Patient Safety Assessment

 

Review Purpose

Patient safety reviews of mobile applications are conducted by The Veterans Health Administration (VHA) Informatics Patient Safety Office (IPS), whose purpose is to improve the safety of Health Information Technology (HIT) products used by the VA and Veterans.

IPS reviews are centered on the context of use from user and patient safety perspectives. Specific combinations of user, task, technology and environment are identified and safety critical tasks analyzed. A safety critical task is any action or decision whose failure could cause patient harm or a significant delay in care delivery.

How to request an IPS Compliance Review

Project Managers (PMs) designated to a mobile application by Connected Care may request an IPS review. In order to help IPS understand the context of use, identify safety critical tasks, walkthrough realistic scenarios, and manage the review process efficiently and effectively, PMs are asked to complete an IPS Mobile Application Review Request Form (available to MAE members as an attachment here). The PM should then send the completed form and associated documentation via E-mail to VHA10P2AIPSMobileTeam@va.gov. IPS will respond via E-mail and include the contact information for the person assigned to lead the patient safety review. Note: Requests for a preliminary review (i.e. review before the compliance review stage) of an executable application may be granted if sufficient IPS resources are available during the time the review is requested. As much of the review request form as possible should be completed when requesting a preliminary review.

IPS Review Results

When IPS has completed its review the PM will receive an E-mail with an attached document that provides a detailed description of the review conducted and any patient safety issues found. This is presented in a Standardized Review Form (available to MAE members as an attachment here). IPS will send the complete report as a pdf file, and in addition send an editable Microsoft Word document so the PM may respond to each issue. IPS welcomes questions about the review results and also requests that after the PM has discussed the results with the application business owner the response to each issue is communicated back to the IPS person who led the application’s review.

IPS Recommendations for Development

IPS is sometimes asked to conduct a review of the requirements or design documentation for a mobile application. Resources permitting, IPS will accommodate such a request and work with the PM and development team to determine what is applicable to a particular application from a patient safety perspective. In general, however, the following processes will help develop a safety-enhanced HIT application:

  • Clearly define usage context: Users, Tasks, Technology, Environment of use
  • Identify high-level tasks (clinical/medical tasks) early
  • Connect User Stories to high-level tasks
  • Explicitly connect functionality to high-level tasks (this is sometimes called a Conceptual model)
  • Identify usage risks and mitigation strategies
  • Pay particular attention to safety-critical tasks
  • Employ independent clinical review and usability testing of patient safety critical tasks
  • Develop or utilize a user accessible post-deployment issue reporting system

References

  1. Bagian, J.P., Lee, C., Gosbee, J., DeRosier, J., Stalhandske, E., Eldridge, N., Williams, R., & Burkhardt, M. (2001). Developing and deploying a patient safety program in a large health care delivery system: You can’t fix what you don’t know about. Joint Commission Journal of Quality Improvement, 27, 522–532.
  2. Chapman R. J., Taylor, L. M., & Wood, S. D. (2012). Cataloging Errors from Reported Informatics Patient Safety Adverse Events. Proceedings of Human Factors and Ergonomics Society Healthcare Symposium, Baltimore, MD. (Available to MAE members as an attachment here).
  3. DeRosier, J., Stalhandske, E., Bagian, J.P., & Nudell, T. (2002). Using Health Care Failure Mode and Effect Analysis™: The VA National Center for Patient Safety’s prospective risk analysis system. Joint Commission Journal of Quality Improvement, 28, 248–267.
  4. Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
  5. Johnson, J., ‎ Henderson, A., (2012). Conceptual Models: Core to Good Design. Morgan & Claypool.
  6. NIST EHR Usability Protocol (Lowry, et al. 2012)
  7. (NISTIR 7804) Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records.
  8. Wharton, C. Rieman, J., Lewis, C. and Polson, P. (1994). The Cognitive Walkthrough Method: A Practitioner's Guide. In J. Nielsen and R. Mack (eds.) Usability Inspection Methods (New York: Wiley) 105-140.
  9. Wood, S. D., Chapman R. J., Taylor, L. M., Wright, P., & Scott J. (2014). Identifying Latent Design Issues in Mobile Products to Prevent Patient Harm. Proceedings of Human Factors and Ergonomics Society Healthcare Symposium, Chicago, IL. (Available to MAE members as an attachment here).