The Seventh Annual Quality Colloquium New Challenge For

The Seventh Annual Quality Colloquium New Challenge For 　Patient Safety　in Japan Toshihiko Hasegawa, MD. , MPH. , Ph. D Nippon Medical School August 21, 2008 Cambridge, MA

My C. V. 1975 Graduation: Poor post-graduation education in Japan Resident: Generaｌ Surgery, St. Joseph Hospital (Milwaukee, US) 1980 Student：　M. P. H　Harvard School of Public Health　(US) Educator： Assistant Professor of 1985 Gastrointestinal Surgery: 　　　　　Shiga Univ. of Medical Science 1995 Bureaucrat 1990 1995 National Cancer Center: Director o Planning Office Deputy director of the Elderly Care Div, MHLW Director of Health ODA, JICA Vice President, Kyushu Region National Hospitals from Bureaucrat to Researcher： 2000 2005 Director of Health Policy National Institute of Health Services Management National Institute of Public Health Researcher　&　 Educator ： Nippon Medical School Ｃ T Hasegawa NMS, Japan Death

Did Research on Patient Safety Advised Government for Policy Developed Teaching Program Japanese bib for the Patient Safet Initiatives

PART　1　　 For Your Surprise

Can You Learn from Japanese Experience? Yes a lot In the case of other industries! Not yet In the case of health industries! Ｃ T Hasegawa NMS, Japan

Why Japan is Champion in Quality ? Yes in the case of other industries Not because factories are excellent But because Japanese customer is very demanding Why not in the case of health industries g n i g n a Because Japanese patient was not very demanding h C y r e So hospitals did not need to prepare n Fi Ｃ T Hasegawa NMS, Japan

Why Changing? Trigger Medical Accident-Yokohama Medical School Wrong Patient Surgery ! Background Consumerism-Baby Boomer Becoming Patient Cost Drive-Rapid Ageing Standerdization-Outcome Orientation Policy Functional Differentiation-Length of Stay Shortenin Ｃ T Hasegawa NMS, Japan International influence : Pizza Syndrome

Pizza Syndrome Foreign reputation defines domestic value Italians did not know pizza is good until Americans told them so Or Like a Dr Deming Case We will learn from you & make it better Invite Me Again in 10 years! Ｃ T Hasegawa NMS, Japan

PART　2　　 Trigger

Historical Trend of Number of Accredited Hospitalｓ　by　JCQHC 3000 Yokohama Accident Additional Payment 2500 2000 1500 1000 Very Slow！ 500 0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Ｃ T Hasegawa NMS, Japan

Articles on Medical Errors 700 600 45 1, 1200 1000 79 6 800 59 1400 1, 900 57 1600 , 5 1000 71 1800 1, 1100 3 Yokohama Accident 60 Medical Lawsuits Filed 800 500 19 92 19 93 19 94 19 95 19 96 19 97 19 98 19 99 20 00 20 01 20 02 20 03 200 Ｃ T Hasegawa Counted by the Supreme Court NMS, Japan 44 56 10 3 14 2 14 13 5 7 10 82 35 26 6 22 1 300 400 200 0 19 89 90 91 92 93 94 95 96 97 98 9 20 9 00 01 02 03 400 600 Year In 5 Major Newspapers

International Consequence for Patient Safety and Quality Improvement Ｃ T Hasegawa NMS, Japan

History of Patient Safety Activity in Japan 1999 Accident at One Reputable Teaching Hospital 2000 Teaching Hospital Patient Safety System Division of Patient Safety at Ministry of Health, Labor & Welfare 2001 National Council for Medical Safety Research Funding 2002 Comprehensive Strategy for Patient Safety National Complaint System 2003 Epidemiological Study on Medical Accident National Reporting System 2004 System for Analysis of Deaths Related to Medical Accident

National Patient Safety System Development People Consumer Insurance Patient Law Health Institution Stakeholder Legal Field Ministry of Law Mass Media Insurer NMS, Japan Provider Association Ministry of Science & Education Insurance Bureau Ｃ T Hasegawa Academic Policy Bureau Health Ministry Health Industry Other Industry Ministry of Economics & Industry Pharmaceutical Bureau Government

MHLW Council &Committee on Patient Safety National Council for Medical Safety Formulation of mid & long term policy & emergency measures Evaluation & advice on medical safety measures in Japan May 18, 2001 – Human Error Div. Safety of human/organizational factors Exam of measures of securing of mng’nt system June 28, 2001 – April 25, 2003 Pharmaceuticals & Medical Devices Div. of Handling of Medical Accident Info Exam of security mng’nt measures relevant to physical factors Exam of measures of handling of info on medical accident August 8, 2001 – June 10, 2003 July 29, 2002 – April 15, 2003 Standard WG Mark similarity WG Injection formal similarity WG Transfusion WG Eye Drug WG Study Group on “Near Miss” Cases Analysis of “Hiyari-hatto” cases Exam of measures for improvement Ｃ T Hasegawa NMS, Japan October 2001 – September 29, 2003 Study Group on Range of Reporting Accidents Exam of range of reporting medical accidents July 29 2003 -

