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Quality and Process Improvement Program
(QPIP)David R. West, PhD
Member, CCTSI Executive Committee
Professor of Family Medicine, Medicine, Emergency Medicine, and
Public Health
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Specific AimsReview
• Aim 1: Identify and remove obstacles to efficiency and process improvement in priority areas
• Aim 2: Form clearly identified and empowered process improvement teams
• Aim 3: Link with evaluators to ensure efforts are complementary rather than redundant
• Aim 4: Integrate quality and process improvement into CCTSI governance and decision-making structures
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Goals
• Efficient use of resources, streamline processes and eliminate waste
• Eliminate unnecessary variation to maintain the high-quality and client-centered delivery of services and support
• Achieve cost-savings that can be reinvested in mission-critical aspects of the infrastructure and environment for CTR.
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A Word About Quality and Process Improvement
• Requires fidelity to stakeholder ownership
• Must follow a structured process to:
– Define scope (Logic model)
– Define Timeline and End Points (Project Plan)
– Engage process owners and stakeholders
– Fully understand current processes to be “improved” (process mapping)
– Process Owners publically espouse process revisions (not the QPIP team)
– Formal implementation and rapid cycle revision/improvement
– Accountability to Sponsor (Exec. Committee and PI)
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Year 1-2 Priority Area
Clinical Research Support Center (CRSC): Assist the CRSC to develop and implement work flows and support for pre-study approval and ongoing compliance .
Process Owner: Dr. Alison Lakin
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Pre-IRB Review Process Improvement
• Goal:
– Unified Pre-IRB review process for CHCO, UCH, SARC, and UCD
– Single port of entry for all investigators
– Single approval letter for all protocols
• Many fits and starts
• Human Subjects Research Portal went “live” 8/14 (www.UCDenver.edu/HSRPortal)
– Ongoing adjustments throughout the fall
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Next Priority Area
Three options considered by the Executive Committee:
– Biostats support through the BERD
– Leadership training and pipeline programs
– Community engagement training and partnerships
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BERD Process Improvement Progress to Date
• Define the scope– Create a logic model (in progress)
• Identify and engage the process owner(s) and stakeholders (in progress)– Dr. Nichole Carlson (process owner)
• Fully understand the processes to be improved
– Identify the process(es) to be improved (complete): Intake, Triage, Investigator-Biostatistician Match, and Project Management (including billing)
– Initial process mapping underway (next slide)
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Response to EAC Critiques
• The EAC at its last meeting encouraged the CCTSI to hold all partners accountable for their pieces of the IRB pre-review process, including one particular partner that generated a great deal of discussion.
• Problems not entirely solved, but have been clearly isolated – putting pressure on that partner to redesign its internal processes (underway)
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Questions for EAC
With Regard to BERD, Appropriate Performance Metrics?
• Reach: Number and “type” of investigators
• Productivity # of projects completed/FTE of biostats) # of Funded Grants # of published manuscripts Drop-out rate (# of projects w/ initial consultation only) # of Abandoned Projects