UCSF Medical Center Care Technology Governance Meeting CTG - September 5 th, 2013 Interfaces UCSF -Office of Research - 1
Requesting Phase 1 Prioritization - Will return to CTG for Phase 2 prioritization. Project Title: Clinical Trials Research Infrastructure Interface and Interoperability with APeX Program: UCSF Office of Research UCSF Program Primary Project Sponsor & Business Contacts Susanne Hildebrand-Zanki Sorena Nadaf Project Impact Immediate and Institution Wide SOM, SON, SOP, SOD - All Programs, All Departments Medical Center Operations Hundreds of end users 2
Project Scope Phase I Demographics via HL7 ADT Lab Values via HL7 ORU CoPath via HL7 (Optional Phase I, or Phase II) Phase II RPE (Retrieve Process for Execution - Epic) Protocol Billing Grid Size (IT/CS) : Small (440 hrs) Go-Live Potential Timelines: TBD Phase I : Preferred is Nov Jan 2014 Phase II: Preferred is Aug 2014 or earlier 3
Integration Drivers: a few 1. Eliminating Duplicate Data Entry for all Patient Demographics and Lab Values Institution wide, eliminating errors, discrepancies, and waste of valuable time. 2. Ensuring Quality Control Quality Assurance and Consistency of Patient Records across Systems. 3. Receiving Patient Demographics from APeX via interface quantifies accuracy of reporting of patient/protocol associations by the research system back to the EMR (RPE). 4. RPE Facilitates Patient Billing within the EMR Impacting Billing Compliance, Audits. 5. APeX knowing patient is a research subject streamlines operations and patient management impacting care 6. Return on Investment: Phase I impact ~ I FTE immediately. Pay for itself within first year. 4
Online Collaborative Research Environment Clinical Trials Research Management Integration Billing Compliance Patient Registries Electronic Data Capture Slide 5 BioSpecimen Management
Clinical Trials Research Statistics as of August 2013 Total Protocols : 3904 Total Active Protocols : 1494 Total Protocol Documents : 28,695 Total SAE s : 2246 Total Active Subjects : 13,902 Total Occurred Subject Visits in last Twelve Months : 17,225 Slide 6
at UCSF In Production Since 2009 Management and Oversight by UCSF program HIPPA Controlled Environment at TI Data Coordinating Center (DCC), Mission Bay Campus Management & Support team: Made up of Clinical Research Subject Matter Experts, Certified Application Mangers, Trainers, Biomedical and Clinical Informaticians, Application and Database Engineers, Unix Engineers, Data Managers, Project Managers : CRISS Clinical Research Informatics Support Services Slide 7
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Funding/Costs Funding: UCSF TI Operating Budget FY 13/14 EVCP dpa/fund: 660819/66714 IT/CS Hardware/Software Costs: IT Interface License (reuse current) $ n/a Epic implementation (reuse current) $ n/a Epic renewal fee (reuse current) $ n/a Total IT/CS HW/S Costs $ n/a IT/CS Labor, by team: IT Interface back-fill ADT split at IE ~ 120 hrs $16,200 Lab split at IE ~ 200 hrs $27,000 CoPath split at IE ~ 120 hrs $16,200 Total IT Labor $59,400 Ancillary Labor, by team: Lab (Testing) CoPath (Testing) Total Labor Total Cost of Project $59,400 Assumptions: 1) CS resources not needed in Phase 1 except for minimal amount of consultation hours. 2) PMO PM is not needed; Sudeep Basnet will manage the project and reach out to PMO for guidance if/when needed. 3) CoPath txtual messages will be forwarded to. 4) Should alteration of messages be required of interface team, labor costs will be adjusted. 5) Lab can absorb hours to assist with basic testing (not every test); No coding or mapping changes are expected. 4) CoPath can absorb hours to assist with basic testing (not every test); No coding or mapping changes are expected. 5) Vendor Hardware/Software and Labor costs breakdown is out of scope of this slide. $ TBD (Lab OT hours- if incurred due to this project) $ N/A (CoPath to absorb) $59,400 (+ Lab OT if incurred due to this project) ROI: Phase I impact ~ I FTE immediately (100K). Pay for itself within first year. 9
Questions 10
Appendix 11
Overview : /APeX Integrations Demographics Pull subject demographics information from EMR Laboratory RPE Populate ecrfs with lab results from lab system Information from is pushed to Epic to flag subjects on a research study in. Protocol Billing Grid Provides an EMR with relative time points of a research study calendar including codes, billing designations and modifiers for assigned charge events & items. Purpose is to support billing compliance. Slide 12
Laboratory Interface Overview Transfer lab results from lab system (APeX) to Implementation Considerations: Unique identifier calendar and ecrfs HL7 lab exam coding Required resources Slide 13
RPE Retrieve Process for Execution Overview Technical profile contained within the IHE QRPH technical framework. Defines how research systems exchange data with EMRs. Implementation Considerations Unique identifiers (recommend demographics interface) Protocol identifier Subject identifier Currently Epic EMR is the only EMR to use RPE with Slide 14
RPE Operations & EMR - RPE (v1.0) Operations EMR Subject Status Updates Patient/Protocol Association Create/Update Protocol New Active/ Updated Protocol Patient Enrolled in Protocol Subject Status Update RetrieveProtocolDefResponse (Unsolicited) EnrollPatientRequest (Unsolicited) AlertProtocolState (Unsolicited) New Study Patient Associated with Study Update Patient Status Slide 15
Protocol Billing Grid Integration Overview Defined by CRPC, a supplement to the RPE profile. Provides an EMR with relative time points of a research study calendar including codes, billing designations and modifiers for assigned charge events & items. Purpose is to support billing compliance. Implementation Considerations RPE integration is required Epic 2012 version required Epic Beacon oncology module considerations financials implementation Slide 16
TI : Integration Process Forte and Customer teams discuss business need with Translational Informatics program at UCSF : Scope of project Discuss distribution of tasks Forte develops SOW for project with TI Project plan developed Forte Project Manager facilitates regular meetings Interface developed & tested Deployed to test environment for validation Deployed to production environment Slide 17
API Overview SOAP based service endpoint Facilitates data exchange with other internal systems Coexists with, simple deployment Secured and encrypted Implemented, tested, and ready for use at UCSF Slide 18
UCSF HL7 ADT Demographics Interface HL7 Engine Integration Framework APeX OnStage Database n = f(emr) Slide 19
UCSF ApEX HL7 ORU Lab Interface HL7 Engine Integration Framework Lab System OnStage n = f(emr) Slide 20
UCSF API Application & API Internal System API Client iris Research Data Mart Other Slide 21
Demographics Web Service : As Needed Internal System Research Data Mart Tumor Registry RDW TI CRDW Slide 22
ApEX PatientLookup Web Service: As Needed APeX RDW Slide 23
API Service Operations Data Points Protocol Protocol Institution Protocol Sponsor Protocol Staff Protocol IND/IDE Protocol Deviations Protocol Subject Deviations Protocol SAEs Protocol Attachment Protocol Summary Accrual Protocol SIP Configuration Protocol PRS Data IRB Reviews IRB Review Changes SRC Reviews SRC Review Changes Service Operations Get, Create, Update Add(Existing) Add(Existing) Add(Existing) Add Get Get Get Add Add Update Get, Update Search(Get), Create, Update Search(Get), Update [Create executed within IRB Review Create] Search(Get), Create, Update Search(Get), Update [Create executed within SRC Review Create] Slide 24