VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R019

is an effort to find and overcome problems with quality, directing the performance and behaviors of practitioners and institutions toward more appropriate and acceptable health outcomes, expenditures, or both. The central QA question is reactive, “Are we doing a task/procedure the way it is supposed to be done?” Quality Improvement (QI): A proactive and continuous process of enhancing performance and quality over time. It is forward-looking, seeking to implement new and better ways to do things, which can involve changing systems and processes. QI activities are intended to improve services or clinical care based on a known issue through a “plan, do, check, act” cycle. With this cycle, processes can be continuously revised and improved on the basis of the data derived from them. The central QI question is proactive, “How can we improve the way we do things?”. Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Systematic Investigation: An activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. Generalizable Knowledge: Information is expected to expand the knowledge base of a scientific discipline or other scholarly field or study and yield one or both of the following: • Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied. • Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study. Generalizable Knowledge: Information where the intended use of the results can be applied to populations or situations beyond those studied. A QA/QI study where the intent is to assess, improve, or develop programs or services for an organization would NOT be considered generalizable. Outcomes will remain specific to the organization, programs or services, although other organizations may use the results for their own programs. If the findings are unique to an organization, it is not generalizable. 3. POLICY Determining if an activity is Research or Quality Assurance (QA)/Quality Improvement (QI) can be challenging. Federal regulations require human subject research to be reviewed and approved by the IRB, while strictly QA/QI activities do not require IRB oversight. However, some QI activities may also be research and therefore need IRB approval. Traditionally QA/QI is designed to improve the quality of a process, service, or product to ensure compliance with standards (QA) or make proactive changes for better performance (QI). Research involves a “systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” thus potentially applying beyond the individual facility and allowing for projects not expected to directly benefit all of the current patients. 3.1 QA/QI Activities Related to the Academic Program Only faculty or academic leadership of the institution are authorized to design, conduct, or oversee QA/QI activities involving the academic program. Students, volunteers, external partners, and other non‑employees may not independently engage in QA/QI activities and may only assist when explicitly supervised and when approved by the Provost. This requirement is in place because VCOM already maintains formal systems for collecting student feedback, along with a structured, faculty‑driven process for reviewing and improving the academic program. These mechanisms ensure that the academic program evaluation is conducted consistently, responsibly, and in

VCOM Policy on Quality Assurance (QA) and Quality Improvement (QI)

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