Kaiser Permanente (KP), headquartered in Oakland, Calif, first signed its electronic medical record (EMR) contract in February 2003. In April 2004, Hawaii was the first KP region to implement ambulatory EMR. Other regions followed, establishing both ambulatory and inpatient EMRs. Completion of the rollout is expected in 2009. Throughout the process, no system has gone live without its lab component.

“Many of our doctors insisted that the lab component be functional when the system went live. Because it was such an important piece of data for physicians, we opted to wait. So every system has gone live with the lab,” says Suzanne Spradley, CLS, MT(ASCP), MS, senior manager of ancillaries and terminology for the KP HealthConnect team.

Walter Sujansky, MD, PhD, president of Sujansky & Associates LLC (San Carlos, Calif), does not find this surprising. “Lab-result reporting is one of the top three EMR clinical functions identified by physicians in surveys as bringing value to the EMR. If this function doesn’t work well or can’t be implemented, it decreases the value of the EMR and will affect how quickly these systems are adopted,” Sujansky says.

But the benefits of the EMR, particularly with lab and pharmacy functionality, are expected to quickly sway health care as a whole to electronic systems. Thought to decrease errors and improve efficiency, EMRs are expected to positively impact both patient care and the bottom line—so much so that the US Department of Health and Human Services (HHS of Washington, DC) announced new regulations this summer intended to encourage EMR adoption among physicians.

Many anticipate the move will work, and as more providers implement EMRs, laboratories can expect to begin communicating with more providers through these systems. Unfortunately, there may be some hurdles to establishing communication between an EMR and a laboratory information system (LIS). With the diversity in systems, integration can be a challenge.

To alleviate these translation hurdles, the EHR-Lab Interoperability and Connectivity Standards (ELINCS) project was established 2 years ago. Its first goal is to establish standards for the electronic delivery of results. “With a common standard and implementation guide, laboratories benefit by knowing they have a secure, compliant pathway for results to be received,” says John Tooker, MD, MBA, FACP, executive vice president and CEO of the American College of Physicians (ACP of Philadelphia) and a steering committee member of ELINCS.

The End of the Chain
Eventually, standards will be developed for information going the other way as well, such as lab orders. The electronic delivery of information, whether orders, results, or other information, brings benefits that can result in better and more efficient care. Will Shipley, a project leader at Schuyler House (Valencia, Calif), notes that some hospitals have seen an 85% reduction in medication errors. Time has been saved, too. “In a couple of facilities, the physicians have found 25% more time to spend with patients without increasing their workday,” Shipley says.

Research conducted by the Rand Corp (Santa Monica, Calif) and published in the Los Angeles Times suggests that EMRs can save a minimum of $81 billion per year and as much as $346 billion per year. These savings would be realized primarily through lower administrative costs, with greater savings seen with greater use.1

Very little other research exists that quantifies the impact the EMR has on the lab, but the tool stands to improve laboratory workflow and visibility. Kaiser’s laboratories found they had more influence over the ordering process. “We can customize by test,” Spradley says. This means that collection information, testing procedures, or compliance steps are seen at the point of order. Duplications can be avoided, and specimen integrity can be improved.

“The EMR makes the physician fill in needed information, such as specimen source and type. And it’s legible. The system can suggest that a physician order a cheaper screening test before another more expensive and possibly unnecessary test,” Spradley says. Coding allows the laboratories to track specimens received.

On the results side, the laboratory may find greater reliability in delivery and have an easier time with compliance. “In the past, we had just a moderately good record of whether a result report had been faxed. Now, there will be an acknowledgement of receipt. And in the future, the laboratory will be able to verify not only that the report was received, but also that the result was stored in the correct place,” says William W. Ferguson, MD, FAAFP, a physician with Southern Sierra Medical Clinic in Ridgecrest, Calif.

Electronic information is also more usable. “Rather than just images of files, like you get with scanning, actual data is stored in the medical record, making it graphable and searchable. We don’t even know all of the things we’ll be able to do with the information,” Ferguson says, suggesting graphing cholesterols or providing automatic alerts as examples.

Simply being able to access information readily can provide benefits. “In the past, the chart was not present 60% of the time when the patient came to see a physician in the office. Now, our caregivers have access to the EMR 7 days a week, 24 hours a day,” says Pamela Hudson, vice president of business services for KP HealthConnect.

