POCT Newsletter – The Point

Bringing Provider Performed Microscopy into focus: What POCT Professionals Need to Know

Nicholas Larkey, PhD, DABCC

Provider Performed Microscopy Procedures (PPMP) are a category of testing that often falls under the supervision of a point-of-care (POC) coordinator and the laboratory. PPMP tests occupy a unique space in laboratory testing that sits at the intersection of patient care and laboratory oversight. These procedures are often performed in clinical settings under the supervision of POC coordinators and the laboratory, yet they differ from other forms of moderate complexity testing in important ways that directly affect compliance, quality, and training. Here are some essentials of what you need to know as a point-of-care testing (POCT) professional.

What makes PPMP different

PPMP tests are classified as nonwaived because they require specific skills, training, and expertise to perform and interpret correctly. Only qualified professionals such as physicians, mid-level practitioners, and dentists may perform these tests (1). Samples are typically collected, minimally processed, and analyzed during the patient visit using a bright-field or phase-contrast microscope at the point-of-care, as any delay can negatively affect the accuracy of the test results.

The nine tests currently included under the PPMP umbrella are:

  1. Direct wet mount preparations
  2. Potassium hydroxide (KOH) preparations
  3. Pinworm examinations
  4. Fern testing (for premature rupture of fetal membranes)
  5. Post-coital direct qualitative vaginal/cervical mucus examinations
  6. Urine sediment examinations
  7. Nasal smear granulocytes
  8. Fecal leukocyte examinations
  9. Qualitative semen analysis (presence/motility)

Certification requirements

Since PPMP fall under nonwaived moderate-complexity testing, these procedures cannot be performed under a CLIA Certificate of Waiver. Sites must hold either a Certificate of Provider Performed Microscopy Procedures or a certificate for moderate- or high-complexity testing to conduct PPMP (2). A PPMP certificate allows both PPMP and waived testing to be performed at the same site and by the same staff.

For POC coordinators, this distinction matters as it carries additional regulatory expectations for oversight, documentation, and competency of testing personnel.

Oversight and quality practices

Oversight of PPMP testing involves ensuring training, competency, and proper test performance. Common challenges for POC teams who supervise this testing include ensuring consistent verification, lack of quality control materials, microscope maintenance, environmental monitoring, and test record documentation. While proficiency testing is not required for PPMP, sites can enroll in proficiency testing to satisfy the requirement of biannual performance assessment (3).

Competency and roles

CLIA regulations outline specific roles and responsibilities for individuals overseeing and performing PPMP testing. For a Certificate of Provider Performed Microscopy Procedures, the laboratory director must be a physician, a midlevel practitioner, or dentist, and is responsible for assessing the competency of all testing personnel. For sites with CLIA certificates for moderate-complexity testing, a Technical Consultant may also perform competency assessments. Molecular testing resources

Competency for PPMP testing includes five key areas:

  1. Direct observations of routine patient test performance
  2. Monitoring test result recording and reporting
  3. Review of test results or worksheets 
  4. Assessment of test performance (internal blind testing samples or external proficiency testing samples)
  5. Assessment of problem-solving skills

The competencies for PPMP do not include the sixth competency seen for other moderate-complexity testing, which is direct observation of performance of instrument maintenance and function checks. This was not included due to a bright-field or phase-contrast microscope being the only equipment used for testing under PPMP.

Why PPMP matters for POCT professionals

For POCT professionals, PPMP is a unique subset of nonwaived testing that occurs at the point-of-care. They require specialized expertise to perform and provide a large benefit and impact for patients. These tests are subject to nonwaived testing standards as well as training, competency, and documentation specific to procedures falling under the PPMP umbrella. Frequent communication between the POCT team and the providers performing PPMP is paramount to maximizing the quality of patient care. As leaders in the field, it is important for POCT professionals to be aware of these intricacies and the regulations involved to keep policies and procedures up to date and to maintain regulatory compliance.

Reference

  1. Code of Federal Regulations. Title 42, Chapter IV, Subchapter G, Part 493, Subpart A, § 493.19 Provider-performed microscopy (PPM) procedures. https://www.ecfr.gov/current/title-42/section-493.19 Accessed October 24, 2025.
  2. Graden KC, Bennett SA, Delaney SR, Gill HE, Willrich MAV. A High-Level Overview of the Regulations Surrounding a Clinical Laboratory and Upcoming Regulatory Challenges for Laboratory Developed Tests. Lab Med. 2021 Jul 1;52(4):315-328. doi: 10.1093/labmed/lmaa086. PMID: 33283241.
  3. Centers for Disease Control and Prevention. Provider-Performed Microscopy Procedures: A Focus on Quality Practices. US Department of Health & Human Services; 2025. https://www.cdc.gov/lab-quality/media/pdfs/2025/07/PPMP_2025_Final-508c.pdf Accessed October 24, 2025.
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