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 XXV No. 17 – December 3, 2018 issue
IN RECENT DAYS, RUMORS HAVE SURFACED that UnitedHealthcare has begun to terminate the contracts it holds with a number of regional and non-national clinical laboratories.
This news surfaced just as The Dark Report went to press. Given its importance to the clinical laboratory industry, we wanted to alert lab executives and pathologists to this development as
By Joseph Burns, from the Volume XXV No. 17 – December 3, 2018 issue
CEO SUMMARY: Since 2011, the University of Florida Health System has used pharmacogenetic test (PGx) results to guide physicians when they prescribe certain drugs. This initiative has improved patient outcomes, reduced the overall cost per episode of care, and gained partial reimbursement from health insurers for PGx test claims. As this testing becomes more widespread, clinical
By Joseph Burns, from the Volume XXV No. 17 – December 3, 2018 issue
CEO SUMMARY: Legislation signed into law on Oct. 24 was designed to stem the nation’s opioid crisis. But in addition to applying to sober homes and addiction treatment centers, the law also applies to clinical laboratories. Called the ‘Support for Patients and Communities Act,’ the law could authorize criminal penalties for labs that pay sales
CEO SUMMARY: At the last minute, Congress added all clinical laboratories to a far-reaching provision in the newly-enacted Support for Patients and Communities Act. Unlike the Anti-Kickback Statute, this provision applies to all payers, both government and private, and offers no safe harbors. Lab experts say this new law could turn relatively innocuous and heretofore
By Joseph Burns, from the Volume XXV No. 17 – December 3, 2018 issue
CEO SUMMARY: At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act. This provision applies to all payers, both government and private. Lab experts say this new law could have a negative effect on patient care because it could make relatively innocuous
By R. Lewis Dark, from the Volume XXV No. 17 – December 3, 2018 issue
Traditionally, the new year is a time of optimism. People make resolutions such as exercising more and losing weight. Companies get to start the year with a fresh budget and the new opportunity to achieve their goals.
Unfortunately, events of the last 90 days of this year are not auspicious for clinical laboratories and anatomic pathology
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
