PROPOSED HEALTH SERVICES (PRIVATE HOSPITALS AND DAY PROCEDURE CENTRES) REGULATIONS 2002 REGULATORY IMPACT STATEMENT Produced by: Service Development Branch Metropolitan Health and Aged Care Division Department of Human Services Victoria ~ State of Victoria Contents Executive Summary. . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 1 Foreword ............................................................... page iii Terms Used in this Regulatory Impact Statement .............. page v Chapter 1............ ........................ ....... .............. .... page 1 Nature Dnd extent of the Problem Chapter 2 ........... ........................ .. ....... ................. page 5 The Statutory Framework Chapter 3 .............. ..... ........................ .. ................ page 9 Objective and Overview of Proposed Regulations Chapter 4 ............ ... .... .... ..... ... ....................... .. .... ...page 15 Impact of the Proposed Regulations and Assumptions Chapter 5 ............................................................... page 17 Prescribed Kinds of Health Services (Regul ations 6 and 7) Chapter 6 .............. ..... .. ...... .............. . ...... . ...... .... ....page 23 Application Forms and Fees (Regulations 8 - 13) Chapter 7 .................... ....... .............................. ...... page 31 Senior Appointments (Regulations 14 and 15) Chapter 8 ......................................... ... .... ............... page 33 Admission of Patients (Regulations 16 2 1) Chapter 9 ................................... ............................ page 39 Care of Patients (Regulations 22 - 25) Chapter 10 .................. ........................................... page 43 Complaints (Regulations 26 · 29) Chapter 11 ............................................................. page 47 Transfer and Discharge of Patients (Regulations 30 and 3 I) Chapter 12 .................................... . ..... .. ................. page 51 Registers and Records (Regulations 32 - 35) Chapter 13 ............................................ .. ... . ........... page 55 Premises and Equipment (Regulations 36 - 40) Chapter 14 ............................. ........ ........................ page 59 Infection Control (Regulation 41) Chapter 15 .............................................. . .............. page 61 Display ofInformation (Regulation 42) Chapter 16 ................................................... . ......... page 63 Statistical returns (Regulation 43) Chapter 17 ........................ ....... . ....... . ....... ... .. .........page 65 Summary of Costs and Benefits Chapter 18 ............................................................. page 69 Penalties and Sanctions Chapter 19 .......................... . .......................... .. ...... page 73 Alternatives to Regulation Chapter 20 ......................... .. ..... ... . .... . ........... . ........ page 77 National Competition Policy Chapter 21.. ....... . ................................................... page 81 Conclusion Chapter 22 ..................... ........................................ page 83 Consultation Attachments Attachment A Calculations of Costs of Processing Applications Attachment B Proposed Health Services (Private Hospitals and Day Procedure Centres) Regulations 2002 ii III PROPOSED HEALTH SERVICES (PRIVATE HOSPITALS AND DAY PROCEDURE CENTRES) REGULATIONS 2002 EXECUTIVE SUMMARY The Health Services (Private Hospitals and Day Procedure Centres) Regulations 2002 replace the Health Services (Private Hospitals and Day Procedure Centres) (Interim) Regulations 2001. They are to be made under section 158 of the Health Services Act 1988. Their objective is to • provide for the safety and quality of care of patients receiving health services in private hospitals and day procedure centres; and prescribe fees, forms and other matters required to be prescribed under the Health Services Act 1988 in relation to such health service establishments. • In the case of the former, the proposed regulations prescribe various requirements to be observed by proprietors of private hospitals and day procedure centres to ensure that patients receive high quality health care. In the case of the latter, the proposed regulations contain such administrative and machinery provisions as are necessary to implement the Health Services Act as it applies to such health service establishments. This Regulatory Impact Statement discusses the effects of the proposed regulations and, where an appreciable economic or social burden is imposed on a sector of the public, sets out to assess the likely costs and benefits. It concludes that the benefits of the proposed regulations outweigh the potential costs and recommends that the proposed regulations be made. The Statement also canvasses other practicable options for achieving the objectives of the proposed regulations. An invitation is extended to interested parties to make submissions with respect to the Statement. A copy of the proposed regulations accompanies this Regulatory Impact Statement. ii FOREWORD Section 7 of the Subordinate Legislation Act 1994 provides that "unless an exception certificate or an exemption certificate is issued in respect of a proposed statutory rule, the responsible Minister must ensure that a regulatory impact statement is prepared in respect of a proposed statutory rule". This Regulatory Impact Statement has been prepared with respect to the proposed Health Services (Private Hospitals and Day Procedure Centres) Regulations 2002. The proposed regulations are statutory rules within the meaning of that Act. The Regulatory Impact Statement assesses the likely costs and benefits of the proposed statutory rule and discusses possible alternatives. Notice of the preparation of this Regulatory Impact Statement has been given by the responsible Minister - the Minister for Health - in accordance with section 11 of the Subordinate Legislation Act. Interested organisations, health and allied professionals and members of the public are now invited to make comments and submissions. Responses to the Regulatory Impact Statement should be addressed toThe Manager Private Hospitals Unit Service Development Branch Department of Human Services Level 10 589 Collins Street MELBOURNE VIC 3000 (Fax No. (03) 9616 2880) The closing date for the receipt of comments and submissions is 6 July 2002. It should be noted that all comments and submissions received in response to this Regulatory Impact Statement will be treated as public documents. iii iv TERMS USED IN THIS REGULATORY IMPACT STATEMENT A number of expressions in this document are used in an abbreviated form. The more important are as follows: former regulations means the Health Services (Private Hospitals and Day Procedure Centres) Regulations 1991; day procedure centre is defined in section 3 of the Act as meaning "premises where(a) a major activity carried on is the provision of health services of a prescribed kind or kinds and for which a charge is made; and persons to whom treatment of that kind or kinds is provided are reasonably expected to be admitted and discharged on the same date- (b) but does not include a public hospital, denominational hospital or private hospital"; interim regulations means the Health Services (Private Hospitals and Day Procedure Centres) (Interim) Regulations 2001; in writing must be read in the context of the Electronic Transactions (Victoria) Act 2000. Under that Act, information which is required to be kept or given in writing may be kept or given in electronic form subject to a number of provisos; Minister means the Minister administering the Health Services Act 1988; private hospital is defined in section 3 of the Act as meaning "premises where persons are provided with health services of a prescribed kind or kinds and for which a charge is made and includes a privately operated hospital but does not include(a) (b) (c) a public hospital or denominational hospital; or a day procedure centre; or a residential care service"; proposed regulations means the proposed Health Services (Private Hospitals and Day Procedure Centres) Regulations 2002; Secretary means the Secretary to the Department of Human Services; v the Act means the Health Services Act 1988; the Department means the Department of Human Services. vi CHAPTER 1 NATURE AND EXTENT OF THE PROBLEM Private hospitals have been regulated in Victoria since the late 19 century. The principal statute currently governing the private hospital sector in this State is the Health Services Act 1988. It is, among other things, an offence under that Act for the proprietor of a private hospital or day procedure centre to carry on such an establishment unless (a) it is registered with the Secretary to the Department of Human Services; and the proprietor is the holder of the certificate of registration1 . 1h (b) In considering whether or not to register an establishment, the Secretary is required by the Act to take a number of factors into account. These include whether the proprietor is a fit and proper person to carry on the establishment, the suitability of the premises, its design and construction, whether the proposed arrangements for the management and staffing are satisfactory and whether appropriate arrangements have been, or will be, made for evaluating, monitoring and improving the quality of the health services provided by the establishment. However, requirements relating to the safety of patients, hygiene and standards of care are basically left to be prescribed by regulation3 . There is no doubt that the majority of private hospitals and day procedure centres in Victoria are well run and provide quality health care services to the community. Nevertheless, there are several reasons why continued regulation of the private hospital industry is considered necessary. The first is to set basic minimum standards which must be observed by the operators of all private hospitals and day procedure centres. A variety of mechanisms such as funding and service agreements is available to Government to ensure that public hospitals provide quality health care but similar mechanisms are not available in the case of the private sector. The only certain way in which private hospitals and day procedure centres can be compelled to provide quality health services is by regulation. I Section III of the Act. The criteria which must be considered by the Secretary are set out fully in section 83( I) of the Act. 3 The regulation making powers are contained in section 158 of the Act. 2 There are, of course, other forces at work which encourage proprietors of private hospitals and day procedure centres to provide quality health care. For instance, many private hospitals have entered into purchaser-provider agreements with health funds andlor have accredited with recognised accreditation agencies either as a condition of such agreements or to demonstrate a commitment to the provision of quality services. Nevertheless, accreditation is by no means universal within the industry and, in a competitive environment, incentives will always exist for less scrupulous operators to cut comers. The prescribing of standards by regulation also serves as a benchmark against which services provided by a facility can be assessed. Moreover, by fixing penaHies for non compliance, appropriate legal action can be taken by the Department if the quality of services falls below the optimum acceptable level. The second reason why continued regulation is considered necessary is to counter-balance the information asymmetry in the industry. Unlike most other markets, private hospital patients rely on their primary health service provider for advice and information on treatment options at a time they are extremely vulnerable and may be either unable or unwilling to access additional information about treatment options. In addition, if a patient wishes to be treated by a particular medical practitioner, the patient may not necessarily be admitted to a hospital or centre of his or her choice but rather to a hospital or centre in which his or her medical practitioner has practising rights. As the Health Services Policy Review Discussion Paper puts it: Although the consumer can have relative preferences about the outcome of different options of treatment, they necessarily rely on the provider for information on the full range of treatment options, including referral options. Because of this information asymmetry, traditional forms of market regutation do not work. The market does not operate perfectly and policy makers need to regulate the market in various ways. Further, when the consumer is seeking health care they (sic) are often extremely vulnerable and are not able to access additional information to make full and informed choices. Consumers may atso feel unwilling to seek information about the relative price of different treatment options or different providers, and may assume that price differences also reflect quality differences when they do not. There are thus good reasons to develop a regulatory framework in the health care market to protect consumers 4 . The use of regulations to require private hospitals and day procedure centres to provide their patients with key information especially about the costs of their 4 The Health Services Policy Review Discussion Paper prepared by Phillips Fox and Casemix Funding pubtished in March 1999 (at page 38). 