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Clinical Laboratory

A 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: Units included here are histopathology, cytopathology, and electron microscopy. Other disciplines pertaining to this section include anatomy, physiology, histology, pathology, and pathophysiology.
  • Clinical pathology, which includes:
    • Clinical Microbiology: This encompasses five different sciences. These include bacteriology, virology, parasitology, immunology, and mycology.
    • Clinical Chemistry: Units under this section include instrumental analysis of blood components, enzymology, toxicology and endocrinology.
    • Hematology: This section consists of automated and manual analysis of blood cells.
    • Genetics is also studied along with a subspecialty known as cytogenetics.
    • Reproductive biology: Semen analysis, Sperm bank and assisted reproductive technology.

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.

Accreditation is done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. CLIA 88, the Clinical Laboratory Improvement Amendments, also dictate testing and personnel.

In addition, many clinical laboratories have adopted quality management programs such as Six Sigma and Lean quality to improve clinical quality, reduce turnaround time, cut costs, and boost productivity. Lean and Six Sigma are both process improvement methodologies. At a very basic level, Lean is about speed and efficiency, while Six Sigma is about precision and accuracy, leading to data-driven decisions. Lean and Six Sigma methods are finding numerous applications in anatomic pathology laboratories and pathology group practices.

LIS Market Will Change After Oracle and CliniSys Acquisitions

This is an excerpt of a 843-word article in the January 31, 2022 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: The Oracle and CliniSys acquisitions will create major changes. With its purchase of Cerner Corpo…

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Witness the Land Grab to Control Healthcare Data

LIKE MOST OF YOU, IT CERTAINLY CAUGHT MY ATTENTION WHEN I LEARNED in December that Oracle will pay $28 billion—with a B!—to buy Cerner Corporation.  I don’t question the value of Cerner’s products; the company has an EHR product tha…

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LIS Market Will Change After Oracle, CliniSys Deals

CEO SUMMARY: With its purchase of Cerner Corporation, Oracle becomes the owner of Cerner’s Millennium laboratory information system (LIS) and CoPathPlus, Cerner’s anatomic pathology LIS. Only three weeks later, CliniSys, a division of Roper Technologies, announced it was acquiri…

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Oracle’s $28b Cerner Deal Shows Value of Health Data

CEO SUMMARY: For three decades, pathologists and clinical lab executives regularly pointed out that clinical laboratory data was extremely valuable. But it seemed nothing changed, no one listened, and labs could not monetize their lab data. Now, one of Silicon Valley’s bigger play…

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More LIS Consolidation as CliniSys Buys Horizon Lab

CEO SUMMARY: By acquiring Horizon Lab Systems, CliniSys has committed to moving some of its services beyond the clinical laboratory as Horizon sells into other lab markets, such as environmental management. Also, CliniSys will combine with Sunquest Information Systems,…

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Microbiome Startups Pushing into the Clinical Lab Space

REPUTABLE CLINICAL LABORATORY COMPANIES HAVE A NEW COMPETITOR in what has been called the Wild West of microbiome startups.  Some of the companies in this nascent industry have been hailed for developing health breakthroughs while others have been indict…

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Labs Can Team with Employers to Improve Worker Productivity

HEALTHCARE’S ONGOING TRANSFORMATION AND THE EMPHASIS ON VALUE-BASED REIMBURSEMENT are creating a new opportunity for savvy clinical laboratory executives and pathologists. This opportunity is centered around the need of self-insured employers to address the problem of employee presenteeism….

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January 31, 2022 Intelligence: Late-Breaking Lab News

DNA-based breast cancer testing is taking a step forward. Illumina in San Diego, which sells next-generation sequencing (NGS) technology, announced a partnership with Agendia in Irvine, Calif., to develop in vitro diagnostic tests for oncology. Agendia offers proprietary breast …

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Primary Care’s Shift to Telehealth and Pharmacies

Primary care patients are a major source of lab test referrals to the nation’s clinical laboratories. Until recent years, the typical primary care clinic was located in or near the medical campus of the local hospital and was probably owned by the doctors who staffed the clinic….

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New Primary Care Providers May Change Who Buys & Who Orders Lab Tests

This is an excerpt of a 2,445-word article in the June 14, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new playe…

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