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THE OPEN
DISCLOSURE STANDARD
Professor Loane Skene
5th Annual Obstetric Malpractice
Conference, Melbourne 20-21 June 2013
1. BACKGROUND There has been growing
recognition in legislation and case law that there should be
greater openness between health professionals and
patients.
1.1 Informed decision making
Health Services Act 1988 (Vic)
s 9 Objectives
To ensure that …
(e) users of health services are provided with sufficient information in appropriate forms and languages to make informed decisions about health care; and …
(g) users of health services are able to choose the type of health care most appropriate to their needs.
Rogers v Whitaker (1992) 175 CLR 479
“paramount consideration: patient entitled to make his own decisions about his life” …
Rogers v Whitaker l a doctor must disclose material risks
l “a risk is material if … a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it or if the [doctor] is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it”
Rogers v Whitaker l Mrs Whitaker - 47 - blind in one eye since
childhood - stick in eye - consulted Mr
Rogers - ophthalmic surgeon specialising
in anterior segment surgery
l He operated to improve vision and
appearance of eye (removing scar tissue)
l 1:14,000 risk of sympathetic ophthalmia
l She was nervous, anxious patient- asked
lots of Qs - but not about blindness
l became blind - over $700,000 damages
The test of material risk is patient- centred - Bolam
principle rejected
Bolam: Not negligent to act in accordance with a responsible body of opinion within the medical profession
Bolam v Friern Barnet Hospital Management Committee [1957] 1 WLR 582
1.2 Professional guidelines
Physician Charter On Medical Professionalism 2002
Competence
Honesty
Confidentiality
Maintaining appropriate relationships
Improving quality care/access to care
Just distribution of finite resources
Scientific knowledge
Maintenance of trust
Professional duties – unprof behaviour
1.3 Freedom of information
Freedom of Information Act
1982 (Vic)
s 13 Subject to this Act, every person has a legally enforceable right to obtain access in accordance with this Act to
(a) a document of an agency*, other than an exempt document;
*includes public hospitals
Health Records Act 2001 (Vic)
s 25 (1) …an individual has a right of access … to health information relating to the individual held by a health service provider or any other organisation*.
*includes private sector hospitals/ doctors.
Also Privacy Act 1988 (Cth)
1.4 Apologies: tort law reform
Wrongs Act 1958 (Vic) s 14J:
s 14J(1) In a civil proceeding where the death or injury of a person is in issue or is relevant to an issue of fact or law, an apology does not constitute
(a) an admission of liability for the death or injury; or
(b) an admission of unprofessional conduct, carelessness, incompetence ...
2. QUALITY ASSURANCE
There has been growing awareness of medical error in hospitals and the need to identify and remedy systemic issues.
Sunday Mail Adelaide 11 July 2010
Lucie van den Berg, ‘Hospitals kill 26’ Herald Sun,
23-Jun-2011 20
21
One response has been quality assurance committees
to review adverse events, protecting all discussion
from disclosure, to encourage complete honesty and improve care in future.
Health Services Act 1988 (Vic)
s 139(3) A person who is or has been a member, officer or employee of a [quality assurance] committee … must not either directly or indirectly-
(a) make a record of or divulge or communicate to any person any information …
Other responses require reporting to public agencies
Coroners Act – certain deaths
reportable
Public Health laws – notifiable diseases
Health Practitioner Regulation
National Law - mandatory notification for all HPs
2. OPEN DISCLOSURE STANDARD
(Australian Commission on Safety and Quality in Health
Care; first published ten years ago)
Open Disclosure Standard A NATIONAL STANDARD
FOR OPEN COMMUNICATION IN PUBLIC AND PRIVATE
HOSPITALS, FOLLOWING AN ADVERSE
EVENT IN HEALTH CARE
Recommends that public and private hospitals and other
organsisations should engage in “open communication … about what has happened,
why it happened and what is being done to prevent it from
happening again”.
Open disclosure The open discussion of incidents that have harmed a patient receiving health care.
Elements
–expression of regret
–factual explanation - what happened
and potential consequences
–the steps being taken to manage the event and prevent recurrence …
Open disclosure (cont)
–contact details/services by social workers, religious representatives etc who can provide emotional support
–contact details of a staff member who will have an ongoing relationship with the patient.
–how to make a complaint/access records.
Staff must not - Divulge or record any information other
than established facts in appropriate
language (record may later be accessed
under FOI)*
Admit liability – state that they, or another
HP, or the hospital are legally responsible.
Breach any applicable law/obligations.**
* exception: expert opinion based on facts
** eg under hospital’s/MDO’s insurance contracts;
privileged information (next slide); Coroner
Legal professional privilege
Covers documents created for giving/receiving legal advice, or use in legal proceedings eg reports, witness statements.
Protected from disclosure, FOI.
Qualified privilege legislation covers information from QA activities; eg Health Services Act 1988 (Vic) s 139
Staff support from hospital Recognise health care is risky; don’t
blame – improve system
Culture encouraging communication
Advice and training on managing adverse
events; debriefing, including process of
investigation
Not discriminate against staff involved in
OD process
Tell staff about support available (eg
Doctors Health Advisory Service)
Scenario Elderly patient in public hospital falls from
her bed when going to the toilet > broken ankle.
Is this an adverse event? (‘incident in which unintended harm resulted to a person receiving health care’).
Does the hospital have an OD policy?
Member of clinical team conducts initial assessment of patient and consults senior HP to confirm evaluation....
Scenario (cont) Is this an injury requiring ‘high level response’(death, permanent loss or lessening of function, surgery needed)? Multi-disciplinary team and treating staff establish facts and response needed; who will discuss with patient/support person; consistent approach.
Could there be media attention? Consult CEO/management.
What staff support is needed? ...
Scenario (cont)
What is hospital/lawyers’/insurers’ policy on disclosure?
Initial discussion with patient by most senior HP treating the patient, with senior HP’s support. Only facts, regret, steps being taken; listen to patient; offer support. Note matters disclosed/discussed.
Inform hospital risk manager, insurer, patient’s GP (with patient’s consent), Coroner (for death); hospital CEO (if serious)
Investigate; analyse; change; feedback to patient.
Comments and questions ...