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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.
Pandemic Helped Lab with Hospital Leaders
CEO SUMMARY: Growth at Atrium Health during the COVID-19 pandemic elevated its clinical laboratory’s profile with medical leaders and health system administrators. What followed was a new spirit of collaboration that led to lab involvement in cost savings efforts, such as improved…
February 13, 2023, Intelligence: Late-Breaking Lab News
Laboratory leaders should prepare now for the end of the federal public health emergency (PHE) for SARS-CoV-2. The White House announced the PHE would cease on May 11. One big change is that patients covered by Medicare, Medicaid, or private insurance may pay higher costs for COVID-19 t…
Use Histology Laboratory Data to Illustrate Specimen ‘Life Cycle’
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
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
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
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
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
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
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
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…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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