Update to the Licensing and Regulation of Health Care Facilities

Discussion

Paper

ACT Health

Directorate

August 2020

Update to the Licensing and Regulation of Health Care Facilities i

Contents

Contents ................................................................................................................................................... i

Submissions ............................................................................................................................................ 2

Introduction ............................................................................................................................................ 3

What is a Health Care Facility? ............................................................................................. 3

Licencing Health Care Facilities in the ACT ........................................................................... 3

Discussion ............................................................................................................................................... 4

Prescribed medical and dental procedures .......................................................................... 4

Anaesthesia ........................................................................................................................... 6

Sedation in dentistry ............................................................................................................. 7

Cosmetic surgery ................................................................................................................... 8

Liposuction ............................................................................................................................ 9

Accreditation and governance ............................................................................................ 10

Next steps ............................................................................................................................................. 11

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Submissions Written submissions are invited from stakeholders on the questions and implementation options

presented in this paper. ACT Health invites submissions in writing via email (preferred) or to the

address below. A submission form is available to download on the ACT Health website:

www.health.act.gov.au/hcfconsultation

Email: hps@act.gov.au (with the subject ‘Health Care Facility Discussion Paper’)

Post: Health Care Facility Regulation Unit

Health Protection Service

Locked Bag 5005

WESTON CREEK ACT 2611

The closing date for submissions is Friday 18 September 2020.

All submissions will be treated as public and may be published unless the author indicates that it is

to be treated as confidential.

All requests for submissions to be treated confidentially will be respected and dealt with in

accordance with any applicable laws, including freedom of information legislation.

ACKNOWLEDGMENT OF COUNTRY

ACT Health acknowledges the Traditional Custodians of the land, the Ngunnawal people. ACT Health respects their continuing culture and connections to the land and the unique contributions they make to the life of this area. ACT Health also acknowledges and welcomes Aboriginal and Torres Strait Islander peoples who are part of the community we serve.

ACCESSIBILITY

If you have difficulty reading a standard printed document and would like an alternative format, please phone 13 22 81.

If English is not your first language and you need the Translating and Interpreting Service (TIS), please call 13 14 50.

For further accessibility information, visit: www.health.act.gov.au/accessibility

www.health.act.gov.au | Phone: 132281

© Australian Capital Territory, Canberra March 2020

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Introduction

What is a Health Care Facility? A Health Care Facility (HCF) is currently defined as a facility that provides overnight patient stays or

undertakes prescribed medical and dental procedures such as hospitals, medical clinics, cosmetic

and day surgery centres.1

Licensed HCFs include a range of public and private facilities such as hospitals, day procedure

surgical centres, cosmetic surgery centres, sleep clinics and some dentists who perform intravenous

sedation.

At present, in accordance with the Public Health Act 1997 (the Act), several procedures must only be

performed in an HCF. These procedures are:

• the administration of a general, spinal, epidural or major regional block anaesthetic or

intravenous sedative for the purpose of performing an elective procedure (excluding

mandibular blocks);

• endoscopy;

• dialysis, haemofiltration or haemoperfusion;

• prolonged intravenous infusion of a single cytotoxic agent or sequential intravenous

infusions of more than one cytotoxic agent; and

• cardiac catheterisation.

Health care providers that do not offer a prescribed medical or dental procedure, such as Maternal

and Child Health Clinics, physiotherapy providers or General Practice medical clinics, do not require a

HCF licence.

Licencing Health Care Facilities in the ACT In Australia, states and territories are responsible for the regulation of HCFs to ensure they maintain

high standards of quality to ensure the safety of the community.

These include maintaining appropriate hygiene and infection control standards; ensuring staff

availability and training; maintaining equipment; reporting and investigating adverse events; and

record keeping.

In the ACT, HCFs are managed through a licensing framework and supported by the Health Care

Facilities Code of Practice 2001 (The Code). The Code is an enforceable document under the Act and

outlines core requirements for HCF operators.

