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.
Doctor Notices Different Vitamin D Results over Time
CEO SUMMARY: Psychiatrist John J. Cannell, M.D., was in a unique position to see the noticeable upward shift in the Vitamin D results reported on his patients by Quest Diagnostics Incorporated over the past 24 months, along with the recent decline in test result levels in recent weeks. Hi…
Vitamin D Test Expert Discusses Mass Spec
CEO SUMMARY: Those labs performing Vitamin 25(OH) D testing by mass spectrometry face an interesting challenge. For more than two decades, physicians, patients, and a majority of credible clinical studies have accepted RIA and IA Vitamin 25(OH) D results as a familiar standard. That is wh…
Quest Diagnostics Explains Confidence in LC-MS/MS Method
ONE ASPECT IN THE DEBATE about the integrity of Vitamin D tests produced by liquid chromatography–tandem mass spectrometry (LC 0150MS/MS) is the discussion about how this method can produce results that are significantly higher than those produced by immunoassay-based methods. Quest Diagnostics add…
Quest Discusses Use of Mass Spec Methodology
CEO SUMMARY: Having made the decision to perform nearly all Vitamin 25(OH) D testing by liquid chromatography–tandem mass spectrometry (LC–MS/MS), Quest Diagnostics Incorporated found the transition to be challenging. That was particularly true as the volume of Vitamin D specimens tri…
Retest Program Offers Useful Lessons for Labs
CEO SUMMARY: Every day in every laboratory, there is the potential for some aspect of the testing process to go wrong and not be immediately detected. In such circumstances, the lab can then unknowingly report inaccurate test results to physicians and patients. That is why lab managers sh…
Low Vitamin D Linked To Greater Risk of Death
CEO SUMMARY: A new report in the Archives of Internal Medicine is likely to further spur demand for vitamin D testing. Already, labs are dealing with a dramatic increase in testing for vitamin D deficiency, with test volumes more than doubling in the past 12 months. This new research is c…
Quality Guru Joseph M. Juran Dies Six Weeks Ago at Age 103
HE DESCRIBED THE 20TH CENTURY as the Century of Productivity and expected the 21st Century to be the Century of Quality. Noted quality guru and management consultant Joseph M. Juran, Ph.D., died in his home in Rye, New York, on February 28 at the age of 103. Juran was the second seminal figure in th…
ACLA Prepares to Tackle Tough Lab Industry Issues
CEO SUMMARY: At its annual meeting last month, the American Clinical Laboratory Association (ACLA) rolled out a new campaign to educate Congress, government and private payers, and the American public about the value of laboratory testing. Called “Results for Life,” the campaign is a …
CDC Seeks to Identify Best Laboratory Practices
CEO SUMMARY: To advance the goal of enhancing the practice of laboratory medicine, the CDC has organized two teams of laboratory experts. They will study best practices and proficiency testing in medical labs nationwide. Such approaches as lab standards, voluntary reporting of adverse eve…
Placenta Registry Stirs Unwarranted Controversy
CEO SUMMARY: On the surface, the “exposé” published by The Oregonian newspaper on February 12 seemed designed to sensationalize an effort by local obstetricians, hospitals, and pathologists to do a better job of evaluating placentas taken from patients who had experienced a difficult…
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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