Lauren Smith
PFD Report
All Responded
Ref: 2023-0454
All 5 responses received
· Deadline: 10 Jan 2024
Coroner's Concerns (AI summary)
Paramedics failed to correctly interpret an abnormal ECG and lacked fundamental knowledge of key indicators, despite auto-diagnostic warnings. Inadequate qualitative training assessment and lack of post-incident training pose a significant patient safety risk.
View full coroner's concerns
Some of the concerns I have identified are directed at multiple organisations and some are specific.
During the course of the inquest I heard live evidence from Paramedic , Technician and patient Safety Lead
1. An ecg reading was taken at 08:56 am when both the paramedic and technician were in attendance on Miss Smith. That ecg was abnormal. The ecg identified pathological Q waves in V1, V2 and V3, an isolated ST elevation in V2 and a positive AVR deflection. Although the rhythm was sinus rhythm, 3 abnormal indicators were clearly present on the ecg. In addition, the auto diagnostic monitor clearly recorded the ecg as abnormal and reported an anterior infarct which was available for attending paramedics.
2. Interpretation of a 12 lead ecg is fundamental part of the job of a paramedic and the ecg was not interpreted correctly by either the paramedic technician or the attending paramedic with over 8 years’ experience.
3. Paramedic gave evidence at inquest that she’d never heard of Q waves before and didn’t see the ST elevation on the ecg. She’d never heard of the term pathological Q waves nor an AVR positive deflection.
4. Technician told me she had never heard of pathological Q waves and that she wouldn’t know what they were. She told me she didn’t recognise the ST elevation on the ecg.
5. The ecg print out clearly indicated a cardiac event in progress at the time the ecg was taken. Lauren Smith died from an acute MI.
6. I am concerned that neither the paramedic nor the technician was able to interpret the ecg correctly and that neither paramedic appears to have noted or acted upon the auto diagnostic monitor report.
7. Lauren Smith was informed that her observations and ecg were normal. This information was not correct, and it is likely that Lauren Smith based her decision not to attend hospital on this incorrect information.
8. I was told in evidence that paramedic training includes identifying Q waves and ST elevations and any abnormal rhythms. I was told that a positive AVR deflection (which was a view) was not ‘normal’ and should have been identified as abnormal. I was told that the diagnostic monitor display reported what was seen on the ecg.
9. I heard in evidence that ecg interpretation forms part of a paramedics initial training and mandatory annual training, but I am concerned that there was no evidence at inquest of any qualitative assessment of the ecg aspect of their training. I was informed that Technician was undertaking a Paramedic BSc at Wolverhampton University. The training provider and/or regulator must ensure that training is effective. I am concerned the absence of such assessment presents a risk to patient safety at this time.
10. I heard in evidence that neither paramedic nor technician had received any further training from WMAS following the death of Lauren Smith and the internal SI investigation which specifically identified the incorrect interpretation of the ecg. I am concerned this presents a risk to patient safety at this time.
11. I am concerned that whilst and may’ve undertaken their own additional learning/self-reflection NO qualitative assessment of this learning has been undertaken and no action has been taken by their employer WMAS and no restrictions or sanctions placed on their practice nor further individual training provided by WMAS and they continue in their respective roles. I am concerned this presents a clear existing risk to patients which remained unaddressed at the time of inquest.
12. I was told in evidence that neither paramedic nor technician had been referred to the HCPC. I have reported my concern about the fitness to practice of both and to the HCPC however there appears to be a lacuna in respect of .
is a technician and not a fully qualified paramedic and as such is not yet registered with the HCPC. Therefore, the HCPC can take no action at the present time. I am informed the report I have made will be considered at such time as applies for full registration. I am concerned this presents a risk to patient safety at this time.
13. I am informed that as is a Student Paramedic (qualified/trained to technician level), WMAS as her employer are responsible for her professional competency. I am concerned that the lacuna I have identified in relation to her technician status has not been addressed and that despite WMAS applying the same HCPC standards to trainees as fully qualified paramedics, that WMAS have taken no action in relation to fitness to practice and provided no further training. I am concerned this presents a risk to patient safety at this time.
14. I am concerned that there has been no collective learning by West Midlands Ambulance Service following the death of . There has been no action to address the learning gaps identified by WMAS own internal investigation report in respect of both the paramedic and technician. Therefore, I have addressed this aspect of my PFD to the CQC/Chief Inspector of Hospitals/HSIB as part of their regulation as to the safety of the West Midlands Ambulance Service considering the risk I have identified in relation to patient safety due to inaction by WMAS.
During the course of the inquest I heard live evidence from Paramedic , Technician and patient Safety Lead
1. An ecg reading was taken at 08:56 am when both the paramedic and technician were in attendance on Miss Smith. That ecg was abnormal. The ecg identified pathological Q waves in V1, V2 and V3, an isolated ST elevation in V2 and a positive AVR deflection. Although the rhythm was sinus rhythm, 3 abnormal indicators were clearly present on the ecg. In addition, the auto diagnostic monitor clearly recorded the ecg as abnormal and reported an anterior infarct which was available for attending paramedics.
2. Interpretation of a 12 lead ecg is fundamental part of the job of a paramedic and the ecg was not interpreted correctly by either the paramedic technician or the attending paramedic with over 8 years’ experience.
3. Paramedic gave evidence at inquest that she’d never heard of Q waves before and didn’t see the ST elevation on the ecg. She’d never heard of the term pathological Q waves nor an AVR positive deflection.
4. Technician told me she had never heard of pathological Q waves and that she wouldn’t know what they were. She told me she didn’t recognise the ST elevation on the ecg.
5. The ecg print out clearly indicated a cardiac event in progress at the time the ecg was taken. Lauren Smith died from an acute MI.
6. I am concerned that neither the paramedic nor the technician was able to interpret the ecg correctly and that neither paramedic appears to have noted or acted upon the auto diagnostic monitor report.
7. Lauren Smith was informed that her observations and ecg were normal. This information was not correct, and it is likely that Lauren Smith based her decision not to attend hospital on this incorrect information.
8. I was told in evidence that paramedic training includes identifying Q waves and ST elevations and any abnormal rhythms. I was told that a positive AVR deflection (which was a view) was not ‘normal’ and should have been identified as abnormal. I was told that the diagnostic monitor display reported what was seen on the ecg.
9. I heard in evidence that ecg interpretation forms part of a paramedics initial training and mandatory annual training, but I am concerned that there was no evidence at inquest of any qualitative assessment of the ecg aspect of their training. I was informed that Technician was undertaking a Paramedic BSc at Wolverhampton University. The training provider and/or regulator must ensure that training is effective. I am concerned the absence of such assessment presents a risk to patient safety at this time.
10. I heard in evidence that neither paramedic nor technician had received any further training from WMAS following the death of Lauren Smith and the internal SI investigation which specifically identified the incorrect interpretation of the ecg. I am concerned this presents a risk to patient safety at this time.
11. I am concerned that whilst and may’ve undertaken their own additional learning/self-reflection NO qualitative assessment of this learning has been undertaken and no action has been taken by their employer WMAS and no restrictions or sanctions placed on their practice nor further individual training provided by WMAS and they continue in their respective roles. I am concerned this presents a clear existing risk to patients which remained unaddressed at the time of inquest.
12. I was told in evidence that neither paramedic nor technician had been referred to the HCPC. I have reported my concern about the fitness to practice of both and to the HCPC however there appears to be a lacuna in respect of .
is a technician and not a fully qualified paramedic and as such is not yet registered with the HCPC. Therefore, the HCPC can take no action at the present time. I am informed the report I have made will be considered at such time as applies for full registration. I am concerned this presents a risk to patient safety at this time.
13. I am informed that as is a Student Paramedic (qualified/trained to technician level), WMAS as her employer are responsible for her professional competency. I am concerned that the lacuna I have identified in relation to her technician status has not been addressed and that despite WMAS applying the same HCPC standards to trainees as fully qualified paramedics, that WMAS have taken no action in relation to fitness to practice and provided no further training. I am concerned this presents a risk to patient safety at this time.
14. I am concerned that there has been no collective learning by West Midlands Ambulance Service following the death of . There has been no action to address the learning gaps identified by WMAS own internal investigation report in respect of both the paramedic and technician. Therefore, I have addressed this aspect of my PFD to the CQC/Chief Inspector of Hospitals/HSIB as part of their regulation as to the safety of the West Midlands Ambulance Service considering the risk I have identified in relation to patient safety due to inaction by WMAS.
Responses
Action Taken
West Midlands Ambulance Service acknowledged the ECG was abnormal and that policy wasn't followed; clinicians received a case review, participated in a Serious Incident process, completed reflective practice, and are scheduled for additional ECG/ACS training. Additional actions include updating policies and providing additional equipment/training to improve chest pain management and ECG interpretation. (AI summary)
West Midlands Ambulance Service acknowledged the ECG was abnormal and that policy wasn't followed; clinicians received a case review, participated in a Serious Incident process, completed reflective practice, and are scheduled for additional ECG/ACS training. Additional actions include updating policies and providing additional equipment/training to improve chest pain management and ECG interpretation. (AI summary)
View full response
Dear Mrs Lees
Re: Regulation 28 Report to Prevent Future Deaths – Lauren Page Smith (Deceased)
Thank you for your email dated 15 November 2023 attaching your Regulation 28 Report.
