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 an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group.
CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical laboratory and anatomic pathology managers. CMS
By Robert Michel, from the Volume XXVII No. 1 – January 6, 2020 issue
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 report their private payer lab test data. This means no
By Joseph Burns, from the Volume XXVII No. 1 – January 6, 2020 issue
CEO SUMMARY: Among hospital administrators, the popular wisdom is that their clinical lab is a cost center. This thinking leads them to consider drastic cost-management strategies that include partnering with commercial labs to manage in-hospital lab testing and the outright sale of lab outreach programs. On the other side of this debate, innovative health system
By Joseph Burns, from the Volume XXVII No. 1 – January 6, 2020 issue
CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could promote lab test fraud. Now, labs will have to wait for
By Mary Van Doren, from the Volume XXVI No. 17 – December 16, 2019 issue
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 news are clear opportunities –
By Robert Michel, from the Volume XXVI No. 17 – December 16, 2019 issue
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 (BS) and UCLA Medical School, Mattsen
By Joseph Burns, from the Volume XXVI No. 17 – December 16, 2019 issue
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 Medicare, Medicaid, or commercial health plans charged. Allegations include overcharging,
By Joseph Burns, from the Volume XXVI No. 17 – December 16, 2019 issue
MAYBE CHARGING CONSUMERS THE LOW PRICE of $599 for a whole human genome sequence is not a winning financial strategy. That’s one possible reason why closely-watched Veritas Genetics of Cambridge, Mass., will stop operations in the United States.
It was in July that Veritas announced it was cutting its already-low price to sequence a genome from
By Robert Michel, from the Volume XXVI No. 17 – December 16, 2019 issue
CEO SUMMARY: There are both surprises and several valuable insights to be harvested from THE DARK REPORT’s “Top 10 Lab Industry Stories for 2019.” Financially, 2019 proved to be a tough year for both clinical labs and anatomic pathology groups in the United States. One reason is because Medicare and private payers continue to use
By R. Lewis Dark, from the Volume XXVI No. 17 – December 16, 2019 issue
Is it a coincidence that a number of uninsured consumers filed separate lawsuits in federal courts against Laboratory Corporation of America and Quest Diagnostics—alleging, in both cases, that they were overcharged for clinical laboratory tests—just months before the federal government published final rules requiring hospitals and other providers to publish their prices?
Last month, the federal Centers
