Jennifer McKoy

r.!1:kj Black Country Pathology Services ... 5?t5$ A S? 4 < Regulation 28: Response to prevent future deaths - Response Date: 23 April 2020 Coroner: Zafar Siddique, Senior Coroner, for the coroner area of the Black Country. Inquest: Death of Ms Jennifer McKoy. Inquest date 19 February 2020 Matters of concern: Evidence emerged during the inquest that there was an inadequate audit process in place for monitoring non-suspicious samples by way of dip- sampling. Action should be taken: In consultation with the Black Country Hospital Trusts the Black _Country Pathology Services may wish to review their audit/ dip-sampling processes for both suspicious and non-suspicious samples.
1. Background: Black Country Pathology Service (BCPS) is a partnership,· across the four NHS providers within the Black Country. BCPS is hosted by The Royal Wolverhampton NHS Trusts and was established in October 2018. Since then, there has been a planned transition period in which pathology services are being migrated to the target operating model. As part of the transition all histology services currently spread across 4 sites will be consolidated together and based at the New Cross Hospital site in Wolverhampton; this includes the clinical histopathology team. The aim is to provide a more robust pathology service across the BCPS. The BCPS inherited a number of issues regarding the histology services, mainly associated with the national shortage of Histopathologist; this was of particular-concern at Walsall Healthcare NHS Trust (WHT) site. Several of the Consultant Histopathologists at Walsall had retired and returned and were working an excessive number of PA's (15 PA's), which was not sustainable long term. The Walsall Histology Clinical Lead also left for a new post outside the BCPS, increasing the risk level. Reporting turnaround times for histology cases across the BCPS were not meeting the recommended standard stated by the Royal College of Pathologists, resulting in a backlog of cases (backlog varied across the various sites). As such there was significant pressure from the Trusts to improve turnaround times especially for patients on cancer pathways. Both WHT and BCPS recorded the reporting pressures in histology on their risk registers; BCPS also raised the risk regarding the issues around the recruitment and retention of Consultant Histopathologists, with particular concern at the Walsall site. As a result ·of the concerns around the service provision at WHT the decision was made to move the service to RWT earlier than planned as part of the BCPS reconfiguration. Across the entire Black Country region, all malignant cases are reviewed at the appropriate MDT. NHS Pathology Serving the Black Country Provided by Sandwell and West Birmingham NHS Trust. The Dudley Group NHS Foundation Trust, The Royal Wolverhampton NHS Trust and Walsall Healthcare NHS Trust.

r.!1:k1 Black Country Pathology Services < .g .... s;ess A To support quality assurance systems within histology, a programme of Southampton audits had been in place at RWT. The audits involved the review of both malignant and benign cases (equivalent to 2% of the workload) to assess the technical and clinical quality of the individual departments. Due to the pressures to meet cancer targets, staffing shortages and increased activity, the audit programme was not maintained. To rectify the slippage in the Southampton audit programme, the BCPS has revised the audit programme and metho_dology across the network to ensure the programme is achievable and provides assurances for both malignant and benign cases. The audit programme incorporates: .
• A review of all histology multi-disciplinary team meeting cases, prior to MDT, to provide quality assurance for all malignant cases.
• A modified Southampton audit programme, which audits 2% of the workload selected from non-malignant cases to cover benign cases; both the technical and clinical quality of the laboratories are reviewed. NHS Pathology Serving the Black Country Provided by Sandwell and West Birmingham NHS Trust, The Dudley Group NHS Foundation Trust, The Royal Wolverhampton NHS Trust and Walsall Healthcare NHS Trust.