Hudson quotes a Kaiser physician as saying about the new EMR, “I no longer have to spend time looking for the chart when I come to the nursing unit, nor do I have to wait for it if it is being used. I can get all the laboratory information in one place and no longer have to write it down. I can see all notes without having to flip through the chart.”

Linking Together
But to make a system this seamless takes some work. “It’s never completely automatic. You never roll the EMR in and turn it on, but usually the work needed is minor,” says Joe Landau, president of VersaForm Systems Corp (Campbell, Calif), a health systems software provider.

When all the modules of an integrated system are from the same vendor—such as the EMR, the LIS, the billing, and the practice-management system—they tend to work very well together. When these modules are from different vendors, challenges can arise in getting the systems to communicate. 

Dan Pollard, PhD, director of product management for Misys Healthcare Systems (Raleigh, NC), which develops and distributes electronic health care products, notes the problem usually occurs as a result of differing transmission protocols. Misys gets around this by using a type of “lab clearinghouse,” which acts as the middleman between laboratories and providers. “The labs then have a common pathway to send results back,” Pollard says.

It is more often the case, however, that different systems are asked to exchange information. “Most physician practices do not control the lab or LIS,” Sujansky says. Similarly, many labs serving providers outside of their institution have little influence over the purchasing decisions of clients.

“In a hospital, the same business entity or IT organization is operating both the lab system and the EMR, so it’s easier to develop, maintain, and run those types of interfaces. Outpatient [lab service] is difficult and time-consuming,” Sujansky says.

It’s possible that one lab will have to interface with many systems. “If there is a diversity of interface, it makes it costly and difficult for the lab. At the end of the day, the lab might not have the resources to implement different interfaces with every EMR. Nor will it be able to validate that all of them are working properly,” Sujansky says. A system rollout can be more costly and take longer than expected as a result.

Kaiser’s EMR, a system from Epic Systems Corp of Verona, Wis, had to integrate with a different LIS in each of the organization’s eight regions, according to Spradley. “The process was very labor-intensive. We had to map every lab test to a test in the EMR. We had to make sure relevant information appeared in the results. We did lots of testing in the regions to make sure test ‘A’ was test ‘A,’ ” Spradley says, adding that as a result, the interfaces are very strong.

If the systems were to communicate using industry standards, much of this initial work could be eliminated. “Standards, such as those in development through ELINCS, are important because they permit interoperability messaging. If all of the vendors are consistent with a standard, then the lab only needs to implement one type of interface,” Sujansky says.

EMR to Replace LIS?
Rumors suggest that the laboratory information system (LIS) will be replaced by the electronic medical record (EMR), but the experts CLP spoke with disagreed.

Donald H. French, senior vice president of research and development, Optio Software Inc (Alpharetta, Ga), suggests that the two systems complement each other. “There are too many things the LIS handles that you wouldn’t want to replicate with the EMR,” French says.

Suzanne Spradley, CLS, MT(ASCP), MS, senior manager of ancillaries and terminology for the KP Health Connect team of Kaiser Permanente (Oakland, Calif), emphasizes that the LIS stores all of the laboratory data that may be needed at some time but that is not kept within the EMR. “The LIS is the system of record for the laboratory. Not all information is transmitted to the EMR, because the doctors don’t need it,” Spradley says.

Differing market needs will keep both systems around for a while. “I think there are two very different markets in terms of the users and their needs,” says Dan Pollard, PhD, director of product management at Misys Healthcare Systems (Raleigh, NC). —RD

Keeping It Reliable
Some physicians are a little like cowboys—you can pry their patient charts from their cold, dead hands. Others have moved quietly into the 21st century. Others cannot wait to implement the latest technical gadgets. But all of them fear unplanned computer downtime, which could translate to no access to patient charts and a major work slowdown. Fortunately, however, users have some control over uptime.

The first step is to do thorough homework before purchasing an electronic medical record (EMR) system. Vendor and product reputation and references can help to uncover reliability problems. Ideally, the vendor should be able to illustrate 99.99% uptime. “That’s the optimum level to achieve,” says Mike McGuire, senior vice president and general manager of health care for Optio Software Inc (Alpharetta, Ga). Many of the users CLP spoke with, including representatives from Kaiser Permanente (Oakland, Calif) and Southern Sierra Medical Clinic (Ridgecrest, Calif), reported that reliability has not been an issue with their systems.

Users can also minimize downtime with access to technical help during implementation and after, particularly on-site. “If you have a practice where someone internally is a computer expert, they can often respond to problems,” says John E. Kralewski, PhD, professor in the division of health services research and policy at the University of Minnesota (Minneapolis).

