WORKSAFE V HOOPER & OXYMED
* Worksafe in evidence stated, "this is not about causation" but "risks, procedures and an unsafe environment"
Craig Dawson - April 2016
Craig Dawson had been attending OXYMED for Hyperbaric Oxygen Therapy for a 3+ year period.
In contrast to the media, Craig Dawson did not suffer a seizure whilst inside a chamber, and did not die whilst inside a hyperbaric chamber.
Craig required assistance whilst asleep inside a hyperbaric chamber.
It was thought that Craig had suffered a cardiac arrest and had stopped breathing.
Craig was immediately extracted from the chamber and provided CPR for 10-minutes until the ambulance arrived.
Craig was resuscitated but remained in a coma state.
Craig had a long standing request to 'donate' his body to science if confronted with a terminal situation.
Craig's family and the Alfred hospital fulfilled his request and elected to withdraw him from life support 5-days later.
Worksafe Victoria issued a series of charges against Malcolm Hooper and OXYMED Australia.
Charges are a mixture of "procedural charges" and "failure to ensure a safe workplace".
Worksafe has offered Hooper opportunity to plead to "recklessly endangering lives".
The matter will be run before a judge and jury, anticipated to be heard in 2020.
Procedural charges relate to "not informing Worksafe at the time" and "failing to fully preserve the area".
The chamber in question continued to be in use until Worksafe arrived, as there were no issues with the operations of the chamber.
The patient's individual mask items however, were preserved.
During the initial period of Worksafe attendances, I was never advised that I had an obligation to inform Worksafe.
'Prohibition Order' was placed on the chamber until independent testing and assessment was conducted.
* The Prohibition Order was lifted when testing confirmed safe operations of the chamber.
** Improvement Notices' issued were subsequently lifted by the Worksafe improvement officers.
Worksafe charges include failing to provide a safe workplace setting with significant "risk" to the operations and safety of staff and persons attending:
* Mr Thinh Phuc Tran, Worksafe Senior Investigator and Applicant to these proceedings, stated inter alia that "he did not know" that the OXYMED clinic continued to operate without restrictions since the day of the incident, 8 April 2016.
The committal hearing heard evidence being relied on by Worksafe.
* Fire Risk
Worksafe charges include "increased risk of fire, explosion and death".
OXYMED chambers are "air filled" chambers with the 100% Oxygen delivered by a Built In Breathing System (BIBS).
The treatment pressures adopted at OXYMED are 2.0ATA or less, depending on the individual needs of the patient.
Neurologic disorders are treated at considerably less pressure than hospital HBOT facilities treating limb and life threatening disorders requiring higher treatment pressures.
The Worksafe Hyperbaric 'experts' identified fire risks in a hospital hyperbaric facility to be significantly higher in a chamber "completely filled with 100% Oxygen" and operating at "higher pressures" in a hospital ie 2.8 ATA.
* Clothing and items inside the Chamber
Worksafe charges include failing to monitor patient contraband with "increased risk of fire, explosion and death".
Evidence before the committal hearing acknowledged OXYMED consent forms, safety requirement form and an operating checklist system before a patient went inside a hyperbaric chamber.
The Worksafe Hyperbaric 'expert' stated that wearing a diving watch or low voltage watch is acceptable. Street clothes, as long as they are predominately cotton were also satisfactory.
* Oxygen Toxicity
In contrast to the media, Craig Dawson never seized whilst inside a chamber over the 3+ year period attending.
The Coroner was asked 'how seizures could be induced' with HBOT?
The Coroner spoke of Oxygen Toxicity but recommended that the topic be referred to a 'Hyperbaric Expert'.
- The media printed otherwise.
The Worksafe Hyperbaric 'experts' stated that Oxygen Toxicity is rare below 2 ATA and further reduced if provided with 'air-breaks'.
The Worksafe 'experts' stated that hospital monoplace chambers operate at higher operating pressures, and pressurising with 100% Oxygen and not air.