2 care and their rights as patients will go some way towards counterbalancing the information asymmetry identified by the Review. The third reason why continued regulation is considered necessary is to enable Victoria to give effect to its obligations under various national agreements. These include the National Health Information Agreement and the Australian Health Care Agreement. Without legislation, the private sector could not be compelled to provide the information required by the Department to comply with these agreements and to monitor the utilisation and performance of acute health services in this State. 3 4 CHAPTER 2 THE STATUTORY FRAMEWORK The health care industry is, arguably, subject to more statutes, more regulations, more common law, more guidelines, standards, directions, protocols, codes, conventions, agreements, and understandings than perhaps any other industry in Australia. In Victoria, the private hospital sector is mainly regulated by the Health Services Act 1988. Comparable legislation exists in the other States and Territories. New South Wales, for instance, has its Private Hospitals and Day Procedure Centres Act 1988 backed by the Private Hospitals Regulation 1996 and the Day Procedure Centres Regulation 1996. In South Australia, the private acute health care sector is governed by the South Australian Health Commission Act 1975 together with the South Australian Health Commission (Private Hospitals) Regulations 1985 (although it should be mentioned that both the Act and regulations do not apply to day procedure centres which are currently unregulated in that State. Western Australia has its Hospitals and Health Services Act 1927 coupled with its Hospitals (Licensing and Conduct of Private Hospitals) Regulations 1987. The comparable legislation in Tasmania is that State's Hospitals Act 1918 while Queensland has the most modern legislation following the enactment of the Private Health Facilities Act 1999. The Health Services Act of Victoria sets out to encourage and promote quality health care in both the public and private sectors. Its objectives are set out in section 9. These areto make provision to ensure that (a) (b) health services provided by health care agencies are of a high quality; and an adequate range of essential health services is available to all persons resident in Victoria irrespective of where they live or whatever their social or economic status; and public funds (i) are used effectively by health care agencies; and (c) 5 (ii) are allocated according to need; and (d) heallh care agencies are accountable to the public; and users of health services are provided with sufficient information in appropriate forms and languages to make informed decisions about health care; and health care workers are able to participate in decisions affecting their work (e) (f) environment; and (g) users of health services are able to choose the type of health care most appropriate to their needs. The Health Services Act applies to both the public and the private sectors. The provisions which apply exclusively to the private sector are contained in Part 4. These regulate what the Act calls "health service establishments". "Health service establishments" encompass• • • private hospitals; day procedure centres; and supported residential services. (It should be noted that supported residential services are subject to their own 5 regulations and, thus, are outside the scope of this Regulatory Impact Statement). Under Part 4, a "health service establishment" must be registered with the Secretary6. However, before an establishment can be registered, the applicant must obtain the approval in principle ("AlP") of the Secretary. An AlP can be granted for the use of particular land or premises, for premises proposed to be constructed or for alterations or extensions to premises used or proposed to be used as a health service establishment, or to the variation of registration of a health services establishment'. It is an offence under the Act to construct, alter or extend a health service establishment unless an AlP is in forces. If an AlP is in force, the Secretary cannot refuse a subsequent application for registration on any ground inconsistent with that AlP 9. 5 Health Services (Supported Residential Services) Regulations 200 I 'S. 111. 'Ss.70-76. 's. t 15. °S.83. 6 A private hospital or day procedure centre can be registered for 2 years, or for such longer or shorter period as the Secretary determines 10 Registration can be renewed". 12 Other provisions provide for variation of registration , cancellation of 13 registration , and for a change of directors if the proprietor of an establishment is a body corporate 14. Appeals against decisions of the Secretary can be directed to the Victorian 1s Civil and Administrative Tribunal As well as Part 4, Part 7 of the Act also includes provisions which impact on the private sector. These include its clauses relating to the confidentiality of patient 16 H information , and to the enforcement of the Act Part 7 also includes the Act's regulation making powers18. The proposed regulations are to be made in exercise of those powers. \0 S. 85. Ss. 88-9l. 12 S. 92. Jl S. 95A. " S. 86. " S. 110. "S. 14l. 17 Such as S. 147 which sets out the powers of authorised officers. " S. 158. II 7 8 CHAPTER 3 OBJECTIVE AND OVERVIEW OF PROPOSED REGULATIONS Objective The objective of the proposed regulations is to (a) provide for the safety and quality of care of patients receiving health services in private hospitals and day procedure centres; and prescribe fees, forms and other matters required to be prescribed under the Health Services Act 1988 in relation to such health service establishments. (b) The proposed regulations replace the Health Services (Private Hospitals and Day Procedure Centres) Regulations 1991 ("the former regulations") which· were modelled on the even earlier Health (Private Hospitals) Regulations 1983. The former regulations were revoked on 27 January 2002. Pending finalisation of the proposed regulations, interim regulations - the Health Services (Private Hospitals and Day Procedure Centres) (Interim) Regulations 2001 - were made by the Govemor in Council late last year. The interim regulations expire on 26 September 2002. The proposed regulations follow an extensive review of the former regulations to determine whether, and to what extent, they continue to be relevant to the private hospital industry today. The review included consideration of the recommendations of the Duckett Review mentioned in Chapter 1, the Government response to those recommendations, and a number of issues raised by stakeholders19. As a result of this review, it is proposed to retain the fundamental character of the former regulations. However, a number of obsolete or unnecessary requirements will be omitted, and some new initiatives introduced to give effect to the Government's commitment to achieving equivalent minimum standards of 20 safety in both the public and private hospital sectors • The opportunity is also being taken to present the new regulatory requirements in a more logical and easier to understand form. Outline of proposed regulations ]9 These include an initial discussion group meeting convened by the Department on 28 March 2000 and matters raised by proprietors in correspondence with the Department. 20 Heal th Services Policy Final Report - Government Response. 9 The proposed regulations are divided into 15 Parts as follows: Part 1 Part 2 contains the preliminary provisions. prescribes "health services of a prescribed kind or kinds" for the purposes of the definitions of "private hospital" and "day procedure centre" in section 3 of the Act. prescribes the various forms of application which can be made under the Act and fees payable to the Department. requires the proprietor of a private hospital or day procedure centre to notify the Secretary if he or she appoints a Director of Nursing, Chief Executive Officer or Medical Director, if such an appointment is terminated, or if the position becomes vacant. deals with the admission of patients to private hospitals and day procedure centres. Proprietors are required to ensure that unit record numbers are allocated to patients and that, on or before admission, a patient is given information about his or her rights and the fees to be charged. Other regulations require the creation of a clinical record for each patient, and deal with the identification of patients and neonates. contains provisions relating to the care of patients. They require proprietors to ensure that patients are treated with dignity and respect, are entitled to privacy and are not subject to unusual routines. The regulations also require proprietors to ensure that a sufficient number of appropriately educated or experienced nursing and other health professional staff is on duty and that the needs of patients are met promptly and effectively. requires proprietors of private hospitals and day procedure centres to establish a mechanism for dealing with complaints made by, or on behalf of, patients. deals with the transfer and discharge of patients from a private hospital or day procedure centre. prescribes the various registers and records private hospitals and day procedure centres must keep. Part 3 Part 4 Part 5 Part 6 Part 7 Part 8 Part 9 Part 10 contains regulations requiring rooms in private hospitals and day procedure centres to be properly identified, an effective electronic communication system to be installed, and a device fitled to prevent the scalding of patients. Other regulations require the premises to be kept in a clean and hygienic 10 condition and equipment to be suitable, clean and kept in a proper state of repair. Part 11 requires proprietors of private hospitals and day procedure centres to develop and implement an Infection Control Management Plan. Part 12 requires the certificate of registration (or a copy), the names of senior staff, and the name of the complaints liaison officer to be displayed at the entrance foyer or reception area of the private hospital or day procedure centre. Part 13 requires proprietors of private hospitals and day procedure centres to provide certain statistical information to the Secretary. Part 14 prescribes the form of the Notice of Seizure for the purposes of the Act. Part 15 contains a transitional provision. Comparison of proposed and former regulations The following table sets out the main issues addressed in the proposed regulations and indicates differences between the proposed and the former regulations. REQUIREMENT FORMER REGULATIONS PROPOSED REGULATIONS Admission of patients Patients to be advised of medical condition and any proposed treatment, Patients to be given statement of rights. information about fees to be investigation or procedure and likely costs. charged and out of pocket expenses and a clear explanation of services La Transfer and Discharge of patients Unit record number to be allocated. Transfer form to be sent with patient if transferred to another establishment Of agency. be prOl,ded. Similar requirement. Relevant information and documents to enable ongoing treatment and care No equivalent. to be sent with patient. On discharge. patient to be advised of recommendations and arrangements