Open disclosure of Adverse Events in Fertility Practice
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Open disclosure of Adverse Events in Fertility Practice

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Tina Cockburn, Associate Professor, from Queensland University of Technology has presented at the Obstetric Malpractice Conference. If you would like more information about the conference, please ...

Tina Cockburn, Associate Professor, from Queensland University of Technology has presented at the Obstetric Malpractice Conference. If you would like more information about the conference, please visit the website: http://bit.ly/10xh1iO

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Open disclosure of Adverse Events in Fertility Practice Open disclosure of Adverse Events in Fertility Practice Presentation Transcript

  • Disclosure ofadverseevents infertilitypracticeAssociate ProfessorTina CockburnQueensland University ofTechnologyFaculty of Lawt.cockburn@qut.edu.au
  • Disclosure of adverse eventsin fertility practice The nature and extent of adverse events infertility practice Why disclose adverse events in fertility practice? Implementing open disclosure: policy andguidelines Consequences of failure to disclose adverseevents: Disciplinary action Civil liability
  • THE NATURE AND EXTENTOF ADVERSE EVENTS INFERTILITY PRACTICE
  • Adverse events in fertilitypractice Loss of sperm, eggs or embryos IVF mix-ups
  • Loss of sperm, eggs orembryos Errors that lead to gametes being lost whichmay result in diminished reproductiveopportunity
  • IVF mix-ups Gametes or embryos of one person or couplemistakenly used with gametes or embryos ofanother person or are mistakenly transferredto another person or couple, potentiallyleading to the birth of a child with anunintended genetic parentage
  • Incidence of adverse eventsin fertility practice Human Fertilisation and Embryology Authority (HFEA)UK: April 2010 - March 2011: 564 errors, including losingembryos and sperm (50,000 IVF cycles) Category A or B (IVF mixups) - 275 cases 2010/2011 cf 62 cases 2007/2008 Compare: April 2007 - March 2008: 182 incidents IVF errors have trebled in three years HFEA spokesperson: ―The HFEA openly encourages the reporting ofincidents and continues to work closely with centres to improve quality. As aresult, centres are continuing to respond positively to the opportunity toshare lessons learned from incidents which have been reviewed andvigorously investigated.‖ http://www.bionews.org.uk/page_104952.asp?dinfo=TxOkrAWWidfdjhQtYxoK6pUW
  • WHY DISCLOSE ADVERSEEVENTS IN FERTILITYPRACTICE?
  • Why disclose adverse events? Duty of candour Honest and open communication Good clinical practice Respect for patients by treating them as autonomousindividuals Aspect of informed consent Health systems and individual service provisionquality improvement Patient expectations Organisational and individual risk managementbenefits
  • Why disclose adverse events infertility practice?―Principles of open and honest communication withpatients have special significance in reproductivemedicine. Fertility treatments are often stressful, andpatients may be particularly sensitive to the statementsof their doctors. In addition, errors in reproductivemedicine may affect the couple‘s ability to have a child.In errors that are particularly serious—where embryosare mistakenly transferred to the wrong couple—theerror may lead to the birth of a different child than wasintended. Such births can lead to significant emotionalturmoil and the burdens of custody lawsuits, which canadversely affect all involved parties, including thechildren.‖Disclosure of medical errors involving gametes and embryos,http://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf, 1313
  • Duty of candour―Honest, effective and opencommunication is the foundation of therelationship between clinicians andpatients. Telling the truth is always theright thing to do. Concealing the truth iswrong.‖Barron and Kuczewski (2003)
  • Australian Medical AssociationCode of Ethics 2004 (rev 2006) 1.1a Consider first the well-being of your patient 1.1v When referring your patient to institutions orservices in which you have a direct financial interest,provide full disclosure of such interest. 1.1w If you work in a practice or institution, place yourprofessional duties and responsibilities to your patientsabove the commercial interests of the owners or otherswho work within these practices. 2.1a Build a professional reputation based on integrityand ability. 2.1d Report suspected unethical or unprofessionalconduct by a colleague to the appropriate peer reviewbody 2.1gKeep yourself up to date on relevant medicalknowledge, codes of practice and legal responsibilities.
