Prior to 1988, less that 10% of all clinical laboratories were required to meet quality standards. Approximately 12,000 hospitals and independent laboratories were regulated under the Clinical Laboratory Improvement Act of 1967 (CLIA '67) and the Medicare and Medicaid programs. Currently, under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), all 150,000 clinical laboratories, including physician office laboratories, are regulated to ensure the quality of test results.
A clinical laboratory is defined as a place where materials derived from the human body are examined for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or assessment of the health of human beings. Laboratories may be located in hospitals, freestanding facilities or physician offices.
Why Was CLIA '88 created?
In 1988, Congress responded to public concerns over the quality of laboratory testing by passing CLIA '88. Prior to that time, as much as 25% of all patient testing performed in laboratories was not subject to minimum quality standards. Congressional hearings revealed serious deficiencies in quality in physician office laboratories and in Pap smear testing. Studies have demonstrated that laboratories meeting minimum personnel and quality requirements perform better than those that do not. CLIA '88 was passed to provide assurance to the public that access to safe, accurate laboratory testing is available.
Why is CLIA '88 necessary?
A test is a test no matter where it is performed. As explained by Senator William Cohen (R-ME) in his remarks on the Senate floor on October 11, 1988, CLIA '88 "put(s) all labs under one standard...all laboratories--independent, in a hospital, in the physician's offices--are covered." On the same day Senator Carl Levin (D-MI) continued, "the legislation...fills an important gap...patients should be able to expect the same level of accuracy from a lab test done by their personal physician as they do from those conducted in a hospital or large commercial lab."
The late Representative Edward Madigan (R-IL) concluded, "One benefit of this legislation will be to unify the regulation of clinical labs by implementing a uniform standard. (It) also provides for the regulation of physician office laboratories which are currently exempt from federal regulation."
How Does CLIA '88 Work?
The CLIA '88 regulation unified and replaced past standards with the single set of requirements that apply to laboratory testing of human specimens. Standards for laboratory personnel, quality control and quality assurance are based on test complexity and potential harm to the patient. The regulations also establish application procedures and fees for CLIA registration as well as enforcement procedures and sanctions applicable when laboratories fail to meet standards.
Determining which CLIA '88 standards apply to a test depends upon the level of complexity of that test. Three categories of testing complexity have been defined under CLIA '88. They are waived, moderate and high. A subcategory of moderate complexity testing was also created, physician-performed microscopy. One reason the tests are placed into categories is to reduce the burden of regulation for those laboratories performing tests for which a low probability of an erroneous result exists. For example, there are no personnel or inspection requirement for the waived category of testing. In addition, 75% of all tests falls within the moderate complexity category which permits an individual with only a high school degree and appropriate training to perform these tests.
Are the Personnel Requirements Under CLIA '88 Necessary?
Yes. Physicians use clinical laboratory test results as an important tool in making a diagnosis or planning treatment. Test results have a significant impact on patient treatment, case management, and on the length of a hospital stay. Appropriately trained and experienced personnel are necessary to assure both quality control and quality assurance.
Personnel requirements are especially useful in settings when personnel may have little experience with appropriate laboratory practices.
What is Proficiency Testing?
Proficiency testing is a system for checking a laboratory's testing capabilities. Laboratories enroll in a proficiency testing program. Three times a years, the program will send samples of laboratory specimens that the laboratory must accurately test. If a laboratory fails the proficiency test two times in a row, surveyors will work with the laboratory to improve its performance. All laboratories are first given an opportunity to submit a plan of corrective action before any sanctions are applied. Proficiency testing is required for tests that fall within moderate and high complexity categories.
Why Should CLIA Apply to Low Volume Testing Facilities?
The purpose of CLIA '88 is to ensure that all laboratory testing, wherever it is performed, is done accurately and according to good scientific practices. Studies have shown that low volume testing are more likely to obtain inaccurate test results which can seriously affect patient care. Initial CLIA '88 inspection results point to a number of problems in physician office laboratories which typically perform low volume testing. These problems can and are being corrected with the help and guidance of federal and private inspectors.