Competency Assessment and Continuing Education

Training versus competency

Training teaches someone to perform a test and is documented before they test patient specimens on their own. Competency assessment is the recurring proof that a trained person still performs the test correctly. Both are required, and inspectors check both.

Molecular labs add training on the hazards particular to amplification: the amplicon risk, one-way workflow, pipetting technique, and how to handle a spill or a contamination event ¹.

The six elements

For high-complexity testing, the technical supervisor is responsible for evaluating competency using six elements ²:

1. Direct observation of routine patient test performance, including specimen handling, processing, and testing.
2. Monitoring the recording and reporting of test results.
3. Review of intermediate results or worksheets, QC records, proficiency testing results, and preventive maintenance records.
4. Direct observation of instrument maintenance and function checks.
5. Assessment of test performance using previously analyzed specimens, internal blind samples, or external PT samples.
6. Assessment of problem-solving skills.

All six apply to each test (or test system) a person performs, though one observation can cover several tests run on the same platform. Assessors are qualified individuals the technical supervisor designates.

The schedule

Competency is evaluated ²:

• At least semiannually during a person’s first year of testing,
• At least annually thereafter,
• And before reporting patient results whenever test methods or instruments change.

A new hire in March is therefore assessed around September and the following March, then yearly.

Practical examples

For a technologist running a real-time PCR viral load assay:

When someone fails an element, the lab documents retraining and reassessment before they resume independent testing.

Continuing education

MB(ASCP) certification is maintained through ASCP’s Credential Maintenance Program, which requires 36 points of continuing education every three years, with required points in molecular biology and in laboratory or patient safety. State licenses (in states that license lab personnel) and CAP also expect ongoing education, and many labs track it alongside competency records.

What to take from this

Training comes before independent testing; competency assessment checks a trained person on a schedule. CLIA’s six elements are direct observation of testing, monitoring reporting, records review, observation of maintenance, blind or previously tested samples, and problem-solving. Assess twice in the first year, annually after, and before reporting on a new method or instrument. Keep MB(ASCP) current through ASCP’s three-year Credential Maintenance Program.