CEO SUMMARY: There have been two benefits from the use of sophisticated laboratory informatics at the laboratory division of Geisinger Health System in Danville, Pennsylvania. Benefit one is a standardized, fully-integrated lab information system that collects all lab test results, including point-of- care, into a single data repository that feeds Geisinger’s electronic medical record. The second benefit is how this enriched lab informatics capability is supporting Geisinger’s new bio-repository.
AS PRESSURE MOUNTS TO CREATE an integrated national health information system, so does the threat for laboratory managers and pathologists who fail to initiate a proactive information technology strategy in their laboratory organization.
One early-adopter laboratory has taken innovative steps to achieve comprehensive information integration on a hefty scale, well ahead of most providers in the United States. Utilizing wide area networks (WANs), Lean informatics, and Medicare’s first Physician Pay-for- Performance financial incentive, the laboratory at Danville, PA-based Geisinger Health System (GHS) has achieved two unique goals. First, it played a significant role in helping introduce evidence-based medicine into clinical practice through- out Geisinger’s regional health network. Second, the laboratory has created a sophisticated and integrated laboratory test data base that now plays a key role in Geisinger’s efforts to create a regional “bio-repository.”
Role Of Informatics
“When I think of our healthcare enterprise, I don’t think so much of bricks and mortar and hospital beds,” stated Jay B. Jones, Ph.D., Director, Chemistry and Health Group Labs at Geisinger. “I think of statistics running through our information system. This is the essence of today’s laboratory.
“Laboratorians and pathologists have to get out of the factory mindset of primarily producing numbers and verifying them to the lab computer,” he continued. “This shift in mindset is necessary if the lab industry is to position itself as a proactive asset in meeting the healthcare challenges that face us all.”
It is not a coincidence that the Geisinger laboratory is capable of supporting the advanced clinical initiatives at this fully-integrated health delivery network. For the past 15 years the laboratory has worked steadily to integrate several dimensions of its lab testing services.
First came consolidation of laboratory operations. Next was an upgrade to the information system that formed the backbone of the laboratory data repository. This was followed by a deliberate effort to follow point-of-care testing wherever it was performed within the Geisinger Health System, to electronically capture all POC test results, and to maintain a data base of test results that represented a complete record for each Geisinger patient.
“We have 55 decentralized, owned practice sites with salaried physicians handling 1.5 million outpatient visits per year,” observed Jones. “Our wide area network (WAN) has over 10,000 devices attached to it, including printers, POC connectivity devices, and EPIC. We have EPIC— our electronic medical record (EMR) system—in every examination room and nursing station. This was part of our strategy of full integration. We recognized that we could not take a fragmented approach.
“GHS captures data from laboratory, radiology, pharmacy, and other departments and uses a DataGate feeder system to get that information into the EMR,” he noted. “We port lab results via internet browser to patients and similarly use an EMR Link for referring physicians. Twenty different applications run on the lab’s client servers alone. Our client server version of EP Evaluator helps us to maintain methods standardization with minimized maintenance.
“Integrating point-of-care testing (POCT) into the informatics mainstream was a critical component,” he noted. “Earlier this year, we introduced a thick client work station program at both of our medical centers. The various POC devices—glucose meters, I-STATs—are multiplexed within these work stations.
“Anticipating the future of POC testing, we’re already developing the structure to electronically capture POCT information. In a standardized way, it flows through our informatics, first into our LIS and then into the enterprise EMR,” added Jones. “The leverage potential for these products is enormous if you can integrate them into the LIS/EMR. We use a TelCor connectivity package. MAS Technology has a similar product.”
All of these strategic initiatives in the laboratory are designed to complement and support Geisinger’s master vision for the evolution of healthcare services. This includes the introduction of evidenced-based medicine and the goal of encouraging all clinicians to closely follow clinical guidelines. In fact, Geisinger Health System is one of only 10 sites around the United States participating in the Medicare Physician Pay-for-Performance demonstration program. (See TDR, February 14, 2005.)
