ever had sexual contact with another male? - 12-month deferral - No deferral if only close contact (living in the same house, kissing, shaking hands, working with)
15. In the past 12months, have you had sexual contact with a person who has hepatitis? Have you lived with a person who has hepatitis? - Sexual contact or close contact with person who has acute or chronic hepatitis B (HBsAg or HBV positive) or who has symptomatic hepatitis C: 12-month deferral
16. In the past 12 months, have you been treated for syphilis or gonorrhea? - 12-month deferral after completion of therapy - Treponema pallidum - May live for 1 to 5 days in cold storage - Fresh unit RBCs may transmit infection - Thrives very well at room temperature
17. Have you been in juvenile detention, lockup, or prison for more than 72 hours? - 12-month deferral
18. In the past 3 years, have you been outside of the United States or Canada? CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 5
a. Malaria - 1-year deferral no signs and symptoms of malarial infection - Immigrants resided in the endemic area for at least 5 consecutive years: 3-year deferral
b. CJD and vCJD - Indefinitely deferred - Transmissible spongiform encephalopathies or prion diseases - Affect sheep, cows, and humans - CJD Results in progressive dementia and spongiform alterations in the brain Rapidly fatal May be transmitted by: o Corneal transplants o Human dura mater grafts o Pituitary-derived human growth hormone o Neurosurgical instruments
c. Leishmaniasis - 12-month deferral - Intracellular protozoan parasites (Leishmania spp) - Endemic tropical and subtropical areas in the Middle East, Mediterranean coast, Africa, Cantral and South America, and Asia
19. From 1980 through 1996: a. Did you spend time that adds up to 3 months or more in the United Kingdom? - Indefinitely deferred
b. Were you a member of the U.S. military, a civilian military employee, or a dependent of a member of the U.S. military? - Indefinitely deferred - Spent 6 months or more at U.S. military base in Europe (United Kingdom, Belgium, Netherlands, Germany) from 1980-1990 - Who were at a base in Spain, Portugal, Turkey, Italy, or Greece from 1980-1996
20. From 1980 to the present, did you: a. Spend time that adds up to 5 years or more in Europe? - Indefinitely deferred as donors of whole blood, blood components, or source of leukocytes - Not deferred as donor source of plasma
b. Receive a blood transfusion in the United Kingdom or France? - Received transfusion of blood, platelets, plasma, cryoprecipitate, or granulocytes - Indefinitely deferred
21. From 1977 to the present, have you: a. Received money drugs, or other payment for sex? - Permanently deferred
b. Male Donors: Have you had sexual contact with another male, even once? - Permanently deferred
22. Have you ever: a. Had a positive test for HIV/AODS virus? - Indefinitely deferred
b. Used needles to take drugs, steroids, or anything not prescribed by your doctor? - Indefinitely deferred
c. Used clotting factor concentrates? - 12-month deferral
d. Had hepatitis? - Indefinitely deferred
e. Had malaria? - 3-year deferral after being asymptomatic
f. Had Chagas disease? Had babesiosis? - Indefinitely deferred - Chagas disease American trypanosomiasis Caused by protozoan parasite Trypanosoma cruzi Hematophagous bug (Vector)- Reduviidae Mucous membranes or breaks in skin are contaminated with the feces of infected hematophagous bug Endemic in Central and South America and Mexico Maybe transmitted congenitally by breastfeeding, organ transplant, or blood transfusion - Babesiosis Babesia microti utilizes the vector Ixodes scapularis Penetrates erythrocytes where throphozoite multiplies; upon lysis of RBC, merozoites are released into the blood and infect other RBCs Transfusion-associated infection carries an incubation period of 2 to 8 weeks Symptoms: o Malaise o Fatigue o Anorexia o Arthralgias o Nausea o Vomiting o Abdominal pain o Fever reaching 40C
g. Received a dura mater (or brain covering) graft? - Indefinitely deferred
h. Had any type of cancer, including leukemia? - Indefinitely deferred - History of cancer, leukemia, or lymphoma - Exceptions: Basal or squamous cell cancer Carcinoma in situ of the cervix Papillary thyroid carcinoma
i. Had any problems with your heart or lungs? - Deferral CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 6
- History of cardiovascular, coronary, or rheumatic heart disease - Active pulmonary tuberculosis or other pulmonary disease
