36C24718Q9415-001.docx

STATEMENT OF WORK

Title: Transplant Medication Monitoring Dashboard

1. Background Organ transplant is the gold-standard treatment for patients with end organ diseases of the kidney, liver, heart and lungs, as it substantially improves survival and quality of life. Over the past 20 years, the use of contemporary immunosuppression has reduced the risk of acute rejection rates by upwards of 80%; yet long-term allograft survival remains suboptimal. Studies have demonstrated that causes of late graft loss is predominantly driven by immunosuppression adverse events and late allograft rejection episodes from medication errors and non-adherence, which encompass issues directly related to medication safety. Our research demonstrates that medication errors occur in nearly two-thirds of transplant recipients, leading to hospitalization in 1 in 8 recipients. Recipients that develop significant medication errors are at considerably higher risk of graft loss, leading to higher costs and mortality. Thus, in order to improve medication safety and long-term outcomes in transplant recipients, enhancements in immunosuppressant therapy management is needed.

This proposal will develop an expanded version of a dashboard system currently utilized within VISN 7 and 12, which was built and developed using Microsoft SQL software. The current dashboard runs a query each morning and determines which patients meet reporting criteria. The site pharmacist can then run a list of patients that meet triggering criteria. This list contains the patient information, prescriber information, immunosuppressants and which laboratory values are required to optimize monitoring. For this proposal, we will expand this dashboard to significantly improve its query and reporting capabilities and disseminate it using a national CDW data feed in the Field Reporting Enclave (FRE) environment. The FRE is a newly developed VA environment that allows for project space and access to national VA data. End-users will be given remote access to their specific patients by evoking user-level permissions. Thus, the dashboard will be functional at a national level, but will ensure patient confidentiality and prevention of PHI breaches through this end-user remote access plan. This is a similar system that is set up at the VISN level for the current dashboard, and will be expanded to a national level as part of this proposal

The dashboard expansion will contain four additional immunosuppressant safety monitoring domains. The first will be monitoring for immunosuppressant non-adherence, through the tracking of refill activity and expiring medications. The dashboard will also expand its laboratory monitoring capabilities, to include not only monitoring for missing labs, but also monitoring for labs values that would indicate the development of a potential adverse drug event (immunosuppressant toxicity or ineffectiveness). This will be accomplished by setting threshold definitions for key labs. Similarly, tacrolimus blood concentrations below or above a threshold level would also trigger an alert. The dashboard will also monitor laboratory value trajectories and alert the pharmacist of patients that have trends in key laboratory values suggesting the development of a potential adverse drug event; for example, setting a trigger such that the serum creatinine concentration has increased more than 30% since the last recorded value. This information will also allow the transplant pharmacist to determine patients that may need medication dose adjustments due to changes in organ function. Finally, the dashboard will be refined to include a drug interaction monitoring function, such that the addition of new clinically relevant interacting drugs to the patient’s list would trigger an alert. Concomitantly, changes in the dose or dosing regimen of an interacting drug would also trigger an alert.

The current dashboard system will also has the capability of developing summary reports. These reports summarize data across each VAMC and the VISN, as a whole. These summary reports will also be refined as part of this grant proposal. Currently, the reports summarize the adherence to laboratory monitoring and notes by the transplant pharmacist. We will expand these adherence assessments to include the percent of patients that are adherent to prescribed immunosuppressant therapy, the percent of patients that have alarming trends in laboratory values and the percent of patients that have recently had the initiation or dose change for a clinically significant interacting drug

2. Objectives

a. Developed an expanded transplant medication monitoring dashboard system with the following capabilities (alerts)

i. Missing Labs

ii. Lab values alerts based on absolute values and trends

iii. Immunosuppression Non-adherence

iv. Drug interactions

v. Hospital discharge or ED visit

b. Test and validate the expanded dashboard system

c. Provide real-time support during the ongoing use of the dashboard system across the five VA sites utilizing the system

3. Scope Develop and support an expanded dashboard system, as detailed within the above-mentioned objectives. The dashboard will need to be fully operational by December 1, 2018. Real-time support of the dashboard will be needed for at least three years.

4. Statement of Required Deliverables

a. Web-based application

b. Application programmed in a ‘VA approved’ language, .NET strongly preferred. Report Tools specific software, of type approved for use by VA, will be used to provide the graphic reporting of statistics on the dashboard.

c. SQL database on the backend of the application.

i. If real-time data is required, and subject to VA approval, the application can pull data directly from an application specific view of the VISTA (EHR) database via web service calls.

ii. For performance and/or security reasons if real-time data is not essential, it may be preferable to run regular, timed scripts to populate the application database with the relevant data.

iii. The graphics for comparisons across sites, would potentially be a nightly script run, if that would satisfy requirements.

d. Utilize the VA’s LDAP system for user authentication to govern access to the application and to define user permissions to data. David Taber and Cory Fominaya will have access to all site data (“superuser” access), all other users will be restricted to site specific data and summary data for all sites.

e. Required features of the dashboard system:

i. Login page

ii. Home page (if required, may use graphic reporting summary page)

iii. Graphic Reporting Dashboard page

1. missing labs graphs (site specific % & all sites %)

2. alarming lab values without note since trend trigger graphs(site specific % & all sites %)

3. non-adherent to each immune graphs -PDC < 80% (site specific % & all sites %)

4. significant drug interaction without note since trigger graphs (site specific % & all sites %)

5. hospital discharge or ED visit without note since trigger graphs (site specific % & all sites %)

iv. Patient Level Report – list of patients, ordered by name, with relevant medication safety issue(s) and link to page with more detailed information, and checkbox to suppress alert. Alerts include (see table below for thresholds):

1. missing labs

2. lab values

3. immunosuppression non-adherence

4. drug interactions

5. hospital discharge/ED visit

v. Graph (monthly/weekly %) and list view – missing labs

vi. Graph (monthly/weekly %) and list view – alarming lab values without note since trend trigger

vii. Graph (monthly/weekly %) and list view – non-adherent to each immune

viii. Graph (monthly/weekly %) and list view – significant drug interaction with note since trigger

ix. Graph (monthly/weekly %) and list view – hospital discharge or ED visit without note since trigger

x. Detailed Medication Safety Issue page (see below for example)

5. Tasks

a. Phase 1

i. Identify the BMIC staff – developer, system administrator, database administrator, analyst

ii. Obtain WOC approval for one BMIC staff (developer or sys admin) – expected to take 4-6 weeks

iii. Set up initial application, private github repository.

iv. Identify deployment strategy

b. Phase 2

i. Deploy development, testing and production versions of application on the VA Network

ii. Develop the graphic reporting and patient level summary pages and associated sub-level pages.

iii. Set up the VA approved authentication on the application

c. Phase 3

i. Develop any additional reporting and enhancements as identified

ii. Support ongoing use of dashboard across five VA sites

6. Training

a. There is no training being provided by the VA or required for this scope of work

7. Government-furnished property

a. There is no government furnished property being supplied for this proposed scope of work

8. Security requirements

a. There is no special security requirements needed for this proposed scope of work

9. Place of performance/Delivery address Ralph H Johnson VAMC 109 Bee Street Charleston, SC 29401

10. Period of performance/Requested Delivery Date

11. Invoices

a. Vendors may invoice after each phase of the project is completed, as detailed above image1.png image2.png