The licencing and regulatory framework that supports health care facilities in the ACT must keep

pace with new technologies and industry standards to ensure the public health risks posed by HCFs

1 Public Health Risk (Health Care Facilities) Declaration 2001 (ACT)

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are effectively identified and mitigated. It is also important to ensure consideration of

interjurisdiction consistency where possible to reduce regulatory complexity.

In order to ensure the Code remains up to date and relevant in protecting the safety of Canberrans

and reflects contemporary best practice, ACT Health is seeking to update the Code.

In 2019, ACT Health contracted consulting firm KPMG to undertake an independent review of HCF

regulation in the ACT. The KPMG review recommended strengthening the regulatory requirements

and better alignment with other jurisdictions. To progress these updates, ACT Health seeks

stakeholder views to ensure the proposed changes are fit for purpose and meets the needs of

Canberrans.

Discussion

Prescribed medical and dental procedures

To ensure the Code captures new health technologies, medical and dental procedures it is proposed

that the current list of prescribed medical and dental procedures be updated. This update would

capture services that carry a higher patient safety risk and remove lower risk services and better

reflect contemporary best practice.

Proposed approach

ACT Health is proposing that the current list of prescribed medical and dental procedures be

replaced by a new list of activities (prescribed health services) as listed in Table 1. These prescribed

health services would be restricted to being performed in licenced HCFs.

The list of ‘prescribed health services’ is based on the agreed list of procedures which should be

restricted to licensed hospitals or day surgery facilities endorsed by the Australian Health Ministers’

Advisory Council (AHMAC).

These new ‘prescribed health services’ are intended to more adequately capture HCFs that are

performing higher-risk procedures and better align the ACT with other jurisdictions.

ACT Health is seeking feedback on the list of prescribed health services listed in Table 1. ACT Health

is also interested in receiving feedback regarding the inclusion of specific health services due to

these services being regulated differently across jurisdictions. The procedures are:

• anaesthesia,

• sedation in dentistry,

• cosmetic surgery and liposuction

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Table 1 – current regulation versus proposed regulation

Current: Activities restricted to licensed HCFs Proposed: Activities restricted to licensed HCFs Prescribed Medical and Dental procedures Prescribed Health Services

a) Administration of anaesthesia The administration of a general, spinal, epidural or major regional block

anaesthetic or intravenous sedative for the purpose of performing an

elective procedure (excluding mandibular blocks)

a) Administration of anaesthesia*

the treatment involving the administration of general anaesthesia, major regional anaesthetic blocks, or intravenous sedation (excluding mandibular

blocks) that results in deeper than conscious sedation or has the potential to cause system toxicity.

b) Endoscopy b) Cardiac catheterisation

procedures 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) Dialysis, haemofiltration or haemoperfusion

c) Chemotherapy (cytotoxic infusion)

treatments using parenteral administration of one or more cytotoxic agents. d) Chemotherapy (cytotoxic infusion)

The prolonged intravenous infusion of a single cytotoxic agent or sequential

intravenous infusions of more than one cytotoxic agent

d) Cosmetic surgery**

includes any defined cosmetic procedure (excluding a dental procedure) that is intended to alter or modify a person’s appearance or body.

e) Cardiac catheterisation

e) Emergency medicine

any procedure or treatment relating to the immediate care of people suffering from an acute medical emergency, through the provision of

resuscitation, medical and surgical interventions and use of life support systems (excluding emergency service vehicles and General Practice

settings).

f) Gastrointestinal endoscopy treatment using a flexible, hollow endoscope that can accommodate the passage of an instrument to examine the upper or lower gastrointestinal tract.

g) Obstetric services

assistance and care immediately prior to, or following childbirth, including surgical intervention in achieving childbirth and care and assistance of a

mother admitted to the premises immediately after childbirth. h) Radiotherapy

treatments involving the use of ionising radiation from a radioactive source.

i) Surgery any planned or elective surgical procedure (excluding dentistry and General practice settings) not otherwise captured by this list that:

i) requires the use of surgical instruments within an operating theatre, procedure room, or treatment room for purposes of investigation,

reconstruction, treatment or correction of a disease state, injury, or bodily function; and

ii) involves the administration of intravenous anaesthesia or patient sedation.

j) Renal dialysis (haemodialysis)

includes any treatment that uses a dialyzer machine to remove waste and excess water from the blood.

k) Mental health services

any treatment of mental or emotional illness symptoms, conditions or disorders where patients are admitted overnight.

