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Health Bulletin 4 June 2020

In this edition: General Practice Accreditation Scheme, Draft COVIDSafe legislation, NSW organ donation guidelines, Aged Care Quality and Safety Commission, community pharmacists substituting specific medicines, legal issues for telehealth services, and the appointment of Michael Gorton AM to President of the Board of Wellways Australia.

The latest insights from our Health Law team:

General Practice Accreditation Scheme on hold

Draft COVIDSafe Privacy Legislation Introduced

New South Wales updates organ donation guidelines

Aged Care Quality and Safety Commission response to COVID-19 pandemic

COVID-19 - Community pharmacists to be permitted to substitute specific medicines

Legal Issues for Telehealth Services

Michael Gorton AM appointed President of the Board of Directors, for Wellways Australia

Learn more about Russell Kennedy's expertise in the Health sector here.

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General Practice Accreditation Scheme on hold

The Australian Commission on Safety and Quality in Health Care (Commission) has made an announcement regarding changes to the National General Practice Accreditation Scheme (Scheme) in response to COVID-19.

The Scheme has been changed effective immediately to assist general practices and to ensure compliance with social distancing measures. The changes mean that:

  • the accreditation status of general practices will be maintained during the response phase of the COVID-19 pandemic and will be reviewed moving into the recovery phase;
  • general practices that have completed onsite assessment, are in the remediation phase of their assessment cycle, and require further onsite assessment will not be assessed until the recovery phase commences; and
  • re-introduction of onsite assessment will take into account lead-time for planning and preparation of assessments.

General practices are not required to take any action as the changes are administrative in nature. General practices are still required to continue implementing the RACGP Standards for general practices to ensure continued safe and quality care for patients. 

Learn more on the Commission’s website here.

Read the RACGP’s alert on the changes here.

Draft COVIDSafe Privacy Legislation Introduced

Earlier this month, the Department of Health undertook a Privacy Impact Assessment in relation to the COVIDSafe contact tracing app — and now with over 5 million Australians registered to use the app, the federal government has introduced the Privacy Amendment (Public Health Contact Information) Bill 2020 (Bill) to amend the Privacy Act 1988 (Cth) (Privacy Act) so that many of the privacy protections already set out in the Minister for Health’s Determination under the Biosecurity Act 2015 (Cth) are reinforced in the Privacy Act.

For the purposes of the Privacy Act, the Bill specifies that COVIDSafe app data relating to an individual is classified as “personal information” and COVIDSafe app data generally is the property of the Commonwealth.

The draft legislation outlines several criminal offences relating to the improper use of the COVIDSafe app, including:

  • retaining or disclosing uploaded data outside Australia;
  • decrypting encrypted COVIDSafe app data; and
  • coercing individuals to use the COVIDSafe app.

The Bill also empowers the Office of the Australian Information Commissioner to manage complaints, conduct assessments relating to COVIDSafe app data and share information with state or territory privacy authorities where necessary.

You can read the Attorney-General’s media release here and the full text of the Bill here.

New South Wales updates organ donation guidelines

The NSW Office of the Chief Health Officer has updated its procedures for health facilities to follow in relation to the retrieval of organs and tissues from deceased donors in NSW.

The Guideline for Organ Donation after Circulatory Death (Guideline) describes the necessary requirements for health facilities to undertake organ donation after cardiac death (where death is characterised by the cessation of circulation of blood in the body, rather than neurological criteria). The Guideline includes requirements for referral criteria, patient and family management and criteria for the declaration of death.

The Policy Directive for Deceased Organ and Tissue Donation - Consent and Other Procedural Requirements (Policy Directive) outlines the requirements of the Human Tissue Act 1983 (NSW) and introduces new procedures for health facilities to follow in the donation process. In particular the Policy Directive reinforces that proper consent must be obtained from the deceased or their senior available next of kin, and a designated officer in the health facility must give written authority for the removal of any organ or tissue. This replaces the former 2013 Policy Directive.

Quality end of life care remains paramount, and the donation process must not detract from that. The NSW Organ and Tissue Donation Service is responsible for procedural compliance with the Guideline and Directive.

You can read the Guideline here. You can read the Policy Directive here.

Aged Care Quality and Safety Commission response to COVID-19 pandemic

In response to growing community concerns, the Aged Care Quality and Safety Commissioner, Janet Anderson, issued a statement on 2 April 2020 that the Aged Care Quality and Safety Commission (the Commission) continued to be committed to fulfilling its statutory obligations to provide for the “safety, health, wellbeing and quality of life of aged care consumers”.

In response to the COVID-19 pandemic, the Commission has published a “proportionate, risk-based approach” to minimise the risk of infection to aged care consumers, staff and the Commission’s employees.

Regulatory measures are focused on:

  • Managing and addressing complaints;
  • Engaging the aged care sector to share information and discuss potential responses;
  • Developing resources for aged care service providers;
  • Engaging consumers about the quality of care and services received during the pandemic; and
  • Monitoring aged care providers in relation to their response to the pandemic, including site visits, visitor restrictions and other forms of communication.

