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© 2006 AmericanSociety for HealthcareRisk Management of the American HospitalAssociationOne North FranklinChicago, IL 60606(312) 422-3980

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About ASHRM’sPearlsEach edition of theASHRM Pearls seriesincludes tips on how to minimize liabilityexposures in the subjectareas identified by thetitles. These easy-to-usepocket guides cover riskmanagement and legalissues that busy healthcare practitioners mayencounter on a day-to-day basis.

For a complete list of ASHRM Pearls, pleasevisit www.ashrm.org.

Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Foreword & IntroductionA Growing Concern in Health Care . . . . . . . .3

Current State of AffairsWhat We Have Learned . . . . . . . . . . . . . . . . .7Impact of Disclosure on Patient Safety . . . . .8Impact of Disclosure on Litigation . . . . . . . .9New Expectations . . . . . . . . . . . . . . . . . . . .11

Facing ChallengesPsychological Barriers . . . . . . . . . . . . . . . .12Legal Barriers . . . . . . . . . . . . . . . . . . . . . . .13

Managing the ProcessOne-Person Model . . . . . . . . . . . . . . . . . . .16Team Model . . . . . . . . . . . . . . . . . . . . . . . .17Train the Trainer Model . . . . . . . . . . . . . . .17Just-in-Time Coaching . . . . . . . . . . . . . . . . .18

Specific Steps for DisclosureDisclosure Triggers . . . . . . . . . . . . . . . . . . .20The Physician’s Role . . . . . . . . . . . . . . . . . .21Nuts and Bolts of Disclosure . . . . . . . . . . . .22

Disclosure TechniquesBenefits to Patients and Caregivers . . . . . . .25

Effective DisclosureAcknowledging Strengths, Weaknesses . . . .26Preparing for Disclosure . . . . . . . . . . . . . .26Initiating the Conversation . . . . . . . . . . . . .28Presenting the Facts . . . . . . . . . . . . . . . . . .29Ending the Conversation . . . . . . . . . . . . . . .29Documentation . . . . . . . . . . . . . . . . . . . . . .30

ApologyRequirements . . . . . . . . . . . . . . . . . . . . . . .31

Other ConsiderationsSubsequent Discussions . . . . . . . . . . . . . . .34Hints for Effective Communication . . . . . . .35Managing Patient/Family Emotions . . . . . . .37

References . . . . . . . . . . . . . . . . . . . . . . . . . . .39

AppendixBuilding a Disclosure Policy . . . . . . . . . . . .41Components of an Effective Policy . . . . . . .43

T A B L E O F C O N T E N T S

1Disclosure of Adverse Events

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Pearls on Disclosure of Adverse Events

A u t h o r

Geri Amori, Ph.D., ARM, CPHRM, DFASHRMThe Risk Management & Patient Safety InstituteShelburne, VT

2 0 0 6 P e a r l s Ta s k F o r c e

Kathryn Wire, JD, MBAChairKathryn Wire Risk StrategiesSt. Louis

Rose Braz, RNC, FASHRM, DFASHRMWyoming Medical CenterCasper, WY

Gregory Henry, MD, ACEPMedical Practice Risk Assessment, Inc.Ann Arbor, MI

Kathleen Knoppe, RN, ARM, FASHRM, CPHRMJohn H. Stroger, Jr. Hospital of Cook CountyChicago

Arlene Taylor, MS, Ph.D.St. Helena HospitalSt. Helena, CA

Sue Wedemeyer, RN, BSN, MBACatholic Health InitiativesErlanger, KY

Lynn Worley, RN, JD, CENBoston Medical CenterBoston

Douglas Borg, MHA, ARM, CPHRMASHRM board liaisonDuke University Medical Center and Health SystemDurham, NC

Foreword

T he importance of effective disclosure ofmedical events must not be understated. It is characterized by a culture of safety

and defined by trust, respect for human rights andforgiveness. It is enabled by ongoing and transparentcommunication with patients and families.

The following pages represent the work of theAmerican Society for Healthcare Risk Managementsince 2001 to identify emerging practices for dis-closure. We invite you – the risk manager, patientsafety officer, clinician, administrator, trustee,underwriter or policy expert – to share this documentwith your patient safety team, keeping in mind thatpatients and family members also are on the team.

We believe that Risk Management Pearls onDisclosure of Adverse Events – by describing orga-nizational scenarios and strategies for implementingand enhancing the communication of disclosure inyour organization – will further inform and facilitatethe dialogue around the practice of disclosure anddraw us all toward ASHRM’s vision of “safe andtrusted health care.”

This vision is grounded in our patients’ perspectives,as presented during the December 2005 Institutefor Healthcare Improvement Forum “Reflections of Patient and Family Voices”:

Patient Expectations: 100 Percent of the Time• To be listened to, taken seriously and respected

as a care partner

• To be told the truth – always

• To have my care timely and impeccably documented

• To be supported emotionally as well as physically

• To receive high quality, safe care

Your colleagues in safety,

Peggy Martin Jim Conway2006 President, ASHRM Senior Fellow, IHI

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Foreword

Disclosure of Adverse Events

Introduction

T he disclosure of adverse events, or unan-ticipated outcomes, is an evolving processin health care. Issues center on when,

how and what to say during disclosure.

This booklet does not address the legal considerationssurrounding disclosure, which should be part of eachfacility’s planning process based on local law andpractice. Rather, it is designed to help health careproviders understand the regulatory background ofdisclosure and the interpersonal concerns it raises.

A Growing Concern in Health Care“Disclosure” has been part of health care for manyyears. Physicians and other health care providersdisclose daily. They share information about diag-noses, prognoses or complications of treatment.

However, physicians have long debated the extent towhich devastating prognostic information should berevealed. Once malpractice liability first became aparticular concern in the late 1970s, the decisionwhether to disclose unanticipated treatment outcomes,especially when there was possible error and thereforelitigation potential, was pre-empted by legal consid-erations and emphasis on evidentiary protection.

Nevertheless, professional organizations have longpromulgated ethical statements that required fulldisclosure of outcomes and the providers’ role inthem.(1)

Joint Commission Standard amplifies debateIn 2001, Standard RI.1.2.2 of the Joint Commissionon Accreditation of Healthcare Organizations (JCAHO)required accredited facilities to establish a processfor the disclosure of unanticipated outcomes of care.This new standard amplified the debate about theroles of patients and providers in a new, patient- andfamily-focused health care world, forcing providersto re-think their former responses. Accreditedhealth care organizations were suddenly requiredto be forthcoming about information often viewed

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as potentially damaging. Now compelled to disclose,health care providers are learning that the practicemay be less detrimental to malpractice outcomes thanpredicted and that it may be beneficial to reasonableclaim management efforts. In spite of earlier fears,experience is demonstrating that disclosure actuallymay be viewed favorably by jurors and the community.(2, 3)

Unfortunately, the infrastructures that respond to suchhonesty are not changing so quickly. The legal systemstill functions in a punitive mindset. Licensure andprofessional boards still hold individuals, not systems,accountable for error. The availability of emotionalsupport for those involved in treatment gone awryhas lagged the need. Insurance companies andclaims committees may respond slowly with thefinancial follow-up to a smooth disclosure.

