fA ~Queensl Queensland Government and Health REGULATORY IMPACT STATEMENT Private Health Facilities Regulation 2000 and Standards under the Private Health Facilities Act 1999 August 2000 ISBN 1 876532 98 X INTRODUCTION This Regulatory Impact Statement has been prepared under the provisions of the StatutOf)' Instruments Act 1992. The matters presentcd in this document are intcnded for discussion and do not represent Government policy. Y uu are invited to consider the issues raised and make a response to those issues. For reference purposes, the Private Health Facilities Act /999 may be purchased from Goprillt and is also available electronically on the Intemet. The rclevant Intemet address is www.lcgislation.qld.goy.aulBills/BI149_99.htm. The Regulatory Impact Statement can also be electronically accessed on the Internet at www.health.qld.gov.au/lpu/private.htm Enquiries about the Regulatory Impact Statement can be made to: Bernie Ridsdill-Kenny, Legislative Projects Unit, Queensland HealLh Tclephone: Fax: E-mail: (07) 32340405 (07)32341455 bcmic_ridsdill-kenny@health.qld,gov.au Responses and comments on the proposals presented in the Regulatory Impact Statement must be made in writing and should he sent to: The Manager Legislative Projects Unit Queensland Health GPO Box 48 BRISBANE Q 400 I The closing date for comments is t 1 September 2000. REGULATORY IMPACT STATEMENT Private Health Facilities Act 1999 PRIVATE HEALTH FACILITIES REGULATION 2000 TITLE Primt/! I/c>ultlz Facilitic's Regulation 20()() BACKGROUND Privatc hospitals and day hospitals ("private health facilities") are currcntly regulated in Quccnsland under Division 4 of Part 3 of the Health Act 1937. This legislation is to bc rcpealed and replaced by the Private Health Facilities Act 1999, which was passed by thc Legislative Assembly on 23 Novcmber 1999. The Private Health Facilities Act 1999 ("the Act") was developed following a comprehensive review process which involved extensive consultation wilh key stakeholders. The commencemcnt of the Act is planned to coincide with the introduction of the Private Ilealth Facilities Rr!gu/atiol1 20()() ("the Regulation") and the making of standards relating to plivate health facilities. This Regulatory Impact Statement outlines the Govcmmenfs proposals regarding the development of the Regulation and standards relating to private health facilities. The Queensland Government invites you to participate in the development of the Regulation and the Standards. by commenting on any of the matters contained in the Regulatory Impact StatemcnL AUTHORISING LAW Section 151 of the Act provides the general head of power for the making of a regulation. Specific provisions regarding the matters to be covered by the Regulation arc contained in sections lO, 12,23.48,144,147,154, 155, 156 and Schedule 3 of the Act. Section 12 of the Act empowers the Chief Health Officer to make standards for the protection of the health and wellbeing of patients receiving health services at private health facilities. Standards may be made about the following matters: • the particular type!' of health services to which patients at a private health facility must have access (whether or not the services arc provided at the facility) when other health services arc provided at the facility; proces!'es for: • cvaluating the credentials of medical practitioners providing, or secking to provide, health services at private health facilities; and • deciding which health services may be provided by the medical practitioners at the facilities; processes for deciding ethical issues; • • • • • • • • • processes for monitoring. evaluating and improving the quality of health servIces at private health facilities: the day to day care and safety of patients. including admission and discharge procedures and patient records; management and staffing arrangements; minimum patient throughput for health services provided at private health facilities and prescribed under a regulation: equipment. fittings and furnishings at private health facilities; infection control: and any other matter prescribed by regulation. Under the Act, it is a condition of licensing that the licensee must comply with the Standards relevant to the private health facility Lo which the licence relates. It should be noted that the Standards will not be suhordinate legislation. However, section 12 of the Act stipulates that the Minister for Health must publish a gazette notice about the making of a standard. and any such gazelle notice shall be subordinate legislation. It is therefore appropriate that the proposed Standards be considered as part of this Regulatory Impact Statement. POLICY OBJECTIVES All health care interventions involve the risk that the patient may suffer hann through the occurrence of an adverse patient outcome. In the hospital environment. the risk of harm is particularly prevalent in the case of surgical or