Focus On: Clinical Lab Regulation: CLIA PT Changes Get ‘Thumbs Up,’ but With Caveats

Proposals that would modify rules under the Clinical Laboratory Improvement Amendments (CLIA) that govern the referral of proficiency testing (PT) samples won support from leading clinical laboratory and pathology organizations, though many sought clarification on specific provisions, in particular, the narrow one-time-only exception for intentional referrals. The proposals were published in the Feb. 7 Federal Register in a broader rulemaking on regulatory provisions to promote program efficiency, transparency, and burden reduction. The comment deadline was April 8. How Significant Are the Changes? The CLIA program, housed in the Centers for Medicare and Medicaid Services (CMS) gets greater flexibility in determining the scope and severity of penalties for a clinical lab that sends PT samples to an outside laboratory for analysis. CLIA officials previously adopted a strict interpretation of the term “intentional referrals,” stating that when a lab for any reason refers a PT sample to another lab for analysis for testing that it is certified to perform, they had no choice but to impose the harshest sanctions: revocation of the lab’s CLIA certification and its approval to receive Medicare and Medicaid payment for one year as well as barring the lab’s owner and operator from owning or operating another lab for two years from the date of revocation. Now they agree that the changes would “prevent confusion on the part of labs, reduce the risk of noncompliance, and establish policies under which certain PT referrals would not generally be subject to revocation of a CLIA certificate or a two-year prohibition on laboratory ownership or operation that may be applied to an owner and an operator when a CLIA certificate is revoked.” The proposals emphasize that PT samples are never to be referred to another laboratory. “The requirement to treat PT samples in the same manner as patient specimens does not mean that it is acceptable to refer PT samples to another laboratory for testing even if that is the standard operating procedure for patient specimens—a PT sample must never be sent to another laboratory under any circumstances.” But since there are cases where this does occur, the agency would explicitly note that this requirement applies only up to the point where the PT sample leaves the lab. The carve-out for referrals deemed improper and subject to intermediate sanctions, but not intentional and thus subject to revocation, would apply when it is not a repeat referral, when it is a reflex or confirmatory test, and when the referral is in accord with the lab’s written and legally accurate standard operating procedures. The expectation is that labs will ensure that improper referrals are addressed and eliminated, CMS said, “or we will find that future referrals are intentional. The carve-out is meant to be a one-time exception.” Separately, Congress last year passed the Taking Essential Steps in Testing (TEST) Act (Public Law 112-202) which gave CMS discretion in using its enforcement authority to consider penalties on a case-by-case basis for breaches of the PT referral rules. CMS may make the CLIA certificate revocation optional rather than mandatory and may levy intermediate sanctions instead of the two-year prohibition against lab ownership or operation that would otherwise apply. Comments on the Changes COLA, a physician-directed organizations which accredits labs under CLIA, supported the proposals and the TEST Act, noting in particular that they “emphasize an educational rather than a punitive approach toward correcting the behavior of those who improperly refer PT samples.” The American Association for Clinical Chemistry (AACC) also backed the proposed changes, pointing out that in recent years, a number of clinical labs have inadvertently sent a PT specimen to another lab for testing. “Frequently, this mistake is the result of laboratory personnel sending the specimen to an outside facility for reflex or confirmatory testing as specified in their standard operating procedures. According to CMS, nearly one-third of the 41 cases of PT referral errors during 2007-2011 were the result of this type of mistake.” But AACC argued that the one-time carve-out exception should be broadened so the agency has greater discretionary authority in deciding when to apply the alternative sanctions. “Inserting such language now would ensure that CMS didn’t need to make future regulatory changes to address an unforeseen situation that may warrant lesser penalties.” The College of American Pathologists (CAP) expressed strong support for amending CLIA to give CMS discretion in prosecuting improper PT referral cases, saying this is “an important initial step in modernizing the PT referral regulations.” But CAP requested more information on how and under what circumstances the exception for improper PT referrals will be applied given the different possible scenarios to accidentally occur or go undetected. CAP also asked whether the exception would cover the directors of labs that have referred PT specimens and meet the carve-out criteria, and whether the agency would share its guidance on enforcing the rule. The American Clinical Laboratory Association (ACLA) believes that “CMS should implement the TEST act, which was targeted at the same issue, rather than engaging in multiple rulemakings on the same topic. The act was passed to give CLIA more discretion in responding to a lab’s inadvertent or accidental violation of the PT referral rule. The proposals still severely limit when the agency can exercise this discretion.” ACLA believes that CMS should develop a “facts and circumstances test” in the current rulemaking to ensure the appropriateness of the penalties it applies in response to unintentional violations. Instead of narrowly defining the precise circumstances in which it will determine that a PT referral is “not intentional,” CMS should set forth in regulations the factors it will consider when making such a determination, ACLA said, “including, but not limited to the accuracy and adequacy of a lab’s written standard operating procedures; the degree of automation in the lab’s work flow; the training and experience level of the person(s) referring the PT sample; the incidence of PT referrals from the lab in the past five years; and other relevant factors. Only if CMS determines that a PT referral was made willfully or in reckless disregard of CLIA and its implementing regulations, or that a laboratory has not made sincere and credible efforts to rectify inadequacies in its written manuals and in its training, should it resort to the harsh penalty of certificate revocation.”