Get Proficiency Testing Program For Drug Screening Laboratory Registration Form

Proficiency testing is NOT required for waived testing; however, it can be used by waived labs as an indication of accuracy of testing. Proficiency testing is required for non-waived testing; however, it is required only for regulated analytes. The regulated analytes are listed in subpart I of the regulations.

Proficiency testing, or PT, is the testing of unknown samples sent to a laboratory by an HHS-approved PT program. Most sets of PT samples are sent to participating laboratories on a scheduled basis (usually three times per year). After testing, the laboratory reports its sample results back to their PT program.

Conclusion: Proficiency testing allows an individual laboratory to evaluate if its performance is satisfactory for the intended clinical purpose. Comparison of results among laboratories allows evaluation of the effectiveness of calibration procedures in the field.

Proficiency testing or PT is the testing of unknown samples sent to a laboratory by a CMS approved PT program. Most sets of PT samples are sent to participating laboratories three times per year.

As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.

In a proficiency test one or more artifacts are sent around between a number of participating laboratories. Each laboratory measures the artifacts (e.g. a ring gage or a set of gage blocks) ing to a given set of instructions and reports its results to the administrator.

Before testing patients, federal regulations require testing sites to have a CLIA certificate issued by CMS. Sites performing only waived tests must obtain a Certificate of Waiver by applying for this certification for each location performing testing.

CLIA requires that, at least twice annually, you verify the accuracy of any test or procedure that you perform that is not listed in Subpart I.