On behalf of West Midlands Ambulance Service (WMAS), I am sorry that you have had to raise concerns following the inquest of Ms Smith. May I please take this opportunity to pass on my sincere condolences to the family of Ms Smith. I am deeply saddened by this case.
Our Trust prides itself on the training and education provided to our staff and overall patient safety, therefore it is disappointing that our Serious Incident investigation did not reflect this. I hope that our responses to your concerns below together with the evidence you heard in court from will provide you with assurance in our training and education and patient safety.
Concern 1 An ecg reading was taken at 08:56 am when both the paramedic and technician were in attendance on Miss Smith. That ecg was abnormal. The ecg identified pathological Q waves in V1, V2 and V3, an isolated ST elevation in V2 and a positive AVR deflection. Although the rhythm was sinus rhythm, 3 abnormal indicators were clearly present on the ecg. In addition, the auto diagnostic monitor clearly recorded the ecg as abnormal and reported an anterior infarct which was available for attending paramedics.
Response It is accepted by the Trust that the ECG taken at 08:56am was abnormal. The Zoll monitor clearly reported this as anterior infarct and the patient should have been transferred to hospital in accordance with existing established policy.
Concern 2 Interpretation of a 12 lead ecg is fundamental part of the job of a paramedic and the ecg was not interpreted correctly by either the paramedic technician or the attending paramedic with over 8 years’ experience.
Response It is accepted by the Trust the interpretation of a 12 lead ECG including the auto diagnostic system employed by the Zoll is a fundamental part of the job of a paramedic, which is why we provide comprehensive education, training and regular refresher training and provide the very best diagnostic equipment such as the Zoll ECG monitor.
Concern 3 gave evidence at inquest that she’d never heard of Q waves before and didn’t see the ST elevation on the ecg. She’d never heard of the term pathological Q waves nor an AVR positive deflection.
Response attended paramedic training from 23 February 2015 at Staffordshire University, and the relevant sections from the programme are detailed below. Institute for Health Care Development and Paramedic Science Diploma with Staffordshire University (IHCD Student Paramedic Training Programme)
Appendices attached for IHCD and Diploma
Cardiac monitoring – Appendix 1 Clinical Skills module – Appendix 2 WMAS Clinical Progress and Practical Record
Module D4.3 page 36 D5.1 Pages 40 & 88
WMAS Clinical Progress and Practical Record Student Paramedic Course
Cardiac Monitoring D4:3 CARDIAC MONITORING
• Assist in positioning the patient on a firm surface ready for cardiac monitoring/defibrillation.
• Correctly position the electrodes and leads as directed and an interpretable ECG is obtained.
• Avoid inflicting any unnecessary injury/discomfort to the patient.
• Maintain the dignity and wishes of the patient at all times.
• Seek any clarification of instructions and pass on any wishes of the patient to the practitioner/rescuer immediately. Key learning points; The importance of following directions and notifying the practitioner / rescuer of any changes in the patient’s condition. Principles of patient sensitivity. Equipment types, use and application. The importance of patient consent. W.M.A.S. Additional Requirements.
Review of electrical conduction system of the heart. Interpretation of a Normal Sinus Rhythm E.C.G. Introduction of E.C.G. analysis plan. Recognition and interpretation of:
• N.S.R.
• V.F.
• V.T pulse / pulseless.
• Asystole.
• Sinus Tachycardia / Bradycardia.
• PVC’S
• P.E.A.
D5:1 CARDIAC MONITORING / DEFIBRILLATION
Correctly position the electrodes and leads and ensure an interpretable ECG is obtained.
Patient Assessment Scenario
• Breathing – Rate / Rhythm / Volume
• SP02
• Peak Flow
• Pulse - Rate / Rhythm / Volume
• Colour / Temperature / Texture of skin
• Capillary refill
• Blood pressure
• ECG 6 or 12 lead
• Temperature
• Blood sugar reading
• GCS
• FAST
The Trust can confirm that it provides a full day of clinical updates annually in addition to other statutory and mandatory training. The dates that undertook these clinical updates, which covered Q waves and ST elevation, are included below. Only the sections relevant to ACS (acute coronary syndrome) care and ECGs are included in this table. Relevant mandatory refresher clinical training for the last four years
Training Year Date complete Course Type Summary of training
Timetable or guide learning Total (mins) 2020-21
19.11.20 Clinical Update Hyperventilation vs Pulmonary Embolism (Appendix 3) 90 2021-22
20.01.22 Clinical Update ACS, 12 lead ECGs, Zoll Analysis (Appendix 4) 60 2022-23
01.09.22 Clinical Update Patient Safety - ACS case study, 12 Lead ECG, Zoll analysis (Appendix 5) 60 2023-24
07.11.23 Clinical Update ACS, STEMI inc progression of a STEMI and pathological Q waves (Appendix 6) 60
Total 270
was a clinical team mentor (CTM) for the Trust at the time of this incident, this role requires her to train other paramedics in specific clinical areas. As part of her role as a CTM she received the following CTM training.
CTM Mandatory Training Training Year Date complete Course Type Summary of training Timetable or guide learning Total (mins) 2020-21
01.03.21 Clinical Update Clinical Decision Making - ECGs (Appendix 7) 90 2021-22
30.03.22 Clinical Update Bias, ACS case reviews (Appendix 8a and 8b) 60 2022-23
17.03.23 Clinical Update Learning from adverse incidents - Zoll data in investigations (Appendix 9) 60
Total 210
Furthermore, the JRCALC (Joint Royal Colleges Ambulance Liaison Committee) guidelines for Non - Traumatic Chest Pain/Discomfort (Appendix 10) provides guidance on ECG’s and accompanying features. These can be accessed via a mobile phone, an individual Trust issued ipad or an Electronic Patient Record (EPR) device, all of which are provided by the Trust.
Concern 4 Technician told me she had never heard of pathological Q waves and that she wouldn’t know what they were. She told me she didn’t recognise the ST elevation on the ecg.
Response undertook an ECG assessment on 4 August 2020 as part of her Technician training (Appendix 11) which tested her knowledge on ECG interpretation, she passed this assessment with a score of 92.5%. This assessment covered Q waves and ST elevation.
has also undertaken the following ECG training on her technician training course;
Level 4 Associate Ambulance Practitioner Course from May to August 2020 Component No Session Title Summary of training (Appendix 12a – 12f) Timetabled Time (mins) 15 Cardiovascular Examination Principles of pain assessment, physiological measurements and common deviations.
240
ECGs ECG Fundamentals, electrical conduction system of the heart, PQRST waveform, ECG monitoring preparation, 4 Lead ECG, Paper and timings and 11 point guide. Sinus Rhythms, ACS, STEMI, NSTEMI & Supraventricular rhythms, conduction abnormalities, ventricular rhythms and non-shockable rhythms of cardiac arrest. 12 lead ECG Placement, 12 lead ECG - views of the heart, 10 rules of the ECG, Stable Angina, ST segment abnormalities, ST segment recognition, posterior MO, ST Depression, ST Elevation, ECG Interpretation, Primzmetal Angina and Ventricular Paced Rhythms. 240 19 Cardiovascular Conditions Understand the pathophysiology and management of cardiovascular system disorders. Be able to assess and manage medical conditions, in accordance with agreed ways of working.
240 Total 720
The Trust can confirm that it provides a full day of clinical updates annually in addition to other statutory and mandatory training. The dates that undertook these clinical updates, which covered Q waves and ST elevation, are included below. Only the sections relevant to ACS (acute coronary syndrome) care and ECGs are included in this table. Relevant mandatory refresher clinical training Training year Date completed Course Type Summary of training Timetable or guide learning Total (mins) 2021-22
28.09.21 Clinical Update ACS, 12 lead ECGs, Zoll Analysis (Appendix 2) 60 2022-23
01.06.22 Clinical Update Patient Safety - ACS case study, 12 Lead ECG, Zoll analysis (Appendix 3) 60 2023-24
09.09.23 Clinical Update ACS, STEMI inc progression of a STEMI and pathological Q waves (Appendix 4) 60
Total 180
JRCALC (Appendix 10) guidelines for Non- Traumatic Chest Pain/Discomfort would also be available to via the EPR device, etc, all of which are provided by the Trust. Concern 5 The ecg print out clearly indicated a cardiac event in progress at the time the ecg was taken. died from an acute MI.
Response The Trust accepts that a cardiac event was in progress.
Concern 6 I am concerned that neither the paramedic nor the technician was able to interpret the ecg correctly and that neither paramedic appears to have noted or acted upon the auto diagnostic monitor report.
Response All our clinicians have received education and training on ECG intrerpretation some of which is as evidenced within concern 3 and concern 4.
As part of the Trusts ongoing education and training for staff we have undertaken a range of initiatives to improve the understanding of ECGs and the auto diagnostic function of ECGs.
The Trust have issued a number of articles to educate staff on the use of the auto diagnostic monitor.
