Source · Prevention of Future Deaths

Victor Hall

Ref: 2019-0482 Date: 16 Oct 2019 Coroner: Rachel Syed Area: Manchester (West) Responses identified: 1 / 3 View PDF

Ambiguous medication packaging contributed to an error, which the MHRA failed to address. There's a need for enhanced guidance and training for nursing and pharmacy staff on thorough medication checks and documentation at all stages.

Date 16 Oct 2019
56-day deadline 11 Dec 2019 est.
Responses identified 1 of 3
Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary
Ambiguous medication packaging contributed to an error, which the MHRA failed to address. There's a need for enhanced guidance and training for nursing and pharmacy staff on thorough medication checks and documentation at all stages.
View full coroner's concerns
During 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: ; During the Inquest; evidence was heard that: - 1,Salford Royal Hospital had undertaken an internal investigation and concluded that one of the root causes for the medication error, was the Phosphate Polyfusor product design. The Pharmacy and Nursing Matron Lead, concurred that the staff involved in the incident had relied on the word Polyfusor, without actually checking the medication packaging against the prescription chart and label. Salford Royal Hospital, wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018, requesting the word Polyfusor be removed from the Phosphate design product packaging to prevent future medication errors Despite repeated requests from Salford Royal Hospital for an MHRA update, the product design for Phosphate Polyfusor remains the same:
2. I request that The Chief Executive , Medicines and Healthcare products Regulatory Agency (MHRA) reviews the: Product design on the Polyfusors in question 3 The Chief Executive_Nursing & Midwifery Council, 23 Portland Place;London Injury 50Omg every the the day. the

WIB 1PZ reviews the;
i.Guidance given to their members in relation to the administration of medication to consider and include the simplest of steps, namely that Healthcare Professional should check the name of the medication on the prescription chart against the name of the medication on the packaging and iabelling of the medication at the time of each administration of medicatontta ensure that the correct medication is always administered to a patient:
ii.Guidance given to their members in relation to their duties, to accurately record and contemporaneously document the packaging, label an prescription checks have undertaken to ensure the correct medication is always administered to a patient; 4The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane; Salford M6 8HD reviews the:
i.Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward: Furthermore; to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgement of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient: iiTraining, Auditing Supervision and monitoring of all staff, particularly Nursing and Pharmacy staff, in relation to the above issues.

Responses

1 respondent
Northern Care Alliance NHs Trust NHS / Health Body
16 Oct 2019 PDF
Action Planned

The Trust will undertake a full review of the dispensary environment at Salford Royal Hospital, looking at workspace design and dispensing processes, with implementation by the Learning and Development team by 31st December 2019. Nursing staff will ensure medicine safety mandatory training compliance, weekly senior nurse walkabouts will observe medication procedures, and a policy will be published to provide guidance about medicine safety incidents. (AI summary)

View full response
Dear Ms Syed

Re: Victor Hall (Deceased)

I write following the conclusion of this inquest on 16th October 2019. At the outset please accept my sincere condolences to the family of Victor Hall. I am sorry that they have been given cause for concern at such a difficult time.

Thank you for bringing the concerns raised to my attention The Trust is dedicated to ensuring patient safety is maintained throughout all services. I would like to take this opportunity to provide assurance to both you and the family that the Trust takes the concerns raised very seriously and have conducted a thorough review into the concerns raised. I have set the concern to The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane, Salford, M6 8HD out in bold below:

i. Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include a system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward. Furthermore, to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgment of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient.

In response to the issues raised a full review of the dispensary environment at Salford Royal Hospital will be undertaken. This review will look at the workspace design and the processes involved in the dispensing and checking of medication in the pharmacy department with the aim of reducing noise and distractions. I have set out the Trust’s action plan to achieve this below:

Action Action Lead Completion By Preventing staff entering the dispensary unless they have a relevant reason to be in there and so minimise the risk of interruption. This will be enforced with signage and staff awareness at daily huddles.

31st January 2020 Introducing library conditions within the dispensary.

Commencing with immediate effect. Changing the exit route (after 5pm) from the department which is currently located next to the accuracy checking area. Staff will exit the department via the pharmacy reception exit, preventing staff using the dispensary as a thoroughfare.

