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.
MT Contracts HIV & HCV In Hospital Lab Scandal
CEO SUMMARY: An extraordinary story is unfolding in a Baltimore hospital laboratory. Maryland state health officials have uncovered serious operational deficiencies, particularly with HIV and HCV testing performed over a 14-month period. During this same time, a medical technologist now i…
Side-by-Side Comparison: U.S. Lab Versus British Lab
CEO SUMMARY: Do clinical laboratories in any of the world’s most developed countries have a performance advantage that makes them “best of breed?” Recently, a laboratory in the United States and a laboratory in the United Kingdom had the opportunity to evaluate their financial, prod…
Boost for Labs: Study Reveals Big Care Gap
CEO SUMMARY: This research project involved 13,000 patients and a detailed review of medical records. The startling conclusion: the health system provides proper diagnosis and treatment only 55% of the time! Because of the study’s depth, it provides a compelling argument that the nation…
Genomic Health, LabCorp, DIANON Systems
GENETIC ANALYSIS FROM TISSUE BLOCKS UNVEILED IN CHICAGO IT WAS A SPECTACULAR DEBUT for a Northern California company now developing technology to allow genetic analysis of tissue blocks as a way to classify tumors. The company is Genomic Health, Inc., based in Redwood City,…
HealthcheckUSA Makes Progress With Consumers
CEO SUMMARY: There’s a story behind the story at HealthcheckUSA, one of the nation’s best-known sources offering consumers direct access to laboratory testing. Its primary business is holding community screens and grocery store lab testing programs throughout the United States. Becaus…
Con Man Rips Off Lab In Kingsport, Tennessee
CEO SUMMARY: It will certainly rank as one of the major executive frauds in the clinical laboratory industry. In the wake of MEDex Laboratories’ Chapter 11 Bankruptcy filing in April, an amazing tale of deceit and deception began unfolding. At the center of the story is ex-MEDex CEO Mic…
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…
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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