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.
Clinical laboratories are at the forefront of the personalized medicine trend. However, they are also targets for cost-cutting measures by payers, and increased regulation by CMS and FDA, making the industry a challenging one in which to succeed.
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. Under their respective approaches to laboratory licensure and accreditation, many countries have legal requirements that medical laboratories must be accredited to ISO 15189. This is not true in the United States.
In the United States, there are federal and state laws that address the licensure and accreditation of medical laboratories. 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.
OPKO’s BioReference, Sonic Each Release Earnings Reports
BELOW IS A SUMMARY OF RECENT FINANCIAL EARNING REPORTS for OPKO’s BioReference Laboratories and Sonic Healthcare Ltd’s lab operations in the U.S. This finishes our coverage of Q3-23 financial reporting by the larger public laboratory corporations. …
Q3 2023 Financial Reports Show Growth at Labcorp, Quest
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UHC’s Z-Code Requirement to Commence on Aug. 1
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Data Analytics Improves Lab Productivity, Turnaround Time
CEO SUMMARY: An increased ability to analyze internal diagnostic data helped MultiCare Health System improve laboratory test turnaround times in real time and more efficiently staff i…
CLIA Lab Accreditors Reveal Most Frequent Deficiencies
CEO SUMMARY: CAP, The Joint Commission, COLA, and A2LA took the stage at the recent Executive War College to detail their respective lists of the 10 most often-cited standards during…
Elizabeth Holmes Still Wants ‘To Contribute’ in Healthcare
CLINICL LABORATORY AND ANATOMIC PATHOLOGY PROFESSIONALS have another reason to shake …
Despite COVID-19 Losses, IVD Executives Remain Upbeat
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Major Events on Horizon to Reshape Lab Market
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Lab Execs Allegedly Lied to FDA about Faulty Tests
CEO SUMMARY: Three former executives of a lab testing company face criminal charges. Federal prosecutors claim that the three plaintiffs who previously worked at Magellan Diagnostics flagrantly hid…
CURRENT ISSUE
Volume XXXII, No. 17 – December 8, 2025
Laboratory professionals are urged to make their voices heard in Congress as the end of a brief reprieve to PAMA cuts comes on January 30, 2026. Congress is said to be inclined to address reformation of PAMA now. Also, pathologists are slowly switching to cloud storage for their digital slides.
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