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2. Actions taken: Action Comment Status 1 Case review audit of the pathologist responsible for the interpretation No clinical relevant errors were identified. Completed and reporting error of this incident. 2 Case review audit of non-cancerous WHT cases reportec;i over 2 month No clinical relevant errors were identified. Completed period. 3 Formal process in place to document any discrepancies identified Final site in process of instigating. Partial during routine review of malignant cases in preparation of multidisciplinary team meetings to access individual pathologists p~rformance. 4 Commenced audit (modified Southampton audit) of the technical and Cases audited on monthly basis. Audit Completed clinical quality of non-malignant cases; accounts to 2% of workload commenced from January 2020 cases. activity at each site across the BCPS. 5 Clinical audit lead from each site collates modified Southampton and malignant case audit data and presents findings bi-monthly to the BCPS Meeting . schedule in place and minutes of meetings documented. Completed histology clinical meeting. 6 Implement audit of cases outsourced to the private sector for reporting, Historical audit of outsourced cases from RWT Completed to assess the quality and accuracy of reporting. completed. Frequency of audit dependant on outsourcing of cases. 7 Recruitment of Consultant Histopathologists to fill vacancies to achieve full workforce establishment. 7 additional Consultants recruited since BCPS formed. Ongoing 8 Additional support for clinical teams across BCPS (including WHT Completed Histology prior to relocation) from RWT clinical team and UHB.
• Laboratory Information System (LIMs) installed at RWT Histology lab to enable remote reportinQ across the network. 9 Accelerated the relocation plan of Walsall histology laboratory (including Improved robustness of histology services at Completed clinical staff) to the Wolverhampton site as part of the national Walsall, includinq qreater support for October 2019 NHS Pathology Serving the Black Country : t . Provided by Sandwell and West Birmingham NHS Trust. The Dudley Group NHS Foundation Trust, The Royal Wolverhampton NHS Trust and Walsall Healthcare NHS Trust.

r~1:b1 Black Country Pathology Services pathology consolidation programme. histopathologists (easier access to second opinions from peers, supported MDT attendance, workload manaQement~.
3. Actions proposed to be taken: Action Comment Target date completion of 1 Complete implementation of audit at remaining BCPS site for the routine review of malignant cases in preparation of MDT meetinQs. Currently implementing on all sites; this involves moving from previous audit process to new audit process. 31 May 2020 2 Complete modified Southampton audits roll out. .
- Currently implementing on all sites; this involves moving from previous audit process to new audit Process . 31 May 2020 3 Audit of cases outsourced to the private sector for reporting, to assess the quality and accuracy of reporting across entire BCPS. . No cases outsourced for reporting. As required 4 Recruitment of Consultant Histopathologists Consultant Histopathologist post to continue to be advertised on a regular basis until the . service is fullv established. Continue until established fully 5 Improve pathways to notify BCPS of increasing cancer work due to waiting list initiative's etc. which then impact directly on the lab and histopathology consultants. Raised at STP Cancer Group meeting- contact emails to be shared. 31 May 2020 a,s NHS Pathology Serving the Black Country Provided by Sandwell and West Birmingham NHS Trust. The Dudley Group NHS Foundation Trust, The Royal Wolverhampton NHS Trust and Walsall Healthcare NHS Trust.

Dear Mr Siddique

Re: Mrs Jennifer McKoy - Deceased Date of Death: 17/05/2019 Date of Inquest: 19th February 2020

I am writing in response to your report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. I fully accept that the inquest conclusion was reached with the potential to identify learning to prevent future deaths.

I would like to take the opportunity to assure you that as an organisation we have taken this case seriously and have and will continue to ensure actions and lessons from this are enacted and shared widely with staff across the organisation.

Circumstances of the death

Mrs McKoy was was a 58-year-old female patient who initially attended Walsall Manor Hospital for a laparoscopic cholecystectomy on 14 August 2018. Prior to this she was referred by her GP in March 2018 for pain in her right side. A subsequent ultrasound at hospital confirmed she had a thick-walled gall bladder with multiple gall stones.

The surgical procedure was described as difficult due to a very thick-walled gallbladder packed full of stones and she was discharged home the following day. The gall bladder was sent for histology and reported to show 'chronic cholecystitis'.

Mrs McKoy re-attended the emergency department at Manor Hospital on 14 February 2019 with pain and a growing mass at the port site, this was reviewed and felt to be a haematoma or scar tissue and the patient was discharged home with plans for follow up.

Mrs McKoy was then seen in the vascular clinic on 20 March 2019 and ultrasound completed of mass at port site which was suggestive of haematoma. A further MRI completed on 15 March 2019 identified adenocarcinoma of gallbladder bed, abdominal wall, multiple hepatic and peritoneal and bony metastases with some ascites.

A retrospective review of the histology from 2018 showed that these slides demonstrated a carcinoma at that time which had not been identified.

Mrs McKoy was referred to oncology for palliative chemotherapy and sadly died on 17 May 2019.

Legal Services Department Manor Hospital Moat Road Walsall West Midlands WS2 9PS

Tel: 01922 721172 ext 5809 Email: walsallhealthcare.nhs.uk Website:

Coroner’s Concerns

1. Evidence emerged during the inquest that there was an inadequate audit process in place for monitoring non-suspicious samples by way of dip-sampling.

