Immediate Assistants Pty Ltd v Chief Executive, Queensland Health
[2012] QCAT 245
•21 June 2012
| CITATION: | Immediate Assistants Pty Ltd v Chief Executive, Queensland Health [2012] QCAT 245 |
| PARTIES: | Immediate Assistants Pty Ltd |
| v | |
| Chief Executive, Queensland Health |
| APPLICATION NUMBER: | GAR162-10 |
| MATTER TYPE: | General administrative review matters |
| HEARING DATE: | 22, 23 September 2011 7, 8 March 2012 |
| HEARD AT: | Brisbane |
| DECISION OF: | M McLennan, Member |
| DELIVERED ON: | 21 June 2012 |
| DELIVERED AT: | Brisbane |
ORDERS MADE: | 1. The decision is confirmed. 2. Publication of any part of the Applicant’s Clinical Governance Framework, held on the tribunal file or produced to the tribunal and to the Respondent is prohibited. |
| CATCHWORDS: | Endorsement with condition – paramedic situated in remote area – controlled drug – restricted drug – consultation with medical practitioner – credentialing and training of paramedic – medical and pharmacological protocols – non-publication – enabling Act – jurisdiction Queensland Civil and Administrative Tribunal Act 2009, ss 19, 20, 24, 28, 66 Minister for Aboriginal Affairs v Peko-Wallsend Ltd (1986) 162 CLR 24 |
APPEARANCES and REPRESENTATION (if any):
| APPLICANT: | Mr M Snell, counsel, instructed by Stirling Henry Legal Solutions |
| RESPONDENT: | Ms H Bowskill, counsel, instructed by DLA Piper |
REASONS FOR DECISION
Immediate Assistants Pty Ltd (the Applicant) applied on 7 May 2010 to the Queensland Civil and Administrative Tribunal (the tribunal) for review of a decision made on 31 March 2010 by a delegate of the Chief Executive, Queensland Health (the Respondent) pursuant to section 28(2)(b) of the Health (Drugs and Poisons) Regulation 1996 (Regulation)[1], refusing to amend the endorsement (approval)[2] previously signed on 25 February 2010 and granted pursuant to section 18(1)(a) of the Regulation as effective from 28 February 2010.[3]
[1] The Regulation made pursuant to section 132 of the Health Act 1937.
[2] Approval EH-ATH-4222.
[3] The approval, due to expire 28 February 2012 was extended for six months.
Jurisdiction to review the decision is conferred on the tribunal by section 33 of the Regulation which provides that an “endorsement holder” may apply to the tribunal for review of a decision of the Respondent to refuse to amend an approval which is subject to conditions.
Section 19 of the Queensland Civil and Administrative Tribunal Act 2009 (the QCAT Act) provides that in exercising its review jurisdiction, the tribunal:
“(a) must decide the review in accordance with this Act and the enabling Act under which the reviewable decision being reviewed was made; and
(b) may perform the functions conferred on the tribunal by this Act or the enabling Act under which the reviewable decision being reviewed was made; and
(c) has all the functions of the decision-maker for the reviewable decision being reviewed.”
The review involves a fresh hearing on the merits and the purpose of the review is to produce the correct and preferable decision.[4] Section 24 of the QCAT Act provides that the tribunal may confirm or amend the decision; set aside the decision and substitute its own decision; or set aside the decision and return the matter for reconsideration to the decision-maker for the decision, with the directions the tribunal considers appropriate.
[4] QCAT Act, section 20.
The Applicant, which is a private provider of paramedic services, contends that the decision imposes conditions unnecessary for the safety of the administration of the drugs and were not imposed upon the Applicant in its first approval under which it had operated without incident or complaint for two years preceding the current decision.[5] These conditions have not been imposed upon comparable paramedics and ambulance employees of the State of Queensland. Further, the decision impermissibly distinguishes between private sector paramedics and State paramedics. The distinction is offensive to the obligations of competitive neutrality.
[5] First approval issued without restriction effective for two years on 28 February 2008.
There were general conditions to the approval:
a)scheduled drugs and poisons must be obtained from a licensed seller of scheduled drugs and poisons on the signed written order of a doctor employed, contracted or otherwise engaged by the Applicant;[6]
b)the scheduled drugs and poisons could only be possessed and issued by nominated persons employed, contracted or otherwise engaged by the Applicant for the purpose of performing their functions under the approval;[7]
c)in relation to qualifications and training, “the approval holder” must satisfy the criteria equivalent for appointment to paramedic level 4 of the Queensland Ambulance Service (QAS) granted by an Australian tertiary institution or a Registered Training Organisation registered under the relevant State legislation;[8]
d)in relation to administration, scheduled poisons listed in Table 1 of the schedule to the approval must only be administered to a patient in an acute situation and in accordance with the Applicant’s Paramedic Practice Guidelines;[9]
e)the scheduled poisons listed in Table 2 of the schedule required that they be administered only in an acute situation following consultation with and an instruction by a doctor employed by, contracted to or providing services to the Applicant. There was an exception to this requirement of consultation. In a clinical emergency, if in the opinion of a qualified paramedic, it was immediately life-threatening and consultation with a doctor was not possible immediately, the scheduled drugs and poisons must be only administered in accordance with the Applicant’s paramedic practice guidelines. Consultation with a doctor must occur as soon as possible after administration of the scheduled drugs and poisons.[10]
[6] Condition 1.2.
[7] Condition 1.3.
[8] Condition 2.1.
[9] Condition 3.1.
[10] Condition 3.2.
Table 2 drugs listed, in so far as they remained relevant to this review, are:[11]
Schedule 4 drugs
Metoclopramide
Midazolam
[11]The tribunal was informed by both parties in the course of the hearing that the impugned drugs were limited to this list.
Schedule 8 drugs
Morphine
There were other conditions in relation to records,[12] storage[13] and stolen or lost scheduled poisons.[14]
[12] Condition 4.
[13] Condition 5.
[14] Condition 6.
The Respondent’s reason for the imposition of condition 3 was: “Limits the use of the scheduled drugs and poisons and ensures safe, correct and appropriate use of the scheduled drugs and poisons.”
The Respondent referred to the basis of the condition. Included were:
a)consistency with similar approvals which had recently been given to other private providers;
b)the primary consideration of the protection of public health and safety and the necessary exercise of due caution in relation to the scheduled drugs and poisons particularly since the Applicant’s paramedics operate at distant and even remote sites away from immediate higher level medical and hospital assistance;
c)optimum provision of health care at sites by a teamwork approach between on-site paramedics and off-site medical practitioner(s);
d)urgent and immediate administration of approved scheduled drugs and poisons is possible with consequent consultation with off-site medical practitioner adviser and early review of the original action by the paramedic in a teamwork approach to the continuing clinical management of the patient.
The Respondent also referred to earlier correspondence from the Applicant[15] where it was stated that wherever the Applicant’s organisation is operating it develops “appropriate relationships with other medical personnel, especially local doctors and hospitals as well as allied health professionals ...”[16] The Respondent stated that this was not a reason for the decision but it indicated consistency with the principles expressed in the imposed condition.
[15] 24 January 2008.
[16]Letter dated 24 January 2008 addressed to Chris Healey, Manager, Drugs and Poisons Policy and Regulations, Queensland Health.
In the course of the hearing and consequent upon negotiations, the drugs upon which the application turned were reduced to metoclopramide, midazolam and morphine.
Evidence
In addition to two written statements[17] Dr Adrian Cohen told the tribunal that since its inception in 1986,[18] he had been the director and chief executive officer (CEO) of the Applicant which provides emergency services with personnel including paramedics, emergency service officers and security guards. His day-to-day role as CEO is administrative. There are two divisions, administrative and operational, the latter having a general manager. It employs 80 full-time personnel with 150 casual or part-time[19] presently located in New South Wales, Western Australia, New Zealand and Queensland. The Applicant describes its capacities in a marketing document[20] which states that it holds “... our own overseeing professional Medical Board, Medical and Pharmacology Protocols registered with the relevant departments, Pharmaceutical Wholesale Licences and we act legally, ethically and efficiently.” This document also states that it is a Registered Training Organisation.
[17] Dated 28 January 2010 and 5 July 2011 respectively.
[18]Amended Statement of Agreed Facts dated 8 March 2012 states the Applicant was registered as a corporation 28 January 1987, paragraph 1; Clinical Governance Framework 1.6.7 states it as 1986.
[19]“IA employs over 100 people from a wide range of medical, nursing and paramedical backgrounds with diverse experience encompassing clinical pre-hospital skills, rescue, helicopter, clinical governance, mine site and hospital-based care credentials.” Statement Dr Adrian Cohen 28 January 2010 paragraph 15.
[20] An Open Letter to Mine Management from Immediate Assistants undated file copy.
In Queensland it supplies remote area medical services to mining.
“The system that we use to identify and to certify them [paramedics] is referred to [as] the emergency services registry of Australasia[21] levels 1 through 5 for paramedics, there not being a nationally-agreed competency level for paramedics or certification system for paramedics as there are for doctors or nurses or podiatrists, and the typical paramedic that we would utilise would be a level 4 paramedic. On some sites we have level 5, also called intensive care paramedics, who have the full gamut of interventional skills and drugs that are used in state ambulance services that utilise intensive care paramedics.”[22]
The higher the grade of paramedic, the greater the latitude with respect to the drugs. There is no transportation provided from the mine site to hospitals. This is provided by the Queensland Ambulance Service (QAS) or via the Royal Flying Doctor Service (RFDS).[23]
[21] Emergency Services Registry Australasia Transcript page 21.
[23] Amended Statement of Agreed Facts dated 8 March 2012 paragraph 6.
Dr Cohen designed the pharmaceutical and medical procedures that the Applicant uses in conjunction with the medical director Dr Mark Gillett “together with having overall responsibility for our Quality Assurance programme and Clinical Governance requirements.”[24] Dr Cohen designed the systems, equipment and pharmaceutical requirements of the paramedics who work for the Applicant;[25] is personally responsible for the applications and annual renewals of pharmaceutical licences for the five States in Australia as well as a similar process for “our New Zealand company and a kindred role nationally with the Treaties and Monitoring unit of the Department of Health and Ageing covering import and export of pharmaceuticals.”[26] He is principally responsible for the Applicant’s commercial activities in Queensland.
[24] Statement Dr Adrian Cohen 28 January 2010 paragraph 6.
[25] Statement Dr Adrian Cohen 28 January 2010 paragraph 8.
