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CLIA congress mounts comments to HCFA.

CLIA congress mounts comments to HCFA

A Washington gathering last month of 300 representatives from the lab community compiled a broad range of responses to proposed regs that would implement the Clinical Laboratory Improvement Amendments of 1988.

Results of the National Congress on CLIA '88, hosted by the National Committee for Clinical Laboratory Standards, were submitted in detail to the Health Care Financing Administration. The annotated transcript of the proceedings held Aug. 6-8 will give regulators volumes of reading material as they analyze responses to their May 21 proposals.

Attendees widely praised the CLIA forum, which gave representatives from across the spectrum of lab professions a chance to air and debate their views. It also presented the opportunity to hear from HCFA representatives who encouraged further input on design changes. Congress Chairman Dennis Dorsey, M.D., said that attendees gained "a better sense of the information bases and assumptions used in writing the regulations, and [HCFA's] mindset in implementing them."

Overall, attendees considered five main aspects of the proposed regs and divided them into 20 key issues. Most of the work took place in breakout sessions where individuals were allowed to present views and other information for the official record. Following are some highlights and conclusions from those sessions as reported by congress moderators at the closing plenary session: * Complexity. Participants in these discussions focused on tests designated among HCFA's three regulatory classifications (waivered, Level I, and Level II), personnel standards, and the functions of a technical advisory committee.

The participants found two main flaws in the test designations. First, the assignments based on perceived risk of the tests were arbitrary and highly subjective. Second, the structure failed to recognize that current technology allows a variety of tests to be performed on the same instrument.

There was general agreement that the test categories need to take those factors into account, perhaps through some form of methodology matrix. There was no clear consensus, however, on changes for Levels I and II; some felt the categories should be combined, while others said they should be subdivided.

Majority opinion concluded that proposed personnel standards below the level of lab director should be relaxed. A finding presented by the American Medical Technologists said that 24 per cent of its members would face job demotion or unemployment if the regs were implemented as is.

Finally, many professionals expressed concern over development of the technical advisory committee that will advise HCFA on emerging test technology. They said that, depending on committee membership and organization, the gatekeeper function could stifle new technology rather than promote it.

During the three-day meeting it was learned that seven lab groups had sent a joint letter to HCFA Administrator Gail Wilensky, Ph.D., concerning the complexity model.

The letter cited a consensus that HCFA's list of 28 waivered tests (see Washington Report, July MLO) should be trimmed by at least 11 procedures.

The groups' own list eliminates the following: spun microhematocrit, microscopic exam of urine sediment, vaginal wet mount preparation, whole blood clotting time, ASO screen, CRP screen, rheumatoid factor screen, Gram stain, infectious mononucleosis screen, KOH preparation on cutaneous scrapings, and semen analysis.

The letter was endorsed by the following groups: American Society of Clinical Pathologists, Pathology Practice Association, American Association for Clinical Chemistry, American Clinical Laboratory Association, American Society for Medical Technology, Clinical Laboratory Management Association, and American Society for Microbiology. * Access to care. Key portions of the discussion in this area centered on regulatory effects facing physicians' office labs (POLs).

A presentation given by A. Samuel Koenig, M.D., featured results from a survey of 100 family physicians in his home state of Arkansas. In essence, the findings showed the proposed regs would exacerbate personnel problems and force many doctors out of diagnostic testing.

Specifically, 81 per cent of the physicians said they do Level II testing, yet only 24 per cent would meet the proposed personnel standards. Thirty-six per cent said that they do not have a pathologist in their community to serve as a laboratory director,

Further, 27 per cent said they would eliminate all testing if the standards were enacted as published. Roughly half the members of that group are in rural areas with populations of less than 10,000. While many doctors said they would simply shift testing to a hospital or independent lab, 37 per cent of those in rural areas said there would be no testing available in their community if they quit. * Cytology. Proposals affecting gynecological services are among the most contentious offered by HCFA, as discussions at the congress showed.

Recommendations offered by participants generally ask HCFA to delete or modify numerous points. They proposed that proficiency testing (PT) for individuals be conducted every two years rather than twice a year, and that the events be carried out at the lab site on an announced basis.

Leaders said the PT format should allow technologies other than slide screening, and asked that the agency drop its requirement for reexamining an individual's previous 500 negative slides following a failed event. There was also agreement that individuals who fail an event "should not be denied the right to make a living," but should be given retraining and reeducation. Sanctions should not be imposed until a cytotechnologist fails twice, this group concurred.

In terms of workload, participants said limits should be set at 100 rather than 120 screenings within a 24-hour period. They also suggested that records be kept by the individual cytotechnologist, not by the laboratory. * Proficiency testing. Attendees recommended that HCFA delete its proposal that a PT failure on one analyte be judged as a failure for an entire specialty or subspecialty. Such failures would terminate the lab's Medicare or Medicaid approval and suspend CLIA certification in that specialty or subspecialty. Participants also recommended an appeals option before any sanctions are imposed.

A number of lab professionals, citing the complexity of the proposed system, said new PT requirements should be phased in. Some considered one year appropriate; others, two years.

About half the participants expressed concerns that PT provisions would affect the availability of specimens and drive up prices. The College of American Pathologists estimates that direct costs of the new PT to labs will be $50 million to $70 million a year, with internal expenses of perhaps double that amount. * QC and QA. Members of the congress generally supported the goals of CLIA '88 in this regard, although they had some problems with HCFA's implementation.

For example, they said the proposals would not allow labs to use manufacturer data to meet some of the standards. And they believe the rules would increase the cost of testing to patients, force some labs to crumble under the administrative burden, and generally reduce lab efficiency.

QC measures were deemed excessive. Some called HCFA unclear in its use of such terms as validation, screening, sensitivity, and specificity. A straw poll indicated strong support for testing the regs in a cross section of labs prior to blanket implementation.

Another straw poll taken during the plenary session showed near-unanimous support for extending HCFA's Aug. 20 comment deadline by at least 60 days. But at press time it appeared those wishes would not be granted by either the agency or Congress.

HCFA announces

inspection fees

Clinical labs would pay up to $2,870 every two years for inspections determining their compliance with CLIA '88 standards, according to a fee schedule published by HCFA Aug. 3.

The agency has divided labs into 10 categories with fees determined by size. For example, a lab performing tests in no more than three specialties with a total annual volume of up to 10,000 tests would pay #840 every other year. A lab testing in at least one specialty with volume of more than one million tests would pay the maximum of $2,870.

HCFA also has set fees for follow-up investigations, sanctions, and hearings that could add another $1,680 for the largest facilities.

Labs would also pay a one-time certification fee of $261. Waivered facilities performing only the simplest tests would pay $156 every two years.

The law requires HCFA to assess fees to cover the cost of the inspection and certification activities. The Federal government would pass most of the fees on to the state agencies performing the inspections. HCFA is allowing a 60-day comment period, ending Oct. 2, before finalizing the fee schedule.
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Title Annotation:Clinical Laboratory Improvement Amendments; Health Care Financing Administration
Publication:Medical Laboratory Observer
Article Type:column
Date:Sep 1, 1990
Words:1395
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