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.
MedUnite, Bio-Reference Labs, X-Fin, Sunquest/Misys, Roche Holdings
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Pacificare, IBM, Keane, MedicaLogic/MedScape, WebMD, DrKoop.com
PACIFICARE BEGINS SERIOUS RESTRUCTURING TO SHIFT EMPHASIS NOT SO MANY YEARS AGO, PacifiCare Health Systems Inc. was considered the quintessential embodiment of all that was expected to be good with managed healthcare. The company’s business model was studied and copied in…
Patent Access Limits Rapid HIV Testing in USA
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DIANON Systems, United Health, Aetna, Quest Diagnostics, Orchid, AmeriPath
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Hermann Lab Rebuilt in Weeks, Reopens With Entire Hospital
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Labs in NY & Wash, DC Get Anthrax Test Orders
CEO SUMMARY: In both New York City and Washington, DC, widespread publicity about exposure to anthrax generated a steady volume of test requests. Clinical labs in both cities adopted similar management strategies to deal with the sudden public interest in anthrax testing. One common step …
Roche, Digene, Centrex, Labtest.com, Specialty Labs, Tripath Imaging
ROCHE DIAGNOSTICS POSITIONED TO SERVE PUBLIC HEALTH LABS HEIGHTENED CONCERNS over bioterrorist attacks have accelerated plans within the public health lab sector to acquire state-of-the art diagnostic technology in DNA typing and enzyme immunoassay. Roche Diagnostics has in…
Nation’s Anthrax Cases Bring Bioterror to Labs
CEO SUMMARY: America’s clinical laboratories are soon to be enlisted in the war against terrorism. Concerns about chemical and biological terrorist attacks have reached high levels following the death of a Florida man from pulmonary anthrax and the discovery of letters containing anthra…
Washington G-2, AACC, Cerner, IBM, Visible Genetics, Bio-Reference Labs
LAB MEETINGS CONTINUE WITH STRONG ATTENDANCE DESPITE THE HASSLES that now come with cross-country travel, laboratorians throughout the United States continue to support industry meetings. Traditionally the largest lab meeting of the fall season, “Lab Institute 2001” expects good attenda…
NYC Lab Hand-Entered Reqs After Terrorist Acts
CEO SUMMARY: Crisis management was the watchword at Centralized Laboratory Services, Inc. of New York City following the terrorist attacks on September 11. Damage around the World Trade Center knocked out the communications link between the lab and a data server which transmitted electron…
CURRENT ISSUE
Volume XXXII, No. 14 – October 6, 2025
The Dark Report examines increasing healthcare costs for employers and how clinical labs can help those employers. Also, an in-depth case study shows how one hospital system regained its outreach program after originally ceding it to a national lab company, adding millions to the system’s bottom line.
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