Tag: Clinical Laboratory

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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.

Michigan’s Ascension to Standardize Labs Throughout the State

CEO SUMMARY: Two trends are driving a movement to standardize laboratory operations across large regions: the integration of clinical care and the need for hospitals and health networks to improve patient outcomes continuously. In Michigan, Ascension Health is an example of a lab team working to standardize lab testing activities among seven organizations, 14 hospitals,

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August 20, 2018 Intelligence: Late Breaking Lab News

Intelligence Late & Latent News

There is a new sector in the clinical laboratory industry. It is called “global direct-to-consumer (DTC) genetic health testing” by Kalorama Information, a market research firm based in Rockville, Md. In a recent report, Kalorama says this sector is comprised of the direct-to-consumer genetic tests which are initiated by the consumer, meaning that the consumer decides

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FDA Issues Response to Draft Legislation to Regulate LDTs

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At

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Québec’s Laboratory Consolidation Plan Aims to Save $13.5M

CEO SUMMARY: In the Province of Québec, an ambitious project is under-way to consolidate the clinical laboratory testing of 123 laboratories into 11 centralized lab clusters. It is one of the largest lab consolidation projects nowhappening in the world. Among the goals of this project is to improve qualityand efficiency while incurring no additional costs.

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