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South Yarra Day Surgery By-Laws

 

Index

1. Medical Advisory Committee …………………………………………………………………………………………………..

2. Appointment of Medical Practitioner …………………………………………………………………………………………

3. Responsibilities of Credentialed Medical Practitioner ……………………………………………………………………

4. Consent for Medical Treatment ……………………………………………………………………………………………….

5. Pre Admission Advise ……………………………………………………………………………………………………………

6. Medical Record Documentation ……………………………………………………………………………………………….

7. Disclosure of Patient Information …………………………………………………………………………………………….

8. Open Disclosure of Adverse Patient Events ………………………………………………………………………………..

9. Code of Conduct ………………………………………………………………………………………………………………….

10. Antimicrobial Stewardship ………………………………………………………………………………………………………

11. Quality & Safety …………………………………………………………………………………………………………………..

12. Partnering with consumers …………………………………………………………………………………………………….

 

1. Medical Advisory Committee

The Medical Advisory Committee is committed to ensuring patients receive high quality services. The Medical Advisory Committee is responsible for:

  • Reviewing and approving Credentialing and Scope of Clinical Practice for Medical Practitioners
  • Ensuring the safety and quality of service delivery across the organisation for all patients through practice of high clinical standards
  • Identification of risks. Understanding key risks and ensuring controls and mitigation strategies are in place to mitigate them. Review of the risk register.
  • Adherence to relevant legislative and regulatory requirements and for the planning, implementation, monitoring and evaluation of the safety and quality systems.
  • Being accountable for the quality and safety of the care provided by the organisation

setting a clear vision, strategic direction and ‘just’ organisational culture that drives consistently high-quality care and facilitates

  • Effective employee and consumer engagement and participation, staying engaged, visible and accessible to staff
  • Ensuring it has the necessary skill set, composition, knowledge and training to actively lead and pursue quality and excellence in healthcare
  • Monitoring and evaluating all aspects of the care provided through regular and rigorous reviews of benchmarked performance data and information
  • Ensuring robust clinical governance structures and systems across the health service
  • Effectively support and empower staff to provide high-quality care
  • To approve, review and implement new clinical procedures, services or equipment
  • Review, analyse and make recommendations and improvements on clinical incidents and sentinel events
  • Discuss and make recommendation regarding any clinic matters
  • Review Infection Control Audits and Reports
  • Review Internal Audits

The Medical Advisory Committee is the highest level of Governance at South Yarra Day Surgery.

Members of the Medical Advisory Committee will be appointed by the Medical Director. Appointments will be for a term of three years after which point the member can be re-elected.

 

2. Appointment of Medical Practitioner

Visiting Medical Officers who wish to work at South Yarra Day Surgery are required to have their qualifications and experience screened by Medical Advisory Committee.

VMOs only permitted to perform duties and tasks, including operations, which are within their qualifications and approved appointment credentials.

Obtain training in new procedures

Must inform SYDS if they have been involved in a critical incident or there have been major complications from surgery resulting in the need for intervention by other specialist in another hospital or if any conditions are imposed on their AHPRA Registration

NEW APPOINTMENTS

New Appointments Upon initial application, the Medical Practitioner must complete an application form and provide the following to the Medical Director at South Yarra Day Surgery:

• Proof of identity (100 points)

• National police check history

• International police check if applicant has lived overseas for 12 months or more during the past 10 years

• Original qualifications or certified copy including the primary medical degree and a certified translation if not in English.

• Original or certified copy of specialist qualifications and a certified translation if not in English.

• Other evidence of clinical training and experience as required

• Medical Registration including: – current Medical Board of Australia (AHPRA) registration – confirmation of the presence or absence of conditions, undertakings, endorsements, notations, and reprimands – confirmation of the type of registration (for example, general or specialist)

• The original or certified copy of current Practitioners Medical/Professional Indemnity Insurance certificate ensuring that the cover reflects the requested scope of practice

• Health status, (complete a staff health survey or this may be discussed privately with the director of medical services (or equivalent, who will then be responsible for deciding how this will affect the scope of clinical practice)

• Continuing Professional Development (CPD) statements that are college approved or relevant to the scope of clinical determined by the health service and include either” – copies of compliance certificates, – statements verifying CPD participation by relevant college or Australian Medical Association CPD tracker printouts