Built-in contingencies are another excellent solution to unplanned downtime. Fail-over capabilities that switch to backup servers is one way of having redundancy. Smaller systems are more at risk from power outages and computer viruses than server crashes. Backups can be created for these situations as well. Stephanie Rich, a project leader with Schuyler House (Valencia, Calif), suggests an extra laptop stored in a desk could be used while another unit undergoes maintenance. —RD

Unfortunately, until an official standard is in place, this benefit won’t be realized, Sujansky says. “It’s a chicken and egg game. The labs are waiting for the vendors to implement standards, and the vendors are waiting for the labs. They both need to implement them at the same time,” he says.

The ELINCS project aims to move this transition along. Participants in a collaborative effort funded by the California HealthCare Foundation (CHCF of Oakland, Calif) include laboratories, vendors, and provider organizations. Sujansky and Associates is leading the technical workgroup, and five health care organizations are implementing the current draft standard to evaluate its use in an ambulatory setting. Southern Sierra Medical Clinic is one of these facilities.

“We have not found many problems with the standard itself, but we’ve had some difficulty with the communication protocols,” Ferguson says. One system unloaded information using TCP/IP, while the EMR protocol used htp to store it. “We needed hardware and software to create an interface engine to translate between the two,” Ferguson says.

In addition, the clinic has had to enter the Logical Observation Identifiers Names and Codes (LOINC). The vendor and IT department are completing the related programming now, with electronic results delivery expected by year’s end, according to Ferguson. The feedback will be used to improve the ELINCS guideline document.

The ELINCS standard, which is based on HL7-compliant specifications, has already been incorporated into the Certification Commission for Healthcare Information Technology (CCHIT of Chicago) criteria for ambulatory EMRs, published this summer.

The final guidelines are expected to cover standardized interoperability messaging, including formats. If the information is structured in a uniform way, the EMR can understand the information and manipulate it in more ways. “The system can recognize the test type and apply internal logic that can be linked to reference ranges or alerts. The system truly processes information, rather than just throwing information up on the screen to mimic a paper document,” Sujansky says.

Standardization also leads to greater compliance in ensuring that the information the provider needs to see has been seen. “If a lab is sending a result to an EMR that is certified to be compliant with the ELINCS standard, then the lab knows that the EMR is displaying those elements that need to be seen and doesn’t need to verify this information for itself at every installed site,” Sujansky says. He notes that the elements required by the Clinical Laboratory Improvement Amendments (CLIA) are also required by ELINCS.

Tooker, a member of the ELINCS general oversight team, shares his sense that the format, though tailored, would be very structured and consistent. “All the stakeholders should know what to expect when they receive a message,” Tooker says.

However, from CLIA’s point of view, the lab is still responsible for compliance. For this to change, the regulations would need to be altered, Sujansky adds. “We are in discussions with CLIA to modify the regulations so that labs are no longer held responsible for something that is outside of their control,” Sujansky says.

Electronic results reporting will have a positive impact on the lab regardless, but Sujansky admits that labs could see even greater benefit from the digitization of the lab ordering process. However, with a finite amount of time and resources, the project focused first on results delivery. “We felt results delivery is better understood since it is already supported by a lot of EMRs and was a good first step in standardizing the electronic exchange of both results and orders,” Sujansky says.

Community Bonds
Easier integration will lead to greater adoption. The Rand Corp study found that roughly 20% to 25% of hospitals and 15% to 20% of physician offices have adopted EMR, according to the Los Angeles Times. One factor contributing to the low adoption rate is thought to be cost.

New regulations released by the Centers for Medicare and Medicaid Services (CMS of Baltimore) and the Office of the Inspector General (OIG of Washington, DC) create exceptions and safe harbors within the Stark Law and federal antikickback statutes, respectively. The relaxation in the rules will now allow hospitals and other entities to donate EMR-related products and services to physicians.

John E. Kralewski, PhD, professor in the division of health services research and policy at the University of Minnesota (Minneapolis), thinks the move may have its intended effect of spurring adoption not only because of the financial assistance, but also because it is a good marketing move. “Hospitals will take advantage of the relaxation in the law because they believe it will help lower costs and because it will build another relationship with referring physicians,” Kralewski says.

Kralewski thinks the medical community will slowly move toward communitywide connectivity. That vision is often referred to as the electronic health record or EHR, encompassing the information stored in all health care organizations. A nationwide project would have to meet challenges similar to those presented integrating the EMR with the LIS. But that’s another story.

