The Great Plains Laboratory, Inc. is fully certified under the federal law of the United States of America called CLIA. In addition, all laboratories to which The Great Plains Laboratory, Inc. sends samples are also CLIA certified.
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, the impairment of, or assessment of health.
Under the CLIA regulations, the federal Centers of Medicare and Medicaid Services will inspect any size laboratory for adherence to the CLIA requirements. However, if a state agency has an acceptable laboratory inspection program, then that state can perform the necessary laboratory inspections. If that laboratory complies with all of the quality control procedures, that laboratory is then awarded a CLIA license. The CLIA license means the laboratory has met all federal requirements for operating a laboratory. Other agencies including CAP, COLA, and JCAHO can also offer similar laboratory licensure programs but participation in such programs is not required. A copy of the current CLIA license of The Great Plains Laboratory, Inc. is given below.
All laboratories in the United States must comply, as required by law, with proficiency testing regulations for certain tests. Participation in proficiency testing for other tests is voluntary. Some labs participate while other labs do not. For example, The Great Plains Laboratory, Inc. has voluntarily participated in the organic acid testing program (Biochemical Genetics) of the College of American Pathologists (CAP) since the inception of The Great Plains Laboratory, Inc. in 1996.
The Great Plains Laboratory, Inc. participates voluntarily in all proficiency testing programs of the College of American Pathologists for which The Great Plains Laboratory, Inc. offers testing. Many other laboratories do not perform this extra voluntary testing.
The College of American Pathologists is a medical society serving nearly 16,000 physician members and the laboratory community throughout the world. It is the world's largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance.
Approximately 23,000 laboratories throughout the world are enrolled in the proficiency testing programs of the CAP.
The CAP Surveys is the largest laboratory peer comparison program in the world. The programs allow laboratories to regularly evaluate their performance and improve the accuracy of the patient results they provide. Through this program, the CAP provides individual laboratories with unknown specimens for testing. The participants analyze the specimens and return the results to the CAP for evaluation. In turn, each participating laboratory receives a report of their performance, as well as a report summarizing the results of all participating laboratories.
INTERNAL QUALITY CONTROL
In addition to inspections by the state and participation in external proficiency testing programs of the CAP, The Great Plains Laboratory, Inc. also has a strong internal quality control program in which portions of quality control samples are analyzed with every test batch to ensure laboratory quality. Also, patient samples are frequently split to make sure that different technologists perform similar work.
FOOD AND DRUG ADMINISTRATION (FDA) APPROVALS
The FDA regulates companies that sell instruments and reagents to clinical testing laboratories. The Great Plains Laboratory, Inc. uses many FDA approved instruments and reagents. In some cases, there are no commercially available instruments or reagents. Such tests, termed “home brew” tests are regulated by the CLIA regulatory agencies. The FDA does not directly regulate clinical laboratories.