Concerns remain about the legal damage that canresult from a poorly conducted disclosure discussion.Providers (and their attorneys) fear that hearsay maybecome “fact” by virtue of thoughtless comment orpatient misunderstanding. Apology may be misinter-preted as culpability. Discloser discomfort may beinterpreted as dishonesty. Fortunately, careful education,process development and training can overcomethese concerns.

The purpose of disclosureHealth care providers must focus on the overridingpurpose of disclosure: to provide patients and familiescomplete information about their care. Appropriatetreatment decisions and planning require this levelof honest communication. The decision to discloseshouldn’t revolve around efforts to avert litigation,but rather around the shared goal of providingpatients and families information needed to makedecisions about next actions.

This educational booklet is intended to help providersdisclose in ways that provide the most effectivecommunication with the least risk, based on researchabout techniques for effective communication withpatients and families.

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Current State of Affairs

What We Have Learned

A search of the literature on disclosurefrom the release of the Institute ofMedicine (IOM) report in December

1999, “To Err Is Human: Building a Safer HealthSystem,” to the present reveals more than 450 published articles related to disclosure, apologyand the impact of disclosure on litigation.

Most of the literature reiterates what has beenassumed intuitively and established by earlyresearch: Patients want to know what has happenedduring care. They want the health care entity andtheir providers to assume responsibility for errors.Patients and their families want an explanation,apology, and assurance that the health care organi-zation is making steps to assure that system problemsare addressed so that their suffering is acknowledgedand not taken lightly.(4)

But it’s not that easy. Legal constraints and human fear inhibit the transparent discussion of adverse/unanticipated events. Moreover, the nature of medical care which complicates the discernment of error from outcome renders discussion a delicateand tricky matter.

Need for provider support, tooHealth care providers live in a very stressful envi-ronment, with huge personal responsibility and theconstant threat of burnout.(5, 6) After an event, anyprovider is devastated, often feeling as much painand anguish as the family or patient. Support systemsare notably absent. Providers refrain from talkingabout their involvement in an untoward eventbecause of fear of judgment, being ostracized orbeing considered incompetent.(7) Consequently,there is a second “victim” of the event in need ofguidance and support.

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Resources are appearing to meet that need for support.A multitude of articles, books, videos and trainingprograms have emerged that approach this delicateissue. Furthermore, organizations such as MedicallyInduced Trauma Support Services (www.mitss.org)and Consumers Advancing Patient Safety(www.patientsafety.org) have come forward to supportproviders as well as patients. Other organizations suchas the Sorry Works! Coalition (www.sorryworks.net)have been formed to encourage change in legislationsuch that apology and transparency are supported andrewarded instead of punished by the legal system.

Impact of Disclosure on Patient SafetySafety science and aviation industry models show thathealth care providers can prevent the re-occurrenceof system breakdown only through evaluating thefull range of latent failures that led to the ultimateoutcome.(8) To move health care from a “craft” toa science, the focus should be on becoming “highreliability organizations,” preoccupied with failure andits prevention.(9) This ideal can be achieved only inan environment of transparency and open dialogueabout misadventures.

Roles in root cause analysesDisclosure of adverse/unanticipated events topatients and families includes them in the discus-sion of system failure. It makes them partners inefforts to improve care. Furthermore, when they areincluded in a root cause analysis (RCA) or otherevaluation of the process, they are engaged in thepatient safety process.

The patient safety movement is predicated upon theconcept that errors occur in complex systems andthat information must be received from all parts ofthe system in order to avoid error and to correctlatent system failures.(10) Initiatives such as TheASHRM Foundation’s Patient Safety Toolkit(www.ashrmfoundation.org) and JCAHO’s Speak UpInitiative (www.jcaho.org) are designed to teachpatients and families how to be advocates and partners.Nonetheless, the best-designed programs are doomedto failure unless both parties to the communicationare willing and able to trust the other to be honestand forthright with information.

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Although many organizations maintain that the resultsof an RCA should be protected for quality assuranceand peer review purposes, other organizations haveopened up the RCA process for inclusion of familymembers. Others have openly shared their findingswith families in an effort to communicate the orga-nization’s sincere efforts to assure the same injurywill not re-occur to another patient.

The seminal Vincent study (1994)(11) implied thatpatients and families not only wanted an explanationfor their own knowledge, but also wanted assurancesthat the same mistake would not be experienced byanother patient. This leads to the question: What isthe best way to prevent liability, if by including thepatient and family we satisfy their deep-seateddesire for involvement and improvement?

The ramifications of sharing the results of the RCA aresubject to state laws. If sharing would jeopardizethe confidentiality or privilege attached to the entirequality assurance process, then the organizationshould make steps to communicate key findingswith the persons involved.

Impact of Disclosure on LitigationHealth care is fraught with a history of distrustbetween providers and patients/families they serve,reinforced by the notion of medical authority.(12)The legal system has exacerbated this tension throughlitigation procedures. Plaintiff’s attorneys are quick tosay that fear of conspiracy or cover up is a primarymotivator for families to seek legal counsel after anunanticipated event.

This journey of transparency and disclosure is stillnew. Few completed studies accurately measure theimpact of disclosure and transparency on litigation.The evolution of an event to a claim and suit withits commensurate litigation lag is long. In addition,the number of people who are adequately trainedto lead an effective disclosure is still small, althoughit is growing. There simply is not a sufficient amountof data to make long-term predictions about theeffect of disclosure on litigation at this time.

