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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.
Use Histology Laboratory Data to Illustrate Specimen ‘Life Cycle’
By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue
BECAUSE OF THE CHALLENGING LABOR MARKET, pathology labs need ways to boost staff productivity. To help identify workflow bottlenecks, one approach is to examine lab data and encourage bench teams to think holistically about specimen movement in the lab. [caption id=”attachment_36932″ align=”alignl…
Eight Macro Trends for Clinical Labs Will Shape Diagnostic Services in 2023 and Beyond
By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue
The Dark Report’s “Eight Macro Trends for Clinical Labs in 2023” delivers the insights that lab administrators and pathologists will want to study as they formulate their future business strategies. These include staffing shortages, factors threatening the stability of…
LIS Market Will Change After Oracle and CliniSys Acquisitions
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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…
Witness the Land Grab to Control Healthcare Data
By R. Lewis Dark | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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…
LIS Market Will Change After Oracle, CliniSys Deals
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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…
Oracle’s $28b Cerner Deal Shows Value of Health Data
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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…
More LIS Consolidation as CliniSys Buys Horizon Lab
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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,…
Microbiome Startups Pushing into the Clinical Lab Space
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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…
Labs Can Team with Employers to Improve Worker Productivity
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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….
January 31, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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 …
CURRENT ISSUE

Volume XXX No. 2 – January 23, 2023
The Dark Report explores the decision by The Joint Commission to no longer accept COLA-accredited facilities at its own accredited organizations, and reprints the letters sent by both TJC and COLA relative to the move. In other news, CLIA changes are coming and The Dark Report has an exclusive interview with a member of the committee studying those potential changes.
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