Private Health Facilities Regulation 2010



Part 1 Preliminary
1   Name of Regulation
This Regulation is the Private Health Facilities Regulation 2010.
2   Commencement
This Regulation commences on 1 March 2010 and is required to be published on the NSW legislation website.
3   Definitions
(1)  In this Regulation:
anaesthesia means the administration of general, epidural or major regional anaesthetic or sedation resulting in more than conscious sedation, other than sedation provided in connection with dental procedures.
Australasian Health Facility Guidelines means the Australasian Health Facility Guidelines endorsed by the Australasian Health Infrastructure Alliance in Australia and New Zealand that commenced on 23 November 2007.
cardiac catheterisation means the passing of a catheter, or other instrument, through a major blood vessel and into the heart for a diagnostic or therapeutic purpose.
chemotherapy means parenteral treatments using one or more cytotoxic agents.
cosmetic surgery means:
(a)  any cosmetic surgical procedure that is intended to alter or modify a person’s appearance or body and that involves anaesthesia (including a Biers Block), or
(b)  any of the following surgical procedures (however described):
(i)  abdominoplasty (tummy tuck),
(ii)  belt lipectomy,
(iii)  brachioplasty (armlift),
(iv)  breast augmentation or reduction,
(v)  buttock augmentation, reduction or lift,
(vi)  calf implants,
(vii)  facial implants that involve inserting an implant on the bone or surgical exposure to deep tissue,
(viii)  fat transfer that involves the transfer of more than 2.5 litres of lipoaspirate,
(ix)  liposuction that involves the removal of more than 2.5 litres of lipoaspirate,
(x)  mastopexy or mastopexy augmentation,
(xi)  necklift,
(xii)  pectoral implants,
(xiii)  penis augmentation,
(xiv)  rhinoplasty,
(xv)  superficial musculoaponeurotic system facelift (SMAS facelift),
(xvi)  vaginoplasty or labiaplasty,
but does not include any dental procedure.
extended recovery accommodation standards means the standards set out in Part 2 of Schedule 3.
gastrointestinal endoscopy means the use of a flexible endoscope with an internal lumen for the passage of an instrument to examine the upper or lower gastrointestinal tract.
interventional neuroradiology means the passing of a catheter or other instrument through the spinal canal, the cranial cavity or through a major blood vessel, to the brain or spine.
medical advisory committee, in relation to a private health facility, means the medical advisory committee appointed for the facility under section 39 of the Act.
overnight accommodation standards means the standards set out in Part 1 of Schedule 3.
radiotherapy means the use of ionising radiation from a radioactive substance.
rapid opioid detoxification means the use of one or more opioid antagonists, in particular naltrexone or naloxone or a combination of the two, in a person who is physiologically dependent on opioids for the purpose of accelerating opioid withdrawal in the person and rendering the person opioid free.
Note—
The Act and the Interpretation Act 1987 contain definitions and other provisions that affect the interpretation and application of this Regulation.
(2)  In this Regulation, a reference to a class of private health facility is a reference to a class specified in clause 5.
(3)  Notes included in this Regulation do not form part of this Regulation.
cl 3: Am 2015 (186), Sch 1 [1]; 2016 (288), Sch 1 [1].
3A   Definition of “private health facility”: prescribed services or treatments
For the purposes of the definition of private health facility in section 4 (1) of the Act, the following are prescribed services or treatments (irrespective of whether the person being provided with the service or treatment is admitted to the facility):
(a)  anaesthesia,
(b)  cardiac catheterisation,
(c)  chemotherapy,
(c1)  cosmetic surgery,
(d)  services or treatments relating to the care of patients injured in accidents, or those suffering from medical or other emergencies, through the provision of reception, resuscitation, medical and surgical treatment and use of life support systems,
(e)  gastrointestinal endoscopy,
(f)  interventional neuroradiology,
(g)  radiotherapy,
(h)  rapid opioid detoxification,
(i)  renal dialysis,
(j)  surgical procedures performed on patients who are administered general, epidural or major regional anaesthetic or sedation resulting in more than conscious sedation, other than a surgical procedure carried out by a dentist.
Note—
The definition of private health facility in section 4 (1) of the Act also includes certain facilities at which a person is admitted, provided with medical or surgical treatment and then discharged.
cl 3A: Ins 2015 (186), Sch 1 [2]. Am 2016 (288), Sch 1 [2].
Part 2 Licensing of private health facilities
Division 1 Classes of private health facilities
4   Licensing standards
(1)  For the purposes of section 5 of the Act:
(a)  the standards set out in Schedule 1 are prescribed for all private health facilities, and
(b)  a standard specified in Schedule 2 in relation to a specified class of private health facility is prescribed for private health facilities of that class.
(2)  The licensee of a private health facility must ensure that the private health facility is conducted in accordance with the provisions of Schedules 1 and 2 applicable to the private health facility.
Maximum penalty (subclause (2)): 5 penalty units.
(3)  A licensee is not guilty of an offence under this clause if the licensee:
(a)  was not aware of the circumstances giving rise to the alleged offence, and
(b)  could not reasonably be expected to have been aware of those circumstances.
(4)  A contravention of a provision of Schedule 1 or 2 by any person other than the licensee does not constitute an offence under this Regulation.
5   Classes of private health facilities
The classes of private health facilities are as follows:
(a)  anaesthesia (being a facility licensed for the treatment of patients who are administered general, epidural or major regional anaesthetic or sedation resulting in more than conscious sedation, but does not include sedation provided in connection with dental procedures),
(b)  cardiac catheterisation (being a facility licensed for any procedure involving the passing of a catheter, or other instrument, through a major blood vessel and into the heart for a diagnostic or therapeutic purpose),
(c)  cardiac surgery (being a facility licensed for surgery within, or on, the heart),
(d)  chemotherapy (being a facility licensed for parenteral treatments using one or more cytotoxic agents),
(d1)  cosmetic surgery (being a facility licensed for cosmetic surgery),
(e)  emergency (being a facility licensed for the care of patients injured in accidents, or those suffering from medical or other emergencies, through the provision of reception, resuscitation, medical and surgical treatment and use of life support systems),
(f)  gastrointestinal endoscopy (being a facility licensed for the use of a flexible endoscope with an internal lumen for the passage of an instrument to examine the upper or lower gastrointestinal tract),
(g)  intensive care (level 1 or level 2) (being a facility licensed for the observation, care and treatment of patients with life threatening or potentially life threatening illnesses, injuries or complications, from which recovery is possible, in a facility that is specially staffed and equipped for that purpose),
(h)  interventional neuroradiology (being a facility licensed for the diagnosis and treatment of diseases and conditions of the brain or spinal cord using procedures involving the passing of a catheter or other instrument through the spinal canal, the cranial cavity or through a major blood vessel, to the brain or spine),
(i)  maternity (being a facility licensed for maternity care, including antenatal care related to child birth, assistance and care associated with normal child birth, surgical intervention in achieving childbirth and care and assistance of a mother admitted to the facility immediately after childbirth),
(j)  medical (being a facility licensed for the diagnosis or treatment of admitted patients by a procedure or technique not referred to elsewhere in this clause, where the patient is admitted overnight),
(k)  mental health (being a facility licensed for the provision of mental health care to admitted patients),
(l)  neonatal (being a facility licensed for the provision of care and treatment to a baby under the age of 28 days),
(m)  paediatric (being a facility licensed for the provision of care and treatment to admitted patients between the age of 28 days and 14 years),
(n)  radiotherapy (being a facility licensed for treatments involving the use of ionising radiation from a radioactive substance),
(o)  rapid opioid detoxification (being a facility licensed for the use of one or more opioid antagonists, in particular naltrexone or naloxone or a combination of the two, in a person who is physiologically dependent on opioids for the purpose of accelerating opioid withdrawal in the person and rendering the person opioid free),
(p)  rehabilitation (being a facility licensed for rehabilitation, including long-term rehabilitation and specialised physical rehabilitation where the patient is admitted over night),
(q)  renal dialysis (being a facility licensed for the provision of haemodialysis),
(r)  surgical (being a facility licensed for surgical procedures performed on patients who are administered general, epidural or major regional anaesthetic or sedation resulting in more than conscious sedation, but does not include a surgical procedure carried out by a dentist).
