Spire Healthcare conducted a Root Cause Analysis investigation, implemented a new checklist for agency staff, and took other actions to address concerns raised in the report, including measures related to escalation to consultant, deteriorating patient care, and recruitment. (AI summary)
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Regulation 28 Report - Response
We write in response to your Regulation 28 Report dated 28 June 2023 issued following the inquest into the sad death of Mrs Carol Hatch. Please consider this letter as Spire Healthcare Limited’s formal response to the concerns raised in the report.
We would like to take this opportunity to offer our sincerest condolences to Mrs Hatch’s family. Prior to the inquest, we conducted a thorough and candid Root Cause Analysis (“RCA”) investigation into the circumstances surrounding Mrs Hatch’s death and had identified the majority of the issues which were recorded in the Regulation 28 report. To that extent, we consider it important that it is acknowledged that that the concerns raised in the Regulation 28 report are comprised largely of concerns Spire had already highlighted and was taking steps to address prior to the inquest. Notwithstanding this, as an organisation we have considered the concerns raised in the Regulation 28 report with the utmost seriousness and have undertaken further work to address these concerns.
We have set out our response to the Regulation 28 concerns in the table below with reference to evidence in support of those actions both in the form of the evidence which formed part of Spire’s RCA action plan as presented at the Inquest, as well as evidence of the further work undertaken since the hearing took place.
Coroner’s Concern Spire’s Response Evidence
Escalafion to consultant
1. Mrs Hatch's condifion deteriorated markedly during the night of 31 August/1September 2022 (some hours after surgery). Neither the surgeon nor the anaesthefist were alerted to this unexpected deteriorafion. The Surgeon only became aware of the posifion when he contacted the hospital and came in around 7 am.
The RCA invesfigafion completed prior to the inquest clearly idenfified that, wholly regreftably, on this occasion, some of the staff involved in the pafients’ care made errors in clinical judgement in failing to appreciate the signs of the pafient’s deteriorafing condifion and sepsis was not considered during the night and up unfil the pafient was reviewed by the consultant surgeon. As soon as the consultant contacted the hospital at 07:00 hours and received an update on the status of the pafient he ADDITIONAL INFORMATION
Integrated Quality Governance Team (”IQG”) Review of Learnings from Serious Incidents in 2022 and Q1 2023 Leeds Incident Review of Escalafing to Consultants
Coroner’s Concern Spire’s Response Evidence
responded promptly and aftended the hospital. As a result of this incident, Spire conducted a full and thorough RCA idenfifying areas of concern pufting in place an acfion to address those concerns. As stated above, the majority of the issues idenfified in the Regulafion 28 report are mafters which had already been idenfified and addressed. Notwithstanding this, Spire is commifted to ongoing learning from this event and improving its systems and processes.
Nursing/RMO care
2. Mrs Hatch was cared for during the night by an agency nurse who had not worked at the hospital previously. No records were produced to the Inquest to demonstrate she was (a) competent (b) had an inducfion to the hospital or (c) received a handover at the start of the shift.
3. The nurse took observafions at fimes during the night but either omifted some elements or misinterpreted the informafion with the result that the NEWS scores were inaccurately portrayed. This resulted in missed opportunifies to escalate concerns to a doctor, more senior colleagues, or the surgeon.
These points were addressed in the RCA with remedial acfion listed in acfion points 9, 10, 12, 13, 14, 17, 18, 19 and 20 and evidence on these acfions was presented at the inquest.
