Business Process Opportunities in Research Administration

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Business Process Opportunities in Research
Administration

• David Lynch, Administrator
• Office of Sponsored Projects Administration
• NCURA Region IV, Kansas City Meeting

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What is Business Process Opportunity (BPO) All
About?

• Research Administrative Services Initiative,
  sponsored by Quality Office with assistance from
  Systems and Procedures
• Develop future state process using Lean
  techniques
• Retain value added steps in process
• Remove non-value added steps
• Eliminate waste (rework, revision, waiting,
  duplicate entry)
• Measure improvements, consider other alternatives
  until gain obtained and maintain the gain

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Industry-sponsored ResearchPre-Award Process
Improvement

• Issues
• Delays in proposal development and study
  initiation for industry sponsored research
  resulted in slow/delayed patient accrual and
  research contracts lost
• There are different processes system-wide

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Responsible Parties Identified

• Process Owner
• Operations Administrator
• Project Manager
• Research Quality Office Liaison
• Lean Facilitator and Support
• System-wide Content Experts

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New Metrics Needed

• Develop metrics to measure baseline and
  post-process improvement
• Collect data for time required in pre-award
  activities
• Databases used to collect data for volume of work
  performed

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Baseline Datatime requirements
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Baseline Datavolume of work
Percentage of Budgets created Jan Mar 06 that
were handed off to LCA by Dec 2006
Budgets captured in ReSIS
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Whats next?

• Create the project charter
• Conduct value stream mapping at each site
• Create future state process
• Collect baseline and future state metrics
• Apply knowledge gained to other areas of
  improvement

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Project TimelineDMAIC
Confirm project charter (mid Jan)
Consensus on baseline data, targets/goals
(late Feb)
Map current state process all 3 sites
(Mar) Design single future state process and
implement (late Mar)
Initiate improvement teams at all sites to
implement changes (Apr Jun)
Establish internal controls and responsibilities
to hold gains. (Jul)
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Project Charter

• Turnaround time from receipt of complete budget
  request from the PI to hand-off to Legal Contract
  Administration in no more than 7 working days.
• Target 100 percent of budgets created
• Best practices from the three sites will be
  incorporated into a single, unified future state
  process
• Specialist schedule Protocol Initiation Meeting
  and phone conference with sponsor within 24 hours
  of receipt of complete budget request package.
• Target 100 percent
• Specialist to establish proposed cost at
  conclusion of Protocol Initiation Meeting.
  Target 100 percent

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Current state process map
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Current state process map
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Current State Summary
OSPA
Sponsor
OSPA
Sponsor
OSPA
PI
OSPA
PI
Prepares Summary Of Budget On Spreadsheet For
the Sponsor
Declines And Approves Terms Or Ask For
Revisions
Send Complete Request To LCA
Prepares Budget and Returns to PI for Review
Approve Budget for the Sponsor
Prepares Payment Terms and Presents to
Sponsor
Declines Or Approves Budget or Asks for
Revisions
Develops the Budget and Sends Requests to
OSPA or Requests Revision of Previous
Draft

Less than 2 days
Process now takes several weeks
Process Now Takes Several Weeks
Process now takes several weeks
Process now takes several weeks
Less than 1 day
Less than 1 day
Less than 2 days
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Current state analysis
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Future State Plan

• Moved from 11 steps to mainly 2 step process
• Reduce cycle time from many weeks to lt 7 days
• Use Protocol Initiation Meeting (PIM) to finalize
  cost proposal (eliminate rework)
• Final budget estimate at completion of meeting
• Budget ready for specialist to present to sponsor
  immediately after approval by PI and Department
  Chair
• Specialist to negotiate budget and payment terms
  2 days of the PIM.
• Implement proposal development database (planning
  and completion tools, patient care look up tools,
  tracking tools, electronic forms available)

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Why a Protocol Initiation Meeting?

