In the information technology domain, few activities rise to a higher level of "mission critical" status than the reliable and efficient integration of the laboratory information system (LIS) with the hospital information system (HIS). Clinicians send orders for laboratory examinations and base decisions on the results they receive. Patient lives may hang in the balance. And the healthcare facility owes its very mission and survival to the smooth flow of clinical and administrative data through the enterprise.

HIS/LIS integration has been enabled by the development and adoption of a variety of standards. Laboratories use HL7 to send electronic data results from their equipment as their systems rely on LOINC (Logical Observations, Identifiers, Names and Codes) as a clinical terminology suite based on SNOMED (Systematized Nomenclature of Medicine) Clinical Terms. This unified strategy serves as a foundation for a common computerized language used around the world.

"The bulk of laboratory results are highly structured digital data produced by blood analyzers," explains John Quinn, chief technology officer for healthcare practice and principal at Capgemini Health in New York City. "The LIS that sits between the blood analyzers and the HIS environment is specific to the workflow and organization of the laboratory, whether it is an internal hospital laboratory department or an outside reference lab."

Dennis Winsten, president of Dennis Winsten & Associates, Inc. in Tucson, Ariz., urges anyone involved in building the interface between systems from two different vendors to make sure that both vendors support the LOINC model as their means of exchanging information. "If it is not LOINC, make sure that what is being passed from one system to the other is what the other system expects."

The laboratory portion of LOINC contains a number of categories: chemistry, hematology, serology, microbiology and categories for drugs, such as antibiotic susceptibilities. Winsten describes expansions in LOINC include more clinical activities such as vital signs, intake and output data, EKGs, urologic imaging and other clinical parameters, including nursing functions.


INTEGRATED SYSTEM OR BEST OF BREED?

Health institutions begin the process of HIS/LIS integration with their initial IT purchase decisions. The primary controversy involves a "best of breed" vs. "integrated system" rationale.

Best of breed involves building a system that has the best laboratory system, best pharmacy system, best radiology system, including the best computerized physician order system (CPOE), and nursing entry system. This yields multiple systems to connect, which Winsten describes as a challenge even with all of the standards currently applied. An up-front integrated approach entails a system with a single architecture where everything is defined once in terms of meaning and it provides all of the components.

Proponents of best of breed argue that with an integrated system up front, the individual departmental effectiveness and efficiency are compromised, while the integrated system advocates maintain that effective integration should serve as the driving force.

Winsten suggests that as the integrated systems have evolved, many of the former "best of breed" companies have disappeared or expanded to become more comprehensive clinical systems, by offering laboratory, radiology and pharmacy in one suite.

"The argument I would make for the [up-front] integrated approach is that if you're the CIO in a hospital, irrespective of the fact that all of these systems can be interconnected, and the technology is proven, now you're dealing with multiple vendors," says Winsten. On the other hand, from an institutional standpoint, using this model, certain departments may believe they have a sub-optimal system for their work, he observes.


HURDLES TO JUMP

Once the initial decisions about approach are resolved, there are specific issues that must be addressed, such as security, patient privacy, patient access to lab results and distributing results to multiple departments.

Kevin D. Lyles, partner in the healthcare practice of Jones Day in Columbus, Ohio, raises the issue of security as it relates to HIPAA regulations and patient privacy.

Often the personnel charged with integrating networks are not security professionals. There are the usual in house challenges of maintaining a secure network within firewalls, and limiting access while insuring that clinicians can accomplish their important functions.

Further complicating the security concerns, Lyles describes that on the LIS side, many of their clients want to provide laboratory results at the patient's home via the internet.

"We are seeing solutions being developed to make that available on the internet and then patients do secured messaging with their provider if there are questions about results," explains Lyles. While this entails the same type of security and privacy issues that arise in providing laboratory results to physicians' offices, there is an additional layer of concern within the home on the human side. Would a patient want their spouse or children or others in the home to have access to sensitive laboratory reports?