The agency staff hospital inducfion process includes a documented local inducfion based on a standard format for inducfion used across the group. The invesfigafion idenfified that the agency nurse (who had worked at Spire Leeds on a previous occasion) received a verbal inducfion when she arrived on shift on 31.08.22. A documented record of this inducfion could not be located but from the evidence obtained during the invesfigafion and the events that occurred, we are confident that the agency staff member was orientated to the hospital as she completed Spire’s care plans and pafient records during the shift, accessed the handover, knew where to locate equipment, RCA ACTIONS EVIDENCE
Acfion No. 9 Refresher Training for NEWS 2 Acfion No. 10 Heads Together Clinical Night Staff Acfion No. 12 NEWS 2 Training for Nafional Agency Supplier Acfion No. 13 Online Training to Recognise a Deteriorafing Pafient Acfion No. 14 Spot Audit of NEWS 2 Scores Acfion No. 17 Departmental On-Call Service Acfion No. 18 Updated Inducfion Checklist – Leeds Acfion No. 19 Key Learning Points to Nursing Agency Acfion No. 20 Completed Agency Inducfion
AGENCY NURSE & RMO INFORMATION Confirmafion from Nursing Agency of Acfion Taken
ADDITIONAL INFORMATION Ward Handover 31.08.22
Coroner’s Concern Spire’s Response Evidence
4. No observafions whatsoever were taken in the period between 3 am and 6.25am, despite the pafient having been recorded as "crying in pain" around 10pm.
5. The records kept were inaccurate; for example, there was no record of oxygen being provided around 2 am.
and escalated her concerns to the Resident Medical Officer (“RMO”) via a senior member of nursing staff for advice.
Spire has a series of checks to ensure that agency staff are assessed as competent to care for pafients, as follows:
- The nursing agency screens the candidates via their CV and ensures that they meet Spire Healthcare’s statutory and mandatory training requirements of BLS, Anaphylaxis, Safeguarding Adults and Children, Infecfion Prevenfion and Control, Informafion Governance and Manual Handling and provides a Proforma Confirmafion Form to the hospital.
- The hospital will then thoroughly review the informafion provided to them in the Proforma Confirmafion Form before they accept the nurse for the shift.
- In this case, it was documented that the nurse who cared for the pafient overnight had “recent and credible experience in surgical nursing, Immediate Life Support (“ILS”)/Advanced Life Support (“ALS”) and had met the mandatory training requirements” and was suitable to care for pafients at Level 1A+ per our policy for Safe Staffing.
- If suitable, the hospital agrees to the placement of the candidate, but careful considerafion is given in each case and it is not uncommon to reject a candidate based on insufficient skills and experience to meet the hospital’s requirements. Agency Confirmafion Form 31.08.22
Coroner’s Concern Spire’s Response Evidence
As part of the learning from this event, the team at Spire Leeds have shared and discussed the findings in the RCA with this nurse’s agency. The core supplier competency checklist includes requires that agency staff are competent in the management of the deteriorafing pafient. The new checklist must be signed by the candidate as well as the agency to ensure both are confirming the informafion is correct.
In addifion to addressing NEWS training with agency staff, the hospital have ensured that a NEWS update refresher has been provided to all relevant colleagues and have conducted regular audits to provide assurance in relafion to compliance.
6. The RMO was called to review Mrs Hatch twice during the night but failed to appreciate that the deteriorafion in her condifion necessitated an escalafion to the surgeon and/or anaesthefist.
As heard in evidence during the inquest, this point was idenfified in the RCA and was addressed in the acfion plan at point 8 and 11. The RMOs for the majority of Spire hospitals are provided by an external agency. The agency provides training before RMOs start with us and provide top-up training as required. The training provided includes on-line elements and a residenfial course. The Group Medical Director (GMD) has visited the training site to get assurance of the extent of training. RMOs’ CVs are provided to a site before they commence. When RMOs are new to a site, they have a period of shadowing with a previous RMO. In addifion, there is have a RMO handbook with an inducfion checklist.
RCA ACTIONS EVIDENCE
Acfion No. 8 to share the RCA with RMO and NES Acfion No. 11 Recognising a gastric perforafion complicafion
AGENCY NURSE & RMO INFORMATION Confirmafion of RMO Appraisal Clinical Policy 18 RMO Handbook NES Resident Doctor Pre Checks
Coroner’s Concern Spire’s Response Evidence
Spire Leeds has the appraisal for the RMO covering the period when the incident occurred. The appraisal for that year documented mandatory training including sepsis. We have the doctor’s full CV which includes an NES Healthcare inducfion which covers ECGs, BNF Medicafion, NEWS, Medical Note Wrifing, Pharmacology, and clinical self- declarafion of competencies dated 23rd January 2017. At the fime of the incident the RMO was trained in Advanced Life Support and EPALS. Compliance was assured in accordance with the contractual Spire requirements.
