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 Joseph Burns, from the Volume XXIV, No. 9 – June 26, 2017 issue
CEO SUMMARY: Since 2014, a toxicology lab at the University of Colorado has used mass spectrometry to offer low-cost, accurate multi-analyte test panels that can detect hundreds of therapeutic drugs and drugs of abuse. However, CU Toxicology’s chief medical officer says health insurers are slow to accept this diagnostic technology, despite its demonstrated clinical benefit
By Robert Michel, from the Volume XXIV, No. 9 – June 26, 2017 issue
NEWS STORIES ABOUT TWO DIFFERENT FEDERAL WHISTLEBLOWER CASES against lab companies provide a reminder that managers of every clinical laboratory and pathology group must be vigilant about compliance, because potential whistleblowers can emerge from the unlikeliest of places.
The first example involves Piedmont Pathology in Hickory, N.C. In May, it agreed to pay the federal government
By Robert Michel, from the Volume XXIV, No. 9 – June 26, 2017 issue
CEO SUMMARY: News that Quest Diagnostics had exited the long-running CompuNet Clinical Laboratory joint venture in Dayton, Ohio, caught many observers by surprise. The only clues as to possible problems and the motivation of Premier Health, the 51% owner, to buy out Quest’s ownership share are contained in an announcement the health system issued. The
By R. Lewis Dark, from the Volume XXIV, No. 9 – June 26, 2017 issue
IT IS ALWAYS A BIG DEAL WHEN ONE OF THE NATION’S LARGEST HEALTH INSURERS TAKES A MAJOR STEP. That is certainly true of Anthem’s decision to launch a new program that requires physicians to obtain pre-authorization when ordering genetic tests for its members.
THE DARK REPORT is first to report this news to the clinical laboratory
By Mary Van Doren, from the Volume XXIV, No. 9 – June 26, 2017 issue
This is an excerpt from a 1,362-word article in the June 26, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: For lab managers worried about being parceled out to a national
By Joseph Burns, from the Volume XXIV, No. 8 – June 5, 2017 issue
INNOVATIVE CLINICAL LABS are making significant changes to accommodate the shift from volume to values. In one change, they are collaborating with clinicians to use lab test data to improve patient outcomes.
In another, they are collecting the clinical data from these efforts to publish the outcomes in peer-reviewed medical journals to spread the word about
By Joseph Burns, from the Volume XXIV, No. 8 – June 5, 2017 issue
CEO SUMMARY: By now, there is widespread recognition among pathologists and clinical lab managers that the era of fee-for-service reimbursement is giving way to new forms of payment that reward value. First-mover lab leaders are in the earliest stages of developing enhanced lab testing services that contribute to improved patient outcomes while reducing costs. These
This is an excerpt from a 1,485-word article in the June 5, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: At a time when most molecular and genetic testing companies are
By Robert Michel, from the Volume XXIV, No. 8 – June 5, 2017 issue
CEO SUMMARY: Last month’s lawsuit filed by Blue Cross Blue Shield of Mississippi against a small rural hospital in Mississippi and multiple defendant lab companies in Texas is the latest attempt by health insurers to rein the widespread fraud that threatens to overwhelm the pain management and toxicology sectors of healthcare. Increasingly, the nation’s community
By Joseph Burns, from the Volume XXIV, No. 8 – June 5, 2017 issue
CEO SUMMARY: At a time when most molecular and genetic testing companies are struggling to gain coverage for their tests, this Silicon Valley-based lab company has become an in-network lab provider for a number of health insurers—including three of the nation’s largest payers. It did this by establishing a patient-friendly price of $249 for its