Appendix 13 - Clinical Times issue 39 – issued on 10 April 2019 Appendix 14 - Clinical Times issue 45 – issued on 30 November 2022 Appendix 15 - Clinical Times issue 49 – issued on 11 September 2023
Prior to the inquest there were a number of clinical improvements undertaken in relation to cardiac arrest cases, these were;
January 2023
• The Trust delivered a session to CTM staff at Lichfield Hub on STEMI Care/Safety themes regarding the discharge on scene of ACS (Acute coronary syndrome)
• There was a CPD day at Erdington hub alongside the Research team to provide presentation on STEMI clinical times article on ACS and the new JRCALC update, including the ambulance quality indicators and time from 999 call to inflation of a balloon in a specialist coronary catheter
February 2023
• Engagement with Zoll medical to provide ECG recognition and ALS (Advanced Life Support) sessions to staff – 2 free sessions delivered
• Review of cases of all non-traumatic chest pain discharged at scene vs the clinical risk assessment tool March 2023
• Development of monitoring of on scene time for crews at cases of STEMI as defined by the national ambulance quality indicators taken to the national audit group
• Article in Weekly Brief on gender disparity in cardiac care April 2023
• Evening training session on ECGs and Resus skills delivered May 2023
• Further sessions of education delivered in evening on ECG and resus skills alongside Zoll June 2023
• Delivered in person CPD (Continuing professional development) event, which included ECG skills and recognition
• The Trust began contacting crew in cases of STEMI where AQI (Ambulance Quality Indicators) was not met to explore reasoning August 2023
• ACS discharge on scene case study published in clinical times, including information on Zoll automatic interpretation data
• Article published in weekly brief linking to ACS educational Resources learning September 2023
• 52 ECG cases reviewed by WMAS senior clinical leads group, publishing in our weekly briefings & clinical times began on these cases to share learning with clinical staff
• Microsoft teams channel set up for regular publication of ECG case studies and to allow for discussion
Concern 7 was informed that her observations and ecg were normal. This information was not correct, and it is likely that based her decision not to attend hospital on this incorrect information.
Response It is accepted by the Trust that the information provided to by the clinician in relation to the ECG was incorrect.
Concern 8 I was told in evidence that paramedic training includes identifying Q waves and ST elevations and any abnormal rhythms. I was told that a positive AVR deflection (which was a view) was not ‘normal’ and should have been identified as abnormal. I was told that the diagnostic monitor display reported what was seen on the ecg.
Response Q wave changes and AVR deflection does feature in our training but is not a significant feature, as this is high level ECG competency. The ECG auto diagnostic did identify an abnormal ECG and this should have been acted upon.
Concern 9 I heard in evidence that ecg interpretation forms part of a paramedics initial training and mandatory annual training, but I am concerned that there was no evidence at inquest of any qualitative assessment of the ecg aspect of their training. I was informed that
Technician was undertaking a Paramedic BSc at Wolverhampton University. The training provider and/or regulator must ensure that training is effective. I am concerned the absence of such assessment presents a risk to patient safety at this time.
Response In addition to the training evidenced in response to concern 3 & 4, the Trust can confirm that all internally delivered initial paramedic training includes qualitative ECG assessments. undertook an ECG assessment on 4 August 2020 as part of her Technician training (Appendix 11) which tested her knowledge on ECG interpretation, she passed this assessment with a score of 92.5%. This test covered Q waves and ST elevation.
The Trust regularly meets with each of its partner universities at its contract meetings. The course provision is reviewed regularly to ensure it meets the requirements for both WMAS and the HCPC. has not yet completed the full University BSc training at the University of Wolverhampton.
Concern 10 I heard in evidence that neither paramedic nor technician had received any further training from WMAS following the death of and the internal SI investigation which specifically identified the incorrect interpretation of the ecg. I am concerned this presents a risk to patient safety at this time
Response The Trust accepts that this should have been rectified following the Serious Incident investigation. The Trust can provide assurances that although there was no further specific formal training documented as part of the Serious Incident investigation both clinicians attended a root cause analysis meeting on the 7 March 2023 which forms part of the Serious Incident and learning process.
The clinicians also completed clinical supervision shifts. completed this shift on 26 July 2023 (Appendix 16) and completed her shift on 11 July 2023 (Appendix 17). also completed a CTM update day on 17 March 2023 due to her role as a CTM.
Both the clinicians are booked to attend training school for remedial training on the 1 December 2023. In addition to this will be meeting with the Trust’s Consultant Paramedic who is the Head of Clinical Care, to review and reflect on the ECG abnormalities as part of an additional self reflection request.
Since the incident has also requested to attend a level 6 university course to further her knowledge on ECG’s. has been approved and supported by WMAS to attend a level 6 ECG in practice course, commencing in January 2024.
Concern 11 I am concerned that whilst may’ve undertaken their own additional learning/self-reflection NO qualitative assessment of this learning has been undertaken and no action has been taken by their employer WMAS and no restrictions or sanctions placed on their practice nor further individual training provided by WMAS and they continue in their respective roles. I am concerned this presents a clear existing risk to patients which remained unaddressed at the time of inquest.
Response Following the clinicians attending to , they were both asked to provide documented reflective practice. The Trust can confirm these have been completed by both clinicians.
Technicians and student paramedics always work with a fully qualified registered paramedic.
Both clinicians will be attending training school on 1 December 2023 for remedial training.
Concern 12 I was told in evidence that neither paramedic nor technician had been referred to the HCPC. I have reported my concern about the fitness to practice of both
to the HCPC however there appears to be a lacuna in respect of . is a technician and not a fully qualified paramedic and as such is not yet registered with the HCPC. Therefore, the HCPC can take no action at the present time. I am informed the report I have made will be considered at such time as
applies for full registration. I am concerned this presents a risk to patient safety at this time.
Response The Trust follows the guidance provided by the HCPC in relation to circumstances in which a referral by an employer should be made. This guidance can be found on the HCPC website (https://www.hcpc-uk.org/employers/managing-concerns/refer-an-employee-to- us/). Reference the section ‘When to refer’, the Trust did not believe that a referral was required following the serious incident investigation. Accepting that a referral has now been made, the Trust will review its practices to ensure appropriate referrals are made.
Concern 13 I am informed that as is a Student Paramedic (qualified/trained to technician level), WMAS as her employer are responsible for her professional competency. I am concerned that the lacuna I have identified in relation to her technician status has not been addressed and that despite WMAS applying the same HCPC standards to trainees as fully qualified paramedics, that WMAS have taken no action in relation to fitness to practice and provided no further training. I am concerned this presents a risk to patient safety at this time.
Response WMAS are responsible for the professional competency of our Student Paramedics. All technicians and student paramedics always work with a fully qualified registered paramedic. WMAS is the only ambulance service in the country to have a fully qualified registered paramedic on every emergency ambulance. A paramedic working with a student paramedic is responsible for scene management and clinical decision making. will be attending training school on the 1 December 2023. will also be attending training school on the same date.
Concern 14 I am concerned that there has been no collective learning by West Midlands Ambulance Service following the death of Lauren Smith. There has been no action to address the learning gaps identified by WMAS own internal investigation report in respect of both the paramedic and technician. Therefore, I have addressed this aspect of my PFD to the CQC/Chief Inspector of Hospitals/HSIB as part of their regulation as to the safety of the West Midlands Ambulance Service considering the risk I have identified in relation to patient safety due to inaction by WMAS.
Response The Trust takes patient safety and the education and training of our staff very seriously.
The Trust has undertaken a significant programme of work, which is ongoing, in relation to clinical improvement in the management of chest pain, ECG recognition and cardiac arrest management, evidence of can be found within concern 6.
Once the Trust became aware of this incident, the clinicians involved received a case review with a CTM on 3 February 2023 to discuss learning points and reflect on the incident. The clinicians were also part of the Serious incident process and attended a root cause analysis meeting on 7 March 2023 where the case was discussed in detail. Following the Serious Incident investigation both staff members were also asked to undertake reflective practice, which has been completed. Additional training specific to ECGs and ACS is scheduled to be completed on 1 December 2023. Both clinicians also received a clinical supervision shift. completed this shift on 26 July 2023 (Appendix 16) and completed her shift on 11 July 2023 (Appendix 17).
also completed a CTM update day on 17 March 2023 due to her mentor role.
I hope this response provides you with the appropriate level of assurance that as a Trust we have dealt with the concerns highlighted within your report and the extent to which we take patient safety very seriously.
May I once again please pass on my sincere condolences to the family of Ms Smith. I am sorry we let Lauren down, and we let her family down.
If you require any further assistance, please do not hesitate contact me.
Re: Regulation 28 Report to Prevent Future Deaths – Lauren Page Smith (Deceased)
Thank you for your email dated 15 November 2023 attaching your Regulation 28 Report.
On behalf of West Midlands Ambulance Service (WMAS), I am sorry that you have had to raise concerns following the inquest of Ms Smith. May I please take this opportunity to pass on my sincere condolences to the family of Ms Smith. I am deeply saddened by this case.
Our Trust prides itself on the training and education provided to our staff and overall patient safety, therefore it is disappointing that our Serious Incident investigation did not reflect this. I hope that our responses to your concerns below together with the evidence you heard in court from will provide you with assurance in our training and education and patient safety.
Concern 1 An ecg reading was taken at 08:56 am when both the paramedic and technician were in attendance on Miss Smith. That ecg was abnormal. The ecg identified pathological Q waves in V1, V2 and V3, an isolated ST elevation in V2 and a positive AVR deflection. Although the rhythm was sinus rhythm, 3 abnormal indicators were clearly present on the ecg. In addition, the auto diagnostic monitor clearly recorded the ecg as abnormal and reported an anterior infarct which was available for attending paramedics.
