Aug 29, 2016 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Intense rains triggered unprecedented flooding; anatomic pathology group continues lab testing services while helping staff members whose homes and vehicles were damaged
Clinical laboratory medicine is a community and this fact is being proven by the help now flowing to employees of an anatomic pathology laboratory who were catastrophically affected by the recent flooding in Louisiana, which was caused by an historic and unexpected rain event. The Red Cross called this the worst natural disaster since Hurricane Sandy just four years ago.
At Pathology Group of Louisiana (PGL) in Baton Rouge, 31 of its employees (24% of the staff) have “sustained total loss of their homes and belongings,” stated Pika Sdrougias, PGL’s Chief Executive Officer. “The unprecedented floods took everything: their homes, personal possessions, even their cars are now a total loss.” (more…)
Aug 26, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
FDA issues press release following clearance of a clinical lab test to detect genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae
Clearance by the US Food and Drug Administration (FDA) of a new rapid, multi-marker genetic test designed to identify bacteria that are resistant to Carbapenem antibiotics was considered significant enough that the federal agency issued a press release announcing that the test was cleared and now available for use by physicians and clinical laboratories in the United States.
In the race to develop molecular assays and genetic tests for infectious disease that deliver improved sensitivity and specificity with a faster time-to-answer, this new test offers all three benefits. Results are available in just 48 minutes, for example.
It was on June 29, 2016, that the FDA cleared Cepheid’s Xpert Carba-R rapid-diagnostic test for marketing in the United States. This is the first clinical laboratory test cleared for market by the FDA that detects healthcare-associated infections (AKA, hospital-acquired infections or HAIs) through the use of genetic markers taken directly from clinical samples. The assay tests for genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae (CRE). (more…)
Aug 22, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Because of MIPS (a section of Medicare’s MACRA law), in coming years pathologists who participate will receive a bonus of as much as 9%, while those who do not participate will be penalizing up to 9%
If you are an anatomic pathologist, are you prepared to be paid more by Medicare starting on January 1, 2017? Do you and your pathology practice administrator know that, if you and your pathology group do nothing in 2017, Medicare could pay you significantly less in 2019 and the years beyond?
Answer no to either question and you have money at risk. In 2017, Medicare introduces a new payment program called the Merit-based Incentive Performance System (MIPS). This was authorized as part of the Medicare Access and CHIP Reauthorization Act (MACRA), which was passed in 2015. (more…)
Aug 17, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology
Powered by massive data sets, precision medicine is unlocking new insight into the treatment of diseases and conditions. At the same time, pathology groups and medical laboratories are leading the way to creating the storage solutions, analytic tools, and networks that will power tomorrow’s advances in precision medicine
There is exponential growth in the amount of data generated at medical laboratories, pathology groups, and hospital diagnostic facilities. As gene sequencing technologies and tools continue to decrease in price but increase in both speed and accessibility, the volume of data will grow further still.
This has major implications for the field of precision medicine. In order for physicians, hospitals, and clinical laboratories to move forward with precision medicine, to advance, it will be essential that they have sophisticated capabilities in data handling, storage, and analysis.
Yet, hospitals wanting to do more with precision medicine might not be the providers that unravel the technicalities of harnessing this new pool of big data. Pathology groups and medical laboratories are already familiar with the challenges of managing complex data, such as that created by genome sequencing and molecular diagnostic assays. As they continue to bolster their information technology (IT) staffing and infrastructure, these labs are positioned to be the keepers for much of the data driving new medical developments.
Hospital IT Departments Lag in Preparations to Handle Genomic Data
In a Health Catalyst survey, 59% of healthcare executives polled do not believe that precision medicine will play a significant role in their organizations by 2020. Nearly two-thirds of respondents have no plan to integrate genomic data into their electronic health record (EHR) systems.
Despite the trend against genomic data integration, the same survey noted that half of the respondents believe that DNA sequencing could improve patient treatment strategies within their organizations.
However, as medical laboratories have known for some time, obtaining data from molecular and genetic testing is only the beginning. Without the ability to analyze results, communicate information, and store lab test data for access by other parties, the potential benefits of precision medicine will remain unrealized.
Medical Laboratories Leading the Charge for Better Data Handling and Analysis
The good news is that within many health systems, medical laboratories are already adapting IT systems to manage the large data sets required for molecular diagnostics and genetic testing. One of the lessons these labs are learning is that the more molecular and genetic testing the do, the more informatics staff they need.
