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.
Eritrea Uses St. Louis For Reference Testing
CEO SUMMARY: On one level, it’s the classic story of volunteerism and help for a developing nation. But on another level, it’s a dramatic demonstration of how new technologies allow two hospital laboratories in St. Louis, Missouri to effectively provide reference laboratory tests and …
SARS Contained in Toronto, Labs Still in Caution Mode
IN RECENT DAYS, public health officials in the Canadian province of Ontario have declared the SARS outbreak to be contained. As described in the last issue of THE DARK REPORT, the outbreak of SARS in Ontario had a significant operational impact on clinical laboratories in the province. (See TDR,…
Specialty Laboratories, IMPATH, Roche, Abbott Laboratories, Celera Diagnostics
SPECIALTY LABORATORIES RESTORING STABILITY IN SPECIMEN VOLUME IT’S NO SURPRISE THAT COMPETITORS of Specialty Laboratories, Inc. have been willing to spread a variety of rumors about the laboratory company, given its well-publicized troubles with government regulators last …
Toronto Hospital Labs Cope With SARS Impact
CEO SUMMARY: Canada has become one of the world’s hot spots for SARS. Concern about the unexpected number of hospital workers who contracted the disease triggered a halt to all but the most life-threatening patient care needs in many hospitals in Ontario. The manner in which this diseas…
Commercial Labs React To Ontario SARS Outbreak
CEO SUMMARY: Ontario’s SARS outbreak has affected commercial laboratory companies in the province. Because so many healthcare workers were contracting SARS, laboratory directors at MDS Diagnostic Services took swift action to protect both patients and laboratory staff—to prevent expos…
LabCorp’s MacMahon Provides Insights About Lab Marketplace
CEO SUMMARY: Pathologists will be particularly interested in what Thomas MacMahon has to say about the evolution of laboratory medicine. As Chairman, President, and CEO of Laboratory Corporation of America Holdings, he has continuous access to some of the best strategic analysis about the…
Oldest “Working” Pathologist Dies at 104 on March 9
WORKING EIGHT-HOUR DAYS until a few weeks before his death on March 9, pathologist F. William Sunderman, M.D., Ph.D., Sc.D., lived a remarkable life. During his 104-year life, Dr. Sunderman played a key role in founding the Pennsylvania Association of Clinical Pathologists in 1946 a…
Bio-Reference Labs, Quest Diagnostics, TriPath Imaging, Specialty Labs, SARS
BIO-REFERENCE LABS POSTS 20% INCREASE IN ANNUAL NET REVENUE LAST YEAR’S FRENZY of laboratory acquisitions left Bio-Reference Laboratories, Inc. of Elmwood Park, New Jersey as the nation’s third-largest public laboratory company focused primarily on physicians’ office t…
Carolina Blood Bank, PSA, Carolinas Healthcare, Leapfrog Group, CMS
PATHOLOGY GROUP IN SALT LAKE CITY BECOMES PSA MEMBER UTAH IS THE NEWEST STATE to have a pathology group practice become part of Pathology Service Associates, LLC (PSA). Based in Salt Lake City, Utah Pathology Services, Inc. is the first PSA-affiliated pract…
Liquid Prep Testing Market Causing Much Aggravation
SEVERAL RECENT ISSUES of THE DARK REPORT addressed issues that resonated with our clients and regular readers. The mailbag has been plenty full of late. These responses are interesting in their own right. Among those with a point to make is Laboratory Corporation of America Holdings…
CURRENT ISSUE
Volume XXXII, No. 14 – October 6, 2025
The Dark Report examines increasing healthcare costs for employers and how clinical labs can help those employers. Also, an in-depth case study shows how one hospital system regained its outreach program after originally ceding it to a national lab company, adding millions to the system’s bottom line.
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