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A few things are known:

• The Lexington, KY, Veterans AdministrationHospital made significant changes in its approachto communicating with patients and familiesabout unanticipated events when risk managerssaw their claims activity rising. The hospitalbegan to offer full and spontaneous disclosureof all relevant information. Thereafter, the claimvolume remained consistent with other similarVA facilities, while the total indemnity paymentsdid not increase. Lexington apparently substan-tially reduced the defense costs associated withits claims. The Lexington protocol is now therule in all VA hospitals.(13)

• A mock trial of a 2002 suit that resulted in amulti-million dollar judgment in favor of theplaintiff was conducted before two juries, oneincluding disclosure, the other without disclosure.The disclosure trial yielded a judgment millionsof dollars smaller than the original award to theplaintiff. The jury de-briefing revealed that wherethere was no disclosure, the jury assumed theorganization was hiding information. In the trialinvolving disclosure, the jury process was lessadversarial to the hospital. The jury expectedhonesty and therefore centered the discussion on the actual needs of the plaintiff and not onhow much money was required to punish theorganization.(14)

• A more recent study reviewed the literature on theimpact of disclosure on litigation. It found that:

-- Disclosure did not necessarily reducethe likelihood of litigation.

-- Where litigation was pursued, the discloser was seen more favorably than the non-discloser,resulting in lower awards.(15)

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New ExpectationsDisclosure has become expected behavior for thehealth care system. With the JCAHO standard andgrowing public awareness, people within and outsidethe system expect that adverse/unanticipated eventsshould be disclosed to patients and families. Thismoves health care away from the “medical authority”model where the physician is expected to have all theanswers, to a “system authority” model where thephysician is part of a group of people who provideservices in an effort to restore health and provide safe,humane care. In this new model, the expectationsfor disclosure have grown from simple adherence toa standard to a new height of personal commitmentand compliance.

Expectations in this new environment include:

• Disclosure is the normative expectation forbehavior, not the exception, in the minds ofpatients and families.

• Disclosure goes beyond legal compliance to fullymeet ethical requirements. The culture in theUnited States values autonomy, or the right todirect what is done to one’s person. Individualshave the right to know what has happened thatwas not within their control.

• If a party has been injured at the hands of anotherand compensation is appropriate, patients/familiesexpect that remuneration to be forthcoming.Increasingly, patients and families are heard tosay that the goal is not litigation, but appropriateacceptance of responsibility and appropriateremuneration.

• Disclosure can reduce the severity, and possiblythe frequency of litigation, although that is notits primary goal.

• Disclosure is both a process (technique) and art(interpersonal communication skill). Patientsand families recognize the difference betweensincere and insincere communication.

• The future of patient safety as a pervasive culturalinfluence is contingent on transparent commu-nication and disclosure. Without open commu-nication with patients and families, errors willcontinue to be hidden and impede the fullexploration and evaluation of error components.

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Facing Challenges

T he barriers to disclosure fall into two primary areas: psychological and legal.Although both are important, the psycho-

logical barriers are more entrenched in the individualand are more difficult to address. The legal barriers,although genuine and important, are often theexcuse to avoid disclosure. Both come into play inorganizations’ struggles to improve the culture ofsafety. When both are addressed, the culture oftransparency can move forward.

Psychological BarriersPsychological barriers to disclosure are the strongerof the two. They are no different from barriers toany other difficult communication that involves badnews. Physicians and other providers have difficultydeciding what to say to patients and families, howmuch to disclose and when to disclose. Psychologicalbarriers may include:

• Fear of retribution from the recipient of the news.“Will the recipient try to punish or harm me?”

• Fear of retribution from colleagues or peers.“Will I be ostracized or otherwise criticized formy involvement in the unanticipated event, or formy action as part of the disclosure discussion?”

• Fear of conducting the conversation poorly. “Whatif I upset the patient or family if I don’t conveythe information effectively? Will the hospital beangry with me for communicating ineffectively?”

• Fear of having to handle the recipient’s as well astheir own emotions.“What if the patient or familymember cries, becomes angry or threatens me?”

• Belief that the disclosure is unnecessary. “If wedidn’t tell the family, they would never know thishad happened.”


Facing Challenges

• Belief that disclosure is primarily a factual conversation and not a complex interpersonalconversation. “If I just state the facts, haven’t I disclosed adequately?”

• Belief that the outcome is not related to action onthe part of the discloser. “If I were not directlyinvolved in the event leading to the outcome, whyshould I be involved in disclosing the outcome?”

• Belief that the outcome would potentially haveoccurred without the error or intervention.“What difference would it make? The patientmight have had the outcome anyway. He/She was very old and/or sick.”

Legal BarriersLegal barriers to disclosure are a moving targetwith a history. Unfortunately, the legal system in the United States is entrenched in a culture of blameand punitive approaches. After decades of litigation-phobia, health care providers are finding thatresponses based on relationship rather than fear of litigation may be the best. In other words, the“legal” barriers to disclosure are based on ourfears, not necessarily on the law.

The system rewards itself (attorneys) through paymentbased upon how much time is spent on a claim, orwith a piece of the take (plaintiff’s counsel). In neithercase does the reward depend on the benefit to theparties.

Additionally, the legal system is based upon a systemof discovery that relies on the protection of infor-mation as a tool for defense. When providers begansearching for a risk management and loss controlmodel 30 years ago, they turned to their defenselawyers for advice. Health care organizationsarguably learned how to defend cases, but learnedvery little about preventing litigation in the firstplace. That history has generated some unfortunateperceptions among health care providers about theimpact of their actions after an incident.


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The following fears have overtaken the managementof events:

• Fear: There is no legal protection for any informationprovided during the disclosure of a medicalerror.

Reality: It is true that information we share withthe patient will be admissible.

• Fear: Information about the disclosure in themedical record may be used in court.

Reality: It is true that information in the medicalrecord is admissible.

• Fear: Disclosure increases our risk if there is a suit.

Reality: This is not clear. Simply because infor-mation is admissible does not mean that it willbe either used against us or perceived by thejury as indicative of guilt or greater culpability.In fact, the failure to disclose information thatlater becomes known is much riskier.

• Fear: An apology is an admission of guilt; therefore you automatically lose a lawsuit.

Reality: An apology is simply an expression ofemotion, not a legal conclusion. It may or maynot support a factual determination of negligence,but the apology cannot alter the facts.

Though there are no real studies of the issue, anec-dotal evidence is quickly mounting that most juriesfind an apology and full disclosure the most humaneapproach and that they may actually help the defenseof a suit. Unless the defense is based on differentfacts than those disclosed (a separate problem),dealing with the facts in an open and honest mannergenerally helps the defense.(16)

Because so many providers fear apology, some stateshave enacted statutes that prohibit the use of anapology as evidence of guilt, or prohibit its intro-duction into evidence. In 2006, SorryWorks reportedthat 18 states have law governing the use apologiesin trial. In most states, the laws protect apologies ofsympathy, but not apologies of responsibility. A personcould apologize that the plaintiff had been harmed,but would not be protected if the apology includedan admission responsibility for the harm.


