Associate Professor Tina Cockburn

Queensland University of Technology Faculty of Law

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

Duty of candour
Honest, effective and open communication is the foundation of the relationship between clinicians and patients. Telling the truth is always the right thing to do. Concealing the truth is wrong.
Barron and Kuczewski (2003)

Australian Medical Council Good Medical Practice: A Code of Conduct for Doctors in Australia
3.10 Adverse Events When adverse events occur, you have a
responsibility 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 including seeking 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 term consequences 3.10.4 Acknowledging any patient distress and providing appropriate support

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 event

and prevent its recurrence

NOTE: ACSQHC Review of the Open Disclosure Standard 2012

Australian Charter of Health Care Rights

Communication
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.

Percentage of high and very high rating for honesty and ethical standards
100 90 80 70 60 50 40 30 20 10 0 Nurses Doctors Lawyers Used car salesman

1979

1995
2011

Roy Morgan Image of Professional surveys of Ethics and Honesty 2011

Physicians attitudes and behaviour regarding communication with patients

Physicians should:
100% 80% 60% 40% 20% 0% disclose errors fully inform risks and errors never tell untruths somewhat agree or disagree

completely agree

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 patients Health Affairs, 31, no.2 (2012): 383-391

Physicians attitudes and behaviour regarding communication with patients

In the past year how often have you:
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% told described not fully patient an prognosis disclosed untruth more mistake positively due to than fear of actual being sued Iezzoni et al (2012)

rarely sometimes or often never

To what extent are adverse events found in patient records reported by patients & healthcare professionals via complaints, claims & incident reports?
4000 3500 3000 2500 2000 1500 1000 500 0 Total patient Adverse events Reported records (3575) (498) adverse events (18: 3.6%)
I Christiaans-Dingelhoff et al, To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports? BMC Health Services Research 2011, 11:49

Surgeons and residents attitudes towards error disclosure

40
35

30
25 20 15 10 5 0 Proactive disclosure minor error Reactive disclosure minor error Proactive disclosure major error Reactive disclosure 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

 Errors do not necessarily constitute

improper, negligent, or unethical behaviour, but failure to disclose them may.

Ethics manual, fourth edition: disclosure. Ann Int Med 1998; 7: 576-94

Failure to disclose, especially where patients are deliberately 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

Skidmore v Dartford & Gravesham [2003] UKHL 27

Dr S performed keyhole surgery to remove Mrs As gall

bladder. During procedure Mrs As 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 or required resuscitation. Held: professional misconduct - Dr S deliberately misled Mrs A & her family

Re Steven L Katz MD Medical Board of California (2005)

Dr K (IVF specialist) mistakenly transferred 3 embryos intended

for DB into SB Dr K knew of mistake 10mins after procedure but failed to tell either patient and did not record in medical records SB had son and DB had daughter Alleged deception and cover up for 1 years and attempt to terminate SBs pregnancy HELD: mistaken transfer not gross negligence but failure to advise of error and get informed consent to continued care was active concealment was gross negligence. Licence revoked and $91,000 fine

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 right ovary 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/future implications discussed ... Apology offered. Patient happy and grateful. 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 actively falsified medical records; provided dishonest or misleading advice to superiors

Registration cancelled for 3yrs

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

Wighton v Arnot [2005] NSWSC 367

Dr Arnot severed Ms Wightons 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 patients 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

Therapeutic Privilege?
Dr Arnot said that he did not tell the plaintiff because of her emotional state and because it was only a possibility that he had severed this nerve, and that possibility he considered to be probably wrong because of his examination following surgery. I do not find the defendants explanation for not telling the plaintiff about the division of the nerve to be an acceptable explanation. Wighton v Arnot per Studdert J at [69]

