South Australia regulation

Health Care Regulations 2023

In ForceSA

Jurisdiction

South Australia

Collection

regulation

Plain English Summary

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These regulations add detailed rules under the Health Care Act 2008 about what counts as a health service, how governing boards must consult clinicians and consumers, licensing and accreditation conditions for private hospitals and day procedure centres, compulsory data and registers (including pregnancy and cancer reports), procedures for root cause analysis teams, and confidentiality protections. They primarily affect hospitals, private day centres, ambulance and emergency providers, governing boards and health practitioners by imposing reporting, accreditation and governance duties.

Who pays and decides: regulated entities must collect and submit data and maintain registers; the Minister prescribes certain services and data and may receive reports (see regs 4, 19, 23, 26, 27, 32).

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What it does

These regulations, the Health Care Regulations 2023, are subordinate legislation made under the Health Care Act 2008. They come into operation immediately on the day they were made (r 2) and repeal the previous Health Care Regulations 2008 (Schedule 3). Mechanically the instrument does the following.

Expands the statutory ambit of “health service” to include linen and laundry services to hospitals and other health care providers (r 4). That change imports additional activities into the regulatory scope of the principal Act.
Prescribes processes, timelines and grounds relevant to the establishment, consultation, administration and dissolution of hospital advisory councils (HACs) and governing boards, including specific consultation steps the Minister must take for s 15(5)(a) of the Act, and grounds for dissolution or administration (rr 5-6).
Specifies required content and relationships for clinician engagement and consumer and community engagement strategies that governing boards must develop (r 7).
Preserves certain accrued employee rights at the South Australian Ambulance Service (SAAS) for the purposes of s 53(2)(c) of the Act (r 8).
Identifies entities prescribed as providers of emergency ambulance services and entities that may be licensed for non-emergency ambulance services (rr 9-10).
Adds named entities to the definition of “health services entity” under s 68 of the Act (r 11).
Sets out detailed requirements for root cause analysis (RCA) teams, including minimum composition, leader training, tertiary qualifications for members, disclosure of conflicts and investigation timeframes (r 12), together with procedures for stopping an RCA investigation where a suspected prescribed act is identified and referral to a designated authority (r 13). It also prescribes who may receive parts of RCA second reports and protections for use and disclosure of report material (r 14).

Current sections

Direct links to the current provisions in Health Care Regulations 2023.

Health Care Regulations 2023

South Australia Health Care Regulations 2023 under the Health Care Act 2008

Contents Part 1—Preliminary 1 Short title 2 Commencement 3 Interpretation Part 2—Regulations relating to specific provisions of Act 4 Health service 5 Establishment of Councils 6 Administration 7 Prescribed requirements for engagement strategies 8 Accrued rights for employees 9 Emergency ambulance services 10 Licence to provide non-emergency ambulance services 11 Health services entities 12 Appointment of RCA teams 13 Restrictions on RCA teams 14 Reports and protection of information 15 Recognised organisations Part 3—Deductible gift recipient status 16 Deductible gift recipient status Part 4—Private hospitals 17 Duration of licences 18 Prescribed records—licensee to keep register 19 Provision of health services data and statistics to Minister Part 5—Private day procedure centres 20 Interpretation 21 Certain services excluded from definition of health services for purposes of Part 10A of Act 22 Prescribed health service 23 Conditions of licence 24 Duration of licences 25 Prescribed records—licensee to keep register 26 Provision of health services data and statistics to Minister Part 6—Pregnancy outcome data and statistics 27 Provision of pregnancy outcome information 28 Notification of diagnosis of congenital abnormality 29 Obligation of medical practitioner etc to provide information 30 How information to be provided 31 Confidentiality Part 7—Reporting of cancer 32 Reporting obligations of hospitals or health services incorporating radiotherapy clinics 33 Reporting obligations of pathology laboratories 34 Provision of information by medical practitioners Part 8—Clinical competencies and scope of practice 35 Clinical competencies and scope of practice Schedule 1—Private hospitals Part 1—Prescribed information for annual return 1 Prescribed information for annual return Schedule 2—Pregnancy outcome data and statistics Part 1—Pregnancy outcome information Part 2—Information relating to congenital abnormalities Schedule 3—Repeal of Health Care Regulations 2008 Legislative history

