SafeWork NSW v Crown in the Right of New South Wales in respect of the Ambulance Service of NSW

Relevant Workers

1. Paramedics employed by ASNSW in the Hunter Zone worked at various ambulance stations, including: 1. Belmont Station, situated at 8 Herbert Street, Belmont NSW ('Belmont Station'); and 2. Birmingham Gardens Station, situated at 140 Wilkinsons Avenue, Birmingham Gardens NSW ('Birmingham Gardens Station').
2. Mr Anthony Jenkins was at all material times employed by ASNSW as a Paramedic in the Hunter Zone ('Paramedic Jenkins').
3. Mr Chris Wylie was responsible for the day-to-day management of Belmont Station ('Station Officer Wylie').
4. Ms Jeanine Bond was the Acting Station Officer for Belmont Station as at 9 April 2018 ('A/Station Officer Bond').
5. Station Officer Wylie and A/Station Officer Bond reported to several Duty Operations Managers ('DOM'), including Mr Michael O'Connor ('DOM O'Connor'), Mr Andrew Steenson ('DOM Steenson'), Mr Mark Gardiner ('DOM Gardiner') and Mr Matthew Liebregts ('DOM Liebregts').
6. The DOMs reported to Ms Kerry Akester who was responsible for the management of the Hunter Zone ('Zone Manager Akester'). Zone Manager Akester reported to Mr Robert Akester (her husband) who, as at 9 April 2018, was Acting Deputy Director of Operations ('A/DDO Akester'). A/DDO Akester reported to Director Beech.

Restricted Medications

1. At all material times, ASNSW was responsible for storing, handling and administering various medications.
2. Certain types of medication are restricted medications for the purposes of s 8 of the Poisons and Therapeutic Goods Act 1966 (NSW). Medications listed in schedule 8 of the Poisons and Therapeutic Goods Proclamation 2016 (NSW) require restriction to reduce drug abuse or dependence ('restricted medication').
3. Fentanyl is a restricted medication used to treat acute pain. Unauthorised chronic consumption of Fentanyl can lead to impaired cognitive function.
4. Morphine is another restricted medication that is stored, handled and administered by ASNSW.

Contextual background leading to the investigation by SafeWork NSW of ASNSW (discovery of misuse of restricted medications in the Hunter Zone)

Initial discovery of tampered medication at Belmont Station

1. At around 7:00am on 9 April 2018, A/Station Officer Bond, together with a paramedic employed by ASNSW, Ms Larelle Chapman-Davis ('Paramedic Chapman-Davis') were 'checking-out' medication from the restricted medication safe ('safe') at Belmont Station.
2. When examining two vials of Fentanyl to ensure that their packaging was intact and that the vials were in date, Paramedic Chapman-Davis noticed that the plastic wrap around the vials had been opened. Paramedic Chapman-Davis then inspected the remaining 11 vials of Fentanyl in the safe and noticed that each of them had had their plastic wrap cut and that some had sticky tape placed around their lids.
3. Paramedic Chapman-Davis informed A/Station Officer Bond that she suspected the Fentanyl vials had been tampered with.
4. A/Station Officer Bond examined the Fentanyl vials in the medication safe and also formed the view that they had been tampered with.
5. When the night crew paramedics arrived later that day, A/Station Officer Bond inspected their Fentanyl supplies and suspected that they had also been tampered with.
6. A total of 16 vials of Fentanyl were suspected as having been tampered with at Belmont Station.

Initial investigation by ASNSW

1. A/Station Officer Bond telephoned DOM Steenson to report her suspicions. DOM Steenson then informed Zone Manager Akester.
2. Zone Manager Akester asked DOM Steenson and DOM Gardiner to investigate the suspected tampering and to arrange for the matter to be reported to the NSW Police Force. Zone Manager Akester then asked DOM O'Connor to review electronic access to the safe at Belmont Station. Zone Manager Akester also informed DOM O'Connor that a ASNSW audit conducted in 2017 had revealed that Paramedic Jenkins was at that time the second-highest administrator of Fentanyl in ASNSW.
3. DOM O'Connor's review of electronic access to the safe revealed discrepancies, including that Paramedic Jenkins had on several occasions accessed the safe before the start of his shift.
4. Zone Manager Akester reported her suspicions and the investigations that had taken place to A/DDO Akester. A/DDO Akester reported the circumstances to Director Beech.
5. Around the same time, having conducted an audit of the Fentanyl stock at other stations in the Hunter Zone, DOM Steenson and DOM Gardiner discovered that several other vials of Fentanyl had been tampered with at other stations.
6. Director Beech asked A/DDO Akester to arrange a meeting with Paramedic Jenkins as soon as possible.

The meeting with Paramedic Jenkins

1. Later that day, A/DDO Akester and DOM O'Connor met with Paramedic Jenkins. During the meeting, Paramedic Jenkins disclosed the following information:

• He had been taking Fentanyl from ASNSW stocks and using it as a sleeping aid.
• He initially obtained the Fentanyl by taking residual medication leftover after treating patients.
• In the past several months, his need for Fentanyl had increased and he had started tampering with Fentanyl vials at various stations in the Hunter Zone by withdrawing Fentanyl from the vials and replacing it with saline solution.
• On the morning of 9 April 2018, having discovered that all the Fentanyl had been removed from the safe at Belmont Station, he took two vials of Morphine instead.
• Two broken vials of morphine had been left in the ambulance vehicle he had been working in earlier which was parked at Birmingham Gardens Station.

1. Following the meeting, DOM O'Connor found a further two vials of Fentanyl in the ambulance vehicle that Paramedic Jenkins had been using during his shift that day. Those vials were also suspected of having been tampered with. DOM O'Connor attended the Birmingham Gardens Station and located an empty vial of Morphine in the ambulance vehicle that Paramedic Jenkins had driven earlier that day. There was a syringe in the rubbish bin.

Identification and testing of tampered vials

1. The audits conducted by ASNSW across the Hunter New England Zone on or after 9 April 2018 revealed that a total of 44 vials of Fentanyl had been tampered with at various stations.
2. Subsequent testing revealed that a total of 10.1mg of Fentanyl was missing from the 44 vials.
3. Between 1 January 2009 and 18 June 2019, ASNSW was aware of 13 recorded cases of misuse of restricted medication by paramedics.

