CTBS Documentation 3 — Questions and Answers
Question 1: What is the significance of a 'chain of custody' document in tissue banking?
- It records the financial transactions between tissue banks
- It tracks possession and handling of tissue from recovery through distribution to ensure accountability (Correct answer)
- It lists all transplant recipients for a given year
- It authorizes tissue destruction
Correct answer: It tracks possession and handling of tissue from recovery through distribution to ensure accountability
Chain of custody documentation establishes accountability by recording each transfer of possession and the condition of tissue at each step.
Question 2: Under AATB standards, what must be documented when a tissue bank receives a customer complaint about an allograft?
- Only complaints resulting in legal action
- The complaint details, investigation findings, and any corrective actions taken (Correct answer)
- The name of the employee who received the complaint
- Financial settlement terms
Correct answer: The complaint details, investigation findings, and any corrective actions taken
AATB requires tissue banks to document the nature of the complaint, the investigation process, findings, and any corrective or preventive actions.
Question 3: Which document type is used to formally approve a change to a tissue bank's standard operating procedure?
- Deviation report
- Change control record (Correct answer)
- Adverse event report
- Batch release record
Correct answer: Change control record
Change control records document the review, approval, and implementation of changes to SOPs, ensuring changes are authorized before use.
Question 4: A tissue bank must document the identity of personnel who performed each critical processing step primarily to:
- Calculate payroll for processing staff
- Enable traceability and accountability if a quality issue arises (Correct answer)
- Comply with OSHA workplace safety rules
- Track employee productivity metrics
Correct answer: Enable traceability and accountability if a quality issue arises
Documenting personnel identity at each critical step allows investigators to trace actions back to specific individuals if a quality or safety problem is identified.
Question 5: What type of document communicates a temporary authorized departure from a standard operating procedure during tissue processing?
- Master batch record
- Approved deviation or variance (Correct answer)
- Equipment calibration log
- Donor screening checklist
Correct answer: Approved deviation or variance
An approved deviation (or variance) formally authorizes and documents a temporary departure from an SOP for a specific situation.
Question 6: Which information is essential on a donor record to satisfy AATB traceability requirements back to the original recovery?
- The donor's social security number in plain text
- The recovery agency's unique donor identifier and recovery date (Correct answer)
- The transplant surgeon's license number
- The tissue bank's annual revenue
Correct answer: The recovery agency's unique donor identifier and recovery date
AATB traceability requires linking every allograft to a unique donor identifier and recovery date so the full chain can be reconstructed.
Question 7: How should electronic records in a tissue bank be protected to ensure data integrity?
- Stored on a single unencrypted USB drive
- Backed up regularly with access controls, audit trails, and secure authentication (Correct answer)
- Printed and stored only in paper form
- Accessible to all employees without password protection
Correct answer: Backed up regularly with access controls, audit trails, and secure authentication
FDA 21 CFR Part 11 and AATB standards require electronic records to have access controls, audit trails, and regular backups to ensure integrity.
CTBS Documentation 3
What is the significance of a 'chain of custody' document in tissue banking?