More recent statutes (for example, Colorado RevisedStatutes Title 13, Article 25) may protect somestatements of responsibility or fault. Organizationssuch as SorryWorks are lobbying to get as many statesas possible to support legislation like Colorado’s.

States With Apology Laws

Arizona

California

Colorado

Florida

Georgia

Illinois

Maryland

Massachusetts

Montana

North Carolina

Ohio

Oklahoma

Oregon

Texas

Virginia

Washington

West Virginia

Vermont has no apology statute; however, case law provides immunity for a doctor’s apology.

Source: SorryWorks, 2006

Facing Challenges

Managing the Process

E very organization has a unique cultureand a unique path to addressing the issuesin patient safety and disclosure. Needs and

available resources vary dramatically. No one modelfor disclosure will satisfy all facilities’ needs; four arepresented here, together with a discussion of theirbenefits and drawbacks. Generally, other activitieswill be concurrent with the disclosure process. Forexample, if there is likely liability, the facility and itscarrier should be evaluating necessary settlementauthority and the best person to present the financialposition.

In deciding on a model, a facility should evaluate theneed for staff to also participate in quality activities,the role and identity of malpractice claims contactsand the realistic time commitment various staffmembers can make to the process.

One-Person Model• Description: The organization designates one

person as the anchor for all disclosure commu-nication.

• Benefit: The organization can assure itself thatthe designated person can be trained to have thecommunication skills for effective disclosure.

• Drawback: Anything that happens to that personleaves the organization in a state of jeopardy.Furthermore, this model does not move theorganization forward to having all communicationwith patients/families be transparent and all clinicians skilled at breaking bad news. If therisk manager is appointed, it will be difficult toseparate the clinical disclosure discussion, withits emphasis on complete openness, from anylater discussion of compensation in which thefacility may have to take a more rigid position.This is less of a concern if the facility’s carrierwill provide the negotiator for the “money” discussion.

• Typical fit: A small organization.


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Team Model• Description: This approach involves intense

training of a select group of individuals in theeffective disclosure skills and the communicationpolicies of the organization. They are likely to befrom a variety of services and known for theirinterpersonal skills. Subsequent to training,team members are assigned to coach physicians/clinicians or staff and accompany them in disclosure discussions.

• Benefits: The organization can be assured thateffective communicators are involved in everydisclosure discussion. The team shares respon-sibility for participation and coaching of disclosurecommunication so the best “fit” for any situationcan be selected to participate in that discussion.

• Drawback: Health care staff may be divertedfrom daily responsibilities to participate in a disclosure discussion. That diversion could be a burden.

• Typical fit: A small- to medium-sized organization.

Train the Trainer Model• Description: The organization invests in the

comprehensive training of a large group ofphysicians and other staff. The trained individualstrain a certain number of people in the organi-zation each year. They become more comfortablein the concepts of disclosure. In addition, theybecome mentors and role models.

• Benefits: This model uses individuals throughoutthe organization, including physicians and clinicians,to spread the skills and the philosophy of honestcommunication through the organization. Inaddition, it provides an economical way to ensurethat all staff and employees are introduced to theconcepts of honest communication with patients.

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• Drawbacks: Quality control and distribution ofresponsibility are the main drawbacks. Thismodel must include a single individual who isultimately responsible to ensure that the trainersare training at the level expected and that trainingopportunities are scheduled throughout theorganization.

• Typical fit: Large- to medium-sized organizationswith several campuses might find this methodthe most efficient and effective for consistenteducation. In addition, this method could beeffective to generate physician/clinician buy-in if respected members of the medical staff aretrainers.

Just-in-Time Coaching• Description: The individual practitioner at the

site of the event discloses what is known at thetime. The discloser may be a nurse, attendingphysician or other practitioner with whom thepatient has a relationship depending upon thesignificance of the event and seriousness of theoutcome. There generally is an in-house coach,frequently the risk manager, with whom practi-tioners can discuss the disclosure prior to thediscussion.

• Benefits: It is direct and easy. It places theresponsibility for effective communication skillsat the point of care. It is the ultimate in maturepatient/family partnering.

• Drawbacks: This model is dependent upon theskill of the individuals at the point of care.Where there is the potential to lay blame or failto support the organization’s improvementefforts, or where communication skills areinsufficiently empathetic, this model can resultin less effective patient/family partnering.

• Typical fit: Any organization that is mature in itspatient safety and transparency culture coulduse this approach. By the time the organizationhas passed through the various stages of culturalmaturation, the staff and physicians/ clinicianswill be knowledgeable of their own strengthsand shortcomings and will know when and howto seek coaching.

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Risk Management Strategies

Determining a Model

Evaluate the organization’s resources:

• Individuals in the organization who could betrained.

• Number of patients being treated/events reported.

• Number of clinicians needing support.

• Nature of support among departments.

• Nature of physician willingness to accept support.

• Which model could provide the most consistent,quick response and effective support given theorganization’s culture and volume of care.

Decide upon a measurement plan and periodicallyre-evaluate the efficacy of the model to meet theorganization’s specific needs in one year.

Managing theProcess


Specific Steps for Disclosure

T he practical discussion that started withthe release of the JCAHO standard in 2001continues today. What and when should

patients be told about their care? Who tells them?How should the process work?

Disclosure TriggersWhat sort of event should trigger a disclosure process?The JCAHO standard explains that disclosure isappropriate when an outcome differs significantlyfrom the anticipated outcome. Technically, this doesnot involve error, nor does it necessarily involveharm to the patient. The standard and its relatedexplanations do not indicate if the standard isobjective, or subjective to the patient.

Some hospitals disclose if there has been harm, whichthey may define as a condition requiring furthertreatment, treatment to reverse an inadvertent treat-ment, additional days of hospitalization or permanentinjury or death. This definition may comfort healthcare providers because it significantly limits theconditions under which disclosure is required.However, it is not part of the JCAHO standard.

Other hospitals, in an effort to be transparent andinclusive, define “harm” as anything the patient orfamily might consider harmful. Furthermore,“unanticipated” is anything the patient or familymight not have anticipated. This covers a wide rangeof conditions and situations, but is more likely toprovide for a disclosure discussion and the resultingclosure in situations when the patient/family subjectivelyhas encountered an unanticipated situation.

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The Physician’s RoleThe attending physician’s required involvement inthe disclosure generates a debate with many facets.Many physicians believe they are jeopardizing theirown legal status if they disclose an error that is not oftheir doing. Other physicians lack the interpersonalskills to disclose effectively. Some physicians refuseto disclose believing that the JCAHO standard appliesto organizations and not individuals. Each of thesearguments has apparent validity, but each is false.