Part 1—Preliminary 1—Short title These regulations may be cited as the Health Care Regulations 2023. 2—Commencement These regulations come into operation on the day on which they are made. 3—Interpretation In these regulations— Act means the Health Care Act 2008; authorised person has the same meaning as in section 63 of the Act; baby means a baby whether born dead or alive, but does not include a baby who does not achieve a gestational age of 20 weeks or a birth weight of 400 grams; cancer means— (a) a malignant growth of human tissue which, if unchecked, is likely to spread to adjacent tissue or beyond its place of origin and which has the propensity to recur, including but not limited to— (i) a malignant neoplasm, whether invasive or in situ (including in situ melanoma, breast cancer and bladder cancer); or (ii) any lymphohaematopoietic neoplasm; or (b) a neoplasm of the brain, spinal cord or cranial nerves, or other intracranial neoplasm whether benign, malignant or of uncertain malignant potential; congenital abnormality means an abnormality of prenatal origin, and includes structural, genetic and chromosomal abnormalities and biochemical defects, but does not include minor malformations that do not require medical treatment; sentinel event has the same meaning as in the Australian Commission on Safety and Quality in Health Care. Australian Sentinel Event List (version 2): Specifications. Sydney: ACSQHC; 2020. Part 2—Regulations relating to specific provisions of Act 4—Health service The provision of linen and laundry services to hospitals or other health care providers is brought within the ambit of the definition of health service in section 3 of the Act. 5—Establishment of Councils (1) For the purposes of section 15(5)(a) of the Act, the following is prescribed (with respect to the relevant HAC or each relevant HAC): (a) the provision of a letter to the members of the HAC from the Minister— (i) setting out the course of action that is under consideration; and (ii) setting out the grounds for that proposed course of action; and (iii) containing a request that the HAC consult broadly with the relevant community (or with groups within the community) for a period of at least 4 weeks specified in the letter (and to the extent specified by the Minister); (b) at the request of the HAC—the setting up of a meeting between members of the HAC and the Chief Executive or a person nominated by the Chief Executive; (c) the provision of a written response to the Minister from the HAC that includes— (i) a fair summary of the consultation under paragraph (a)(iii) (providing details of both the consultation undertaken and the outcomes from that consultation); and (ii) any comments or response that the members of the HAC wish to make in relation to the matter. (2) For the purposes of section 15(5)(b)(ii) of the Act, the following grounds are prescribed: (a) in the case of an incorporated HAC established in relation to a body in connection with the provision of health services at a particular site—that the undertaking of health services at that site has been transferred to another site; (b) that the purpose for which the HAC was established no longer exists; (c) that services in relation to which the HAC was established are no longer required or sought within the relevant part of the community; (d) that the community has reasonable access to services that are a reasonable alternative to services in relation to which the HAC was established. 6—Administration For the purposes of section 28 of the Act, the following grounds are prescribed: (a) the HAC has contravened, or failed to comply with, a provision of the Act or of its constitution; (b) the HAC has, in the opinion of the Minister, been guilty of serious financial mismanagement; (c) the HAC has, in the opinion of the Minister, persistently failed properly to perform the functions for which it was established; (d) the HAC seeks its own dissolution on the basis that a majority of its members are of the opinion that the HAC is unable to perform properly the functions for which it was established. 7—Prescribed requirements for engagement strategies (1) For the purposes of section 33A(3)(a) of the Act, the clinician engagement strategy developed by a governing board must— (a) include the following: (i) the objectives of the strategy; (ii) an outline of how the strategy will contribute to the achievement of the functions of the governing board; (iii) the manner in which consultation with health professionals will be conducted; (iv) an outline of the key issues that will form the basis of consultation with health professionals, including issues focussed on the safety and quality of health services, service planning and design, service delivery and the monitoring and evaluation of service delivery; (v) an outline of how the governing board will use information obtained from implementing the strategy to continuously improve consultation with health professionals; (vi) an outline of how the effectiveness of consultation with health professionals under the strategy will be measured and publicly reported; and (b) have regard to national and State strategies, policies, agreements and standards relevant to promoting consultation with health professionals; and (c) outline the relationship between each of the following: (i) the governing board's consumer and community engagement strategy; (ii) the governing board's clinician engagement strategy; (iii) providers of health services, including providers of primary health care services. (2) For the purposes of section 33A(3)(a) of the Act, the consumer and community engagement strategy developed by a governing board must— (a) include the following: (i) the objectives of the strategy; (ii) an outline of how the strategy will contribute to the achievement of the functions of the governing board; (iii) the manner in which consultation with health consumers and members of the community will be conducted, including the manner in which consultation by health professionals and staff members with health consumers and members of the community will be conducted; (iv) an outline of the key issues that will form the basis of consultation with health consumers and members of the community, including issues focussed on the safety and quality of health services, service planning and design, service delivery and the monitoring and evaluation of service delivery; (v) an outline of how the governing board will use information obtained from implementing the strategy to identify and consult with health consumers and members of the community— (A) who are or are at risk of experiencing poor health outcomes; or (B) who may have difficulty accessing health services; (vi) an outline of how the effectiveness of consultation with health consumers and members of the community under the strategy will be measured and publicly reported; and (b) have regard to national and State strategies, policies, agreements and standards relevant to promoting consultation with health consumers and members of the community about the provision of health services; and (c) outline the relationship between each of the following: (i) the governing board's consumer and community engagement strategy; (ii) the governing board's clinician engagement strategy; (iii) providers of health services, including providers of primary health care services. 8—Accrued rights for employees For the purposes of section 53(2)(c) of the Act, employment at SAAS as constituted immediately before the commencement of section 49 of the Act is prescribed. 