made for his or her future health care needs. tl Rights of patients Patients to be treated with dignity and respect, with regard to their entitlement to privacy and not subject to Similar requirement except unusual routines. Identification of patients Patients to be identified by arm bands. Staff Nursing staff to be registered and professionally qualified. Minimum nurse/patient ratios to be 1:10 for day and evening shifts (and in DPC's) and 1:15 for night shifts. that respect of religious beliefs has been included and references 10 taking of property and release of information (covered by section 141 of the Act) omitted. Patients to be identified by identity band or photograph. Two identity bands required in the case of neonates. Similar requirement. Sufficient nursing and other health professional staff to be on duty to care for Complaints No equivalent. Infection control No equivalent. patients. Needs of patients to be met promptly and effectively by appropriately qualified or skilled staff. System for dealing with patient complaints to be established. Infection Control Management Plan to be developed and implemented. Registers and records The following registers and records to be kept (a) Patient Admission and Discharge Register; (b) Operalion Theatre Register; (a) similar requirement; (b) similar requirement; (c) similar requirement; (d) similar requirement [excepl title has been changed to "clinical record'1; (e) no equivalent; (I) no equivalent; (g) similar requirement. (c) (d) Birth Register; patient's medical record; Facilities staff roster; record of patient's nursing needs; (g) register of nursing and olher staff responsible for care and treatment of patients. Equipment, facilities and premises to be kept in a proper state of repair. Rooms to be identified. (e) (n Similar requirement. Similar requirement. Similar requirement. Similar requirement. Electronic communication system to be installed. Hot waler control device to be installed. Cleaning materials and other chemicals to be securely stored and labelled. No equivalent. 12 Other Certificate of registration to be prominently displayed. No equivalent. Similar requirement [but a copy may be displayed in lieu of original]. Name of complaints officer, and, if appointed, Director of Nursing, Chief Executive Officer and/or Medical Director to be prominently displayed. Copy of Act and regulations to be kept available. Statistical returns to be No equivalent. Returns to be provided provided on a monthly and on a quarterly basis. Director of Nursing, or in his or monthly. No equivalent. her absence, an Acting Director, to be appointed. Secretary to be advised of Similar requirement. appointment of DON. Secretary to be notified if a Chief Executive Officer or Medical Director is appointed. Similar requirement. Patient Records A number of provisions in the former regulations relating to the keeping of patient records appear not to have an equivalent in the proposed regulations. This has been done intentionally so that, wherever possible, the keeping of such records are fully regulated by the Health Records Act 2001. 13 14 CHAPTER 4 IMPACT OF THE PROPOSED REGULATIONS AND ASSUMPTIONS The Health Services Act, as it applies to private hospitals and day procedure centres, makes the proprietors of such establishments responsible for compliance with its provisions. It, therefore, follows that the proposed regulations impact most directly on the proprietors of the 76 private hospitals, 13 bush nursing hospitals and 53 day procedure centres currently registered with the Department of Human Services. Private hospitals fall into one of two broad groups. The first is the "private enterprise hospital". These are private hospitals run for profit such as the chain operated by Mayne Health. The second is the "not-far-profit hospital". The "not-far-profits" consist of • • bush nursing hospitals; and hospitals run by, or under the auspices of, religious or charitable organizations. Examples of bush nursing hospitals are the Balian & District Soldiers' Memorial Bush Nursing and the Euroa Hospital. The "not-far-profits" include Epworth, Freemasons, St John of God, St Vincent's Private and St Francis Xavier Cabrini. As well as private hospitals, the regulations impact on the proprietors of day procedure centres. Day procedure centres, unlike private hospitals, are mainly owner operated. The major difference between a day procedure centre and a private hospital is that patients admitted to the former expect to discharged on the same date they are admitted while patients admitted to the latter are normally accommodated ovemight. None of the top 5 private hospital chains owns a free standing day procedure 21 centre but all conduct private hospitals with day procedure beds • Day procedure beds within a private hospital are not registered separately by the Department but, rather, are encompassed by the facility's private hospital registration. 21 Health Services Policy Review Discussion Paper. Department of Human Services, March 1999, page 76. 15 Assumptions Nationally, the private hospital sector treated 2.15 million admitted patients during 1999/2000, provided 6.2 million days of hospitalisation to those patients, performed 1.74 million surgical, obstetric and other procedures, employed 44,600 (full time equivalent) staff, earned $4,204 million in revenue, spent $3,957 million for recurrent purposes and invested $342 million in buildings and 22 other capital assets . For the purposes of this Regulatory Impact Statement, it has been assumed that, in Victoria, (a) an average of 580,000 patients are admitted to private hospitals and day procedure centres each year; the average length of stay for all patients (same day and overnight) is 3.4 days; and the average expenditure per patient day is $609 23 • (b) (c) (d) and the average salary of adults employed in the health and 24 community sector is $838.90 per week or ($21 per hour based on a 40 hour week). Australian Bureau of Stat is lies July 200 I 4390.0 Private Hospitals 1999-2000. This and the preceding figures are based on figures published by the Australian Bureau of Statistics in July 2001 entitled Private Hospitals 1999-2000 Cala/ogue No4390.0. 24 Employee earnings and hours published by the Australian Bureau of Statistics, August, 2001, Average Weekly Earnings: Australia; Catalogue No. 6302.00. 22 21 16 CHAPTERS PRESCRIBED KINDS OF HEALTH SERVICE (REGULATIONS 6 AND 7) Regulations 6 and 7 are key provisions in the proposed regulations. They prescribe "health services of a prescribed kind or kinds" for the purposes of the definitions of "private hospital" and "day procedure centre" in section 3 of the Act. The way in which such services are prescribed is fundamental in determining how the Act is applied. A new list of prescribed health services was introduced by the interim regulations and the list in the proposed regulations is almost identical. However, while the new list was circulated to the industry at the time the interim regulations were made, the reasons for the new list were not set out in any detail. In the circumstances, the opportunity of this Regulatory Impact Statement is being taken to explain publicly why the new list is considered necessary. The expression "health services of a prescribed kind or kinds" (or variants) appears 13 times in the Act. It is used twice in section 3, once in section 5, and ten times in Part 4 - twice in section 70(1)(c), twice in section 73(c), twice in section 85, twice in section 92(2), and twice in section 95. Although Parliament uses similar language in all of these provisions, the regulations prescribing "health services of a prescribed kind or kinds" have, in fact, to serve two purposes. This leads to a regulatory dilemma. The first and principal reason for prescribing "kind or kinds of health service" is to identify what kinds of health care should be regulated under the Act. For instance, "private hospital" is defined In section 3 of the Act as being premises where persons are provided with health services of a prescribed kind or kinds and for which a charge is made and includes a privately-operated hospital but does not include - (a) (b) (c) a public hospital or denominational hospital; or a day procedure centre; or a residential care service. (emphasis added) t7 Thus, provided a charge is made for the service, the effect of prescribing a health service for the purpose of the definition is to bring within the scope of the Act any facility at which that service is provided. However, the prescribing of a health service has to serve a second function. Under section 85 of the Act, the Secretary is required to state on a certificate of registration "the kinds of prescribed health services that may be carried on on the premises". This is an important provision because it is an offence under the 5 Ad for the proprietor to provide any kind of prescribed health service for which the private hospital or day procedure centre facility has not been registered. It follows that the health services prescribed must encompass all the services which can legitimately be provided by private hospitals or day procedure centres in Victoria. The dilemma which arises in prescribing "health services of a prescribed kind or kinds" is that the needs of section 3 and those of section 85 are not necessarily compatible. This can be illustrated at its most basic by the case of "medical health services". Virtually every private hospital in Victoria provides medical health services and, obviously, "medical health services" has to be a health service prescribed under the Act. But an undesirable side effect of just prescribing "medical health services" is that most medical practices in Victoria would then become registrable with the Secretary. This happens because most medical practices provide medical health services for which they charge fees and, therefore, would fall within the ambit of the definition of "private hospital" (or the definition of "day procedure centre") in section 3 of the Act. Clearly, it was never the intention of Parliament that the Act apply to traditional medical practices and, therefore, the way in which kind or kinds of health service is prescribed is crucial to ensuring that the Act only attracts those facilities the Parliament originally intended to regulate. The regulatory dilemma was obviously recognised when the former regulations were drafted more than a decade ago. They attempt to resolve the dilemma by prescribing health services in terms of descriptors. 2~ section 113(a). 18 Schedule 8 to the former regulations, for instance, prescribes kinds of health service for private hospitals in the following way: Service 1. Medical Description The provision of clinical services by a medical practitioner related to the diagnosis and non~opcrative treatment of ill health ofa patient and the provision of nursing supervision and/or care ofa patient. This may include endoscopy, The provision of clinical services by a medical practitioner to a patient 2. Surgical which require(i) the use of surgical instruments; and (ii) the use of an operating room; and (iii) nursing supervision and/or care of a natient. 