Nov 7, 2016 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
What causes diagnostic errors? This was the question asked by researchers at the Michael E. DeBakey VA Medical Center (EDVA) in Houston. It is also a question of great interest to pathologists and clinical laboratory scientists, since the failure of physicians to properly order and interpret medical laboratory tests can be a cause of diagnostic errors.
Researchers were investigating how access to patient data embedded in hospital electronic health records (EHRs) affects patient safety. The results of their study—and the challenges they encountered accessing the data during the research—led to some startling conclusions about accessibility to patient data, and the nature of the data itself.
The researchers published their findings online in “Challenges in Patient Safety Improvement Research in the Era of Electronic Health Records.” Their paper examines ways in which EHRs can assist healthcare professionals in improving patient safety and guaranteeing proper follow-up care. (more…)
Oct 19, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Engineers have designed a microfluidics and nano-scale diagnostic toolkit suitable for attaching directly to muscle and tissue to monitor biomarkers and stream results wirelessly to care providers and medical laboratories
What would change in medicine if physicians had sutures that could collect and report biomarker data, including the kinds of biomarkers that are used in clinical laboratory tests? Such a product may be feasible, based on newly-published research.
“Smart sutures” are a joint project between Tufts University, Harvard University, and Massachusetts Institute of Technology (MIT) engineers. They announced a thread-based diagnostic device (TDD) system capable of detecting biomarkers and analytes using 3D sutures composed of cotton and synthetic threads.
Processing the cotton and synthetic threads in various ways enhances their natural properties. The toolkit of different sutures developed by the team has exhibited a range of uses—including measuring physical stress at an incision, monitoring pH of tissues and fluids, and measuring glucose. (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
Jun 29, 2016 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
An earlier Johns Hopkins study looked at diagnostic errors and determined that such errors were the leading cause of malpractice payouts. Can clinical laboratories help?
At a time of heightened transparency in healthcare outcomes, a Johns Hopkins University School of Medicine (Johns Hopkins) study makes a startling conclusion: medical errors are an under-recognized cause of patients’ deaths in the United States. In fact, medical errors rank third—after heart disease and cancer—in causing patients’ deaths, according to a Johns Hopkins statement.
This finding has many implications for pathologists and clinical laboratory managers. Often, medical errors are associated with the failure of physicians to order correct medical laboratory tests at critical junctures. Alternatively, a medical error can result if the physician fails to take appropriate action after getting an accurate lab test result. Thus, any effort within the health system to reduce medical errors will probably bring pathologists and medical laboratory scientists into closer consultation with clinicians.
What the researchers at Johns Hopkins also learned during their study is that medical error is not reported as a cause of death on death certificates. Further, the Centers for Disease Control and Prevention (CDC) has no “medical error” category in its annual report on deaths and mortality, The New York Times (NYT) reported. (more…)
May 18, 2016 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Laboratory Testing
As technologies used by fitness wearables mature, medical laboratories will want to develop ways to access and process the flood of data that will become available
Point-of-care testing and remote patient monitoring are two technologies that could be disruptive to the clinical laboratory industry, particularly if use of these devices was to reduce the volume of patient specimen that are referred to the nation’s large, centralized medical laboratories.
This is one reason why savvy pathologists watch the stream of new products designed to allow athletes and consumers to monitor their fitness and other characteristics of good health. These devices are at the very front of the curve for remote monitoring of an athlete’s performance during training and competition, as well as enabling consumers to track different parameters of their health. What’s a toy for today’s sophisticated consumers could later be easily adopted for clinical diagnostic purposes.
One great example of how swiftly technology advances are changing remote diagnostic monitoring involves heart rate monitors. It wasn’t long ago that even basic heart rate monitors were a pricey purchase for consumers. But thanks to strong interest in gathering healthcare data, costs are dropping. (more…)
