Applications of Lean Principles to Pre and PostAward Management of

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Applications of Lean

Principles to Pre and

Post-Award Management of

Presenta(on Objec(ves

•  Provide introduc-on and overview of Lean and Six Sigma principles

•  Provide brief overview of NIH roadmap for clinical research

•  Provide overview of Clinical Transla-onal Research

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Objec(ves Con(nued

•  Discuss a case study on applying Lean Principles to clinical and transla-onal research

•  Extrapolate and apply Lean Principles to

ﬁnancial management of sponsored awards:

•  Proposal Development, Sub Recipient Monitoring, Monthly Reconcilia-on, Clinical Trial Contrac-ng

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A Day In the Life of a Research Administrator

•  Mee-ngs, emailing, training, benchmarking, tex-ng, reviewing, social networking, signing, conﬁguring, applying, mentoring,

troubleshoo-ng, problem solving, consul-ng, consoling, studying…

•  And maybe a lunch now and then…

•  Research Administrator or Fireﬁghter?

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The Perfect Job

•  Mo-vate and treat individuals with respect and dignity

•  Immediate response to ques-ons and issues

•  Work delivered error-‐free and delivered on-‐-me •  Proﬁtable

•  Minimal waste (ex. email, approval signatures) •  Informa-on communicated in just the right

amount

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What Do Those Concepts

Provide?

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Who Recognizes the Value?

•  You

•  Your supervisor •  Senior leadership

•  Your customers (faculty, suboordinates, other staﬀ/colleagues)

•  Your friends •  Your family •  Your pets

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What Is LEAN?

•  Tools and methods to:

•  eliminate waste •  improve eﬃciency •  determine value

•  Originally applied to the manufacturing industry to eliminate wated -me and resources in

processes

•  less -me and eﬀort •  less space

•  less investment in non-‐salary costs, ex. IT, tools, consul-ng

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Lean Tools: New or déjà vu?

•  Value Stream Mapping •  Five S

•  Bo]leneck Analysis

•  Key Performance Indicator (KPI) •  Just In Time (JIT)

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Brief History of Lean

•  Documented as far back as Benjamin Franklin’s -me

•  Frank Gilbreth, Frederick Winslow Taylor, Henry Ford

•  Named by John Krafcik in “Triumph of the Lean Produc-on System”; approach credited to Taiichi Ohno and Eiji Toyoda for The Toyota Way 1

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Types of Waste

•  Waste: something that does not add value from a customer’s viewpoint

•  Includes defec-ve or error-‐ridden products, things wai-ng in queue, delayed, etc.

•  Original seven muda: transport, inventory, mo-on, wai-ng, overproduc-on, over-‐

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Back to the Perfect Job

•  “Lean implementa-on is…focused on gehng the right things to the right place at the right -me in the right quan-ty to achieve perfect work ﬂow, while minimizing waste and being ﬂexible and able to change.”3

•  While Lean focuses on elimina-ng waste to ul-mately beneﬁt the customer, one could

extrapolate a major secondary beneﬁt is adding value to employees

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Cri(cisms and Concerns

•  Lean requires buy-‐in all the way to the top: it is a culture

•  Lifestyle change – not an individual process change

•  Management focuses too much on tools and subsets of processes that aﬀect their areas, not thinking of the

larger process aﬀec-ng the organiza-on

•  Management olen not consul-ng with those who actually perform the processes before implemen-ng change

•  Short lived – li]le follow-‐through or con-nued commitment

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Concepts of Six Sigma

•  Also intended to improve the eﬃciency of products and processes

•  Relies on sta-s-cal methods to compliment and reduce product and process varia-ons

•  Eliminate defects eﬃciency and prevent them from re-‐occurring

•  Defect: a product that does not conform to the standards or sa-sfac-on of the customer

•  Ideally would lead to improved proﬁts,

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Concepts of Six Sigma cont’d

•  Current movement fueled by its success at large companies such as Motorola, General Electric, Sony, and Allied Signal3

•  It is a con-nuous process

•  Inspired by Deming’s Plan-‐Do-‐Check-‐Act4

•  DMAIC or DMADV

•  Training and cer-ﬁca-on: receive a “belt status” based on level of cer-ﬁca-on, ex. black belt

•  Cri-cism: use of consultants, focus too narrow, no room for crea-vity5

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Applica(ons of Lean Six Sigma

•  Complimentary disciplines: improve processes and decrease waste AND focus on varia-on and design6

