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.
WSJ ‘Sticks’ Theranos, Raises Serious Questions
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Investment Bank Bullish On Clinical Labs, Pathology
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Lab Test Utilization Delivers Big Gains at Cleveland Clinic
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Fewer Blood Draws at UCSF Boost Patient Satisfaction
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Leveraging Testing Technology To Identify MRSA, C. Difficile
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‘Nanotainer’ vs. ‘Microtainer’: Theranos Sues Becton Dickinson
BY FILING A LAWSUIT IN FEDERAL COURT against Becton Dickinson, Theranos, the ultra-secretive lab testing company based in Palo Alto, California, has once again put itself in the headlines. In papers it filed in the United States District Court for the Northern District of California, …
Is PAML to Be Sold? ‘No Comment!’ Say Execs
CEO SUMMARY: It is one of the 10 largest lab companies in the United States. Thus, if Pathology Associates Medical Laboratories in Spokane, Washington, were to be sold, it would trigger a major shift in the competitive market for lab testing service…
The Curious Case of Dr. Cockerill, Mayo Clinic and Quest Diagnostics
MOST PEOPLE WOULD CONSIDER the job of Chairman of the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic and CEO of Mayo Medical Laboratories (MML) to be at the pinnacle of the pathology profession. This makes it all the more curious as to why pat…
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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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