{"id":"F2021L01783","name":"Health Insurance (Quality Assurance Activity – Australian Vigilance and Surveillance System for Organ Donation for Transplantation) Declaration 2021","slug":"health-insurance-quality-assurance-activity-australian-vigilance-and-surveillance-system-for-organ-d","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":102216,"registerId":"commonwealth-F2021L01783-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1— Preliminary\n\n#### 1 Name\n\n This instrument is the Health Insurance (Quality Assurance Activity – Australian Vigilance and Surveillance System for Organ Donation for Transplantation) Declaration 2021.\n\n#### 2 Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

The day after this instrument is registered.

15 December 2021

\n```\n\n> Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n#### 3 Authority\n\n This instrument is made under subsection 124X(1) of the Health Insurance Act 1973.\n\n#### 4 Repeal\n\n This instrument is repealed when it ceases to be in force in accordance with subsection 124X(4) of the Health Insurance Act 1973.\n\n#### 5 Schedule\n\n The quality assurance activity described in the Schedule to this declaration is, to the extent that the quality assurance activity relates to health services provided in Australia, declared to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies.\n\nSchedule 1— Description of quality assurance activity\n\n#### 1A Definitions\n\n In this Schedule:\n\n> SAER (short for serious adverse event or reaction) means:\n\n (a) a serious adverse event; or\n (b) a serious adverse reaction.\n\n> serious adverse event means any undesired or unexpected occurrence associated with any stage of an organ donation and transplantation process (from the donation of the organ to the transplantation of the organ) that might:\n\n (a) lead to:\n (i) the transmission of a communicable disease to the transplantation recipient; or\n (ii) the death of, or a life‑threatening, disabling or incapacitating condition for, the transplantation recipient; or\n (b) result in, or prolong, hospitalisation or morbidity for the transplantation recipient.\n\n> serious adverse reaction means any unintended response of an organ transplantation recipient, including a communicable disease in the transplantation recipient, that:\n\n (a) might be associated with any stage of the organ donation and transplantation process (from the donation of the organ to the transplantation of the organ); and\n (b) either:\n (i) is fatal, life‑threatening, disabling or incapacitating for the transplantation recipient; or\n (ii) results in, or prolongs, hospitalisation or morbidity for the transplantation recipient.\n\n#### 1 Name of activity:\n\n Australian Vigilance and Surveillance System for Organ Donation for Transplantation.\n\n#### 2 Description of activity:\n\n The Australian Vigilance and Surveillance System for Organ Donation for Transplantation (the Activity) is the central location for reporting SAERs relating to organs from deceased donors and is managed by the Australian Organ and Tissue Donation and Transplantation Authority, also known as the Organ and Tissue Authority (OTA). The Activity is designed to:\n (a) work in parallel with state and territory clinical incident management systems in deceased organ donation and transplantation;\n (b) receive and coordinate responses to SAER notifications;\n (c) monitor, record and retrospectively analyse SAER notifications;\n (d) inform future processes in organ donation for transplantation; and\n (e) improve the safety and quality of organ donation and transplantation, thereby improving patient outcomes.\n The Australian Vigilance and Surveillance System for Organ Donation and Transplantation collects data through notification of SAERs.\n (a) The Activity operates in the following ways: A reporter, who is typically, (but not always) a member of the medical, nursing or laboratory staff associated with the donation, retrieval or transplantation of an organ, becomes aware of a SAER and initiates the notification to the State Medical Director;\n (b) The State Medical Director (or a delegate) oversees the deceased donation process for consistency of practice within jurisdictions, completes preliminary assessments, reviews information provided by the reporter against the Severity Grading and Imputability Grading and generates a SAER notification form to inform the National Medical Director;\n (c) The National Medical Director (or a delegate) coordinates national communication and dissemination of information relating to SAER notification as deemed necessary, in conjunction with the State Medical Director and the Vigilance and Surveillance Expert Advisory Committee (VSEAC), which is established by the OTA; and\n (d) The VSEAC monitors the performance of the Activity, recommends action to address non‑compliance and risks, prepares submissions for international reporting publishes de‑identified data and case studies, recommends best practice and strategic intervention and formulates policy advice.\n Deidentified information and key findings relevant to health service delivery and practice improvement arising from the Activity are disclosed through:\n (a) communiques disseminated to clinical and government stakeholders after each VSEAC meeting;\n (b) Red Notices, which notify stakeholders of immediate and severe risks;\n (c) discussions with relevant national advisory groups, including the OTA’s Transplant Liaison Reference Group and the Renal Transplant Advisory Committee;\n (d) VSEAC’s annual report, of which a high‑level version is publicly available and a more detailed confidential version is available to clinicians; and\n (e) contributions to the international Project Notify Library, which catalogues adverse outcomes associated with organ and tissue donation.\n Access to identifying information about patients is limited to the clinicians involved in their treatment and the VSEAC.","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Health Insurance (Quality Assurance Activity – Australian Vigilance and Surveillance System for Organ Donation for Transplantation) Declaration 2021.","sortOrder":1},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

The day after this instrument is registered.

