In this section, we review our findings regarding the nature of electronic lab data exchange today, including a brief discussion of the related functions and uses supported by lab exchange, the stakeholders involved, typical processes for setting up an exchange, and a summary of some of the costs involved. We also introduce discussion of the use of standards in lab data exchange which we described in greater detail in the subsequent section. While much of this section is relevant to any ambulatory care provider that is seeking to establish functionality allowing for lab exchange, we focus on health center and health center network specific issues throughout.
Below we provide a basic workflow model which is not representative of all the different processes for exchanging lab information, but outlines common processes used by ambulatory providers and health centers today to exchange information with laboratories.
Exhibit 1: Overview of Lab Data Exchange, Provider View
Exhibit 1 above shows the typical functions and stakeholders supported by an interface between an ambulatory care providers’ EHR application and a laboratory information system (LIS). As noted in the diagram, these interfaces may support unidirectional reporting where lab test results are transmitted electronically from the LIS to the providers’ EHR but orders are not transmitted, or bi‐directional reporting where both lab orders originating with the provider and going to the LIS and the results back from the LIS are transmitted electronically through the same interface to a provider EHR.
In all cases, it is important to note that lab exchange involves more than just information passing back and forth between systems. There is a physical specimen (e.g. blood) to be taken from the patient and transferred with a paper requisition to the lab facility for testing and processing. The paper requisition accompanies the test specimen which is sent to a clinical laboratory. The clinical lab processes the order, and sends the results electronically to the host EHR system. We discuss our findings related to ordering and results retrieval below.
Ordering lab tests. We found that there are a few basic workflows associated with ordering clinical labs using a lab exchange interface depending on the presence of a uni‐ or bi‐directional interface. Where a bi‐directional interface is present, orders are placed by clinicians through their EHR. When this occurs, data regarding the patient, clinician, lab test, specimen and other key fields are forwarded to the clinical laboratory’s LIS, typically via a Health Level 7 or HL7 message (described in greater detail on page 14) and the order is assigned a unique identifier.
At the same time, a requisition with this information is printed in hard copy from the provider’s EHR to accompany the physical specimen to the laboratory facility. These requisitions typically include bar codes which map to the unique identifier on the electronic order. Whether the specimen sample (e.g. blood) is taken at the clinician’s own site or at another location, the requisition is attached to the specimen and accompanies it to the laboratory’s testing facility. When the specimen arrives, the bar‐coded requisition is scanned and there is a check to ensure that the data in the LIS for that particular requisition matches the data on the physical requisition and specimen label. Once the appropriate tests are conducted and results determined, these results are entered into the LIS and associated with the appropriate order identifier.
When there is not a bi‐directional interface, the key difference is that the initial order is not transmitted to the laboratory’s LIS directly via the clinician’s EHR. Rather, the order information is submitted to the clinical laboratory’s LIS through a separate process which may involve the use of an online ordering system that is supported by most of the major national laboratories. In this case, it would be typical for the online ordering system to also generate a bar‐coded paper requisition that could be printed and attached to the specimen. In addition, many orders are also forwarded to labs via paper requisition. Linking these orders to an EHR and receiving results electronically requires the use of a consistent order number between the EHR and the reporting laboratory. Without a bi‐directional interface that supports ordering, the clinician office staff must record the order data in two places: the patient’s individual medical chart where the order is noted by the clinician; and the separate online portal where information from that chart is re‐entered by a member of the clinic or health center staff.