 Contractual duty of candour endorsed

Statutory duty of candour rejected

Contractual duty of candour

UK Government response to the NHS Future Forum report (June 2011):
we could strengthen transparency of organisations and increase

patient confidence by introducing a duty of candour: a new contractual requirement on providers to be open and transparent in admitting mistakes. We agree. This will be enacted through contractual mechanisms... The Committee welcomes the Governments announcement that it will introduce a contractual duty of candour. The Committee does not think that placing further statutory duties on the NHS will produce the shift in culture that is required to ensure that patients get full disclosure of information when things go wrong. The emphasis on culture change ... may have more impact than further statutory change. However, the Committee believes that service agreements between NHS commissioners and their providers should include a contractual duty of candour to the commissioner. A duty of candour to patients from providers should also be part of the terms of authorisation from Monitor, and of licence by the Care Quality Commission.

Contractual duty of candour consultation launched October 2011

Statutory duty of candour rejected

February 2012 House of Lords rejected proposed

amendment to the Health and Social Care Bill calling for statutory 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 to continue, where there is no statutory obligation on a healthcare organisation 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 that professionals should be encouraged to take responsibility when they have done something wrong, rather than withhold instances of harm.

 Apology protections

Disclosure laws

Features of US Disclosure Laws

Provision CONTENT OF COMMUNICATION LEGAL LY PROTECTED Statement of sympathy and explanation Statement that unanticipated outcome occurred None COVERED PARTIES Institutional and individual health care providers Institutional health care providers only TRIGGERING EVENT Unanticipated outcomes of medical care Serious unanticipated outcomes of medical care Preventable serious adverse outcome of medical care 1 7 1 1 8 1 5 3 No of states

US Disclosure Laws (cont...)

Provision TIMING OF COMMUNICATION No time frame specified 5 No of states

Communication must be made within X days of discovery

FORM OF COMMUNICATION May be oral or written (not specified) Must be written Must be oral (if patient is available)

4
6 2 1 9 7 2

RECIPIENT OF COMMUNICATION
Recipient must be injured patient, family or representative VOLUNTARINESS Communication is mandatory Communication is discretionary

US Disclosure Laws (cont...)

Provision INFORMATION REQUIRED TO BE CONVEYED Statement that unanticipated outcome occurred 9 No of states

Explanation of facts, context of unanticipated outcome

Acknowledgement of harm Explanation of impact on treatment plans or health status, or both Explanation of investigation or follow-up done or to be done Explanation of cause of unanticipated outcome

0
0 0 0 0

Offer of support services

Statement of accountability or responsibility Statement of patients legal rights

0
0 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

Best practice for Disclosure laws

Provision Protected content Recommended Practice Drafted broadly to protect statements that an unanticipated outcome occurred and statements of sympathy, explanation, and fault Cover individual and institutional health care Providers Require disclosure of all unanticipated outcomes Specify a time frame in which communications must be made . Time frame should encourage prompt initial disclosures that an unanticipated outcome occurred but should permit additional investigation time before an explanation of the outcome is required. Require both oral and written notification for serious unanticipated outcomes, but permit oral communications to suffice for less serious events. Statute should provide a definition of a serious unanticipated outcome.

Covered parties Triggering event Timing of communication

Form of communication

Best practice (cont...)

Provision Recipient of communication Voluntariness Required content Recommended Practice Apply only to communications made to the injured patient, his or her family, representative, or friend Should mandate communications following unanticipated outcomes Should require that the communication include a statement that an unanticipated outcome occurred, an explanation of the facts or context of the event, an acknowledgment of harm, an explanation of the impact on the patients treatment plans and health status, an explanation of the investigation or follow-up done or to be done, and an offer of support 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

Conclusions
Ethics, policy and guidelines support open disclosure

of adverse events Patients expect open and honest communication following adverse events but this does not always happen Failure to disclose adverse events may give rise to disciplinary and civil liability consequences Proposals for law reform to ensure open disclosure include enacting a statutory duty to disclose Policy makers and health care providers need to have realistic expectations about what disclosure laws can accomplish