The experts stated that 'air-breaks' are not performed on individual patients whilst inside a hospital monoplace chamber.
The reason for NO air breaks was because the monoplace chamber was 100% Oxygen filled and the time taken to attempt to flush the chamber with 21% air would take an extraordinary length of time.
- When asked if the Oxygen toxicity is greater at higher treatment pressures and using 100% Oxygen without an air break - the Hyperbaric 'experts' agreed.
OXYMED protocols include 'air-breaks' that are conducted at regular intervals.
This is not a technical or clinical requirement when the chamber operating pressure is 2.0 ATA or less.
An 'air break' is when the Oxygen to the patient is switched back to air from 100% O2 during the actual HBOT session.
- Worksafe 'experts' stated that Oxygen Toxicity is rare below 2 ATA and further reduced if provided with air breaks.
* Emergency Extraction from a hyperbaric chamber whilst at depth
Worksafe identified significant risk stating Craig Dawson should have been removed from the chamber whilst at depth, within 90-seconds.
- The 'experts' stated during the hearing that the extraction for an emergency will vary within a hospital setting, but acceptable at 3 minutes.
* Australian Standards - Ambient air at 25%
Worksafe identified significant risk of 'imminent fire, explosion and death' where OXYMED patients are exposed to the ambient air inside the chamber rising to 25%.
The Australian standard recommends the ambient air to be no greater than 23,5% with intervention in response ie flushing the chambers.
- The USA Navy Dive Tables recommends intervention at 23.5% with the upper limit recommended not greater than 25%. This is not dissimilar to most international countries.
In contrast to the Australian Standards, the Worksafe 'experts' stated that the 100% Oxygen filled chambers operating at higher pressures are significantly higher in risk to both fire and Oxygen toxicity.
* Ability to operate the emergency button, remove the mask
Worksafe charges are based on the view that Craig could not use his arms and hands, remove his mask whilst inside the chamber or operate the emergency switch if in difficulty.
- This is not supported by the evidence of Hooper or Ted Dawson (father) and is disputed by Worksafe.
* Other forms of treatment
- When the Worksafe 'expert' was asked if the patient had the right to pursue other forms of treatment not offered in the hospital system - he agreed.
WORKSAFE HAVE NOT REPORTED ON MR DAWSONS' LONG STANDING MEDICATION REGIME.
* MR DAWSONS' COCKTAIL OF DRUGS IS NOT DISSIMILAR TO THE MAJORITY OF PATIENTS SUFFERING NEURODEGENERATIVE DISORDERS.
Eur J Neurol. 2018 Aug 22. doi: 10.1111/ene.13787. [Epub ahead of print]
Where mitoxantrone for multiple sclerosis is still valuable in 2018.
Mitoxantrone is a cytotoxic anthracenedione that has been employed mainly in Europe to treat patients with aggressive forms of multiple sclerosis (MS) since the early 1990s. The use of this strong immunosuppressive drug is mainly limited by its cardiotoxicity, by a risk of drug-induced amenorrhea and by a risk of haematologic malignancies. Its long-term efficacy and safety remains to be further characterised. This article is protected by copyright. All rights reserved.
Expert Rev Neurother. 2014 Jun;14(6):607-16. doi: 10.1586/14737175.2014.915742. Epub 2014 May 16.
The current role of mitoxantrone in the treatment of multiple sclerosis.
Multiple Sclerosis Center, Department of Public Health, Clinical and molecular medicine, University of Cagliari, Cagliari, Italy.
Mitoxantrone is an immunosuppressive drug approved for aggressive relapsing and progressive multiple sclerosis. In recent years, its use has decreased due to the risk of severe adverse events and the introduction of novel therapies, such as natalizumab or fingolimod. Mitoxantrone is effective in reducing inflammatory activity by decreasing the number of relapses and MRI lesions and simultaneously decreasing the worsening of disability. Apart from its role as a second/third-line therapy, some studies suggest its use as an induction therapy.
