PT referral rules bring regulatory relief for labs

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• Reflex testing is the confirmatory or additional laboratory testing that is automatically requested by a laboratory under its standard operating procedures for patient specimens when the laboratory’s findings indicate test results that are abnormal, are outside a predetermined range, or meet other pre-established criteria for additional testing.
• Confirmatory testing is performed by a second analytical procedure that could be used to substantiate or bring into question the result of an initial laboratory test. It may be performed by the same laboratory that performs the initial test or by a second laboratory operating under a different CLIA certificate than the laboratory performing the initial testing.
• Distributive testing is when a laboratory test performed on the same specimen, or an aliquot of it, requires sharing it between two or more laboratories to obtain all data needed to complete an interpretation or calculation necessary to provide a final reportable result for the originally ordered test.

The PT referral incidents would still be improper but not considered intentional as long as the referral was “in full conformance with written, legally accurate, and adequate standard operating procedures for the laboratory’s testing of patient specimens,” the CMS says.

For example, protocols require a laboratory to send all HIV-positive test results to a second laboratory for confirmatory testing. However, if a CMS investigation finds that an individual referred only one of two positive HIV PT samples to another laboratory, thus not in conformance with standard operating procedures, the laboratory may be subject to revocation and a ban against the owner and operator, the agency said.

The PT referral also must not be a repeat offense for two survey cycles prior to the time of the incident. “The key to this exception is the expectation that laboratories will ensure that improper referrals are addressed and eliminated, or we will find that future referrals are intentional,” the CMS says in the May 12 rule. “The exception is meant to be a one-time exception to a finding of general intent to forward a PT sample to another laboratory. Upon learning that the laboratory’s training materials, training, or staff capabilities are inadequate to ensure compliance with the PT referral requirements, we expect the laboratory to correct the problems, and will treat subsequent referrals as ‘intentional’ in keeping with our long-standing practices.”

The alternative sanctions are much less severe. In the May 2 CMS regulation, the agency outlined three categories of sanctions. The sanctions in the third category for relatively minor violations include civil monetary penalties and a plan for corrective action.

For instance, a laboratory places PT samples in an area with other patient specimens for a courier to take to a reference laboratory. The courier takes the PT samples to the reference laboratory, but the original testing laboratory notices the PT samples are missing. After realizing the mistake, the laboratory calls the reference laboratory and orders the PT specimens to be destroyed. The CMS says alternative sanctions would be appropriate in this situation.

The CMS estimates there are about six PT referral cases a year that could be subject to the new alternative sanctions. The average loss to laboratories for revocation as a result of a PT referral violation was $578,000 per laboratory. The penalties under alternative sanctions are estimated to be $150,000.

PT referrals would be in the middle category when a laboratory refers PT samples to a laboratory operating under a different CLIA number before the PT event close date and while the laboratory reports results to the PT program. If an investigator finds the referral does not constitute a repeat offense, the CMS would propose to suspend or limit the CLIA certificate for less than a year and impose the alternative sanctions of monetary fines and a corrective action plan.

In the first category, the most severe penalties are reserved for egregious violations involving repeat PT referral or cases where a laboratory reports another laboratory’s results as its own. The penalty for these violations is revocation of the CLIA certificate for one year, at least a one-year ban for the laboratory owner and operator, and possible civil monetary penalties.

The penalties are a message to laboratories that they should never try to cheat a PT, Dr. Williams says. But there are additional incentives that laboratories should keep in mind.

“We understand that failures occur, and when they do, laboratories can then identify problems to be fixed,” Dr. Williams says. “That’s just one reason why no one should try to cheat a proficiency test. If you are cheating, you are not looking to identify the root cause of a problem and improve testing for your patients.”n

Charles Fiegl is CAP manager of advocacy communications, Washington, DC. The May 2 rule is at www.gpo.gov/fdsys/pkg/FR-2014-05-02/pdf/2014-09908.pdf. The May 12 rule is at www.gpo.gov/fdsys/pkg/FR-2014-05-12/pdf/2014-10687.pdf.