Prevention of Future Deaths reports · 2018
Regulation 28 report to prevent future deaths, reference 2018-0069, written 9 Mar 2018. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 9 Mar 2018 |
|---|---|
| Reference | 2018-0069 |
| Deceased | David Sketchley |
| Coroner | Caroline Saunders |
| Coroner area | Gloucestershire |
| Category | Care Home Health related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
H M Assistant Coroner for Gloucestershire Caroline Saunders [ REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: BUPA UK, Bridge House, Outwood Lane, Horsforth, Leeds, LS18 4UP 4 CORONER 1 am Caroline Saunders, H M Assistant Coroner for Gloucestershire. 2 CORONER’S LEGAL POWERS | make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On the 27" July 2017 | commenced an investigation into the death of David Anthony Sketchley. The investigation concluded at the end of the inquest on 28" February 2018. The conclusion of the inquest was a narrative conclusion. The following factors contributed to and caused the death of David Anthony Sketchley: 1) Inadequate Supervision a) During incident an appropriate carer was absent during the incident b) Lack of clarity in care plan. His supervision needs were unclear, as were the definitions of supervision. 2) Suitability of commode a) There is insufficient to no evidence of David Anthony Sketchley’s suitability for a bariatric commode in terms of documented risk assessment. The medical cause of death was 1a) Sepsis and bronchopneumonia 1b) traumatic perianal laceration 2 Hypertensive heart disease and cerebro-vascular accident 4 CIRCUMSTANCES OF THE DEATH | Mr Sketchley was a resident at Ashley House Nursing Home, in Cirencester, a residential facility run by BUPA. On 16" July 2017, Mr Sketchley was seated in a commode chair. He attempted to raise himself from the chair and in the process managed to dislodge the commode pan and flip the seat on the chair. The commode chair was a bariatric chair with a horse shoe design. This design means there is a gap at the front of the seat and it appears that on raising himself from the chair, one of Mr Sketchley’s legs became lodged in the gap thus causing the pan to dislodge and the seat to flip up. Mr Sketchley’s body then fell between the gap in the front of the chair and in so doing his anus was impaled on one of the supporting bars beneath the seat (no longer in situ). The injuries Mr Sketchiey sustained caused his death the following day. Gloucestershire Coroner's Court, Corinium Avenue, Barnwood, Gloucester, GL4 3D) Tel 01452 305661 | Fax 01452 412618 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. — At the time of the incident Mr Sketchley was to be supervised. The evidence that | heard was the main carer thought that whilst on the commode Mr Sketchley was to be supervised at all times. The care plan dictated that generally Mr Sketchley was to be supervised regularly. | heard no evidence that staff understood exactly what level of supervision was required. | heard from Demelza James that it is deemed acceptable to not observe / watch a resident who is being supervised but just to listen to them. | heard no evidence that Mr Sketchley’s care plan stated this was a sufficient level of supervision, nor that there are any guidelines to assist staff when making decisions about the level of supervision a resident requires. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you have the power to take such action. In light of the evidence | should like to know what action if any BUPA has taken to review its practices in relation to the supervision of residents and whether consideration has been given to develop guidelines for staff in making decisions about frequency and intensity of supervision. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 4pm Friday 4° May 2018. |, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons (1) Performance Health (2) Care Quality Commission (3) Mr Sketchley’ s family. | am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. Dated 9" March 2018 Signature CQou.0léc% Caroline Saunders H M Assistant Coroner for Gloucestershire Gloucestershire Coroner's Court, Corinium Avenue, Barnwood, Gloucester, GL4 3D) Tel 01452 305661 | Fax 01452 412618 H M Assistant Coroner for Gloucestershire Caroline Saunders REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: i. BUPA, Bridge House, Outwood Lane, Horsforth, Leeds, LS18 4UP ii. | CARE QUALITY COMMISSION, City Gate, Gallowgate, Newcastle upon Tyne NE1 4PA CORONER | am Caroline Saunders, H M Assistant Coroner for Gloucestershire. CORONER’S LEGAL POWERS | make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. INVESTIGATION and INQUEST On the 27" July 2017 commenced an investigation into the death of David Anthony Sketchley. The investigation concluded at the end of the inquest on 28" February 2018. The conclusion of the inquest was a narrative conclusion. The following factors contributed to and caused the death of David Anthony Sketchley: 1) Inadequate Supervision a) During incident an appropriate carer was absent during the incident b) Lack of clarity in care plan. His supervision needs were unclear, as were the definitions of supervision. 