cl 5: Am 2012 (156), Sch 1 [1]; 2016 (288), Sch 1 [3].
Division 2 Licensing application fees and other fees
6   Applications for licence for private health facility
For the purposes of section 6 (2) (f) of the Act, the prescribed application fee is $6,719 and the following particulars and documents are prescribed:
(a)  in respect of a private health facility that is a corporation (other than a corporation referred to in paragraph (b))—the extract of particulars (within the meaning of the Corporations Act 2001 of the Commonwealth) for the current year, and
(b)  in respect of a private health facility that is operated by a church or religious organisation—a certificate of incorporation for the organisation or, if it is a corporation incorporated by an Act, a copy of the Act incorporating the church or organisation.
cl 6: Am 2011 (519), Sch 1 [1]; 2012 (546), Sch 1 [1]; 2013 (486), Sch 1 [1]; 2014 (535), Sch 1 [1]; 2015 (306), Sch 1 [1]; 2016 (289), Sch 1 [1]; 2017 (266), Sch 1 [1].
7   Request for extension of approval in principle
For the purposes of section 8 (4) of the Act, the prescribed application fee is $3,423.
cl 7: Am 2011 (519), Sch 1 [2]; 2012 (546), Sch 1 [2]; 2013 (486), Sch 1 [2]; 2014 (535), Sch 1 [2]; 2015 (306), Sch 1 [2]; 2016 (289), Sch 1 [2]; 2017 (266), Sch 1 [2].
8   Annual licence fees
(1)  For the purposes of section 14 of the Act, the annual licence fee for a private health facility, of any class, that:
(a)  provides for the accommodation of patients who are admitted for more than 24 hours, and
(b)  is licensed to accommodate a number of patients within the range specified in Column 1 of the Table to this subclause,
is the fee specified opposite that range in Column 2 of that Table.
Table
Column 1
Column 2
Number of persons licensed to be accommodated
Licence fee
$
Fewer than 51
5,985
51–75
7,441
76–100
8,896
101–150
11,807
151–200
13,263
more than 200
14,718
(2)  For the purposes of section 14 of the Act, the annual licence fee for any other private health facility, of any class, is $5,985.
cl 8: Am 2011 (519), Sch 1 [3] [4]; 2012 (546), Sch 1 [3] [4]; 2013 (486), Sch 1 [3] [4]; 2014 (535), Sch 1 [3] [4]; 2015 (306), Sch 1 [3] [4]; 2016 (289), Sch 1 [3] [4]; 2017 (266), Sch 1 [3] [4].
9   Transfer of licence
For the purposes of section 15 (3) (b) of the Act, the prescribed application fee is $3,947.
cll 9–12: Am 2011 (519), Sch 1 [5]; 2012 (546), Sch 1 [5]; 2013 (486), Sch 1 [5]; 2014 (535), Sch 1 [5]; 2015 (306), Sch 1 [5]; 2016 (289), Sch 1 [5]; 2017 (266), Sch 1 [5].
10   Alterations or extensions to private health facility
For the purposes of section 16 (2) (b) of the Act, the prescribed application fee is $3,947.
cll 9–12: Am 2011 (519), Sch 1 [5]; 2012 (546), Sch 1 [5]; 2013 (486), Sch 1 [5]; 2014 (535), Sch 1 [5]; 2015 (306), Sch 1 [5]; 2016 (289), Sch 1 [5]; 2017 (266), Sch 1 [5].
11   Amendment of licence
For the purposes of section 17 (2) (e) of the Act, the prescribed application fee is $3,947.
cll 9–12: Am 2011 (519), Sch 1 [5]; 2012 (546), Sch 1 [5]; 2013 (486), Sch 1 [5]; 2014 (535), Sch 1 [5]; 2015 (306), Sch 1 [5]; 2016 (289), Sch 1 [5]; 2017 (266), Sch 1 [5].
12   Application for review of Director-General’s decision
For the purposes of section 24 (2) (b) of the Act, the prescribed application fee is $3,947.
cll 9–12: Am 2011 (519), Sch 1 [5]; 2012 (546), Sch 1 [5]; 2013 (486), Sch 1 [5]; 2014 (535), Sch 1 [5]; 2015 (306), Sch 1 [5]; 2016 (289), Sch 1 [5]; 2017 (266), Sch 1 [5].
Part 3 Conduct of private health facilities
13   Qualifications for director of nursing of facility
For the purposes of section 37 (2) of the Act, the minimum necessary qualifications for a registered nurse to be appointed as a director of nursing at a private health facility are:
(a)    (Repealed)
(b)  5 years post basic or post graduate nursing experience, and
(c)  2 years administrative experience in a position of, or more senior than that of, nursing unit manager in a hospital.
cl 13: Am 2010 No 34, Sch 2.41.
14   Register of patients
For the purposes of section 38 (4) of the Act, a particular required to be entered in the register of patients must be entered by a member of staff of the private health facility:
(a)  in the case of a particular relating to the admission of a patient—at the time of admission of the patient, and
(b)  in the case of a particular relating to the discharge of a patient—at the time the patient ceases to be a patient.
Part 4 Medical advisory committee
15   Membership of medical advisory committee
For the purposes of section 39 (1) of the Act, the licensee of a private health facility must appoint to the medical advisory committee for the private health facility at least one medical practitioner who has no pecuniary interest in the private health facility.
Part 5 Root cause analysis teams
16   Reportable incident
For the purpose of the definition of reportable incident in section 41 of the Act, Appendix D of the document entitled Ministry of Health Policy Directive PD2014_004 Incident Management Policy, as published in the Gazette on 24 January 2014, is adopted.
cl 16: Subst 2014 (164), cl 3.
17   Disclosure of information
For the purposes of section 45 (d) of the Act, a person who is or was a member of a root cause analysis team may make a record of, or divulge or communicate, information acquired by the person as such a member, if the information is recorded, divulged or communicated to any of the following committees in connection with any research or investigation the committee is authorised to conduct under section 23 (1) of the Health Administration Act 1982:
(a)  the Special Committee Investigating Deaths Under Anaesthesia (SCIDUA),
(b)  the Collaborating Hospitals Audit of Surgical Mortality Committee (CHASM),
(c)  the NSW Maternal and Perinatal Mortality Review Committee,
(d)  the NSW Mental Health Sentinel Events Review Committee.
cl 17: Am 2014 (795), cl 3 (1) (2).