Investigation by SafeWork NSW

1. SW was notified on 11 April 2018 of the suspected tampering with restricted medication in the Hunter Zone. SW subsequently commenced an investigation into ASNSW.
2. ASNSW cooperated with SW's investigation.
3. As part of SW's investigation, some of Paramedic Jenkins' former colleagues were interviewed. In the period leading up to April 2018, some of them recalled observing instances where Paramedic Jenkins appeared to be 'asleep on his feet' whilst at work, that he would sleep at the station whilst on shift and talk to colleagues with his eyes closed. Paramedic Jenkins' colleagues had also observed changes in his behaviour when driving ambulances including pulling out in front of oncoming vehicles, swerving between lanes, missing turn-offs, failing to indicate when changing lanes and almost crashing into a bridge.
4. When colleagues asked about his behaviour, Paramedic Jenkins said that the medication he was taking for his prostate made him tired. With the benefit of hindsight, some of Paramedic Jenkins' colleagues agreed that his behaviour was consistent with drug use.
5. None of Paramedic Jenkins' behaviours were reported to ASNSW prior to 9 April 2018.

Auditing of restricted medications

1. As part of its investigation, SW examined ASNSW's auditing practises.
2. Between 1 July 2016 to 30 June 2017, the ASNSW Professional Standards Unit ('PSU') had conducted a state-wide audit to identify unusual patterns of Fentanyl use. The audit report was completed on 28 September 2017 ('Fentanyl Audit Report').
3. The Fentanyl Audit Report revealed that Paramedic Jenkins was the second-highest administrator of Fentanyl in the state.
4. The restricted medications register at Belmont Station showed that between January 2017 and November 2017, Paramedic Jenkins was the most common administrator of Fentanyl by a considerable amount. Paramedic Jenkins had administered Fentanyl on 59 occasions in that period. A considerable amount was left over after each administration. In the same period, the next highest administrator of Fentanyl at Belmont Station had done so on 18 occasions.
5. Paramedic Jenkins' Fentanyl administration habits were not escalated to relevant ASNSW management staff in accordance with internal auditing procedures.
6. The PSU provided the Fentanyl Audit Report to the Deputy Director of Operations of the Hunter and New England sector, Mr Jeff Hescott ('DDO Hescott') on 9 January 2018, together with a memorandum from the Acting Director of the PSU, Ms Alice Murphy ('AD Murphy').
7. In the memorandum, AD Murphy warned: 'High Fentanyl use, in particular where the entire vial was not used, often indicates a Fentanyl use problem by the staff member. This information is normally considered in relation to other concerns raised about their conduct… I ask that you use this information to see if local staff or managers have any other concerns that would indicate there are concerns with his Fentanyl use… the PSU will not monitor your enquiries, however if you believe any misconduct is identified please refer this misconduct issue to the PSU.'
8. DDO Hescott provided the Fentanyl Audit Report to Zone Manager Akester. It was not provided to Paramedic Jenkins' direct supervisor, Station Officer Wylie or to A/DDO Akester. DDO Hescott asked Zone Manager Akester to conduct an initial assessment. Zone Manager Akester delegated the task to DOM Liebregts.
9. DOM Liebregts conducted a retrospective documentation review in light of the Fentanyl Audit Report and produced a report on his findings ('Liebregts Report'). The Liebregts Report involved:

• randomly reviewing 54 electronic medical records ('EMR') prepared by Paramedic Jenkins;
• a review of the Incident Information Management System ('IIMS'); and
• a Restricted Medication Incident Tool ('RMIT') audit.

1. It is agreed that in producing the Liebregts Report, DOM Liebregts did not:

• interview Paramedic Jenkins, Station Officer Wylie or A/DDO Akester;
• review Paramedic Jenkins' personnel file; or
• refer to rosters or perform a Cyber Audit report to ascertain the frequency with which Paramedic Jenkins accessed the safe before, during and after his shifts.

1. The Liebregts Report identified that Paramedic Jenkins was regularly administering Fentanyl without obtaining a signature from a second witness. On 89% of the reviewed clinical records prepared by Paramedic Jenkins, more than half of the Fentanyl was leftover in the vial following administration of the drug. However, the Liebregts Report found no evidence to support a conclusion that Paramedic Jenkins' behaviour was indicative of personal medication use or addiction.
2. The Liebregts Report recommended that Paramedic Jenkins undergo further education with a Clinical Training Officer and that DDO Hescott advise the PSU that no misconduct had been found.
3. The Liebregts Report was approved and signed by Zone Manager Akester and DDO Hescott on 31 January 2018.
4. The Liebregts Report was not provided to Station Officer Wylie.
5. Zone Manager Akester stated that she did not know what was done to implement the recommendations of the Liebregts Report.
6. As at 9 April 2018, Paramedic Jenkins had not received any further education with a Clinical Training Officer.
7. Other relevant incidents that were not included in the Liebregts Report but uncovered by the SW investigation included:

• In October 2017, a paramedic found a Fentanyl vial that had been tampered with and recorded the event in the IIMS. The responsible DOM determined that the incident was an 'unexplained breakage'.
• On 22 January 2018, Paramedic Peter Clemenson ('Paramedic Clemenson') believed that he witnessed Paramedic Jenkins place a vial of Morphine into his private bag after treating a patient. Paramedic Clemenson reported the event to Station Officer Wylie. No IIMS report was completed in relation to the incident.
• On 31 March 2018, A/Station Officer Bond discovered vials of Fentanyl that may have been tampered with. A/Station Officer Bond did not report the incident on the IIMS or escalate it to her supervisors.

1. In the months preceding April 2018, Station Officer Wylie and the DOMs did not notice any suspected tampering with restricted medication when conducting Restricted Medications Audit Tool ('RMAT') audits at Belmont Station.
2. On 8 April 2018 (the day before the tampered vials were discovered), A/Station Officer Bond conducted an RMAT audit of the safe at Belmont Station. She did not discover any evidence to suggest that restricted medication had been tampered with.
3. Similar RMAT audits conducted by DOMs and Station Officers at other stations in the Hunter Zone in the months leading up to April 2018 did not uncover any evidence of suspected tampering with restricted medication.
4. Compliance with RMAT auditing procedures was found to be inconsistent across different stations in the Hunter Zone.
5. Station Officers in the Hunter Zone did not have separate time allocated to them in which to perform RMAT audits of restricted medication. The RMAT audits performed by Station Officers were often interrupted by callouts.

