Laboratory tests are used to assist medical personnel in diagnosing disease, measuring treatment success, or evaluating the general health status of a person. All laboratories analyzing specimens taken from humans for chemical, biological, or microscopic testing are required to meet national quality standards. The impetus for developing these standards arose from accusations that certain laboratories were using untrained and overworked employees to perform Pap smear testing. Women were dying of cervical cancer not identified until the disease had progressed; a comparison with previous test results showed abnormal cells that had been missed in the earlier tests. As the legislation addressing this public health concern developed in the United States Congress, testimony supported rules and standards for all human testing.
In 1988 Congress passed legislation entitled the Clinical Laboratory Improvement Amendments (CLIA), which required all laboratories doing human testing to meet standards which were verifiable by inspection and proficiency testing (i.e., specimens sent to grade laboratory performance). Prior to this law only laboratories that accepted specimens across state lines and those performing tests for Medicare/Medicaid-insured persons were regulated by the federal government. A small number of states had either personnel or laboratory licensing procedures addressing quality performance.
The Secretary of the U.S. Department of Health and Human Services was instructed to prepare rules outlining the requirements for certified laboratories. These rules set minimum standards for educational, training, and experience qualifications for directors and supervisors; specified required documentation of quality assurance and quality control programs; and defined adequate performance in proficiency testing. Between 1990 and 1998 additional rules were drafted and revised to state the specific laboratory quality and documentation requirements, categorization of test difficulty, rules for allowing states and private groups to accredit laboratories, and penalties for failing to meet the standards. The standards were geared toward addressing complexity of testing rather than location or size of laboratory. Previous regulations had emphasized education and training of laboratory analysts and technical managers rather than laboratory processes and quality monitoring of testing. A major difference between these rules and previous laboratory regulations was the segmentation of laboratories into levels of technical proficiency.
Congress recognized there were certain tests which could be performed with little danger of harm to the patient even if performed incorrectly, were simple and easy to use, or approved by the U.S. Food and Drug Administration for home use. These were waived from the regulatory requirements. Most of these tests are performed in nonprofessional laboratories (e.g., nursing homes, small or rural clinics, and physician's offices). These testing sites were excused from meeting the standards only if they applied to do so and agreed to use the tests only as designed and marketed by the manufacturer.
Early expectations were that over 200,000 laboratories would apply for certification, but closings and consolidation limited that number to 150,000 by the mid-1990s. In 1999 there were nearly 170,000 laboratories certified to perform tests on humans. Over half of those were small laboratories doing limited procedures in clinics or small testing facilities. Concerns about restricted access to laboratory services as a result of this user-paid program were never realized.
(SEE ALSO: Assurance of Laboratory Testing Quality; Diagnostic Testing for Communicable Diseases; Laboratory Technician; Practice Standards for Communicable Diseases; Regulatory Authority)
Bibliography "Medicare, Medicaid and CLIA Programs: Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88); proposed rule.1990." Federal Register 55:20,896–20,959.
— RONALD L. ČADA
