All laboratories applying for or holding a clinical laboratory permit must successfully participate in proficiency testing for tests/analytes offered by the laboratory that are described in CLIA subparts H and I (42 CFR 493 subpart H and 42 CFR 493 subpart I). Laboratories must designate annually the proficiency testing providers and products they will use to satisfy NYS requirements. Laboratories designate PT using the eCLEP module on the Health Commerce System for each category held; laboratories applying for new categories or new permits are contacted by CLEP. Failure to comply with these requirements and adhere to the following testing procedures may result in sanctions being brought against participating laboratories under state and federal regulations.
- The laboratory shall participate in a CMS-approved proficiency testing program for each permit category and tests for which the laboratory seeks or currently holds a permit, and is formally evaluated by the CMS-approved proficiency testing program.
- The laboratory shall examine, test, or analyze the proficiency samples in the same manner as clinical specimens, consistent with its routine workload.
- The proficiency samples shall be examined or tested with the laboratory's routine workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods, unless otherwise instructed by the proficiency testing provider.
- Repeated testing or analysis of proficiency samples is not permitted unless the laboratory performs the same repetitive testing or analysis on patient, donor, insurance applicant or other client samples.
- Laboratories that test proficiency samples shall not engage in any inter-laboratory communication or discussion pertaining to the results of test samples until after the date the laboratories are required to report the results to the CMS-approved proficiency testing provider. Laboratories with multiple testing sites or separate locations cannot participate in any communication or discussion between or among sites/locations concerning test results until after the date the laboratories are required to report the results to the CMS-approved proficiency testing provider.
- Laboratories shall not send proficiency samples or portions of samples to any other laboratory or location for testing, analysis or review.
- Any laboratory that has referred its proficiency samples to another laboratory for analysis and/or submitted the other laboratory's results as its own will face administrative sanctions and may have its permit revoked and/or denied for at least one year.
Any laboratory that receives proficiency samples from another laboratory for testing must notify the proficiency testing provider and the Clinical Laboratory Evaluation Program within seventy-two hours of receipt or identification of such samples.