Documentation Flashcards

Which document provides written evidence that a tissue bank employee has read, understood, and is competent to perform a specific SOP?

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.

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?

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.

What is the primary purpose of maintaining a tissue distribution log at a tissue bank?

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.

Under AATB standards, informed consent documentation for tissue donation must include evidence that:

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.

Which of the following represents a critical content requirement for a tissue bank's environmental monitoring log?

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.

If a tissue bank uses electronic signatures on regulated documents, which requirement applies under 21 CFR Part 11?

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.

A tissue bank discovers that a storage freezer temperature exceeded acceptable limits and that several allografts were potentially compromised. What documentation step is mandatory?

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.