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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.
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, an…
Health Insurers Spending Billions to Diversify
CEO SUMMARY: One big development affecting the health insurance business is how four of the nation’s largest health insurers are diversifying in significant ways. Last spring, a healthcare strategist explained how each of these companies has spent billions of dollars in recent years to …
Labs Need to Act on New Medicare Enrollment Rules
CEO SUMMARY: For all healthcare providers—including clinical laboratories and pathology groups—a new rule became effective this month. The rule allows Medicare to revoke or deny enrollment if a provider or supplier’s affiliates pose an undue risk of fraud. Lawyers familiar with the …
November 4, 2019 Intelligence: Late Breaking Lab 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 …
DOJ Charges 35 Individuals In Genetic Testing Scam
CEO SUMMARY: Federal prosecutors said those charged illegally lured elderly patients nationwide into giving cheek swabs for fraudulent genetic tests. The indicted individuals allegedly paid kickbacks and bribes to medical professionals working with telemedicine companies in exchange for r…
Strategist Explains Key Trends in Healthcare’s Transformation
CEO SUMMARY: Four trends are disrupting the nation’s healthcare system in ways that no one would have predicted just a few decades ago. Ted Schwab, a healthcare strategist, described these trends during his keynote presentation at the 24th Annual Executive War College in May. His insig…
Alverno Labs Adds Eight Hospitals to Its Network
CEO SUMMARY: In September, Alverno Laboratories, one of the largest networks of regional laboratories in the Midwest, added two Chicago hospital laboratories and six other hospital labs from the AMITA Health system to its network. The additional AMITA Health facilities joined Alverno as a…
Are Feds Now More Serious about Prosecuting Fraud?
IS IT A COINCIDENCE THAT, IN THIS ISSUE OF THE DARK REPORT, we cover two related developments, both involving the federal government’s efforts to control healthcare fraud and abuse? First, you’ll read about the new federal rule scheduled to take effect on Nov. 4. It gives federal healthcare inve…
ASCP, CAP Ask Anthem to Roll Back Price Cuts
CEO SUMMARY: One association representing pathologists says new payment rates that Anthem, Inc., is introducing in 14 states do not cover the costs of performing anatomic pathology and clinical lab testing for the tests in question. Another association says the steep payment cuts threaten…
Monitoring Patients on Opioids Is Opportunity for Clinical Labs
CEO SUMMARY: When developing a program to identify and treat patients who misused opioids or needed chronic opioid therapy, Community Health Network (CHN) of Indianapolis recognized that clinical lab toxicology tests were one of the few sources of objective data about patient compliance….
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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