CLINICAL SOFTWARE QUALITY REVIEW PROCESS

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DESCRIPTION (taken from application abstract): In July 1996, the FDA called for discussion of medical software regulations. In response, a consortium of organizations dedicated to improving health care through information technology developed recommendations for responsible monitoring of such systems. A primary recommendation made was that monitoring of clinical software systems should be placed at the local level wherever possible, and that this monitoring should occur through local Clinical Software Process Quality Committees (CSP-QC's) in conjunction with software vendors. The specific aims of this project are twofold. First, to test the feasibility of having institution-specific CSP-QC's: 1) serve as a workable alternative to FDA regulation of medical software, 2) facilitate more reliable and integrated medical computing and 3) oversee software selection, development, and implementation to ensure quality and problem resolution. Second, to develop and refine a widely applicable methodology for instituting CSP-QC's within the general medical computing community. Four institutions, each with different clinical computing systems and with diverse training and patient care strategies will participate. The differences between the participating institutions will allow us to verify that the concept of CSP-QC's is workable in multiple environments and will help ensure the generalizability and robustness of the methodology that is developed. The proposed project is highly significant. There are no national standards, in terms of expectations or function, for local review and monitoring of complex clinical software systems. The CSP-QC's will monitor procedures by which an institution selects vendors' products or develops local software and will focus on the safety, efficacy, reliability, currency, and security. Participating institutions will plan, share, and evolve their activities in conjunction with each other, with LDS Hospital acting as the coordinating center. CSP-QC's will evaluate (on an ongoing basis) existing medical computing systems and all new software development and acquisition. CSP-QC impact on software-related policy and activities will be evaluated. The general feasibility of using CSP-QC's to ensure the quality of medical software will be assessed. A generally applicable methodology for instituting and operating CSP-QC's will be developed. (n.b. At the time of the meeting with reviewers, the CSP-QC's were designated as Software Oversight Committees or SOC's.)