HI595 Unit 2 Project Proposal Example

One Artifact by Unit 10: A Unit 2 Capstone Project Proposal for Recording Implants So MRI Screening Can Find Them

[Student Name]

Purdue University Global

HI595: Master's Capstone in Health Informatics

Unit 2 Project Proposal

[Instructor Name]

[Date]

Carrowby Health, its departments, sponsor and every figure are composite; the sources cited are real.

Summary for the Sponsor

To the vice president of imaging services: this capstone will produce, by the end of the term, version 1.0 of a specification that defines how implant details are recorded in Carrowby's record so that MRI screening can find them before the patient arrives, together with a patient letter and a wallet card template. It will not configure the record or change any clinical policy; those decisions remain yours and the MRI safety committee's after the specification is reviewed.

Problem Statement

A patient with an implanted device needs specific information before an MRI: what the device is, its manufacturer and model, and whether its labeling allows scanning and under what conditions. Devices labeled for conditional use can be scanned safely only within stated limits, and a device that cannot be identified must be treated as unsafe until proven otherwise (Harwood et al., 2024). At Carrowby, that information usually sits in free text in an operative note, a scanned outside record or the patient's memory.

This proposal defines a missed identification as an outpatient MRI for a patient whose screening reveals an implant, where the device's manufacturer, model and MRI labeling are not recorded in a structured, searchable field before the scheduled scan date. The definition is precise enough to count, which the evaluation will depend on.

A preliminary review by the MRI safety officer found that 18 of 58 such exams last spring, 31 percent, had structured implant details before arrival. The capstone will measure its own baseline from a larger audit rather than rely on that figure.

Setting

The project covers outpatient MRI at Carrowby's two hospitals, which together perform about 1,400 outpatient MRI exams a month. Screening identifies an implant in roughly 9 percent, so about 125 eligible exams a month. Inpatient and emergency MRI are excluded, because their screening runs through a different, faster process.

The Deliverable

The deliverable is a set of documents, each of which can be handed over and judged:

1. A specification for a structured implant entry in the record, defining each field, its source and who may enter or verify it.

2. A specification for an MRI screening worklist that shows, for each scheduled patient, whether implant details are complete, and routes incomplete ones to a screening nurse.

3. Rules for exceptions, such as a device implanted elsewhere with no model recorded.

4. A patient letter explaining why implant details matter, and a wallet card template listing the device and its labeling.

Each document will be reviewed by the person who would use it: the MRI safety officer, the imaging informatics manager, a screening nurse and a patient advisor.

Target and Measures

The target is that 80 percent of eligible exams have structured implant details before arrival, measured after the specification is configured. Because configuration happens after the term, the capstone will deliver the evaluation plan rather than the post-implementation result. Process measures will include the share of new implants entered from the operating room's implant log within one day, and balancing measures will watch scheduling lead time and screening nurse workload.

Why This Approach

Two options were set aside. Purchasing an MRI safety software product would cost far more than the problem justifies at this volume, and it would still need the same structured data to work. Training technologists to search harder treats the symptom. The operating room already scans each implant's barcode into a supply log, which carries the device identifier that federal rules require on most implants (21 C.F.R. § 830.300, 2024); the data exist but never reach the place screening looks. Work on implant identifiers has shown that capturing them at the point of use is feasible and that the problem is usually moving them into the clinical record (Drozda et al., 2018).

The device identifier is already scanned in the operating room for every implant; the project's job is to carry it twenty feet to where MRI screening can read it.

Why Now

Carrowby's outpatient MRI volume grew by about a fifth over two years, and the share of patients with implants rises with an aging population, so the delays will grow if nothing changes.

Timeline

Weeks 1 to 3: scope and literature. Weeks 4 to 5: approvals. Weeks 6 to 8: baseline audit and interviews. Weeks 9 to 11: draft specification and tabletop test. Weeks 12 to 14: revisions and evaluation plan. Week 15: final report.

Risks

The baseline audit depends on data access approval, scheduled for week 4. If approval is delayed, the audit can shrink from 150 to 100 exams without losing its purpose. The operating room supply log may not link cleanly to the patient record for older implants, which is why exception rules are a named deliverable. Improvement reporting standards ask projects to state what is known locally before they begin and how their measures were chosen (Ogrinc et al., 2016), and both appear in this proposal.

Stakeholders the Proposal Depends On

Four people are essential to the deliverable. The MRI safety officer is the clinical reviewer and the source of the preliminary count. The operating room materials manager controls the supply log that holds implant identifiers. The imaging informatics manager must confirm that the specification can be configured. And a lead screening nurse represents the people who would work the list. Each has agreed to a thirty-minute interview and one review of the draft. The fuller stakeholder and approval plan follows in Unit 5, but the proposal names these four because the deliverable cannot be finished without them.

What the Project Will Not Promise

The proposal does not promise fewer MRI cancellations within the term, because nothing will be configured before week 15. It does not promise that every outside implant can be identified; some patients will arrive with devices placed decades ago at hospitals that no longer exist. And it does not promise to replace the screening conversation, which radiology guidance treats as essential even when records are complete. Saying this now protects the sponsor from expecting results the design cannot deliver in one term.

The Measure of a Finished Term

At the end of the term, the sponsor will have a reviewed specification ready for configuration, a measured baseline and a plan to evaluate the change. Success is not a configured system; it is a decision-ready document.

References

21 C.F.R. § 830.300 (2024). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830/subpart-E/section-830.300

Drozda, J. P., Jr., Roach, J., Forsyth, T., Helmering, P., Dummitt, B., & Tcheng, J. E. (2018). Constructing the informatics and information technology foundations of a medical device evaluation system: A report from the FDA unique device identifier demonstration. Journal of the American Medical Informatics Association, 25(2), 111-120. https://doi.org/10.1093/jamia/ocx041

Harwood, M., Fahrenholtz, S. J., Wellnitz, C. V., Kawashima, A., & Panda, A. (2024). MRI in adult patients with active and inactive implanted MR-conditional, MR-nonconditional, and other devices. RadioGraphics, 44(3), e230102. https://doi.org/10.1148/rg.230102

Ogrinc, G., Davies, L., Goodman, D., Batalden, P., Davidoff, F., & Stevens, D. (2016). SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised publication guidelines from a detailed consensus process. BMJ Quality & Safety, 25(12), 986-992. https://doi.org/10.1136/bmjqs-2015-004411