• Employment and/or visiting history: Current Curriculum Vitae, verified by checking with other sources and including: – clinical appointments – academic appointments and teaching experience – quality activities

• Evidence of current compliance with all maintenance of professional standard requirements as determined by speciality colleges

• Referee Checks (at least 2) that: – must not be limited to unsolicited written references – if undertaken by verbal contact must be documented, preferably in a structured format – may be undertaken by templates sent to nominated referees – consider the appropriateness and the bona fides of referees – include referees who work largely in the specialty of the applicant practitioner and have been in a position to judge the practitioner’s experience and performance during the previous three years and have no conflict of interest in providing a reference

• Existing contract or employment arrangements outside of the current appointment checked, with relevant documentation available.

This information will be provided to the The Medical Advisory Committee who will consider the following:

Training and recent experience

Competence and clinical judgment

Professional capability and knowledge

Current fitness to practice and good character

Confidence in applicant’s capability and knowledge

Referees reports

Following the MAC meeting, the Medical Practitioner will be notified in writing if the application was successful. A letter outlining the terms of their appointment will be sent to the VMO to be signed and one copy to be sent back to the South Yarra Day Surgery to be filed in their personnel file.

A Medical Practitioner who has their application denied has the right to appeal the decision.

 

RE-CREDENTIALING

 

The formal process used to Re-appoint a Medical Practitioner with no change of scope to clinical practice and to re-confirm the qualifications, experience and professional standing (including history of and current status with respect to professional registration, disciplinary actions, indemnity insurance and criminal record) of medical practitioners, for the purpose of forming a view about their ongoing competence, performance and professional suitability to provide safe, high quality healthcare services within specific organisational environments. :

Reappointment of a medical practitioner at the same health service with no change to scope of practice Reappointment must take place every three years. The Medical Advisory Committee must verify the following information:

• Medical registration including: – current Medical Board of Australia (AHPRA) registration – confirmation of the presence or absence of conditions, undertakings, endorsements, notations and reprimands – confirmation of the type of registration (for example, general or specialist

• The original or certified copy of current Practitioners Medical/Professional Indemnity Insurance certificate ensuring that the cover reflects the requested scope of practice

• CPD: college certificate or evidence of relevant CPD, confirming with the relevant college if indicated

• Health status, (this may be discussed privately with the director of medical services (or equivalent) who will be responsible for deciding how this will affect the scope of clinical practice)

• Recent employment and/or visiting history – an updated curriculum vitae including (but not restricted to): – clinical appointments – quality activities – academic appointments and teaching experience

The re-application will be presented to the Medical Advisory Committee who will decide if clinical privileges will be approved for a further 3 years. Following the MAC meeting, the Medical Practitioner will be notified in writing if the application was successful. A letter outlining the terms of their appointment will be sent to the VMO to be signed and one copy to be sent back to South Yarra Day Surgery to be filed in their personnel.

 

ANNUAL REQUIREMENTS

To fulfil credentialing requirements, each year the Medical Practitioner must provide the centre with:

  • Current AHPRA Registration confirming the presence or absence of conditions, notations, undertakings or reprimands.
  • Relevant CPD
  • Current Medical Indemnity Insurance that reflects the scope of practice

Where new services are introduced or where a Medical Practitioner wishes to extend their scope of clinical practice, they must formally undergo appropriate credentialing specifically for the new service or practice. They must provide the MAC with:

  • The change to the scope of clinical practice requested
  • Additional procedural qualifications or experience needed for the requested change
  • Medical Indemnity Insurance that reflects the requested change to scope of clinical practice
  • CPD- College certificate or evidence of relevant CPD

The MAC is responsible for confirming that the requested changes fit the need and capability of South Yarra Day Surgery

A scope of clinical practice may also be reduced for example due to underperformance or if CPD requirements have not been met, When this occurs, the MAC must notify the Practitioner in writing and provide an amended position description.

In case of unforeseen circumstances such as severe illness of the surgeon or anaesthetist, emergency Clinical Privileges will be granted to the nominated Medical Practitioner temporarily. The CEO has the responsibility of undertaking credentialing and defining the scope of clinical practice in this situation.

