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A medical laboratory or clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.

Laboratory medicine is generally divided into two sections, each of which being subdivided into multiple units. These two sections are anatomic pathology and clinical pathology.

Distribution of clinical laboratories in health institutions varies greatly from one place to another.

The staff of medical laboratories may include:

  • Pathologist
  • Clinical biochemist
  • Pathologist’s assistant (PA)
  • Medical laboratory scientist (MT, MLS or CLS)
  • Medical laboratory technician (MLT)
  • Medical laboratory assistant (MLA)
  • Phlebotomist (PBT)

In many countries, there are two main types of labs that process the majority of medical specimens. Hospital laboratories are attached to a hospital, and perform tests on patients. Private (or community) laboratories receive samples from general practitioners, insurance companies, clinical research sites and other health clinics for analysis.

These can also be called reference laboratories where more unusual and obscure tests are performed. These include Mayo Medical Laboratories, ARUP Laboratories, Quest Diagnostics and LabCorp. For extremely specialized tests, samples may go to a research laboratory. Many samples are sent between different labs for uncommon tests. It is more cost effective if a particular laboratory specializes in a rare test, receiving specimens (and money) from other labs, while sending away tests it cannot perform.

Laboratories today are held together by a system of software programs and computers that exchange data about patients, test requests, and test results known as a laboratory information system or LIS. The LIS is interfaced with the hospital information system.

This system enables hospitals and labs to order the correct test requests for each patient, keep track of individual patient or specimen histories, and help guarantee a better quality of results as well as printing hard copies of the results for patient charts and doctors to check.

Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. The international standard in use today for the accreditation of medical laboratories is ISO 15189. In the United States, under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), accreditation of medical laboratories is done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. CLIA 88 or the Clinical Laboratory Improvement Amendments also dictate testing and personnel.

Quest Diagnostics to File Regular Reports with DHCS

CEO SUMMARY: Pathologists, clinical lab executives, and lawyers in California are going to find some surprises when they study the “Settlement Agreement and Release” that was recently signed by the California Attorney General and Quest Diagnostics Incorporated. Quest Diagnost…

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Office-Based Physicians Want In-Clinic Laboratories

CEO SUMMARY: Interest by office-based physicians in creating an in-clinic medical testing laboratory is on the increase. This has direct consequences for independent commercial labs, hospital lab outreach programs, and anatomic pathology groups, since office- based physicians are…

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$241 Million May Settle Quest Medi-Cal Claims

CEO SUMMARY: There’s movement in the negotiations between California state officials and Quest Diagnostics Incorporated over allegations that discounted lab test prices violated state law. In January, Quest disclosed that it had an “understanding” with California regulators…

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Putting Centrifuges Into Courier Cars For Mobile Processing

CEO SUMMARY: To improve the quality of lab services it provides to more than 300 skilled nursing facilities (SNF) while reducing costs, MuirLab of Concord, California, has created a “mobile specimen processing” solution. It operates a fleet of courier cars with centr…

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Did Qui Tam Suit Trigger Medi-Cal Price Concerns?

CEO SUMMARY: It is easy to track backwards to understand why the California Department of Healthcare Services (DHCS) began aggressive enforcement of its interpretation of statute 51501(a) against a number of labs this summer. DHCS officials were given a full education and a roadm…

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October 25, 2010 “Intelligence: Late Breaking Lab News”

Southern California’s always-crazy lab testing marketplace has a new laboratory competitor. In recent months, Richard Nicholson re-entered the business by acquiring West Pacific Medical Laboratory, based in Santa Fe Springs, California. He is assembling a team of experienced profes…

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New Criticisms in Ireland About Cervical Screening

CEO SUMMARY: Pathologists worldwide are witnessing how a government health service can erode its nation’s pathology capabilities in cytology. Ireland’s experiment in off-shoring all its Pap testing even as it requires women to register in a national database in order to get f…

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ISO 15189 Accreditation Earned by Spectra Labs

CEO SUMMARY: Spectra Laboratories Inc., recently announced that it had earned accreditation to the ISO 15189:2007 standard, following an assessment by a team from the Association for Laboratory Accreditation (A2LA). Spectra is a high-volume laboratory that serves renal patients. …

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Genetic Testing Genie Is Now Out of the Bottle

CEO SUMMARY: There’s been an uneasy standoff between companies that want to sell genetic tests directly to consumers over the Internet and both state and federal regulators. But now it appears that the FDA is ready to take off the gloves and assert greater control over genetic …

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Westcliff Labs Announces BK and Sale to LabCorp

CEO SUMMARY: Subject to court approval, Laboratory Corporation of America is poised to acquire the assets of California-based Westcliff Medical Laboratories, Inc., which just filed a Chapter 11 bankruptcy action in federal court on May 19. In a separate transaction, LabCorp has a…

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