CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Anne Paxton
October 2015—With the New Year approaching, many laboratories that test New York state specimens can look forward to breathing a sigh of relief. Regulatory relief, that is. Thanks to a policy change by the state’s Clinical Laboratory Evaluation Program (CLEP), beginning Jan. 1, 2016, laboratories will still have to be inspected by the state, but can fill New York’s proficiency requirement with the proficiency tests of any organization to which the CMS has granted deemed status under CLIA.
As a result, laboratories that employ the CAP’s proficiency testing program will no longer be required to use the PT program of the New York CLEP as well.
Dr. Lifshitz
For hundreds of laboratories in New York, the change will mean lower costs and a lighter staff burden because they will be able to go from paying for two PT programs to paying for one. “I think the state has taken a very positive step forward to help labs,” says Mark Lifshitz, MD, clinical professor of pathology and director of clinical laboratories for NYU Langone Medical Center.
He welcomes the ability to scale back to one PT program, and in NYU’s case, that will be the CAP’s program. “It means fewer surveys to perform, less recordkeeping, and you’re not duplicating the surveys you’re already performing,” he says.
New York state has always had a robust laboratory oversight system and was the first state to have an exemption from CLIA, Dr. Lifshitz notes. “A lot of labs in New York state do a whole lot of PT. The CAP Surveys tend to be more comprehensive in the sense that they cover more analytes, but the state’s surveys are excellent and very thorough. They probably cover almost everything—if not everything—that a small hospital laboratory does.”
But the policy change reflects the “reality in health care and diagnostics, and trying to make PT as efficient as possible, the same way we’re trying to make testing in general as efficient as possible.”
Laboratories already participating in the proficiency testing programs of other providers “potentially have the immediate flexibility to choose only one PT provider and so they are probably the most affected,” Victoria Derbyshire, PhD, deputy director of the New York State Department of Health’s Wadsworth Center (which administers CLEP), said in an email to CAP TODAY.
This category of laboratories includes not only those based in New York. National commercial laboratories and specialty labs like Mayo Medical and ARUP laboratories, even though their headquarters are out of state, have also been required to use New York state proficiency testing in order to perform testing on any specimen originating in New York.
The PT policy change is one that laboratories in the state have long been advocating. “This is something we’ve been after for a few years, and it stemmed from concerns within the lab community that laboratories were paying twice for proficiency testing inspections,” says Tom Rafalsky, president of the New York State Clinical Laboratory Association.
Rafalsky
“Many labs had to get PT done by CAP or some other entity for various reasons, but if they did, New York state did not recognize it. But PT is expensive,” Rafalsky says. “For some labs it runs in the six figures. It also took a lot of staff time to do the PT, and that was almost as big a concern as the financial concern.”
One factor in turning the tide may have been New York governor Andrew Cuomo’s preference for more business-friendly regulation, Rafalsky notes. “Finally, after years of discussion with the Department of Health—and the governor’s office got involved with this—the DOH determined in 2015 that they had enough confidence in the PT performed by other CMS-approved vendors that, going forward, they would accept their PT results.” The Hospital Association of New York State also was involved in advocating for the plan, he adds.
As the New York CLEP noted in its announcement to laboratories, several months ago the agency had convened focus groups to look at how to reduce costs and improve quality, and eliminating the PT requirement was raised as a possibility. “Several people representing the clinical laboratory community have asked for this change in policy for a few years,” Dr. Derbyshire says. “A number of factors—feedback from labs, long-term changes in lab testing, and availability of other PT programs that we feel satisfy our requirements—converged to lead us to look at our PT program as a whole and to implement this new policy change.”
Some of New York state’s PT programs have already been marked for discontinuation. CLEP recently announced that the PT scheduled for Oct. 26 will be the last one provided by CLEP for urinalysis, urine pregnancy, and urine chemistry. Also as of Jan. 1, the program will drop several other proficiency tests that satisfy PT requirements under CLIA, such as gonorrhea and chlamydia, mycobacteriology identification and drug susceptibility, comprehensive parasitology, toxicology blood lead, and comprehensive virology. Others being canceled (for example, human papillomavirus and fetal defect markers) are proficiency tests that are not required under CLIA. All the discontinued New York PT modules are available PT modules under the CAP Surveys program.
Other New York state-run PT programs could be eliminated later. “I expect that they’re waiting to see how many people want to continue with New York state before they determine if they’re going to drop any additional areas next year,” Rafalsky says. CLEP says it will proceed on the basis of which PT providers laboratories choose for 2016.
Analytes for some of the PT programs that CLEP has discontinued—for example, Oncology-Molecular and Cellular Tumor Markers—are not subject to either a NY state or CLIA PT requirement. Laboratories currently enrolled in those PT programs are therefore not required to find a replacement program.
But CLEP notes that under its Quality Assessment Sustaining Standard of Practice 3 (QA 3), Ongoing Verification of Examination Accuracy, laboratories must have a system to verify every six months the reliability and accuracy of each test for which no New York state PT is offered. And participation in external PT is one mechanism that can be used to satisfy QA 3. (Others include re-testing blinded samples and parallel testing with another laboratory.)
Rafalsky says the state has long required some kind of validation of test results even for non-regulated analytes. “They tried to cover as many areas as they could” with their own PT—“if there were enough labs wanting it to create a big enough pool so there would be scientific validity and it would cover its costs.”
The rationale for having such an extensive PT program is that the purpose of CLEP goes beyond CLIA-regulated analytes, Dr. Derbyshire explains. “More broadly, the purpose of the PT program, of course, is to maintain lab quality. That mission cannot be limited to the narrow set of tests and analytes listed in the CLIA regulations.”
CLEP considers it likely that some labs will continue participating in more than one PT module for a given test or analyte, even after Jan. 1. “Some of the permitted labs do this because PT is a valuable component of quality management,” Dr. Derbyshire notes. “Others do it because they have to participate in PT from a given provider to maintain accreditation, but prefer the format or support associated with a different provider. We have had multiple labs ask us whether they could participate in both NYS and non-NYS PT.”