Prevention of Future Deaths reports · 2015
Regulation 28 report to prevent future deaths, reference 2015-0088, written 9 Mar 2015. 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 2015 |
|---|---|
| Reference | 2015-0088 |
| Deceased | Leonardus Vries |
| Coroner | Geraint Williams |
| Coroner area | Worcestershire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | The Royal Orthopaedic Hospital NHS Foundation Trust |
| 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.
ANNEX A REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Chief Executive Royal Orthopaedic Hospital NHS Foundation Trust 3 4 | CORONER | am Geraint Urias Williams, Senior Coroner, for the coroner area of Worcestershire 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 10" October 2014 | commenced an investigation into the death of Leonardus Adrianus Gerardus VRIES then aged 48 years. The investigation concluded at the end of the inquest on 4” March 2015. The conclusion of the inquest was accidental death the medical cause of death being 1(a) respiratory depression, 1(b) combined toxicity of bupivacaine and morphine and diamorphine . 4 | CIRCUMSTANCES OF THE DEATH Mr Vries apparently acquired medical grade drugs from his place of work and used them to inject himself at his family home where died. 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. — (1) It appeared in the evidence given iii that there were significant documentary failings in the control of medication at the Royal Orthopeadic Hospital. Specifically he said that there was no audit or any paper trail of the use of non-controlled medication. With regard to controlled medication it was accepted that there were documentary deficiencies which meant it could not be precisely ascertained what controlled medication had been taken or used or administered to patients. Whilst the control of controlled medications appears ddressed by way of training and increased scrutiny and audit procedures onfirms that there is still no audit of non-controlled medication. Specifically he said that when stocks of non- controlled medication are delivered to wards and departments there is no check as to who uses the medication or for what purpose. It appears to me therefore that there is a significant opportunity for the abuse or theft of non-controlled medication. HE ‘01d me that the hospital were acting in accordance with the Department of Health guidelines in the matter and that unless the Department of Health issued further guidelines there would be no change in this process. | suggest that the Trust needs to consider putting in place its own audit guidelines to ensure that what [IE described as a "hole" in control measures Is addressed, (2) (3) ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 25" May 2015 |, 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 a | 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. GU Williams 9th day of March 2015 H M Senior Coroner
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.
ze The Royal Orthopaedic Hospital NHS) We dD NHS Foundation Trust Your ref GUW/TW/W2075.14 Our Ref JC/BS/GS/15052001 20 May 2015 re Mr G U Williams HM Senior Coroner for the County of Worcestershire The Court House Bewdley Road Stourport on Severn Worcestershire DY139XE Dear Mr Williams The late Leonardus Adrianus Gerardus VRIES Regulation 28 Response In response to your Regulation 28 Report To Prevent Future Deaths | wish to clarify the existing controls on drugs used within theatres and document the changes in the last six months. With regard to “non controlled” drugs, the existing controls in place are: ¢ All medicines are prescribed by an authorised registered prescriber and an audit trail exists on the patient record. All administrations of medicines are documented on the patient drug chart or the anaesthetic record both of which are stored in the patient's notes. Throughout the UK, this is the standard method of control and monitoring of medicines use. e Pharmacy staff manage all drug issues to theatres and all clinical areas by regularly assessing drug stock levels in the area and supplying stock to a minimum stock level previously agreed by the department manager and the pharmacy team. This minimum stock level is determined by the historical use of the drug and the time between stock replenishment (normally weekly in ward areas and daily in theatres). Pharmacy staff report any concerns regarding increased drug use picked up at this point to the Chief Pharmacist who will investigate in conjunction with the Trust’s Local Security Management Specialist and the police if required. e In theatres, all drug deliveries are placed into an Omnicell secure electronic storage system by pharmacy staff after running a report on what has been issued through the machine since the last assessment. Theatres staff can then access these medicines using an individual username / password or fingerprint recognition. Stock is then transferred from this central storage point into secure lockable cupboards in each anaesthetic room. Only registered staff may hold the keys to these cupboards. Individual staff have a professional responsibility for the safe, secure and legal storage of medicines under their control and only approved, registered staff may hold the keys. Registration is under the General Medical Council for doctors, Nursing and Midwifery Council for nurses and the Health and Care Professions Council for The Royal Orthopaedic Hospital NHS Foundation Trust, Bristol Road South, Northfield, Birmingham, B31 2AP Telephone: 0121 685 4000 Fascimile: 0121 685 4100 a The Royal Orthopaedic Hospital NHS) 4 G SiN NHS Foundation Trust Operating Department Practitioners. Pharmacy staff are regulated by the General Pharmaceutical Council. ¢ Amonthly issue report is generated using the Pharmacy electronic stock control system. This is monitored by pharmacy, theatres management and finance looking for any unexplained changes in drug use. It is however unlikely that diversion bya single individual could be identified in this way because of the volume of legitimate drug use. ¢ Medicines incidents (“non controlled” drugs and Controlled Drugs) are reported electronically and the management / resolution of these incidents is monitored by the Chief Pharmacist and the Trust Medicines Safety Committee, which is a sub group of the Trust Drugs and Therapeutics Committee. Action and learning is shared across the organisation by involving all relevant staff groups including matrons and clinical directors, coordinated by the Trust Chief Pharmacist, the Lead Nurse for Medicines and the Trust Medication Safety Officer who is a senior doctor and also chairs the Drugs and Therapeutics Committee. A letter was issued to all staff in February 2015 clarifying individual staff responsibilities regarding the safe and secure handling of medicines and Standard Operating Procedures (SOPs) were issued to each anaesthetic room. Staff have signed to confirm that they have received, read and understand the SOPs. Since February 2015 a weekly audit of Controlled Drug documentation is carried out by theatres management. Since March 2015 the Chief Pharmacist has carried out unannounced snapshot audits (normally two per week) on drug storage (all drugs) and documentation in theatres. No concerns regarding diversion or theft of medicines have been identified through this audit cycle and all documentation is correctly completed. Additional requirements for the safe and secure storage and use of Controlled Drugs are detailed in The Controlled Drugs (Supervision and Management of Use) Regulations 2013. The Trust is compliant with these regulations and has an Accountable Officer for Controlled Drugs (the Director of Nursing and Governance) who delegates operational responsibility for this to the Chief Pharmacist. The trust is compliant with the legislation and best practice and contributes to the NHS England Birmingham Solihull and Sandwell Controlled Drugs Local Information Network. The Chief Pharmacist audited the organisational governance structures for the safe and secure use of Controlled Drugs using the Care Quality Commission’s audit tool in March 2015 and has reported these audit findings, action plans and progress on action plans to the Accountable Officer for Controlled Drugs, the Trust Drugs and Therapeutics Committee and the Trust Clinical Governance Committee. In summary, the controls around both Controlled Drugs and “non-controlled” drugs have been reviewed. Standard Operating Procedures for Controlled Drugs have been updated and audits conducted by the Chief Pharmacist have shown compliance with the standards required. Controls around “non-controlled” medicines have been reviewed and found to be compliant with or indeed exceed all national guidance. There remains a small risk that these medicines could be diverted as is the case in all hospitals. This is mitigated by the professional responsibilities of all staff regarding the use of medicines. To further mitigate The Royal Orthopaedic Hospital NHS Foundation Trust, Bristol Road South, Northfield, Birmingham, B31 2AP Telephone: 0121 685 4000 Fascimile: 0121 685 4100 ZZ ® The Royal Orthopaedic Hospital NHS this risk the Chief Pharmacist will continue to monitor trends in usage of drugs in all areas of the Trust Yours sincerel Chief Executive Officer
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