Quality Assessment/Quality Improvement (QA/QI)
Overview
A QA/QI project is a systematic, data-guided activity designed to bring about immediate (or nearly immediate) improvements in health care delivery or other program operations. Projects that are done solely for the purpose of QA/QI do not require IRB review. However, some QA/QI projects may also have a human subjects research (HSR) component and should be submitted to the IRB.
What are the Differences between QA/QI and Research?
| Points to Consider | Research | QA/QI |
|---|---|---|
| Purpose | 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 |
| Starting Point | An evidence-based hypothesis OR a identified gap in the knowledge base within a particular area of focus | An identified need for improvement within a specific program or department |
| Benefits | The results are intended to contribute to generalizable knowledge and may or may not benefit individual participants | The results will be used to promptly benefit a process/program/system and may or may not benefit patients |
| Risks/Burdens | May place subjects at some amount of risk | Does not increase patient’s risk (with exception of possible privacy/confidentiality concerns) |
| Data Collection | Systematic data collection | Systematic data collection |
| End Point | Sufficient data collected to answer a research question | Promptly improvements made to a program/process/system |
| Testing/Analysis | Statistical analysis to prove/disprove a hypothesis | Compare a program/process/system to an established set of standards |
QA/QI in a Medical Setting
In medical institutions, QA/QI is a necessary, integral part of hospital operations and is governed by Joint Commission and hospital standards. Activities conducted by one or more institutions are considered to be QAQI rather than research when the primary purposes are limited to:
- implementing a practice to improve the quality of patient care, and
- collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes,
However, if the project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also HSR under the federal regulations. See Do I Need IRB Review? for more information on what is considered HSR.
QA/QI generally refers to a range of activities conducted to assess, analyze, critique, and improve current processes of health care delivery in an institutional setting. QA/QI activities are typically observational and can involve the collection and analysis of data to which investigators have access through their institutional roles. These activities do not prevent or hinder the delivery of clinically-indicated care to patients, nor do they impose more than minimal additional risks or burdens on patients.
- Consult with Hospital Privacy & Compliance when conducting a QA/QI project at Stanford Medicine Health Care (SMHC).
- Consult with V21PALIRBQuestions@va.gov when conducting QA/QI at Veterans Affairs Palo Alto Health Care System (VAPAHCS).
The Stanford Medicine Center for Improvement has developed a Research or QI? decision tool to help determine if a project is considered research or quality improvement. Please contact SMCI to request an expert consultation.
See also information on how to submit a Not Human Subjects Research (NHSR) Determination Form to the IRB.
- ensuring new evidence-based interventions are incorporated into practice
- improvement of over-all quality of life
- reduction of morbidity and mortality
- ensuring that patients receive evidence-based interventions for their particular illness
- improvement in patient and family comprehension
- reduction in in-patient admissions and length of stay
- reduction of ER visits
- reduction in costs of service
- evaluating procedures no greater than minimal risk to patients
- usual care practices, and
- interventions offered to all patients.
Traditional definitions are becoming more and more blurred as a new model of health care is emerging in which practice and learning are integrated, and where a central goal of the health care system is to collect, aggregate, analyze and learn from patient-level data (learning health care systems). This paradigm suggests that a learning health care system is a natural outgrowth and product of health care delivery, and need not be subject to oversight by the IRB in many instances.
See information on Learning Health Systems at Stanford.
Yes. The following characteristics make it more likely that a project involves both QA/QI and research and would fall under the jurisdiction of both the Hospital and IRB. Consult with the IRB if you are uncertain.
- Randomization of patients into different intervention groups in order to enhance confidence in differences that might be obscured by nonrandom selection (but not to achieve equitable allocation of a scarce resource).
- Testing issues that are beyond current science and experience, such as new treatments.
- The involvement in key project roles of researchers who have no ongoing commitment to improvement of the local care situation.
- Delayed or ineffective feedback of data, especially if feedback is delayed or altered in order to avoid biasing the interpretation of results.
- Funding from an outside research organization with an interest in the use of the results.
No. An example of a QA/QI study that involved medication compliance included the randomization of patients to one of three arms:
- In one arm patients were given a cell phone and a reminder call when it was time to take their medication.
- Patients in a second arm were given a reminder call but no cell phone.
- Patients in a third arm took their medication while being directly observed by staff (direct observation therapy--DOT).
The intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research, according to OHRP.
When QA/QI is published or presented, the intent is usually to discuss potentially effective models, strategies, assessment tools or to provide benchmarks, rather than to develop or contribute to generalizable’ knowledge.
Outside external funding may make a difference in distinguishing between QA/QI and research. An NIH research grant to support a project would often be considered research. Internal funding to improve a program may not.
HIPAA makes an exception for QA/QI activities, including outcomes evaluation and development of clinical guidelines or protocols. These activities fall under the category of ‘health care operations’ for which no HIPAA Authorization or Waiver of Authorization needs to be sought. The hospital’s Privacy Office can authorize the use of PHI for QA/QI projects.