Part 6 Disclosure of pecuniary interests
18   Definitions
(1)  For the purposes of this Part:
pecuniary interest in a private health facility means any one or more of the following interests:
(a)  a pecuniary interest in the licence to conduct the private health facility, being:
(i)  an interest as the holder of the licence to conduct the private health facility, or as one of the holders of such a licence, or
(ii)  an interest in any corporation (other than a public company) that is the licensee of the private health facility, or
(iii)  a holding of 5 per cent or more of the issued share capital of a public company that is the licensee of the private health facility,
(b)  a pecuniary interest in the premises on which the private health facility is conducted, being:
(i)  an interest (whether at law or in equity) in the premises at which the private health facility is conducted, or
(ii)  an interest in any corporation (other than a public company) that has any interest (whether at law or in equity) in the premises at which the private health facility is conducted, or
(iii)  a holding of 5 per cent or more of the issued share capital of any public company that has any interest (whether at law or in equity) in the premises at which the private health facility is conducted,
(c)  a pecuniary interest in the services provided to the private health facility, being:
(i)  an interest in any clinical or administrative services provided to the private health facility (other than an interest in fees from medical or dental services provided to any patient in the private health facility), or
(ii)  an interest in any corporation (other than a public company) that has an interest in any clinical or administrative services provided to the private health facility, or
(iii)  a holding of 5 per cent or more of the issued share capital of any public company that has an interest in any clinical or administrative services provided to the private health facility.
relative of a practitioner means the spouse, de facto partner, parent, child, brother or sister of the practitioner.
Note—
“De facto partner” is defined in section 21C of the Interpretation Act 1987.
(2)  For the purposes of section 58 (4) of the Act, a practitioner has a pecuniary interest in a private health facility if the practitioner has a pecuniary interest in that facility within the meaning of this Part or if a relative of the practitioner has such a pecuniary interest.
cl 18: Am 2010 No 19, Sch 3.81 [1] [2].
19   Manner in which pecuniary interest to be notified
(1)  For the purposes of section 58 (2) of the Act, a practitioner is to notify a person of the practitioner’s pecuniary interest:
(a)  by a statement made by the practitioner, and
(b)  by written notification given by the practitioner, and
(c)  by a notice displayed at the private health facility, and
(d)  by a notice displayed in any office or other premises of the practitioner.
(2)  The notification must identify the practitioner to which it relates and must specify the nature and extent of the pecuniary interest.
(3)  A notice referred to in subclause (1) (c) or (d) must comply with the following requirements:
(a)  the notice must have a surface area of at least 2,500 square centimetres,
(b)  the information on the notice must be printed in plain, bold letters at least 1 centimetre high on a contrasting background,
(c)  in the case of a notice displayed at a private health facility, the notice must be displayed in a prominent place in the waiting room or in every room in which the practitioner to whom the notice relates attends to patients or other persons,
(d)  in the case of a notice displayed at an office or other premises, the notice must be displayed in a prominent place.
Part 7 Miscellaneous
20   Display of licence
At all times while a private health facility is conducted, the licensee must cause the licence (or a full size copy of the licence) to be displayed in a prominent place in the entrance foyer of the private health facility.
Maximum penalty: 5 penalty units.
21   Notification of Council orders
The licensee of a private health facility must, as soon as practicable after being made aware of an order being made by a Council under section 124 of the Local Government Act 1993 or section 121B of the Environmental Planning and Assessment Act 1979 in relation to the premises of the facility, ensure that the Director-General is notified of the making of the order.
Maximum penalty: 5 penalty units.
22   Information to be provided by licensees
(1)  The licensee of a private health facility must, for each month, provide to the Department a statistical statement in the form approved by the Director-General.
Maximum penalty: 5 penalty units.
(2)  The statement must contain the information required to complete the statement in the approved form and must be provided to the Director-General within 14 days after the end of the month to which the information relates.
cl 22: Am 2013 (283), cl 3.
23   Transitional provision for rapid opioid detoxification facilities
A private health facility providing rapid opioid detoxification class procedures is not required to be licensed under the Act until the day that is 3 months after the commencement of the Act.
24   Transitional provision for existing facilities
(1)  In this clause:
existing facility means an establishment licensed under the former Act immediately before the commencement of this Regulation.
existing licensing standards for an existing facility means the licensing standards applicable to that facility under the former Act immediately before the commencement of this Regulation.
new licensing standards for an existing facility means the standards applicable to the facility under Schedules 1, 2 and 3 to this Regulation.
(2)  An existing facility is not required to comply with the new licensing standards for the facility until the day that is 6 months after the commencement of the Act, if the facility complies with the existing licensing standards for the facility.
cl 24: Am 2010 No 59, Sch 2.78.
25   Transitional provision for cosmetic surgery class facilities
A private health facility providing cosmetic surgery is not required to be licensed under the Act as a cosmetic surgery class private health facility until the day that is 9 months after the commencement of this clause.
cl 25: Ins 2016 (288), Sch 1 [4].
Schedule 1 Licensing standards for private health facilities generally
(Clause 4 (1) (a))
Division 1 Environment
1   Compliance with Australasian Health Facility Guidelines
The design of a private health facility must comply with the Australasian Health Facility Guidelines, as in force on the issue of the licence or such later date as may be specified in the licence, to the extent that those guidelines relate to the health services provided by the facility.
2   Compliance with Building Code of Australia
(1)  Any part of a building comprising a private health facility must comply with the requirements of a class 9a building as defined in the Building Code of Australia, as in force on the issue of the licence or such later date as may be specified in the licence.
(2)  This clause does not apply in respect of any part of a private health facility that is only used to provide chemotherapy or renal dialysis class treatments to patients who are admitted and discharged as patients on the same day.
3   Regular risk assessment and safety inspection program
(1)  A private health facility must have a written risk assessment and safety inspection program for the assessment of risks and hazards in the private health facility.
(2)  Without limiting subclause (1), a risk assessment and safety inspection program must include:
(a)  a process for carrying out risk assessments and safety inspections, and
(b)  a timetable for carrying out those assessments and inspections.
(3)  A private health facility must ensure that risk assessments and safety inspections are carried out in accordance with the risk assessment and safety inspection program.
4   Maintenance of buildings, facilities and equipment
(1)  All buildings, furniture, furnishings, fittings and equipment of a private health facility must be maintained in good repair and operational order.
(2)  Without limiting subclause (1), a suitable maintenance program (consistent with the manufacturer’s specifications, if any) must be current for:
(a)  all hot and warm water systems, and
(b)  all air-conditioning, heating, warming and cooling systems and appliances, and
(c)  all sterilising equipment, and
(d)  all communication, alarm and emergency call systems.
5   Equipment and stores
(1)  Medical, surgical and nursing equipment, appliances and materials that are necessary for the type and level of patient care in the private health facility must be readily available at the facility.
(2)  Without limiting subclause (1), the following equipment must be readily available at a private health facility:
(a)  resuscitation equipment, for use in advanced life support, that complies with the Standards for Resuscitation: Clinical Practice and Education published by the Australian Resuscitation Council and the Australian College of Critical Care Nurses in March 2008, in so far as those standards are relevant to the facility, and
(b)  in the case of a facility that admits child patients, paediatric resuscitation equipment.