Argument 1: A physician who discloses an error notof his/her doing may be psychologically associatinghimself with the error in the eyes of the patient/family and could increase the likelihood that he is named in a suit.

Fact: An angry patient/family is likely to sue becauseof the injury if they feel they have not been educatedand respected or if they have damages requiringremuneration. If a suit is filed, the physician is likelyto be named regardless of whether he/she was thediscloser. If anything, the literature shows that theprovider who discloses is more likely to be viewedfavorably.(17)

Argument 2: The attending does not have theskills to disclose effectively therefore he/she shouldnot be a participant in the disclosure discussion.

Fact: A physician who is an ineffective communicatorshould not be the leader in a disclosure discussion.Nonetheless, the attending should be present at themeeting to answer any questions about future careraised by the patient/family. In addition, the attendingis the person the patient/family considers theircaregiver, not the hospital. Their absence from themeeting sends a far louder message than their silentor limited participation in the discussion.



Argument 3: The JCAHO standard applies to theorganization, not the attending.

Fact: The standard suggests that a licensed independentpractitioner provide the information, implying thata person with a high level of medical informationshould be involved. Furthermore, the physician is governed by the medical staff by-laws, many ofwhich now require the attending to participate inthe disclosure of unanticipated outcomes.

Although the debate continues, in an ideal world,providers would feel comfortable discussing the fullrange of potential errors to actual errors with patientsand families. This would increase the co-responsibilityfor collaborative care and involve patients and familiesin their own safety.

Nuts and Bolts of Disclosure

Responsibilities and caution

1. Designate personnel roles. Who is expected to be contacted prior to a disclosure conversation,and who is expected to participate in the discussionitself? Who is investigating the facts?

2. Suggested conversation outline. Each situation isunique and requires preparation. All participantsshould invest time preparing, including anticipationof the patient/family’s reactions and questions. Ifthere are unanswered questions about the situation,then plan for several conversations as facts aredeveloped. Generally, the discussion should include:

• Objective statement of what happened (withoutspeculation as to causes)

• Clear, honest communication of regret

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• Discussion of change in the patient’s care plan(if any)

• Steps taken to take care of the patient (if appropriate)

• Identification of steps taken to prevent re-occurrence

• Identification of whom the family will hear from next or next steps they have to take

• Offer of appropriate support services topatient/family

3. Accommodations for special communication or cultural needs. Are there language, disability orhealth literacy needs that require interpreters, signersor other communication support? Some patientsand families would be more upset and harmed byknowledge of the root cause findings – family ethnic,cultural and psychological needs have to be takeninto consideration.

4. Support services available to the patient. Whenpossible, support should be made available imme-diately. There will be future support needs andpatients/families should be given information about that support.

5. Steps for follow-up conversations. It is not enoughto say “Here’s my card. Call me with questions.”Patients and families may interpret that as emptyinvitation. It is more effective to both give a cardand ensure a follow-up call is made to them withinan agreed upon timeframe. In addition, the doorshould be left open for questions that come up inthe interim.

6. Documentation of the conversation. The keycomponents of the conversation should be includedin the medical record, as would any family meetingor key patient discussion. The key elements of thediscussion listed above, including what happened,changes in care, apology, identification of nextsteps and offer of services should be documented.(See documentaion tips on Page 30.)


7. Planning for subsequent meetings. Many times,the initial disclosure meeting is simply the meetingwhere events are revealed and sorrow is expressed.Often there will be a need for second or even athird meeting. Once the full weight of the event isgrasped, the patient/family will experience expectedand acceptable anger. At the same time, they willidentify genuine needs. The steps for conflict resolution should be delineated not only for patientrelations and possible claim management, but alsoin accordance with the Centers for Medicare &Medicaid Services Conditions of Participation (CMS CoPs).

8. Circumstances where disclosure may not beappropriate. Where the harm of disclosure outweighsthe benefit, a decision may be made to defer theconversation. Those occasions are rare. Documentationof this decision including the rationale is essential.


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DisclosureTechniques

Disclosure Techniques

W hat makes disclosure effective? In theearly days of the disclosure journey,people believed that an effective

disclosure averted litigation while an ineffective disclosure resulted in litigation anyway. It is nowknown that a claim or litigation may follow aneffective disclosure because of the anger or genuineneed of the aggrieved parties.

An effective disclosure provides the patient/familywith the information they need about the patient’scare outcome, allowing them to make decisions aboutappropriate next steps including the possibility ofseeking appropriate compensation. It leaves themfeeling respected, included and cared about.

An ineffective disclosure may include the sameobjective information. However, at the close of anineffective disclosure, the patient/family may feeltheir views and values have not been respected, that they have not been provided the information in a way that is understandable and usable, and that their anger has been exacerbated because ofthe manner in which the information is delivered.

Benefits to Patients and CaregiversEffective disclosure provides patients/families theopportunity to:

• Get information needed to make next decisions,including the possibility of pursuing litigation.

• Directly deal with issues of distrust through inter-action with those whom they trusted.

• Directly deal with anger through direct interactionwith those who are part of the injury, thus initiatingthe healing process.

Effective disclosure also provides clinicians and theorganization the opportunity to:

• Build trust, communicate openly and demonstratea patient/family-centered philosophy.

• Heal psychologically.

• Learn and improve systems so that mistakes arenot repeated.


Effective Disclosure

C onducting an effective disclosure discussionis a multi-faceted activity. Part of the skillinvolves a thorough understanding of the

mechanics of disclosure. How to prepare, what tosay and what to document are process techniquesthat are easily understood and learned.

The other skills for effective disclosure are theinterpersonal skills of communication. Thoseinclude initiating the conversation, ending the conversation and conducting the conversation so it supports rather than diminishes the relationshipbetween the clinician and the patient/family.

Acknowledging Strengths, WeaknessesAs with any skill-based activity, each person will bestronger in some areas and weaker in others. Potentialparticipants must determine where their strengthsand weaknesses lie. Once an area ripe for furtherdevelopment is identified, the organization shouldsupport further training to improve skill levels ofthose who will be involved in disclosure discussions.

Because some staff members and physicians haveinnate talent for the process, the facility shouldencourage involvement of those individuals astrainers and in the disclosure conversations.Similarly, if a physician lacks talent for interpersonalcommunication, he/she should consider bringing ina trained partner from the practice, possibly alongwith a higher level manager. It is counter-productiveto force people into their weakest roles.