NB: The activities listed in Table 1 deliberately exclude aged care facilities, opioid detoxification centres or patient transport services. * Please see discussion 1.2 - Anaesthesia for further information and discussion.

** Please see discussion point 1.3 - Cosmetic Surgery for further information and discussion.

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Key questions to guide consultation response - Table 1, Prescribed Health Services

1. Does the list of prescribed health services (see Table 1, Column 2) appropriately capture all

activities that should be restricted to a licensed HCF? It not, please explain why?

2. Do the proposed changes create access to care issues? If so, how should these be

addressed?

3. Should non-invasive health services such as sleep clinics or inpatient care for family health

be included on the list of prescribed health services? If yes, which services should be

included and why?

Anaesthesia Current approach

Under current arrangements, any procedure performed under intravenous sedation (excluding

mandibular blocks) must be performed in a licensed HCF. All health practitioners administering

sedation may only do so in accordance with their professional registration, scope of practice,

employment and the Medicines, Poisons and Therapeutic Goods Act 2008 (MPTG Act).

It is recognised that the improper administration of anaesthesia, or an inappropriate medical

response to an event associated with anaesthesia, has the potential to cause patient harm including

system toxicity or death.

Effective regulation of HCFs that provide anaesthesia may help to reduce patient risk by ensuring the

HCF has appropriate equipment and training to manage adverse patient outcomes, such as allergic

reaction or anaphylaxis. Regulation can also help to ensure that HCF staff are able to identify and

respond to events requiring life support interventions.

Interstate approach

In response to growing levels of office-based surgery, the Victorian Government bolstered their

public health regulations in 2018 to restrict the provision of intravenous sedation to licensed HCFs or

a registered mobile provider. In contrast, New South Wales, Queensland and Tasmania permit

intravenous sedation to occur in non-licensed facilities provided it is performed in accordance with a

health professional's national registration and any applicable guidelines or standards set by a

National Health Professional Board.

Proposed approach

ACT Health recognises that placing restrictions on where intravenous anaesthesia can occur must

ensure the right balance between ensuring the access to medical treatment and effectively

managing the risk of to the public of the procedure.

ACT Health proposes that the provision of intravenous sedation resulting in deeper than conscious

sedation be restricted to licensed HCFs. These HCFs would need to demonstrate consistency with

core guidelines, such as the Australian and New Zealand College of Anaesthetists (ANZCA) Guidelines

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on Sedation and/or Analgesia for Diagnostic and Interventional Medical, Dental or Surgical

Procedures.2

The proposed approach to the regulation of anaesthesia in HCFs would also consider the use of

mobile sedationists in order to allow businesses the option of contracting mobile sedation services

within their facility to complement available health procedures. This proposed approach is broadly

consistent with other jurisdictions.

Key questions to guide consultation response - Anaesthesia

4. Is the proposal to regulate anaesthesia as described above targeted at the right level to

ensure patient safety without impeding procedures that can safely be done in practices?

5. Will the proposed regulatory requirements diminish patient access to care or

disproportionately increase the regulatory burden on HCFs providing anaesthetic services?

6. What minimum guidelines or standards should HCFs that provide anaesthesia be required to

meet?

