1. Licensing
   • Licensee issues:
     • insolvency, other legal matters, financial difficulties
   • Commissioning of a new facility/alterations & additions/ new services or classes:
     • lack of processes and resources e.g. insufficient staff numbers/experience
     • director of nursing not appointed
     • lack of policy/procedure i.e. specialised services
     • insufficient equipment for services/classes
     • relevant certification not provided
     • building works do not meet plan approval conditions
     • Medical Advisory Committee membership non compliant
   • Licence conditions:
     • patients accommodated in unlicensed areas
     • overcrowding – more recovery spaces than scheduled
     • paediatric patients accommodated in unapproved areas
     • closure/relocation of ward/service/beds without notice
     • commencement of a new service
   • Patient data:
     • trends identified – excessive number of transfers for higher level of care
     • evidence that facility is operating outside of licence conditions/admission criteria.
2. Governance/management
   • Medical Advisory Committee:
   • inadequate membership
   • inadequate governance processes (by-laws/terms of reference)
   • inadequate health professional credentialing
   • Management:
     • director of nursing not appointed
     • director of nursing not approved by the Ministry of Health
     • high turnover of management staff
     • insufficient management systems
3. Environment
   • Non-compliance with Australasian Health Facility Guidelines.
   • Non-compliance with Building code of Australia.
   • Inadequate risk assessment and safety inspection program.
   • Inadequate maintenance of building facilities and equipment.
   • Inadequate maintenance program.
   • Inadequate provision of equipment and stores for services for which the facility is licensed.
   • Inadequate communication system provided.
   • Inadequate policies and procedures for the management of environmental issues (e.g. waste & hazardous substances, fire safety, disaster management).
   • No or insufficient back-up power supply.
4. Clinical care
   • Insufficient number of appropriately qualified staff to carry out the services provided at the facility.
   • Inadequate clinical record documentation.
   • Lack of policies and procedures for the management of patient's clinical care (e.g. identification, admission & separation, transfer, privacy).
   • Infection control:
     • inadequate policies and procedures for the management of infection control
     • decontamination systems and processes do not comply with AS/NZS 4187
     • inadequate staff infection control education.
5. Quality improvement
• Incidents/root cause analysis (RCA):
  • inadequate policies and procedures for the management of incidents/RCA
  • inadequate reporting of incidents/RCA to Ministry of Health
  • reportable incident reported
  • any other adverse event reported to Ministry of Health that has been identified as an ongoing potential risk to patient safety
• Complaints:
  • inadequate policies and procedures for the management of complaints
  • complaint received by Ministry of Health for investigation and report
• Quality management system:
  • inadequate policies and procedures for the management of quality processes
  • lack of regular compliance/outcome audits
  • notification of "not met" with the National Safety and Quality Health Service Standards.
6. Compliance response from licensee:
   Refers to the level of compliance demonstrated by a licensee in response to recommendations made by the Regulation and Compliance Unit i.e. no response, incomplete/inappropriate response, written response but actions not implemented. The response is assessed over a 12 month period.

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