Response It is accepted by the Trust that the ECG taken at 08:56am was abnormal. The Zoll monitor clearly reported this as anterior infarct and the patient should have been transferred to hospital in accordance with existing established policy.
Concern 2 Interpretation of a 12 lead ecg is fundamental part of the job of a paramedic and the ecg was not interpreted correctly by either the paramedic technician or the attending paramedic with over 8 years’ experience.
Response It is accepted by the Trust the interpretation of a 12 lead ECG including the auto diagnostic system employed by the Zoll is a fundamental part of the job of a paramedic, which is why we provide comprehensive education, training and regular refresher training and provide the very best diagnostic equipment such as the Zoll ECG monitor.
Concern 3 gave evidence at inquest that she’d never heard of Q waves before and didn’t see the ST elevation on the ecg. She’d never heard of the term pathological Q waves nor an AVR positive deflection.
Response attended paramedic training from 23 February 2015 at Staffordshire University, and the relevant sections from the programme are detailed below. Institute for Health Care Development and Paramedic Science Diploma with Staffordshire University (IHCD Student Paramedic Training Programme)
Appendices attached for IHCD and Diploma
Cardiac monitoring – Appendix 1 Clinical Skills module – Appendix 2 WMAS Clinical Progress and Practical Record
Module D4.3 page 36 D5.1 Pages 40 & 88
WMAS Clinical Progress and Practical Record Student Paramedic Course
Cardiac Monitoring D4:3 CARDIAC MONITORING
• Assist in positioning the patient on a firm surface ready for cardiac monitoring/defibrillation.
• Correctly position the electrodes and leads as directed and an interpretable ECG is obtained.
• Avoid inflicting any unnecessary injury/discomfort to the patient.
• Maintain the dignity and wishes of the patient at all times.
• Seek any clarification of instructions and pass on any wishes of the patient to the practitioner/rescuer immediately. Key learning points; The importance of following directions and notifying the practitioner / rescuer of any changes in the patient’s condition. Principles of patient sensitivity. Equipment types, use and application. The importance of patient consent. W.M.A.S. Additional Requirements.
Review of electrical conduction system of the heart. Interpretation of a Normal Sinus Rhythm E.C.G. Introduction of E.C.G. analysis plan. Recognition and interpretation of:
• N.S.R.
• V.F.
• V.T pulse / pulseless.
• Asystole.
• Sinus Tachycardia / Bradycardia.
• PVC’S
• P.E.A.
D5:1 CARDIAC MONITORING / DEFIBRILLATION
Correctly position the electrodes and leads and ensure an interpretable ECG is obtained.
Patient Assessment Scenario
• Breathing – Rate / Rhythm / Volume
• SP02
• Peak Flow
• Pulse - Rate / Rhythm / Volume
• Colour / Temperature / Texture of skin
• Capillary refill
• Blood pressure
• ECG 6 or 12 lead
• Temperature
• Blood sugar reading
• GCS
• FAST
The Trust can confirm that it provides a full day of clinical updates annually in addition to other statutory and mandatory training. The dates that undertook these clinical updates, which covered Q waves and ST elevation, are included below. Only the sections relevant to ACS (acute coronary syndrome) care and ECGs are included in this table. Relevant mandatory refresher clinical training for the last four years
Training Year Date complete Course Type Summary of training
Timetable or guide learning Total (mins) 2020-21
19.11.20 Clinical Update Hyperventilation vs Pulmonary Embolism (Appendix 3) 90 2021-22
20.01.22 Clinical Update ACS, 12 lead ECGs, Zoll Analysis (Appendix 4) 60 2022-23
01.09.22 Clinical Update Patient Safety - ACS case study, 12 Lead ECG, Zoll analysis (Appendix 5) 60 2023-24
07.11.23 Clinical Update ACS, STEMI inc progression of a STEMI and pathological Q waves (Appendix 6) 60
Total 270
was a clinical team mentor (CTM) for the Trust at the time of this incident, this role requires her to train other paramedics in specific clinical areas. As part of her role as a CTM she received the following CTM training.
CTM Mandatory Training Training Year Date complete Course Type Summary of training Timetable or guide learning Total (mins) 2020-21
01.03.21 Clinical Update Clinical Decision Making - ECGs (Appendix 7) 90 2021-22
30.03.22 Clinical Update Bias, ACS case reviews (Appendix 8a and 8b) 60 2022-23
17.03.23 Clinical Update Learning from adverse incidents - Zoll data in investigations (Appendix 9) 60
Total 210
Furthermore, the JRCALC (Joint Royal Colleges Ambulance Liaison Committee) guidelines for Non - Traumatic Chest Pain/Discomfort (Appendix 10) provides guidance on ECG’s and accompanying features. These can be accessed via a mobile phone, an individual Trust issued ipad or an Electronic Patient Record (EPR) device, all of which are provided by the Trust.
Concern 4 Technician told me she had never heard of pathological Q waves and that she wouldn’t know what they were. She told me she didn’t recognise the ST elevation on the ecg.
Response undertook an ECG assessment on 4 August 2020 as part of her Technician training (Appendix 11) which tested her knowledge on ECG interpretation, she passed this assessment with a score of 92.5%. This assessment covered Q waves and ST elevation.
has also undertaken the following ECG training on her technician training course;
Level 4 Associate Ambulance Practitioner Course from May to August 2020 Component No Session Title Summary of training (Appendix 12a – 12f) Timetabled Time (mins) 15 Cardiovascular Examination Principles of pain assessment, physiological measurements and common deviations.
240
ECGs ECG Fundamentals, electrical conduction system of the heart, PQRST waveform, ECG monitoring preparation, 4 Lead ECG, Paper and timings and 11 point guide. Sinus Rhythms, ACS, STEMI, NSTEMI & Supraventricular rhythms, conduction abnormalities, ventricular rhythms and non-shockable rhythms of cardiac arrest. 12 lead ECG Placement, 12 lead ECG - views of the heart, 10 rules of the ECG, Stable Angina, ST segment abnormalities, ST segment recognition, posterior MO, ST Depression, ST Elevation, ECG Interpretation, Primzmetal Angina and Ventricular Paced Rhythms. 240 19 Cardiovascular Conditions Understand the pathophysiology and management of cardiovascular system disorders. Be able to assess and manage medical conditions, in accordance with agreed ways of working.
240 Total 720
The Trust can confirm that it provides a full day of clinical updates annually in addition to other statutory and mandatory training. The dates that undertook these clinical updates, which covered Q waves and ST elevation, are included below. Only the sections relevant to ACS (acute coronary syndrome) care and ECGs are included in this table. Relevant mandatory refresher clinical training Training year Date completed Course Type Summary of training Timetable or guide learning Total (mins) 2021-22
28.09.21 Clinical Update ACS, 12 lead ECGs, Zoll Analysis (Appendix 2) 60 2022-23
01.06.22 Clinical Update Patient Safety - ACS case study, 12 Lead ECG, Zoll analysis (Appendix 3) 60 2023-24
09.09.23 Clinical Update ACS, STEMI inc progression of a STEMI and pathological Q waves (Appendix 4) 60
Total 180
JRCALC (Appendix 10) guidelines for Non- Traumatic Chest Pain/Discomfort would also be available to via the EPR device, etc, all of which are provided by the Trust. Concern 5 The ecg print out clearly indicated a cardiac event in progress at the time the ecg was taken. died from an acute MI.
Response The Trust accepts that a cardiac event was in progress.
Concern 6 I am concerned that neither the paramedic nor the technician was able to interpret the ecg correctly and that neither paramedic appears to have noted or acted upon the auto diagnostic monitor report.
Response All our clinicians have received education and training on ECG intrerpretation some of which is as evidenced within concern 3 and concern 4.
As part of the Trusts ongoing education and training for staff we have undertaken a range of initiatives to improve the understanding of ECGs and the auto diagnostic function of ECGs.
The Trust have issued a number of articles to educate staff on the use of the auto diagnostic monitor.
Appendix 13 - Clinical Times issue 39 – issued on 10 April 2019 Appendix 14 - Clinical Times issue 45 – issued on 30 November 2022 Appendix 15 - Clinical Times issue 49 – issued on 11 September 2023
Prior to the inquest there were a number of clinical improvements undertaken in relation to cardiac arrest cases, these were;
January 2023
• The Trust delivered a session to CTM staff at Lichfield Hub on STEMI Care/Safety themes regarding the discharge on scene of ACS (Acute coronary syndrome)
• There was a CPD day at Erdington hub alongside the Research team to provide presentation on STEMI clinical times article on ACS and the new JRCALC update, including the ambulance quality indicators and time from 999 call to inflation of a balloon in a specialist coronary catheter
February 2023
• Engagement with Zoll medical to provide ECG recognition and ALS (Advanced Life Support) sessions to staff – 2 free sessions delivered
• Review of cases of all non-traumatic chest pain discharged at scene vs the clinical risk assessment tool March 2023
• Development of monitoring of on scene time for crews at cases of STEMI as defined by the national ambulance quality indicators taken to the national audit group
• Article in Weekly Brief on gender disparity in cardiac care April 2023
• Evening training session on ECGs and Resus skills delivered May 2023
• Further sessions of education delivered in evening on ECG and resus skills alongside Zoll June 2023
• Delivered in person CPD (Continuing professional development) event, which included ECG skills and recognition
• The Trust began contacting crew in cases of STEMI where AQI (Ambulance Quality Indicators) was not met to explore reasoning August 2023
• ACS discharge on scene case study published in clinical times, including information on Zoll automatic interpretation data
• Article published in weekly brief linking to ACS educational Resources learning September 2023
• 52 ECG cases reviewed by WMAS senior clinical leads group, publishing in our weekly briefings & clinical times began on these cases to share learning with clinical staff
• Microsoft teams channel set up for regular publication of ECG case studies and to allow for discussion
Concern 7 was informed that her observations and ecg were normal. This information was not correct, and it is likely that based her decision not to attend hospital on this incorrect information.
