{"id":"sr:health-services-health-service-establishments-regulations-2024","name":"Health Services (Health Service Establishments) Regulations 2024","slug":"health-services-health-service-establishments-regulations-2024","collection":"regulation","jurisdiction":"vic","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":181380,"registerId":"vic-sr:health-services-health-service-establishments-regulations-2024-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Health Services (Health Service Establishments) Regulations 2024","content":"Version No. 001\n\n**Health Services (Health Service Establishments) Regulations 2024**\n\n**S.R. No. 77/2024**\n\nVersion as at  \n31 August 2024\n\n**TABLE OF PROVISIONS**\n\n*Regulation Page*\n\nPart 1—Preliminary 1\n\n1 Objectives 1\n\n2 Authorising provision 2\n\n3 Commencement 2\n\n4 Revocations 2\n\n5 Definitions 2\n\nPart 2—Prescribed health services 7\n\n6 Day procedure centres 7\n\n7 Private hospitals 8\n\nPart 3—Health service establishment protocols for quality and safety 10\n\n8 Health service establishment protocols for quality and safety 10\n\n9 Determination of quality and safety guidelines 12\n\n10 Review of health service establishment protocols for quality and safety 13\n\nPart 4—Forms of application and fees 14\n\n11 Application for approval in principle 14\n\n12 Application for transfer or variation of certificate of approval in principle 15\n\n13 Application for registration of a health service establishment 15\n\n14 Annual fees for health service establishments 16\n\n15 Application for renewal of registration of a health service establishment 16\n\n16 Application for variation of registration of a health service establishment 17\n\n17 Application for approval of alterations to clinical area within a health service establishment 17\n\nPart 5—Senior appointments 18\n\nDivision 1—Director of Nursing 18\n\n18 Director of Nursing must be appointed 18\n\n19 Appointment of acting Director of Nursing 18\n\n20 Secretary must be notified of appointment 19\n\nDivision 2—Other appointments 19\n\n21 Chief Executive Officer and Medical Director 19\n\n22 Secretary to be notified of termination or vacancy 19\n\nPart 6—Admission of patients 20\n\nDivision 1—Unit record number 20\n\n23 Unit record number must be allocated 20\n\nDivision 2—Information to be given to patients 20\n\n24 Information about fees and services 20\n\nDivision 3—Clinical risk assessments 22\n\n25 Pre-admission assessment 22\n\n26 Pre-presentation assessment 23\n\nDivision 4—Clinical records 24\n\n27 Clinical record must be created and updated 24\n\n28 Information to be included in clinical record 24\n\nDivision 5—Identification of patients 26\n\n29 Means of identifying patients 26\n\n30 Identification of infants 26\n\nPart 7—Care of patients 28\n\nDivision 1—Management of patient care 28\n\n31 Respect, dignity and privacy 28\n\nDivision 2—Nursing and professional care 28\n\n32 Nurses must be registered and competent 28\n\n33 Post-operative care of surgery patients 29\n\n34 Care of maternity, obstetric and neonatal patients 29\n\n35 Sufficient nursing staff must be on duty 29\n\n36 Needs of patients must be met 30\n\n37 Reversal agents must be available 30\n\nPart 8—Complaints 31\n\n38 Nomination of complaints officer 31\n\n39 Dealing with a complaint 31\n\n40 Record of complaint 32\n\n41 Person making complaint must not be adversely affected 33\n\nPart 9—Transfer and discharge of patients 34\n\n42 Documentation required for transferred patients 34\n\n43 Information provided to patient transport 34\n\n44 Discharge information 35\n\nPart 10—Registers, records and permits 37\n\nDivision 1—Patient admission and discharge records 37\n\n45 Patient admission and discharge records 37\n\nDivision 2—Staff records 38\n\n46 Staff records 38\n\nDivision 3—Registers 38\n\n47 Surgical Procedure Register 38\n\n48 Birth Register 39\n\nDivision 4—Permits 40\n\n49 Permit issued under section 19 of the Drugs, Poisons and Controlled Substances Act 1981 40\n\nPart 11—Premises and equipment 42\n\n50 Identification of rooms 42\n\n51 Communications 42\n\n52 Repair and cleanliness of premises 43\n\n53 Suitability and cleanliness of facilities, equipment, furnishings and fittings 43\n\n54 Premises, staff and equipment outside health service establishment premises 44\n\n55 Evacuation plan 44\n\nPart 12—Infection control 45\n\n56 Infection Control Management Plan 45\n\nPart 13—Display of information 46\n\n57 Information to be prominently displayed 46\n\nPart 14—Enforcement 47\n\n58 Form of notice of seizure 47\n\n59 Infringement offences and infringement penalties 47\n\nPart 15—Returns and reports to be given to the Secretary 48\n\n60 Returns and reports to be given to the Secretary 48\n\n61 Reporting of compliance with the duty of candour 49\n\nPart 16—Quality and safety review data 52\n\n62 Open disclosure policy 52\n\n63 Review of quality and safety of health services provided 52\n\n64 Patient experience survey data 53\n\n65 Staff safety culture survey data 53\n\nPart 17—Sentinel events 55\n\n66 Reporting of sentinel events 55\n\n67 Review of sentinel events 55\n\nSchedule 1—Revocations 56\n\nSchedule 2—Application for approval in principle in relation to a health service establishment 57\n\nSchedule 3—Application for transfer or variation of certificate of approval in principle of a health service establishment 59\n\nSchedule 4—Application for registration of a health service establishment 61\n\nSchedule 5—Application for renewal of registration of a health service establishment 63\n\nSchedule 6—Application for variation of the registration of a health service establishment 64\n\nSchedule 7—Application for approval of alterations to a clinical area within a health service establishment 66\n\nSchedule 8—Notice of seizure of document or thing from a health service establishment 67\n\nSchedule 9—Infringements 68\n\n═════════════\n\nEndnotes 70\n\n1 General information 70\n\n2 Table of Amendments 72\n\n3 Explanatory details 73\n\n**Version No.** **001**\n\n**Health Services (Health Service Establishments) Regulations 2024**\n\n**S.R. No. 77/2024**\n\nVersion as at  \n31 August 2024\n\nPart 1—Preliminary\n\n\t1 Objectives\n\nThe objectives of these Regulations are—\n\n(a) to provide for the quality and safety of care of patients receiving health services in or from health service establishments by prescribing—\n\n(i) requirements for staffing; and\n\n(ii) procedures for the handling of complaints; and\n\n(iii) records to be kept; and\n\n(iv) reporting requirements; and\n\n(v) requirements for health service establishment protocols for quality and safety; and\n\n(vi) other requirements to ensure the welfare of patients; and\n\n(b) to prescribe fees, forms and other matters required to be prescribed under the **Health Services Act 1988** in relation to health service establishments.\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 31 August 2024.\n\n\t4 Revocations\n\nThe Regulations listed in Schedule 1 are **revoked**.\n\n\t5 Definitions\n\nIn these Regulations—\n\n***Aboriginal person*** means a person who—\n\n(a) is descended from an Aboriginal or Torres Strait Islander; and\n\n(b) identifies as an Aboriginal or Torres Strait Islander; and\n\n(c) is accepted as an Aboriginal or Torres Strait Islander by an Aboriginal or Torres Strait Island community;\n\n***admission*** means the recording in writing of a person's admission as a patient to a health service establishment under the care of—\n\n(a) a registered medical practitioner; or\n\n(b) a registered dental practitioner; or\n\n(c) a registered medical radiation practitioner; or\n\n(d) a registered podiatrist;\n\n***anaesthesia***—\n\n(a) means any of the following—\n\n(i) general anaesthesia;\n\n(ii) a major regional anaesthetic block;\n\n(iii) intravenous sedation;\n\n(iv) a high dose of local anaesthetic that has the potential to cause systemic toxicity; and\n\n(b) does not include a dental nerve block;\n\n***bed*** includes any of the following—\n\n(a) an emergency bed;\n\n(b) an intensive care unit bed;\n\n(c) an in-patient overnight or day bed;\n\n(d) an in-patient overnight or day cot;\n\n(e) a stage 1 recovery bed;\n\n(f) a stage 2 recovery bed;\n\n(g) an oncology chair;\n\n(h) a renal treatment chair;\n\n***emergency medicine*** means the medical or surgical treatment of patients as a matter of urgency for the purpose of—\n\n(a) saving life; or\n\n(b) preventing further serious damage to health; or\n\n(c) preventing suffering or the continuation of suffering of significant pain or distress;\n\n***emergency stabilisation treatment*** means treatment of a patient to stabilise and manage a serious or life-threatening condition or to manage significant pain while waiting to transport the patient to an appropriate health service establishment;\n\n***enrolled nurse*** means a person registered in Division 2 of the Register of Nurses under the Health Practitioner Regulation National Law to practise in the nursing and midwifery profession (other than as a student);\n\n***medical health service*** means a health service (other than emergency stabilisation treatment) that—\n\n(a) is provided to a patient by a registered medical practitioner; and\n\n(b) involves diagnosis and treatment that requires—\n\n(i) nursing supervision and care; or\n\n(ii) the use of anaesthesia;\n\n***registered dental practitioner*** means a person registered under the Health Practitioner Regulation National Law to practise in the dental profession (other than as a student);\n\n***registered health practitioner*** means a person registered under the Health Practitioner Regulation National Law  to practise in a health profession (other than as a student);\n\n***registered medical radiation practitioner*** means a person registered under the Health Practitioner Regulation National Law to practise in the medical radiation profession (other than as a student); and\n\n***registered midwife*** means a person registered in the Register of Midwives under the Health Practitioner Regulation National Law to practise in the nursing and midwifery profession (other than as a nurse or student);\n\n***registered nurse*** means a person registered in Division 1 of the Register of Nurses under the Health Practitioner Regulation National Law to practise in the nursing and midwifery profession (other than as a midwife or student);\n\n***registered podiatrist*** means a person registered under the Health Practitioner Regulation National Law to practise in the podiatry profession (other than as a student);\n\n***renal dialysis*** means (haemodialysis) treatment that uses a dialyzer machine to remove waste and excess water from the blood;\n\n***sentinel event*** means an unexpected and adverse event that occurs infrequently in a health service establishment 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 establishment;\n\n***speciality health service*** means a health service (other than emergency stabilisation treatment) that—\n\n(a) is ordinarily undertaken by, or under the supervision of, a registered medical practitioner, a registered dental practitioner, a registered medical radiation practitioner or a registered podiatrist; and\n\n(b) requires one or both of the following—\n\n(i) specialist equipment;\n\n(ii) an area that is specifically fitted out for the kind of service provided;\n\n***surgical health service*** means a health service (other than emergency stabilisation treatment) that—\n\n(a) is ordinarily provided by a registered medical practitioner, a registered dental practitioner, a registered medical radiation practitioner or a registered podiatrist; and\n\n(b) involves the use of surgical instruments and an operating theatre, procedure room or treatment room; and\n\n(c) uses or requires one or more of the following—\n\n(i) anaesthesia;\n\n(ii) the attendance of at least one other registered health practitioner;\n\n(iii) post-operative observation of the patient by nursing staff;\n\n***the Act*** means the **Health Services Act 1988**;\n\n***unit record number*** means an identifying number unique to a patient that is allocated under regulation 23.\n\nPart 2—Prescribed health services\n\n\t6 Day procedure centres\n\nFor the purposes of paragraph (a) of the definition of ***day procedure centre*** in section 3(1) of the Act, the following are health services of a prescribed kind or kinds—\n\n(a) medical health services;\n\n(b) surgical health services;\n\n(c) speciality health services for the provision of one or more of the following—\n\n(i) anaesthesia;\n\n(ii) bariatric procedures;\n\n(iii) cataract surgery;\n\n(iv) endoscopy;\n\n(v) liposuction (removing in total at least 200 ml of lipoaspirate);\n\n(vi) mental health services;\n\n(vii) oncology (chemotherapy);\n\n(viii) oncology (radiation therapy);\n\n(ix) oocyte retrieval;\n\n(x) paediatric services (provided to patients aged at least 28 days and under 18 years when admitted);\n\n(xi) renal dialysis;\n\n(xii) specialist rehabilitation services.