Ericka L. Adler, JD, LLM has practiced in the area of regulatory and transactional healthcare law for more than 20 years. She represents physicians and other healthcare providers across the country in their day-to-day legal needs, including contract negotiations, sale transactions, and complex joint ventures. She also works with providers on a wide variety of compliance issues such as Stark Law, Anti-Kickback Statute, and HIPAA. Ericka has been writing for Physicians Practice since 2011.
For medical practices with clinical laboratories, compliance with formal proficiency testing must be a priority.
Many of the clients I work with have clinical laboratories within their practices. Some of these labs offer tests that are “waived,” while others offer non-waived tests. Practices can confirm which type of testing they offer here.
Depending on the type of testing a practice offers, different requirements must be satisfied to assure accuracy and compliance. For waived testing, the Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires continuous quality oversight and internal testing to assure standards are met. For non-waived testing, labs must engage in formal proficiency testing (PT).
PT is a program that requires labs to test unknown samples through a CMS approved PT program three times per year to assure the quality of the lab’s tests results as well as consistency with other labs across the country. Every lab offering non-waived tests (even if it also offers waived tests) must enroll and participate in a PT program for each CLIA certificate that it maintains. Failure to comply with and pass PT can jeopardize a lab’s CLIA certificate.
For practices with laboratories, assuring compliance with PT must be a priority. Any practice that relies on its laboratory as a key part of its physician services (i.e., a practice specializing in reproductive medicine, or one that does extensive pathology testing) can be destroyed by the loss of CLIA certification. For this reason, stringent oversight and training of staff on PT is essential.
When it comes to PT, the number one rule is that all specimens must be tested in the same manner as patient specimens. This means the same number of times, with the same personnel, and using the same test system and equipment. However, there is an important exception to this rule which has frequently created significant issues for laboratories: You must never send out your PT to another laboratory (i.e., for confirmation or identification) even if that is the way in which a particular type of specimen might normally be handled. The consequences of referring out a sample for any reason, whether innocent or not, can be severe and can include loss of a lab’s CLIA certificate as well as a prohibition on the owners and lab director owning or directing a lab for two years.
To avoid violating PT requirements, every practice should have specific policies and training in place on how to handle PT samples. This might include color-coding the sample so it is not accidentally referred, or finding another approach that draws attention of lab personnel to the proper handling of PT. If a lab typically refers out specific types of samples for staining, interpretation, or more sophisticated testing, a PT sample of that type would need to be returned with the explanation it could not be completed because the test would be referred out under standard procedures. Unfortunately, CMS does not differentiate between a PT sample accidentally shipped out or a rogue employee who sends a PT sample to a friend at another lab to confirm results. Both events have been treated as equally serious PT referrals in the eyes of CMS.
Although there are many different types of PT violations that occur, PT referrals have particularly plagued many institutions, whether caused by automatization, human error, or other reasons. As a result of vocal critics of PT, new legislation was proposed. On Dec. 4, 2012, Obama signed the Test Act which amends Section 353 of the Public Health Service Act and is intended to allow CMS a little more regulatory flexibility under CLIA for referrals of PT.
The rules create three levels of sanctions for cases of PT referrals based on the severity of the referral or violation. Among factors taken into account in determining consequences are past PT violations, the type of violation, and the availability of other lab resources in the community. Other penalties that may now be considered include fines, staff training, and even a directed plan of correction.
Unfortunately the Test Act does not appear to go far enough, since still it fails to differentiate between intentional and non-intentional PT referrals and still mandates harsh minimum penalties for certain violations without requiring a case-by-case review of the facts and circumstances involved. For this reason, it’s still very important for practices with labs that offer non-waived testing to remain vigilant when it comes to handling PT samples