Utilizing Systems Theory for Successful Quality Improvement Projects

2019 QI PROJEC T GUIDE SUPPLEMENT

June 2019 2019 QI Project Guide Supplement Utilizing Systems Theory for Successful Quality Improvement Projects Society for Vascular Surgery Patient Safety Organization

Table of Contents

Section Content Page

1 Introduction/Overview 1

2 Acknowledgements 3

3 Systems Theory and the SVS PSO 4

4 Systems Theory at the CENTER Level 5

4.1 Case Study – Iowa Heart Center Claims Validation Audit: Return on Investment 5

4.2 Failure Modes and Effects Analysis (FMEA) 6

4.3 Plan-Do-Check-Act (PDCA/PDSA) 8

5 Systems Theory at the ORGANIZATION Level (Regional) 11

5.1 Using the #Hashtag for a regional QI project 11

5.2 #Hashtag for a contrast-induced nephropathy project 12

5.3 #Hashtag for a frailty project 13

6 Systems Theory at the ENVIRONMENT Level (National) 15

6.1 Resources 16

6.2 Long-Term Follow-Up table 17

7 Quality Improvement and the Participation Awards 18

2019 QI Project Guide Supplement Utilizing Systems Theory for Successful Quality Improvement Projects Society for Vascular Surgery Patient Safety Organization

1. Introduction/Overview

The Society for Vascular Surgery’s Patient Safety Organization is a system of 18 regional groups consisting of over 565 centers, 4,100+ physicians and vascular providers, and over 110 data abstractors/managers and quality personnel with the vascular patient at the center.

The original 2016 QI Project Guide provided step-by-step strategies and tools that guided members through a successful QI Project; from initiating a QI project, implementing processes, and evaluating improvement. The 2018 supplement contained information specifically selected to help VQI members improve prescribing rates for AP/ statins at discharge and improving EVAR LTFU imaging rates using tools provided by the SVS PSO and real-life case studies from members. This 2019 supplement will assist you, the VQI member, in initiating a quality improvement project at the center, regional, and national level while utilizing tools that other centers and regions have successfully implemented and have willingly shared to help our VQI system. The 2016 QI Project Guide and 2018 Supplement can be found at https://www.vqi.org/national-data/qi-project-management/ and https://www.vqi.org/wp- content/uploads/Member-Guide-v-June-2018.pdf, respectfully.

Implementing an organizational change does not take place in a silo. A multi-, inter-disciplinary approach is needed to accomplish this feat. Getting all appropriate stakeholders involved in the process as early as possible is a must for a successful system level project. It is known in Systems Theory, that a microsystem is part of a macrosystem. According to Nelson, Batalden, & Godfrey (2007), a clinical microsystem is formed at the first exchange between a patient and a health care provider. Clinical microsystems are embedded in smaller systems which are embedded in larger systems.1 1 General Systems Theory (GST) was initially introduced in the 1930s by Karl Ludwig von Bertalanffy who stated:” The whole is more than the sum of its parts”. Systems Theory works on the premise of “No man is an island” and “It takes a village” ideology. Quality improvement (QI) necessitates an investment of time and resources at every level of the health system, and the VQI registry data provides the foundation for this work. All of us benefit from learning about each other’s QI successes and sharing ways of overcoming challenges. The purpose of this 2019 supplement is to take all of those isolated villages and islands (healthcare centers) and demonstrate through real-life case studies that the VQI membership can collaborate to create a strong platform for better patient outcomes and demonstrate a positive financial impact to SVS PSO healthcare centers.

1 Nelson, E., Batalden, P., & Godfrey, M. (2007). Quality by design: A clinical microsystems approach. San Francisco, CA: Jossey-Bass.

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The SVS PSO will continue to provide QI resources by providing:

• Focus group discussions • Webinars on the QI initiatives • Monthly newsletters • More reports showing your data • Discussions at regional QI meetings • Increased communications with members and key stakeholders

Cheryl Jackson, DNP, MS, RN, CNOR, CPHQ SVS PSO Director of Quality

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2. Acknowledgements

The SVS PSO would like to thank staff from the following VQI centers for their invaluable contributions. Their ability to successfully complete QI projects and their willingness to share their stories have helped the SVS PSO create a QI Project Guide Supplement that is practical and relevant to other VQI centers.

