All laboratory testing is regulated by the Center for Medicare and Medicaid Services (“CMS”) pursuant to the Clinical Laboratory Improvement Amendments of 1988 ( “CLIA”) 42 USC 263(a) et seq. and the applicable Medicare and Medicaid requirements for laboratories codified together at 42 CFR Part 493 (the federal laboratory requirements).
Laboratory testing is classified as highly complex, moderately complex (including provider performed microscopy- PPM), or waived under CLIA. The Food and Drug Administration (FDA) determines which tests are approved waived.
University CLIA Registered Compliance Committee
Waived Testing
A list of current waived testing is available on the CMS website or through the FDA database.
You must obtain a CLIA certificate before performing any testing. If only waived testing is performed, the facility must obtain a Certificate of Waiver. Laboratories with a Certificate of Waiver are not required to participate in proficiency testing and are not routinely inspected. For waived testing, the manufacturer’s instruments must be following exactly. If testing personnel change the procedure in any way, the test may not be considered waived and results may not be accurate.
Good laboratory practices for waived testing include: appropriate training, quality control, quality assessment, organized records and proficiency testing.
Provider-Performer Microscopy (PPM) Testing
To quality for a Certificate of PPM, the laboratory must perform the following procedures only:
- Wet mounts, including preparations of vaginal, cervical, or skin specimens
- All potassium hydroxide (KOH) preparations
- Fern test
- Post-coital direct, qualitative examinations of vaginal or cervical mucous
- Urinalysis, microscopic only
- Fecal leukocyte examination
- Qualitative semen analysis; presence and/or motility of sperm only
- Nasal smears for eosinophils
- Pinworm examinations (regulated analyte, proficiency testing required)
PPM tests must be performed by a physician, dentist, nurse midwife, nurse practitioner or physician assistant.
PPM tests are classified as moderately complex and are subject to all applicable CLIA regulations. All subparts, including proficiency testing, quality system, facility administration and personnel, apply to PPM testing. These laboratories / health care facilities are not subject to routine inspections. PPM laboratories may also perform waived testing.
CLIA Resources
CLIA Brochures available from the CMS website:
- http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures.html
- Brochure #1 - How do they affect my laboratory?
- Brochure #2 - Verification of Performance Specifications
- Brochure #3 - Calibration and Calibration Verification
- Brochure #4 - Equivalent Quality Control Procedures
- Brochure #5 - How to Obtain a CLIA Certificate
- Brochure #6 - How to Obtain a CLIA Certificate of Waiver
- Brochure #7 - Laboratory Director Responsibilities
- Brochure #8 - Proficiency Testing
- Brochure #9 - Complaints, Do You Have a Concern About a Laboratory's Operation?
- Brochure #10 - What Do I Need to Do to Assess Personnel Competency?