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.
‘Pull Through’ Is Key Issue in Lab Whistleblower Suit
CEO SUMMARY: Now comes a whistleblower lawsuit in federal court with the claim that, in the 2007 contract between UnitedHealth Group and Laboratory Corporation of America, LabCorp’s discounted lab test prices were a kickback that violated Medicare law. LabCorp has denied the al…
9 Pennsylvania Hospitals Tackle Lab Specimen Errors
CEO SUMMARY: In this unusual collaboration, the participating Pennsylvania hospitals dramatically reduced blood specimen labeling errors. This initiative to share best practices incorporated techniques that were refined in other projects designed to reduce medical errors and improve patie…
In Massachusetts, AG Targets Drug Testing Labs
CEO SUMMARY: Since taking office in 2007, Massachusetts Attorney General Martha Coakley has aggressively pursued civil charges against drug testing labs. Last month, Coakley announced a criminal arrest in one ongoing investigation after a grand jury indicted a physician in a kick…
POC Testing Plays Role In Penna. Patient’s Death
CEO SUMMARY: In the report by the Pennsylvania Department of Health on the death of a patient at Lehigh Valley Hospital, it was noted that the clinical staff failed to notice discrepancies between results from point-of-care (POC) tests at the bedside and lab test results from blo…
Destructive Tornado Hits Joplin Hospital, Lab Rebuilds Swiftly
CEO Summary: One week after one of the worst storms ever to strike a hospital in the U.S., St. John’s Regional Medical Center in Joplin, Missouri, was back treating patients. Surprisingly, the hospital’s lab was one of the first departments to get up and running again. Within…
Hospital Lab Operations Expert H.W. “Bud” Gandee, Jr., Dies
IN BRENTWOOD, TENNESSEE, the family of H.W. “Bud” Gandee, Jr., reported his death on April 30, at the age of 69. Gandee was an early master of hospital laboratory operations and management. He trained as a medical technologist and had graduate training in immunohematology. Early in his career, h…
Mid America Clinical Laboratories Discusses Recent Lab Errors
IN FOLLOWING UP THE DISCOVERY of false positive results for Chlamydia tests it had performed on a limited number of patients, Mid America Clinical Laboratories (MACL) found itself the subject of news coverage. This included interviews with an irate patient who told one television ne…
False Positive STD Tests Get News Coverage in Indy
CEO SUMMARY: After going public with the discovery that it had reported false positive lab test results for Chlamydia to eight female patients, Mid America Clinical Laboratories (MACL) found itself the subject of stories broadcast by a local television news program. The news cove…
Analysis of Lab Test Error Offers Lessons for Labs
CEO SUMMARY: As happens now and again, a rather typical example of an error in lab testing has made the nightly news in Indianapolis because of one justifiably irate patient who got a false positive test report for an STD. One pathologist, asked by THE DARK REPORT to assess the p…
PAML to Enter Kentucky With New Laboratory JV
CEO SUMMARY: This latest laboratory joint venture, in partnership with Saint Joseph Health System, gives Pathology Associates Medical Laboratories, LLC (PAML), a solid presence in Kentucky’s laboratory testing marketplace. Over the past 10 years, PAML, which is based in the Pac…
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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