Health Services (Quality and Safety) Regulations 2020
S.R. No. 77/2020
Version incorporating amendments as at
30 November 2022
TABLE OF PROVISIONS
Regulation Page
1 Objective 1
2 Authorising provision 1
3 Commencement 1
3A Definitions 1
3B Serious adverse patient safety event 2
3C Appointment of SAPSE review panel 3
3D Membership of SAPSE review panel 3
3E Serious adverse patient safety event review report 3
3F Restrictions on SAPSE reviews 4
4 Quality and safety—prescribed entities 4
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Endnotes 5
1 General information 5
2 Table of Amendments 7
3 Explanatory details 8
Version No.002
Health Services (Quality and Safety) Regulations 2020
S.R. No. 77/2020
Version incorporating amendments as at
30 November 2022
1 Objective
The objective of these Regulations is to prescribe entities authorised to collect, use and disclose confidential information for a quality and safety purpose under Part 6B of the Health Services Act 1988.
Reg. 2 amended by S.R. No. 121/2022 reg. 5.
2 Authorising provision
These Regulations are made under section 158 of the Health Services Act1988.
3 Commencement
These Regulations come into operation on 27 August 2020.
Reg. 3A inserted by S.R. No. 121/2022 reg. 6.
3A Definitions
In these Regulations—
harm includes moderate harm, severe harm and prolonged psychological harm;
moderate harm means harm that requires a moderate increase in treatment to a patient, such as an unplanned or unexpected return to surgery, but does not include harm that causes permanent damage or injury to an individual;
prolonged psychological harm means psychological harm which a patient has experienced, or is likely to experience, for a continuous period of at least 28 days;
registered health practitioner has the same meaning as in the Health Practitioner Regulation National Law;
sentinel event means an unexpected and adverse event that occurs infrequently in a health service entity and results in the death of, or serious physical or psychological injury to, a patient as a result of system and process deficiencies at the health service entity;
severe harm means harm that causes a permanent lessening in the functioning of an individual that is unrelated to the natural course of a person's illness or underlying condition, including harm that can lead to a person experiencing a permanent impairment or disability, or death.
Reg. 3B inserted by S.R. No. 121/2022 reg. 6.
3B Serious adverse patient safety event
(1) For the purposes of the definition of a serious adverse patient safety event in section 3(1) of the Health Services Act 1988, a prescribed class or category is an event that—
(a) occurred while the patient was receiving health services from a health service entity; and
(b) in the reasonable opinion of a registered health practitioner, has resulted in, or is likely to result in, unintended or unexpected harm being suffered by the patient.
(2) To avoid doubt, an event in subregulation (1) includes an event that is identified following discharge from the health service entity.
Reg. 3C inserted by S.R. No. 121/2022 reg. 6.
3C Appointment of SAPSE review panel
For the purposes of section 128P(2) and (3) of the Health Services Act 1988, a joint SAPSE review panel—
(a) must include at least one member from each health service entity involved with the serious adverse patient safety event; and
(b) must consist of no less than 4 members; and
(c) may include a representative appointed by the Secretary; and
(d) if a SAPSE review relates to a sentinel event, must contain a consumer representative.
Reg. 3D inserted by S.R. No. 121/2022 reg. 6.
3D Membership of SAPSE review panel
For the purposes of section 128Q(1)(e) of the Health Services Act 1988, the following requirements are prescribed—
(a) a SAPSE review panel must consist of no less than 3 members;
(b) if a SAPSE review relates to a sentinel event, the SAPSE review panel must contain a consumer representative;
(c) a member of a SAPSE review panel who has a potential or actual conflict of interest with respect to a SAPSE review they have been appointed to conduct must disclose the conflict of interest to the other members of that panel.
Reg. 3E inserted by S.R. No. 121/2022 reg. 6.
3E Serious adverse patient safety event review report
For the purposes of section 128T(3)(b) of the Health Services Act 1988, the name and address of a person who has provided information to a SAPSE review panel (other than a person specified in section 128T(3)(a) of the Health Services Act 1988) is prescribed information.
Reg. 3F inserted by S.R. No. 121/2022 reg. 6.
3F Restrictions on SAPSE reviews
For the purposes of section 128Z of the Health Services Act 1988, the following procedures are prescribed—
(a) after the suspension of its activities, the SAPSE review panel must notify the chief executive officer (however named) of the health service entity that is the subject of the SAPSE review in writing regarding the suspected prohibited act;
(b) the SAPSE review panel may recommence its review once it receives written notice from the chief executive officer (however named) of the health service entity that the chief executive officer is satisfied that either—
(i) the suspected prohibited act did not occur; or
(ii) the suspected prohibited act is able to be investigated independently of the SAPSE review.
4 Quality and safety—prescribed entities
For the purposes of the definition of a quality and safety body in section 134V of the Health Services Act 1988, the following are prescribed entities—
(a) Safer Care Victoria, being an Administrative Office within the meaning of the Public Administration Act 2004;
Reg. 4(b) substituted by S.R. No. 121/2022 reg. 7.
(b) the Chief Quality and Safety Officer.
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Endnotes
1 General information
See www.legislation.vic.gov.au for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.
The Health Services (Quality and Safety) Regulations 2020, S.R. No. 77/2020 were made on 28 July 2020 by the Governor in Council under section 158(1)(q) of the Health Services Act1988, No. 49/1988 and came into operation on 27 August 2020: regulation 3.
The Health Services (Quality and Safety) Regulations 2020 will sunset 10 years after the day of making on 28 July 2030 (see section 5 of the Subordinate Legislation Act 1994).
INTERPRETATION OF LEGISLATION ACT 1984 (ILA)
Style changes
Section 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.
References to ILA s. 39B
Sidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided regulation, rule or clause of a Schedule is amended by the insertion of one or more subregulations, subrules or subclauses the original regulation, rule or clause becomes subregulation, subrule or subclause (1) and is amended by the insertion of the expression "(1)" at the beginning of the original regulation, rule or clause.
Interpretation
As from 1 January 2001, amendments to section 36 of the ILA have the following effects:
• Headings
All headings included in a Statutory Rule which is made on or after
1 January 2001 form part of that Statutory Rule. Any heading inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.
This includes headings to Parts, Divisions or Subdivisions in a Schedule; Orders; Parts into which an Order is divided; clauses; regulations; rules; items; tables; columns; examples; diagrams; notes or forms.
See section 36(1A)(2A)(2B).
• Examples, diagrams or notes
All examples, diagrams or notes included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule. Any examples, diagrams or notes inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, form part of that Statutory Rule. See section 36(3A).
• Punctuation
All punctuation included in a Statutory Rule which is made on or after
1 January 2001 forms part of that Statutory Rule. Any punctuation inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.
See section 36(3B).
• Provision numbers
All provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after
1 January 2001. Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs. See section 36(3C).
• Location of "legislative items"
A "legislative item" is a penalty, an example or a note. As from 13 October 2004, a legislative item relating to a provision of a Statutory Rule is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision. For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision. See section 36B.
• Other material
Any explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of a Statutory Rule. See section 36(3)(3D)(3E).
2 Table of Amendments
This publication incorporates amendments made to the Health Services (Quality and Safety) Regulations 2020 by statutory rules, subordinate instruments and Acts.