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Clinical Laboratory

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.

New Primary Care Providers May Change Who Buys & Who Orders Lab Tests

This is an excerpt of a 2,445-word article in the June 14, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new playe…

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MedPAC Advises Congress on Lab-Data Reporting

CEO SUMMARY: For years, the clinical lab industry has sought unsuccessfully to get the federal Centers for Medicare and Medicaid Services to address the inequities in the payment formula CMS adopted after Congress passed the Protecting Access to Medicare Act (PAMA). In April, the la…

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New Players May Alter Who Buys & Who Orders Lab Tests

CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new player in healthcare that will transform the lab testing marketplace as we know it today in two ways. First, a new category of primary care providers has the potential to eventu…

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$400,000 Settlement in VA Wrongful-Death Case

CEO SUMMARY: Did “the system” fail patients and physicians at one Veterans Health Administration center? The public disciplinary records of pathologist Robert Morris Levy over several decades show that any laboratory employing Levy had reason to monitor closely the accuracy of h…

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Preparing Your Lab for Post-Pandemic Success

MOST OF US WOULD CONSIDER IT GOOD NEWS that the number of Americans vaccinated continues to grow even as the daily number of new COVID-19 cases and deaths has fallen since its peak last winter.  Data from USAFacts.com, a website developed by teams…

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UnitedHealthCare’s New Policy Further Narrows Its Lab Network

UNITEDHEALTHCARE’S (UHC) RECENT MOVE to designate certain clinical and anatomic pathology laboratories as Designated Diagnostic Providers appears to be yet one more way that the insurer is narrowing its network. Effective July 1, 2021, and subject to st…

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Lab Professions ‘Haves,’ ‘Have Nots,’ and Thieves

ONCE AGAIN, THE LATEST NEWS OF IMPORTANCE in the clinical laboratory industry includes disparate topics that include legal/regulatory, new technology in anatomic pathology, fraud involving lab testing, and more consolidation in the in vitro diagnostics (IVD) industry….

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Restitution and Guilty Plea in Two Lab Fraud Cases

CEO SUMMARY: In one case, owners and a sales rep agreed to pay restitution totaling almost $10 million. In the second case, three defendants pled guilty to federal charges involving payment or receipt of kickbacks and illegal inducements. A fourth defendent in this second case, a ph…

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April 12, 2021 Intelligence: Late-Breaking Lab News

One clinical laboratory company now says it provides COVID-19 testing services to all five of the major men’s professional sports leagues in the United States. On April 1, BioReference Laboratories, Inc. (BRLI), a division of Opko Health, announced a new agreement with Major League…

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Despite COVID-19, Regular Lab Testing Expands

TIMES ARE GOOD FOR THE REGULAR RANGE of clinical laboratory and anatomic pathology testing services. Despite the COVID-19 pandemic, the daily number of routine test specimens is near pre-pandemic levels and certain sectors of lab testing—particularly genetic tests and some high-cost assays—are sh…

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