What is CLIA?
The Clinical Laboratory Improvement Amendments (CLIA) were established by the federal government in 1988 for the purpose of setting quality standards for all laboratory testing. A laboratory is defined as any facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of 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. All labs meeting this definition must receive a CLIA certificate of compliance.
Are there different types of CLIA labs?
Yes, CLIA sets guidelines for labs based on complexity levels of tests. There are three levels of complexity:
- Waived – simple tests that do not require additional quality assessment (for a list of these tests, see www.cms.hhs.gov/CLIA/downloads/waivetbl.pdf)
- Moderate Complexity – most automated tests that do not meet the waiver criteria (e.g., KOH exams, Tzanck smears, fungal cultures with DTM, and staining procedures) or provider performed microscopy procedures (PPMP)
- High Complexity – non-automated tests (e.g., histopathology, Mohs surgery, cytodiagnosis of molluscum contagiosum, and microscopic hair shaft evaluation)
Within the moderate complexity guidelines, there is a PPMP category that contains all tests personally performed by a provider. In order to meet the criteria for this level of complexity the following criteria must be met:
- Moderate complexity test.
- Uses microscope.
- Personally performed by either an M.D., D.O., PA, or NP.
- Labile specimen.
- Quality control is not available.
- Limited specimen handling or processing required.
A list of these tests is also available at www.cms.hhs.gov/CLIA/downloads/ppmp.list.pdf. Some common dermatologic tests within this category include KOH exams and ectoparasites.
How do I apply for a CLIA certificate?
After you have determined what level of complexity your laboratory is, you may apply for a CLIA certificate. There are two options available to physicians when applying for a CLIA certificate.
- • Option 1: One option is to go through your state CLIA office and submit the appropriate application materials and fees. Contact information for each state is available at www.cms.hhs.gov/CLIA/downloads/CLIA.SA.pdf.
- • Option 2: The second option is to go through COLA, a physician-directed accreditation program which certifies laboratories in place of the state. For more information on this organization, please see www.cola.org.
All laboratories must pay certificate fees to the Centers for Medicare and Medicaid Services (CMS) and have additional fees depending on their level of complexity.
What are the requirements for CLIA certification for each type of laboratory?
The requirements vary depending on the level of complexity of your laboratory. For waived testing, you must only follow the manufacturer instructions for each test and allow unannounced surveys from CMS. For PPMP testing, you must meet the CLIA guidelines for facility administration (e.g., OSHA and safety requirements), quality systems (e.g. quality assessment procedures), personnel, and proficiency testing. For all other moderate complexity procedures and high complexity testing, you must meet those guidelines and allow routine inspections every two years.
What are the personnel requirements?
To run a CLIA-certified laboratory, staff must meet minimum requirements set forth by the CLIA law. Laboratories performing only waived testing do not have any requirements regarding personnel; however, you should consult your state scope of practice laws to ensure the correct personnel are performing these tests. If you are part of a PPMP laboratory, the lab director and testing personnel must have either an M.D., D.O., DPM, NP, or PA degree. If you perform other procedures that are part of a moderate complexity lab, the lab director must have either an M.D., D.O., Ph.D., M.S., or B.S. degree and have 20 hours of CLIA CME credit. The minimum requirement for testing personnel in this environment is a high school diploma. For high complexity labs, the lab director must be a certified pathologist or a physician with an M.D. or D.O. degree who received one year of laboratory training in residency or has two years of experience directing high complexity testing. Testing personnel in this type of laboratory must have at least an associate’s degree in a field of science.
What are the proficiency testing requirements?
Proficiency testing is a way to verify your lab tests through an external source. CMS requires that all labs performing regulated analytes testing and are either a moderate or high complexity lab abide by proficiency testing guidelines. A list of regulated analytes is available on the COLA Web site at www.cola.org/storage/ff10.pdf. If you perform one of these tests and you are a non-waived laboratory, you must enroll in a proficiency testing program through a CMS accredited agency. A list of approved agencies is available at http://www.cms.hhs.gov/CLIA/downloads/ptlist.pdf. If you do not perform any of the tests on the list of regulated analytes, you do not have to enroll in a proficiency testing program but you must assess the quality of your testing through two specimens twice a year. This can be done by splitting samples with another provider in your area and comparing results, or you can also enroll in a proficiency testing program.
How should I prepare for a CLIA inspection?
CLIA inspections are performed every two years if you are in a moderate or high complexity lab.
The top 10 deficiencies found in CLIA inspections over the past several years have been:
- Director qualifications
- Test reports missing
- General systems/written policies incomplete
- Director not following quality assessment program
- Expired reagents
- Incomplete procedure manuals
- No formal quality assessment program
- Not maintaining equipment
- Lack of proficiency testing
- Poor storage of reagents
Ensure that your laboratory is following the proper procedures in these areas and provide your inspector with the proper documents in an organized manner ahead of time. The more organized you are, the easier it is for the inspector to evaluate your documents and complete the assessment.