(3)  The medical, surgical and nursing equipment, appliances and materials required to be available at a private health facility by this clause must be provided in quantities that are appropriate for the safe and effective provision of the services for which the facility is licensed.
6   Communication system
A private health facility must have an electronic communication system in place that enables patients and staff to summon assistance from:
(a)  each bed, recovery trolley and recovery chair, and
(b)  each patient toilet, shower and bathroom, and
(c)  each staff station.
7   Fire safety and emergency response
(1)  A private health facility must have a written fire safety and emergency response policy outlining the procedures to be adopted in the event of a fire or other emergency (including contingency arrangements for the transfer of patients where necessary).
(2)  If a fire occurs in a private health facility, the licensee, as soon as practicable and regardless of whether or not the fire brigade is called to extinguish the fire:
(a)  must notify the Director-General verbally of that fact, and
(b)  must send to the Director-General written notice of the fact and of all relevant details of the circumstances in which the fire occurred.
8   Disaster planning
A private health facility must have a written disaster response policy outlining the procedures to be followed in the event of a natural disaster or other emergency affecting the provision of services at the facility.
9   Back-up power supply
A private health facility must have a back-up power supply in place that is capable of maintaining essential services, including the following:
(a)  lighting in all clinical and patient areas of the facility,
(b)  operating theatres,
(c)  life support systems.
10   Waste and hazardous substances
(1)  A private health facility must have a written waste and hazardous substances policy outlining the procedures that are to be followed in relation to the handling, transport and disposal of waste and hazardous substances generated at the facility.
(2)  Without limiting subclause (1), the policy should prevent or minimise the risk of harm to the health and safety of patients, staff, the public and the environment.
(3)  A private health facility must ensure that waste and hazardous substances are handled, transported and disposed of in accordance with the waste and hazardous substances policy.
11   Food services
The licensee of a private health facility that provides for the accommodation of patients who are not discharged on the same day as they are admitted must ensure that the personal, nutritional and clinical dietary needs of each patient are assessed and satisfied, including any necessary help with feeding.
Division 2 Clinical care
12   Staff qualifications and experience
A private health facility must have:
(a)  a sufficient number of qualified and experienced staff on duty, at all times, to carry out the services provided by the facility, and
(b)  nursing staff holding qualifications and experience appropriate for the services provided by the facility, and
(c)  nursing staff that are trained in the use of the equipment, including resuscitation equipment, provided by the facility.
13   Clinical records and patient information
(1)  A private health facility must have clinical records created and maintained, in respect of each patient (including each neonate) born or treated at the facility, by the appropriate staff of the facility.
(2)  If the licence of a private health facility is to be transferred, the existing licensee of the private health facility must ensure that all clinical records are made available to the new licensee for the facility.
(3)  Prior to a private health facility ceasing to operate, the licensee of the facility must make arrangements for the safe keeping of clinical records and must provide the Director-General with the details of the arrangements.
14   Infection control
(1)  A private health facility must have a written infection control policy outlining the procedures to be followed to prevent or reduce the risk of a patient acquiring an infection while at the facility.
(2)  Without limiting subclause (1), an infection control policy must make provision for the on-going education of staff with respect to infection control.
(3)  A private health facility must ensure that the infection control policy is complied with.
(4)  All decontamination systems and processes for reusable medical devices and clinical equipment must comply with AS/NZS 4187:2003, Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities.
15   Dispensaries
The following provisions apply to any dispensary conducted at a private health facility:
(a)  the dispensary must be under the control of a pharmacist at all times,
(b)  all dispensing must be personally supervised by a pharmacist,
(c)  the dispensary must comply with the standards prescribed by the regulations under the Pharmacy Practice Act 2006 for or with respect to the safe and competent delivery of pharmacy services,
(d)  if the dispensary is not a pharmacy business within the meaning of the Pharmacy Practice Act 2006—the functions of the dispensary are to be limited to the provision of a service to the private health facility and its patients,
(e)  the services provided by the pharmacist in control of the dispensary must include:
(i)  the provision of all medication for patients, whether on prescription or otherwise, in a form that is suitable, as far as practicable, for direct administration or utilisation, and
(ii)  the provision of advice on drug compatibility, possible adverse drug reactions, appropriate doses for different classes of patients and medication policy, and
(iii)  regular inspection of drug stocks and records to ensure proper storage of medication, proper stock rotation, withdrawal of stock that is outdated or no longer required and proper recording of drug use, and
(iv)  the establishment of written policies and procedures on the procurement, preparation, distribution and administration of medication and other therapeutic goods,
(f)  the pharmacist in control of the dispensary must make adequate provision for emergency drugs to be available to staff of the private health facility for the treatment of patients outside the normal hours of operation of the dispensary.
16   Identification of patients
Each patient or newborn at a private health facility must be easily identifiable at all times.
17   Admission and separation
Each patient being discharged from a private health facility must be provided with a clear explanation, in writing, of any recommendations and arrangements that have been made for follow-up care.
18   Transfer of patients
A private health facility must have procedures in place to transfer a patient to another private health facility or public hospital for care if:
(a)  the facility is not authorised to provide the care that the patient requires, or
(b)  in the event of complications arising during the treatment of the patient, the patient requires a higher level of care than is provided by the facility.
19   Patient records to be transferred with patients
If a patient is transferred from a private health facility to another private health facility or public hospital for care, a copy of any relevant clinical records and patient information maintained under clause 13 (1) of this Schedule must be transferred to the facility or hospital that is to receive the patient.
20   Privacy of patients
The privacy of the patients of the facility must be considered and respected by all staff of the private health facility.
Division 3 Quality improvement
21   Incident and adverse event management
(1)  A private health facility must have a written incident management system outlining the procedures to be followed in the case of an incident or adverse event.
(2)  Without limiting subclause (1), an incident management system must provide for the following:
(a)  identification of incidents and adverse events,
(b)  notifying the Department about adverse events,
(c)  investigation of incidents and adverse events,
(d)  management of the outcomes of any such investigation.
(3)  A private health facility must ensure that the incident management system is complied with.
(4)  In this clause:
adverse event means an unintended injury to a patient, or a complication caused by the health care management of a patient, that results in disability, death of the patient or a prolonged hospital stay by the patient.
incident means any unplanned event resulting in, or that is likely to cause, injury or damage to a patient at a private health facility.
22   Complaints
(1)  A private health facility must have a written complaints policy outlining the procedure to be followed in managing and responding to complaints.
(2)  The licensee of a private health facility must ensure that patients, relatives of patients and other carers are provided with information about the procedure for making complaints, and the process for managing and responding to any complaints.
(3)  The licensee of a private health facility must ensure that the complaints policy is complied with.
23   Compliance audits
The licensee of a private health facility must conduct regular audits to ensure that the facility is complying with statutory requirements as well as the facility’s policies and procedures.
24   Outcome audits
The licensee of a private health facility must ensure that regular audits are conducted to monitor the effectiveness of the policies and procedures of the facility as well as clinical services and patient outcomes.