other invasive procedures or procedures involving the usc of sedation or anaesthetic. The public expect that appropriate standards of care will be provided in private health facilities and that all reasonable steps arc taken to minimise the risk of harm to patients. The policy objective of the Act is to protect the health and well-being of patients receiving services at private health facilities by minimising the risk of hann through ensuring that appropriate standards of care arc provided at those facilities. The principal objective of the Regulation is to give effect to particular provisions of the Act which seck to ensure that health services provided in private health facilities meet appropriate standards. Similarly. the Standards have been developed so that compliance with the standards. as required by the Act, will minimise the risk of harm to patients. Therefore. the objective of the Regulation and the Standards is consistent with the objective of the Act. HOW THE POLICY OBJECTIVES WILL BE ACHIEVED Private Hea/tlr Facilities Regulation 2000 Day Hmpital Health Sen'ices The Act will apply to day facilities at which "day hospital health services", as defined in section 10 of the Act, are provided. The purpose of the definition of "day hospital health services" is to ensure that day facilities which provide higher risk health services arc licensed so as to minimise the risk ofhaml to patients receiving services at those facilities. The health services covered by this definition fall into two categories, namely: • • procedures perfonTIed by medical practitioners involving specified types of anaesthetic or sedation; and prescribed procedures performed by, or at the direction of, a medical practitioner which involve a significant risk that the patient may, because of cardiac, respiratory or other complications, require resuscitation. The Regulation will prescribe the procedures for the purposes of the second of the above categories. These specific procedures have been identified as involving a level of risk of haml to the patient which justities the licensing of the facility at which they arc pertolmed. Minimum Patient Throu~hput Standard A standard may be made by the Chief Health Officer under section 12 of the Act about the minimum number of patients required to receive a particular health service at a private health facility during a stated period to maintain the clinical skills of the staff providing the service (eg. the minimum annual caseload for a cardiac surgeI)' unit). The Regulation will specify those health services about which minimum throughput standards may be made. Quality ASSI11'(/l/cC Requiremcnts Section 48 of the Act imposes, by way of conditions of licensing, a number of obligations upon licensees of private health facilities including that the licensee must: • • • within 90 days after the issue of the licence, start a prescribed quality assurance program, conducted by a prescribed quality assurance entity, for the facility; within 3 years after the issue of the licence, receive certification from the quality assurance entity that the facility operates under a quality assurance system; and ensurc that the facility continues to be so certified while Iiccnsed. The Regulation will give effect to these obligations by prescribing the quality assurance programs, and the respective quality assurance entities, for the purpose of compliance by licensees with these obligations. Miscellaneous Matters Thc Regulation will also specify: • the types of matters about whieh approval holders or licensees must notify the Chief Health Ofticcr if any change occurs sincc they were disclosed in an application under the Acl; the times at which licensees must give reports to the Chief Health Officer to monitor the quality of the health services at private health facilities and for other purposes; the agreements under whieh the Chief Executive of Queensland Health may give to the Commonwealth or another State, information obtained in connection with the administration of the Act; and • • • the fees to be charged under the Acl. III Specific details about the provisions to be contained Attachment I. Standards the Regulation are set out III As previously staled, section 12 of the Act empowers the Chief Health Officer to make standards for the protection of the health and wellbeing of patients receiving health services at private health facilities aboul the specific matters set out in that provision. The Standards will set out the measures designed to minimise the risks of hann associated with the provision or health services at private health facilities. Many of the Standards will adopt or be based on recognised standards, guidelines or protocols published by bodies such as thc Medical Colleges. thc Standards Association of Australia and the National Health and Medical Research Council. Specitic details about the provisions to be contained Attachment 