j. Had a bleeding condition or a blood disease? - History of bleeding problem following surgery, invasive dental procedures, cuts, or abrasions must be further evaluated by the blood bank director. - Indefinitely deferred Hemophilia von Willebrand disease Sickle cell anemia Thalassemia Kaposis sarcoma Polycythemia History of receiving clotting factor concentrates
k. Been in Africa? - Indefinitely deferred
l. Had sexual contact with anyone who was born in or lived in Africa? - Indefinitely deferred - African Countries at Increased Risk of HIV-1 Group O Benin Cameroon Central African Republic Chad Congo Equatorial Guinea Gabon Kenya Niger Nigeria Senegal Togo Zambia
m. Have any of you relatives had Creutzfeldt-Jakob disease? - Permanently deferred
The Physical Examination 1. General appearance - Should observe for presence of: Excessive anxiety Drug or alcohol influence Nervousness
2. Weight - Standard: Maximum of 10.5 mL of blood/kg of donor weight - Weigh <100 pounds: Amount of blood collected must be proportionately reduced as well as anticoagulant - Formulas used to calculate the adjusted volume of blood to be collected and anticoagulant to be used: - Volume to collect = (Donors weight in kg/50) x 450 mL
- Reduced volume of anticoagulant= Volume to collect/450 x 63 mL
- Amount of solution to be removed= 63 mL above calculated volume
3. Temperature - Standard: Must be less than or equal to 37.5C or 99.5F - Donors are asked not to drink coffee while waiting, as this may affect their temperature. - Oral temperatures that are lower than normal are not cause for deferral.
4. Pulse - Should be between 50 and 100 bpm - Athletic donors will have a pulse less than 50 bpm, which is not cause for deferral - Should be counted for at least 15 seconds - Any irregularities should be evaluated by blood bank physician
5. Blood pressure - Systolic blood pressure: Should be less than or equal to 180 mmHg - Diastolic blood pressure: Should be less than or equal to 100 mmHg - Blood pressure above these should be evaluated by a blood bank physician.
6. Hemoglobin and Hematocrit - For allogeneic donation: Hemoglobin: Should be greater than or equal to 12.5 g/dL Hematocrit: Should be greater than or equal to 38% - For analogous donation: Hemoglobin: Should be greater than or equal to 11 g/dL Hematocrit: Should be greater than or equal to 33% - Methods used for measuring Hgb: Copper sulfate Point-of-care instruments using spectrophotometer - Methods used for measuring Hct or Packed Cell Volume: Manually by centrifugation Blood is usually acquired via finger stick
7. Skin lesions - Donors arms should be inspected for skin lesions prior to donation. - Evidence of skin lesions (e.g., multiple puncture marks) is cause for indefinite deferral. - Skin disorders that are not cause for deferral: Poison ivy and other rashes Should not be present in the venipuncture site May need to be evaluated by a blood bank physician Review of Permanent Deferral File - Allogeneic whole blood donation: 8 weeks or 56 days CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 7
- Apheresis donation (platelets, leukocytes, granulocytes): At least 48 hours Types of Deferral 1. Temporary deferral 12 months deferral: - Blood transfusion during pregnancy - Blood transfusion - Organ transfusion - Tissue and bone marrow transplant - Accidental needle-stick injury - Tattoo - Permanent make up - Ear or body piercing - Sexual contact with: Someone who has HIV/AIDS Prostitute Anyone who takes money or drugs or other payment for sex Past or present IV drug user Person with hemophilia who has received factor concentrates - Women who have had sex with men who have had sex with another man, even once since 1977 - Sexual contact or close contact with Acute/ Chronic Hepatitis B (HBsAg/HBV) - Hepatitis C - Syphilis - Gonorrhea - Prisoner for more than 72 hours
2. Indefinite deferral - Prospective donor is unable to donate blood for someone else for an unspecified period of time due to current regulatory requirements - May be eligible to donate autologous blood - Cancer, except: Basal or squamous cell carcinoma Carcinoma in the site of cervix Papillary thyroid carcinoma - Leukemia - Lymphoma - HBsAg (+) - HBc (+) - Hepatitis after 11 th birthday - Blood diseases: - Hemophilia - vW disease - Sickle cell anemia - Kaposis sarcoma - Polycythemia vera - Babesiosis and Chagas disease
