Lean Applications in Healthcare

Muhanad Hirzallah Mayo Clinic

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What is Lean?

Background
Clinical 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 is Too slow Costly Redundant Too many steps Difficult to keep track

DMAIC Methodology
Define

What problem needs to be solved. Compliance with the target Best practices and deficiencies Generate creative solutions Monitor the improvement
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Measure

Analyze

Improve

Control

Define

What problem needs to be solved.

Scope Multidisciplinary Cancer, Cardiovascular, Transplant research Multisite Jacksonville, Scottsdale, Rochester Primary measure time from protocol submission to coordinators to IRB submission. Goals To 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.

Define Define

What problem needs to be solved.

Benchmarking Deliverables
PI Manual Training Tools Access database for tracking Measurement Readiness Checklist Deployment Plan
All tools replicable to the research community

DMAIC Methodology
Define

What problem needs to be solved. Compliance with the target Best practices and deficiencies Generate creative solutions Monitor the improvement
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Measure

Analyze

Improve

Control

Measure

Compliance with the target

Value Stream Map

Define and measure individual subprocesses Count the number of items in queue Calculate total process time, total actual time, and the value added ratio
Total time > 188 days Process time 14 days Value added ratio 7.4%

Current State Kaizens

Protocol template standardization FDF improvements Communication/Approvals plan Committee approvals process
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Measure

Compliance with the target

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Measure

Compliance with the target

Communication & Approvals Plan Financial Disclosure Form Improvements

Principal Investigator / Study Team

Standardize Coding Process Tools & Training

Expedited IRB Review for Externally Authored

IRB Committee Approval Process

Standardize within/with Protocol Template

Concept Approval & Protocol

Sponsor

Funding Agency

Protocol Development Coordinator

Protocol Development Coordinator, Protocol Coordinator, Research Secretarial Assistant

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Protocol Development Coordinator, Protocol Coordinator, Research Secretarial Assistant

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Protocol Development Coordinator, Research Secretarial Assistant

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Protocol Development Coordinator, Research Secretarial Assistant

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Protocol Development Coordinator

Protocol Development Coordinator, Protocol Coordinator

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Develop Consent Form & Send to PI Develop Budget & Send to Preaward Develop Contract Checklist & Send to LCA

Compile & Send Protocol, Budget with Consent to Peer Review, Dept. Review, Funding Agency Get Financial Disclosure Form & Conflict of Interest Prepare Other Regulatory Documents P/T: 3.5-8 hrs Errors From Upstream: 100% Batch Size: 1 Protocol

Review For Consistency & Accuracy

Make Changes and Respond to Peer Reviewers

Update Funding Agency with Final Protocol

Data Management Services Meeting

Fill in IRBe Application

P/T: 1-9 hrs Errors From Upstream: 100% Batch Size: 1 Protocol Staff: 22 15 days

P/T: 1.5-24 hrs Errors From Upstream: 100% Batch Size: 1 Protocol Staff: 40 10 days

P/T: 6-24 hrs Errors From Upstream: 100% Batch Size: 1 Protocol 30 days Staff: 22

P/T: 0.05 hrs Errors From Upstream: 100% Batch Size: 1 Protocol Staff: 36 20 days

P/T: 18-127 hrs Errors From Upstream: 100% Batch Size: 1 Protocol Staff: 22

P/T: 1.5-8 hrs Errors From Upstream: 100% Batch Size: 1 Protocol Staff: 26

Staff: 40

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

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Measure

Compliance with the target

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DMAIC Methodology
Define

What problem needs to be solved. Compliance with the target Best practices and deficiencies Generate creative solutions Monitor the improvement
13

Measure

Analyze

Improve

Control

Analyze

Best practices and deficiencies

Root Cause Analysis

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

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

Box plot
The peer review process was measured and shown to be highly variable.
Average process time = 17 weeks Range = 1.1-49.3 weeks
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Analyze

Best practices and deficiencies

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Analyze

Best practices and deficiencies

Time From PR to IRB/NCI Final Submission 60

50

49

40

Min(IQR): st 1 Quartile: Median: Mean: rd 3 Quartile: Max(IQR): Minimum Minimum Minimum 25th 25th 25tj 75th 75th 25th Median Median 75th 75th Max Max Max Mean