Iowa Heart Center / Mercy Medical Center (Des Moines, IA) • Cynthia A. Bik, RN, BSN • David Chew, MD • David Ebaugh, MD

Rocky Mountain Vascular Quality Initiative • Julie Beckstrom, RN, MSN, RN, CCRC • Ben Brooke, MD, PhD

Participating Centers: • University of Utah • St. Luke’s Regional Medical Center (Boise, ID) • St. Vincent Healthcare (Billings, MT) • Carondelet Heart & Vascular Institute (Tucson, AZ) • Penrose St. Francis (Colorado Springs) • St. Patrick Hospital (Missoula, MT)

Peter Munk Cardiac Centre (Toronto, Canada) • Naomi Eisenberg, PT, MEd, CCRP

SVS PSO Contributors and Reviewers

Carrie Bosela, RN, Director of Clinical Operations Jens Eldrup-Jorgensen, MD, Chief Medical Officer Nancy Heatley, Education and Research Projects Manager Cheryl Jackson, RN, Quality Director Dan Neal, Analytics Director James Wadzinski, Senior Director Yuanyuan Zhao, Statistician

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3. Systems Theory and the SVS PSO

The patient is the focal point of a healthcare system as shown in Figure 1 below.

Figure 1 (Adapted from https://www.ncbi.nlm.nih.gov/books/NBK22878/, A Framework for a Systems Approach to Health Care Delivery)

(Health Care professionals, family, data managers/abstractors, Health Care Centers, IT)

Regional Groups

Society for Vascular Surgery Patient Safety Organization VQI

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4. Systems Theory at the CENTER Level

The Care Team includes vascular providers (surgeons, cardiologists, radiologists, APNs, PAs), the family, data abstractors/managers, and all departments of a health center, including Informatics. (Figure 1, page 4) Although separate entities, they all need to work together to provide continuity in care with the goal of an optimal outcome for the patient.

4.1 Iowa Heart Center Case Study

Iowa Heart Center (IHC) joined the SVS VQI in July 2012 and went through their second claims validation audit in the Fall of 2017, which covered cases performed in 2015. Every center participating in VQI is required to participate in the claims validation process to ensure consecutive procedure entry of appropriate cases and to eliminate inconsistencies between claims data and procedures entered into VQI. The purpose of the audit is to eliminate selection bias from the dataset by ensuring 100% of the eligible procedures are entered into the registry. Validation is accomplished by comparing procedures entered into the VQI registry with claims data provided by VQI participants and rectifying any inconsistencies between the two data sources. All new centers, who began collecting procedures in the prior calendar year, will be required to participate in the annual claims audit occurring the following year. A random number of previously reporting VQI centers will be selected annually to participate in the claims audit.

Many QI tools were used by IHC: Swiss Cheese Model, Failure Modes and Effects Analysis (FMEA), Plan- Do-Check-Act (PDCA), and perseverance.

After completing the validation audit, IHC discovered they had 12 unbilled patients.

“The VQI Claims Validation Audit provided our practice with some incredible insight into our scheduling and billing processes we may never have discovered otherwise.” Cynthia Bik, RN

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What fell through the holes?

• Emergencies • Add-on cases in the hospital • Bedside procedures • Hospital consults

QI Tools used to facilitate a successful QI project:

“I had recently watched a Webinar from the SVS PSO and thought I should give it a try.” C. Bik, RN

“Starting a QI Project” https://drive.google.com/a/m2s.com/file/d/1e7ks3ugQ2-FM8HZSD6lmtKXSrn- R7J0s/view?usp=sharing

4.2 Failure Modes and Effects Analysis (FMEA)

The Failure Mode and Effects Analysis is a structured approach to discover potential failures that may exist within a design or process. Developed in the 1950s, FMEA was one of the earliest structured reliability improvement methods. Today, it is still a highly effective method of lowering the possibility of failure.

