Understanding CLIA: Provider-Performed Microscopy-What is it and what is required?

In a previous blog I addressed waived testing.  All testing complexities beyond waived testing are sometimes called “non-waived testing.” The first level above non-waived testing is moderately complex testing.  42 CFR §493.19 addresses a specific category of moderately complex testing called Provider-Performed Microscopy (PPM).

Because PPM is nonwaived testing, laboratories performing it must have additional CLIA requirements beyond those applicable to a Certificate of Waiver.

What qualifies as PPM?

To qualify under §493.19, the procedure must meet specific criteria. Among other requirements:

•       It must be personally performed by an eligible physician, midlevel practitioner, or dentist during the patient's visit and be performed by that provider him/herself or by another provider that is a member of that practice.

•       The procedure must be categorized by CLIA as moderately complex.

•       The primary instrument must be a microscope using bright-field or phase-contrast microscopy.

•       The specimen must be labile, or delaying examination could compromise the accuracy of the result.

•       Quality Control (QC) material is not available to monitor the whole testing process.

•       Limited specimen handling or processing is required.

The regulation identifies specific procedures that may (among others) be performed under the PPM category, including certain wet preparations, KOH preparations, pinworm examinations, fern tests, urine sediment examinations, fecal leukocyte examinations, and limited qualitative semen examinations.

Why is this important for a physician office laboratory?

It is important in a discussion of PPM to also look at 42 CFR §493.1775. Laboratories holding a certificate for PPM are exempt from the biennial inspections. However, this does not exempt the laboratory from operating under proper laboratory procedure and practice. The test, methodology, specimen, practitioner performing the examination, and other regulatory criteria all matter. A laboratory must also have the appropriate CLIA certification for the testing it performs. CMS identifies PPM as a nonwaived category of testing with specific certification and regulatory requirements.

PPM laboratories are subject to applicable CLIA requirements addressing areas such as quality systems, personnel, and laboratory operations, as well as inspection requirements.

CMS may conduct an inspection of that laboratory at any time for any of the following reasons;

•       To determine if the testing is performed in a manner that does not constitute an imminent threat to patient health.

•       To evaluate a complaint from the public.

•       To determine if the laboratory is performing testing only within the scope of the certificate that is held by the laboratory.

•       To evaluate information regarding the appropriateness of tests specified as waived or PPM.

Additionally, if a physician office laboratory performs other moderately complex testing under a higher level of certification, all testing, including waived testing and PPM come under the purview of the inspecting agent and must comply with all applicable regulations.

Where can a laboratory consultant help?

This is an area where an experienced laboratory consultant can provide valuable assistance.

A consultant can help a physician office laboratory:

•       Determine whether the microscopy procedures being performed actually qualify as PPM

•       Review the laboratory's CLIA certificate and testing menu for consistency

•       Evaluate procedures and workflows against applicable CLIA requirements

•       Identify gaps in policies, documentation, quality practices, and personnel requirements

•       Help establish appropriate quality and compliance processes

•       Prepare staff and providers for regulatory surveys

•       Conduct a mock compliance assessment to identify potential deficiencies before an actual survey

Most importantly, a consultant can help the laboratory recognize when a seemingly small change in a testing procedure, methodology, personnel, or specimen type could affect the regulatory status of the test.

If you have questions about your test menu and what regulations apply to your testing, contact us. And stay tuned as I continue working through the regulations and translating the language of 42 CFR Part 493 into practical steps for physician office laboratories.