A Certificate of Provider-Performed Microscopy Procedures (PPMP) permits a laboratory to perform a limited list of moderate complexity tests, as well as any waived tests. No survey is required but may be conducted and compliance with CLIA regulations is required. The following criteria must be met:
- The laboratory must obtain a CLIA certificate and pay the $200 fee which authorizes the facility to perform only waived and PPMP tests for a period not to exceed two years.
- The PPMP procedures must be personally performed by one of the following practitioners:
- A physician during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or an employee.
- A midlevel practitioner, under the supervision of a physician or in independent practice authorized by the State, during the patient's visit on a specimen obtained from his or her own patient or from a patient of a clinic, group medical practice, or other health care provider of which the practitioner is a member or an employee.
- A dentist during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group dental practice of which the dentist is a member or an employee.
- The laboratory director must meet the following requirements:
- Be a physician
- Be a midlevel practitioner
- Be a dentist
- The PPMP procedures are categorized as moderately complex.
- The primary instrument for performing the PPM procedures is a microscope, limited to a bright field or phase-contrast microscopy.
- The PPMP specimens are labile and a delay in performing the test could compromise the accuracy of the test result.
- Control materials are not available to monitor the entire testing process; but two levels of controls must be performed if available.
- Limited specimen handling or processing is required.
- The Physician, midlevel practitioner or dentist may perform one or more of the following procedures:
- All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites or cellular element
- All potassium hydroxide (KOH)preparations
- Pinworm examinations
- Fern test
- Post-coital direct, qualitative examinations of vaginal or cervical mucous
- Urine sediment examinations
- Fecal leukocyte examination
- Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility)
- Nasal smears for eosinophils
In addition, the laboratory may also perform any test classified as waived.
- The laboratory must verify the accuracy of PPMP test results at least twice a year.
- The laboratory must meet all the applicable requirements of participation in proficiency testing, patient test management, quality control and quality assurance.
--For waived testing, the laboratory must follow the manufacturer’s instructions.--