To make sure that laboratories are following the requirements outlined in CLIA, state law, and/or the rules established by the professional organizations to qualify for their accreditation, laboratories also must undergo regular inspections every two years. Several particularly important areas for inspection are leadership, personnel training and competency requirements, proficiency testing, performance improvement, and quality control requirements. For the most part, these inspections are unannounced to eliminate any opportunity for the laboratory to "ramp up" for the inspection. Unannounced inspections assure that the laboratory is in a continual state of readiness to provide safe, quality care to all patients.
- 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. (For more information on laboratory personnel, their various roles and education requirements, read our article entitled Who's Who in the Lab.)
- 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 the accuracy of the laboratory's test results by sending test samples to be analyzed. The outside agency knows the levels of the substances, or analytes, contained in the samples - the sodium level, for example - but the laboratory does not. PT includes 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 laboratorians know what these control samples contain, so the samples provide a built-in check on the process of analysis, which in many cases is carried out by an automated instrument called an analyzer. The control samples contain high and low concentrations of the analyte being measured, to make sure the analyzer is running correctly across the range of concentrations the patient samples may contain. If the results vary from the known quantities, the laboratorians know there is a problem. The problem identified must be corrected before patient testing can be reported. Laboratory inspectors also examine these records during their evaluations.
- National Patient Safety Goals – The goals highlight problematic areas in the laboratory and describe evidence and expert-based solutions to these problems. The purpose of these National Patient Safety Goals is to promote specific improvements in patient safety. For example, correct patient identification is one of the goals that must be met throughout the process for specimen collection, analysis, and result reporting.