\n\n\t7 Private hospitals\n\nFor the purposes of the definition of ***private hospital*** in section 3(1) of the Act, the following are health services of a prescribed kind or kinds—\n\n(a) medical health services;\n\n(b) surgical health services;\n\n(c) speciality health services for the provision of one or more of the following—\n\n(i) alcohol or drug withdrawal (detoxification—acute phase);\n\n(ii) anaesthesia;\n\n(iii) bariatric procedures;\n\n(iv) cardiac catheterisation;\n\n(v) cardiac surgery;\n\n(vi) cataract surgery;\n\n(vii) emergency medicine;\n\n(viii) endoscopy;\n\n(ix) intensive care;\n\n(x) liposuction (removing in total at least 200 ml of lipoaspirate);\n\n(xi) mental health services;\n\n(xii) neonatal services (provided to patients aged 28 days and under when admitted);\n\n(xiii) neurosurgery;\n\n(xiv) obstetrics;\n\n(xv) oncology (chemotherapy);\n\n(xvi) oncology (radiation therapy);\n\n(xvii) oocyte retrieval;\n\n(xviii) paediatric services (provided to patients aged at least 28 days and under 18 years when admitted);\n\n(xix) renal dialysis;\n\n(xx) specialist rehabilitation services.\n\nPart 3—Health service establishment protocols for quality and safety\n\n\t8 Health service establishment protocols for quality and safety\n\n(1) For the purpose of ensuring the quality and safety of health services provided at a health service establishment, the proprietor of a health service establishment must prepare health service establishment protocols in accordance with this regulation.\n\n(2) The health service establishment protocols must be—\n\n(a) documented in writing; and\n\n(b) made available to the public—\n\n(i) on the health service establishment's website; or\n\n(ii) in the manner and form determined by the Secretary; and\n\n(c) made available to the Secretary on request.\n\n(3) The health service establishment protocols must include the following—\n\n(a) processes for assessing every 3 years the credentials of each health professional practising at the health service establishment;\n\n(b) processes for setting the scope of practice for each health professional practising at the health service establishment;\n\n(c) processes for continually assessing the competence and performance of each health professional practising at the health service establishment;\n\n(d) processes for continually assessing and reviewing health services provided by each health professional practising at the health service establishment;\n\n(e) processes for continually assessing the capacity of the health service establishment to provide safe, patient‑centred and appropriate health services to patients at each of its premises;\n\n(f) setting the frequency of, and procedures for, meetings of any committees of the health service establishment with responsibility for the quality and safety of health services provided at, or from, the health service establishment;\n\n**Note**\n\nRelevant committees may include, but are not limited to, a medical advisory committee, a quality and safety committee and the board of the health service establishment.\n\n(g) processes for ensuring that appropriate arrangements have been made for evaluating, monitoring and improving the quality and safety of health services provided at each premises of the health service establishment;\n\n(h) on and from 31 August 2025, the description and allocation of quality and safety roles in relation to the health service establishment;\n\n(i) on and from 31 August 2025, having regard to the kind or kinds of health services being provided at, or from, the health service establishment, processes and procedures for the following—\n\n(i) the availability of appropriate adjunct diagnostic services;\n\n(ii) review of adverse patient safety events, including participation of all relevant personnel in the review (whether employees or not);\n\n(iii) addressing the specific needs of Aboriginal persons;\n\n(iv) recognising and responding to deteriorations in the condition of patients.\n\n(4) The proprietor of a health service establishment must ensure that the health service establishment's quality and safety protocols are implemented and complied with.\n\n(5) In this regulation—\n\n***health professional*** means a registered medical practitioner, a registered dental practitioner, a registered medical radiation practitioner or a registered podiatrist.\n\n\t9 Determination of quality and safety guidelines\n\n(1) The Secretary may determine approved quality and safety guidelines in relation to the health service establishment protocols for quality and safety set out in regulation 8.\n\n(2) The Secretary must cause a notice of a determination under subregulation (1) to be published—\n\n(a) in the Government Gazette; and\n\n(b) on the Department's Internet site.\n\n(3) A notice of a determination of approved quality and safety guidelines must state—\n\n(a) where a copy of the approved quality and safety guidelines may be obtained; and\n\n(b) the date on which the approved quality and safety guidelines take effect.\n\n\t10 Review of health service establishment protocols for quality and safety\n\n(1) On and from 28 February 2026, the Secretary may determine to conduct a review of the health service establishment protocols for quality and safety prepared by a health service establishment under regulation 8(1).\n\n(2) The Secretary may, after conducting a review of a health service establishment's protocols for quality and safety, determine to issue a written direction to the proprietor of that health service establishment to update the protocols for quality and safety in the manner directed by the Secretary.\n\n(3) The Secretary may determine to issue a written direction to the proprietor of a health service establishment if the Secretary considers that the protocols for quality and safety of that health service establishment—\n\n(a) are inconsistent with the Act or these Regulations; or\n\n(b) are otherwise inadequate for ensuring the quality and safety of health services provided at, or from, the health service establishment.\n\n(4) In conducting a review of health service establishment protocols for quality and safety, the Secretary may have regard to an approved quality and safety guideline referred to in regulation 9(1).\n\n(5) The proprietor of a health service establishment must ensure that a written direction of the Secretary to update the health service establishment's protocols for quality and safety is complied with.\n\nPart 4—Forms of application and fees\n\n\t11 Application for approval in principle\n\n(1) For the purposes of section 70(2)(a) of the Act, the prescribed form is the form in Schedule 2.\n\n(2) For the purposes of section 70(2)(b) of the Act, the following fees are prescribed—\n\n(a) for an application for approval in principle to use particular land or premises as a private hospital or day procedure centre—325 fee units;\n\n(b) for an application for approval in principle to construct premises for use as a private hospital—325 fee units;\n\n(c) for an application for approval in principle to make alterations or extensions to premises used or proposed to be used as a private hospital—290 fee units;\n\n(d) for an application for approval in principle to construct premises for use as a day procedure centre—285 fee units;\n\n(e) for an application for approval in principle to make alterations or extensions to premises used or proposed to be used as a day procedure centre—276 fee units;\n\n(f) for an application for approval in principle to use particular land or premises as a health service establishment from which health services are to be provided at premises other than the first-mentioned premises—91 fee units;\n\n(g) for an application for approval in principle to vary the registration of a health service establishment—161 fee units.\n\n\t12 Application for transfer or variation of certificate of approval in principle\n\nFor the purposes of section 74(2) of the Act—\n\n(a) the prescribed form is the form in Schedule 3; and\n\n(b) the prescribed fee is 161 fee units.\n\n\t13 Application for registration of a health service establishment\n\n(1) For the purposes of section 82(2)(a) of the Act, the prescribed form is the form in Schedule 4.\n\n(2) For the purposes of section 82(2)(b) of the Act, the following fees are prescribed—\n\n(a) for an application for registration of a health service establishment with 0 to 26 beds—366 fee units;\n\n(b) for an application for registration of a health service establishment with 27 to 50 beds—405 fee units;\n\n(c) for an application for registration of a health service establishment with 51 to 75 beds—445 fee units;\n\n(d) for an application for registration of a health service establishment with 76 to 100 beds—484 fee units;\n\n(e) for an application for registration of a health service establishment with 101 to 150 beds—543 fee units;\n\n(f) for an application for registration of a health service establishment with 151 to 200 beds—623 fee units;\n\n(g) for an application for registration of a health service establishment with 201 to 300 beds—701 fee units;\n\n(h) for an application for registration of a health service establishment with 301 to 400 beds—820 fee units;\n\n(i) for an application for registration of a health service establishment with 401 to 500 beds—978 fee units;\n\n(j) for an application for registration of a health service establishment with 501 or more beds—1175 fee units.\n\n\t14 Annual fees for health service establishments\n\nFor the purposes of section 87(1) and (2)(a) of the Act, the prescribed annual fee is nil fee units.\n\n\t15 Application for renewal of registration of a health service establishment\n\n(1) For the purposes of section 88(2)(a) of the Act, the prescribed form is the form in Schedule 5.\n\n(2) For the purposes of section 88(2)(b) of the Act, the following fees are prescribed—\n\n(a) for an application for renewal of the registration of a health service establishment with 0 to 26 beds—366 fee units;\n\n(b) for an application for renewal of the registration of a health service establishment with 27 to 50 beds—405 fee units;\n\n(c) for an application for renewal of the registration of a health service establishment with 51 to 75 beds—445 fee units;\n\n(d) for an application for renewal of the registration of a health service establishment with 76 to 100 beds—484 fee units;\n\n(e) for an application for renewal of the registration of a health service establishment with 101 to 150 beds—543 fee units;\n\n(f) for an application for renewal of the registration of a health service establishment with 151 to 200 beds—623 fee units;\n\n(g) for an application for renewal of the registration of a health service establishment with 201 to 300 beds—701 fee units;\n\n(h) for an application for renewal of the registration of a health service establishment with 301 to 400 beds—820 fee units;\n\n(i) for an application for renewal of the registration of a health service establishment with 401 to 500 beds—978 fee units;\n\n(j) for an application for renewal of the registration of a health service establishment with 501 or more beds—1175 fee units.\n\n\t16 Application for variation of registration of a health service establishment\n\n(1) For the purposes of section 92(2)(a) of the Act, the prescribed form is the form in Schedule 6.\n\n(2) For the purposes of section 92(2)(b) of the Act, the prescribed fee—\n\n(a) in the case of an application for the transfer of a certificate of registration or certificate of renewal of registration to another person who intends to become the proprietor is 478 fee units; and\n\n(b) in any other case is 161 fee units.\n\n\t17 Application for approval of alterations to clinical area within a health service establishment\n\n(1) For the purposes of section 108(2)(a) of the Act, the prescribed form is the form in Schedule 7.\n\n(2) For the purposes of section 108(2)(b) of the Act, the prescribed fee is nil fee units.\n\nPart 5—Senior appointments\n\nDivision 1—Director of Nursing\n\n\t18 Director of Nursing must be appointed\n\n(1) The proprietor of a health service establishment that provides one or more of its health services at the premises for which it is registered must appoint a suitably qualified person as the Director of Nursing.\n\nPenalty: 50 penalty units.\n\n(2) For the purposes of subregulation (1), a person is suitably qualified if the person—\n\n(a) is a registered nurse; and\n\n(b) has at least 12 months' practical experience in nursing management; and\n\n(c) has at least 5 years' clinical experience as a registered nurse.