By Rachna Chaudhari, June 02, 2014
If your dermatology practice has a CLIA certificate or you are considering applying for a CLIA certificate for your practice, you need to be aware of the regulations for proficiency testing (PT). PT is a quality control method to verify your lab tests through an external source.
Who has to do PT?
The Centers for Medicare and Medicaid Services (CMS) requires that all labs performing regulated analytes testing and non-waived testing abide by PT guidelines. A list of regulated analytes is available on the COLA website at www.cola.org/storage/ff10.pdf or on the CMS website at www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/CLIAbrochure8.pdf. If you perform one of these tests, you must enroll in a PT program through a CMS-accredited agency; 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 PT program but you must assess the quality of your testing through two specimens twice a year. This can be done by splitting specimens with another provider in your area and comparing results. You can also enroll in a formal PT program, but as discussed below, this has risks.
Does this generally apply to dermatologists?
Dermatologists need to be aware that most dermatology tests do not fall on the regulated analytes list; exceptions include gram stain and parasitology. Thus, you may not be required to perform PT in your practice.
Some dermatology practices are not aware of this criterion and have enrolled in formal PT programs in which they are not obligated to participate. But even if you are not required to perform PT, if you choose to enroll in a formal PT program, you must follow all of the associated regulations during your one-year enrollment and any subsequent years you enroll. Failure to abide by these regulations could result in your CLIA license being revoked for at least one year.[pagebreak]
What could go wrong?
One dermatology practice that enrolled in a PT program but didn’t have to was unaware of the regulation concerning the sharing of PT samples. CLIA specifically prohibits sample-splitting, discussion, or any activity that results in PT samples being shared amongst laboratories. This dermatology practice was sending PT samples for review to a laboratory in a different location, which violates PT testing protocols. Even though this other laboratory happened to be affiliated with the same practice, it operated under a separate CLIA certificate so the practice was found to be in violation and had its CLIA certificate immediately revoked. The practice ended up receiving a reprieve through a CMS administrative judge; however, it took significant time, effort, and money to achieve this result and legal representation was required.
Can a practice appeal a CLIA judgment related to PT?
If your practice faces any CLIA judgment, an appeals process is available at www.hhs.gov/dab/divisions/appellate/guidelines/clia.html#appeal. However, it is vital to insure your practice is following the key steps outlined below.
- If applicable, enroll in a formal PT program for each CLIA certificate in your office. If you have multiple practice locations with multiple CLIA certificates, you must enroll each location in a separate PT program.
- Perform PT three times per year.
- Analyze the PT samples in the same manner as patient samples. Use the same testing personnel, test systems, and timeframes you would normally use with patient samples.
- PT samples can be rotated amongst testing personnel in the laboratory however, they should never be sent out of the laboratory for any reason, even if patient specimens are normally sent outside the laboratory.
- Record all the steps required in preparing and handling your PT sample as well as testing parameters and results.
- Return the samples and test results to the PT program in the timeframe requested.
- Review the results from your PT program with your testing personnel and laboratory director even if you passed all tests successfully.
- If you received a score of 80 percent or lower on a PT sample, document your corrective action.
- Maintain all PT records for at least two years from the date of performing the PT sample test.
No matter how you choose to maintain the quality control of your tests with respect to CLIA, ensure your practice is complying with all of the necessary regulations and state-specific laws through effective communication with your state CLIA office. The ramifications of not complying can be drastic, so it is prudent to stay up to date with the latest compliance issues. The Academy also provides updates on CLIA at www.aad.org/members/practice-and-advocacy-resource-center/compliance-and-legal-issues/clia and members can contact Academy staff for further guidance at firstname.lastname@example.org.