[26] Statement Dr Adrian Cohen 28 January 2010 paragraph 14.
Since 1986, it has been operating commercially in various pre-hospital services, “as well as supplying a wide range of training, accreditation and specialised products ...” These, either alone or in collaboration, include rescues competencies (fire, vehicle, vertical rescue and breathing apparatus, pre-employment medicals, occupational medicine and return to work co-ordination, drug and alcohol testing, vaccination programmes, nationally accredited training and wellness programs which can include sleep apnoea, skin cancer and weight loss).[27]
[27] Statement Dr Adrian Cohen 28 January 2010 paragraph 16.
Paramedics are drawn from those who have recently left State or defence force work.
“We have a process that looks at their level of professional qualification, which degree or diploma that they hold. We look at the practice level that they have within their ambulance service and the most recent re-currency training or re-certification at that level. We undertake a clinical assessment of them if there is any doubts [sic] as to their recency or their currency or their capability.”[28]
If there are doubts either the clinical support managers, who are senior paramedics, or the medical directors undertake a process of clinical evaluation similar to the recertification assessments that occur in ambulance services including multiple choice written papers, short answer papers, the type of viva voce examination or scenario that is typically put to paramedics.[29] For such employees there was monitoring done every two years, a recertification based on annual clinical assessment of their skills, an examination of their professional development activities and various activities undertaken that contribute to their practice at that level.[30]
[28] Transcript page 22.
[29] Transcript page 22.
[30] Transcript page 22.
In hiring paramedics there are two pathways[31] to achieving certification with the Applicant. Pathway A applied to current practising paramedics from other ambulance services or the defence forces where the paramedic is facing annual assessment and recertification to practise. Pathway B applied to those who had been away from practice for a time and required skills validation or from a private paramedic service. The Applicant “will accept copies of the equivalent from recognised Ambulance Services for Employment Status A staff.”[32] He conceded that this system relied upon the paramedic having the necessary qualifications, certification and experience based on good State paramedic service standards. The current certificate to practise does not disclose level of paramedic practice.[33] Initially in NSW a payslip that indicated level of pay was requested.[34] There is an interview by two clinical operation managers and an induction process into the company. The Application Process Flowchart and Induction and Supervision apply to both pathways A and B.[35] The difference between the two pathways is the time involved. Pathway A applies to the State and defence force paramedics. They are “interviewed by the two clinical operations managers. If necessary, a form of assessment or challenge protocol. And then, . . . an induction process into our company ... that says, here’s our paperwork, our protocols, our procedures, our leave forms, our medical certificates, our patient records, and so forth. So that forms part of their induction process into the company.”[36] In relation to the Authority to Practice (ATP) Recertification[37] Employment Status B staff will undergo Annual Skills Assessment and Biennial ATP Recertification. Dr Cohen could not recall ever employing anyone from a private ambulance service.[38] The paramedics working in Queensland are all Advanced Life Support or Intensive Care paramedics with a minimum five years on-road experience.
[31]Applicant’s Clinical Governance Framework 3.4.1 Employment Status A and 3.4.2 Employment Status B.
[32] Applicant’s Clinical Governance Framework 4.0.
[33] Transcript page 66.
[34] Transcript page 66.
[35] Applicant’s Clinical Governance Framework 3.7.
[36] Transcript page 64.
[37] Applicant’s Clinical Governance Framework 4.0 & following.
[38] Transcript page 66.
Induction into the Applicant’s protocols involved “talk them through it.”[39] There were few discernible differences between protocols which were generally standardised across Australia, with some State protocols different but not dramatically so.
[39] Transcript page 67.
There is no induction course rather a program of learning which is worked through with a clinical supervisor over a week wherever the paramedic is located.[40] The Applicant certifies and issues an authority to practise on the basis of the State certification. Outside training, distance education or employer provided courses were encouraged and participation in international areas of the business. In response to the question that it was up to the paramedics to decide what training, if any, they would undertake, Dr Cohen said that the Applicant accredits points for courses, for example, five points for forensic cardiology. Recertification requires 100 points for both pathways comprised of all clinical development activities, regular monthly clinical papers for which they submit their answers as part of the process in their annual clinical assessment.
[40] Transcript page 68.
The Applicant’s paramedics are required to undergo periodic recertification[41] to the same standard as State ambulance services through a “triennial process administered by a senior paramedic with State ambulance service capabilities.”[42] Dr Cohen told the tribunal that the Applicant required a minimum one year commitment from the paramedic and the paramedic could as fly-in, fly-out workers, undertake online learning or use self-directed learning. Sponsorship of paramedics through, for example, resuscitation or hyperbaric courses or to conferences was possible. He conceded that in the absence of a national equivalence system for qualifications or disciplinary action, responsibility devolved upon the employer.[43]
[41] Statement Dr Adrian Cohen 28 January 2010 paragraph 61.
[42] Statement Dr Adrian Cohen 28 January 2010 paragraph 24.
[43] Transcript page 90.
The clinical audit and review process involved 20% of cases plus a review of 12 cases where there had been serious injury or a death.[44] All this amounted to a biennial review as part of the operations. The clinical competency may be assessed on a random basis or identified concerns re outcome. This was done by the clinical operational support managers and presented to the medical director. The employee can also have peer review. It is also communicated through the organisation if there are “learnings” from it. In approaching the issue of comparable skills the Applicant’s paramedics were assessed against the paramedic skill set per State.
[44] Transcript page 22.
Dr Cohen stated that protocols are limited to known drugs in known quantities. Dosage is graded for paramedics and designed for no discretion on the part of paramedics. He stated that it was possible for an experienced paramedic to have more expertise than a general practitioner or a specialist in another field. If there was an adverse effect, there are protocol answers. A remotely situated doctor was in no better a position to anticipate problems such as adverse reactions to certain drugs. Delay is an impediment to the treatment flow to a patient in the “golden hour”.
There are now restrictions imposed by the Respondent where paramedics have worked without restriction for up to 10 years. Dr Cohen acknowledged that discussion with a doctor could be helpful but it was rare for a metropolitan based paramedic to seek consultation and remote based paramedics practise on their own according to the protocols. Dr Cohen was adamant that a remotely placed doctor was in no better position than the paramedic to make a firsthand clinical judgment about a patient. In any event, the protocols provide guidance as to the clinical course in the event of adverse reactions to drugs. There had been no adverse event with any of the restricted compounds under the first or second approval.
The Applicant operates predominantly in remote areas in Queensland or within one hour of a major centre with a significant proportion of revenue in the coal sector. The Applicant is concerned there could be commercial ramifications with the Respondent’s conditions. There were competing assumptions re the competency of QAS paramedics and the adequacy of other private providers. In relation to the restricted drugs, “once or twice per month” there were questions why the Applicant but not the QAS paramedics were subject to conditions. Given the scale and the nature of what the Applicant does, it could not emulate the large QAS but has a system of checks and balances appropriate to what it does.
In relation to the condition 3.2 administration of morphine, Dr Cohen raised the incident at the Curragh North mine site of a miner with a fractured femur which was a traumatic injury where a concrete or steel pipe had fallen and caused the injury. The closest hospital centre was at Rockhampton 250 kilometres away. Phone contact to the contact doctor was patchy. It was not the practice of the Applicant to employ satellite phones but two-way radios are available. The single paramedic was faced with a situation which was not life threatening. Dr Cohen then went through the sort of questions a doctor might ask including age, nature of injury, co-morbidity, distal pulse, pulse oximetry, level of consciousness, deformation. He conceded that all these considerations are required under the protocol.[45] The length of time to administer the morphine would be “several minutes”. Dr Cohen did concede that this patient was given appropriate analgesia.[46] He had received a phone call after the patient had been dispatched to hospital to authorise the use of morphine.[47] There was no adverse outcome for the patient.[48]
[45] Transcript page 84.
[46] Transcript page 84.
[47] Transcript page 83.
[48] Transcript page 84.
Dr Cohen said there were between 30-40 paramedics in Queensland with a single paramedic on any one shift and paramedics may be co-located with the emergency personnel. The Applicant does employ a number of contact doctors experienced in emergency medicine available for the paramedics who have the contact phone numbers. There is also a “working relationship” with local doctors “so that we can refer patients and talk to them about patients in return to work”.[49] He speculated that paramedics had to exercise phone contacts once or twice per month[50] and the contact is usually about analgesia. Dr Cohen stated that he is one of the doctors available to a paramedic to contact when needed.
[49] Transcript page 59.
[50] Transcript page 48.
The Applicant has a Clinical Governance Group with Dr Mark Gillett as its head. It meets at least annually or more often if there is a specific issue.[51] This is made up of medical directors from Australia and New Zealand, with clinical operations support managers. It deals with the content of the pharmacological or medical protocols. There is no requirement for physical presence only electronic communication. Minutes were taken and Dr Cohen would discuss with the Clinical Governance Group, Dr Stephen Rashford’s[52] view re making these minutes available to the Respondent.[53] The Medical Advisory Panel which includes a film producer for commercial reasons, meets less frequently.
[51] Transcript page 60. Dr Cohen also stated it met “... at least quarterly” at page 61.
[52] Affidavit of Dr Stephen Rashford dated 21 July 2011 paragraphs 28-31.
[53]Minutes of the Clinical Governance Group Meeting dated 18 October 2011 were provided and appended to Dr Jeanette Young’s [JRY01] Further Statement of Dr Jeanette Young dated 24 February 2012.
Dr Cohen confirmed that the 2011 Medical Protocol provided to the Respondent in September 2011[54] under which the Applicant’s paramedics were then working was a draft protocol which had not yet been approved by the Clinical Governance Group but was expected to be approved in the following month’s meeting.[55] He acknowledged that it might not be the most current as the protocols had been changed in the last three months.
[54] Dated 20 September 2011.
[55]Transcript page 63. An updated copy dated 11 March 2012 was provided to the tribunal on 8 March 2012.
In relation to Midazolam which is mainly used in the treatment of seizures, Dr Cohen said that seizures were not usually life threatening but demurred[56] with Dr Rashford that Midazolam can be dangerous for sedation.[57] He indicated his openness to considering Dr Rashford’s suggestions in the evolution of the drug protocols.
[56] Transcript page 79.
[57] Affidavit of Dr Stephen Rashford dated 21 July 2011 paragraphs 40 and 41.2.
