Medical Disclosure When Things go Wrong

7/27/2019 Medical Disclosure When Things go Wrong

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Associate ProfessorTina Cockburn

Queensland University of

TechnologyFaculty 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 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)



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



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





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.



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



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



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)



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



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



http://images.google.com.au/imgres?imgurl=http://www.medicallawreporter.com/images/Logo.gif&imgrefurl=http://www.medicallawreporter.com/&usg=__q46Vb20IZ6Vxh8VsB21fTfclEPk=&h=1172&w=1177&sz=193&hl=en&start=1&tbnid=Vb88cem2L-aunM:&tbnh=149&tbnw=150&prev=/images?q=medical+law&gbv=2&hl=en&sa=G



“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



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



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



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



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



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 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



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]





• 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 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



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.”



•

Apology protections• Disclosure laws



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



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



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



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.



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



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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Documents

Medical Disclosure When Things go Wrong