Lean Applications in Healthcare

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Lean Applications in Healthcare

Muhanad Hirzallah

Mayo Clinic

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What is Lean?

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BackgroundClinical trial protocol development consists of the documentation, logistical and scientific reviews, approvals, and financial planning required for conveying a study from concept to activation and the beginning of patient accrual.Stakeholder input from verbal and formal survey information:

The process isToo slowCostlyRedundantToo many stepsDifficult to keep track

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DMAIC Methodology

Define

Improve

Analyze

Measure

Control

What problem needs to be solved.

Compliance with the target

Best practices and deficiencies

Generate creative solutions

Monitor the improvement

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ScopeMultidisciplinary – Cancer, Cardiovascular, Transplant researchMultisite – Jacksonville, Scottsdale, RochesterPrimary measure – time from protocol submission to coordinators to IRB submission.

GoalsTo reduce timeframe from 39 weeks to a maximum of:

10 weeks for internally-authored protocols.4 weeks for externally-authored protocols.

Reduce rework.Standardize, streamline, and eliminate redundancy in the protocol development process across 3 sites.Develop a system that allows the capture of data for quality assurance.

Define What problem needs to be solved.

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Define What problem needs to be solved.

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Benchmarking

DeliverablesPI ManualTraining Tools

Access database for trackingMeasurement

Readiness ChecklistDeployment Plan

All tools replicable to the research community

DefineDefine What problem needs to be solved.

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DMAIC Methodology

Define

Improve

Analyze

Measure

Control






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Measure Compliance with the target

Value Stream MapDefine and measure individual subprocessesCount the number of items in queueCalculate total process time, total actual time, and the value added ratio

Total time > 188 daysProcess time ≈ 14 daysValue added ratio ≈ 7.4%

Current State KaizensProtocol template standardizationFDF improvementsCommunication/Approvals planCommittee approvals process

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Concept Approval &Protocol

8.5d 30+15d 7.7+10d 10.8+30d 4.6d 15.4+20 21.5d

1-9 hrs 1.5-24 hrs 3.5-8 hrs 6-24 hrs 0.05 hrs 18-127 hrs 1.5-8 hrs

20 days15 days 10 days 30 days

Protocol Development Coordinator

Review For Consistency & Accuracy

P/T: 1-9 hrs

Errors From Upstream: 100%

Batch Size: 1 Protocol

Staff: 22

Protocol Development Coordinator, Protocol

Coordinator, Research Secretarial Assistant

Develop Consent Form & Send to PI

Develop Budget & Send to Preaward

Develop Contract Checklist & Send to LCA


Coordinator, Research Secretarial Assistant

Compile & Send Protocol, Budget with Consent to Peer

Review, Dept. Review, Funding Agency

Get Financial Disclosure Form & Conflict of Interest

Prepare Other Regulatory Documents

Protocol Development Coordinator, Research Secretarial Assistant

Make Changes and Respond to Peer Reviewers

11 39 10 14 28

Principal Investigator / Study Team

Communication & Approvals Plan

Standardize Coding Process Tools & Training

Protocol Development Coordinator, Research Secretarial Assistant

Update Funding Agency with Final Protocol

Sponsor Funding Agency


Data Management Services Meeting


Coordinator

Fill in IRBe Application

IRB

6 20

P/T: 1.5-24 hrs



Staff: 40

P/T: 3.5-8 hrs



Staff: 40

P/T: 6-24 hrs



Staff: 22

P/T: 0.05 hrs



Staff: 36

P/T: 18-127 hrs



Staff: 22

P/T: 1.5-8 hrs



Staff: 26

Expedited IRB Review for Externally Authored

Standardize within/with Protocol Template

Financial Disclosure Form Improvements

Committee Approval Process

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DMAIC Methodology

Define

Improve

Analyze

Measure

Control






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Root Cause AnalysisFish diagrams were used to discover the root causes of process defects as discovered through surveys and customer feedback

BrainstormingTeam members brainstormed ideas and circulated for review and approval. Higher rated ideas were given higher priority due to limited resources.

Box plotThe peer review process was measured and shown to be highly variable.

