What regulation governs PPM testing and what specifically does it state?
The monitoring of PPM tests falls under the Clinical Laboratory Improvement Amendments (CLIA) 88 Federal Register documentation of April 25, 1995 and revised in October of 1998. The regulation specifically states the criteria for PPM procedures as follows:
- The examination must be personally performed by a practitioner.
- The procedure must be categorized as moderately complex.
- The primary instrument for performing the test is the microscope, limited to bright-field or phase-contrast microscopy.
- The specimen is labile, or delay in performing the test could compromise the accuracy of the test result.
- Control materials are not available to monitor the entire testing process.
- Limited specimen handling or processing is required.
A CLIA certificate is required to perform PPM testing. It can be a certificate of moderate, PPM, or high complexity testing. A PPM certificate must be obtained by the testing area for physicians, dentists, or midlevel practitioners to perform the testing. The two accrediting bodies, the Joint Commission on Accreditation and Healthcare Organizations (JCAHO) and the College of American Pathologists (CAP) have two different views on physician competency for PPM tests.
Is it necessary to monitor physician competency for PPM tests?
The JCAHO states that there is no requirement for documentation of physician competency when the test is a logical part of his or her specialty, unless the organization requires it through policy. The expectation is that a physician has received this training during his or her residency or fellowship. Competency for mid-level providers is required, however. The JCAHO requires that the accuracy and reliability of PPM testing be assessed at least twice per year. This requirement is usually due to the lack of quality control procedures for the test. This can be accomplished through proficiency testing, duplicate reading of a defined number of slides, or identification of previously analyzed samples. Examples of this include: the CAP Excel and Wisconsin State Proficiency programs, Kodachrome images, intranet enabled exams, and tutorial software (the University of Washington School of Medicine has an excellent software program).
The CAP does not distinguish between complexity levels of testing, or the personnel performing the test. The CAP states that laboratories that have PPM are held to the same checklist questions for training and competency as any other point-of-care area. The laboratory director is responsible for deciding who is appropriately trained, and what training is required for all laboratory tests. Because many of the physicians are performing tests in their area of expertise, the laboratory director may decide that there is a reasonable expectation that these individuals are competent and do not require additional training or competency testing. This would not apply to residents or physicians performing testing outside their scope of training.
Whether or not it is necessary, how would one go about it?
Most agree that it is difficult to enforce the monitoring of this testing, whether for competency or accuracy and reliability. A champion for PPM testing at the peer level for these physicians is often times successful at implementing a sound PPM testing program.