Applications of Lean Principles to Pre and PostAward Management of

Transcription

1 Applications of Lean Principles to Pre and PostAward Management of Sponsored Projects Presented by: Jennifer Foley, CRA The Medical College of Wisconsin

2 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

3 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

4 A Day In the Life of a Research Administrator Mee-ngs, ing, 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?

5 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. , approval signatures) Informa-on communicated in just the right amount Informa-on readily accessible

6 What Do Those Concepts Provide? VALUE!

7 Who Recognizes the Value? You Your supervisor Senior leadership Your customers (faculty, suboordinates, other staff/colleagues) Your friends Your family Your pets

8 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

9 Lean Tools: New or déjà vu? Value Stream Mapping Five S Bo]leneck Analysis Key Performance Indicator (KPI) Just In Time (JIT)

10 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 Both share a goal to minimize waste

11 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- processing, defects2

12 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

13 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

14 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, employee morale and customer sa-sfac-on

15 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

16 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

17 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 But what about improving pa-ent outcomes?

18 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

19 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

20 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

21 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

22 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

23 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

24 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

25 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

26 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.

27 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 Sigma Techniques to Clinical Transla4onal Research17

28 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

29 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

30 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?

31 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! Who is customer?

32 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) How is knowledge of process transferred?

33 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 Exercise for Audience: Sub- Contract Processing

34 Exercise Bo]leneck Analysis Demonstra-on: Sub- Contract Ini-a-on Exercise for Audience: Clinical Trial Contract Review

35 Ques-ons?

36 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:// 4. Six Sigma, (n.d.) In Wikipedia. Retrieved January 31, 2015, from h]p://en.wikipedia.org/wiki/ Six_Sigma#cite_note- juran Six Sigma, (n.d.) In Wikipedia. Retrieved January 31, 2015, from h]p://en.wikipedia.org/wiki/ Six_Sigma#cite_note- juran Six Sigma, (n.d.) In Wikipedia. Retrieved January 31, 2015, from h]p://en.wikipedia.org/wiki/ Six_Sigma#cite_note- juran 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/ 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): What is Lean Sigma? (n.d.). Retrieved January 31, 2015, from h]p:// innova-on_quality_pa-ent_care/areas_exper-se/lean_sigma/about/

37 References cont d 10. Clinical and Transla-onal Science Awards (CTSA) Consor-um Governance Working Document. (2011) , Retrieved January 31, 2015, from h]ps:// CTSA_Governance_Manual.pdf 11. Clinical and Transla-onal Science Awards (CTSA) Consor-um Governance Working Document. (2011) , Retrieved January 31, 2015, from h]ps:// CTSA_Governance_Manual.pdf 12. Clinical and Transla-onal Science Awards (CTSA) Consor-um Governance Working Document. (2011) , Retrieved January 31, 2015, from h]ps:// 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 Web site]. Available at: h]p://grants.nih.gov/grants/guide/rfa- files/ RFA- RM html. Accessed January 31, What is transla-onal research? (n.d.). Retrieved January 31, 2015, from h]ps://ctsi.mcw.edu/community/ what- is- transla-onal- research/ 15. 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): 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: 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):