UVAHS Infusion Pump Project Charter

Program Management Office (PMO) ______

Document Version : Draft v 2.42 Document Date: 2014-09-29 Program Management Office (PMO) ______

Revision History Revision Date Revised By Changes Made – Reasons for the Change 1.0 09/24/14 Daniel Roe Incorporated first blush elements 2.0 09/27/14 Daniel Roe/Cory Expanded objectives and success criteria Skeens/Nanette Keanan 2.1 09/28/14 Daniel Roe Adds deliverables and assumptions 2.2 09/29/14 Daniel Roe Modified quantity of infusion pumps verbiage 2.21 09/29/14 Daniel Roe Right justified pages 2.3 09/29/14 Daniel Roe Inserted Table of Contents (TOC) 2.4 09/30/14 Daniel Roe Added reports 2.41 10/01/14 Daniel Roe Added success criterion that eliminates the loud alarm in patient’s room 2.42 10/01/14 Daniel Roe Added risk of sufficient throughput 2.43 11/03/14 Daniel Roe Modified Lori Strauss’ title

HS Infusion Pump Project Charter Page 2 of 11 2018-04-04 Draft Program Management Office (PMO) ______Table of Contents

HS Infusion Pump Project Charter Page 3 of 11 2018-04-04 Draft Program Management Office (PMO) ______Infusion Pump Project Charter

Date: Executive Sponsor(s): Richard Skinner, CITO, Lorna Facteau, CNO & James Amato, Chief of Clinical Ancillary Services Project Owner: UVAHS Project Management Office (PMO) Sponsoring Department: UVAHS Information Technology Project Manager: Daniel Roe Project Title: Wireless Infusion Pump System

Current Environment

At present, none of the infusion pumps in use within the UVAHS are connected to a network, either wireless or hardwired, and therefore cannot be monitored by, nor share data with UVAHS’s electronic health record. The absence of a remote tracking capability prevents the clinical staff from efficiently tracking and monitoring the operational status of the infusion pumps. Nursing often are forced to take time away from their clinical duties to search for a given pump and once located, the nurses have no way of knowing the units condition or usability status (e.g. . Has the pump been cleaned since its last use and is ready to be used?).

This lack of connectivity represents an increased risk in the likelihood of both adult and pediatric drug dosage errors as the clinical staff is not able to conduct real-time, remote monitoring of dosing rates. As is often the case, syringe pumps are stacked on poles which, because of the multiple tubes running from these pumps, represent a real risk of these poles falling to the floor. Additionally, from a pediatric perspective, the staff often provides multiple medications and dosages which further complicates an already risky care environment.

All of the infusion pumps are at least ten (10) + years old and are at the upper limits of their operational life cycle. It is reasonable to assume that the organization can expect these units to fail at an increasing rate as time goes by.

Business Need and Impact

The superordinate goal of the Infusion Pump Project at the University of Virginia Health System (UVAHS) is to design a secure, efficient, scalable, reliable and wirelessly-networked, medical- grade system of infusion pumps. Replacing existing infusion pumps, currently reaching the end of their operational lifecycles, will serve to automate the medicine administration process while keeping in line with existing health practices, thereby substantially reducing the risks to safety for both patient and clinical staff alike. Lack of integration with Health System’s IT infrastructure represents an increased and inherently dangerous risk of improper adult and pediatric dosing. Furthermore, reduction of existing operational wastes associated with time spent to locate, clean, program and track the status of each infusion pump will be realized with this implementation.

HS Infusion Pump Project Charter Page 4 of 11 2018-04-04 Draft Program Management Office (PMO) ______

Project Stakeholders

 UVA Health System Patient Community

 Rick Skinner, Chief Information & Technology Officer (CITO)

 Tracey Hoke, MD, Chief Of Quality and Performance Improvement

 Lorna Facteau, RN, DNSc, Chief Nursing Officer (CNO)

 Jeff S. Young, MD, Chief Patient Safety Officer

 Lori Strauss, RN, Chief Corporate Compliance and Privacy Officer

 James Amato, Chief of Clinical Ancillary Services

 Rafael Saenz, PharmD, Pharmacy Administrator

 Karin W. League, Children’s Hospital Operations

 Mike Friesen, Clinical Engineering

 Donna Via, Perioperative Services

 Daniel Roe, Infusion Pump Project Manager

 UVAHS Clinical Staff Members

 UVAHS Project Management Office (PMO)

Project Goals Primary goal of the project is to implement a comprehensive suite of solutions designed to improve patient safety, quality of care, reduce healthcare costs and medication errors, and optimize infusion management best practices.