Dr Cohen stated that the Applicant had a number of consultant emergency physicians who could be contacted for advice on an ad hoc basis.[58] He did not know and could not estimate how many cases the Applicant had dealt with in the last 12 month period in Queensland.[59] He subsequently gave an approximation of 10-12 patients per day at each site in Queensland.[60]
[58] Statement Dr Adrian Cohen 28 January 2010 paragraph 10 and Transcript page 98.
[59] Transcript page 70.
[60] Transcript page 101.
Dr Mark Gillett, a specialist in emergency medicine, had been the Medical Director of the Applicant since 1998 and in this role, had overseen the development and implementation of the Applicant’s medical and pharmacological protocols which had been developed in association with the Applicant’s senior paramedic advisory panel. He annually reviews and updates all aspects of the Applicant’s clinical practice.[61] He was also a member of the medical advisory panel which oversees the protocol development which he advises upon after review of the literature. He makes recommendations to the medical advisory panel which advice is accepted.[62]
“Ms Bowskill: And, then, from that panel, do the protocols go to the clinical governance group for approval?
Dr Gillett: I’m not aware of that. The clinical governance committee is really looking at the skills base of the paramedics and their maintenance and upgrading of skills within that group, but I’m sure that within the internal communications it would go to all the members but it basically is to the medical advisory committee that produces this.”[63]
[61] Statement of Dr Mark Gillett 10 February 2011.
[62]Transcript page 117. The nomenclature tended to be somewhat confusing being variously: “clinical governance committee” or “clinical governance group” by Dr Cohen or “expert advisory committee” or “medical advisory committee”.
[63] Transcript page 117.
On his review of a number of State protocols he found there were subtle differences between them. The Applicant’s medical and pharmacological protocols which he oversees, were reviewed annually[64] with the medical paramedic consultative group which develops the protocols within the current literature. His annual review took him a couple of Sundays of four to six hours while a major review would take the whole week-end. Reasonable clinical minds might differ re dosage regime and so there were subtle differences but since the Applicant employs a lot of NSW ambulance officers, they would tell the Applicant if there are differences in NSW State protocols made during a year.
[64] Statement of Dr Mark Gillett 10 February 2011 paragraph 14.
With the Clinical Support Manager, he is involved in the oversight of the credentialing process of the paramedic staff “to the standard of the skills and knowledge levels expected of ambulance services of the various states of Australia.”[65] He was a member of the Clinical Governance Group which looks at the skills base of the paramedics in an annual update and one of the people that makes recommendations for various levels of practice within the organisation for paramedics. The tests applicable in the Induction and Supervision[66] applied only to those in Employment Status B unless there were concerns with any persons in Employment Status A.[67] The tribunal notes there is some discrepancy here between what Dr Gillett understands re the pathways and Dr Cohen’s understanding although Dr Gillett had qualified this by saying a lot of this happened below his level. Employment Status B personnel undergo annual skills tests but this is not applied to those coming from State ambulance services because of the regular recertification within those services.[68]
[65] Statement of Dr Mark Gillett 10 February 2011 paragraph 12.
[66] Applicant’s Clinical Governance Framework 3.7
[67] Transcript page 119.
[68] Transcript page 120.
In relation to the pathways he said that the Clinical Governance Framework deals with the training and accreditation of paramedics.[69] “...because of the processes that already exist within the ambulance services, we give weight to that and we do also look at people on the job and, if there are special needs that arise for that person, then we obviously address those on an individual basis as ... there’s a skill that somebody fills it, they’re not up to scratch with, then we will attempt to address that.”[70] As to how one would find out if a paramedic applicant had had a restriction imposed, the Applicant “would seek open disclosure” from the person, ascertain if anything could be done to ameliorate and it would be dealt with on a case by case basis. The paramedic’s records would be reviewed.
[69] Applicant’s Clinical Governance Framework 3.4,1, and 3.4.2 and following.
[70] Transcript page 118.
In relation to the drugs in 3.2 it was paradoxical that drugs which needed to be given in a timely fashion were subject to the condition. The paramedic in front of the patient was better situated than a remotely located medical practitioner who may or may not have the necessary experience. He could not conceive a situation where a doctor would say no; the average remotely located general practitioner would be semi-informed; not have the experience to assess by phone and would ask the same questions as the paramedic. Dr Gillett is contactable especially where the paramedic comes across something unusual and needs advice. He had been contacted once in the last 18 months.[71] He did not know how many times in the last 18 months the 3.2 condition had needed to be invoked. There had been no adverse outcomes in the last 18 months.[72] The paramedics are very good and exercise their discretion re when to call even outside restricted drugs for advice and they do call when they meet something atypical. In relation to arrangement of transport to a hospital, the first priority is to control the pain rather than enter into a lengthy phone call.
[71] Transcript page 132.
[72] Transcript page 117.
Remote and rural practice meant added difficulties because treatment needed to be given rapidly where a paramedic is working solo. Delay or prolonged pain have adverse psychological consequences for a patient. The “cornerstone” of management of the patient was to prevent agitation and provide appropriate use of analgesia.
Dr Gillett stated that it involves a “complex grid” trying to standardise the level of skills in paramedics.[73] There is a process of an interview with a paramedic, examination of references and scrutiny of the record. Dr Gillett confirmed that 20-25% of cases were audited but he did not know the total number of cases. He only knew the audit of critical cases. He stressed that comparative to QAS there was a minuscule number of events.
[73] Transcript page 124.
Dr Gillett stated that Dr Rashford was not recognising prior learning when he considered that the Applicant’s system was insufficient and did not assume full responsibility for their paramedics who needed to be trained in the Applicant’s medical, drug and general organisational protocols because each service was different[74]. Dr Gillett conceded that a paramedic needed to be oriented to “our nuances” but considered these were minor since protocols are parallel documents with very similar modes of practice.[75] The Applicant does take responsibility for certification of its employees: “... any differences in practices need to be highlighted on induction, but the actual basic skills of practice, the competency of practice, the knowledge of practice is absolutely equivalent. What they’re expected to do with us is what they’re expected to do in the ambulance service and vice versa.”[76] Dr Gillett was aware that Dr Rashford has a policy of maintaining level 3 paramedics on mine sites because:
“there is a very small number of very high activity cases in mine sites and other remote areas that may require intervention from a level 4 paramedic. This volume of intervention does not enable the paramedic to maintain an appropriate level of currency as a level 4 paramedic.”[77]
Dr Gillett was unaware of drug restrictions for QAS level 3 paramedics[78] and did not see a problem with placement of level 4 paramedics at remote sites. While Dr Rashford was making a decision on how he disposes his workforce, the Applicant’s experience is that there had been a fatality at one of the mine sites within the last three years; there was major trauma; as well as a litany of minor to moderate trauma occurring.
[74]Affidavit of Dr Stephen Rashford dated 21 July 2011 paragraphs 33-35, especially paragraph 34.
[75] Transcript pages 121-122.
[76] Transcript page 122.
[77] Affidavit of Dr Stephen Rashford dated 21 July 2011 paragraph 24.
[78] Atropine and lignocaine: appendix 2A of the Regulation.
In further evidence to the tribunal Dr Gillett stated that there were undertakings by the Applicant to align its practice with the QAS practice and these had been adopted by the Applicant’s Clinical Governance Committee. The matters to which the Respondent’s Guideline[79] drew attention were now all vested in Dr Gillett not Dr Cohen. While Dr Gillett has not signed for medical purchases in the past he will do so in the future. It was submitted that there should now be no residual concerns re Dr Cohen’s fitness or entitlement to deal with the Schedule 8 drugs and poisons.[80] This was because Dr Gillett as chair of the Clinical Governance Committee had oversight.
[79]“Approvals for organisations providing commercial paramedic services in Queensland” (Guideline) endorsed by Dr Jeannette Young 20 February 2012: Statement of Dr Jeanette Young 24 February 2012.
[80] See decision of NSW Medical Tribunal page 23 and following.
Mr John Knight worked as a full-time lecturer at Monash University in the Department of Community Emergency Health and Paramedic Practice as well as continuing to work as a casual paramedic/safety officer in the offshore oil and gas industry.[81] He told the tribunal that in his experience based in remote localities in the Australian Defence Forces (ADF), paramedics can independently administer drugs in life threatening situations and seek authority afterwards from a doctor. “When working alone or in geographical isolation medics are to seek advice, however if circumstances require the immediate management and subsequent need for medications or procedures to be undertaken, the medic should seek medical advice as soon as possible.”[82] In this way, ADF paramedics were more restricted than State ambulance paramedics.
[81] Statement of John Knight dated 27 June 2011.
[82] Statement of John Knight dated 27 June 2011.
Because of the deployment to very remote locations, ADF paramedics are required “to remain clinically competent”[83] and “the most effective method was for medics deploying to support an activity to be assessed and authorised by a Senior Medical Officer (doctor) to ‘prescribe, issue and dispense’ a range of emergency medications to which they had been taught the underlying principles. These medications were always derived from their inherent Emergency Guidelines.”[84] As a paramedic on oil rigs, while you rely on a workforce being fit and healthy, the reality is that people do have problems and where, for example, there is entrapment, it is inappropriate to delay giving the drugs because it is detrimental to the patient. On offshore oil rigs, the presence of hydrogen sulphide alarms ruled out use of satellite phones so communication was a problem. He used a “give first, speak later” principle there. On mine sites if communications are difficult, a back up plan was necessary.
[83] Statement of John Knight dated 27 June 2011.
[84] Statement of John Knight dated 27 June 2011.
The conditions set by the Respondent were similar to those imposed on ADF paramedics. He said that where the imposition of a delay in the administration of drugs can have an adverse outcome, it is better for the paramedic to independently administer and later report to the doctor as long as the paramedic is appropriately trained to administer the drugs. If the paramedic is equivalent to level 4 and above, if the guidelines are current and the drugs are used in line with the protocol, there should be no danger to the patient. A level 4 paramedic in NSW and Queensland had advanced life support training but Mr Knight agreed that a level 4 paramedic could be the equivalent of a level 3 or an Advanced Diploma in another State. As in the ADF, he considered the principle of phone doctor first and then administer the drugs, a sound principle. If paramedics were appropriately trained, he thought restrictions on drug usage were unnecessary. He had read through the Applicant’s documents and found them adequate though he had not observed its process.
He considered that the Applicant should train and accredit its paramedics and needed to go through the process in relation to skills and currency but also thought the Applicant’s training and skills program was pretty reasonable. Maintaining levels and currency were “incredibly difficult” especially costly for higher level skills so QAS level 3 placement on mine sites was about right. A level 4 paramedic could be equivalent to a level 3 paramedic. He said, for example, an ACT intensive care paramedic applying to work in Victoria, that “no-one in their right mind” will accept just a piece of paper. You would need to hear from their clinical supervisor, do a viva voce assessment, contact referees and go through simulations.