Schedule 2 Licensing standards
(Clause 4 (1) (b))
Part 1 Anaesthesia class private health facilities
1   Sedation and anaesthesia
An anaesthesia class private health facility must have the following:
(a)  anaesthetic equipment recommended by the Australian and New Zealand College of Anaesthetists in its publication Recommendations on Minimum Facilities for Safe Administration of Anaesthesia in Operating Suites and other Anaesthetising Locations,
(b)  monitoring equipment recommended by the Australian and New Zealand College of Anaesthetists in its publication Recommendations on Monitoring During Anaesthesia,
(c)  recovery equipment and drugs recommended by the Australian and New Zealand College of Anaesthetists in its publication Recommendations for the Post-Anaesthesia Recovery Room.
2   Minimum staffing requirements
An anaesthesia class private health facility must provide staff to assist an anaesthetist in accordance with the recommendations of the Australian and New Zealand College of Anaesthetists in its publication Recommendations on Minimum Facilities for Safe Administration of Anaesthesia in Operating Suites and Other Anaesthetising Locations.
Part 2 Cardiac catheterisation class private health facilities
3   Design and construction
A cardiac catheterisation class private health facility must comply with the Guidelines on Support Facilities for Coronary Angiography and Percutaneous Coronary Intervention (PCI) published by the Cardiac Society of Australia and New Zealand.
4   Transfer of patients
(1)  A cardiac catheterisation class private health facility that carries out cardiac catheterisation class procedures for therapeutic purposes must have access to a cardiac surgery or intensive care (level 1 or level 2) class private health facility (whether in the same, or another, private health facility), or a public hospital, to which a patient may be transferred for cardiac surgery in less than 30 minutes.
(2)  If the cardiac surgery or intensive care class private health facility is not in the private health facility in which the cardiac catheterisation class procedures for therapeutic purposes are carried out, the cardiac catheterisation class private health facility must have a suitably equipped vehicle available for the transfer of the patient at all times during which any such procedure is performed.
5   Minimum accommodation requirements
A cardiac catheterisation class private health facility must provide for the accommodation of one or more of the following groups of patients:
(a)  patients who are admitted for more than 24 hours,
(b)  patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours,
(c)  patients who are admitted and discharged on the same day.
6   Accommodation standards
A cardiac catheterisation class private health facility must comply with such of the following standards as are applicable to the facility:
(a)  if the facility provides for the accommodation of patients who are admitted for more than 24 hours—the overnight accommodation standards,
(b)  if the facility provides for the accommodation of patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours—the extended recovery accommodation standards.
Part 3 Cardiac surgery class private health facilities
7   Concurrent licensing
A cardiac surgery class private health facility must also be licensed as an intensive care (level 1 or level 2) class private health facility, surgical class private health facility and anaesthesia class private health facility.
8   Minimum operating requirements
A cardiac surgery class private health facility that carries out open heart surgery must have at least two independent operating rooms that are equipped to carry out cardiac surgery class procedures.
9   Minimum accommodation requirements
A cardiac surgery class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
10   Accommodation standards
A cardiac surgery class private health facility must comply with the overnight accommodation standards.
Part 4 Chemotherapy class private health facilities
11   Design and construction
Any part of a building comprising a chemotherapy class private health facility must comply with the requirements of a class 5 building as defined in the Building Code of Australia, as in force on the issue of the licence for the private health facility or on such later date as may be specified in the licence.
12   Preparation of cytotoxic agents
Cytotoxic drugs administered at a chemotherapy class private health facility must be administered from a cytotoxic drug cabinet:
(a)  that complies with AS 2567–2002Laminar flow cytotoxic drug safety cabinets, and
(b)  that is heated in a room that complies with AS 2639–1994, Laminar flow cytotoxic drug safety cabinets—Installation and use.
13   Minimum accommodation requirements
A chemotherapy class private health facility must provide for the accommodation of one or more of the following groups of patients:
(a)  patients who are admitted for more than 24 hours,
(b)  patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours,
(c)  patients who are admitted and discharged on the same day.
14   Accommodation standards
A chemotherapy class private health facility must comply with such of the following standards as are applicable to the facility:
(a)  if the facility provides for the accommodation of patients who are admitted for more than 24 hours—the overnight accommodation standards,
(b)  if the facility provides for the accommodation of patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours—the extended recovery accommodation standards.
Part 5 Emergency class private health facilities
15   Design of emergency area
Any part of an emergency class private health facility that is used for the provision of emergency treatment must be designed for the reception, assessment, stabilisation, treatment and transfer of patients.
16   Staffing
An emergency class private health facility must have the following:
(a)  an appropriately qualified and experienced medical practitioner appointed as director of the emergency service,
(b)  appropriately qualified specialists available on call at all times,
(c)  a sufficient number of appropriately trained and experienced staff on duty at all times.
17   Triage of patients
An emergency class private health facility must have arrangements for the triage of a patient to be carried out at the time of the patient’s arrival by appropriately experienced clinical staff.
18   Policy and procedures
An emergency class private health facility must have written policies addressing the following:
(a)  the co-ordination of services with other private health facilities and public hospitals in the same or adjacent areas,
(b)  the integration of the emergency services with the other clinical and educational programs carried on at the facility,
(c)  the safe movement of patients in any part of the facility that is used for the provision of emergency class procedures,
(d)  the review of care plans for patients.
19   Transfer of patients
An emergency class private health facility must have:
(a)  effective communication arrangements with the Ambulance Service of New South Wales, and
(b)  written procedures for the transfer of patients requiring a higher level of care than is provided by the facility.
20   Clinical records
(1)  An emergency class private health facility must have a clinical record for each patient at the facility.
(2)  Without limiting subclause (1), a clinical record must include the following:
(a)  the date and time of the patient’s arrival,
(b)  details of the patient’s presenting symptoms and condition,
(c)  the triage category allocated at the time of first assessment,
(d)  details of significant clinical, laboratory and radiological findings,
(e)  accurate details of the treatment (if any) provided to the patient,
(f)  details of any follow-up directions given to the patient prior to the patient’s departure,
(g)  the date and time of the patient’s departure,
(h)  the identity and signature of the attending medical officer.
21   Minimum accommodation requirements
An emergency class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
22   Accommodation standards
An emergency class private health facility must comply with the overnight accommodation standards.
Part 6 Gastrointestinal endoscopy class private health facilities
23   Concurrent licensing
A gastrointestinal endoscopy class private health facility must also be licensed as an anaesthesia class private health facility.
24   Disinfection of endoscopes
Endoscopes used at a gastrointestinal endoscopy class private health facility must be disinfected by the use of an automatic endoscope reprocessor or otherwise in accordance with the manufacturer’s instructions in an area with atmospheric extraction facilities that is adjacent to the procedure room in which the endoscope is to be used.
25   Reprocessing of other equipment
(1)  Instruments and other equipment used at a gastrointestinal endoscopy class private health facility must be decontaminated, cleaned and reprocessed in accordance with AS/NZS 4187:2003, Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities.
(2)  Without limiting subclause (1), the decontamination, cleaning and reprocessing of equipment and instruments used in the facility must be carried out by a staff member who has appropriate training and experience.
26   Minimum accommodation requirements
A gastrointestinal endoscopy class private health facility must provide for the accommodation of one or more of the following groups of patients:
(a)  patients who are admitted for more than 24 hours,
(b)  patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours,
(c)  patients who are admitted and discharged on the same day.
