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.
New Flu Strain Expected In Upcoming Flu Season
CEO SUMMARY: Public health labs continue to monitor for new cases of the A/Novel H1N1 flu, while preparing for what may be a difficult flu season this fall. Having coped with a 10-fold increase in testing volume, public health labs are assessing the lessons learned from the April…
Elevating Lab Testing At Policymaking Table
CEO SUMMARY: With the help of contributing clinical laboratories, the CDC has launched an ambitious effort to gather data, apply evidence review methods used in clinical studies, then identify and publish best practices in laboratory medicine. The goal is to advance the value of …
DARK REPORT and Editor Michel Earn National Reporting Award
FOR THE SECOND TIME in recent years, Editor Robert L. Michel and THE DARK REPORT have won a national award for “Best Investigative Reporting.” In Washington, DC, last month, at the Specialized Information Publishers Association (SIPA) annual conference, Editor Michel learned tha…
Teamwork Between Labs Helped NYC Flu Response
CEO SUMMARY: Shaped by the experiences of 9/11 and the anthrax outbreak in 2001, the New York City Department of Health and Mental Hygiene revised and improved its preparedness plan. With the outbreak of influenza A/Novel H1N1 this spring, the Public Health Department be…
Kaiser in Colorado Uses Lab Test Data to Improve Cardiac Care
CEO SUMMARY: Proud of a 73% reduction in mortality among patients with coronary artery disease (CAD) at Kaiser Permanente Colorado, clinical care teams there demonstrate how integrated care and more effective use of laboratory test data can lead to remarkable improvements in pati…
Need Rigorous Validation For Home Brew Assays
CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. On…
Staunch Laboratory Advocate Retires After 31 Years of Service
LAST MONTH, THE LABORATORY INDUSTRY lost one its most dedicated, full-time advocates. With his retirement in January, Joe Boone, Ph.D., ended a 31-year career with the Centers for Disease Control and Prevention (CDC). Boone started with the CDC in 1977. In 1992, he …
Dennis Monahan of ARUP Dies on Christmas Eve
HE HAD A CAREER THAT SPANNED the birth of the esoteric/reference testing industry and its evolution into a major source of advanced diagnostic services to the nation’s hospitals and commercial laboratory companies. Dennis Patrick Monahan was Vice President for National Contracts at ARUP La…
Lab Conserves Blood When Drawing Patients
CEO SUMMARY: New attention on both the risks associated with blood transfusions and the cost of blood products is triggering action by the nation’s hospitals. At the 719-bed Rhode Island Hospital, the laboratory is on the front line of the hospital’s blood management initiative. One c…
Vitamin D Test Issues Trigger Doctor Discussion
CEO SUMMARY: In recent months, Quest Diagnostics Incorporated quietly launched a campaign to notify certain patients and their physicians that they had received “inaccurate results” for Vitamin D tests it had performed. This notice includes an offer to retest the patient at no charge….
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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