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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.
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.
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.
Sonic Healthcare Acquires Labs from Aussie Competitor
LABORATORY CONSOLIDATION continues in Australia with news that Sonic Healthcare Limited of Sydney, Australia, has agreed to acquire three clinical laboratory business units from competitor Healthscope, Ltd., of Melbourne, Australia. The acquisition was announced on …
In Florida, New Law Bans Certain Lab Sales Practices
CEO SUMMARY: Florida law has long prohibited clinical laboratories from giving kickbacks and other forms of remuneration to physicians to induce specimen referrals. Specifically, state regulations have prevented labs from placing specimen collectors in physicians’ offices. Despite these…
Lab Restructuring Moves Ahead in United Kingdom and Ireland
IT IS TOUGH TIMES FINANCIALLY for pathology and clinical laboratories in the British Isles. In both the nations of the United Kingdom and Ireland, the budget woes of the respective national governments are driving major changes in the organization and delivery of laboratory testing services. In the …
Executive War College Looks at Threats to Lab Industry
CEO SUMMARY: Taken collectively, the speakers at the opening session of the 17th Annual Executive War College on Lab and Pathology Management had a powerful message to the nearly 700 attendees. After years of slow movement, a rapid transformation of the American healthcare system is about…
Inadvertent PT “Errors” Trigger CLIA Sanctions
CEO SUMMARY: Despite taking appropriate steps to complete proficiency testing (PT), in recent years an unknown number of labs were determined to be in violation of CLIA requirements. Federal regulators are enforcing penalties ranging from suspension of the labs’ licenses to transition t…
Sarasota Hospital Lab Reduces Number of Hemolyzed Specimens
CEO SUMMARY: Seeking to improve turnaround time for stat lab tests, the laboratory at Sarasota Memorial Health Care System identified high rates of hemolysis as the chief reason for less than ideal TAT. Because 32% of blood draws were handled by the lab’s phlebotomy staff while 68% of b…
Patient Service Center Theft Highlights Labs’ Need to Protect Paper Records
LABS PUT SO MUCH EFFORT INTO SECURING electronic health records, that it’s easy to overlook the need to protect paper records. St. Joseph’s Medical Center in Stockton, California, learned this lesson the hard way recently when thieves stole more than 700 paper re…
Magnets to Move Tubes on ARUP’s Testing Line
CEO SUMMARY: In Salt Lake City, Utah, work is underway to pioneer use of an electro-magnetic conveyor system to automate the movement of large volumes of lab test specimens throughout the testing facility of ARUP Laboratories. Within two years, this new lab automation technology could all…
MD Self-Referral Issues Target of Utilization Study
CEO SUMMARY: When it comes to the in-office ancillary service (IOAS) exception to physician self-referral, the issue of in-clinic pathology services has become a hot potato. Publication in Health Affairs of a study of urologists’ self-referral of their patients for anatomic pathology se…
Hospitals Get Bad News Re: TC Grandfather Expire
CEO SUMMARY: During negotiations to extend the payroll tax cut in February, Congressional negotiators agreed to end the technical component (TC) grandfather provision for more than 1,000 rural hospitals. Seeking to save $50 million annually, Congress said anatomic pathologists would no lo…
CURRENT ISSUE
Volume XXXII, No. 14 – October 6, 2025
The Dark Report examines increasing healthcare costs for employers and how clinical labs can help those employers. Also, an in-depth case study shows how one hospital system regained its outreach program after originally ceding it to a national lab company, adding millions to the system’s bottom line.
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