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 Robert Michel, from the Volume XXVI No. 13 – September 23, 2019 issue
Spectra Laboratories, a division of the national dialysis company Fresenius Medical Care, will soon open a new 200,000 square foot laboratory facility in Memphis. The new lab will employ more than 300 people and will be located only 15 minutes from the Memphis International Airport and the Memphis world hub operated by FedEx Corporation. The
By Joseph Burns, from the Volume XXVI No. 13 – September 23, 2019 issue
CEO SUMMARY: Hospitals and health systems developing programs to manage patients on chronic opioid therapy (COT) are finding that an essential element of these programs is regular toxicology testing. In its role as the toxicology test provider for a health network in Indiana, AIT Laboratories of Denton, Texas, has found that COT patients improved their
By Joseph Burns, from the Volume XXVI No. 13 – September 23, 2019 issue
CEO SUMMARY: When developing a program to identify and treat patients who misused opioids or needed chronic opioid therapy, Community Health Network (CHN) of Indianapolis recognized that clinical lab toxicology tests were one of the few sources of objective data about patient compliance. When CHN developed its Chronic Opioid Therapy (COT) program, protocols were included that
By Joseph Burns, from the Volume XXVI No. 13 – September 23, 2019 issue
CEO SUMMARY: One association representing pathologists says new payment rates that Anthem, Inc., is introducing in 14 states do not cover the costs of performing anatomic pathology and clinical lab testing for the tests in question. Another association says the steep payment cuts threaten the viability of small and rural pathology groups. State-by-state, Anthem is
By Mary Van Doren, from the Volume XXVI No. 13 – September 23, 2019 issue
This is an excerpt of a 2,883-word article in the Sept. 23, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group.
CEO SUMMARY: In this first industry briefing on such a program, THE DARK REPORT explains that Community Health Network (CHN) of Indianapolis recognized that clinical
By Mary Van Doren, from the Volume XXVI No. 12 – September 3, 2019 issue
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group.
CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In
By Robert Michel, from the Volume XXVI No. 12 – September 3, 2019 issue
Two more clinical laboratory organizations that used American Medical Collection Agency (AMCA) to handle their lab test claims announced in July that their patients’ data was breached. Inform Diagnostics of Irving, Texas, disclosed that the data of 173,716 patients was compromised. Within days of that announcement, CompuNet Clinical Laboratories of Moraine, Ohio, stated that about 110,000
By Joseph Burns, from the Volume XXVI No. 12 – September 3, 2019 issue
CEO SUMMARY: Federal prosecutors in Arkansas charged a former Veterans Administration pathologist with three counts of involuntary manslaughter and 28 other criminal counts related to his work at the Veterans Health Care System of the Ozarks. In the indictment, officials charged that the pathologist’s misdiagnoses contributed to the deaths of 15 patients. The pathologist had
By Joseph Burns, from the Volume XXVI No. 12 – September 3, 2019 issue
FACED WITH DEEP CUTS in payment for anatomic pathology professional component services from Anthem Inc., pathologist have only a few options in how they can respond, according to consultants who work with AP groups.
“These are dire cuts to anatomic pathology reimbursement,” said one consultant who asked not to be named. He suggested that small regional
By Joseph Burns, from the Volume XXVI No. 12 – September 3, 2019 issue
CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory testing. One issue is how to educate physicians