This mafter was recognised in the RCA, has been discussed with the RMO and there is a plan in place for training to be delivered to RMOs on recognising signs of a deteriorafing pafient and recognising signs of gastric perforafion. In addifion, Spire has received confirmafion that the RMO has undertaken a recent appraisal. We refer the Coroner to evidence file relafing to the RMO which includes evidence of acfion taken in relafion to this concern.
Enhanced monitoring/further invesfigafions
7. When Mrs Hatch was observed to be in pain there was a delay in moving her to an extended care unit ('ECU') bed or otherwise escalafing the level of monitoring. This did not take place unfil
9.50 am.
Care provided in ECU is governed by Clinical Policy 80 – Elecfive Adult Surgical Admission – Level 1 Provision and Clinical Policy 88 – Crifical Care Standards. Level 1 Care is described as “Enhanced care provides care for pafients requiring more detailed observafions than level 0 (ward and HOC) or step down from Level 2-3 care”, examples of which are, pafients requiring close physiological monitoring after major surgery – may have addifional monitoring devices in situ e.g. arterial line, pafients ADDITIONAL INFORMATION
Clinical policy 80 Enhanced Care Service Provision Clinical Policy 88 Crifical Care Standards
Coroner’s Concern Spire’s Response Evidence
requiring a single vasopressor support (peripheral or central) but otherwise stable and not deteriorafing. E.g. post-op pafient with a “saggy” blood pressure secondary to an epidural, pafients stepping down from level 2 crifical care whose needs are greater than those that can be met by ward level care, pafients requiring ongoing intervenfions from crifical care outreach teams.
All colleagues across the group and at Spire Leeds undergo competency assessment, with colleagues working in Level 1 ECUs also undergoing the Nafional Competency Framework for Registered Nurses in Adult Crifical Care Step 1. Of the nine colleagues who work within Spire Leeds ECU two have addifionally completed a Crifical Care Degree and another has completed a Crifical Care Cerfificate.
In addifion, Spire Leeds has close links with Spire Manchester, who provide Level 3 (ICU) care and an agreement with Leeds NHS Hospital where our colleagues can aftend to maintain ongoing competence in specific areas, for example, arterial lines, inotropes, non-invasive venfilafion, transfer training.
8. When the surgeon sought an x ray at
8.35 am there was a delay unfil this took place at 10.09 am. There was a failure to appreciate the urgency of the situafion in a pafient who was displaying symptoms of sepfic shock.
As heard in evidence during the inquest, this mafter was idenfified in the RCA and addressed in the acfion plan at points 1, 2, 11, and 21. When Consultants commence their pracfice at Spire Leeds, they undergo an inducfion process which includes out of hours provision. The hospital has improved on call service documentafion and has RCA ACTIONS EVIDENCE Acfion No. 1 RCA to Consultant Acfion No. 2 RCA to Anaesthefist Acfion No. 11 Consultant Training on Symptoms and Signs of Gastric Perforafion Acfion No.17 Departmental On-Call Service
Coroner’s Concern Spire’s Response Evidence
communicated this to all consultants pracfising at the hospital.
Acfion No. 21 Per-operafive Communicafion of Difficult Surgeries
9. It was not readily apparent to some of those involved at that fime that an out of hours radiographer could have been called in. This was a further missed opportunity to invesfigate her condifion before it deteriorated.
This mafter was idenfified in the RCA and addressed in the acfion plan at point 17. When Consultants commence their pracfice at Spire Leeds, they undergo an inducfion process which includes out of hours provision. The hospital has improved on call service documentafion and has communicated this to all consultants pracfising at the hospital.