\n\n\t19 Appointment of acting Director of Nursing\n\nIf the Director of Nursing is absent or incapacitated, or the position is vacant, the proprietor of a health service establishment must appoint a person to act as the Director of Nursing during the period of the absence, incapacity or vacancy.\n\nPenalty: 50 penalty units.\n\n\t20 Secretary must be notified of appointment\n\n(1) The proprietor of a health service establishment must notify the Secretary in writing of the name, qualifications and experience of any person appointed under this Division as the Director of Nursing within 28 days after making the appointment.\n\nPenalty: 20 penalty units.\n\n(2) The proprietor of a health service establishment must notify the Secretary in writing of the name, qualifications and experience of any person appointed under this Division to act as the Director of Nursing for a period of more than 28 days within 28 days after making the appointment.\n\nPenalty: 20 penalty units.\n\nDivision 2—Other appointments\n\n\t21 Chief Executive Officer and Medical Director\n\nIf the proprietor of a health service establishment appoints a Chief Executive Officer or Medical Director (however titled), the proprietor must notify the Secretary in writing of the name, qualifications and experience of the person appointed within 28 days of the appointment.\n\nPenalty: 20 penalty units.\n\n\t22 Secretary to be notified of termination or vacancy\n\nIf the proprietor of a health service establishment terminates the appointment of a Chief Executive Officer or Medical Director (however titled), or the position otherwise becomes vacant, the proprietor must notify the Secretary in writing within 28 days of the termination or vacancy.\n\nPenalty: 20 penalty units.\n\nPart 6—Admission of patients\n\nDivision 1—Unit record number\n\n\t23 Unit record number must be allocated\n\nThe proprietor of a health service establishment that provides one or more of its health services at the premises for which it is registered must ensure that a unit record number is allocated to a patient on or as soon as practicable after the admission of the patient to the health service establishment.\n\nPenalty: 30 penalty units.\n\nDivision 2—Information to be given to patients\n\n\t24 Information about fees and services\n\n(1) The proprietor of a health service establishment must ensure that on or before admission each patient of the hospital or centre is given—\n\n(a) a statement containing information in relation to the health services provided at the health service establishment that complies with subregulation (2); and\n\n(b) information about health service establishment fees and likely out of pocket expenses to be charged by the health service establishment, and any likely third party fees and out of pocket expenses in relation to the health services to be provided to the patient at the health service establishment; and\n\n(c) a clear explanation of the treatment and other health services to be provided to the patient at the health service establishment.\n\nPenalty: 50 penalty units.\n\n(2) A statement referred to in subregulation (1) must contain information about the following matters—\n\n(a) the quality or standard of health care and services provided at the health service establishment;\n\n(b) courteous treatment of patients;\n\n(c) consideration of a patient's gender identity, beliefs and ethnic, cultural and religious practices;\n\n(d) consideration of a patient's special dietary needs (if any);\n\n(e) a patient's privacy;\n\n(f) that a patient may request the names and roles of the key health workers involved in the patient's care;\n\n(g) a patient's entitlement to ask for a referral if they want to seek another medical opinion;\n\n(h) that any personal information or identifying material about a patient is dealt with in a confidential manner except—\n\n(i) if necessary to enable another health care worker to assist in the patient's care; or\n\n(ii) if authorised by or under a law;\n\n(i) a patient's consent to treatment;\n\n(j) that a patient may refuse the presence of health workers not directly involved in the patient's care;\n\n(k) that a patient may discharge themselves at any time despite the advice of the attending registered health practitioner or staff of the health service establishment;\n\n(l) that a patient may comment on or complain about the treatment or the quality of the health services or care being provided, including to whom any complaint should be made.\n\nDivision 3—Clinical risk assessments\n\n\t25 Pre-admission assessment\n\nThe proprietor of a health service establishment must ensure that for a non-emergency patient admitted to the health service establishment—\n\n(a) a pre-admission clinical risk assessment is carried out by a registered health practitioner for that patient before admission; and\n\n(b) the following matters are recorded in writing, not less than 24 hours before admission—\n\n(i) the matters considered and assessed by the registered health practitioner as part of the pre-admission clinical risk assessment;\n\n(ii) the results of the pre-admission clinical risk assessment;\n\n(iii) the name and signature of the registered health practitioner carrying out the pre‑admission clinical risk assessment; and\n\n(c) the health service for which the patient is admitted is assessed in relation to the scope of practice of the registered health practitioner who will provide the health service to that patient.\n\n\t26 Pre-presentation assessment\n\nThe proprietor of a health service establishment must ensure that for each non-emergency patient that is provided with a health service by the health service establishment but is not admitted to the health service establishment—\n\n(a) a pre-presentation clinical risk assessment is carried out by a registered health practitioner; and\n\n(b) the following matters are recorded in writing, not less than 24 hours before the health service is provided—\n\n(i) the matters considered and assessed by the registered health practitioner as part of the pre-presentation clinical risk assessment;\n\n(ii) the results of the pre-presentation clinical risk assessment;\n\n(iii) the name and signature of the registered health practitioner carrying out the pre‑presentation clinical risk assessment; and\n\n(c) the health service for which the patient presents is assessed in relation to the scope of practice of the registered health practitioner who will provide the health service to that patient.\n\nDivision 4—Clinical records\n\n\t27 Clinical record must be created and updated\n\n(1) The proprietor of a health service establishment must ensure that a separate clinical record for each patient is created on or as soon as practicable after the admission of the patient to the health service establishment.\n\nPenalty: 30 penalty units.\n\n(2) The proprietor of a health service establishment must ensure that, whenever a patient receives a health service from the health service establishment, any clinical record for the patient is updated.\n\nPenalty: 30 penalty units.\n\n\t28 Information to be included in clinical record\n\nThe proprietor of a health service establishment must take reasonable steps to ensure that each clinical record contains the following information—\n\n(a) the patient's unit record number;\n\n(b) the patient's name, address, date of birth and sex;\n\n(c) the name and contact details of a relative or friend nominated by the patient;\n\n(d) relevant clinical details of the patient including the following—\n\n(i) clinical history on admission;\n\n(ii) progress notes whenever the patient is receiving health services from the health service establishment, including notes of any incidents that are clinically relevant;\n\n(iii) any medication ordered or given;\n\n(iv) known allergies and drug sensitivities;\n\n(v) current medication;\n\n(vi) clinical risk assessments conducted before the patient receives a health service, including a pre-admission assessment conducted in accordance with regulation 25;\n\n(vii) results of any relevant diagnostic tests;\n\n(e) if a procedure is carried out on the patient, the following information—\n\n(i) the consent form for the procedure and anaesthesia;\n\n(ii) the date of the procedure;\n\n(iii) the name and signature of each registered health practitioner carrying out the procedure;\n\n(iv) the type of procedure carried out;\n\n(v) the pre-procedure check list by the attending practitioner or by the assisting nurse;\n\n(vi) administered drugs and dosages;\n\n(vii) a record of any monitoring undertaken;\n\n(viii) a record of any intravenous fluids administered;\n\n(ix) a procedure room report including any procedure findings;\n\n(x) the final diagnosis of the patient on discharge.\n\nPenalty: 30 penalty units.\n\n**Note**\n\nThe **Health Records Act 2001** contains provisions relating to the retention of records. See HPP 4 of the Health Privacy Principles in that Act.\n\nDivision 5—Identification of patients\n\n\t29 Means of identifying patients\n\nThe proprietor of a health service establishment must ensure that a patient can be readily identified at all times when the patient is receiving a health service at the health service establishment by—\n\n(a) an identity band or other suitable device attached to the patient; or\n\n(b) a photograph, a copy of which must be attached to the clinical record of the patient.\n\nPenalty: 40 penalty units.\n\n\t30 Identification of infants\n\n(1) The proprietor of a health service establishment must ensure that if an infant is born at the health service establishment, at least 2 identity bands or other suitable devices which contain the birth information are attached to that infant—\n\n(a) as soon as practicable after the birth and before leaving the delivery room; and\n\n(b) while the infant remains in the health service establishment.\n\nPenalty: 30 penalty units.\n\n(2) The proprietor of a health service establishment must ensure that at least 2 identity bands or other suitable devices which contain the birth information are attached to an infant for as long as the infant remains in the health service establishment if, immediately after giving birth to the infant, the mother is admitted as a patient of a health service establishment for—\n\n(a) the receipt of medical services in connection with the birth; or\n\n(b) the provision of nursing services by a suitably qualified nurse that are directly related to the birth.\n\nPenalty: 30 penalty units.\n\n(3) In this regulation, ***birth information*** means—\n\n(a) the surname of the infant; and\n\n(b) the full name of the mother; and\n\n(c) the unit record number of the mother.\n\nPart 7—Care of patients\n\nDivision 1—Management of patient care\n\n\t31 Respect, dignity and privacy\n\nThe proprietor of a health service establishment must ensure that a patient—\n\n(a) is treated with dignity and respect, and with due regard to their gender identity, religious beliefs and ethnic and cultural practices; and\n\n(b) is given privacy; and\n\n(c) is not subjected to unusual routines, particularly with respect to the timing of meals and hygiene procedures, unless the routines are for the benefit of the patient.\n\n**Examples**\n\n1 Facilities are provided to allow patients to undertake personal activities, including bathing, toileting and dressing in private.\n\n2 Facilities are designed to ensure auditory and visual privacy for patients whenever patients are receiving health services from the health service establishment.\n\n3 If facilities are shared, provision is made to ensure patient privacy.\n\n4 Patients are provided with meals in accordance with their religious beliefs and ethnic and cultural practices.\n\nDivision 2—Nursing and professional care\n\n\t32 Nurses must be registered and competent\n\nThe proprietor of a health service establishment must ensure that each nurse at the health service establishment—\n\n(a) is an enrolled nurse or a registered nurse; and\n\n(b) is professionally competent through education or experience to provide nursing care at the health service establishment, having regard to the kind or kinds of health services being provided.\n\nPenalty: 50 penalty units.\n\n\t33 Post-operative care of surgery patients\n\nIf the Director of Nursing is not present at a health service establishment on a day on which a surgical health service is provided at the health service establishment, the proprietor of the health service establishment must ensure that a registered nurse with at least 3 years' relevant clinical experience is present to supervise the provision of the surgical health service to, and the post-operative care of, any patient receiving that surgical health service.