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.

Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry

“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.”

—Ralph Taylor, President, Sysmex America, Inc.

CEO Summary: To bring testing closer to patients, clinical laboratories will need to offer sophisticated point-of-care systems

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Use of ‘1099 Marketers’ and Lab Compliance Risk

CEO SUMMARY: Experts in lab compliance predict that clinical laboratories and anatomic pathology groups must anticipate tougher enforcement of federal and state laws this year. One source of increased compliance risk for lab companies is the rising use of third-party marketing agreements. David Gee, an experienced lab industry attorney at Davis Wright Tremaine, said lab

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January 22, 2018 Intelligence: Late Breaking Lab News

Intelligence Late & Latent News

In a first for Australia, a pathology lab was given authorization to use patient-collected cervical specimens from eligible women for cervical cancer screening purposes. VCS Pathology of Melbourne, Victoria, was given this authorization by Australia’s National Association of Testing Authorities (NATA). Other pathology labs in Australia are expected to be granted similar authorization in coming

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Allegations of Lab Test Fraud Involve Multiple Defendants

CEO SUMMARY: UnitedHealth made national news when it filed a $100 million lawsuit against Next Health and other defendants in Dallas in January 2017. The insurer alleged fraud involving clinical laboratory tests. That lawsuit is just the latest chapter in an almost decade-long string of legal proceedings involving the healthcare businesses some of the defendants have

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After Court Decision, India Faces Shortage of Lab Professionals

THERE IS ALREADY A SHORTAGE of competent professionals available to sign off on medical laboratory reports in India. Now a recent Supreme Court decision may exacerbate this problem.

On Jan. 11, the Hindu Business Line, a newspaper, reported that medical labs across India could face a significant shortage of competent professionals to sign lab reports after

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