(P-IT-7) Implementation of a new Laboratory Information System in a Blood Center Based Immunohematology Reference Laboratory: A Single-Center's Experience

Background/Case Studies: Immunohematology reference laboratories (IRL) face unique challenges that include manual documentation, staffing shortages, and high complexity testing. Several available laboratory information systems (LIS) specialize in transfusion medicine. These programs are configured for high-throughput testing and many are not adequately customized to address the complex testing algorithms in an IRL setting. The implementation of an LIS designed specifically for use in an IRL has the potential to bring significant benefits such as reduced errors, improved staff productivity, and cost savings. The purpose of this study is to systematically outline the processes for incorporating an FDA 510(k) cleared blood bank application software for an IRL at a community-based blood center, and identify challenges and limitations to implementation of a new LIS.

Study

Design/Methods: Input from staff and stakeholders contributed to the selection of an IRL-specific LIS. The LIS implementation was planned over a 9-month period. The project team included the IRL leadership, members of the IT, regulatory and quality departments from the blood center, with the IRL manager designated as the project leader and members from the LIS software development team. Prioritizing test requirements was the first step in test development. Testing worksheets were categorized by test type, prioritized and ranked for order of incorporation, and further categorized into a test menu. The ABO/Rh test was considered the highest priority and was the focus of the initial test design. Editable logic codes consisting of rules and trigger questions were created to reduce transcription errors and misinterpretation of test results (Figure 1). The software development team provided support to the IRL project manager with creating the test layout and design, while code writing was carried out by the LIS development team.

Results/Findings: A detailed process evaluation was completed to identify the major enhancement goals and cost savings by implementing the program. Features that a) manage patient historical records, b) allow for order entry and specimen processing, c) provide test entry and verification steps, and d) generate a results report to submit to the hospital were key factors in the selection process. In addition, the need for a process to allow for documentation of supervisory review was identified. Customization and integration of new LIS with the current laboratory software and workflow was most challenging.

Conclusions: Selection of an FDA 510(k) cleared IRL-specific LIS that is customizable and integrates with existing laboratory software has enabled multiple laboratories to operate within one single patient database and provide a significant time-saving improvement as well as a cost-effective means of conducting a thorough and secure review of patient records. Improved efficiency and reduction in errors were significant enhancements.

Importance of research: Few LIS companies exist that are targeted for use in the IRL. The development and implementation of an LIS in the IRL enabled multiple locations within a blood enter to share a common patient database, allowing for better tracking of patient information and associated lab results. It provided an opportunity to improve efficiency and reduce errors associated with the manual documentation of test results and management of patient historical records.