• Failure modes are the ways a process can fail. • Effects are the ways these failures lead to poor outcomes. • Effects analysis refers to studying the consequences of those failures or outcomes. • Define the FMEA topic – why are we missing billing? • Assemble the team – staff and key stakeholders for all aspects of the process. Multi-disciplinary teams help ensure the results are credible and comprehensive. • Describe the process and who is responsible for what – clearly identify which steps are within each team members scope. • Conduct the analysis – a. Identify the Failure Modes for each process step. b. Score each Failure Mode. Assign a risk score of 1, 2, or 3 points for severity, frequency of occurrence, and probability that the failure would be detected and corrected before harm (lack of billing) could occur. i. Severity – how bad is the effect? ii. Frequency – how often does it happen? iii. Detection – when it happens, how hard is it to know? c. Calculate a Risk Priority Number (RPN) for each failure mode by multiplying the assigned value for severity, occurrence, and detection. i. RPN = severity x occurrence x detection

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This helps to develop an Action Plan based on risk and prioritize the Action Plan process steps using the highest RPN.

Note: a word of caution when using RPN values to assess risk – RPNs have no value or meaning in themselves. Although it is true that larger RPN values normally indicate more critical failure modes, this is not always the case. Severity is given the most weight when assessing risk. http://www.fmea-fmeca.com/fmea-rpn.html

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4.3 Plan – Do – Check/Study – Act (PDCA/PDSA)

PLAN

• Determine what can be improved - capture 100% of surgery cases, bedside procedures, and consults for Physician billing. • Established a team of key stakeholders and staff o Director of Billing o Director of Vascular Department o Rounding Hospital RNs o Coding / billing personal o Registry Coordinator o Office Scheduler

• Identified changes to make in daily process to implement the proposed improvements they were hoping for. • Rounding/Triage hospital RN will email all emergent / after-hours cases to office scheduler and to the billing department to be added into the office Practice Manager (PM) system. • The scheduler will add all cases into PM each day. • Billing will maintain a list of all cases billed.

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• Both the scheduler and billing will do a final check of surgery cases in PM and those billed using the hospital monthly OR log.

CHECK/STUDY

• Once the changes were implemented, they established a monthly check of the results to verify they were making a process improvement. o If the improvement change does not achieve the results expected – modify the process and start the cycle again with the new proposed process. o By the 15th of each month, the office scheduler and billing will check PM and the billing list against the hospital OR case log for the prior month. Any missing patients will be noted and communicated to the PV Director. o Missing patients will be investigated quickly to determine the reason missed and added to PM. Billing will be done once deemed appropriate.

ACT

• When the trial period ends, each month, results will be studied and compared to performance before and after the proposed improvements. o If they achieved the improvement in billing of all surgery cases to 100% - the improvements trialed will become permanent. o If the results are not satisfactory, they will have to decide whether to make more changes to adjust the results or start over.

IHC Results

• IHC identified the billing “failure” in Jan. 2018 from their VQI audit results. The team began their first PDCA improvement process cycle the end of Feb. o In a retrospective review of Jan. - 6 cases missed. o In Feb. – 2 cases o In March – 2 cases o In April – 0 cases o In May – 3 cases o In June – 3 cases o In July – 0 cases o In August – 2 cases again and 2 cases under the wrong surgeon name • Without the Quality Improvement project - 18 surgery cases would have been missed for billing in 2018! o All missed cases have been added to Practice Manager and billed within insurance timelines. However, there are still opportunities to improve. SO… • Take-aways o The PDCA cycle will continue o They will be looking for new ideas to “plug” the holes and will begin the next PDCA cycle.

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• ROI for SVS PSO membership o All 18 surgery patients missed in 2018 have been billed. o Two cases of wrong surgeon name have been corrected. o Identified over 20 cases of bedside procedures that were referred to the billing/coding department for review. o Identified 12 cases for billable hospital consults. o As a team - They are continuing to improve their process!