In this Situation the ‘Application for credentialing and scope of clinical practice- urgent situations’ must be completed and the applicant must provide:

  • Current Medical Indemnity Insurance certificate relevant to scope of clinical practice
  • Current AHPRA Registration
  • 100 points of ID
  • Current CV
  • Working with Children Check (if applicable)

Temporary credentialing must be followed-up as soon as practical in line with the formal credentialing process and should not exceed 3 months.

EMERGENCY CLINICAL SITUATION

Should the need arise, a credentialed Medical Practitioner has the authority to administer necessary treatment outside their scope of clinical practice in an emergency situation when the interest of the patient are best served. Should this occur, a IIIR should be raised and the incident discussed at the next MAC meeting.

3. Responsibilities of Medical Practitioners

The Credentialed Medical Practitioner:–

  • Has responsibility for the medical care and treatment of the patient and has overall accountability for patients care
  • Must work as part of multidisciplinary collaboration and work as a team
  • Must include patients in shared decision making in all aspects of their treatment and care

4. Consent for Medical Treatment

It is the responsibility of the Medical Practitioner to ensure that the informed consent of patients to the nature and form of all treatment is obtained prior to the day of surgery. Consent must be informed and patients advised of any side effects and complications of the procedure. Surgery will not proceed until consent is obtained

5. Pre Admission

All patients must complete pre-admission paperwork and undergo Pre-admission screening with the Medical Practitioner prior to procedure day to ensure they are suitable for the facility and do not fall within the exclusion criteria. Pre-admission assessment must be documented in the patients’ healthcare record and must be completed at a minimum of 24 hours prior to admission. All Medical Practitioners must adhere to the South Yarra Day Surgery Medicine Pre-admission policy and exclusion criteria.

6. Medical Record Documentation

During the course of a patient’s treatment at the Centre, clear, legible and relevant information shall be documented in the patient’s medical record.

All orders for treatment of the patients shall be clearly conveyed to the nursing staff by the Medical Practitioner directing such treatment.

Ambulatory Report must be completed for each procedure including documentation of medications given, procedure notes and post procedure notes.

Observations must be documented on the coloured Track and Trigger Observation Chart.

The nursing staff must be provided with clear written instructions regarding discharge of patients and the arrangements for follow-up.

All pre-medication and procedure medication must be documented in the medical record.

All paperwork in the medical record must be completed.

7. Disclosure of Patient Information

South Yarra Day Surgery is committed to the protection of personal privacy of our patients. Our policy is based on the Health Privacy Principles as detailed in the Health Records Act 2001, (VIC) and the Australian Privacy Principles as detailed in the ‘The Privacy (Private Sector Amendment) Act 2000 as amended’. The policy deals with the collection, use and disclosure of personal health information as well as access and correction, data security and data retention.

All staff employed are required to sign a confidentiality agreement.

South Yarra Day Surgery complies with the Notifiable Data Breach scheme. We notify affected individuals and the Office of the Australian Information Commissioner (OAIC) when a data breach is likely to result in serious harm to individuals whose personal information is involved in the breach.

A data breach occurs when personal information held by an organisation is lost or subjected to unauthorised access or disclosure.

8. Open Disclosure & Statutory Duty of Candour

An open disclosure policy is in place for all clinical adverse events, including Statutory Duty of Candour that includes Serious Adverse Patient Safety Events (SAPSE). It is the responsibility of the Medical Practitioner to complete the Open Disclosure Procedure and Statutory Duty of Candour process as per the timeframes listed in the policy.

9. Code of Conduct

It is expected that in line with the Occupational and Safety Regulations 2017, all credentialed Medical Practitioners will adhere to the hospital code of conduct when dealing with all staff, patients and contractors. Serious breaches of the code of conduct will result in a review of credentialed status.

10. Antimicrobial Stewardship

Antibiotics are not to be routinely prescribed at South Yarra Day Surgery. If Antibiotics are prescribed or used, they must be documented in the Antibiotic Register. A formulary for approved antibiotics and indications is documented in the Antimicrobial Stewardship Policy. An audit of antibiotic use will be audited by our Infection Prevention Australia Infection Control Consultant to ensure compliance.

11. Quality & Safety

Credentialed Medical

Practitioners are expected contribute to the ongoing quality and safety of the Centre by participation in the quality management program through peer review , collection of relevant clinical indicators and assistance with quality and safety activities as required. All Credentialed Medical Practitioners

are to follow South Yarra Day Surgery policies and procedures, National Safety & Quality Health Service Standards, Infection Control Standards and Dept of Health regulations.