Dr Toby Fogg, an emergency specialist physician with no affiliation with the Applicant, provided a written statement[85] and gave oral evidence to the tribunal. He was in substantial agreement with Dr Gillett’s evidence about immediate administration of the relevant drugs.
[85] Statement of Dr Toby Fogg dated 17 March 2011.
Dr Rashford[86] confirmed that the QAS is established under the Ambulance Service Act 1991 (AS Act); paramedics act as ambulance officers under the AS Act which provides a disciplinary process; the QAS is government funded; its primary service is to all Queensland residents and it has responsibility for out of hospital care. The QAS makes a risk assessment of where its personnel is placed, for example, if the risk of an event is low and the consequences high. Sometimes risk can outweigh benefit and the literature supports that. He could not agree that doing something is better than doing nothing: if procedures go wrong, there can be a “catastrophic” effect on the patient.
[86]Specialist Emergency Physician, holds Senior Staff Specialist Medical Officer positions in the Royal Brisbane and Women’s Hospital Department of Emergency Medicine and is the Medical Director of QAS; Statement Dr Rashford 21 July 2011.
The QAS does provide some service on a cost recovery basis to the private sector such as mine sites or for special events such as a music festival or rodeo. For remote areas and camp sites its paramedics are equipped with satellite phones however paramedics working at mine sites do not need satellite phones as there are communication systems in place.[87]
[87] Statement Dr Rashford 21 July 2011 paragraph 23.
Before QAS will employ someone qualified in another State or by another entity as a level 4 paramedic, the QAS puts them through a rigorous process of induction and training. This process includes:
a)Three week induction course;
b)Three months of working on the road alongside a QAS paramedic;
c)One month’s intensive program for a level 4 paramedic;
d)Examination involving multiple vivas and multiple scenarios.[88]
[88] Statement Dr Rashford 21 July 2011 paragraph 25.
In reviewing the Applicant’s Clinical Governance Framework, he recommended that, to assess its effectiveness, the minutes of the Applicant’s Expert Medical Advisory Panel be examined by the Respondent to review how regularly it meets; who attends, and the discussions, decisions or recommendations that have been made over the last two years.[89]
[89] Statement Dr Rashford 21 July 2011 paragraphs 28-29.
He was critical of the Applicant’s credentialing system, reliant as it was on other ambulance services certifying and recertifying paramedics because he found it “insufficient”.[90] The Applicant should certify and train all paramedics within their employ to match its scope of practice and procedures[91] because it was important to ensure paramedics are “trained to and maintain currency” with the system they are working within because there are differences.[92] Clinical governance needed a “whole system” approach in a “feedback loop” to ascertain what is needed to maintain skill levels as well as reference to the literature and evidence based on the scope of the practice so protocols should be amended. He agreed there could be variations between organisations but QAS was attempting to develop “a gold standard”. If things are being done more infrequently then scrutiny should be higher. If something is being done repeatedly then there was less oversight.
[90] Statement Dr Rashford 21 July 2011 paragraph 33-34.
[91] Statement Dr Rashford 21 July 2011 paragraph 37.
[92] Statement Dr Rashford 21 July 2011 paragraph 35.
He was approached to provide an opinion on the Applicant’s processes on the basis of his position in the QAS; his out of hospital clinical experience since 1993 and because of experience in remote locations. He was not trying to “benchmark” the Applicant’s processes against those of the QAS but took a pragmatic approach and examined those processes against his own experience. If the Applicant could demonstrate it has the same level of credentialing, ongoing training and professional development as the QAS then the condition imposed by the Respondent should not be necessary.[93]
[93] Statement Dr Rashford 21 July 2011 paragraph 31.
In reviewing the medical protocols relied upon by the Applicant, he considered the drug protocols do not reflect contemporary practice in a small number of areas. Medications can be added or taken out depending on the literature and the experience of the paramedics. For example this might involve the removal of metoclopramide and the addition of ondansetron. The Medical Advisory Council for the QAS met twice yearly; had a variety of specialties and if there is a new drug, data is presented to the group; assessed and a copy of the minutes of the meeting provided to Respondent. QAS now considers ondansetron a better medication than metoclopramide because side effects are greatly reduced. The Medical Advisory Council approved it but the Respondent refused it requiring more literature for its usage.
Level 3 paramedics are baseline and most paramedics in Australia fit into this category. QAS level 3 pharmacology was currently “in a good place”: better drugs with fewer side effects are replacing other drugs. Level 4 paramedics have intensive care skills, extra tertiary training and are able to undertake more risky procedures. Based on risk benefit analysis, there is no QAS emplacement of level 4 paramedics in remote areas where a level 3 paramedic is a better option. These are areas of low acuity so there can be a propensity for incidents with loss of skills. He compared it with a neurosurgeon in a six bed hospital. Level 4 paramedics are best placed in high acuity situations.
QAS has started to review the placement of its paramedics in remote areas. While there are not many so placed, QAS is interested in restricting their practice. If there are high risk procedures, the risk of an adverse outcome for a patient is high. The “two-heads” model is used so that there is available throughout the State a 24/7 dedicated access line to senior clinicians and specialists to ensure a standardised approach to clinical protocols and higher safety margin. QAS ceased using local hospital doctors because they were not au fait with the protocols. The tribunal notes here some consonance with Dr Cohen’s and Dr Gillett’s evidence of the Applicant’s contactable doctors who have an interest in emergency medicine and less reliance on local medical practitioners though the reason did not involve lack of familiarity with protocols.
Within the categories, QAS imposes conditions on full-time and part-time work for paramedics and is about to develop a policy in regards to these aspects of work. Level 4 constitute 10% of the workforce and must be full-time. QAS has a robust internal quality assurance procedure to ensure that all personnel trained as a level 4 paramedic maintain the currency of their qualifications at all times.[94] To maintain this currency the level 4 paramedic must have a certificate of practice, complete professional development activities, undergo skills assessment and ongoing quality assurance auditing.[95] “A lot of time is invested into looking at the standard of work of level 4 paramedics.”[96] Given the nature of the emergencies to which they respond, they require significant ongoing investment by QAS to ensure maintenance of their qualification.[97] Were a level 4 paramedic to be placed on a mine site, QAS would restrict their practice. QAS level 4 paramedics give medications as part of the quality assurance in the organisation. Their procedures and ability to give the medications are part of their training and professional development but even level 4 paramedics are not allowed to practice in certain areas.
[94] Statement of Dr Rashford 21 July 2011 paragraph 14.
[95] Statement of Dr Rashford 21 July 2011 paragraph 15.
[96] Statement of Dr Rashford 21 July 2011 paragraph 16.
[97] Statement of Dr Rashford 21 July 2011 paragraph 17.
The tribunal notes some consonance between Dr Rashford’s evidence and Mr Knight’s statement in relation to the “incredible difficulty” in maintaining training for higher level skills.
Each year of approximately 800,000 cases, 15% of cases are audited. This provides a snapshot of what paramedics are doing and means training can be tailored to any area in default. A tiered approach is used: every cardiac arrest is mandatorily audited; there are escalating levels of review with grades 1-4 offences; level 1 is a minor variation; level 2 indicates poor documentation but good treatment; level 3 equates to a near miss with the possibility of patient harm; level 4 incidents of which there are 3 to 4 each year indicate actual harm to the patient and such incidents are obliged to be reported to the Health Quality and Complaints Commission. Following the audit and review process, “learnings” are identified as well as further training and assessment. Paramedics involved in a level 3 or 4 incident may be put on a learning support plan. Paramedics are put on restricted practice where there is an adverse event. The QAS also undertakes “Root Cause Analysis” on selected cases.[98] Performance review audits of a region are done twice per year and this target can be onerous. The goal of the QAS through the system of auditing is to have a culture of transparency and visibility. Audit is seen as part of the practice scope and restricted practice is part of patient safety.
[98] Statement of Dr Rashford 21 July 2011 paragraph 22.
In 2012 QAS is introducing changes to its clinical practice manual with examinations and tests tailored to those changes. A paramedic needing recertification will complete this in days not weeks. It is now nearly impossible for a paramedic to practice without an updated recertification. All paramedics should be appropriately trained and there should be a professional development program with the same standards.
At mine sites, there is a solo practitioner paramedic at any one time with generally eight days on shift and 6 days off with the appropriate handover in between. QAS which has legislative responsibility for emergencies, in relation to transport, makes a handover to an equal or higher set of skills such as hospital staff, flight nurse, paramedic on a helicopter or a doctor in the case of fixed wing transport. The transport works in co-ordination with the Queensland Emergency Medical System Co-ordination Centre now co-located at the Queensland Co-Ordination Centre, the State disaster centre. The focus is on critical advice and the co-ordinated movement of the patient.[99]
[99]Available are two specialists in emergency medicine, an anaesthetist, helicopters and fixed wing aircraft.
Dr Rashford stated that most paramedics should be able to recognise an individual displaying life threatening symptoms. Intravenous morphine is the tried and true analgesia medication for use in and out of hospital. If, for example, an individual breaks an ankle and it is deformed, the paramedic should consult but give morphine immediately. Emergency care practitioners provide palliative care and it is a “laid down misere” to provide pain relief to a patient as soon as possible. In an acute emergency, morphine would not treat the underlying injury and the absence of morphine does not cause impairment but, in the case of the broken ankle, if the vascular nerves are affected, there are consequences. His preference would be to administer morphine before consultation. Narcan can by and large reverse effects of morphine but it is rare for a paramedic to administer it. QAS experience was for the administration of 17,000 doses of morphine per quarter it was very rare to administer narcan as well. In the case of a compound fracture of the femur, this is life-threatening and very different from a fractured ankle. For any paramedic to administer morphine, there needs to be the level of training and certification and morphine could be administered by a paramedic even if there is infrequent use by the paramedic.
Metoclopromide side effects profile was low.
Midazolam is a more dangerous and difficult medication: it is short acting and used in seizure control which is life threatening and the conditions set in clause 3.2 allow administration of the drug without consultation. It is used to stop airways closing. Use in procedural sedation is more dangerous both for paramedics and clinicians. Consultation is necessary. Throughout the country there are a number of cases before coroners’ courts in relation to this.
