HCFA report card: where CLIA stands.

THE MOST SWEEPING legislation to affect laboratories in roughly 30 years has traveled a difficult path to implementation. But Government regulators maintain that the Clinical Laboratory Improvement Amendments (CLIA) of 1988 are on a steady course.

Judith Yost, director of the Division of Laboratory Standards and Performance within the Health Care Financing Administration (HCFA), agrees with the assessment that "it has been a long and winding road" to implementing the 6-year-old statute, although she told MLO she feels there has been "steady forward progress."

* Diverse players. It is tempting but probably unreasonable to lay CLIA's slow pace solely at the doorstep of Government bureaucracy. First, the goals of the legislation require coordination of responsibilities among several agencies: HCFA, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). Second, regulators' marching orders have been muddled by ongoing disputes in Congress, not the least of which being those over comprehensive health care reform. Third, the laboratory industry and other affected parties have filled the Government's mailbox with suggestions every time there has been a request for public comment.

Still, Yost recently cited a list of "major accomplishments" to date on CLIA, along with some interesting facts and figures. She notes that as of mid-September, for example, there were 150, 143 laboratories registered and that the average lab conducts fewer than 10,000 tests a year. As of that time, 144,270 certificates had been issued, and collections for certificate and compliance fees topped $73 million. HCFA further reported a total certification survey workload of 39,730 facilities, about half of which had been completed as of July 1994.

* Catch-up date. The latest projection is that all the initial surveys will be completed by April 1995, although that estimate has met with some understandable skepticism. Yost explained that HCFA recently hired about 100 medical technologists--referred to as "temporary experts"--who have been trained to perform the surveys and thereby increase overall productivity.

CLIA's history does, however, include the following accomplishments as cited by HCFA:

* Approval of proficiency testing programs. Regulations require annual approval of programs; 16 such programs were approved in 1993, and 19 were approved in 1994. Twenty-one programs (19 current and 2 new ones) are soliciting approval for next year.

* CLIA-exempt state licensure programs that have requirements at least as stringent as those of the Federal statute. Washington State received approval in October 1993; its reapproval was pending notice in the Federal Register at this writing. Puerto Rico and New York State are also under review.

* Approval of private nonprofit accreditation programs. The Commission on Office Laboratory Accreditation was approved 1 year ago. Three more organizations (the College of American Pathologists, the Joint Commission on Accreditation of Healthcare Organizations, and the American Society for Histocompatibility and Immunogenetics) are approved pending public notice, and two others are under review (the American Association of Blood Banks and the American Osteopathic Association).

By type of facility, nearly 60% of the 150,000 CLIA-enrolled labs are in physicians' offices. Skilled nursing/nursing facilities accounted for 8.5% of the total, compared with 5.8% in hospitals and 3.8% independents. Laboratories identified themselves from a list provided by the Government. Nearly 7%, or about 10,000 facilities, show up in the "other" category.

* Most common deficiencies. Other statistics compiled by HCFA reveal the CLIA compliance problems uncovered to date. All told, not quite 11% of surveyed labs registered condition-level deficiencies. The most frequent of these deficiencies included lack of enrollment in proficiency testing programs (44%), no plan for quality assurance (26%), general quality control either not performed or not documented (24%), responsibilities of the lab director not being met (17%), and bacteriology quality control not performed or not documented (17%).

Perhaps of no surprise, the highest rate of deficiencies has been found among physicians' office laboratories (POLs). For example, a HCFA summary shows that 35% of POLs were cited for breaching regulations stating a lab must perform and document control procedures using at least two levels of control materials for each day of testing. That compares with the 13% of independent laboratories cited and 22% of hospital labs.

Similar patterns emerge in cited deficiencies for failure to establish and follow written policies and procedures for quality assurance, failure TABULAR DATA OMITTED to follow a manufacturer's instructions, and failure of the laboratory director to specify the responsibilities of each person engaged in testing.

* Improvement expected. HCFA's Yost says it is not surprising that laboratories the agency regulated under earlier statutes fare better in the assessments, and she notes that some of the hospitals under question were probably not accredited and may be located in rural areas. Yost adds that states with prior experience in laboratory regulation find similar patterns and that improvement can logically be expected over time.

CLIA's progress still faces some significant twists and turns. For example, the relationship between Government regulators and the experts appointed to advise them is still evolving. Members of the Clinical Laboratory Improvement Advisory Committee (CLIAC) recently learned that CDC is still actively looking at a proposal to create a subcategory within moderate complexity testing--for "accurate and precise technology" (APT)--against committee recommendations. Sources suggest those members may have been lulled into a false sense of security because their earliest advisories received rubber-stamp treatment. But the latest developments also raise questions about whether CLIAC can continue to attract the best and brightest advisors if there is a perception their collective judgment goes unheeded.