Donor Selection (from Harmening [7th ed.] | F) Flashcards
(330 cards)
True or False
The selection of potential blood donors has become more rigorous in the last 5 yrs w/ congent additions to the medical history questionnaire and serologic testing
True
True or False
The transfusion of blood to a pt in need is safer than it has ever been
True
Safety and therapeutic benefit are dependent on what?
Guidelines established by U.S. Food and Drug Administration (FDA) and AABB
What is done to the guidelines (established by U.S. FDA and AABB in terms of safety and therapeutic)?
These are carried out by the qualified and trained personnel in blood collection centers
Who are the organizations / associations who wrote the guidelines and regulations for donor selection and serologic testing?
1) FDA
2) AABB
While the purview of the 2 entities (/ guidelines and regulations [written by FDA and AABB]) may overlap in some areas of donor collection and donor testing, their institutional goals and national donation guidelines provide a what?
An effective framework of processes utilized by all blood donor centers across the U.S.
What is the meaning of CAP?
College of American Pathologists
What are the actions of CAP?
1) It conducts inspections of all clinical lab depts (including transfusion services, awarding accreditation to facilities that are deemed to be compliant w/ established stds)
2) It also provides a voluntary inspection and accreditation program (for its member institutions)
What is U.S. FDA?
It is a regulating agency
Where are the regulations (for donor screening) of U.S. FDA outlined?
These are outlined in the Code of Federal Regulations (CFR), Title 21, parts 211, 600-799
Blood is regarded as what (under the auspices of the FDA)?
It is regarded both as a biologic and a drug
What happened in 1988?
The Center for Biologics Evaluation and Research (CBER) was formed
What are the actions of CBER?
1) It is responsible for regulating the collection of blood and blood cmpts (used for transfusion and for the manufacture of pharmaceuticals derived from blood and blood cmpts )
2) It develops and enforces quality stds
3) It inspects blood establishments
4) It monitors reports errors, accidents, and adverse clinical events
What is the action of the FDA (in the early 1990s)?
It began to treat blood establishment the same as any drug manufacturer, requiring strict compliance w/ all aspects of transfusion medicine, including donor selection and screening
What are the other actions of FDA?
1) It establishes and maintains the regulations
2) It inspects blood collection and processing centers
3) It is also responsible for licensing:
a. Collection and processing facilities
b. Blood products and derivatives
c. Rgnts (used in the processing | and testing of these products)
4) It provides recommendations and requirements (regarding infectious diseases as well as potential emerging diseases)
What may be done by blood establishments?
They may adapt stricter requirements than those published by the FDA as written in the blood center’s standard operating procedure (SOP)
The AABB is formerly known as what?
American Association of Blood Banks
When is AABB established?
1947
What is AABB?
It is an international association of blood centers, transfusion and transplantation services, and individuals involved in transfusion medicine
What is the action of AABB?
It provides a voluntary inspection and accreditation program for its member institutions that meet the requirements of the Centers for Medicare and Medicaid Services (CMS) and the Clinical Laboratory Improvement Amendments of 1998 (CLIA)
What is the mission of AABB?
To establish and provide the highest std of care for pts and donors in all aspects of transfusion medicine
Did the AABB already published books on transfusion medicine throughout its existence?
Yes
What are the 2 resources w/c are vital to donor screening procedures?
1) AABB Standards for Blood Banks and Transfusion Services
2) AABB Technical Manual
What are discussed in the publications (/ books) published by the AABB?
The sp. guidelines for donor screening