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CLIA '88 rules go final, HCFA details sweeping changes.

The wait is over, although the full weight of final regulations implementing the Clinical Laboratory improvement Amendments CLIA) of 1988 will not be fully felt for many months.

Three of the four rule components, quality standards, user fees/applications, and enforcement procedures, were published in the Feb. 28 Federal Register. The fourth rule, on criteria for state and private nonprofit accrediting agencies, was to be published at an unspecified later date.

The quality standards and enforcement procedures take effect Sept. 1. The fee and application rules went into force April 1, primarily because Congress allocated no transition money for the selffunding system.

The published rules incorporate many revisions suggested by approximately 60,000 public comments. But some members of the lab industry still say there are shortcomings, and they express hope that there's still opportunity for fine-tuning. At the same time, a juggling of personnel within the Bush Administration may affect the leadership continuity on CLIA.

Putting the Department's best foot forward, Health and Human Services Secretary Louis W. Sullivan, M.D., said, "HHS has pursued twin goals in implementing the law. We must ensure the reliability of tests, and at the same time we must preserve access to laboratory testing for all patients." He added that the rules "provide the flexibility necessary to expand Federal quality standards to many new sites" while meeting those goals.

The Health Care Financing Administration HCFA) estimates the price of CLIA 88 at 1.2 billion to $2.1 billion, which works out to a cost increase of 25 cents per lab test. That will cover the expanded vigilance over some 200,000 facilities testing human specimens, including an estimated 130,000 physician office laboratories.

* Quality thrust unchanged. As expected, the final rules retain an emphasis on the complexity of tests being performed as the basis for regulation. In consultation with the Public Health Service, the Centers for Disease Control, and the Food and Drug Administration, HCFA has kept a three-tiered model that divides all tests into waivered, moderately complex, and highly complex categories.

Perhaps the most significant change from earlier proposals is that the waivered category was reduced from 28 to 8 tests (see Figure 1). Facilities conducting only tests on that list basically need only conform to good laboratory practices.

Tests were waivered based on the determination that they are simple and have an insignificant risk of erroneous results. The statute said the category could include tests that have been approved by the FDA for home use, those employing methods so simple and accurate as to make the risk of erroneous results negligible, and those that pose no reasonable risk of patient harm if performed incorrectly.

All other test methodologies are categorized according to criteria that factor in the degree of knowledge, training, and experience needed to perform the test; the complexity of reagent and materials preparation, as well as the number, difficulty, and other characteristics of the operational steps; characteristics of the testing device, such as calibration, quality control, and maintenance needed to assure accuracy; and the degree of interpretation and judgment required in the testing process.

About 75% of the approximately 10,000 regulated testing procedures fall into the moderately complex category (see Figure II for a summary). HCFA officials believe the broad scope of this category will capture the majority of smaller lab facilities, particularly those in doctors' offices.

According to a regulatory summary released by the agency: "We expect most primary care physicians to find that the tests they need to provide immediate, acute care of patients are in the moderate complexity category. The remaining tests are high complexity. High complexity tests are done by hospitals and large commercial laboratories and certain physician specialist, such as hematologists and oncologists."

* Personnel standards. The most significant differences between moderate and high complexity testing are in the personnel qualifications. The waivered category has no personnel standards.

Labs performing only moderately complex tests must have employees who qualify and can perform specific functions in four areas. However, one person may qualify for more than one area of responsibility. The four areas are:

[paragraph] Laboratory director, responsible for overall administration. The director must be a physician or hold a bachelor's, master's, or doctoral degree in one of the sciences. Training or experience requirements vary from one year at the doctoral level to two years at the master's and four at the bachelor's.

[paragraph] Clinical consultant, serving as liaison between the lab and its clients in matters related to interpreting and reporting results. The clinical consultant must be a physician or a board-certified doctoral-level scientist.

[paragraph] Technical consultant, responsible for technical and scientific oversight, available on an as-needed basis. These persons must either be a physician or have a bachelor's, master's, or doctoral degree in science. Those with a master's or doctoral degree must also have at least one year of lab training or experience in each of the specialties or subspecialties for which they have responsibility; those with a bachelor's must have at least two years.

[paragraph] Testing personnel, responsible for processing specimens and reporting results. They must have at least a high school diploma and either military qualifications or "documentation of training appropriate for the testing performed." Persons with an associate science degree or above need no special training or experience.

The latter provision on testing personnel has already set off a howl of protest from the American Society of Clinical Pathologists. Rex B. Conn, M.D., chairman of the ASCP government relations committee, said those ruies eliminate the personnel standards which have been in effect for Federally regulated laboratories for more than 20 years."

In a strongly worded statement, ASCP said the new ruies provide, in effect, that "personnel performing the majority of laboratory testing, including testing for blood typing, diabetes, cholesterol, thyroid diseases, AIDS, and syphilis can be on-the-job trained and have less education for their work than a barber has for cutting hair."

