Focus on: Electronic Health Records: Laboratory Professionals Have Key Role to Play In Developing Safer EHR Systems

Laboratory professionals can contribute to the development of safer electronic health record (EHR) systems through engagement, data integrity and usability, and innovation, according to a new white paper from the Centers for Disease Control and Prevention (CDC). The development of EHR systems and other health information technologies (HITs) is changing how laboratory data are transmitted and displayed throughout the health care system. Thoughtfully designed and rigorously tested EHR systems improve patient care by making it easier to collect, share, and interpret patient data, notes the CDC in the paper, “The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems.” Examples of preventable safety risks include misdiagnosis, delays in treatment, and inappropriate treatment. Nationwide efforts are under way to implement EHR systems that can seamlessly exchange health information to improve patient care and, ultimately, health outcomes. The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services are promoting this development through two sets of regulations: the ONC’s EHR Standards and Certification Criteria and the Medicare and Medicaid EHR Incentive Program. As the percentage of providers using EHR systems has significantly increased over the last decade, there is concern that EHR system-related events may also be on the rise. While it is hard determine the extent of the risks to patient safety, several patient safety events related to the use of laboratory data in EHR systems are identified in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database. The concerns for potential and real harm as shared by individual experts, the Clinical Laboratory Improvement Advisory Committee, and patient safety organizations (PSOs) prompted CDC to develop the white paper identifying examples of safety risks and highlight how lab professionals’ experience can contribute to the development of safer EHR systems. The CDC proposes three focus areas where lab professionals can help address patient safety concerns. The three areas are discussed below. Engagement Laboratory professionals can provide lab expertise for HIT decisionmaking in the design, development, and implementation of EHR systems at both national and local levels. Given the complexity of EHR systems, expert consultation with lab professionals, as well as clinicians who use lab data, is critical to bridging the knowledge gap between clinical practice and EHR system technology design and implementation. Among engagement strategies suggested by CDC:

• »Serve on policy and standards federal advisory committees and the numerous workgroups that support the ONC health care initiatives.

• »Monitor and submit comments on proposed rules and guidelines related to EHR implementation.

• »Work with ONC, National Institute of Standards and Technology, and the Healthcare Information and Management Systems Society and other policy, certification, and standards development organizations to determine opportunities for collaboration.

Data Integrity and Usability Laboratory professionals can guide and maintain data integrity and usability to ensure that laboratory data are accurately presented in the EHR and available at the point of care. The CDC cites the case of a young woman whose abnormal Pap smear results went undetected for years due to a usability issue with the physician’s EHR system. Due to a default setting, the system presented the physician with the patient’s previously normal laboratory result and the most recent abnormal result went unnoticed. The young women’s advanced cervical cancer was only detected when she sought treatment for other symptoms that had developed. As a result of the delay in diagnosis and treatment, the young woman had a hysterectomy. The CDC notes there are opportunities for lab professionals to have an impact on data integrity and usability, including these:

• »Engage with EHR developers on the development and design of laboratory-related EHR system features, such as critical results alerts.

• »Provide laboratory expertise for assessing and improving the interoperability and usability of EHR systems at both organizational and national levels.

• »Facilitate rigorous assessment of the usability of laboratory test ordering and reporting functions in the EHR for high-risk patient testing.

Innovation Laboratory professionals can partner with stakeholders to stimulate innovation in EHR technology and usability to reduce laboratory data-related errors attributed to the use of EHR systems. Innovative clinical decision support (CDS) tools can be created to analyze patient records automatically when new information is received in the EHR. If such CDS tools existed, the reduction in time to diagnosis and treatment for an acute condition could be lifesaving, says the white paper. Emergent conditions such as sepsis can be detected earlier, prompting clinicians to further evaluate the patient. Among innovation strategies recommended by the CDC for lab professionals and organizations are these:

• »Champion collaborative efforts and support research agendas to provide more detail on laboratory data-related patient safety concerns in the EHR.

• »Collaborate with human factor engineers, EHR system interface designers, and others to advance innovation and the usability of laboratory data displays.

• »Encourage participation in EHR system assessments and voluntary reporting of EHR-related issues to PSOs.

The CDC white paper is available at www.cdc.gov/labhit/paper/Laboratory_Data_in_EHRs_2014.pdf. Takeaway: Lab professionals have a role to play in helping develop safer electronic health record systems.