ASNSW systems of work regarding the storage and handling of restricted medications as at 9 April 2018

Medication management policies

1. ASNSW had the following procedures and policies in place to address the risk: 1. ASNSW Medication Management Policy Directive PD2016-018 dated 12 January 2017 ('MMPD'). 2. ASNSW Medications Management Operating Procedure PRO2016 dated 12 January 2017 ('MMOP'). 3. ASNSW Work Instruction - Service Delivery - Standardised Systematic Review of Electronic Medical Records WI2016-55 dated 30 November 2016 ('EMR Review instructions'). 4. ASNSW Clinical Records Policy Directive PD 2016-019 dated 12 January 2017 ('Clinical Records Policy').
2. These documents outlined the rules governing ASNSW's administration and management of restricted medications and provided for loss or discrepancies, breakage, recall, disposal, and audit requirements.

Access to restricted medication

1. ASNSW procedures and policies for access to restricted medication were outlined in Part 2 of the MMPD and the MMOP which provided that:

• only operational managers and authorised clinicians (such as on-duty paramedics) could handle, carry and administer restricted medication;
• the Station Officer was responsible for overseeing access to restricted medication at each station;
• access to restricted medication should be limited to authorised clinicians who are rostered to the station for the applicable period; and
• the Station Officer was required to review and, if required, modify the level of access to restricted medications on a monthly basis.

Storage and handling of restricted medication

1. ASNSW procedures and policies for access to restricted medication were outlined in Parts 3, 4 and 7 of the MMPD and Checklists 1 and 2 of the MMOP which provided that: 1. Restricted medications needed to be stored in a safe at the station. 2. The safe was to be kept locked when not in immediate use. 3. Restricted medications needed to be signed out to the authorised clinician and not to a particular vehicle. 4. Each station needed to have a restricted medications register ('register'). 5. All transactions for restricted medications needed to be recorded in the register. All restricted medicine stock, breakages and mandatory stock checks were to be recorded in red. 6. The authorised clinician who opened the safe was responsible for recording transactions and entries in the register until they closed the safe. 7. On each occasion an entry was made in the register, the authorised clinician was required to count the stock in the safe and reconcile the balance in the register. 8. Each entry made in the register needed to be countersigned by a witness, who was required to physically witness the stock count. 9. At the beginning of a shift, the authorised clinician was required to take the restricted medication needed for the shift from the safe. In the presence of a witness, the physical stock check and reconciliation of the register was to take place after which both the authorised clinician and the witness needed to countersign the register. The safe was required to be locked after use. 10. At the end of a shift, authorised clinicians needed to remove all restricted medications from their vehicle and return them to the safe. Another reconciliation was required to be conducted in the presence of a witness and a record made in the register, countersigned by the authorised clinician and the witness. The safe was required to be locked after use.
2. The safes were electronic and had a cyberkey electronic locking mechanism, opened using an electronic key combined with an employee number and pin number.

Administration of restricted medication

1. ASNSW procedures and policies for administering restricted medication were outlined in Parts 5 and 7 of the MMPD, Checklists 1 and 2 of the MMOP and the Clinical Records Policy which provided that: 1. Only clinicians who were on-duty were authorised to carry and administer medications. 2. Authorised clinicians needed to comply with all ASNSW procedures and policies relating to the administration of medication. 3. Prior to administration, clinicians were required to check the medication expiry date and the integrity of the packaging. 4. Prior to the administration of Fentanyl in particular, clinicians were required to use the Removal, Integrity, Penetration, and Effervescence methodology ('RIPE') to check each vial for: 1. Evidence of removal of the cap and any substitution of its contents. 2. Integrity of the packaging. 3. Evidence of penetration of the protective membrane which may indicate tampering. 4. A lack of effervescence (bubbles) when the vial is shaken, which may indicate that the Fentanyl had been removed or replaced.
2. All administration of medications needed to be documented in the clinical record which was also to be signed and witnessed.

Disposal of restricted medication

1. ASNSW procedures and policies for the disposal of any unused restricted medication were outlined in Part 6 of the MMPD and Checklist 1 of the MMOP which provided that: 1. Any unused portion of restricted medication needed be removed from its original container and discarded. 2. Unused restricted medication needed to be disposed in a manner preventing its retrieval and reuse. 3. The 'draw up' and discarding of the unused portion was required to be witnessed by a second clinician. 4. The amount discarded needed to be recorded in the register and signed by both the clinician and the witness.

Suspected tampering of restricted medication

1. ASNSW procedures and policies for the suspected tampering of restricted medication were outlined in Parts 5 and 8 of the MMPD and Checklists 1 and 7 of the MMOP which provided that: 1. Incidents involving restricted medication needed to be recorded in the IIMS. 2. If suspected tampering of restricted medication was identified, the matter should be escalated to management, documented in the IIMS and reported to the NSW Police Force. 3. The restricted medication suspected of having been tampered with was required to be quarantined, packaged and sent for analysis.

Information, instruction and training in relation to restricted medication

1. Every three years, each ASNSW staff member was required to renew their restricted medication certificate. The certificate verified the staff member's compliance with ASNSW's restricted medication policies including with respect to handling, storage, disposal, record keeping and checking requirements.

Drug and alcohol policies

1. The ASNSW Policy and Procedures for Dealing with Drug and Alcohol Use by Staff dated July 2003 ('drug and alcohol policy') was operative at all material times.
2. The drug and alcohol policy required that:

• Employees must not consume drugs or alcohol at work and not attend work under the influence of drugs or alcohol.
• Station Managers and Unit Managers were responsible for ensuring that employees do not perform their duties under the influence of drugs or alcohol.
• Employees were responsible for advising their supervisor if they suspected that a colleague was affected by drugs or alcohol at work.
• If a clinician disclosed a drug or alcohol problem, the Operations Manager needed to consider whether to withdraw the officer's authority to administer restricted medication and discuss the incident with the PSU as soon as possible.
• If an incident occurred where a clinician was suspected of being affected by drugs or alcohol on duty, the following steps were to be taken: 1. The employee was to be relieved of their duties involving driving or caring for patients immediately. 2. The employee's manager was to advise the employee of their concerns. 3. The employee's manager was required to request that the employee go home to recover on sick leave. 4. The employee's manager was required to ensure that the employee was provided with a safe way of getting home (e.g. by providing a taxi voucher or by organising a lift). 5. The employee was to be encouraged to seek support from the employee assistance provider.