Iowa Heart Center’s story was highlighted in a webinar on September 26, 2018. To access the webinar, go to: https://drive.google.com/a/m2s.com/file/d/1suyVl9TH-W-RK3KCadcNnK0LatVpMVsR/view?usp=sharing

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5. Systems Theory at the ORGANIZATION Level (Regional)

An added benefit to belonging to the SVS PSO is the ability to network with peers through regional groups. (Figure 1, page 4) The SVS PSO assists regional groups with a Spring and Fall regional meeting where physicians of multiple specialties, advanced practice nurses, physician assistants, data managers/abstractors, and quality personnel collaborate, network, and share best practices which are validated through data provided by the SVS PSO. The SVS PSO believes and research supports that regional quality groups are the most effective way to translate registry data into practice improvement.

The Rocky Mountain Vascular Quality Initiative (RMVQI) initiated a QI project to address the issue of contrast-induced nephropathy, which has been targeted by patient safety groups such as the National Quality Forum and may become a “never event” that Medicare will not reimburse.

The #hashtag feature provided by the SVS PSO was one method the RMVQI utilized to aggregate data for this regional project.

5.1 Method to collect ad hoc data elements in VQI using #hashtag

The hashtag-based solution provided by M2S is extremely flexible and allows regional groups to collect data quickly and efficiently. However, there is no error or range checking upon data entry, so each group using this system must take full responsibility for quality of data. We believe that this method provides an efficient way for various projects to be implemented immediately. While dedicated variables in each data form would be ideal, the hashtag method allows us to test new variables quickly, conduct temporary projects, and use this information to then justify the higher cost of permanent creation of new variables in the data forms. This approach has been approved by the SVS PSO Governing Council. This system uses the concept of hashtags to separate and identify discrete variables, which can be entered into the existing comments section of each data form. Each Tag must follow the #[Tag:value] format, where ‘Tag’ is the unique variable name and the ‘value’ is a numeric or textual value. Any number of Tags may be placed in the comments section as long as they are separated by at least one space. The procedure and the follow-up forms utilize independent comments fields, such that comments (and therefore Tags) can be easily associated to the procedure or the follow-up. See attached examples.

Data entered as Tags for a particular project will be available in blinded datasets. The SVS PSO will include a dedicated ‘Tags’ column in any blinded dataset upon request. This column will include Tags utilized in the comments section of the dataset that apply to the project. The comments field is also included in the “Procedure & Follow-Up Data Download” report for each center, enabling individual centers to easily access all their Tag data.

In order to avoid confusion or inadvertent duplication of Tag names being used by different projects, the SVS PSO staff will maintain a library of all approved Tags, and the potential values for each Tag (variable). Tag use must be approved by each regional group, for a regional quality or research project, and the

Page 11 2019 QI Project Guide Supplement Utilizing Systems Theory for Successful Quality Improvement Projects Society for Vascular Surgery Patient Safety Organization information appropriately communicated to SVS PSO staff. For VQI-wide or multi-regional projects, the SVS PSO Quality Committees or Research Advisory Committee must approve the proposed use of Tags before they will be entered into the Tag Library.

Request for projects requiring tags that have been approved by a regional group or requests for national tag projects by the SVS PSO Quality Committees or Research Advisory Council should be forwarded to Carrie Bosela ([email protected]). Requests must contain the abstract of the approved project, the list of each tag and name requested, and the options for values of each tag. Carrie will assist in name designation to avoid overlap and return the final list of tag names and values. Project owners will then be responsible for distributing this information to participating sites, with instructions to ensure that the tags and values are correctly entered. 5.2 Examples of the data entry values used for the #hashtag tool for contrast-induced nephropathy

Table 5.2

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5.3 The RMVQI regional group also used the #hashtag tool for a frailty project

Table 5.3

Frailty4Site #Hashtags FFI #Hashtag Question Format Answer Choices Shrinking #F4_ffi_shrinking_score_ Calculated field 0=No; 1=Yes Exhaustion #F4_ffi_exhuastion_score_ Calculated field 0=No; 1=Yes Weakness #F4_ffi_gripstrength_score_ Calculated field 0=No; 1=Yes Slowness #F4_ffi_slowwalking_score_ Calculated field 0=No; 1=Yes Low Activity #F4_ffi_lowactivity_score_ Calculated field 0=No; 1=Yes

FFI Total #F4_ffi_fr_ Calculated field 0=Robust; 1 or 2=pre-frail; 3, 4, or 5=Frail

