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Is it Quality Improvement or Research ?
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What is QA/QI? There is no regulatory definition.
Often QA/QI is described as “systematic, data-guided activities designed to bring about immediate (or nearly immediate) improvements in health care delivery.
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Points to Consider
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Purpose Research QA/ QI To test a hypothesis OR establish clinical practice standards where none are accepted To assess or promptly improve a process, program, or system; OR improve performance as judged by accepted/ established standards
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Starting Point To answer a question or test a hypothesis
Research QA/ QI To answer a question or test a hypothesis To improve Performance
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Design Research QA/QI Typically a fixed protocol with fixed interventions that are not revised as data is collected Typically interventions are adjusted based on data collected if quality goal is not being met
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Benefits Research QA/QI Designed to contribute to generalizable knowledge and may or may not benefit subjects Designed to promptly benefit a process, program, or system and may or may not benefit patients
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Risks/ Burdens May place subject as risk and stated as such
Research QI/ QA May place subject as risk and stated as such By design, does not increase patient’s risk, with exception of possible privacy/ confidentiality concerns
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End Point Answer a research question/ prove or disprove a hypothesis
QA/ QI Answer a research question/ prove or disprove a hypothesis Promptly improve a program/ process/ system, typically has a quality goal to measure improvement. Compare results to established set of standards.
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IS THE PROJECT AN INSTITUTIONAL PROJECT OR BEING CONDUCTED BY AN OUTSIDE ENTITY?
IF the answer is no – the project can go through the QI/ QA process. IF the answer is yes
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THE PROJECT MUST BE SUBMITTED TO IRB FOR REVIEW
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Expedited Retrospective Chart Review Exempt
Rare – Only used if project did not contain patient data/ identifiers If project is complete and now want to compare data If project is conducted by outside entity If data being collected prospectively
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What approval is needed in order to conduct a QA/QI project?
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All Quality projects must be registered at https://qipr. ese. ufhealth
This process will help determine if your project is a quality project or if you need to submit to the IRB. The software will also identify others in the institution that have or are working on similar projects that may result in collaborations
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What is QIPR? The Quality Improvement Project Registry (QIPR) for UF Health quality improvement projects.
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Why should I use QIPR?
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Share your QI projects, learn from others, and see current improvement projects to connect and collaborate
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Apply credit to New Innovations (for Residents and Magnet only)
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Access to BMJ Quality website to manage projects and facilitate QI publications and presentations
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Access to Quality Department experts and data resources
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If you are still confused or not sure whether or not you need IRB review. Call the IRB office at (904) or (904)
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