2) Suitability of commode a) There is insufficient to no evidence of David Anthony Sketchley’s suitability for a bariatric commode in terms of documented risk assessment. The medical cause of death was 1a) Sepsis and bronchopneumonia 1b) Traumatic perianal laceration 2 Hypertensive heart disease and cerebro-vascular accident CIRCUMSTANCES OF THE DEATH Mr Sketchley was a resident at Ashley House Nursing Home, in Cirencester, a residential facility run by BUPA. On 16" July 2017, Mr Sketchley was seated in a commode chair. He attempted to raise himself from the chair and in the process managed to dislodge the commode pan and flip the seat on the chair. The commode chair was a bariatric chair with a horse shoe design. This design means there is a gap at the front of the seat and it appears that on raising himself from the chair, one of Mr Sketchley’s legs became lodged in the gap thus causing the pan to dislodge and the seat to flip up. Mr Sketchley’s body then fell between the gap in the front of the chair and in so doing his anus was impaled on one of the supporting bars beneath the seat (no longer in situ). The injuries Mr Sketchley sustained caused his death the following day. Gloucestershire Coroner's Court, Corinium Avenue, Barnwood, Gloucester, GL4 3D) Tel 01452 305661 | Fax 01452 412618 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. — The main vehicle for ensuring that future deaths are prevented is to undertake a rigorous investigation. This is especially so in the case of a reportable death and indeed an investigation was undertaken by BUPA under the auspices of the Care Quality Commission. However | am concerned about the quality of the investigation. Inter alia; The investigation did not come to a conclusion on the level of supervision that Mr Sketchley required. The investigation did not take the opportunity to collaborate with the manufacturers of the commode. The investigation did not apparently attempt to determine exactly how the incident had occurred The investigation did not inquire intothe method by which the bariatric commode was considered suitable for Mr Sketchley Evidence was heard about the standards demanded by Gloucester Care Services in relation to the assessments required when determining if a commode is suitable for a particular person. There there was no evidence that these standards are reflected in BUPA practice. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you have the power to take such action. In light of the evidence | should like to know if the CQC and BUPA intend to commission a new investigation. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 4pm_ Friday 4"° May 2018. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons (1) Performance Health (2) Mr Sketchley’s family. | am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. Dated 9" March 2018 Sig nature Coulee’ Caroline Saunders H M Assistant Coroner for Gloucestershire Gloucestershire Coroner's Court, Corinium Avenue, Barnwood, Gloucester, GL4 3DJ Tel 01452 305661 | Fax 01452 412618 H M Assistant Coroner for Gloucestershire Dr Simon Fox QC REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: Medicines and Healthcare Products Regulations Authority, 151 Buckingham Palace Road, Belgravia, London SW1W 9SZ CORONER | | am Caroline Saunders, H M Assistant Coroner for Gloucestershire. CORONER’S LEGAL POWERS | make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. INVESTIGATION and INQUEST On the 27" July 2017 | commenced an investigation into the death of David Anthony Sketchley. The investigation concluded at the end of the inquest on 28" February 2018. The conclusion of the inquest was a narrative conclusion. The medical cause of death was: The following factors contributed to and caused the death of David Anthony Sketchley: 1) Inadequate Supervision a) During incident an appropriate carer was absent during the incident b) Lack of clarity in care plan. His supervision needs were unclear, as were the definitions of supervision. 2) Suitability of commode a) There is insufficient to no evidence of David Anthony Sketchley’s suitability for a bariatric commode in terms of documented risk assessment. 1a) Sepsis and bronchopneumonia 1b) Traumatic perianal laceration 2 Hypertensive heart disease and cerebro-vascular accident CIRCUMSTANCES OF THE DEATH Mr Sketchley was a resident at Ashley House Nursing Home, in Cirencester, a residential facility run by BUPA. On 16" July 2017, Mr Sketchley was seated in a commode chair. He attempted to raise himself from the chair and in the process managed to dislodge the commode pan and flip the seat on the chair. The commode chair was a bariatric chair with a horse shoe design. This design means there is a gap at the front of the seat and it appears that on raising himself from the chair, one of Mr Sketchley's legs became lodged in the gap thus causing the pan to dislodge and the seat to flip up. Mr Sketchley’s body then fell between the gap in the front of the chair and in so doing his anus was impaled on one of the supporting bars beneath the seat (no longer in situ). The injuries Mr Sketchley sustained caused his death the following day. Ashley House immediately stopped using this design of bariatric commode. Gloucestershire Coroner's Court, Corinium Avenue, Barnwood, Gloucester, GL4 3D) Tel 01452 305661 | Fax 01452 412618 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. — That the design of the chair contributed to the injuries that Mr Sketchley received. | heard evidence from Performance Health, the manufacturers of the commode, that the Medical Devices Agency has taken the decision to downgrade the commode into a category such that when a patient is damaged when using the commode, even if the injury proves fatal that there is no need for this to be reported to the MDA. Therefore no MDA investigation in relation to the product’s safety has taken place. In addition the main vehicle by which any potential problems with products is brought to the attention of other users, is lost. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you have the power to take such action. In light of the evidence | should like to understand the rationale for downgrading the commode in the terms set out above, and following this incident whether that decision will be reviewed. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 4pm_ Friday 4" May 2018. |, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons (1) BUPA (2) Care Quality Commission (3) Mr Sketchley’ s family. (4) Performance Health | am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. Dated 9™March 2018 Signature. Caroline Saunders H M Assistant Coroner for Gloucestershire Gloucestershire Coroner's Court, Corinium Avenue, Barnwood, Gloucester, GL4 3D) Tel 01452 305661 | Fax 01452 412618 H M Assistant Coroner for Gloucestershire Caroline Saunders REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: Performance Health, Nunn Brook Road, Huthwaite, Sutton in Ashfield, Nottinghamshire NG17 2HU CORONER | am Caroline Saunders, H M Assistant Coroner for Gloucestershire. CORONER’S LEGAL POWERS | make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. INVESTIGATION and INQUEST On the 27" July 2017 commenced an investigation into the death of David Anthony Sketchley. The investigation concluded at the end of the inquest on 28" February 2018. The conclusion of the inquest was a narrative conclusion. The following factors contributed to and caused the death of David Anthony Sketchley: 1) Inadequate Supervision a) During incident an appropriate carer was absent during the incident b) Lack of clarity in care pian. His supervision needs were unclear, as were the definitions of Supervision. 2) Suitability of commode a) There is insufficient to no evidence of David Anthony Sketchley’s suitability for a bariatric commode in terms of documented risk assessment. The medical cause of death was 1a) Sepsis and bronchopneumonia 1b) traumatic perianal laceration 2 Hypertensive heart disease and cerebro-vascular accident CIRCUMSTANCES OF THE DEATH Mr Sketchley was a resident at Ashley House Nursing Home, in Cirencester, a residential facility run by BUPA. On 16" July 2017, Mr Sketchley was seated in a commode chair. He attempted to raise himself from the chair and in the process managed to dislodge the commode pan and flip the seat on the chair. The commode chair was a bariatric chair with a horse shoe design. This design means there is a gap at the front of the seat and it appears that on raising himself from the chair, one of Mr Sketchley’s legs became lodged in the gap thus causing the pan to dislodge and the seat to flip up. Mr Sketchley's body then fell between the gap in the front of the chair and in so doing his anus was impaled on one of the supporting bars beneath the seat (no longer in situ). The injuries Mr Sketchley sustained caused his death the following day. Gloucestershire Coroner's Court, Corinium Avenue, Barnwood, Gloucester, GL4 3D) Tel 01452 305661 | Fax 01452 412618 5 CORONER'S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. — That the design of the chair contributed to the injuries that Mr Sketchiey received. | heard evidence that the design of the chair has not been reviewed, in part because the exact mechanism of injury was not known until the inquest. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you have the power to take such action. In light of the evidence | should like to know whether a review of the design of this commode will be undertaken. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 4pm Friday 4"" May 2018. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons (1) BUPA (2) Care Quality Commission (3) Mr Sketchley’ s family. | am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the Telease or the publication of your response by the Chief Coroner. 9 | Dated 9" March 2018 Signature Cox she vS Caroline Saunders H M Assistant Coroner for Gloucestershire Gloucestershire Coroner's Court, Corinium Avenue, Barnwood, Gloucester, GL4 3DJ Tel 01452 305661 | Fax 01452 412618