Sedation in dentistry Current approach

The administration of intravenous sedation (with exception to mandibular blocks) must be

performed in a licenced HCF. The exception for mandibular blocks was originally provided to allow

dental procedures to be performed under sedation in accordance with a dentist’s professional scope

of practice and employment. However, since 2015 registered dentists may also provide treatment

under conscious sedation if the dentist holds current registration with the Dental Board of Australia

(DBA) and their registration is endorsed by the DBA to provide conscious sedation services.3

While a health professional’s registration is recognised across all jurisdictions, the current

regulations that restrict intravenous sedation to a licensed HCF could create access to care issues

and pose a barrier to dentists providing sedation services within their professional scope of practice.

In balancing health service accessibility and public safety arguments, most jurisdictions either

exclude sedation services provided by endorsed dentists or regulate only procedures that result in

deeper than conscious sedation or have the potential to create system toxicity.

Proposed approach

In recognising the scope of practice for DBA endorsed dentists to provide conscious sedation as well

the facility requirements set by the DBA for sedation, ACT Health proposes that dental procedures

performed under intravenous conscious sedation not be restricted to licenced HCFs. This position is

broadly consistent with other states and territories.

2 Australian and New Zealand College of Anaesthetists (ANZCA), P209 (2014) Guidelines on Sedation and/or

Analgesia for Diagnostic and Interventional Medical, Dental or Surgical Procedures 3 Dental Board of Australia, Registration Standard: Endorsement for Conscious Sedation (2015). DBA1602.01

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Key questions to guide consultation response - Sedation

7. Is the proposal to regulate sedation as described above appropriate?

8. Will the proposed regulatory requirements diminish patient access to care?

9. Does the proposal to allow dentists to provide intravenous conscious sedation (without

being licensed as a HCF) strike the right balance between public health and access to health

services?

Cosmetic surgery The type, availability and popularity of cosmetic procedures has grown dramatically in Australia over recent years and cosmetic procedures are now frequently carried out by medical practitioners in a variety of health and office-based environments.

As the number of cosmetic procedures has grown there have been increased concerns about its safety and regulation across Australia.

Interstate approach

Following extensive consultation in 2016, all jurisdictions agreed to a draft list of cosmetic surgical procedures that should be limited to licensed HCFs. The regulation of these specified procedures has been further reviewed by the Queensland, Victoria and New South Wales Health departments, resulting in minor jurisdictional differences in regulating cosmetic surgery in HCFs. 4-5 Proposed approach

Feedback is sought on a draft list of Cosmetic Procedures (at Table 2) that would be limited to licensed HCFs. Table 2 is based on defined cosmetic procedures that were agreed by all jurisdictions.

To avoid doubt, the procedures listed in the draft Cosmetic Procedures list would be limited to HCFs,

regardless of the method (e.g. non-surgical) or level of anaesthesia.

Table 2 - Cosmetic procedures proposed for regulation

Defined Cosmetic Procedures

a) Abdominoplasty

b) Belt lipectomy

c) Brachioplasty (armlift)

d) Bicep implants, tricep Implants, calf implants, deltoid implants, pectoral implants

e) Breast augmentation or reduction

f) Buttock augmentation, reduction or lift

g) Facelift, other than a mini-lift that does not involve the superficial musculoaponeurotic system (SMAS);

h) Facial implants that involve— (i) inserting an implant on the bone; or (ii) surgical exposure to deep tissue;

4 QLD Health (2017) Discussion paper, Review of cosmetic surgery regulation 5 NSW Government Health (April 2018) Report on the Review of the Regulation of Cosmetic Procedures.

https://www.health.nsw.gov.au/

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i) Fat transfer of more than 500mls of lipoaspirate

j) Labiaplasty

k) Liposuction that involves removing more than 2500mls of lipoaspirate

l) Mastopexy or mastopexy augmentation

m) Monsplasty or vaginoplasty

n) Neck lift

o) Penis augmentation

p) Rhinoplasty

Key questions to guide consultation response - Cosmetic Surgery

10. Are the defined cosmetic procedures in Table 2 appropriate? What (if any) procedures

should be added or removed from this list?

