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.
LabCorp, Quest Diagnostics Report Improved Q-3 Revenue
THIRD QUARTER EARNINGS at each of the nation’s two biggest public lab companies showed improved growth in revenue and specimen volume, as compared to recent years. Laboratory Corporation of America was first to release its financial report for the quarter ending September 30, 2014…
Alberta Picks Sonic Health for $3 Billion Lab Contract
CEO SUMMARY: For more than a year, Alberta’s C$3 billion RFP to develop an integrated laboratory testing service for Edmonton and surrounding regions has been the focus of intense interest. On October 17, health officials announced that Sonic Healthcare Limited was the preferred propone…
Doctors at Johns Hopkins Improve Lab Test Utilization
CEO SUMMARY: Efforts to help physicians improve their utilization of clinical lab tests paid big dividends at the Johns Hopkins Bayview Medical Center in Baltimore, Maryland. Working collaboratively, physicians and the clinical lab team identified overused or needless cardiac biomarker te…
Emmanuel Farber Dead at 95, First to Describe Carcinogenesis
ONE OF THE PATHOLOGY PROFESSION’S MOST RESPECTED cancer researchers died last month. On August 3, Emmanuel Farber, M.D., passed away. He was 95 years old. Farber was noted for his work in furthering the understanding of chemical carcinogenesis. His studies in experimental pathology revealed that c…
Ignoring Lab Industry, Theranos Goes Its Way
CEO SUMMARY: With each passing month, Theranos pulls open the curtain a bit more on its business structure and its market growth plans. Its clinical lab tests are now offered in Walgreens pharmacies in Palo Alto, California, and Phoenix, Arizona. Recent news coverage in Fortune and USATod…
My Visit to Walgreens for Theranos Lab Tests
CEO SUMMARY: One of the biggest unknowns in the lab testing industry today is Theranos, the lab testing company based in Palo Alto, California. It says its proprietary technology is poised to transform the lab testing experience for patients and physicians. It says it can perform hundreds…
Test Utilization Targeted by UnitedHealth, LabCorp
CEO SUMMARY: Many independent laboratories serving patients in Florida are unhappy about the decision by UnitedHealth (UNH) to initiate a pilot program that calls for LabCorp’s BeaconLBS subsidiary to handle prior authorization for certain lab tests. UNH’s laboratory benefit managemen…
Labs Wary of BeaconLBS, Express Major Concerns
CEO SUMMARY: Lab executives asked to join UnitedHealth’s new BeaconLBS lab benefit management system soon to launch in Florida have multiple and serious concerns. The primary issue is that BeaconLBS is a subsidiary of LabCorp—their major competitor. These executives understand why a p…
UCLA, Centre to Open Lab in China to Offer High Quality Testing
CEO SUMMARY: To fill the unmet demand for quality clinical laboratory testing in China, a partnership between pathologists at UCLA and Centre Testing International Corp. of Shenzen have built and will operate a lab facility in Shanghai. The new lab will open by late September and…
Quest Gets into Wellness By Acquiring Summit Health
IT IS NO SURPRISE THAT THE NATION’S largest laboratory companies are looking for new revenue opportunities now that fee-for-service payment for lab tests is soon to end. One striking example of this trend was the move last week by Quest Diagnostics Incorporated to acquire …
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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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