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.
Geisinger’s Coag Clinics Located in Docs’ Offices
CEO SUMMARY: It was six years ago when Geisinger Health System pushed laboratory testing and pharmacy services closer to the patients and referring physicians. By establishing coagulation clinics in six multi-specialty clinic sites, Geisinger ha…
Lab “Day of Disaster” Provides Useful Lessons
CEO SUMMARY: On Friday, May 5, laboratory administrators and pathologists who guided their labs through some of the nation’s biggest natural disasters and emergencies will gather in Miami to share their experiences in contingency planning and disaster response. It is no understatement t…
Lab Tests in Pharmacies, Genzyme, Healthe, Singing River Hospital, VA
IT IS OFTEN SUGGESTED that pharmacies are a logical place to combine laboratory testing with prescription services. Such an arrangement would be consumer-friendly and has the potential to improve patient care while lowering costs. In Great Britain, the National Health Service has launched a pilot pr…
Cervical Cancer Vaccine Trial Generates Huge Headlines
THIS IS AN UPDATE ABOUT THE RACE to be first to market a vaccine to prevent cervical cancer. Merck & Co. is currently in the lead. On October 6, 2005, Merck released results of a trial that is part of a phase III study of its vaccine, called GARDASIL™ (a “quadrivalent human …
Houston Lab Fills Gap For Katrina Evacuees
CEO SUMMARY: Literally overnight, Houston found itself dealing with tens of thousands of evacuees fleeing the destruction in New Orleans and surrounding areas. Many evacuees arrived in poor health. The Harris County Hospital District laboratorians of Houston pitched in to create an emerge…
Lab Suppliers Step Up In Katrina’s Aftermath
CEO SUMMARY: It’s a story that escapes media coverage. As Hurricane Katrina advanced northward, often the first source of fresh supplies and disaster relief for laboratories affected by the storm was their instrument vendor or other supplier. Many of these companies were prepositioning …
Michel Wins Investigative Reporting Award from Peers
IN A PRESTIGIOUS JOURNALISM CONTEST conducted by NEPA (Newsletter and Electronic Publishers Association), THE DARK REPORT’S Editor-In-Chief, Robert L. Michel, was recognized last month in the category of “best investigative reporting” for his story series on anatomic pathology …
Baylor University Lab Serves ED Needs With STAT Lab
CEO SUMMARY: Throughout the United States, hospital laboratories are working to meet ever-increasing lab testing demands by emergency department physicians. In response, many labs debate the benefits of a point-of-care testing (POCT) solution versus operating a rapid response lab in or ne…
British Early-Adopter Labs Respond to New Trends
CEO SUMMARY: On which side of the Atlantic are clinical labs better operated? This February will be the third consecutive year that progressive lab leaders from the USA and the United Kingdom convene in England to explore each country’s laboratory best practices, to swap innovations, an…
HPV Vaccine Developers Racing to Marketplace
CEO SUMMARY: At least ten companies are working on an HPV vaccine that can prevent cervical cancer. The leading two companies have Phase III clinical trials under way and expect to earn regulatory approval within the next 24 to 30 months. The speedy arrival of an HPV vaccine in the market…
CURRENT ISSUE
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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