Auditing of restricted medications

1. ASNSW procedures and policies regarding auditing of restricted medication were outlined in Part 11 of the MMPD and Checklist 2 of the MMOP and the EMR review Instructions which provided that: 1. Station Officers were responsible for: 1. Daily stock checks and reconciliations of restricted medication with the register. 2. A weekly audit of all restricted medications using the RMAT, which included: a. Examination of the integrity of restricted medication packaging. b. A retrospective review of entries in the register against clinical records. c. Recording when the electronic safe codes were changed and by whom. d. Reporting restricted medication incidents (including breakages, mishandling, discarding, clinical administration or documentation issues) using the RMIT. 1. A monthly review of 20 randomly selected EMR records for their station, with any emerging clinical trends to be reported to the DOM. 1. DOMs were responsible for: 1. Ensuring that audits of restricted medication were done using the RMAT. 2. Completing a monthly check of the restricted medication balance and stock levels. 3. Assisting Station Officers with their monthly random EMR review. 4. Reporting any emerging trends to the Zone Manager. 1. Zone Managers were responsible for overseeing and evaluating the audit results for their zone.
2. The responsibilities of Station Officers, DOMs and Zone Managers included conducting random audits.

Guidance material available to ASNSW

1. ASNSW had guidance material available to it in relation to handling the risk.

National Safety and Quality Health Service Standards

1. The Australian Commission on Safety and Quality in Health Care established the National Safety and Quality Health Service Standards ('NSQHS Standards') in November 2017.
2. The NSQHS Standards provided that an organisation such as ASNSW must: 1. Use risk management practises to monitor and take action to improve adherence to policies, procedures and protocols. 2. Support their workforce to maintain accurate healthcare records. 3. Support systematic audits of clinical information. 4. Implement and use training systems to assess the competency of its workforce. 5. Monitor workforce training participation. 6. Support its workforce to perform their roles and responsibilities for safety and quality. 7. Comply with legislative requirements for the safe and secure storage and distribution of medicines. 8. Identify high risk medicines it uses and have a system to store, prescribe and administer them safely.

Federal Scheduling Policy Framework

1. The Scheduling Policy Framework for Medicines and Chemicals ('Scheduling Policy') was endorsed by the Australian Health Ministers Advisory Council in December 2017.
2. The Scheduling Policy provided that Schedule 8 restricted medications carry a high propensity for producing dependency, misuse, abuse or illicit use.

Operation Tone Report

1. In September 2017, the Victorian Independent Broad-Based Anti-Corruption Commission released a special report concerning corrupt conduct involving Ambulance Victoria paramedics ('Operation Tone Report').
2. The Operation Tone Report detailed allegations that Ambulance Victoria paramedics engaged in various illicit practises including using drugs of dependence.
3. ASNSW was aware of the contents of the Operation Tone Report as at 9 April 2018.

NSW Health Drug and Alcohol Withdrawal Guidelines

1. The NSW Health Drug and Alcohol Withdrawal Guidelines dated 4 July 2008 were at all material times available to ASNSW and provided that: 1. Substance abuse can lead to clinical impairment. 2. Withdrawal occurs in drug-dependent people who stop or considerably reduce their drug use. 3. When a person is drug-dependent, withdrawal carries significant risk including physical and psychological harm and, in rare cases, death.

The Offences

1. In respect of particular 30(a) of the Amended Summons filed 4 April 2023 regarding witnessing movement from the safe and the disposal of restricted medication, it is agreed that ASNSW in the Hunter Zone:

• routinely failed to comply with its own policies and procedures in relation to the storage and handling of restricted medication;
• occasionally failed to ensure that the removal of restricted medication from the safe was witnessed by a second clinician;
• occasionally allowed clinicians to sign the register as a witness without actually having witnessed the removal or return of restricted medication from the safe, even when rostered as part of a dual crew;
• occasionally failed altogether to ensure that clinicians witnessed and recorded the removal or return of restricted medication from the safe on the register, even when rostered as part of a dual crew;
• did not always ensure the removal of the unused portion of the restricted medication from its original packaging before disposal;
• failed to ensure that clinicians, including Paramedic Jenkins, always disposed of restricted medication in the presence of a witness;
• failed to ensure consistent methods of disposal of restricted medication across different stations; and
• failed to provide space on EMRs to document the witnessing of the disposal of restricted medication.

1. In respect of particulars 30(b)-(d) of the Amended Summons relating to auditing and reporting to identify potential Fentanyl misuse, it is agreed that between 9 April 2017 and 9 April 2018, ASNSW in the Hunter Zone failed to implement formal procedures and policies for: 1. unannounced independent station audits to assess compliance with restricted medication policies; 2. escalation processes for corrective action after any unannounced audit; 3. regular audits of restricted medication use as recorded by EMRs so as to identify atypical use; 4. responding to any identified patterns of atypical use of restricted medication; 5. regular trend reporting on reported incidents involving restricted medication; and 6. reviewing trend reports to identify potential misappropriation of restricted medication.
2. It is agreed that ASNSW's auditing procedures (outlined at paragraphs 75 and 76 above) were insufficient to identify instances of potential restricted medication misuse by its staff.
3. It is agreed that as at 9 April 2018, ASNSW's auditing procedures were insufficient such that: 1. the tampering of 44 vials of Fentanyl across the Hunter Zone was not discovered; 2. routine failings by ASNSW staff to witness and co-sign EMRs were unknown; and 3. Paramedic Jenkins' atypical use and possible clinical misuse of Fentanyl which would have demonstrated the possibility of his illicit consumption of that drug was unknown.
4. It is agreed that as at 9 April 2018, Station Officers could not access Cyber Audit tools to determine whether clinicians were accessing restricted medication safes outside their shift times. Although senior ASNSW staff had access to Cyber Audits, they were not routinely performed.
5. In respect of particular 30(e) of the Amended Summons regarding information, instruction and training in relation to restricted medication, it is agreed that between 12 January 2017 and 9 April 2018, managerial staff at ASNSW had not completed their three yearly certifications in respect of the MMOP and the MMPD which meant that not all staff had received training on those procedures.

