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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.
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.
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.
Preparing for New Lab Role In Personalized Medicine
CEO SUMMARY: Laboratory medicine is about to find itself between the two jaws of a powerful vise. One jaw is pending major legislative overhaul of the entire healthcare system, along with dwindling reimbursement as Medicare and Medicaid runs out of money. The other jaw is personalized med…
Pace of Lab Acquisitions Increased during 2009
CEO SUMMARY: After two years of relatively slow sales of clinical labs, there is pent up demand for lab acquisitions and a declining supply of independent labs available for sale. That’s the assessment of one expert on laboratory mergers and acquisitions, who predicts that the accelerat…
Predict 2010 To Be Busy For Lab Owners & Buyers
CEO SUMMARY: Along with a recovering economy, the possibility of an increase in the capital gains tax rate for 2011 may encourage owners of clinical labs and anatomic pathology companies to sell their businesses during 2010. That could make 2010 a busy year for laboratory…
Multispectral Tests Use “Smart” Systems To Analyze Tissue
CEO Summary: Pathologists at the Hospital of the University of Pennsylvania are using a new system that combines image analysis software and algorithms to evaluate images containing numerous stains and biomarkers. Pathologists teach the system to identify tumor cells and distinguish them …
Beckman Coulter, Olympus, LabCorp, Anthem, WellPoint, Medtox, University of Toronto
BECKMAN COULTER REPORTS EARNINGS THAT INCLUDE OLYMPUS THERE WAS A BIG JUMP in fourth quarter revenue at Beckman Coulter Inc., of Brea, California, which increased by 22% over the previous year, to $989.6 million. This number included $120.2 million in reven…
Anatomic Pathology’s Likely Path of Transformation
RECENT DEALS INVOLVING PRIVATE EQUITY FIRMS and several of the nation’s larger pathology groups hint at a major transformation soon to come to the pathology profession. No one should be surprised that pathologists of the baby boomer generation will be an important trigger in this transformation. I…
Ireland Is Restructuring National Lab Test System
CEO SUMMARY: Working from a consultant’s report and recommendations based on studies dating back to 2006 and 2007, Ireland’s Health Service Executive is moving forward to effect a comprehensive reconfiguration of clinical laboratory testing across the nation. This ma…
Predict 60,000 Doctors To Adopt EMRs Each Year
CEO SUMMARY: Only about 180,000 U.S. physicians have adopted electronic medical record (EMR) systems over the past 14 years—mostly in larger medical groups. Now experts believe as many as 60,000 physicians per year will begin to adopt EMRs because of new federal incenti…
Two Big Pathology Groups Tap Investors for Capital
CEO SUMMARY: Pathology supergroups in California and Tennessee have each announced major recapitalizations. Both groups will use some of the money to cash out retiring partners. The balance of the new capital will be used to expand their businesses. With so many baby boomer pathologists a…
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
CURRENT ISSUE
Volume XXXIII, No. 4 – March 23, 2026
A federal court ruling has established a safe harbor for clinical labs when they run tests ordered by physicians. Lab leaders should examine this briefing for pitfalls. Also, it turns out that providers may be ordering inappropriate vitamin D tests, according to one expert.
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