12. Partnering with Consumer

Patients and their carers are to be involved in shared decision making and all aspects of their care in relation to the procedure and discharge planning. They must be provided with adequate written information for pre-procedure and discharge. Patient goals and needs should be taken into consideration when care planning

 

 

 

Open Disclosure & Statutory Duty of Candour

 

 

Purpose

To ensure Clinicians communicate with and support patients, their family and carers who have experienced harm during healthcare and follow Victorian Duty of Candour Guidelines for Serious Adverse Patient Safety Events (SAPSE.

Process

What is Open Disclosure?

Open disclosure is the open discussion of adverse events that result in harm to a patient while receiving health care with the patient, their family and carers. The elements of open disclosure are:

-an apology or expression of regret, which should include the words ‘I am sorry’ or ‘we are sorry’

-a factual explanation of what happened

-an opportunity for the patient, their family and carers to relate their experience

-a discussion of the potential consequences of the adverse event

-an explanation of the steps being taken to manage the adverse event and prevent recurrence.

It is important to note that open disclosure is not a one-way provision of information. Open disclosure is a discussion between two parties and an exchange of information that may

Open Disclosure should be used for the equivalent of an ISR 3 or 4 within public health services (VHIMS). SDC (Refer to Statutory Duty Of Candour Section) should be used be used for ISR 1 or 2.

Open Disclosure Principles

Open and timely communication

If things go wrong, the patient, their family and carers should be provided with information about what happened in a timely, open and honest manner.

Acknowledgement

All adverse events should be acknowledged to the patient, their family and carers as soon as practicable. Health service organisations should acknowledge when an adverse event has occurred and initiate open disclosure.

Apology or expression of regret

As early as possible, the patient, their family and carers should receive an apology or expression of regret for any harm that resulted from an adverse event. An apology or expression of regret should include the words ‘I am sorry’ or ‘we are sorry’, but must not contain speculative statements, admission of liability or apportioning of blame

Supporting, and meeting the needs and expectations of patients, their family and carers

The patient, their family and carers can expect to be:

-fully informed of the facts surrounding an adverse event and its consequences

-treated with empathy, respect and consideration

-supported in a manner appropriate to their needs.

Supporting, and meeting the needs and expectations of those providing health care

Health service organisations should create an environment in which all staff are:

-encouraged and able to recognise and report adverse events

-prepared through training and education to participate in open disclosure

-supported through the open disclosure process

Integrated clinical risk management and systems improvement

Thorough clinical review and investigation of adverse events and adverse outcomes should be conducted through processes that focus on the management of clinical risk and quality improvement. Findings of these reviews should focus on improving systems of care and be reviewed for their effectiveness. The information obtained about incidents from the open disclosure process should be incorporated into quality improvement activity

Good governance

Open disclosure requires good governance frameworks, and clinical risk and quality improvement processes. Through these systems, adverse events should be investigated and analysed to prevent them recurring. Good

governance involves a system of accountability through a health service organisation’s senior management, executive or governing body to ensure that appropriate changes are implemented and their effectiveness is reviewed. Good governance should include internal performance monitoring and reporting.

Confidentiality

Policies and procedures should be developed by health service organisations with full consideration for patient and clinician privacy and confidentiality, in compliance with relevant law (including Commonwealth, state and territory privacy and health records legislation).

When does the Open Disclosure Process begin?

Open Disclosure is part of Incident Reporting. As soon as an incident is identified and the risk level identified, the open disclosure response is graded as a general level response (usually low to medium risk) or a high-level response (usually high to very high risk).

General indications of a lower-level response are:

-Near Miss/ no-harm incident

-No permanent injury

-No increased level of care required

-No, or minor, psychological or emotional distress

General indications of a higher-level response are:

-Death or major permanent loss of function

-Permanent or considerable lessening of body function

-Significant escalation of care/ change in clinical management

-Major psychological or emotional distress

-At the request of the patient

See Open Disclosure Flowchart (Australian Commission on Safety and Quality in Health Care)

The Open Disclosure Checklist should be started.

The Open Disclosure Documentation and Discussion Summary should be completed for any discussions.

General Level Response

The purpose of the first meeting is to support and inform the patient. If direct communication with the patient is hindered because of the patient’s clinical condition or language/cultural/disability difficulties or his/her emotional state, consideration should be given to initiating communication with the support person.

