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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.

Value-Based Care Is One Goal Of WHCN-Sonic Lab JV

CEO SUMMARY: Announced last month, the new laboratory joint-venture partnership with Sonic Healthcare’s Sunrise Clinical Laboratories will allow WCHN to compete with other health systems and prepare to respond to health insurers’ requests that hospital systems offer lower rates in value-based payment models. WCHN has already seen payers shift to low-cost providers. For this reason,

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Health System Lab Is Genotyping To Identify Best Drugs for Patients

CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers and Medicare to reimburse for pharmacogenomic tests, Avera Institute for Human Genetics (AIHG) in

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Another Pharmacogenomic Lab Hit With Audit, Multi-million Dollar Repayment Demand

CEO SUMMARY: In 2014, during a ZPIC audit of an unnamed pharmacogenomic testing lab, a federal auditor reviewed a small number of claims that had been filed over a period of several years. Despite supporting letters from physicians, the auditor rejected those claims, then extrapolated the findings to declare payments for thousands of tests over

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