  • Medical Professionalism 2010(AMA) 2. The medical profession in society ―2.4 Society grants the medical profession a high levelof professional autonomy and clinical independencebecause it trusts doctors to put the individualpatient’s interests first.‖ 3. Medical professionalism ―3.2 Although individual doctors have their ownpersonal beliefs and values, the medical professionupholds a core set of values, including (but notlimited to): respect; trust; compassion; altruism;integrity; justice; accountability; protection ofconfidentiality; leadership, and collegiality.‖
  • Australian Medical CouncilGood Medical Practice: A Code ofConduct for Doctors in Australia3.10 Adverse Events When adverse events occur, you have aresponsibility to be open and honest in your communicationwith your patient, to review what has occurred and to reportappropriately. When something goes wrong, good medical practiceinvolves:3.10.1 Recognising what has happened3.10.2 Acting immediately to rectify the problem, if possibleincluding seeking any necessary help and advice3.10.3 Explaining to the patient as promptly and fully aspossible what has happened and the anticipated short andlong term consequences3.10.4 Acknowledging any patient distress and providing appropriatesupport
  • Ethics Committee of the AmericanSociety for Reproductive Medicine(2011)1. Clinics have an ethical obligation to disclose errors out of respect forpatient autonomy and in fairness to patients.2. Errors that affect the number or quality of gametes or embryosshould be disclosed unless they clearly have a minimal effect onpatient interests.3. It is obligatory to disclose immediately errors in which the wrongsperm are used for insemination or gametes or embryos aremistakenly switched and the result is embryo transfer, conception,or the birth of a child with a different genetic parentage thanintended.4. Clinics should promote a culture of truth-telling and should establishwritten policies and procedures regarding disclosure of errors topatients.5. Fertility programs should have in place rigorous procedures toprevent the loss of gametes and embryos and to ensure properidentification of all gametes, embryos, and patients.http://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf
  • PATIENTEXPECTATIONS
  • Being open with patients when things gowrong is an important component in thequality of care people receive; it is whatpatients expect and is indicative ofopenness and learning in order to preventfurther incidents.
  • Australian Charter of HealthCare RightsCommunication MY RIGHTS: I have a right to be informed about services,treatment, options and costs in a clear andopen way. WHAT THIS MEANS: I receive open, timely and appropriatecommunication about my health care in a wayI can understand.
  • Percentage of high and very highrating for honesty and ethicalstandardsRoy Morgan Image of Professional surveys of Ethics and Honesty 2012
  • IMPLEMENTING OPENDISCLOSURE: POLICY ANDGUIDELINES
  • Open Disclosure Standard National Open Disclosure Standard 2003 Open disclosure: open communication when things gowrong in health care. Elements: Expression of regret (cf. Apology) Factual explanation of what happened Explanation of potential consequences of incident Explanation of steps being taken to manage the event andprevent its recurrence NOTE: ACSQHC Review of the Open Disclosure Standard 2012
  • Implementing open disclosureis difficult Legal barriers: adequacy of legislative protection for apologies Uncertainty about law and fear of increased litigation Physician barriers: guilt and embarrassment fear of reaction from peers fear of punitive sanctions Uncertainty about policy and practical guidelines communication difficulties See Iedema et al ―The National Open Disclosure Pilot: Evaluation of apolicy implementation initiative‖ MJA 2008
  • Barriers to error disclosureGhalandarpoorattar, Kaviani and Asghari ―Medical error disclosure: the gap between error and practice‖ Postgrad Med J 2012; 88:130-122
  • The process of disclosing adverseevents in fertility practice ―We conclude that the best ethical practice is forprograms to have in place rigorous procedures toprevent errors. To prepare for the possibility that errorsmay occur despite these procedures, programs shouldfoster an environment of truth- telling that will allowprompt identification and disclosure of errors to patients.It is recommended that clinics have written policies andprocedures that outline how to reduce and disclosemedical errors.‖ Disclosure of medical errors involving gametes and embryoshttp://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf, 1314
  • Facilitating Open disclosure:Apology protections Definitions Apology of sympathy Apology of fault Legal consequences of apologies Common law: Dovuro Pty Ltd v Wilkins [2003]HCA 51 Legislation: Civil Liability Acts Watson v Meyer [2012] NSWDC 36
  • Apology provisionsApologydefn inclfaultNotadmissionof liabilityNotrelevant tofaultNotadmissibleevidenceACT X X X XNSW X X X XTas X X XWA X X XQld X X X XNT XVic XSA XBased on Prue Vines ―Apologising to Avoid Liability: Cynical Civility or Practical Morality‖ (2005) 27 Sydney Law Review483 at 490 , as amended following subsequent legislative changes
  • Civil Liability Act (NSW)2002 68 Definition In this Part:"apology" means an expression of sympathy or regret, or of a general sense ofbenevolence or compassion, in connection with any matter whether or not theapology admits or implies an admission of fault in connection with the matter. 69 Effect of apology on liability (1) An apology made by or on behalf of a person in connection with any matteralleged to have been caused by the person: (a) does not constitute an express or implied admission of fault or liability by the person in connectionwith that matter, and (b) is not relevant to the determination of fault or liability in connection with that matter. (2) Evidence of an apology made by or on behalf of a person in connection withany matter alleged to have been caused by the person is not admissible in anycivil proceedings as evidence of the fault or liability of the person in connectionwith that matter.