RCA ACTIONS EVIDENCE Acfion No. 17 Departmental On-Call Service
10. Blood samples taken at 8.02am were not delivered to the laboratory unfil
9.06 am and then not reported on unfil
10.21 am as they had not been marked as ‘urgent’. This also reflects a failure to appreciate the gravity of the situafion.
As heard in evidence during the inquest, this mafter was idenfified in the RCA acfion plan at point 22.
As stated in Spire’s RCA, learning has been developed surrounding the appropriate labelling of bloods in relafion to the urgency of a clinical situafion. This learning has been shared with staff across the hospital RCA Acfions Evidence Acfion No. 22 Labelling of Urgent Bloods
11. The RMO was the senior doctor at the hospital overnight. The RMO recorded a note at 8.45 am "feeling much befter now". The Inquest noted a discrepancy between this comment and the fact that Mrs Hatch was deemed too unwell to be moved to the radiology department at 9.10am, some 25 minutes later.
12. Overall, the cluster of failings on 31 August/1 September brought into quesfion the competence of the staff This incident was escalated to the RMO’s agency, NES Healthcare, at the fime of the inifial event. The agency reviewed the incident and considered it to be a learning opportunity rather than requiring referral to the GMC. At the fime of the incident, the RMO had an in-date Sepsis training record (23/1/22) and he was asked to reflect on the issue in his appraisal. In his appraisal, he presented a case study about Upper GI surgery and its complicafions. He completed the GMC Medical Pracfice in Acfion in October 2022 to update himself on the GMC guidance for doctors. He also completed the EPALS course in December 2022 where a lecture and a pracfical case included sepsis training. AGENCY NURSE & RMO INFORMATION Confirmafion of RMO Appraisal Clinical Policy 18 RMO Handbook NES Resident Doctor Pre Checks
RCA ACTIONS EVIDENCE
Coroner’s Concern Spire’s Response Evidence
looking after Mrs Hatch on duty at the Spire Hospital that night. The Inquest was informed that such concerns had not been reported to the regulatory bodies of those involved, The RMO confinues to pracfice at the Spire Hospital.
Evidence was heard at the inquest that considerafion was given to referring the RMO to the GMC following this incident. The RMO’s skill set, and competency were discussed at a Scrufiny Panel on 17th February 2023 aftended by hospital and senior clinical and medical management at Spire. It was concluded that the findings of the RCA and the known pracfice of the RMO did not meet the threshold for referral to the GMC. It was agreed that the hospital team would share the RCA with the RMO’s agency, which was completed on 16th March 2023. It was agreed that the RMO’s agency were best placed to assist us in understanding whether this was an isolated episode or not, whether there were any wider performance concerns that needed to be addressed or mafters requiring escalafion to the GMC.
We have a quarterly meefing with NES Healthcare and have strengthened the process to include case by case discussion if we have raised any concerns about an RMO, and vice versa if the RMOs have raised any concerns about our hospital. If we have significant or unresolved concerns, the RMO is replaced by the agency. The RMOs undertake annual appraisal with their employing agency, and our hospital Directors of Clinical Services meet regularly with them.
Acfion No. 4 RCA to RMO’s Acfion No. 7 RCA Sent to Nursing Agency Acfion No. 8 RCA Sent to NES Healthcare Acfion No. 11 Recognising a gastric perforafion complicafion
13. The Inquest was informed that Spire Healthcare Limited rely on agencies As stated above, the agency staff hospital inducfion process includes a documented local inducfion based on a ADDITIONAL ACTIONS EVIDENCE Mandatory Training Planner
Coroner’s Concern Spire’s Response Evidence
who supply clinical staff to assess their competence (whilst retaining a power of veto any individual put forward). Given the importance of having competent nurses and doctors on duty overnight further considerafion should be given to the methods by which professional competence is assessed and staff from agencies are engaged.
standard format for inducfion used across the group. The RCA idenfified that the agency nurse (who had worked at Spire Leeds on a previous occasion) received a verbal inducfion when she arrived on shift on 31.08.22. A documented record of this inducfion could not be located, but from the evidence obtained during the RCA invesfigafion and the events that occurred, we are confident that the agency staff member was orientated and completed Spire’s care plans and pafient records during the shift, accessed the handover, and escalated her concerns to the RMO for advice.
