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.
LabOne, Humana, Pathology Reference Services of Maryland
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Esoterix & UnitedHealth Sign National Test Pact
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UnitedHealth’s Decision Reveals Lab Market Shift
CEO SUMMARY: News that UnitedHealth Group, Inc. added Esoterix, Inc. to its national laboratory services contract is a big story. UnitedHealth’s decision to expand the laboratory panel demonstrates that factors other than lowest price played an important role. The move to supplement its…
Congress Holds Hearing On Hospital Lab Fiasco
CEO SUMMARY: Problems at the laboratory of Maryland General Hospital came under scrutiny at a recent Congressional hearing. There was plenty of criticism and embarrassment for several entities which should have detected the problems and reacted to the situation more effectively. Serious q…
CalPERS Drops 38 Hospitals From Its Preferred Network
IF CALPERS HAS ITS WAY, 38 hospitals and 17 physician groups will no longer be able to provide services to its healthcare network. On May 19, 2004, the California Public Employees’ Retirement System (CalPERS) announced a list of providers that it was excluding from its provider n…
Baltimore Hospital Lab Problems Put Spotlight On CAP Inspections
CEO SUMMARY: Here’s an exclusive peek into a three-year battle between medical technologists wanting to do the right thing and a laboratory manager—backed by hospital administration—who aggressively stifled well-justified dissent. It is an inside look at one of the most grievous fai…
Health Line Clinical Labs, ChromaVision, Cytyc, TriPath, Quest Diagnostics
HEALTH LINE CLINICAL LABS SIGNS $10 MILLION FRAUD SETTLEMENT WITH FEDS DESPITE THE EVIDENCE that packing unnecessary tests into test panels is not acceptable to Medicare and Medicaid authorities, some laboratories continue the practice. Health Line Clinical Laboratories, Inc…
New Esoteric Lab Firm Does Two Acquisitions
CEO SUMMARY: Armed with $70 million, American Esoteric Laboratories (AEL) wants to build a national laboratory that offers a full menu of esoteric tests. It is building a primary laboratory in Dallas, which has one of the nation’s best air transport hubs. ThromboCare Laboratories and Vi…
Growing Criticism Hits Maryland General Hospital Lab
CEO SUMMARY: “Like peeling back layers of rotten fruit, the deeper state and federal inspectors looked into the management of the hospital’s lab, the more problems they found.”–Editorial, Baltimore Sun, April 7, 2004. Public response to the inspection report of the Maryland Genera…
Specialty Laboratories, Cytyc, Quest Diagnostics, DakoCytomation, Abbot
SPECIALTY LABORATORIES SHOWS VOLUME GROWTH DURING CALENDAR 2003 If the financial performance of Specialty Laboratories, Inc. in fourth quarter 2003 is an accurate measure, it appears the company has moved past its troubling problems of 2002. For fourth quarter 2003, Special…
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Volume XXXII, No. 6 – April 21, 2025
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