27   Accommodation standards
A gastrointestinal endoscopy class private health facility must comply with such of the following standards as are applicable to the facility:
(a)  if the facility provides for the accommodation of patients who are admitted for more than 24 hours—the overnight accommodation standards,
(b)  if the facility provides for the accommodation of patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours—the extended recovery accommodation standards.
Part 7 Intensive care (level 1 or level 2) class private health facility
28   Staffing
An intensive care (level 1 or level 2) class private health facility must have:
(a)  a medical practitioner with appropriate qualifications appointed as director of the unit, the appropriate qualifications being (in the case of an intensive care (level 2) class private health facility) a recognised post-graduate qualification in intensive care, and
(b)  in the case of an intensive care (level 1) class private health facility—a medical practitioner on duty at the private health facility at all times, with priority for attendance on patients in the intensive care unit, and
(c)  in the case of an intensive care (level 2) class private health facility—a medical practitioner with an appropriate level of experience present in the unit at all times, and
(d)  sufficient nursing staff on duty at all times, being:
(i)  a nursing staff to patient ratio of at least 1:1 for all critically ill patients, and
(ii)  in the case of an intensive care (level 2) class private health facility—at least 50% of whom are registered nurses with intensive care certification.
29   Minimum operating requirements
An intensive care (level 1 or level 2) class private health facility must comply with the requirements of the Minimum Standards for Intensive Care Units published by the Joint Faculty of Intensive Care Medicine.
30   Minimum accommodation requirements
An intensive care (level 1 or level 2) class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
31   Accommodation standards
An intensive care (level 1 or level 2) class private health facility must comply with the overnight accommodation standards.
Part 8 Interventional neuroradiology class private health facility
32   Minimum accommodation requirements
An interventional neuroradiology class private health facility must provide for the accommodation of one or more of the following groups of patients:
(a)  patients who are admitted for more than 24 hours,
(b)  patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours,
(c)  patients who are admitted and discharged on the same day.
33   Accommodation standards
An interventional neuroradiology class private health facility must comply with such of the following standards as are applicable to the facility:
(a)  if the facility provides for the accommodation of patients who are admitted for more than 24 hours—the overnight accommodation standards,
(b)  if the facility provides for the accommodation of patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours—the extended recovery accommodation standards.
Part 9 Maternity class (level 1 or level 2) private health facility
34   Term of pregnancy
(1)  A maternity class private health facility must not admit a patient for maternity class procedures:
(a)  in the case of a maternity (level 1) class private health facility—prior to 37 weeks completed gestation, or
(b)  in the case of a maternity (level 2) class private health facility—prior to 34 weeks completed gestation.
(2)  Despite subclause (1), a maternity (level 2) class private health facility may admit a patient for maternity class procedures prior to 34 weeks completed gestation, but not less than 32 weeks completed gestation, if the licence for the facility is subject to a relevant condition and the facility is also licensed as a neonatal class private health facility.
(3)  In this clause, relevant condition means a condition to the effect that the private health facility must have support services, infrastructure and staff with appropriate clinical expertise that, in the opinion of the Director-General, are appropriate for the provision of maternity class procedures to patients that have completed between 32 and 34 weeks gestation.
35   Normal risk pregnancies
A maternity (level 1 or level 2) class private health facility must have support services, infrastructure and staff with appropriate clinical expertise to provide care for normal risk pregnancies, including the following:
(a)  obstetricians, anaesthetists and a paediatrician on call at all times,
(b)  a medical practitioner at the facility at all times,
(c)  experienced midwives on duty at all times,
(d)  established links with clinical nurse consultants or clinical nurse educators in midwifery and neonatal nursing.
36   Moderate risk pregnancies
(1)  A maternity (level 1) class private health facility must not admit a maternity patient with a moderate risk pregnancy.
(2)  A maternity (level 2) class private health facility must not admit a maternity patient with a moderate risk pregnancy unless:
(a)  the medical advisory committee is satisfied that the facility is able to provide appropriate care for a patient having regard to any risk factors relevant to the patient, and
(b)  the facility has appropriate support services and infrastructure and has staff with clinical expertise relevant to the risk factors of particular patients, including:
(i)  obstetricians, anaesthetists and a paediatrician on call at all times, and
(ii)  a medical practitioner at the facility at all times, and
(iii)  experienced midwives on duty at all times, and
(iv)  established links with clinical nurse consultants or clinical nurse educators in midwifery and neonatal nursing, and
(v)  a special care nursery.
37   Accommodation of neonates
A maternity (level 1 or level 2) class private health facility must have appropriate accommodation and procedures for the management of healthy neonates and neonates with minimal complications.
38   Patient transfer policy
(1)  A maternity (level 1 and level 2) class private health facility must have procedures in place that provide for the transfer of patients requiring a higher level of care than is provided by the facility.
(2)  Without limiting subclause (1), the facility must have procedures in place for the transfer of a patient in premature labour.
(3)  Without limiting subclause (1), procedures for the transfer of neonates must provide for the resuscitation and stabilisation of neonates prior to their transfer.
(4)  The procedures referred to in subclause (1) must be reviewed at least every 3 years and must be submitted to the medical advisory committee for approval and comment.
(5)  In this clause:
premature labour, in relation to a patient, means a patient that is in labour but has not completed the number of weeks gestation required for admission to the private health facility.
39   Birth register
(1)  A maternity class private health facility must maintain a birth register that records the details of every child born at the facility.
(2)  Without limiting subclause (1), the birth register must contain the following:
(a)  the mother’s full name and clinical record number,
(b)  the date and time of the child’s birth,
(c)  the sex of the child,
(d)  whether the child was born alive,
(e)  the method of delivery,
(f)  the name of any midwives or medical practitioners present at the birth.
(3)  A maternity class private health facility must retain a child’s record on the birth register for at least 25 years after the birth of the child.
40   Minimum accommodation requirements
A maternity class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
41   Accommodation standards
A maternity class private health facility must comply with the overnight accommodation standards.
Part 10 Medical class private health facility
42   Minimum accommodation requirements
A medical class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
43   Accommodation standards
A medical class private health facility must comply with the overnight accommodation standards.
Part 11 Mental health class private health facility
44   Design and construction
(1)  Any part of a mental health class private health facility that is used for the provision of mental health class treatments must be designed to meet the needs of mentally ill and mentally disordered persons with:
(a)  suitable arrangements for patient safety and protection, and
(b)  areas for observation of patients, and
(c)  accommodation providing personal privacy, consistent with the treatment being provided.
(2)  If electro convulsive therapy is to be administered at the private health facility the facility must have treatment and recovery areas set aside for that purpose.
45   Concurrent licensing
A mental health class private health facility, at which electro convulsive therapy is to be administered, must also be licensed as an anaesthesia class private health facility.
46   Conduct of mental health class private health facilities
A mental health class private health facility:
(a)  must have a written policy on the provision of psychiatric services, including a statement of the private health facility’s philosophy of service, and
(b)  must have written policies and procedures for:
(i)  supporting the functions of the Mental Health Review Tribunal constituted under the Mental Health Act 2007, and
(ii)  supporting the functions of official visitors, authorised officers and welfare officers, and
(iii)  supporting the administration of the Guardianship Act 1987, and
(iv)  the management of patients’ trust funds, and
(c)  must have clear, written criteria and assessment procedures for the admission of both inpatients and outpatients to psychiatric programs, and
(d)  must have a written treatment plan for each patient that:
(i)  is based on the assessment of that patient, and
(ii)  includes provision for discharge, continuing care and review, and
(e)  must have access at all times to a psychiatrist, and
(f)  must have access to a general practitioner and relevant specialists for consultation, and
(g)  must have sufficient registered nurses with appropriate psychiatric qualifications or experience on duty at all times.
