Documentation Standards Flashcards

How often must competency be assessed for testing personnel during their first year performing patient testing?

Answer: Semiannually

CLIA requires competency assessment twice in the first year and annually after that.

Which is one of the six CLIA-required elements of competency assessment that must be documented?

Answer: Direct observation of routine patient test performance

The six elements include direct observation of testing, monitoring result recording, review of QC records, instrument checks, blind samples, and problem-solving.

A lab runs a proficiency testing (PT) sample. How must it be handled and documented?

Answer: Tested the same way as patient samples, with records kept for at least 2 years

CLIA requires PT samples to be integrated into routine testing and all PT records to be kept for at least 2 years.

Under CLIA, how long must surgical pathology (histopathology) reports be kept?

Answer: 10 years

CLIA requires pathology test reports to be kept for at least 10 years after the date of reporting.

How often must calibration verification be performed and documented, at minimum, for a nonwaived quantitative test under CLIA?

Answer: Every 6 months, and when certain events occur

CLIA requires calibration verification at least every 6 months and after events such as major maintenance or a reagent lot change.

An instrument goes down in the middle of a run. Which documentation is most appropriate?

Answer: An instrument log entry with the date, problem, corrective action, and verification before restart

Malfunctions, repairs, and the verification done before resuming testing must be recorded in the instrument's maintenance log.

A tech learns that a patient result was released before QC was reviewed, and the QC later failed. What document should be filed?

Answer: An occurrence or incident report, with patient impact review and corrected reports

Nonconforming events need an occurrence report, a look-back at affected patients, and corrected reports as part of quality assurance.