CLT Documentation & Record Keeping 2 — Questions and Answers
Question 1: Under CLIA regulations, how long must general laboratory records be retained?
- 1 year
- 2 years (Correct answer)
- 5 years
- 10 years
Correct answer: 2 years
CLIA requires most general laboratory records to be retained for a minimum of 2 years.
Question 2: Which term describes a documented, approved change to a validated procedure that has been reviewed before implementation?
- Corrective action
- Change control (Correct answer)
- Audit trail
- Variance report
Correct answer: Change control
Change control is the formal process of documenting, reviewing, and approving modifications to validated procedures before they take effect.
Question 3: A laboratory result is reported and later found to be erroneous. What is the correct documentation practice?
- Delete the original result and enter the correct one
- Draw a single line through the error, correct it, initial, and date (Correct answer)
- Use correction fluid to cover the error
- Leave the error and attach a sticky note
Correct answer: Draw a single line through the error, correct it, initial, and date
Proper correction requires a single line through the error with the correction, initials, and date to maintain a clear audit trail.
Question 4: Which document outlines step-by-step instructions for performing a specific laboratory test?
- Quality manual
- Standard operating procedure (SOP) (Correct answer)
- Corrective action report
- Competency assessment form
Correct answer: Standard operating procedure (SOP)
A standard operating procedure (SOP) provides detailed, step-by-step instructions for performing a specific laboratory test or task.
Question 5: A patient sample is collected but the requisition lacks a specimen type. Which action best supports proper documentation?
- Process the sample and guess the type
- Contact the ordering provider and document the clarification in the record (Correct answer)
- Discard the sample immediately
- Report results without noting the discrepancy
Correct answer: Contact the ordering provider and document the clarification in the record
Contacting the ordering provider and documenting the clarification ensures the record is complete and traceable.
Question 6: What is the primary purpose of an audit trail in laboratory information systems (LIS)?
- To speed up result reporting
- To track all changes made to records, including who made them and when (Correct answer)
- To automatically reject out-of-range results
- To archive old patient data
Correct answer: To track all changes made to records, including who made them and when
An audit trail records every modification to a record along with the user identity and timestamp, supporting accountability and traceability.
Question 7: Which regulatory body requires laboratories to maintain records of personnel qualifications and training?
- FDA only
- OSHA only
- CLIA and applicable accrediting organizations (Correct answer)
- EPA only
Correct answer: CLIA and applicable accrediting organizations
CLIA regulations and accrediting bodies such as CAP and TJC require documentation of personnel qualifications, training, and competency.
CLT Documentation & Record Keeping 2
Under CLIA regulations, how long must general laboratory records be retained?