Documentation & Record Keeping Flashcards

Under CLIA regulations, how long must general laboratory records be retained?

Answer: 2 years

CLIA requires most general laboratory records to be retained for a minimum of 2 years.

Which term describes a documented, approved change to a validated procedure that has been reviewed before implementation?

Answer: Change control

Change control is the formal process of documenting, reviewing, and approving modifications to validated procedures before they take effect.

A laboratory result is reported and later found to be erroneous. What is the correct documentation practice?

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.

Which document outlines step-by-step instructions for performing a specific laboratory test?

Answer: Standard operating procedure (SOP)

A standard operating procedure (SOP) provides detailed, step-by-step instructions for performing a specific laboratory test or task.

A patient sample is collected but the requisition lacks a specimen type. Which action best supports proper documentation?

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.

What is the primary purpose of an audit trail in laboratory information systems (LIS)?

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.

Which regulatory body requires laboratories to maintain records of personnel qualifications and training?

Answer: CLIA and applicable accrediting organizations

CLIA regulations and accrediting bodies such as CAP and TJC require documentation of personnel qualifications, training, and competency.