CEO SUMMARY: Two trends are driving a movement to standardize laboratory operations across large regions: the integration of clinical care and the need for hospitals and health networks to continuously improve patient outcomes. THE DARK REPORT outlines an ambitious program in Michigan, where Ascension Health is working to align itself with an integrated health system
Tag: Clinical Laboratory
Skip to articlesA 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:
- Anatomic pathology: Units included here are histopathology, cytopathology, and electron microscopy. Other disciplines pertaining to this section include anatomy, physiology, histology, pathology, and pathophysiology.
- Clinical pathology, which includes:
- Clinical Microbiology: This encompasses five different sciences. These include bacteriology, virology, parasitology, immunology, and mycology.
- Clinical Chemistry: Units under this section include instrumental analysis of blood components, enzymology, toxicology and endocrinology.
- Hematology: This section consists of automated and manual analysis of blood cells.
- Genetics is also studied along with a subspecialty known as cytogenetics.
- Reproductive biology: Semen analysis, Sperm bank and assisted reproductive technology.
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.
September 10, 2018 Intelligence: Late Breaking Lab News
By Robert Michel, from the Volume XXV No. 13 – September 10, 2018 issue
News that a laboratory’s courier truck was high-jacked in broad daylight with patient specimens aboard puts the spotlight on whether the security practices labs use to protect drivers, vehicles, and the patient specimens they may be carrying are adequate. On Aug. 3 in Durham, N.C., a driver of a courier vehicle owned by Laboratory Corporation of
Michigan’s Ascension to Standardize Labs Throughout the State
By Joseph Burns, from the Volume XXV No. 13 – September 10, 2018 issue
CEO SUMMARY: Two trends are driving a movement to standardize laboratory operations across large regions: the integration of clinical care and the need for hospitals and health networks to improve patient outcomes continuously. In Michigan, Ascension Health is an example of a lab team working to standardize lab testing activities among seven organizations, 14 hospitals,
Morgan Stanley Report Shows 8% of Hospitals at Risk of Closure
By Joseph Burns, from the Volume XXV No. 13 – September 10, 2018 issue
AMONG THE ROUGHLY 6,500 HOSPITALS OPERATING in the United States, only about 125 (2.5%) have closed in the past five years. But in the coming years, some 450 hospitals are at risk of closing. Analysts at Morgan Stanley said 600 other hospitals have weak finances that could lead them to close.
In the report, Morgan Stanley,
Biggest Lab Firms Diverge on Hospital Lab Strategies
By Joseph Burns, from the Volume XXV No. 13 – September 10, 2018 issue
CEO SUMMARY: Almost half of the nation’s hospitals and health systems are rethinking how to use their clinical labs to support clinical and financial strategies. Options range from outright sale of their lab outreach businesses to lab management agreements or joint ventures with one of the nation’s three billion-dollar public lab companies. Each of the
August 20, 2018 Intelligence: Late Breaking Lab News
By Robert Michel, from the Volume XXV No. 12 – August 20, 2018 issue
There is a new sector in the clinical laboratory industry. It is called “global direct-to-consumer (DTC) genetic health testing” by Kalorama Information, a market research firm based in Rockville, Md. In a recent report, Kalorama says this sector is comprised of the direct-to-consumer genetic tests which are initiated by the consumer, meaning that the consumer decides
FDA Issues Response to Draft Legislation to Regulate LDTs
By Joseph Burns, from the Volume XXV No. 12 – August 20, 2018 issue
DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At
ProMedica, Sonic Form Lab Outreach Joint Venture
By Joseph Burns, from the Volume XXV No. 12 – August 20, 2018 issue
CEO SUMMARY: Fast-growing ProMedica Health System of Toledo, Ohio, agreed to a laboratory joint venture with Sonic Healthcare USA. As lab budgets and prices for lab tests are squeezed downward, ProMedica sees opportunity to add volume to this new core lab facility to improve efficiency and reduce costs per test. At the same time, it
CMS physician fee schedule: Will hospital labs be excluded again from PAMA price reporting?
By maryv
CEO SUMMARY: Publication of the draft CMS Physician Fee Schedule on July 12 brought unwelcome news for the clinical lab industry, at least as it pertains to that perennial question: Should hospital lab outreach data be included in a PAMA market study? The federal Centers for Medicare and Medicaid Services must conduct a new market
Québec’s Laboratory Consolidation Plan Aims to Save $13.5M
By Joseph Burns, from the Volume XXV No. 11 – July 30, 2018 issue
CEO SUMMARY: In the Province of Québec, an ambitious project is under-way to consolidate the clinical laboratory testing of 123 laboratories into 11 centralized lab clusters. It is one of the largest lab consolidation projects nowhappening in the world. Among the goals of this project is to improve qualityand efficiency while incurring no additional costs.