However, mitoxantrone use is limited because of its potential risk of severe adverse events, such as cardiotoxicity and the induction of therapy-related acute leukemia. Genetic markers are on evaluation to predict side effects and therapeutic efficacy, which is consistent with the direction of personalized treatment. Considering its efficacy and the potential risks, mitoxantrone use is limited to active patients after a careful, individualized evaluation of the risk/benefit balance.
The side effects of Mitoxantrone and their severity depend on how much Mitoxantrone is given.
* In other words, higher doses may produce more severe side effects.
The following side effects are common occurring in greater than 30%, for patients taking Mitoxantrone:
* Your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding.
* Increases in blood tests measuring liver function.
These side effects are less common side effects occurring in about 10-29%, of patients receiving Mitoxantrone:
* Mouth sores
* Hair loss
* Abnormal EKG, Heart rhythm abnormalities (arrhythmia).
* Low blood pressure.
* Blue/green discoloration of whites of eyes and/or urine for 1-2 days after treatment.
** Mitoxantrone Delayed Effects: "Life time Maximum Dose"
* A serious side effect of Mitoxantrone can be interference with the pumping action of the heart.
* You can receive only up to a certain amount of Mitoxantrone during your lifetime.
* This "lifetime maximum dose" may be lower if you have heart disease risk factors such as radiation to the chest, advancing age, and use of other heart-toxic drugs."
5. Valproate Sodium
Other Media reported 'events':
Bacchus Marsh hospital investigated over 'avoidable' baby deaths.
- Described by Jill Hennessy Health Minister as a "Catastrophic event".
"No Criminal Charges" have been laid against the hospital, doctors or staff!
- The regulator said the health service had informed it of improvements in supervision, training and clinical governance.
- "We have new leadership, new equipment, new clinical governance and additional training and education for staff,"
- Overall, AHPRA said it had opened 101 matters in relation to reported stillbirths and neonatal deaths at the Bacchus Marsh Hospital.
- AHPRA said 84 matters relating to 38 health practitioners had been finalised.
- Six practitioners had been cautioned, five practitioners had conditions imposed on their registration and five were referred to a panel hearing or to VCAT.
Midwife banned from practising
Wednesday, 31 October, 2018
A former midwife has been permanently banned from practising midwifery.
The Victorian Civil and Administrative Tribunal found that previously registered midwife Dianne Jean Macrae had engaged in professional misconduct while providing care to patients at Bacchus Marsh Hospital; a decision was made that she should never practise again. Macrae is one of 38 practitioners at the hospital under investigation or who have had actions taken against them.
The outcome was welcomed by the Nursing and Midwifery Board of Australia (NMBA) and the Australian Health Practitioner Regulation Agency (AHPRA), who referred Macrae to the tribunal. It is the first tribunal outcome from AHPRA’s investigation into matters relating to Bacchus Marsh Hospital (Djerriwarrh Health Services). Other practitioners have been dealt with by the NMBA through other regulatory actions.
In February 2016, AHPRA and the NMBA launched investigations in relation to the care provided by individual practitioners at the Bacchus Marsh Hospital during the period of October 2011 to February 2013. The investigations included Macrae, a registered midwife, who was employed as an Associate Nurse Unit Manager (ANUM) by the Djerriwarrh Health Services at the hospital:
On 3 March 2016 the NMBA decided to impose conditions on Macrae’s registration requiring her to practise only with supervision.
On 9 September 2016 that action was escalated to an undertaking from Macrae that she would not practise at all.
On 13 July 2017, Macrae surrendered her registration, which means she is no longer able to practise as a registered midwife.
The NMBA referred a series of allegations to the tribunal on 1 May 2018 relating to Macrae’s performance as a midwife. The allegations included:
failure to carry out clinical assessment and care (inadequate interpretation of foetal cardiotocography (CTG)
failure to recognise and respond to an urgent situation
inadequate clinical records.