\n\n\t34 Care of maternity, obstetric and neonatal patients\n\nIf maternity services, obstetric services or neonatal services are provided at a health service establishment, the proprietor of the health service establishment must ensure that a registered midwife with at least 3 years' relevant clinical experience is present to provide clinical oversight of those health services.\n\n\t35 Sufficient nursing staff must be on duty\n\n(1) The proprietor of a health service establishment must ensure that whenever patients are receiving health services from the health service establishment, a sufficient number of nursing staff are on duty to provide care for those patients.\n\nPenalty: 50 penalty units.\n\n(2) For the purposes of subregulation (1), a sufficient number of nursing staff is—\n\n(a) in the case of a private hospital—\n\n(i) at least one registered nurse for every 10 patients or fraction of that number during day and evening shifts; and\n\n(ii) at least one registered nurse for every 15 patients or fraction of that number during night shifts; or\n\n(b) in the case of a day procedure centre, at least one registered nurse for every 10 patients or fraction of that number.\n\n(3) Despite subregulation (2), in determining the number of nurses on duty, if 3 or more nurses are on duty at a health service establishment during a shift, up to one-third may be enrolled nurses.\n\n\t36 Needs of patients must be met\n\nThe proprietor of a health service establishment must take reasonable steps to ensure that the needs of patients are met promptly and effectively by nursing staff and other professionally competent registered health practitioners.\n\nPenalty: 50 penalty units.\n\n\t37 Reversal agents must be available\n\nIf health services are provided at a health service establishment involving the use of anaesthesia or other sedation for which there are reversal agents, the proprietor of the health service establishment must ensure that these reversal agents are available for immediate access at the premises of the health service establishment.\n\nPart 8—Complaints\n\n\t38 Nomination of complaints officer\n\n(1) The proprietor of a health service establishment must nominate in writing a person to receive and deal with any complaints that may be made against the health service establishment by, or on behalf of, a patient of the health service establishment.\n\nPenalty: 50 penalty units.\n\n(2) The proprietor of a health service establishment must take reasonable steps to ensure that every patient and member of the staff of the health service establishment is informed of the name of the person nominated under subregulation (1) by the proprietor to receive and deal with complaints.\n\nPenalty: 50 penalty units.\n\n\t39 Dealing with a complaint\n\n(1) The proprietor of a health service establishment must ensure that a complaint made against the health service establishment is responded to as soon as practicable after the complaint has been made.\n\nPenalty: 40 penalty units.\n\n(2) The proprietor of a health service establishment must ensure that a complaint made against the health service establishment is dealt with as discreetly as possible in the particular circumstances.\n\nPenalty: 40 penalty units.\n\n(3) The proprietor of a health service establishment must ensure that a person who makes a complaint against the health service establishment is informed of the action taken in respect of the complaint.\n\nPenalty: 40 penalty units.\n\n\t40 Record of complaint\n\n(1) The proprietor of a health service establishment must ensure that a written record is kept of every complaint made against the health service establishment by, or on behalf of, a patient of the health service establishment.\n\nPenalty: 30 penalty units.\n\n(2) For the purposes of subregulation (1), the written record must contain the following information—\n\n(a) the nature of the complaint;\n\n(b) the date of the complaint;\n\n(c) the action taken in respect of that complaint.\n\n(3) The proprietor of a health service establishment must ensure that a written record of a complaint referred to in subregulation (1) is kept in a secure place for a period of 7 years after the complaint was made.\n\nPenalty: 30 penalty units.\n\n\t41 Person making complaint must not be adversely affected\n\nThe proprietor of a health service establishment must take reasonable steps to ensure that, if a complaint has been made against the health service establishment by a patient or a person on behalf of the patient, the patient or the person is not adversely affected because the complaint has been made.\n\nPenalty: 60 penalty units.\n\nPart 9—Transfer and discharge of patients\n\n\t42 Documentation required for transferred patients\n\nIf a patient is transferred from a health service establishment to another health service establishment or health care agency, the proprietor of the health service establishment from which the patient is transferred must ensure that all information and copies of any documents relating to the patient's medical condition and treatment necessary for the establishment or agency to provide appropriate ongoing treatment or care are sent with the patient.\n\nPenalty: 40 penalty units.\n\n\t43 Information provided to patient transport\n\n(1) The proprietor of a health service establishment must ensure that the crew of a vehicle used by a non-emergency patient transport service or by an ambulance service to transport a patient from the health service establishment is provided with—\n\n(a) handover notes in writing in relation to the patient's clinical condition; and\n\n(b) a copy of any advance care directive given by the patient in accordance with the **Medical Treatment Planning and Decisions Act 2016**.\n\n(2) In this regulation—\n\n***non-emergency patient transport* service** has the same meaning as in the **Non‑Emergency Patient Transport and First Aid Services Act 2003**;\n\n***ambulance service*** has the same meaning as in the **Ambulance Services Act 1986**.\n\n\t44 Discharge information\n\n(1) The proprietor of a health service establishment must ensure that, at the time of the discharge of an admitted patient from the health service establishment, the following is given to the patient—\n\n(a) the name and contact details in writing of whom to contact for post-procedure medical advice;\n\n(b) a copy of the patient's discharge summary that complies with subregulation (3).\n\n(2) The proprietor of a health service establishment must ensure that a copy of the patient's discharge summary that complies with subregulation (3)—\n\n(a) is provided to the patient's registered medical practitioner as soon as practicable after the discharge of the patient; or\n\n(b) has been given to the patient at discharge for the patient to provide to the patient's registered medical practitioner.\n\n(3) A patient's discharge summary must include the following information—\n\n(a) the full name of the patient;\n\n(b) the date of birth of the patient;\n\n(c) a description of the health service that the patient received at the health service establishment;\n\n(d) the post-discharge instructions for patient care;\n\n(e) an itemised list of any new medication prescribed for the patient in relation to the health services received at the health service establishment and any cessations of, or variations to, any regular prescribed medication of the patient;\n\n(f) in the case of a patient of a private hospital who was admitted overnight—a list, summary or statement regarding the unchanged, regular prescribed medication of the patient.\n\n(4) The proprietor of the health service establishment must have regard to the clinical profile of a patient in deciding the nature and detail of information to be included in a list, summary or statement of unchanged, regular prescribed medication prepared in accordance with subregulation (3)(f).\n\nPart 10—Registers, records and permits\n\nDivision 1—Patient admission and discharge records\n\n\t45 Patient admission and discharge records\n\nFor the purposes of section 109(1) of the Act, with respect to persons who receive care in the health service establishment—\n\n(a) the prescribed manner is in writing; and\n\n(b) the prescribed period is 7 years; and\n\n(c) the prescribed particulars are the following—\n\n(i) the unit record number of the patient;\n\n(ii) the full name of the patient;\n\n(iii) the sex of the patient;\n\n(iv) the address and telephone number of the patient;\n\n(v) the patient's date of birth;\n\n(vi) the date of the patient's admission and discharge;\n\n(vii) a description of care received and the status of the patient at discharge;\n\n(viii) if the patient is transferred to another health service establishment or health care agency, the name of that establishment or agency and the reason for the transfer.\n\nDivision 2—Staff records\n\n\t46 Staff records\n\nFor the purposes of section 109(1) of the Act, with respect to staff employed in the health service establishment—\n\n(a) the prescribed manner is in writing; and\n\n(b) the prescribed period is 2 years; and\n\n(c) the prescribed particulars are the following—\n\n(i) the full name of every member of the nursing staff and other registered health practitioners;\n\n(ii) the date of birth of every member;\n\n(iii) the designation of every member;\n\n(iv) the qualifications of every member;\n\n(v) if applicable, the registration number or code of every member.\n\nDivision 3—Registers\n\n\t47 Surgical Procedure Register\n\n(1) The proprietor of a health service establishment at which surgical health services or speciality health services for the provision of endoscopy may be provided must ensure that a Surgical Procedure Register that complies with subregulation (2) is kept at the health service establishment.\n\nPenalty: 30 penalty units.\n\n(2) For the purposes of subregulation (1), a Surgical Procedure Register must be in writing and contain the following records with respect to each procedure performed at the health service establishment—\n\n(a) the date and time of the procedure;\n\n(b) the unit record number of the patient;\n\n(c) the patient's full name, sex and date of birth;\n\n(d) the nature of the procedure;\n\n(e) the names of the registered health practitioner undertaking the procedure and assistant (if any);\n\n(f) the names of the anaesthetist and assistant (if any);\n\n(g) the names of attending clinical staff;\n\n(h) any remarks concerning the outcome of the procedure;\n\n(i) any anaesthetic or procedural complications encountered.\n\n**Note**\n\nThe **Health Records Act 2001** contains provisions relating to the retention of records. See HPP 4 of the Health Privacy Principles in that Act.\n\n\t48 Birth Register\n\n(1) The proprietor of a health service establishment in which speciality health services for the provision of obstetrics may be provided must ensure that a Birth Register that complies with subregulation (2) is kept at the health service establishment.\n\nPenalty: 30 penalty units.\n\n(2) For the purposes of subregulation (1), a Birth Register must be in writing and contain the following records with respect to each birth at the health service establishment—\n\n(a) the date and time of the birth;\n\n(b) the full name of the mother;\n\n(c) the unit record number of the mother;\n\n(d) the sex of the infant;\n\n(e) the names of all health care personnel in attendance at the birth.\n\n(3) The proprietor of a health service establishment must retain a Birth Register for at least 25 years after the date of the last entry.\n\nPenalty: 30 penalty units.\n\nDivision 4—Permits\n\n\t49 Permit issued under section 19 of the Drugs, Poisons and Controlled Substances Act 1981\n\n(1) The proprietor of a health service establishment must hold a permit issued under section 19 of the **Drugs, Poisons and Controlled Substances Act 1981** by which the proprietor is authorised under section 20(3) of that Act to purchase or otherwise obtain certain poisons or controlled substances for the provision of health services.\n\n(2) Subregulation (1) does not apply to the following—\n\n(a) a proprietor of a health service establishment at or from which the health services provided do not usually require the purchase or otherwise obtaining of any poisons or controlled substances, other than a patient's own medicine, for the provision of those health services;\n\n**Example**\n\nDrug and alcohol withdrawal treatment services and dialysis services.