More stringent qualifications will apply to personnel in labs performing highly complex tests.

The four functions of the moderately complex category apply here as well. But overall training and experience requirements are higher and more specialized. A general supervisor who is accessible at all times is required and must provide on-site direct supervision of testing personnel who are high school graduates and do not meet other qualification requirements.

Except for histopathology (which requires board-certified pathologists or pathology residents), persons who perform this level of testing without direct supervision must have at least an associate degree in a lab science or medical lab technology. High school grads will have five years to obtain an associate degree while they work, but they must be directly monitored by the general supervisor.

* Proficiency testing. All labs in the moderate or high complexity category must participate in an approved proficiency testing (PT) program. But labs being regulated for the first time (all but about 12,000 facilities) will not have to enroll until 1993 and need not participate until 1994. HCFA does not plan to impose any sanctions on these labs before 1995.

Wayne Smith, Ph.d., director of HCFA'S hospitals and ambulatory services division, said the agency expects to draw criticism for the phase-in. But at a meeting of the Biomedical Marketing Association, he said the rules "will provide PT programs with the ability to gear up for an enormous increase in demand for PT materials."

The most stringent PT standards apply to cytology, which the HCFA summary document notes was "a major catalyst" behind passage of the CLIA law. The final regulations, however, are actually less stringent than the earlier proposed regs.

Specifically, cytology PT events will be required only once a year, not twice, and sets will contain slides instead of 20. Individuals must correctly read 9 of the 10 and will automatically fail if they interpret as negative or benign even one slide that shows a high-grade lesion or cancer. Those who fail must be retested within 45 days. But bowing to protests, HCFA has dropped the requirement for reexamination of the last 500 slides read by a person who flunks.

Donald Senhauser, M.D., president of the College of American Pathologists, said the rules display "movement toward workable requirements" in cytology and other areas. "However, to deliver quality services under these regulations, there are still many areas that need further refinement." He expressed hope that Federal officials will continue to work with pathologists as adjustments are suggested.

* Quality assurance/quality control. Each lab must establish and follow written QC procedures that monitor and evaluate the quality of the testing process for each test method to assure accurate and reliable patient test results. The regulation contains general QC requirements and additional mandates for specialties and subspecialties.

Implementation of some general QC requirements is being delayed for two years to allow for a new Federal review of medical devices. During that period, labs using instruments, kits, or test systems categorized as moderately complex and cleared for in vitro use by the FDA must at a minimum follow manufacturer instructions, have a procedure manual, perform calibration every six months, and perform QC with two levels of control each day in use.

Labs must also establish and follow written policies and procedures for a comprehensive QA program. The program must be designed to monitor and evaluate the ongoing and overall quality of the complete testing process. For example, in addition to assessing patient test management, quality control, and personnel, the lab must create procedures for rectifying communication breakdowns and investigating complaints.

* Cost of doing business. To stay in business under CLIA 88, testing facilities must have either a certificate of waiver (for those performing only waivered tests) or a registration certificate (moderate to high complexity categories). Waivers will cost $100; registration, $100 to $600, depending on the type and volume of testing. in addition, biannual inspection fees will range from $300 to $3,115, based on test volume.

Labs that don't play by the new CLIA rules face a number of possible penalties. Under "intermediate" sanctions, HCFA may direct a plan of correction, impose civil money penalties of up to $1 0,000 per violation or per day, or extract payment for state on-site monitoring.

Through "principal sanctions," the agency can suspend, limit, or revoke a lab's CLIA certificate. If the noncompliance poses a threat to patient or public health, the certificate can be suspended or limited prior to an otherwise required Government hearing.

In addition, HCFA may enjoin a lab from continuing any activity that constitutes a significant hazard to public health. The agency can also prohibit anyone who owned or operated a lab that had its license revoked from owning or operating any other lab for two years.

With the regulations finalized, attention now turns to making the system run smoothly. At a press conference, HCFA Administrator Gail Wilensky said, "Because of its scope, this regulation will require the cooperation and patience of all involved."

Wilensky, however, was at that very moment about to accept a White House post as a Deputy Assistant to the President for Policy Development. And another key CLIA player, Tom Morford, chief of HCFA'S Health Standards and Quality Bureau, is expected to move to the Social Security Administration. While no two individuals can claim responsibility for the massive CLIA regulations, and while Witensky appears to be strengthening her hand, the shake-up adds a new and uncertain factor to the implementation process.
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Title Annotation:Clinical Laboratory Improvement Amendments of 1988; Health Care Financing Administration
Author:Albertson, David
Publication:Medical Laboratory Observer
Date:Apr 1, 1992
Previous Article:Two magic words with an exhilirating effect.
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