2. There was limited evidence of any protocol or policy in place for managing the anticoagulation/prophylaxis regime for community patients who have identifiable risk factors for developing complications.

Action Required

1. In consultation with the Black Country Hospital Trusts the Black Country Pathology services may wish to review their audit/dip-sampling processes for both suspicious and non-suspicious samples.

The Hospital Trust may wish to consider reviewing their policy on anticoagulation/prophylaxis for community patients.

Action Taken

1. The Black Country Pathology Service is responding separately to detail the actions taken regarding their audit/dip-sampling processes for samples

2. A review of available guidance and local practice has been completed with regard to Venous Thromboembolism (VTE) anticoagulation/ prophylaxis for community patients, including those discharged from hospital, those with cancer and those residing in care homes.

2.1 Discharge from Hospital

NICE Guidance ‘Venous Thromboembolism in adults: reducing the risk in hospital’ Quality Standards (https://www.nice.org.uk/guidance/qs3), contains 2 relevant standards:

Standard 6 - Patients/carers are offered verbal and written information on VTE prevention as part of the discharge process.

Standard 7- Patients are offered extended (post hospital) VTE prophylaxis in accordance with NICE Guidance

TRUST ACTION:

In order to promote and ensure compliance with Quality Standards 6 & 7, we will be monitoring discharge assessments of patients through the Trust’s clinical audit programme

2.2 Community Services

1.2.1. Cancer Patients: There is no formal guidance for patients with cancer diagnoses, other than at discharge from Hospital (as above 2.1), though the All-Party Parliamentary Thrombosis (APPT) group has recommended that all patients with cancer should be risk assessed wherever they are in the system. In addition they recommend that all cancer patients should receive information about reducing VTE risk, raising awareness of it happening, and clear instruction of when and where to get help if they have symptoms of it (http://apptg.org.uk/research/). In practice, there is evidence to suggest that VTE prophylaxis for palliative cancer patients, is futile and may be burdensome to them, however, the review team feels it is important that VTE risk assessments are done nonetheless (in any setting) and a discussion had with the patient and families to decide on prophylaxis. Recording that appropriate assessments and conversations have happened is also important.

TRUST ACTION:

We are establishing a Task & Finish Group, led by one of our Consultant Haematologists, to put procedures in the ensure that:

i) VTE risk assessments are completed for all cancer patients in hospital, on discharge and in community services, and ii) all cancer patients are being provided with appropriate information about VTE risk and prophylaxis

1.2.2. Community Patients (generally). There is no national VTE guidance for community patients, however the literature demonstrates that there are community services where VTE risk assessments being done for those patients who are inpatients (within Intermediate Care Facilities), attend day case surgery or are seen in a Minor Injuries Unit (https://www.evidence.nhs.uk/search?q=vte%20risk%20assessment). The Trust’s review team has assessed that there is a risk to future patients in the absence of local policy. TRUST ACTION:

i) The Task & Finish Group will develop a Community Standard Operating Procedure for VTE risk assessment and prophylaxis:
• for all patients admitted to Inpatient Intermediate Care Services (including beds in Care Homes)
• for all patients receiving Day Case interventions
• to check the VTE risk assessment on discharge from Hospital, or for those with trauma who have attended the Emergency Department of the Urgent Treatment Centre, for all patients known to Community Services on contact with them (and so aiding in compliance monitoring);

1.2.3. Care Home Residents. The Trusts review team has noted that around 9% of all hospital admissions for VTE are for patients who live in Care Homes. The APPT group has recommended VTE risk assessments for all Care Home residents, though has suggested more research is needed to be clear its of benefit (https://www.anticoagulationuk.org/admin/resources/downloads/prevention-and-management- of-vte-in-care-homes.pdf). TRUST ACTION:

The Trust will be liaising with Walsall Clinical Commissioning Group (CCG) to assess the need for procedures to be established in Walsall’s Care Homes.

We expect to complete all actions by 31 October 2020 and would be happy to provide you with confirmation at that time.

I hope you are satisfied that the Trust has taken the circumstances surrounding Mrs McKoy’s death seriously and that the action detailed above is acceptable.

Finally, may I take this opportunity to offer our unreserved apologies to the family of Mrs McKoy for distress caused to them along with our sincere condolences for their loss.