\n\n(b) a proprietor of a health service establishment—\n\n(i) that provides health services solely at premises other than the premises for which it is registered; and\n\n**Note**\n\nAn example of a health service establishment that provides health services solely at premises other than the premises for which it is registered is the provider of mobile anaesthetic services at a dental clinic.\n\n(ii) where at those other premises only one registered health practitioner (other than the additional nursing staff required under regulation 35 or one or more additional registered midwives) provides the health services.\n\n(3) In this regulation, ***patient's own medicine*** means a poison or controlled substance that has been supplied to a patient by a registered health practitioner other than—\n\n(a) the proprietor of the health service establishment; or\n\n(b) a registered health practitioner employed by or contracted to provide health services prescribed under Part 2 for or at the health service establishment.\n\nPart 11—Premises and equipment\n\n\t50 Identification of rooms\n\nThe proprietor of a health service establishment must ensure that each room in which beds or recovery chairs are provided for the accommodation of patients is clearly identified at the entrance to that room by a sign stating—\n\n(a) the letter or number of that room; and\n\n(b) the number of beds and recovery chairs ordinarily in that room.\n\nPenalty: 10 penalty units.\n\n\t51 Communications\n\n(1) The proprietor of a health service establishment that provides one or more of its health services at the premises for which it is registered must ensure that an effective electronic communication system that complies with subregulation (2) is provided and kept operational at the health service establishment.\n\nPenalty: 60 penalty units.\n\n(2) For the purposes of subregulation (1), an electronic communication system must—\n\n(a) enable patients and staff to summon assistance; and\n\n(b) enable calls to be made from the following—\n\n(i) each bed;\n\n(ii) any recovery chair in a recovery room;\n\n(iii) each toilet, shower or bath or other facility used for the bathing of patients;\n\n(iv) any common room, recreational or rest area or other place where patient care is provided.\n\n\t52 Repair and cleanliness of premises\n\nThe proprietor of a health service establishment must ensure that the premises are kept—\n\n(a) in a clean and hygienic condition; and\n\n(b) in a proper state of repair; and\n\n(c) free of hazards or the accumulation of materials which may become offensive, injurious to health or likely to facilitate the outbreak of fire.\n\nPenalty: 80 penalty units.\n\n\t53 Suitability and cleanliness of facilities, equipment, furnishings and fittings\n\n(1) The proprietor of a health service establishment must ensure that facilities, equipment, furnishings and fittings at the health service establishment are suitable for the kind or kinds of health services being provided by the health service establishment.\n\n(2) The proprietor of a health service establishment must ensure that facilities, equipment, furnishings and fittings at the health service establishment are—\n\n(a) kept in a proper state of repair and maintained in good working order; and\n\n(b) kept in a clean and hygienic condition.\n\nPenalty: 80 penalty units.\n\n\t54 Premises, staff and equipment outside health service establishment premises\n\nFor the purpose of ensuring the quality and safety of health services provided by a health service establishment at premises other than the premises for which it is registered, the proprietor of the health service establishment must ensure that—\n\n(a) those other premises are suitable for the provision of safe patient care; and\n\n(b) persons with appropriate training and experience provide those health services; and\n\n(c) the equipment used to provide those health services is suitable for the type of health services provided.\n\n\t55 Evacuation plan\n\nThe proprietor of a health service establishment must ensure that—\n\n(a) an evacuation plan for all patients and members of staff at the health service establishment is prepared; and\n\n(b) the evacuation plan is displayed in a prominent position at the entrance foyer or reception area of the health service establishment and in any common room, recreational or rest area or other place where patient care is provided; and\n\n(c) all staff are trained in the implementation of the evacuation plan.\n\nPart 12—Infection control\n\n\t56 Infection Control Management Plan\n\n(1) The proprietor of a health service establishment must implement and maintain an Infection Control Management Plan that complies with subregulations (2) and (3).\n\nPenalty: 80 penalty units.\n\n(2) For the purposes of subregulation (1), an Infection Control Management Plan must provide for the surveillance, prevention and control of infection at the health service establishment.\n\n(3) Without limiting subregulation (2), an Infection Control Management Plan must—\n\n(a) state its objectives; and\n\n(b) identify and assess all the infection risks specific to the health service establishment which the proprietor knows, or can reasonably be expected to know, exists or may exist, and state how these risks are to be minimised; and\n\n(c) provide for an ongoing infection control education program for the staff of the health service establishment; and\n\n(d) state the particulars of training for persons who provide services at the health service establishment that involve infection control risks; and\n\n(e) set out how the proprietor will monitor and review the implementation and effectiveness of the Plan.\n\nPart 13—Display of information\n\n\t57 Information to be prominently displayed\n\nThe proprietor of a health service establishment must display in a prominent position at the entrance foyer or reception area of the health service establishment the following information—\n\n(a) the certificate of registration of the premises as a health service establishment or a full size copy of the certificate;\n\n(b) the certificate of accreditation for any accreditation scheme applicable to the health service establishment and approved by the Secretary under section 107(1) of the Act;\n\n(c) the name of the Director of Nursing (if required to be appointed) and the name of any appointed Chief Executive Officer or Medical Director (however titled);\n\n(d) the name and telephone number of the person nominated under regulation 38 to receive and deal with complaints.\n\nPenalty: 20 penalty units.\n\nPart 14—Enforcement\n\n\t58 Form of notice of seizure\n\nFor the purposes of section 147(2)(a) of the Act, the prescribed form is the form in Schedule 8.\n\n\t59 Infringement offences and infringement penalties\n\n(1) For the purposes of section 155(1) of the Act, an offence specified in Column 1 of the Table in Schedule 9 is prescribed as an infringement offence.\n\n(2) For the purposes of section 155(1) of the Act, the prescribed infringement penalty for an infringement offence referred to in subregulation (1) is the penalty specified in Column 2 of the Table in Schedule 9 in respect of that infringement offence.\n\nPart 15—Returns and reports to be given to the Secretary\n\n\t60 Returns and reports to be given to the Secretary\n\n(1) The proprietor of a health service establishment must prepare a return for each month containing data in relation to each patient admitted to the health service establishment during that month as determined by the Secretary.\n\n(2) The proprietor of a health service establishment must ensure that a return prepared under subregulation (1) is given to the Secretary—\n\n(a) in the case of admission and discharge data, within 17 days after the end of the month to which the return relates; and\n\n(b) in the case of clinical care data, within 47 days after the end of the month to which the return relates.\n\n(3) The proprietor of a private hospital must prepare a return for each month containing the following—\n\n(a) data about infections acquired by patients and staff at the private hospital and infection prevention and surveillance activities implemented at the private hospital;\n\n(b) data in relation to any electroconvulsive treatment (within the meaning of the **Mental Health and Wellbeing Act 2022**) provided at the private hospital;\n\n(c) data as determined by the Secretary about patients who presented at the private hospital's emergency department.\n\n(4) The proprietor of a private hospital must ensure that a return prepared under subregulation (3) is given to the Secretary within 17 days after the end of the month to which the return relates.\n\n(5) The Secretary may determine to direct the proprietor of a health service establishment that provides health services solely at premises other than the premises for which it is registered to prepare a return in the manner and form determined by the Secretary.\n\n(6) The proprietor of a health service establishment must ensure that a return prepared under subregulation (5) is given to the Secretary within the time determined by the Secretary.\n\n(7) The proprietor of a health service establishment must ensure that a return prepared under this regulation does not include the name or address of a patient.\n\n(8) The proprietor of a health service establishment must provide a copy of each report received from the accreditation scheme applicable to the health service establishment and approved by the Secretary under section 107(1) of the Act, to the Secretary within 14 days of the receipt of the report.\n\n\t61 Reporting of compliance with the duty of candour\n\n(1) The proprietor of a private hospital or day procedure centre must submit a report that complies with subregulation (2) to the Secretary concerning compliance by that private hospital or day procedure centre with the requirements of its duty of candour under section 128ZC(1) of the Act for each reporting period within 14 days after the end of a reporting period.\n\n(2) A report submitted to the Secretary under subregulation (1) must include the following information—\n\n(a) data specifying the number of serious adverse patient safety events suffered by patients in the course of receiving health services from that private hospital or day procedure centre that were identified in the first 3 months of the reporting period;\n\n(b) in relation to the serious adverse patient safety events specified for the purposes of paragraph (a), the following data for the reporting period—\n\n(i) the number of serious adverse patient safety events if the requirements of the duty of candour under section 128ZC(1) of the Act were commenced in the reporting period;\n\n(ii) the number of serious adverse patient safety events that occurred where the patient has been provided with the information specified in section 128ZC(1)(a) of the Act in the reporting period;\n\n(iii) the number of serious adverse patient safety events that occurred where the patient chose under section 128ZC(2) of the Act not to receive the information specified in section 128ZC(1)(a) of the Act.\n\n(3) The proprietor of a private hospital or day procedure centre must ensure that the report prepared for the purposes of this regulation is submitted to the Secretary in the manner and form determined by the Secretary.\n\n(4) In this regulation, ***reporting period*** means each of the following periods—\n\n(a) the period beginning on 1 October and ending on 31 March;\n\n(b) the period beginning on 1 January and ending on 30 June;\n\n(c) the period beginning on 1 April and ending on 30 September;\n\n(d) the period beginning on 1 July and ending on 31 December.\n\nPart 16—Quality and safety review data\n\n\t62 Open disclosure policy\n\n(1) For the purpose of ensuring the quality and safety of health services provided at a health service establishment, the proprietor of a health service establishment must prepare an open disclosure policy in accordance with this regulation.\n\n(2) The open disclosure policy must be—\n\n(a) documented in writing; and\n\n(b) published on the health service establishment's website.\n\n(3) The open disclosure policy must include processes by which open discussion between the health service establishment and a patient and the patient's family and carers are to occur following any adverse event that results in harm to the patient.\n\n(4) The proprietor of a health service establishment must ensure that the open disclosure policy is implemented.