Quality Flashcards
Quality control for the process of lyophilizing musculoskeletal tissue shall include:
monitoring the temperature at each step of the cycle
What is NOT a universal precaution regarding health care worker performance?
Reporting all HIV and HCV positive donors to the Centers for Disease Control and Prevention (CDC)
What information regarding reagents used to process and/or preserve tissue should NOT be documented in the tissue bank’s records?
Sterility of the reagent
The purpose of record keeping in tissue banking is to document:
the performance of all steps in the process
Which of the following organisms is considered normal skin flora?
Coagulase-negative staphylococcus
A cardiac/vascular QA program needs to ensure that a representative cardiac/vascular tissue sample shall be cultured for all of the following organisms EXCEPT:
mycobacterium
Non-AATB accredited facilities that perform activities and/or services for an accredited bank must be certified (audited) by the accredited bank at LEAST:
every 2 years
Documentation of the review of standard operating procedures by staff members must be maintained for a period of how many years after termination of employment?
16
Human cells, tissues, and cellular and tissue-based products, as defined by 21 CFR Part 1271 (Current Good Tissue Practices), include all of the following EXCEPT:
vascularized organs
AATB Accredited Establishments are inspected by AATB every:
Three years