1 Harvard Shool of Publi Health, Boston, Massahusetts, USA; 2 Institute for Healthare Improvement, Cambridge, Massahusetts, USA; 3 Ageny for Healthare Researh and Quality, Bethesda, Maryland, USA; 4 National Patient Safety Foundation, Boston, Massahusetts, USA; 5 Consumers Union, Yonkers, New York, USA; 6 Kaiser Foundation Health Plan (retired), Oakland, California, USA; 7 Vanderbilt University Medial Center, Nashville, Tennessee, USA; 8 The Joint Commission (retired), USA; 9 Aloa (retired), Pittsburgh, Pennsylvania, USA; 10 Dana-Farber Caner Institute, Boston, Massahusetts, USA Dr L L Leape, Harvard Shool of Publi Health, 677 Huntington Avenue, Boston, MA 02115, USA; leape@hsph.harvard.edu Aepted 13 Otober 2009 Transforming healthare: a safety imperative L Leape, 1 D Berwik, 1,2 C Clany, 3 J Conway, 2 P Gluk, 4 J Guest, 5 D Lawrene, 6 J Morath, 7 D O Leary, 8 P O Neill, 9 D Pinakiewiz, 4 T Isaa, 10 for the Luian Leape Institute at the National Patient Safety Foundation ABSTRACT Ten years ago, the Institute of Mediine reported alarming data on the sope and impat of medial errors in the US and alled for national efforts to address this problem. While efforts to improve patient safety have proliferated during the past deade, progress toward improvement has been frustratingly slow. Some of this lak of progress may be attributable to the persistene of a medial ethos, institutionalized in the hierarhial struture of aademi mediine and healthare organizations, that disourages teamwork and transpareny and undermines the establishment of lear systems of aountability for safe are. The Luian Leape Institute, established by the US National Patient Safety Foundation to provide vision and strategi diretion for the patient safety work, has identified five onepts as fundamental to the endeavor of ahieving meaningful improvement in healthare system safety. These five onepts are transpareny, are integration, patient/onsumer engagement, restoration of joy and meaning in work, and medial eduation reform. This paper introdues the five onepts and illustrates the meaning and impliations of eah as a omponent of a vision for healthare safety improvement. In future roundtable sessions, the Institute will further elaborate on the meaning of eah onept, identify the hallenges to implementation, and issue reommendations for poliy makers, organizations, and healthare professionals. Healthare is unsafe. In its groundbreaking report, To Err Is Human, the Institute of Mediine (IOM) estimated that, in the USA, as many as a million people were injured and 98 000 died annually as a result of medial errors. 1 Subsequent studies in multiple ountries suggest these may be underestimates. 2 5 The IOM alled in 2000 for a major national effort to redue medial errors by 50% within 5 years, 1 but progress sine has fallen far short. 6 8 Many patients ontinue to fear, justifiably, that they may be harmed when they enter a hospital. The slow progress is not for want of trying. Both publi and private organisations have initiated major programmes to develop and implement new safe praties and to train healthare workers in patient safety. 9 16 In the USA, sine 1997, the National Patient Safety Foundation has worked with stakeholder groups to advane learning and bring forward new solutions. The Ageny for Healthare Researh and Quality has invested in defining measures to assess and improve safety and to build apaity through its Patient Safety Improvement Corps. 17 The National Quality Forum has ertified safe praties ready for use. 18 The Joint Commission has required hospital ompliane with new patient safety goals. 19 The Institute for Healthare Improvement has launhed two massive national and international ampaigns 11 to inspire thousands of hospitals to adopt evidene-based safe praties. Similar advanes have ourred in many other ountries. Voluntary nongovernmental patient safety organisations have been established in Denmark, Canada, Spain, Sweden, and Switzerland. Many have onduted studies to determine the extent of medial injury, and several have developed reporting systems. 20 21 In Australia, the work of the Australian Counil on Safety and Quality ontinued when the Australian Commission of Safety and Quality in Health Care was established by the government to develop a national strategi framework and assoiated patient safety work programme. The UK has led the way in government ommitment to safety, with the establishment of the National Patient Safety Ageny under the Department of Health, and has developed a reporting system and a linial assessment servie. The department has also established and enfored performane measures. In addition, voluntary efforts, suh as the Patient Safety First ampaign, have been extensive. Liam Donaldson from the National Health Servie also led the formation of the World Alliane for Patient Safety, whih has launhed seven major programmes, inluding suessful worldwide hand hygiene and surgial 22 23 heklist ampaigns. However, these efforts have been insuffiient. As other industries have learned, safety does not depend just on measurement, praties and rules, nor does it depend on any speifi improvement methods; it depends on ahieving a ulture of trust, reporting, transpareny and disipline. For healthare organisations in every ountry, this requires major ulture hange. Too many healthare organisations fit James Reason s definition of the sik system syndrome. They are hierarhial and defiient in mutual respet, teamwork and transpareny. Blame is still a mainstay solution. Mehanisms for ensuring aountability are weak and ambiguous. Few have the apaity to learn and hange that is harateristi of the so-alled high reliability industries. 