Preparing for DisclosurePreparation is an important component of disclosure.Although circumstances may limit time for prepara-tion, certain steps should always be taken to ensurethe discloser enters the meeting ready for the types ofquestions and issues that may arise. Furthermore,proper preparation reduces the likelihood that theinformation given is inaccurate or based uponassumptions rather than knowledge. Information

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Effective Disclosure

provided during a disclosure discussion becomesfact in the mind of the patient/family. There is littleroom for recovery from a mistake, especially onethat affects credibility.

The following are components of a thorough preparation:

1. Review the facts

• What is certain at this point?

• What do we know about causal factors?

• What are the outcomes of the treatment (injury,death, nothing permanent)?

• What further steps are being taken or recom-mended to care for the patient?

• What are the anticipated results of that treat-ment/intervention?

• When will we know more?

2. Identify appropriate participants

• Family members (if appropriate).

• Attending physician (although the attending maynot conduct the meeting, he/she should be thereto answer questions about care).

• Because the initial disclosure meeting often conveys the first information of injury, the riskmanager's presence may convey a wrong messageabout the meeting's purpose. After the adverseevent is explained, the risk manager can beintroduced to address patient/family needsand/or financial expectations. The facility shouldbalance this concern against potential advantagesof including the risk manager from the start,including his/her communication skill level.

• However, the risk manager can assist in thepreparation and subsequent support of theprovider and patient. It’s advisable to notify therisk manager in the event of disclosure, eitherbefore or immediately following.

3. Select an appropriate setting that is neutral,quiet, comfortable and free from interruptions.


Initiating the ConversationPeople tend to remember clearly the beginning andend of experiences, so it is essential that the disclosuremeeting be conducted from beginning to end in a veryempathetic, humane manner – reflective of genuineconcern and sorrow about what has happened.

When initiating a disclosure discussion:

• Ensure that participants from the organizationare aware of and sensitive to HIPAA PrivacyRules (www.hhs.gov/ocr/hipaa) and the desireof the patient.

• Assess the patient/family’s readiness to partici-pate in the conversation:

-- Are they impaired by medication?

-- Are they too distraught?

• Assess the patient/family’s general level of healthliteracy:

-- Look for signs of lack of understanding (terminology used, questions asked, the absenceof questions, seeming to agree too readily).

-- Recognize that patients/families will oftenuse terms that sound familiar from TV yet havelimited understanding. This can lead the clinicianto assume information is being understood whenit is not.

-- Use simple, plain language. Avoid usingmedical terms except where absolutely necessary.(Example: “The test results were negative”implies to some people that they were bad.Instead: “The test didn’t find anything out of the ordinary.”)

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Disclosure

Presenting the FactsThis is the core of disclosure.

• Describe simply, in plain language, what happenedand the outcome.

• Describe simply, in plain language, the next steps:

-- What was done immediately for the patient.-- What is being done now.-- Changes in the treatment plan.-- What the organization is doing to ensure

this does not happen again.

• Apologize when appropriate (See apology discussion on Page 31.)

Ending the Conversation• Summarize the facts simply.

• Repeat key questions asked.

• Describe follow up plans. Ensure that promises arekept. Remember: The trust of patients/familiesinvolved in these conversations has been shattered.A promise broken, no matter how small, willseriously impede the chances of salvaging thepatient/family relationship. Clearly state: -- From whom will the patient/family hear next.-- When will they hear.-- Anything they are expected to do themselves.-- A plan for following up with them to address

questions.

-- An invitation to contact you with questions(along with your card and a handwritten note or comment about contacting you written on it).If the discloser is not the appropriate person for follow-up, then the name and number of thatperson should be given along with informationabout when that person will contact the family.

• Offer support (spiritual services, family services,grief counseling, a place to stay, food, etc.).

• Repeat expressions of support, sympathy andconcern. Sincere humility and empathy are keysto effectively ending a conversation.


DocumentationDocumentation is vital to the disclosure process. It should describe the key components of the discussion, including:

• The facts given, including outcomes of the eventand changes in treatment course.

• The key questions asked and answers given.

• Next steps.

• Services offered and accepted.

• The apology.

Documentation will become evidence should litigationoccur so it is essential that the writing be factual,concise and professional. The entry will create animpression of how the disclosure discussion washandled, therefore opinions about causality notbased in fact and emotional reactions to the eventor the patient/family should not be included.

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Apology

A pology is a sincere expression of regret.The specific words used are less importantthan their sincerity. Nonetheless, in our

society, the words “I’m sorry” spoken truly and withaccountability delineate whether an apology hasoccurred. Furthermore, although health care leadershave long taught that an apology can be focused onthe patient/family experience and not on assumingresponsibility for the experience, recent argumentsare challenging that position, indicating that a “non-accountable” apology may do more harm thangood.(18)

When is apology appropriate?In health care it can be difficult to know when anapology is in order. Do we know if we have betrayedpatient trust? Do we know if we have contributed tounmet expectations? For physicians who can tuneinto their own feelings, this is easier to determine.However, when fear of reprisal, belief that there isno responsibility or lack of empathy for the effecton the patient/family intervenes, then knowing that an apology is in order becomes a challenge.

RequirementsFor an apology to be effective, it must have specificcomponents. Beverly Engel in The Power of Apologystates that there are three vital factors: sincerelyregretting, assuming responsibility and providingremediation. (20)

Engel’s components of an effective apology (“ASAP”)include:

• Acknowledging the need for apology.-- Has there been a medical error?

-- Are patient/family expectations unmet due to something you have done or failed to do?

Apology


• Sincerely expressing remorse for your role inthe event.

-- If there is an error that does not involve youdirectly, express remorse for the organization. At that moment, you represent the system in theeyes of the patient/family.

-- If it is an error of your judgment, thenexpress sincere remorse.

-- Insincere remorse is worse than none. It willresult in an apology that can do more harm thangood by fueling greater distrust.

• Assuming responsibility where appropriate.

-- Has an error occurred? If so, unless otherwiseadvised that doing so would jeopardize yourinsurance coverage, assume responsibility. Inthe long run, the opportunity for both the healthcare provider and the patient/family to heal thepsychological wounds of distrust is greater withsincere apology.

-- Is it unclear that an error has occurred? Then,say so. Assume responsibility for ensuring thatthe organization will find out what happenedand will share that with the patient/family: “Youmust feel awful this has happened, and so do I.We do not know yet how this happened. Whenwe have found out, we will share that with youand will take responsibility for anything that wedid that contributed to this.”

-- If no error occurred, and there was nothingthat could have been done differently, thenexpress sincere sadness for the event, but noresponsibility.