REDCap ID #F4_REDCap_PtID_ Calculated Field XXXX-X, XXXX-XX, XXXX-XXX

CFS #F4_CFS_cfsscore_ Multiple Choice - drop down 1, 2, 3, 4, 5, 6, 7, 8, 9, 10

RAI #F4_RAI_score_total_ Calculated Field 0-75 No hashtag for RAI %. Will be 4, 7, 11, 17, 27, 36, 47, 58, 69, 79, 89, 90, n/a calculated on the backend 93, & 100%

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Below is the #hashtag poster presented at the 2018 VQI Annual Meeting:

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6. Systems Theory at the ENVIRONMENT Level (National)

The SVS PSO hosts the SVS VQI Annual Meeting which is held in conjunction with the SVS Vascular Annual Meeting (VAM) where vascular colleagues gather to collaborate, network, and share best practice in a global environment (Figure 1, page 4). This meeting allows centers to display their success through poster and podium presentations, participate in interactive data abstraction sessions, and hear quality improvement presentations from leaders in vascular care and other disciplines.

The SVS PSO provides networking opportunities on its website at www.vqi.org. The site has a Members Only section that gives you access to a National Shared Area and Members’ Forums where participants can ask each other questions and share their successes.

The SVS PSO has two national quality initiatives: Discharge Medications and EVAR LTFU Imaging. In Systems Theory, “The whole is more than the sum of its parts” is demonstrated by the continuous progress of these two national initiatives. Although we have not met the goal of 100%, the regions are gaining momentum.

Figure 6.1

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6.1 Resources

The 2016 QI Project Guide and the 2018 QI Project Guide Supplement focused on national QI initiatives and provided many resources to assist members with these QI projects. Please click on the following links to access tools, webinars, meeting minutes and other resources to get your center started on one of these projects. To access the Members Only section, contact Nancy Heatley at [email protected].

• VQI website https://www.vqi.org/ • Charters, focused call minutes, posters/podium presentations, links to 2018 abstracts/podium presentations https://www.vqi.org/national-data/

• Blank charter with detailed directions https://www.vqi.org/resources/quality-improvement/ (last link at the bottom of the page) • 2018 QI Project Guide Supplement – provides case studies, QI tools, and charter samples https://www.vqi.org/see-new-qi-project-guide-supplement-national-quality-initiatives/ • 2016 QI Project Guide https://www.vqi.org/national-data/qi-project-management/

The new, user friendly VQI website:

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6.2 Long-Term Follow-Up

One of the most confusing elements of LTFU is keeping track of 9-21 months post-procedure. This table is designed to help. Look at the current month (2019) to see where you should be in entering LTFU (see Table 6.2 below, in collaboration with Naomi Eisenberg).

To receive credit for Long-Term Follow-Up:

Table 6.2

If procedure occurred in . . . Patient must receive a FU visit between . . . September 2017 June 2018 and June 2019 October 2017 July 2018 and July 2019 November 2017 August 2018 and August 2019 December 2107 September 2018 and September 2019 January 2018 October 2018 and October 2019 February 2018 November 2018 and November 2019 March 2018 December 2018 and December 2019 April 2018 January 2019 and January 2020 May 2018 February 2019 and February 2020 June 2018 March 2019 and March 2020 July 2018 April 2019 and April 2020 August 2018 May 2019 and May 2020 September 2018 June 2019 and June 2020 October 2018 July 2019 and July 2020 November 2018 August 2019 and August 2020 December 2018 September 2019 and September 2020 January 2019 October 2019 and October 2020 February 2019 November 2019 and November 2020 March 2019 December 2019 and December 2020 April 2019 January 2020 and January 2021 May 2019 February 2020 and February 2021 June 2019 March 2020 and March 2021 July 2019 April 2020 and April 2021 August 2019 May 2020 and May 2021 September 2019 June 2020 and June 2021 October 2019 July 2020 and July 2021 November 2019 August 2020 and August 2021 December 2019 September 2020 and September 2021

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7. Quality Improvement and the Participation Awards

Quality Improvement Activities: There are five activities in the Quality Improvement category, each worth two points. This allows centers to pick from a variety of activities to reach the maximum of 6 points that can be awarded for this category. Since this category is weighted at 20%, a center’s score in this category will be multiplied by two before calculation of its overall score.

