Wexford General says it ‘deeply regrets this incident’
KEN MEALY, Wexford General Hospital’s Consultant Surgeon and Clinical Lead, said the hospital ‘deeply regrets this incident’.
‘Since notification of the first cancer case, our priority at all times has been to conduct a thorough and immediate review,’ he said in a statement.
‘Our first action was to identify, recall and treat all patients who may have been affected. We have worked with BowelScreen to strengthen governance procedures around this incident and shared our learnings, with a view to ensuring that this never happens again.’
A summary of the HSE review of the screening errors says in that October 2014, Wexford General Hospital identified two cancer cases in patients who had recently undergone a colonoscopy, but were not diagnosed at that time, and immediately began working with BowelScreen to conduct a thorough and immediate review of colonoscopies under the care of an individual consultant at WGH. He is not identified, and is referred to as Clinician Y throughout the report.
Following a review of both cases, a Safety Incident Management Team (SIMT) drawn from BowelScreen, Wexford General, patient focus representatives, the Ireland East Hospital Group (IEHG) and clinical expertise was established, in line with the HSE’s lookback policy.
All colonoscopy patients under the care of an individual consultant at WGH between March 2013 and November 2014 and their GPs were written to and received a follow-up phone call from liaison staff working within either WGH or BowelScreen. A total of 615 patients were recalled, 401 of whom, following review, were deemed necessary to have a repeat colonoscopy. Over three quarters of recalled patients attended a colonoscopy within a month of being contacted. This process was completed using the clinical pathways within the IEHG, with follow-up colonoscopies carried out at St Vincent’s Hospital in Dublin, the Mater Hospital in Dublin, and Wexford General. In total, 13 cancers were detected, including the two cases that prompted the recall and the case of a deceased gentleman who died before the lookback started. The clinical subgroup of the SIMT for this lookback has categorised all cancers detected as ‘probable missed’. The consultant whose work this review concerns has been on leave since 2015.
Wexford General also began an immediate process of open disclosure with the patients and families concerned and has apologised on behalf of the hospital for any failings in the services provided to them. A copy of the report of this review has been provided to those families and patients.
Assurance measures are in place to ensure all colonoscopy services delivered on behalf of BowelScreen at both Wexford General and all other units are of the highest standards possible.
This process is now complete. The review contains important findings and recommendations which are being implemented.
The HSE is assured that services are operating to a high standard, but given the gravity and scale of this incident, the HSE is commissioning an external expert to review the Quality Assurance measures put in place and the overall management of the incident. Terms of reference for this next process have been agreed and an expert has been identified. This reflective process as the incident concludes is in line with best practice.
The report reveals that the BowelScreen programme was informed on October 8, 2014, of a recently diagnosed case of caecal cancer, who had undergone a screening colonoscopy in April 2013 at Wexford General. The notification was made by the Consultant Surgeon, not attached to Wexford General, who had performed the cancer surgery. In accordance with the MOU between Wexford General and BowelScreen, Wexford General was informed of the case and asked to undertake an immediate case review.
A second case of caecal cancer in a
patient screened in June 2013 was notified by the BowelScreen Clinical Lead at Wexford General to management there on October 22, 2014.
The Wexford General BowelScreen Clinical Lead also informed the BowelScreen programme at that time. He performed cancer surgery on that patient in October 2014. BowelScreen then asked Wexford General to undertake a second case review.
Both patients had been screened by the same endoscopist (Clinician Y). Clinician Y’s adenoma detection rate was 26.56 per cent; this was within the BowelScreen quality assurance (QA) standard of 25 to 35 per cent. Agreement was reached between Wexford General, BowelScreen and Clinician Y on November 13, 2014, that Clinician Y would cease performing BowelScreen colonoscopies until the reviews of the cases were undertaken and completed.
Clinical governance arrangements were put in place by Wexford General, and Clinician Y continued to perform colonoscopy on symptomatic patients under supervision.
In agreement with BowelScreen, the BowelScreen Clinical Lead at Wexford General also reviewed all BowelScreen colonoscopy reports since the programme commenced. This was completed in December 2014 and revealed the absence of evidence in photographs that the caecum was reached in approximately 30 per cent of Clinician Y’s screening colonoscopies. The colonoscopy records of the two cancer cases that prompted the review did not contain a photograph of the caecum either. No issues were detected with the work of other endoscopists at Wexford General. BowelScreen was informed of these findings on December 16 2014. A validation audit of the same records was completed by the BowelScreen Clinical Director on January 7 and 8, 2015, and the findings were consistent.
Clinician Y does not accept these findings and has reported a caecal intubation rate of 91%, from data gathered at Wexford General in 2013.
The SIMT does not accept this rate because when the BowelScreen colonoscopies were reviewed following the notification of two cancers, the caecal intubation rate for Clinician Y’s BowelScreen colonoscopies was calculated to be 71 per cent.
Two independent reviewers arrived at this rate, on the basis that that either photos were not taken, or were not adequate in 118 patients’ records.
A section headed ‘Adverse Events’ says that in the management of the incident, 13 cancers were detected in a population of 384 patients who had their first screening colonoscopy performed by Clinician Y during the period March 5, 2013, to November 7, 2014, two cases prompted the recall, four cases were identified in phase 1, two cases presented independently during phase 1, four cases were identified in phase 2 and one case was identified at a planned surveillance colonoscopy of a high risk patient. The clinical sub-group categorised all of these 13 as presumed missed cancers