Advisory No: A13/01 (Amended)
TITLE
Notification of Significant Risk
VERSION
Version 3.0
DATE OF
PUBLICATION
8 September 2015
REPLACES
Version 2.0 issued 13 October 2013
STATUS
Active
COMPLIANCE
Mandatory
APPROVED FOR
DISTRIBUTION BY
COO
REVIEW DUE
DATE
September 2017
INFORMATION IN
THIS ADVISORY
APPLIES TO:
All approved accrediting agencies
KEY
RELATIONSHIP
All NSQHS Standards
RESPONSIBLE
OFFICER
Margaret Banks
Senior Program Director
CONTACT
DETAILS
Phone: 1800 304 056
Email: accreditation@safetyandquality.gov.au
TRIM NO.
D15-14936
LINKAGES TO
OTHER
ADVISORIES
and/or
DOCUMENTATION
ATTACHMENTS
NOTES
(if applicable)
Advisory No: A13/01
1) Significant Patient Risk – A paper and table outlining examples
of major risks that result in significant harm to patients and may
need to be reported
Amended August 2015
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Advisory No: A13/01 (Amended)
Notification of Significant Risk
PURPOSE:
To describe the requirements for approved accrediting agencies to notify significant risks
identified in health services to regulators and the Australian Commission on Safety and Quality in
Health Care (the Commission).
ISSUE:
Accrediting agencies have sought clarification on the reporting of significant risks identified during
an onsite assessment of a health service organisation.
Approved accrediting agencies have signed agreements as part of the approvals process to liaise
with health department contact officers. In particular, to notify regulators when a significant
patient risk is identified during assessment of a health service.
Ministers have tasked the Commission with the coordination of the Australian Health Services
Safety and Quality Accreditation Scheme. This includes receiving information, including
notification of significant risk.
A definition of significant risk has been agreed and is at Attachment 1 and available on the
Commission’s website at:
http://www.safetyandquality.gov.au/publications/significant-patient-risk/
REQUIREMENTS:
Approved accrediting agencies are to notify the regulator from the jurisdiction in which the health
service organisation is located when a significant patient risk is identified during assessment.
Notification should be made within 48 hours of a significant risk being identified and include an
action plan developed by the health service organisation to mitigate the patient risk.
The Commission also requires accrediting agencies to notifying the Commission when a
significant patient risk is identified.
Approved accrediting agencies are to inform their clients and include relevant clauses in any
contractual arrangements that information on significant risk in the private sector will be provided
to the regulators when it is required in regulation or policy of a government agency.
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Attachment 1 (TRIM: 72918)
Significant Patient Risk
The Australian Health Services Safety and Quality Accreditation (AHSSQA) Scheme requires
approved accrediting agencies to notify regulators if a significant risk of patient harm is identified
during an onsite visit to a health service organisation.
A significant risk is one where there is a high probability of a substantial and demonstrable
adverse impact. In each case a significant risk will be sufficiently serious to warrant an immediate
response to reduce the risks to patients. This may include interventions or changes to systems,
clinical care or clinical practice. While the focus of reporting by surveyors will be on significant
risks of patient harm, it will not necessarily exclude other significant risks. For each of the 10
NSQHS Standards examples of the risks that could be considered significant are detailed in
Table 1 below.
Few, if any Australian health service organisations pose an ongoing significant risk to patients,
however from time to time, lapses and errors may occur that result in an increased risk to
patients accessing care in that health service.
Where a surveyor identifies one or more major risks in a health service organisation that could
result in significant harm to patients the following actions are to be taken:
1. Surveyors are to notify both the health service organisation and their accrediting agency
that a significant issue has been identified
2. Surveyors and / or an accrediting agency is to negotiate with the health service
organisation a plan of action and timeframe to remedy the issues
3. An accrediting agency is to notify the relevant regulator that a significant issue has been
identified and confirm the action being taken as soon as practical, usually within one
working day.
