{"id":"sr:health-services-quality-and-safety-regulations-2020","name":"Health Services (Quality and Safety) Regulations 2020","slug":"health-services-quality-and-safety-regulations-2020","collection":"regulation","jurisdiction":"vic","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":183749,"registerId":"vic-sr:health-services-quality-and-safety-regulations-2020-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Health Services (Quality and Safety) Regulations 2020","content":"Version No. 002\n\n**Health Services (Quality and Safety) Regulations 2020**\n\n**S.R. No. 77/2020**\n\nVersion incorporating amendments as at  \n30 November 2022\n\n**TABLE OF PROVISIONS**\n\n*Regulation Page*\n\n1 Objective 1\n\n2 Authorising provision 1\n\n3 Commencement 1\n\n3A Definitions 1\n\n3B Serious adverse patient safety event 2\n\n3C Appointment of SAPSE review panel 3\n\n3D Membership of SAPSE review panel 3\n\n3E Serious adverse patient safety event review report 3\n\n3F Restrictions on SAPSE reviews 4\n\n4 Quality and safety—prescribed entities 4\n\n═════════════\n\nEndnotes 5\n\n1 General information 5\n\n2 Table of Amendments 7\n\n3 Explanatory details 8\n\n**Version No.** **002**\n\n**Health Services (Quality and Safety) Regulations 2020**\n\n**S.R. No. 77/2020**\n\nVersion incorporating amendments as at  \n30 November 2022\n\n\t1 Objective\n\nThe objective of these Regulations is to prescribe entities authorised to collect, use and disclose confidential information for a quality and safety purpose under Part 6B of the **Health Services Act 1988**.\n\nReg. 2 amended by S.R. No. 121/2022 reg. 5.\n\n\t2 Authorising provision\n\nThese Regulations are made under section 158 of the **Health Services Act** **1988**.\n\n\t3 Commencement\n\nThese Regulations come into operation on 27 August 2020.\n\nReg. 3A inserted by S.R. No. 121/2022 reg. 6.\n\n\t3A Definitions\n\nIn these Regulations—\n\n***harm*** includes moderate harm, severe harm and prolonged psychological harm;\n\n***moderate harm*** means harm that requires a moderate increase in treatment to a patient, such as an unplanned or unexpected return to surgery, but does not include harm that causes permanent damage or injury to an individual;\n\n***prolonged psychological harm*** means psychological harm which a patient has experienced, or is likely to experience, for a continuous period of at least 28 days;\n\n***registered health practitioner*** has the same meaning as in the Health Practitioner Regulation National Law;\n\n***sentinel event*** means an unexpected and adverse event that occurs infrequently in a health service entity and results in the death of, or serious physical or psychological injury to, a patient as a result of system and process deficiencies at the health service entity;\n\n***severe harm*** means harm that causes a permanent lessening in the functioning of an individual that is unrelated to the natural course of a person's illness or underlying condition, including harm that can lead to a person experiencing a permanent impairment or disability, or death.\n\nReg. 3B inserted by S.R. No. 121/2022 reg. 6.\n\n\t3B Serious adverse patient safety event\n\n(1) For the purposes of the definition of a ***serious adverse patient safety event*** in section 3(1) of the **Health Services Act 1988**, a prescribed class or category is an event that—\n\n(a) occurred while the patient was receiving health services from a health service entity; and\n\n(b) in the reasonable opinion of a registered health practitioner, has resulted in, or is likely to result in, unintended or unexpected harm being suffered by the patient.\n\n(2) To avoid doubt, an event in subregulation (1) includes an event that is identified following discharge from the health service entity.\n\nReg. 3C inserted by S.R. No. 121/2022 reg. 6.\n\n\t3C Appointment of SAPSE review panel\n\nFor the purposes of section 128P(2) and (3) of the **Health Services Act 1988**, a joint SAPSE review panel—\n\n(a) must include at least one member from each health service entity involved with the serious adverse patient safety event; and\n\n(b) must consist of no less than 4 members; and\n\n(c) may include a representative appointed by the Secretary; and\n\n(d) if a SAPSE review relates to a sentinel event, must contain a consumer representative.\n\nReg. 3D inserted by S.R. No. 121/2022 reg. 6.