Simply said, these innovative labs are devoting more physical space to informatics and a larger proportion of the laboratory staff are informatics specialists. In The Dark Report, Gregory J. Tsongalis, PhD, Professor of Pathology and Director of Molecular Pathology at the Theodore Geisel School of Medicine at Dartmouth College, stated, “We just opened a new clinical lab facility of 11,000 square feet at the Geisel School. Over 25% of that space will be devoted to data management. Because of the increasing volume of data generated at this site, there are more computational technologists than lab technicians.” (See The Dark Report, “New Molecular Analyzers to Bring Big Data to All Labs, July 13, 2015.)
Gregory J. Tsongalis, PhD (center right), is Professor of Pathology and Director of Molecular Pathology at the Theodore Geisel School of Medicine at Dartmouth College. (Photo copyright: The Geisel School of Medicine at Dartmouth.)
Tsongalis believes that labs themselves are positioned to become the storage providers and gatekeepers for much of the data driving precision medicine. Noting an increasing shift toward staffing informaticists in clinical labs to handle data, he says, “This is probably one aspect of the big data trend where pathologists and lab scientists are ahead of health system administrators.”
Medical Labs Must Address Issues Associate with Handling Genomic Data
Regardless of who holds the increasing amount of genomic data coming out of assays and tests, healthcare providers, laboratories, and vendors must create a set of standards to address both integration with EHR systems, and maintaining privacy and security on a scale never-before addressed.
In an article published in Health Data Management, Deven McGraw, Deputy Director for Health Information Privacy at the Department of Health and Human Services Office for Civil Rights, stressed the importance of data security as the regulatory agency begins work on aspects of the Precision Medicine Initiative. “A robust data security framework will be built in from the start. This is a new model for scientific research, but it is not widespread,” McGraw stated.
The Action Collaborative on Developing Guiding Principles for Integrating Genomic Information into the Electronic Health Record Ecosystem also is piloting a collaborative between Intermountain Healthcare, ARUP Laboratories, and Cerner, to examine privacy standards as well as standards for integration and representation of genomic data sets.
As pools of healthcare data and medical laboratory test results continue to grow and clinical laboratories continue to explore new methods of genetic testing and analysis, partnerships such as the Action Collaborative will remain critical opportunities for medical laboratories and pathology groups to use their current advantage to further their future roles in precision medicine.
—Jon Stone
Related Information:
Survey: Most Healthcare Organizations Unprepared for Precision Medicine
Big IT Challenges Ahead for Precision Medicine
About the Precision Medicine Initiative Cohort Program
Fact Sheet: President Obama’s Precision Medicine Initiative
DIGITizE: Displaying and Integrating Genetic Information Through the EHR
Newer, Smaller Analyzers Will Bring Big Data to Labs
Aug 15, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
New vaccine has potential to reduce volume of clinical laboratory testing for bacterial and viral infections
By now, nearly all pathologists and clinical laboratory scientists acknowledge that advances in molecular diagnostics and genetic testing are contributing to significant improvements in patient care. Now comes news of a comparable breakthrough in another field of medicine with the potential to protect many individuals from pneumonia and similar infectious diseases.
A new way to develop vaccines made the news recently. Researchers at the University of Buffalo (UB) in New York have found a new way to reduce infections of specific and widespread Streptococcus pneumoniae (pneumococcus) diseases.
This cutting-edge pneumococcal vaccine allows Streptococcus pneumoniae to colonize and live inside the body as long as there is no risk to the host. When a threat is detected, the vaccine establishes an immune system response to annihilate the disease-causing bacteria. (more…)
Aug 12, 2016 | Instruments & Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
As the number of on-site and near-site clinics grow, medical laboratories and pathologists could find unique opportunities to bridge the information gap between traditional health systems and new employer-based offerings
Employers have a big stake in lowering the cost of healthcare. That is one reason why more employers are incorporating employee wellness programs into their health benefit offerings. This is a favorable trend for medical laboratories, because such wellness programs often incorporate clinical laboratory tests as benchmarks from which employees can monitor their progress.
In 2013, Dark Daily reported on the increase in employee wellness programs across corporations. Medical laboratories and pathology groups found new opportunities to help with wellness monitoring, screening, and helping individuals through medical consultations.
Three years later, this trend continues to evolve and grow. Today, employers are going beyond simple wellness programs, creating on-site or near-site clinics to save their employees a trip to their local doctor, urgent care, or hospital. (more…)