3. Obstetrics 4. Emergency Medicine 5. Coronary Care 6. Intensive Care 7. Radiation Oncology 8. Organ Transplantation 9. Infertility Treatment 10. Psychiatric 11. Specialist Rehabilitation The provision of clinical services by a medical practitioner and the provision of nursing services by a suitably qualified nurse to a patient which is directlv related to the Dfocess of nrel!nancv and/or childbirth. The provision of clinical services by a medical practitioner in a discrete area ofa private hospital which is directly related to the care of persons requiring ument medical care for anv reason. The provision of relevant clinical services in a discrete area ofa private hospital which has appropriately qualified staff and is equipped for the care of Datients sufferinl! from acute coronarY disease and/or dvsrhvthmias. The provision of relevant clinical services in a discrete area ofa private hospital which has appropriately qualified staff and is equipped for the care of critically ill, injured and/or post~operative patients who have a high likelihood of requiring mechanical assistance with respiration and/or the function of other or~an systems. The provision of relevant clinical services in a discrete area of a private hospital which has appropriately qualified staff and is equipped for the provision of radiation therapy for the treatment of certain, usually malignant. medical conditions. The provision of clinical services which involve the transplantation of onc or more human organs from one human being to another. The provision by a rcgistered medical practitioner of services of the kind defined as a treatment procedure in the Inrertilitv Treatment Act 1995. The provision of clinical services in a private hospital which require the supervision of a psychiatrist and which has appropriately qualified staff and is equipped for the care of patients suffering from acute and/or chronic mental illness. The provision of relevant clinical services in a discrete area ofa private hospital which has appropriately qualified staff and is equipped for the treatment of patients requiring intensive rehabilitation from illness and/or injury and requiring the overall supervision ofa medical practitioner with relevant and aODfoDfiate exoerience in rehabilitation medicine. The problem with descriptors is that they are limiting and can be, and sometimes are, construed as describing the way in which a particular kind of health service should be delivered. Moreover, descriptors are relatively inflexible and doubts have been raised whether or not a number of services uncommon a decade ago are captured by the above descriptors. 19 Some of these services, such as liposuction and cosmetic surgery, have been the subject of complaints to the Health Services Commissione,.z6 and the 27 Medical Practice Board and have generated concerns in the literature and the 28 media . These procedures all involve a significant degree of risk to patients and there should be no doubts that health care facilities at which these services are provided fall within the scope of the Act. A number of alternative methods of prescribing kind or kinds of health service have been explored in an effort to avoid, or at least minimise, the effect of the dilemma created by the wording of the current legislation. These include linkages with Medicare item numbers, the incorporation of references to anaesthesia and sedation, and the possibility of adapting Australian and overseas standards. However, for various reasons, none of these alternatives adequately resolve the dilemma and, more often than not, create problems of their own. After a great deal of consideration, it is proposed to deal with the dilemma by prescribing only 3 kinds of health service. These are• • • medical health services; surgical health services; and speciality health services. There will be a number of speciality health services. These areCardiac services; Emergency medicine; Endoscopy; Infertility treatment; Intensive care'; Mental health services; Neonatal services'; Obstetrics; Oncology (chemotherapy); Oncology (radiation therapy); Renal dialysis; and Specialist rehabilitation services. 'private hospitals only 17 Press release Annual Report Health Services Commissioner 1998/99 pp. 11-16. Rao B., Ely S. F. and Hoffman R. S. 1999 Deaths related to liposllction, The New England Journal of Medicine, Vol 340, No. 19 May 13 1999; Hoeyberghs 1. L. 1999 Clinical review: Cosmetic surgely. 8MJ Vo1318, 20 February 1999. 2M Gibson R. When plastic surgelY goes wrong, The Age, Wednesday 10 November 1999. 26 20 The crucial difference between the former regulations and the proposed regulations is that, rather than relying on descriptors, each of the 3 proposed kinds of health service will be defined by risk-based criteria . "Surgical hea~h services", for instance, will mean - health services provided by a registered medical practitioner that (a) involve (i) (ii) the use of surgical instruments; and the use of an operating theatre , procedure room or trea tment room ; and (b) require either (i) (ii) the attendance of one or more other registered health care practitioners: or post operative observation of the patient by nursing staff. It is intended that, by applying the criteria in the definitions of the various kinds of prescribed health service, it will be possible to readily determine whether the risk involved in undertaking a particular procedure is such that it should only be carried out in a properly equipped and registered facility. The proposed regulations are not the perfect solution to the dilemma posed by the wording of the Act (this would require the passage of amending legislation). Nevertheless, it is considered that they are viable and a realistic way of giving effect to the intentions of the enabling legislation. 2t 22 CHAPTER 6 APPLICATION FORMS AND FEES (REGULATIONS 8-13) Part 4 of the Act makes provision for making various applications to the Secretary. These are for(a) (b) approval in principle (section 70(2); variation or transfer of certificate of approval in principle (section 74); registration (section 82(2); renewal of registration (section 88(2); transfer of registration (section 92(2); any other variation of registration (section 92(2) - (c) (d) (e) (f) of a private hospital or day procedure centre. Applications under the Act "must be in the prescribed form". These forms are prescribed by regulations 8 to 12 (inclusive). Application Fees As well as requiring that applications be made in the prescribed form, the provisions of the Act mentioned above require applications to be accompanied by "the prescribed fee". The fees will also be prescribed by regulations 8 to 12. The application fees currently payable to the Secretary were originally fixed in 29 3 1991 and have only been adjusted once (in 1996 °). Department of Treasury and Finance guidelines require Departments and budget sector agencies to set all user-pay type fees and charges "to recover the full cost of the product or service provided to users, unless there are explicit policy or public good reasons for not doing SO,,31 (underlining in the original). By the Health Services (Private Hospitals and Day Procedure Centres) (Fees) Regulations 1991. Health Services (Private Hospitals and Day Procedure Centres) (Amendment) Regulations 1996 . . Guidelines/or Setting Fees and Charges Imposed by Department') alld Budget Sec/or Agencies, \1 2000-01. published by the Department of Treasury and Finance, p. 3. N In 23 The fees fixed in 1991 were intended to fully recover the costs of processing applications by the (then) Health Department of Victoria. It was foreshadowed at the time that they would be adjusted each year to take account of changes in the Consumer Price Inde,(l2. No such adjustments were actually made apart from the one CPI adjustment in 1996. As a result, revenue derived from fees has not maintained parity with the actual costs of processing applications by the Department. This can be illustrated in the following table which shows current fees and the actual costs associated with the processing of each type of application. TYPE OF APPLICA TION Approval in principle Variation of approval in principle Transfer of approval in principle Reg istration Transfer of registration Any olher variation of registration Renewal of registration CURRENT FEE ACTUAL COSTS $504 $126 $126 $441 $378 $126 $504 $1,327.81 $601.14 $287.85 $564.83 $801.11 $354.14 $555.36 A breakdown of the costings is attached to this Regulatory Impact Statement (Attachment A). Most fees would increase substantially if full cost recovery were introduced. The fee for an approval in principle, for instance, would jump from $504 to $1328 - more than 2Y:. times. However, apart from recovering the cost of dealing with each kind of application, other factors can be taken into account in the process of fee setting. In situations where there are both direct and indirect beneficiaries (as in the case of private hospitals and day procedure centres), these include the impact the fees might have on the provision of services and their flow on effects to the community'l3 . There is no doubt that the nature of some of the increases necessary if full cost recovery was pursued would have a detrimental effect on the industry and particularly the smaller operators and the not-for-profit hospitals. Regulatory lmpact Statement- Health Services (Private Hospitals and Day Procedure Centres) Regulations 1990 (page 17). H Office of Regulation Reform: Regulatory Impact Statement Handbook, p.33. )2 24 In the circumstances, two alternatives have been considered. The first is to adjust fees by the "approved rate". The second is to increase fees at a rate somewhere between the approved rate and full cost recovery. Approved rate The first alternative is to increase fees by the "approved rate". This is the rate by which fees can be adjusted each year without a regulatory impact statement. 34 The rate is approved by the Treasurer . The annual rates approved since the last fee increase in 1996 were1997/1998 1998/1999 1999/2000 2000/2001 2001/2002 5% 5% 3.5% 2.5% 2.5% If the fees prescribed in 1 996 had been adjusted each year by the approved rate, they would now be at the level shaded in the final column of the table. 1997-98 Current fee 1998-99 1999-2000 2000-2001 2001-2002 +5% +5% +3.5% +2.5% +2.5% Application for approval in principle $504 $529.20 I $555.66 $575.11 I $589.49 Application for variation or transfer of an approval in principle $126 $132.30 I $138.92 $143.78 I $147.37 Application for reoistration $441 $463.05 I $486.20 $503.22 I $515.80 Application for renewal of reqistration $504 $529.20 $575.11 I $589.49 1$555.66 Application for transfer of registration $378 1$396.90 I $$416.75 $431.33 I $442.11 Application for anv other variation of reqistration $126 I $132.30 I $138.92 $143.78 I $147.37 The effective increase in fees under this option would be about 20%. $604.22 $151.06 $528.70 $604.22 $453.17 $151.06 Alternative rate The second alternative is to adjust fees to a level which would recover a greater proportion of the costs associated with processing applications. The rate chosen is a nominal 30%. Under this alternative, the proposed fees for each kind of application would becomesee section 8 of the Subordinate Legislation Act 1994. 34 2S Application for approval in principle - $655 Application for variation of approval in principle - $164 Application for transfer of approval in principle - $164 Application for registration - $573 Application for renewal of registration - $655 Application for transfer of registration - $491 Application for any other variation of registration - $164 Summary The effect of these two alternatives can be seen frorn the following table: Current Fee Actual Costs Increase by Approved Rate Increase by 30% Application for Approval in principle $504 $1328 $604 Application for variation of approval in principle $126 $601 $151 Application for transfer of approval in principle $151 $$126 $287 Application for registration $441 $564 $528 Application for renewal of registration 1$555 $504 $604 Application for transfer of registration $378 1$801 $453 Application for any other variation of registration $151 $126 1$354 1$655 $164 $164 $573 $655 $491 $164 Proposal The proposed fee increase of 30% represents a higher rate of cost recovery than an increase by the approved rate and, in the circurnstances, this option has been adopted. The effect is that fees will be adjusted by about 30% (rounded to the nearest $5) or to the actual cost of providing the service, whichever is the less. The proposed fees are shown shaded in the following table KIND OF APPLICA TION Approval in principle Variation of approval in principle Transfer of approval in CURRENT FEE PROPOSED FEE APPROX. INCREASE $504 $126 $126 $655 $165 $165 29.96% 30.95% 30.95% 26 principle Registration Renewal of registration Transfer of registration $441 $504 $378 $126 $565 $555 $490 $165 28.11% 10.00% 29.62% 30.95% Any other variation of registration About $57,000 will be raised from the new fees in an average year. This represents a recovery rate from the industry of about 85% of the actual costs of processing applications. Details of anticipated revenue are set out in the following table: Type off•• Approvals in principle Variation of AlP Transfer of AlP Registration Renewal of registration Transfer of reqistration Variation of reqistration TOTAL Number Proposed Fee Anticipated Revenue 15 1 1 5 70 5 15 $655 $165 $165 $565 $555 $490 $165 $9,825 $1 65 $165 $2.825 $38.850 $2.450 $2,475 $56,755 Comparisons with other States are difficult to make because fee structures in each jurisdiction are different. However, the fee for an application for registration does have a parallel in New South Wales. Under that State's Private Hospitals Regulation, the fee for an application for registration is $615. It can be seen that the equivalent fee of $565 proposed in Victoria is comparable. Annual Fee As well as fees for applications, proprietors of private hospitals and day procedure centres registered in Victoria are required by section 87 of the Act to pay "the prescribed annual fee" to the Secretary. The annual fee is payable not later than 7 days after the date of issue, or date of renewal, of a certificate of registration. Regulation 13 prescribes the annual fee. Annual fees are intended to generate sufficient revenue to offset the costs of the support services provided to the industry not otherwise recovered from application fees. These include the cost of the Department's monitoring and inspection services, enforcement, policy development, service planning and the enhancement of information systems. 