BLOOD DONATION
A. Standards, Regulations and Governing Bodies
1. The blood banking industry is very regulated and many agencies are involved in setting
the standards and guidelines for practice.
2. The Food and Drug Administration (FDA - http://www.fda.gov/ ) is the governmental
agency responsible for ensuring the safety of the nation’s blood supply by mandating all
facilities comply with their standards. The 2 following agencies fall under the “umbrella”
of the FDA.
a. The Center for Biologics Evaluation and Research
(CBER-http://www.fda.gov/cber/blood.htm) regulates the collection and
manufacture of blood and blood components.
b. Code of Federal Regulations (CFR- http://www.gpoaccess.gov/cfr/ )
mandates that all blood collection facilities comply with "Current Good
Manufacturing Practice (cGMPs) for Blood and Blood Components".
3. American Association of Blood Banks (AABB- http://www.aabb.org) is the
professional organization which sets standards for practitioners in the field of transfusion
medicine.
a. Provides minimum standards for blood centers and transfusion services.
b. Two publications, AABB Standards for Blood Banks and Transfusion Services and
the Technical Manual.
4. The College of American Pathology (CAP-http://www.cap.org) provides laboratory
inspection and accreditation in the hospital setting.
5. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO -
http://www.jcaho.org) inspects all operations of healthcare organizations every other
year, including the laboratory.
6. The National Committee for Clinical Laboratory Standards
(NCCLS-http://www.nccls.org) is an organization that provides published standards for
clinical laboratory science in all areas of practice, e.g., a standard format for procedure
manuals. Effective January 2005 will be called Clinical and Laboratory Standards Institute.
B. Donor Screening
1. Serves 2 purposes:
a. Assess health of potential donor to ensure donation will not harm them.
b. Protect potential recipient by preventing selection of donors who may have
infectious diseases.
2. Will have one of four outcomes: acceptance, temporary deferral, indefinite deferral or
permanent deferral. “Indefinite” deferrals are for those conditions for which a test to
definitively determine infectious status is not available. For the purposes of this lecture
guide “indefinite” and “permanent” will be synonymous.
3. Three components of donor screening:
a. Registration
b. Medical History
c. Physical Examination
4. Donor selection is based on a limited physical exam and medical history.
a. Performance should be done in a way to maintain privacy, allay apprehension
and allow time for discussion.
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, b. Upon successful completion of the screening process the donor will go on to the
actual phlebotomy.
C. Registration of the Donor
1. Must obtain complete and accurate demographic information about each donor.
2. Records must be kept 5 years or 6 months after component expires.
3. Information to be obtained from donor
a. Date of current donation
b. Date of previous donation
c. Full name or previous names
d. Address
e. Phone number
f. Gender
g. Age and/or date of birth.
1) At least 17 years of age.
2) Elderly accepted if they meet all requirements
3) Autologous donation
h. Reason for previous deferrals
i. Written informed consent must be obtained.
4. Additional useful information:
a. Additional identification information such as social security or drivers license
number
b. Name of patient or group to be credited
c. Race
d. Unique characteristics of the donor
5. Information which must be provided to the prospective donor.
a. Educational materials about high risk activities for exposure to HIV, must
document.
b. Warnings about possible donor reactions to donation, first time donors may need
more extensive information.
c. Information on tests that will be done and notification of results.
d. Post phlebotomy care instructions.
D. Medical History
1. Blood donation - should not donate more than 525 ml every 8 weeks, for hemapheresis
it is 48 hours.
2. Have they been deferred as a donor before and, if yes, what was the reason.
3. AABB has simplified and standardized this process by providing a "Uniform Medical
History Questionnaire for Whole Blood Donors” http://tinyurl.com/6yo3k
4. Reasons for deferral and time limits of deferral are changing constantly, must keep
procedures up to date.
5. Permanent deferral:
a. Men and women who have engaged in sex for drugs or money since 1977.
b. Men who have had sex with another male, even one time, since 1977.
c. People who have used IV drugs (even once).
d. Taking clotting factors for a bleeding disorder such as hemophilia.
e. People with clinical or laboratory evidence of HIV infection.
f. Hepatitis after age 11.
g. Cancer: Leukemia and lymphoma, individuals who had treatment and have been
disease free for 5 years may be acceptable after evaluation by a qualified
physician.