Summary Range Time From PR to IRB/NCI Final Submission 1.1 7.1 13.1 17.1 24.0 49.3 1 1 1 7.142857143 7.142857143 7.142857143 24 24 7.142857143 13 13 24 24 49 49 49 17

30
24

20

13

10
7

1 0 1.1

1 1 3 5 4 4 6 2 2 6 6 6 2 2 4 4 5 3 4

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DMAIC Methodology
Define

What problem needs to be solved. Compliance with the target Best practices and deficiencies Generate creative solutions Monitor the improvement
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Measure

Analyze

Improve

Control

Improve

Generate creative solutions

Future State Value Stream Map

3-4 week process First in First Out mentality Total process time = 4 working days Total wait time Non value added essential = 10 working days Value added ratio = 27.5%

Additional Future State Kaizens

Clarify principal investigator roles Provide project management training for coordinators Improve fist time quality (checklist creation)

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Improve

Generate creative solutions

Standardize Coding Process Tools & Training Communication & Approvals Plan

Financial Disclosure Form Improvements

Principal Investigator / Study Team Clean Protocol 8 7 PDC training in project mgmt

IRB 9 Multi dept checklist for DMS

Standardize within/with Protocol Template

Clarify PI roles

Protocol Development Coordinator

FIFO FIFO

Multiple concurrent tasks

Protocol Development Coordinator

Committee Approval Process

Review Protocol Develop Consent form and email to PI Prepare LCA checklist and send to LCA Start IRBe Application Ask for codes Start regulatory documents (FDF) Add on agendas (committee, reviewers..) P/T: 12-18 hrs
Errors From Upstream: 0%

PI reviews consent (3 days) Peer review (upto 10 days) FDFs (7 days) Committee Approval (14 days)

Attend PIM Conduct review meeting Finish IRB application and submit DMS meeting (if applicable)

Expedited IRB Review for Externally Authored

P/T: 2 hrs Within 14 days

P/T: 4-5 hrs

Batch Size: 1 Protocol Staff: 22

DMS Specialist

Study Team

DMS Specialist/ Assistant

FIFO

FIFO

Mock up forms

Review forms

Combine comments & finalize forms

P/T: 4 hrs
Errors From Upstream: 0%

P/T: 1 hr WAIT 3 days

P/T:4hrs

Batch Size: 1 Protocol Staff: 5

10 w. days

16-22 hrs

3 hrs

8-9 hrs

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Improve

Generate creative solutions

3 Week FIFO Process

Step 11 Step
11Week Week 1-2 Weeks 1-2 Weeks

Step 22 Step

Step 33 Step
11Week Week

Review protocol Review protocol Define study in NCCS Define study in NCCS Complete Correlative Complete Correlative

Research Information Research Information form form Draft Consent and send Draft Consent and send to PI/Sponsor to PI/Sponsor Start IRBe application Start IRBe application Obtain CPT codes from Obtain CPT codes from sponsor (if applicable) sponsor (if applicable) Start regulatory Start regulatory Send out for Peer Review Send out for Peer Review Add on to PRC/HRC Add on to PRC/HRC agenda agenda LCA-drug only, no LCA-drug only, no funding funding

PI/Sponsor PI/Sponsor

Conduct post peer Conduct post peer

review meeting to review meeting to finalize protocol finalize protocol (and possibly (and possibly forms) forms) Complete IRB Complete IRB application and application and submit OR- NCI submit OR- NCI submission submission Attend PIM Attend PIM (OSPA) (OSPA)

Reviews Consent Reviews Consent PIM Requested PIM Requested through MIRIS through MIRIS PRC/HRC PRC/HRC approval obtained approval obtained

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Improve

Generate creative solutions

Logistics Review Meeting

Replaces Peer Review Replaces multiple disconnected emails Transitions into fully electronic environment Allows for open discussion and debate Brings in study team members from across the country and across the world Eliminates inconsistencies & contradictory language Positive customer feedback

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Improve

Generate creative solutions

Standardized Templates
Color coded for responsible party Reduction from 64 total templates to 22 1-on-1 PI education Available to community PI upon request

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Happy Customers
Ultimate Goal: Accelerating the time to improve patient access to trials Meet customer demands Improve staff satisfaction

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Questions
Project Process Owner: Terre McJoynt Unit Head, Protocol Development McJoynt.Terre@mayo.edu

Quality Improvement Advisor: Muhanad Hirzallah Director, Business Applications hirzallah.muhanad@mayo.edu

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