Response It is accepted by the Trust that the information provided to by the clinician in relation to the ECG was incorrect.
Concern 8 I was told in evidence that paramedic training includes identifying Q waves and ST elevations and any abnormal rhythms. I was told that a positive AVR deflection (which was a view) was not ‘normal’ and should have been identified as abnormal. I was told that the diagnostic monitor display reported what was seen on the ecg.
Response Q wave changes and AVR deflection does feature in our training but is not a significant feature, as this is high level ECG competency. The ECG auto diagnostic did identify an abnormal ECG and this should have been acted upon.
Concern 9 I heard in evidence that ecg interpretation forms part of a paramedics initial training and mandatory annual training, but I am concerned that there was no evidence at inquest of any qualitative assessment of the ecg aspect of their training. I was informed that
Technician was undertaking a Paramedic BSc at Wolverhampton University. The training provider and/or regulator must ensure that training is effective. I am concerned the absence of such assessment presents a risk to patient safety at this time.
Response In addition to the training evidenced in response to concern 3 & 4, the Trust can confirm that all internally delivered initial paramedic training includes qualitative ECG assessments. undertook an ECG assessment on 4 August 2020 as part of her Technician training (Appendix 11) which tested her knowledge on ECG interpretation, she passed this assessment with a score of 92.5%. This test covered Q waves and ST elevation.
The Trust regularly meets with each of its partner universities at its contract meetings. The course provision is reviewed regularly to ensure it meets the requirements for both WMAS and the HCPC. has not yet completed the full University BSc training at the University of Wolverhampton.
Concern 10 I heard in evidence that neither paramedic nor technician had received any further training from WMAS following the death of and the internal SI investigation which specifically identified the incorrect interpretation of the ecg. I am concerned this presents a risk to patient safety at this time
Response The Trust accepts that this should have been rectified following the Serious Incident investigation. The Trust can provide assurances that although there was no further specific formal training documented as part of the Serious Incident investigation both clinicians attended a root cause analysis meeting on the 7 March 2023 which forms part of the Serious Incident and learning process.
The clinicians also completed clinical supervision shifts. completed this shift on 26 July 2023 (Appendix 16) and completed her shift on 11 July 2023 (Appendix 17). also completed a CTM update day on 17 March 2023 due to her role as a CTM.
Both the clinicians are booked to attend training school for remedial training on the 1 December 2023. In addition to this will be meeting with the Trust’s Consultant Paramedic who is the Head of Clinical Care, to review and reflect on the ECG abnormalities as part of an additional self reflection request.
Since the incident has also requested to attend a level 6 university course to further her knowledge on ECG’s. has been approved and supported by WMAS to attend a level 6 ECG in practice course, commencing in January 2024.
Concern 11 I am concerned that whilst may’ve undertaken their own additional learning/self-reflection NO qualitative assessment of this learning has been undertaken and no action has been taken by their employer WMAS and no restrictions or sanctions placed on their practice nor further individual training provided by WMAS and they continue in their respective roles. I am concerned this presents a clear existing risk to patients which remained unaddressed at the time of inquest.
Response Following the clinicians attending to , they were both asked to provide documented reflective practice. The Trust can confirm these have been completed by both clinicians.
Technicians and student paramedics always work with a fully qualified registered paramedic.
Both clinicians will be attending training school on 1 December 2023 for remedial training.
Concern 12 I was told in evidence that neither paramedic nor technician had been referred to the HCPC. I have reported my concern about the fitness to practice of both
to the HCPC however there appears to be a lacuna in respect of . is a technician and not a fully qualified paramedic and as such is not yet registered with the HCPC. Therefore, the HCPC can take no action at the present time. I am informed the report I have made will be considered at such time as
applies for full registration. I am concerned this presents a risk to patient safety at this time.
Response The Trust follows the guidance provided by the HCPC in relation to circumstances in which a referral by an employer should be made. This guidance can be found on the HCPC website (https://www.hcpc-uk.org/employers/managing-concerns/refer-an-employee-to- us/). Reference the section ‘When to refer’, the Trust did not believe that a referral was required following the serious incident investigation. Accepting that a referral has now been made, the Trust will review its practices to ensure appropriate referrals are made.
Concern 13 I am informed that as is a Student Paramedic (qualified/trained to technician level), WMAS as her employer are responsible for her professional competency. I am concerned that the lacuna I have identified in relation to her technician status has not been addressed and that despite WMAS applying the same HCPC standards to trainees as fully qualified paramedics, that WMAS have taken no action in relation to fitness to practice and provided no further training. I am concerned this presents a risk to patient safety at this time.
Response WMAS are responsible for the professional competency of our Student Paramedics. All technicians and student paramedics always work with a fully qualified registered paramedic. WMAS is the only ambulance service in the country to have a fully qualified registered paramedic on every emergency ambulance. A paramedic working with a student paramedic is responsible for scene management and clinical decision making. will be attending training school on the 1 December 2023. will also be attending training school on the same date.
Concern 14 I am concerned that there has been no collective learning by West Midlands Ambulance Service following the death of Lauren Smith. There has been no action to address the learning gaps identified by WMAS own internal investigation report in respect of both the paramedic and technician. Therefore, I have addressed this aspect of my PFD to the CQC/Chief Inspector of Hospitals/HSIB as part of their regulation as to the safety of the West Midlands Ambulance Service considering the risk I have identified in relation to patient safety due to inaction by WMAS.
Response The Trust takes patient safety and the education and training of our staff very seriously.
The Trust has undertaken a significant programme of work, which is ongoing, in relation to clinical improvement in the management of chest pain, ECG recognition and cardiac arrest management, evidence of can be found within concern 6.
Once the Trust became aware of this incident, the clinicians involved received a case review with a CTM on 3 February 2023 to discuss learning points and reflect on the incident. The clinicians were also part of the Serious incident process and attended a root cause analysis meeting on 7 March 2023 where the case was discussed in detail. Following the Serious Incident investigation both staff members were also asked to undertake reflective practice, which has been completed. Additional training specific to ECGs and ACS is scheduled to be completed on 1 December 2023. Both clinicians also received a clinical supervision shift. completed this shift on 26 July 2023 (Appendix 16) and completed her shift on 11 July 2023 (Appendix 17).
also completed a CTM update day on 17 March 2023 due to her mentor role.
I hope this response provides you with the appropriate level of assurance that as a Trust we have dealt with the concerns highlighted within your report and the extent to which we take patient safety very seriously.
May I once again please pass on my sincere condolences to the family of Ms Smith. I am sorry we let Lauren down, and we let her family down.
If you require any further assistance, please do not hesitate contact me.
Noted
The Health and Care Professions Council acknowledges the concern but states that the individual in question is not registered with them, so the concerns do not fall within their remit for further investigation, but the individual's name has been added to a watchlist. (AI summary)
The Health and Care Professions Council acknowledges the concern but states that the individual in question is not registered with them, so the concerns do not fall within their remit for further investigation, but the individual's name has been added to a watchlist. (AI summary)
View full response
Dear Joanne Lees, Health and Care Professions Council I write to acknowledge receipt of your email dated 9th November 2023. The Fitness to Practice Triage team reviews all new concerns that the HCPC receives to decide whether a concern is within the HCPC remit. We can only investigate concerns that raise questions about an HCPC registrant’s fitness to practise. This means that the individual concerned in the matter must have an active registration with the HCPC. A review of our Register has revealed that is not registered with us. As the individual is not registered with us, these concerns do not fall within our remit for further investigation. However, I have added her name to our Watchlist. This provides that should she attempt to apply for registration in the future, we will take the concerns you have raised with us into account when considering whether to admit her name to the HCPC Register. You can find out more about the Fitness to Practise process via our website at: www.hcpc-uk.org. Thank you for taking the time to raise this matter with us. If you have any questions or queries, please email us at the following address ftp@hcpc-uk.org. Alternatively, please do not hesitate to contact the department on
Action Planned
The Health Services Safety Investigations Body is undertaking exploratory work regarding paramedic interpretation of ECGs in the community and will consider the scope for a formal investigation by the end of January 2024. (AI summary)
The Health Services Safety Investigations Body is undertaking exploratory work regarding paramedic interpretation of ECGs in the community and will consider the scope for a formal investigation by the end of January 2024. (AI summary)
View full response
Dear Coroner,
RE: REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)
Thank you for sharing this report with the Health Services Safety Investigation Body (HSSIB), we are sorry to hear of Lauren’s death and to read the findings within your report.
On 20 December 2023, our Investigations and Insights team held an Intelligence Review Meeting; at this meeting we review all patient safety concerns and insights received into our organisation and consider them for further exploratory work. I would like to assure you that the Regulation 28 Report sent to us was considered in this meeting, along with other information available to us and I can confirm that further exploratory work is being undertaken in relation to the issues raised in your report.