IN GENERAL LEVEL RESPONSES, the clinician directly involved in the incident is the most appropriate person to communicate with the patient and their support person. This may be a nurse, allied health professional or junior medical staff.

The general response involves:

-a meeting with the patient and their support person, where practicable

-an explanation of what happened, the immediate effects, and prognosis

-an apology

–The contact names and phone numbers of people in South Yarra Day Surgery who are available to address concerns and complaints, including psychological and social support contacts

–For a general level response, this first meeting with the patient and their support person may bet he only meeting about the incident.

–This meeting may simply be a conversation between the clinician and the patient at the bedside ora telephone conversation with the patient if discharged. It is up to the clinician to initiate a follow-up, if necessary.

–Regardless of the level of response, the patient and their support person must be advised of the known facts of the incident within 24 hours of identification of the incident by South Yarra DaySurgery

-See Open Disclosure Framework Flow Chart

–The incident must be recorded in the patient’s health care record and on the IIIR Form and IIIRRegister

–If the incident escalates to a high or very high- risk incident, a high- level response should be initiated. A general level response can also be escalated to a high -level response at the discretionof the senior clinician and the senior manager.

High Level Response

The High -level response involves the full open disclosure process as follows:

Establish the open disclosure team. Senior Management forms an open disclosure team as soon as the severity of the incident has been established. The teams role is to support and assist with managing the open disclosure process and develop a robust plan to ensure that communication is consistent and accurate.

Team members may include the following:

-Patients senior clinician

-Director of Nursing/ Senior Manager or equivalent

-Another involved clinician

-A patient advocate

-If required, CEO

The team

meets as soon as possible after the incident to discuss the following:

-Nominating the team leader who communicates with the patient and their support person

-Immediate patient care

-Ongoing patient care and support

-Basic clinical and other facts relevant to the incident

-Level of support for the patient’s family and support person

-Level of support for staff and responsibility for providing that support

-How to maintain a consistent approach in discussions with the patient and their support person

Reporting of very high- level risk to Department of Health.

The Department of Health has a schedule of Sentinel Events that require reporting. The Sentinel Event form must be completed via https://www.bettersafercare.vic.gov.au/our-work/incident-response/sentinel-events/how-to-report

Notifying the Medical Defence Organisation

It the incident is significant or involves the high-level open disclosure response, it is recommended that Medical Practitioners contact their Medical Defence Organisation at the earliest practical opportunity for advice and support, at the same time meeting any insurance notification obligations.

Notifying other people/ groups

Other notifications may include (subject to observing applicable privacy requirements):

-The patient’s General Practitioner

–The Coroner (note that the patients family and support person must be notified if the Coroner isnotified)

Meeting with the patient

The initial disclosure meeting with the patient and their support person may involve the team leader, the person(s) directly involved with the treatment that resulted in the incident and the responsible Senior Clinician.

The discussion should include:

-An explanation of what happened and the known facts

-An apology

–The contact names and phone numbers of people in the health facility who are available to address concerns and complaints, including psychological and social support contacts

–Names of people on the open disclosure team

-How the incident will be investigated, what tools will be used

-Steps for ongoing feedback

-Anticipated timelines for investigating the incident

–A statement that an explanation of how or why the incident occurred may be delayed untilinvestigations are complete.

If there is a breakdown in communication between the patient/support person and the team leader, the patient should be offered another person as the team leader.

Follow-up with the patient

The purpose of follow-ups with the patient and their support person is to inform them of the progress of any investigations. Follow-ups must be undertaken either in face-to-face interviews or by letter or both. If there are delays in the investigation, frequent updates should be supplied, together with an explanation of the reason for delays. Following discharge of the patient, a series of follow-up arrangements with the patient and their support person may need to be established to provide updates on findings of investigations.

Final follow-up interview and letter

Issues covered in the final follow-up interview and letter are:

-An apology and expression of regret for the harm suffered

-Acknowledgement of the concerns or complaints of the patient and their support person

–Details of the Root Cause Analysis Final Report and explanation of the report in plain English.

–A summary of the factors contributing to the incident and information on measures being implemented to prevent a similar incident from occurring.

–How improvements will be monitored.

