Documentation & Record Keeping Flashcards

During a CAP inspection, an inspector asks for evidence that method verification was performed before a new test went live. Which document satisfies this request?

Answer: Method verification report including precision, accuracy, and reportable range data

A method verification report documenting precision, accuracy, and reportable range studies is required before placing a new test method into routine use.

Which of the following best describes the role of a document control system in a laboratory?

Answer: Ensuring only current, approved versions of documents are in use and obsolete versions are removed or identified

Document control ensures that only the most current, approved versions of SOPs and policies are accessible to staff, preventing use of outdated procedures.

A laboratory computer system experiences downtime. Which documentation practice is most important during this period?

Answer: Use a manual downtime procedure and paper logs to record all results, then enter them when the system is restored

Downtime procedures require manual paper logs of all activities and results, which are then entered into the LIS once the system is restored to maintain a complete record.

What is the significance of a 'wet signature' versus an 'electronic signature' on laboratory documents?

Answer: Electronic signatures are acceptable if the system meets 21 CFR Part 11 requirements for authenticity and integrity

Electronic signatures are legally acceptable for laboratory records when the system complies with FDA 21 CFR Part 11, which governs security, traceability, and integrity of electronic records.

Which retention period applies to blood bank (transfusion medicine) records under AABB and FDA guidelines?

Answer: 10 years

Blood bank records must be retained for a minimum of 10 years under AABB standards and FDA regulations due to the potential long-term consequences of transfusion errors.

A laboratory's SOP is due for its annual review but no changes are needed. What must be documented?

Answer: The review date, reviewer's signature, and a statement that the procedure was reviewed and found current

Even when no changes are required, the annual review must be documented with the date, reviewer's signature, and confirmation that the SOP remains current and accurate.

Which of the following scenarios represents a breach of laboratory record integrity?

Answer: Using correction fluid (white-out) to cover an error in a paper record

Using correction fluid destroys record integrity by hiding the original entry, making it impossible to review the audit trail and violating documentation standards.