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 maryv
CEO SUMMARY: As the debate grows more heated, supporters of hospital outpatient department (HOPD) billing schemes have ramped up their defense of the practice. The president of the National Association of Rural Hospitals tells THE DARK REPORT that rural hospitals are permitted to bill for hospital lab outreach program services under Medicare’s 70/30 shell rule.
By Joseph Burns, from the Volume XXV No. 10 – July 9, 2018 issue
CEO SUMMARY: As health networks and hospitals consider outsourcing their lab outreach programs, the lab team at Dartmouth-Hitchcock Medical Center (D-H) offers lessons about the value of retaining outreach. D-H is now in the eighth year of a sustained expansion of its laboratory outreach business. It has combined its lab outreach strategy with a proven
By Joseph Burns, from the Volume XXV No. 10 – July 9, 2018 issue
HOW THE LAB OUTREACH BUSINESSES of rural hospitals originate lab specimens and bill for lab tests is getting increased scrutiny. The reason for this rise in interest is that a growing number of rural hospitals are generating almost as much revenue from laboratory outreach testing as they get from all other inpatient services.
Most rural hospitals
By Joseph Burns, from the Volume XXV No. 10 – July 9, 2018 issue
CEO SUMMARY: In recent years, many rural hospitals have entered into agreements to expand their laboratory outreach businesses. In an interview, the president of the National Association of Rural Hospitals said rural hospitals often bill for lab outreach services under Medicare’s 70/30 shell rule. This rule, as modified by the Omnibus Budget Reconciliation Act of
By Robert Michel, from the Volume XXV No. 10 – July 9, 2018 issue
CEO SUMMARY: This summer, both Geisinger Health and Sanford Health will introduce genetic tests designed specifically for use by primary care physicians in their daily practice. This is a significant milestone on the road to wider deployment of precision medicine services. In the case of Sanford Health, it plans to offer patients a $49 genetic
By maryv
CEO SUMMARY: In a tale of two fraudsters, the Department of Justice has filed a warning shot to all technology startups: Criminal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani could mean prison time and massive fines. In this latest Theranos news, The DOJ cited harm to investors, doctors and patients by the two company
By Joseph Burns, from the Volume XXV No. 9 – June 18, 2018 issue
CEO SUMMARY: Rulings from Judge Amy Berman Jackson of the U.S. District Court in Washington, D.C., are expected soon in the ACLA’s lawsuit against HHS concerning the PAMA final rule that set the course for the new Medicare CLFS rates implemented in January 2018. One lawyer following the lawsuit explains that ACLA has presented strong
By Joseph Burns, from the Volume XXV No. 9 – June 18, 2018 issue
CEO SUMMARY: Despite the challenges hospital and health system laboratory outreach programs face today, there are many ways they can remain viable, according to an outreach expert from Mayo Medical Laboratories. By taking specific steps to increase volume and the value they provide, lab outreach programs can keep their costs down while bringing in more
By Joseph Burns, from the Volume XXV No. 9 – June 18, 2018 issue
CEO SUMMARY: Federal criminal indictments were unsealed last Friday in San Francisco against Elizabeth Holmes and Ramesh “Sunny” Balwani for their actions as executives at Theranos, Inc., the once high-flying lab test company. Officials at the Department of Justice said the counts against Holmes and Balwani are based on the alleged actions of each to
By R. Lewis Dark, from the Volume XXV No. 9 – June 18, 2018 issue
IT’S NOW CLEAR THAT TWO CLINICAL LABORATORY EXECUTIVES COMMITED one of the largest corporate fraud schemes in the past century.
Reading the federal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani unsealed Friday provides insights into the extensive scale and wide scope of the alleged fraud the two Theranos executives perpetrated against patients, doctors, and investors.
When