• Pursuing remediation. You may not be in theposition at the initial disclosure meeting toknow if financial remediation is called for. Thatmay be a discussion at a second or subsequentdisclosure. At a first disclosure meeting, theremediation may be the commitment to pursuefinding answers, which will be shared.

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• Find out if you have a state statute that protectsapology and under what circumstances. Find out if your insurance company discourages orencourages apology. This is a financial decisionas well as a philosophical decision.

• Do not take responsibility for an error if there hasbeen no error. Not only is it legally a problem, butpsychologically as well. Studies by Kim, Ferrin,Cooper, et al in 2004 showed that trust can berestored when an apology is made and subsequentevidence supports the responsibility for the act.However, when subsequent evidence shows thatthere is no responsibility on the part of the partyapologizes, trust is not restored.(21)

• If it is unclear there has been an error, thenexpress sincere regret for the outcome andassume responsibility to ensure that the factswill be pursued and findings will be shared.

• Feel free to use the words “I’m sorry.” Sincerelystated, they have the power to heal.

• Do not apologize without true concern, sadnessand regret about the patient/family’s pain. Thisis about them – their needs, their expectations,their hopes. This is not about the caregiverexcept as sharing in the personal pain of thefamily. (The organization should have immediatesupport for the caregiver.)

• Recognize that for apology to be successful, wemust separate our fear for our own survival fromour human feelings about the suffering of others.This is the defining moment of the disclosurediscussion. If we are not sorry for the patient/family and do not share in their pain, we lose theopportunity to heal their distrust as well as ourown injured professional self-esteem and heart.

Apology


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Other Considerations

Subsequent Discussions

A s noted earlier, there will often be morethan one meeting. The initial meetingshould occur as soon after the event as

possible, but that means some information will not be available and the patient/family will need time toprocess what you say. Subsequent meetings will covera number of topics:

• Results of investigations to the extent that youcan discuss them.

• Activities the organization is taking to preventre-occurrence of the event.

• An exploration of the patient/family needs andmechanisms for remuneration or assistance.

• A further sincere apology for any role the physicianand the organization had that contributed to theoutcome.

These meetings can benefit from the application of dispute resolution skills or alternative disputeresolution processes. Mediators can facilitate contentious discussions about financial concerns.The risk manager should participate in these meetingsbecause she/he can best understand the ramificationsof decisions and facilitate the implementation ofagreements.


OtherConsiderations

Hints for Effective Communication

• Use simple language. There are two reasons touse non-technical language during a disclosure:

-- Health literacy. A 2004 IOM report indicatesthat nearly 50 percent of American adults have a health literacy level low enough to endangertheir health and the health of their families.Though many individuals will not admit to lackof understanding of medical terminology,providers should assume this is an issue.

-- Human reaction to stress. People cannot listeneffectively while processing difficult information.

• Select the most important information to shareat the first meeting. Patients/families shouldreceive all the information needed to make next-step decisions. Do not overwhelm themwith information that is not useful at the time.There should be future meetings and thosemeetings can provide additional detail. Anexception is where the patient/family asks foradditional information or detail.

• Speak slowly to optimize the potential forpatients/families to understand the implicationsof the information presented.

• Be aware of body language and non-verbal communication. Any message largely is conveyedthrough body language and other unconsciousthings we do as we speak. In addition, there areaspects of non-verbal communication aboutwhich speakers can do nothing, such as gender,age, ethnic background and education that mayinfluence how people hear and accept a message.The key here is to be aware of controllableaspects and strive to present a caring and warmdemeanor.

• Be aware of cultural implications. Communicationis interpreted through cultural filters.

-- Ethnic perceptions affect not only foreignborn individuals, but even second and third generations. Often these perceptions are subconscious.

-- Different generations have different beliefsabout the role of the patient and the relationshipof the patient/family to the clinician as well asbeliefs about authority and patient rights.

-- Different levels of education, perceived differences in life experiences and perceived differences in status affect whether an individualwill believe the discloser appreciates their pointof view. Educational differences also may affectthe ability of the person to understand his or her role in the health care process.

-- Spiritual beliefs affect how a person interpretshealth and illness beyond the physical sympto-matology. Those beliefs about causation and therole of faith in healing influence the way thatcommunication is interpreted.

-- Research indicates that racial backgroundmay affect the patient/family’s willingness to trustcaregivers or to share problems.(21)

• There are areas where ethnic, generational, religious and socioeconomic influences exert an impact on how information is received:

-- Beliefs about the appropriate role of womenin health care and in society; beliefs about therole of women as patients in relation to theirhusbands or male family members.

-- Beliefs about the etiology of ill health andpurpose, if any, it serves in the spiritual world.

-- Beliefs about mechanical and chemicalinterventions.

-- Beliefs about death and permanent injury.


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OtherConsiderations

Managing Patient/Family EmotionsThe discloser’s primary job is to convey information,allow the patient/family to express emotions, andmanage those emotions so they do not escalate tothe detriment of both the patient/family and theorganization. The most common emotional reactionsare anger, denial and blame. It is also important toremember that while emotions may be based onincorrect facts or interpretations, the emotions arealways real.

Anger is a difficult yet expected emotion. The beststrategy is to allow the patient and family membersto express themselves without becoming defensive.Direct accusations may reflect their frustration andhelplessness. (Do not put yourself into a dangeroussituation. Call for help if needed.)

Denial occurs because the information is too muchto process. It is important in this situation to quietlyand firmly reinforce the reality of the situationwhile giving the patient/family permission to taketheir time.

Blame is the most difficult reaction to handle, particularly for disclosers in an event for whichthey have no responsibility. As with anger, it isimportant to allow the patient/family to have theirfeelings without argument. Accept their right tohold those feelings, but do not accept the blame.An example might be: “I understand how youwould see this as my fault. I just want to tell youthat I feel terrible, and yet, I was not a part of what happened.”

Risk Management Strategies A health care organization’s risk manager should:

• Assess organizational readiness for disclosure:

-- What is the current philosophy about transparent communication?

-- What is currently the behavior relative to transparent communication?

• Engage and educate leadership.

• Develop an effective communication policy that includes disclosure.

• Provide support for caregivers (education aboutthe organization’s philosophy, the litigationimplications, available resources, and the components of the policy and the education plan).

• Ensure all staff are educated about the organization’scommunication policy, how to find it and itsimplications

-- Provide ongoing regular reinforcementthrough education, e-mails, etc.

-- Provide education about the role of staffother than disclosers in supporting the factualtransmission of information about unanticipatedevents.

• Ensure that staff knows what to do immediatelyafter an adverse event and with whom to speakprior to a disclosure.

• Ensure staff is educated about resources availableto support them after an adverse event.

