Ensuring Compliance with Proficiency Testing Programs in Diagnostic Laboratories
Summary
- Laboratories must treat Proficiency Testing samples in the same manner as they treat human body materials and are not allowed to refer PT samples to another lab for analysis.
- CLIA Regulations require individuals examining gynecologic preparations to be enrolled in a CMS-approved Proficiency Testing program.
- For cytology Proficiency Testing, laboratories can utilize programs such as those offered by the College of American Pathologists and the American Society for Clinical Pathology.
Proficiency Testing Programs for Diagnostic Labs
Proficiency Testing (PT) programs are an essential aspect of ensuring the accuracy and reliability of diagnostic laboratory testing. These programs help laboratories to assess the competency of their staff and the effectiveness of their testing procedures. For laboratories to maintain their CLIA certification, participation in approved PT programs is required.
PT Samples on Secondary Instruments/Methods
It is crucial for laboratories to follow the guidelines set forth by the Public Health Service Act and CLIA Regulations regarding the handling of Proficiency Testing samples. PT samples should be treated with the same care as materials derived from the human body that are referred for testing. Labs are not permitted to send PT samples to another facility for analysis, and PT samples should only be tested on secondary instruments if patient specimens are also tested in the same manner.
Cytology Proficiency Testing
For laboratories conducting cytology testing, it is necessary to ensure that individuals examining gynecologic preparations are enrolled in an approved Proficiency Testing program. The Centers for Medicare & Medicaid Services (CMS) has approved PT programs specifically for cytology testing to maintain the quality and accuracy of these critical Diagnostic Tests.
Two of the CMS-approved Cytology Proficiency Testing Programs for the calendar year 2025 include:
- College of American Pathologists program
- American Society for Clinical Pathology program
By enrolling in these approved programs, laboratories can guarantee that their staff are proficient in cytology testing and are providing accurate results to Healthcare Providers and patients.
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