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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.
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…
Lab Benefit Managers Want to Help Health Plans
CEO SUMMARY: Laboratory benefit management companies that offer a range of services to health insurers are gaining influence over clinical lab testing in important ways. On behalf of health insurers, LBMs will select labs for a payer’s network, then manage that network. They also manage…
ICD-10 Gives Payers More Data About Lab Claims
CEO SUMMARY: Evidence shows that adoption of ICD-10 diagnosis codes in 2015 made it possible for health insurers to track clinical laboratory testing more closely, ask more questions about those tests, and deny coverage. Increased detail about each patient’s condition has led to increas…
Prediction of ICD-10 as Negative for Labs Comes True
IMPLEMENTATION OF ICD-10 DIAGNOSIS CODES in the United States happened on Oct. 1, 2015. At that time, a national laboratory association predicted that use of ICD-10 codes would cause Medicare Administrative Contractors (MACs) to pay labs less often and with lower reimbursement. The Dark Report ag…
ICD-10 Codes Give Payers More Data About Lab Claims
This is an excerpt of a 1,484-word article in the Nov. 25, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: It’s an unreported trend tracked only by THE DARK REPORT, but which is essential reading for clinical …
January 6, 2020 Intelligence: Late Breaking Lab News
On Dec. 19, Congress passed a year-end spending bill that included the Laboratory Access for Beneficiaries (LAB) Act. The bill went to the President for his signature. The bill mandates that the federal Centers or Medicare and Medicaid Services (CMS) delay by one year having labs rep…
December 16, 2019 Intelligence: Late Breaking Lab News
John M. Mattsen, III, MD, one of the founders of ARUP Laboratories of Salt Lake City, died on November 9, at the age of 86. As a pathologist and an executive leader, he was at the forefront of laboratory medicine for many decades. A graduate of Brigham Young University…
Lawsuits Alleging Overcharges to Proceed in Two Courts in 2020
CEO SUMMARY: Two lawsuits filed in federal courts against Laboratory Corporation of America and Quest Diagnostics may have consequences for the entire lab industry. The plaintiffs are patients who allege that the two defendant lab companies charged them as much as 10 times more than what …
2019’s Top 10 Lab Stories Reveal Major Laboratory Industry Trends
This is an excerpt of a 3,163-word article in the Dec. 16, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There was plenty of bad news in 2019 for clinical labs and pathology groups. Yet lurking inside this new…
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 …
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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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