27 The actual cost of maintaining the Private Hospitals Unit of the Service Development Branch of the Metropolitan Health and Aged Care Services Division of the Department over the last financial year (2000 - 2001) was: (a) (b Salaries On costs (20%) TOTAL $349,987 $69,997 $419,984 The cost of processing the various applications mentioned earlier is about $65,000 each year of which just under $57,000 will be recovered from the proposed new application fees. If the $65,000 cost of processing applications is discounted, the amount required to fully fund the Private Hospitals Unit would be in the order of $355,000. About $89,000 is collected in annual fees each year. This leaves a shortfall of about $265,000. To fully recover costs, the average fee payable by each private hospital and day procedure centre in Victoria would jump from about $635 to about $2535. A 400% increase is not considered conscionable bearing in mind the potential impact on the industry and consumers, and especially the effect on not-far-profit agencies. On the other hand, it is not unreasonable to expect the industry to make a more realistic contribution to the costs of the services provided by the Department. With this in mind, It is proposed to adjust annual fees to recover from the industry about 30% of the costs of the Private Hospitals Unit. Two ways of achieving this objective have been considered. The first is to increase current fees sufficiently to generate the necessary additional revenue. The second is to restructure the way fees are fixed. The annual fee currently payable by private hospitals and day procedure centres in Victoria is fixed at $477 .50 plus $3.15 for each bed for which the hospital or centre is registered. As in the case of application fees, the annual fee was last revised in 1996. If the annual fee had been adjusted each year by the approved rate discussed earlier in this Chapter, the present fee would be the amount shaded at the bottom of the right hand column - 11997-98 11998-99 11999-2000 1 2000-2001 1 2001-2002 28 Current fee $477.50 + $3.15 per bed +5% $501.37 + $3.31 per bed +5% $526.44 + $3.47 per bed +3.5% $544.86 + $3.59 per bed +2.5% $558.48 + $3.68 per bed +2.5% $572.45 + $3.78 per bed The revenue generated (in round figures) would be: 140 (say) private hospitals and DPe's @ $572.45 = 7336 beds @ $3.78 TOTAL = $80,143 $27,704 $107,847 This would meet the objective of recovering about 30% of the costs of the Private Hospitals Unit. However, another way of achieving the same objective is to restructure the way fees are fixed. This option envisages the introduction of a sliding scale of fees calculated according to size of the institution. Fees proposed under this scenario would be: 501 + The annual revenue raised from this option would be about $112,000 or about 31 % of the costs of the Private Hospitals Unit (excluding application processing). A sliding scale of fees has several advantages over the current regime of a flat fee plus an additional fee per bed. Firstly, a sliding scate of fees better represents the amount of work involved in undertaking inspections of, and providing support services to, facilities of roughly comparable size. Secondly, a sliding scale also does not have the appearance of being a "bed tax" and, therefore, should be less likely to act as a disincentive to the provision of the optimum number of beds in the industry. 29 Finally, the proposed sliding scale will make annual fees more straightforward and transparent and much easier to calculate than the existing flat fee/fee per bed system under which fees have to be calculated individually for each facility. Sliding scales of fees are not novel. For instance, the Health (Private Hospitals) Regulations 1983, which were the precursor to the former regulations, prescribed a sliding scale of fees for the registration or renewal of registration of a private hospital as followsUp to 10 beds 11 to 35 beds 36 to 100 beds 101 beds and over $110 $165 $275 $550 (Note: no annual fee was prescribed as annual fees were not required under the (now repealed) provisions of the Health Act 1958.) Likewise, a sliding scale of annual fees exists in New South Wales. In that State the prescribed annual fees" are: Number of persons licensed to be accommodated Fee $1,130 $1,570 $2,020 $2,470 $2,945 $3375 $3,810 $4270 Less than 40 40-49 50-59 60-69 70-79 80-89 90-99 More than 100 It can be seen from the above table that the annual fees proposed in Victoria are not unreasonable in comparison to those prescribed for facilities of a comparable size in New South Wales. H Regulation 9 of the NSW Private Hospital Regulation 1996. 30 CHAPTER 7 SENIOR APPOINTMENTS (REGULATIONS 14 AND 15) Proposed regulations 14 and 15 require the proprietor of a private hospital or day procedure centre to notify the Secretary if he or she(a) appoints a(i) (ii) (iii) (b) Director of Nursing; Chief Executive Officer; or Medical Director; or terminates the appointment of a Director of Nursing, Chief Executive Officer or Medical Director, or if such a position otherwise becomes vacant. Notice of an appointment must be in writing and include the name, qualifications and experience of the appointee. Proposed regulations 14 and 15 replace regulations 501 - 506 (inclusive) of the former regulations. Under those regulations, proprietors of private hospitals and day procedure centres • must appoint a Director of Nursing and an Acting Director during any prolonged absence of the Director; and may appoint a Chief Executive Officer or Medical Director. • The rationale underpinning proposed regulations 14 and 15 is that the regulations should not dictate to a proprietor the nature of the management structure of his or her facility. Thus, the proposed regulations do not require proprietors to appoint a Director or Acting Director of Nursing, Chief Executive Officer, or Medical Director. However, if such an appointment is made, the regulations oblige the proprietor to fumish the Secretary with the name, qualifications and experience of the appointee to the Secretary. Likewise, the Secretary must be notified if such an appointment is terminated or a position becomes vacant. Other than requiring notifications to be in writing, the proposed regulations are silent as to the way in which they are to be met. This is deliberate. It is intended that a simple letter or email containing the requisite information would be sufficient to satisfy its requirements. 31 The turnover of senior staff at private hospitals or day procedure centres is not high and the cost of notifying the Secretary of the occasional changes which occur in the senior management of a private hospital or day procedure centre should be insignificant. The benefit of the proposed regulation is that it will enable the Department to maintain a record of key staff in the private hospital industry. This is necessary for several reasons. First, it assists the Department in determining whether quality health services are being provided at a particular health service establishment. Indeed, one of the criteria in the Act for determining whether or not a health service establishment should be registered by the Secretary iswhether the proposed arrangements for the management and staff of the establishment are suitable 36 . Second, it facilitates communication between the Department and the industry. From time to time, officers of the Department need to talk to senior staff of a private hospital or day procedure centre (e.g. about rectifying a defect identified during an inspection or resolving a patient complaint) and an ability to contact the person with direct responsibility for the matter makes it a great deal easier to settle issues as they arise. l6 Section 83(1 )(h). 32 CHAPTER 8 ADMISSION OF PATIENTS (REGULATIONS 16-21) Proposed regulations 16, 17 18, 19, 20, and 21 deal with the admission of patients to private hospitals and day procedure centres. Unit record numbers Regulation 16 requires the proprietor of a private hospital or day procedure centre to ensure that a unit record number is allocated to a patient on admission or as soon as possible thereafter. Unit record numbers are a way of namelessly identifying patients. They are used principally for the purposes of data collection because they enable a great deal of information to be collected about the admission and discharge of patients, their diagnosis and the type of care provided without breaching patient confidentiality. The former regulations required private hospitals and day procedure centres to provide certain statistical information to the Department. A similar requirement is included in the proposed regulations. However, while the allocation of unit record numbers was not expressly required by the former regulations, such an obligation was inferred of necessity because of the references to unit record numbers which appear throughout those regulations. Examples include regulation 402 which requires unit record numbers to be entered into the Admission and Discharge Register and regulation 410 which requires unit numbers to be included in patients' medical records. With this in mind, the opportunity of the proposed regulations is being taken to include an express, rather than implied, provision requiring proprietors to allocate a unit record number on admission of a patient. No significant costs are expected to be incurred by the industry. Information to be given to patients Regulation 17(1) will require each patient to be given • a statement of his or her rights relating to the health services to be provided; 33 • information about the fees to be charged by the private hospital or day procedure centre (and any out of pocket expenses which the patient may incur): and a clear explanation of the treatment and services to be provided - • before or at the time of admission to the private hospital or day procedure centre. The proposed regulation replaces former regulation 301 (1) which requires proprietors to ensure that patients are provided wilh information aboul the nalure of lheir medical condition and any proposed treatment, investigation or procedure and the likely costs of the treatment, investigation or procedure. Former regulation 301(1) was the subject of a great deal of debate when the Regulatory Impact Statement in support of the former regulations was published in 1991. A number of responses argued that the regulation was inappropriate because it should be the responsibility of the admitting or treating doctor, and not that of the proprietor, to provide a patient with information about his or her condition and the costs of any treatment. These criticisms have been ta ken into account in the drafting of proposed regulation 17. In lieu, it will only oblige proprietors to provide patients with information which clearly should be in their possession. The first of these requirements - that proprietors provide their patients with a statement of rights - is novel. It is being introduced partly to counterbalance the problem of information asymmetry discussed in Chapter 1 and partly to reflect the objectives of the Health Services Act. It will be recalled that these, among other things, are to make provision to ensure thatusers of