Clinical Laboratory Improvement Amendments otherwise known as CLIA ’88 is a law that federally placed lab facilities under federal regulations administrated by the CMS and the CDC. CMS is the administration of our government’s Medicaid and Medicare insurance program and the CDC is the Centers of Disease Control and Prevention, which is our nation’s health protectors. CLIA was enacted by congress in 1988 and updated in 1992. CLIA ’88 standards apply to four areas of laboratory operations: standards, fees, enforcement, and accreditation programs.
(Booth, Whicker, & Wyman, 2014) The required standards for laboratory testing depend on the level of complexity. The three divided categories: are: Certificate of Waiver, tests of moderate complexity, and tests of high complexity. A laboratory office can apply for a Certificate of Waiver only if the tests pose as an insignificant risk to the patient if they are performed and interpreted incorrectly. The test involved is simple and accurate and the risk of obtaining incorrect results is minimal, and the test is approved by the Food and Drug Administration (FDA).
If the office is approved for their lab is subject to inspections and investigations. Tests of moderate complexity consist of 75% of all tests performed in a lab. These tests include studies of bacteriology, mycobacteriology, mycology, parasitology, virology, immunology, chemistry, hematology, and immunohematology.
Tests of high complexity are complicated tests in specialties and sub-specialties such as clinical cytogenics, histopathology, histocompatibility, and cytology. Both moderate and high complexity tests are subject to inspections and proficiency testing, must be run by a medical doctor or scientist with a PhD degree, and are required to participate in quality assurance program.The quality assurance program includes 5 parts: quality control, instrument and equipment maintenance, proficiency testing, and standard operating procedures documentation. Quality control requires a lab to calibrate test equipment regularly, have control samples that show both positive and negative results, and have reagent control of the chemicals and the chemical treated substances used for test procedures. For the maintenance component, a lab must have a maintenance log that provides a complete record of all work done on instruments and equipment.
To satisfy CLIA’s training and education and documentation components of the quality assurance program, Employers are required to provide employee training and continuing education, and documentation of standard operating procedures must include a reference laboratory log and a daily workload log.