Amendment to ASNSW's systems of work after April 2018

State-wide audit - Operation RIPE

1. Between June 2018 and November 2018, ASNSW conducted a state-wide random medication management audit called Operation RIPE.
2. Operation RIPE was designed to establish and categorise medication issues in all ASNSW stations.

Medication Management Working Group

1. A Medications Management Working Group was established to review ASNSW's governance framework and identify opportunities to update its medications management policies and procedures.

Restricted Medications Management Option Paper

1. On 6 March 2019, ASNSW published a Restricted Medications Management Option Paper.

Amended policies and procedures

1. ASNSW has updated its policies and procedures as follows: 1. MMOP in July 2019; 2. MMPD in July 2019; 3. Use of Electronic Restricted Medication Safe and Cyber Audit Web Policy Directive PD2018-021; 4. Use of Electronic Restricted Medication Safe and Cyber Audit Web Operating Procedure PRO2018-029; 5. Drug and Alcohol Policy Directive PD 2019-013 on 21 June 2019; 6. Drug and Alcohol Operating Procedure PRO2019-009 on 21 June 2019; 7. Reporting Misconduct and Criminal Conduct PRO2022-013; and 8. Work Instruction 2019-076, Atypical Prescriber.

Risk

1. The risk is described in Annexure "A" to the Summons in the following terms: '[28] Risks to the health and safety of workers, including Paramedic Jenkins, could arise where paramedics handling Restricted Medications, including Fentanyl, misappropriated the Restricted medications whilst working for their own illicit consumption. [29] In particular, there was a risk that such conduct may cause impairment to the workers' judgment, including Paramedic Jenkins', either by way of an acute intoxication or because of impairments associated with long-term drug misuse that could affect their capacity to undertake their required functions, including driving and providing medical assistance, with a consequential risk of harm to themselves or other workers (the Risk).'

The Defendant's Duty

1. The defendant had a duty s 19(1) of the WHS Act to 'ensure' the health and safety of its workers, so far as reasonably practicable. The duty requires the identification of risks in the workplace, so far as is reasonably practicable. The duty requires the identification of risks in the workplace and the adoption of measures to eliminate or minimise them, so far as is reasonably practicable (see Kirk v Industrial Commission of New South Wales [2010] HCA 1 at [34]). The duty is positive, nondelegable and requires duty holders to search for, detect and eliminate, so far as is reasonably practicable, risks to safety.
2. The reasonably practicable measures to control the risk are set out in paragraph 30 of the Amended Summons as follows: '[30] The Crown in the Right of New South Wales in respect of the Ambulance Service of NSW failed to ensure, so far as is reasonably practicable, the health and safety of workers, including Paramedic Jenkins, in that it failed to take one or more of the following measures, each of which is alleged to have been reasonably practicable, to eliminate or, alternatively minimise, if it was not reasonably practicable to eliminate, the Risk: (a) Ensuring that whenever a paramedic was working as part of a dual crew, the removal from the safe, return to the safe, and the disposal of Restricted Medications was witnessed by another paramedic and the witnessing recorded on the Restricted Medications Register; (b) Conducting unannounced independent station audits to assess compliance with Restricted Medications policies (including policies relating to storage; maintenance of registers (including witness signatures), stock checks and integrity checks) to be conducted by an independent clinician and implementing an escalation process for corrective action; (c) Conducting regular audits of patterns of use of Restricted Medications as recorded in the eMR by paramedics to create trend reports so as to identify any atypical use which may suggest possible misappropriation and implementing an a policy to respond to and identified atypical use including by requiring notification to and consultation with the immediate supervisors of any paramedic identified as involved in such atypical use; (d) Creating regular trend reports on reported incidents involving Restricted Medications in the NSW Health Incident Information Management System to identify potential risks associated with the use of such Medication and reviewing these trend reports to identify potential misappropriation; (e) Providing every managerial staff member with line management duty for paramedics, specific training as to the contents of the MMOP and MMPD.'

Sentencing

1. The penalty to be imposed must be one which will give overall effect to the policy of the WHS Act, in particular, ensuring the safety, health and welfare of workers and others on workplace premises. I have had regard to the principle contained within the WHS Act that workers should be given the highest level of protection against harm to their health, safety and welfare from hazards and risks arising from work: s 3 of the WHS Act.
2. The Court is to be guided by the provisions of the Crimes (Sentencing Procedure) Act 1999 (NSW) ('Sentencing Act') which include: 1. Section 3A which sets out the purpose of sentencing; 2. Section 21A which sets out the aggravating, mitigating and other factors in sentencing; and 3. Section 22 which provides that a guilty plea is to be taken into account on sentence, as is the time when the plea was effectively indicated or entered.
3. The Court is to approach a sentencing exercise on the basis of it being one of 'instinctive synthesis': Markarian v The Queen (2005) 228 CLR 357.
4. The approach to sentencing has been identified by Russell SC DCJ in SafeWork NSW v HCM Building Pty Ltd [2019] NSWDC 632 at [109] in this way: 'The court must identify all the factors that are relevant to the sentence, discuss their significance and then make a value judgment as to what is the appropriate sentence given all the factors of the case: Muldrock v The Queen [2011] HCA 39; [2011] 244 CLR 120. This approach to sentencing, known as the "instinctive synthesis" approach, involves the making of a global judgement without any attempt to state precisely how any given factor has influenced the judgement.'
5. The charge in this prosecution is under s 33 of the WHS Act, and as such no allegation of risk of death or serious illness or injury is made as such matters are not an element of the offence (cf. 31 and 32 of the WHS Act). If I were to make any finding of that nature, I accept that it would offend the principle in The Queen v De Simoni (1981) 147 CLR 383.
6. The offending in the present case is in a unique category. The risk is a risk of misappropriation for consumption of restricted medications. Such misappropriation and consumption is a crime: Poisons and Therapeutic Goods Act 1996 (NSW); Drug (Misuse and Trafficking) Act 1985 (NSW). The reasonable practicability of any measures to address this risk must therefore be analysed in a context where the fact of criminal sanction (and consequential permanent loss of employment as a paramedic) has been an insufficient deterrent for the worker's behaviour.
7. Accordingly, the measures in this case are not to prevent an employee suffering injury as a result of the employee's own negligence, inadvertence or carelessness, but rather taking precautions to prevent a worker's intentional criminal conduct. Such conduct is committed by trained paramedical professionals who understand the dangers associated with the misuse of restricted medications including Fentynal.
8. Because it involves intentional criminal conduct, the risk is also one that has to be managed in circumstances where the worker can be expected to be taking care to conceal such offending from their employer, often using sophisticated means to do so.
9. To some extent, one wonders what else the defendant could do? During the breach period the defendant had in place extensive steps, programs and policies designed to ensure that the Restricted Medications were not used illicitly. The breach of the WHS Act can be summarised here, in my view, as a failure to take adequate steps to prevent knowingly unlawful conduct.
10. The defendant also confronts a difficulty in that the risk cannot be eliminated. To the contrary, it is imperative that the workers in this case (trained medical professionals with professional obligations) need to have ready access to restricted medications, including Fentynal, for the purpose of discharging their important public safety functions. Any measure aimed to reduce a risk to a worker cannot come at a cost of an increased risk to a patient or the community.
11. I accept that the context of the present offending therefore, can be readily distinguished, for example, from the types of measures that might be considered to be reasonably practicable to prevent a construction or manufacturing worker from wilfully or carelessly misusing a piece of equipment on the one hand, and from preventing a medical professional from having ready access to lifesaving medical equipment on the other.

