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.
NeoGenomics Acquires Inivata to Access Liquid Biopsy Technology
SOME BELIEVE THAT LIQUID BIOPSY TECHNOLOGY has the potential to develop into a Holy Grail of cancer diagnostics. Yet progress in this field has been slow. Now a recent lab acquisition may accelerate the development of clinically-useful liquid biopsies. There is keen interest in how to achieve the …
India’s Neuberg Diagnostics Expands into U.S. Market
“Our idea is to enhance the access and affordability for next-generation techniques, meaning molecular diagnostics, genomics, pathology, digital pathology, proteomics, metabolomics, and all that. This is the spirit behind Neuberg Diagnostics. —GSK Velu, PhD, BPharm …
Lab Briefs
University of Miami Settles Lab Qui Tam Lawsuit for $22 Million EARLIER THIS MONTH, THE FEDERAL DEPARTMENT OF JUSTICE (DOJ) announced a settlement with the University of Miami that resolves allegations that the university ordered medicall…
Lab Briefs
Lighthouse Lab Services Acquires Vachette Pathology Last month, it was announced that Lighthouse Lab Services of Charlotte, N.C., had acquired Vachette Pathology of Sylvania, Ohio. Price and terms of the acquisition were not d…
Hospitals Say New UHC Policy on Lab Network Is Anticompetitive
IT’S NOT OFTEN THAT HOSPITAL ASSOCIATIONS WILL DIRECTLY OPPOSE the changes that health insurers want to make in how they pay for clinical laboratory tests. But that is now happening with UnitedHealthcare’s new lab test payment policy that directly reduces what many hospital labs are paid fo…
Academic, Commercial Collaboration for Testing
CEO SUMMARY: In several important ways, this collaboration involving an academic clinical laboratory and a commercial company has paid big dividends, not just for the two partners, but also the parent university that oversaw the project. The two partners developed a SARS-CoV-2 test, t…
Variant Sequencing of SARS-CoV-2 Creates Opportunities for Labs
CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants will infect people in several different countries. Here in the United States, interest is growing in having clinical laboratories sequence specimens from patients who test pos…
Understanding Differences Between 2 CLIA Accreditors
MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation …
One Genetic Test CPT Code Earns ‘Fraudomatic’ Title
CEO SUMMARY: Several genetic testing companies have noticed that some of the nation’s Medicare Administrative Contractors (MAC) pay about $2,000 for test claims billed with CPT code 81408. From 2018 through and 2019, the number of 81408 claims rose dramatically at just two of thes…
Memphis Path Lab Pivots to COVID, Pooled Testing
CEO SUMMARY: When routine testing volume declined sharply last winter and spring, one of the nation’s largest anatomic pathology groups added testing for COVID-19 and boosted revenue significantly. Since then, the laboratory has become the first in the nation to gain an Emergency …
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.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.