3. Permanent deferral - Prospective donor will never be eligible to donate blood for someone else - AIDS (+) - HIV (+) - Tegison - Etretinate - HBsAg (+) HBc (+) Informed Consent - AABB Standards: informed consent of allogeneic, autologous, and apheresis donors be obtained before donation - Donor must be informed of the risks of the procedure and of tests - Donor must be able to ask questions concerning element of collection or testing process. - If the donor is a minor or is unable to comprehend the informed consent protocol, applicable state law provisions will intercede. Autologous Donors - The one who donates blood for his or her own use - Such a donor is referred to as the donor patient - Most autologous blood is used to treat surgical blood loss: To avoid homologous transfusions or When compatible allogeneic blood is not available - Potential advantage of using autologous blood over allogeneic blood includes decreased risk of: Disease transmission Transfusion reactions Alloimmunization - However, there is still a risk of: Bacterial contamination Circulatory overload Cytokine-mediated reaction Misidentification of the product or patient - Greatest advantage to patients: With very rare blood types With multiple antibodies where compatible units in the general blood supply may be difficult or impossible to find - Disadvantages: Higher cost due to: o Added administrative processes o Special labeling requirements to ensure that units get transfused to the proper patient There is a high wasted units (30% to 50%) Patients end up not requiring any or all of the units donated AABB Standards do not permit crossing over of unused autologous units to general inventory, except in exceptional circumstances. - Various methods and techniques for obtaining autologous blood: Preoperative collection Acute normovolemic hemodilution Intraoperative collection Postoperative collection Preoperative Collection - Occurs during the 5 to 6 weeks immediately preceding a scheduled, elective surgical procedure unless the red blood cells and plasma are scheduled to be frozen - Procedures that typically might use preoperative autologous blood include: Orthopedic procedures CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 8
Vascular surgery Cardiac or thoracic surgery Radical prostatectomy - Some women do participate in autologous blood collection during pregnancy for unseen complications Blood is seldom needed except when the mother has: o Multiple antibodies to high-frequency antigens o Risk for placenta previa o Intrapartum hemorrhage - Decision to use preoperative autologous blood requires: Order from the patients physician Approval from the blood bank medical director - MSBOS Maximal Surgical Blood Order Schedule Provide guidance for surgical procedures to estimate the number of units need for transfusion Last blood collection should occur no later than 72 hours (3days) before the scheduled surgery to allow volume replacement. - Medical history and physical exam requirements are less stringent than those for allogeneic donations - There is no minimum or maximum age requirement - Donor must be able to tolerate the procedure - For young donors, most centers limit the age to children whose veins can accommodate the phlebotomy needle and who can understand the procedure. - Minimum hemoglobin/ hematocrit: 11 g/dL and 33% - Blood pressure and pulse are same with allogeneic unless otherwise defined by the blood bank director. - Donors temperature should not be elevated or indicate any sign of possible infection - Medical history questions to ensure safety of the donor: Cardiac history Bleeding disorders Major illness Previous donor reactions Fainting problems - There should be question to rule out bacteremia. Includes: Information on current medications Antibiotics Fever Recent minor procedures Dental procedures Gastrointestinal problems Diarrhea - Standard of autologous donor units: 450 or 500 mL 10% - Weigh less than 50 kg (110 lb): total amount of blood collected must be reduced proportionately Amount of blood to be collected is determined 300 to 450 mL: unit must be labeled as low volume No requirement to reduce the volume of anticoagulant-preservative solution Plasma is not suitable for transfusion - Unit less than 300 mL: anticoagulant-preservative solution must be adjusted Approval by the blood bank director is required - Testing requirements for autologous donor units are somewhat less stringent than with allogeneic. Collecting facility must determine the ABO and Rh of the blood Antibody screening is optional - If the collecting facility and transfusion are the same: Viral marker testing is not required - If they are different, the collecting facility must test for: HBsAg Anti-HBc Anti-HCV HCV RNA Anti-HIV-1/2 HIV-1 RNA Anti-HTLV-I/II WNV RNA STS - On at least the first unit collected from the donor in every 30-day period - If positive (any markers): patients physician and transfusion facility must be notified of the result - Transfusing facility must confirm the ABO and Rh of the unit, but a crossmatch is optional. - Immediate spin crossmatch would be a good safety check that the selected unit is identified properly. - Units collected must be labeled correctly. The label should include: Patients name Medical record number or ID number Expiration date of the unit Name of the facility where the donor-patient will be transfused Label must also clearly state For Autologous Use Only - Autologous units generally have a distinct green label and tag. Done to both ensure: The unit is linked correctly with the donor-patient To make the blood bank technologists aware that certain patients have autologous units on the shelf that must be transfused for allogeneic units - Oldest units should be transfused first - Blood banks should have a system in place to ensure autologous units must be selected first.
Acute Normovolemic Hemodilution (ANH) - Results in the collection of whole blood with the concurrent infusion of crystalloid or colloid solutions - Maintaining normal volume but decreasing the patients hematocrit - Ratio of replacement: For crystalloids= 3:1 For colloids= 1:1 - The number of units collected depends on the patients ability to tolerate the decrease in hemoglobin/hematocrit. - Limited hemodilution will reduce the hematocrit to 28% - Severe dilution will reach 21% or less - It is recommended that the patient start with a hemoglobin of at least 12 g/dL - Performed in surgery immediately prior to beginning the surgical procedure and is managed by anesthesiology - Blood is collected in standard blood bags containing anticoagulant or preservative and is stored in the room at RT. CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 9
- Blood is normally reinfused to the patient during or immediately following the surgery, but within 8 hours of collection Maintains the viability of both platelets and coagulation factors In the reverse order of collection The last unit carries the highest hematocrit level - Blood generally does not leave the operating room, the units generally are not tested, labeled, or tracked, and blood bank is generally not involved - If the blood is not transfused during surgery, it can be stored up to 24 hours in a monitored blood bank refrigerator if refrigerated within the first 8 hours - If the units leave the OR and are stored, they must be appropriately tested and labeled as with predeposit autologous units
Intraoperative Collection - Involves collecting shed blood from surgical site - Process blood through an instrument that washes it with saline - To remove tissue debris, free hemoglobin, and plasma that may contain activated coagulation factors - Concentrating the residual red cells to a hematocrit of 50% to 60% - Reinfusing those cells immediately - This process is repeated continually during the surgical procedure - This type of collection has been used in: Cardiothoracic Major orthopedic Cardiac surgeries Vascular surgeries Liver transplantation - Advantages: May be used in cases where preoperative donation is not possible due to the: Urgency of the surgery Patient cannot be scheduled for multiple preoperative donations The risk of misidentifying the patient and the blood product is minimized No labeling, testing, and storing costs - Disadvantages: High cost of the instrumentation involved and training of the personnel to run the instrument Frequent amount of blood collected is not sufficient for the patients total needs, and allogeneic blood may still be given - Labeled with: Patients full name Medical record number Date and time of collection With For Autologous Use Only - Blood may be stored : At room temperature for up to 6 hours At 1C to 6C for up to 24 hours, as long as within 4 hours from the end of the collection