healLh services are provided with sufficient information in appropriate forms and languages 10 make informed decisions about health care37 The matters to be included in a statement of rights are listed in proposed regulation 17(2). While the actual form of the statement is left to the discretion of the proprietor, proposed regulation 17 has been framed on the premise that most proprietors will give their patients a copy of the Private Patients' Hospital Charter 3 published by the Commonwealth •. This publication explains the basic rights and entitlements of patients receiving private hospital care. )7 3lt Section 9(c). The Charter can be accessed on the Internet at www.health.gov.au.!privatehealth/consumer.htm 34 Copies of the Charter are available from the Commonwealth Department of Health and Aged Care free of charge and, consequently, there should be lillie, if any, costs incurred in providing a copy of the Charter to each patient. Proposed regulation 17(1)(b) goes on to require proprietors to ensure that, on or before admission, patients are given information about the fees to be charged and any likely out of pocket expenses that patients may incur. This requirement parallels similar requirements on health funds under the National Health Act 1953. Obviously, it is in the interests of both proprietors and patients that there should be no doubts about the financial commitments which a patient will incur on admission to a private hospital or day procedure facility. Proprietors, of course, will have a scale of fees and charges for their services and should also be aware what fees and charges will (or will not) be covered by insurance especially if the hospital or centre has a purchaser-provider agreement with the patient's health fund. Consequently, the provision of this information to patients should not involve proprietors in any significant costs. Information about fees and charges is important to a patient especially if he or she is uninsured, or only partly insured. The provision of information of this nature will not only help a patient make informed choices about his or her health care but also help avoid potential misunderstandings about any financial liabilities being incurred. Proposed regulation 17(1)(c) will also require proprietors to ensure that, on admission, patients are given a clear explanation of the treatment and services to be provided to the patient at the hospital or centre. Again, this information should be readily available to proprietors of private hospitals and day procedure centres and should already be given to patients as part of the admission process. Any costs associated with compliance with the proposed regulation should also be negligible. Clinical records Regulation 18 requires a separate clinical record to be created for each patient admilled to a private hospital or day procedure centre. Regulation 19 prescribes the basic information which each clinical record must contain . Essentially, regulations 18 and 19 remake former regulation 410. 35 Clinical records are commercially available in packs of 100 for $14 (Le. 14 cents each) and it is estimated that an average clinical record runs to about 15 pages per patient. On this basis, it is estimated that the cost of purchasing clinical records each year would be in the order of $1,218,000 (Le. 580,000 patients x $0.14 x 15). There are also some labour costs associated with the keeping of clinical records. On the assumption that about 45 minutes of professional and administrative staff time is required to initiate a clinical record at the time of admission and about 15 minutes is spent each day maintaining a patient's clinical record, labour costs would be(a) admission 580,000 patients x 45 minutes @ $21 per hour = $9,135,000. (b) ongoing maintenance 580,000 patients x 3.4 days x ';:I hour@ $21 per hour = $10,353,000. The total costs of compliance would, therefore, beMaterials Labour TOTAL $1218000 $19488000 $20706000 A good clinical record documents the needs of, and the care provided to, a patient during his or her stay in a private hospital or day procedure centre. It facilitates communication between members of the health care team by recording what was done, why and how, and enables other professional health carers to assume responsibility for the care of the patient. It is, therefore, important that private hospitals and day procedure centres keep good clinical records and that the information they contain is meaningful and apposite to the health care services being received by a patient. Even without the proposed regulation, it is expected that private hospitals and day procedure centres would keep at least a basic form of patient record. However, the benefit of the proposed regulation is that it clearly sets out the essential information which patient records should include. Identification of patients Regulations 20 and 21 deal with the identification of patients and neonates. 36 It has been a requirement of Victorian regulations for many years that a patient admitted to a private hospital be identified by an identity band attached to his or her wrist or ankle. This fundamental requirement will be continued into the proposed regulations. However, in the case of neonates, the regulations specify that 2 identity bands be attached (rather than 1 as at present). This change is being introduced in the light of field experience and is intended to ensure that a neonate can still be identified despite the loss of one of its identity bands. Identity bands are inexpensive and a box of 500 costs in the vicinity of $80 (i.e. about 16 cents each). On the assumption that 3 identity bands are used for each patient stay, the estimated cost to the industry over a year would be $278,400 (i.e. 580,000 patients x $0.16 x 3). As an alternative to identity bands, the proposed regulations will permit patients to be identified by means of a photograph. Advice from a 45 bed private hospital which has trialled photographic identification is that its costs are as follows: (a) (b) initial purchase of a Polaroid camera - $400 cost of Polaroid film - $50 per annum. The proper identification of patients in a private hospital or day procedure centre is crucial. Unless a patient (and in the case of a birth, the neonate) can be readily and correctly identified by staff, there is a danger that he or she may be given inappropriate care, treatment or medication or even the wrong procedure undertaken. Mistakes in identification do occur and proper identification is important especially when patients are sedated or unconscious or otherwise unable to communicate. In such cases, it is vital to the treating team that there be no doubts about the identity of the person they are treating, the nature of his or her condition and the treatment which has been given. The traditional method of identifying patients (and babies born in obstetric wards) is by affixing an identity band to an arm or foot. It is expected that this will be the principal way in which both patients and neonates will be identified for the foreseeable future. However, the alternative of photographic identification is expected to be more appropriate in some situations. 37 It has proved particularly effective in situations where there are high levels of casual nursing staff and in facilitating the identification by police or emergency care workers of a patient who has strayed especially if the patient is confused or unconscious. 38 CHAPTER 9 CARE OF PATIENTS (REGULATIONS 22 - 25) Proposed regulations 22, 23, 24 and 25 deal with the care of patients following their admission to a private hospital or day procedure centre. Respect, dignity and privacy Under proposed regulation 22, the proprietor of a private hospital or day procedure centre must ensure that patients are treated with dignity, and with due regard to their religious beliefs, and ethnic and cultural practices. A patient will be entitled to privacy and must not be subject to unusual routines. This, essentially, mirrors former regulation 301 (2). Proposed regulation 22 enshrines some of the key rights to which patients are entitled while receiving health care services. Many patient rights are long established and do not need to be spelled out in legislation. For example, under the common law a patient cannot be treated without his or her consent (or, in some circumstances, unless consent is given on the patient's behalf). Likewise, a patient always has the right to discharge himself or herself from hospital at any time notwithstanding the contrary advice of his or her medical practitioner or other professional health staff. However, the right to be treated with dignity and to have one's religious beliefs respected and so on are rights which must be respected by others. These rights can be overlooked in a busy hospital environment although they should be respected as part of everyday routines. The aim of the proposed regulation is to enable the Department to act if these rights are infringed. The proposed regulation should not involve proprietors in any significant costs. Staffing Proposed regulation 23 requires proprietors of private hospitals and day procedure centres to ensure that members of the nursing staff are currently registered under the Nurses Act 1993 and competent to provide nursing care at the establishment having regard to the kind or kinds of health service being provided. Proposed regulation 24 also requires proprietors to ensure that, whenever patients are receiving health services, a sufficient number of appropriately 39 educated or experienced nursing and other health professional staff are on duty to provide care for those patients. Proposed regulation 25 obliges proprietors to ensure that the needs of patients are met promptly and effectively by staff who are appropriately qualified or skilled to meet those needs. These three regulations are designed to ensure that patients receive suitable and timely health care services. They replace regulations 507, 508 and 509 of the former regulations which require nursing staff to be currently registered and professionally qualified and prescribe various staff/patient ratios for private hospitals and day procedure centres. The concept of staff/patient ratios was introduced by the former regulations in 1991. They require proprietors to ensure that nursing staff is provided on the basis of one nurse for each 10 patients or fraction thereof in a day procedure centre and during day and evening shifts in a private hospital, and one nurse to each 15 patients in a private hospital during night shifts. The reason for introducing staff/patient ratios was explained in the supporting Regulatory Impact Statement in the following way: The minimum staffing requirements are consistent with the relevant provision in the existing regulations", the Nurses Act 1958 and the Registered Nurses Award (No 6 of 1987). It is anticipated that there will be strong pressures to amend these minimum staffing levels in the coming twelve months as a result of award restructuring processes which are currently underway. While the reason for introducing staff/patient ratios may have been valid a decade ago, the world has moved on and it is not considered appropriate that the regulations now being proposed should anticipate, give effect to, or abrogate any agreement, award or other determination in the industry, whether existing or prospective, in relation to levels of staffing. Moreover, prescribing staff/patient ratios by regulation leads to inflexibility as the former Regulatory Impact Statement indirectly acknowledged. The very real danger, of course, is that, over the lifetime of the regulations, any staff/patient ratios which may be prescribed will not only become irrelevant but possibly even hamper the introduction of new technologies in the dynamic and constantly evolving area of health care. " This is only partly correct. Regulation 30 I (I) ofthe Health (Private Hospitals) Regulations 1983 actually reads that "the proprietor ofa private hospital shall appoint such nursing staff as are necessary to ensure efficient nursing of patients in the private hospital and such other staff as are necessary to keep the private hospital and its grounds clean and in good order". 