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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.

Final Three Labs Settle California Qui Tam Case

CEO SUMMARY: In recent months, the California Attorney General (AG) entered into settlement agreements with the last three defendant laboratory companies involved in the Medi-Cal discount pricing whistleblower lawsuit. The AG did not make this news public. In their respective settlement a…

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Rite Aid Offers Free Tests to Preferred Customers

CEO SUMMARY: National pharmacy chain Rite Aid now offers free clinical laboratory tests to members of its customer-rewards program once they reach certain spending levels. After the customer’s specimen is tested, the laboratory test results are sent directly to the customer’s local Ri…

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Lab Testing, Pathology Is Fast-Growing in China

CEO SUMMARY: It was record attendance at the major pathology congress which took place in Hangzhou, China, last month. Because of the ongoing growth of China’s economy, the demand for healthcare—and for high-quality clinical lab and pathology testing—is rising at an accelerated pace…

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In Massachusetts, AG Targets Drug Testing Labs

CEO SUMMARY: Since taking office in 2007, Massachusetts Attorney General Martha Coakley has aggressively pursued civil charges against drug testing labs. Last month, Coakley announced a criminal arrest in one ongoing investigation after a grand jury indicted a physician in a kick…

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In-Practice Histology Lab Splits Biopsies; ID’s Patient with DNA

In response to continuing requests by clients and readers of THE DARK REPORT, this issue institutes a new feature titled “Lab Fraud Watch.” It will provide information about activities in the medical laboratory testing marketplace which could be interpreted as violatin…

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ELINCS Specifications Released in California

CEO SUMMARY: Clinical laboratories and pathology groups have a new tool to use for interfacing their LIS (laboratory information systems) with the electronic health record (EHR) systems of their office-based physician clients. It is ELINCS, an IT standard designed to support elec…

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September 6, 2011 “Intelligence: Late Breaking Lab News”

Cleveland Heart Lab closed on a Series B financing round that totals $18.4 million. The money was provided by Excel Venture Management, Healthcare Ventures, and existing investors. Executives at Cleve- land Heart Lab said the new funds will be used t…

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Why Canada Has Growing Shortage of Pathologists

CEO SUMMARY: In Canada, it is known that the supply of pathologists and laboratory physicians has diminished since 1998. Further, a federal program that measures patient wait times for certain surgical and imaging procedures does not measure how long patients wait for ana…

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Will Lawsuits Re-shape Current Lab Practices?

CEO SUMMARY: Recent events in California, triggered by a lab whistleblower lawsuit filed in 2005 and unsealed in 2009, provide the latest example of how these lawsuits and related government enforcement actions can cause fundamental changes in the pricing and marketing p…

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July 05, 2011 “Intelligence: Late Breaking Lab News”

Two laboratory companies based in Spokane, Washington, were recently recognized in a list of Washington State’s “100 Best Companies to Work For” in 2011. One was Incyte Pathology, Inc., an anatomic pathology group. The other was Pathology Associates Medical Laboratori…

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