1. Alonso-Zaldivar R. Bill seeks national medical records system. Los Angeles Times. August 13, 2006:A22.

EMR Product Showcase
As of July, the Certification Commission for Healthcare Information Technology (CCHIT of Chicago) had certified 22 products, but far more exist in the market. Each offers features tailored to its specific audience, whether a large hospital or a small physician’s office. CLP takes a quick look at just a few of the products on the market.

—The 25-year-old Optio Software Inc (Alpharetta, Ga) has installed its electronic health record (EHR) in more than 700 health care organizations. The QuickRecord Suite features secure, Web-based access to patient charts, desktop imaging for scanning documents into the EHR, electronic document delivery, electronic signature authentication for physicians, and deficiency management for accelerated chart completion. The company also offers forms-automation solutions that digitize paper trails.

—Misys Healthcare Systems (Raleigh, NC) offers a number of electronic solutions for the medical market. The company’s physician electronic medical record (EMR) system is in its eighth version and was certified by the Certification Commission for Healthcare Information Technology (CCHIT) this past summer. Options include specialty-specific products such as cardiology, family practice, pediatrics, and surgery. The system can integrate with those from outside vendors as well as other Misys modules. The company does offer a laboratory information system (LIS). “Relating the EMR to the lab, there is a full orders-management module with which orders are electronically captured and sent to the lab, requisitions and specimen labels can be created, and results can be reported back,” says Dan Pollard, PhD, Misys director of product management. The company reduces interfacing problems through use of a “clearinghouse.”

—Schuyler House (Valencia, Calif) is rolling out its EMR now, according to William Shipley, its president and chief system architect. The company has offered a LIS for 15 years. Because of this focus, the company has a unique approach to its EMR development. “About 60% to 70% of the EMR information comes from the laboratories, and we can provide a lot of information that will be very useful. But we have also designed the information to be delivered to the physician in a searchable and useable format,” Shipley says.

— VersaForm Systems Corp (Campbell, Calif) has offered EMR systems to physician’s offices for 8 years and billing systems for 25. A basic version of the company’s EMR introduces physicians to the system with capacity for 20 patients. Paid versions offer unlimited patient storage, stronger security measures (such as different access levels for staff members), and data analysis. Other company modules include practice-management and appointment scheduling.

The List of CCHIT-Certified Ambulatory EHR Products:
• Centricity EMR 2005 v6.0 by GE Healthcare (Waukesha, Wis)
• Companion EMR v8.5 by Companion Technologies (Columbia, SC)
• eClinicalWorks v7.0 Release 2 by eClinicalWorks (Westborough, Mass)
• e-MDs Solution Series 6.1 by e-MDs (Austin, Tex)
• EncounterPro EHR 5.0 by JMJ Technologies (Atlanta)
• EpicCare Ambulatory EMR Spring 2006 by Epic Systems (Verona, Wis)
• HealthMatics Electronic Health Records 2006 by Allscripts (Chicago)
• Horizon Ambulatory Care v9.4 by McKesson (Newton, Mass)
• iMedica Patient Relationship Manager 2005, v5.1 by iMedica Corp (Santa Clara, Calif)
• Intergy EHR v3.00 by Emdeon Practice Services (Tampa, Fla)
• MEDENT 16 by Medent Community Computer Service (Auburn, NY)
• Medical and Practice Management Suite Client Server v5.5 (Service Release 2.1) by LSS Data Systems (Eden Prairie, Minn)
• Misys EMR 8.0 by Misys Healthcare Systems (Raleigh, NC)
• MMD.Net HER 9.0.9 by MCS (Medical Communications Systems of Woburn, Mass)
• myNightingale Physicians Workstation 5.1 by Nightingale Informatix Corp (Markham, Ontario, Canada)
• NextGen EMR 3.3 by NextGen Healthcare Information Systems (Horsham, Pa)
• Practice Partner 9 by Practice Partner (Seattle)
• PowerChart 2005.02 by Cerner Corp (Kansas City, Mo)
• Praxis Electronic Medical Records v3.4 by Infor-Med Corp (Woodland, Calif)
• Record 2006 (v3.0) by MedcomSoft (Toronto)
• TouchWorks Electronic Health Record 10.1.1 by Allscripts
• WebChart 4.23 my Medical Informatics Engineering (Fort Wayne, Ind)

Renee DiIulio is a contributing writer for Clinical Lab Products.