9—Emergency ambulance services For the purposes of section 57(1)(b) of the Act, the following persons are prescribed: (a) Royal Flying Doctor Service of Australia Central Operations; (b) Babcock Mission Critical Services Australasia Pty Ltd; (c) the Commonwealth Department of Defence or an arm of the Australian Defence Force. 10—Licence to provide non-emergency ambulance services For the purposes of section 58(1)(c) of the Act, the following persons are prescribed: (a) Royal Flying Doctor Service of Australia Central Operations; (b) Babcock Mission Critical Services Australasia Pty Ltd; (c) the Commonwealth Department of Defence or an arm of the Australian Defence Force. 11—Health services entities For the purposes of the definition of health services entity under section 68 of the Act, the following entities involved in the provision of health services are brought within the ambit of the definition: (a) SAAS; (b) Royal District Nursing Service of SA Incorporated. 12—Appointment of RCA teams (1) For the purposes of section 69(2) of the Act, the following requirements are prescribed: (a) an RCA team is to consist of not less than 3 members; (b) the leader of an RCA team must have completed a formal training course in root cause analysis; (c) at least 1 member of an RCA team must have a formal tertiary qualification in a health related field or significant experience in a health related field relevant to the investigation; (d) each member of an RCA team must have knowledge and understanding of the member's obligations under Parts 7 and 8 of the Act. (2) For the purposes of section 69(5) of the Act, the following procedures and processes are adopted in relation to the conduct of an investigation: (a) in the case of an RCA team appointed in relation to a hospital incorporated under the Act or SAAS—the RCA team must commence the investigation within 14 days after its appointment; (b) in the case of an RCA team appointed in relation to a hospital incorporated under the Act or SAAS—the RCA team must provide any part of the report referred to in regulation 14— (i) within 10 weeks after the commencement of the investigation; or (ii) with the written consent of a member of the Safety and Quality Unit of the Department, within 20 weeks after the commencement of the investigation or such longer period as may be allowed under the terms of the consent; (c) if an RCA team member becomes aware that they have, or may have, a direct or indirect personal or pecuniary interest in an adverse incident under investigation or to be investigated by the team, the following procedure is adopted: (i) the member must, as soon as reasonably practicable after becoming aware of the interest, disclose in writing to the designated authority full and accurate details of the interest; and (ii) the member is, subject to the designated authority's determination, precluded from taking part or taking further part in the investigation into the incident or the preparation of reports in relation to the incident. (3) For the purposes of subregulation (2)(c) but without limitation, an RCA team member will be taken to have an interest in an adverse incident if a relative of the member or of the member's spouse or domestic partner has an interest in the incident. 13—Restrictions on RCA teams For the purposes of section 70(2) of the Act, the following procedures are prescribed: (a) the RCA team must notify the designated authority in writing of the suspected prescribed act and the reasons for the team's suspicion; (b) if the RCA team is of the view that a prescribed act of the same kind is or may be imminent, the team must immediately notify the designated authority of that view; (c) the RCA team must not, unless authorised to do so in writing by the designated authority, continue its investigation into the adverse incident; (d) the designated authority must not authorise the RCA team to continue its investigation unless satisfied that the suspected prescribed act— (i) did not occur; or (ii) is able to be investigated independently of the adverse incident. 14—Reports and protection of information (1) For the purposes of section 72(3)(d) of the Act, members of the Safety and Quality Unit of the Department who are members of the Patient Safety Team are prescribed as a class of persons who are entitled to receive the following parts of a second report prepared by an RCA team appointed in relation to a hospital incorporated under the Act or SAAS: (a) any description of the adverse incident; (b) any causation statement; (c) the recommendations of the RCA team; (d) any other material considered relevant by the RCA team. (2) For the purposes of section 73(2)(e) of the Act, a person who receives a report under section 72(3)(b) or (d) of the Act may make such records or use or disclose such information as is reasonably necessary in order— (a) to analyse the report and assess and discuss any incident, contributing factor, statement, recommendation or other material identified or contained in the report; or (b) to provide information or any report to an authorised quality improvement body. (3) For the purposes of subregulation (2), a reference to a report includes a reference to part of a report. 15—Recognised organisations For the purposes of section 90 of the Act, the following organisations are declared to be recognised organisations: (a) Ambulance Employees Association of South Australia; (b) Association of Professional Engineers, Scientists & Managers, Australia (APESMA); (c) Australian Nursing & Midwifery Federation (SA Branch): (d) United Workers’ Union; (e) Public Service Association of South Australia Incorporated; (f) South Australian Salaried Medical Officers' Association. Part 3—Deductible gift recipient status 16—Deductible gift recipient status (1) This regulation applies to a hospital incorporated under the Act that is endorsed as a deductible gift recipient under the Income Tax Assessment Act 1997 of the Commonwealth. (2) At the first occurrence of— (a) an incorporated hospital ceasing to be a deductible gift recipient; or (b) the winding up of a gift fund maintained by an incorporated hospital; or (c) the dissolution of an incorporated hospital, the surplus assets of any gift fund or, if the hospital has not maintained a gift fund, the surplus— (d) gifts of money or property for the principal purpose of the hospital; (e) deductible contributions received in relation to fund‑raising events held for the principal purpose of the hospital; or (f) money received by the hospital because of such gifts or contributions, must be transferred to a fund, authority or institution gifts to which can be deducted under the Income Tax Assessment Act 1997 (Commonwealth). Part 4—Private hospitals 17—Duration of licences For the purposes of section 84(2) of the Act— (a) the prescribed day is 30 April; and (b) the prescribed information is that set out in Schedule 1 Part 1. 18—Prescribed records—licensee to keep register The holder of a licence under Part 10 of the Act in respect of a private hospital must keep a register in which is recorded, in relation to every patient admitted to the hospital, the following details: (a) the full name, age, sex and usual place of residence of the patient; (b) the patient's date of admission; (c) the name and address of the patient's medical attendant; (d) the name and home address of the patient's next of kin; (e) the date of discharge, or in the event of death, the date of the patient's death; (f) in the case of a maternity patient, the patient's date and time of confinement and the sex and weight of any infant. 