A. Standards, Regulations and Governing Bodies
1. The blood banking industry is very regulated and many agencies are involved in setting
the standards and guidelines for practice.
2. The Food and Drug Administration (FDA - http://www.fda.gov/ ) is the governmental
agency responsible for ensuring the safety of the nation’s blood supply by mandating all
facilities comply with their standards. The 2 following agencies fall under the “umbrella”
of the FDA.
a. The Center for Biologics Evaluation and Research
(CBER-http://www.fda.gov/cber/blood.htm) regulates the collection and
manufacture of blood and blood components.
b. Code of Federal Regulations (CFR- http://www.gpoaccess.gov/cfr/ )
mandates that all blood collection facilities comply with "Current Good
Manufacturing Practice (cGMPs) for Blood and Blood Components".
3. American Association of Blood Banks (AABB- http://www.aabb.org) is the
professional organization which sets standards for practitioners in the field of transfusion
medicine.
a. Provides minimum standards for blood centers and transfusion services.
b. Two publications, AABB Standards for Blood Banks and Transfusion Services and
the Technical Manual.
4. The College of American Pathology (CAP-http://www.cap.org) provides laboratory
inspection and accreditation in the hospital setting.
5. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO -
http://www.jcaho.org) inspects all operations of healthcare organizations every other
year, including the laboratory.
6. The National Committee for Clinical Laboratory Standards
(NCCLS-http://www.nccls.org) is an organization that provides published standards for
clinical laboratory science in all areas of practice, e.g., a standard format for procedure
manuals. Effective January 2005 will be called Clinical and Laboratory Standards Institute.
B. Donor Screening
1. Serves 2 purposes:
a. Assess health of potential donor to ensure donation will not harm them.
b. Protect potential recipient by preventing selection of donors who may have
infectious diseases.
2. Will have one of four outcomes: acceptance, temporary deferral, indefinite deferral or
permanent deferral. “Indefinite” deferrals are for those conditions for which a test to
definitively determine infectious status is not available. For the purposes of this lecture
guide “indefinite” and “permanent” will be synonymous.
3. Three components of donor screening:
a. Registration
b. Medical History
c. Physical Examination
4. Donor selection is based on a limited physical exam and medical history.
a. Performance should be done in a way to maintain privacy, allay apprehension
and allow time for discussion.
[Type here]
, b. Upon successful completion of the screening process the donor will go on to the
actual phlebotomy.
C. Registration of the Donor
1. Must obtain complete and accurate demographic information about each donor.
2. Records must be kept 5 years or 6 months after component expires.
3. Information to be obtained from donor
a. Date of current donation
b. Date of previous donation
c. Full name or previous names
d. Address
e. Phone number
f. Gender
g. Age and/or date of birth.
1) At least 17 years of age.
2) Elderly accepted if they meet all requirements
3) Autologous donation
h. Reason for previous deferrals
i. Written informed consent must be obtained.
4. Additional useful information:
a. Additional identification information such as social security or drivers license
number
b. Name of patient or group to be credited
c. Race
d. Unique characteristics of the donor
5. Information which must be provided to the prospective donor.
a. Educational materials about high risk activities for exposure to HIV, must
document.
b. Warnings about possible donor reactions to donation, first time donors may need
more extensive information.
c. Information on tests that will be done and notification of results.
d. Post phlebotomy care instructions.
D. Medical History
1. Blood donation - should not donate more than 525 ml every 8 weeks, for hemapheresis
it is 48 hours.
2. Have they been deferred as a donor before and, if yes, what was the reason.
3. AABB has simplified and standardized this process by providing a "Uniform Medical
History Questionnaire for Whole Blood Donors” http://tinyurl.com/6yo3k
4. Reasons for deferral and time limits of deferral are changing constantly, must keep
procedures up to date.
5. Permanent deferral:
a. Men and women who have engaged in sex for drugs or money since 1977.
b. Men who have had sex with another male, even one time, since 1977.
c. People who have used IV drugs (even once).
d. Taking clotting factors for a bleeding disorder such as hemophilia.
e. People with clinical or laboratory evidence of HIV infection.
f. Hepatitis after age 11.
g. Cancer: Leukemia and lymphoma, individuals who had treatment and have been
disease free for 5 years may be acceptable after evaluation by a qualified
physician.