47   Telephone access
A mental health class private health facility must provide at least one telephone, on each floor of the facility that is used for the provision of mental health class treatments, for the use of patients and their next of kin for both incoming and outgoing calls.
48   Visiting hours
(1)  Patients in a mental health class private health facility must be allowed to receive visitors at any reasonable time.
(2)  However, a medical practitioner or the senior nurse on duty may, if necessary for the care of a patient:
(a)  restrict the hours for visiting a patient and, if necessary, other patients in the same ward, and
(b)  restrict the number of persons who may visit the patient at any one time.
49   Minimum accommodation requirements
A mental health class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
50   Accommodation standards
A mental health class private health facility must comply with the overnight accommodation standards.
Part 12 Neonatal class private health facility
51   Accommodation of neonates
A neonatal class private health facility must have appropriate accommodation and procedures for the management of healthy neonates, neonates with minimal complications and convalescing neonates, including an intensive care nursery.
52   Transfer of neonates
(1)  A neonatal class private health facility must have a written neonate transfer policy that outlines the procedures to be followed for the transfer of patients requiring a higher level of care than is provided by the facility.
(2)  Without limiting subclause (1), procedures for the transfer of neonates must provide for the resuscitation and stabilisation of neonates prior to their transfer.
(3)  The procedures referred to in subclause (1) must be reviewed at least every 3 years and must be submitted to the medical advisory committee for approval and comment.
53   Minimum accommodation requirements
A neonatal class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
54   Accommodation standards
A neonatal class private health facility must comply with the overnight accommodation standards.
Part 13 Paediatric class private health facilities
55   Admission policy
(1)  A paediatric class private health facility must have a written policy for determining whether a person may be admitted to the facility for the purpose of receiving paediatric class procedures.
(2)  The policy referred to in subclause (1) must make provision for the following:
(a)  the age of patients who may be admitted to the facility,
(b)  the types of procedures that may be performed on, and treatments that may be given to, paediatric patients,
(c)  the maximum period for which a paediatric patient may be admitted,
(d)  the maximum number of paediatric patients who may be admitted to the facility at any one time,
(e)  the facilities that are available for the treatment and care of paediatric patients.
(3)  The policy referred to in subclause (1) must be reviewed at least every 3 years and must be submitted to the medical advisory committee for approval and comment.
56   Visitor policy
A paediatric class private health facility must have a written visitor policy that:
(a)  allows any person having the care of a paediatric patient to have access to the paediatric patient at all times, except while the patient is undergoing surgery, and
(b)  while the paediatric patient is undergoing surgery—allows any person having the care of a paediatric patient to have access to the patient while the patient is in pre-anaesthesia or recovery unless, in the opinion of the medical practitioner responsible for the treatment of the patient, it would not be in the best interests of the patient, and
(c)  ensures that resources are made available to allow any person having the care of a paediatric patient to remain at the private health facility during the patient’s stay at the facility.
57   Patient transfers
(1)  A paediatric class private health facility must have procedures in place that provide for the transfer of patients who require care or treatment that is not provided by the facility.
(2)  The procedures referred to in subclause (1), must be reviewed at least every 3 years and must be submitted to the medical advisory committee for approval and comment.
58   Bedding for patients under 2 years of age
A paediatric class private health facility must ensure that any patient admitted to the facility who is under 2 years of age is accommodated in a cot that complies with AS/NZ 2130:1998, Cots for day nursery, hospital and institutional use—Safety requirements.
59   Minimum operating requirements
A paediatric class private health facility must, at all times during which a paediatric patient is admitted to the facility:
(a)  have a paediatric physician available for consultation, and
(b)  have a registered nurse on duty at the facility who has appropriate paediatric experience or qualifications, and
(c)  in respect of any paediatric patient who is under 12 months of age—have microchemistry available for analysis of capillary blood specimens.
60   Minimum accommodation requirements
A paediatric class private health facility must provide for the accommodation of one or more of the following groups of patients:
(a)  patients who are admitted for more than 24 hours,
(b)  patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours,
(c)  patients who are admitted and discharged on the same day.
61   Accommodation standards
A paediatric class private health facility must comply with such of the following standards as are applicable to the facility:
(a)  if the facility provides for the accommodation of patients who are admitted for more than 24 hours—the overnight accommodation standards,
(b)  if the facility provides for the accommodation of patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours—the extended recovery accommodation standards.
Part 14 Radiotherapy class private health facility
62   Minimum accommodation requirements
A radiotherapy class private health facility must provide for the accommodation of one or more of the following groups of patients:
(a)  patients who are admitted for more than 24 hours,
(b)  patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours,
(c)  patients who are admitted and discharged on the same day.
63   Accommodation standards
A radiotherapy class private health facility must comply with such of the following standards as are applicable to the facility:
(a)  if the facility provides for the accommodation of patients who are admitted for more than 24 hours—the overnight accommodation standards,
(b)  if the facility provides for the accommodation of patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours—the extended recovery accommodation standards.
Part 15 Rapid opioid detoxification class private health facility
64   Guidelines
A rapid opioid detoxification class private health facility must comply with the Rapid Opioid Detoxification—Guidelines published by the Ministry of Health on 21 July 2011.
65   Transfer of patients
(1)  A rapid opioid detoxification class private health facility must have access to an intensive care (level 1 or level 2) class private health facility (whether in the same, or another, private health facility), or a public hospital, to which a patient may be transferred for intensive care in less than 30 minutes.
(1A)  A rapid opioid detoxification class private health facility that is not also licensed in the intensive care (level 1 or level 2) class must have written procedures in place that provide for the transfer of a patient in less than 30 minutes to an intensive care (level 1 or level 2) class private health facility or a public hospital if the patient requires a higher level of care than that provided at the facility.
(2)  If the intensive care class private health facility is not in the private health facility in which rapid opioid detoxification class procedures are carried out, the rapid opioid detoxification class private health facility must have a suitably equipped vehicle available for the transfer of patients to the intensive care class facility at all times during which any such procedure is performed.
66   Minimum accommodation requirements
A rapid opioid detoxification class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
67   Accommodation standards
A rapid opioid detoxification class private health facility must comply with the overnight accommodation standards.
67A   Minimum staffing requirements
(1)  A rapid opioid detoxification class private health facility:
(a)  must have a medical practitioner on staff or on-call at all times who has experience in opioid treatment and in the management of detoxification (including severe withdrawal management), and
(b)  must have a medical practitioner on-site for the first 4 hours following the carrying out of any induction procedure on any patient, and
(c)  must have a medical practitioner on-site or on-call between 4 and 48 hours following the carrying out of any induction procedure on any patient.
(2)  A rapid opioid detoxification class private health facility must have sufficient nursing staff on duty at all times, including:
(a)  a nursing staff to patient ratio of at least 1:2 in the first 8 hours following the carrying out of any induction procedure on any patient, and
(b)  a nursing staff to patient ratio of at least 1:4 between 8 hours and 24 hours following the carrying out of any induction procedure on any patient.