31st January 2020 Arranging feedback sessions for all staff to highlight elements of the clinical check, dispensing and accuracy check processes that need to be improved. Staff will be made aware of this at daily huddles.

31st January 2020 Reviewing the layout of the dispensary with the aim of separating the areas used for different parts of the dispensing process and improving the flow of work.

29th February 2020 Implementing “closed loop dispensing” (linking the electronic prescribing system to the pharmacy dispensing system and robot) with the aim of reducing dispensing errors and improving efficiency and therefore reducing the number of staff needed in the dispensary.

30th June 2020

Changes will be made to the processes involved in administering medication by both the nursing and pharmacy staff to inpatients at Salford Royal NHS Foundation Trust by:

Action Action Lead Completion By Implementing “closed loop medication administration” (electronic barcode scanning of patients and medications) to ensure that patient’s receive the right drug at the correct dose by the right route at the intended time. This will indicate to nursing staff (at the point of administration rather than the point of receipt) that the prescribed medication has been correctly sourced. Digital Team 30th June 2020

i. Training, Auditing, Supervision and monitoring of all staff, particularly nursing and pharmacy staff, in relation to the above issues.

We acknowledge as a learning organisation that we need to review our training and supervision for both our nursing and pharmacy staff. The pharmacy department will ensure the following actions will be taken:

Action Action Lead Completion By Updating the accuracy checking procedure which will incorporate a second check for all intravenous fluids.

31st December 2019 Introducing an electronic sign off to indicate that key procedures have been read and understood by relevant staff.

31st December 2019 Reviewing the number of items required to complete dispensing and accuracy checking logs during induction.

31st December 2019 Introducing a formal revalidation procedure for staff involved in dispensing errors

29th February 2020 Introducing a recurrent accuracy checking log for all accuracy checkers to ensure competence.

29th February 2020 Identifying formal supervisory duties and responsibilities in the dispensary.

29th February 2020 Analysing near miss data to identify common dispensing errors and introducing on-going communication of this to staff.

29th February 2020 Reviewing the accuracy checking test to incorporate a wider range of medications.

29th February 2020 Monitoring of compliance of medicines safety training completed by nursing staff on Ward H2.

Commenced Monitoring of medicine safety incidents on ward H2

Commenced Policy to be published about the process to follow when involved in a medicines safety incident.

29th February 2020 All nursing staff to be made aware that there are many different types of Polyfusor products. In order

29th Feb 2020

to prevent errors all details must be checked in full as per any medication. Implementation by the Learning and Development team learning from this incident within the medicines learning package.

31st December 2019

In addition the nursing staff recognise that there are lessons to learn and will ensure that the following actions are taken:

 Deborah Hindle, Deputy Director of Nursing for the Integrated Care Division will ensure that all nursing staff on ward H2 are compliant with their medicines safety mandatory training. Deborah Hindle will monitor medicines safety mandatory training and ensure all staff are compliant. Weekly senior nurse walkabouts will include ward H2, where observations will be undertaken of nursing medication/fluids dispensary checking procedure.  A policy will be published to provide guidance about the process to follow if a member of staff is involved in a medicine safety incident. This will provide instruction to clinical staff about the framework of processes for all aspects of medicines management including the administration of medication. It will also provide guidance on whether staff need to repeat their medicines management workbook.  The senior nursing staff will be responsible for the dissemination of the policy, monitoring the implementation and adherence to the policy.

I do hope the above gives assurance that the concern raised the Trust has recognised and taken the concerns raised seriously and taken prompt steps to ensure lessons have been learnt.

