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Professional groups weigh new lab bills.

Professional groups weigh new lab bills

Now that Congress's opening bids are on the table, professional associations in Washington are formulating their positions on the proposed restructuring of clinical laboratory regulation.

Most groups appear to be accepting the probability that some reforms will be enacted by this time next year. Discussions are now focusing primarily on adjustments that might be made in lawmakers' draft proposals.

The action heated up this spring as Rep. Ron Wyden (D-ORE.) introduced a bill to "shore up" Federal oversight of testing procedures. His Medical Testing Improvement Act of 1988 calls for annual inspection, mandatory licensing, and mandatory proficiency testing for all test sites, including physicians' office laboratories (POLs).

On June 6, Sen. William Cohen (R-Me.) introduced his own plan, dubbed the Quality in Medical Testing Act of 1988.

The bill would require all clinical labs to be licensed and would establish a new system of regulation. It would require the Health and Human Services Department to create classifications based on the complexity of testing methodology used. The three classes would be "basic," "intermediate," and "complex."

Labs falling into the "basic" category would be those facilities using test methodologies that require no interpretation, no complex activities, instruments, or independent judgments. Labs falling into the higher categories would be those using methodologies requiring technical skill interpretation, independent judgment, or complex activities.

Within one year of enactment, HHS would provide standards for each class of lab in the areas of quality control, record keeping, successful participation in proficiency testing, enforcement, and personnel qualifications. Among the bill's other key provisions:

*To be licensed, a lab would need to 1) submit information on the kinds of testing performed and the qualifications of personnel, and 2) pay a registration fee that will vary by classification and develop a system to directly bill the patient or third-party payer for each test or procedure.

*HHS may exempt from licensing requirements any laboratory it determines has been inspected and accredited by an organization the department approves purpose.

* In consultation with professional organizations, HHS would establish a national uniform proficiency testing program for all labs. The program would include a grading system for individual tests and aggregate scores for specialties and subspeciallies, as well as definitions of failure based on lab performance over time.

* For cytology service, HHS would develop standards on: workload guidelines and limits; rescreening of high-risk groups; continued proficiency of personnel doing interpretations; satisfactory performance on external proficiency evaluations developed by HHS; and periodic inspection of cytology services. * HHS would perform overall inspections to determine whether a lab is in compliance with the appropriate standards. Inspections would be performed by persons experienced in the kinds of testing done in a particular lab.

* Exemptions could be granted, at the discretion of HHS, to any state whose lab regulations are more stringent than those contained in the bill.

In introducing his proposal, Senator Cohen A complexity-based system is, in my opinion, a fair and logical approach to lab regulation, as labs will be bound to standards that are appropriate for the tests they perform.

"If a lab chooses to perform more complex tests, it is only reasonable that it should be subject to more regulation. Similarly, all labs performing the same types of tests should be subject to the same level of regulation, whether the lab is an independent or is in a hospital or physician's office."

At press time, lab professional associations were taking their first look at the Cohen proposal and considering its merits. It was uncertain whether the new plan would be judged preferable to the Wyden bill, which has already gained a measure of support.

In the latter regard, the American Association for Clinical Chemistry sent a letter to the House member stating that his proposal would be a "significant and important move" toward making lab regulation uniform. AACC president Theodore Peters Jr., Ph.D., wrote that the new provisions, coupled with existing rules, "will constitute a strong and comprehensive regulatory system for the clinical laboratory community."

Peters did, however, take issue with a portion of Wyden's bill directing the National Bureau of Standards to set target values for proficiency testing.

According to the letter, "NBS, although an extremely important and competent agency, especially adept at developing standard reference materials vital to clinical labs, is not an enforcement agency, nor is it, we believe, going to be able to develop the PT values within 180 days of enactment of the act. I suggest that the Centers for Disease Control would be a more appropriate agency for this task."

Other groups are having a more difficult time forming a position, partly because of the bill's scope. The College of American Pathologists , for example, has charged a committee with the task of reconciling member views. A statement passed by the CAP board of governors in February broadly said, "Rigid legislation and regulatory rules should be avoided. Adherence to appropriate and adequate voluntary standards should be required."

Concerning the current discussions, AI Ercolano, director of CAP's Washington office, explained, "Right now, there are portions [of the Wyden bill] we could agree with, but there are other pieces that don't seem to make much sense."

Specifically, CAP agrees that there needs to be some form of regulation of labs not currently licensed by the states, and that physician office laboratories should participate in proficiency testing.

CAP shares the view that NBS is the wrong agency to set PT standards. The College also questions the feasibility of Federal licensing and inspection of all lab sites. As Ercolano notes, "It boggles the mind when you think of the logistics of trying to do that."

On another front, the Health Industry Manufacturers Association, which includes diagnostic manufacturers, has formed a special task force to establish strategies and priorities on lab issues. That group held its first meeting in mid-May, and a HIMA spokesperson said members will be comparing positions with AACC, CAP, and the American Clinical Laboratory Association.

While the HIMA spokesperson declined to discuss current view of the task force, it's clear that increased regulation of POL testing is a focus of concern. Some manufacturers have stated individually that restrictions such as those embodied in the Wyden bill would cast a chill on what has become an extremely lucrative market for them.

The American Medical Association is also likely to become a factor in the debate over POL regulation . In April, the AMA board of trustees approved six principles for lab services in response to rumblings in Congress. They are:

* Accurate office testing provides a valuable service to patients and doctors through greater convenience and diagnostic timeliness.

* AMA opposes direct Federal regulation or licensure of POLs.

* AMA supports private-sector quality assurance standards for POLs based on factors such as proficiency testing, quality control, and continuing education.

* Further state legislation, where appropriate, should establish POL standards. Such legislation should allow "deemed status" for office labs that comply with voluntary standards where those standards meet or exceed state requirements.

* Voluntary clinical lab testing standards should relate to the complexity and difficulty of the specific tests being performed.

*The 1987 law requiring POLs doing more than 5,000 tests a year to meet all independent lab standards by Jan. 1, 1990, should be re aled.

An AMA Washington official said the group has not taken any formal position on proposed legislation. But he noted that many physicians are upset by what they see as a regulatory backlash from Government incentives to move more treatment into the office setting. As the debate continues, AMA might well flex its considerable lobbying muscle to win concessions to its concerns.

It's anticipated that Representative Wyden will push for hearings on his bill by the House Energy and Commerce health panel after work is completed on catastrophic care insurance. That debate was drawing to a close at press time.

On the other side of the Hill, Senator Cohen will likely convene a session of the Governmental Affairs Committee to discuss his bill. No hearing date had been set as of this writing.
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Publication:Medical Laboratory Observer
Date:Jul 1, 1988
Previous Article:The question of quality.
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