CEO SUMMARY: Federal regulators rely on interpretations from administrative law judges (ALJ) for guidance in how to apply the Clinical Laboratory Improvement Amendments (CLIA) as they pertain to proficiency testing (PT) and the issue of inadvertent PT referrals. Representatives of the Centers for Medicare & Medicaid Services (CMS) and the College of American Pathologists (CAP) provide comments about this issue and offer insight as to how laboratories can comply with the law.
IT WAS 1988 when Congress passed the law known as the Clinical Laboratory Improvement Amendments (CLIA). Congress asked the Centers for Medicare & Medicaid Services (CMS) to administer the requirements laid out in the CLIA statute.
One important element of CLIA was that clinical laboratories meet the law’s proficiency testing (PT) requirements. For this article, CMS officials provided information about some of the issues associated with PT compliance. CMS Public Affairs Specialist Don McLeod responded via email to a request from THE DARK REPORT. He sent a written statement that is presented in the sidebar on page 13. McLeod also provided additional comments relating to aspects of CLIA and proficiency testing.
On the question of whether CMS makes a distinction between a clinical lab that self-reports an inadvertent clerical error with a proficiency test sample and a lab that is deliberately trying to cheat the proficiency testing program, McLeod noted that CMS does not make that distinction, because “the sanctions for PT referral originate directly from the CLIA law, which is very clear. There is no language in the section on sanctions or in the regulations that provide for self-reporting,” he wrote.
In cases where a laboratory employee has unintentionally referred a PT sample to another lab, McLeod stated that CMS considers any such referral as prohibited, regardless of whether the lab intended to refer the sample in an attempt to cheat or the lab referred the sample mistakenly.
Intentional PT Referrals
“A referral is viewed as intentional if any employee of the laboratory was aware that a PT sample was sent to another laboratory for testing,” said McLeod. “To make that determination, CMS reviews all cases in the central office and evaluates policies, procedures, records, documents, and data to consistently verify that referral has occurred.
“CMS defines referral as whether anyone in the lab was aware that the PT sample was sent to another lab, based on previous cases heard by administrative law judges (ALJ),” McLeod wrote. “When this occurs, the statute is invoked.
“It is our advice to labs to have robust policies and procedures in place to prevent referral and to provide training to any employee who might handle a PT sample,” he wrote. “The CLIA statute is quite specific that, when a laboratory intentionally sends PT samples to another laboratory, the CLIA certificate must be revoked for one year. In addition, the statute also requires that no person who has owned or operated a laboratory that has had its certificate revoked may operate a laboratory within two years of the revocation.”
Confusion About PT Referral
One pathologist thoroughly familiar with CAP’s accrediting program is Bruce Williams, M.D., who is a Clinical Associate Professor of Pathology at the Louisiana State University Health Science Center in Shreveport. Some labs are confused about the issue of PT referral, he said.
“Under the general instructions for how to handle a PT specimen, labs should treat them as they would a normal patient sample,” he explained. “But that doesn’t apply when it comes time to send out the PT sample—as would be done with a sample from a real patient.
“It is critically important to understand, that at this point in the PT protocol, you cannot send any PT sample outside the four walls of the lab,” noted Williams. “Take the example of reflex testing, where the lab would normally send out that test. If it is a PT specimen, you can’t do that.
“A number of labs have done this [inadvertently referred a PT specimen to another lab],” he added. “These labs were sanctioned and lost their CLIA licenses.
“With revocation of the CLIA license, the lab owner is prohibited from owning a laboratory for two years and the lab director is prohibited from serving as a lab director for two years,” stated Williams. “This punishment is fairly severe for something that is often an inadvertent mistake.
“This issue has been recognized over the years, but given the way the original CLIA legislation is written one could interpret it to mean that any referral outside of the lab would mandatorily result in this sanction,” he said.
“CAP has tried to resolve the issue with CMS, but the answer probably rests in legislation now before Congress that would grant CMS discretion in cases where mistakes have been made,” he added. “Clearly it is important for legislation that gives CMS the latitude it needs to investigate individual violations and adjust the penalties to fit the crime.”
