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This article discusses the importance of open disclosure in healthcare, the legal aspects surrounding informed decision-making and access to health information, and the role of quality assurance committees in improving patient safety. It also highlights the development and integration of the Open Disclosure Framework in national quality and safety standards.
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OPEN DISCLOSURE Professor Loane SkeneAustralasian Association of Bioethics and Health Law (AABHL) Conference Sydney 11-14 July 2013
1. BACKGROUND There has been growing recognition in legislation and case law that there should be greater openness between health professionals and patients.
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 • a doctor must disclose material risks • “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”
The test of material risk is patient-centred - Bolamprinciple 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
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
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)
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.
Lucie van den Berg, ‘Hospitals kill 26’ Herald Sun, 23June 2011
$20 million compo for birth bungles, Herald Sun 13 Dec, 2010 http://www.heraldsun.com.au/ipad/million-birth-bungle-compo/story-fn6bfkm6-1225969808379#content
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
3. OPEN DISCLOSURE STANDARD (Australian Commission on Safety and Quality in Health Care; first published ten years ago)
Later developmentsSlide below from Prof Rick Iedema, Professor & Director, Centre for Health Communication, University of Technology, Sydney 2005-7 ACSQHC* pilot involving 42 hospitals 2007-8 UTS-CHC evaluation of the pilot 2009-11 “100 patient stories project” 2011-12 ACSQHC drafting “Open Disclosure Framework” 2013 ACSQHC publication of “Open Disclosure Framework” [this will replace OD standard] 2014 integration of OD Framework into National Q&S Standards [*Australian Commission on Safety and Quality in Health Care]
OD 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 – opportunity for patient, family, carers to relate their experience – dialogue, over time [new]. • Elements: what staff should say • Apology (say ”sorry” [new]); expression of regret • factual explanation - what happened and potential consequences
Open disclosure (cont) • the steps being taken to manage the event and prevent recurrence … • 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) (exception: expert opinion based on facts) Admit liability – state that they, or another HP, or the hospital are legally responsible. Breach any applicable law/obligations. Eg: - under hospital’s/MDO’s insurance contracts - privileged information (next slide)
Staff must not disclose privileged information 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 “Supporting and meeting the needs and expectations of those providing health care” [new] 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, apology, regret, steps being taken (not privileged information); 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.