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.

Rural Hospital Spokesman: Hospital Lab Outreach Programs Are Legal

CEO SUMMARY: As the debate grows more heated, supporters of hospital outpatient department (HOPD) billing schemes have ramped up their defense of the practice. The president of the National Association of Rural Hospitals tells THE DARK REPORT that rural hospitals are permitted to bill for hospital lab outreach program services under Medicare’s 70/30 shell rule.

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Rural Hospital Group Says Lab Billing Model Is Legal

CEO SUMMARY: In recent years, many rural hospitals have entered into agreements to expand their laboratory outreach businesses. In an interview, the president of the National Association of Rural Hospitals said rural hospitals often bill for lab outreach services under Medicare’s 70/30 shell rule. This rule, as modified by the Omnibus Budget Reconciliation Act of

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Theranos News Gets Worse for the Former Silicon Valley Hero

CEO SUMMARY: In a tale of two fraudsters, the Department of Justice has filed a warning shot to all technology startups: Criminal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani could mean prison time and massive fines. In this latest Theranos news, The DOJ cited harm to investors, doctors and patients by the two company

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Theranos’ Elizabeth Holmes Prepares to Meet Justice

IT’S NOW CLEAR THAT TWO CLINICAL LABORATORY EXECUTIVES COMMITED one of the largest corporate fraud schemes in the past century.

Reading the federal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani unsealed Friday provides insights into the extensive scale and wide scope of the alleged fraud the two Theranos executives perpetrated against patients, doctors, and investors.

When

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