CTBS Documentation 5 — Questions and Answers
Question 1: Which document provides written evidence that a tissue bank employee has read, understood, and is competent to perform a specific SOP?
- Personnel training and competency record (Correct answer)
- Employee time sheet
- Equipment use log
- Adverse event form
Correct answer: Personnel training and competency record
Training and competency records link specific SOPs to individual employees, documenting that training was completed and competency was verified.
Question 2: A tissue bank's SOP for donor screening is updated. According to documentation best practices, what must happen before staff begin using the new SOP?
- Staff may use the new SOP immediately upon request
- The new SOP must be approved, effective-dated, distributed, and staff must be trained and documented as competent before use (Correct answer)
- Only the department manager needs to review the new SOP
- The old SOP should be destroyed immediately upon update
Correct answer: The new SOP must be approved, effective-dated, distributed, and staff must be trained and documented as competent before use
New or revised SOPs must go through approval, be assigned an effective date, and staff must receive documented training before implementation.
Question 3: What is the primary purpose of maintaining a tissue distribution log at a tissue bank?
- To calculate revenue from tissue sales
- To provide a complete record of which allografts were sent to which facilities and when, enabling rapid traceability if a recall is needed (Correct answer)
- To track employee overtime during busy distribution periods
- To satisfy state business licensing requirements
Correct answer: To provide a complete record of which allografts were sent to which facilities and when, enabling rapid traceability if a recall is needed
Distribution logs enable rapid traceability of each allograft to a specific recipient facility, which is critical during recall or adverse event investigations.
Question 4: Under AATB standards, informed consent documentation for tissue donation must include evidence that:
- The next-of-kin was compensated financially for consent
- Consent was obtained from the legally authorized person and the scope of donation was clearly explained (Correct answer)
- The hospital waived liability for the donation process
- The donor's employer was notified
Correct answer: Consent was obtained from the legally authorized person and the scope of donation was clearly explained
Informed consent records must show that an authorized person gave consent and that the nature, scope, and purpose of donation were explained.
Question 5: Which of the following represents a critical content requirement for a tissue bank's environmental monitoring log?
- Names of visitors to the facility
- Date, location, parameter measured (e.g., temperature or air quality), result, and identity of staff performing monitoring (Correct answer)
- Annual budget allocation for environmental controls
- Supplier invoice numbers for HVAC maintenance
Correct answer: Date, location, parameter measured (e.g., temperature or air quality), result, and identity of staff performing monitoring
Environmental monitoring logs must capture the date, location, measured parameter, result, and responsible staff to demonstrate controlled conditions were maintained.
Question 6: If a tissue bank uses electronic signatures on regulated documents, which requirement applies under 21 CFR Part 11?
- Electronic signatures are never acceptable for regulated tissue records
- Electronic signatures must be unique to one individual and linked to their signed record, and cannot be repudiated (Correct answer)
- Any employee may use another's electronic signature with verbal permission
- Electronic signatures only apply to financial documents
Correct answer: Electronic signatures must be unique to one individual and linked to their signed record, and cannot be repudiated
21 CFR Part 11 requires that each electronic signature be unique, verifiable, and permanently linked to the signed record, preventing repudiation.
Question 7: A tissue bank discovers that a storage freezer temperature exceeded acceptable limits and that several allografts were potentially compromised. What documentation step is mandatory?
- Destroy the allografts quietly and document nothing to avoid regulatory attention
- Document the excursion event, the tissues affected, the investigation, disposition decision, and any corrective actions taken (Correct answer)
- Document only if the allografts were already distributed
- File only an internal email noting the temperature spike
Correct answer: Document the excursion event, the tissues affected, the investigation, disposition decision, and any corrective actions taken
Any temperature excursion must be fully documented including the event details, affected tissues, investigation, final disposition, and corrective actions to prevent recurrence.
CTBS Documentation 5
Which document provides written evidence that a tissue bank employee has read, understood, and is competent to perform a specific SOP?