Objective Seriousness of the Offence

1. The primary consideration requires a determination of the objective seriousness of the offence. The High Court made this clear in Muldrock v The Queen (2011) 244 CLR 120 at [27]: '…The objective seriousness of an offence is to be assessed without reference to matters personal to a particular offender or class of offenders. It is to be determined wholly by reference to the nature of offending.'
2. Subjective factors play a subsidiary role: Lawrenson Diecasting Pty Ltd v WorkCover Authority (NSW) (1999) 90 IR 464, 474-5.
3. The duty of the defendant requires that it ensure the health and safety of workers as far as reasonably practicable. This duty is not delegable, and the duty requires the identification of risks in the workplace and an assessment of measures to address such risks.
4. The gravity of the offence is determined by the extent of the duty holder's failure to ensure, so far as was reasonably practicable, that its workers were not exposed to risks to their safety: Orbit Drilling v The Queen (2012) 35 VR 399 at [62] (Maxwell P, Bongiorno JA and Kyrou AJA); Veen v R (No. 2) (1988) 164 CLR 465.
5. The objective degree of foreseeability is a matter for the Court to have regard to when considering the gravity of the offence: Capral Aluminium Ltd v WorkCover Authority (NSW) (2000) 49 NSWLR 610 ('Capral Aluminium') at [81].
6. The affidavit of Clare Louise Beech sworn 30 March (exhibit 1) provides very important and relevant descriptions of the defendant's operations. Director Beech is the Executive Director - Clinical Systems for the defendant. She has been a paramedic and working with the ASNSW in March 2007 despite commencing her tertiary studies in paramedics and ambulance management in 2003. In my view, she is imminently qualified to express the matters contained in exhibit 1. Paragraph 25 of her affidavit is illustrative of the relationships between paramedics: 'Managing the risk of fentanyl misuse/abuse is a complex matter, made difficult by a number of practical factors in the work performed by paramedics, including the following: a. access to and use of Restricted Medications is a necessary and integral part of the functions performed by paramedics in delivering a health service to the NSW public. Access cannot be completely prohibited, and even the implementation of systems of control which may limit or delay access must be considered carefully in light of their potential to impact on NSW Ambulance's service delivery; and b. the "culture of trust" which exists between NSW Ambulance paramedics. By a "culture of trust", I refer to the trust which develops given the nature of their workflow and the time demands in responding to emergency calls, and the act that paramedics typically working in pairs rely on other trained and qualified health professionals. While it is obviously important that a level of trust in your co-workers be maintained to ensure effective service delivery, the risk posed by potential diversion and misuse/abuse of Restricted Medication and the need for monitoring cannot be discounted in this context.'
7. I am satisfied that ASNSW had in place policies and procedures with regard to witnessing, auditing and monitoring the use of Restricted Medications during the breach period, however, they needed some amending, which has been done.
8. An offence will be serious where there is an obvious or foreseeable risk to safety against which appropriate measures were not taken even though such measures were available and feasible: Morrison v Powercoal Pty Ltd (No. 3) (2005) 147 IR 117.
9. Subjective factors should not be permitted to produce a sentence which fails to adequately reflect the seriousness of the offence: WorkCover Authority (NSW) v Profab Industries Pty Ltd (2000) 49 NSWLR 700 at [31].
10. The Court of Criminal Appeal examined the sentencing process with regard to the WHS Act in the matter of Nash v Silver City Drilling (NSW) Pty Ltd [2017] NSWCCA 96 ('Nash v Silver City'). Justice Basten at [34], under the heading 'Assessment of Risk' said: 'The sentencing judge commenced his consideration with the proposition that '[g]reater culpability attaches to the failure to guard against an event the occurrence of which is probable rather than an event the occurrence of which is extremely unlikely.' However, the truth of that proposition depends upon other considerations, including (a) the potential consequences of the risk, which may be mild or catastrophic, (b) the availability of steps to lessen, minimise or remove the risk and (c) whether such steps are complex and burdensome or only mildly inconvenient. Relative culpability depends upon an assessment of all those factors.'
11. His Honour further observed at [42]: 'The culpability of the respondent is not necessarily to be determined by the remoteness of the risk occurring, nor by a step-by-step assessment of the various elements. Culpability will turn upon an overall evaluation of various factors, which may pull in different directions. Culpability in this case is reasonably high because, even if the pressure event of the force which occurred might not be expected to occur often, the seriousness of the foreseeable resultant harm is extreme and the steps to be taken to avoid it, which were not even assessed, were straightforward and involved only minor inconvenience and a little, if any, cost. That assessment will involve both objective considerations and a consideration of what the respondent's responsible officers knew or ought to have known.'
12. I accept that s 3A of the Sentencing Act is generally regarded as a codification of the common law principles of sentencing: R v MA [2004] NSWCCA 92. The purposes of punishment in the section are constrained by the sentencing principles that exist under the common law such as the principles of proportionality and totality: R v MMK [2006] NSWCCA 272.
13. The Court is obliged to make an assessment of where on the scale of criminality the offence lies referable to the maximum penalty prescribed by the legislature: R v Cage [2006] NSWCCA 304 at [17]-[18] (Latham J).