1. Objective: Design, test and implement a system-wide group of infusion pumps that are wirelessly connected to, and do not interfere with, the Health System’s existing IT infrastructure (wireless or otherwise.)

Success Criteria:

 Ability to communicate patient-specific infusion administration information, analytics and reporting on infusion data accurately and in a timely manner.

HS Infusion Pump Project Charter Page 5 of 11 2018-04-04 Draft Program Management Office (PMO) ______o Ability to support real-time, actionable reporting that promotes continuous quality improvement (CQI) of infusion therapy by capturing and managing data for device specific pump reports.

o Ability to receive automated wireless drug library updates.

o Ability for full infusion data collection at the point of care that will help evaluate the safety, efficiency and efficacy of our IV therapy.

o Ability to enable reprogramming, including drug library and firmware updates, without physically handling the pumps, yet keeps pump current with the latest revisions.

 Successful completion of a pre-implementation spectrum analysis study showing acceptable results

 Successful post go-live audit of newly implemented infusion pumps showing 100% functionality of these pumps, along with end user reports reflecting that the pumps are operating as expected.

2. Objective: Build a wireless infusion pump system that reliably accepts barcode scanning technology currently in use at UVAHS.

Success Criteria:

 Ability to scan the clinician ID

 Ability to scan the patient wristband.

 Ability to scan the medication.

 Ability to scan the pump channel to upload infusion information.

 Ability to verify that all captured data are correct.

3. Objective: Successfully and seamlessly integrate the new infusion pump system with the UVA systems such as the Epic electronic health record (EHR) and Siemens Invision for registration data.

Success Criteria:

HS Infusion Pump Project Charter Page 6 of 11 2018-04-04 Draft Program Management Office (PMO) ______ Ability to accept inbound ADT (admission, discharge, transfer) data from Siemens Invision.

 Ability to accept inbound provider data updates.

 Ability to inbound IV order information to enable the system to automatically program pump settings from the order onto the IV pump.

 Provide infusion pumps data integration to/from Epic

 Ability to automatically provide infusion information in near real-time to Epic which will help improve safety, speed up workflows and documentation completion.

 Successful workflow validation of existing clinical processes that make use of infusion pump functionality, e.g. medication bar code scanning.

 Successful unit and integrated testing of any system build required to accommodate the new infusion pump technology.

4. Objective: Contribute to an improvement of the I Care scores for operational excellence relating to patient satisfaction, patient experience, and voluntary turnover metrics.

Success Criteria:

 When a problem/error exists at the pump, ability to eliminate the loud alert alarm in a patient’s room, and have the nurses alerted at the nurses station, by pager, or some other means. The current alarms tend to scare patients.

Post-Implementation Project Evaluation The project will be successful if the clinical integration of the infusion pumps impacts/improves safety, efficiency, and cost.

1. Reduction in medication administration errors.

2. Reduction in nursing time to program pumps.

3. Reduction of costs in preventable adverse drug events per year.

Linkage with UVA Health System Key Strategies I Care

HS Infusion Pump Project Charter Page 7 of 11 2018-04-04 Draft Program Management Office (PMO) ______ Impact: We expect to realize a demonstrable reduction in medication dosage errors currently seen when using existing non-wireless infusion pumps.

I Build  Impact: Nurses will no longer have to waste valuable time searching for infusion pumps, cleaning, and determing pump status and each pump can be configured for use remotely from a centralized location.

I Heal  Impact: Nurses will have more time to focus on their patients, thereby increasing the quality of care provided to our patient community.

Project Timeline/Milestones

Project timelines have yet to be determined. What is known is that this project is expected to be a “big bang” implementation occurring over a two-day period starting first with Inpatient Services, then Outpatient (Ambulatory).