• Best Practice Identified
• Currently effective at Mayo Clinic Arizona and
  Jacksonville
• Standardize process system-wide
• Not currently supported by pre-award database,
  but functionality can be added
• New concept at Mayo Clinic Rochester
• Complete planning with PI and OSPA at one meeting
• Standardize current collection of data for the
  PIM by study team using MIRIS

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Future state map
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Future state analysis
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Pre-award relative to overall process
Department, PI
PI, OSPA Sponsor
PI, IRB, IACUC
PI, LCA Sponsor
LCA, OSPA
PI, OSPA, RA
Post Award
Award
Pre-Award
Protocol Development
Human or Animal Compliance Aspects
Budget Negotiation Payment
Contract Negotiation
Post-Award
Award

• Activate the
• Contract
• Send award
• documents to
• RA
• Other
• Regulatory
• Requirements

• Set up contract in Accounting System
• Approve expenses as appropriate to complete the
  specific aims
• Perform work and Complete the Specific Aims
• Close contract when complete

• Develop the Research Protocol
• Develop Specific Aims
• Define Metrics and Output to be monitored

• Budget prep
• Negotiate Price
• Negotiate payment terms
• Send to LCA
• Other regulatory requirements

• Obtain IRB or IACUC approval as needed
• Other regulatory requirements

• Negotiate
• Contract and
• terms of
• contract
• Obtain
• Signatures
• Other
• Regulatory
• Requirements

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Communication Plan

• Internal
• Principal investigators
• Study coordinators
• Finance specialists
• Research Leadership and Committees
• Operational Committees
• Department/Division Chairs
• External
• Industry Sponsors
• Other Collaborators

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Key Message 1

• The future state will be implemented system-wide
  by May 15, 2007
• Complete budget and cost proposal finalized at
  the scheduled PIM
• Total turnaround time lt 7 working days.

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Key Message 2

• PI roles and responsibilities include
• Participation in a Protocol Initiation Meeting
  (PIM) with finance specialists, and other key
  personnel
• Submission of all appropriate required
  information for the PIM at least one day prior to
  the meeting
• Use of Electronic Proposal Routing Form (in
  MIRIS) which generates the Human Subjects
  Training, Financial Conflict of Interest and PI
  Authorization
• Finance specialists roles and responsibilities
  will include
• Setting up the PIM and subsequent meeting with
  sponsors 48 hours after the PIM to achieve final
  negotiations for the budget.
• Conducting the PIM and completing the final
  Budget at the PIM
• Negotiation of Budget and Payment Terms with the
  Sponsor
• Forward to LCA for completion of legal terms and
  conditions

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Key Message 3

• The MIRIS system will begin implementation at all
  3 sites by the first week of May 2007 and will
  support the future state of this process
• Proposal Routing Form is built into MIRIS and
  will be used for all new industry sponsored
  research studies

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OSPA Pre-award Metric 1
Metric
Schedule PIM within 1 working day
Schedule Protocol Initiation Meeting (PIM), and
Phone Conference with Sponsor within 1 working
day of receipt of complete budget request package
from the Principal Investigator/ Study Team.
Explanation of any Deficiencies
Process owner would describe and explain any
deficiencies, especially if metrics were yellow
or red.
Compliant
Action Plan
Top Challenges and Issues
Process owner would describe any actions taken to
address any deficiencies.
Process owner would describe any challenges and /
or issues around metrics.
Quit
Quit
1
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OSPA Pre-award Metric 2
Metric
Negotiate Budget and Payment Terms within 7
working Days
Turnaround time from Protocol Initiation Meeting
with the P.I. to completion of negotiation with
Sponsor (accept or decline) and subsequent
hand-off to the Legal Contract Administration is
no more than 7 working days.
Explanation of any Deficiencies
Process owner would describe and explain any
deficiencies, especially if metrics were yellow
or red.
Compliant
Action Plan
Top Challenges and Issues
Process owner would describe any actions taken to
address any deficiencies.
Process owner would describe any challenges and /
or issues around metrics.
Quit
Quit
1
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Lessons Learned

• The end result is important, but the process
  itself provided the greatest value
• Not everyone is willing to change either support
  the new process or move on
• Use Kaizens to make further improvements
• Beware of reversion to past practices
• Lead PIs and study personnel by example

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More Lessons Learned

• Maintain metrics and review/analyze on a regular
  basis
• Document the new process and clearly state it on
  your website
• Reward and recognize movement toward the goal
• Report progress and issues to OSPA staff,
  departmental and institutional leadership
• Be open to suggestions for further improvement

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