NY cuts labs loose from requirement to use state’s PT

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Dr. Derbyshire

Virtually all the larger labs in New York are using an additional PT vendor now, Rafalsky says, but with New York’s new PT rules, “now they can mix and match—they can do some with CAP, some with New York state—they just have to have all the different CLIA-regulated analytes covered by somebody’s PT.”

CLEP deserves credit for working with the clinical laboratories to get this change made, Rafalsky says. “It’s a big deal, because they had no mechanism to recognize other PT vendors, so they had to figure that out. The big thing was how do you get information from the private vendor to CLEP, because when the private vendor does the PT, it still has to report results to CLEP.” In fact, CLEP will require all PT providers, whether or not the PT for a particular analyte is required by NY state or CLIA, to submit enrollment and performance data.

Rafalsky hopes laboratories are realizing they will now need to specify their PT provider. “CLEP has been trying to warn labs that this decision is coming up, but you can say something and for some labs it won’t register until push comes to shove. And then a lab will not be able to register its PT results for the rest of the year until they choose a provider in 2016.”

When labs get up to speed on the new PT policy, he sees increased competition as a positive outcome. “Now labs that want to operate in New York no longer have to have redundant PT testing. They can choose PT based upon the qualifications of the provider, on value-added, on cost, and on the areas offered, and they’re not mandated by the government to go with the government program. The government has to compete.”

New York’s shift in PT policy was preceded by extensive advocacy from the CAP, says Mary Fowkes, MD, PhD, president of the New York State Society of Pathology.

New York is probably the most heavily regulated state for labs, she says, pointing to the state’s recent adoption of a requirement for histology technicians to be state-licensed as an example. In the case of PT, “New York state regulators finally recognized that the state PT didn’t provide anything unique or different from what CAP PT already gave, and that we needed regulatory relief on this issue.”

Dr. Fowkes expects the policy change to reduce burdensome and redundant testing at Mount Sinai Medical Center in New York City, where she is director of neuropathology and autopsy services.

Dr. Fowkes

But the policy shift does not affect the requirement for New York laboratories to be New York inspected, Dr. Fowkes emphasizes. “These are changes just for PT; everything else remains the same. The state is still going to inspect; you just don’t have to have two sets of proficiency surveys.” Most labs are happy with that outcome, she says. “A lot of labs prefer to do the CAP PT, and given that a very high percentage of labs want CAP accreditation, eliminating the state PT requirement is an economic relief to labs.”

The state should have a good idea soon of the direction in-state labs intend to take, because when labs submit their fall proficiency results between August and November, for each analyte they are required to indicate which survey they intend to use in 2016 to satisfy the PT requirement. “You can’t submit the current DOH survey results without doing so,” Dr. Lifshitz says.

And once laboratories decide on their survey providers, their choices will be locked in for 2016.

So far, Dr. Derbyshire says, “We have begun to receive notification from some labs. But it is too early to report” on how many labs will be using outside PT providers. She expects there to be cost savings for the Wads­worth Center as a result of the new policy. “But we do not know to what extent until we understand the impact on our programs as the permitted labs do or do not choose to participate in alternate PT programs.”

Stallone

Large health systems with many hospitals in New York, in particular, are likely to shift to just using CAP PT, says Robert Stallone, executive vice president, laboratories, Northwell Health (formerly Northshore-Long Island Jewish Health System), which has the largest laboratory network in New York. “As a large health system, we’re always concerned about expending our resources where they have value relative to patient care. For several years, we’ve had discussions with the state asking them to take a look at the PT program, which was redundant for many of us. As part of the state’s listening to its constituents, I think they heard our voice and agreed to do it.”

“So for us, this is terrific. The reduction in cost and effort in the laboratory will be achieved immediately within our own labs,” Stallone says. “I think it will be a little more work and challenge for those who are only using New York state proficiency testing, because the state will not be able to maintain all their proficiencies; they will have to go through and determine which ones they will need to get from another source. And there are several CMS-recognized providers of PT, not only CAP. So that gives laboratories a pretty wide field to choose from.” He hopes, if the change in PT policy works well, that the state will consider revising its laboratory surveillance program to allow use of private providers for inspection as well, sometime in the future.

Stallone has found laboratories to be upbeat about the impending policy change. “We had a meeting with the NYSCLA, and everyone was very pleased we were finally able to accomplish this. I think any time there is a change there is always a little concern. That’s the nature of lab people to be concerned about detail. And we have to be very careful with the transition, to make sure we get everything communicated to our staff at the hospitals and laboratories, and also stay in close communication with the state to clarify any questions.”

New York’s program is particularly visible and influential, Stallone notes. “It’s the state that requires labs outside the state to have a New York state lab permit if they do testing on New York patients, which is unique. And to have that permit you’d have to have, until now, New York state PT. So this was a big expense not only for labs in the state but across the country.”

By helping to stem that added expense, Stallone says, New York’s new PT policy is reflecting the concept that “all segments of government and industry here in health care are doing what can be done to work together to reduce costs as we transition to value-based health care, because we just can’t afford not to.”

From the Wads­worth Center’s viewpoint, Dr. Derby­shire says, “We want to emphasize that we are reviewing the PT program to maintain lab quality in response to long-term changes and trends in clinical lab testing. We believe quite strongly that the change in policy is an improvement in the program. We will have the ability to carry out a more systematic review of more PT results since we will be directly seeing and reviewing all PT events in which the permitted labs participate.”

CLEP sees its primary role not specifically as a PT provider, she says, but as ensuring the overall quality of laboratory services in New York. “Our mission is to ensure lab quality. If providing PT is the best way at a given time to maintain lab quality, we’ll provide PT. If monitoring other providers’ results is the best way to maintain lab quality under other circumstances, that’s what we’ll do,” she says.
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Anne Paxton is a writer in Seattle./em>