Prevention of Future Deaths reports · 2015

Leonardus Vries

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 report9 Mar 2015
Reference2015-0088
DeceasedLeonardus Vries
CoronerGeraint Williams
Coroner areaWorcestershire
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedThe Royal Orthopaedic Hospital NHS Foundation Trust
Sourcejudiciary.uk record · original PDF
Responses published1

The report

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

Responses

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.

Response from Royal Orthopaedic Hospital (PDF)
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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