Quality

Regulations: The Key Players

The key participants in the quest for laboratory quality have been the federal and state governments and the laboratory professional community. Very briefly, their roles are as follows:

• Federal Government – All laboratories that perform tests on “specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease” fall under the Clinical Laboratory Improvements Amendments (CLIA). This means that if your doctor wants to run a blood test or urinalysis, or asks you for a stool or sputum sample, then CLIA will influence how these samples are handled and how the tests are performed.
• Established in 1988 by the federal government, CLIA regulations were adopted to ensure the accuracy, reliability, and timeliness of patient test results. CLIA covers testing in all U.S. states, and every clinical laboratory in the country must obtain a certificate that defines the complexity of tests that the particular lab can perform.
• State Government – Several states have additional requirements that are equal to or more stringent than those outlined in CLIA. In these cases, the state, not the federal government, assumes primary responsibility for oversight of laboratory practices.
• Laboratory Professional Organizations - The most visible line of defense for accurate results is federal regulation, but the foundation for this regulatory system is the voluntary self-policing systems developed by laboratory professionals and their organizations.
• Two professional organizations, the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Healthcare Organizations, had stringent, voluntary laboratory accreditation programs many years before the government required it. Today, both organizations continue to offer highly respected laboratory accreditation programs. Other organizations, such as the NCCLS, a globally recognized, standards-developing organization, are involved in improving medical testing through the development and dissemination of standards, guidelines, and best practices.

Inspections 

To make sure that laboratories are following the requirements outlined in CLIA, state law, and/or the rules established by the professional societies to qualify for their accreditation, labs also must undergo regular inspections. Three particularly important areas for inspection are personnel training requirements, proficiency testing, and quality control.  In January 2004, we were inspected by CAP.

Education and Training Requirements - There are many roles to fill in a laboratory, and both the voluntary systems and the federal regulations spell out educational requirements for laboratory personnel, such as the minimum educational level that a person must have in order to perform each laboratory test. In addition, laboratory personnel may be certified for their profession, obtained through successful completion of the national certification exam. Some state and other federal regulations also require that the laboratory staff participate in documented continuing education.

Proficiency Testing - Laboratories that perform the kinds of tests typical of a hospital laboratory participate in a proficiency testing (PT) program.  For this program, an outside agency approved by the federal government checks on accuracy of the laboratory's test result by sending samples to the lab to be analyzed.  The outside agency knows the levels of the subtances, or analytes, contained in the samples - the sodium level, for example - but the lab does not.  PT inlcudes samples for each specialty and subspecialty area in which the laboratory performs testing.  The laboratory must test the samples the same way it would test patients' specimens.  The outside agency uses PT to grade the laboratory's accuracy.  Laboratory inspectors verify that the lab has an acceptable score in an approved PT program.

Quality Control - To ensure the quality of the results, clinical laboratories test "control" samples along with the patient samples.  The laboratories know exactly what these control samples contain, so the samples provide a built-in check on the process of the analysis, which in many cases is carried out by an automated machine called an analyzer.  The control samples contain high and low concentrations of the analyte being measured, to make sure that analyzer is running correctly across the range of concentrations the patient samples may contain.  If the results vary from the known quantities, the laboratories know there is a problem.  Laboratory inspectors also examine these records during evaluations.

©2001 American Association for Clinical Chemistry