Transmitting lab results. Transmitting results is more streamlined from a workflow perspective. After an ordered test is performed, the labs feed the results into their LIS and the interface delivers the laboratory test result along with all of the information identifying the original order (lab order number, patient name, ordering physician, lab ordered, time and date) to the authorized provider on record. In the cases where unidirectional interfaces have been set up the test result is sent to the clinic’s EHR. Once the results are transmitted, the provider reviews the lab results that he or she ordered on a specific screen within the EHR, authenticates the results, and writes off the disposition at which point typically, the result and disposition becomes part of the patient’s clinical record. In the case of one interviewed network, results are first sent electronically to the provider’s task list. If a test result is abnormal, it is routed to the abnormal taskforce, a set of designated providers, other than the ordering physician, who are thus notified of this outcome. This special feature is particularly useful if the ordering clinician is out of town or off‐duty; in such cases, another clinician can intervene and provide timely care. Once a test result is viewed and accessioned (or recorded), it is cleared from the list. The result is then routed to the patient’s record within the EHR. When lab test results are being sent to a stand‐alone EHR, the lab does not directly control the EHR’s display of the lab results. In addition, the lab receives an acknowledgement that a result has been delivered to the EHR but does not receive further verification when a particular test result has been viewed.
In some circumstances, clinicians without interfaced‐EHRs can also view laboratory results electronically either via a portal set up by the clinical laboratory for this use or through a mechanism made available by a state or regional health information exchange. In cases where the labs provide portal access for providers, they have significantly more control over the manner in which test results are displayed and are able to more closely monitor how and when the results are reviewed. In this case, however, even though the information can be viewed electronically, it usually needs to be printed and included in the paper record; it may also be necessary to re‐enter the data into a non‐interfaced EHR.
There is a general agreement among the interviewed representatives that bi‐directional exchange is ideal and an integral part of a comprehensive EHR. Laboratory stakeholders in particular indicated that bi‐directional interfaces are an optimal solution as they do not involve redundant data entry and thus, leave far less room for human error. While the number of bi‐directional interfaces is increasing, one of our laboratory discussants estimated that 70 percent of the interfaces currently used by their lab are unidirectional and only allow for reporting results.
Health Center and Health Center Network Considerations. In addition to the fact that health centers are subject to the issues described above, there are particular issues of note for health centers, health center networks and the populations they serve. In particular, because relatively few health centers have the ability to adopt EHRs on their own, they are less likely to have a sophisticated provider application layer as depicted in Exhibit 1. Given that health centers are focused on quality improvement as a result of their grant obligations and mission and because they treat many chronically ill patients, even if they do not have EHRs, they are likely to have disease registries or other tracking databases where staff enters lab values for specific groups of patients. Currently, there is limited information regarding the use of lab exchange to automate the population of disease registries in the absence of an EHR. However, it is not likely that this occurs often.
Those health centers that have adopted EHRs often do so as part of a consortium of health centers, often referred to as a health center controlled network (HCCN), which allows member health centers to leverage grant dollars and achieve the economies of scale necessary to procure human resources, infrastructure and software in support of clinical applications, such as EHRs and interfaces. While there are many models for how health centers use HCCNs to support their operations, several of these models involve the use of networked applications and interfaces maintained centrally and accessed by member health centers over a secure network.
In the case of a network that provides health centers access to a centrally maintained EHR, establishing laboratory interfaces to that EHR requires a separate set of considerations for each health center and clinical laboratory. A network that administers one EHR works with a series of health centers with multiple sites to establish interfaces with all of their labs. Thus, networks may have to support scores of different versions of an Exhibit 1 workflow in order to provide a consistent level of service. For example, a network serving five health centers who together have 10 health center sites that each work with three laboratories may have to set up and maintain up to 30 unique workflows even though all sites are using the same networked EHR.
Linking the exchange to quality improvement. It is important to note that in order for lab exchange to achieve broader population‐based objectives and provide some return for providers, the workflow associated with the establishment of the exchange cannot end with what is described in Exhibit 1. Instead, additional steps are necessary between the provider’s clinical application or EHR and the registries, reports, alerts or other functionalities that automate the tracking of key lab values and provide feedback, and in some cases decision support, to providers based on lab results. Many EHRs do not come with a built‐in registry capability or even automated reminders to inform providers that, for example, they have diabetic patients who have missed an HbA1c test. Building this functionality and working it into the clinical workflow requires additional effort. However, such enhanced reporting capabilities and registries are increasingly being used to support quality improvement at the point of care and to promote overall population health.