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With more questions than answers, industry studies impact of CLIA '88.

With the crucial elements of CLIA 88 unveiled, members of the lab industry are laboring to define the impact of the Clinical Laboratory Improvement Amendments of 1988.

Those following the process closely recognize that there are currently at least as many questions as answers about CLIA's effects. And that may continue to be the case even after key provisions of the law's implementing regulations take effect this September.

The element of the complexity-based system that has thus far drawn the most heat is the personnel standards. Some of the harshest criticisms were articulated in a letter to Rep. Ron Wyden (D-Ore.) signed by the American Society of Clinical Pathologists (ASCP), the American Society for Medical Technology (ASMT), and the American Society for Microbiology (ASM). According to the letter, "The elimination of strong personnel standards, in existence under Medicare and CLIA '67 for over 20 years, is evidence that the regulations fail to provide the assurance of quality testing intended by Congress."

In requesting Congressional oversight of implementation by the Health Care Financing Administration, the three groups asked Wyden to consider these concerns:

* The list of tests in the moderately complex grouping is inappropriate, given the "lax" personnel standards outlined. The rules for that category fail to encompass the risk to the patient as required under the statute. Test classifications need to reflect accurately the depth of knowledge and independent judgment necessary to perform and manage the testing.

* Eliminating the previous personnel standards will cause serious lab quality problems. Because monitoring mechanisms such as inspection and proficiency testing (PT) will be phased in, it may not be possible to document these problems until 1996.

* General supervisors of high Complexity testing should be required to have a baccalaureate degree in a laboratory science. The requirement of an associate degree is "inadequate" for this level of testing since this person is responsible for insuring lab quality every day.

* Distinctions between the scope of practice of technologists and technicians, which exist in training and practice, should be retained in regulation. Failure to recognize traditional baccalaureate education and training for testing in high complexity labs "threatens lab quality and seriously undermines a struggling educational system."

* Lab directors with no formal lab training should be given time to get training, not automatically grandfathered into the position. Similar to non-physician personnel performing testing, directors should be given two to five years to meet minimum qualification requirements, the extent of which would depend on the scope and complexity of the testing they direct.

The Government's methodology for classifying tests into waivered, moderately complex, and highly complex categories has come under fire as well.

The regulations categorize all non-waivered tests according to seven criteria. Three of these address the degree of knowledge, skills, and experience that personnel need to perform tests adequately. The other four are procedure-specific, addressing the complexity of reagent and materials preparation, characteristics of testing devices (calibration, quality control, and PT materials), and test system troubleshooting and maintenance.

A score of 1 to 3 (3 being the highest degree of complexity) was assigned to each of the seven criteria for every procedure. A total score of 13 or more placed a procedure in the high complexity category; a score below 13 placed it in moderate complexity.

In comments filed with the Public Health Service, ASMT said the Government's complexity model is "fundamentally flawed, since it fails to include pre- and post-analytic considerations, focusing almost exclusively on the analytic phase" in rating each criterion.

ASMT experts examined a sampling of 17 tests defined in the Government model as moderately complex. In their opinion, none of these tests scored low enough to be placed appropriately in that category. In hematology, for example, ASMT rated CBCs with and without automated differentials as highly complex. Using the 1-3, seven-criteria system, automated CBCs drew a total score of 16. At this writing, ASMT was planning to elaborate on its concerns and present recommendations for change.

These and other considerations have been discussed at industry CLIA seminars. At the one in March sponsored by the Health industry Manufacturers Association (HIMA), participants heard from officials at HCFA, the Food and Drug Administration, and the Centers for Disease Control. Other presentations by the College of American Pathologists (CAP) and the American Association of Bioanalysts (AAB) covered implications for PT programs.

The give-and-take underscored the high level of uncertainty over how CLIA will actually work--not the least of which was displayed by Government representatives themselves. In some cases, they conceded that parts of the regulations are necessarily ambiguous, so as not to tie the regulators' hands.