•  Use both to increase eﬃciency and grow

•  Originally applied to manufacturing industry •  Now healthcare and other industries

•  Back to the perfect job: increase sa-sfac-on, reduce errors, and save money by improving processes

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Total Quality Management

•  Use of Total Quality Management and

Con-nuous Quality Improvement (TQM and CQI); precursor processes to Lean Six Sigma implementa-on

•  Focus on improving processes to increase pa-ent sa-sfac-on

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Lean Six Sigma and Healthcare

•  According to a USA Today ar-cle, “Each of the na-on’s 5,700 hospitals must cut $2.6 million a year on average in costs in the next 10 years to meet the demands of President Obama’s

proposed health care reform, a daun-ng task when half of those hospitals lose money.”7

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Lean Six Sigma and Healthcare

•  Lean Six Sigma improves on TQM/CQI by making deliverables “more discreet and measureable, retaining a strong customer (rather than

organiza-onal) focus, quan-fying results, and a]emp-ng to deliver speciﬁc quality

improvements within a designated -meframe.”8

•  Areas improving pa-ent outcomes: surgery,

pharmacy, blood bank, transcrip-on, billing, etc.

•  Lower costs, decrease medical errors, decrease

waste (-me, labor, supplies, space), manage chronic disease

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Lean Six Sigma and Healthcare

•  Organiza-ons travel on two interdependent paths: culture and systems pathways

•  Systems: value stream mapping and implementa-on and review

•  Culture: training, implementa-on, and respect

•  “…puts quality improvement tools in the hands of frontline providers, who are familiar with the ineﬃciencies and hazards facing their pa-ents, so that they can be catalysts for organiza-onal change.”9

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Lean Six Sigma and Healthcare

•  Challenges:

•  Providing cost-‐eﬀec-ve, high-‐quality healthcare •  Obtaining staﬀ and physician buy-‐in

•  Senior management understanding concepts and receiving appropriate training

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NIH Roadmap

•  “The Na-onal Ins-tutes of Health (NIH) engaged in a series of ini-a-ves collec-vely known as the ‘NIH Roadmap for Medical Research’

h]p://nihroadmap.nih.gov that promote clinical and transla-onal inves-ga-on and aim to

improve health and prevent disease. The CTSA consor-um was envisioned as a Na-onal Center for Research Resources (NCRR) program that

drew on the NIH Roadmap ini-a-ve to re-‐

engineer the clinical and transla-onal research enterprise.”10

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CTSA Consor(um Vision

•  “The vision for the Clinical and Transla-onal Science Award (CTSA) program is to improve

human health by transforming the research and training environment to enhance the eﬃciency and quality of clinical and transla-onal

research.”11

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CTSA Consor(um Goal

•  “A major goal of the CTSA ini-a-ve is to create an environment that will overcome challenges and impediments to clinical and transla-onal science. The consor-um works towards

adop-ng and implemen-ng agreed-‐on best prac-ces, policies, procedures, and other

measures to advance collabora-ve clinical and transla-onal research while reducing burdens on individual inves-gators.”12

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Clinical Transla(onal Research

•  “Clinical Research comprises studies and trials in human subjects mee-ng the NIH deﬁni-on in the PHS 398

instruc-ons.

•  “Transla-onal research includes two areas of transla-on.

•  One is the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans.

•  The second area of transla-on concerns research aimed at enhancing the adop-on of best prac-ces in the community. Cost-‐eﬀec-veness of preven-on and treatment strategies is also an important part of transla-onal science.”13

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Phases of Transla(onal Research

•  T1: Applies new knowledge generated in the laboratory to new methods that can be tested on humans.

•  T2: Takes the results of the above human

studies and reﬁnes them for use in daily clinical prac-ce.

•  T3: Takes these prac-ces beyond the academic health clinic and into the community.

•  T4: Evaluates the outcomes from the above steps and provides feedback.

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Prac(cal Applica(ons to Clinical

Transla(onal Research

•  Lean Six Sigma “imported from the industrial environment, can be applied to help

systemically analyze and improve the array of process steps involved in most clinical

transla-onal research projects”15

•  University of Virginia, A systems approach to the

promo4on and implementa4on of medical

transla4onal research at the University of Virginia16

•  University of Ohio, The Applicability of Lean and Six

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Prac(cal Applica(ons to Research

Administra(on

•  Can you think of a process at your ins-tu-on that could beneﬁt from Lean Six Sigma?