This exploratory work will be further reviewed by the end of January 2024 when we will consider the scope for an HSSIB investigation into issues related to Paramedic interpretation of ECGs in the community.
RE: REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)
Thank you for sharing this report with the Health Services Safety Investigation Body (HSSIB), we are sorry to hear of Lauren’s death and to read the findings within your report.
On 20 December 2023, our Investigations and Insights team held an Intelligence Review Meeting; at this meeting we review all patient safety concerns and insights received into our organisation and consider them for further exploratory work. I would like to assure you that the Regulation 28 Report sent to us was considered in this meeting, along with other information available to us and I can confirm that further exploratory work is being undertaken in relation to the issues raised in your report.
This exploratory work will be further reviewed by the end of January 2024 when we will consider the scope for an HSSIB investigation into issues related to Paramedic interpretation of ECGs in the community.
Action Planned
The University of Wolverhampton will present case evidence to students, incorporate ECG interpretation into Objective Structured Clinical Examinations, liaise with coronary care units for anonymised ECG readings, add an ECG interpretation workbook to the virtual learning environment, and organise continuing professional development ECG masterclasses. (AI summary)
The University of Wolverhampton will present case evidence to students, incorporate ECG interpretation into Objective Structured Clinical Examinations, liaise with coronary care units for anonymised ECG readings, add an ECG interpretation workbook to the virtual learning environment, and organise continuing professional development ECG masterclasses. (AI summary)
View full response
Dear Madam, Regulation 28 Report to Prevent Future Deaths Inquest into the death of Lauren Page We acknowledge receipt of your Regulation 18 Report to Prevent Future Deaths. We have considered the Report and have sought to provide you with an overview of the training programme undertaken at the University of Wolverhampton on the BSc (Hons) Paramedic Science (Professional Pathway) programme. The key points as they relate to the University of Wolverhampton are points 9 and 13. In respect of Ms Smith, we have reviewed our admissions data and Ms Smith has no known affiliation to the University of Wolverhampton and did not undertake her paramedic training at the University of Wolverhampton . Student paramedic
Student paramedic undertook her Associate Ambulance Practitioner (AAP) course with West Midlands Ambulance Service University NHS Foundation Trust (WMAS) prior to starting her BSc (Hons) Paramedic Science (Professional Pathway) programme at the University of Wolverhampton. The AAP programme is a level four apprenticeship that is run by WMAS against the agreed apprenticeship standards. The apprenticeship standard and teaching around ECG interpretation materials are included for completeness (Appendix A and Appendix B) . It should be noted that ST-elevation is discussed on slide 40 and pathological Q waves are discussed on page 42 of item 2. would have undergone these sessions when she was undertaking her AAP training with WMAS. Also included at Appendix C, is a copy of the PowerPoint presentation on ECG arrhythmias used by WMAS, and at Appendix D, an ECG workbook used by WMAS. University of Wolverhampton, Offices of the Vice-Chancellor, City Campus Wulfruna, Wolverhampton WVl lLY, United Kingdom T: +44 01902 321000 W: www.wlv.ac.uk .,, __ ~ ,, THE UNIVERSITY OF OPPORTUNITY .
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commenced her education at the University in June 2022, and is not due to complete her studies until January 2024. It is important to emphasise, that is not a registered paramedic and will not be eligible to apply for professional registration until such time as she has met all of the outcomes of her current programme of study. As a student, does not have all of the competencies and skills of a registered paramedic so would be working with a practice educator who is there to support and supervise her as she develops those competencies and skills. It is not expected that she would be making independent decisions on patient care whilst in her role as a student paramedic. The practice educator will always have the ability to override the decision of a student should they deem the proposed course of action to be sub-optimal for the patient. It should also be noted that on the 6 January 2023, was working as an employee of WMAS and was not there in her student capacity. was working within the remit of an associate ambulance practitioner. At the time of the incident, had not undergone the full ECG interpretation sessions so it may be reasonable for her to say that she did not have the full understanding of the meaning of the ECG at that time. The uncontrolled nature of paramedic placements means that it is not uncommon for students to encounter situations in practice where they have not yet had the training. Placements are spread throughout the programme and the focus for development changes as the student progresses. The risks associated with this are ameliorated by placing a student with a registered paramedic who is responsible and accountable for the clinical care of all patients. The sessions on 12-lead ECG interpretation were delivered on the 30 June 2023. Appendix E is the scheme of work for the level 6 module on the Paramedic Programme currently being sat by
The scheme of work provides an outline of what is taught in relation to cardiac physiology and ECGs, although it should be noted that ECGs are re-visited throughout the teaching as and where appropriate. Particula r note should be taken of sessions 6 and 29, which identify specific teaching around the ECG and its relation to emergency conditions. Also appended is Apper:,dix F, which is combined presentations on ECGs and taught across multiple sessions. You will note that the ECG in relation to cardiac emergencies commences from slide 161 with ST-elevation myocardial infarction discussed from slide 165 and specific reference to pathological Q-waves on slide 166. There are other slides that discuss pathologies impacting the QRS complex as well as the other waves of the ECG. Please note, these are not didactic teaching sessions, the presentation is there to support learning. Please be assured that ECGs are summatively assessed in practice (appendix G) by a student's Practice Assessor and do therefore feature within the University of Wolverhampton programme. Practice assessors are registered healthcare professionals (usually Paramedics) who have undertaken additional training to support and assess students. A Registrant must meet the Standards of Proficiency of the Health and Care Professions Council (HCPC) in order to remain on the Register, so it is reasonable to conclude that they have the skillset to assess trainee paramedics. To provide assurance to the Coroner the assessment process in practice is described below with a table showing how the modified Bondy system is used in clinical practice. Assessment Process - Formative and summative assessment The assessment of each competency consists of formative assessment and summative assessment. Formative assessment refers to what is learnt and how it is learnt. This should involve a continuing and systematic appraisal of the students' performance throughout their clinical placement to determine the degree of mastery of the given learning task. It also helps to focus on the particular learning necessary to achieve mastery of the required competences. Formative assessment is linked to the initial and midpoint interviews and is part of the continuous assessment. The purpose of the
interviews is to identify the learn ing needs and to discuss the student's progression . This w ill allow the student to observe, discuss and practice the skill in preparation for their summative assessment. Summative assessment refers to what to learn and what counts. This is linked to the final interview, and this will determine whether the student can competently and consistently undertake the competence without direct supervision in a safe, effective manner to ensure they are fit to practice at the point of registration with the Health and Care Professions Council as a Registered Paramedic. The key point, with in the summative assessment, is highlighted and noted above and goes to the point that a student is deemed to be fit to practice at the point of registration with the Health Care Professions Council as a Registered Paramedic. Assessment of Learning - Educational Taxonomy To determine the achievement of competences the assessment process is based on the Bondy (1983) criterion-referenced definitions for rating scales in clinical evaluation. This system allows mentors to evaluate student performance against the standard of procedure (safety and accuracy), the quality of the performance, and the level of assistance required by the student. The Practice Assessment Document (PAD) allows the student to show continuing progression throughout the placement period and encourages mentors to allow sufficient time for students to demonstrate competence over a wide range of presentations and patient groups before signing off a student as 'independent' . The more evidence that is generated for each competence, the more robust the decision so it is usual for students to continue to work through each of the competences even when they have been signed off at the appropriate level on a number of occasions. This will help to ensure that standards are maintained and that students are not signed off too early when there is insufficient evidence available. Figure 1. The Five-Point Bondy Rating Scale Level Standard of Procedure Quality of Performance Level of Assistance Independent 5
• Safe and accurate each time
• Achieved intended outcome Behaviour is appropriate to context
• Proficient, coordinated and confident
• Occasional expenditure of excess energy
• Within an expedient time period Without supporting cues Supervised 4
• Safe and accurate each t ime
• Achieved intended outcome Behaviour is appropriate to context
• Efficient, coord inated and confident
• Some expend iture of excess energy
• Within a reasonable time period Occasional supportive cues Assisted 3
• Safe and accurate each time
• Achieved most objectives for intended outcome
• Behaviour generally appropriate to context
• Skilful in part of the behaviour
• Inefficiency and incoordination
• Expends excess energy
• Delayed time period Frequent verbal and occasional physical cues in addition to supportive cues Marginal 2
• Safe only with guidance
• Not completely accurate
• Incomplete achievement of intended outcome
• Unskilled, inefficient
• Considerable expenditure of excess energy
• Prolonged time period Continuous verbal and frequent physical cues
Dependent 1 Unsafe Unable to demonstrate behaviour Lack of insight into behaviour appropriate to context Unable to demonstrate behaviour/procedure Lacks confidence, coordination and efficiency Continuous verbal and physical cues Not Observed X Adapted from Bondy, K. N. (1983}. Criterion-referenced definitions for rating scales in clinical evaluation. J Nurs Educ, 22(9):376-382. Fitness to Practice In response to point 13 regarding Fitness to Practice (FtP), it is pertinent to state that the University of Wolverhampton has its own robust FtP processes that relate to all students registered on courses of study that lead to provisional or full registration with an appropriate statutory or regulatory body or which confer a· professional qualification or entitlement to practise a particular profession or calling. For courses leading to eligibility to apply for registration with the HCPC, students are required to adhere to the Guidance on Conduct and Ethics for Students (HCPC, 2016} throughout their programme. Students also work towards achieving the Standards of Proficiency required to meet the HCPC criteria, but they are not expected to demonstrate competence in all of these Standards until close to the point of registration. At the time of the incident, was working as an employee of WMAS and not in her capacity as a student on placement. As such, WMAS did not notify the University of the incident and we remained unaware of it until two days prior to the receipt of the Regulation 28 report. Had we known earlier, we may have considered whether a referral to an FtP panel was appropriate, but it seems unlikely that the event would have met the criteria for referral. still had over 15-months of her programme remaining (including the sessions on ECGs}, and she was working with a registered paramedic who held overall responsibility and accountability for the decisions made. Steps taken by the University of Wolverhampton The University understands and accepts without reservation that its training must be effective. We have reviewed all of the ECG training and assessment that takes place on the programme and are confident that our teaching fully covers the abnormalities found in the ECG in this case, the pathological implications of such findings, and the appropriate course of action to be taken. However, we are completely committed to ensuring the safety of the public so will implement additional steps to further minimise the risks associated with the failure to accurately interpret a 12- lead ECG. Evidence from the case will be presented to students to exemplify the potential harm from inadequate understanding of the ECG and the implications for the patient - we would welcome a copy of the ECG if this is possible Interpretation of 12-lead ECGs will be incorporated into one or more of the Objective Structured Clinical Examinations that students sit throughout their programme. This will supplement rather than replace the current assessments in practice. Members of the paramedic team are liaising with local coronary care units to obtain anonymised 12-lead ECG readings from real patients to further enhance the teaching