Average process time = 17 weeksRange = 1.1-49.3 weeks

Analyze Best practices and deficiencies

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Time From PR to IRB/NCI Final Submission

Min(IQR): 1.11st Quartile: 7.1

Median: 13.1Mean: 17.1

3rd Quartile: 24.0Max(IQR): 49.3 1

1Minimum 1 3Minimum 1 5Minimum 1 425th 7.142857143 425th 7.142857143 625tj 7.142857143 275th 24 275th 24 625th 7.142857143 6Median 13 6Median 13 275th 24 275th 24 4

1 Max 49 4Max 49 5Max 49 3Mean 17 4

Summary Range

1.11.1

7

13

24

49

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10

20

30

40

50

60

Time From PR to IRB/NCI Final Submission

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DMAIC Methodology

Define

Improve

Analyze

Measure

Control






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Future State Value Stream Map3-4 week process First in First Out mentalityTotal process time = 4 working daysTotal wait time – Non value added essential = 10 working daysValue added ratio = 27.5%

Additional Future State KaizensClarify principal investigator rolesProvide project management training for coordinatorsImprove fist time quality (checklist creation)

Improve Generate creative solutions

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Clean 9Protocol

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10 w. days

16-22 hrs 3 hrs 8-9 hrs


Review ProtocolDevelop Consent form and email to PIPrepare LCA checklist and send to LCAStart IRBe ApplicationAsk for codesStart regulatory documents (FDF…)Add on agendas (committee, reviewers..)

P/T: 12-18 hrs



Staff: 22

Multiple concurrent tasks

PI reviews consent (3 days)

Peer review (upto 10 days)

FDFs (7 days)Committee Approval (14 days)


Attend PIMConduct review meeting

Finish IRB application and submit

DMS meeting (if applicable)

Principal Investigator / Study Team

Communication & Approvals Plan

Standardize Coding Process Tools &

Training

IRB

P/T: 2 hrs

Within 14 days

P/T: 4-5 hrs

Expedited IRB Review for

Externally Authored

Standardize within/with Protocol Template

Financial Disclosure Form Improvements

Committee Approval Process

DMS Specialist

Mock up forms

P/T: 4 hrsErrors From Upstream: 0%


Staff: 5

FIFO

FIFO

Study Team

Review forms

P/T: 1 hr

WAIT 3 days

FIFO

Clarify PI roles

PDC training in project mgmt

Multi dept checklist for DMS

DMS Specialist/ Assistant

Combine comments & finalize forms

P/T:4hrs

FIFO

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Step 1 Step 2 Step 31 Week 1-2 Weeks 1 Week

Step 1 Step 2 Step 31 Week 1-2 Weeks 1 Week

•Review protocol•Define study in NCCS•Complete Correlative

Research Information form

•Draft Consent and send to PI/Sponsor

•Start IRBe application•Obtain CPT codes from

sponsor (if applicable)•Start regulatory•Send out for Peer Review•Add on to PRC/HRC

agenda•LCA-drug only, no

funding

•Review protocol•Define study in NCCS•Complete Correlative

Research Information form

•Draft Consent and send to PI/Sponsor

•Start IRBe application•Obtain CPT codes from

sponsor (if applicable)•Start regulatory•Send out for Peer Review•Add on to PRC/HRC

agenda•LCA-drug only, no

funding

•PI/Sponsor Reviews Consent

•PIM Requested through MIRIS

•PRC/HRC approval obtained

•PI/Sponsor Reviews Consent

•PIM Requested through MIRIS

•PRC/HRC approval obtained

•Conduct post peer review meeting to finalize protocol (and possibly forms)

•Complete IRB application and submit – OR- NCI submission

•Attend PIM (OSPA)

•Conduct post peer review meeting to finalize protocol (and possibly forms)

•Complete IRB application and submit – OR- NCI submission

•Attend PIM (OSPA)


3 Week FIFO Process

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Logistics Review MeetingReplaces Peer ReviewReplaces multiple disconnected emailsTransitions into fully electronic environmentAllows for open discussion and debateBrings in study team members from across the country and across the worldEliminates inconsistencies & contradictory languagePositive customer feedback


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Standardized TemplatesColor coded for responsible partyReduction from 64 total templates to 22 1-on-1 PI educationAvailable to community PI upon request


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Happy CustomersUltimate Goal: Accelerating the time to improve patient access to trials

Meet customer demandsImprove staff satisfaction

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Questions

Project Process Owner:

Terre McJoynt

Unit Head, Protocol Development

[email protected]

Quality Improvement Advisor:

Muhanad Hirzallah

Director, Business Applications

[email protected]

Lean Applications in Healthcare

Documents

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