IFCC-Approved Recommendations on Quality Control in Clinical Chemistry

The Centers for Disease Control and Prevention report one billion laboratory tests identify and measure bacteria and chemicals in the human body annually in the United States. These laboratory tests are often the basis for medical diagnoses. The International Federation of Clinical Chemistry (IFCC) holds international meetings to exchange clinical chemistry, science and technology research. The Clinical Laboratory and Standards Institute (CLSI) has joined the IFCC in approving and recommending quality control standards in clinical chemistry.

International Federation of Clinical Chemistry

• The IFCC strives to improve the quality of clinical chemistry and laboratory medicine internationally. Membership in the IFCC is open to all health care providers. The IFCC awards funds to six clinical chemists at the annual International Congress of Clinical Chemistry and Laboratory Medicine and recognizes their contributions in the Journal of the International Federation of Clinical Chemistry. Through innovative research and education, the IFCC is improving the quality of diagnosis and medical care worldwide. The IFCC establishes international standards. IFCC standards are published and communicated through electronic media and via national health care organizations worldwide.

Clinical Laboratory and Standards Institute

• The IFCC and the CLSI certify clinical laboratory diagnostic equipment for manufacturers and the consumer. CLSI improves the quality of clinical laboratory standards through industry, government and health care professionals. CLSI improves technical quality and health care services worldwide. CLSI solves clinical laboratory technical problems for health care providers and public health facilities by standardizing laboratory tests worldwide. A clinical test result from one laboratory returns the same measurable result as a diagnostic test from another laboratory. Treatment is standard in all health care facilities to maintain continuity of quality service and to make quality medical treatment available to all patients worldwide. The U.S. Food and Drug Administration recommends that manufacturers certify their clinical laboratory products meet CLSI standards.

Centers for Disease Control

• The Centers for Disease Control (CDC) uses standardized clinical laboratory tests to alleviate public health concerns. Researchers at the CDC maintain statistics of incidence, severity and duration of disease and bacterial infections. The CDC compiles medical best practices, standards and accepted treatment methods including pharmaceuticals. The CDC provides StatisPro method evaluation software, which evaluates and verifies laboratory tests and the precision, validity and limits of test methods. The CDC provides tables for comparing test results from related tests and dissimilar tests, bias, rate of detection and standards of control based on CLSI recommendations. CDC researchers work with the federal government, state and local governments, community organizations and foundations.

Food and Drug Administration

• The U.S. Food and Drug Administration (FDA) maintains standard operating procedures for laboratory equipment and testing that can be enforced legally. FDA regulations apply to human specimens used for assessment, diagnosis, prevention and treatment of disease. Medicare and medicaid services finance the FDA clinical laboratory program. The FDA categorizes diagnostic test systems by complexity and maintains lists of CLSI standard laboratory equipment and tests. The FDA approves all laboratory tests and drugs before they are released to the public.