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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.

Mayo Medical Laboratories Will Close Massachusetts Lab

IN AN ANNOUNCEMENT MADE LAST MONTH, Mayo Medical Laboratories said that it would close the lab facility it operates in Andover, Massachusetts, by the end of the year. As a result of this move, Mayo will eliminate 105 jobs in this leafy suburb north of Boston. For 20 years, MML…

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February 29, 2016 Intelligence: Late Breaking Lab News

Sandy, Utah-based Sure Genomics is the latest genetic testing company to get a letter from the Food and Drug Administration asking why the company is marketing its SureDNA genetic testing kit to consumers without first obtaining clearance from the federal agency. Th…

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Official Makes Case in Favor of FDA LDT Guidance

IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed …

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MT/MLT Distance Learning Goal of Collaboration: ARUP and Weber State team up to make it easier for interested lab staff to advance skills

CEO SUMMARY: To encourage more students to pursue medical technology (MT) and medical laboratory technician (MLT) degrees, ARUP Laboratories and Weber State University (WSU) are collaborating to promote the distance learning programs offered at WSU. Online students can work any shift…

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Letter to Florida Doctor Offers to Waive Lab Test Fees

CEO SUMMARY: Florida’s highly-competitive market for lab testing services is again seeing some lab companies use “Waiver of Charges to Managed Care Patients†agreements with physicians in situations where the lab is an out-of-network provider. This means the lab will do free testing…

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Lab Professionals Long Knew of Challenges at Theranos

CEO SUMMARY: As THE DARK REPORT has continually reported, pathologists and medical laboratory professionals in the San Francisco and Phoenix markets were aware for most of the past year that Theranos was not delivering to patients and consumers the specific lab testing services it regula…

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Lab Professionals Knew of Challenges at Theranos

CEO SUMMARY: For most of the past year, pathologists and medical laboratory professionals in the San Francisco and Phoenix markets were aware that Theranos was not delivering to patients and consumers the specific lab testing services it regularly touted in news stories and at conferences…

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WSJ ‘Sticks’ Theranos, Raises Serious Questions

CEO SUMMARY: Following months of investigation, reporter John Carreyrou of The Wall Street Journal published back-to-back reports about aspects of Theranos that the…

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Tasso’s Device Collects Capillary Blood for Testing

CEO SUMMARY: In Seattle, Tasso Inc., a start-up company, is developing a device that adheres to the skin and collects capillary blood that can be used for lab testing. Tasso says the device is a less invasive than a venipuncture. At the same time, executives at Tasso recognize that, for m…

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October 5, 2015 Intelligence: Late Breaking Lab News

More venture capital money is moving into the medical laboratory industry in India. In September, Metropolis Healthcare Ltd of Mumbai, India, disclosed that Carlyle, a private equity company, had purchased a 36.5% ownership interest in the lab company. In April, Warburg Pincus …

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