Once the laboratory is in production with NBS data exchange with at least one hospital, the project enters a long-term maintenance and operations phase. During this phase, the development team will ramp down activities, and the team will focus on providing support for the users of the message. This phase also provides the opportunity for the laboratory to monitor the new processes for the purpose of documenting improvements to data integrity and turnaround times as a result of the implementation.
The maintenance and operations phase is an ongoing need for laboratories and their partners. As the laboratory becomes more familiar with electronic messaging and adds hospitals to the program, this effort will become a routine quality assurance task for the laboratory. Strong communication with partner hospitals and a commitment to continuous improvement will provide a long-term return on investment for electronic messaging.
Communications Post Go-Live
Although the laboratory should have laid out plans for monitoring and support during the planning phase of the project, these plans may have to be modified as the project progresses and more hospitals are participating in data exchange. As with paper reporting, the laboratory should have a clear plan for communicating issues with the partner hospital. These plans should include what type of monitoring the laboratory and hospital is responsible for and how issues will be reported.
Since hospitals operate 24 hours a day, many laboratories are moving to a 6 or 7-day work week, with staff running NBS samples all hours of the day and night. Therefore, the laboratory will need to decide how to handle issues after regular laboratory hours. These issues may necessitate setting up an “on-call” schedule for providing real-time assistance or provide a help desk option where issues can be entered remotely by the partner.
Importantly, the laboratory should make every effort to keep the monitoring and support agreements identical for all hospitals to streamline the support provided by the laboratory. The laboratory may want to set up a method for entering and recording issues as they are uncovered and provide a clear method for their partners to report issues. The laboratory will also need to make sure any vendor contracts include this level of support, especially if there is a vendor who is providing IT support for messaging infrastructure.
Identifying the points of contact for each partner is vital to an effective communication plan and the speedy resolution of any issues that arise with the data exchange. The laboratory should assign specific personnel to handle issues within particular domains. For example, an issue with partner connectivity may be handled by IT staff, while an issue with the data may be addressed by a data entry supervisor. Additionally, the laboratory informatician can manage issues with usability, coded values or message structure. Ideally, the laboratory will be able to coordinate with a single point of contact for an entire hospital system who will communicate with each hospital regarding any connectivity or system-wide reporting issues or testing communications. The partner agreements with the hospitals should also include these same considerations, the laboratory should be very clear who to contact at the hospital in case an issue is found.
Monitor Data Exchange
The laboratory should monitor the data exchange process when it is in the maintenance and operation phase. Monitoring will allow the laboratory and its partners to proactively address issues and record statistics for quality assurance purposes.
Closely monitoring the delivery and receipt of abnormal and critical results will provide both partners with the assurance that the electronic messages are working properly. The laboratory should be aware of factors that might impact the exchange process and actively review the exchange after these events. Factors that might impact the exchange process include upgrades to IT hardware and software, power outages, and any other major disruptions to laboratory or hospital functions. Additionally, the laboratory may want to review any singular, unusual test results, such as abnormal or critical results that are extremely rare, or uncommon combinations of results to make sure the message accurately represents these results.
"The monthly quality assurance reports provided to submitters by the newborn screening lab showed a dramatic decrease in the instances of missing key demographic information for the ETOR partners. Internal tracking of amended result reports also showed the elimination of amended reports for demographic changes requested by ETOR partners."
-Wisconsin Newborn Screening Program; State Case Study #2
Newborn screening programs are encouraged to monitor the number of electronic orders received. By monitoring this information, the laboratory may be able to identify issues at the submitting hospital as well. For example, a sharp decrease in the number of orders received may indicate an issue in the test order process at the hospital. Proactively monitoring these electronic exchange indicators will allow the laboratory and its partners to identify issues and find solutions more quickly.
