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.
This is a summary of two articles in the Nov. 13, 2018 issue of THE DARK REPORT. The complete articles are available only to paid members of the Dark Intelligence Group.
CEO SUMMARY: On Nov. 2, the federal Centers for Medicare and Medicaid Services released its Physician Fee Schedule for 2019. CMS says it will expand
By Joseph Burns, from the Volume XXV No. 16 – November 13, 2018 issue
CEO SUMMARY: In its work for a federally qualified health center, Sonic Healthcare USA helped physicians use a data-driven approach to population health management that incorporated integrated financial and clinical analytics. Also, Sonic developed technologies that give ordering physicians clinical decision support and targeted patient engagement tools. It then developed a way to contact patients
By Joseph Burns, from the Volume XXV No. 16 – November 13, 2018 issue
CEO SUMMARY: No bigger threat looms over the financial security of the nation’s clinical laboratories than healthcare’s transition from fee-for-service payment to value-based reimbursement. To navigate that transition successfully, medical labs and pathology groups will need to adopt the Clinical Lab 2.0 model. Member labs of Project Santa Fe are themselves working to develop and
By Joseph Burns, from the Volume XXV No. 16 – November 13, 2018 issue
CEO SUMMARY: On Nov. 2, the federal Centers for Medicare and Medicaid Services released its Physician Fee Schedule for 2019. It says it will expand the number of labs from which it collects data about the lab test prices paid by private health insurers. While some labs may welcome these changes, groups representing clinical laboratories
By R. Lewis Dark, from the Volume XXV No. 16 – November 13, 2018 issue
How many consecutive 10% and 15% cuts to the prices Medicare pays for clinical laboratory tests can smaller community labs absorb before they are forced to shut their doors and go out of business? This nation is about to find out. As this happens, Medicare beneficiaries (and their physicians) in small towns and rural areas
By Robert Michel, from the Volume XXV No. 15 – October 22, 2018 issue
Efforts to enroll one million veterans in a program to determine how genetic variations affect health is moving swiftly. Current enrollment is 700,000 veterans and the one million goal is expected to be reached by 2021. In 2011, the federal Department of Veterans Affairs instituted the VA Million Veterans Program (MVP).
MORE ON: Million Vets
Recently the VA extended
By Joseph Burns, from the Volume XXV No. 15 – October 22, 2018 issue
CEO SUMMARY: In the span of four days in September, Quest Diagnostics agreed to buy two lab companies and the lab testing service line of a third firm. In August, it purchased wellness company Provant Health, which had earlier filed a bankruptcy action. Each of these transactions helps Quest concentrate more on proprietary products and
By Joseph Burns, from the Volume XXV No. 15 – October 22, 2018 issue
CEO SUMMARY: Is it a violation of federal healthcare laws when clinical labs pay physicians to mail specimens and/or forgive all or part of patients’ copayments and deductibles? A federal judge’s ruling in a lawsuit against Boston Heart Diagnostics last month dealing with these two actions created a precedent that could affect all labs. It
By Joseph Burns, from the Volume XXV No. 15 – October 22, 2018 issue
TWO NATIONAL COMPANIES just signed the lab industry’s largest agreement to put clinical laboratory patient service centers (PSCs) into retail stores. Earlier this month, Walgreens Boots Alliance and Laboratory Corporation of America announced plans to open 600 PSCs in Walgreens stores in coming years.
Since June 2017, Walgreens and LabCorp have opened 17 patient service centers
By Joseph Burns, from the Volume XXV No. 15 – October 22, 2018 issue
CEO SUMMARY: As a going business, Theranos may have been dissolved in September, but it continues to be in the news. The biggest development was a disclosure in federal court earlier this month by federal prosecutors that there may be additional criminal charges to come that go beyond the indictments of former CEO Elizabeth Holmes