In other instances, there are decisions that simply remain to be made prior to Sept. 1. During one illustrative exchange, HIMA attendees wanted to know whether a lab would be eligible for Medicare reimbursement for new tests not covered under its operating certificate. Under the rules, labs have six months to notify HCFA of an expansion in testing services and apply for a revised certificate.

Wayne Smith, Ph.D., director of HCFA's division of hospital and ambulatory services, said it is unclear whether the grace period is linked under statute to reimbursement. In other words, must Medicare pay for non-certified services during the six-month time frame?

Besides the legal question, an operational issue pertains: HCFA's computers are programmed not to cut checks for procedure codes that don't show up on a lab's certificate. Smith said the matter would be resolved soon. But he indicated HCFA may be forced to pay for new services during the grace period and then seek refunds if it later determines that the lab is not qualified to perform such testing.

Government officials were generally sympathetic to the uncertainty over how the rules should be interpreted, and they indicated that they will give labs a degree of leeway. Still, they made it clear the standards will be applied diligently.

"Congress has given us a tremendous amount of firepower on the enforcement side," Smith said, "and it's important for labs to take that seriously. We're not interested in putting notches on our gun, but we won't blink in the face of threats to health and safety."

What follows is a sampling of some of the more pressing questions arising from CLIA '88, along with responses gleaned from the HIMA meeting, the rules themselves, and other sources.

* Will labs have to hire more or better-trained and -educated employees? What about potential shortages?

The Government doesn't see a problem. It says that most laboratories will be able to keep operating with existing personnel. Requirements are most stringent for high complexity testing, but most of this is done in laboratories that were already regulated, by employees who will probably meet the personnel standards. But in recognizing the cytotechnologist shortage, the Government is allowing a two-year window for those currently employed to obtain the necessary experience and education.

* Since the rules will dramatically increase the demand for proficiency testing programs, is there likely to be a shortage of PT samples?

It is precisely because of such concerns that the Government is allowing a two-year delay in PT participation for newly regulated labs. CAP Vice President William Williamson told HIMA attendees, "Given sufficient advance notice [and] time to plan production quantities and work with our manufacturers, we're confident we can meet the needs of CLIA '88."

* But what if there are shortages and all PT programs are full?

It appears that if a PT program were full, the program would send the lab a letter to that effect. The laboratory could thus avoid being cited for failure to enroll in PT--providing that all such programs were full.

* What's the status of the fourth rule component, on criteria for state and private nonprofit accrediting agencies?

Those regulations are expected to be published this month. Officials are not predicting which groups will receive deemed status, but expect to get applications from JCAHO, CAP, and the Commission on Office Laboratory Accreditation.

* Will standards exist for computers or lab information systems?

No. The proposed regulations did outline requirements in such areas as computer system environment, scheduled and unscheduled interruptions, data entry, and security. But after a review of public comments, HCFA deleted those requirements from the final rules.

* Has the complete list of tests in the moderate and high complexity categories been published?

Not yet. The Feb. 28, 1992, Federal Register contained a list of roughly half the estimated 10,000 procedures to be covered. Additional installments were slated for this month and June, with a complete list to be finished by Sept. 1. Also, manufacturers, the FDA, and the CDC will be coordinating a review of products that are not quite on the market yet.

* Won't the new rules drive many physicians and other health care providers out of lab testing, thereby limiting access to services?

Officials believe the changes in test categorization, personnel requirements, user fees, and the gradual implementation of PT adequately address the concerns raised by doctors and rural facilities.

* How does a laboratory sign up?

The immediate step is to obtain either a certificate of waiver (for performing waived tests only) or a registration certificate (for moderate or high complexity testing). If HCFA has not already contacted you about CLIA, applications are available from any of the agency's 10 regional offices.
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Title Annotation:Clinical Laboratory Improvement Amendments of 1988
Author:Albertson, David
Publication:Medical Laboratory Observer
Date:May 1, 1992
Words:1541
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