“As part of the Centers for Medicare and Medicaid Services’
(CMS) Physician Pay-for-Performance Pilot Program—with improving care and reducing costs as our overall goals—our first objective was to standardize practice throughout the system,” explained Jones. “To support this, the laboratory also needed to standardize many aspects of its operations.
Bio-Repository Project For Mining Health Data
ONGOING INTEGRATION OF INFORMATICS and clinical services at Geisinger Health System has created an information-rich environment. To capitalize on this resource, Geisinger has created the Center for Health Research and Rural Advocacy (CHRRA) as a resource to further its efforts to boost healthcare quality.
It is a stand-alone facility focused on outcomes. CHRRA enables researchers at Geisinger to mine the health system’s information-rich data bases in support of research pro- jects to identify genetic links to disease, along with analysis of health outcomes. ““The Center is organized around two missions,” stated Jay Jones, Ph.D., Director, Chemistry and Health Group Labs at Geisinger. “One is to validate cost-effective means of improving and protecting health for our population and the other is to discover new diagnostic tests. A bio-repository is linked to this effort.
“This is envisioned to be a three-step process,” he continued. “First, we would focus on identifying the problems that substantially impact our region. Second, we would produce evidence-based algorithms. Third, we would measure clinical and financial outcomes. Our overall goal would be to produce ‘best practices’ for defined disease states, then implement these guidelines throughout the Geisinger network with as little disruptive impact on our operations as possible.
“The process would involve seven steps: 1) embed best practices into EMR; 2) get a clinical champion to pilot the new best practice; 3) pilot the new best practice at a site; 4) refine the best practice; 5) get feedback from providers; 6) identify and tweak any problems; and, 7) template out the new best practice throughout the other parts of the network,” said Jones.
“Laboratorians will recognize this is the fulfillment of many predictions over the years,” noted Jones. “Medical informatics is amalgamating into a statistical science for doing the right tests at the right time for the right reasons—evidence-based medicine. What we are talking about is an emerging era of lab information management.”
Three Clinical Strategies
“At the system-wide level,” explained Jones, “Geisinger’s three-fold strategy includes: 1) developing best practice guidelines based on evidence from our EMR/LIS archive; 2) replicating these best practices throughout the system; and 3) embedding best practice algorithms into our EMR. The embedding strategy allows us to monitor improvement and healthcare outcomes.
“Within the laboratory, it is an evolving process to support these goals. There are a number of tactical drivers. We have realized significant savings with Lean Materials Management and by using a single GPO (Group Purchasing Organization),” added Jones.
“It is essential to choose standardized technology across our laboratory system. For this reason we stick with one vendor. We use the Roche Modular, E170 with 917s and 2010s at our two medical centers and smaller Integras at our five decentralized practice sites. These are harmonized in terms of reagent platform, LIS test codes, quality control, etc. We also use Lean to minimize the number of standardized test codes in the LIS, further reducing complexity and gaining consistency for our clinicians,” he said.
“At Geisinger, the move toward preventative healthcare is ultimately driving everything we do,” said Jones. “Within the laboratory, we developed a Lean structure to support this strategic goal. Since we have control over all facilities that collect specimens, we were able to gain efficiencies in pre-analytical work processes. We’ve also standardized labeling and specimen prep across all facilities.”
One exciting development at Geisinger is the initiative to form a bio-repository. Geisinger’s CEO recognized that many of the pieces needed to create a bio-repository already existed within the Geisinger system. One of the most important components already in existence was a lab test data repository that contained the full lab test result records for Geisinger patients, stretching back eight years.
Jones is enthusiastic about the potential of Geisinger’s bio-repository to trigger advances in medical care. The bio-repository is in the first phases of studying several diseases. One role for the laboratory is to collect DNA specimens in support of these studies as patients involved in the study show up for regular blood draws.