Evaluate and Improve Process
Electronic orders and results offer multiple opportunities to improve the quality of the data associated with newborn screening as well as the timeliness of the results. NewSTEPs has established quality indicators to measure multiple factors regarding newborn screening. Electronic messaging may directly affect the indicators related to timeliness and missing data. The laboratory should be able to measure the impact of electronic messaging on these indicators to demonstrate a return on investment.
Quality Indicator 2: Percent of dried blood spot specimens with at least one missing state-defined essential field upon receipt at the laboratory.
Because the implementation of electronic orders can enforce the data included in the message, incomplete submissions can be flagged before the order is sent to the laboratory. Having defined the required fields during the creation of constrained order profile, previous problems associated with missing required data fields should be eliminated by electronic messaging.
Related to this quality indicator, programs should also monitor and provide feedback to hospitals on the quantity of remote ordering errors per facility. Erroneous entry of key data elements into the HL7 order can result in specimen processing delays and a loss of the benefits of electronic ordering. Chronic system wide issues can also be used to identify potential improvements to the HL7 order validation requirements both on the laboratory receiving end and the hospital order entry interface.
Quality Indicator 5: Timeliness of newborn screening activities.
(c) Time from specimen receipt at your state’s newborn screening laboratory to reporting out specimen results.
(d) Time from birth to reporting out specimen results.
Electronic messaging should decrease turnaround time for samples tested by reducing the time needed for manual data entry and avoiding the need to rely on the postal system for delivery of results. Additionally, electronic transmission of NBS results should eliminate delays that previously occurred as hard-copy reports were routed internally throughout the hospital after delivery.
By comparing the data from these quality indicators to the values collected before implementation, the laboratory can demonstrate the value of the implementation. The laboratory may also want to collect these data specifically for each hospital submitter. This analysis may reveal a marked difference in quality between hospitals participating in electronic data exchange and those that are not. The laboratory can then use these data to encourage additional hospitals to on-board and, as a proof of concept, to apply for funding opportunities as they arise. Many laboratories share these quality indicator data with their partners through a “report card” that measures the hospital’s compliance with meeting data integrity and turnaround time goals. By sharing these quality data with the hospital, the laboratory provides a baseline against which the hospital can improve their practices and ultimately improve the health of its newborns.
Hospital report cards have been shown to be extremely effective in improving process and quality. Laboratories who share these quality data with their partners reported beginning a valuable dialogue with the hospital to provide additional training and services to the partner, as needed. Additionally, some laboratories have provided de-identified aggregate data of all the submitting hospitals, which allows an individual hospital partner to compare its performance to other hospitals in the area.
Perform Change Control
During the operation phase, the laboratory and its partner hospitals will occasionally need to make changes to the data exchange process. These changes can include new screening tests, changes to the constrained profile, LIMS changes, and hospital system changes. In order to mitigate any adverse effects, the laboratory should evaluate each change in light of the existing process.
The laboratory should consider forming a change control board whose members include laboratory, hospital and IT resources. These members can evaluate the proposed changes for the impact they may have on each of these sectors of the team. The team can review the change and approve or deny it (if possible). If approved, they can lay out a plan for implementation and testing of the change. It is important to include previously on-boarded hospitals as well as those currently being on-boarded so that the team can come to a consensus on the best option for the whole community. The figure below outlines this process. Further details on the format of a change request and detailed change control workflows can be found in Section 5: Tools Reference Guide.
Fulfill Ongoing Training Needs
The laboratory must determine the on-going training needs of its staff while in the maintenance phase. New employee training, regular competency assessment and updates are some of the artifacts the laboratory might consider including in its training plans. Additionally, the laboratory may want to reach out to its hospital partners to reiterate the importance of newborn screening and following the protocols involved in electronic data exchange. As the hospital experiences staff turnover, establishing consistent communication and reinforcement will provide a solid baseline for continued success.
Strong project documentation is vital for ongoing success of a data exchange project. As laboratory and hospital staff experience turnover, readily accessible and understandable documentation is paramount. The laboratory should consider setting up a document storage and sharing system (ex. SharePoint) to provide a project knowledgebase useful to current and future staff.