Section 26
Quality Assurance/Quality Improvement (QA/QI) Activities
Vs.
Research Activities
(June 2007)

Pending issuance of definitive policy and/or guidance at the federal level, the Office of Research Compliance (ORC), SBUMC’s Division of Medical and Regulatory Affairs, and other key hospital officials have developed local policy and guidance to help our investigators distinguish the ‘grey area’ between QA/QI initiatives and research activities that involve use of patients, their data, and/or their biological specimens.

QA/QI initiatives are a mandated function of our hospital. Some of these initiatives are implemented after thorough evidenced-based best practices are identified, in response to an identified safety issue, or to improve the delivery of care and avoid potential safety issues.  The overarching intent of the initiatives is continuous monitoring of hospital operations and improved care of our patients here at Stony Brook University Medical Center.

Please note that the 'Application for Designation of Activity as Quality Assurance/Quality Improvement or Research" is available here.

A.      QA/QI initiatives

The following activities are not considered research activities at SBU. The responsible conduct of the activities below falls under the jurisdiction of SBUMC’s Division of Medical and Regulatory Affairs and/or a hospital-recognized departmental quality assurance committee (collectively referred to from this point on as ‘Hospital QA’):

• Any hospital QA initiatives, and presentation/publication of results thereof, that are conducted within SBUMC only, and that serve to:
  • measure or improve SBU’s ability to meet or exceed an existing national standard of care or benchmark (JCAHO, etc)

  OR

  • develop a standard of care or benchmark for applicability within SBUMC
  
  
• Submission of data to a national or state registry/database:
•  that is mandated at the state or federal level

  OR

• That directly impacts reimbursements and funding available from the state,  Department of Health, or federal Centers for Medicare & Medicaid Services (CMS) based on performance and/or clinical or quality outcomes.

  OR

• That is maintained by an organization/consortium, formally recognized by SBUMC’s Division of Medical and Regulatory Affairs, the principal purpose of which is benchmarking and/or performance improvement, the use of which is for internal SBU activities


•  Hospital QA use of data from a registry/database, meeting any of the criteria above, for the purpose of:
  • measuring or improving SBU’s ability to meet or exceed an existing national standard of care or benchmark (JCAHO, etc). 

OR

• developing a standard of care or benchmark for applicability within SBUMC.

B.       Research Activities

The following activities are considered research activities. The responsible conduct of the activities below fall under the jurisdiction of the Office of Research Compliance (ORC) and/or Institutional Review Board (IRB):

• Any hospital QA initiative, conducted within SBUMC only, designed to develop a standard of care or benchmark for general applicability (i.e., not only for operations within SBUMC, but to outside entities as well). 
• Any QA or QI initiatives (including those proposing to develop an operational standard of care of benchmark) that are “investigator-initiated”, i.e., that have not been vetted through, and endorsed by, SBUMC’s Division of  Medical and Regulatory Affairs and/or a hospital-recognized departmental QA committee).
• Submission of data to a registry/database that is not covered by those described in Section II.A above.
• Use of data from any registry/database for the purpose of measuring, improving or developing a standard or benchmark, under any condition not covered in section II.A above, including the use of registry data for the purpose of research. 
• Any activity that proposes comparisons of one or more prospective interventions that are deliberately administered or made available (through a randomization or other process) to some patients (if within SBU) or some hospitals (if part of a consortium or organizational effort) and not to others. This does not include, e.g., initiating a QI process in a small % of patients at SBUMC first to ensure feasibility, before introducing it to the entire patient population.

C.      Activities that have a mix of both QA/QI and Research Components

Where your activity involves a mix of activities from Sections A and B, you will need to ensure compliance with the applicable entity, i.e., SBUMC’s Division of Medical and Regulatory Affairs for the QA/QI aspects and the Office of Research Compliance/Institutional Review Board for the research aspects of the activity (including securing approval prior to conducting the research aspect)

For any ‘questionable’ (QA vs. Research) activity not described above, please consult with the Office of Research Compliance and/or the Division of Medical and Regulatory Affairs for assistance. 

Return to Human Subjects Research at SBU

Last Updated: 2007-09-20