CTBS Documentation 4 — Questions and Answers
Question 1: What action is required when a tissue bank identifies a distributed allograft that may pose a risk to recipients?
- Issue an urgent medical device report only
- Initiate a formal recall and document all notification and retrieval activities (Correct answer)
- Wait for recipients to report adverse events
- Notify only the FDA and take no other action
Correct answer: Initiate a formal recall and document all notification and retrieval activities
When a safety concern is identified post-distribution, a formal recall must be initiated and all notification, retrieval, and disposition activities must be documented.
Question 2: What is the role of a Master Processing Record (MPR) in tissue banking documentation?
- It serves as a financial ledger for tissue sales
- It provides the approved template of all steps, materials, and controls for processing a specific tissue type (Correct answer)
- It documents recipient outcomes after transplantation
- It records employee training completions
Correct answer: It provides the approved template of all steps, materials, and controls for processing a specific tissue type
The MPR is the approved master template that defines all required steps, materials, equipment, and acceptance criteria for processing a specific tissue type.
Question 3: A Batch Processing Record (BPR) differs from a Master Processing Record primarily because the BPR:
- Contains only regulatory citations
- Documents the actual performance of each step for a specific tissue lot, including real-time data and technician initials (Correct answer)
- Is used solely for financial audits
- Replaces the need for SOPs
Correct answer: Documents the actual performance of each step for a specific tissue lot, including real-time data and technician initials
The BPR is the executed record for a specific tissue lot, capturing real values, observations, and signatures as each step is performed.
Question 4: Which regulatory body must tissue banks notify when they identify a biologic product deviation that may have affected distributed human tissue?
- Centers for Medicare and Medicaid Services (CMS)
- Food and Drug Administration (FDA) (Correct answer)
- Joint Commission
- Occupational Safety and Health Administration (OSHA)
Correct answer: Food and Drug Administration (FDA)
FDA requires tissue establishments to submit a Biological Product Deviation Report (BPDR) when a distributed HCT/P may have been affected by a deviation.
Question 5: What information must be captured in a tissue bank's equipment maintenance and calibration log?
- Employee work schedules
- Date of service, type of maintenance or calibration performed, results, and identity of who performed the work (Correct answer)
- Donor family contact information
- Marketing campaign performance metrics
Correct answer: Date of service, type of maintenance or calibration performed, results, and identity of who performed the work
Calibration and maintenance logs must capture the date, nature of the work, results, and the identity of the technician to demonstrate equipment reliability.
Question 6: When a tissue bank transfers donor records to a successor organization, what must be ensured under FDA regulations?
- Records may be destroyed to protect donor privacy
- All required records must be transferred and retained for the remainder of the required retention period (Correct answer)
- Only records from the past 12 months need to be transferred
- No transfer is required if the original bank closes voluntarily
Correct answer: All required records must be transferred and retained for the remainder of the required retention period
FDA requires that records be transferred to a successor organization and retained for the full required period, ensuring continued traceability even after closure.
Question 7: Which of the following best describes a 'look-back' investigation in tissue banking documentation?
- An annual review of financial records
- A retrospective review triggered when a donor tests positive for a relevant communicable disease after tissue distribution, to assess risk to recipients (Correct answer)
- A quarterly audit of storage temperatures
- A review of employee performance evaluations
Correct answer: A retrospective review triggered when a donor tests positive for a relevant communicable disease after tissue distribution, to assess risk to recipients
A look-back investigation is initiated when post-donation information suggests donor infection, requiring review of all associated distributed tissues and potential recipient notification.
CTBS Documentation 4
What action is required when a tissue bank identifies a distributed allograft that may pose a risk to recipients?