Jun 3, 2015 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Authors of the published study wrote that use of HD optical technology during colonoscopies gives patients a faster answer and may eliminate the need to refer biopsies to pathologists
High definition optical technology is reaching the point where gastroenterologists are able to identify pre-cancerous polyps with 96% accuracy during colonoscopies, according to a recent study conducted at the Mayo Clinic. Pathologists will want to pay close attention to the published findings of this study. That’s because GI biopsies represent a significant proportion of specimens referred to anatomic pathologists.
Researchers at Mayo Clinic worked with high-definition (HD) imaging systems, such as the Olympus Evis Exera II 180 and the Evis Exera III CV-190. The study was published in the June 24, 2014 issue of Gastrointestinal Endoscopy. (more…)
Mar 23, 2015 | Compliance, Legal, and Malpractice, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
As proposed, the President’s Precision Medicine Initiative would incorporate a large, volunteer study cohort in innovative ways
Even as a new presidential initiative to boost precision medicine makes headlines, there is uncertainty as to how the program can be funded. The Precision Medicine Initiative was announced by President Obama on January 30, 2015.
Many pathologists, clinical chemists, and medical laboratory scientists recognize that such a program would pump additional funds into the research and development of new diagnostic tests that are designed to aid physicians in their practice of precision medicine.
The big question is how to pay for this initiative. President Obama proposed budgeting $215 million to fund this effort. But such funding must be approved by a Congress that is at odds with the President on nearly every issue. Additionally, The American Clinical Laboratory Association (ACLA) warns that the Food and Drug administration’s (FDA) 2014 announcement to regulate laboratory developed testing services (LDTs) is in conflict with the President’s initiative. (more…)
Dec 26, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Some clinical laboratory and pathology equipment are Class III (high-risk) medical devices and may be eventually subject to FDA adverse patient event reporting rules
Effective on September 1, 2014, providers using Class III (high-risk) medical devices are required to report adverse patient events involving such devices. That reporting is to include the unique device identification (UDIs) labels of the Class III device.
The primary goal of the new regulation is to have specified providers report patient deaths that involved high-risk medical devices, such as stents and heart valves, for example. Specified facilities include hospitals, ambulatory surgery centers, and nursing homes. Manufacturers must also report adverse patient events involving their Class III medical devices.
All Class III in vitro diagnostic systems used by clinical laboratories and pathology groups here in the United States will now have a UDI label. (more…)
Sep 10, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label
Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs.
UDIs also will apply to certain combinations of products that contain devices licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)
Aug 29, 2014 | Coding, Billing, and Collections, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Uncategorized
In both the hospital market and the ambulatory market, Epic has the best-selling electronic health records system, according to data issued by ONCHIT
Across the nation, clinical laboratories and pathology groups are busy interfacing their laboratory information (LIS) systems to the electronic health record (EHR) systems of their client hospitals and physicians. Yet, few lab managers know which EHR systems are dominating the market and which EHR systems are barely surviving.
In fact, it can be a challenge to understand market share by vendor. That is because market share can be determined in multiple ways. Dark Daily found three different rankings of EHR vendors. Each was based on slightly different sets of data. (more…)
