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New proposals, findings surface on lab regulation.

New proposals, findings surface on lab regulation

Washington officials continue to lay the groundwork for a sweeping overhaul of clinical laboratory regulation.

It's becoming increasingly unlikely that any significant changes will be enacted this year, however, as both Congress and the Administration continue to wrestle with such major issues as catastrophic care insurance and foreign trade.

Further, key lawmakers have expressed little interest in any new budget-busting bills--at least until after the fall elections. Most are hoping to end the year quietly, without putting health care programs on the table again for potential cuts.

While it may seem to be a long, drawn-out process, the work currently being advanced in Washington will probably come to fruition by this time next year.

After a series of hearings on the quality of lab work, Rep. Ron Wyden (D-Ore.) introduced a bill he claims wil"shore up" testing procedures. The bill, H.R. 4325, calls for annual inspection, mandatory licensing, and mandatory proficiency testing for all test sites, including physician office laboratories (POLs). It would require that proficiency testing use state-of-the-art targets for assessing performance. This has been a sticking point with Wyden since he learned that private-sector PT programs use a form of peer comparison.

Unveiling his plan, Representative Wyden said: "It is important to recognize that there are significant differences in the regulations needed to assure quality in large commercial laboratories and in small physicians' office labs. I am working with professional organizations to develop distinct standards for assuring quality in physician labs. These standards will recognize the differences in types of testing, technology, and personnel necessary for the majority of work [done in these labs].' Specifically, the Wyden bill would:

* Regulate all labs under the Clinical Laboratory Improvement Act (CLIA) and subject them to licensure, annual inspection, and quarterly PT for each testing category they are licensed to perform.

* Require the Centers for Disease Control to reestablish a PT program, and require the Health and Human Services Department to field a technical staff to assist laboratories in maintaining highquality operations. PT could be provided by a private-sector group, but only if it meets standards established by CDC.

* Provide public access to lab performance in PT under the Freedom of Information Act.

The bill authorizes grants to the states for implementing the requirements by two effective dates: Jan. 1, 1990, for hospital, independent, and interstate labs, and Jan. 1, 1992, for POLs.

The longer lead time for POLs apparently stems from Wyden's recognition that more research remains to be done on standards that should apply to those sites. Current law stipulates that high-volume POLs (performing 5,000 or more tests a year) will be subject to the same standards as independent labs as of Jan. 1, 1990.

Health Care Financing Administration chief William Roper had indicated that his agency's longawaited report on POL testing would be released by May 1. But at press time, it still had not been issued. Agency sources believed the work had been completed, but none could explain the delay.

In the interim, however, HHS Inspector General Richard Kusserow unveiled preliminary findings of his office's own POL investigation.

As part of that review, the IG's office interviewed national associations representing physicians, medical technologists, bioanalysts, clinical chemists, lab equipment manufacturers, hospitals, and independent laboratories. Health officials in all 50 states were contacted, as were regulators within HHS. Investigators also conducted a survey of 200 randomly selected physicians to ascertain whether they were engaged in office testing. Among the key findings:

* An estimated 98,000 POLs currently operate in the U.S., generating billings of about $5 billion a year ($400 million paid by Medicare).

* Approximately 25,000 physicians' office labs perform more than 5,000 tests a year and thus would be subject to the performance rules scheduled for 1990. Those regulations alone could cost the Federal Government about $45 million a year to implement. *Of the total estimated POLs, less than 7 per cent participate in voluntary PT programs, and even fewer choose to participate in comprehensive quality assurance programs. Thirty-four states do not regulate POLs, citing a lack of legislative support, insufficient funding, and/or physician opposition as reasons. The 16 states that regulate some 9,000 POLs typically require that the labs submit to PT and registration.

Kusserow was summoned to Capitol Hill to discuss his preliminary findings in early May. At a House subcommittee hearing chaired by Wyden, Kusserow stated: "Our work revealed that the greatest risk of test error comes from the operator's lack of training and attention to quality control rather than from the equipment itself.

"Most laboratories we spoke with acknowledge that today's analyzers are designed and built to produce test results rapidly and accurately. However--and I wish to stress this point--the equipment used by operators who are not properly trained in how to maintain, operate, and calibrate it will not yield accurate results."

Kusserow went on to describe for Congress some "disturbing examples" of untrained personnel not following the manufacturer's operating instructions.

In one of the incidents that he discussed, "A manufacturer of a 'fully automated' clinical chemistry analyzer for POLs reported receiving a call from a POL employee who wanted to know, and I quote, 'Where do you get the serum?' Apparently this POL employee expected the serum to be provided by the manufacturer."

There was more. Kusserow recounted a story from one independent lab worker. As the IG told it, "A POL employee complained, 'We can't get your pregnancy test to work.' When asked if he had examined the expiration date, the POL employee's response was, 'Oh, is there such a thing?'"

The HHS official said his office is currently working on recommendations based on those and other findings, but noted that further research must be done before addressing all aspects of physicians' office testing.

Not all the testimony presented at the most recent House hearing proved critical of physician office testing. Richard Betsey, M.D., a widely published pathologist from the Oregon Health Sciences University, explained that patients appreciate and routinely benefit from the rapid turnaround afforded by office tests. "Clinical test analysis in physicians' offices can promote the quality of patient care provided in the ambulatory care setting," he noted.

"I don't believe that office laboratory testing poses a serious threat to the public health, although some errors might lead to erroneous medical management decisions that result in patient injury. The risk to patients is small compared with the risks posed by other parts of the health care system, " he explained.

Rather, Belsey said it would be better to take a more general approach to clinical lab quality management, in which office, bedside, and home testing quality would be viewed in the context of competing societal needs.

According to Belsey, "It is important to understand what aspects of contemporary quality management programs are most effective in promoting reliable results before continuing to commit limited health care or human resources to maintain or improve the current level of laboratory quality. If we are to increase regulation of any laboratories, it is best to first understand where we want to go and where we are subject to the greatest jeopardy so we can reduce these risks to acceptable levels."

HIV reporting being reviewed

A rule being considered at HHS would eliminate the requirement that labs maintain identification of persons being tested for HIV antibody or causative agent if the lab is not billing Medicare or Medicaid for the test. But the proposal would not supersede state laws on such reporting requirements.

A Federal Register notice on March 31 explained that the action was being taken to promote wider voluntary testing among those at risk of contracting AIDS. Final review is now pending.
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Publication:Medical Laboratory Observer
Date:Jun 1, 1988
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