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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.

Eight Macro Trends for Clinical Labs in 2023

CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…

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Labs Face New Challenges in New Year, New Decade

TYPICALLY, PEOPLE CELEBRATE THE ARRIVAL OF A NEW YEAR and a new decade with optimism. That should be just as true for clinical lab managers and pathologists. After all, medical laboratory testing is fundamental to how physicians diagnose disease, select the most appropriate therapies, and monitor the…

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Lawsuits Allege LabCorp, Quest Overcharged Uninsured Patients

CEO SUMMARY: Court documents filed in U.S. District courts in New Jersey and North Carolina provide details about how each of the two lab companies set lab test prices differently—as much as 10 times higher—for cash-paying patients than for patients who have Medicare, Medicaid, or com…

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2019’s Top 10 Lab Stories Reveal Major Laboratory Industry Trends

This is an excerpt of a 3,163-word article in the Dec. 16, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There was plenty of bad news in 2019 for clinical labs and pathology groups. Yet lurking inside this new…

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How Labs Can Add Value for Providers, Insurers, Pharma

CEO SUMMARY: For pathologists and clinical, molecular, and genetic testing labs, appropriate reuses of lab data can provide a new source of revenue. Labs that serve as preferred providers of diagnostic testing data can help health systems, ordering physicians, pharmaceutical companies, an…

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November 4, 2019 Intelligence: Late Breaking Lab News

Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage …

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Are Feds Now More Serious about Prosecuting Fraud?

IS IT A COINCIDENCE THAT, IN THIS ISSUE OF THE DARK REPORT, we cover two related developments, both involving the federal government’s efforts to control healthcare fraud and abuse? First, you’ll read about the new federal rule scheduled to take effect on Nov. 4. It gives federal healthcare inve…

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Opportunity for Labs to Help with Opioid Crisis

IT’S CALLED THE OPIOD CRISIS AND IT’S OFTEN A MAJOR STORY in the nightly news. In 2017, deaths from drug overdoses totaled 70,237, of which 68% (47,600) were opioid overdose deaths, according to the federal Centers for Disease Control and Prevention. Across the nation, government h…

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Northwell Health Lab Team Leverages Data to Add Value

CEO SUMMARY: Today, insurers get risk-adjusted payments for treating patients who have high-cost health conditions and they make risk-adjusted payments to physicians, hospitals, and other providers. At Northwell Health, the clinical lab saw the opportunity to leverage lab test data with …

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May 20, 2019 Intelligence: Late Breaking Lab News

Canada faces a similar shortage of medical technologists (MTs) as exists in the United States. “We have reached the point now where some laboratories have been closed for weeks due to insufficient staffing, which is a cascading problem for patients and the healthcare system,” stated Maria Klement…

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