Proficiency Testing Requirements
The Department no longer provides proficiency testing samples, effective January 1, 2017.
Notification of this change was sent to Laboratory Directors on July 22, 2016.
Laboratories applying for or holding a New York State clinical laboratory permit must successfully participate in proficiency testing with a CMS-approved provider for all tests described in 42 CFR 493 subpart H and/or subpart I. The laboratory must inform the Department annually or upon addition of a new test or category of the survey and provider to be used to meet proficiency testing requirements.
Please contact CLEP if you have any questions.
For tests/analytes that are not included in CLIA subpart I, laboratories are required to have an alternate system for verifying the reliability and accuracy of their test results at least twice a year through participation in external proficiency testing programs or through the implementation of an internal proficiency testing program. Refer to Quality Assessment Sustaining Standard of Practice 3 (QA S3): Ongoing Verification of Examination Accuracy in the New York State Clinical Laboratory Standards of Practice.
When external proficiency testing is used to satisfy QA S3, New York State Clinical Laboratory Standards of Practice for proficiency testing also apply.
Should a laboratory perform unsatisfactorily for the entire permit category or for a test/analyte, the laboratory must investigate the cause of unsatisfactory performance and document the corrective action for review by the Department. The corrective action must be acceptable to the Department and performance in the subsequent test event must be satisfactory to meet proficiency requirements for the permit category. See PT Review and Performance for detailed information regarding unsatisfactory performance.
Special Proficiency Testing Requirments for New Permits or Categories
Once a complete clinical laboratory permit application has been received and all other administrative requirements have been met, the laboratory will be placed into application for a NYS clinical laboratory permit. The laboratory must enroll in appropriate proficiency testing for any tests described in CLIA subparts H and/or I with a CMS-approved proficiency testing provider and inform the Department of its proficiency testing selections.
To be eligible for a NYS clinical laboratory permit or addition of a new category, the laboratory must successfully perform on proficiency testing. In addition, continued participation and satisfactory performance must be achieved to maintain fulfillment of proficiency testing requirements until all other permit requirements are met.