REGULATORY CONSIDERATIONS Flashcards
______ and ____ are the primary regulatory bodies providing federal oversight in the field of Transfusion Medicine and Cellular Therapy
Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS)
What are the two organizational bodies that publish specific sets of standards that need to be met in order for accreditation to be granted?
AABB and Joint Commission
CMS regulates laboratory testing through which organizational body?
A. FDA
B. CLIA
C. AABB
D. State health department
B. CLIA
Which establishment/ regualtory body/ agency enforces federal laws related to drugs and biologics, which include blood and blood components, needles, devices and manufcturing facilitiees? A. AABB B. State health department C. FDA D. CMS
C. FDA - Food and Drug Administration
True/ false - FDA guidance documents are usually made to establish legally enforceable responsibilities and specific regulatory or statutory requirements.
False
Guidance documents are published as recommendations or to clarify/explain compliance or GMP; can be used to satisfy requirements applicable to law
Which of the ff is exempted from registering from FDA as blood establishments/ device manufacturing facilities?
A. A blood bank that only performs compatibility testing and pooling blood components right before transfusion
B. A blood bank that routinely irradiates and washes blood products before dispensing
C. A blood center that routinely performs testing of donor and blood components
D. A transfusion service that acts as a depot for forwarding products to other hospitals
A. A blood bank that only performs compatibility testing and pooling blood components right before transfusion
-must be CLIA certified in order to be exepmt
D. - this facility must register as a distribution center
Which of the ff scenarios would be considered as a blood product deviation event and is reportable to the FDA?
A. A blood distribution facility that delivered platelets to the wrong hospital location
B. An RBC unit was dropped and broken by hospital staff prior to dispensing
C. A blood donor disclosing a recent diagnosis of syphillis to the blood center days after donating
D. A donor deferred from donating because of their history of recent travel
C. A blood donor disclosing a recent diagnosis of syphillis to the blood center days after donating
A ______ is defined as the removal or correction of a marketed product that is found to be in violation of the law.
Recall
A ______ is when a product is found to have a minor violation an is voluntarily removed by the manufacturer from the market.
Market withdrawals
Which of the ff laboratory testing would be rated as “waived” by the FDA as a CMS rating ? A. Urinalysis dipsticks B. Direct coombs testing using PS AHG C. Over the counter pregnancy test D. Infectious disease testing
A. Urinalysis dipsticks
C- not usually done in lab
Which of the ff laboratory testing would be rated as “moderate” by the FDA as a CMS rating ? A. Urinalysis dipsticks B. Direct coombs testing using PS AHG C. Over the counter pregnancy test D. Infectious disease testing
B and D - rated moderate or high
________ are defined as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient.
Human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Which of the ff HCT/Ps are derived from deceased donors? A. Reproductive cells and tissues B. Skin C. Pancreatic islets D. Hematopoietic stem cells
B. Skin
________ is an organization that fosters international collaboration to facilitate the exchange of high quality hematopoietic stem cells for clinical transplantation world wide and to promote the interest of donors.
Worldwide Network for Blood and Marrow Transplantation (WBMT)
________ is an accreditation organization under the Worldwide Network for Blood and Marrow Transplantation (WBMT) who is working to harmonize standards that cover all aspects of the process, from assessment of donor eligibility to transplantation an clinical outcome for hematopoietic stem cell and related cellular therapies.
The Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA)
