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When Things Wrong - macoalition.org

RESPONDING TO ADVERSE EVENTSA consensus Statement of the Harvard HospitalsMARCH 2006 WhenThingsWronggoThe concepts and principles in this document are unanimously supported by the Harvard teaching institutions:BETH ISRAEL DEACONESS HOSPITALBRIGHAM AND WOMEN S HOSPITALCAMBRIDGE HEALTH ALLIANCECHILDREN S HOSPITALDANA-FARBER CANCER INSTITUTEFAULKNER HOSPITALJOSLIN DIABETES CENTERHARVARD VANGUARD MEDICAL ASSOCIATESMASSACHUSETTS EYE AND EAR INFIRMARYMASSACHUSETTS GENERAL HOSPITALMCLEAN HOSPITALMOUNT AUBURN HOSPITALNEWTON-WELLESLEY HOSPITALNORTH SHORE HOSPITALSPAULDING REHABILITATION HOSPITALVA BOSTON HEALTHCARE SYSTEMC opyright 2006 Massachusetts Coalition for the Prevention of Medical ErrorsAll rights reserved. All or parts of this document may be photocopied for education, not-for-profit uses. It may not be reproducedfor commercial, for-profit use in any form, by any means (electronic, mechanical, xerographic, or other).This document may be downloaded or printed copies ordered from: March 2004, responding to evidence of widevariation in the way both Harvard hospitals andhospitals nationally communicate with patientsabout errors and adverse events, a group of riskmanagers and clinicians from several Harvard teaching hospitals, the School of Public Health, and the Risk Management Foundation (MalpracticeCaptive for the Harvard Teaching Institutions)assembled to explore and discuss issues surroundingthis subjec

RESPONDING TO ADVERSE EVENTS A Consensus Statement of the Harvard Hospitals MARCH 2006 When Things goWrong

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Transcription of When Things Wrong - macoalition.org

1 RESPONDING TO ADVERSE EVENTSA consensus Statement of the Harvard HospitalsMARCH 2006 WhenThingsWronggoThe concepts and principles in this document are unanimously supported by the Harvard teaching institutions:BETH ISRAEL DEACONESS HOSPITALBRIGHAM AND WOMEN S HOSPITALCAMBRIDGE HEALTH ALLIANCECHILDREN S HOSPITALDANA-FARBER CANCER INSTITUTEFAULKNER HOSPITALJOSLIN DIABETES CENTERHARVARD VANGUARD MEDICAL ASSOCIATESMASSACHUSETTS EYE AND EAR INFIRMARYMASSACHUSETTS GENERAL HOSPITALMCLEAN HOSPITALMOUNT AUBURN HOSPITALNEWTON-WELLESLEY HOSPITALNORTH SHORE HOSPITALSPAULDING REHABILITATION HOSPITALVA BOSTON HEALTHCARE SYSTEMC opyright 2006 Massachusetts Coalition for the Prevention of Medical ErrorsAll rights reserved. All or parts of this document may be photocopied for education, not-for-profit uses. It may not be reproducedfor commercial, for-profit use in any form, by any means (electronic, mechanical, xerographic, or other).This document may be downloaded or printed copies ordered from: March 2004, responding to evidence of widevariation in the way both Harvard hospitals andhospitals nationally communicate with patientsabout errors and adverse events, a group of riskmanagers and clinicians from several Harvard teaching hospitals, the School of Public Health, and the Risk Management Foundation (MalpracticeCaptive for the Harvard Teaching Institutions)assembled to explore and discuss issues surroundingthis subject.

2 We soon agreed it would be useful to consider all aspects of an institution s response to an unanticipated event and to try to develop anevidence-based statement addressing these crucialissues. The Working Group began to meet monthlyand quickly expanded to include patients and resulting document was distributed to all of the Harvard-affiliated hospitals in April, 2005 withthe request that it be distributed widely within theinstitutions for discussion, critique and modificationas appropriate. The objective was, if possible, toproduce a consensus statement that all the Harvardhospitals and the Risk Management Foundationwould endorse, and that would serve as the foundationfor the development of specific institutional practicesand responses to the draft document were over-whelmingly positive. A number of modificationswere suggested, however, particularly in differentiatingbetween responses to preventable and unpreventableadverse events, reimbursement, and training.