I would like to conclude by offering my personal apologies to Victor Hall’s family for their sad loss and would like to reiterate that we are committed to embedding the learning from this case to ensure ongoing improvements to patient care at the Trust

Report sections

Investigation and inquest
On the 16th January 2019, I commenced an Investigation into the death of Victor James Hall, born on the 24th 1934. The Investigation concluded at the end of the Inquest on the 16th October 2019. The medical cause of death was:- Ia Cardiac enlargement and coronary artery atheroma in combination with Chronic Obstructive Pulmonary Disease (COPD): The conclusion of Inquest was that Mr Hall died natural causes: CIRCUMSTANCES OF THE DEATH Victor James Hall (hereinafter referred to as deceased") died at the Salford Royal Hospital on 29th June 2018. The deceased suffered from a number of underlying co-morbidities, namely Bronchiectasis , Chronic Obstructive Pulmonary Disease and Heart Disease_ and was fitted with pacemaker around 2010. 3_ On the 250 June_2018, the deceased was admitted to the_Salford Royal CBE,; Place, May the from "the

Hospital with shortness of breath and an exacerbation of his Chronic Obstructive Pulmonary Disease. Mr Hall was diagnosed with Acute Kidney and prescribed, of IV sodium bicarbonate, 1.4% six hours. Akmember of the pharmacy dispensing team, in error , manually dispensed Phosphate Polyfusor which was close to the sodium bicarbonate Polyfusors box and generated a label for Sodium Bicarbonate. The Pharmacist tasked with checking the dispensed medication, failed to identify error, by checking the medication packaging against the prescription and label' and authorised release for delivery to the Wards:
5. Two Ward Nurses; both responsible for checking and signing the prescription chart; failed to check the medication packaging, against prescription and label and at around 23.30 on 28t June 2018, Mr Hall was infused with Phosphate Polyfusor. At approximately 01.20 on 29t June 2018, Mr Hall was found to be unresponsive and the Resuscitation Team was summoned. Despite resuscitation efforts, Mr Hall died on the same
6. The Post Mortem and Toxicology evidence concluded that Mr Hall could have died at any time from his underlying heart, lungs and kidney conditions and the medication error was not in keeping with levels associated with fatalities therefore had played no role in his death. CORONER'S CONCERNS During 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: During the Inquest; evidence was heard that: - 1,Salford Royal Hospital had undertaken an internal investigation and concluded that one of the root causes for the medication error, was the Phosphate Polyfusor product design. The Pharmacy and Nursing Matron Lead, concurred that the staff involved in the incident had relied on the word Polyfusor, without actually checking the medication packaging against the prescription chart and label. Salford Royal Hospital, wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018, requesting the word Polyfusor be removed from the Phosphate design product packaging to prevent future medication errors Despite repeated requests from Salford Royal Hospital for an MHRA update, the product design for Phosphate Polyfusor remains the same:
2. I request that The Chief Executive , Medicines and Healthcare products Regulatory Agency (MHRA) reviews the: Product design on the Polyfusors in question 3 The Chief Executive_Nursing & Midwifery Council, 23 Portland Place;London Injury 50Omg every the the day. the

WIB 1PZ reviews the;
i.Guidance given to their members in relation to the administration of medication to consider and include the simplest of steps, namely that Healthcare Professional should check the name of the medication on the prescription chart against the name of the medication on the packaging and iabelling of the medication at the time of each administration of medicatontta ensure that the correct medication is always administered to a patient:
ii.Guidance given to their members in relation to their duties, to accurately record and contemporaneously document the packaging, label an prescription checks have undertaken to ensure the correct medication is always administered to a patient; 4The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane; Salford M6 8HD reviews the:
i.Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward: Furthermore; to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgement of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient: iiTraining, Auditing Supervision and monitoring of all staff, particularly Nursing and Pharmacy staff, in relation to the above issues. ACTION SHOULD BE TAKEN In my opinion urgent action should be taken to prevent future deaths ad believe that you have 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 11t December 2019. 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: Son of deceased Iam also under a to send the Chief Coroner a copy of your response: they the the duty

The Chief Coroner may publish either Or both in complete or redacted Or summary form: Heemay send a COPV of this report to ay 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 release or the publication of your response by the Chief Coroner: Dated Signed 16th October 2019 ub Rachel Syed HM Assistant Coroner the Sd
Circumstances of the death
Victor James Hall (hereinafter referred to as deceased") died at the Salford Royal Hospital on 29th June 2018. The deceased suffered from a number of underlying co-morbidities, namely Bronchiectasis , Chronic Obstructive Pulmonary Disease and Heart Disease_ and was fitted with pacemaker around 2010. 3_ On the 250 June_2018, the deceased was admitted to the_Salford Royal CBE,; Place, May the from "the

