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.
Helping Uninsured Access Affordable Lab Tests
CEO SUMMARY: Here’s an innovative way to help uninsured and underinsured patients gain access to affordably priced laboratory tests. In Akron, Ohio, physicians organized a partnership between the Summit Country Medical Society and PrePaidLab, LLC, to offer laboratory tests at prices tha…
How One Akron Physician Helped Uninsured Patients
CEO SUMMARY: For one primary care physician, treating uninsured and underinsured patients was challenging, since these patients could not afford to pay for the lab tests necessary for their healthcare. This physician enlisted the help of his local county medical society and eventually fou…
Solstas Lab Partners, DNA Direct, Pathology, Inc., Slone Partners, PAML
SPECTRUM-CARILION NOW WILL BE CALLED SOLSTAS LAB PARTNERS IT IS THE NEXT STEP IN THE INTEGRATION of Spectrum Laboratory Network and Carilion Laboratories. Effective February 1, 2011, their combined businesses will use the name Solsta…
New Criticisms in Ireland About Cervical Screening
CEO SUMMARY: Pathologists worldwide are witnessing how a government health service can erode its nation’s pathology capabilities in cytology. Ireland’s experiment in off-shoring all its Pap testing even as it requires women to register in a national database in order to get f…
Better Blood Utilization Reduces Costs by 29%
CEO SUMMARY: Use of an innovative two-pronged approach helped University of Alabama at Birmingham Hospital rein in runaway cost increases in blood products. Not only did it achieve annual savings of $3.5 million in three years—a 29% reduction—but it increased blood donations …
Ireland Is Restructuring National Lab Test System
CEO SUMMARY: Working from a consultant’s report and recommendations based on studies dating back to 2006 and 2007, Ireland’s Health Service Executive is moving forward to effect a comprehensive reconfiguration of clinical laboratory testing across the nation. This ma…
Some Docs Fail to Tell Patients About Critical Results 25% of Time
PRIMARY CARE PHYSICIANS often do not report patients’ lab test results, according to a recent study of 5,434 patients aged 50 to 69. That won’t be news to most lab directors and pathologists. But there is something new and useful in this study. Its findings are revealing for three reasons. One, …
New Lab Company Is Launched By Geisinger Health System
WITH A SIMPLE ANNOUNCEMENT last month, Geisinger Health System of Danville, Pennsylvania, launched a new laboratory outreach company, called Proven Diagnostics. From a facility located in Bethlehem, Pennsylvania, Proven Diagnostics intends to compete for lab testing…
Our Editor Gets His Vitamin D Test Results From 9 Different Labs
CEO Summary: Editor-In-Chief Robert L. Michel gave blood for the cause and it’s another laboratory industry first! To understand what doctors and patients see as national labs use different methodologies and reference ranges to report Vitamin 25(OH) D results, his blood was tes…
All-Star Vitamin D Panel Looks at Lab Challenges
CEO SUMMARY: Need proof that the issues surrounding today’s Vitamin 25(OH) D are of keen interest to laboratory professionals? Not only did the EXECUTIVE WAR COLLEGE’S in depth sessions on Vitamin D draw a large audience and enthusiastic participation by attendees, but within…
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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