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Lab groups assess implementation of CLIA.

Laboratory associations are finding once again that there's plenty of opportunity for turmoil when trying to reconcile the letter and the spirit of the law.

The Clinical Laboratory Improvement Amendments of 1988 seemed reasonably clearcut when they were enacted last November. But the Health Care Financing Administration, which is charged with implementing the law, has its own interpretation of what's to be done.

Among the most controversial topics, HCFA is apparently standing by its position that all personnel standards below the lab director/supervisor level should be eliminated. And some rubbery wording from Congress may allow the agency to make that position stick.

The exact language of the bill states that certified labs must "use only personnel meeting such qualifications as the Secretary [of Health and Human Services] may establish for the direction, supervision, and performance of examinations and procedures within the laboratory. . ."

Use of the words "may establish" rather than "shall establish" connotes discretion over the development of personnel standards, many analysts infer. At a recent meeting with lab officials, HCFA indicated it still believes proficiency testing is sufficient to insure quality lab results. One source who was at the meeting remarked that HCFA seemed to be taking a "so what" attitude toward the CLIA provisions.

At press time, it was uncertain whether the agency would revise its Aug. 5 proposed lab reform regulations in light of CLIA '88, or publish a separate version covering just the added requirements.

In either case, most provisions of CLIA '88 are slated to take effect Jan. 1, 1990. However, personnel and inspection requirements for intrastate and physician office labs (POLs) won't take hold until July 1, 1991. The following is a breakdown of key elements of the new law:

*Certification. Starting in January 1990, all labs will be required to have a certificate issued by HHS, valid for up to two years. To obtain one, a lab must submit an application detailing the number, type, and methodologies of procedures performed, plus the qualifications of personnel directing, supervising, and performing the procedures. The application may be submiffed by an HHS-approved accrediting agency if the lab meets that program's requirements.

Certification waivers may be granted to labs performing only simple examinations and procedures that have an insignificant risk of erroneous result. That includes those tests that have been approved by FDA for home use, employ methodologies so simple and accurate that chances of an erroneous result are negligible, and pose no significant patient risk if performed incorrectly.

* Standards. To be certified, labs must have a quasity assurance and quality control program; maintain necessary records, equipment, and facilities; use qualified personnel as (or perhaps io defined by HHS; and successfully participate in an approved proficiency testing program.

In developing standards, HHS will consider factors such as the examinations and procedures performed, degree of independent judgment involved, amount of interpretation involved, and calibration and quality control requirements for instruments.

* Proficiency testing. HHS will set standards for PT programs conducted by itself, a private nonprofit organization, a state, or an approved accrediting body. Labs will be tested quarterly for each exam and procedure within categories for which they are certified whenever such tests are possible.

HHS will establish uniform national criteria for acceptable performance for all analytes. Labs failing PT may be required to undertake additional training/technical assistance or enroll in a program of "enhanced" PT. Proficiency testing results will become available to the public.

* Cytology. The Government will create national standards for quality assurance including the maximum number of slides an individual may screen in 24 hours, records on the number of slides individuals screen, criteria for requiring rescreening, and periodic confirmation and evaluation of personnel.

Rules will also cover procedures for detecting inadequately prepared slides, requirements that all screens be done on laboratory premises, guarantees that slides will be retained for an appropriate period of time, and requirements for periodic inspection of laboratory services by qualified persons.

*Inspections. HHS may make announced or unannounced inspections and have access to all facilities, equipment, materials, records, and relevant information. The Federal department may copy any such material or require it to be submitted. Labs not accredited by an approved agency will be inspected at least biannually. Accredited labs will be checked as often as HHS deems necessary.

Fees will be charged for both applications for certificate and waiver from certificate. Various civil money penalties and other sanctions may be applied to labs that HHS determines no longer meet certification requirements. Certificates may be suspended, revoked, or limited if efforts to make corrections fail.

Although many lab representatives applauded enactment of the new CLIA, most are upset with HCFA's sole reliance on outcome measures for quality assurance. Reaction has been mounting since HCFA made its position clear in the Aug. 5 proposed regs.

During the public comment period, American Society of Clinical Pathologists (ASCP) President Joseph H. Keffer, M.D., warned HCFA of the "serious risk" involved in eliminating bench-level personnel standards. While PT is "an excellent educational tool," leaders in laboratory medicine "recognize the limitations of such programs and the importance of a structure that includes a number of other laboratory quality assurance mechanisms," Keffer said.

In other comments, American Association for Clinical Chemistry (AACC) President Theodore Peters suggested that HCFA's proposed exemption of test sites where no performance problems are evident may "risk the loss of existing consistently high quality performance."

Many laboratorians are also concerned about HCFA's intention to press "enhanced" PT on facilities that falter on even one analyte. ASCP's Keffer said the proposed grading system is so stringent it can be "expected to produce high failure rates," adding that enforcement would be "extremely costly" for labs. And AACC's Peters believed enhanced PT would be "unnecessarily punitive" and "unreasonable" as currently envisioned.

Perhaps the best hard data on that front came from the American Association of Bioanalysts (AAB). Applying the proposed grading system to just three common analytes, AAB's Proficiency Testing Service concluded that 26 per cent of enrolled labs would be required to participate in enhanced testing. Other estimates suggest that up to half of all labs would be subject to the more onerous PT requirements at any given time.

Wheels are still in motion, but here's a rundown of priorities from the agendas of various lab associations:

Among its other activities, ASCP is picking up the gauntlet on challenges to the need for personnel standards. HCFA points toward the experience of hospital labs as proof that bench standards are unnecessary. ASCP will build a case that hospitals have experienced few problems because they hire only top personnel. One sticky point: The College of American Pathologists has spoken out in favor of HCFA's view on this issue. One ASCP insider concedes "that is a problem," because regulators are deft at the divide-and-conquer strategy of enforcing their views.

The American Society for Medical Technology strongly opposes HCFA's position on dropping personnel standards, but is generally pleased with enactment of CLIA '88. Beyond pressing HCFA on the standards issue, ASMT officials are holding their breath on treatment of POLs under agency interpretation. In the new Congress, the group will also push for legislation requiring direct billing for lab tests and a ban on self-referral (doctors referring tests to labs in which they have a financial interest).

AAB also figures to be heard in the personnel standards debate. Associate Administrator Mark S. Birenbaum said: "Relying on PT as the sole judgment of what a lab can do is unrealistic."

Congress, of course, will also have input on the law it passed. Some observers believe key Democrats rejected stronger wording on lab personnel standards as part of an optimisti"we'll fix it after we win the White House" philosophy. Yet the election of George Bush and the transition he will bring make it difficult to predict what fruits lab lobbying will bear.
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Title Annotation:Clinical Laboratory Improvement Amendments of 1988
Publication:Medical Laboratory Observer
Date:Jan 1, 1989
Previous Article:Two worlds: independent and hospital labs.
Next Article:Lab salaries: still too low, but rising.

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