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Bupa Care Services Regulation 28 — Prevention of Future Death Care Home: Ashley House Resident: David Anthony Sketchley Background: Circumstances of Death Mr Sketchley was a resident at Ashley House Nursing Home, in Cirencester. On the 16" July 2017 he was seated in a commode chair. He attempted to raise himself from the chair and in the process he inadvertently dislodged the commode pan and flipped the seat on the chair. The commode chair was a bariatric chair with a horse shoe design. This design means there is a gap at the front of the seat and it appears on raising himself from the chair, one of Mr Sketchleys legs became lodged in the gap thus causing the pan to dislodge and the seat to flip up. His body then fell between the gap in the front of the chair and in doing so his anus was impaled on one of the supporting bars beneath the seat (no longer insitu). The injuries Mr Sketchley sustained caused his death the following day. Actions that should be taken (identified by the coroner): 1. Inadequate Supervision : e During the incident an appropriate carer was absent during the incident e Lack of clarity in the care plan. His supervision needs were unclear, as were the definitions of supervision 2. Suitability of commode e There is insufficient to evidence of DAS suitability for a bariatric commode in terms of documented risk assessment 3. Bupa should consider undertaking a further investigation taking into account the following: e The initial investigation - Did not come to the conclusion on the level of supervision DAS required e = The initial investigation - Did not take the opportunity to collaborate with the manufacturers of the commode e The initial investigation - Did not apparently attempt to determine exactly how the incident had occurred e = The initial investigation - Did not inquire into the method by which the bariatric commode was considered suitable for DAS e The initial investigation - What are the standards by Gloucester Care Services in relation to the assessments required when determining if a commode is suitable for a particular person : no evidence that these standards are reflected in Bupa practice Bupa actions required: 1. 3. Inadequate Supervision : Specifically; Safety, Moving Around, Going to the Toilet sections of the ‘My day my life’ documents do not currently highlight a supervision plan if a resident requires close monitoring and by whom and neither do any of the other sections. All sections ask what support a person requires but if a resident does require close supervision, none of the sections specifically ask what the plan would look like. None of the sections prompt staff to consider what an individualised definition of supervision is for the specific resident or who would supervise the resident. We now advocate the use of a two tier care documentation filing system which is a mandatory process and has been in use since 2017. The main care file is to be housed at the nurse’s station and is where the care plans sit. The second file, which is known as the supplementary file is to be housed at the point of care delivery i.e. in a resident’s bedroom. At the front of the supplementary file is a document named ‘My Day, My Life, and My Portrait’. This document is designed to give an overview of the care needs an individual requires and is available at the point of care delivery, allowing care staff immediate access to imperative information regarding a resident’s care needs. Therefore this document should be reviewed to incorporate an individual’s supervision requirement, including who carries out the supervision, during each activity of daily living requirement. Supporting guidance and Resident Care policies will also need to be reviewed to incorporate this change .This work is currently underway and all clinical policies will be reviewed during 2018 Suitability of commode Each resident has their body mass index (BMI) established on admission by staff using the MUST nutritional screening tool, this is then reviewed on a monthly basis. The eating and drinking plan asks what support a person requires from us but there is no formal Bariatric Risk assessment, which should include assessment and requirement of specialised equipment. This assessment should form part of the ‘My Day My Life’ care documentation process and also be triangulated in the Resident Care policies and the Clinical Equipment policy. Therefore there is a requirement to develop a Bariatric Risk Assessment form and update the underpinning policies. A first draft of the Bariatric Risk Assessment form has been produced and was considered at the Clinical Governance Committee in April 2018. It will be re-submitted at the May committee following further review. The underpinning policies are also in the process of being updated. Further investigation Bupa will allocate resource to undertake further investigations into the issues highlighted above under point 3 by the coroner, which were not covered in the original investigation. Any findings from the new investigation will be discussed at the BCS Clinical Governance Committee and actions and learning’s agreed. Governance process Any documents developed will be agreed and signed off by members of the Bupa Care Services Clinical Governance Committee Cascade of learning’s and Actions Cascade of new documentation and learning’s will be via Need2Read which is a weekly communication and the Quality Matters quarterly bulletin, both of which are cascaded via email to the Operational team and the Quality & Compliance team, including Home Managers and support teams who will then cascade at home level. All new or updated documents will be uploaded onto Bupa Oneplace which is an online electronic filing system available to all Bupa staff. Review completed by: ae... of Clinical Governance 3" April 2018 PERFORMANCE | performancehealth.co.uk | Nunn Brook Road, Huthwaite, Main: +44 (0) 3448 730 035 Sutton-in-Ashfield, HEA LTHS i +44 (0) 1623 557 769 Nottinghamshire, NG17 2HU, UK. at April 2018 Ms Caroline Saunders, HM Assistant Coroner for Gloucestershire Gloucester Coroner’s Court Corinium