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Hearings begin on need for increased lab regulation.

Hearings begin on need for increased lab regulation

The opening salvos have been fired in what promises to be a lengthy debate over the need for increased regulation of clinical laboratories.

On the heels of widespread media reports about questionable lab work, the House Subcommittee on Regulation and Business Opportunities convened to address pertinent issues. Chairman Ron Wyden (D-Ore.), who led hearings last fall on the accuracy of AIDS testing, announced some of the latest findings from the College of American Pathologists' quarterly proficiency testing program.

Calling the latest data "disturbing," Wyden focused on numbers showing that one in ten hospital labs consistently fell outside CAP's acceptable accurracy range for platelet counts. He further noted that hospital labs failed to identify 12 per cent of potentially fatal Salmonella infections. Physician office labs (POLs) that participated missed 18 per cent of those infections.

Wyden remarked that there are no uniform standards for lab accuracy, and said in an undisputed estimate that at least 3,000 U.S. lab settings are completely unregulated. He called it "particularly frightening that no one seems to know where those labs are, what tests they do, and how accurately they do them."

In a prepared statement, Rep. Wyden said: "The need for a complete overhaul of the Federal regulatory system is clear. To insure quality testing, laboratories must be required to meet uniform standards for accuracy.

"Labs must be held to public accountability so that individuals and their physicians can make informed medical choices. Finally, the Federal Government must establish quality controls and enforce those controls so that our regulatory 'patchwork' becomes a seamless web the public can count on."

Wyden went on to question the method by which labs are graded against peer facilities rather than independent scientific standards.

Following that blast, CAP vice president Loyd Wagner, M.D., took the witness stand for what turned into a defense of laboratory self-regulation, as well as the College's proficiency testing and accreditation programs.

Wagner began by asserting, "There has been a quantum leap in the last 20 years in both what we can test for and how well we can do it. And it is largely through the diligent self-policing by the private sector that such high standards of quality and integrity have been achieved and maintained.

"Now," Wagner stated, "Congress and regulatory agencies must do their parts -- not through further legislative and regulatory initiatives that would result in decreased efficiency and increased costs but through recognition of worthy private-sector quality assurance programs, appropriate payment for laboratory procedures, and the dedication of research funds for improving analytic methodology at the National Bureau of Standards and the CDC."

In what emerged as a bone of contention, Rep. Wyden quizzed Wagner and other CAP spokesmen on what penalties exist for labs that fail to meet professional standards. CAP stressed its proficiency testing program is a voluntary improvement system designed to help labs achieve quality performance rather than sanctioning them for failures. At one point Wyden broke in, "You've put your finger on the greatest indictment: that no one is out there doing enforcement."

CAP officials conceded there may be a "self-selection" problem in that only labs that are confident they do quality work pursue proficiency testing verification. Thus the "bad" labs may go unmonitored. It further came out that the Government may not be doing all that it could with the information CAP currently provides Federal regulators.

The College did get in a pitch for its accreditation reviews, leaving the door open for some Administration response. As Wagner stated, "I would like to point out that the Health Care Financing Administration has noted on several occasions that the CAP Laboratory Accreditation Program is "equal to or more stringent than' Medicare requirements.

"Even though the Secretary of Health and Human Services is allowed to grant deemed status to private accrediting organizations having standards at least equivalent to those of the Medicare program, the College's application for deemed status has been pending since 1984." Under questioning, CAP representatives said they would support a proposal requiring all labs to take part in some accreditation program.

At the hearing, Wyden released a General Accounting Office assessment of state regulation of the nation's estimated 90,000 hospital, independent, and physician office laboratories. As of last year, the Congressional watchdog agency found that regulation varied widely among the three types.

Overall, some 22 states made independent laboratories subject to "full regulation," defined as including licensure, proficiency testing programs, quality assurance programs, personnel requirements, and inspection authority. Thirteen states had no formal regulation, and the rest had some but not all five of these elements.

Eighteen states reported full regulation of hospital labs, while six had none. Only 14 states had programs to regulate POLs, and most of those applied only to labs operated by a group of physicians. None of the remaining states had any formal regulation.

Among the variations, 17 states issued licenses to hospital labs as separate entities; 23 additional states required licensed hospitals to have laboratories that meet certain requirements.

Personnel was found to be the most widely regulated aspect of independent lab operation, with 33 states having some specific personnel licensing or other requirements. Some of the differences: five states required most personnel be licensed or certified; five required only directors be licensed or certified. Five states had education and experience requirements for most personnel; eight had such requirements only for directors or supervisors.

The House panel heard from one of the most stringent state regulatory systems, administered by the New York Department of Health. Commissioner David Axelrod gave an overview of his department's efforts and opined that private-sector efforts are insufficient policing mechanisms.

"While voluntary programs such as the one run by CAP are laudable," Axelrod said, "we believe that mandatory testing and licensure are the only ways to assure that all labs are providing accurate test findings.

"Voluntary programs attract only those laboratories that are responsible enough to want to know how they are doing and where they need to improve. And there is the problem of accountability with a voluntary program run by a professional association. With a state-run program, practitioners and the public have a place to go with problems and know we have the regulatory authority to take action when needed."

Beyond the blizzard of statistics, viewpoints, and political rhetoric, the most compelling part of the early-March hearings came from a Maryland woman who had a tragic experience with laboratory testing. Although the details of her ordeal may be an aberration, the story is essential to an understanding of what lawmakers are hearing.

Summarized: Eileen Moseley visited her family doctor in 1981 for a routine checkup and removal of a mole from her arm. The inoffice procedure went well, and the doctor routinely sent off a specimen for lab analysis. The patient heard nothing further and assumed "no news is good news." No news wasn't. The estimate is that if Moseley's malignant melanoma had been detected immediately, her chance for recovery would have been close to 100 per cent. With the detection of the error for her type of cancer coming six months later, most people wouldn't have been alive to tell Congress.

A statement read by Eileen's husband, Robert, described some terrible results. Among other questions, the statement asked: "Why didn't the pathologist check on Eileen's age? Why didn't her doctor take a little more tissue to prevent the return and spread of the cancer as the pathologist suggested? And why weren't we told about any of this? The whole system seemed to break down, and there wasn't a thing we could do about it until it was too late...Maybe we can at least make people understand what can happen and make them decide that something has to be done about it."

Although no legislation has been proposed as yet, a statement from HCFA, other HHS officials, or CDC was conspicuously absent at the recent House hearings. And at press time, it was questionable whether the Administration would marshal its regulatory defenses any time soon.

Rep. Wyden beat his Senate counterparts to the punch with the hearings early last month. On the Senate side of Capitol Hill, the Governmental Affairs Committee had set hearings for March 23 and 24. But it was unclear whether an Administration spokesman would testify then.
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Publication:Medical Laboratory Observer
Date:Apr 1, 1988
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