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Maintaining the accuracy and reliability of laboratory testing is critical for both facilities and the patients served. The Clinical Laboratory Improvement Amendments (CLIA) certification sets federal standards that ensure healthcare facilities deliver accurate and reliable laboratory results. By complying with these requirements, facilities not only meet regulatory obligations but also provide patients with reliable results that support diagnosis and treatment. Ultimately, CLIA certification plays a vital role in safeguarding public health and fostering trust in laboratory services.
What is CLIA, and What is its Purpose?
CLIA is a federal program overseen by the Centers for Medicare & Medicaid Services (CMS), in partnership with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), to oversee laboratory testing on human specimens. Its purpose is to ensure that testing is accurate, reliable, and timely.
Some states also have separate laboratory licensing laws. In those states, laboratories must comply with both CLIA requirements and applicable state-specific laboratory laws.
To confirm state-specific laws and CLIA requirements, we recommend that you contact your state agency using the following hyperlink: Clinical Laboratory Improvement Amendments (CLIA) State Agency Contacts.
Overview: Waived vs. Non-Waived CLIA Certification
While CMS CLIA officially categorizes laboratories by certificate type, the program fundamentally distinguishes between waived and non-waived laboratories.
Waived: These are simple laboratory tests with a low risk of incorrect results. Examples include, but are not limited to, point-of-care (POC) pregnancy tests or blood glucose testing.
While some point-of-care tests are approved for a CLIA Certificate of Waiver (CoW), certain devices used for testing are more technologically advanced and capable of performing more complex, rapid testing. Therefore, it is imperative that facilities review the manufacturer’s instructions for use (IFUs) of devices to determine certificate status.
Provider-Performed Microscopy (PPM): PPM procedures are a limited category of moderately complex microscopic examinations that may be performed by a physician, midlevel practitioner, or dentist under a CLIA Certificate for Provider-Performed Microscopy Procedures. A PPM certificate also permits the performance of waived testing.
Non-Waived Testing: Non-waived testing includes moderate- and high-complexity testing. Facilities performing non-waived testing must hold the appropriate CLIA certificate (such as a Certificate of Compliance or Certificate of Accreditation, with Certificate of Registration typically serving as the initial certificate while awaiting survey), and must comply with applicable CLIA quality standards.
Examples may include many molecular diagnostic assays, microbiology cultures, and other testing categorized as moderate or high complexity based on the specific test system.
To determine which tests are categorized as waived or nonwaived, refer to the FDA CLIA Database.
Who is Required to Obtain CLIA Certification?
CLIA applies to all QUAD A facilities, Medicare and non-Medicare, that perform any tests on human specimens for diagnosis, disease prevention, treatment, or health assessment – regardless of the frequency with which testing is performed, and even if Medicare is not billed for these services.
Instructions on obtaining the appropriate CLIA certificate can be found at the following link: CMS Clinical Laboratory Improvement Amendments - How to obtain a CLIA Certificate.
The table below summarizes QUAD A standards specific to CLIA, and the cross-reference to the regulatory requirements:
| QUAD A Standard | Standard Language |
Anesthesia
Classification |
Program Applicability | Regulatory Requirement |
| 3-H-2 | If laboratory services are provided, these laboratory services must be provided in accordance with the Clinical Laboratory Improvement Act (CLIA) requirements at 42 CFR 493 operating under a current CLIA certificate appropriate to the level of services performed. | A, B, C, C-M |
OBS
OBP ASC OMS PD Polyclinic I-Surgical I-Dental |
416.49(a) |
| 9-D-1 | If the facility does not provide laboratory services, any referral laboratory must be certified in the appropriate specialties and sub-specialties of service to perform the referred tests in accordance with the requirements of part 493 of 42 CFR. The referral laboratory must be certified in the appropriate specialties and subspecialties of service to perform the referred tests in accordance with the requirements of Part 493 of this chapter of the Code of Federal Regulations. | A, B, C | ASC | 416.49(a) |
| 14-F-11 | The clinic provides laboratory services that implement the provisions of section 353 of the Public Health Service Act, wherein the RHC provides basic laboratory services essential to the immediate diagnosis and treatment of the patient. | N/A | RHC | 491.9(a)(4) 491.9(c)(2) |
Evaluating Compliance and Documentation
- Review CLIA or equivalent internationally recognized certificate for evidence that the:
- Type of certification matches services provided (waived, provider-performed microscopy, moderate complexity)
- Personnel are appropriately trained and qualified for the services performed, and evidence is located in the personnel file.
- Review policies for directive to perform quality control testing per the manufacturer's instructions for use (IFU)
- IFUs are available upon request
To conclude, adherence to CLIA certification not only meets regulatory requirements but also enables facilities to establish standardized procedures and quality controls, resulting in reliable test outcomes and enhanced patient safety.
Thank you for your continued dedication to safety and excellence.
Should you have any questions, please email them to standards@quada.org.
Since 1980, QUAD A (a non-profit, physician-founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of healthcare they provide – believing that patient safety should always come first.