• A 12-lead ECG interpretation workbook will be added to the virtual learning environment for completion by students. Students who do not complete the activity will be followed up by their personal academic tutor
• The University will organise continuing professional development ECG masterclasses to offer to registered paramedics
Student paramedic undertook her Associate Ambulance Practitioner (AAP) course with West Midlands Ambulance Service University NHS Foundation Trust (WMAS) prior to starting her BSc (Hons) Paramedic Science (Professional Pathway) programme at the University of Wolverhampton. The AAP programme is a level four apprenticeship that is run by WMAS against the agreed apprenticeship standards. The apprenticeship standard and teaching around ECG interpretation materials are included for completeness (Appendix A and Appendix B) . It should be noted that ST-elevation is discussed on slide 40 and pathological Q waves are discussed on page 42 of item 2. would have undergone these sessions when she was undertaking her AAP training with WMAS. Also included at Appendix C, is a copy of the PowerPoint presentation on ECG arrhythmias used by WMAS, and at Appendix D, an ECG workbook used by WMAS. University of Wolverhampton, Offices of the Vice-Chancellor, City Campus Wulfruna, Wolverhampton WVl lLY, United Kingdom T: +44 01902 321000 W: www.wlv.ac.uk .,, __ ~ ,, THE UNIVERSITY OF OPPORTUNITY .
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commenced her education at the University in June 2022, and is not due to complete her studies until January 2024. It is important to emphasise, that is not a registered paramedic and will not be eligible to apply for professional registration until such time as she has met all of the outcomes of her current programme of study. As a student, does not have all of the competencies and skills of a registered paramedic so would be working with a practice educator who is there to support and supervise her as she develops those competencies and skills. It is not expected that she would be making independent decisions on patient care whilst in her role as a student paramedic. The practice educator will always have the ability to override the decision of a student should they deem the proposed course of action to be sub-optimal for the patient. It should also be noted that on the 6 January 2023, was working as an employee of WMAS and was not there in her student capacity. was working within the remit of an associate ambulance practitioner. At the time of the incident, had not undergone the full ECG interpretation sessions so it may be reasonable for her to say that she did not have the full understanding of the meaning of the ECG at that time. The uncontrolled nature of paramedic placements means that it is not uncommon for students to encounter situations in practice where they have not yet had the training. Placements are spread throughout the programme and the focus for development changes as the student progresses. The risks associated with this are ameliorated by placing a student with a registered paramedic who is responsible and accountable for the clinical care of all patients. The sessions on 12-lead ECG interpretation were delivered on the 30 June 2023. Appendix E is the scheme of work for the level 6 module on the Paramedic Programme currently being sat by
The scheme of work provides an outline of what is taught in relation to cardiac physiology and ECGs, although it should be noted that ECGs are re-visited throughout the teaching as and where appropriate. Particula r note should be taken of sessions 6 and 29, which identify specific teaching around the ECG and its relation to emergency conditions. Also appended is Apper:,dix F, which is combined presentations on ECGs and taught across multiple sessions. You will note that the ECG in relation to cardiac emergencies commences from slide 161 with ST-elevation myocardial infarction discussed from slide 165 and specific reference to pathological Q-waves on slide 166. There are other slides that discuss pathologies impacting the QRS complex as well as the other waves of the ECG. Please note, these are not didactic teaching sessions, the presentation is there to support learning. Please be assured that ECGs are summatively assessed in practice (appendix G) by a student's Practice Assessor and do therefore feature within the University of Wolverhampton programme. Practice assessors are registered healthcare professionals (usually Paramedics) who have undertaken additional training to support and assess students. A Registrant must meet the Standards of Proficiency of the Health and Care Professions Council (HCPC) in order to remain on the Register, so it is reasonable to conclude that they have the skillset to assess trainee paramedics. To provide assurance to the Coroner the assessment process in practice is described below with a table showing how the modified Bondy system is used in clinical practice. Assessment Process - Formative and summative assessment The assessment of each competency consists of formative assessment and summative assessment. Formative assessment refers to what is learnt and how it is learnt. This should involve a continuing and systematic appraisal of the students' performance throughout their clinical placement to determine the degree of mastery of the given learning task. It also helps to focus on the particular learning necessary to achieve mastery of the required competences. Formative assessment is linked to the initial and midpoint interviews and is part of the continuous assessment. The purpose of the
interviews is to identify the learn ing needs and to discuss the student's progression . This w ill allow the student to observe, discuss and practice the skill in preparation for their summative assessment. Summative assessment refers to what to learn and what counts. This is linked to the final interview, and this will determine whether the student can competently and consistently undertake the competence without direct supervision in a safe, effective manner to ensure they are fit to practice at the point of registration with the Health and Care Professions Council as a Registered Paramedic. The key point, with in the summative assessment, is highlighted and noted above and goes to the point that a student is deemed to be fit to practice at the point of registration with the Health Care Professions Council as a Registered Paramedic. Assessment of Learning - Educational Taxonomy To determine the achievement of competences the assessment process is based on the Bondy (1983) criterion-referenced definitions for rating scales in clinical evaluation. This system allows mentors to evaluate student performance against the standard of procedure (safety and accuracy), the quality of the performance, and the level of assistance required by the student. The Practice Assessment Document (PAD) allows the student to show continuing progression throughout the placement period and encourages mentors to allow sufficient time for students to demonstrate competence over a wide range of presentations and patient groups before signing off a student as 'independent' . The more evidence that is generated for each competence, the more robust the decision so it is usual for students to continue to work through each of the competences even when they have been signed off at the appropriate level on a number of occasions. This will help to ensure that standards are maintained and that students are not signed off too early when there is insufficient evidence available. Figure 1. The Five-Point Bondy Rating Scale Level Standard of Procedure Quality of Performance Level of Assistance Independent 5
• Safe and accurate each time
• Achieved intended outcome Behaviour is appropriate to context
• Proficient, coordinated and confident
• Occasional expenditure of excess energy
• Within an expedient time period Without supporting cues Supervised 4
• Safe and accurate each t ime
• Achieved intended outcome Behaviour is appropriate to context
• Efficient, coord inated and confident
• Some expend iture of excess energy
• Within a reasonable time period Occasional supportive cues Assisted 3
• Safe and accurate each time
• Achieved most objectives for intended outcome
• Behaviour generally appropriate to context
• Skilful in part of the behaviour
• Inefficiency and incoordination
• Expends excess energy
• Delayed time period Frequent verbal and occasional physical cues in addition to supportive cues Marginal 2
• Safe only with guidance
• Not completely accurate
• Incomplete achievement of intended outcome
• Unskilled, inefficient
• Considerable expenditure of excess energy
• Prolonged time period Continuous verbal and frequent physical cues
Dependent 1 Unsafe Unable to demonstrate behaviour Lack of insight into behaviour appropriate to context Unable to demonstrate behaviour/procedure Lacks confidence, coordination and efficiency Continuous verbal and physical cues Not Observed X Adapted from Bondy, K. N. (1983}. Criterion-referenced definitions for rating scales in clinical evaluation. J Nurs Educ, 22(9):376-382. Fitness to Practice In response to point 13 regarding Fitness to Practice (FtP), it is pertinent to state that the University of Wolverhampton has its own robust FtP processes that relate to all students registered on courses of study that lead to provisional or full registration with an appropriate statutory or regulatory body or which confer a· professional qualification or entitlement to practise a particular profession or calling. For courses leading to eligibility to apply for registration with the HCPC, students are required to adhere to the Guidance on Conduct and Ethics for Students (HCPC, 2016} throughout their programme. Students also work towards achieving the Standards of Proficiency required to meet the HCPC criteria, but they are not expected to demonstrate competence in all of these Standards until close to the point of registration. At the time of the incident, was working as an employee of WMAS and not in her capacity as a student on placement. As such, WMAS did not notify the University of the incident and we remained unaware of it until two days prior to the receipt of the Regulation 28 report. Had we known earlier, we may have considered whether a referral to an FtP panel was appropriate, but it seems unlikely that the event would have met the criteria for referral. still had over 15-months of her programme remaining (including the sessions on ECGs}, and she was working with a registered paramedic who held overall responsibility and accountability for the decisions made. Steps taken by the University of Wolverhampton The University understands and accepts without reservation that its training must be effective. We have reviewed all of the ECG training and assessment that takes place on the programme and are confident that our teaching fully covers the abnormalities found in the ECG in this case, the pathological implications of such findings, and the appropriate course of action to be taken. However, we are completely committed to ensuring the safety of the public so will implement additional steps to further minimise the risks associated with the failure to accurately interpret a 12- lead ECG. Evidence from the case will be presented to students to exemplify the potential harm from inadequate understanding of the ECG and the implications for the patient - we would welcome a copy of the ECG if this is possible Interpretation of 12-lead ECGs will be incorporated into one or more of the Objective Structured Clinical Examinations that students sit throughout their programme. This will supplement rather than replace the current assessments in practice. Members of the paramedic team are liaising with local coronary care units to obtain anonymised 12-lead ECG readings from real patients to further enhance the teaching
• A 12-lead ECG interpretation workbook will be added to the virtual learning environment for completion by students. Students who do not complete the activity will be followed up by their personal academic tutor
• The University will organise continuing professional development ECG masterclasses to offer to registered paramedics
Action Taken
The CQC has reviewed WMAS's actions following the death and found no evidence of provider-level failings, although they identified concerns regarding the timeliness of addressing the training needs of staff involved. The training needs of one staff member have been addressed, and the second staff member's training will be met upon their return to work. (AI summary)
The CQC has reviewed WMAS's actions following the death and found no evidence of provider-level failings, although they identified concerns regarding the timeliness of addressing the training needs of staff involved. The training needs of one staff member have been addressed, and the second staff member's training will be met upon their return to work. (AI summary)
View full response
Dear HM Coroner
Prevention of future death report following inquest into the death of Miss Lauren Page Smith Thank you for sending CQC a copy of the prevention of future death report issued following the death of Miss Lauren Page Smith. The report identifies concerns about the care provided by West Midlands Ambulance Service NHS Foundation Trust on 6 January 2023.