“In today’s informatics-based laboratory, delivering results is just the first step,” stated Jones. “To produce evidence-based outcome information, we have to think about archiving information, rather than just delivering it.
“There are two reasons for this. One is to enable the use of future innovations in diagnostics and therapeutics for the individual patient. Second is to enable the aggregation of data for public health and research purposes,” he explained. “For example, data and bio-repositories are important to enable correlating candidate genes to be analyzed by microarray. We can then make genomic associations to information in the electronic medical record.”
Geisinger leveraged logistics and its pre-analytical system informatics to capture residual specimens for DNA extraction analysis. Geisinger also recognized and leveraged another asset.
“We have a very stable population in rural Central Pennsylvania,” observed Jones. “We have a very rich eight years of deep electronic medical record data archived from our EPIC care system. We have a lot of archived outpatient information. Our CEO, Glenn Steele Jr., M.D., Ph.D., recognized the value of combining these assets to establish a disease-specific, regional bio-repository.
Lab Is Collecting DNA
“Our laboratory supported an initiative to collect and store DNA samples for analysis in conjunction with associated electronic medical data from the LIS/EMR. We throw away 3,000 specimens each day. Now we capture certain ones for storage and DNA extraction.
“It’s important to think about the value of the biomaterial which flows through your healthcare system and laboratory,” he added. “We are now able to archive genomics and phenotype data. So Geisinger’s bio-repository is more than a simple DNA bank.
“One challenge has been the consenting process and guarding patients’ HIPAA rights,” noted Jones. “We’ve learned that having phlebotomy do the consenting is not efficient because they don’t have time. We’re still working on this. One positive factor is that the actual data mining process is simple. We’ve had M.T.s and M.T. students performing that function.
“Part of the incentive for investing in the bio-repository is a recognition of what payers, employers, and consumers will want in the future: health- care that focuses on prevention,” said Jones. “Efforts to organize and align our clinical services with this goal have been corollary benefits of the Medicare pay-for-performance pilot initiative. It has also spurred further integration of our IT systems through- out the Geisinger Health System.”
In Healthcare’s Forefront
THE DARK REPORT believes that the laboratory division at Geisinger Health Systems may be one of the most fully-integrated, multi-site laboratory organizations now operating in the United States. Its ability to provide standardized testing across the continuum of care, from hospital inpatient services to rural clinics, to electronically capture, in real time, all test results, including POCT, and to feed this data into an enterprise- wide electronic medical record, puts it in healthcare’s forefront.
From one perspective, this is operational integration—a goal pursued by many laboratories serving integrated delivery networks. But at Geisinger Health System, laboratory integration has been directed toward other goals. The most important is to enable clinicians to improve outcomes. One element of this initiative is the need to standardize clinical practices around accepted guidelines and treatment algorithms. The deep integration of laboratory services at Geisinger becomes an important tool in supporting this clinical objective.
The laboratory is justifiably proud of this accomplishment. It is the future of healthcare and laboratorians at Geisinger are direct contributors. “The broad application of informatics-supported, evidence-based medicine remains theoretical at the national level,” commented Jones. “We’ve actually put it into practice throughout an extensive integrated health system.”
Geisinger’s other primary objective—to further the practice of evidence- based medicine—depends significantly on the contribution of laboratory medicine. Pathologists and laboratory managers may want to pay closer attention to the work unfolding at Geisinger’s Center for Health Research and Rural Advocacy (CHRRA), including its recently-organized bio-repository.
It is an early example of how cumulative and complete laboratory test data, compiled from a stable population over eight years, combined with the laboratory’s role in collecting DNA specimens to create a DNA bank, underpins research into the causes of disease and potential cures. CHRRA has already launched bio-repository research into osteoporosis, obesity, and schizophrenia.
Given its history as an early-adopter laboratory organization for more than 15 years, THE DARK REPORT predicts that Geisinger’s laboratory division will continue to be a leader in the laboratory industry.