Enforce CLIA Competency Assessment Procedures

CLIA '88 requires that competencies for moderate and high complexity tests include six assessment procedures for each test, each employee. These assessment procedures are:

  • 1. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
  • 2. Monitoring the recording and reporting of test results;
  • 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
  • 4. Direct observations of performance of instrument maintenance and function checks;
  • 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
  • 6. Assessment of problem solving skills.

"Competency assessment, which includes the six procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform." That means that all point-of-care testing personnel who perform a non-waived test MUST have their competency on that test assessed using ALL SIX procedures. That includes physicians performing non-waived PPM tests!

Source: CMS.gov: "What Do I Need to Do to Assess Personnel Competency?" (PDF)

Do You Use All Six Procedures For Every Test?

Many laboratories do not include all six procedures for each competency assessment and each employee. Because of this, their competency assessment program is legally deficient, and the laboratory is subject to deficiencies and penalties.

Ensure That You Meet the Standard

Make sure that your competency assessments are complete. Compass correlates all of your competency activities to the appropriate CLIA assessment procedure, so you can see instantly what kinds of activities you may need to add. Reports alert to you any competency assessments that do not include the required elements. Catch any gaps in your assessments BEFORE the inspectors arrive.

Prove Compliance to Inspectors and Regulatory Agencies

Compass generates clear, concise reports that show the content of your assessments, including what activities address which CLIA assessment procedures. Inspectors appreciate having easy access to this information.