11. Should cosmetic procedures involving laser treatment be included in the list of defined

cosmetic procedures?

12. Should the list of defined cosmetic procedures be amended to allow for cosmetic procedures

to be performed in a non-licensed HCF if they are performed non-surgically?

Liposuction The inclusion of liposuction as a defined cosmetic procedure in Table 2 is proposed because of the

significant associated risks such as fluid imbalance or perforation. Australian jurisdictions have

endorsed varying volume limits on the amount of lipoaspirate that can be removed during

liposuction. Given these variations, ACT Health is seeking feedback on the volume limit that should

be applied that would restrict liposuction and fat transfer procedures to licenced HCFs.

The proposed volume limits of 2500mls liposuction and 500mls fat transfer (see Table 2) are based

on similar restrictions in New South Wales, South Australia and Queensland. While it is

acknowledged that volumetric restrictions on liposuction and patient fat transfer are not proven

indicators of patient risk, volume limits have been a useful tool used in other jurisdictions to capture

and control the risks associated with these procedures.

Key questions to guide consultation response - Liposuction and fat transfer volume limits

13. Is it appropriate to require liposuction (2500 ml or more of lipoaspirate) to only be carried

out in licensed HCF? If not, what limit should be set?

14. Is it appropriate to require fat transfer (500 ml or more of fluid transfer) to only be carried

out in licensed HCF? If not, what limit should be set?

15. Should additional guidelines be posted/considered/performed?

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Accreditation and governance The regulation of HCFs often includes a requirement for the HCF to have established governance

arrangements to ensure it can appropriately detect, investigate and respond to matters of clinical

significance, improve transparency, and complement quality improvement processes. In recognition

of the importance of strong governance frameworks, it is proposed that the Code for HCFs be

updated to require HCFs to:

• appoint a dedicated health professional with responsibility for the coordination of patient

care and records;

• maintain accreditation with the National Safety and Quality Health Service (NSQHS)

Standards as it applies to their HCF;

• establish a committee responsible for overseeing clinical practices of the HCF including

accreditation matters, clinical policies and procedures, and implementing change in

response to significant adverse events;

• meet minimum infection control, laundering standards and equipment requirements; and

• report serious adverse events associated with the HCF’s care or treatment of a patient e.g.

incidents under the Australian sentinel events list.6

In addition to the above regulatory updates, it is proposed that ACT Health create a public register of

licensed HCF to improve available information. It is recognised that a vast majority of currently

licenced HCFs would already satisfy these requirements, including accreditation to the NSQHS

Standards, however these updates to the Code would set a minimum standard for all existing and

new HCFs going forward.

It is recognised that maintaining accreditation to the NSQHS Standards can be costly to businesses

and that these costs may vary depending on the size of the HCF, the scope of services offered and

any applicable exclusions. It is therefore proposed that any rule requiring facilities to engage with

the NSQHS Standards include sufficient implementation time to allow facilities to review their

business models, to consider their NSQHS accreditation status, and apply for relevant exemptions.

Key questions to guide consultation response – Accreditation and Governance

16. Do you support requiring licensed HCFs to maintain accreditation with the applicable NSQHS

Standards?

17. Do you support the bolstering of HCF governance and reporting requirements as described

above? If not, please detail reasons why.

18. What specific HCF governance and reporting requirements would you like see included or

excluded in future regulations (e.g. patient experience data)?

19. What do you believe would be a reasonable timeline to allow HCFs to comply with any new

accreditation requirements?

6 Australian Commission on Safety and Quality in Health Care, Australian Sentinel events list (V2)-

https://www.safetyandquality.gov.au/our-work/indicators/australian-sentinel-events-list

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Next steps

Please provide feedback on the questions in this paper by following the submission instructions on

page 2. The consultation closes on Friday 18 September 2020. All feedback is appreciated and will be

considered in the development of consultation outcome report.