3 Thepaper was then revised to incorporate these changesand recirculated to all of the hospitals. The conceptsand principles in this final document are supportedby all of the Harvard teaching hospitals, which will now use them to develop specific policies andpractices to implement the paper is organized into three major divisions:The Patient and Family Experience (Sections II IV),The Caregiver Experience (Sections V, VI), andManagement of the event (Sections VII XI). Each of the major sections is organized into three parts: A brief summary of expert consensus about the issue The reasoning and evidence behind the consensus Recommendations ForewordMEMBERS OF THE FULL DISCLOSURE WORKING GROUPJ anet Barnes, RN, JD, Director, Risk Management, Brigham & Women s HospitalMaureen Connor, RN, MPH, VP for Quality Improvement and Risk Management, Dana-Farber Cancer InstituteConnie Crowley-Ganser, RN, MS, Principal, Quality HealthCare StrategiesThomas Delbanco, MD, General Medicine and Primary Care, Beth-Israel Deaconess Medical CenterFrank Federico, BS, RPh, Director, Institute for Healthcare ImprovementArnold Freedman, MD, Medical Oncology, Dana-Farber Cancer InstituteMary Dana Gershanoff, Patient, Co-chair, Dana-Farber Adult Patient & Family Advisory CouncilRobert Hanscom, JD, Director, Loss Prevention & Patient Safety, Risk Management FoundationCyrus C.

4 Hopkins, MD, Director, Office of Quality and Safety, Massachusetts General HospitalGary Jernegan, Parent, Co-chair, Dana-Farber Pediatric Patient & Family Advisory CouncilHans Kim, MD, MPH, Medical Director, Clinical Effectiveness, Beth-Israel Deaconess Medical CenterLucian Leape, MD, Health Policy Analyst, Harvard School of Public Health, ChairDavid Roberson, MD, Program for Patient Safety and Quality, Children s HospitalJohn Ryan, JD, Attorney, Sloane & Wal, Risk Management FoundationLuke Sato, MD, Chief Medical Officer and Vice President, Risk Management FoundationFrederick Van Pelt, MD, Director, Out-of-OR Anesthesia, Brigham & Women s PATIENT AND FAMILY with the of the Patient and Care of the Patient and Family16 THE CAREGIVER of and Education18 MANAGEMENT OF THE of a Hospital Incident Policy20 VIII. Initial Response to the Event of the A: The Words for Communicating with the Patient26 Appendix B: A Case Study in Communicating with the Patient and Family26 Appendix C: Elements of Emotional Support of Caregivers 27 Appendix D: Training for Communication29 Appendix E: JCAHO Bibliography on Medical Disclosure30 REFERENCES33 MARCH 20061 ContentsINTRODUCTIONS ince the turn of this century, medical error and tort reform have increasingly taken center stage in the health care debate in the United , politicians, policy makers and health professionals grapple with the striking prevalenceand consequences of medical error, whether a near miss or resulting in patient injury.

5 Debateranges from legislating restrictions on dollar awardsin malpractice trials to ethical and moral imperativesgermane to untoward clinical incidents, whether inthe hospital or outpatient settings. Fears of malpractice liability, difficulties in commu-nicating bad news, and confusion about causationand responsibility have long impeded comprehensiveand bold initiatives designed to change the patient,family and clinician experience with medical debate and inquiry provides, however, aspecial opportunity for investigating the circumstancesthat breed errors, and for creating, deploying, andanalyzing the impact of large-scale change in the wayinstitutions address patient safety and medical error. This consensus statement examines the potentialbenefits and risks of an institutional response quitedifferent from what most hospitals choose today. Itfocuses on rapid and open disclosure and emotionalsupport to patients and families who experience serious incidents.

