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 Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. (CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a ) of 1988 are on a steady course.
Judith Yost, director of the Division of Laboratory Standards and Performance within the Health Care Financing Administration Health Care Financing Administration,
n.pr department in the U.S. agency of Health and Human Services responsible for the oversight of the Medicaid and Medicare benefit programs, including guidelines, payment, and coverage policies. (HCFA HCFA
Health Care Financing Administration
n.pr See Health Care Financing Administration. ), agrees with the assessment that "it has been a long and winding road" to implementing the 6-year-old statute, although she told MLO MLO Mycoplasma-like organism(s) 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 FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ), and the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice.
CDC - Control Data Corporation ). 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 This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. , the Joint Commission on Accreditation of Healthcare Organizations Joint Commission on Accreditation of Healthcare Organizations,
n.pr the United States body that accredits healthcare organizations.
Joint Commission on Accreditation of Healthcare Organizations (JCAHO/TJC),
n. , and the American Society for Histocompatibility histocompatibility: see transplantation, medical.
A term used to describe the genes that influence acceptance or rejection of grafts. and Immunogenetics Immunogenetics
A scientific discipline that uses immunological methods to study the inheritance of traits. Traditionally, immunogenetics has been concerned with moieties that elicit immune response, that is, with antigens (antigenic determinants). ) are approved pending public notice, and two others are under review (the American Association of Blood Banks and the American Osteopathic Association American Osteopathic Association,
n.pr an organization that promotes the development and progression of osteopathic medicine and serves as a professional society for osteopathic practitioners within the United States. ).
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 Policies and Procedures are a set of documents that describe an organization's policies for operation and the procedures necessary to fulfill the policies. They are often initiated because of some external requirement, such as environmental compliance or other governmental 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 accredited
recognition by an appropriate authority that the performance of a particular institution has satisfied a prestated set of criteria.
cattle herds which have achieved a low level of reactors to, e.g. 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.