The GAEPC is pleased to introduce a recurring column in the ASC bulletin dealing with issues related to coding, compliance and regulatory questions posed by our readers. The readership is encouraged to send in questions to the GAEPC ( GAEPC will research the topic and provide answers in subsequent bulletins.

Swati Mehrotra, M.D. Chair, GAEPC

A frequently asked question refers to “competency assessment” and its site-specific documentation.  This question was encountered as “competency” question while preparing for laboratory inspection by one of our members.

Here we provide a brief overview for our readers related to this complex topic:


Ranjana Nawgiri, M.D. and Pamela Gibson, M.D.

  1. Does competency assessment need to be done at each site if a health system/ hospital has same cytology personnel working at multiple sites?

Yes, it needs to be performed at each site that carries its own CLIA#. As detailed in Subpart C, §493.43 of the Electronic Code of Federal Regulation (source: 57 FR 7143, Feb. 28, 1992) all laboratories (with some exceptions) performing nonwaived testing must file a separate application for each laboratory location. Laboratories within a hospital that are located at contiguous buildings on the same campus and under common direction may file a single application or multiple applications for the laboratory sites within the same physical location or street address. For College of American Pathologists (CAP) accredited laboratories, the CAP document on Competency assessment states: “A laboratory may not share competency assessment records and performance across a system (at multiple sites) for non-waived testing. Competency is required to be performed at each site where the testing is performed. The laboratory director may determine how competency assessment is performed at multiple sites for waived testing.

  1. What are the competencies that need be assessed?

CLIA defines six elements of competency assessment.  These are to be documented for each person every year. The six elements of competency are:

  • Direct observation of routine test performance
  • Monitoring, recording and reporting test results
  • Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
  • Direct observation of performance of instrument maintenance and function checks
  • Test performance as defined by laboratory policy (e.g., testing previously analyzed specimens, internal blind testing samples, external proficiency or testing samples)
  • Evaluation of problem-solving skills as appropriate to the job.

3. Is competency assessment the same as a proficiency test?

No, the purpose of competency assessment is broader and more detailed than proficiency testing as it involves observing and documenting that each individual knows how to properly perform all the elements of their job and that they are following the procedures and safety measures that are in place for that institution. Proficiency testing however is used as one of the elements of competency (#5 see above)


  1. Is training and personnel evaluation the same as competency testing/ Can training and personnel evaluation be used to assess competency?

No, the difference between training and competency is that training happens before someone begins testing and competency assessment confirms that they are doing the testing correctly. Personnel evaluations evaluate other behaviors and attributes as they relate to the position or job.

  1. How often does competency needs to be assessed?

Initially 6-monthly, then annually. According to the CAP checklist support document “During the first year of an individual’s duties, competency must be assessed at least semi-annually and then annually. There are two assessments in the first year of patient testing. The timing starts once the person is reporting patient test results independently.”

These guidelines established by CMS under the auspices of CLIA-88 ruling serve as a basis of the required framework established by different accreditation agencies like College of American Pathologists (CAP), The Joint Commission (TJC), Commission on Office Laboratory Accreditation (COLA) and other local state and federal oversight agencies

1) College of American Pathologists Checklist Requirement GEN.55500 – Competency assessment – Nonwaived testing-Phase II

2) guidance/legislation/clia/downloads/clia_compbrochure_508.pdf