2. OPTIONS AND ALTERNATIVES 111 the Standards arc set out 10 The policy objectives of the Act cannot be fulfilled without the making of supporting subordinate legislation and standards. For this reason. it is not appropriate to consider any allcrnative to making the Regulation or the Standards. The Regulation and the Standards will assist in achieving the objectives of the Act by. for instance: • specifying, under the Standards, the measures necessary to minimise the risks of harm associated with the provision of health services at private health facilities. The Act requires. as a condition of licensing, that a licensee of a private health facility must comply with the Standards relevant to the facility. ensuring that licensing requirements arc met in day facilities at which procedures are performed involving a significant risk that the patient may require resuscitation, by prescribing the specific procedures identified as falling within this category. These procedures, as well as procedures involving specified types of anaesthetic or sedation, will only be able to be performed in a day facility if the facility is licensed under the Acl. ensuring that all licensed private heallh participate in quality assurance activities, by prescribing the quality assurance programs. and the respective quality assurance entities, for the purpose of compliance by licensees with the quality assurance obligations under the Act. enahling the Chief Health Officer to be made aware of circumstances which might adversely affect a person's suitability to hold. or continue to hold, an approval or a licence under the Act, by prescribing the changes of circumstances in respect of which notification must be given to the Chief Health Officer. • • • COST-BENEFIT ANALYSIS An analysis of the costs and benefits of implementing the Regulation and the Standards has becn undcl1aken for community. industry and government stakeholders likely to be affected. The analysis is set out below. Com,,"mi~J' Benefits The Regulation and the Standards will potentially improve the quality of services provided to patients at private health facilities. For example, the Regulation will givc effect to the provisions of the Act which impose quality assurance requirements and extend coverage of licensing requirements to all day facilities performing "higher risk" procedures. An improvement in the quality of health services is likely to reduce the ratc of adverse patient outcomes and increase public confidence in the private health care system. A reduction in the rate of adverse patient outcomes will benefit the community by reducing the social costs (eg. penllanent disability/death of a patient and the impact of this on the patient's family/carers) and economic costs (eg. hospital/medical costs incurred through an extended hospital stay or re~admission; loss of income/earning capacity) which can flow from adverse patient outcomes. Costs Compliance with the requircments of the Regulation and the Standards may result in additional costs (discussed below) for operators of private health facilities. Howcver, it is not considered that these costs will have any significant negative flow-on effects for consumers in relation to the cost or availability of health services. lmlu.'ifl:J' Benefits Operators Adverse patient outcomes in private health facilities may lead to damages claims being brought against the operator of the facility (cg. whcre an adverse outcome resulted from an unsafe physical/clinical environment in the facility). Therefore. a reduction in the rate of adverse patient outcomes in private health facilities could potentially reduce the likelihood of the operators of the facilities being exposed to damages claims and incurring consequential costs (eg. uninsured losses. increased insurance premiums). TIIC Regulation and the Standards will, in conjunction with thc Act. provide greater transparency than the existing legislation in relation to licensing criteria and the obligations of licensees. This will benefit existing and potcntial licensees and facilitate compliance with the legislation. Consumcr confidcnce in private health facilities could potentially increase if consumers perceive that the new Icgislation will improve the quality and safety of services provided in private health facilities. This may lead to increased utilisation of privatc health facilities and a consequential increase in profits for operators. Helllth Prr?