QI Determination form: Submit Now

About QI Determination

Sharing Our Work

A QI Determination must be received for all quality improvement work to be shared outside of the University of Chicago Medicine.

Quality improvement occurs on a continuous basis throughout the institution. Most quality improvement efforts are very local and will not be shared outside of the institution (e.g. Managing for Daily Improvement huddles). Quality improvement initiatives that are NOT shared outside of the institution are outside the scope of this policy.

Publication of a project has no bearing on whether it is human subjects research or quality improvement. You may wish to publish something if you believe others would be interested in learning about your activities without it being human subjects research. Conversely, some improvement projects are in fact better classified as human subjects research even when there is no intention of disseminating or publishing the findings.

A Formal Review Process

Defining Your Project

To protect our patients, investigators, and the institution, a formal review process is required to ensure clear distinction between human subjects research and quality improvement initiatives. QI Determination is required for all quality improvement projects that will be shared outside of UChicago Medicine. This process was implemented in 2015 in conjunction with UChicago Medicine leadership and the Office of Clinical Research (OCR).

Human subjects research, which aims to discover new generalizable knowledge, is governed by the Institutional Review Board (IRB) and other applicable policies.

Quality improvement projects, which are based on existing knowledge, do NOT incorporate human subjects research.

Regardless of whether an activity is quality improvement or human subjects research, teams must follow Institutional Security Policies and HIPAA regulations for protecting information, including ensuring that appropriate legal and business associates agreements are in place prior to sharing any individual or identifiable information outside of the institution (e.g. presentations at meetings, poster presentations, abstracts, and publications).

doctor reviewing results on multiple computer screens
medical simulation training at UChicago Medicine
two doctors in scrubs reviewing results on multiple computer screens
QI Determination Process

Meeting the Definition of QI

Please read; the QI Determination process has recently changed.

  1. Complete the online QI Determination form. There’s nothing more the submitter needs to do
  2. Department Quality Chief reviews submission
  3. Chief QI Determination Reviewer conducts second review of submission
  4. Submitter receives an email: either the submission meets the definition of QI, or the project is deemed research and should be submitted to the IRB for review
Additional Information

Definitions & Examples

  • Human subjects research is governed by the IRB and other applicable policies.
  • Human subjects research is defined in CFR §46.102 as:
    • Research: a systematic investigation … designed to develop or contribute to generalizable knowledge
    • Human subject: living individual about whom an investigator conducting research obtains
      • Data through intervention or interaction with the individual, or
      • Identifiable private information.
Quality improvement work is governed by organizational structures and committees, culminating in the University of Chicago Medicine Quality Committee. The senior institutional officials responsible for quality improvement and patient safety are the Health System Chief Medical Officer (CMO) and the Chief Integration & Transformation Officer/Chief Compliance Officer.

Quality improvement is sometimes defined in the following ways:

  • “Quality improvement (QI) consists of systematic and continuous actions that lead to measurable improvement in health care services and the health status of targeted patient groups.”[1]
  • Quality improvement is “the combined and unceasing efforts of everyone—healthcare professionals, patients and their families, researchers, payers, planners and educators—to make the changes that will lead to better patient outcomes (health), better system performance (care) and better professional development”[2]
  • The pursuit of the triple aim: “Improving the U.S. health care system requires simultaneous pursuit of three aims: improving the experience of care, improving the health of populations, and reducing per capita costs of health care.”[3]

[1] U.S DEPARTMENT OF HEALTH AND HUMAN SERVICES, HEALTH RESOURCES AND SERVICES ADMINISTRATION.  QUALITY IMPROVEMENT. 2011. ACCESSED 29 OCTOBER 2015 AT HTTPS://WWW.HRSA.GOV/QUALITY/TOOLBOX/508PDFS/QUALITYIMPROVEMENT.PDF.

[2] BATALDEN P, DAVIDOFF F. WHAT IS ‘‘QUALITY IMPROVEMENT’’ AND HOW CAN IT TRANSFORM HEALTHCARE? QUAL SAF HEALTH CARE 2007;16:2–3

[3] BERWICK D, NOLAN TW, WHITTINGTON J. THE TRIPLE AIM: CARE, HEALTH, AND COST. HEALTH AFFAIRS, 27, NO.3 (2008):759-769

Examples of Quality Improvement projects:

  • A team changes the approach of scheduling in clinic and uses Lean principles to reduce waiting. To assess impact, they measure throughput, potentially preventable hospital admissions, and patient satisfaction with care, all of which are collected as part of routine operations.
  • A guideline for managing pneumonia is published by a national specialty society. A multidisciplinary team adapts this guideline to UCM and implements it using PDSA tools. To assess improvement, the team uses data from the electronic health record on compliance with the guideline, patient outcomes and costs of care.

For more information regarding the background of quality improvement determination, read the following resources:

Contacts

Departmental Quality Chiefs

Name Department
Avery Tung, MD Anesthesia & Critical Care
Sandra Laveaux, MD Gynecology
Andy Davis, MD Medicine
Scott Mendelson, MD Neurology
Ben Laughton, DNP, MSN, MBA

Students, please discuss with your preceptor before submitting a QI Determination form.

 Nursing (including DNP Students)
Sara Wallace, MD Orthopaedic Surgery
Abbe Kordik, MD Obstetrics
Peter Veldman, MD Ophthalmology and Visual Science
Melissa Pessin, MD Pathology
Allison Bartlett, MD Pediatrics
Randall Knoebel, PharmD, BCOP Pharmacy
Royce Lee, MD Psychiatry
Stanley Liauw, MD Radiation Oncology
Jonathan Chung, MD Radiology
Vivek Prachand, MD Surgery

Requesting Data

Neither QI Determination nor IRB process guarantees resources. All data requests go through ACRES.

  • Projects that will be shared go through QI Determination and then Privacy Office before ACRES request is granted

Resources:

For more information, please contact the QI Determination Project Manager, Kimisha Cassidy.