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.

Judge Issues Split Ruling on Quest’s Motion to Dismiss

CEO SUMMARY: There have been significant developments in the case against Quest Diagnostics for allegedly overcharging uninsured patients for clinical laboratory tests. This second section covers the federal judge’s most recent decisions, along with an assessment of how the plaintiffs and the defendent each received favorable rulings.
First of Two Parts: Section Two
IN THE FEDERAL LAWSUIT

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Lawsuits Allege LabCorp, Quest Overcharged Uninsured Patients

CEO SUMMARY: Court documents filed in U.S. District courts in New Jersey and North Carolina provide details about how each of the two lab companies set lab test prices differently—as much as 10 times higher—for cash-paying patients than for patients who have Medicare, Medicaid, or commercial health insurance plans. In court filings, plaintiffs allege that

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Lab Benefit Managers Want to Help Health Plans

CEO SUMMARY: Laboratory benefit management companies that offer a range of services to health insurers are gaining influence over clinical lab testing in important ways. On behalf of health insurers, LBMs will select labs for a payer’s network, then manage that network. They also manage claims and lab-test utilization, often reviewing medical necessity. A primary

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ICD-10 Gives Payers More Data About Lab Claims

CEO SUMMARY: Evidence shows that adoption of ICD-10 diagnosis codes in 2015 made it possible for health insurers to track clinical laboratory testing more closely, ask more questions about those tests, and deny coverage. Increased detail about each patient’s condition has led to increased demands for medical-necessity documentation and to denied payments of as much

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ICD-10 Codes Give Payers More Data About Lab Claims

This is an excerpt of a 1,484-word article in the Nov. 25, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group.
CEO SUMMARY: It’s an unreported trend tracked only by THE DARK REPORT, but which is essential reading for clinical labs and pathology groups that must

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Prediction of ICD-10 as Negative for Labs Comes True

IMPLEMENTATION OF ICD-10 DIAGNOSIS CODES in the United States happened on Oct. 1, 2015. At that time, a national laboratory association predicted that use of ICD-10 codes would cause Medicare Administrative Contractors (MACs) to pay labs less often and with lower reimbursement.

The Dark Report agreed with this prediction and published the warnings of the American Clinical

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November 4, 2019 Intelligence: Late Breaking Lab News

Intelligence Late & Latent News

Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage to multi-gene testing for antipsychotic drugs. In writing about this decision, www.clinicalomics.com said, “UnitedHealthcare’s policy

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How Labs Can Add Value for Providers, Insurers, Pharma

CEO SUMMARY: For pathologists and clinical, molecular, and genetic testing labs, appropriate reuses of lab data can provide a new source of revenue. Labs that serve as preferred providers of diagnostic testing data can help health systems, ordering physicians, pharmaceutical companies, and other organizations when they reuse lab test data to support evidence-based care and

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