/i!ssionals/Prolessional Indemnity Insurers Adverse patient outcomes at private health facilities can result in legal action and/or disciplinary action against individual health professionals practising in thc facility. Such actions can arise directly or indirectly from licensing-related matters. For example, an adverse outcome resulting fi'om an unsafe physical or clinical environment may result in a claim against the health practitioner as well as the operator of the facility. The Regulation and the Standards. in conjunction with the Act, could potentially reduce the rate of adverse patient outcomes and thereby reduce legal costs for health professionals and professional indemnity insurers and professional indemnity premiums/insurance payouts for those respective groups. Private I!ealth Insurance Funds/Health Insurance Commission Adverse patient outcomes in private health facilities can result in an increase in payouts by private health insurers (eg. if an increased length of stay in hospital is required) and Medicare payments by the Health Insurance Commission (eg. for treatment provided to patients as a result of the adverse outcome). As noted above, the Regulation and the Standards will potentially reduce the rate of adverse patient outcomes and thereby reduce these costs. QlIali~l' Assurance Bodie.'i Increased industry participation in quality assurance programs through compliance with requircments of the new legislation would result in additional income for quality assurance bodies as well as consultants providing services to health facilities participating in quality assurance programs. However, the potential benefits for these groups are not expected to be significant on thc basis that there is already a high level of participation in quality assurance programs by the private health care industry, either on a voluntary basis, or to meet health insurance requirements. Costs Existing UC(!J1see.l' Existing licensees of private health facilities will incur additional costs by way of payment of fees under the Act and in complying with the Standards and the reporting requirements under the Act. However, these costs are not expected to be significant as the principal fees will be based on the fees under the existing legislation with increases in line with the Consumer Price Index. In addition, many of the obligations imposed under the Standards and the reporting requircmcnts are already being met by licensees under the existing legislation or as a consequencc of membership of professional bodies eg. Medical Colleges. The costs of complying with thc quality assurance requirements in the new legislation will only affect about 10% of current licensees as around 90% of licensed private health facilities arc already accredited/certified by a quality assurance entity, or have entered into a quality assurance program but have yet to achieve accreditation/certification. Operators orDay Hospitals The new detinition of "day hospital" contained in the Act means that licensing requirements will apply to a number of day facilities which arc not required to be licensed under the existing legislation. Operators of these facilities will have 6 months from the commencement of the legislation to apply for an approval and a licence for the facility and meet the requirements of the legislation. The main licensing compliance costs to be met by these operators will be the payment of fees and the costs of complying with the Standards and the quality assurance requirements. Compliance costs associated with the quality assurance requirements will include on-going fees payable to the relevant quality assurance body. For example, the annual membership fee for day facilities participating in the accreditation program conducted by the Australian Council on HeaIthcare Standards is currently $2900. Operators entering into a quality assurance program may also engage consultants to provide training as to how the program works and what is required to achieve accreditation/certification. (iovernment Benefits In conjunction with the Aet, the Regulation and the Standards will enhance the government's ability to ensure that appropriate standards arc maintained in private health facilities and thereby more effectively mel:! public expectations about the govcmmcnt's role in protecting consumers /i'om the inherent risk of hann associated with health care interventions. Costs The cost of administering the new legislation is likely to be slightly higher than the cost associated with the current licensing regime. This is becausc it is expected that a small numbcr of day facilities that are not required to be licensed under the current legislation will he subject to licensing as they will fall within the new definition of a "day hospital" in the Act. FUNDAMENTAL LEGISLATIVE PRINCIPLES The proposed Regulation and the Standards have sufficient regard to the rights and liberties of individuals and the institution of Parliament. ATTACHMENT 1 PRIVATE HEALTH FACILITIES REGULATION 2000 LEGISLATIVE PROPOSAL Legislative Proposal - Private Health Facilities Regulation 2000 DAY HOSPITAt HEALTH SERVICES The new legislation will apply to private hospitals and day hospitals as defined under the Act. Section 10 of the Act defines a "day hospital" as a facility at which day hospital health services arc providcd to persons who are admitted to, and discharged