Postoperative Blood Salvage - Collected from a drainage tube placed at the surgical site - Reinfused with or without processing - Via a microaggregate filter to screen out any debris - Characterized as: Dilute Partially hemolyzed Defibrinated - Recommended that no more than 1, 400 mL be reinfused - Procedures that have used postoperative blood collection: Orthopedic (e.g., arthroplasty) Cardiac surgeries - Blood must be reinfused within 6 hours of collection or it is to be discarded - Advantage: Very low cost Can be used in conjunction with other autologous blood collection procedures No risk of blood being transfused with other person - Disadvantage: Does not yield a large volume of blood Do not produce enough blood for patients needs Significant risk of producing transfusion reactions, due to presence of: o Activated coagulation factors o Fibrin degradation products o Cytokines - Blood bank is frequently not responsible for managing ANH, intraoperative recovery and postoperative blood salvage - AABB and CAP have recommendations and guidelines. This includes: Assisting with the development of procedures Maintaining the equipment Monitoring quality control Training personnel Assessing competency
Directed Donation - Unit collected is directed toward a specific patient - Tag for the directed unit is a distinct color (e.g., yellow, salmon) - Unit must be irradiated if the donor is blood relative: To prevent graft versus host disease Viable T cells from the donor enter the patients circulation do not mount an attack against patients cells and tissues
Apheresis Donation - For collecting specific blood component while returning the remaining whole blood components back to the patient. - Use an automated cell separator device whose centrifugal force separates blood into components based on difference in density - Can be used to collect: Platelets CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 10
Plasma White cells(leukocytes) Red cells Stem cells - Designed to collect large volumes of the intended component - The only effective method for collecting leukocytes and stem cells - Regulated by FDA, AABB and ASFA
Plateletpheresis
- More than 75% of platelet transfusion are platelet-derived platelets - A pheresis platelet unit is equivalent to six to eight random donor platelets - Advantage: Reduces the recipients donor exposure Makes routine leukoreduction of the product practical Allows compatibility matching of the donor and patient possible May donate more often - Interval between donations is at least 2 days - Aspirin, Feldene, or aspirin-containing medications: 48 hour-deferral - PLavix (clopidogrel) or Ticlid (ticlopidine): 14-day deferral - If the donor has donated whole, or if 100 mL or more of red cells were not able to be returned to the donor: 8- week deferral - Platelet count is not required on the first donation, it is required if the interval between donations is less than 4 weeks. In that case: Must be above 150, 000/ uL - Total amount of plasma that can be removed along platelets: 500 mL (600 mL for donors weighing more than 175 lb) - Each platelet unit contain at least 3 x 10 11 platelets - Donor reactions: Reaction to the citrate or anticoagulant used Vasovagal and hypovolemic reactions rare - Testing requirements: ABO group Rh type Antibody screen Infectious disease markers - If the donor is donating repeating for a specific patient: Repeat testing every 30 days Platelet count is determined and recorded, but not recorded on product label - if the product contains more than 2 mL of red cells, a pilot smaple must be attached - FDA guidelines: record of regular platelet pheresis donors be reviewed by physician at least every 4 months
Plasmapheresis - Plasma first product to be collected by apheresis - Primarily used as a method for collecting source plasma - Also used to collect transfusable fresh frozen plasma - Classified as either: infrequent/occasional or serial - Infrequent donor Undergoes no more than one procedure in a 4-week period - Serial donors May donate more frequently than 4 weeks but no more than every 48 hours and no more than two donations in a 7-day period - Red cell loss must not exceed 25 mL/week or 200 mL in an 8-week period - If the donors red cells cannot be returned: 8-week deferral - At 4-month intervals, the donor must be tested for: Total serum/plasma protein levels Quantitative immunoglobulin levels Protein electrophoresis - Performed manually - There should be separate forms of identifications. May use: Full names Signatures Unique numbers Pictures