40 The ability to offer nursing and skilled allied support services is the main raison d'etre of a private hospital or day procedure centre. Clearly, then, it is in the interests of the community that these services be of the highest possible standard. According to figures published by the Australian Bureau of Statistics for 199940 2000 , private acute and psychiatric hospitals in Victoria employed approximately 11,500 full time equivalent staff of whom about 6,700 were nursing staff. ABS figures indicate that the total cost of salaries and wages (including oncosts) for that year was $604 million. (These do not include the salary and wages costs of day procedure centres). While the proposed regulations do not require proprietors to employ particular numbers of nursing staff, the replacement of staff/patient ratios by performancedriven requirements will have the effect of setting a high standard of nursing care in the private sector. A further advantage of the proposed regulations is that will not impinge on recent workplace agreements in the industry. In a number of these agreements, proprietors make a commitment to ensuring that staffing levels are appropriate, thus ensuring the delivery of quality patient care and keeping with best practice principles which take into account patient acuity. A similar philosophy of flexibility underpins the proposed regulations. In other words, they are designed to enhance quality patient care by putting a clear obligation on operators in the industry to ensure that adequate and appropriately trained or qualified staff are on hand to meet the needs of their patients. They are also intended to be flexible according to circumstances and to foster best practice in the way staffing resources are allocated within the industry in the interests of the well being and safety of patients. The benefit of the proposed regulations is that they establish a high performance expectation without, at the same time, being unduly prescriptive. 40 Australian Bureau of Statistics, Private Hospital.t: Allstralia J 999~2000, (4390.0) published in July 2001. 41 42 CHAPTER 10 COMPLAINTS (REGULATIONS 26-29) Proposed regulations 26, 27, 28, and 29 require proprietors of private hospitals and day procedure centres to establish a system for receiving and. dealing with complaints made by, or on behalf of, patients. The regulation comes into operation on 1 January 2003. Under the proposed regulations, proprietors will be required to(a) (b) (c) nominate a person to whom complaints may be directed; ensure that patients and staff are informed of his or her name; ensure that complaints are responded to as soon as practicable and dealt with as discreetly as possible' keep a record of complaints. (d) It will be an offence to adversely affect any person as a result of making a complaint. The cost of nominating dedicated complaints liaison officers is difficult to estimate given the wide range in the size of facilities and the nature of the services offered by the private hospital sector in Victoria. It is understood that most of the larger private hospitals already employ Complaints Liaison Officers either full time or as a part of another role. If a position of full time Complaints Liaison Officer were to be created, the estimated cost would be about $40-$50,000 per annum plus, say, 18% on costs and any costs associated with publicity. On the other hand, the complaints liaison officer of a small day procedure centre might well be the Director of Nursing who could take on the function in addition to his or her other duties at little, if any, additional cost to the facility. It should be pointed out that, in complying with the proposed regulation, proprietors can seek help from the Office of the Health Services 41 Commissioner . The Commissioner already offers an orientation program inducting new complaints liaison officers. This program includes private hospitals and day procedure centres. 41 The office of Health Services Commissioner is established by the Health Services (Conciliation and Review) Act 1987. 43 The Commissioner's Office has also developed a database (the Health Complaints Information Program) which is readily available to private hospitals and day procedure centres. The database is used at a local level to capture complaints data and to produce reports that may be used by Quality Assurance Committees to improve service within a facility. Proposed regulation 29 requires the proprietor of a private hospital or day procedure centre to take reasonable steps to ensure that neither the patient nor the person making the complaint is adversely affected as a result of a complaint. It effectively applies section 108G(2) of the Act to private hospitals and day procedure centres. Section 108G(2) reads thatThe proprietor of a supported residential service must take all reasonable steps to ensure that a resident is nol adversely affecled because a complaint has been made by the resident or on behalf of the resident. The number and type of complaints made, and dealt with, internally by the private hospital sector is unknown but, in her Annual Report for 1999-2000, the Health Services Commissioner notes that she received a total of 116 complaints (representing 16% of hospital complaints) relating to private hospitals during that year. The Commissioner states that 42 - As with previous years treatment issues remain the most common. In the case of private hospitals the trealment issues relate to staff olher than doctors because these hospitals do not employ their own doctors. Complaints are an important means of monitoring and assessing quality in a private hospital or day procedure centre. As well, they are a valuable risk management tool which can save management both time and money. Complaints are also one of the means of safeguarding the interests of patients, their families and carers, and staff alike. As the (United States) President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry puts it'"Consumers have the right 10 a fair and efficient process for resolving differences wilh their health plans, health care providers, and Ihe institutions that serve them, including a rigQroys system of internal review and an external system of external review (emphasis added). It has been said that a complaint is an "opportunity to right a wrong, generate good will and remedy a weakness"". 42 43 At page 36. Page 4 of the Executive Summary published by the United States of America 18 July 1998. 44 Complaints should be one of the mechanisms used by the industry to monitor the quality of care provided by a health service and to improve its performance. The experience of the Health Services Commissioner is that the successful resolution of complaints is a therapeutic process for both patients and health services providers. The proposed regulations do not specify how complaints are to be managed. This has been done deliberately so that proprietors can develop their own systems and strategies for receiving and acting on complaints . Several established options are available including Australian Standard AS 4269 Complaints Handling as well as Every Complaint is an Opportunity, and the Health Complaints Toolkit which are obtainable through the Health Services Commissioner. Both patients and proprietors stand to benefit from the introduction of an effective complaints system. Patients gain because there will be a formal mechanism for bringing matters of concern to an identified person with the capacity to ana lyse and review that complaint. Proprietors benefit because complaints can be an effective means of identifying potential problems and identifying areas where there is room for improvement. An added benefit is that an effective response to a complaint could well avert potentially expensive litigation. 44 Quote is from the Abstract 2 "Complaint to Correction" by Mr John Love and Mrs Cheryl Miller, Royal Perth Hospital, 3'J National Health Care Complaints Conference. 45 46 CHAPTER 11 TRANSFER AND DISCHARGE OF PATIENTS (REGULATIONS 30 - 31) Proposed regulations 30 and 31 require the proprietor of a private hospital or day procedure centre to ensure that(a) if a patient is transferred to another health service establishment or health care agency, all information and documents relating to the patient's medical condition or treatment necessary for the establishment or agency to which the patient is being transferred to provide appropriate ongoing treatment or care are sent with the patient; and on discharge, a patient is given a clear explanation of any recommendations and arrangements which have been made with respecl to his or her future health care. (b) Regulation 30 replaces former regulation 411 which provides that, if a patient is being transferred to another establishment or agency, a transfer form containing the prescribed information must be sent with the patient and a copy filed in the medical record at the transferring establishment. The aims of regulation 30 are to(a) (b) streamline current obligations imposed on proprietors; and obviate any potential liability of proprietors under section 141 of the Act. The first aim will be achieved by relieving proprietors of the necessity to complete a transfer form whenever a patient is being transferred to another facility. Instead, proprietors need only forward such patient information and copies of such documents as are necessary to provide for his or her ongoing treatment or care. The second aim will be achieved by making it obligatory for proprietors to provide such information and documentation. While section 141 permits the proprietor of a private hospital or day procedure centre to provide identifying information to a "relevant health service" in connection with the further treatment of a patient, it is questionable whether this extends to nursing homes and other aged care facilities. This is because nursing homes and other aged care facilities- 47 (a) are not included in the statutory definition of "relevant health service"; and provide "ongoing care" rather than "further treatment". (b) It is lawful under section 141 (2)(c) for a "person to whom this section applies,,'5 to make available otherwise confidential patient information if "he or she is expressly authorised, permitted or required to give (that information) under this or any other Act". By expressly requiring that the information referred to in regulation 30 be provided to a health care agency on the transfer of a patient, the regulation sets out to protect proprietors by invoking this exemption. Proposed regulation 31 is a new requirement consistent with current good practice. It reflects the increasing importance of proper discharge planning in the hospital industry and is intended to ensure that, on discharge, patients are adequately briefed and have the capacity to participate in the making of decisions about their future health care. About 563,500 patients are discharged from private hospitals and day procedure centres in Victoria each year while another 16,500 are transferred to other establishments or agencies (such as a nursing homes). In the case of transfers, it has been assumed for the purposes of this Regulatory Impact Statement that about 10 minutes of photocopying is involved and that 20 pages of documentation (at 2 cents per page) would need to be sent with each patient. On this basis, it is estimated that the cost to the industry of compliance with regulation 31 would be in the order ofLabour Materials (10 minutes @ $21 ph x 16,500) = (20 pages @ 2cents x 16,500) = $57,750 $6,600 $64,350 TOTAL Likewise, the requirement in proposed regulation 32 that, on discharge, a patient is to be given a clear explanation of any recommendations and arrangements which have been made with respect to his or her future health care time may involve, perhaps, 10 minutes of the time of the nurse or other person arranging for the discharge of the patient. ~'This includes a person who is Of has been the proprietor ofa private hospital or day procedure centre. 48 On this basis , it is estimated that the cost to the industry will not exceed (10 minutes @ $21 ph x 563,500 =) $1,972,249. 49 50 CHAPTER 12 REGISTERS AND RECORDS (REGULATIONS 32-35) Proposed regulations 32, 33, 34 and 35 prescribe certain registers and records which must be kept by private hospitals and day procedure centres. For the purpose of this chapter, it is assumed that (a) it takes an average of about 10 minutes to make an entry in a register: the labour cost is about $3.50 (i.e. $21 per hour/6); about 271,000 procedures are undertaken in private hospitals and day procedure centres in Victoria; and about 15,800 babies are bom in private hospitals each year in this State. 