\n\n\t63 Review of quality and safety of health services provided\n\n(1) The proprietor of a health service establishment must ensure the following information is recorded in writing and reviewed at least every 3 months—\n\n(a) information in relation to the decisions and actions taken for the purposes of improving the quality and safety of health services provided;\n\n(b) if applicable, information in relation to—\n\n(i) all adverse events occurring at the health service establishment; and\n\n(ii) all sentinel events occurring at the health service establishment; and\n\n(iii) mortality and morbidity occurring at the health service establishment; and\n\n(iv) all transfers of patients from the health service establishment to another health service establishment or health care agency for the escalation of patient care; and\n\n(v) compliance with the health service establishment's protocols; and\n\n(vi) results from surveys about patient experience and about staff safety culture.\n\n(2) The proprietor of a health service establishment must make information recorded under this regulation available to the Secretary on request.\n\n\t64 Patient experience survey data\n\nThe proprietor of a health service establishment must ensure that at each premises of the health service establishment—\n\n(a) patient experience survey data is collected; and\n\n(b) the patient experience survey data is reviewed; and\n\n(c) the patient experience survey data is made available to the Secretary on request.\n\n\t65 Staff safety culture survey data\n\nThe proprietor of a health service establishment must ensure that at each premises of the health service establishment—\n\n(a) staff safety culture survey data is collected; and\n\n(b) the staff safety culture survey data is reviewed; and\n\n(c) the staff safety culture survey data is made available to the Secretary on request.\n\nPart 17—Sentinel events\n\n\t66 Reporting of sentinel events\n\nThe proprietor of a health service establishment must report in writing each sentinel event that occurs at the health service establishment to the Secretary—\n\n(a) within the time determined by the Secretary; and\n\n(b) in the form and manner determined by the Secretary.\n\nPenalty: 40 penalty units.\n\n\t67 Review of sentinel events\n\n(1) For the purpose of ensuring the quality and safety of health services provided by a health service establishment, the proprietor of a health service establishment must ensure that a review is conducted of each sentinel event that occurs at the health service establishment.\n\n(2) A review conducted under subregulation (1) must be conducted in the manner and within the time determined by the Secretary.\n\n(3) The proprietor of a health service establishment must record the outcome of a review conducted under subregulation (1) in writing and submit it to the Secretary within the time and in the form determined by the Secretary.\n\nSchedule 1—Revocations\n\nRegulation 4\n\n| *S.R. No.* | *Name* |\n| --- | --- |\n| 113/2013 | Health Services (Health Service Establishments) Regulations 2013 |\n| 83/2018 | Health Services (Private Hospitals and Day Procedure Centres) Amendment Regulations 2018 |\n| 99/2019 | Health Services (Health Service Establishments) Amendment Regulations 2019 |\n| 57/2023 | Health Services (Health Service Establishments) Amendment Regulations 2023 |\n\n\nSchedule 2—Application for approval in principle in relation to a health service establishment\n\nSection 70(2)(a) of the **Health Services Act 1988**\n\nRegulation 11(1)\n\nSECTION A\n\n1. Full name of applicant:\n\n2. Postal address of applicant:\n\n3. The name, telephone number and email address of a contact person for the purposes of the application:\n\n4. If the applicant is a body corporate, the *ABN/*ACN of the applicant and the name and address of any director or officer of the body corporate who may exercise control over the health service establishment:\n\nSECTION B\n\n1. The kind of health service establishment to which the application relates is:\n\n*a private hospital\n\n*a day procedure centre\n\n2. Are any or all of the health services to be provided by the health service establishment at premises other than the premises for which it is or is to be registered?\n\n*yes / *no\n\n3. The name (or proposed name) of the health service establishment, its street address and the municipal district in which the health service establishment is, or is to be, located or, if all the health services are to be provided by the health service establishment at premises other than the premises for which it is or is to be registered, the business address of the health service establishment.\n\n4. This application is for an approval in principle for:\n\n*the use of particular land or premises as a health service establishment;\n\n*premises proposed to be constructed for use as a health service establishment;\n\n*alterations or extensions to premises used, or proposed to be used, as a health service establishment;\n\n*a variation of the registration of a health service establishment to alter the number of beds to which the registration relates;\n\n*a variation of the registration of a health service establishment to vary the kinds of prescribed health services that may be carried on at the premises;\n\n*a variation of the registration of a health service establishment to vary the number of beds that may be used for the specified kinds of prescribed health services;\n\n*use of a premises as a health service establishment from which health services are to be provided at premises other than the first-mentioned premises;\n\n*a variation of the registration of a health service establishment to vary the kinds of prescribed health services that may be carried on at premises other than the premises for which the health service establishment is registered.\n\nSECTION C\n\nIn accordance with section 70(3) of the **Health Services Act 1988**, I have given notice in writing of this application to any other person who has an interest in the land as owner or lessee.\n\nSignature of applicant:\n\nName of each signatory (in BLOCK LETTERS):\n\nDate:\n\n*Delete if not applicable\n\nSchedule 3—Application for transfer or variation of certificate of approval in principle of a health service establishment\n\nSection 74(2) of the **Health Services Act 1988**\n\nRegulation 12(a)\n\nSECTION A\n\n1. Full name of applicant:\n\n2. Postal address of applicant:\n\n3. The name, telephone number and email address of a contact person for the purposes of the application:\n\nSECTION B\n\n1. The kind of health service establishment to which the application relates is:\n\n*a private hospital\n\n*a day procedure centre\n\n2. Are any or all of the health services to be provided by the health service establishment at premises other than the premises for which it is or is to be registered?\n\n*yes / *no\n\n3. The name (or proposed name) of the health service establishment, its street address and the municipal district in which the health service establishment is, or is to be, located or, if all the health services are to be provided by the health service establishment at premises other than the premises for which it is or is to be registered, the business address of the health service establishment.\n\n4. This application is for approval in principle for:\n\n*variation of the certificate of approval in principle or any condition to which it is subject;\n\n*transfer of the certificate of approval in principle to another person.\n\n5. Reason for the proposed variation:\n\n6. If the application relates to the transfer of the certificate to another person—\n\n(a) the name of that person; and\n\n(b) the postal address of that person; and\n\n(c) that person's telephone number and email address.\n\n7. If the transferee is a body corporate, the name and address of any director or officer of the body corporate who may exercise control over the health service establishment:\n\nSECTION C\n\nIn accordance with section 70(3) of the **Health Services Act 1988**, I have given notice in writing of this application to any other person who has an interest in the land as owner or lessee.\n\nSignature of applicant:\n\nName of each signatory (in BLOCK LETTERS):\n\nDate:\n\n*Delete if not applicable\n\nSchedule 4—Application for registration of a health service establishment\n\nSection 82(2)(a) of the **Health Services Act 1988**\n\nRegulation 13(1)\n\nSECTION A\n\n1. Full name of applicant:\n\n2. Postal address of applicant:\n\n3. The name, telephone number and email address of a contact person for the purposes of the application:\n\n4. If the applicant is a body corporate, the *ABN/*ACN of the applicant and the name and address of any director or officer of the body corporate who may exercise control over the health service establishment:\n\nSECTION B\n\n1. The kind of health service establishment for which registration is sought:\n\n*a private hospital\n\n*a day procedure centre\n\n2. Are any or all of the health services to be provided by the health service establishment at premises other than the premises for which it is to be registered?\n\n*yes / *no\n\n3. The name (or proposed name) of the health service establishment, its street address and the municipal district in which the health service establishment is, or is to be, located or, if all the health services are to be provided by the health service establishment at premises other than the premises for which it is to be registered, the business address of the health service establishment.\n\n4. The proposed number of beds:\n\n5. The kind or kinds of health services for which registration is sought:\n\n*Medical health services\n\n*Surgical health services\n\n*Speciality health services for the provision of—\n\n*alcohol or drug withdrawal (detoxification—acute phase)\n\n*anaesthesia\n\n*bariatric procedures\n\n*cardiac catheterisation\n\n*cardiac surgery\n\n*cataract surgery\n\n*emergency medicine\n\n*endoscopy\n\n*intensive care\n\n*liposuction (removing in total at least 200 ml of lipoaspirate)\n\n*mental health services\n\n*neonatal services (provided to patients aged under 28 days when admitted)\n\n*neurosurgery\n\n*obstetrics\n\n*oncology (chemotherapy)\n\n*oncology (radiation therapy)\n\n*oocyte retrieval\n\n*orthopaedic surgery\n\n*paediatric services (provided to patients aged at least 28 days and less than 18 years when admitted)\n\n*renal dialysis\n\n*specialist rehabilitation services\n\n6. Is the applicant the owner or tenant of the premises?\n\n*yes / *no\n\n7. If the applicant is not the owner, please state the name and address of the owner:\n\nSignature of applicant:\n\nName of each signatory (in BLOCK LETTERS):\n\nDate:\n\n*Delete if not applicable\n\nSchedule 5—Application for renewal of registration of a health service establishment\n\nSection 88(2)(a) of the **Health Services Act 1988**\n\nRegulation 15(1)\n\nSECTION A\n\n1. Full name of applicant:\n\n2. Postal address of applicant:\n\n3. The name, telephone number and email address of a contact person for the purposes of the application:\n\n4. If the applicant is a body corporate, the *ABN/*ACN of the applicant and the name and address of any director or officer of the body corporate who may exercise control over the health service establishment:\n\nSECTION B\n\n1. The name of the health service establishment and its street address or, if all the health services are to be provided by the health service establishment at premises other than the premises for which it is registered, the business address of the health service establishment:\n\n2. Date of expiry of current registration:\n\nSECTION C\n\nIn accordance with section 88(3) of the **Health Services Act 1988**, I have given notice in writing of this application to any other person who has an interest in the land as owner or lessee.\n\nSignature of applicant:\n\nName of each signatory (in BLOCK LETTERS):\n\nDate:\n\nSchedule 6—Application for variation of the registration of a health service establishment\n\nSection 92(2)(a) of the **Health Services Act 1988**\n\nRegulation 16(1)\n\nSECTION A\n\n1. Full name of applicant:\n\n2. Postal address of applicant:\n\n3. The name, telephone number and email address of a contact person for the purposes of the application:\n\nSECTION B\n\n1. The nature of the variation sought:\n\n*change of the kind of establishment to which the registration applies\n\n*transfer of the certificate of registration or certificate of renewal to another person who intends to become the proprietor of the establishment\n\n*a variation of any condition to which the registration is subject\n\n*an alteration in the number of beds to which the registration relates\n\n*a variation of the kinds of prescribed health services that may be carried on at the premises\n\n*a variation of the number of beds that may be used for specified kinds of prescribed health services\n\n*a variation of registration of a health service establishment to vary the kinds of prescribed health services that may be carried on at premises other than the premises for which the health service establishment is registered.