medical disclosure when things go wrong
TRANSCRIPT
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Associate ProfessorTina Cockburn
Queensland University of
TechnologyFaculty of Law
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Disclosure when things go wrong:
are present guidelines enough? Disclosure of adverse events Ethics, Policy and Guidelines
Patient expectations vs reality the incident disclosure gap
Consequences of failure to disclose adverse events Disciplinary consequences
Civil liability
Reform: a statutory duty to disclose? UK case study
The US experience
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Duty of candour“Honest, effective and open communication is thefoundation of the relationship between clinicians andpatients. Telling the truth is always the right thing todo. Concealing the truth is wrong.”
Barron and Kuczewski (2003)
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Australian Medical Council
Good Medical Practice: A Code of Conduct
for Doctors in Australia
3.10 Adverse Events W hen adverse events occur, you have aresponsibility to be open and honest in your communication with
your patient, to review what has occurred and to report appropriately. When something goes wrong, good medical practice involves:
3.10.1 Recognising what has happened
3.10.2 Acting immediately to rectify the problem, if possible includingseeking any necessary help and advice
3.10.3 Explaining to the patient as promptly and fully as possible what has happened and the anticipated short and long termconsequences
3.10.4 Acknowledging any patient distress and providing appropriatesupport
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Open Disclosure Standard National Open Disclosure Standard 2003
Open disclosure: open communication when things go wrong 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 eventand prevent its recurrence
NOTE: ACSQHC Review of the Open Disclosure Standard 2012
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Australian Charter of Health Care
RightsCommunication
MY RIGHTS: I have a right to be informed about services, treatment,
options and costs in a clear and open way.
WHAT THIS MEANS: I receive open, timely and appropriate communication
about my health care in a way I can understand.
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Percentage of high and very high rating for
honesty and ethical standards
0
1020
30
40
50
6070
80
90
100
Nurses Doctors Lawyers Used carsalesman
1979
1995
2011
Roy Morgan Image of Professional surveys of Ethics and Honesty 2011
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Physicians attitudes and behaviour
regarding communication with patients
0%
20%
40%
60%
80%100%
discloseerrors
fully informrisks and
errors
never telluntruths
Physicians should:
completely agree somewhat agree or disagree
LI Iezzoni, SR Rao, C M Des Roches, C Vogeli and E Campbell “Survey shows that at least some physicians are not always open or honest with atients” Health A airs, 31, no.2 (2012): 383-391
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Physicians attitudes and behaviour regarding
communication with patients
0%10%20%30%40%50%60%
70%80%90%
100%
toldpatient anuntruth
describedprognosis
morepositively
thanactual
not fullydisclosedmistakedue tofear ofbeing
sued
rarely sometimes oroften
never
In the past year how often have you:
Iezzoni et al (2012)
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To what extent are adverse events found in patient
records reported by patients & healthcare professionals
via complaints, claims & incident reports?
0
500
1000
1500
2000
25003000
3500
4000
Total patientrecords (3575)
Adverse events(498)
Reportedadverse events
(18: 3.6%)
I Christiaans-Dingelhoff et al, ‘To what extent are adverse events found in patient records reported by patients and healthcarerofessionals via com laints, claims and incident re orts?’ BMC Health Services Research 2011, 11:49
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Surgeons and residents’ attitudes
towards error disclosure
0
5
10
15
20
25
30
35
40
Proactivedisclosure
minor error
Reactivedisclosure
minor error
Proactivedisclosure
major error
Reactivedisclosure
major error
Disclose
Not disclose
Unsure
Ghalandarpoorattar, Kaviani and Asghari “Medical error disclosure: the gap between error and practice” Postgrad Med J 2012; 88: 130-122
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“Errors do not necessarily constituteimproper, negligent, or unethical
behaviour, but failure to disclose themmay.”
Ethics manual, fourth edition: disclosure. Ann Int Med 1998; 7: 576-94
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Failure to disclose, especially where patients aredeliberately misled may be unprofessional conduct:
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
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Skidmore v Dartford & Gravesham
[2003] UKHL 27 Dr S performed keyhole surgery to remove Mrs A’s gall
bladder. During procedure Mrs A’s artery punctured
large blood loss operation converted to open surgery short period of cardio-pulmonary resuscitation. 8 units of blood transfused during operation and 2 more units post
operatively.
Eventually operation completed successfully, full recovery.
Mrs A's husband sought explanation. Dr S blamed faulty instrument, suggested blood loss
normal (only 2 units) and that Mrs A had not arrested orrequired resuscitation.
Held: professional misconduct - Dr S deliberately misled
Mrs A & her family
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Re Steven L Katz MD
Medical Board of California (2005) Dr K (IVF specialist) mistakenly transferred 3 embryos intendedfor 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 to
terminate SB’s pregnancy
HELD: mistaken transfer not gross negligence
but failure to advise of error and get informed consent tocontinued care was – active concealment was grossnegligence.
Licence revoked and $91,000 fine
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Medical Board of Queensland v Popov
[2009] QHPT 11 Alleged professional misconduct including:
April 2007: agreed to undertake hysterectomy right ovary removed > surgical error
May 2007: P incorrectly/inappropriately advised Mrs McQ that rightovary covered in cysts, diseased and required removal > not true
Operation report: patient had “abnormal looking ovary” and“erroneous removal of ovary discussed with pt. Health/futureimplications discussed ... Apology offered. Patient happy andgrateful.” Allegation: P knowingly and actively falsified medical records.