Hospital with shortness of breath and an exacerbation of his Chronic Obstructive Pulmonary Disease. Mr Hall was diagnosed with Acute Kidney and prescribed, of IV sodium bicarbonate, 1.4% six hours. Akmember of the pharmacy dispensing team, in error , manually dispensed Phosphate Polyfusor which was close to the sodium bicarbonate Polyfusors box and generated a label for Sodium Bicarbonate. The Pharmacist tasked with checking the dispensed medication, failed to identify error, by checking the medication packaging against the prescription and label' and authorised release for delivery to the Wards:
5. Two Ward Nurses; both responsible for checking and signing the prescription chart; failed to check the medication packaging, against prescription and label and at around 23.30 on 28t June 2018, Mr Hall was infused with Phosphate Polyfusor. At approximately 01.20 on 29t June 2018, Mr Hall was found to be unresponsive and the Resuscitation Team was summoned. Despite resuscitation efforts, Mr Hall died on the same
6. The Post Mortem and Toxicology evidence concluded that Mr Hall could have died at any time from his underlying heart, lungs and kidney conditions and the medication error was not in keeping with levels associated with fatalities therefore had played no role in his death.
Action should be taken
In my opinion urgent action should be taken to prevent future deaths ad believe that you have power to take such action;
Inquest conclusion
During the Inquest; evidence was heard that: - 1,Salford Royal Hospital had undertaken an internal investigation and concluded that one of the root causes for the medication error, was the Phosphate Polyfusor product design. The Pharmacy and Nursing Matron Lead, concurred that the staff involved in the incident had relied on the word Polyfusor, without actually checking the medication packaging against the prescription chart and label. Salford Royal Hospital, wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018, requesting the word Polyfusor be removed from the Phosphate design product packaging to prevent future medication errors Despite repeated requests from Salford Royal Hospital for an MHRA update, the product design for Phosphate Polyfusor remains the same:
2. I request that The Chief Executive , Medicines and Healthcare products Regulatory Agency (MHRA) reviews the: Product design on the Polyfusors in question 3 The Chief Executive_Nursing & Midwifery Council, 23 Portland Place;London Injury 50Omg every the the day. the

WIB 1PZ reviews the;
i.Guidance given to their members in relation to the administration of medication to consider and include the simplest of steps, namely that Healthcare Professional should check the name of the medication on the prescription chart against the name of the medication on the packaging and iabelling of the medication at the time of each administration of medicatontta ensure that the correct medication is always administered to a patient:
ii.Guidance given to their members in relation to their duties, to accurately record and contemporaneously document the packaging, label an prescription checks have undertaken to ensure the correct medication is always administered to a patient; 4The Chief Executive, Salford Royal Hospital, NHS Trust Hospital, Stott Lane; Salford M6 8HD reviews the:
i.Guidance and procedures in relation to the dispensing and transfer of medications from the Pharmacy Department to a ward, to include system of checking medications against the packaging, labelling and prescription chart at the time of receipt by the ward: Furthermore; to consider documentary evidence of the fact that the medication packaging has been checked against the prescription chart and an acknowledgement of receipt of the correct medication by the pharmacy and ward staff, evidenced by a signature of the recipient: iiTraining, Auditing Supervision and monitoring of all staff, particularly Nursing and Pharmacy staff, in relation to the above issues. ACTION SHOULD BE TAKEN In my opinion urgent action should be taken to prevent future deaths ad believe that you have 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 11t December 2019. 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: Son of deceased Iam also under a to send the Chief Coroner a copy of your response: they the the duty

The Chief Coroner may publish either Or both in complete or redacted Or summary form: Heemay send a COPV of this report to ay 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 release or the publication of your response by the Chief Coroner: Dated Signed 16th October 2019 ub Rachel Syed HM Assistant Coroner the Sd

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Report details

Reference
2019-0482
Date of report
16 October 2019
Coroner
Rachel Syed
Coroner area
Manchester (West)

Responses identified

Responses identified 1 of 3
2 responses not yet linked

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 11 Dec 2019 (estimated).

Sent to

Medicines and Healthcare products Regulatory Agency
Nursing and Midwifery Council
Salford Royal Hospital NHS Trust

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