Avenue Barnwood Glottcester Gia 322) ) Dev Ms. Saunders, Ref: The Late David Anthony Sketchley Thank you for your letter dated the 9" March 2018 and the Prevention of Future Death Report related to the recent inquest which we have now considered. On a personal level | am, of course, very regretful that one of our products was involved in this tragic incident and wish to restate my sympathies to Mr Sketchley’s family which | conveyed in person at the conclusion of the resumed inquest. | have carefully reviewed your findings in this case, and reflected on the evidence | heard during the inquest which provided a fuller, but still largely theoretical explanation of the exact incident. The jury found that the main factors in the death were 1) Inadequate Supervision and 2} the Suitability of the commode. | agree that this commode was entirely unsuitable for Mr Sketchley, given his particular conditions. After careful thought and comparison with other bariatric commodes on the market which also use a similar design and considering the long and uneventful history associated with the Atlantic Bariatric Shower Commode, our conclusion is that no design change is required. Yours sincerely, Company Registration No. 4374752 VAT Registration No. 945765283 35 BIOFREEZE Ways = xhomecrott JAMAR (metron fee? — MRolyan Pal robes tat works: ton ~=(@}) serbothane HERABAND — @THER“PEARL Tumble Forms? \. Aa a Medicines & Healthcare products Requiating Medicines and Medical Devices Regulatory Agency Ms Caroline Saunders MHRA HM Assistant Coroner for Gloucestershire 151 Buckingham Palace Road Gloucestershire Coroner’s Court London Corinium Avenue SW1W 98Z Barnwood United Kingdom Gloucester www.gov.ukimhra GL4 3DJ 26 April 2018 Your ref: TJ/je Our ref: 18337 Dear Ms Saunders, Reference: Mr David Anthony SKETCHLEY | write with reference to your Regulation 28 letter following the inquest into the death of Mr Sketchley. You requested that we take action to prevent similar events of this kind occurring. The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and is responsible for the regulation of medical devices and medicinal products. The aim of the MHRA Devices Division is to take all reasonable steps to protect the public’s health and safeguard the interests of patients and users by ensuring that medical devices and equipment meet appropriate standards of safety, quality and performance and that they comply with relevant Directives of the European Union. One major area of the MHRA’s responsibilities is the investigation of adverse incidents. An adverse incident is an event involving a medical device, which produces, or has the potential to produce, unwanted effects involving the safety of patients, users and other persons. These effects may arise from shortcomings in the device, its operating instructions, user practice or conditions of use. Incident summary Mr Sketchley sustained fatal injuries when he fell between the gap in the front of a commode chair he was using at the Ashley House Nursing Home in Cirencester. The commode chair was intended for bariatric use (manufactured by Performance Health) and Mr Sketchley's leg became trapped in the gap at the front of the seat when he dislodged the commode pan as he tried to stand. From your communication, it would appear that there was no supervision in place at the time of the incident and that the risk assessment conducted for Mr Sketchley’'s use of this chair was inadequate. Although the type of commode provided for Mr Sketchley may have been inappropriate and contributed to his death, there should have been a risk assessment conducted by the healthcare professionals with the responsibility for his care before its use. This is a key requirement for all = RA Regulating Medicines and Medical Davices = ledicines & Healthcare products | | egulatory Agency Be) Occupational Therapy equipment and is always emphasised in the Instructions for Use issued by the manufacturers of such equipment and general guidance published by organisations such as the CQC. The MHRA is unable to comment on the level of supervision, or lack of it, that was in place for Mr Sketchley at the time of the incident that led to his death. Classification of commodes as Medical Devices Under the heading “Coroner’s Concerns’ in the Reg 28 report you have highlighted the fact that the MHRA (formerly the Medical Devices Agency) has downgraded the commode into a category which does not require investigation of incidents associated with the product. This is in fact incorrect, commodes are not regulated as medical devices in the UK, as they are regarded as aids to personal hygiene and do not perform the function of a medical device in accordance with the definitions contained in the Medical Device Directives. Therefore, manufacturers of commodes are not obliged to report adverse incidents involving their products to the MHRA, as the Competent Authority for medical devices, under the vigilance process. In that respect, the evidence heard at the inquest into Mr Sketchley’s death from Performance Health was correct. However, the MHRA is prepared to receive reports of adverse incidents involving commodes (or similar products) from manufacturers, healthcare professionals, members of the public etc. Where we consider there is a safety issue that needs addressing we would pass the report to the