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HCFA issues first round of revised lab regs.

HCFA issues first round of revised lab regs

The Health Care Financing Administration has finished the first leg of a two-part process that will produce the most dramatic changes in clinical laboratory regulation in some 20 years.

In mid-March, HCFA published final rules consolidating requirements for about 12,000 labs, including Medicare and Medicaid suppliers and those licensed under CLIA '67. The original proposals, published Aug. 5, 1988, were designed to remove outdated and overly prescriptive requirements, shift emphasis from personnel standards to outcome measures as performance indicators, and force labs to develop and implement their own internal QA programs.

The next step will be issuance of regulations to implement CLIA '88 legislation, which for the first time will attempt to regulate testing by complexity rather than location or type of laboratory. These proposals were expected to be released by the end of April, but were not available for review at this writing.

Many members of the lab community were pleased by modifications made in the final HCFA rules, although pathologists are concerned over the proficiency testing requirements for cytology. Most labs must comply with the new rules by Sept. 10, with the exception of PT requirements, which take effect Jan. 1, 1991.

In one of the most significant reversals in the final regulations, HCFA decided to retain personnel requirements for MTs and MLTs in independent labs.

The agency had initially intended to drop those standards in the belief that outcome measures are a more reliable means of assuring quality testing. Officials said, however, "an overwhelming majority" of the 1,600 commenters on the proposed regs requested that the standards be retained. Many of those who wrote perceived that the requirements for education, training, experience, and/or credentials were being diminished.

In other personnel matters, HCFA added a new requirement for technical supervisors in clinical cytogenetics in all settings, and applied to hospitals the current independent lab requirement for technical supervisor in cytology. The final rules also implement a 1987 Omnibus Budget Reconciliation Act provision allowing a person qualified as a lab director under state law to serve as such within that stake.

Officials could not say whether or how long existing personnel standards may stay in effect, pending implementation of the forthcoming CLIA '88 rules.

According to the Federal Register notice of March 14: "We want the public to understand that since CLIA '88 requires [the Department of] Health and Human Services to set personnel requirements as a function of test complexity rather than location or type of laboratory, we will soon propose an approach to regulating personnel qualifications that may be very different from the approach used in the final rule. We cannot state whether the regulations implementing CLIA '88 will or will not be similar [to existing requirements]."

Still, the interim decision was viewed as "a huge victory" by the American Society for Medical Technology, according to government affairs specialist Lisa Creeden. "The standards that are out there aren't perfect, but something is better than nothing.... Ideally, we would like to see HCFA take the opportunity with CLIA '88 to set up a career ladder, which is something the lab community has never been able to do on its own," she said.

Not all the personnel decisions have met approval, however. Al Ercolano, director of the College of American Pathologists' Washington office, says the hospital requirement for a technical supervisor of cytology raises serious access-to-care concerns. "There are many small hospitals with cyto-technologists doing Pap smears for physicians in the community, and they may look at this and say, "We're not going to do that any longer,'" he explained.

On other fronts, HCFA ceded to popular demand by dropping its plans for expensive and complex "enhanced PT." Opponents argued the program would have knocked many labs out of business by forcing them to pay for an excessively punitive approach that would also be an administrative nightmare. As originally drafted, a lab failing one subspecialty would have been flunked for that entire specialty of testing. As modified, the lab would fail only for that subspecialty.

Still, HCFA is seeking to assimilate elements of the enhanced program by increasing the number of samples in a routine PT event to five. Labs must successfully participate in one PT event prior to Medicare approval or CLIA licensure. Unsuccessful participation is defined as three unsatisfactory testing events, or two consecutive or two out of three failing scores for the same analyte.

For most categories, labs must score at least 80 per cent to pass each PT event. That's measured by having the PT program compare the lab's findings against 10 or more reference labs or against all participants. For immunohematology, labs must score 100 per cent, with the exception of unexpected antibody detection and antibody identification. For those areas, an 80 per cent score is considered passing.

Again, many in the lab community found a lot to like about the HCFA revisions. Officials of the American Association for Clinical Chemistry, for example, said they were particularly pleased that the number of PT events for initial Medicare approval or licensure was reduced from three to one, and that labs failing in one subspecialty would not be flunked for the entire specialty.

CAP, on the other hand, is unhappy with PT provisions for cytology. "The most serious deficiency is that the [1988] proposals offered three options for PT, and they have chosen the most difficult one to implement," Ercolano stated.

Under the new rules, programs approved for cytology PT must adhere to the following conditions: * Unannounced PT will be conducted on site in each lab once a year. In addition, PT will be conducted at least four times a year at another designated location. Each person examining slides must participate in two events annually. * Each test set must include 20 glass-slide preparations representing at least some of the following: unsatisfactory preparations; normal challenges; infectious agents; and benign reactive processes, premalignant processes. A passing score is 80 per cent or better. * Those who fail a PT event must be provided immediate remedial training and education in the area of failure, and all subsequent gynecologic slides must be reexamined until the individual achieves a passing score. Further, at least the last 500 slides examined by that person must be reexamined by someone who passed his most recent PT event.

The CAP believes these requirements are, in essence, PT overkill. For example, Ercolano notes that the state of New York, which has had Pap smear screening PT for 15 years and is often considered a model program, only requires a test of 10 slides every two years. The new HCFA rules say the 20-slide number was selected as "a reasonable number ... that may be used to evaluate an individual's performance on a variety of challenges without resulting in undue penalty for the testing event if the individual has minor problems in slide preparation."

Pathologists are also concerned that the PT requirements will create manpower problems. Ercolano observes that states will be required to have PT program leaders trained and experienced in cytotechnology, a factor that could mean shortages of qualified personnel.

The final rule did provide a 60-day comment period for additional input, and CAP will be among the voices pushing for further modifications. Many observers believe, however, that the best window of opportunity for change will be in the forthcoming CLIA regulations.

At press time, these regs had reportedly been forwarded to the White House Office of Management and Budget for approval. Drafts were leaked earlier this year, but it appeared HCFA has had great difficulty deciding which testing areas might qualify a lab for waiver from certification. It was generally expected that HCFA would establish three levels of regulatory requirements determined by the complexity of lab activity being conducted, regardless of location.

At a Senate committee hearing in March, new HCFA Administrator Gail Wilensky, Ph.D., felt the wrath of lawmakers who are disgruntled by the agency's slow progress in issuing lab rules.

Wilensky defended HCFA's decision to proceed on a two-track regulatory approach with the consolidated lab rules and CLIA '88 implementation. She cited the scientific community's lack of consensus on categorization of testing by complexity as a main reason for the delay.

The agency chief attempted to persuade lawmakers that CLIA '88 implementation would proceed quickly. But Wilensky was unable to offer a specific timetable, and she may be quickly using up the political goodwill that Capitol Hill normally accords new members of the Administration.
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Title Annotation:Health Care Financing Administration
Publication:Medical Laboratory Observer
Article Type:column
Date:May 1, 1990
Words:1412
Previous Article:Closing the loop on quality.
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