Licensing process

Issuing an approval in principle and the licence for a private health facility

(s7 & s9 Private Health Facilities Act 2007)

Applications are assessed against the Private Health Facilities Act 2007 and Private Health Facilities Regulation 2017, with particular reference to the Australasian Health Facilities Guidelines.

Approval in principle

On receipt of an application for a licence, an acknowledgement letter is sent to the applicant advising that the application is being processed and routine checks have commenced to determine whether the Directors/Secretary are fit and proper persons to hold a licence to operate a private health facility.

The Ministry will review the 1:100 architectural plans supplied, and recommend modifications as required.  This process can delay plan approval if extensive modifications are required, or if the applicant suggests alternative solutions which require further review.

Following the consideration of all available information, a letter will be sent to the proposed licensee advising whether approval in principle is given.  If approval in principle is refused, written advice stating the reason for refusal and giving details on how to seek a review of the decision will be provided.  If an approval in principle is issued the letter will nominate a contact officer to assist with the process prior to licensing.

An approval in principle of an application will only be issued under section 7 of the Private Health Facilities Act 2007 after:

• satisfactory assessment that the applicant is fit and proper to operate a private health facility (including National Criminal Record Check)
• consultation with the relevant Local Health District, and relevant Branches in the NSW Ministry of Health such as Health Service Planning and Investment, Mental Health and Drug and Alcohol, Integrated Care, and Government Relations, has taken place; and
• proper consideration of any submissions received from third parties following public advertisement of the proposed private health facility.

The approval in principle letter will contain advice and detail conditions which must be complied with before the licence is issued. 

 Assessment of the architectural plan

Prior to issue of the licence

The conditions that must be complied with include:

• provide confirmation that the private health facility is compliant with all the requirements of the Private Health Facilities Regulation 2017 including but not limited to the following:
• disclosure of pecuniary interest as defined in clauses 19 and 20 of the Private Health Facilities Regulation 2017
• maintenance of buildings, facilities and equipment
• risk assessment and safety inspection program
• quality improvement
• communication system
• fire safety and emergency response
• disaster planning
• back-up power supply
• staffing
• clinical records and patient information
• infection control, waste and hazardous substances
• incident and adverse event management
• licensing standards for the relevant class(es)
• all building works associated with the private health facility must be undertaken in accordance with plans and specifications approved by the relevant local government authority
• on completion of building works, a copy of the certificate of classification issued by the relevant local government authority under the Local Government Act must be provided to the Regulation and Compliance Unit
• submit electronic Inpatient Statistics Collection (ISC) data to the NSW Ministry of Health
• establish a medical advisory committee in accordance with section 39, Private Health Facilities Act 2007 and advise the Regulation and Compliance Unit of the members of the committee
• advise the Regulation and Compliance Unit in writing of the person who is appointed as the director of nursing and that this person meets the requirements of section 37, Private Health Facilities Act 2007 and clause 14, Private Health Facilities Regulation 2017
• respond in writing to any correspondence issued by the delegate or the Secretary, NSW Health in respect of this facility, acknowledging receipt of the correspondence and answering in writing any request for information or enquiries issued in writing by the delegate or the Secretary, NSW Health
• put into effect within the time period specified any written recommendations or directions issued by the delegate or the Secretary, NSW Health
• furnish to the Regulation and Compliance Unit, as soon as practicable after the change occurs, particulars of any change in the directors/secretary or management of the licensee corporation
• advise the Regulation and Compliance Unit in writing of the name of the accrediting body, approved by the Australian Commission on Safety and Quality in Health Care under the Australian Health Service Safety and Quality Accreditation Scheme, you have engaged to accredit the private health facility against the National Safety and Quality Health Service Standards
• a commissioning inspection of the private health facility is required by officers of the Regulation and Compliance Unit.

An approval in principle of an application for a licence is valid for a period of twelve months and is not transferable.  The applicant may apply for an extension of the approval in principle, but the application for extension must be in writing, made before the twelve month period has expired, and be accompanied by the prescribed fee.

Issue of licence

Before the licence is issued, a final inspection is carried out to ensure that the private health facility has been built in accordance with the approved plans and complies with the conditions of the approval in principle and all relevant legislation. The following information, as relevant to the classes of health services to be provided, is required before a licence is issued:

• copy of the certificate of classification from an authorised certifier under the Local Government Act, for the use of the premises as a BCA Class 9(a) health care building;
• certification from the relevant manufacturer or registered professional that the following items have been correctly installed and meet the relevant Australian Standard:
• new equipment (equipment in the CSSD, dirty utility rooms, operating theatres, monitors etc.)
• fire retardancy for new furnishings, curtains and floorings
• warm water system (thermostatic mixing valves)
• nurse and emergency call bells
• medical gases
• air-conditioning
• backup power supply
• laminar flow cabinets installed at chemotherapy clinics
• EPA certification of lead lining in operating theatres. 
• letter of notification from the applicant concerning the appointment of the Director of Nursing for the facility, indicating that the person nominated meets legislative requirements & including a copy of current Authority to Practise;
• letter of notification from the applicant containing the Medical Advisory Committee (MAC) Membership details;
• letter of confirmation from the applicant that the nursing staff have the relevant qualifications and experience for all specialties;
• for a mental health class facility, an environmental risk assessment with action plan and timeframes from a recognised mental health professional;
• letter of confirmation from the applicant that the MAC has approved the admission criteria for each class(es);
• letter of confirmation from the applicant that the resuscitation equipment for use in advanced life support complies with the current Standards for Resuscitation published by the Australian Resuscitation Council and the Australian College of Critical Care Nurses;
• letter from accredited cardiologist that the Guidelines on Support Facilities for Coronary Angiography and Percutaneous Coronary Intervention (PCI) published by the Cardiac Society of Australia and New Zealand are adhered to, where applicable;
• letter from a recognised sterilising/reprocessing consultant confirming that the reprocessing complies with the Australian and New Zealand Standard AS/NZS 4187, where applicable;
• copy of current formal agreement with a nearby hospital or Local Health District capable of providing a higher level of patient care in the event of an emergency transfer – relevant to new facilities and class(es). In the case of cardiac catheterisation class there must be access to a hospital with cardiac surgery, or a private health facility with intensive care class, or a public hospital to which the patient may be transferred for cardiac surgery in less than 1 hour;
• letter from an anaesthetist or sedationist credentialed to the facility confirming the facility complies with the Australian and New Zealand College of Anaesthetists publications, where applicable;
• letter signed by a registered anaesthetist or sedationist stating the level and type of anaesthetic to be used for the procedures or treatment specified;
• copy of the notification letters from the applicant to the NSW Ambulance and Fire & Rescue NSW in relation to the opening of the new facility;
• a letter from a paediatric physician agreeing to be available for consultation while paediatric patients are accommodated at the private health facility, where applicable.

At the onsite commissioning inspection, all building, fire and other relevant certification will be required.  Following the successful commissioning, a licence will be issued, endorsed for the specific classes and services specified in the application. 

The new licensee is responsible for the conduct of the establishment as from the date of the licence.​​​​​​​​​​