Ctbs Aatb 14Th Edition Standards For Tissue Banking 2024 688 Questions With Complete Answers Graded A+

When was the AATB founded? - CORRECT ANSWER The American Association of Tissue Banks (AATB) was founded in 1976 as a voluntary, scientific, and educational not-for-profit organization to promote the exchange of information, methods, and procedures that would increase donation and provide safe, transplantable tissues of uniform high quality in quantities sufficient to meet national needs. What does AATB stand for? - CORRECT ANSWER American Association of Tissue Banks When were the first AATB guidelines published - CORRECT ANSWER A book of "Proceedings" from the first annual meeting was published in 1978 that offered a detailed overview of current tissue banking practices and described the ethics of donation and transplantation. When was the first edition of AATB's Standards for Tissue Banking published? - CORRECT ANSWER 1984 When was the voluntary accreditation program for tissue banks first launched? - CORRECT ANSWER 1986 GMPs - CORRECT ANSWER good manufacturing practices What is the strictest device classification? - CORRECT ANSWER Class III medical device manufacturer What is the Uniform Anatomical Gift Act? - CORRECT ANSWER The Uniform Anatomical Gift Act (UAGA or the Act) was passed in the US in 1968 and has since been revised in 1987 and in 2006. The Act sets a regulatory framework for the donation of organs, tissues, and other human body parts in the US. The UAGA helps regulate body donations to science, medicine, and education. What is the mission of the AATB? - CORRECT ANSWER A mission of the AATB is to establish and promulgate standards to provide tissue banks with performance requirements intended to prevent disease transmission and support quality measures that assist clinical performance of transplanted tissue. Furthermore, the AATB fosters education and research, and promotes quality and safety in cell and tissue banking and transplantation. These Standards establish performance requirements for - CORRECT ANSWER informed consent or authorization, donor eligibility assessment through donor screening and testing, as well as for the recovery, processing, storage, packaging, labeling, and distribution of transplantable human tissue (A) - CORRECT ANSWER autologous tissue (BT) - CORRECT ANSWER birth tissue (C) - CORRECT ANSWER cardiac tissue (CT) - CORRECT ANSWER cellular tissue (DM) - CORRECT ANSWER dura mater (LD) - CORRECT ANSWER living donors (MS) - CORRECT ANSWER musculoskeletal tissue (OA) - CORRECT ANSWER osteoarticular graft (R) - CORRECT ANSWER reproductive tissue (S) - CORRECT ANSWER skin (SB) - CORRECT ANSWER living donor surgical bone for allogeneic use (V) - CORRECT ANSWER vascular tissue What 3 things are required to request a variance to the standards? - CORRECT ANSWER 1) A request for variance or modification including the particular standard number(s) that applies to the request; 2) Justification of the alternative procedure(s), policy or process that assure(s) equivalency to the intent of Standards; 3) Supporting information such as worksheets, records, data, or other information (e.g., validation of the protocol to be used in the proposed variance, including the scientific data and quality assurance steps). ACCIDENT - CORRECT ANSWER Any occurrence, not associated with a deviation from standard operating procedures (SOPs), standards, or applicable laws and regulations, during donor screening or testing, or tissue recovery, collection or acquisition, processing, quarantining, labeling, storage, distribution, or dispensing that may affect the performance, biocompatibility, or freedom from transmissible pathogens of the tissue or the ability to trace tissue to the donor. ACQUISITION (BT) - CORRECT ANSWER The point after delivery at which tissue is under the control of the tissue bank. ADEQUATE INFORMATION - CORRECT ANSWER - Information sufficient for the donor, the authorizing person or the living donor to make a voluntary decision regarding the gift of tissues for transplantation, therapy, research and/or education. The parameters of what constitutes adequate information must include ''Core Elements'' contained in D2.400 or D3.400, and such additional information as the donor, authorizing person, or living donor requests or which the donation coordinator reasonably believes the donor, authorizing person or living donor should know. When the donor is authorizing the gift of tissue, publicly available information concerning the scope and use of the gift shall be deemed adequate information. ADVERSE OUTCOME - CORRECT ANSWER An undesirable effect or untoward complication in a recipient consequent to or reasonably related to tissue transplantation. ALLOGENEIC - CORRECT ANSWER Used as an adjective to modify donation, tissue, donor or recipient when transplantation is intended for a genetically different person. ALLOGRAFT - CORRECT ANSWER Tissue intended for transplantation into a genetically different person. ANNUAL - CORRECT ANSWER A frequency of activity defined by each tissue bank as 12 months including reasonable tolerance limits (up to 3 months). Justification for the tolerance limits shall be documented by the tissue bank with consideration for the risk associated with the specific activity scheduled. ANONYMOUS DONOR (R) - CORRECT ANSWER A reproductive donor of tissue whose identity is unknown to the recipient (R) AORTOILIAC GRAFT (C) - CORRECT ANSWER The distal segment of the abdominal aorta including the bifurcation and proximal segments of both the left and right common iliac arteries. ARTERIAL GRAFT (V) - CORRECT ANSWER A segment of peripheral artery that is recovered, processed and preserved. ARTIFICIAL INSEMINATION (R) - CORRECT ANSWER The placement of semen within the reproductive tract of a recipient (R) ASEPTIC PROCESSING - CORRECT ANSWER The processing of tissue using aseptic techniques where tissue, containers and/or devices are handled in a controlled environment in which the air supply, materials, equipment and personnel are regulated to prevent microbial contamination of tissue.