The following list provide examples only, it is not exhaustive and should not be used exclusively
in identifying significant risks.
Table 1: Examples of major risks that result in significant harm to patients and may need
to be reported
Standard 1: Governance for Safety and Quality in Health Service Organisation
Risks
Impact
 A process for credentialing staff does not
 Staff practicing outside of their
exist and insufficient action is being taken
competency and/or agreed scope of
to address this issue.
practice which leads to patient harm.
 Patient care records do not accurately
 Patients receive the wrong care,
reflect care provided, notes are missing,
inappropriate care, are misidentified or
documentation is fragmented and no action
care is not provided as directed or
has been taken to address deficiencies in
required.
medical records
Standard 2: Partnering with Consumers
No significant risks of direct patient harm
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Standard 3: Preventing & Controlling Healthcare Associated Infections
Risks
Impact
 Hand hygiene is not evident across the
 Preventable infections are transmitted to
organisation
patients.
 Single use invasive devices are being
reused
 Multiple instances of aseptic technique is
not being practiced in the health service
 Multiple instances of standard precautions
and transmission based precautions are
not being practiced in the health service
 Reusable medical devices are not
decontaminated before reuse
Standard 4: Medication Safety
Risks
 A system to manage authorisations to
prescribe, dispense and administer
medications does not exist
 Patient medication histories are not taken
or recorded in patients clinical records
 Adverse drug reactions are not recorded in
patient clinical records or available at point
of care
 Storage of medicines is unsafe or not
secure.
Impact
 Patients are given the wrong
medication, do not receive the
medication they require which leads to
patient harm.
 Patients have adverse reactions to
medicines which were preventable.
 Patient medicines can not be dispensed
because they are not available, unsafe
or ineffective resulting in harm.
Standard 5: Patient Identification and Procedure Matching
Risks
Impact
 Lack of an organisation-wide system for
 Patients are misidentified and
patient identification and procedure
experience preventable harm.
matching
 No evidence of action to address multiple
near misses and/or incidents of mismatch
between patients with their care
Standard 6: Clinical Handover
Risks
 Lack of a structured clinical handover
system by the health service
 No evidence of action or the action taken is
insufficient to address multiple clinical
handover failures that have resulted in
serious patient harm
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Impact
 Patient information and/or accountability
for care is not transferred and patients
experience preventable harm.
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Standard 7: Blood and Blood Products
Risks
 No evidence of action or insufficient action
to address risks of serious patient harm
from the delivery of blood or blood
products
 Major adverse events related to blood and
blood products are not recorded, reported
or analysed
 Use, storage, collection and transportation
of blood and blood product is unsafe
Impact
 Blood or blood products are not
available for patients requiring care.
 Preventable harm occurs to patients
receiving blood or blood products.
 Unnecessary wastage of blood products
reduces patient access to product,
delaying care and or resulting in harm
from contamination.
Standard 8:Prevention and Management of Pressure Injuries
Risks
Impact
 Failure to identify or monitor the risks of
 Patients develop preventable pressure
developing a pressure injury by the health
injuries.
service
 Skin inspections are infrequent or not
undertaken on ‘at risk’ patients
Standard 9: Recognising and Responding to Clinical Deterioration in Acute Health
Care
Risks
Impact
 No evidence of action or insufficient action  Preventable patient harm occurs due to
to address multiple instances of delayed or
undetected or managed deterioration.
failed escalation and/or response to clinical
deterioration
 Multiple instances of the clinical workforce
without basic life support skills
 No access to clinicians with advanced life
support skills for deteriorating patients
Standard 10: Preventing Falls and Harm from Falls
Risks
Impact
 Failure to identify or monitor patient falls
 Patients are at risk of being injured from
and harm from falls by the health service
a preventable fall.
 No evidence of action or insufficient action
to address multiple instances of falls
prevention plans that are not developed or
not applied
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