19—Provision of health services data and statistics to Minister (1) The holder of a licence under Part 10 of the Act in respect of a private hospital must provide to the Minister the data specified under subregulation (2) in respect of each month of operation of the private hospital. (2) For the purposes of subregulation (1), the Minister may specify any of the following kinds of data: (a) data relating to admitted patient care, which may include (without limitation) the health status of admitted patients, health services provided to those patients and health outcomes for those patients; (b) data relating to non-admitted patient emergency department care for presentations to an emergency department or emergency health service, which may include (without limitation) the health status of persons presenting to the service, health services provided to those persons and health outcomes for those persons; (c) data relating to the occurrence of sentinel events. (3) Data required to be provided under this regulation relating to a particular month must be provided— (a) in a form and manner acceptable to the Minister; and (b) within the period specified by the Minister following the end of that month (which may vary according to the data or other circumstances to which it applies). (4) Subject to this regulation, a person must not in any circumstances (including proceedings before any court, tribunal or board) divulge confidential information obtained directly or indirectly as a result of a disclosure made under this regulation. Maximum penalty: $10 000. (5) Subregulation (4) does not prevent a person from disclosing confidential information in accordance with an authorisation given by the Chief Executive. (6) A person must not, when appearing as a witness in any proceedings before a court, tribunal or board, be asked, and, if asked, is not required to answer, any question directed at obtaining confidential information obtained by that person directly or indirectly as a result of a disclosure made under this regulation and any such information volunteered by such a person is not admissible in any proceedings. (7) In this regulation— confidential information has the same meaning as in section 63 of the Act. Part 5—Private day procedure centres 20—Interpretation In this Part— emergency service includes— (a) the South Australian Metropolitan Fire Service; and (b) the South Australian Country Fire Service; and (c) the Royal Flying Doctor Service. 21—Certain services excluded from definition of health services for purposes of Part 10A of Act For the purposes of the definition of health services in section 3(1) of the Act, the following services will be taken to be excluded from the ambit of that definition for the purposes of Part 10A of the Act: (a) paramedical or ambulance services; (b) services provided by a member of an emergency service in the course of an emergency (including, to avoid doubt, services provided in the course of a trauma retrieval). 22—Prescribed health service (1) For the purposes of paragraph (d) of the definition of prescribed health service in section 89(1) of the Act, the following health services are prescribed: (a) cardiac catheterisation; (b) chemotherapy (except when provided by or on behalf of an incorporated hospital, the holder of a private day procedure centre licence or another entity that ordinarily provides a prescribed health service at a private day procedure centre); (c) gastrointestinal endoscopy; (d) renal dialysis (except when provided by or on behalf of an incorporated hospital, the holder of a private day procedure centre licence or another entity that ordinarily provides a prescribed health service at a private day procedure centre); (e) the following cosmetic surgical procedures: (i) abdominoplasty; (ii) belt lipectomy; (iii) biceps implants; (iv) brachioplasty; (v) breast augmentation or reduction; (vi) buttock augmentation, reduction or lift; (vii) calf implants; (viii) deltoid implants; (ix) facelift (other than a mini-lift that does not involve the superficial musculoaponeurotic system (SMAS)); (x) facial implants that involve— (A) inserting an implant on the bone; or (B) surgical exposure to deep tissue; (xi) fat transfer that involves the transfer of more than 500 millilitres of lipoaspirate; (xii) labiaplasty; (xiii) liposuction that involves the removal of more than 2.5 litres of lipoaspirate; (xiv) mastopexy or mastopexy augmentation; (xv) monsplasty; (xvi) neck lift; (xvii) pectoral implants; (xviii) penis augmentation; (xix) rhinoplasty; (xx) triceps implants; (xxi) vaginoplasty; (f) a health service, or health service of a class, determined by the Minister by notice in the Gazette. (2) For the purposes of section 89(2)(c) of the Act, health services of the following kinds are prescribed: (a) a health service consisting of the use of topical local anaesthetic; (b) a health service provided by a registered health practitioner (being a person who is permitted or authorised under a law of the State to administer local anaesthetic of the relevant kind). 23—Conditions of licence For the purposes of section 89D(1) of the Act, it is a condition of each private day procedure licence that the private day procedure centre to which the licence relates must be, at all times while the licence is in force, accredited under the Australian Health Service Safety and Quality Accreditation Scheme in accordance with the National Safety and Quality Health Service Standards published by the Australian Commission on Safety and Quality in Health Care under the National Health Reform Act 2011 of the Commonwealth. 24—Duration of licences (1) For the purposes of section 89F(2) of the Act, the prescribed day is 30 April. (2) For the purposes of section 89F(2)(b) of the Act, such information as may be determined by the Minister is prescribed. 25—Prescribed records—licensee to keep register The holder of a licence under Part 10A of the Act in respect of a private day procedure centre must keep a register in which is recorded, in relation to every person attending at the private day procedure centre for the provision of a prescribed health service, the following details: (a) the full name, age, sex and usual place of residence of the person; (b) the person's date of attendance at the private day procedure centre; (c) the name and address of the person's medical attendant; (d) the name and home address of the person's next of kin. 26—Provision of health services data and statistics to Minister (1) The holder of a licence under Part 10A of the Act in respect of a private day procedure centre must provide to the Minister the data specified under subregulation (2) in respect of each month of operation of the private day procedure centre. (2) For the purposes of subregulation (1), the Minister may specify any of the following kinds of data: (a) data relating to admitted patient care, which may include (without limitation) the health status of admitted patients, health services provided to those patients and health outcomes for those patients; (b) data relating to non-admitted patient emergency department care for presentations to an emergency department or emergency health service, which may include (without limitation) the health status of persons presenting to the service, health services provided to those persons and health outcomes for those persons; (c) data relating to the occurrence of sentinel events. (3) Data required to be provided under this regulation relating to a particular month must be provided— (a) in