  • Watson v Meyer [2012]NSWDC 36 Personal injury claim arising out of P falling from D‘shorse Evidence: I said, "Did she have a fall from her horse?"and he said, "No, it was my fault, my horse". Held: [244] ―All that the defendant was saying was that the plaintiff had notfallen from her horse but had fallen because it was "my fault, my horse". That isnot an admission about liability, but a description of the accident. Accordingly,the evidence does not amount to an admission.‖
  • CONSEQUENCES OFFAILURE TO DISCLOSEADVERSE EVENTS:DISCIPLINARY ACTIONCIVIL LIABILITY
  • ―Errors do not necessarily constituteimproper, negligent, or unethicalbehaviour, but failure to disclosethem may.‖ Ethics manual, fourth edition: disclosure. Ann Int Med 1998; 7: 576-94
  • Disciplinary actionFailure to disclose, especially where patients aredeliberately misled may be unprofessionalconduct: Skidmore v Dartford & Gravesham [2003] UKHL 27 Re Steven L Katz MD Medical Board of California 2005 Medical Board of Qld v Popov [2009] QHPT 11
  • Re Steven L Katz MDMedical Board of California(2005) Dr K (IVF specialist) mistakenly transferred 3 embryosintended for DB into SB Dr K knew of mistake 10mins after procedure but failed to telleither patient and did not record in medical records SB had son and DB had daughter Alleged deception and cover up for 1 ½ years and attempt toterminate SB‘s pregnancy HELD: mistaken transfer not gross negligence but failure to advise of error and get informed consent to continuedcare was – active concealment was gross negligence. Licence revoked and $91,000 fine
  • Re Steven L Katz MDMedical Board of California2005―Medical mistakes happen and when they do the only course opento the physician is to advise the patient of the medical error. In thisrespect, the situation facing respondent was not complex at all. Thedecision to tell the truth is foundational, as is the basicprinciple that the patient has the right to make complexchoices and decisions relating to her medical planning andcare. The standard of practice requires physicians to promptly andfully disclose errors to their patients. Patients have a right to be fullyinformed of errors and to have their medical options fully disclosedand discussed. Physicians are to be honest in theirinteractions with their patients, and in particular, to respectthe right of their patients to makes choices about theirhealthcare. Physicians are required to recognise potentialand actual conflicts of interest, and to place their patients’interest above their own. These are the long standing andcommonly understood principles guiding every physician confrontedwith a medical error.‖ p13
  • Civil liability Tort – Negligence:• Aspect of duty to provide proper medicaltreatment and advice: Breen v Williams (1994)per Bryson J• Aspect of reasonable aftercare and duty to followup: Wighton v Arnot [2005] NSWSC 367
  • Duty to disclose in tort―Informing a patient of what treatment has beengiven and what has taken place while doing so,whether or not there has been a catastrophe, isintegrally and necessarily part of givingmedical treatment to a person. One cannotstick a needle into a person and walk awaywordless, as one would with a horse.‖ Breen v Williams (1994) per Bryson J
  • Wighton v Arnot [2005] NSWSC367 Dr Arnot severed Ms Wighton‘s right spinal accessory nerveduring surgical procedure. Studdert J found negligent the failures to: inform patient of his suspicion that he had severed that nerve Disclosure to the patient‘s general practitioner may have been sufficient by appropriate examination to confirm that he had severed the nerve Refer patient to an appropriate specialist for timely remedial surgery. Dr Arnot may not have been held negligent if adverse eventhad been disclosed as no allegation of negligence in conductof procedure