14. The following matters are relevant to determining the culpability of the defendant: 1. The risks associated with Restricted Medications, in particular relating to their abuse, misuse and persons developing a physical or psychological dependence were well known as at 'the breach' period and were the subject of legislation and regulations. 2. ASNSW was aware that acute and chronic misuse/abuse of Fentanyl could lead to impaired cognitive function and impair the capacity of paramedics to perform their required functions. 3. During the breach period the defendant was aware of the potential for its staff, and in particular paramedics, engaging in conduct including theft, trafficking and use of drugs of dependence, such as Fentanyl, as a result of the Operation Tone Report. 4. To address such risks the defendant had a series of policies, directives and operating procedures in relation to the Restricted medication that were operative during the breach period. They are as follows: 1. Access to restricted medications. 2. Storage and handling of restricted medications. 3. Administration of restricted medications. 4. Disposal of restricted medications. 5. Suspected tampering of restricted medications. 6. Drugs and alcohol. 7. Auditing of restricted medications, including monthly random audits and trend reports. 1. ASNSW were aware that the effective implementation and enforcement of their systems for the management of Restricted medications was vital to ensure the safe and appropriate use of the medications by ambulance staff and paramedics. As such the risk was foreseeable and known to ASNSW during the breach period which is evident from the documented systems that it had in place at the time. 2. I find that ASNSW was aware that there was a risk that paramedics could misappropriate Restricted Medications whilst working, including Fentanyl, for their own illicit consumption and that there was a risk that such conduct may cause impairment to the workers' judgment, either by way of acute intoxication or because of impairments associated with long-term drug misuse that could affect their capacity to undertake their required functions, including driving and providing medical assistance, with a consequential risk of harm to themselves. 3. Whilst the defendant concedes that the risk was known, I accept the defendant had taken significant measures to meet it prior to the breach period. 4. The prosecutor concedes (PWS at [33]) that the implementation and enforcement of its existing systems for the removal of Restricted Medications from the safes, their return to safes and the appropriate disposal of Restricted medications by paramedics was a suitable and available measure. These procedures are described in the MMOP and the MMPD. 5. There is no allegation that the method of disposal of restricted medications and the policy with regard to the same constituted a breach of the WHS legislation. 6. After the breach period, ASNSW amended its requirements as to the witnessing process which is set out in the PTB at tabs 15 and 16. 7. These documents included additional requirements to the witnessing process, which in summary required two clinicians to witness the drawing up, administration and discarding process, and such procedures be recorded and signed by the witness. 8. ASNSW also amended their systems to include unannounced audits of stations performing inspection of records and signatures, stock cheques and integrity checks, and also of trend reports. Furthermore, specific training as to these checks was provided to all relevant personnel, particularly with management staff. 9. Although the damage or injury caused by the breach does not of itself dictate the seriousness of the offence or the penalty, I accept that here, the breach created circumstances where there was a real prospect of serious consequences. In this instance there were possible consequences that clinicians, including Paramedic Jenkins, could misappropriate Restricted Medications, such as Fentanyl, whilst working, for their own illicit consumption. 10. Importantly however, the risk was one that could only be minimised not entirely eliminated. 11. I accept that the measures that were available to minimise the risk were not simple and low cost, contrary to [42] of the PWS, but were resource-intensive and required ongoing analysis and reassessment about the extent to which they were continuing to minimise the risk. 12. There were strong countervailing factors that needed to be balanced in assessing the practicability of the implementation of any potential measures designed to address the risk, including the need for paramedics to have ready access to medications, the need to ensure public safety, the need to avoid delay in the provision of public health services (including medications), as well as measures involved in managing a large number of workers across a large geographical area. 13. The relevant works undertaken by the offender's employees will always necessarily involve a degree of trust to be given to trained medical professionals and relies upon a culture of trust between paramedics and their managers working together. Such culture, while important to produce effective outcomes in high-pressure situations, can present as a practical impediment in the implementation of potential measures as well as impacting how efficacious they are.
15. I accept that it is the risk that I am assessing the seriousness of, and not the manifestation of it. At [53] in Nash v Silver City, Basten JA dealt with the proper approach to considering the objective seriousness of offences under the Act, saying: 'It is important to note that the risk to be assessed is not the risk of the consequence, to the extent that a worker is in fact injured, but is the risk arising from failure to take reasonably practicable steps to avoid the injury occurring. To discount the seriousness of the risk by reference to the unlikelihood of the injury occurring is apt to lead to error. The conduct in question is the failure to respond to a risk of injury, conduct which will be more serious, the more serious the potential injuries, whether or not they are likely to materialise. The objective seriousness of the conduct will also be affected by the ease with which mitigation steps could have been taken.'
16. Where there was an obvious or foreseeable risk to safety against which appropriate measures were not taken, in circumstances where such measures were available and feasible, it will be a serious offence: WorkCover Authority (NSW) v Sarjame Storage Pty Ltd [2015] NSWDC 151 at [37] (Kearns DCJ).
17. The objective seriousness of an offence under s 32 of the WHS Act is considered in the context of the gradation of offences contained in ss 31-32 of the WHS Act: Nash v Silver City at [54]-[56]. The matters relevant to objective seriousness for a s 32 offence include:

• The potential consequences of the risk. Consequences may range from mild to catastrophic. Offending will be more serious where the potential injuries are severe, regardless of whether they are likely to materialize: Ibid [34];
• The availability of steps to eliminate or minimise the risk: Ibid [34];
• Whether those steps are complex, burdensome or mildly inconvenient. If mitigating steps could easily have been taken, the offending will be more serious: Ibid [34] and [53];
• Whether the risk was known or ought reasonably have been known to or identified by the offender;
• Whether the risk was an obvious or clear one; and
• The vulnerability of the workers exposed to the risk: SafeWork NSW v Grandcity Constructions Pty Ltd [2018] NSWDC 398 at [55] (Russell SC DCJ).

