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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.
Italy’s SARS-CoV-2 Outbreak Brings Out Best in Clinical Labs
CEO SUMMARY: Italy was one of the first countries outside of China to experience an explosive outbreak of COVID-19 and its northern provinces were hit hardest by this novel coronavirus. In this exclusive interview with THE DARK REPORT,…
DOJ Says Georgia Man Got Kickbacks for COVID-19 Tests
JUST WEEKS AFTER THE FIRST CASES OF SARS-CoV-2 appeared in the United States, federal prosecutors filed criminal charges in a COVID-19 lab test fraud scheme. Erik Santos, 49, of Braselton, Ga., was charged with conspiracy to defraud federal and private healthcare programs by submitting fraudule…
Chicago Lab Launches LDT, Finds 20% Positive
CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…
APRIL 20, 2020 Intelligence: Late-Breaking Lab News
Not only did the outbreak of SARS-CoV-2 in the United States show how unprepared the nation was for an event like this, but it exposed numerous problems and weaknesses in the federal agencies tasked with protecting the health and safety of the American public. One high-profile failure hap…
In New York, Lab Offers Mobile Virus Sample Collections
CEO SUMMARY: To allow patients and physicians to order at-home specimen collections of the novel coronavirus, Northwell Labs trained its 12-member mobile phlebotomy service in the procedures needed to collect samples using nasopharyngeal (NP) swabs. Since training occurred in …
This Coronavirus Outbreak Will Change Lab Industry
CEO SUMMARY: COVID-19 is causing a level of global disruption not seen since the influenza outbreak of 1918. This new infectious disease exposes flaws in the strategies and planning of public health officials and governments in the United States and abroad. In this country…
Northwell Health Labs Produce Value-Added Outcomes, Growth
>CEO SUMMARY: In 2008, the administration at the Northwell Health system on Long Island considered selling its inpatient and outpatient laboratory services to a commercial laboratory company. In response, the leaders of the Northwell Health Laboratories proposed a plan to s…
First EKRA Guilty Plea Involves Lab Kickback
CEO SUMMARY: Federal investigators wasted little time in using the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) to prosecute fraud involving clinical laboratories and providers. The manager of an opioid treatment center in Kentucky pleaded guilty last month to three counts…
January 27, 2020 Intelligence: Late-Breaking Lab News
In recent weeks, the Supreme Court declined to consider an appeal in a case which challenged a lab company’s patent on a clinical laboratory test. On Jan. 13, the justices rejected the appeal made by Athena Diagnostics, a division of Quest Diagnostics. In an earlie…
NeoGenomics Spends $37M for Human Longevity’s Oncology Division
Once again, Neogenomics, Inc. is using an acquisition to build up its cancer-testing business. In a deal that closed on Jan. 10, the lab company acquired the Oncology Division of Human Longevity, based in San Diego. Neogenomics said it paid $37 million f…
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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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