For example – resource posters restricting visitors who have not been vaccinated against the flu from entering aged care facilities in accordance with the Care Facilities Directions (No 2) VIC that came into force on 13 April 2020 (and similarly, such other directions and orders made in other States and Territories). To read the Victorian direction, click here

Further information and guidance resources are available here

To read the Commission’s statement, click here.

COVID-19 - Community pharmacists to be permitted to substitute specific medicines

In an effort to address the actual or imminent serious shortage of particular medicines at a national level due to the COVID-19 pandemic, the Australian Government is implementing changes to allow community pharmacists to substitute specific medicines without prior approval from the prescribing doctor in certain situations where a medicine is unavailable at the time of dispensing.

‘Serious shortages’ in medicine are categorised by strong evidence of an imminent gap in supply and the expectation of significant and immediate negative health consequences if patients went without the relevant medication at the prescribed intervals.

The changes will allow a pharmacist to dispense, for example:

  1. different strengths of a product (such as two 20mg tablets in place of a 40mg tablet); or
  2. dispensing a different dose form of the same medicine (such as a capsule instead of a tablet).

Medicines identified for substitution will be the subject of Serious Shortage Substitution Notice on the Therapeutic Goods Administration (TGA) website https://www.tga.gov.au/

The changes will only apply during the COVID-19 pandemic period, but over the coming months the Commonwealth and states and territories will consider whether different, longer-term approaches for substitution (including the Pharmaceutical Benefits Scheme (PBS) dispensing) are appropriate. 

Further information regarding the Serious Shortages Medicine Substitution initiative may be accessed here.

Mandatory healthcare worker vaccinations in Victoria and lowered flu shot age limit in NSW

Victoria recently introduced compulsory vaccination legislation through the Health Services Amendment (Mandatory Vaccination of Healthcare Workers) Act 2020 (Vic).The mandatory scheme captures those with direct patient contact including nurses, doctors, paramedics, dentists, orderlies, cleaners as well as staff working in public sector residential aged care facilities.  This new law comes after last year’s devastating flu season which saw 69,000 confirmed flu cases and numerous deaths.

The upcoming seasonal flu, combined with the risks posed by COVID-19, have also led the NSW government to lower the age where pharmacists can administer flu vaccinations to children to 10 years, down from the previous 16 years. Although the flu vaccine is not effective against COVID-19, immunity against the flu is key in reducing the likelihood a person will be susceptible to other illnesses. You can read the New South Wales Minister for Health’s media release here.

National Safety and Quality Digital Mental Health Standards Consultation

The Australian Commission of Safety and Quality in Health Care (Commission) is seeking feedback on its recently developed draft National Safety and Quality Digital Mental Health (NSQDMH) Standards.

The NSQDMH Standards aim to improve the quality of digital mental health service provision and protect service users from harm.  “Digital mental health services” means information, digital counselling services, treatment services and peer to peer support services delivered via telephone, videoconferencing, web-based services, SMS or mobile health applications.

Within the NSQDMH Standards there are three individual Standards:

  1. Clinical and Technical Governance Standard, which relates to the governance, safety and quality systems required to maintain and improve the safety and quality of digital mental health care;
  2. Partnering with Consumers Standard, which describes the systems and strategies to create a person-centred digital mental health system; and;
  3. Model of Care Standard, which describes the processes for developing and delivering digital mental health services, minimising harm, communicating for safety and responding to acute mental health deterioration.

The Commission has published the consultation draft of the NSQDMH Standards on its website and is seeking feedback from consumers, carers, clinicians, service providers, developers and any other interested stakeholders until 8 May 2020.

Access the NSQDMH Standards and more information about how to provide feedback here.

Legal Issues for Telehealth Services

The rapid growth in telehealth services by practitioners and health services, necessitated by the COVID-19 pandemic, raises issues of legal risk. It has also been noted by many that an expanded use of telehealth services is likely to continue after the COVID-19 pandemic is gone.

It is easy to minimise the potential risks at present when the only options are telehealth services or none. However, there are real risks in this present situation with are likely to be even more significant in more “normal” times.

To read the Alert authored by Michael Gorton AM please click here

Michael Gorton AM appointed President of the Board of Directors, for Wellways Australia

Russell Kennedy is pleased to congratulate Michael Gorton AM on his appointment as President of the Board of Directors for Wellways Australia.

Wellways Australia is a prominent disability and mental health organisation providing services across Queensland, New South Wales, Victoria and Tasmania, and the organisation services thousands of people each year.

Michael became a Director in 2019 and replaces long-term chair Paul Montgomery who is stepping down after nine years as President.

Of his appointment to President of the Board of Directors, Michael said, “The treatment and public attitudes to mental health issues, disability support and carer services are all topics about which I care passionately and was the reason I was originally attracted to the Board of Wellways. Wellways has achieved so much in the sector and is one of the leading organisations within the community mental health sector. I look to support its continued growth, while sustaining its existing programs and services."

To read more please click here.

Learn more about Russell Kennedy's expertise in the Health sector here.

If you'd like to stay up to date with Russell Kennedy's Insights, please sign up here.

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