Supporting the Clinician When an incident occurs, the clinicians involved may require emotional and psychological support and advice on how to deal with their response to the incident. Each health facility should have systems in place to ensure that staff are aware and can access adequate support. Opportunities for staff debriefing should be provided as required. Staff involved in the incident should also be advised of the outcomes of the open disclosure process, including recommendations and implementation strategies.

STATUTORY DUTY OF CANDOUR (SDC) FOR SERIOUS ADVERSE PATIENT SAFETY EVENTS (SAPSE) Victoria Duty of Candour Guidelines are in place that apply to all serious adverse patient safety events (SAPSE). A SAPSE is an event that:

  1. a)Occurred while the patient was receiving health services from a health service entity; and b)In the reasonable opinion of a registered health practitioner, has resulted in, or is likely to result in, unintended or unexpected moderate or severe harm or prolonged psychological harm being suffered by the patient. This includes an event that is identified following discharge from the health service entity.

A SAPSE is the equivalent of an ISR 1 or 2 event within public health services (VHIMS).

•ISR 1 – Severe (including death)

•ISR 2 – Moderate

SDC is a legal obligation for Victorian health service entities to ensure that patients and their families or carers are apologised to and communicated with openly and honestly when a SAPSE has occurred. It builds on the Australian Open Disclosure Framework currently utilised for all cases of harm and near miss. If a patient suffers a SAPSE in the course of receiving health services, the health service entity responsible for providing those services owes a SDC to the patient and must do the following unless the patient

has opted out:

  1. provide the patient with:
  2. a written account of the facts regarding the SAPSE;
  3. an apology for the harm suffered by the patient;
  4. a description of the health service entity’s response to the event;
  5. the steps that the health service entity has taken to prevent re-occurrence of the event
  6. any prescribed information;
  7. comply with any steps set out in the Victorian Duty of CandourGuidelines

Stage 1: Apologise and provide initial information

Requirement 1: The health service entity must provide a genuine apology for the harm suffered by the patient and initial information, as early as practicable (and no longer than 24 hours) after the SAPSE has been identified by the health service entity. Refer to Form # F-1.27 Checklist for SDC Process The apology must be provided to the patient, or if the patient lacks capacity or has died, the patient’s immediate family, carer, NOK or a person nominated by the patient, as early as practicable and clinically appropriate with regards to the needs of the patient. The health service entity may decide on the appropriate person to provide the apology, such as a suitably qualified health professional. The health service entity should consider the following in providing the apology:

–express compassion, regret or sympathy;–say the words ‘I am/We are sorry’; and–avoid jargon or legalistic wording.

– Apology not an admission of liability:

–In a civil proceeding where the death or injury of a person is in issue or is relevant to an issue, an apology:–does not constitute an express or implied admission of liability for the death or injury; and–is not relevant to the determination of fault or liability in connection with that proceeding.–This is relevant whether the apology is made orally or in writing or is made before or after the civil proceeding was in contemplation or commenced.–Evidence of an apology made by or on behalf of a person or a health service entity in connection with any matter alleged to have been caused by the person or health service entity is not admissible in any civil or disciplinary proceedings as evidence of the fault or liability of the person or health service entity in connection with that matter.1–The initial information may be provided with the initial apology, however, should ideally be performed by a suitably qualified health professional.–When providing initial information, the health service entity must:–provide factual information that is known at the time about the event

–offer written patient information on the adverse event review process (e.g. information flyer);and–provide the details of key contacts the patient can liaise with, including where relevant, anAboriginal Hospital Liaison Officer (AHLO).–When providing initial information, the health service entity should:–be sensitive and empathetic;–acknowledge that these events can be confronting matters for patients to deal with; and–avoid inferring blame, admitting fault or offering opinion.

