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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.

DOJ Charges 35 Individuals In Genetic Testing Scam

CEO SUMMARY: Federal prosecutors said those charged illegally lured elderly patients nationwide into giving cheek swabs for fraudulent genetic tests. The indicted individuals allegedly paid kickbacks and bribes to medical professionals working with telemedicine companies in exchange for referring Medicare beneficiaries for unnecessary genetic tests. Indictments were announced on Sept. 27 in an investigation that

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Strategist Explains Key Trends in Healthcare’s Transformation

CEO SUMMARY: Four trends are disrupting the nation’s healthcare system in ways that no one would have predicted just a few decades ago. Ted Schwab, a healthcare strategist, described these trends during his keynote presentation at the 24th Annual Executive War College in May. His insights and predictions will help clinical laboratory directors and pathologists develop

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Alverno Labs Adds Eight Hospitals to Its Network

CEO SUMMARY: In September, Alverno Laboratories, one of the largest networks of regional laboratories in the Midwest, added two Chicago hospital laboratories and six other hospital labs from the AMITA Health system to its network. The additional AMITA Health facilities joined Alverno as a result of health system consolidation. The consolidation of hospitals into health

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Monitoring Patients on Opioids Is Opportunity for Clinical Labs

CEO SUMMARY: When developing a program to identify and treat patients who misused opioids or needed chronic opioid therapy, Community Health Network (CHN) of Indianapolis recognized that clinical lab toxicology tests were one of the few sources of objective data about patient compliance. When CHN developed its Chronic Opioid Therapy (COT) program, protocols were included that

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Monitoring Patients on Opioids with Toxicology Screens Is Opportunity for Clinical Labs

This is an excerpt of a 2,883-word article in the Sept. 23, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group.
CEO SUMMARY: In this first industry briefing on such a program, THE DARK REPORT explains that Community Health Network (CHN) of Indianapolis recognized that clinical

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