a form and manner acceptable to the Minister; and (b) within the period specified by the Minister following the end of that month (which may vary according to the data or other circumstances to which it applies). (4) Subject to this regulation, a person must not in any circumstances (including proceedings before any court, tribunal or board) divulge confidential information obtained directly or indirectly as a result of a disclosure made under this regulation. Maximum penalty: $10 000. (5) Subregulation (4) does not prevent a person from disclosing confidential information in accordance with an authorisation given by the Chief Executive. (6) A person must not, when appearing as a witness in any proceedings before a court, tribunal or board, be asked, and, if asked, is not required to answer, any question directed at obtaining confidential information obtained by that person directly or indirectly as a result of a disclosure made under this regulation and any such information volunteered by such a person is not admissible in any proceedings. (7) In this regulation— confidential information has the same meaning as in section 63 of the Act. Part 6—Pregnancy outcome data and statistics 27—Provision of pregnancy outcome information (1) The following persons must provide the Minister with so much of the information required by Schedule 2 Part 1 as is applicable in the particular circumstances: (a) if a baby is born at a place other than a hospital—the person in charge of the birth; (b) if a baby is born in a hospital—the person responsible for the management of the hospital; (c) if, within 28 days after its birth, a baby or its mother or both a baby and its mother are admitted to a hospital—the person responsible for the management of the hospital. (2) For the purposes of subregulation (1), the applicable information must be forwarded to the Minister— (a) in the case of a baby that has not been discharged from hospital within 28 days after its birth—within 7 days after the baby's discharge; or (b) in any other case—within 30 days after the birth of the baby. (3) If, within 28 days after the birth of a baby at a place other than a hospital, the baby or its mother or both the baby and its mother are admitted to a hospital— (a) the person in charge of the birth must, within 2 days after the admission, forward to the person responsible for the management of the hospital so much of the information required by Schedule 2 Part 1 as is applicable up to the time of the admission; and (b) subregulation (1) applies to both the person in charge of the birth and the person responsible for the management of the hospital. (4) If, within 28 days after the birth of a baby, the baby or its mother or both the baby and its mother are transferred from 1 hospital (the transferor hospital) to another (the transferee hospital)— (a) the person responsible for the management of the transferor hospital must, within 2 days after the transfer, forward to the person responsible for the management of the transferee hospital so much of the information required by Schedule 2 Part 1 as is applicable up to the time of the transfer; and (b) subregulation (1) applies to both the person responsible for the management of the transferor hospital and the person responsible for the management of the transferee hospital. (5) For the purposes of this regulation, if a baby is born at a place other than a hospital, the person in charge of the birth is— (a) if a medical practitioner supervises, attends or assists the birth or attends the baby or its mother immediately following the birth—the medical practitioner; (b) if there is more than 1 such medical practitioner—the medical practitioner primarily responsible; (c) if no medical practitioner supervises, attends or assists the birth or attends the baby or its mother immediately following the birth but a midwife does so—the midwife; (d) if there is more than 1 such midwife—the midwife primarily responsible. 28—Notification of diagnosis of congenital abnormality If a congenital abnormality is diagnosed in a child before the child's fifth birthday and there are reasonable grounds to believe that it has not previously been diagnosed, the following persons must, within 30 days of the diagnosis, notify the Minister of the diagnosis and forward to the Minister the information required by Schedule 2 Part 2: (a) in the case of a diagnosis made in a hospital—the person responsible for the management of the hospital; (b) in any other case—the medical practitioner who made the diagnosis. 29—Obligation of medical practitioner etc to provide information A medical practitioner, midwife or nurse who— (a) supervised, attended or assisted with the birth of a baby; or (b) attended a baby or its mother within 28 days after the birth of the baby, must, when requested by a person who is required by these regulations to provide the Minister or a hospital with information, supply to that person such of the information required to be provided as is known to the medical practitioner, midwife or nurse. 30—How information to be provided Information required to be provided by this Part must be provided— (a) in writing (either personally or by post); or (b) in an electronic form acceptable to the Department, so long as a printed copy of the information can be produced if required. 31—Confidentiality (1) Subject to this regulation, a person must not in any circumstances (including proceedings before any court, tribunal or board) divulge confidential information obtained directly or indirectly as a result of a disclosure made under this Part. Maximum penalty: $10 000. (2) Subregulation (1) does not prevent a person from disclosing confidential information to any of the following: (a) an authorised person; (b) a person providing technical, administrative or secretarial assistance to an authorised person; (c) SA NT DataLink; (d) the Australian Institute of Health and Welfare of the Commonwealth. (3) A person must not, when appearing as a witness in any proceedings before a court, tribunal or board, be asked, and, if asked, is not required to answer, any question directed at obtaining confidential information obtained by that person directly or indirectly as a result of a disclosure made under this Part and any such information volunteered by such a person is not admissible in any proceedings. (4) In this regulation— confidential information means information relating to a health service in which the identity of a patient or a registered health practitioner providing the service is revealed. Part 7—Reporting of cancer 32—Reporting obligations of hospitals or health services incorporating radiotherapy clinics (1) The person responsible for the management of a hospital or health service that incorporates a radiotherapy clinic must provide the Minister with a report within 3 months after— (a) a patient presenting at the hospital or health service— (i) is diagnosed with a cancer of a particular type at the hospital or health service (including where the diagnosis is made in respect of a recurrence of cancer); or (ii) first discloses a history of, or is first treated for, a cancer of a particular type at the hospital or health service; (b) a patient of a kind referred to in paragraph (a) dies (whether as a result of the cancer or any other cause) at the hospital or health service. (2) The report must contain the following: (a) the name and address of the hospital or health service; (b) a unique identifier for the patient; (c) the name of the medical practitioner responsible for the patient; (d) the