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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.

Walgreens To Go National with Lab Tests in Stores

CEO SUMMARY: A disruptive innovation is one that shakes up an entire market or industry. By adding clinical lab testing to its health services offerings in more than 8,100 stores nationwide, Walgreens could disrupt the status quo in the clinical lab industry. Walgreens says its lab partne…

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Theranos Won’t Discuss Disruptive Lab Technology

CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …

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CMS’ Proposed Lab Rules May Not Fly with Congress

CEO SUMMARY: Many clinical lab administrators have noticed the new activism at the federal Centers for Medicare Medicaid Services (CMS) when it comes to control of establishing prices for clinical laboratory tests. In this exclusive interview, two long-time advocates for the National Inde…

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Reporters & Investigators Target Fraud in Pain Management Market

PAIN MANAGEMENT IS COMING under increased scrutiny by law enforcement officials and government regulators. Even the national media have begun to notice the fraud and abuse that is rampant in this rapidly-expanding sector of healthcare. Many pathologists and clinical laboratory managers will welcome …

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Hospital System Acquires Labs In ACO Strategy

CEO SUMMARY: Moving to deliver services as an accountable care organization (ACO), Genesis Health System of Davenport, Iowa, has acquired the laboratory assets in two hospitals previously operated by Metropolitan Medical Laboratory, PLC, a lab company owned by local patho…

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Lab Landscape Changing as ACOs Get Started

FOR THOSE OF YOU INTERESTED IN HOW the development of accountable care organizations (ACOs) in a community causes a realignment among providers and the clinical laboratories serving them, I offer you the example of Genesis Health System in Davenport, Iowa. As you will read …

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OIG Tells CMS It Could Save $910 Million on Lab Test Costs

IT IS ONE MORE POWERFUL SIGN of the changing times. Last week, the Office of the Inspector (OIG) publicly released a study it had done of the prices paid for lab testing and how the Medicare program could use this information to reduce the cost of Part B clinical laboratory testing. It was The W…

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Aetna To Lower Lab Test Prices, New Fees Are Effective on July 1

IN RECENT MONTHS, labs are reporting the receipt of letters from Aetna, Inc., announcing that it will pay dramatically less than Medicare prices for many key lab tests. Aetna said that these lower prices will take effect on July 1, 2013. Three examples illustrate the deep fee cuts t…

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April 15, 2013 “Intelligence: Late Breaking Lab News”

Geisinger Health System broke ground last month on construction of a new $52 million medical laboratory facility. It will be 115,000 square feet and will be located at the site of the Geisinger Medical Center in Danville, Pennsylvania. LAB COMPANY COMPLET…

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Tennessee AG Opinion Adds Unease to EHR Donation Issue

ANOTHER STATE ATTORNEY GENERAL (AG) has issued an opinion on the donations of electronic health record (EHR) systems by clinical laboratories to referring physicians. The opinion says that such donations would violate Tennessee state law. The Tennessee AG’s opinion is similar to one issued in Nove…

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