Quality and Safety

What is the Medical Defence Organisation's stand on open disclosure?: Medical Defence Organisations (MDOs), through their nominated representative, voted in favour of the adoption of the National Open Disclosure Standard. The guidelines on how members will be assisted throughout an open disclosure process have been developed in collaboration with medical defence organisations. Treasury Managed Fund (TMF) has also been actively involved in consultations with NSW Health. Members of MDOs may wish to obtain further specific information and guidance from their organisations.
MDOs are committed to supporting their members, on the understanding that they will be informed at an early stage of any open disclosure process and have the opportunity to advise and assist.
This position will be confirmed to a doctor who reports an open disclosure event to his/her MDO. The first point of contact should be the medico-legal advisory telephone service of the MDO.
Issues that will be addressed by an adviser include:

confirmation of member details
nature of incident
nature/extent of member involvement
the need, if any, to provide written notification under the relevant medical indemnity insurance policy
advice in relation to the terms of the policy, which will probably require the doctor not to make any admission of liability, offer or promise without insurer consent
advice in relation to the Civil Liability Act provisions concerning apologies
suggestions, if appropriate, about language and communication, to assist the member in making a frank disclosure and/or expressing regret, without offending the insurance policy conditions
in some cases, a meeting between member and a legal adviser may be arranged and further support may be provided in negotiating the open disclosure process and in reviewing reports and other documents.
I am a privately insured VMO or other medical practitioner. When should I notify my MDO?: If you are a VMO or other medical practitioner who is insured with an MDO, your insurance policy specifies when you must notify your MDO of an adverse event. You should notify your insurer before commencing the open disclosure process, after ensuring that the patient is safe. You should notify your MDO of the incident regardless of its severity. A seemingly minor incident may have serious ramifications for you later.
Many MDOs also provide legal advice to their members, including legal advice on the open disclosure process.
I am a privately insured VMO or other medical practitioner. How can I ensure I do not jeopardise my insurance coverage by participating in the open disclosure process?: Admitting liability may fall within an exclusion clause of your insurance policy and may result in you not having independent legal representation or assistance in relation to any investigation by, for example, the Health Care Complaints Commission, the Medical Board or a Coronial Inquiry.
How should the open disclosure process be managed when more than one indemnity provider (ie TMF and an MDO) is involved?: If necessary, representatives from MDOs and TMF will liaise to ensure that the information provided to patients as part of the open disclosure process does not jeopardise the insurance cover of any of the health professionals involved in the incident.
If written information is to be provided to the patient, TMF and MDOs may review the draft version to ensure that it satisfies their requirements. This process should also ensure that the information provided to patients is consistent and not contradictory or duplicated.
What is an apology/admission of liability?: a key aspect of open disclosure is saying sorry or offering an apology to the patient and their support person following an incident. According to the Open Disclosure Policy (page 3), an apology...
... an expression of sympathy or regret, or of a general sense of benevolence or compassion, in connection with any matter whether or not the apology admits or implies an admission of fault in connection with the matter.
An apology is defined by s68 of the Civil Liability Act 2002 as an expression of sympathy or regret, or of a general sense of benevolence or compassion, in connection with any matter whether or not the apology admits or implies an admission of fault in connection with the matter. An apology does not constitute an express or implied admission of fault or liability and is not admissible in any civil proceedings as evidence of fault or liability.
The Open Disclosure Guidelines provide advice on how to offer an apology or expression of regret. The apology should include an expression of sorrow for the harm done to the patient, but it must not be an admission of liability. Staff must be careful not to make any verbal or written statement that admits liability. An admission of liability means admitting that the hospital or a staff member breached their duty of care to the patient, which led to the patient suffering harm or injury.
An apology:

does not blame the health facility for harm caused to the patient
does not blame a clinician for harm caused to the patient
does not blame the Health Service for harm caused to the patient
does not indicate that the incident could have been avoided.

For example, the following statement does not admit liability. It provides facts but no conclusions:
"Your husband, John, was given an injection of penicillin shortly before his death. There were notes in his medical records that he was allergic to penicillin, but the person who gave the injection did not see the notes. We are sorry about this incident."
The following statement admits liability by admitting breach and causation. Duty should not be an issue in an apology.
"The nurse knew your husband, John, was allergic to penicillin, because it is written all over the notes; but she gave him the injection by mistake that caused him to have an anaphylactic reaction, from which he could not be resuscitated. We are very sorry about this incident".
In discussions with the patient and their support person, health care professionals may:

acknowledge that an adverse event has occurred
acknowledge that the patient is unhappy with the outcome
express regret for what has occurred
provide known clinical facts and discuss ongoing care
indicate that an investigation is being or will be undertaken, and agree to provide feedback on the investigation when available.
Health professionals should not:

state that they are liable for the harm caused to the patient
state that another health care professional or the PHO is liable for the harm caused to the patient
say the event should not have happened or could have been avoided.

