Documentation & Record Keeping Flashcards
7 cards from real CLT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Documentation & Record Keeping flashcards as text
What is the purpose of a reagent lot-to-lot verification record?
Answer: To confirm a new reagent lot performs comparably to the previous lot before patient use
Lot-to-lot verification records document testing performed to confirm that a new reagent lot gives results consistent with the validated lot before it is used for patient testing.
Under HIPAA, which of the following is considered protected health information (PHI) in laboratory records?
Answer: A patient's test result linked to their name or medical record number
PHI includes any health information that can identify an individual, such as test results linked to a name or medical record number.
Which document type provides written evidence that an employee has been trained on a specific procedure?
Answer: Training record or competency checklist
Training records and competency checklists document that an employee received instruction and demonstrated proficiency in a specific procedure.
When must a laboratory document a corrective action?
Answer: Whenever a quality control failure or out-of-specification result occurs
Corrective actions must be documented whenever a QC failure or nonconformance occurs so the problem, investigation, and resolution are all recorded.
Which type of document establishes the overall quality policies and objectives of a clinical laboratory?
Answer: Quality manual
The quality manual is the top-level document that defines a laboratory's quality policies, objectives, and the structure of its quality management system.
A technologist notices that QC data for the past week shows a Westgard 10-x violation. What must be documented?
Answer: The violation, investigation findings, corrective action taken, and outcome
All QC violations require documentation of the violation, root cause investigation, corrective action taken, and verification that the action resolved the problem.
Which piece of information is essential on a quality control log for a chemistry analyzer?
Answer: QC lot number, expiration date, results, and technologist initials
A QC log must include the lot number, expiration date, QC results, and the technologist's initials to ensure the record is complete and traceable.