24 Most do not reognise that safety should be a preondition, not a priority. Or that fulfilling the interests of their patients in safe are and of their staffs in a safe workplae will enhane produtivity and profitability. Many physiians do not know how to be team players and regard other health workers as assistants. Outmoded hierarhial strutures inhibit 424 Qual Saf Health Care 2009;18:424 428. doi:10.1136/qsh.2009.036954 Qual Saf Health Care: first published as 10.1136/qsh.2009.036954 on 2 Deember 2009. Downloaded from http://qualitysafety.bmj.om/ on 19 July 2018 by guest. Proteted by opyright.
ollaboration and learning. Nurses are trapped in rigid organisational strutures in whih they often spend more time tending to their reords than to their patients. Often, their work environment does not permit them to realise their full potential and is unsafe beause of system vulnerabilities and leadership inattention. Too many pratitioners dotors, nurses, pharmaists, therapists, tehniians funtion in silos, fousing on their own performane and ommuniating with others in fragmented and ineffiient ways that inhibit teamwork. Patients are seldom inluded in organisational planning or in 25 26 the analysis of adverse events that have harmed them. WHAT NEEDS TO BE DONE? The Luian Leape Institute was established by the National Patient Safety Foundation to provide strategi guidane for ahieving safe healthare. Like the vast majority of safety experts, we believe that healthare entities must beome highreliability organisations that hold themselves aountable to onsistently offer safe, effetive, patient-entred are. 24 This will require all parties hospitals and their boards, dotors, nurses, pharmaists, administrators, regulators, government offiials, payers, professional soieties, and patients to move beyond the IOM reommendations for hanges in systems and to radially hange the ways in whih they think about are and how it is provided. Healthare needs not just to be improved but to be transformed. A VISION FOR TRANSFORMATION We envision a ulture that is open, transparent, supportive and ommitted to learning; where dotors, nurses and all health workers treat eah other and their patients ompetently and with respet; where the patient s interest is always paramount; and where patients and families are fully engaged in their are. We envision a ulture entred on teamwork, grounded in mission and purpose, in whih organisational managers and boards hold themselves aountable for safety and learning to improve. In a learning organisation, every voie is heard and every worker is empowered to prevent system breakdowns and orret them when they our. The ulture we envision aspires to, strives for, and ahieves unpreedented levels of safety, effetiveness, and satisfation in healthare. How do we get there? We believe that to beome safe, effetive, high reliability organisations, healthare organisations must implement five major transforming onepts. Although many other ideas and ations are needed to bring about the hanges needed in our omplex system, we believe these are the essential ore: if an organisation ahieves them all, it will be well on the way to beoming a high reliability organisation. If not, it is unlikely to sueed. The five transforming onepts are as follows: (1) transpareny must be a pratied value in everything we do; (2) are must be delivered by multidisiplinary teams working in integrated are platforms; (3) patients must beome full partners in all aspets of healthare; (4) healthare workers A vision for healthare We envision a ulture that is open, transparent, supportive and ommitted to learning; where dotors, nurses and all health workers treat eah other and their patients ompetently and with respet; where the patient s interest is always paramount; and where patients and families are fully engaged in their are. need to find joy and meaning in their work; and (5) medial eduation must be redesigned to prepare new physiians to funtion in this new environment. Eah of these onepts alls for moving thinking beyond urrent boundaries and eah implies profound behavioural hanges. We will develop these ideas further in stakeholder roundtables for eah onept that will define the hallenges in detail and make speifi reommendations to poliy makers, organisations and healthare professionals. TRANSPARENCY Transpareny the free, uninhibited sharing of information is probably the most important single attribute of a ulture of safety. In omplex, tightly oupled systems like healthare, transpareny is a preondition to safety. Its absene inhibits learning from mistakes, distorts ollegiality and erodes patient trust. Healthare leaders have been far too timid about beoming truly transparent. We urge giant steps now. Healthare organisations must beome transparent in all dimensions: among aregivers, between aregivers and patients, between organisations, and with