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CLIA competency assessment form

CLIA competency assessment form

Streamline CLIA compliance with our competency assessment form, evaluating laboratory personnel skills and knowledge to ensure accurate and reliable test results.

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CLIA competency assessment form

Streamline CLIA compliance with our competency assessment form, evaluating laboratory personnel skills and knowledge to ensure accurate and reliable test results.

Use this template with Lumiform

  • Customize this template or build your own
  • Fill out templates via mobile app
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

The CLIA competency assessment form documents laboratory personnel’s ability to accurately perform testing procedures according to federal regulations. This template captures all six required elements for proper assessment: direct observation of testing, result reporting monitoring, documentation review, instrument maintenance observation, performance testing, and problem-solving skills evaluation.

When facing upcoming laboratory inspections, you can use this form to quickly identify competency gaps and implement targeted training before regulators arrive. According to the Centers for Medicare & Medicaid Services, competency must be assessed semiannually during an employee’s first year of testing and annually thereafter, making consistent documentation essential for compliance.

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Preview of the template
Page 1
Technical Skills
Performs specimen collection procedures correctly
Demonstrates proper use of laboratory equipment
Follows standard operating procedures accurately
Procedural Knowledge
Understands purpose and principle of laboratory tests
Recognizes sources of error and takes corrective action
Interprets and reports test results correctly
Safety Protocols
Wears appropriate personal protective equipment
Properly handles and disposes of hazardous materials
Adheres to all safety policies and procedures

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

Competency assessment: Your complete guideGood laboratory practices (GLP): A comprehensive guideCare Quality Commission standards (CQC): A practical guide for healthcare providersBehavior based safety: Your guide for improving workplace safety
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Template collections

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Frequently asked questions

What are the six elements required in a CLIA competency assessment form?

The six required elements are: direct observation of testing procedures, monitoring result recording/reporting, review of documentation (worksheets, QC records, PT results), observation of instrument maintenance, assessment of test performance using known samples, and also evaluation of problem-solving skills. You must document each element for every testing staff member to meet CLIA requirements.

Who needs an assessement using a CLIA competency assessment form?

Anyone performing moderate or high complexity laboratory testing requires documented competency assessment, including testing personnel, general supervisors, technical consultants, technical supervisors, and clinical consultants who perform testing. While not required for waived testing personnel, many accrediting organizations recommend competency assessment for all testing staff regardless of test complexity.

Can I use the same CLIA competency assessment form for different laboratory tests?

You need separate competency assessments for each test system, not each analyte. If you use two different methods to measure the same analyte (like automated and manual glucose testing), you need separate assessments. However, multiple analytes on a single test system (like a chemistry panel) should undergo assessment using one form with appropriate documentation.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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