from, the facility on the same day, but docs not include a facility operated by the State. Scction 10 of the Act also dcfines a "day hospital health service" as a diagnostic, surgical or other proccdmc: (n) performed by a medical practitioner and: • involving the administration of a general, spinal or epidural anaesthetic; or • sedation, other than simple sedation; performed by, or under the direction of, a medical practitioner and: • involving a significant risk that a person on whom the procedure is performed may, because of cardiac, respiratory or other complications arising from the performance of the procedure. require resuscitation: and • prescribed under a regulation. (h) Specific procedures need to be prescribed under (b) above as they have been identified as involving a level of risk of harm to the patient which justifies the licensing of the facility at which tbey arc perfonned. It is therefore proposed that, for the purposes of the above definition, the Regulation will prescribe the following procedures: • • • • Cardiac Stress Testing: Ilaemodialysis: Cytotoxic Infusion: and Endoscopy excluding Proctoscopy, Sigmoidoscopy and flexible Cystoscopy. MINIMUM PATIENT THROUGHPUT STANDARD A standard may be madc by thc Chief Health Officer under section 12 of the Act about the minimum number of patients required to receive a particular health service at a private health tacility during a stated period to maintain the clinical skills of the staff providing the service (cg. the minimum annual caseload for a cardiac surgery unit). It is proposed that the Regulation will specify that the health services about which minimum throughput standards may be made arc as follows: • • • • Cardiac Surgcly: Cardiac Catheterisation: Intensive Care: and Obstetrics. Legislative Proposal - Private Health Facilities Regulation 2000 QUALITY ASSURANCE REQUIREMENTS Section 48 of the Act imposes, by way of conditions of licensing, a number of obligations upon licensees of private health facilities including that the licensee must: • • • within 90 days after the issue of the licence, start a prescribed quality assurance program, conducted by a prescribed quality assurance entity, for the facility; within 3 years attcr the issue of the licence, receive certification o'om the quality assurance entity that the facility operates under a quality assurance system; and ensure that the facility continues to be so cCltified while licensed. It is proposed that, for the purpose of compliance by licensees with the above requirements, the Regulation will specify that the relevant quality assurance entities and quality assurance programs are as follows: • • • Australian Council on Healthcarc Standards - Evaluation and Quality Improvement Program; International Standards Organisation - ISO 9000 Series; and Institute for Healthy Communities Australia Inc. - Quality Improvement Council Limited's Australian Health and Community Services Standards. Certification from anyone of the above entities will constitute compliance with the relevant requirements under the Act. The Regulation will also specify that facilities at which procedures involving assisted reproductive technology are pcrfonned must also be accredited by the Fertility Society of Australia under that body's Assisted Reproductive Technology Accreditation Committee's Code of Practice tor Centres using Assisted Reproductive Technology. FEES Under the Act, fees may be charged for various matters relating to approvals and licences, for the replacement of approvals and licences (eg. that have been lost), and for applications to make a "prescribed alteration" undel' section 63 of the Act. A new fec structure is proposed whieh is largely based on the fees payable under the existing legislation with increases in line with the Consumer Price Index. It is proposed that the Regulation set out that the following fees are to be charged under the Act: Approvals Application The application fce fol' an approval will be $255. Extension otTerm v(Approval The fcc for an application to extend the term of an approval will be $100. Legislative Proposal - Private Health Facilities Regulation 2000 3 Change.\' to an Approval The fcc lor an application to change the particulars about the proposed facility stated in an approval will be $100. Replacement of'Approval The fce for the replacement of an approval that has been lost, stolen, destroyed or damaged will be $10. Licences Initial Application The fcc for an initial application for a licence will havc two components, an application fee and a licence fcc, The application fce will be $255. The amount of the licence fce will depend on the tcrm l of the licence and will be: • for I year or less $65 • for more than 1 year but not more than 2 years $130 • lor more than 2 years but not morc than 3 ycars $195 RC!newal of'Ucl'nce The fee for an application to rcnew a licence will be the relevant licence fcc as abovc (whereas an applicant for a new licence must pay a licence fee and an application fcc). ChangC!s to a Licence The fcc for an application to change the particulars about the facility stated in a licence will be S I00. RC!placl'lIlL'llf (?fLicencC' The fcc for the replacement of a licence that has been lost, stolcn. destroyed or damaged will be $10, Trall.