QI Project Charter Initiation: A center may submit a project charter to the SVS PSO that documents a 2019 quality improvement project. It is up to the site to determine what the project will be, but the SVS PSO asks that it is a new activity, initiated in 2019. If a site is looking to identify a potential QI project, we recommend that the site refer to its semi-annual reports to identify areas of opportunity. The SVS PSO staff are available to assist with selection of QI projects. Sites are also encouraged to initiate improvement activities around the two VQI national quality initiatives, “Discharge Medications” and “EVAR Imaging LFTU.” Information on the VQI National Quality Initiatives can be found in the Members Only area of the VQI website at www.vqi.org/national-data. Project charters should provide an overview of the QI Project and include the following elements:

• QI Project Title • Problem Statement • Project Leader • Clinical Sponsor • Expected Start Date • Goal Statement and Metrics

For 2019, the SVS PSO will award two points for the receipt of a project charter. Only one project, per site, will be awarded points. A project charter template can be accessed at www.vqi.org/vqi-resource- library/quality-improvement/. Project charters are accepted at any time and should be sent to [email protected].

Multiple hospitals within a hospital system can work on the same quality improvement project, but the SVS PSO staff ask that systems clearly identify which hospitals are involved with a given project and identify any differences in staffing, goals and metrics, by hospital.

Presentation of a QI or research project at a VQI regional meeting or a regional society meeting: A key component to helping achieve the VQI’s quality mission is attending and sharing of information at VQI regional meetings. To encourage and reward such participation, we are awarding 2 points if a site has a poster or presentation on a QI/research project at a regional VQI or vascular society meeting. Posters or presentations can be based on 2018 or 2019 projects, but the presentation must occur in 2019 and be

Page 18 2019 QI Project Guide Supplement Utilizing Systems Theory for Successful Quality Improvement Projects Society for Vascular Surgery Patient Safety Organization the first time the project/data has been presented at a regional meeting. The QI/research projects must use VQI data to be eligible for credit. The SVS PSO will collect information and award points on presentations at VQI regional meetings. Sites will be responsible for sending information on presentations at regional vascular societies to [email protected] by 12/31/19.

Presentation of a QI or research project at the VQI Annual Meeting or the SVS Vascular Annual Meeting: The SVS PSO would also like to encourage and reward sites for presenting VQI quality improvement presentations at a national level. As such, the SVS PSO will award two points for poster/presentations at these national meetings. Posters or presentations can be based on 2018 or 2019 projects, but the presentation must occur in 2019. The QI/research projects must use VQI data to be eligible for credit.

The SVS PSO will collect information and award points on presentations at the VQI Annual Meeting. Sites will be responsible for sending information on presentations at the SVS Vascular Annual Meeting to [email protected] by 7/31/19.

Publication in a peer reviewed journal: VQI data have long been used for research and publication purposes and have changed the way care is practiced in several areas. Sites will be awarded two points for activity in this domain. The publication must be based on VQI data. Evidence of publication needs to be sent to [email protected] by 1/31/20.

VQI national QI initiatives performance improvement: To further promote the importance of the two VQI national quality improvement initiatives, “Discharge Medications” and “EVAR Imaging LTFU,” the SVS PSO are including these in quality improvement activities scoring. Sites will not have to submit any data, as SVS PSO staff will calculate and award points for this category. Points can be earned for either improvement or maintenance of excellent performance, as follows:

o Any hospital that shows a statistically significant improvement (based on a chi-square test of rates) in either its rate of EVAR LTFU imaging or DC medications from the year prior to the scoring year will receive two points. o Any hospital that was at or above the 75th percentile for either measure in the prior year will get two points if it remains at or above the 75th percentile in either measure in the scoring year, as long as either of its rates has not gotten significantly worse.

If you have any questions about the Participation Awards or the scoring system for 2019, please contact Cheryl Jackson at [email protected] or Jim Wadzinski at [email protected].

Page 19 Join us next year for the VQI Annual Meeting 2020 in Toronto, Canada, on June 15-16