Leukopheresis - Apheresis is the only effective method for collecting leukocytes or, more specifically, granulocytes - Typical therapeutic dose: at least 1 x 10 11 granulocytes each day for 2 consecutive days - Drugs or sedimenting agents is given to collect large volume of leukocytes: Hydroxyethyl starch (HES) o Common sedimenting agent o Enhances separation of the white cells from red cells during centrifugation o Increases the amount of leukocytes collected o Decreases the amount of red cell contamination o Disadvantage: HES is a colloid It expands the donors blood volume Remains in the circulation for extended periods of time Corticosteroids such as prednisone or dexamethasone o Given prior to the collection procedure o Pulls the granulocytes from the marginal pool into the general circulation o Increase the supply of cells available for collection Recombinant hematopoietic growth factors o Advantage: Can produce four to eight times the volumes of cells in each collection Quite well tolerated by the donor - Testing requirements: ABO group Rh type HLA type of the leukocytes - If the amount of contaminating red cells exceeds 2 mL, the product should be crossmatched with the recipient, and a pilot tube sample must accompany the product CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 11
Double RBC Pheresis - Collected in 1990s - Can be used to collect either allogeneic or autologous units - Hemoglobin level must be determined by a quantitative method, copper sulfate method is not acceptable - Saline infusion Minimizes volume depletion Male donors must weigh at least 130 lbs and be at least 51 tall Female donors must weigh at least 150 lbs and be at least 55 tall Hematocrit level must be a minimum of 40% - Donors participating in double red cell pheresis: 16-week deferral - Procedure is discontinued prior to completion and the total red cell loss is less than 200 mL: 8-week deferral - If the red cell loss is greater than 200 mL but less than 300 mL: 8-week deferral - If the total red cell loss is greater than 300 mL: 16-week deferral WHOLE BLOOD COLLECTION I. Donor Identification - Numeric or alpha numeric system - Avoid duplicate numbers, voided numbers, or other mistakes in labeling system - Issues must be investigated and kept on record - Attach all labels to blood bags, donor record and pilot tubes II. Aseptic Technique - most blood centers use an iodine compound such as PVP- iodine or polymer iodine complex - area is scrubbed at least 4 cm for at least of 30 seconds - donors who are allergic or sensitive to iodine compounds may use chlorhexidine gluconate and isopropyl alcohol - all methods must be approved by the FDA
III. Collection Procedures
CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 12
DONOR REACTIONS
Mild Reactions
a. Syncope or fainting - Signs and symptoms: Sweating Dizziness Pallor Convulsions Instructions apply for a donor who has fainted: 1. Remove the tourniquet and withdraw needle 2. Place cold compresses on the donors forehead 3. Raise the donors legs above the level of the head 4. Loosen tight clothing and secure airway 5. Monitor vital signs
b. Twitching and muscle spasm - For donors who are extremely nervous
c. Hyperventilation - Conversing the donor - Having the donor breath into a paper bag - It is not advised to give oxygen to donors
d. Nausea or vomiting Instructions apply for a donor who started to feel nauseated or vomits: 1. Instruct the donor to breath slowly 2. Apply cold compress to the forehead 3. Turn the donors head one side and provide an appropriate receptacle CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 13
4. The donors may be given water after vomiting has ceased Moderate Reactions - Decreased pulse rate - May hyperventilate - May exhibit a fall in systolic pressure to 60 mmHg Instructions: 1. Check the vital signs frequently 2. Administer 95% oxygen and 5% carbon dioxide
Severe Reactions - Convulsions, can be caused by: Cerebral ischemia. Associated with: o Vasovagal syncope o Reduced blood flow to the brain o Shock symptoms
Marked hyperventilation o Marked depletion of carbon dioxide
Epilepsy Instructions: 1. Call for help immediately; notify blood bank physician. 2. Try and restrain the donor to prevent injury to self or others 3. Ensure an adequate airway
- In the event of cardiac or respiratory difficulties, should perform CPR until medical help arrives
Hematomas - Bluish discoloration of the skin after collection of blood - Caused by needle going through the vein, with subsequent leakage of blood into the tissue Instructions: 1. Remove the tourniquet and needle from the donors arm 2. Apply pressure with sterile gauze pads for 7 to 10 minutes, with the donors raising his or her arm above the heart 3. Apply ice to the area for 5 minutes