~/~r o(Licence The fec for an application to transfer a licence will be $255. 1 Under scction SO(2) oCthe P,.il'ut(' Health Facilities Act }9(1), the term of a Iicencc must not exceed 3 years if the ll\l:ility has hecn ccrtified as operating under a quality assurance system, or otherwise. 1 year. .:L~e.2.gi~s;,:la;.:.;tj.:..ve.:;...:..P..:..r0:lp:...:o;.:s..::a..:..1-_P..:..r..:..iv....:a:...:.te=--H....:e.:;a:...:.lth..:..-F-=a.;..ci_lit_ie....:s..:..R--'eg~u_!a.:....t_io_n--'2~O_O_O 4 Approval of prescribed alterations The fcc for an application for approval of a prescribed alleration (ie. a change in the purpose for which part of the facility is used or a change to the physical structure of the facility) will be $100. Refund of fees It is proposed that the Regulation specify that the licence fce payable on an application for the grant or renewal of a licence is to be refunded if the Chief Health Officer refuses the application or the applicant withdraws the application before it is decided. The application fcc payable on an application for the grant of a lieence will be retained to cov~r the administration costs associated with the processing of the application. MISCELLANEOUS Notification o(Cllll1lges ill Circumstances Under sections 23 and 4~ of the Act. the holder of an authority (an approval or licence for a private health facility) must notify the Chief Health Officer if there is a change, of a kind prescribed under a regulation, in a mattcr disclosed by the authority holder in an application under the Act. Notification must be provided within 2 I days after thc change occurs. A similar ohligation is imposed under the transitional provisions in sections 154-156 of the Act. This requirement is to ensure the Chief Health Officer is made aware of any changes in circumstances which may affect the person's suitability to hold an authority under the Act. It is proposed that the Regulation will specity that the notification requirement will apply to changes in any of the following matters: • • • • • • • • name of authority holder or associatc 2 ; address/registered office of the authority holder; name of the quality assurance entity and quality assurance program for the facility (in relation to the quality assurance requirements under section 4R of the Act); the proposed date on which the facility is to be reviewed by the quality assurance entity prior to initial certification or re-certification by that entity: any recommendations made by the quality assurance entity as a consequence of a review; name of the executive officers of a corporate authority holder/associate; name of the person who has the day to day management of the facility: Ilame and registration number of the registered nurse who is in charge of the nursing staff at the facility; ! "associatc", of an applicant for an authOrity or an authority holder, is delincd under the Act to mean: a corpllr.1 19(J7. Oil £tlli(',\ Cllld I All ,!!uiuelinc'i/policy documents. standards and puhlications as updated from tIme to lime. Proposed Standards - Private Health Facilities Act 1999 9 Rcfcrcnce~ (cont'): AS 4264 - 1995 Complaints handling AS 2639 - 1994 Laminar now cytotoxic drug safety cabinets· Installation and usc AS 3695 - 1<)lJ2 Wheelchairs - Product requirements AS'N!S 221 1.1 Supp 1: I99 t ) Laser safety. Equipment classification, requirements and user's guide Applicntinn guidelines amI explanatory notes AS/N7.S 11.1: I \j1)7 Laser safety - Equipment classification. requirements and user's gUlde AS'NZS Jll25: 191)8 Procedures and devices for the removal and disposal of scalpel blades from scalpel hamllcs AS/NZS 4173: 1q94 Guide tll the safe usc of lasers in health care i\S/NZS 4236: I \j\)4 Respmltory therapy equipment - Jet nebulizers and jet nebulizer air pumps ASINZS 4237:1lJ94 Respmltory therapy equipment - Peak e:'lpiratory flow meters The Cardiac Society of Australia and Ncw Zealand Practice Guidelines The Australasian College for Emergency Medicine (1997) Poliey Document [lyperharic Oxygen Therapy Facilities Industry Guidelines. IlJlJl'( The Fertility Society of Australia Reproductivc Technology Accreditation Committee (llJ971. Code of Practice for ('entres ll~in~ Assisted Reproductive Tcchnolo~>. The FlI~'ully of Inknsivc Carc ( !l)l)7) Policy D{)cumcnt Natwnal Mental I1ealth Policy (April 19(2) UllItcd Nations: Principles on the Protection of People with Mentaillealth Illness. Natillnal Standards fl)r Mentaillcalth Sen-ices - Mental lIealth Strategy December 1996 I\tillllllum Scrvice Standards ror