\n\n\t3D Membership of SAPSE review panel\n\nFor the purposes of section 128Q(1)(e) of the **Health Services Act 1988**, the following requirements are prescribed—\n\n(a) a SAPSE review panel must consist of no less than 3 members;\n\n(b) if a SAPSE review relates to a sentinel event, the SAPSE review panel must contain a consumer representative;\n\n(c) a member of a SAPSE review panel who has a potential or actual conflict of interest with respect to a SAPSE review they have been appointed to conduct must disclose the conflict of interest to the other members of that panel.\n\nReg. 3E inserted by S.R. No. 121/2022 reg. 6.\n\n\t3E Serious adverse patient safety event review report\n\nFor the purposes of section 128T(3)(b) of the **Health Services Act 1988**, the name and address of a person who has provided information to a SAPSE review panel (other than a person specified in section 128T(3)(a) of the **Health Services Act 1988**) is prescribed information.\n\nReg. 3F inserted by S.R. No. 121/2022 reg. 6.\n\n\t3F Restrictions on SAPSE reviews\n\nFor the purposes of section 128Z of the **Health Services Act 1988**, the following procedures are prescribed—\n\n(a) after the suspension of its activities, the SAPSE review panel must notify the chief executive officer (however named) of the health service entity that is the subject of the SAPSE review in writing regarding the suspected prohibited act;\n\n(b) the SAPSE review panel may recommence its review once it receives written notice from the chief executive officer (however named) of the health service entity that the chief executive officer is satisfied that either—\n\n(i) the suspected prohibited act did not occur; or\n\n(ii) the suspected prohibited act is able to be investigated independently of the SAPSE review.\n\n\t4 Quality and safety—prescribed entities\n\nFor the purposes of the definition of a ***quality and safety body*** in section 134V of the **Health Services Act 1988**, the following are prescribed entities—\n\n(a) Safer Care Victoria, being an Administrative Office  within the meaning of the **Public Administration Act 2004**;\n\nReg. 4(b) substituted by S.R. No. 121/2022 reg. 7.\n\n(b) the Chief Quality and Safety Officer.\n\n═════════════\n\nEndnotes\n\n1 General information\n\nSee [www.legislation.vic.gov.au](http://www.legislation.vic.gov.au) for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.\n\nThe Health Services (Quality and Safety) Regulations 2020, S.R. No. 77/2020 were made on 28 July 2020 by the Governor in Council under section 158(1)(q) of the **Health Services Act** **1988**, No. 49/1988 and came into operation on 27 August 2020: regulation 3.\n\nThe Health Services (Quality and Safety) Regulations 2020 will sunset 10 years after the day of making on 28 July 2030 (see section 5 of the **Subordinate Legislation Act 1994**).\n\nINTERPRETATION OF LEGISLATION ACT 1984 (ILA)\n\nStyle changes\n\nSection 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.\n\nReferences to ILA s. 39B\n\nSidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided regulation, rule or clause of a Schedule is amended by the insertion of one or more subregulations, subrules or subclauses the original regulation, rule or clause becomes subregulation, subrule or subclause (1) and is amended by the insertion of the expression \"(1)\" at the beginning of the original regulation, rule or clause.\n\nInterpretation\n\nAs from 1 January 2001, amendments to section 36 of the ILA have the following effects:\n\n• Headings\n\nAll headings included in a Statutory Rule which is made on or after  \n1 January 2001 form part of that Statutory Rule. Any heading inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.  \nThis includes headings to Parts, Divisions or Subdivisions in a Schedule; Orders; Parts into which an Order is divided; clauses; regulations; rules; items; tables; columns; examples; diagrams; notes or forms.  \nSee section 36(1A)(2A)(2B).\n\n• Examples, diagrams or notes\n\nAll examples, diagrams or notes included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule. Any examples, diagrams or notes inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, form part of that Statutory Rule. See section 36(3A).\n\n• Punctuation\n\nAll punctuation included in a Statutory Rule which is made on or after  \n1 January 2001 forms part of that Statutory Rule. Any punctuation inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.  \nSee section 36(3B).\n\n• Provision numbers\n\nAll provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after  \n1 January 2001. Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs. See section 36(3C).