1. As a consequence of the matters set out above, I am of the view that this is an objectively serious offence. The seriousness of the foreseeable harm to a worker was known. However as conceded by the prosecutor, ASNSW had measures in place to mitigate the risk, prior to the breach period.

Deterrence

1. In fixing a penalty in relation to these offences, an important objective feature is the need for specific and general deterrence. This is enshrined in s 3A(b) of the Sentencing Act.
2. General deterrence is a significant factor when safety obligations are breached. The fundamental duty of the Court to ensure a level of penalty for a breach will compel attention to work health and safety issues so that persons are not exposed to risks to their health and safety at the workplace: Fisher v Samaras Industries Pty Ltd (1996) 82 IR 384 at 388 (Hungerford J).
3. When examining matters of deterrence, both specific and general deterrence apply: R v Miria [2009] NSWCCA 68.
4. The Court of Criminal Appeal in Bulga Underground Operations v Nash (2016) 93 NSWLR 338 at [177]-[180] reaffirmed the principle that both aspects of deterrence are matters which should normally be given weight of some substance in the sentencing process, unless there are exceptional circumstances which would allow a Court to depart from this rule, citing with approval the decision of the Full Bench of the Industrial Court of NSW in Capral Aluminium at [74]-[75] which said: '[74] … It follows that both aspects of deterrence [specific and general] are matters which should normally be given weight of some substance in the sentencing process; and although there may be exceptional cases (see, for example, Page v Walco Hoist Rentals Pty Ltd (No 2) [2000] NSWIRComm 39 at [40]-[43]), we would expect such cases to be very rare and where the relevant circumstances were held by the sentencing judge to be established, the judge must indicate with some precision the circumstances which had led to the exceptional course being adopted. … [75] … Even where an offender demonstrates good character or a commitment to rehabilitation, the court may be obliged to have regard to the need for general deterrence: see R v Thompson (1975) 11 SASR 217 at 222. This is particularly so where the offence in question is prevalent in society and represents a serious threat to the community. The need for general deterrence in relation to serious offences under the Act is undeniable.'
5. General deterrence must be a significant feature of the sentence imposed upon the defendant. It can be appropriately used to direct the industry's attention to the consequences of inattention and the need for greater concentration on the potential risks of death or serious injury associated with working in an environment where Restricted Medications are essential.
6. The requirement to comply with the expectation of the community, that both large and small employers will comply with safety requirements, means that employers must take the obligations imposed by the WHS Act very seriously. However, whilst general deterrence is a matter that I must consider in the sentencing process, it is not a factor to dominate the exercise of sentencing discretion to the exclusion of all other factors.
7. The prosecutor submits that it is appropriate that the penalty imposed on ASNSW communicates a message to other PCBUs that handle Restircted Medications of the necessity to ensure that measures are implemented to address the risks associated with workers misappropriating Restricted Medications for their own illicit consumption.
8. The ASNSW submits that whilst accepting that ordinarily general deterrence looms large in sentencing under the WHS Act, in these circumstances it would take on less prominence. Further, it is submitted that the risk in the present case involves a highly specific risk of trained health professionals misappropriating medications, and that the risk in this case has limited application to other occupations and other sectors, such that general deterrence is of more limited application.
9. I accept that to be the case in this prosecution. The breach that the ASNSW has entered a plea if guilty to is of such a unique failure and involves only one employer to whom the message needs to be enforced, cannot be compared to the message that needs to create general deterrence to a group of employers such as the building industry. I have taken that into account in coming to my determination of the appropriate sentence.
10. In relation to specific deterrence, the attitude of the defendant to questions of workplace safety and any steps taken to improve the safety of its worksites following a breach of a duty are relevant, as is the propensity for the defendant to reoffend. I note that the ASNSW continues to procure, possess, store, handle, administer and dispose of Restricted Medications as part of its operations to provide ambulance services in NSW, and in particular the Hunter Zone.
11. Staff of the ASNSW including paramedics continue to be required to access, possess, handle, administer, dispose of and document the use of Restricted medications, in particular Fentanyl, whilst carrying out their work. It is therefore apparent that the hazards and risks associated with the misappropriation of Restricted Medications by ASNSW staff whilst working, for their own consumption, that were identified as part of the offence, are still likely to arise.
12. Against those factors, I find that the need for specific deterrence is reduced by the fact that the ASNSW has no prior criminal history and by the extensive ameliorative measures that have been taken to date. Such steps also give me confidence that the ASNSW has very good prospects of rehabilitation. Nonetheless, there still needs to be an element of specific deterrence.

The Subjective Features

1. I accept that ASNSW has no prior convictions; s 21A(3)(e) and is a body of prior good character: s 21A(3)(f).
2. I accept that the defendant has good prospects of rehabilitation: s 21A(3)(h) of the Sentencing Act, as it has taken extensive steps to minimise the risk.
3. The defendant co-operated with SW during the investigations: s 21A(3)(m) of the Sentencing Act and is unlikely to re-offend: s 21A(3)(g).
4. I also accept that there has been evidence of remorse: s 21A(3)(i) of the Sentencing Act.
5. The defendant entered a plea of guilty, which of itself demonstrates remorse, and the prosecutor submits it is open to me to find that the defendant is entitled to the maximum discount on that basis. Thus, I will allow the deduction of 25% for the utilitarian value of the pleas in accordance with the principles set out in R v Thomson & Houlton (2000) 49 NSWLR 383: s 21A(3)(k) of the Sentencing Act. The plea and the assistance to my mind demonstrates a willingness to facilitate the course of justice: Cameron v The Queen (2002) 209 CLR 339.
6. Having taken all of those matters into consideration, the appropriate fine for the defendant is $250,000.00. The defendant is entitled to a discount of 25% for the utility of the early plea.

PENALTY

1. I make the following orders: 1. The defendant is convicted. 2. The appropriate fine for the offence is $250,000.00 and that will be reduced by 25% to reflect the plea of guilty. 3. Accordingly, I order the defendant to pay a fine of $187,500.00. 4. Pursuant to s 122(2) of the Fines Act 1996 (NSW), 50% of the fine imposed is to be paid to the prosecutor. 5. Pursuant to s 257B of the Criminal Procedure Act 1986 (NSW), the defendant is to pay the prosecutor's costs, as agreed or assessed.

Amendments 02 May 2023 - Representation amended to read : Mr C Magee for the Prosecution DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 02 May 2023