  • Therapeutic Privilege?― Dr Arnot said that he did not tell the plaintiff…because of her emotional state and because it wasonly a possibility that he had severed this nerve, andthat possibility he considered to be ‗probably wrong‘because of his examination following surgery. … I donot find the defendant‘s explanation for not tellingthe plaintiff about the division of the nerve to be anacceptable explanation.‖Wighton v Arnot per Studdert J at [69]
  • Therapeutic Privilege incases of fertility error? ―Some might argue that the ethical duty to minimize harm justifiesnot telling the patients of the error because disclosure may beharmful, such as leading to a pregnancy termination or creatingstress. We believe this view is misguided. Disclosure of the errorwill enable the persons most directly affected to decide on a courseof action. If a pregnancy has been established, this may involvecontinuing the pregnancy, making advance arrangements aboutparentage, and securing legal counsel to take whatever steps theycan to try for a workable, albeit unfortunate, outcome.Alternatively, it could involve a decision to terminate thepregnancy.‖ Disclosure of medical errors involving gametes and embryos The EthicsCommittee of the American Society for Reproductive Medicinehttp://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf
  • Re Steven L Katz MD Therapeutic privilege: Dr K argued that the complexity of the situationpresented an opportunity for a physician to notdisclose if the physician felt that disclosure wouldcause more harm than good. Finding: ―The rationale for withholding informationfrom a patient should be carefully documented andexercise of the therapeutic privilege is almost never abasis for permanently overriding the obligation ofinformed consent. It is ordinarily viewed as atemporary situation. There is no evidence in this casethat would place either patient within this exception.‖p 15-16
  • Exemplary and aggravateddamages Exemplary (punitive) damages to punish and deter where conduct ―high handed,insolent, vindictive or malicious‖ or ―contumeliousdisregard of plaintiff‘s rights‖ Policy: ―justifying the award of punitive damages is anancillary function of tortious intention‖ (Cane) Aggravated damages compensatory in nature to reflect circumstances andmanner of defendant‘s wrong
  • Backwell v AAA (1996) AustTorts Rep 81-387 P artificially inseminated by D - sperm from incompatibledonor. D discovered mistake, told P not to worry and advisedher to return in a week for pregnancy test. When P discovered that pregnant, D advised terminationbecause of associated complications (including possibilityof a still birth). D also threatened P that if baby stillborn,her identity might be revealed and that publicity mightlead to closure of D‘s clinic. D also told P that if shefailed to terminate, it might be difficult for her to receivefurther IVF at D‘s clinic or elsewhere. P referred back to her own gynaecologist who, at P‘srequest, terminated pregnancy. P subsequently suffered depressive disorder (due toCatholic values and guilt) Held: compensatory damages and $125,000 exemplarydamages.
  • Exemplary and aggravateddamages Post Ipp review of law of negligence: NSW: prohibition on exemplary and aggravateddamages limited to negligence actions: CLA (NSW)s21 Qld: exemplary and aggravated damagesprohibited subject to exceptions including ―unlawfulintentional act done with intention to causepersonal injury‖: CLA (Qld) s52 NT: general prohibition on exemplary damages inpersonal injury claims no exceptions: PIA (NT) s19 Intentional Tort (trespass) or negligence? Rogers vWhitaker (1992) 175 CLR 479 per Mason CJ, Brennan,Dawson, Toohey and McHugh JJ at 490
  • Conclusions Ethics, policy and guidelines support open disclosure ofadverse events Patients expect open and honest communicationfollowing adverse events but this does not alwayshappen Failure to disclose adverse events may give rise todisciplinary and civil liability consequences Proposals for law reform to ensure open disclosureinclude enacting a statutory duty to disclose Policy makers and health care providers need to haverealistic expectations about what disclosure laws canaccomplish