date on which the patient was admitted to or presented at the hospital or health service; (e) the following details relating to the patient to the extent known or reasonably ascertainable: (i) full name and usual residential or postal address; (ii) gender; (iii) date of birth; (iv) country of birth; (v) indigenous Australian status, race and ethnicity; (f) to the extent that it is known, or is reasonably ascertainable or practicable, the occupation of the patient; (g) the following details of the cancer and its diagnosis: (i) a statement of the body part or system where the cancer arose, or if not known, a statement of that fact; (ii) the date of diagnosis of the cancer if known (being the date that the diagnosis was confirmed by pathology, radiology or clinical assessment); (iii) the type of diagnostic procedures and investigations undertaken (such as clinical assessment, cytology, haematology, histopathology, immunology or radiology); (iv) if the diagnosis was confirmed by pathology— (A) the name of, or a code identifying, the laboratory that performed the test to determine the presence in the patient of the cancer; and (B) the type of tumour; and (C) the slide or specimen number assigned to the specimen taken from the patient to test for the presence of the cancer; (v) to the extent that it is known or reasonably ascertainable, the stage or extent of the cancer at the time of diagnosis; (h) to the extent known or reasonably ascertainable, the following information as may be required by the Minister to be provided in relation to the cancer or the patient: (i) the prognosis of the cancer and the factors affecting the prognosis; (ii) details of medical treatment provided to the patient in relation to the cancer at the hospital or health service; (iii) details of patient reported outcome measures recorded in connection with the cancer at the hospital or health service; (i) if the patient has departed or been discharged from the hospital or health service—the date of and reason for the departure or discharge; (j) if the patient has died at the hospital or health service—the date of death. (3) The report must be made in a form and manner acceptable to the Minister. 33—Reporting obligations of pathology laboratories The person in charge of a pathology laboratory must, within 3 months after the completion by the laboratory of a cancer pathology report relating to a person, provide the Minister with a copy of the report along with the information as the Minister may require relating to cancer prognostic tests undertaken by the laboratory. 34—Provision of information by medical practitioners If the Minister is aware of a person (the patient) who is or has been diagnosed with or treated for cancer, the Minister may request a medical practitioner involved in the patient's treatment or diagnosis of the cancer to notify the Minister in writing of any information referred to in regulation 32(2)(e) and (g) relating to the patient, as specified by the Minister, that is known to the medical practitioner, and the medical practitioner is authorised for the purposes of the Act or any other Act or law to provide that information by virtue of this regulation. Part 8—Clinical competencies and scope of practice 35—Clinical competencies and scope of practice For the purposes of section 100(2)(j) of the Act— (a) the Chief Executive may establish policies or protocols that set out practices in order to assess the clinical competencies of, and to determine the scope of the clinical practice of, specified classes of health care providers in specified settings or circumstances (including before a person is engaged as a health care provider) (being policies or practices that may be varied or substituted, and have effect, from time to time and according to their terms); and (b) the Chief Executive may establish committees to undertake practices associated with assessing the clinical competencies of, and to determine the scope of the clinical practice of, specified classes of health care providers under any policy or protocol established under paragraph (a); and (c) an incorporated hospital and SAAS, and any person engaged in connection with the Act, must comply with, and apply, any policies, protocols or practices established under paragraph (a); and (d) an incorporated hospital or SAAS may establish policies, protocols and practices that are secondary or subordinate to (and consistent with) any policies, protocols or practices established under paragraph (a). Schedule 1—Private hospitals Part 1—Prescribed information for annual return 1—Prescribed information for annual return For the purposes of section 84(2)(b) of the Act, the following information is prescribed: (a) the period to which the return relates (the relevant period); (b) the name and address of the private hospital; (c) if the licensee is a private person—the name and address of the licensee; (d) if the licensee is a body corporate—its name and the address of its registered office; (e) if the licensee is an incorporated association—its name and address; (f) a statement as to whether or not there has been any change during the relevant period in the identity of— (i) in the case of a body corporate, the secretary or directors; or (ii) in the case of an incorporated association, the public officer or members, and if any such change has occurred the name, address and occupation of any new person appointed; (g) a statement as to whether or not there has been any change in the membership of the board of management of the private hospital during the relevant period and, if so, details of any such change; (h) a statement as to whether or not there has been any change in the identity of the manager or administrator of the private hospital during the relevant period and, if so, details of any such change; (i) a statement as to whether or not there has been any change, during the relevant period, in the identity of a person who— (i) has any pecuniary interest, whether direct or indirect, in or from the running of the private hospital; or (ii) is involved either directly or indirectly in the management and control of the private hospital, and, if so, details of any such change; (j) a statement as to whether or not, during the relevant period, there has been any change in the purpose for which the private hospital is used and, if so, details of any such change; (k) a statement as to whether or not, during the relevant period, there has been any change in the number of approved beds provided at the private hospital and, if so, details of any such change; (l) a statement as to whether or not, during the relevant period, there has been any change in the number of beds designated for a particular type of service and, if so, details of any such change; (m) a statement as to whether or not, during the relevant period, there has been any change in the clinical services provided as part of or ancillary to the principal services provided at the private hospital and, if so, details of any such change; (n) a statement as to whether or not, during the relevant period, there has been any change in the facilities provided at the private hospital and, if so, details of any such change; (o) a statement as to whether or not, during the relevant period, there has been any change in the specialist diagnostic equipment provided at the private hospital and, if so, details of any such change. Schedule 2—Pregnancy outcome data and statistics Part 1—Pregnancy outcome information The information required for the purposes of regulation 27 is as follows:

