All laboratory testing done in physician offices and other health care facilities is subject to government regulations called the Clinical Laboratory Improvement Act (CLIA). According to the regulations, the Centers for Medicare & Medicaid Services (CMS) oversees all laboratory testing done on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. Only research laboratory testing is exempt from CLIA.
The purpose of the CLIA regulations is to establish quality standards, strengthen federal oversight of clinical laboratories, and ensure the accuracy and reliability of patient test results—no matter how simple the test—no matter how small the laboratory.
All health care settings performing laboratory tests must have a CLIA certificate. The kind of certificate depends on the category of the tests performed (see here for a comprehensive database).
The most common CLIA certificate among physician office laboratories is a Certificate of Waiver (CoW). A CoW allows laboratories to do tests categorized by the FDA as waived tests.
- Certain glucose and cholesterol testing methods
- Some hemoglobin and lead tests
- Urine pregnancy tests
- Rapid strep tests
- Simple urinalysis
Laboratories who wish to perform non-waived tests must apply for a certificate of registration (COR), which permits the lab to perform moderate and/or high complexity tests until the laboratory can be surveyed.
The results of a successful survey might result in a Certificate of Compliance (COC) or a Certificate of Accreditation (COA) depending on the agency who surveys the laboratory. The certificate may further authorize the lab to perform:
- Moderate complexity lab tests, which require minimal knowledge and training. Commonly performed moderate complexity tests include CBCs, chemistries (BMP and CMP) and blood cultures.
- High complexity lab tests, which require specialized knowledge and training. Commonly performed high complexity tests include genetic testing, blood group/antigen typing, and immunological testing.
To get CLIA certification, laboratories must:
- Complete Form CMS-116, Clinical Laboratory Improvement Amendments (CLIA) Application for Certification and mail it to the appropriate CLIA State Agency.
- Pay applicable fees based on certification type. For moderate and high complexity laboratories, additional fees are based on annual testing volume and scope of testing.
- Be surveyed, if applicable.
- Meet CLIA certification standards.
For specific guidance on CLIA registration, categorization of tests, and ongoing compliance you may access this CMS resource.
It is advisable that laboratories, even those in physician offices, have a laboratory supervisor who is responsible for oversight of the laboratory, following manufacturer guidance on operations including quality control and quality assurance, and seeing that all staff performing tests are educated on laboratory procedures and trained annually.
CLIA regulations and test categorizations change frequently. The laboratory supervisor is well placed to keep abreast of these dynamic regulations. But ultimately CLIA compliance is the responsibility of the physician.
For more information:
- AAFP Resource: Preparing a Physician Office Laboratory Procedure Manual
American Academy of Pediatrics