\n\n• Location of \"legislative items\"\n\nA \"legislative item\" is a penalty, an example or a note. As from 13 October 2004, a legislative item relating to a provision of a Statutory Rule is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision. For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision. See section 36B.\n\n• Other material\n\nAny explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of a Statutory Rule. See section 36(3)(3D)(3E).\n\n2 Table of Amendments\n\nThis publication incorporates amendments made to the Health Services (Quality and Safety) Regulations 2020 by statutory rules, subordinate instruments and Acts.\n\n–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––\n\nHealth Services (Quality and Safety) Amendment Regulations 2022, S.R. No. 121/2022\n\n| *Date of Making:* | 18.10.22 |\n| --- | --- |\n| *Date of Commencement:* | 30.11.22: reg. 3 |\n\n\n–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––\n\n3 Explanatory details\n\nNo entries at date of publication.","sortOrder":0}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"The original stated objective is narrow—prescribe entities authorised to use confidential information for quality and safety under Part 6B of the Health Services Act. The 2022 amendments broadened the instrument beyond simply naming authorised bodies by adding operational and definitional material: precise definitions of harm and sentinel events (Reg 3A–3B), rules on SAPSE review panel composition and conflict disclosure (Regs 3C–3D), specification of what identifying information may appear in review reports (Reg 3E), and a suspension/restart procedure where suspected prohibited acts arise (Reg 3F). The addition of Safer Care Victoria and the Chief Quality and Safety Officer as prescribed quality-and-safety bodies (Reg 4) also extends which organisations may exercise the Part 6B authorities. Taken together, these changes expand the Regulations from a declaratory list to a modest operational framework governing how SAPSE reviews run and what they may include."},"complexity_factors":["Short, focused instrument (6 substantive regs added: 3A–3F, plus reg 4 and objective/commencement clauses)","Seven new defined terms in Reg 3A (harm, moderate harm, prolonged psychological harm, registered health practitioner, sentinel event, severe harm, plus the ordinary term 'harm' defined broadly)","Cross-references to multiple provisions of the Health Services Act 1988 (s.3(1) definition, s.128P, s.128Q, s.128T, s.128Z, s.134V) which require users to read the primary Act for full effect","Conditional rules and minimums for panel composition (different minimums for joint panels and ordinary panels; consumer rep requirement tied to 'sentinel event')","Procedural conditionality for suspension and recommencement of reviews (notice and CEO satisfaction required)","One substantive data-disclosure prescription (Reg 3E) that interacts with privacy law and Act provisions"],"plain_english_summary":"**What this instrument does (mechanically)\n\n- These Regulations identify who may collect, use and disclose confidential health information for \"quality and safety\" work under Part 6B of the Health Services Act 1988 (that is, internal safety investigations and related review activities). (Reg 1.)\n\n- They add a set of definitions that the rest of the Regulations and Part 6B rely on, including categories of \"harm\" (moderate, severe, prolonged psychological harm), \"sentinel event\", and \"registered health practitioner.\" (Reg 3A.)\n\n- They define when an event counts as a \"serious adverse patient safety event\" for the purposes of the Act: it must have occurred while the patient was receiving care from a health service entity and, in the reasonable opinion of a registered health practitioner, has resulted in or is likely to result in unintended or unexpected harm. Events discovered after discharge are included. (Reg 3B.)\n\n- They prescribe minimum composition rules for SAPSE (Serious Adverse Patient Safety Event) review panels: joint panels must include at least one member from each involved health service entity, must have at least 4 members, may include a Secretary-appointed representative, and must include a consumer representative if the review relates to a sentinel event. Separate membership rules require panels to have at least 3 members and to disclose conflicts of interest. (Regs 3C, 3D.)\n\n- They specify what information may be treated as \"prescribed information\" in a SAPSE review report: the name and address of a person who provided information to a panel (subject to a statutory exception in the Act). This means the report may include those particulars. (Reg 3E.)