the publi. First, aregivers need to share information openly about hazards, errors and adverse events. People annot improve systems if they annot talk about what they are experiening. Individuals must be able to report errors without fear of punishment or embarrassment. They must be onvined that the response will be, not, Who failed? but, rather, What happened? Seond, aregivers need to be open with patients when things go wrong. Unfortunately, many risk managers still oah liniians to limit what they reveal, blaming the malpratie dragon, despite examples, suh as the University of Mihigan Hospital, that have adopted extreme honesty and seen substantial dereases in the number of suits and osts. 27 We should emulate their bold example: promptly aknowledge when things go wrong, explain the auses as they are understood and apologise when patient harm omes from failures in are. Hospital leaders must fully support aregivers as they strive to be more transparent. This form of transpareny is not just a tehnial imperative, it is a moral imperative. We have neither a legal nor a moral right to withhold from patients information on harm done to them, even if that harm is aidental. Third, just as individual liniians should exhange information on injuries and hazards, so should organisations. In the aviation industry, if a hydrauli devie proves faulty in Dallas, the sun will not set before mehanis know about it in Denver and Dubai. However, in healthare, organisations hesitate to exhange lessons openly for many of the same reasons that individual staff do. To make this sharing worthwhile, healthare organisations also need to invest heavily in the analysis of those reports by experiened professionals. Five transforming onepts Transpareny Integrated are platform Consumer engagement Joy and meaning in work Medial eduation reform Original viewpoint Qual Saf Health Care 2009;18:424 428. doi:10.1136/qsh.2009.036954 425 Qual Saf Health Care: first published as 10.1136/qsh.2009.036954 on 2 Deember 2009. 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The fourth meaning of transpareny is the one that most laypeople, purhasers and regulators use: publi reporting about harmful inidents. Many organisations have hampioned publi reporting on harm, and some states are now requiring it for soalled never events. So far, healthare has addressed transpareny mainly in the form of inident-reporting systems our fourth definition. A more robust approah will serve us better: extreme transpareny of all four types: among staff, between aregivers and patients, among institutions, and in open and lear reports to the publi at large. INTEGRATED CARE PLATFORMS The integrated are platform is an organisational struture within a healthare system that enhanes quality and patient safety by bringing together aross all venues inpatient, outpatient and residential the are and the support systems required to provide evidene-based, appropriate and responsive are to patients aording to their needs (suh as various hroni diseases). 28 The purpose of the platform is to maximise effiieny, safety, quality and reliability to produe onsistently superior outomes at the lowest ost. It fosters the multidisiplinary solutions that are essential for safe management of omplex linial onditions. Distint platforms are designed for onditions that share ommon work and support requirements, suh as hroni disease are, omplex aute are, palliative and endof-life are. Every are platform must have the following harateristis: Patient entredness: personnel, failities and servies are organised to meet all patients needs effiiently and responsively; to be available when and where needed, 24/ 7; and to inlude the patient and family as partners in are. Work assignment: work is assigned to the individuals who are responsible for its ompletion. Assignments strive to maximise the performane apability of eah individual while ensuring that work is done by the least expensive qualified aregiver or multidisiplinary team at the loation most aessible to the patient. The physiian partiipates when his/her speial expertise is required and when patient expetations permit no alternative. Support: The support framework people, systems and tools (eg, tehnologies, IT, teleommuniations) is defined by the work and patient partiipation design. Community linkage: Linkages to ommunity advoay, support, and eduation groups (espeially health literay) are inorporated into the design as appropriate (eg, for patients with hroni onditions). Variation management: Ensuring quality and effiieny requires determining whether variations in proess are appropriate (ie, evidene-based). Exeption analysis assesses whether variations result from (1) adaptations to a speifi patient requirement, (2) evolution of new evidene (good), (3) lak of training in appropriate are or (4) poorly defined are pathways (bad). Transpareny: Beause are is designed and expeted variation is defined, both the output and delivery proess within a platform an be observed, measured and shared with all onerned, inluding patients. Dividing healthare needs into disease or ondition groupings and designing an integrated are platform for eah ahieves the impat laking in other integration approahes. It also plaes aountability at the appropriate level the integrated system rather than solely on the individual liniian. CONSUMER ENGAGEMENT NOTHING ABOUT ME WITHOUT ME The engagement of onsumers in are partnerships is essential to ahieve quality and safety in healthare. 