Formulation of an overall guide for paramedics is difficult because paramedics “consult by exception.” They act within the scope of their training and the level 3 paramedic treats 99.9% without any need to consult. There are however always challenging cases where it is of benefit to consult a doctor or where the case exceeds the scope of the paramedic. The tribunal notes that this view accords with Dr Gillett’s in relation to unusual cases and frequency of contact. Remoteness of mine sites is a factor and that is why QAS reduced the level 4 involvement to level 3: the volume of cases is so low; there can be massive acuity but basic intervention saves lives with basic emergency principles.
In the course of the hearing and in relation to Dr Rashford’s evidence, the Applicant indicated its willingness to adopt the procedures recommended by Dr Rashford.[100] It did so on the basis that these operating procedures appeared to be at the heart of the Respondent’s approval and conditions.[101]
[100]Undertakings proposed and responses undertaken 2 October 2011; National Medical Protocols amended 11 March 12; National Pharmacology Protocols amended 11 March 2012 and Clinical Governance Framework updated 11 March 2012; Clinical Governance Group Meeting Minutes 18 October 2011.
[101]Written Offer Containing Undertakings Proposed on 2 October 2011 appended to letter dated 3 January 2012 to the Respondent from the Applicant’s counsel.
Dr Jeanette Young, the Chief Health Officer for the Respondent[102] told the tribunal that she supported the decision. At the time of this decision, the Respondent did not have guidelines in place for dealing with applications from commercial private paramedic organisations. The purpose of the Guideline[103] now is to clarify the expectations the decision-maker has when making the decision about any application for approval.
[102]Statements of Dr Jeanette Young dated 26 August 2011 and 24 February 2012 were also provided.
[103]“Approvals for organisations providing commercial paramedic services in Queensland” (Guideline) endorsed by Dr Jeannette Young 20 February 2012: Statement of Dr Jeanette Young 24 February 2012 paragraph 6.
She stated:
“This Guideline is intended to operate until such time as paramedics become registered professionals with a registration board, practice standards and the ability to discipline practitioners who do not comply with the standards. Until such time as paramedics are registered, the Guideline aims to put in place steps to ensure medical practitioners are involved in supervising the treatment given to persons requiring urgent medical attention. The purpose of the Guideline is to ensure there is quality assurance involved in the process of paramedics treating patients. The involvement of medical practitioners in this role provides protection for the paramedic as well as the patient.”[104]
[104] Exhibit 5 Statement of Dr Jeanette Young 24 February 2012.
The Guideline makes it a condition that certain drugs “must only be administered to a patient following consultation with, and on the instruction of, a doctor.”[105] The Guideline provides an exception to the condition which:
“allows administration in a clinical emergency which, in the opinion of the qualified paramedic is immediately life threatening or is of such clinical severity and consultation with a doctor is not possible immediately ... In such emergencies, the scheduled medicine must only be administered in accordance with organisation’s clinical practice protocols and consultation with a doctor must occur as soon as possible after administration of the scheduled medicines.”[106]
[105]Statement of Dr Jeanette Young 24 February 2012 paragraph 8 citing page 8 of the Guideline.
[106]Statement of Dr Jeanette Young 24 February 2012 paragraph 10 citing page 8 of the Guideline.
Dr Young defines “life threatening” to include a condition that is potentially fatal or potentially fatal before further higher level emergency medical care eg at a hospital, can be provided.[107] She further stated that “clinical severity” includes an emergency medical condition manifesting itself by acute symptoms (including severe pain) such that the absence of immediate medical attention could reasonably be expected to: place the health of the individual in serious jeopardy; or result in serious impairment to bodily functions or result in serious dysfunction of any bodily organ or part.[108] She notes that the Primary Care Clinical Care Manual as endorsed by the QAS, the Respondent and the RFDS and which provides guidance to, for example, registered nurses, and paramedics provides that for emergency patients, the medical officer should always be consulted “as soon as circumstances allow.”[109] The point being made by Dr Young was that the approval requires the Applicant’s paramedics to work as part of a team to provide care to patients who will be ultimately handed over to what Dr Rashford described as equal or higher level skills in the QAS or RFDS. In this the approval issued to the Applicant is consistent with the manner with which the QAS and the RFDS operate. The early involvement of a medical practitioner is in the best interests of the patient.[110]
[107] Statement of Dr Jeanette Young 24 February 2012 paragraph 11.
[108] Statement of Dr Jeanette Young 24 February 2012 paragraph 12.
[109] Statement of Dr Jeanette Young 24 February 2012 paragraph 13.
[110] Statement of Dr Jeanette Young 24 February 2012 paragraph 16.
The primary factor is the protection, health and safety of all members of the community who will be treated by the paramedics. The division of drugs available to paramedics into two tables was a risk management decision-making framework. The drugs in table 2 contained a higher risk factor and so consultation with a doctor before administering the drug was considered appropriate.
She was not satisfied that unconditional approval for the Applicant was appropriate and was satisfied that the conditions were appropriate particularly in the absence of any national registration scheme for paramedics. The Applicant has a system for maintaining current medical and pharmacology protocols but it had not demonstrated the existence of ongoing professional development and credentialing of paramedics to ensure their awareness of protocols and operation within them nor that it monitored compliance with protocols by their paramedics.[111]
[111] Statement of Dr Jeanette Young dated 26 August 2011 paragraph 11.
Her focus was promoting public health and safety as required by the Health Act1937 and attendant regulations; minimising risk and putting in place systems for mitigating harm. The appropriate balance between doing something and doing nothing was to allow paramedics to operate under strict protocols with the qualification that the paramedics follow the protocols. Without evidence of the skill levels of privately employed paramedics, it could not be assumed that a private organisation’s clinical competence existed. There was reliance that the paramedics employed adhered to minimum standards otherwise it was “extraordinarily risky”.
She was made aware of the decision about Dr Cohen[112] two days before giving her evidence in the tribunal but was, in retrospect, glad that the additional conditions had been set in place. While there was no requirement for disclosure, she was concerned that the individual requesting the approval on behalf of the Applicant had not thought it significant to advise the decision-maker that he was the subject of an order for supervised practice. It was also a concern that, in the application for the first approval in Queensland, when Dr Cohen was under supervised practice, he did not raise with his supervisor the issue of disclosing the fact of his supervised practice to the Respondent.
[112]See below: Health Care Complaints Commissioner v Dr Adrian Cohen [2007] NSWMT 6.
In relation to the first approval, she was of the opinion that Dr Cohen’s understanding of the relevant legislation was incomplete. In relation to the conditions imposed on the second approval, it highlighted that when a person was not part of a rigorous public structure there was a necessity for sensible decisions. She considered that there was a relationship between the decision of the NSW Medical Tribunal and the maintenance of drug registers by paramedics in remote locations. It reinforced the soundness of the additional requirement in the condition because it formed another process in how the drugs were to be used. Dr Cohen was reprimanded for his use of restricted drugs and difficulties with the management of drugs. This affected his drug registers as well as the staff he employed not going through the necessary process. These factors were directly relevant to the situation arising in the 3.2 conditions imposed in the second approval.
It was Dr Young’s “firm belief” that the drugs in question should be restricted and subject to strict protocols with the use of drugs by persons who are not medical practitioners. As a statutory officer, “It is incumbent on me to have firm processes in place to protect the public.” With the conditions imposed for advice and input from different medical sources including emergency medicine physicians, it is not a big burden on the paramedics or on the medical staff taking the call to consult or consult as soon as possible after administration in urgent cases.
She acknowledged that following Dr Rashford’s advice, the Applicant had changed its protocols and addressed certain issues; that Dr Gillett having been informed, through the Clinical Governance Committee, had implemented processes. She was however “not happy to assume matters”. Given the Applicant’s number of paramedics, the size of the operation, the oversight and the recruitment: she did not consider it possible to replicate the same level of credentialing, training and professional development as in QAS even with the Applicant’s stated 20% auditing as compared with the 15% auditing of the QAS.
Dr Young’s assertion presupposes that private, commercial providers are by virtue of their private commercial status necessarily unable to attain what the tribunal accepts are the demonstrably high performance standards of the public QAS. Replication may or may not be possible but every application to provide private paramedic services must be examined and decided upon on its own merits.
The tribunal accepts however that the QAS as a public body can employ, and demonstrates, rigorous credentialing and oversight procedures. The tribunal concurs with Dr Young’s reluctance “to assume”. Amended documentation and assurances that credentialing will in the future become more rigorous do not necessarily transfer to systemic incorporation, practice and quality assurance. The presence of current and amended documentation does not necessarily signify better trained, credentialed, audited and compliance tested paramedics. The tribunal considers that in a matter involving significant public health and safety, it is appropriate to exercise caution.
She stated that morphine is effective pain relief but there is no doubt that it can pose significant risk to the patient; can mask other injury and cause respiratory injury if the dose is too high. Protocols alone are not sufficient and the input of a medical practitioner is sound.
While midazolam and metoclopramide were not Schedule 8 drugs, they have a higher risk level and consultation with a medical practitioner was required. If the drug had to be administered urgently, the paramedic gets the advice of the medical practitioner as soon as possible after the administration and also advice in regard to ongoing care of the patient. This view about these drugs was arrived at by input from appropriate specialists.
NSW Medical Tribunal (NSW MT) decision
On the third of the four day hearing, the Respondent sought to adduce evidence of a decision by the NSW MT made on 4 April 2007 (the decision).[113] There were lengthy submissions from both parties as to admissibility. The tribunal accepted the Respondent’s assurances that it had hitherto been unaware of the document’s existence and had made the Applicant aware of its discovery on 6 March 2012. The tribunal, mindful of its obligations to act fairly,[114] enjoined the Applicant to consider further its submissions on admissibility overnight on 7 March. On 8 March after hearing further submissions from the parties, the tribunal gave an oral decision wherein it allowed the impugned decision into evidence.[115]
[113] Health Care Complaints Commissioner v Dr Adrian Cohen [2007] NSWMT 6.
[114] QCAT Act, section 28(2) and section 28(3)(a).
[115] Exhibit 8.
The tribunal’s power to admit the evidence is based in section 28 of the QCAT Act, in particular sections 28(3) and 28 (4). Relevantly, the tribunal is not bound by the rules of evidence;[116] may inform itself in any way it considers appropriate[117] and has the discretion to admit into evidence the contents of a document despite its non-compliance with requirements imposed under the QCAT Act or an enabling Act.[118] The tribunal also considered the subject matter, scope and purpose[119] of the Regulation particularly section 15 which provides wide discretion to the Respondent to investigate the suitability of the person applying for an approval. The scope of the Regulation covers all aspects of scheduled drugs and poisons, including for example, record keeping, supply, dispensing, storage and administration of them. It institutes a strict regime with respect to the persons who are authorised to deal with scheduled drugs and poisons:
[116] QCAT Act, section 28(3)(b).