appropriate Trading Standards Organisation to take any necessary action, as these products are outside our remit to take direct action against the manufacturer as they are not CE marked as medical devices. Conclusion Commodes and associated equipment are not regulated as Medical Devices in the UK and it is, therefore, outside the remit of the MHRA to take action with the manufacturer in this case. If a product of this type is regarded as unsafe in its design or construction the matter should be referred to the Trading Standards Organisation. MHRA will continue to pass any reports of adverse incidents for commodes to the appropriate TSO and to endorse the general advice issued to healthcare professional using OT equipment and aids to daily living that it is essential to carry out a detailed risk assessment for each individual patient as to the suitability of the product before it is brought into use. Yours sincerely, NO Mecctins: Dr lan Hudson Chief Executive Officer Medicines and Healthcare products Regulatory Agency 151 Buckingham Palace Road, London, SW1W 9SZ 30 APR 2019 CareQuality FE ne aie urther Information Commission Citygate Gallowgate Newcastle upon Tyne NE1 4PA Telephone: 03000 616161 For attention of: Fax: 03000 616171 Ms Caroline Saunders : HM Assistant Coroner for Gloucestershire Gloucestershire Coroner’s Court Corinium Avenue Barnwood Gloucester GL4 3DJ 19 April 2018 Care Quality Commission Our Refererice: ENQ1-4973662699 Dear HM Assistant Coroner Prevention of future death report following inquest into the death of Mr David Anthony Sketchley. D.0.B (11/03/1933) We write to acknowledge receipt and provide a response to the prevention of future death report dated 9" March 2018 issued jointly to CQC and BUPA following the death of Mr David Anthony Sketchley. In the report you ask whether, in the light of the evidence provided, CQC and BUPA intend to commission a new investigation. We can assure you that CQC is gathering information into the circumstances that contributed to Mr Sketchley’s death in accordance with our regulatory powers. As you may be aware since 1 April 2015 CQC has been given new powers to prosecute registered providers (operators of care homes and nursing homes) and registered managers for failures to provide safe care and treatment. The offence is found within Regulations 22 and 12 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The CQC does not have the power to prosecute individual care workers or nurses. Our prosecution powers are limited to failures at registered provider or registered manager level. In order to successfully prosecute this offence CQC must establish to the criminal standard (beyond reasonable doubt) that; * The registered provider or manager failed to provide safe care and treatment to the service user (service user is the language used in the legislation); and * That the failure resulted in avoidable harm to the service user; or * Resulted in a significant risk of exposure to avoidable harm. Once the CQC has established these elements of the offence the burden then shifts to the registered provider or manager to establish on the balance of probabilities that they took all reasonable steps and exercised all due diligence to ensure safe care and treatment was provided. In order to prosecute any offence the Code for Crown Prosécutors must be satisfied. The Code has two stages; the evidential test and the public interest test. In order to Satisfy the evidential test the CQC must be satisfied there is sufficient evidence to amount to a realistic prospect of conviction. If the evidential test is satisfied the public interest test must also be met; is it in the public interest to bring the case to Court? The public interest test cannot be considered unless the evidential test is satisfied. You are aware that the CQC is gathering evidence into this matter with a view to deciding whether there has been a failure by BUPA and/or the Registered Manager to comply with the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (‘the Regulations’). We will update you when decisions have been made. With regard to BUPA’s investigation, we have no regulatory remit to judge the quality and effectiveness of the provider’s investigation or require that they carry out an additional investigation into this concern. The BUPA investigation outcome came after our responsive inspection on 31 July 2017 of Ashley House Care Centre, Cirencester during which we gained assurances that action was being taken to prevent further similar incidents. CQC will also contact BUPA to request a copy of their response to the prevention of future death report once the 56 days response time has passed. We will also be requiring regular updates from BUPA to monitor and ensure Progress is being made to complete the action(s) they intend to take. Any information regarding these actions will be explored at the next inspection to ensure they have been effectively implemented and embedded in the work practices at Ashley House Care Centre, Cirencester to prevent future harm. Please send any correspondence to: By email: CQCiInquestsandCoroners1 @cqc.org.uk By post: Care Quality Commission Citygate Gallowgate Newcastle upon Tyne NE1 4PA Please include the reference number ENQ1-4973662699. Yours sincerely Head of Inspection
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