Another issue that is specific to LIS integration involves the proliferation of laboratory results to multiple departments within the institution - such as dieticians, pharmacy, and therapy departments as described by Arthur Hauck, MD, physician executive for the laboratory enterprise for Cerner Corp. in Kansas City. If laboratory results reside only on the LIS and HIS, and not all other departmental systems can access the HIS directly, care could be compromised.

"As you begin to draw a spiderweb of all who need those results, and how many places you are going to have to propagate them to, it can be challenging to keep everything flowing in the right directions and keep the results updated and corrected in all of those disparate systems," says Hauck.


STRATEGIES FOR JUMPING HURDLES

In a situation where the interface between various components of the network provides challenges, there are some central solutions to assist in overcoming resulting barriers.

Many hospitals have begun using interface engines as devices that sit between the HIS and the LIS and other clinical systems that basically serve as the translator and converter between the systems. These engines are designed to insure that information is flowing smoothly in a bi-directional manner.

A central clinical data repository called Open Clinical Foundation is the approach Cerner employs in their integrated system to provide an electronic medical record capable of organizing all electronic datafeeds from across the enterprise and beyond.

"Our clinical data repository is able to store results both from our own departmental systems as well as from other suppliers' systems, that we send via HL7 and integrate into the EMR," says Hauck, who notes that some competitors offer the same capability. This becomes important because many of the current laboratory results are produced in reference laboratories that may not be housed within the institution. Hauck describes another specific challenge that involves anatomic pathology, where images may be included in the laboratory report. If they just send results over an interface, images would be lost, and the clinician would have only the text of the report. "At Cerner, on the HIS side, we're able to display those images just as the pathologist created them," he says

Some organizations have overcome data flow challenges through integration at the desktop, so says Joe Poats, vice president of Capgemini Health. Instead of creating large databases of information, they integrate information in real-time using web services and integration engines like Microsoft's BizTalk so that reference lab data and hospital data can be aggregated for the benefit of the patient. This scheme requires the patient's express approval to adopt.

Imagine a network that spans 26 hospitals, with a variety of vendors of LIS, RIS, PACS and HIS across the enterprise. Debbie Sleigh, vice president and CIO of enterprise strategy and integration for Sutter Health in Sacramento is meeting the challenges of providing patient information across the entire 26 institution system via Initiate Systems' Enterprise Master Patient Index (EMPI). Their ultimate goal is to have any patient in their system able to obtain healthcare from any of their institutions, and have all of their laboratory and other data available to all clinicians involved in their care.

"We looked for a vendor that had an open enough platform to integrate our registration systems from multiple vendors and help us uniquely identify a Sutter patient," says Sleigh. Initiate was able to take the non-integrated systems from several institutions, where the lab information systems could be from multiple vendors and the hospital information system could be from different vendors. "We made a decision to standardize across Sutter Health, so we could make sure we had the same data standards in place." That has not been an easy task because as a federated group coming together as a system, there was a need for compromise in many areas. Strict adherence to standardization enables this complex system to function. Full deployment is scheduled to be complete by 2006.

Lorraine Fernandes, senior vice president healthcare practice for Initiate Systems in Chicago, explains that their technology, the Initiate Identity Hub, is capable of understanding different methods an institution may employ to gather demographic information - such as social security number, birthdate or address - and assign a unique individual identity.

"Bring in the data via HL7 messaging to us, and with our sophisticated algorithms, we will assign a corporate identifier, and link patient data so that they are available for the caregiver at the point at which they are rendering care," says Fernandes.

Data integrity is vital to success in deploying this type of approach, and usually remediation or data cleansing is required.

"Remediation is generally an outsourced project, and may take between two and four months to complete."


CONCLUSION

A seamless interface between disparate clinical information systems and the administrative functions of a HIS is critical to the success of healthcare enterprises. IT professionals stand at the crossroads of data distribution, and must insure that all interfaces perform flawlessly every hour of every day.