Subject Details required 1 The baby's birth Family name (if different from the birth mother's family name) Name of baby (if known)

Place of birth (a) if the baby was born in a hospital—the name and address of the hospital (b) if the baby was born in some other place—the name, or a description of, that place (eg birthing unit/centre, at home etc)

Case record number of the baby

Date and time of birth

Sex of the baby

If the baby's birth was a multiple birth— (a) the number of babies born (b) the baby's birth order

Birth weight

Gestation at birth

Apgar scores (1 minute and 5 minutes)

The time taken to establish regular breathing

If resuscitation was required at delivery, the type of resuscitation used

Details of any condition occurring during the birth (eg a dislocation, fracture, nerve injury etc)

Details of any congenital abnormality apparent in the baby [Note—diagnosis of a congenital abnormality must be notified to the Minister in accordance with regulation 28]

Details of medical treatments provided to the baby after birth (eg treatments such as oxygen therapy for a period greater than 4 hours, phototherapy for jaundice, intravenous therapy etc)

Details of nursery care required and, if the baby was transferred to intensive care, whether this was for a congenital abnormality

Details of the outcome of the baby (eg fetal death, baby discharged alive, baby still in hospital 28 days after birth, neonatal death etc)

If the baby was transferred from 1 hospital to another, details of the date this occurred and the baby's destination

Date of final discharge (or death) of the baby 2 The baby's birth mother Name

Address

Case record number

Date of birth

Indigenous Australian status, race and ethnicity

Country of birth

Type of patient (ie hospital/public patient or private patient)

Marital status

Occupation

Details of the outcomes of any previous pregnancies (eg number of livebirths, stillbirths, neonatal deaths, miscarriages, ectopic pregnancies or terminations)

Details of the pregnancy previous to the pregnancy resulting in the baby's birth, including— (a) the outcome (b) the date of delivery or termination (whether by miscarriage or otherwise)

Details of the method of delivery of the baby born (if any) immediately previous to this baby's birth

Number of caesarean sections (if any) the mother has undergone 3 The pregnancy resulting in the baby's birth Date of last menstrual period

Intended place of birth

Details of any antenatal care received including— (a) type of care (b) number of visits (c) gestation, height and weight at first antenatal visit

Details of the mother's tobacco smoking during pregnancy and, if relevant, details of any cessation advice given

Details of any medical conditions of the mother present in this pregnancy (eg anaemia, epilepsy, diabetes etc)

Details of any obstetric complications of the mother (eg threatened miscarriage, antepartum haemorrhage etc)

Details of medical and surgical procedures performed during the pregnancy (eg medical procedures such as ultrasound examinations and surgical procedures such as amniocentesis, cordocentesis etc)

Date of admission to hospital prior to delivery

Date of— (a) discharge (b) transfer to another hospital (c) death 4 The labour, delivery of the baby and puerperium Details of the onset of labour (eg spontaneous, no labour, induced labour etc)

Details of any induction or augmentation of labour (including the reason for the induction)

Details of the presentation of the baby prior to delivery (eg breech, vertex, brow etc)

Details of the method of delivery of the baby (eg normal spontaneous, forceps, caesarean etc)

If the baby was delivered by caesarean section, the reason for so doing

Details of any complications of the labour, delivery and puerperium (eg fetal distress, retained placenta, cord prolapse etc)

Details of any cardiotocograph (CTG) or fetal scalp pH taken during labour

Details of the perineal status after delivery (eg intact, tear, episiotomy etc)

Details of any analgesia given for the labour (eg nitrous oxide and oxygen, narcotic, epidural etc)

Details of any anaesthesia given for the delivery (eg pudendal, epidural, spinal, general etc) 5 The baby's birth father Occupation Part 2—Information relating to congenital abnormalities The information required for the purposes of regulation 28 is as follows:

Matter Details required 1 The child Name and address

Place of birth (a) if the child was born in a hospital—the name of the hospital and (if available) the child's case record number (b) if the child was born in some other place—the name, or a description of, that place (eg birthing unit/centre, at home etc)

Date of birth

If the child is receiving treatment in a hospital—the case record number from the hospital

If the child was not born in South Australia, the place where the child was born

Sex of the child

If the child's birth was a multiple birth— (a) the number of babies born (b) the child's birth order

The name, address and contact telephone number of any medical practitioner caring for the child

If the child is deceased, the date of death and details of any autopsy performed 2 The child's mother Name (including any previous names) Date of birth Indigenous Australian status, race and ethnicity 3 The diagnosis Each congenital abnormality diagnosed Family history of any congenital abnormalities present in the baby's parents, siblings or other specified relatives Address of the mother during the first 16 weeks of pregnancy Exposure of the baby's parents to possible teratogens Whether any prenatal or postnatal diagnostic tests were carried out and (if so) the results of those tests Name and address of the obstetrician and midwife 4 If the diagnosis was not made in a hospital—the medical practitioner who made the diagnosis Name

Address of medical practice

Date of diagnosis Signature Date 5 If the diagnosis was made in a hospital—the person responsible for the management of the hospital Name Designation Address of hospital

Signature Date Schedule 3—Repeal of Health Care Regulations 2008 The Health Care Regulations 2008 are repealed. Legislative history Notes • For further information relating to the Act and subordinate legislation made under the Act see the Index of South Australian Statutes or www.legislation.sa.gov.au. Principal regulations Year No Reference Commencement 2023 91 Gazette 16.8.2023 p3006 16.8.2023: r 2

Source text: opening excerpt

Sourced from South Australian Legislation (legislation.sa.gov.au), CC BY 4.0.

1 Health Care Regulations 2023

South Australia Health Care Regulations 2023 under the Health Care Act 2008

This section converts the regulations into practical compliance tasks organised by entity and duty. It is a step‑by‑step checklist and process guidance anchored to the relevant regulation citations.

Governance and boards (r 5; r 7):

Prepare templates for Ministerial consultation responses: Governing bodies/HACs should maintain a template that records the consultation steps required by r 5(1)(a)-(c), including documenting a minimum four‑week consultation period, lists of community groups consulted, meeting minutes with Chief Executive (if requested), and a fair summary of consultation outcomes for the HAC’s written response to the Minister (r 5(1)(c)(i)-(ii)).
Develop and publish engagement strategies that meet r 7: Create clinician engagement and consumer/community engagement strategies that include clear objectives, how strategies support governing board functions, consultation methods, key safety and quality issues to consult on, mechanisms for using consultation results, and metrics for measuring and publicly reporting effectiveness (r 7(1)-(2)). Ensure the strategies explicitly map relationships among the board’s consumer strategy, clinician strategy, and health service providers (r 7(1)(c), r 7(2)(c)).