[117] QCAT Act, section 28(3)(c).
[118] QCAT Act, section 28(4).
[119]Minister for Aboriginal Affairs v Peko-Wallsend Ltd (1986) 162 CLR 24 at 39-40 per Mason J.
15 Suitability of person to hold endorsement
(1) In deciding whether a person is a suitable person to hold, or to continue to hold, an endorsement the chief executive may have regard to, and may make inquiries about, the following—
(a) the person’s knowledge and understanding of the person’s obligations under this regulation;
(b) the person’s qualifications and experience;
(c) the person’s character and standing;
(d) any previous convictions the person has under the Act or this regulation;
Example of paragraph (c)—
The chief executive’s inquiries about an applicant’s suitability may include asking the commissioner of the police service for a written report about the applicant’s criminal history.
(e) whether the person engages, or has engaged, in conduct that risks, or is likely to risk, a controlled drug, a restricted drug or a poison being used for a purpose that is unlawful under a law of a State or the Commonwealth.
(2) Subsection (1) does not limit the matter to which the chief executive may have regard in considering the suitability of the person to hold an endorsement.
(3) In this section—
this regulation includes the Poisons Regulation 1973.
Dr Cohen had been charged with nine particulars including identified occasions of obtaining cocaine for his own use by issuing prescriptions in other names; an identified occasion of issuing a prescription for codeine otherwise than for medical treatment and/or for a purpose that did not accord with the recognised therapeutic standard of what is appropriate in the circumstances contrary to the provisions of the Poisons and Therapeutic Good Regulation 1994; between 1998 and 2003 he used cocaine; between June 1997 and February 2003 he improperly filled a Doctor’s Bag Order (DBO) each month with pharmaceuticals which he supplied to a number of medical facilities over which he had control; as the director of Immediate Assistants Pty Ltd, he contravened the provisions of the Poisons and Therapeutic Goods Act 1966 and Regulations by procuring wholesale quantities of medical equipment and pharmaceuticals, knowing that the company did not hold a wholesaler’s licence; and between 1999 and 2003 failed to accurately and appropriately maintain drug registers kept under his care and control and located at the Sydney Cricket Ground, Stadium Australia, Sydney Football Stadium and at his home surgery/office. None of the particulars was disputed with the exception of the one in relation to Immediate Assistants Pty Ltd, the Applicant in these proceedings.
On 4 April 2007 in the use of cocaine and the abuse of the prescribing system to obtain the drug for himself, the NSW MT found Dr Cohen guilty of professional misconduct on all nine charges pursuant to sections 36 and 37 of the Medical Practice Act 1992 (NSW) (MP Act).[120]
[120] Exhibit 8 paragraph 74.
It was found:
“By writing prescriptions for cocaine in the name of a person who was never intended to receive the drug, the Tribunal is satisfied that the respondent [Dr Cohen] has abused the prescription system. The prescription system reposes significant trust in a medical practitioner. The Tribunal accepts the applicant’s [Health Care Complaints Commission] submission that the integrity of the system relies on the honesty of those who are permitted to use it. Of course, the use of cocaine by the respondent was frankly illegal and of itself should be the subject of severe censure. . .The conduct of the respondent in dishonestly misusing the prescription system to supply drugs for his own use and in writing prescriptions for patients for whom the drugs were never intended is conduct which in the view of the Tribunal is both improper and unethical. This conduct was not an isolated instance but constituted a continued course of dishonesty over a period of years.”[121]
[121] Exhibit 8 paragraphs 70 and 73.
The NSW MT was satisfied to the requisite standard that in relation to his keeping of an appropriate drug register:
“that his actions in buying wholesale drugs without the necessary licence and his misuse of the DBO system demonstrated that the respondent lacked appropriate knowledge or skill to discharge those aspects of his practice to the level required of a medical practitioner. His ignorance of the proper use of DBO and his failure to take any proper steps to inform himself provided him with a commercial advantage. In these regards, again being satisfied to the relevant standard, the Tribunal finds that the respondent is guilty of unsatisfactory professional conduct.”[122]
[122]Exhibit 8 paragraph 75. Dr Cohen in relation to particulars (i) to (vi) was found guilty of professional misconduct and in relation to particulars (vii) to ix) guilty of unsatisfactory professional conduct.
The NSW MT considered the lapse of time of three years since the conduct upon which the complaint was based had occurred. In the interim period:
“the respondent says that he no longer uses cocaine. There have been no complaints about the respondent’s conduct since that time and there is no challenge to his competence to perform medical services. The respondent said that he has implemented protocols to ensure that professional responsibilities for the keeping of drug registers and the purchase of wholesale drugs are met.”[123]
[123] Exhibit 8 paragraph 81.
The NSW MT considered that its protective function could be exercised without ordering the deregistration of Dr Cohen.[124] It ordered that Dr Cohen be reprimanded. To address the possibility of relapse in the face of the pressure of business and his lack of full appreciation of the risk to himself of cocaine, for a period of 12 months Dr Cohen was ordered to submit to thrice weekly urinalyses and for that same period of 12 months, attend a psychiatrist skilled in matters of drug addiction for the purpose of educating himself to understand addiction and the risk of relapse, the psychiatrist to be nominated by Dr Cohen from a list provided by the NSW Medical Board.[125] The NSW MT further found that:
“The respondent has demonstrated that he is ignorant of important matters necessary to the regulation of the practice of medical practitioners and has made but a cursory attempt to inform himself of those matters. ... Given the clear flaws in his understanding and application of his professional responsibilities, the Tribunal is of the view that his practice of medicine should be supervised.”[126]
Dr Cohen was ordered to select a supervisor from a list of medical practitioners provided by the NSW Medical Board. This list was to be provided within 28 days of the decision and Dr Cohen had to select a supervisor from that list within 14 days. This practitioner was to meet with Dr Cohen “at least monthly” to discuss with Dr Cohen:
“the legislative and regulatory responsibilities attendant on his practice as a medical practitioner and to inspect the records and drug registers kept by the respondent from time to time.”[127]
The supervisor was required to provide a monthly report to the NSW Medical Board on the “fact of the supervision and the matters discussed during the meetings.”[128]
[124] Exhibit 8 paragraph 83.
[125] Exhibit 8 paragraphs 85-86.
[126] Exhibit 8 paragraphs 87-88.
[127] Exhibit 8 paragraph 88.
[128] Exhibit 8 Order 4.
Dr Cohen was fined $15,000.[129] Dr Cohen agreed “to refund $28,000 being the cost of the drugs obtained by him through his misuse of the DBO system.”[130]
[129] Exhibit 8 paragraph 89.
[130] Exhibit 8 paragraph 90.
This tribunal notes in relation to the first approval[131] issued by the Respondent without restriction for two years on 28 February 2008 that this period was within the time of supervised practice covered by the decision of the NSW MT. It is accepted by this tribunal that Dr Cohen was under no statutory obligation to disclose what had transpired in the NSW MT decision; the following period of 12 months supervised practice or the drug testing he was required to undergo, which period would not have ceased until 4 May 2008 at the earliest. A medical practitioner applying for the approval in Queensland, the sole director of the Applicant in these proceedings, made a significant omission however in choosing non-disclosure. The propriety of the Applicant’s sole director and controlling mind is of particular concern. An inference arises that an aspect of Dr Cohen’s consideration in failing to volunteer the relevant information may have been the commercial disadvantage that would flow to the Applicant were there to have been full disclosure. The tribunal notes that Dr Cohen has overall responsibility for quality assurance, clinical governance requirements including pharmaceutical licences and the commercial operation of the Applicant. It is likely that Dr Cohen did not discuss with his supervisor the propriety of the non-disclosure to the Respondent in his first application for approval. The inference arises that Dr Cohen lacks understanding of the public safety requirements that underpin the relevant legislation.
[131]Applied for on or about 7 May 2007: Amended Statement of Agreed Facts dated 8 March 2012 paragraph 13.
Had there been disclosure, it is likely that the Respondent, mindful of its obligations in the protection of public health and safety and properly apprised of the facts, may have declined to issue the first approval, at least until the successful completion of the supervised practice period. Had the Respondent, on the other hand, once apprised, issued an approval, it is likely that it would have been made contingent upon restrictions such as we are dealing with in this application or even more onerous restrictions.
Of special concern in this application is that Dr Cohen from June 1997 to February 2003 used the DBO system each month to receive supplies to the maximum amount of listed drugs when “at no time relevant to the hearing” did he possess a medical bag. He then allocated the drugs supplied in this way to the various centres from which he dispensed medical services.[132] The drugs in question included Schedule 4D and Schedule 8 drugs[133] provided to patients in emergency situations at the various sporting venues where the Applicant provided medical services. The NSW MT had further evidence that these drugs provided free under the DBO system found their way into medical kits used in overseas travel where Dr Cohen’s services were engaged though he denied he would have charged for their administration.[134] The NSW MT found there was a commercial advantage to Dr Cohen and whether that advantage was large or small, “the gravity ... lies in his misuse of the system.”[135]
[132] Exhibit 8 paragraph 15.
[133] Exhibit 8 paragraph 11.
[134] Exhibit 8 paragraph 16.
[135] Exhibit 8 paragraphs 19 and 23.
Despite not holding a wholesale licence, Dr Cohen bought drugs at wholesale prices for use overseas and at sporting venues in Australia.
“While the respondent maintained that no patients were charged for the drugs it is beyond doubt that the contracts for his medical services included the provision of medicines and the charge for those medicines was included in the contract price.”[136]
[136] Exhibit 8 paragraph 28.
Dr Cohen’s registers of Schedule 8 drugs at each of the sporting venues were found to be deficient. No proper accounting was made for the large number of vials of morphine and pethidine which had been supplied to Dr Cohen over the period of the investigation. There was a discrepancy between the number of vials missing according to the Pharmaceutical Services Branch and Dr Cohen’s reckoning based on his examination of the various drug registers.[137] Investigators found that of the DBO supplies provided to Dr Cohen between 1998-2003, of some 310 vials of morphine and 310 vials of pethidine, after examination of registers and seizure of the balance of Schedule 8 drugs, many vials could not be accounted for.[138] The NSW MT found that even on Dr Cohen’s reckoning of the incompetently maintained registers, at least 21 ampoules of Schedule 8 drugs could not be accounted for.[139]
[137] Exhibit 8 paragraph 49.