Macrae admitted all allegations.
The tribunal found that Macrae had engaged in 10 instances of professional misconduct under the Health Practitioner Regulation National Law, as in force in each state and territory (the National Law). The tribunal noted each practitioner has individual professional responsibility to work in accordance with the relevant standards and codes. Moreover, many of the proven matters related to incompetence, which falls outside of the working conditions.
The tribunal reprimanded Macrae and accepted an undertaking from her that she would never apply for registration as a midwife again.
Overall, AHPRA opened 101 matters in relation to reported stillbirths and neonatal deaths at the Bacchus Marsh Hospital (Djerriwarrh Health Service). As of 18 October 2018, 84 matters relating to 38 health practitioners have been finalised.
For the 38 practitioners whose matters have been finalised, more than half were able to be closed without the need for regulatory action. This includes practitioners who have surrendered their registration or who had already undertaken steps towards remediation, which a National Board considers sufficient to manage any ongoing risk to the public. For example, when a practitioner has completed education or training that addresses any gaps identified in their skills or knowledge.
For those matters where further action was taken:
six practitioners were cautioned
five practitioners had conditions imposed on their registration (including those who were cautioned and had conditions imposed)
five practitioners were referred to a panel hearing or the Victorian Civil and Administrative Tribunal.
Generally speaking, when an investigation is ongoing into conduct of a serious nature by a registered health practitioner, the investigation can continue even if a practitioner surrenders their registration and is no longer practising. Matters that are referred to a tribunal are considered to meet the threshold of ‘reasonable belief’ by a National Board that the practitioner has behaved in a way that constitutes professional misconduct.
Bacchus Marsh Hospital: Former midwife never to practise again after baby death cases
A tribunal has ordered that a former midwife never practise again after finding she had engaged in professional misconduct while giving care to patients at Bacchus Marsh Hospital, north west of Melbourne. The Bacchus Marsh Hospital was at the centre of a cluster of stillbirths and newborn deaths in 2013 and 2014.
Registered midwife Dianne Jean Macrae was linked to the deaths of three babies at the hospital where she worked as an Associate Nurse Unit Manager at the Djerriwarrh Health Services.
The Victorian Civil and Administrative Tribunal (VCAT) yesterday found that Ms Macrae had engaged in 10 instances of professional misconduct while providing care to patients at the hospital.
The tribunal accepted an undertaking from Ms Macrae that she would never apply for registration as a midwife again.
Midwife 'failed to respond to urgent situation'
She admitted to all allegations against her, including that she had failed to carry out clinical assessment and care and had inadequately interpreted foetal cardiotocography (CTG).
She also admitted she had failed to recognise and respond to an urgent situation.
An investigation into obstetric and midwifery care at the hospital led Ms Macrae to surrender her registration in 2017.
She was referred to VCAT by the Nursing and Midwifery Board of Australia (NMBA) and the Australian Health Practitioner Regulation Agency (AHPRA), which both welcomed the VCAT outcome.
In a statement, AHPRA said the investigation was one of a large number started when concerns were raised about obstetric and midwifery care at the Djerriwarrh Health Service.
Overall, AHPRA said it had opened 101 matters in relation to reported stillbirths and neonatal deaths at the Bacchus Marsh Hospital.
It said 84 matters relating to 38 health practitioners had been finalised.
Six practitioners had been cautioned, five practitioners had conditions imposed on their registration and five were referred to a panel hearing or to VCAT.
Bacchus Marsh hospital staff remain 'badly damaged' by baby deaths as new obstetrics unit opens
The Australian Health Practitioner Regulation Agency said it had investigated a total of 44 health workers at the Bacchus Marsh and Melton Regional Hospital — including doctors, midwives and nurses — as a result of the scandal.
The regulator said it was yet to finalise its investigation into seven former health practitioners at the hospital, involving 18 separate cases, but that the practitioners no longer "provide obstetric services" at the hospital.