THE DARK REPORT asked how many laboratories have been cited for violations involving inadvertent PT referrals and the number of labs severely sanctioned for inadvertent PT specimen referrals. Officials from the College of American Pathologists (CAP), a CLIA accrediting organization, responded that CAP does not have a complete record of the number of labs CMS has sanctioned for PT violations. Helena Duncan, CAP’s Assistant Director of Economic and Regulatory Affairs, said that CMS collects this information for all labs regulated under CLIA.
CLIA Laboratory Registry
When asked about the number of laboratories sanctioned for PT violations, CMS responded that it maintains the Laboratory Registry for CLIA enforcement actions at its website (https://tinyurl.com/cgxgbl5). This registry currently shows information about actions resolved through the end of 2010.
CMS officials said that, at the end of each year, time is required for regional offices “to close out all of the enforcement actions, survey info, and any other required info” and submit it to CMS for inclusion in the Laboratory Registry. It expects the enforcement actions from 2012 will be available on the Laboratory Registry by the end of 2013.
CMS Provides Statement about Interpretation And Enforcement of CLIA Proficiency Testing
EDITOR’S COMMENTS: Following the 1988 enactment of the Clinical Laboratory Improvement Amendments (CLIA-Public Law 100-578), one government agency has had the primary responsibility for enforcement. That is the Centers for Medicare & Medicaid Services (CMS).
Proficiency testing (PT) activities figured prominently in the CLIA statute. THE DARK REPORT contacted officials at CMS and asked for comments on how the federal agency interprets the CLIA law and enforces this interpretation. CMS answered this request with the following statement, reproduced in its entirety:
The Clinical Laboratory Improvement Amendments (CLIA) (Pub. L. 100-578, enacted October 31, 1988) established both CLIA PT requirements to ensure quality testing and strong sanctions for PT violations. Congress strongly believed that PT is a good measure of laboratory test accuracy, but also that ‘cheating’ at PT could mean misrepresentation of patient test results. CMS, accrediting organizations, and PT programs have regularly emphasized the importance of abiding by the requirements for PT, along with the consequences of not doing so.
The CLIA statute, 42 USC 263a(i)(4), requires that, when a laboratory intentionally sends PT samples to another laboratory, the CLIA certificate must be revoked for one year. In addition, the statute at 42 USC 263a(i)(3) requires that no person who has owned or operated a laboratory that has had its certificate revoked may operate a laboratory within two years of the revocation.
Because neither the law nor the regulations define the phrase “intentionally refers,” we have utilized determinations made by Administrative Law Judges (ALJ) as a guide affirming that “intentionally referred” requires not specific intent, but general intent, that is, an intent to act. A referral is viewed as intentional if any employee of the laboratory was aware that a PT sample was sent to another laboratory for testing. To make that determination, CMS reviews all cases in the central office and evaluates policies, procedures, records, documents and data to consistently verify that referral has occurred.
Guidance for laboratories to help prevent violations is included in PT program materials, accreditation organization requirements, and the CMS/CLIA website. Additionally, all non-waived laboratory directors were sent a letter and enclosure detailing important information regarding CLIA requirements for PT; specifically, information to clarify the regulations and to help prevent referral situations, based on current laboratory practices. CMS has also addressed this information in multi- ple public presentations in various venues.
A condition-level requirement pertains to significant, comprehensive requirements of CLIA, as opposed to a standard-level requirement which is more detailed, and more specific. A condition-level deficiency is an inadequacy of the laboratory’s quality of services that adversely affects, or has the potential to adversely affect, accuracy and reliability of patient test results. Laboratories who intentionally refer PT samples to another laboratory for analysis are out of compliance with the CLIA condition for enrollment and testing of samples (§493.801(b)(4)). Based on the outcome-oriented survey process, CMS surveyors make the determination of immediate jeopardy when deficiencies are determined to be of such a serious nature that they substantially limit the ability to render accurate and reliable services.
CMS does not comment on cases that are currently involved with the enforcement process.