There are a few key questions to ask as you dive into this project: Most importantly, What do I want to get out of this?
Then ask:
1. What resources do I have available?
2. Whose permission, if any, do I need to participate?
3. What will be the best work flow for me?
And most importantly, What do I want to get out of this?
Remember - the goal of Quality Improvement is to provide you - yes you - with data to help you improve the quality of care you provide patients. As such it is not human research.
Resources: We have two, (a third is pending) levels of engagement with the AFS QIP depending on your goals and, importantly, your resources. If you have minimal resources to help with data entry, then we suggest you start out with AFS QUIK, which requires only entry of a patient's name, dob, email or cell, and about 5 pieces of surgical data.
More here
Permissions (beyond being a member of AFS):
As an individual practitioner you may participate in a Quality Project typically without anyone else's permission (by that we mean patient permission, IRB permission, your boss's permission). In fact, participation in a Quality Project or Registry is required for continual ABS Board Certification. The ACS provides a Single Surgeon Registry - which you can participate in if an ACS member - without any need for patient, IRB, or your boss's permission - and allows entry of limited PHI so that follow-up can be achieved.
That said, there may be some steps to take especially if you are in an academic setting or employed by a large physician group or hospital: 1. Familiarize yourself and download documents supporting your ability, within HIPAA regulations, to conduct quality assessments without requiring patient consent.
2.Go to your institutional IRB and apply for an IRB exemption on the basis that you are doing quality improvement. Form link coming soon.
3.Go to your boss and let him/her/whomever know that you intend to look at patient SATISFACTION with your care by asking the question "Did we make you better?", (bosses are into Patient SATISFACTION these days), show the documentation and the IRB Exemption, and get an okay to go ahead.