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.
New Market Channel For Esoteric Testing
CEO SUMMARY: It’s a new marketing model for specialty esoteric tests that presents both clinical and financial challenges to hospital and health system laboratories. Niche labs offering esoteric tests are sending sales reps directly to physicians and bypassing pathologists and lab direc…
Unfolding Events at Unilab, Specialty Labs and Dynacare
RECENT WEEKS BROUGHT important developments to several public lab companies. Each development changes and alters the competitive marketplace for laboratory testing services. It was big news at Specialty Laboratories, Inc. when the troubled lab company signed a Plan of Correction (PO…
Two New Public Labs Launch Operations in FL
CEO SUMMARY: In 49 states, independent commercial laboratory companies are disappearing. But that’s not the case in Florida. In recent months, two new public laboratory companies completed organizational steps and now offer diagnostic testing services. Both companies are starting small,…
Aetna, AmeriPath, DIANON, IMPATH, JCAHO
AETNA RECOMMENDS PAYERS SUPPORT GENETIC SCREENING TESTS ALL LABORATORIANS SHOULD send a special note of thanks to Aetna Chairman and CEO John W. Rowe, M.D. for his recommendation that the health industry support the concept of genetic testing. He made these recommendations as part of speech…
Myriad Genetics, LabCorp, Abbott Labs, OraSure,TheraSense
DIRECT-TO-CONSUMER ADS FROM MYRIAD GENETICS TO START THIS FALL FOLLOWING THE EXAMPLE of the pharmaceutical industry in using direct-to consumer advertising to build drug sales, Myriad Genetics, Inc. is about to launch an advertising campaign for its predictive genetics tests…
CPI Lab Fee Adjustment Threatened by New Bill
CEO SUMMARY: Once again, the laboratory testing industry has been singled out as a healthcare “whipping boy” by Congressional aides. In working to develop the next federal budget, legislators again propose to deny annual CPI price updates for laboratory tests. This won’t be anything…
Sigma-Aldrich, Ivax Diagnostics, i-STAT, Quest Diagnostics, Unilab
SIGMA-ALDRICH SELLS ITS EIA PRODUCT LINE TO IVAX DIAGNOSTICS FOLLOWING ITS DECISION TO EXIT the clinical diagnostics market, Sigma-Aldrich, Inc. has sold its global enzyme immunoassay (EIA) product line to Ivax Diagnostics, Inc., based in Miami, Florida. Th…
More Lab Consolidation: LabCorp Buys Dynacare
CEO SUMMARY: Recent weeks brought many rumors about an impending deal between Laboratory Corporation of America and Dynacare. That speculation was ended last week when it was disclosed that LabCorp would pay about $685 million in cash, stock and assumed debt to acquire Dynacare. The acqui…
Specialty Labs Coping With Unique Challenges
CEO SUMMARY: Few laboratory executives have ever been tested as intensely as those of Specialty Laboratories, Inc. Since the first of the year, Quest Diagnostics Incorporated has purchased two of its biggest lab clients. In April, state and federal lab regulators issued sanctions. Both de…
THE DARK REPORT’S Annual Ranking of Public Laboratory Companies
Boom times continued during 2001 for both the clinical laboratory industry and anatomic pathology profession. Throughout 2001, almost every public lab company was able to post double-digit revenue growth. For a number of companies, this growth was accomplished b…
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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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