Proficiency Testing Program Requirements: General & Cytology
Here you will find important information about CLIA Proficiency Testing (PT) Program requirements to ensure laboratories and individual personnel perform and report accurate test results.
General Proficiency Testing
Proficiency testing, or PT, is the process used to evaluate a laboratory’s performance. PT is a useful tool to:
- Verify testing accuracy and reliability.
- Validate the entire testing process, including the testing personnel competency.
- Detect issues in the laboratory’s processes, equipment, or personnel.
CLIA regulations require all laboratories with a CLIA certificate performing nonwaived tests (PDF) on the regulated analyte list (moderate or high complexity) to participate in approved PT programs. According to Section 353(d)(1)(E) of the Public Health Service Act and CLIA regulation §493.801(b), PT samples must be treated like human specimens. More specifically PT samples:
- Can’t be referred to another laboratory for analysis.
- Must be tested on the same instrument or use the same method as patient specimen testing.
- Must be tested the same way and the same number of times as testing patient specimens.
Refer to the Proficiency Testing and PT Referral Brochure (PDF) for more information.
Cytology Proficiency Testing
Cytology Proficiency Testing is a specific type of PT required under CLIA regulation §493.855(a) to ensure quality testing of cytology specimens. Specifically, the laboratory and laboratory personnel who examine gynecologic cytology slides must be enrolled in one of these CMS-approved Cytology PT programs:
- College of American Pathologists (CAP)
- American Society for Clinical Pathology (ASCP)
Review the Cytology PT Results, which detail the annual pass/fail rates for the Cytotechnologists and Pathologists.