\n\n2. Details of the variation sought:\n\n3. If the application relates to the transfer of the certificate of registration to another person, the name, postal address, telephone number and email address of the proposed transferee.\n\nSECTION C\n\nIn accordance with section 92(3) of the **Health Services Act 1988**, I have given notice in writing of this application to any other person who has an interest in the land as owner or lessee.\n\nSignature of applicant:\n\nName of each signatory (in BLOCK LETTERS):\n\nDate:\n\n*Delete if not applicable.\n\nSchedule 7—Application for approval of alterations to a clinical area within a health service establishment\n\nSection 108(2)(a) of the **Health Services Act 1988**\n\nRegulation 17(1)\n\nSECTION A\n\n1. Full name of applicant:\n\n2. Postal address of applicant:\n\n3. The name, telephone number and email address of a contact person for the purposes of the application:\n\nSECTION B\n\n1. Name of registered health service establishment:\n\n2. Address of registered health service establishment:\n\nSECTION C\n\n1. The nature of the alterations to a clinical area sought:\n\n2. Details of the alterations to a clinical area sought:\n\n3. Certificate of approval in principle number:\n\nSECTION D\n\nSignature of applicant:\n\nName of each signatory (in BLOCK LETTERS):\n\nDate:\n\nSchedule 8—Notice of seizure of document or thing from a health service establishment\n\nSection 147(2)(a) of the **Health Services Act 1988**\n\nRegulation 58\n\nHealth Services (Health Service Establishments) Regulations 2024\n\nName of health service establishment:\n\nAddress of health service establishment:\n\nI, being an authorised officer of the Department, am  \n[*print full name*]  \nseizing under section 147(1) of the **Health Services Act 1988** the document or thing listed below.\n\nThe seized document or thing will be returned to the place of seizure within 48 hours after the time of seizure.\n\nDOCUMENT OR THING SEIZED\n\n1.\n\n2.\n\n3.\n\n| Signed: | Date: | Time: |\n| --- | --- | --- |\n| [*Authorised Officer*] |  |  |\n| Signed: | Date: | Time: |\n| [*Proprietor/staff member*] |  |  |\n\n\nDOCUMENT OR THING RETURNED\n\n| Signed: | Date: | Time: |\n| --- | --- | --- |\n| [*Authorised Officer*] |  |  |\n| Signed: | Date: | Time: |\n| [*Proprietor/staff member*] |  |  |\n\n\nSchedule 9—Infringements\n\nSection 155 of the **Health Services Act 1988**\n\nRegulation 59\n\n**Table**\n\n| *Item* | *Column 1   Infringement offence* | *Column 2   Infringement penalty* |\n| --- | --- | --- |\n| 1 | Regulation 18(1) | 10 penalty units |\n| 2 | Regulation 19 | 10 penalty units |\n| 3 | Regulation 20(1) | 4 penalty units |\n| 4 | Regulation 20(2) | 4 penalty units |\n| 5 | Regulation 21 | 4 penalty units |\n| 6 | Regulation 22 | 4 penalty units |\n| 7 | Regulation 23 | 6 penalty units |\n| 8 | Regulation 24(1) | 10 penalty units |\n| 9 | Regulation 27(1) | 6 penalty units |\n| 10 | Regulation 27(2) | 6 penalty units |\n| 11 | Regulation 29 | 8 penalty units |\n| 12 | Regulation 30(1) | 6 penalty units |\n| 13 | Regulation 30(2) | 6 penalty units |\n| 14 | Regulation 32 | 10 penalty units |\n| 15 | Regulation 35(1) | 10 penalty units |\n| 16 | Regulation 38(1) | 10 penalty units |\n| 17 | Regulation 38(2) | 10 penalty units |\n| 18 | Regulation 39(3) | 8 penalty units |\n| 19 | Regulation 40(1) | 6 penalty units |\n| 20 | Regulation 40(3) | 6 penalty units |\n| 21 | Regulation 42 | 8 penalty units |\n| 22 | Regulation 47(1) | 6 penalty units |\n| 23 | Regulation 48(1) | 6 penalty units |\n| 24 | Regulation 48(3) | 6 penalty units |\n| 25 | Regulation 50 | 2 penalty units |\n| 26 | Regulation 51(1) | 12 penalty units |\n| 27 | Regulation 56(1) | 12 penalty units |\n| 28 | Regulation 57 | 4 penalty units |\n| 29 | Regulation 66 | 8 penalty units |\n\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 (Health Service Establishments) Regulations 2024, S.R. No. 77/2024 were made on 20 August 2024 by the Governor in Council under section 158 of the **Health Services Act 1988**, No. 49/1988 and came into operation on 31 August 2024: regulation 3.\n\nThe Health Services (Health Service Establishments) Regulations 2024 will sunset 10 years after the day of making on 20 August 2034 (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\nThere are no amendments made to the Health Services (Health Service Establishments) Regulations 2024 by statutory rules, subordinate instruments and Acts.\n\n3 Explanatory details\n\n**Fee Units**\n\nThese Regulations provide for fees by reference to fee units within the meaning of the **Monetary Units Act 2004**. The amount of the fee is to be calculated, in accordance with section 7 of that Act, by multiplying the number of fee units applicable by the value of a fee unit.\n\nThe value of a fee unit for the financial year commencing 1 July 2024 is $16.33. The amount of the calculated fee may be rounded to the nearest 10 cents.\n\nThe value of a fee unit for future financial years is to be fixed by the Treasurer under section 5 of the **Monetary Units Act 2004**. The value of a fee unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.\n\n**Penalty Units**\n\nThese Regulations provide for penalties by reference to penalty units within the meaning of section 110 of the **Sentencing Act 1991**. The amount of the penalty is to be calculated, in accordance with section 7 of the **Monetary Units Act 2004**, by multiplying the number of penalty units applicable by the value of a penalty unit.\n\nThe value of a penalty unit for the financial year commencing 1 July 2024 is $197.59. The amount of the calculated penalty may be rounded to the nearest dollar.\n\nThe value of a penalty unit for future financial years is to be fixed by the Treasurer under section 5 of the **Monetary Units Act 2004**. The value of a penalty unit for a financial year must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year.","sortOrder":0}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"This instrument replaces and revokes earlier regulations (see Schedule 1) and expands operational and reporting obligations compared with a basic registration-focused regime. The Regulations add: (a) prescriptive quality-and-safety protocol requirements that must be published and include credentialing and periodic review processes (reg 8); (b) an open disclosure policy and mandated infection control plan (regs 56, 62); (c) detailed monthly clinical and infection-data returns and duty-of-candour reporting (regs 60–61); (d) explicit nurse staffing ratios and minimum experience requirements for supervision of specific services (regs 32–36); and (e) strengthened powers for the Secretary to determine guidelines and to review and direct updates to proprietors' protocols (regs 9–10). These additions significantly broaden the administrative, data and compliance footprint of the regulatory regime beyond simple registration and minimum premises standards, shifting more of the day-to-day operational specification from guidance into enforceable rules and expanding the Secretary's role in oversight."},"complexity_factors":["17 Parts plus 9 Schedules (comprehensive structure across registration, clinical practice, governance, reporting and enforcement)","Regulation 5 contains approximately 30 defined terms that shape scope (e.g. definitions of anaesthesia, medical health service, surgical health service, sentinel event, unit record number)","Multiple cross-references to the Health Services Act 1988 and other Acts (Drugs, Poisons and Controlled Substances Act 1981; Mental Health and Wellbeing Act 2022; Health Records Act 2001)","Detailed fee and penalty schedules with multiple bed-band fee tiers (reg 13/15: 10 bed bands) and infringement table with 29 items (Schedule 9)","Numerous conditional and staged obligations with different effective dates (e.g. publication and role-allocation required on and from 31 August 2025 in reg 8(3)(h),(i); Secretary review power from 28 February 2026 in reg 10(1))","Extensive reporting regimes with varied timeframes (monthly returns with 17-day and 47-day deadlines; 14-day deadlines for accreditation reports; varied reporting periods for duty-of-candour reporting)","Nested exceptions and conditional tests (for example, permits under reg 49 with exceptions in reg 49(2), and definitions excluding dental nerve blocks)","Prescriptive staffing rules (numerical nurse:patient ratios, minimum experience for supervision) combined with broad Secretary discretion to set guidelines creates interplay of prescriptive and discretionary requirements","Retention and record-keeping obligations with different time periods (patient records 7 years, birth register 25 years, staff records 2 years)"],"plain_english_summary":"**What these Regulations do (mechanics first)**\n\n- They set detailed operating, staffing, record-keeping, safety and reporting rules for health service establishments (private hospitals and day procedure centres) in Victoria.  The Regulations are made under section 158 of the Health Services Act 1988 (reg 2).\n\n- They prescribe which kinds of clinical services count as a private hospital or a day procedure centre (regs 6–7).  That determines whether the establishment is captured by the Health Services Act and these Regulations.\n\n- They impose mandatory governance, staffing and senior-appointment rules: e.g. a suitably qualified Director of Nursing must be appointed (reg 18), Chief Executive/Medical Director appointments and terminations must be notified (regs 21–22), and notification timeframes are set (reg 20).  Failure to appoint or notify attracts penalties (see regs 18–22 and Schedule 9).\n\n- They prescribe clinical and administrative processes to be followed for admission, assessment, identification, records and discharge of patients (Parts 6 and 10).  Examples: a unit record number must be allocated on admission (reg 23); pre-admission and pre-presentation clinical risk assessments are required and must be recorded at least 24 hours before non-emergency care (regs 25–26); separate clinical records must be created and updated for each patient (regs 27–28); patient admission/discharge records must be retained for 7 years (reg 45).\n\n- They set nurse staffing requirements and minimum skill/experience levels for supervision of specific services (regs 32–36).  For example, private hospitals must have at least one registered nurse per 10 patients (day/evening) and per 15 patients (night) (reg 35(2)).\n\n- They require protocols, plans and policies that support quality, safety and infection control: health service establishment protocols for quality and safety must be prepared, published and implemented (reg 8); the Secretary may issue approved quality and safety guidelines and may review and direct updates to protocols (regs 9–10); an Infection Control Management Plan is required (reg 56); an open disclosure policy must be published (reg 62).\n\n- They create substantial reporting and data obligations: monthly returns on admissions, clinical care and (for private hospitals) infection data and some emergency-department data (reg 60); periodic reporting on compliance with the statutory duty of candour (reg 61); patient experience and staff safety culture survey data must be collected and be available to the Secretary on request (regs 64–65); sentinel events must be reported and reviewed (regs 66–67).\n\n- They prescribe fees, forms and processing categories (Part 4 and Schedules 2–7).  Registration/application fees are set by bed bands (reg 13, reg 15).  Annual registration fee is nil (reg 14).  The Regulations reference fee units and penalty units (Endnotes) for monetary calculation.\n\n- They provide enforcement tools: specified acts are infringement offences with listed penalty units (reg 59 and Schedule 9); authorised officers may seize documents in a prescribed form (reg 58 and Schedule 8).\n\n**Who is affected and who decides**\n\n- Proprietors of health service establishments (owners/operators) are the primary duty-holders: they must prepare protocols and plans, run services to the standards prescribed, collect and submit data, employ staff who meet qualification/experience standards, and keep records (see regs 8, 18, 23, 25–28, 35, 45–49, 56, 60–67).\n\n- Registered health practitioners (doctors, dentists, nurses, midwives, medical radiation practitioners, podiatrists) are affected by scope-of-practice, credentialing and supervision obligations embedded in the proprietor's protocols (regs 5 definition of health professional; reg 8(3)(a)–(d); regs 25–26).\n\n- The Secretary (the Department) has wide administrative discretion: to publish approved quality and safety guidelines (reg 9), request and review protocols and direct updates (reg 10), determine forms and timeframes for returns and sentinel-event reporting (regs 9, 10, 60, 66–67), and approve accreditation schemes (reg 57).  