– The health service entity may also consider providing further information including:

–confirming the patient knows how to access their health records if necessary;–confirming any specific needs of the patient, including cultural or linguistic requirements;–confirming how the patient would like to be communicated with;–attempting to answer any questions the patient has since providing the initial information. If the questions cannot be answered immediately, the health service entity should record these questions and inform the patient they will be addressed as part of the SDC process; and–outlining how the patient can raise concerns outside of the SDC process, including the health service entity’s internal complaints process, or the Health Complaints Commissioner (HCC) orMental Health Complaints Commissioner (MHCC).–Where the harm has resulted in the patient’s death, the health service entity should consider:–advising the NOK that there may be additional processes involving third parties, such as theCoroner, and that coronial investigations or inquests may incur lengthy timelines; and–providing psychological support for the NOK and any staff affected by the death

Requirement 2: The health service entity must take steps to organise an SDC meeting within 3 business days of the SAPSE being identified by the health service entity. Refer Form # F-1.39 SDC Initial Meeting Note Template

 

Stage 2: Hold the SDC meeting Requirement 3: The SDC meeting must be held within 10 business days of the SAPSE being identified by the health service entity. Requirement 4: The health service entity must ensure that it provides the following in the SDC meeting:

–an honest, factual explanation of what occurred in a language that is understandable to the patient;–an apology for the harm suffered by the patient;

–an opportunity for the patient to relate their experience and ask questions;–an explanation of the steps that will be taken to review the SAPSE and outline any immediate improvements already made; and–any implications as a result of the SAPSE (if known) and any follow up for the patient.Refer to Form # F-1.40 SDS Meeting Report Template

At a minimum, the health service entity must confirm with the patient:

–when and where the SDC meeting will be held;–who will be at the meeting, including staff and representatives the patient would like to invite;–details of the meeting, including informing them that they will have the opportunity to relate their experience and ask any questions they may have. The health service entity may recommend that the patient write these down in preparation for the SDC meeting; and–details of key contacts, such as a family liaison person, if the patient has any questions before the meeting.

 

In preparing for the meeting, the health service entity may consider the following:

–designing the meeting with the attendee’s needs in mind, such as having the meeting over videoconference;–the opportunity for further planning and discussions before the SDC meeting;–offering the patient practical and emotional support at each stage of the process, such as paying for travel or parking costs to attend the SDC meeting;–having an internal planning discussion before the SDC meeting, including who will lead the meeting;–ensuring all relevant facts have been collected and understood, including seeking advice from relevant staff;–seeking advice from an AHLO for any events involving Aboriginal and Torres Strait island patients ;and–patient preference in regard to relevant staff at the meeting, if the patient requests certain staff do not attend.

At a minimum there must be:

–one member from the health service entity who is experienced and suitably qualified inopen disclosure or the SDC process; and–a senior member of the clinical team that was involved (e.g. doctor or nurse).

There may also be:

–a member of the quality team; and

–a trainee or junior staff member from a development and organisational culture point of view.The SDC meeting is an opportunity for the health service entity to provide all required information, and for the patient to ask questions and relate their experience about the event.

In attending the SDC meeting, the health service entity must:

–take measures to make the attendees feel supported in the meeting. For example, provide materials for them to take notes, and offering a comfortable, quiet environment to conduct the meeting;–present a full, frank and honest explanation of what is known to have occurred. Use terminology and phrases that are likely to be understood by the attendees;–apologise to the patient again for the harm suffered;–allow the patient opportunity to relate their experience. Ask them to share their own thoughts on the event and the outcomes they are seeking from the SDC process;–ensure there is sufficient time for the attendees to ask questions;–explain the steps the health service entity is taking to review and manage the event, and any immediate improvements that have been made or will be made to prevent similar harm in the future (if applicable). This information may not be complete at the time of this meeting, however the patient should be informed that more details will be available in a subsequent review report; and–inform those at the meeting about the implications of the SAPSE, especially any immediate or long-term health or other consequences (if known). Develop a plan to ensure the patient receives appropriate treatment, including notifying their local health service or general practitioner (if agreed).

Requirement 5: The health service entity must document the SDC meeting and provide a copy of the meeting report to the patient within 10 business days of the SDC meeting. Immediately after the meeting The health service entity may consider compiling the initial details of the meeting and provide this to the patient immediately following, including:

–who was present;–the time and date of the meeting;–confirmation that all elements of the SDC were discussed;–a point of contact for ongoing follow up;–clear details of the future timelines and requirements of the SDC process; and–any other comments or questions for noting.–A copy of this note should then be filed in the appropriate records.

The meeting report must include a detailed account of all the different elements of SDC that were discussed. Documentation of the SDC meeting should follow usual clinical documentation conventions and expand on the initial note given after the meeting. The health service entity may consider offering the meeting report in a language understandable to the patient. If the report requires translation, inform the patient that this may require more time and document any delay in the appropriate location. A copy of the SDC meeting report must be stored in an appropriate location.

