It's time for a CLIA refresher!

By Faiza Wasif, MPH, August 1, 2019

What comes to mind when you hear CLIA? Probably that it’s just another burdensome federal regulation you must comply with. While it’s true that the Clinical Laboratory Improvement Amendments (CLIA) are federally mandated standards, they are more than just another regulation. It’s all about quality. Quality ensures that products or services are free from errors or defects. It’s how we can achieve uniformity and standards. It creates reliability and trust. It’s what every industry — particularly health care — strives to achieve.

So how does CLIA fit into health care quality, specifically? Let’s do a quick breakdown of its history and what it means to be CLIA certified.

CLIA was introduced in 1988 (with subsequent amendments) as federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. Clinical laboratories must be licensed by the federal government and undergo continual accreditation to ensure compliance with all regulations placed under the responsibility of the Centers for Medicare and Medicaid Services (CMS).

Do you need to be CLIA certified?

CLIA requires all facilities that perform even one test, including waived tests, 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” to meet certain federal requirements. If a facility performs tests for these purposes, it is considered a laboratory under CLIA and must apply and obtain a certificate from the CLIA program that corresponds to the complexity of tests performed. Even if you only read slides or use a microscope in your office, you must be CLIA certified.

What are the types of certifications?

There are five certification types each valid for two years depending on the type, number, and complexity of testing performed:

• Certificate of Waiver
  This is given to facilities that perform only waived tests which are tests that are approved for home use, have simple methodology that assure accuracy, and pose little or no threat/harm to the patient if performed incorrectly. Some examples include pregnancy tests and urinalysis with dipstick.

• Certificate of Provider Performed Microscopy Procedures (PPM)
  This is for moderately complex tests performed by a provider — primarily a microscope — when transfer of the specimen could affect accuracy. Examples of this include KOH slide preparation or evaluation for ectoparasites.

• Certificate of Registration
  This is issued to a laboratory that enables the entity to conduct moderate- or high-complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations. Examples of moderate complexity testing include Tzanck tests and fungal cultures. High-complexity testing includes the reading of pathology slides. Only laboratories applying for a Certificate of Compliance or a Certificate of Accreditation will receive a Certificate of Registration.

• Certificate of Compliance
  This is given after the inspection is complete and the lab is found to be in compliance with all CLIA regulations. It includes compliance with Mohs and other moderate- and high-complexity procedures. Most dermatology practices will apply for this certificate and renew it every two years.

• Certificate of Accreditation
  This is issued to a lab on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS. Usually, dermatology practices do not apply for this certificate. Find the list of accreditation organizations at www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf.

How do you apply?

To receive a CLIA certification, a practice must apply using the CLIA application (Form CMS-116). This form collects information about your practice operation, which is necessary to determine the fees to be assessed, to establish baseline data, and to fulfill the legal requirements for CLIA.

You must also have a laboratory director in place for moderate- and high-complexity labs. The laboratory director qualifications are as follows:

• Provider Performed Microscopy Procedure (PPMP): Lab director and testing personnel must have either an MD, DO, DPM, NP, or PA degree.

• Moderate complexity: Lab director must have either an MD, DO, PhD, MS, or BS degree and have 20 hours of CLIA CME credit. The minimum requirement for testing personnel in this environment is a high school diploma.

• High complexity: Lab director must be a certified pathologist or a physician with an MD or DO 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 degree in a field of science.

What happens after certification?

Once the appropriate certificate is obtained, it must be displayed in a prominent area and will need to be readily available upon request by CMS or a CLIA inspector.

Be prepared for an inspection at any time — although you are typically notified two weeks in advance of an inspection. The inspection’s success hinges on the lab’s condition and documentation at the time of the inspection. Here is what is typically covered:

Prior to inspection

Provide basic lab information including business hours, test menu, and test volumes. 

During the visit

• Previous inspection report and related corrective action(s)
• Personnel files (both paper and electronic) for everyone involved with the lab. For the lab director, be sure to have documentation license (if physician), level of education, and experience/training
• Installation records for all instruments acquired since the last inspection or both new and replaced instruments 
• Manuals and test procedures. These must be up to date, complete, and signed by the lab director
• Calibration verification, maintenance records, and service reports
• Quality control records, including proficiency testing records (if applicable)
• Patient records

The inspector may request other information as well so be prepared by keeping all the documentation current and organized.

Am I required to do proficiency testing?

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. Most dermatology tests are not classified as regulated analytes. A full list of the tests requiring proficiency testing is available at www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure8.pdf.

If you must enroll in a proficiency testing program, a list of approved agencies is available at 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 formal proficiency testing program. Remember, this requirement is in addition to the regular quality control you must also perform on all your tests.

Clearly, the CLIA regulations help ensure that standards are met, safety is not compromised, and redundancy is eliminated. When it comes to providing optimal care for your patients, knowing and abiding by these regulations will help your practice reach that goal each time. 

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