Current ILS compliance for registered colleagues at Spire Leeds is 77%, against the target of 90%. Colleagues who do not currently have ILS training are booked onto training in the near future. Sepsis training is part of ILS competency. We have 100% compliance in performing quarterly scenarios of which sepsis is included.
In this case, the RMO had documented mandatory training which included sepsis assessment and management.
Similarly, the agency nurse in this case was ILS/ALS trained, which includes the assessment and management of sepsis.
Spire has a series of checks to ensure that agency staff are assessed as competent to care for pafients.
The nursing agency screens the candidates via their CV and ensures that they meet Spire Healthcare’s statutory and mandatory training requirements of Basic Life Support, Oxylog Training Resuscitafion Scenarios
ADDITIONAL INFORMATION Spire Educafion TNA
Coroner’s Concern Spire’s Response Evidence
Anaphylaxis, Safeguarding Adults and Children, Infecfion Prevenfion and Control, Informafion Governance and Manual Handling and provides a Proforma Confirmafion Form to the hospital.
The hospital will then thoroughly review the informafion provided to them in the Proforma Confirmafion Form before they accepted the nurse for the shift. In the case, it was documented that the nurse who cared for the pafient overnight had “recent and credible experience in surgical nursing, ILS/ALS and had met the mandatory training requirements” and was suitable to care for pafients at Level 1A+ per our policy for Safe Staffing.
As part of the learning from this event, the team at Leeds have shared and discussed the findings in the RCA with this nurse’s agency. The core supplier competency checklist includes requires that agency staff are competent in the management of the deteriorafing pafient. The new checklist must be signed by the candidate as well as the agency to ensure both are confirming the informafion is correct.
14. Evidence taken from a consultant surgeon at the Inquest indicated that the failings at Spire Hospital contributed (more than minimally) to the death of Mrs Hatch on 18 October. This view dovetails with the medical opinion obtained by Spire Healthcare Limited This concern is a mafter of evidence before the coroner. Based on the thorough and considered invesfigafions undertaken by Spire (see file enfitled Incident Management), the organisafion formed the view that Mrs Hatch’s death was regreftably avoidable.
INCIDENT MANAGEMENT Dafix Report DW-336489 (Transfer Out)
01.09.22 PSIR DW-336489 01.09.22 CQC Nofificafion DW-336489 (DPL-1355306)
12.09.22 Dafix Report DW-343997 (Pafient Death)
19.10.22
Coroner’s Concern Spire’s Response Evidence
themselves to the effect that this death was “avoidable”. PSIR DW-343997 19.10.22 Medical Examiner Report (Commenced 26.10.22
- Returned 04.01.23) Central Scrufiny Panel 17.02.23 RCA Report DW-343997 08.03.23 Mortality Review Annual Report 2022 28.03.23 Clinical Governance Leads Nafional Meefing
28.04.23 Structured Judgement Review 06.05.23 Group Mortality Review Commiftee 16.05.23
ADDITIONAL ACTIONS EVIDENCE Deteriorafing Pafient Sfickers ECU Equipment Stock Check Agreement in Principle with Leeds Teaching Hospitals NEWS 2 Posters Addifional CPAP Masks Addifional Chest Drains Venous Blood Gas Process for Deteriorafing Pafients ADDITIONAL INFORMATION MAC Q1 2023 Newslefter (legible documentafion)
I hope this letter and evidence attached provides both you and Mrs Hatch’s family with assurance that Spire has taken seriously the matters of concern raised in your report and has taken substantial effective steps to address those concerns.