Mcntal11calth Services in Queensland (1993) Natwnal lIealth and Medical Research Council (19921. Guidelines for Rellal Dialysis and Transplant Services, Australian Government Publishing Service. Canberra. Standards for lIospice & Palliative Care Provision Australian Association for Illlspice & Palliative Carc. March I ()1)4 n Proposed Standards - Private Health Facilities Act 1999 10 Information Managemellt STANDARD u • • • !.J Every patient must have a medical record which: facilitates effcctive patient care management prior to, during and after their stay in the health tacility: provides for effective communication between health care providers: and enables evaluation of the patient's progress and health outcome. Patient clinical records must be rctained and stored for specified minimum periods. Pennanent registers of patient activity must be maintained for medico-lcgalllegislative requirements. All stored personal infonnation must be protected from unauthorised access, alteration or loss through the usc of appropriate security measures. o o This Standard is not satisfied unless: • Medical Records: • • The health facility's medical records comply with Australian Standard 2828 19X5 (Hospital Medical R~cor(l'i). Each patient, including each infant bam or treated at the health facility, has a medical record which includes the following: Jnfonnation required for the provision of reports to the Chief Health Ofticer under section 144 of the Private Health Facilities Act /999; Progress notes which include the patient's medical history, the nature of the principal condition of the patient and the nature of any other condition, including adverse events, treated during the patient's stay in the health facility; The nature of any surgical/diagnostic procedure perfonned on the patient during an episode of care; A daily record of all medical and nursing care given in relation to the patient's medical, physical, psychological and social needs and responses; Details of all medication; and Record of infonned consent for the perfonnance of any surgical and/or potentially hanniul diagnostic procedures. • Retention and Stnragc.': • The minimum period for the retention and storage of medical records is: For clinical records - 10 years after the last clinical attendance or last medico-legal action, whichever is the later; For minors' clinical records and obstetric records - 10 years from the child attaining adulthood (18 years); For patients with a condition affecting their decision-making capacity (eg. intellectually disabled relating to traumatic brain injmy, dementia, or severe mental illness) - 10 years from the date the patient's decision- Proposed Standards - Private Health Facilities Act 1999 making capacity is no longer limited, or RO years from the date of birth of the patient. • • All records of Assisted Reproductive Technology procedures arc retained according to National Health and Medical Research Council guidelines. If the licence for a health facility is to be transfen-ed, the existing licensee ensures that all patient records arc made available and transferred to the incoming licensee; and Prior to a facility ceasing to operate as a health facility, the licensee submits details of the safe keeping of the records to the Chief Health Officer for approval. • • Registers: • Thc following registers arc available where relevant: Admission and Discharge register: a) the patient's full name and usual residential address; b) the patient's gender and date of birth; c) the patient's unit record number; d) the date orthe patient's admission; cl the name of the patient's attending medical practitioner; n the patient's diagnosis on discharge: and g) the date of separation for the patient's episode of care. Birth register: al the mother's full name: h) the mother's unit record number: cl the name of the mother's attending medical practitioner: d) the date and time of delivery of each infant c) the gendcr of each infant: l) whether or not the infant was bom alive; gl the method of delivery; and h) the name of the midwife and medical practitioner in attendance for the delivery. Operation/theatre or procedure register: a) the patient's full name, gender. datc of birth and unit record number; b) the date and time the operation or procedure was perfonncd; c) the serial number of the operation or procedure: d) the nature of the procedure; c) the name of the surgeon, assistant surgeon, anaesthetists and scrub nurse f) the nature and identification number of any prosthesis used during any procedure: and g) any complications that may have occurred during a procedure. Mental health register: a) infonnation required under the relevant Mental Health legislation. • Security: • Security of records complies with AustralianINcw Zealand Standard AS/NZS 4444; 1996 on Infonnation Security Management. Proposed Standards· Private Health Facilities Act 1999 12 Refcnnccs: AS 2R2X·]lJ9