These are decision points that materially shape compliance requirements.\n\n**Why this matters (official rationale, then practical effect and trade-offs)**\n\n- Official purpose-claim: the Regulations exist to \"provide for the quality and safety of care\" and to prescribe fees, forms and other matters required by the Act (reg 1).\n\n- Tested against costs and incentives:\n  - Compliance and administrative burden: proprietors must prepare written protocols, publish them publicly, collect monthly clinical and infection data, maintain registers (surgical, birth), run surveys, keep long retention periods, and make staff appointments to specified standards (regs 8, 45, 47–48, 60, 64–65).  These obligations create ongoing operational costs (staff time, IT systems, data management) and up‑front costs to establish processes and publish materials.\n  - Discretion and implementation risk: the Secretary may determine guidelines and direct updates to protocols (regs 9–10).  That creates regulatory flexibility but also uncertainty for proprietors because compliance standards may change through administrative direction rather than statute.\n  - Behavioural effects on private providers: to avoid penalties (Schedule 9) and meet registration conditions, proprietors are likely to formalise credentialing, increase record-keeping and may change rostering to meet nurse‑to‑patient ratios (reg 35).  Smaller providers who deliver services that trigger high-level obligations (e.g. anaesthesia, intensive care, neonatal care) may face higher marginal compliance costs; some may scale back or specialise to avoid the most demanding regulatory footprint (see regs 6–7).  That is a substitution risk—services may concentrate in larger facilities.\n  - Costs to patients and purchasers: fees for registration and approvals are charged in fee units and scaled by bed bands (regs 11, 13, 15; Schedules 2, 4, 5).  While the annual fee is set to nil (reg 14), application and renewal fees are real cash costs.  Proprietors may pass some compliance costs through to patients or contracting agents; the Regulations also require disclosure to patients about likely out‑of‑pocket costs (reg 24).\n  - Concentrated benefits, diffuse costs: the immediate beneficiaries of quality and safety measures are patients (safer care, transparency) and regulators (more oversight data).  Costs are concentrated on proprietors and their accountants/managers who must establish and run the compliance architecture.\n\n**Concrete behaviour changes required**\n\n- Prepare and publish written quality & safety protocols, open disclosure policy and infection control plan, and implement them (regs 8, 56, 62).\n- Allocate and notify named senior officers (Director of Nursing with specified qualifications; notify the Secretary of appointments/terminations) (regs 18–22).\n- Establish credentialing, scope-of-practice and continual performance review processes for each health professional every three years (reg 8(3)(a)–(d)).\n- Ensure nurse staffing ratios and presence of suitably experienced clinicians for specialised services (regs 32–36, 33–34).\n- Produce monthly returns and specific clinical/infection reporting within prescribed timeframes (reg 60).\n- Report and review sentinel events and provide review outcomes to the Secretary (regs 66–67).\n\n**Penalties and financial measures (how much)**\n\n- The Regulations set infringement offences and penalties in Schedule 9.  Penalty units and fee units are applied to calculate fines and fees; for the 2024–25 financial year the instrument specifies monetary values in the Endnotes (fee unit $16.33; penalty unit $197.59), which shows how a breach or application fee converts to cash.  For example, one of the registration application bands is 366 fee units (reg 13(2)(a); Schedule 4), which at the 2024 fee‑unit rate translates into a mid‑thousands dollar application charge.  (See Endnotes.)\n\n**Implementation risks and trade-offs**\n\n- Secretary discretion (regs 9–10, reg 60) reduces legislative prescription but increases the importance of administrative guidance.  That helps the regime adapt, but creates compliance uncertainty until guidelines and directions are published.\n- The Regulations increase data collection and transparency; this supports regulatory oversight but requires secure IT systems and data governance (reg 51 communications; regs 60, 64–65).  Smaller providers will likely face proportionally higher compliance costs per service delivered.\n- The requirements are operational and prescriptive (staffing ratios, identity bands, registers).  That clarity aids enforcement but leaves less room for alternative models of delivering the same outcomes; it may reduce flexibility and raise the cost of innovative low‑resource service models.\n\nSources: cited provisions are shown inline (for example, regs 1, 6–7, 8–10, 11–17, 18–22, 23–30, 32–37, 45–49, 51–56, 60–67, Schedules 2–9 and the Endnotes on fee/penalty unit values)."},"summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"Insufficient legislative content was provided to assess whether the regulation's scope changed from its original intent. The text supplied contains only metadata, version history headers, and formatting artifacts — no substantive regulatory provisions were extractable. A scope assessment requires access to the full regulation text."},"complexity_factors":["Operates as subordinate legislation under a parent Act (Health Services Act), requiring cross-referencing between the two instruments","Health service regulation typically involves technical clinical and administrative standards requiring specialist knowledge to interpret","Licensing and compliance frameworks often contain intricate procedural requirements with strict timeframes","The regulation appears to have been consolidated/amended (version history referenced), meaning readers must identify which version applies to their situation","Affects multiple stakeholder classes (operators, clinicians, regulators) with different obligations applying to each","Significant portions of the text were unavailable or corrupted, making full complexity assessment impossible — actual score may be higher"],"plain_english_summary":"These regulations set the practical rules for health service establishments in Victoria — hospitals, day-procedure centres and similar facilities — affecting operators, staff, patients and regulators by prescribing licensing/registration, safety and care standards, inspection and compliance duties, and reporting obligations. Non‑compliance can lead to penalties or loss of licence, directly impacting services and patient safety. \n\nNote: this summary is based on the instrument’s title; consult the full text for details."},"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":true,"description":"The legislation has expanded significantly beyond basic registration and licensing. The original 2013 regulations focused primarily on structural requirements and basic operational standards. This 2024 version adds substantial new domains: mandatory quality and safety protocols with 3-yearly credentialing reviews (regulation 8), duty of candour reporting (regulation 61), sentinel event reporting and review (Part 17), patient experience and staff safety culture surveys (Part 16), open disclosure policies (regulation 62), and specific Aboriginal cultural safety requirements (regulation 8(3)(i)(iii)). The scope has shifted from mere compliance with physical standards to active quality improvement, transparency, and cultural safety frameworks."},"complexity_factors":["17 Parts with multiple Divisions creating a layered structure","27 defined terms in the interpretation section (regulation 5), many cross-referencing the Health Practitioner Regulation National Law","Nested conditional logic: multiple exceptions and qualifications (e.g., regulation 49(2) has two layers of exceptions for drug permits; regulation 35(3) modifies the nurse ratio rule)","Phased implementation dates: some requirements apply 'on and from 31 August 2025' (regulation 8(3)(h)-(i)) and 'on and from 28 February 2026' (regulation 10(1))","Extensive cross-referencing to the Health Services Act 1988, Drugs Poisons and Controlled Substances Act 1981, and other legislation","Multiple fee schedules with tiered calculations based on bed numbers (10 tiers in regulations 13 and 15)","Dual penalty structures: some offences carry infringement penalties (Schedule 9) while others carry higher court-imposed penalties","9 detailed application forms in Schedules requiring specific information","Reporting requirements with multiple timeframes (14 days, 17 days, 28 days, 47 days depending on data type)"],"plain_english_summary":"These regulations set the rules for how private hospitals and day procedure centres must operate in Victoria to keep patients safe and ensure quality care.\n\n**Who it affects:**\n- **Private hospitals** and **day procedure centres** (facilities where you go for surgery or medical procedures without staying overnight)\n- **Patients** receiving care at these facilities\n- **Proprietors** (owners/operators) of these establishments\n- **Staff** including nurses, doctors, and administrators\n\n**What it does:**\n\n**Licensing and fees:**\n- Sets out application forms and fees for registering a new facility, renewing registration, or making changes (like adding more beds)\n- Fees vary based on bed numbers — from 366 fee units for small facilities (0-26 beds) up to 1,175 fee units for large hospitals (500+ beds)\n\n**Staffing requirements:**\n- Every facility must appoint a **Director of Nursing** who is a registered nurse with at least 5 years clinical experience and 12 months management experience\n- Minimum nurse-to-patient ratios: 1 registered nurse per 10 patients during day/evening shifts in private hospitals (1 per 15 at night), and 1 per 10 in day procedure centres\n- Special requirements for surgery, maternity, and neonatal care\n\n**Patient care standards:**\n- Patients must be treated with **dignity, respect and privacy**, with consideration for their cultural and religious needs\n- **Pre-admission assessments** must be done at least 24 hours before non-emergency procedures\n- Every patient gets a **unique ID number** and must wear an identity band\n- Newborns must have at least 2 identity bands with birth information\n\n**Records and documentation:**\n- Detailed **clinical records** must be created and kept up-to-date for every patient\n- **Surgical Procedure Registers** and **Birth Registers** must be maintained\n- Patient admission and discharge records kept for 7 years; birth records for 25 years\n\n**Safety and quality:**\n- Facilities must develop **quality and safety protocols** covering staff credentials, scope of practice, and regular reviews\n- **Infection Control Management Plans** required\n- **Open disclosure policies** for when things go wrong\n- **Sentinel events** (serious unexpected incidents causing death or injury) must be reported and reviewed\n- **Duty of candour** reporting — being honest with patients when serious adverse events occur\n\n**Complaints:**\n- Every facility must nominate a **complaints officer**\n- Complaints must be recorded and kept for 7 years\n- Patients who complain must not be treated worse because of it\n\n**Premises and equipment:**\n- Rooms must be clearly identified\n- Working emergency communication systems required\n- Premises must be clean, hygienic, and properly maintained\n- Evacuation plans required and staff must be trained\n\n**Why it matters:**\nThese regulations replace older rules (revoking the 2013 regulations and subsequent amendments) and modernise patient safety requirements. They ensure that whether you're having day surgery or staying in a private hospital, the facility meets minimum standards for staffing, equipment, cleanliness, and accountability. The rules are legally enforceable with penalties up to 80 penalty units (roughly $15,800) for serious breaches."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/health-services-health-service-establishments-regulations-2024","history":"/api/acts/health-services-health-service-establishments-regulations-2024/history","analysis":"/api/acts/health-services-health-service-establishments-regulations-2024/analysis","conflicts":"/api/acts/health-services-health-service-establishments-regulations-2024/conflicts","importantCases":"/api/acts/health-services-health-service-establishments-regulations-2024/important-cases","documents":"/api/acts/health-services-health-service-establishments-regulations-2024/documents"}}