Finding: unsatisfactory professional conduct P “failed to disclose a surgical error to a patient”; “actively
misled patient in this regard and knowingly and activelyfalsified medical records”; “provided dishonest or misleadingadvice to superiors” Registration cancelled for 3yrs
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Tort – Negligence:
• Aspect of duty to provide proper medical treatment
and advice: Breen v Williams (1994) per Bryson J• Aspect of reasonable aftercare and duty to follow up:Wighton v Arnot [2005] NSWSC 367
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Wighton v Arnot [2005] NSWSC 367
Dr Arnot severed Ms Wighton’s right spinal accessory nerve
during 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 event had
been disclosed as no allegation of negligence in conduct of
procedure
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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 telling theplaintiff about the division of the nerve to be anacceptable explanation.”
Wighton v Arnot per Studdert J at [69]
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• Contractual duty of candour endorsed• Statutory duty of candour rejected
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Contractual duty of candour UK Government response to the NHS Future Forum report (June 2011):
“…we could strengthen transparency of organisations and increasepatient confidence by introducing a ‘duty of candour’: a newcontractual requirement on providers to be open andtransparent in admitting mistakes. We agree. This will beenacted through contractual mechanisms...”
“The Committee welcomes the Governments announcement that it will introduce a contractual duty of candour. The Committee doesnot think that placing further statutory duties on the NHS willproduce the shift in culture that is required to ensure that patientsget full disclosure of information when things go wrong. Theemphasis on culture change ... may have more impact than furtherstatutory change.”
“However, the Committee believes that service agreementsbetween NHS commissioners and their providers shouldinclude a contractual duty of candour to the commissioner. Aduty of candour to patients from providers should also be partof the terms of authorisation from Monitor, and of licence bythe Care Quality Commission.” Contractual “duty of candour” consultation launched October 2011
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Statutory duty of candour rejected February 2012 House of Lords rejected proposed
amendment to the Health and Social Care Bill calling forstatutory duty of candour Peter Walsh, chief executive of AvMA:
“This is a bad day for anyone who values patient safety and patients’rights. It cannot be right that the current situation is allowed tocontinue, where there is no statutory obligation on a healthcareorganisation to be open with a patient or their family over incidents
which have caused harm.”
Sir Liam Donaldson, former Chief Medical Officer for
England: “I have always personally agreed that there should be a statutory
duty of candour. I have favoured it because I am of the view thatprofessionals should be encouraged to take responsibility when theyhave done something wrong, rather than withhold instances ofharm.”
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•
Apology protections• Disclosure laws
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Features of US Disclosure LawsProvision No of
states
CONTENT OF COMMUNICATION LEGAL LY PROTECTED
Statement of sympathy and explanation 1
Statement that unanticipated outcome occurred 5
None 3
COVERED PARTIES
Institutional and individual health care providers 1
Institutional health care providers only 8
TRIGGERING EVENT
Unanticipated outcomes of medical care 1
Serious unanticipated outcomes of medical care 7
Preventable serious adverse outcome of medical care 1
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US Disclosure Laws (cont...)Provision No of
states
TIMING OF COMMUNICATION
No time frame specified 5
Communication must be made within X days of discovery 4FORM OF COMMUNICATION
May be oral or written (not specified) 6
Must be written 2
Must be oral (if patient is available) 1
RECIPIENT OF COMMUNICATION
Recipient must be injured patient, family or representative 9
VOLUNTARINESS
Communication is mandatory 7
Communication is discretionary 2
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US Disclosure Laws (cont...)Provision No of
states
INFORMATION REQUIRED TO BE CONVEYED
Statement that unanticipated outcome occurred 9
Explanation of facts, context of unanticipated outcome 0 Acknowledgement of harm 0
Explanation of impact on treatment plans or health status, or both 0
Explanation of investigation or follow-up done or to be done 0
Explanation of cause of unanticipated outcome 0
Offer of support services 0
Statement of accountability or responsibility 0
Statement of patient’s legal rights 1
Mastrioanni et al “The Flaws in State Apology and Disclosure Laws Dilute Their Intended Impact on Malpractice Suits” Health Affairs ,29, no 9 (2010): 1611-1619
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Best practice for Disclosure lawsProvision Recommended Practice
Protected content Drafted broadly to protect statements that anunanticipated outcome occurred and statements ofsympathy, explanation, and fault
Covered parties Cover individual and institutional health careProviders
Triggering event Require disclosure of all unanticipated outcomes
Timing ofcommunication
Specify a time frame in which communications must bemade . Time frame should encourage prompt initialdisclosures that an unanticipated outcome occurred butshould permit additional investigation time before anexplanation of the outcome is required.
Form ofcommunication
Require both oral and written notification for seriousunanticipated outcomes, but permit oral communications to
suffice for less serious events. Statute should provide adefinition of a serious unanticipated outcome.
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Best practice (cont...)Provision Recommended Practice
Recipient ofcommunication
Apply only to communications made to the injuredpatient, his or her family, representative, or friend
Voluntariness Should mandate communications following unanticipatedoutcomes
Required content Should require that the communication include a statementthat an unanticipated outcome occurred, an explanation ofthe facts or context of the event, an acknowledgment ofharm, an explanation of the impact on the patient’s
treatment plans and health status, an explanation of theinvestigation or follow-up done or to be done, and an offer ofsupport services, where available.
Mastrioanni et al “The Flaws in State Apology and Disclosure Laws Dilute Their Intended Impact on Malpractice Suits” Health Affairs ,29, no 9 (2010): 1611-1619
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Conclusions Ethics, policy and guidelines support open disclosure
of adverse 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 can
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