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.
Italy’s SARS-CoV-2 Outbreak Brings Out Best in Clinical Labs
CEO SUMMARY: Italy was one of the first countries outside of China to experience an explosive outbreak of COVID-19 and its northern provinces were hit hardest by this novel coronavirus. In this exclusive interview with THE DARK REPORT,…
Chicago Lab Launches LDT, Finds 20% Positive
CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…
In New York, Lab Offers Mobile Virus Sample Collections
CEO SUMMARY: To allow patients and physicians to order at-home specimen collections of the novel coronavirus, Northwell Labs trained its 12-member mobile phlebotomy service in the procedures needed to collect samples using nasopharyngeal (NP) swabs. Since training occurred in …
Labs in Italy Moved Fast to Develop COVID-19 Tests
Part One in a Series ITALY HAS ONE OF THE WORLD’S SEVEREST OUTBREAKS OF COVID-19 INFECTIONS, based on the number of cases and the mortality rate. In response, clinical laboratories there moved quickly to launch laboratory-developed tests and to increase the volume of COVID-19…
Drive-Up COVID-19 Test Site Launched in 3 Days
CEO SUMMARY: After seeing the largest cluster of confirmed coronavirus infections in one location, New York State took emergency measures “to attack the hotspot at its source.” The state opened a drive-through specimen-collection site offering free testing without an appoi…
Providers Get Creative as FDA Clears More IVD Firms’ Tests
CEO SUMMARY: Clinical and molecular test laboratories, hospitals, public health agencies, and other providers are taking unusual measures to expand the number of tests available to identify the spread of the new coronavirus. When a hospital needed funding to buy test kits for …
Lawsuits Allege LabCorp, Quest Overcharged Uninsured Patients
CEO SUMMARY: Court documents filed in U.S. District courts in New Jersey and North Carolina provide details about how each of the two lab companies set lab test prices differently—as much as 10 times higher—for cash-paying patients than for patients who have Medicare, Medicaid, or com…
Health Insurers Spending Billions to Diversify
CEO SUMMARY: One big development affecting the health insurance business is how four of the nation’s largest health insurers are diversifying in significant ways. Last spring, a healthcare strategist explained how each of these companies has spent billions of dollars in recent years to …
Health Insurers Spending Billions to Diversify
CEO SUMMARY: One big development affecting the health insurance business is how four of the nation’s largest health insurers are diversifying in significant ways. Last spring, a healthcare strategist explained how each of these companies has spent billions of dollars in recent years to …
Alverno Labs Adds Eight Hospitals to Its Network
CEO SUMMARY: In September, Alverno Laboratories, one of the largest networks of regional laboratories in the Midwest, added two Chicago hospital laboratories and six other hospital labs from the AMITA Health system to its network. The additional AMITA Health facilities joined Alverno as a…
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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