Part 16 Rehabilitation class private health facilities
68   Conduct of facility
A rehabilitation class private health facility:
(a)  must have a written policy on the provision of rehabilitation services, including:
(i)  a statement of the private health facility’s philosophy of service, and
(ii)  details of the liaison to be established with community based services to ensure continuity and co-ordination of care, and
(b)  must have clear, written criteria and assessment procedures for the admission of both inpatients and outpatients to rehabilitation programs, and
(c)  must have a written rehabilitation plan for each patient that:
(i)  is based on an assessment of the patient, and
(ii)  states the needs and limitations of the patient and the goals of the rehabilitation plan, and
(iii)  is prepared by a multi-disciplinary team with the active participation of the family of the patient, and
(iv)  includes provision for discharge, continuing care and review, and
(d)  must have procedures for regularly evaluating the progress of each patient against the written rehabilitation plan, and
(e)  must have a formal and planned discharge procedure, and
(f)  must provide for regular case management meetings, involving the treating medical practitioner and appropriate therapists, to review individual rehabilitation plans, and
(g)  must have specialists for consultation, and
(h)  must have sufficient appropriate therapists for the services provided, and
(i)  must have sufficient registered nurses with appropriate rehabilitation qualifications or experience on duty at all times, and
(j)  if patients with brain impairment are being treated, must have access for the services of a neuro-psychologist, and
(k)  if patients with chronic pain are being treated, must have access to the services of a clinical psychologist.
69   Clinical records
The clinical record of a patient in a rehabilitation class private health facility must include:
(a)  a clear statement by the treating medical practitioner giving details of the reason for the administration of, and the perceived need for, rehabilitation that is consistent with the admission policy, and
(b)  a rehabilitation plan based on the assessment of the patient, and
(c)  a record of each evaluation of the patient’s progress, and
(d)  a discharge plan.
70   Minimum accommodation requirements
A rehabilitation class private health facility must provide for the accommodation of patients who are admitted for more than 24 hours.
71   Accommodation standards
A rehabilitation class private health facility must comply with the overnight accommodation standards.
Part 17 Renal dialysis class private health facilities
72   Design and construction
Any part of a building comprising a renal dialysis class private health facility must comply with the requirements of a class 5 building as defined in the Building Code of Australia, as in force on the issue of the licence for the private health facility or on such later date as may be specified in the licence.
73   Minimum accommodation requirements
A renal dialysis class private health facility must provide for the accommodation of one or more of the following groups of patients:
(a)  patients who are admitted for more than 24 hours,
(b)  patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours,
(c)  patients who are admitted and discharged on the same day.
74   Accommodation standards
A renal dialysis class private health facility must comply with such of the following standards that are applicable to the facility:
(a)  if the facility provides for the accommodation of patients who are admitted for more than 24 hours—the overnight accommodation standards,
(b)  if the facility provides for the accommodation of patients who are not discharged on the day that they are admitted, but are admitted for not more than 24 hours—the extended recovery accommodation standards.
Part 18 Surgical class private health facility
75   Concurrent licensing
A surgical class private health facility must also be licensed as an anaesthesia class private health facility.
76   Procedure register
(1)  A surgical class private health facility must have a procedure register that records the details of every surgical procedure that is carried out at the facility.
(2)  Without limiting subclause (1), the procedure register must contain the following:
(a)  the patient’s full name, gender, date of birth and clinical record number,
(b)  the date, time and place that the surgical procedure was carried out,
(c)  the name of the procedure,
(d)  the name of any surgeon, surgeon’s assistant, anaesthetist and scrub nurse involved in the procedure,
(e)  the anaesthetic administered,
(f)  the nature, and identification number, of any prosthesis used during the procedure,
(g)  details of any complications arising during the procedure.
77   Clinical records
(1)  A surgical class private health facility must have a clinical record for each patient at the facility on whom a surgical class procedure is carried out.
(2)  Without limiting subclause (1), a clinical record must include the following:
(a)  in a case where anaesthesia has been employed—the anaesthetic record, which must comply with the recommendations of the Australian and New Zealand College of Anaesthetists in its publication Recommendations on the Recording of an Episode of Anaesthesia Care published in 2006,
(b)  the procedural report, including pre-procedural and post-procedural diagnoses, and a description of the findings, technique used and tissue removed or altered,
(c)  in a case where tissue or body fluid was removed—a pathological report on the tissue or body fluid,
(d)  a record of the swab, sponge and instrument count,
(e)  the post-procedural recovery record.
78   Specialist equipment
A surgical class private health facility must have the following equipment available in each room in which a surgical class procedure is carried out:
(a)  an electrosurgical unit,
(b)  adequate instruments for elective use,
(c)  sterile instrument sets available for emergency procedures.
79   Minimum accommodation requirements
A surgical class private health facility must provide for the accommodation of one or more of the following groups of patients:
(a)  patients who are admitted for more than 24 hours,
(b)  patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours,
(c)  patients who are admitted and discharged on the same day.
80   Accommodation standards
A surgical class private health facility must comply with such of the following standards as are applicable to the facility:
(a)  if the facility provides for the accommodation of patients who are admitted for more than 24 hours—the overnight accommodation standards,
(b)  if the facility provides for the accommodation of patients who are not discharged on the same day that they are admitted, but are admitted for not more than 24 hours—the extended recovery accommodation standards.
Part 19 Cosmetic surgery class private health facility
81   Application of certain standards
(1)  A cosmetic surgery class private health facility must comply with the anaesthesia standards listed in Part 1 of this Schedule.
(2)  Clauses 76–80 of this Schedule apply to a cosmetic surgery class private health facility in the same way as they apply to a surgical class private health facility. For that purpose, references in those clauses to a surgical procedure or surgical class procedure are to be construed as references to cosmetic surgery.
(3)  A cosmetic surgery class private health facility is not required to comply with subclause (1) to the extent that it carries out either of the following surgical procedures without anaesthesia but is, however, required to comply with the Guidelines on Sedation and/or Analgesia for Diagnostic and Interventional Medical, Dental or Surgical Procedures published by the Australian and New Zealand College of Anaesthetists:
(a)  fat transfer that involves the transfer of more than 2.5 litres of lipoaspirate,
(b)  liposuction that involves the removal of more than 2.5 litres of lipoaspirate.
sch 2: Am 2012 (156), Sch 1 [2]–[4]; 2016 (288), Sch 1 [5].
Schedule 3 Accommodation standards
(Clause 3 (1))
Part 1 Overnight accommodation standards
1   Compliance with guidelines
Any part of a private health facility that is used to accommodate patients for more than 24 hours must meet the requirements for an inpatient accommodation unit under the Australasian Health Facility Guidelines as in force on the issue of the licence for the facility, or on such later date as may be specified on the licence.
Part 2 Extended recovery accommodation standards
2   Admission criteria
(1)  A private health facility must have a written policy for determining whether a person may be admitted as a patient of the facility.
(2)  The policy referred to in subclause (1) must be reviewed at least every 3 years and must be submitted to the medical advisory committee for approval and comment.
(3)  A private health facility must not admit a patient otherwise than in accordance with the admission policy.