We note the legal requirement upon us to respond to your report within 56 days.
Your prevention of future death report asks CQC to respond to the following information raised in point 14 of the report:
‘I am concerned that there has been no collective learning by West Midlands Ambulance Service following the death of Lauren Smith. There has been no action to address the learning gaps identified by WMAS own internal investigation report in respect of both the paramedic and technician. Therefore, I have addressed this aspect of my PFD to the CQC/Chief Inspector of Hospitals/HSIB as part of their regulation as to the safety of the West Midlands Ambulance Service considering the risk I have identified in relation to patient safety due to inaction by WMAS’.
We carried out core service inspections of WMAS covering urgent and emergency care and the emergency operations centre on 15 to 17 August 2023. An inspection of the well led key question was also carried out between 3 and 5 October 2023. The draft report for these inspections is currently with the provider HSCA Further Information Citygate Gallowgate Newcastle upon Tyne NE1 4PA
2
for a factual accuracy check. We will share the report with you when it is finalised.
During our inspection, we identified the need for improvements to be made to the processes around serious incident management and learning from deaths. Specifically, there was a focus at the trust around the quantity and timeliness of serious incident investigations rather than on the learning required as a result of the outcome of the investigations.
As you may be aware, CQC has been the lead enforcement body for health and safety incidents in the health and social care sector since 1 April 2015. As such, we contacted WMAS and requested evidence of the action they had taken to date following Miss Lauren Page Smith’s death and any additional action they intended to take in response to the prevention of future death report.
Having carefully reviewed the information the trust has provided, we have concluded there is no evidence of provider level failing in relation to Miss Lauren Page Smith’s death. However, we did identify concerns that supported our inspection findings in relation to the serious incident investigation process, and in particular, the timeliness around addressing the training needs of the staff involved with Miss Lauren Page Smith’s care.
The updated WMAS action plan dated 2 November 2023 and our ongoing communications with WMAS has demonstrated that the training needs of one staff member have now been addressed and the second staff member’s training needs will be met on their return to work.
We will continue to monitor WMAS’s progress in making improvements to their serious incident management and learning from deaths through our ongoing monitoring activities and engagement.
Prevention of future death report following inquest into the death of Miss Lauren Page Smith Thank you for sending CQC a copy of the prevention of future death report issued following the death of Miss Lauren Page Smith. The report identifies concerns about the care provided by West Midlands Ambulance Service NHS Foundation Trust on 6 January 2023.
We note the legal requirement upon us to respond to your report within 56 days.
Your prevention of future death report asks CQC to respond to the following information raised in point 14 of the report:
‘I am concerned that there has been no collective learning by West Midlands Ambulance Service following the death of Lauren Smith. There has been no action to address the learning gaps identified by WMAS own internal investigation report in respect of both the paramedic and technician. Therefore, I have addressed this aspect of my PFD to the CQC/Chief Inspector of Hospitals/HSIB as part of their regulation as to the safety of the West Midlands Ambulance Service considering the risk I have identified in relation to patient safety due to inaction by WMAS’.
We carried out core service inspections of WMAS covering urgent and emergency care and the emergency operations centre on 15 to 17 August 2023. An inspection of the well led key question was also carried out between 3 and 5 October 2023. The draft report for these inspections is currently with the provider HSCA Further Information Citygate Gallowgate Newcastle upon Tyne NE1 4PA
2
for a factual accuracy check. We will share the report with you when it is finalised.
During our inspection, we identified the need for improvements to be made to the processes around serious incident management and learning from deaths. Specifically, there was a focus at the trust around the quantity and timeliness of serious incident investigations rather than on the learning required as a result of the outcome of the investigations.
As you may be aware, CQC has been the lead enforcement body for health and safety incidents in the health and social care sector since 1 April 2015. As such, we contacted WMAS and requested evidence of the action they had taken to date following Miss Lauren Page Smith’s death and any additional action they intended to take in response to the prevention of future death report.
Having carefully reviewed the information the trust has provided, we have concluded there is no evidence of provider level failing in relation to Miss Lauren Page Smith’s death. However, we did identify concerns that supported our inspection findings in relation to the serious incident investigation process, and in particular, the timeliness around addressing the training needs of the staff involved with Miss Lauren Page Smith’s care.
The updated WMAS action plan dated 2 November 2023 and our ongoing communications with WMAS has demonstrated that the training needs of one staff member have now been addressed and the second staff member’s training needs will be met on their return to work.
We will continue to monitor WMAS’s progress in making improvements to their serious incident management and learning from deaths through our ongoing monitoring activities and engagement.
Sent To
- Health & Care Professions Council
- HSIB
- Quality Care Commission
- West Midlands Ambulance Service University NHS Foundation Trust
Response Status
Linked responses
5 of 5
56-Day Deadline
10 Jan 2024
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 27/1/23 I commenced an investigation into the death of Lauren Page Smith aged 29. The investigation concluded at the end of the inquest on 1/11/23.
The medical cause of Lauren’s death was;
1a) Acute Myocardial Infarction 1b) Coronary Artery Thrombosis 1c) Ruptured Coronary Artery Atherosclerosis
The inquest concluded with a narrative conclusion as follows;
Lauren Smith died from an acute myocardial infarction. The ecg reading that was taken at 08:56 am on the morning of her death was abnormal and was incorrectly interpreted. The ecg was likely consistent with a cardiac event in progress at the time which was clearly identified on the auto diagnostic monitor and consistent with the clinical symptoms reported by the deceased. At inquest I found the failure to interpret the ecg correctly was a GROSS FAILURE.
The medical cause of Lauren’s death was;
1a) Acute Myocardial Infarction 1b) Coronary Artery Thrombosis 1c) Ruptured Coronary Artery Atherosclerosis
The inquest concluded with a narrative conclusion as follows;
Lauren Smith died from an acute myocardial infarction. The ecg reading that was taken at 08:56 am on the morning of her death was abnormal and was incorrectly interpreted. The ecg was likely consistent with a cardiac event in progress at the time which was clearly identified on the auto diagnostic monitor and consistent with the clinical symptoms reported by the deceased. At inquest I found the failure to interpret the ecg correctly was a GROSS FAILURE.
Circumstances of the Death
On 6/1/23 Miss Lauren Page Smith passed away at her home address of 142 Essington Way, Wolverhampton. Earlier that day, paramedics had responded to a Category 2 ambulance call whereby Miss Smith reported vomiting, chest and arm pain. Her observations were normal. An ecg showed evidence of pathological q waves in V1, V2 and V3, an isolated ST elevation in V2 and a positive AVR deflection. The ecg was abnormal. The auto diagnostic monitor clearly recorded the ecg as abnormal and reported an anterior infarct. Both the attending paramedic and technician interpreted the ecg as normal and reported it as normal to Miss Smith who based on that information declined to attend hospital. Evidence was heard that the ecg indicated a likely cardiac event in progress at the time the paramedics were in attendance. Miss Smith was found in cardiac arrest several hours later and confirmed as deceased. A post mortem revealed evidence of a blood clot in the left anterior descending artery leading to an acute Myocardial Infarction.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.