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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.
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…
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…
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…
COVID-19 Variant Sequencing Offers Clinical Opportunities
This is an excerpt of a 2,987-word article in the March 1, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In Wisconsin, an oncology research lab started sequencing variants of the SARS-CoV-2 virus and fou…
SARS-CoV-2 Variant Sequencing Offers Clinical Opportunities
CEO SUMMARY: In Wisconsin, an oncology research lab started sequencing variants of the SARS-CoV-2 virus and found multiple uses for such test results to help hospitals, health systems, schools, and municipalities identify infection sources and track the virus’ spread. In one case,…
Academic, Commercial Collaboration for Testing
CEO SUMMARY: In several important ways, this collaboration involving an academic clinical laboratory and a commercial company has paid big dividends, not just for the two partners, but also the parent university that oversaw the project. The two partners developed a SARS-CoV-2 test, t…
SARS-CoV-2 Variant Sequencing Creates New Opportunities for Labs
This is an excerpt of a 2,964-word article in the February 8, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants wil…
Variant Sequencing of SARS-CoV-2 Creates Opportunities for Labs
CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants will infect people in several different countries. Here in the United States, interest is growing in having clinical laboratories sequence specimens from patients who test pos…
Proscia Lands Major Deals as Digital Pathology Demand Grows
EVEN AS THE WORLDWIDE COVID-19 PANDEMIC DERAILED SOME INDUSTRIES, it gave a major boost to digital pathology. That has meant an expanding market for Proscia, a seven-year-old provider of digital and computational pathology solutions. Established in 2014, Proscia recently won …
hc1, Visiun, and Viewics: Analytics Market Evolves
CEO SUMMARY: To understand any development in the marketplace, it is best to follow the money. That Roche, Quest Diagnostics, and LabCorp spent money either to purchase or partner with a lab analytics company in the past 36 months indicates that these enterprises believe acquiring or …
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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