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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.
Unilab & LabOne Demonstrate Improved Revenues and Profits
AFTER AN EXTENDED MULTI-YEAR financial siege, Unilab Corporation seems to be regaining its balance. First quarter financials demonstrate respectable gains in revenue and net income at the California based laboratory. Big gains were posted by LabOne, Inc. of Lenexa, …
Where Do We Go From Here?
THIS IS WRITTEN FOR BOTH LABORATORIANS COMING TO THE DARK REPORT’S Executive War College in New Orleans next week as well as those not attending. As I look at the registration list, I see a diverse range of attendees. Registered for this year’s event are CEOs of public laboratories and…
A Fable For Our Times: Lab Industry’s Golden Era
CEO SUMMARY: The clinical laboratory industry’s “Golden Era” is gone forever. Replacing it is a healthcare environment best described as “Darwinian.” It is now survival of the fittest, as hospital laboratories and commercial laboratories struggle to reinvent themselves. Case stu…
Commercial Lab Values Validated By Recent Sales
CEO SUMMARY: Many current owners of independent laboratories now wish they had sold during the glory days of commercial laboratory acquisitions. Recent sales transactions demonstrate that current market valuation for clinical laboratories is based on actual cash flow. Even at these new va…
1997 LIS Sales Rankings Topped By Cerner, LabSoft
CEO SUMMARY: Consolidation in the LIS industry continued during 1997. The impact for laboratory buyers is that market share is concentrated among fewer vendors. Over the long term, this reduces choice and leads to an oligopoly-type of market. In the short-term, all LIS companies are compe…
SmithKline, AmeriPath, Quest, Tenet
TENET AND MEDPARTNERS CONTINUE TIGHTENING THEIR SO. CALIF. ALLIANCE Remember THE DARK REPORT’S prediction that …
“May 4, 1998 Intelligence: Late Breaking Lab News”
Sales and marketing of laboratory services to physician offices is still feasible and cost-effective… if the effort is professionally managed and supported. Recently THE DARK REPORT was invited to speak at the national sales meeting of a public laboratory. Awards for 1997 sales production demonstra…
Doctors, Hospitals & HMOs Take Their Turn
IT MAY BE PREMATURE OF OUR EDITOR TO PREDICT that increasing numbers of HMOs will choose to withdraw from state Medicaid programs during the next 24 months. (See pages 4-6.) But I do think he is on target with his observations that hospitals, physicians, and insurance companies will not let …
HMOs Abandon Medicaid In Several Eastern States
CEO SUMMARY: In a number of states, certain HMOs have ceased servicing Medicaid patients. This trend will grow. It is the spearpoint for a coming battle between government healthcare programs and private healthcare providers: What level of reimbursement is adequate to provide appropriate …
Selling A Pathology Practice: Do’s, Don’ts & Pitfalls To Avoid
CEO SUMMARY: Physician practice management (PPM) companies represent a powerful new economic trend. Greater numbers of pathologists will soon confront a career-changing decision: should we sell our pathology practice to a PPM? Regardless of how pathologists answer that question, their bus…
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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