•  IRB protocol review and approval •  Clinical trial invoicing and payment •  Inves-ga-onal new drug applica-ons •  Patent ﬁling

•  Sharing of data or specimen banks with external en--es/ins-tu-ons

•  Distribu-on of informa-on on processes and procedures by the ins-tu-on

•  Recharge rate development

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The Oﬃce Environment

•  Individualized Work? •  Informa-on Accessible? •  Processes Not Linked? •  Work piling up?

•  Staﬃng mee-ng demand? •  Unused crea-vity?

•  If yes to all, it is not a Lean oﬃce •  Refer back to Slide 4…

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Exercise

•  Think of a pre or post-‐award process at your ins-tu-on that is ineﬃcient, bureaucra-c, wasteful.

•  What is the product?

•  Who are your customers?

•  What are the steps in the process? •  What is the waste?

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Value Stream Mapping

•  What is the end result of a process? Ex. submission of proposal without errors

•  How do we make that happen? Ex. Set-‐up of award aler receiving NoGA

•  Receive NoGA •  Read NoGA •  Rebudget

•  Submit Budget for Signatures •  Etc!

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Value Stream Mapping

•  Iden-fy processes that add or decrease value •  Determine how to remove wasteful processes •  Who are the people involved? Is there

coverage? Is only one person responsible? (Bo]leneck analysis opportunity)

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Exercise

•  Business Process Mapping

•  Demonstra-on: Making Breakfast

•  Value Stream Mapping

•  Exercise for Audience: Cooking bacon, eggs, toast

•  Business Process Mapping

•  Demonstra-on: Proposal Development (YIKES!)

•  Value Stream Mapping

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Exercise

•  Bo]leneck Analysis

•  Demonstra-on: Sub-‐Contract Ini-a-on

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References

1.  Lean manufacturing. (n.d.). In Wikipedia. Retrieved January 24, 2015, from h]p://en.wikipedia.org/wiki/ Lean_manufacturing

2.  Lean manufacturing. (n.d.). In Wikipedia. Retrieved January 24, 2015, from h]p://en.wikipedia.org/wiki/ Lean_manufacturing

3.  Lean manufacturing – Process Quality Associates, Inc. Process Quality Associates, Inc. Retrieved January 24, 2015, from h]p://www.pqa.net/ProdServices/leanmfg/lean.html

4.  Six Sigma, (n.d.) In Wikipedia. Retrieved January 31, 2015, from h]p://en.wikipedia.org/wiki/ Six_Sigma#cite_note-‐juran-‐9

7.  Kyle, L. (2009, September 9). Hospital CEOs manage staﬀ -me, inventory to cut costs. USA Today. Retrieved January 31, 2015, from h]p://usatoday30.usatoday.com/news/health/2009-‐09-‐09-‐saving-‐money-‐

hospitals_N.htm

8.  Schweikhart SA, Dembe AE. The applicability of lean and six sigma techniques to clinical and transla-onal research. American Federa4on for Medical Research. 2009; 57(7):748-‐755.

9.  What is Lean Sigma? (n.d.). Retrieved January 31, 2015, from h]p://www.hopkinsmedicine.org/ innova-on_quality_pa-ent_care/areas_exper-se/lean_sigma/about/

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References cont’d

10.  Clinical and Transla-onal Science Awards (CTSA) Consor-um Governance Working Document. (2011).

2011.6.16, 1-‐22. Retrieved January 31, 2015, from h]ps://www.ctsacentral.org/documents/

CTSA_Governance_Manual.pdf

13.  Na-onal Ins-tutes of Health (NIH). Ins-tu-onal Clinical and Transla-onal Science Award [NIH Request for Applica-ons, Number: RFA-‐RM-‐09-‐004 Web site]. Available at: h]p://grants.nih.gov/grants/guide/rfa-‐ﬁles/ RFA-‐RM-‐09-‐004.html. Accessed January 31, 2015.

14.  What is transla-onal research? (n.d.). Retrieved January 31, 2015, from h]ps://ctsi.mcw.edu/community/ what-‐is-‐transla-onal-‐research/

16.  Ablowitz JL, Calhoun TD, Farmer MR, et al. A systems approach to the promo-on and implementa-on of medical transla-onal research at the University of Virginia. Systems and Informa4on Engineering Design

Symposium 2008; 25:210-‐215.

Applications of Lean Principles to Pre and PostAward Management of