Quality and Process Improvement Program (QPIP) · cctsi.ucdenver.edu Quality and Process Improvement Program (QPIP) David R. West, PhD Member, CCTSI Executive Committee Professor

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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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QPIP Team

Bethany M. Kwan, PhD

David R. West, PhD

Daniel Holtrop, MA

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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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BERD initial process map

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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

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Metrics Cont’d

• Efficiency # of hours per project/allocated in SOW

• Sustainable Business Model # hours efforts compared to collections ($ of lost revenue/ unreimbursed effort)

• Experience User Satisfaction Biostatistician Experience