25 Whether pursuing healthy living, as patients reeiving are, or as purhasers (future patients), individuals and their families must play a entral role. The guiding priniple is If health is on the table, then the patient and family must be at the table, every table, now. In 2001, the IOM report Crossing the Quality Chasm inluded patient entredness as one of the six ore aims for healthare. 29 Earlier, in 1997, the Salzburg Seminar suggested that efforts to improve are might take strikingly different shape if patients worked as full partners with aregivers to design and implement hange. The patient experiene should be nothing about me, without me. 30 The power of the involvement of patients and families is seen in their ontributions to the safety system, in reognising and responding to literay problems, in the improved management of aute and hroni diseases and in sharing experienes so that 31 32 others an learn. Despite the evidene of the effetiveness of onsumer 33 34 engagement, implementation to date has been modest. Ations are more often for than with the onsumer. Many liniians are relutant to share knowledge and are plans with patients. Analysis of safety systems and adverse events has not usually involved patients, even in areas where they have a great deal to add, suh as mediation management and transitions in are. Consumer advoay groups have not always been welomed as partiipants in organisational and ommunity poliy-setting efforts. We envisage patients as essential and respeted partners in their own are and in the design and exeution of all aspets of healthare. In this new world of healthare: Organisations publily and onsistently affirm the entrality of patient- and family-entred are. They seek out patients, listen to them, hear their stories, are open and honest with them, and take ation with them. The family is respeted as part of the are team never visitors in every area of the hospital, inluding the emergeny department and the intensive are unit. Patients share fully in deision-making and are guided on how to self-manage, partner with their liniians and develop their own are plans. They are spoken to in a way they an understand and are empowered to be in ontrol of their are. JOY AND MEANING IN WORK Caregivers annot meet the hallenge of making healthare safe unless they feel valued and find joy and meaning in their work. The evidene abounds that in the USA, many do not. In a reent survey, 60% of physiians indiated they were onsidering leaving medial pratie beause they are disouraged 35 ; a study of newly liensed registered nurses showed that 33% might seek another job within the year. 36 Among physiians, reasons inlude loss of ontrol, the malpratie liability threat and delining revenues. 37 Among nurses, lak of respet from both administrators and physiians ranks high, along with the inreasing burden of regulation and reord-keeping that separates them from patient are. For many, the transformation of healthare from a publi servie to a business in the last quarter of the 20th entury redued omplex, highly intimate are proesses to transational industrial prodution shemata, divoring work from meaning. 426 Qual Saf Health Care 2009;18:424 428. doi:10.1136/qsh.2009.036954 Qual Saf Health Care: first published as 10.1136/qsh.2009.036954 on 2 Deember 2009. Downloaded from http://qualitysafety.bmj.om/ on 19 July 2018 by guest. Proteted by opyright.
Another ause of poor morale is tolerane of disrespetful and disruptive behaviour. Sixty-two per ent of nurses reported verbal abuse as the most frequently enountered injury at work. 38 A permissive environment exaerbates the risk-prone onditions in 39 40 whih people work, demoralises workers and leads to onflit. Failure of leadership to address interpersonal ommuniation issues depletes the energy of an organisation and raises doubt about the organisation s ommitment to fairness. Although addressing some of these issues requires major national poliy hanges, it is also a fat that some healthare organisations have reated environments where morale is high and workers do find joy and meaning in their work. This strongly suggests that the auses and the remedies are loal. Creating an environment where every worker finds joy and meaning in work is a foundational leadership hallenge for a healthare organisation. What needs to be done? Capturing the soul of an organisation, where joy and meaning resides, requires a true partnership to align values among organisation leaders, professionals and the workfore. Leaders must reate the environment where it is possible for improvements to take plae. However, the rihest soure of ideas for improvement is the frontline workers. It is they who live in the omplexities of the urrent systems, have diret insights into failures and see daily opportunities for improvement. 