DONOR RECORDS
DONOR PROCESSING ABO/Rh - For ABO group: Include both forward and reverse grouping Donors RBCs are tested with anti-A and anti-B reagents Donors serum or plasma is tested with reagent A1 cells and B cells - For Rh type: Determined by testing with anti-D reagent at the immediate spin phase If the initial test is negative, a test for weak-D is performed Involves a 37C incubation and an antihuman globulin (AHG) phase If both immediate spin and weak-D test results are negative, label the donor as Rh-negative
CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 14
SUMMARY CHART An allogeneic blood donor should weigh at least 110 lb (50kg). The pulse rate of a potential blood donor should be between 50 and 100 beats per minute. The hemoglobin/hematocrit level of an allogeneic blood donor should be at least 12.5/38%. A donor must be permanently deferred if she or he had a confirmed positive test for HBsAg after the 11 th
birthday. The deferral period for persons who have been treated for malaria is 3 years following therapy. Persons who have had a blood transfusion are deferred for 12 months owing to risk of exposure to hepatitis, HIV, or other viral diseases. A platelet apheresis donor should not have taken aspirin for 3 days before donation because it decreases platelet function. The interval between whole blood donations is 8 weeks or 56 days. A person with a history of hemophilia A or B, von Willebrand disease, or severe thrombocytopenia must be permanently deferred from donating blood. Attenuated live viral vaccines such as smallpox, measles, mumps, yellow fever, and influenza (live virus) carry a 2-week deferral. A blood donor who has a positive serologic test for syphilis must be deferred for 12 months. Donors who have tested positive for the HIV antibody must be indefinitely deferred. Predeposit autologous donation refers to blood for the donor-patient that is drawn before an anticipated transfusion (e.g., surgery) and stored until use. An autologous donor must have hemoglobin of at least 11 g/dL and a hematocrit of at least 33%. Intraoperative autologous transfusion occurs when blood is collected during a surgical procedure and is usually reinfused immediately. Acute normovolemic hemodilution takes place in the operating room when 1 to 3 units of whole blood are collected and the patients volume is replaced with colloid or crystalloid. The blood is reinfused during surgical procedure. Postoperative salvage is an autologous donation in which a drainage tube is placed in the surgical site and postoperative bleeding is salvaged, cleaned, and reinfused. All whole blood units should be stored at 1C to 6C; those units destined for platelet production should be stored at 20C to 24C until platelets have been removed. Donor units must be tested for the following viral markers: STS. Anti-HIV-1/2, HIV-antigen, anti-HTLV I/II, HBsAg, anti-HBc, and anti-HCV. RBCs must be prepared by a method that separates the RBCs from the plasma and results in a hematocrit level of less than or equal to 80%. Irradiated RBCs must be given a radiation dose of at least 25 Gy to the midplane of the canister, after which the expiration date of the product changes to 28 days from the time of irradiation or maintains the original outdate, whichever comes first. Leukocyte-reduced RBCs are products in which the absolute leukocyte count is less than 5 x10 6 . Random-donor platelets must contain at least 5.5 x10 10 platelets; single donor platelets must contain at least 3 x10 11 platelets; each carries a shelf-life of 5 days. FFR must be prepared within 8 hours of collection for CPD, CPDA-1, and CP2D; it is stored at -18C for 12 months. Cryoprecipitate is prepared from FFP and contains at least 80 units of antihemophilic factor and 150 to 250 mg of fibrinogen; this product is indicated for hemophilia A, factor XIII deficiency, and hypofibrinogenemia. RhIg is a solution of concentrated anti-Rho(D), which is manufactured from pooled hyperimmunized donor plasma. It is used to prevent Rh-negative mother after an abortion, miscarriage, amniocentesis, or delivery of an Rh-positive or Rh-unknown infant. One unit of random-donor platelets typically increases the platelet count in a 70-kg adult by 5,000 to 10,000/uL; 1 unit of apheresis platelets should increase the platelet count in a 70-kg adult by 30,000 to 60,000/uL.
CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 15
REVIEW QUESTIONS 1. Which of the following information is not required for whole blood donors? a. Name b. Address c. Occupation d. Sex e. Date of birth 2. Which of the following would be cause for deferral? a. Temperature of 99.2F b. Pulse of 90 beats per minute c. Blood pressure of 110/70 mmHg d. Hematocrit level of 37% e. None of the above 3. Which of the following would be cause for permanent deferral? a. History of hepatitis after 11 th birthday b. Positive hepatitis C test result c. Positive HTLV-I antibody d. Positive anti-HBc test result e. All of the above 4. Immunization for rubella would result in a temporary deferral for: a. 4 weeks b. 8 weeks c. 6 months d. 1 year e. No deferral required 5. Which of the following donors is acceptable? a. Donor who had a first-trimester therapeutic abortion 4 weeks ago b. Donor whose husband is hemophiliac who regularly received cryoprecipitate before 1989 c. Donor who was treated for gonorrhea 6 months ago d. Donor who had a needlestick injury 10 months ago 6. Which of the following tests is not required as part of the donor processing procedure for allogeneic donation? a. ABO b. Rh c. STS d. Anti-HTLV I e. Anti-CMV 7. Which of the following lists the correct shelf-life for the component? a. Deglycerolized RBCs - 24 hours b. RBCs (CPD) - 35 days c. Platelet concentrate - 7 days d. FFP 5 years e. RBCs (CPDA-1) 21 days
8. Each unit of cryoprecipitate prepared from whole blood should contain approximately how many units of AHF activity? a. 40 IU b. 80 IU c. 120 IU d. 160 IU e. 180 IU 9. Platelet concentrates prepared by apheresis should contain how many platelets? a. 5.5 x10 10
b. 6 x 10 10
c. 3 x 10 11
d. 5.5 x 10 11
e. 6 x 10 11
10. The required storage temperature for frozen RBCs using the high-glycerol method is: a. 4C b. -20C c. -18C d. -120C e. -65C 11. How does irradiation affect the shelf-life of the red blood cells? a. Irradiation has no effect on the shelf-life. b. The expiration date is 28 days from the date of irradiation or the original outdate, whichever is later. c. The expiration date is 28 days from the date of irradiation or the original outdate, whichever is sooner. d. The expiration date is 25 days from the date of irradiation or the original outdate, whichever is later. e. The expiration date is 25 days from the date of irradiation or the original outdate, whichever is sooner. 12. Once thawed, FFP must be transfused within: a. 4 hours b. 6 hours c. 8 hours d. 12 hours e. 24 hours 13. Quality control for RBCs requires a maximum hematocrit level of: a. 75% b. 80% c. 85% d. 90% e. 95% 14. AHF concentrates are used to treat: a. Thrombocytopenia b. Hemophilia A c. Hemophilia B d. Von Willebrand disease e. Factor XIII deficiency
CHAPTER 13 DONOR SCREENING
NIKKA LORI ONG 16
15. Prothrombin complex concentrates are used to treat which of the following? a. Factor IX deficiency b. Factor VIII deficiency c. Factor XII deficiency d. Factor XIII deficiency e. Factor V deficiency 16. How is the antibody screen test different for donors than for patients? a. In donors, a 2-cell screen is used. b. In donors, a 3-cell screen is used. c. In donors, a pooled cell is used. d. There is no difference in testing. 17. RBCs that have been leukoreduced must contain less than _____ and retain at least _____ of original RBCs. a. 8 x 10 6 /85% b. 8 x 10 6 /90% c. 5 x 10 6 /85% d. 5 x 10 6 /90% 18. Random-donor platelets that have been leukoreduced must contain less than _____ leukocytes. a. 8.3 x 10 5
b. 8 x 10 6
c. 5 x 10 6
d. 3 x 10 11
19. A single unit of FFP or PF24 should contain _____ mL of plasma. a. 100-150 b. 200-400 c. 150-250 d. 50-150 20. Cryoprecipitate that has been pooled must be transfused within _______ hours. a. 24 b. 26 c. 4 d. 8