Process flow development for a state-wide research permissions management system

Ethical and legal requirements in the United States mandate that healthcare providers seek patient consent prior to medical treatment. Electronic medical records are increasingly being used by health care organizations to improve the quality of care, suggesting that general consent forms should be integrated into them. To investigate this potential, a state-wide comprehensive mechanism for managing these consents electronically was developed. The system underwent pilot testing at three registration areas at the Medical University of South Carolina Hospital. The study reported here analyzes the existing process flow at these registration areas and proposes a modified workflow for the implementation of such a system. This proposed system, which is HTML-based, is presented in the Safari browser on an iPad. Process flow data of the existing system were independently collected using shadowing and interviews. Based on the results, models of patient movement through the registration process, including a complete representation were developed. The study addresses issues related to the workflow, storage, management, use and safe-keeping of the electronic consenting systems.