15 December 2021

\n```\n\n> Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.","sortOrder":2},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 124X(1) of the Health Insurance Act 1973.","sortOrder":3},{"sectionNumber":"4","sectionType":"section","heading":"Repeal","content":"#### 4 Repeal\n\n This instrument is repealed when it ceases to be in force in accordance with subsection 124X(4) of the Health Insurance Act 1973.","sortOrder":4},{"sectionNumber":"5","sectionType":"section","heading":"Schedule","content":"#### 5 Schedule\n\n The quality assurance activity described in the Schedule to this declaration is, to the extent that the quality assurance activity relates to health services provided in Australia, declared to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies.\n\nSchedule 1— Description of quality assurance activity","sortOrder":5},{"sectionNumber":"1A","sectionType":"section","heading":"Definitions","content":"#### 1A Definitions\n\n In this Schedule:\n\n> SAER (short for serious adverse event or reaction) means:\n\n (a) a serious adverse event; or\n (b) a serious adverse reaction.\n\n> serious adverse event means any undesired or unexpected occurrence associated with any stage of an organ donation and transplantation process (from the donation of the organ to the transplantation of the organ) that might:\n\n (a) lead to:\n (i) the transmission of a communicable disease to the transplantation recipient; or\n (ii) the death of, or a life‑threatening, disabling or incapacitating condition for, the transplantation recipient; or\n (b) result in, or prolong, hospitalisation or morbidity for the transplantation recipient.\n\n> serious adverse reaction means any unintended response of an organ transplantation recipient, including a communicable disease in the transplantation recipient, that:\n\n (a) might be associated with any stage of the organ donation and transplantation process (from the donation of the organ to the transplantation of the organ); and\n (b) either:\n (i) is fatal, life‑threatening, disabling or incapacitating for the transplantation recipient; or\n (ii) results in, or prolongs, hospitalisation or morbidity for the transplantation recipient.","sortOrder":6}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: providing legal protection for reporting of serious adverse events in deceased organ donation and transplantation. The scope has not expanded beyond this specific quality assurance activity."},"complexity_factors":["Short, single-purpose instrument (approximately 1,500 words)","Only 3 defined terms (SAER, serious adverse event, serious adverse reaction)","No cross-references to other legislation beyond the enabling provision (Health Insurance Act 1973, section 124X)","Simple conditional structure: if activity relates to Australian health services → protection applies","Straightforward administrative process description without nested exceptions or complex triggers","Self-repealing provision (automatic repeal when no longer in force) adds no operational complexity"],"plain_english_summary":"This law makes the Australian Vigilance and Surveillance System for Organ Donation for Transplantation a protected quality‑assurance activity, giving legal protection to doctors, nurses and hospitals who report serious adverse events or reactions from transplants. By preventing reported information being used in court or publicly identified, it encourages open reporting to the Organ and Tissue Authority so problems can be investigated, safety warnings issued, and transplant practices improved for patients' benefit."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument formally declares the existing Australian Vigilance and Surveillance System for Organ Donation for Transplantation to be a Part VC quality assurance activity; it defines the activity's subject‑matter (SAERs relating to organs from deceased donors), governance roles and data‑handling rules and limits application to health services provided in Australia. The instrument contains no provisions that expand or narrow that substantive scope beyond this formal declaration."},"complexity_factors":["Statutory basis and timing: made under subsection 124X(1) of the Health Insurance Act 1973 and commencement/repeal tied to subsection 124X(4) (clauses 3, 2 and 4).","Definitions-heavy schedule: multi-part definitions of SAER, serious adverse event and serious adverse reaction with clinical thresholds (Schedule 1A).","Multi-step reporting and governance flow: distinct roles and handoffs for reporters, State Medical Directors, National Medical Director and VSEAC (Schedule, Description of activity).","Data handling and disclosure rules: de‑identified outputs disclosed to stakeholders while identifying information is limited to treating clinicians and VSEAC (Schedule, Description of activity).","Interaction across jurisdictions: operation in parallel with state and territory clinical incident systems, requiring coordination between jurisdictional and national actors (Schedule, Description of activity)."],"plain_english_summary":"This declaration makes the Australian Vigilance and Surveillance System for Organ Donation for Transplantation (run by the Organ and Tissue Authority) a quality‑assurance activity under Part VC of the Health Insurance Act 1973. It centralises reporting, assessment and national coordination of serious adverse events or reactions (SAERs) from deceased‑donor organs, sets roles for reporters, State and National Medical Directors and the Vigilance and Surveillance Expert Advisory Committee, and limits access to identifying patient data to treating clinicians and the VSEAC."}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-quality-assurance-activity-australian-vigilance-and-surveillance-system-for-organ-d","history":"/api/acts/health-insurance-quality-assurance-activity-australian-vigilance-and-surveillance-system-for-organ-d/history","analysis":"/api/acts/health-insurance-quality-assurance-activity-australian-vigilance-and-surveillance-system-for-organ-d/analysis","conflicts":"/api/acts/health-insurance-quality-assurance-activity-australian-vigilance-and-surveillance-system-for-organ-d/conflicts","importantCases":"/api/acts/health-insurance-quality-assurance-activity-australian-vigilance-and-surveillance-system-for-organ-d/important-cases","documents":"/api/acts/health-insurance-quality-assurance-activity-australian-vigilance-and-surveillance-system-for-organ-d/documents"}}