Proficiency Testing Required by New York State or CLIA subpart I
Laboratories applying for or holding a New York State clinical laboratory permit must participate in proficiency testing. 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.
Tests offered in New York State that are offered by the New York State proficiency testing program
Laboratories offering these tests must enroll in New York State proficiency testing or a proficiency testing survey from an alternate provider designated by New York State as equivalent. This requirement applies whether or not a test/analyte is included in 42 CFR 493 subpart I (hereinafter; CLIA subpart I tests).
See the New York State Proficiency Testing Program Guide (we will link this mid January) for currently offered proficiency testing programs.
The ship and due dates for events offered by the New York State proficiency testing program can be found in the proficiency test schedule.
Out-of-sequence proficiency test events may be offered by the New York State proficiency testing program if samples are available and the regularly scheduled proficiency test event is more than four weeks away.
Participation in the New York state proficiency testing program fulfills federal proficiency testing requirements for those subpart I tests included in New York State proficiency testing. New York State Results will be released to the federal Centers for Medicaid and Medicare Services (CMS).
Proficiency testing staff are available to answer questions.
CLIA subpart I tests
Laboratories offering CLIA subpart I tests that are not included in New York State proficiency testing programs must enroll in proficiency testing with a CMS-approved provider. Please see the Guide to Program Requirements and Services for further information (we will link to this mid January).
Tests for which Proficiency Testing is Not Required by New York State or CLIA subpart I
For tests/analytes and areas of laboratory medicine for which there are no New York State or CLIA proficiency testing requirements, the laboratory is 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 New York State clinical laboratory standard of practice QA S3. In addition to alternative monitoring, the laboratory may be required to submit procedure manuals or validation data for review and approval by the Department. Please refer to the Comprehensive Test Approval and Submission Guidelines available under Test Approval.
These changes in the Proficiency Testing Program were described in detail in letters sent to all permitted laboratories:
Initial Letter to Laboratory Directors describing changes, July 23, 2015
Second Letter to Laboratory Directors describing changes, August 14, 2015
Special Proficiency Testing Requirements 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 in "Applied Pending" status. The laboratory must enroll in appropriate proficiency testing with a CMS-approved proficiency testing provider and inform the Department of its proficiency testing selections.
Proficiency test requirements are met for all other permit categories upon satisfactory performance in all components of the initial proficiency test event. However, continued participation and satisfactory performance must be achieved to maintain fulfillment of proficiency testing requirements until all other permit requirements are met.
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.