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:
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.
By Joseph Burns, from the Volume XXVI No. 16 – November 25, 2019 issue
Medicare lab test price cuts mandated by the Protecting Access to Medicare Act (PAMA) are eroding the finances of urology groups that do in-office clinical laboratory testing. In the November issue of Urology Times, urologist Robert A. Dowling, MD, wrote a news story that identified the cuts in Medicare Part B prices for the lab tests
By Joseph Burns, from the Volume XXVI No. 16 – November 25, 2019 issue
CEO SUMMARY: There have been significant developments in the case against Quest Diagnostics for allegedly overcharging uninsured patients for clinical laboratory tests. This second section covers the federal judge’s most recent decisions, along with an assessment of how the plaintiffs and the defendent each received favorable rulings.
First of Two Parts: Section Two
IN THE FEDERAL LAWSUIT
By Joseph Burns, from the Volume XXVI No. 16 – November 25, 2019 issue
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 commercial health insurance plans. In court filings, plaintiffs allege that
By Joseph Burns, from the Volume XXVI No. 16 – November 25, 2019 issue
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 claims and lab-test utilization, often reviewing medical necessity. A primary
By Joseph Burns, from the Volume XXVI No. 16 – November 25, 2019 issue
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 increased demands for medical-necessity documentation and to denied payments of as much
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 labs and pathology groups that must
By R. Lewis Dark, from the Volume XXVI No. 16 – November 25, 2019 issue
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 agreed with this prediction and published the warnings of the American Clinical
By Robert Michel, from the Volume XXVI No. 14 – October 14, 2019 issue
Pharmacogenetic testing is gaining acceptance by a growing number of health insurers. On Oct. 1, UnitedHealthcare (UHC) began coverage of genetic tests that help physicians identify the anti-depressant drugs most likely to benefit their patients. UHC’s policy also extends coverage to multi-gene testing for antipsychotic drugs. In writing about this decision, www.clinicalomics.com said, “UnitedHealthcare’s policy
By Joseph Burns, from the Volume XXVI No. 15 – November 4, 2019 issue
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 acquire other healthcare companies that are not part of the traditional
By Joseph Burns, from the Volume XXVI No. 15 – November 4, 2019 issue
CEO SUMMARY: For pathologists and clinical, molecular, and genetic testing labs, appropriate reuses of lab data can provide a new source of revenue. Labs that serve as preferred providers of diagnostic testing data can help health systems, ordering physicians, pharmaceutical companies, and other organizations when they reuse lab test data to support evidence-based care and