History of Institutionalization of In-hospital Patient Safety by MHLW October 2002 April 2000 All hosp & University　 Hospital clinics with beds Guidelines April 2003 University　 Hospital Guidelines Committees Training →Goal Managers/ administrative dept →Organization →Awareness 2004. 10 Report Ｃ T Hasegawa NMS, Japan Report →Knowledge National Accident Reporting Patient counseling system. System

History of Patient Safety Activity in Japan 1999 Accident at One Reputable Teaching Hospital 2000 Teaching Hospital Patient Safety System Division of Patient Safety at Ministry of Health, Labor & Welfare 2001 National Council for Medical Safety Research Funding 2002 Comprehensive Strategy for Patient Safety National Complaint System 2003 Epidemiological Study on Medical Accident National Reporting System 2004 System for Analysis of Deaths Related to Medical Accident 2005 Revision of Comprehensive Strategy for Patient Safety 2002

Hospital Ranking & Benchmarking Accident Triggered the Interest in Quality T Hasegawa Ｃ NMS, Japan

3 Main Focus of New Strategy 2005 1 Quality & Safety 2 Preventive Measures based on Analysis of Reported Cases 3 Patient Participation Current 2 Hot Issue Discussed 2008 1 Third Party Investigation of Fatal Cases Related to Medical Accident 2 Nonfault Compensation for Birth Injury Ｃ T Hasegawa NMS, Japan

Historical Consequences Risk Management Many Law suits Quality Management Good Tradition Ｃ T Hasegawa NMS, Japan US Safety Management Risk Management Not Well Established Quality Management Emerging Japan

PART　3　　 Background

Average Length of Stay 1960 -2006 Days 60 Mainly Nursing Home Physician Owned Hospital Japan General Average Red Cross Acute Care Hospital Mainly Public Hospital. Public Insurance Company Physician Owned University JAPAN by ownership Australia Germany Netherlands Switzerland United Kingdom OECD country United States convergence 50 40 30 20 10 65 19 70 19 75 19 80 19 85 19 90 19 95 20 00 20 05 19 19 60 0 Ｃ T Hasegawa NMS, Japan OECD & Japanese Gov Statistic

Nursing need Change in Expectation to Hospital 20 years ago & now Shifted various intense additional tests treatment A　　　　　US 4 -5 days recovery towards selfcare US B Europe C × diagnosis outpatient testing Ｃ T Hasegawa NMS, Japan therapy hosp. labs, op. rms. therapy (contd. ) outpatient care recovery Japan rehab. facilities, long-term care facilities, home care, hotels

Percentage of the Elderly (over 65) ％ 20 Surpassing Germany and Italy in 2002 to top the world World Highest in 2004 15 USA 10 5 0 1960 Ｃ T Hasegawa NMS. Japan is now the frontrunner!! 1970 1980 1990 2000 OECD　HEATH 　DATA　２００７ Australia Austria Belgium Canada Czech Republic Denmark Finland France Germany Greece Hungary Iceland Ireland Italy Japan Korea Luxembourg

Population Estimation by age 1884 -2150 Present 14000 12000 　 Toward Super Aged Society 10000 万 8000 Peak Total 6000 4000 2000 Over 50 Over 65 Over 75 0 1880 1900 1920 1940 1960 1980 2000 2020 2040 2060 2080 2100 NMS, Japan Ｃ T Hasegawa Over 85 Over 90

PART　4　　 Past

By Dr Minami Structure of Edo Society

Root of Japanese Modern Hospitals Established in 1722 Koishikawa Hospital The Model of Akahige’s Hospital framing hospitals as a social system Ｃ T Hasegawa NMS, Japan Kazuo Minami “Social Structure of Edo”, Hanawa Shobo.

