CLIA compliance

The Academy’s practice management staff frequently receives inquiries related to compliance issues with CLIA. Whether they have an in-office dermatopathology lab or simply perform a few fungal cultures, most dermatology practices require CLIA certification of one kind or another.

The following FAQs guide practices through this process.

What is CLIA?

CLIA (the Clinical Laboratory Improvement Amendments) was 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.

How do I apply for a CLIA certificate?

There are two options available to physicians when applying for a CLIA certificate:

All laboratories must pay certificate fees to CMS and may have additional fees depending on their level of complexity.

How do I determine what type of CLIA certificate I should apply for?

CLIA has different certificates for labs based on the complexity levels of the tests they perform.

There are three levels of complexity:

  1. 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).
  2. 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).*
  3. High Complexity: Non-automated tests (e.g., histopathology, Mohs surgery, cytodiagnosis of molluscum contagiosum, and microscopic hair shaft evaluation).

    In order to be considered High Complexity, the following criteria must be met:
  • Moderate complexity test
  • Uses microscope
  • Personally performed by either an MD, DO, PA, or NP
  • Labile specimen
  • Quality control is not available
  • Limited specimen handling or processing required

A list of these tests is also available on the CMS website

*Most dermatologists who perform laboratory procedures not affiliated with Mohs surgery will fall into the moderate complexity/PPMP category. This category contains all tests personally performed by a provider that are not considered high complexity tests. 

What do I need to comply with after I receive a CLIA certificate?

There are four main steps you need to perform to comply with CLIA:

  1. Develop a laboratory procedure manual for each of your tests and equipment used.

  2. Establish and implement a quality assessment program for your tests. This includes policies and procedures for maintaining quality control of not only your patient specimens but also competency assessments of your testing personnel and safety procedures. 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 enroll in a proficiency testing program.

  3. Enroll in a proficiency testing program if applicable. Dermatology practices that offer Mohs surgery or have arrangements such that they have chosen to seek accreditation from an outside body may need a proficiency testing program; for most, though, the quality control steps described above will suffice.

    Specifically, if your lab performs regulated analytes testing and is either a moderate or high complexity lab it must abide by proficiency testing guidelines. A list of regulated analytes is available on the COLA (formerly the Commission on Office Laboratory Accreditation) website 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 www.cms.hhs.gov/CLIA/downloads/ptlist.pdf.

  4. Prepare for your inspection when applicable. Depending on the type of certificate you have, your state CLIA agency or accrediting body will inspect your lab on a routine basis.

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 among all labs over the past several years have been:

  1. Director qualifications
  2. Test reports missing
  3. General systems/written policies incomplete
  4. Director not following quality assessment program
  5. Expired reagents
  6. Incomplete procedure manuals
  7. No formal quality assessment program
  8. Not maintaining equipment
  9. Lack of proficiency testing
  10. 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.

What are some common CLIA deficiencies found in a dermatology practice?

One of the most common concerns being noted recently by CLIA inspectors has been the lack of formal personnel requirements for Mohs technicians. CLIA requires that anyone performing a high complexity test like Mohs surgery must possess at least an associate degree in laboratory science or medical laboratory technology, or at least 60 semester hours of higher education, including at least 24 semester hours that are science-based. If your practice has a medical assistant or histotechnologist grossing tissue or performing any high complexity testing, they would be required to meet those educational requirements.

Another common concern is the lack of proper quality control with procedures. Dermatology practices should test a minimum of two controls on each day patient samples are tested for proper quality control. Additionally, if a control is unavailable, the practice can split samples for testing with another CLIA-certified laboratory. There are exceptions to this depending on the type of test being performed.

What are the new IQCP requirements under CLIA?

CLIA allows labs to implement an individualized quality control program (IQCP). Most dermatology practices are not able to participate in this option since pathology testing is specifically excluded from the IQCP guidelines. The ICQP does not require dermatology practices to change any of their quality control procedures. It is a voluntary program that allows for more flexibility as labs can customize their own quality control policies and procedures.

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 MD, DO, 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 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.

For high complexity labs, the 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 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.

In the video below, Rachna Chaudhari, the AAD's practice management manager, explains that most dermatology practices are not required to perform proficiency testing to comply with CLIA. However, if practices do choose to opt in to testing, they must carefully follow all CLIA requirements or risk losing their CLIA certification for up to two years.

 

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. CMS has made modifications to the penalties associated with improper proficiency testing, namely the process of illegally sharing PT samples. If a practice is found to split PT samples with another laboratory, the practice can face a hefty fine and a suspension of their CLIA license for up to one year.