RCA preparedness (r 12-14):

Establish an RCA team roster: Keep a pre‑qualified list of RCA investigators who meet r 12(1) criteria,ensure team leaders have formal RCA training, a minimum of three members, and at least one member with tertiary health qualifications or equivalent experience. Maintain documentation of qualifications and training certificates.
Implement conflict disclosure procedures: Adopt a written conflict-of-interest policy aligned to r 12(2)(c), requiring written disclosure to the designated authority as soon as an RCA member becomes aware of an interest, and establishing a process for the designated authority’s determination regarding participation.
Map RCA timelines into incident response plans: For hospital-related RCAs, ensure capacity to commence within 14 days and to draft reports within 10 weeks, with contingency to seek Safety and Quality Unit written consent for up to 20 weeks where necessary (r 12(2)(a)-(b)).
Procedures when a prescribed act is suspected: Train teams to notify the designated authority in writing immediately and to pause investigations until authorised to continue (r 13). Maintain standard notification forms and contact details for the designated authority.

Data reporting and registers (rr 18-19, 25-26):

Create and maintain registers: For private hospitals, implement patient registers recording the specific fields in r 18 (full name, age, sex, residence, admission/discharge dates, medical attendant, next of kin, and maternity specifics where relevant). For PDPCs, implement attendee registers per r 25.
Build data collection and submission systems: Develop IT workflows to collect, validate and transmit monthly data specified by the Minister. Engage early with the Department to obtain the data specification and acceptable transmission formats (rr 19(2)-(3), 26(2)-(3)). Maintain audit logs of data provided and the Minister-specified period for submission to demonstrate compliance.
Confidentiality controls and staff training: Implement robust access controls and staff training on the confidentiality rules (rr 19(4)-(6), 26(4)-(6), 31(1)-(3)), including procedures for handling Chief Executive authorisation for disclosure (rr 19(5), 26(5)). Ensure staff know that they cannot be compelled to disclose confidential information in proceedings and that volunteered information may be inadmissible (rr 19(6), 26(6), 31(3)).

Pregnancy outcome and congenital abnormality reporting (rr 27-31; Schedule 2):

Establish birth reporting workflows: For each birth, ensure the person in charge (medical practitioner, midwife, or, where relevant, the person responsible for management of the hospital) records Schedule 2 information promptly and meets timing obligations,within 7 days of discharge if not discharged within 28 days, or within 30 days after birth otherwise (r 27(2)). If admission/transfer situations occur, follow the 2‑day internal forwarding rules in r 27(3)-(4).
Congenital abnormality notifications: Implement a 30‑day reporting process for congenital abnormalities diagnosed before the child’s fifth birthday, and collect the Schedule 2 Part 2 fields (r 28).
Data formats and printing capability: Ensure reporting systems can produce both electronic submissions acceptable to the Department and printed copies if required (r 30).

Cancer reporting and pathology reports (rr 32-34):

Radiotherapy clinic reporting: If a hospital or health service incorporates a radiotherapy clinic, implement a three‑month reporting regime for new cancer diagnoses, first disclosures or patient deaths with the detailed fields in r 32(2). Confirm internal processes for generating unique patient identifiers and capturing the specified demographic and diagnostic details.
Pathology laboratory obligations: Set procedures to transmit a copy of every cancer pathology report plus required prognostic test information to the Minister within three months of report completion (r 33).
Medical practitioner cooperation: Where the Minister requests information pursuant to r 34, ensure clinical records are accessible and staff are prepared to comply with authorised requests without breaching other statutory obligations, given r 34 authorises practitioners to provide such information.

Accreditation and licensing (rr 17, 23, 24):

PDPC accreditation: For PDPC licence-holders, secure and maintain continuous accreditation under AHSSQS and NSQHS Standards as a condition of licence (r 23). Budget for accreditation cycles and corrective actions.
Licence renewals and annual returns: Track licence renewal dates (prescribed day 30 April for private hospitals r 17(a) and for PDPCs r 24(1)) and ensure annual returns include prescribed information in Schedule 1 Part 1 and ministerial determinations where applicable.

DGR and financial winding up (r 16):

DGR contingency planning: If an incorporated hospital has DGR status, prepare procedures to transfer surplus gift fund assets in the event of cessation of DGR endorsement, winding up of gift funds, or dissolution. Ensure identification of eligible recipient funds that are deductible under the Income Tax Assessment Act 1997 (r 16).

Administrative liaison and monitoring:

Maintain departmental contact points: Designate an internal point of contact to liaise with the Department for data specifications, RCA report consent requests, and any Chief Executive policies under r 35.
Track Gazette notices: Monitor the Government Gazette for any additions to prescribed health services under r 22(1)(f) that may broaden licensing requirements.
Recordkeeping and audit trails: Keep evidence of timely submissions, consultations and RCA notifications to the designated authority, including written disclosures of interests by RCA members and decisions made by the designated authority (r 12(2)(c), r 13).
Legal and privacy review: Undertake a legal review of reporting processes against professional confidentiality duties and applicable privacy laws, and document legal bases for disclosures, particularly where Chief Executive authorisations are sought or where data are disclosed to SA NT DataLink or AIHW per r 31(2).

Training and resourcing:

Train clinical and administrative staff on obligations under the regulations, including register data capture, privacy/confidentiality protocols, RCA processes, and reporting deadlines.
Budget for training for RCA leaders and for accreditation maintenance for PDPCs.

By mapping responsibilities to specific regulations, maintaining clear audit trails, and establishing operational workflows for reporting and confidentiality, regulated entities can operationalise compliance and reduce the risk of penalties or administrative action. Legal counsel should be involved where Chief Executive authorisations, designated authority decisions or potential conflicts between statutory duties arise.

Health Care Regulations 2023

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Health Care Regulations 2023

Source text: opening excerpt

1 Health Care Regulations 2023

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