4s (b) (c) (d) Patient Admission and Discharge Register and Staff Register Section 109 of the Act provides that(1) The proprietor of a health service establishment must cause to be kept in the prescribed manner and to be retained for the prescribed period the prescribed particutars of (a) persons who receive care in the establishment and the type of care received; and staff employed in the establishment. (b) (2) A person must not during the prescribed period destroy or damage any record kept for the purposes of sub-section (1). Penalty: 120 penalty units. Proposed regulations 32 and 33, respectively, prescribe the particulars to be entered into the Patient Admission and Discharge Register and in the Staff Register. 4b According to the statistics published by the Australian Bureau of Statistics in Private Hospitals: Australia 1999-2000, a lOtal of 1,353,734 procedures (categorised as advanced surgery, surgery, minor or other surgery and obstetrics) were provided in private acute and psychiatric hospitals in Australia. These are not broken up by States. For the purposes of this Regulatory Impact Statement the aggregate figure has been multiplied by 20% (representing the proportion of the national population living in Victoria) as the basis oran indicative figure. 51 They also prescribe the manner in which the prescribed particulars are to be kept (in writing) and the period for which the particulars are to be retained (7 years in the case of the Patient Admission and Discharge Register and 2 years in the case of the Staff Register). Proposed regulation 32 is, essentially a consolidation of former regulations 401 (a), 402 and 416(4) while proposed regulation 33 is based on former regulation 405. Both regulations are considered to be fundamentally machinery or declaratory in nature. This is because the obligation to keep a Patient Admission and Discharge Register and a Staff Register is imposed on proprietors by the Act itself. Regulations 32 and 33 merely prescribe the necessary details. Operation Theatre Register Proposed regulation 34 requires the proprietor of a private hospital or day procedure centre at which surgery or endoscopy is undertaken to keep an Operation Theatre Register. The regulation goes on to specify the information which must be inserted in the register, and requires the register to be kept in writing. The proposed regulation, to all intents and purposes, remakes former regulations 401(b), 403 and 416(4) and will continue an existing obligation imposed on the industry. The estimated cost of compliance, based on the assumptions outlined at the beginning of this chapter, is estimated to be in the order of ($3.50 x 271,000 =) $948,500 each year. Birth register Proposed regulation 35 requires the proprietor of a private hospital or day procedure centre at which obstetric services are provided to maintain a Birth Register. The proposed regulation also prescribes the information to be entered in the register and requires the register to be retained for at least 25 years after the date of the last entry. It effectively "rolls over" the requirements of former regulations 401 (c), 404, and 416(4). The estimated annual cost of compliance would be in the order of ($3.50 x 15,800 =) $55,300. 52 The records prescribed by the proposed regulations will provide primary, and contemporary, evidence about the admission of a patient or the birth of a child, the discharge or transfer of a patient to another agency and the names of staff members during a particular period. Such information forms part of the historical record of the establishment and will be of particular value in the event of further treatment or subsequent legal proceedings. The records prescribed by the proposed regulations will enable facts to be established after a period of time and, thus, not only will they be of potential importance to patients, but will also help in protecting the interests of proprietors and staff. 53 54 CHAPTER 13 PREMISES AND EQUIPMENT (REGULATIONS 36 - 40) Proposed regulations 36, 37, 38, 39 and 40 deal with the provision, and maintenance, of equipment and services at private hospitals and day procedure centres. Identification of rooms Proposed regulation 36 requires each room in which patients are accommodated at a private hospital or day procedure centre to be identified by (a) (b) the letter or number of that room; and the number of beds and recovery chairs normally in that room. To all intents and purposes, it continues in operation regulation 306 of the former regulations. The requirement that rooms be identified by number or letter and the number of beds was originally introduced so that patients could be easily located and safely evacuated in times of emergency. Room identification is intended to facilitate searches by emergency services personnel in the event of a fire or other crisis to ensure that each ward had been checked and that all patients had been accounted for. The need for the proper identification of rooms has not altered since the former regulations were made and, in the circumstances, it is proposed to continue this requirement. As the proposed regulation does not prescribe the manner in which it is to be complied with, the cost to a proprietor will depend upon the way he or she chooses to comply with the requirement. Existing proprietors should not incur any costs but some expense may be involved in the case of new hospitals or centres, or alterations to an existing facility. These should be minimal but the actual amount will depend upon the way in which the proprietor elects to comply with the proposed requirement. Electronic communication system 55 Proposed regulation 37 requires the proprietor of a private hospital; and day procedure centre to ensure that an effeclive electronic communication system is provided, and kept operational, at the hospital or centre. It is similar to former regulation 304 and proprietors of existing facilities should not find it necessary to incur any additional expenditure in complying with the requirement. Some costs may be incurred in the case of new services and an estimate has been obtained of the cost of an electronic call system in a 40 bed facility. This indicates that the cost of installing an electronic call system in a facility of this size would be in the order of $14,000. Actual costs would, of course, depend upon the size of the facility and the nature and degree of sophistication of the call system. The purpose of an effective electronic call system is to enable(a) (b) patients to call nurses and staff; and nurses to call medical practitioners and other health professionals whenever assistance is needed. It follows that an effective communication system is an essential item of equipment in a modern hospital environment and that, without such a system, it would be difficult for staff and patients to summon help or assistance when required. Prevention of scalding Proposed regulation 38 requires the proprietor of a private hospital or day procedure centre to ensure that a system or mechanism is installed to control the outlet temperature of hot water to baths, showers, or hand basins used by patients. The proposed regulation is designed to prevent the scalding of patients. It is, essentially, a remake of former regulation 303 which was introduced in response to a Coronial inquest into the death of an elderly woman from hot water bums at a nursing home. Scalding poses a very real risk to patients, especially those who are elderly or confused. The requirement that a device be installed to regulate the temperature of hot water is, therefore, an important safety measure to preclude any recurrence of the earlier incident. 56 Private hospitals and day procedure centres have been required to have suitable systems or devices installed for many years. The proposed regulation, therefore, should not impose any additional burden on existing operators. In the case of a new facility or alterations to an existing facility, appropriate devices will need to be installed wherever bathing facilities are accessible to patients. A plumbing supplier has indicated that cost of a tempering valve capable of servicing a number of outlets should be in the order of at $60 to $80 (plus installation). Repair and cleanliness of premises etc Proposed regulations 39 and 40 require, respectively, that(a) the premises of a private hospital or day procedure centre be kept in a clean and hygienic condition, a proper state of repair and free of hazards or accumulation of materials which may become offensive, injurious to health or likely to facilitate the outbreak of fire; and facilities, furnishings and fittings be suitable for the kind or kinds of health services being provided, kept in a proper state of repair and in good working order and maintained in a clean and hygienic condition . (b) The proposed regulations are based on former regulation 302. According to figures published by the Australian Bureau of Statistics , the cost of repairs and maintenance undertaken by private acute and psychiatric hospitals in Victoria during 1999-2000 was $24,135,000. This figure includes some capital costs but excludes maintenance and cleaning costs in day procedure centres. On the basis that these more or less cancel each other out, it is expected that the cost of compliance will be in the order of the $24 million already being spent each year on repairs and maintenance by the industry. Patients in a hospital situation are vulnerable and proper maintenance and cleaning services are important steps in minimising the risk of hospital acquired infection. A number of guidelines have been published for the assistance of the industry including the Cleaning Standards for Victorian Public Hospitals published by 47 41 Australian Bureau of Statistics, PrivatI! Hospitals: Alistralia 1999-2000, (4390.0) published in July 2001. 57 the Victorian Governrnent Publishing Service • These standards identify key risk areas and the preventative cleaning rneasures to be taken in particular situations. By putting a clear obligation on proprietors to undertake appropriate cleanliness and maintenance programs, the proposed regulation will help protect the safety of patients receiving private hospital care. 4s 4K The standards can also be accessed on the internet at http://infeetioncontrol.health.vic.go v .aul c Ican i ng/ index/h trn 58 CHAPTER 14 INFECTION CONTROL (REGULATION 41) Proposed regulation 41 requires proprietors of private hospitals and day procedure centres to develop and implement an effective Infection Control Management Plan. An Infection Control Plan must(a) (b) state its objectives; identify and assess all infection risks specific to the hospital or centre which the proprietor knows, or ought reasonably to know, exists or may exist and state how these risks are to be minimised; provide for an on-going infection control education program for the staff of the hospital or centre; state the particulars of training for persons who provide services at the hospital or centre that involve infection control risks; and set out how the proprietor will monitor and review the implementation and effectiveness of the plan. (c) (d) (e) The regulation comes into operation on 1 January 2003. Infection Control Management Plans is a new initiative which mirrors corresponding requirements introduced in the public sector49 . The risk of infection is a very real danger in a hospital environment. Many infections are hospita~acquired. These include infections of the urinary tract, surgical wounds, lower respiratory tract and of the ski n50 It has been said that: Despite the adVances in modern medicine and surgery, approximately 5-7% of patients admitted to hospital subsequently acquire an infection and Lhere is an increasing awareness of the need for rational scientifically based procedures to minimize this problem. Concern about hospital-acquired infection is increasingly ~<) Further details are available in the Guidelines/or Infection Control Strategic Management Planning published by the Acute Health, Quality and Care Continuity Branch of the Department or Human Services, June 2000.