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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.

In March 2004, responding to evidence of wide variation in the way both Harvard hospitals and hospitals nationally communicate with patients about errors and adverse events, a group of risk

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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.

2 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.

3 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.

4 A number of modificationswere suggested, however, particularly in differentiatingbetween responses to preventable and unpreventableadverse events, reimbursement, and training. 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).

5 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.

6 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. 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.

7 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.

8 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. Debateranges from legislating restrictions on dollar awardsin malpractice trials to ethical and moral imperativesgermane to untoward clinical incidents, whether inthe hospital or outpatient settings.

9 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.

10 Itfocuses on rapid and open disclosure and emotionalsupport to patients and families who experience serious incidents. 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.


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