CLIA regulations require that your laboratory enroll in a Centers for Medicare and Medicaid Services (CMS) approved proficiency testing (PT) program for all regulated tests that you perform. Annually, the Joint Commission requires you to submit documentation attesting to your organization's enrollment in an approved PT program for each CLIA certificate surveyed by the Joint Commission under which moderate or high complexity tests of all regulated tests are performed.
To assist your organization in ensuring compliance with CLIA regulations and Joint Commission accreditation requirements for each CLIA certificate requiring enrollment in a CMS approved PT program, you should review each of your CLIA certificates and complete a Proficiency Testing Enrollment Worksheet for each CLIA certificate surveyed by the Joint Commission before submitting your required Attestation Form to the Joint Commission.
- Identify all CLIA certificates surveyed by the Joint Commission.
- For each CLIA certificate surveyed by the Joint Commission, determine if moderate or high complexity testing is performed under that certificate.
- For each CLIA certificate surveyed by the Joint Commission under which moderate or high complexity testing is performed, use the Proficiency Testing Enrollment Worksheet, determine if the moderate and/or high complexity test(s) performed are regulated analytes that require enrollment in proficiency testing.
- Complete one copy of the Proficiency Testing Enrollment Worksheet for each CLIA certificate that is accredited by the Joint Commission and is registered to perform moderate and/or high complexity testing of regulated analytes that require proficiency testing.
- Place a checkmark by each regulated analyte that your laboratory is performing under that CLIA number that requires proficiency testing.
- Ensure that each regulated analyte is enrolled in a CMS approved proficiency testing program for the coming year. Document the name of the proficiency testing provider for each regulated analyte in the column labeled "Approved CMS Proficiency Test Provider." Record the year in the column labeled "Enrolled For The Year Of ____" and, then, place a checkmark in the associated field in the column for each relevant regulated analyte. Obtain the signature of the Laboratory Director.
- Once you have completed a review of all your CLIA certificates that are accredited by the Joint Commission that are registered to perform moderate and/or high complexity testing of regulated analytes that require proficiency testing and verified enrollment with a CMS approved PT provider, download a copy of the Joint Commission-required Attestation Form.
- Complete the Attestation Form and obtain the signature of the Chief Executive Officer of your organization. Fax the completed and signed Attestation Form to (630) 792-4599. Retain a copy of your fax confirmation sheet.
Note: Due to the volume of forms received, the Joint Commission will not be able to respond to individual inquiries for verification of receipt of the Attestation Form. Once all Attestation Forms are received and recorded, Joint Commission staff will contact your organization should we fail to receive the form from your organization based on information currently on file in our database.
- Retain your original completed and signed Attestation Form along with your completed Proficiency Testing Enrollment Worksheets. DO NOT FORWARD the Proficiency Testing Enrollment Worksheets or the original signed Attestation Form to the Joint Commission. Please be prepared to make original source verification of proficiency test enrollment available to Joint Commission surveyors at the time of survey.