\n\n- They set a short procedural rule for pausing and restarting SAPSE reviews if a suspected \"prohibited act\" (an act for which special legal constraints apply) is detected: the panel must notify the relevant health service CEO in writing, and can only restart after written CEO confirmation that either the suspected act did not occur or it can be investigated independently of the SAPSE review. (Reg 3F.)\n\n- They prescribe which organisations count as \"quality and safety bodies\" under the Act: Safer Care Victoria and the Chief Quality and Safety Officer. That prescription gives those entities authority under Part 6B to collect/use/disclose confidential information for quality and safety purposes. (Reg 4.)\n\nWho this affects\n\n- Patients and their families: their confidential health information may be collected, used and disclosed for SAPSE reviews and other quality and safety work.\n- Health service entities (public hospitals and other service providers): they must participate in SAPSE reviews, provide staff to panels where required, and deal with procedural restrictions if suspected prohibited acts arise.\n- Registered health practitioners: their opinions are part of the test used to classify an event as a serious adverse patient safety event; practitioners may also be information providers to panels.\n- Safer Care Victoria and the Chief Quality and Safety Officer: explicitly authorised as quality and safety bodies with powers under Part 6B.\n\nWhy this matters (purpose-claims and practical trade-offs)\n\n- The stated purpose is to enable the authorised collection/use/disclosure of confidential information for quality and safety purposes under the Health Services Act (Reg 1). That creates a legal basis for internal safety investigations and cross-entity reviews.\n\n- What the Regulations add beyond naming authorised bodies is operational detail: definitions that set thresholds for what counts as \"harm\" and a SAPSE; rules on panel size, membership and conflict disclosure; what identifying information may appear in review reports; and a pause/restart procedure where a suspected prohibited (potentially criminal or disciplinable) act is identified (Regs 3A–3F). These are practical rules that determine how reviews run and what material they can lawfully include.\n\n- Costs and compliance burden: health service entities must provide members to joint panels and could be required to furnish information that includes provider names and addresses (Reg 3E). Panels must manage conflicts of interest and include consumer representatives for sentinel events (Regs 3C, 3D). Those requirements create modest administrative and governance costs for entities and for the Secretary/Chief Quality and Safety Officer where appointments or consumer representation are required.\n\n- Confidentiality and privacy trade-offs: prescribing that a panel report can include a person’s name and address (Reg 3E) increases the authorised disclosure of personal information within a statutorily authorised safety process. That is a deliberate choice to prioritise investigatory completeness, but it carries privacy risk unless handled under appropriate safeguards in the Act and other privacy law.\n\n- Interaction with other processes and discretion: the suspension/restart rule (Reg 3F) hands a gatekeeping role to the health service CEO when a suspected prohibited act is identified. That gives the CEO a decisive procedural role (they can confirm the review may continue), which channels investigatory responsibility to existing oversight or disciplinary processes. It also creates a point where reviews can be delayed while parallel investigations proceed.\n\n- Effects on private choice and competition: the Regulations operate within the public health service system and affect how public health bodies and their staff are reviewed. They do not directly regulate market entry, pricing or competition between private firms, but private practitioners working inside public entities may be subject to reviews and to inclusion of their identifying information in reports.\n\n- Concentrated vs diffuse effects: rules on panel membership and suspension concentrate decision power with health service CEOs, and give explicit investigatory authority to named state bodies (Safer Care Victoria; Chief Quality and Safety Officer). The burdens (time, disclosure of information) fall mainly on the involved health service entities and practitioners; the public interest benefit (safer services) is distributed.