41 These lessons an only be harvested if all members of the workfore feel valued and work together in meaningful teams. This requires that everyone is (a) treated with dignity and respet; (b) given the eduation, training, tools and enouragement they need to make a ontribution that gives meaning to their life; and () reognised and appreiated for what they do. 42 Leaders have a hoie: they an view organisations as industrial models and fous on restruturing, prodution and regulation, or they an, as we urge, view them as being omposed of people with the skills and energy to perform meaningful work, and fous on the shared vision and values that provide meaning and joy in work. REFORM OF MEDICAL EDUCATION Medial eduation needs to be restrutured to redue its almost exlusive fous on the aquisition of sientifi and linial fats and to emphasise the development of skills, behaviours and attitudes needed by pratiing physiians. These inlude the ability to manage information; understanding of the basi onepts of human interation, patient safety, healthare quality and systems theory; and possession of management, ommuniation and teamwork skills. Although a similar need exists aross all health professions, it is most ompelling in mediine beause the deisions of physiians influene the are that all other professionals provide. The prinipal onlusion of the To Err Is Human report is that the major ause of adverse events is poorly designed systems, not negligent individual performane. 1 The impliation is that physiians, managers, nurses and others should work together in teams to redesign flawed proesses to prevent harm. One reason this has not happened faster is that physiians have not been eduated to arry out this ritially important work. In the typial medial shool urriulum, little or no instrution is provided in engineering onepts appliable to systems thinking, safety siene, improvement siene, human fators, leadership or teamwork. Students obtain little experiene in examining the patient are proesses, whih onstitute the everyday pratie in the real world of healthare or experiene working with students in nursing, pharmay or other health fields. Nor do they reeive instrution in skills needed to ommuniate effetively with oworkers and patients, or how to deal with their own feelings of doubt, fear and unertainty. Yet, these are the knowledge and skills that most people onsider essential for a physiian. Over the past 5 years, the IOM, 43 the Areditation Counil for Graduate Medial Eduation 44 andtheamerianboardof Medial Speialties 45 have formulated onise sets of desired pratitioner behavioural ompetenies. These suggest that medial shools should pay greater attention to teahing onepts that underlie the behaviours for whih future physiians will be held aountable. That teahing should be undertaken in an interdisiplinary fashion and apitalise on the rapidly expanding appliations of simulation as a teahing tool. Today s medial shools are produing square pegs for our are system s round holes. This disonnet requires immediate attention, as does the need for retraining pratiing physiians, who are the students mentors and role models. CONCLUSION These transformations omprise a major ulture hange for healthare. Ahieving them will require enlightened leadership, ommitment and support from all stakeholders. However, without them, we believe progress in making healthare safe will ontinue to sputter. Competing interests: None. Original viewpoint REFERENCES 1. Kohn KT, Corrigan JM, Donaldson MS, eds. To err is human: Building a safer health system. Washington, DC: National Aademy Press, 1999. 2. 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Greiner AC, Knebel E. Health professions eduation: a bridge to quality. Washington (DC): National Aademy Press, 2003. 44. ACGME. ACGME ommon program requirements: general ompetenies. http:// www.agme.org/outome/omp/generalcompeteniesstandards21307.pdf (aessed 14 Sept 2008). 45. ABMS. ABMS maintenane of ertifiation: MOC ompetenies and riteria. http:// www.abms.org/maintenane_of_certifiation/abms_moc.aspx (aessed 14 Sept 2008). APPENDIX The Luian Leape Institute at the National Patient Safety Foundation Luian L. Leape, MD, leape@hsph.harvard.edu Chair, Luian Leape Institute at NPSF Adjunt Professor of Health Poliy Harvard Shool of Publi Health Diane C. Pinakiewiz, MBA, dpinakiewiz@npsf.org President, Luian Leape Institute at NPSF President National Patient Safety Foundation Donald M, Berwik, MD, MPP, dberwik@ihi.org President and Chief Exeutive Offier Institute for Healthare Improvement Carolyn M. Clany, MD, arolyn.lany@ahrq.hhs.gov Diretor Ageny for Healthare Researh and Quality James B. Conway, MAM, CHE, jonway@ihi.org Senior Vie President Institute for Health Care Improvement James Guest, JD, jguest@onsumer.org President Consumer Union David Lawrene, MD, dmlawrenemd@gmail.om Chairman and CEO (retired) Kaiser Foundation Health Plan and Kaiser Foundation Hospitals Julianne M. Morath, RN, BS, julie.morath@hildrensmn.org Chief Operating Offier Children s Hospitals and Clinis of Minnesota Dennis S. O Leary, MD, do leary@jointommission.org President Emeritus The Joint Commission Paul O Neill, poneillpa@aol.om Former Chairman and CEO: Aloa 72nd Seretary of the US Treasury Ex-Offiio Paul A. Gluk, MD, astrogld2@aol.om Immediate Past Chair NPSF Board of Diretors Thomas Isaa, MD, txi001@gmail.om Institute Fellow Dana-Farber Caner Institute Qual Saf Health Care: first published as 10.1136/qsh.2009.036954 on 2 Deember 2009. 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