Stage 3: Complete a review of the SAPSE and produce report

Requirement 6: The health service entity must complete a review for the SAPSE and produce a report outlining what happened and any areas identified for improvement. If the SAPSE is classified as a sentinel event, the health service entity must also outline in the report clear recommendations from the review findings.

Requirement 7: The report created from Requirement 6 must then be offered to the patient within 50 business days of the SAPSE being identified by the health service entity. If the SAPSE involves more than one health service entity, this may be extended to 75 business days of the SAPSE being identified by the initial health service entity. The report created as a result of the review must include the matters required by section 128ZC of the Health Services Act 1988, being:

–a written account of the facts regarding the SAPSE;–an apology for the harm suffered by the patient;–a description of the health service entity’s response to the event; andthe steps that the health service entity has taken to prevent re-occurrence of the event.2

As part of the SDC process, the review report must then be offered to:

–the patient; or–if the patient is deceased or lacks capacity, a person nominated by the patient, the immediate family, carer or NOK of a patient.

The review is part of the ongoing information gathering process of the SDC. The resulting report forms part of the response to the patient. The health service entity must:

–avoid jargon or legalistic wording, and–ensure the patient is aware of the timeline for review

–When the relevant review or investigation is complete, the health service entity should consider providing the patient with feedback through face-to-face interview or equivalent (e.g. videoconference).

Documentation and reporting

Requirement 8: The health service entity must ensure that there is a record of the SDC being completed, including clear dates of when the SAPSE occurred and when each stage of the SDC was completed.

Requirement 9: The health service entity must report its compliance with the SDC asThe Health Service must have an approprate system to monitor compliance with SDC such as a clinical incident management system; and–report compliance with the SDC undertakings to the relevant bodies as legally required. These reports allow the health service entity’s board to monitor the SDC and must be made available forauditing by the relevant bodies.

Note: If it is identified through the review process that a health professional has acted in a way that constitutes notifiable conduct under the Health Practitioner Regulation National Law Act 2009, a staff member must submit a concern to the Australian Health Practitioner Regulation Agency (Ahpra). It is recommended that this referral take place after a discussion has occurred with the relevant staff member.

Where patients do not want to be involved in the SDC process Patients may opt out from participating in the SDC process or from receiving information from a health service entity. If a patient confirms that they wish to opt out of the SDC process, the health service entity must: ask them to sign a statement to this effect and store this in an appropriate location;3 and provide a point of contact, such as a consumer liaison officer, if the patient wishes to re-initiate the SDC process at any time. When a patient has opted out, the relevant health service entity does not have to comply with the Requirements in the Victorian Duty of Candour Guidelines. However, it is recommended that the health service entity conduct an adverse event review to ensure relevant information is recorded when relevant staff are available. This is recommended as the patient may later re-initiate their participation in the SDC process and elect to receive information required under the SDC.4 If this occurs, the commencement date must be clearly documented in an appropriate location, and the requirements within these Guidelines must then be followed.

 

Circumstances requiring a delay There may be circumstances where the SDC process needs to be delayed, including: if the patient lacks or has lost their capacity (either temporarily or permanently) through the harm; or the patient is medically unable to participate (either temporarily or permanently through the progression of their medical condition). If the above applies and has been assessed and documented by an appropriate medical professional, the health service entity must undertake SDC with: the patient’s immediate family, carer or NOK; or a person nominated by the patient. This must occur, unless the relevant person is not available, or they have opted out. When the patient recovers capacity, regardless of whether the SDC has occurred with a person outlined in the list above or not, the health service entity must commence the SDC process again with the patient (unless the patient has opted out). The agreed commencement date must be clearly documented in the appropriate location, and the requirements within these Guidelines must then be followed.

REPORTING STATUTORY DUTY OF CANDOUR Statutory Duty of Candour will be reported through the Incident reporting system and compliance with Statutory Duty of Candour is reported through AIMS quartly via Health Collect portal https:// www.healthcollect.vic.gov.au

 

Legislation, Standards and References:

Australian Commission for Quality & Safety Open Disclosure Framework

National Safety and Quality Health Services Standards Version 2 Standard 1

Australian Commission for Quality & Safety Open Disclosure Flowchart

Victorian Duty of Candour Guidelines 2022

Safer Care Victoria