\n\nImplementation and risk points to watch\n\n- Practical recruitment of consumer representatives for sentinel-event reviews and operationalising minimum panel sizes (Regs 3C, 3D).\n- Managing conflicts of interest within small panels where members come from involved entities (Reg 3D(c)).\n- Ensuring privacy protections are aligned with these disclosure rules (Reg 3E).\n- Coordinating with parallel investigations when a suspected prohibited act is identified to avoid unnecessary delay or duplication (Reg 3F).\n\nKey references inside the Regulations: Definitions (Reg 3A); SAPSE definition and scope (Reg 3B); panel appointment and composition (Regs 3C–3D); report content (Reg 3E); suspension/restart procedure (Reg 3F); prescribed quality and safety bodies (Reg 4)."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":true,"description":"The original 2020 regulations appear to have been quite narrow, primarily prescribing entities authorised to handle confidential information for quality and safety purposes (Regulation 4). The 2022 amendments significantly expanded the scope by adding an entire framework for 'Serious Adverse Patient Safety Event' (SAPSE) reviews, including definitions of harm types, panel composition rules, reporting requirements, and procedural restrictions. This transformed the instrument from a simple prescriptive list into a comprehensive procedural framework for clinical incident investigation."},"complexity_factors":["Short length (only 4 substantive regulations plus definitions)","Minimal cross-referencing (primarily references to specific sections of the Health Services Act 1988)","Straightforward conditional logic (mostly 'must' and 'may' requirements)","7 defined terms in regulation 3A, all with clear, non-circular definitions","No nested exceptions or complex procedural hierarchies","Amendments clearly marked and integrated (regulations 3A-3F inserted by 2022 amendment)"],"plain_english_summary":"These regulations set up rules for investigating serious medical mistakes in Victorian hospitals and health services. They define what counts as a 'serious adverse patient safety event' (basically, when something goes seriously wrong during treatment that causes or could cause harm to a patient). The regulations also establish review panels to investigate these incidents, specifying who must sit on these panels (including consumer representatives for the most serious cases called 'sentinel events'), and set rules about conflicts of interest. Additionally, they name which organisations are officially allowed to collect and share confidential patient information for quality and safety purposes—specifically Safer Care Victoria and the Chief Quality and Safety Officer."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"Insufficient substantive content was provided to determine whether the scope of this statutory rule changed from its original intent. The document appears to be a consolidated version (version number 77/2020), suggesting amendments may have occurred, but no comparative content was available for analysis."},"complexity_factors":["The document provided contains only metadata and version history — no substantive regulatory content was included for analysis","Regulations of this type typically involve multiple defined terms and cross-references to the parent Act","Healthcare regulation generally involves technical standards and compliance obligations","Limited scope to assess actual complexity due to incomplete source material"],"plain_english_summary":"These regulations prescribe concrete quality and safety requirements for Victorian health services, translating the Health Services Act’s principles into enforceable rules on things like reporting, accreditation and patient safety. \n\nThey affect hospitals, health service providers, their staff and patients by creating specific obligations and accountability mechanisms — though the supplied document contains mostly formatting/version info, so detailed obligations aren’t available here."}},"importantCases":[],"_links":{"self":"/api/acts/health-services-quality-and-safety-regulations-2020","history":"/api/acts/health-services-quality-and-safety-regulations-2020/history","analysis":"/api/acts/health-services-quality-and-safety-regulations-2020/analysis","conflicts":"/api/acts/health-services-quality-and-safety-regulations-2020/conflicts","importantCases":"/api/acts/health-services-quality-and-safety-regulations-2020/important-cases","documents":"/api/acts/health-services-quality-and-safety-regulations-2020/documents"}}