Estimated Financial Costs

Current approved budget stands at $US 10,266,640.

Requirements (wip)

Deliverables The infusion pump system will deliver the following functionality:

1. Ability to accurately and efficiently communicate patient-specific infusion administration information and analytics.

2. Ability to support real-time, actionable reporting that promotes continuous quality improvement (CQI) of infusion therapy by capturing and managing data for device specific pump reports.

3. Ability to receive automated drug library updates.

4. Ability for full infusion data collection at the point of care that will help evaluate the safety, efficiency and efficacy of IV therapy.

5. Ability to enable reprogramming, including drug library and firmware updates, without physically handling the pumps, yet keeps pump current with the latest revisions.

6. Able to incorporate barcode functionality that will:

a. Scan the clinician’s ID

HS Infusion Pump Project Charter Page 8 of 11 2018-04-04 Draft Program Management Office (PMO) ______b. Scan the patient wristband

c. Scan medication

d. Scan the pump channel to upload infusion information

e. Verify that all captured data are correct.

7. Ability to accept inbound ADT (admission, discharge, transfer) data from Siemens Invision.

8. Ability to accept inbound provider data updates.

9. Ability to inbound IV order information to enable the system to automatically program pump settings from the order onto the IV pump.

10. Provide infusion pumps data integration to/from Epic

11. Ability to automatically provide infusion information in near real-time to Epic which will help improve safety, speed up workflows and documentation completion.

12. Able to be pre-populated with essential patient demographic and medication information.

13. The system must allow for the following reports:

a. Pump Compliance Report

b. Pump Near Miss Report (Safety Event)

c. Find Medications Missing MAR Actions in Chemo Infusion (specify dept) Report

d. Drug Program Utilization Report

e. Alarm Event Reports

f. Clinical Engineering Reports

Assumptions

1. FDA-approved

2. AC/Battery operated

3. RF-shielded

4. Scalable

HS Infusion Pump Project Charter Page 9 of 11 2018-04-04 Draft Program Management Office (PMO) ______5. Robust Dose Error Reduction System (DERS)

6. Compatible with UVAHS’ drug information library, eMAR, EpicCare EHR, and point-of- care medication

7. Acceptable and sustainable signal level to all potential patient care areas

Constraints

1. Budget

2. Building design/layout that impede/prohibit effective use of a wireless system in areas where the pumps are used.

3. Level of technical training required to troubleshoot and optimize the performance of the wireless network.

4. Staff availability

1. Electromagnetic interference generated by the infusion pump network having a negative impact on existing UVAHS computer networks or wireless systems.

2. Electromagnetic interference to the wireless infusion pump network from other RF sources, e.g. cordless phones, Bluetooth headsets, microwave ovens, radar, etc. causing packet loss that forces retransmission of the message. This slows throughput and can seriously degrade system performance.

3. Malicious hacking into the network and altering system/unit settings.

4. Jamming of the wireless infusion pump network.

5. Operation of rogue access points configured to operate in between channels.

6. Acquiring technology that will soon be outdated and require replacement in a relatively short period of time.

7. Potential “dead spots” that the wireless RF signal cannot reach (deliver an acceptable Signal to Interference Plus Noise Ratio – SINR).

8. Lack of interoperability/compatibility with the Epic electronic health record (EHR).

HS Infusion Pump Project Charter Page 10 of 11 2018-04-04 Draft Program Management Office (PMO) ______9. Given that it’s likely that the new wireless pumps will make use of the existing wireless network, will there be sufficient throughput to allow for proper pump operation.

Project Manager Assigned and Authority Level Daniel Roe, PMP. Per executive direction, the UVAHS PM/PMO will serve as the governing body for this project and as such, assume full responsibility for project success.

Project Approvals The undersigned hereby endorse this project and agree to support the project through the due diligence and analysis phase to determine if this project should be implemented or cancelled.

Executive Sponsor (name, title and department) Date

Project Owner (name, title and department) Date

HS Infusion Pump Project Charter Page 11 of 11 2018-04-04 Draft