[138] Exhibit 8 paragraph 50.
[139] Exhibit 8 paragraph 61.
Dr Cohen told the NSW MT he did not turn his mind to setting up a protocol for maintaining the drug registers: “simply running a business and not being able to be done at the time and relying on the people that we have working for us to all understand these things”. He had not instructed each of his staff about keeping the drug registers but had administrative staff who went to the venues to supervise staff and “they understood the drug registers were there and how they were to be used.”[140] Dr Cohen then took no further role in the disposition of the Schedule 8 drugs or maintenance of the drug registers. In 2000 the medical director was appointed.[141] Dr Mark Gillett was asked to write drug and medical protocols but was not asked to review or audit the drug registers.[142] The NSW MT remarked:
“Given the scant attention paid by the respondent to his legal responsibility for keeping Schedule 8 drugs of addiction, the Tribunal takes little comfort from his confidence in his employees.”[143]
[140] Exhibit 8 paragraph 53.
[141]The tribunal notes the discrepancy of Dr Gillett’s reported appointment as medical director since 1998.
[142] Exhibit 8 paragraph 54.
[143] Exhibit 8 paragraph 56.
Particular to the application before this tribunal is the following:
“In 2005 the respondent obtained a wholesale licence. He said in evidence that he now uses forms produced by his company to place orders for goods at wholesale process. He is the person who is responsible for placing the orders.”[144]
[144] Exhibit 8 paragraph 29.
The decision of the NSW MT provides evidence that Dr Cohen, the sole director of the Applicant, has engaged in conduct that has risked a controlled drug and a restricted drug being used for a purpose that is unlawful.[145] His identified contraventions are of special concern in relation to his knowledge and understanding of his obligations under the Regulation.[146]
[145] Section 15(1)(e) of the Regulation.
[146] Section 15(1)(a) of the Regulation.
Time has elapsed since Dr Cohen as a medical practitioner and as sole director of the Applicant was the subject of the NSW MT orders. His period of supervised practice has concluded. This application before this tribunal must be dealt with on its own merits. The tribunal must reach its own decision taking into account all the evidence placed before it. A tribunal, placed in the shoes of a decision maker which has strong public safety policy requirements in the relevant legislation and tasked with the granting of approvals to supply, store, administer restricted and controlled drugs in Queensland, would be irresponsible were it not to take into its consideration conduct which was relatively recent and of direct importance to statutory considerations in an approval.
Of direct concern to the tribunal in the present application for statutory approval, if the cocaine usage and falsification of the prescriptions are set aside, is the accurate maintenance of drug registers particularly in relation to schedule 8 drugs. Dr Cohen is the sole director; its chief executive officer; the controlling mind of the Applicant and responsible for its statutory functions. As noted in the NSW MT decision, he appeared to find the stress of the commercial enterprise was a contributing factor to his conduct.
The Applicant has a small but disperse workforce of emergency personnel. The paramedics who enter its employ do so on the basis of their background training and certification from State or defence force paramedic services. Its process of induction was reliant on the adequacy and currency of a previous employer’s certification. It was agreed by the parties that the equivalence of certification across the States and services was complex. The Emergency Services Registry of Australasia (ESRA)[147] lists qualifications in various States but it is not a register of particular paramedics and provides no disciplinary process. The tribunal accepts that this results in difficulty in assessing the equivalence of various paramedic training levels across the nation.
[147] Emergency Services Registry of Australasia (ESRA) (>
The Applicant’s induction process is less than rigorous. The Applicant’s Clinical Governance Framework at 3.4.1 Employment Status A applies to all paramedics “who currently work for a recognised Ambulance Service on a full-time, part-time or casual basis and are subject to clinical recertification and annual skills auditing by that service.” This in effect relies on the former employer’s certification process. Any additional assessment of qualifications is commenced only “if any doubts” arise otherwise pathway A is the faster way to employment with the Applicant. Yet on Dr Cohen’s evidence, there is no level of practice evident on any formal documentation certificate. This is a minimalist induction method. Extra training in pathway B is not triggered unless a paramedic is “not up to scratch” yet how is any deficiency assessed if there is no rigorous credentialing process? It would appear that pathway B is less likely to be employed with for example, no employment of paramedics from private ambulance services. It occurs to the tribunal that, were a paramedic so minded, there is a possibility of some misrepresentation of skills level.[148] The tribunal prefers the evidence of Dr Rashford that there are differences in protocols and that every paramedic needs to be thoroughly trained in the Applicant’s protocols.
[148]Dr Cohen referred to “I certainly, personally, know of individuals who worked within ambulance services or outside calling themselves paramedics and working on sites under a variety of guises without clinical governance at all. Without an organisation above them at all. Referring, on their previous training or experience with the ambulance services in saying, “That’s what I did then so that’s what I do now.” Without having a poisons licence.” Transcript page 90.
The Applicant’s paramedics are, on Dr Cohen’s evidence, level 4 or higher and placed in mine sites on single shifts in the situations which Dr Rashford perceived to be dangerous to maintenance of skill levels and where, were a QAS level 4 paramedic so situated, the practice is restricted.
In the course of these proceedings, the Applicant indicated it could institute more rigorous processes whereby it accepts responsibility for the assessment of qualifications, its own certification and training.[149] This would, if undertaken to a rigorous standard, address some or all of the criticisms levelled by Dr Rashford in his examination of the Applicant’s Clinical Governance Framework. Dr Young, however, has indicated her unwillingness to place reliance on assurances. The Applicant has attempted to address some of these deficiencies with its reworked Clinical Governance Framework.[150] It is then a matter of placing reliance by the Respondent on the Applicant that it will institute those processes which it claims it will. Certification and auditing remain “in-house”. The tribunal notes Mr Knight’s evidence that he had not observed the Applicant’s processes. It also notes Dr Young’s belief that it is not possible for the Applicant to replicate QAS standards. The tribunal is concerned about any discrepancy between updated documentation and actual implementation into process. If the responsibilities devolve upon Dr Gillett[151], his work for the Applicant is not his main job and a part-time focus is still concerning.
[149] See also paragraph 40 above.
[150] March 2012.
[151] See paragraph 40 above.
Actual evidence before the tribunal of the auditing instituted by the Applicant was scant.[152] The evidence of statistics on case load, categories and percentages of incidents, including a fatality, were not made available to the tribunal. The tribunal was surprised there appeared to be no records in relation to calls taken from paramedics either in relation to the conditions imposed in 3.2 or for more unusual cases. As noted in Dr Rashford’s evidence, there are training possibilities arising from such calls where there may be defaults. Neither Dr Cohen nor Dr Gillett could provide an accurate snapshot of how many cases were dealt with. Assurances were provided that no incident had occurred throughout the period of approvals although Dr Gillett mentioned one fatality in three years. It is not improbable that a commercial entity operating in “an intensely competitive commercial environment in Queensland”[153] may be reluctant to volunteer incident information, if incidents had indeed occurred or if such information existed.
[152]Critical Incident Review (i) 7 August 2004 Swans game cardiac arrest; appeared to be in response to confidential report received from NSW Ambulance Service. Deficiency identified: Respondent’s staff did not have clearly identified roles taking into account individual skill levels. (ii) Curragh Mine Facility 12 September 2010: death. No deficiency identified. Paramedic audits: (i) Rotorua 27 March 2010; signed as reviewed 27 April 2010; (ii) 30 December 2008, Blackwater (?) review stamp 12 February 2009; (iii) Curragh 16 September 2009; review stamp 27 May 2010; (iv) 26 February 2010, no venue noted, review stamp 26 May 2010; Sample drug register entries dated 30 June 2005 and 15(?) July 2005.
[153] Statement of Dr Adrian Cohen 28 January 2010 paragraph 72.
The QAS aim of transparency involves a body, publicly funded and operating under legislation, meant to function in a manner accountable and open to public scrutiny. It operates on a hierarchical principle of public safety. The Applicant is a private, commercially operated company that is subject to no public scrutiny. The Applicant’s processes and protocols are examined by a public authority such as the Respondent before it is granted approval. Once approval is granted, it operates free of scrutiny except from that of its own processes, where implemented. Ascertaining the rigour of those processes has involved the tribunal. The public is treated by the Applicant’s personnel and there is an overriding public safety factor to which the Respondent is obliged to have regard and must inform any approval. The tribunal heard a lot of emphasis from Drs Rashford and Young on the aspect of public safety and hierarchical care of a patient.
The Applicant contended that even with the amended conditions noted by Dr Young[154] the condition, however drafted, remained not the correct and preferable decision.
[154] Statement of Dr Jeanette Young 24 February 2012 paragraphs 10-12.
The tribunal accepts that the QAS’ thorough standard of credentialing and monitoring aims at best practice.[155] The tribunal prefers Dr Rashford’s emphasis on and implementation of risk management procedures to maximise standardisation of care with a tiered system for its paramedics using a “two-heads” model, partly replicated in the 3.2 condition imposed in the second approval for the Applicant. The tribunal accepts that this is a public safety measure. In the absence of any national register of standardised paramedic training, the Applicant’s reliance on a certificate to practise which indicated no level of training, which relied on the paramedic having the necessary qualifications and expertise, indicates a degree of laxity.[156]
[155] Affidavit of Dr Stephen Rashford dated 21 July 2011 paragraph 25.
[156]The QAS Equivalence of Qualification Process Application Package includes the following requirements: certified academic qualifications outlining unit descriptions, performance criteria and standard information from course handbooks; training transcript identifying all modules and units applicants have completed in a course and all in- service training completed while employed as a paramedic; employment status requires Patient Care experience; workload re metropolitan, high intensity, rural, low to medium density and variety; full-time, part-time, casual, volunteer; demonstrated currency in the relevant area. QAS policy is that currency must be validated every 12 months. Documentation older than 12 months is not accepted as current; two written references for operational activities and one reference to validate training details. The application form provides for contact with referees.
The tribunal noted that Dr Cohen’s statements re online and self-directed learning as well as sponsorship to courses may amount to professional development but are not equivalent to rigorous clinical oversight and governance. It appears that it is up to the individual paramedic to identify and seek areas of self-development. The tribunal notes that the Applicant’s monitoring of compliance with its protocols by paramedics did not appear to be regular. The biennial or triennial[157] reaccreditation implemented by the Applicant is not the same as “regular reaccreditation”[158] nor is “continuing education/professional development”[159] a substitute for scrutiny of paramedic skills and compliance requirements.
