HA 695 Unit 2 evidence and oversight plan example

Improvement, Not Research, Unless We Publish: An Evidence and Oversight Plan for the Operating Room Supply Waste Capstone, With Seven Data Sources and Their Gatekeepers

Student Name

Health Care Administration, Herzing University

HA 695: Graduate Capstone Project

Instructor Name

January 22, 2026

Improvement, Not Research, Unless We Publish: An Evidence and Oversight Plan for the Operating Room Supply Waste Capstone, With Seven Data Sources and Their Gatekeepers

The Project Question, Restated

In one line: can card cleanup, holding costly items unopened, and showing surgeons what their cards cost cut waste per case by a third in six months, with no added delays or safety events?

Improvement, Evaluation or Research?

This is the determination that shapes everything else, so the reasoning is written out. Under federal regulations, an activity is research when it is a systematic investigation whose design aims at knowledge that generalizes beyond the setting, and define a human subject as a living individual about whom an investigator obtains information through interaction or identifiable private information (45 C.F.R. § 46.102). The project's primary purpose is to improve a process at Ridgeway, using Ridgeway's own data, for Ridgeway's benefit. Its methods, measuring a baseline, testing changes, and measuring again, are ordinary quality improvement activities. It does not assign patients to different treatments, and it uses no patient-identifiable information: supply data are linked to procedure type and surgeon, not to patients. The staff interviews gather information about work processes from employees, not private information about them.

On that reasoning, this is improvement work rather than research involving human subjects. A widely cited analysis of the ethics of quality improvement reaches the same conclusion for projects of this kind, while noting that improvement work still carries ethical obligations, including respect for the people whose work is studied (Lynn et al., 2007). Two conditions would change the answer. If I intend to publish the results as generalizable findings, or if the design adds a comparison that withholds a change from some rooms to test its effect, the regulatory definition of research could apply. I do not currently plan either. Because the determination is not mine to make alone, I will submit Ridgeway's quality improvement determination form to the chair of the institutional review board, and the project will not begin interviews until the chair confirms it.

Data Sources, Owners and What Must Be Asked

Each source is listed with its system, the person who controls access, and the specific request. The October audit, the project's anchor, used direct observation of every opened item, the same approach used in published studies of operating room waste (Zygourakis et al., 2017).

Permissions as Dependencies With Dates

Quality improvement determination: submitted January 26; the board chair's turnaround is typically two weeks; expected by February 9. Nothing involving interviews starts before then. Data requests: sent February 2 to the three data owners, copied to the vice president of perioperative services, who has agreed to sponsor them; the information systems analyst's queue is currently about three weeks, so extracts are expected by February 23. Surgeon interviews: the chair of surgery has been asked to send an email to surgeons in the six services endorsing participation; without it, surgeon response is likely to be low, so this request went out first, on January 20. Contract prices: the supply chain analyst will share costs only under a written agreement that the capstone reports totals and percentages, not unit prices; that agreement is signed with the data request.

Two of these dependencies sit in other departments' queues, and a month's delay in either would compress the analysis. If the extract has not arrived by March 2, the current state analysis will use the October audit alone and state that limit.

Interviews

Who: eight surgeons, chosen from the six services with the highest waste per case and including at least two who updated their cards recently and two who have not; ten circulating nurses and surgical technologists across day and evening shifts. How: semi-structured, 20 minutes, in person or by video, scheduled around the operating room day. Consent: verbal, after a short statement that participation is voluntary, that no one's name will appear in notes or reports, and that answers will not be used to evaluate anyone. Notes: typed during the interview without names, stored on the hospital's secure drive, and deleted at the end of the capstone.

Questions for surgeons: When did you last review your preference cards, and what prompted it? Which items do you want opened before incision, and which would you accept having in the room unopened? Would seeing the cost of your cards, or of unused items, change what you request? What would make a card review worth your time? Questions for staff: What do you do when a card lists items you expect will not be used? When has an unopened item caused a delay? What would make holding items safe?

Ethical Obligations That Remain

Calling the project improvement rather than research does not remove its ethical obligations; it changes who oversees them. Three commitments follow. First, no one will be identified in any report by name, and results by surgeon will be shared only with that surgeon and the chair of surgery, never posted publicly or ranked in front of peers, because a project that embarrasses surgeons will lose them. Second, interview participation will not be reported to anyone's manager, and staff who decline will not be approached again. Third, any change tested later in the term will be judged against patient safety first: if holding an item unopened causes a delay that affects a patient, the change will stop until it is redesigned. These commitments will be written into the determination request so that the board chair can see them.

References

Definitions for purposes of this policy, 45 C.F.R. § 46.102 (2025).

Lynn, J., Baily, M. A., Bottrell, M., Jennings, B., Levine, R. J., Davidoff, F., Casarett, D., Corrigan, J., Fox, E., Wynia, M. K., Agich, G. J., O'Kane, M., Speroff, T., Schyve, P., Batalden, P., Tunis, S., Berlinger, N., Cronenwett, L., Fitzmaurice, J. M., . . . James, B. (2007). The ethics of using quality improvement methods in health care. Annals of Internal Medicine, 146(9), 666-673. https://doi.org/10.7326/0003-4819-146-9-200705010-00155

Zygourakis, C. C., Yoon, S., Valencia, V., Boscardin, C., Moriates, C., Gonzales, R., & Lawton, M. T. (2017). Operating room waste: Disposable supply utilization in neurosurgical procedures. Journal of Neurosurgery, 126(2), 620-625. https://doi.org/10.3171/2016.2.JNS152442