• Ensure that all staff is educated in disclosuretechniques in order to support clinicians whoare involved in a disclosure. In addition, staffmay be called upon to participate with aprovider during a disclosure discussion.

• Ensure that the organization has rapid access to support for disclosure when there are communication difficulties such as languagebarriers, disabilities or health literacy issues.


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References

1. 1992 American College of Physicians’ EthicsManual (ACP, 1992)

2. Mazor, K.M., Simon, S.R., Gurwitz, J.H.“Communicating with patients about medicalerrors: a review of the literature.” Archives ofInternal Medicine 164(1):1690-7.

3. Popp, P.L. “How will disclosure affect future litigations?” ASHRM Journal of Healthcare RiskManagement, 2003; 131(23):963-67.

4. Vincent C., Young M., Phillips, A. “Why do peoplesue doctors? A study of patients and relativestaking legal action.” Lancet. 1994; 343(8913):1609-13.

5. Goehring C., Bouvier, G.M., Kunzi, B., Bovier, P.,“Psychosocial and professional characteristics of burnout in Swiss primary care practitioners: a cross-sectional survey.” Swiss Medical Weekly,2005; 135:101-108.

6. Bruce, S.M., Congalen, H.M., Congalen, J.V.“Burnout in physicians: a case for peer-support.”Internal Medicine Journal. 2005: 35(5): 272-8

7. Christensen, J.F., Levinson, W., Dunn, P.M. “Theheart of darkness: the impact of perceived mistakeson physicians.” Journal of General InternalMedicine. 1992: 7(July/August): 424-431.

8. Reason, J. Human Error. Cambridge: CambridgeUniversity Press, 1990.

9. Roberts, K.H., Yu, K., van Stralen, D. “Patientsafety is an organizational systems issue: lessonsfrom a variety of industries.” In Youngberg, B.and Hatlie, M. (eds.) The Patient SafetyHandbook. Canada: Jones and Bartlett, 2004.

10. Reason, 1990.

11. Vincent, 1994.

12. Halpern, J. From Detached Concern toEmpathy: Humanizing Medical Practice. New York: Oxford Press, 2001.

39

References


13. Kraman, S.S., Hamm, G. “Risk management:extreme honesty may be the best policy.”Annals of Internal Medicine. 1999; 131(23):963-67.

14. Popp, 2003.

15. Mazor, 2004.

16. Ibid.

17. Ibid

18. Taft, L. “Apology and medical mistake: opportunityor Foil?” Annals of Health Law. 2005; 14: 55-94.

19. Engel, B. The Power of Apology. New York:John Wiley and Sons, 2001. Pp 67-68.

20. Kim, P.H., Ferrin, D.L., Cooper, C.D., Dirks, K.T.“Removing the shadow of suspicion: the effectsof apology versus denial for repairing compe-tence-versus integrity-based trust violations.”Journal of Applied Psychology. 2004. 89(1): 104-118.

21. Carroll, K.N., Cooper, W.O., Blackford, J.U.,Hickson, G.B. “Characteristics of families thatcomplain following pediatric emergency visits.”Ambulatory Pediatrics, 2005. 5(6): 326-331.

Gordon, H.S., Street, R.L. Jr., Sharf, B.F., Kelly, P.A.,Souchek, J. “Racial differences in trust and lungcancer patients’ perceptions of physician communication.” Journal of Clinical Oncology,2006. 24(6): 904-909.

Corbie-Smith, G., Thomas, S.B., St. George,D.M. “Distrust, race, and research.” Archivesof Internal Medicine, 2002. 162(21):2458-63.


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Appendix


Appendix

Building a Disclosure Policy

P olicies guide acceptable behavior in anygiven situation. When realistic, they effectivelyprovide staff with the philosophy of action,

the legal or regulatory basis for any requirements, and the steps that will accomplish the task in the mostappropriate manner under most circumstances. Theyalso create a standardized way to communicate bothregulation and philosophy to staff members whouse the policies for information gathering, to guidebehavior and for education.


• Use positive language reflective of the organization’sphilosophy. “We at ABC Hospital value and striveto provide honest communication with patientsthat includes disclosure of any and all informationsurrounding the outcomes of treatment or care.”

• Consider the use of a “communication withpatients” policy of which disclosure of adverse/unanticipated events is only one element. (Ofcourse, it should be easily found when needed.)Use of the term “disclosure policy” implies thatdisclosure is a separate activity from communi-cation. It might imply to some that “we discloseonly when the policy says we must and the rest ofthe time we don’t tell patients about their care.”

• Ensure that policies have room for cliniciandecision-making about where and when to communicate within the parameters of acceptablebehavior. For example: A policy that states, “The attending will talk with the patient within12 hours of the event.” creates expectations thatmay not be appropriate in a given situation.

• Ensure the policy reflects behavior that is feasibleunder normal circumstances.

• Ensure the policy includes description of thesupport that is available for physicians.

• Ensure that the medical staff and all levels ofadministration review and support the policybefore implementation.


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Appendix

Components of an Effective PolicyA well-written policy may include the followingcomponents:

• Policy statement/objectives. An effective policystatement is a positively worded statement, usuallyno more than a sentence or two, that sets outwhat the policy is, when it applies, and what it isintended to do. Avoid negative wording such as,“Do not disclose medication errors where theerror did not reach the patient.” Instead say,“All events are potentially disclosable even whenthe error does not reach the patient. Clinicians arerecommended to use discretion when disclosinga near miss if the patient would be negativelyaffected by such information.”

• Definitions of key terms. Any term that is usedwithin the policy and procedure that is not common usage in the organization should bedefined. It is especially important to include anydefinitions unique to the region or the organization.

• Criteria of an event warranting disclosure. This isa brief, inclusive statement rather than a limitingstatement. Those organizations choosing to basethe necessity for disclosure on the presence ofharm should further define the categories ofharm in this section. For most organizations therange for disclosure includes harm that neverreached the patient (no obligation to disclose)to natural sub-optimal outcomes from treatment ormedical error, both of which must be discussedwith the patient/family.

• Outlining the necessary steps for disclosure. Thisis a guideline, not a detailed blueprint, and shouldtouch on issues such as individuals involved,content of the conversation, accommodation of special needs, planning for follow-up, documentation and conflict resolution planning.

• Support services for providers. They, too, arewounded by the unexpected turn of events andyet, the clinicians are often unable to ask forhelp. The policy should delineate the source of help available when possible.


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Notes

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American Society for HealthcareRisk Management

One North Franklin

Chicago, IL 60606

(312)422-3980

www.ashrm.org

© 2006

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