[157] See paragraph 20 above.
[158] Statement Dr Adrian Cohen 28 January 2010 paragraph 61.
[159] Statement Dr Adrian Cohen 28 January 2010 paragraph 61.
In late September 2011, the medical and drug protocols for 2011 under which the paramedics were operating remained in draft form and were not formally adopted until a meeting of the Clinical Governance Group in October 2011. This is tardy administration. The tribunal notes that Dr Cohen stated that the Clinical Governance Group had had discussions about the changes embodied in the protocols without a meeting to ratify.[160] Dr Gillett however stated in relation to his role on the medical advisory panel he was not aware that the protocols went to the Clinical Governance Group[161] of which he is a member and of which Dr Cohen stated that Dr Gillett was the chair.[162]
[160] Transcript pages 62-63.
[161]See paragraph 32 above; transcript page 117 and Minutes of Clinical Governance Group 18 October 2011 which shows Dr Gillett as attendee; Dr Cohen implies the medical director chairs the clinical governance group: transcript page 23 and page 60.
[162] Transcript page 60.
The tribunal considers that the evidence supports the conditions imposed by the Respondent in 3.2 of the approval. The Applicant has a team of doctors, including specialists such as Dr Gillett, who are contactable by remotely placed paramedics in the employ of the Applicant. Dr Cohen is also one of the doctors who may be contacted. Dr Cohen also develops working relationships with other medical personnel, local doctors and hospitals.[163] While there was no evidence of total volume of calls to doctors from paramedics, the evidence from a witness such as Dr Gillett suggested that it was not a high volume. The tribunal accepts that there may be delays in communication[164] but notes that this was not a problem encountered by QAS paramedics who were not equipped with satellite phones and located at mine sites.
[163] See footnote 16.
[164] Statement Dr Adrian Cohen 28 January 2010 paragraphs 64 -65.
The tribunal found that the evidence provided by Mr Knight endorsed the ADF principle of incorporation of caution in its deployment of paramedics to remote locations. There was also some concurrence between his evidence and that of Dr Rashford’s where Mr Knight commented on the expense of maintaining the skills of higher level paramedics. The concurrence is where Dr Rashford only deploys level 3 paramedics to isolated situations in Queensland because the low level of acuity is such that a level 4 paramedic loses currency of skills. Level 4 paramedics in QAS while comprising only 10% of its workforce were better skilled but at considerable cost and investment. That a level 4 paramedic’s practice would be restricted in a remote area was an indication of the importance Dr Rashford placed on maintenance of skill levels.
Where a situation arises for the immediate administration of a restricted drug by the paramedic, this contingency is available under conditions imposed in 3.2 where the paramedic is then required to check the administration with a doctor at the earliest possible moment. The tribunal considers this forms part of a hierarchy of care which is necessary for optimal outcome for a patient where a paramedic, working remotely, may or may not have the necessary recency in recertification and skill level. The contact forms part of a reasonable check and balance. The tribunal considers it would be for the comfort of the paramedic as well in that the paramedic has the opportunity to discuss what may be a difficult situation and double check dosage of a restricted drug. The tribunal agrees with the evidence of Dr Young where she stated that the condition imposed for consultation placed no particular burden either on the paramedic or on the medical staff fielding the call.
The tribunal is of the view that the condition is sensible in its purpose and the benefit in relation to public safety and patient outcome outweighs any inconvenience. There is built into the condition and the Guideline a flexibility which attempts to strike an appropriate balance between public safety requirements and appropriate response by the paramedic in front of the patient. Importantly, it implements a tiered system of care adverted to by Drs Rashford and Young. In transportation of a patient, the Applicant’s paramedics must handover to, for example, the QAS or the RFDS and a consistent teamwork approach optimises good patient outcome. That is, the Applicant’s paramedics, though privately employed, do not operate in isolation but as part of a team.
Legislation
The Regulation contains separate chapters dealing with controlled drugs[165], restricted drugs[166], poisons[167], records[168] and storage.[169] A person must not have in the person’s possession a controlled drug[170] or a restricted drug[171] unless the person is endorsed to possess the drug. The Regulation authorises particular persons to obtain, possess or administer controlled drugs and restricted drugs, by virtue of their occupation/registration.[172] A QAS ambulance officer[173] is authorised to obtain, possess or administer, under a clinical practice protocol approved by the QAS, a controlled drug[174] and a restricted drug[175] according to qualifications and particular drugs.[176] A level 3 paramedic is restricted in relation to a controlled drug[177] and in relation to a restricted drug.[178] An isolated practice area QAS paramedic working in such an area may administer or supply a controlled drug[179] or a restricted drug[180] to a person on instruction of a doctor, nurse practitioner or physician’s assistant; or under a drug therapy protocol.
[165] Chapter 2.
[166] Chapter 3.
[167] Chapter 4.
[168] For example, Part 7.
[169] For example, Part 8.
[170]The Regulation, s 51(1) and similarly a person must not administer a controlled drug unless endorsed to do so: s 51(4).
[171]The Regulation, s 146(1) and similarly a person must not administer a restricted drug unless endorsed to do so: s 146(4).
[172] Relevant to this review: a doctor under s 58 and s 161.
[173] Regulation, Appendix 9 “ambulance officer” which refers to the AS Act 1991.
[174] Regulation, s 66 and Appendix 2A.
[175] Regulation, s 174 and Appendix 2A.
[176] Regulation, Appendix 2A, part 1 and part 2.
[177] Regulation, s 66(2).
[178] Regulation, s 174(2).
[179] Regulation, s 66(4).
[180] Regulation, s 174(2A).
The remote area QAS level 3 paramedic may in effect operate under not dissimilar conditions to the 3.2 condition imposed on the Applicant. Dr Rashford has adverted to the restriction in practice of a remotely situated QAS level 4 paramedic and diminution in the pharmacological treatments available to level 3 paramedics. The tribunal accepts that to the extent that the QAS provides paramedic services to the mining sector, it does so with level 3 paramedics.[181]
[181] Amended Statement of Agreed Facts 8 March 2012 at paragraph 34.
The Regulation confers power on the Respondent to grant an endorsement to a person, with or without conditions: section 18. The tribunal accepts the Respondent’s submission that the overarching purpose of the Regulation is the protection of public health and safety, in relation to the manufacture, supply and use of scheduled drugs and poisons. In the present matter the approval balances the requirements of safety to public health in the administration of controlled and restricted drugs. It was noted above that the Respondent has wide discretion with which to assess the suitability of a person to hold an endorsement.[182]
[182] Regulation s 15.
The tribunal must make the correct or preferable decision on the material it.[183] The Guideline is included in the new material before it. Generally administrative policy should be applied unless there is good reason such as where the application of policy would give rise to injustice in the individual case.[184] The policy in the Guideline in relation to the treatment of private commercial providers of paramedic services in Queensland is a factor to which the tribunal gives some weight. It is not an over-riding factor. It can be inferred that applications by other private commercial paramedic providers to the Respondent have caused the response embodied in the Guideline. The existence of the Guideline does not replace the necessity to examine each application on its merits.
[183]Drake v Minister for Immigration and Ethnic Affairs [1979] 24 ALR 577 per Bowen CJ and Deane J at 589.
[184]Drake v Minister for Immigration and Ethnic Affairs [1979] 24 ALR 577 per Bowen CJ and Deane J at 589-590.
After consideration of the evidence provided, including the statements made by Drs Cohen and Gillett, Drs Rashford and Young, the policy embodied in the Guideline and the NSW MT decision, pursuant to section 24(1)(a) of the QCAT Act the tribunal confirms the decision.
Pursuant to section 66 of the QCAT Act it is ordered that publication of any part of the Applicant’s Clinical Governance Framework held on the tribunal file or produced to the tribunal and served on the Respondent is prohibited.
Other matter
The Applicant pressed the tribunal both in oral submissions and in written submissions made at the tribunal’s request, to consider competitive neutrality as a relevant consideration in deciding the appropriateness or inappropriateness of the condition 3.2 contained in the approval. Broadly stated, the Applicant contends that the Respondent imposed the impugned condition 3.2 because the Applicant was a commercial organisation and in competition for the provision of paramedic services, without examining the Applicant’s processes. Were this so, it would constitute a decision made by the Respondent based on irrelevant considerations and based on considerations unauthorised by the Regulation.
The Respondent contends that competitive neutrality is an irrelevant consideration. It submits that the principle of competitive neutrality is defined in section 38 of the Queensland Competition Authority Act 1997 (QCAA) and the principle provides that a government agency carrying on a significant business activity should not enjoy a competitive advantage over competitors or potential competitors in a particular market solely because the agency’s activities are not subject to one or more of the elements set out in section 38. Section 39 of the QCAA provides that a significant business activity is a business activity carried on by a government agency and declared to be a significant business activity by the Ministers by gazette notice. The QAS is not so declared and gazetted.
The Applicant conceded this but maintained that this did not negate the fact of significant business activity done by QAS and the Applicant in competition. The Applicant’s counsel pressed the tribunal that a finding that there is a competitive tension may be significant in that such findings, were they to be made, could be taken up in another forum.
The Applicant faces further difficulty. The QAS is formed as a public body, employs paramedics and amongst other regulatory elements, provides disciplinary process under the AS Act. It is located within the Department of Community Safety. The Respondent is a separate entity charged with the administration of, in this matter, the authorisation of particular persons to obtain, possess or administer controlled drugs and restricted drugs, by virtue of their occupation/registration. The QAS, as noted above, is subject to and controlled by authorisations granted pursuant to the Regulation.[185]
[185] For example, sections 66 and 174; Appendix 2A of the Regulation.
The tribunal lacks jurisdiction to enter upon the issue of competitive neutrality. This tribunal is a creature of statute. It is limited to dealing with what is stipulated in the QCAT Act[186] or in an enabling Act.[187] The QCAA is not an enabling Act in this tribunal so it has been not been empowered to deal with competitive neutrality. In this matter, it is the Regulation which is the enabling Act and which provides jurisdiction to the tribunal.[188]
[186] QCAT Act, section 9.
[187] QCAT Act, section 6(2).
[188] Section 33 of the Regulation.
The tribunal is not empowered to consider competitive neutrality as a factor in this review.
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