Like the thoroughbreds that will jockey for lead position on the tracks of Louisville’s Churchill Downs next month, the state of Kentucky is working to become a leader in the statewide exchange of electronic health care information. By 2013, the state expects to be fully operational with a system that will allow pathologists to share laboratory results with each other and with other providers across Kentucky.
“The future is clear: Health information will be traveling electronically over virtual highways so that pa-tients can have access to their medical records wherever they are,” says William D. Hacker, MD, commissioner of the Kentucky Department for Public Health. “The lab is a critical component,” he continues. “Laboratories need to be prepared to be connected to that virtual highway.”
A statewide strategic and operational plan approved in February by the U.S. Department of Health and Human Services, and funded through the American Recovery and Reinvestment Act of 2009, allots approximately $10 million to build the infrastructure for the Kentucky Health Information Exchange. Incentive payments to health care providers for adopting electronic medical record systems will help offset the cost of implementing the system statewide, says Jeff Brady, executive director of the Governor’s Office of Electronic Health Information.
The exchange is expected to eventually encompass the state’s approximately 125 hospitals and 8,000 physicians. “The effort is multi-faceted,” says Brady. “We have Medicaid claims; we have state lab results; we will be updating the statewide immunization registry electronically. We also have reportable diseases that need to go to the health department.”
To implement the system, Kentucky had to change a state law that prohibited pathology reports from being sent to anyone but the physician of record. “The purpose [of the exchange] is to have readily available information for the consulting provider,” notes pathologist Stephanie Mayfield Gibson, MD, director of the division of laboratory services, Kentucky Department for Public Health.
Since the state legislature revised the law last year, about 90 health care organizations have started the process of joining the Kentucky exchange, says Brady. “It’s getting pretty huge, pretty quickly.”
The first priority of the exchange is the state’s newborn screening program. Efforts are underway to upload newborn screening records from the Department for Public Health’s laboratory so that physicians will be able to access the records electronically, rather than having them faxed or mailed. “That will [lead to] broad use right there,” says Dr. Mayfield Gibson. “You’re looking at birthing hospitals; you’re looking at private practitioners using information... as opposed to a hospital lab exchanging information only with its clients.”
While uploading newborn screening information and other data, the state has undertaken painstaking quality control measures, Brady says. The state is devoting a substantial amount of time to making sure data are captured accurately, he emphasizes.
The exchange uses the standard coding system Logical Observation Identifiers Names and Codes, or LOINC. The National Library of Medicine and Association of Public Health Laboratories are helping the Kentucky exchange and other public health labs employ the coding system, says Dr. Mayfield Gibson, who encourages other states to shift from their internal codes to LOINC. With that coding system, she says, “we’re actually validating the exchange. Did this report transmit into something readable? And if it’s readable, is it correct?”
Different hospitals use different laboratory information systems, adds Brady, and the state must properly link to all those systems. “That’s a big part of this—making sure we have standardized, meaningful data to share and it’s not the Tower of Babel by the time we’re through.”
The state’s laboratory information manager plays a crucial role in this process, says Dr. Mayfield Gibson, as well as in coordinating pathologists, scientists, other technical experts, and vendors to make sure the project stays on track. “I can’t stress strongly enough how critical that clear communication is,” she adds.
The statewide exchange, says Dr. Hacker, promises to bring to fruition the goals set forth when the state started building its electronic health records system several years ago using Medicaid funding. “The state laboratory has to be able to do a laboratory test, put information into an electronic format that’s compliant with standards, put it onto the virtual highway, and then it’s off and running,” he says. “At the other end, it needs to be received and put into an electronic medical record in a useful format.” Bringing end-users on board takes time, he adds.
“I would encourage people not to underestimate how hard it is,” Dr. Hacker concludes. “It takes a lot of work.”
Technest Holdings has purchased AccelPath, LLC, a provider of digital telepathology and other telemedicine services for laboratories and hospitals. AccelPath will operate as a wholly owned subsidiary of Technest.
Technest markets imaging and surveillance systems and devices to the health care and security industries.
The FDA recently announced a final rule that eases the path to market for some hardware and software products used with medical devices. The rule reclassifies these products, known as medical device data sys-tems, or MDDSs, from class III to class I, or low-risk devices, making them exempt from premarket review but still subject to quality standards. The rule was scheduled to take effect April 18.
“FDA has determined that MDDSs can be regulated as class I devices because general controls provide a reasonable assurance of safety and effectiveness for this device type,” according to the February 15 Federal Register.
Medical device data systems are off-the-shelf or custom hardware or software products used alone or in combination. They display unaltered medical device data, or transfer, store, or convert medical device data for future use in accordance with preset specifications. Such systems may include software, wireless, hardware, modems, interfaces, and communication protocols. The classification does not include devices for actively monitoring patients.
Manufacturers of MDDSs must comply with all class I requirements, including registering with the FDA, reporting adverse events, and complying with the FDA’s Quality Systems regulation, the Food and Drug Administration reports. The latter is a basic system of manufacturing and design controls that ensures manufacturers test their products before marketing them.
The rule levels the playing field for medical device manufacturers, according to a press release from the FDA. “Information technology companies that design, install, or market these systems, and hospitals that develop them in their facilities, must follow class I requirements as well,” the release says.
The Drummond Group, operating as an Office of the National Coordinator-Authorized Testing and Certification Body, has certified Meditech’s three platforms—Magic 5.6.4, client/server 5.6.4, and 6.05—as complete electronic health records.
Meditech is pursuing modular certification.
Creative Testing Solutions has contracted to install Mediware Information Systems’ LifeTrak blood-management software in its Tampa, Fla., facility. The company has been using LifeTrak at its other two facilities, in Tempe, Ariz., and Bedford, Tex., for more than a decade. The LifeTrak software includes donor, laboratory, and distribution modules.
Mediware Information Systems
Dr. Aller is director of informatics in the Department of Pathology, University of Southern California, Los Angeles. He can be reached at firstname.lastname@example.org. Hal Weiner is president of Weiner Consulting Services, LLC, Florence, Ore. He can be reached at email@example.com.