Five practitioners have had conditions imposed on their registration, and four were referred to a panel hearing or the Victorian Civil and Administrative Tribunal.
- The regulator said the health service had informed it of improvements in supervision, training and clinical governance.
Forty workers investigated over Bacchus Marsh Hospital baby deaths
"Significant failings in clinical governance have previously been identified as contributing to the tragic events which occurred at Bacchus Marsh hospital," AHPRA said in a statement.
Reviews into the cluster of baby deaths at the Djerriwarrh Health Service previously identified at least 11 losses that were potentially avoidable.
The AHPRA investigation team, helped by a team of clinical experts, examined thousands of pages of clinical records, identifying those who provided care, and has interviewed dozens of staff members.
In total, 96 cases were referred to AHPRA over the scandal, including those relating to 13 doctors, 23 midwives and nurses and four other medical staff.
Bacchus Marsh stillborn scandal: Second review finds 11 baby deaths 'potentially avoidable'
- A tearful Health Minister, Jill Hennessy, said all women and families had received the facts about their individual cases.
"Whilst I know there is nothing I can say or do that will heal the pain of losing a child, I do want to assure those families that we are doing everything we can to assure that what happened at Djerriwarrh Health Service never happens at any other health service," she said.
"Every woman who experienced a potentially avoidable loss has been given a full explanation of the care she received and has undergone open disclosure or conciliation processes in a safe and supportive environment."
Maurice Blackburn Lawyers represent four families who lost babies prior to 2012.
"Some of these families received explanations at the time that their baby's death was unavoidable," medical negligence lawyer Dimitra Dubrow said.
"They've gone through lasting grief only to now be told that their baby's death was avoidable and their babies really should be with them now.
"That kind of pain is just indescribable."
The Government replaced the Djerriwarrh Health Service board and appointed a new chief executive following the initial investigation.
All case notes have been handed to the Australian Health Practitioner Regulation Agency (AHPRA) and investigations are ongoing.
In a statement, AHPRA chief executive Martin Fletcher said the organisation was investigating a number of registered health practitioners who practised at Bacchus Marsh Hospital.
"As regulators, our job is to make sure that any ongoing risk to the public posed by individual practitioners has been addressed so patients are safe," he said.
"We have taken steps to ensure new leadership at both a clinical and governance level at Djerriwarrh, and put in place a series of measures to make the hospital as safe as it can possibly be.
"Certainly one of the lessons was that staff who indicated some concerns weren't really listened to in 2012 and 2013 - that was certainly an issue."
Health Services Commissioner Dr Grant Davies said his office was assisting 43 women over birth-related concerns and the quality of care they received at Djerriwarrh Health Service.
Those complaints relate to incidents dating back to 1990.
'Catastrophic event': Bacchus Marsh hospital investigated over seven 'avoidable' baby deaths
The death of seven babies at a regional Victorian hospital could have been avoided in what has been described as a "catastrophic event".
A Health Department probe into 10 stillbirths or deaths in 2013 and 2014 at Bacchus Marsh and Melton Hospital, which is run by Djerriwarrh Health Services, has found that hospital practices could have contributed to the seven deaths.
Professor Wallace said the hospital lacked "high quality staff education" and staff were "inadequately skilled" in monitoring fetal heart rates.
The failings at the hospital were described as "a team issue" by Professor Jeremy Oats, chairman of the Consultative Council on Obstetric and Paediatric Mortality, who reviewed the data.
Staff from the Royal Women's Hospital have been seconded to Bacchus Marsh to train maternity ward staff. Dr John Ballard, who has been appointed to the health services board by the government, said it was safe for women to give birth at the hospital.
- "We have new leadership, new equipment, new clinical governance and additional training and education for staff," he said
Bacchus Marsh Hospital investigated over deaths of seven babies
Bacchus Marsh Hospital: Coroner finds significant failings in care in baby death cases
By Charlotte King, Updated 5 May 2016, 7:53am
There were significant failings in the obstetric care provided to three babies who died soon after being born at a rural Victorian hospital, the state's coroner has found.