Refer to Appendix C: Saying sorry on page 25 of the Open Disclosure Guidelines for useful tips on making an apology.
Do documents created during the open disclosure process have any special status?: No. Any documents created during the open disclosure process should be treated in the same way as any other part of a patient's clinical record. They should also be retained in accordance with the State Records Act and guidelines.
Documents relating to open disclosure may be provided to patients on request, produced under Freedom of Information legislation, or in answer to a subpoena. Patients can also request access to records relating to them, and request amendments to their records, if the records contain incomplete or misleading information, pursuant to the Health Records and Information Privacy Act.
Just like clinical records, health care professionals should take care when creating documents to ensure that they do not contain inappropriate language, and are accurate. As far as is possible, only verified facts should be contained in documents. Documents should not:

attribute blame to any health care professional or PHO
record opinions, unless the opinions are expert opinions and based on supporting evidence
contain statements which are likely to be defamatory.
Although open disclosure documents will not be covered by client legal privilege, notifications of incidents to TMF / VMOIRs / MDOs may be privileged and should not be provided to patients. In addition, documents created during an RCA (other than the final report and causation statements) have a special statutory privilege and cannot be provided to patients. For a discussion of types of privilege, see the Policy Directive on Subpoenas.
What is a defamatory statement?: A defamatory statement is the communication of an insulting or denigrating statement concerning one person to another person, that is capable of injuring the person's reputation, such as an allegation by one health care professional that another is incompetent.
In order to avoid making defamatory statements during the open disclosure process, those involved in the open disclosure process should ensure that:

statements made or recorded are accurate and verified
conclusions are based on the facts and follow logically, fairly and reasonably from the information obtained
rumours, or material known to be false or irrelevant material is excluded
the manner and extent of the disclosure does not exceed what was reasonably required for the purposes of open disclosure.
What about privacy and confidentiality?: Strict confidentiality requirements apply to persons working in the health system. These confidentiality requirements apply generally to patient information, including information gathered as part of the open disclosure process.
Health professionals have statutory duties of confidentiality imposed by section 22 of the Health Administration Act and section 289 of the Mental Health Act. Health professionals also have a common law duty and an ethical duty to maintain patient confidentiality.
PHOs and health professionals also have an obligation to respect the privacy of staff during the open disclosure process. The open disclosure process should be in accordance with the Health Records and Information Privacy Act and the NSW Health Privacy Manual (Version 2).
Can a patient have two support people, and what happens if there is conflict between the support people?: For practical reasons, patients should nominate only one support person. However, in the circumstance where a patient nominates more than one that is acceptable. Common sense should prevail with regards to the actual number. In the case of minors these patients will regularly have two support persons (ie both parents). If a conflict arises between the support people as to how the open disclosure process will progress, this should be managed using strategies such as repeat discussion, mediation, and counselling.
If the parents of a minor (under 18 years of age) are divorced or separated, PHOs should assume that both parents have retained full responsibility for the minor, unless the Family Court has made an order stipulating that one or both parents have particular responsibilities. Unless Court orders have been made, parental responsibility is not affected by changes to relationships (ie if the parents separate).
This means that in order for a PHO to discharge its legal obligations, discussion with, or the consent of, either parent is usually sufficient. There is generally no reason why the consent or participation of both parents would be required, however, in practice, there is no reason why both parents should not be involved in making treatment decisions, and in the open disclosure process. See section 26 of the Consent to Medical Treatment - Patient Information for further information.
What happens if the support person is not the patient's guardian, or 'person responsible"?: In these cases, the open disclosure process should take place with the involvement of the support person, however, discussions relating to further treatment must involve the person who has the legal capacity to make treatment decisions on behalf of the patient.
Who do I contact for assistance?: If you are a VMO with private insurance cover, you should contact your Medical Defence Organisation for assistance relating to insurance or legal issues.
If you are a Risk Manager or Director of Clinical Governance in a PHO, you can contact the following:

insurance issues: Finance and Administration Branch, NSW Department of Health / TMF
legal issues: Legal Branch, NSW Department of Health
If you are an employee of a PHO or a VMO with TMF indemnity cover, you should contact your Risk Manager / Clinical Governance Unit in the first instance.