6 It also addresses ways to supportand educate clinicians involved in such incidentsand outlines the administrative components of acomprehensive institutional policy. The purpose of the document is to codify agreementon principles that individual hospitals will use todevelop specific institutional policies to implementthem. It does not attempt to prescribe those policiesor practices, but rather invites elaboration and awide variety of initiatives in implementation. Thegoal is to stimulate clinicians and hospitals to developtheir own clear, informed, explicit, and effectivepolicies for managing and preventing, where possible,the ongoing pain that such events its landmark 1999 report, To Err Is Human, theInstitute of Medicine (IOM) declared that medicalinjury is a major cause of preventable deaths andcalled on health care to make reduction of medicalerrors a IOM underscored the lessonfrom other industries that faulty systems are themajor cause of errors and accidents.

7 It recommendedstrongly that health care organizations greatlyincrease their efforts to promote safety throughredesign of systems. In response, a major nationalmovement has been launched to redesign healthcare a subsequent report, Crossing the Quality Chasm,the IOM proposed six aims for the redesign ofhealth care. It called on health care organizations toprovide care that is safe, effective, patient-centered,timely, efficient, and urged hospitals to work hard to place the patients interests first. It suggested that how an institution responds to an incident reflects its progress toward becoming a learning organization. Guiding PrinciplesTwo principles guide the recommendations in thisdocument for responding to incidents: medical caremust be safe, and it must be care must be safe. Hospitals must become learning organizations, defined by Peter Senge asorganizations that continually expand their capacityto create the results they truly desire.

8 3We mustcommit ourselves to relentless self-examination andcontinuous improvement. When Things go Wrong ,our obligation becomes two-fold: to intensify ourcommitment to care for the patient harmed, and to change our systems to prevent future Things GO WRONG2 Medical care must be patient-centered. In the after-math of an incident, the primary objective must be to support the patient and maintain the healingrelationship. Patients and families are entitled toknow the details of incidents and their should be open, timely, and sustained. We must eliminate the adversarial relationship that a secretive, liability-focusedapproach to patient communication fosters. Thecaregiver s role is to provide comfort and supportand to consider the full breadth of patients and collaboration are paramount. We are making a moral argument here, not a businesscase or an evidence-based clinical guideline. Wherethere are published data or empirical evidence to support a practice, we cite them, but our primaryjustification is moral.

9 We are committed to full disclosure because it is the right thing to do. Thepatient and family have the right to know what happened. In addition, honest communication promotes trust between the patient and provider, so that the primary focus of the clinician-patientrelationship remains patient care. Further, open discussion about errors can promote patient safetyby encouraging clinicians to seek systems improve-ments that minimize the likelihood of Should an Institution Respond?A serious incident should trigger a cascade ofresponses. The first concern should be to minimizefurther harm to the patient and relieve , to protect evidence, institutions should immediately secure implicated drugs, equipment,and records. Members of the health care team andappropriate administrative and clinical leadershipneed to learn of the event promptly. As soon as possible, the patient and family should learn of theevent and the facts as initially known. They willlikely need emotional and psychological support,and this should arrive seamlessly.

10 Finally, the medicalrecord should document clearly all these actions. Caregivers may also require support, depending onthe type of event. As soon as practical, all involvedparties should participate in an analysis of the event, as they search for the underlying systems failures. The goals of the analysis are to gain fullunderstanding of the circumstances involved in the event, identify contributing factors, and developpractical recommendations for systems changesdesigned to prevent recurrence. In follow-up meet-ings, appropriate staff should communicate theresults of the analysis and planned changes. In whatfollows, we consider each of these elements, focusingon how the institution and the caregivers respond. We approach these issues from the patient s point ofview, asking, What would I want if I were harmedby my treatment? While hospitals and caregiversmay have competing interests, including legitimateconcerns about legal liability, our frame of referenceis the simple question, What is the right thing to do?


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