November 2011
Feature Story

“Management of Pathology Information Systems”—it’s a chapter in Laboratory Administration for Pathologists, a book from CAP Press released in August. The chapter, written by James H. Harrison Jr., MD, PhD, covers everything from database applications, data warehousing and mining, and application and interface management to record retention, system selection and installation, and system and data security. In it, too, are two case studies, excerpted here for CAP TODAY readers as part of our annual laboratory information systems issue.

Case No. 1

Dr. Henry Little is associate laboratory director and medical director of the LIS at a 400-bed hospital that recently finished installing a new EHR system. About six weeks after go-live, the laboratory received a call from a clinician questioning several calcium values over 20 mg/dL. When the laboratory staff checked the results in the LIS, the values were normal, or, in some cases, no calcium assay had been done, but the clinician insisted that the high results were present in the EHR display. The laboratory staff could not review the display because the role-based security of the EHR had been configured so that only staff caring for a patient could see data on that patient. Laboratory staff members were not regarded as patient care staff and thus did not have access to the EHR data display. All interface validation had been completed with no problems before the EHR go-live. Further investigation revealed that a calculation rule had been implemented in the EHR to correct total phenytoin levels for albumin, based on clinician requests and without the knowledge of the laboratory, and the result of that calculation was being inserted erroneously into the calcium result display. The calculation was turned off.

Comments: This case raises several important issues. The most important is that a rule was created that produced a result, and the performance of the rule was not adequately validated. It is tempting to speculate that one reason for this outcome was that the rule was created by hospital computing personnel who were not familiar with patient data calculations and their validation. Though there are well-established procedures in pathology for validating calculations with appropriate test data sets, the advent of EHR with rules engines that are managed outside of pathology raise the possibility of calculations and rules using pathology data that are not managed according to pathology standards. A case could be made that pathologists should participate in the implementation and review of any rule or calculation in a clinical system that uses pathology data and produces an actionable result. In this case, the hospital committee in charge of EHR rules previously did not include a pathologist; this incident yielded an invitation to Dr. Little to join the committee.

The inability of laboratory staff to review the data display is a second issue. Practically speaking, when prob-lems are perceived in the display of pathology data, the pathology service will receive the call for assistance even though the display system may not be under pathology management. To resolve issues rapidly in support of quality patient care, the pathology service should be able to see the same display that the clinician sees and compare its content to their service records. This is also true for any other data-producing clinical service. Security of patient data is critically important, but it should be handled through methods, including appropriate training and access monitoring, that do not create barriers to problem resolution.

Case No. 2

The hospital for which Dr. Little is associate laboratory director has been actively pursuing relationships with regional clinics and small hospitals. A clinic about 30 miles away is forming a relationship with the hospital and is interested in sending testing to Dr. Little’s laboratory but would like to be able to order tests and review results within its EHR.

What are the options for supporting the clinic?

Comments: There are several possibilities. The simplest, which could be appropriate for a physician’s office or small clinic, would be to establish a broadband Internet connection such as a DSL line to the remote site, configure one or more of their office computers to establish a virtual private network connection with the LIS over the Internet, provide appropriate clinic staff with LIS accounts, and allow them to order tests and review results directly in the LIS user interface. The LIS should be configured to recognize users from that location and allow them to view results only on patients from that location. This approach would not satisfy the desire to use the clinic’s EHR, and adding accounts to the LIS could require additional licensing fees that would need to be balanced against the anticipated test revenue.

Another approach would be to establish an HL7 interface running over a secure connection (similar to a VPN) between the LIS and the clinic’s EHR. This would require creating and validating an HL7 interface with the participation of both systems’ vendors, and Dr. Little’s LIS group would probably spend significant time working with the remote site. However, this could also provide access to systems other than the LIS, which might be a benefit depending on the closeness of the business relationship, and some of the cost thus might be picked up by other parts of the organization.

A third option would be to contract with a company that acts as an HL7 interface aggregator, ie, one that connects to systems at different sites and passes HL7 messages between them. Such a company would work directly with the clinic site and the LIS group to help set up interfaces to their locations, and the overall interface development time and cost might be decreased if the company had previously developed interfaces to the systems used by the clinic and the laboratory.

Finally, some reference laboratories offer a service similar to the HL7 aggregator companies at favorable pricing, if esoteric testing from the clinic will be sent to the reference laboratory. In this case, the reference laboratory establishes the interface with the clinic’s system. If the hospital laboratory has an existing interface with the reference laboratory, it can be used to receive information on tests being sent from the clinic to the hospital laboratory and return results to the clinic through the reference laboratory system. This can be a good option if both the clinic and the hospital laboratory are willing to use the reference laboratory for esoteric testing.

Dr. Little should remember that laboratories are not allowed to offer material inducements or “kickbacks” to gain testing business and thus should be careful about, for example, low- or no-cost placement of computers and other communications equipment in the clinic. He should also consider that reporting directly to the clinic system means that his LIS group will need to do regression testing and validation of the interface and the data display in the clinic every two years.