Complying with CLIA | aad.org
Complying with CLIA

Answers in Practice

Rachna Chaudhari

Rachna Chaudhari is the AAD's practice management manager. Her column offers tips in response to common member questions.

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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 the Centers for Medicare and Medicaid Services (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).

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. A list of these tests appears in the sidebar on the next page. [pagebreak]

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. [pagebreak]

What are the most common deficiencies found in 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. [pagebreak]

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’s 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. Thus, 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, and model quality control procedures are contained in the Academy’s CLIA manual.

What are the new IQCP requirements under CLIA?

CLIA began allowing labs to implement an individualized quality control program (IQCP) on Jan. 1. Most dermatology practices would not be 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. [pagebreak]

CLIA manual can help practices develop required policies and programs

The Academy’s CLIA manual, available at www.aad.org/store/product/default.aspx?id=8489, can help dermatology practices ensure that they are complying with CLIA’s requirements. The new CLIA manual includes a model laboratory procedure manual for the 10 most common procedures performed in a dermatology lab. It includes model templates and forms for the following tests:

a. Ectoparasites
b. KOH examination of skin, hair, or nails
c. Vaginal wet preparation/KOH examination
d. Tzanck smear
e. Fungal culture/DTM
f. Staining procedures
g. Cytodiagnosis of molluscum contagiosum
h. Microscopic hair shaft evaluation
i. Histopathology
j. Histopathology – Mohs surgery

                    Additionally, the manual contains model protocol forms for all the common equipment used in a dermatology practice, along with templates and forms for assessing quality on your pre-analytic, analytic, and post-analytic tests.

                    Provider-performed microscopy procedures

                    Q0111 - Wet mounts, including preparations of vaginal, cervical, or skin specimens

                    Q0112 - All potassium hydroxide (KOH) preparations

                    Q0113 - Pinworm examinations

                    Q0114 - Fern test

                    Q0115 - Post-coital direct, qualitative examinations of vaginal or cervical mucous

                    81015 - Urinalysis; microscopic only

                    81000 - Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, with microscopy

                    81001 - Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, with microscopy (NOTE: May only be used when the lab is using an automated dipstick urinalysis instrument approved as waived.)

                    81020 - Urinalysis; two or three glass test

                    89055 - Fecal leukocyte examination

                    G0027 - Semen analysis; presence and/or motility of sperm excluding Huhner

                    89190 - Nasal smears for eosinophils

                    *List found at www.cms.hhs.gov/CLIA/downloads/ppmplist.pdf.

                     

                    Related Resources

                    CLIA manual can help practices develop required policies and programs
                    Provider-performed microscopy procedures