Coroner finds "sub-optimal" care in three newborn death cases
Misinterpretation of foetal heart monitoring system a common feature in each case
Hospital has acknowledged its own failings in the report
The three baby girls were each born at the Bacchus Marsh maternity unit of the Djerriwarrh Health Service in 2013, but died 24 hours, seven days and 16 days after their births.
Each child, the coroner noted, was their parents' first.
The babies' deaths were only reported to the coroner in 2015, after a cluster of stillbirths and newborn deaths at the hospital were identified by Victoria's Consultative Council of Obstetric and Paedeatric Mortality and Morbidity (CCOPMM).
Obstetrics Professor Euan Wallace was recruited by the state's Department of Health and Human Services to examine the cluster, and found seven deaths between 2013 and 2014 could have been avoided.
As the Coroner's Court has no jurisdiction over stillbirths, only the three newborn deaths were investigated.
In each case, the coroner found significant clinical errors were made in the care of the child during the labour and birth.
She described the handling of care in each case as "sub-optimal", with the misinterpretation of the CTG, or foetal heart monitoring system, a feature common to each.
In one instance, the mismanagement of the CTG scans was reported to have continued for hours before the birth, and in another the coroner described the clinical notes provided by the obstetrician as "grossly inadequate".
The coroner found each of the three baby girls required resuscitation after birth, but none had access to a paediatrician at that time.
In each case, the coroner found she "was unable to determine the outcome of [the baby's] clinical course had she been delivered earlier".
The hospital itself has acknowledged its own failings in the report.
"In all three cases it was considered that there may have been a failure on the part of the attending midwives to identify and respond to abnormal CTG traces," Djerriwarrh's current chief executive, Andrew Freeman, said in a note to the coroner included in the findings.
"The deaths would not have been expected if the care and management of the mothers' labours had been different and, in particular the abnormal CTG traces actioned."
If action had been taken earlier as a result of the abnormal foetal monitoring scans, Mr Freeman said "the deaths of the babies might have been prevented".
The Djerriwarrh Health Service was unavailable for comment, but has confirmed a 24-hour paediatric service is now in place, and a new director of obstetrics has been employed.
In a statement, the hospital said it had implemented all of the recommendations made by Professor Wallace in his report, and that "while we can never change the past, the staff and leadership... is working hard to ensure we meet the current and future needs of our local community".
The Australian Health Practitioner Regulation Agency (AHPRA) is currently investigating the obstetricians and midwives involved in the baby death cases.
A State Government review into all baby deaths at the hospital dating back to 2001 was completed in April, but the findings are yet to be made public.
"A Sydney man died from brain damage after a tube was left in his neck for six hours and air bubbles entered his bloodstream, says a NSW coroner, who found the death was preventable. Phillip Ibrahim, 39, suffered an air embolism on October 28 in 2014, a day before he was due to be discharged from the intensive care unit of Concord Hospital where he'd been receiving treatment for pneumonia. The father-of-two and fitness fanatic was then transferred to Prince of Wales Hospital for hyperbaric treatment but had "signs of very severe brain damage" and his life support was turned off on October 30.
Sydney's Bankstown-Lindcombe Hospital
Sydney baby oxygen mix-up: Hospital staff 'did not meet responsibilities', report finds
A report into a deadly south-west Sydney hospital gas mix-up has outlined recommendations including a performance watch for the health district, after a "catastrophic error" left one baby dead and another with suspected brain damage.
The NSW Health report, released to the public on Saturday, also found staff at Sydney's Bankstown-Lindcombe Hospital did not meet their responsibilities.
Staff involved in gas mix-up "did not meet responsibilities", report finds
Failings in the installation, testing of gas piping found
Recommendation to put health district on "performance watch"