The Koishikawa Hospital and the Edo Era of the Edo Era No of Beds. Rise and Establishment Public Hospital 1722 140 Edo Government Kyoho Kansei Genroku Reform Period 120 100 Fall of the Edo Era Tempo Rule of Reform “Rule of Reform Tanuma Ogosho’s” Okitsugu 80 60 40 Bad Reputation 20 0 1600 Ｃ T Hasegawa NMS. Japan 1650 1700 1750 1820 -30 1800 1850 Kazuo Minami “Social Structure of Edo”, Hanawa Shobo. 1900

Annual Treatment Outcomes at the Koishigawa Hospital Kyoho Reform Kansei Reform Hospital Mortality 60 Study ％ Tempo Reform Meiji Restoration 50 140 years before 40 Nightingale Cure rate 30 20 Death rate 10 0 1700 Ｃ T Hasegawa NMS. Japan 1750 1800 1850 Kazuo Minami “Social Structure of Edo”, Hanawa Shobo. 1900

Treatment Outcomes by Each Physicians % Cured 1832 & 1833 internal medicine residents surgery ophthalmology 100% 90% 80% 70% 60% 50% 40% 30% 1831 -1832 20% 1832 -1833 Ｃ T Hasegawa NMS. Japan 馬場瑞伯 牧野升朔 西玄長 成田活元 塙主齢 鎌田庭雲 井上三菴 高木済菴 小川謙次郎 井上玄丹 峰岸昌菴 0% 小川太左衛門 10% 160 years ago!! Kazuo Minami “Social Structure of Edo”, Hanawa Shobo.

Complete Cure 21 Returned Home 7 No Follow-up 1 Death 8 Total 37 　 病不願全 合死揃下快 三　 　 十八一七二 七人人人十 人 一 人 Internal Medicine Dr. Inoue Gentan Ratio of Complete Cure out of Treated Patients a little more than 0. 774 Source: “Records at the Hospital” (Yojojo Kakitome), First Day of December 1831 to the Last Day of November 1832. Ｃ T Hasegawa NMS, Japan 　 　 　本 四全全道 毛快快 　 余之病井 分死上 七差玄 分引丹 七 厘

Where this spirit has gone? Ｃ T Hasegawa NIPH. Japan

Why is Japan in Recession? Productivity has not adapted to the New (Third) Industrial Structure The Services Sector and the Healthcare Industry needs the “Toyota Way” Prof. Iizuka Faculty of Engineering, Univ. of Tokyo Customer Orientation Standardization of Operations

The Big Paradigm Sift of Hospital Management From Hospital Administration World of “Maestro” “collapse of healthcare” collapse of hospitals To Strategic Management Ｃ T Hasegawa NMS, Japan “Toyota Way”

PART　4　　 Future

Leadership Infrastructure Techniques and Cases Step by Step Approach Required

2 leaders Dr Naruo Uehara National Demonstration Program Ｃ T Hasegawa 2000 -2004 NMS, Japan Dr Shuhei Iida TQM Movement with industry

ＩＴ Big Bang in 2011 s e r u ・Electric Claim of Fee t c u r t ・Outcome Information Released s a r f d e In Management Matured ・Disease h s i l b a ・ＤＰＣ（Japanese s ＤＲＧ） Expanded t E e ・Ｐ４Ｐ？ b l l i ・One Patient One Life One Chart？ W Almost Sametime Ｃ T Hasegawa NMS, Japan

Saiseikai Kumamoto Hospital TQM Center Clinical Pathway Ｃ T Hasegawa NMS, Japan Infection Control Nutrition Support Team Information Management Bed sore Control Risk Management Nerima General Hospital Iizuka Hospital etc

KYT Kikenn Yochi Training Danger Detection Training Used for Industrial Hygiene Safety Consciousness Development Group Approach Problem Solving Case Approach QC for Safety Version

Basic & Steady STEPS from 5 S to TQM Total Quality Management Integration Kaizen Leadership 1. 5 yrs RCA FMEA Quality & Safety Fit to Expectation By Six Sigma Improvement Patient, Employee & Standard Benchmarking 1. 5 yrs Productivity Improvement 1. 5 yrs Reduce Waste Good Resource Usage BPR TPM POKAYOKE JIT Organize Hospitals Work Environment Improvement Building Positive Ｃ T Hasegawa Mind Set NMS, Japan 5 S

Mapping out the roles of Risk Management and Patient Safety Hospital Risk Management Could be Conflict Clinical Risk Management Ｃ T Hasegawa NMS, Japan Safety Management Support

history & physical problem clinical examination and testing differential diagnosis definitive diagnosis Good Practice of scientific evidence consideration of treatment options discussions and agreement treatment provision of good quality care return to society Clinical Risk Management 1. Evidence-based Medicine 2. Communication 3. Mediation 4. Teamwork Ｃ 5. T Hasegawa 5. Legal Knowledge NMS, Japan Support resolution This Process

Our Future is Your Future That is Our Future Talk to you in/for 10 years

Hospital Mortality by Nightingale Very High Low Ｃ T Hasegawa NMS. Japan