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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
care is not provided as directed or
action has been taken to address
required.
deficiencies in medical records
Last updated 12 December 2012
1
Standard 2: Partnering with Consumers
No significant risks of direct patient harm
Standard 3: Preventing & Controlling Healthcare Associated Infections
Risks
 Hand hygiene is not evident across the
organisation
 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
Impact
 Preventable infections are transmitted to
patients.
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
 Lack of an organisation-wide system for
patient identification and procedure
matching
 No evidence of action to address multiple
near misses and/or incidents of mismatch
between patients with their care
Last updated 12 December 2012
Impact
 Patients are misidentified and experience
preventable harm.
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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
Impact
 Patient information and/or accountability
for care is not transferred and patients
experience preventable harm.
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
 Failure to identify or monitor the risks of
developing a pressure injury by the health
service
 Skin inspections are infrequent or not
undertaken on ‘at risk’ patients
Impact
 Patients develop preventable pressure
injuries.
Standard 9: Recognising and Responding to Clinical Deterioration in Acute
Health Care
Risks
Impact
 No evidence of action or insufficient
 Preventable patient harm occurs due to
action to address multiple instances of
undetected or managed deterioration.
delayed or 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
Last updated 12 December 2012
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Standard 10: Preventing Falls and Harm from Falls
Risks
 Failure to identify or monitor patient falls
and harm from falls by the health service
 No evidence of action or insufficient
action to address multiple instances of
falls prevention plans that are not
developed or not applied
Last updated 12 December 2012
Impact
 Patients are at risk of being injured from a
preventable fall.
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