Official comment on the Report of the Joint Service Investigation into the Colonoscopy Serve at Shepton Mallet NHS Treatment Centre – 4th October 2005 to 31st March 2008
Background
On the 5th August 2008 436 GP’s local to the Shepton Mallet NHS Treatment Centre (“the Centre”) were contacted by the Centre advising them of the outcome of a formal review of colonoscopy examinations carried out by Dr Ben Mak between the 4th October 2005 and 31st March 2008. The GP’s were advised that there were concerns about the standard of the colonoscopies performed by Dr Mac and the GP’s were advised to contact their patients to explain the need to review and re-examination. The Treatment Centre also wrote to all patients who had undergone a colonoscopy performed by Dr Mac during the relevant period. 1828 patients were contacted.
The Review
Of the 1828 colonoscopy examinations reviewed, the independent review panel chaired by Judith Newman came to the conclusion that 1242 patients did not require a repeat colonoscopy or alternative procedure, 489 patients were advised to have continuing surveillance for existing conditions such as polyps and 97 were advised to have further examinations by the fast-track method.
The need for follow up on the majority of the 97 patients was due to the fact that the doctors on the review panel had come to the conclusion that the colonoscopy performed by Dr Mak did not give a complete review of the patient’s bowel and therefore, as a result of this incomplete view, bowel cancer or other serious conditions such as diverticulitis or Crohn’s disease could have been missed.
The patients were offered a choice of local hospitals for their review. Some had repeat colonoscopies and others had different examinations such as CT scans. Following the repeat examinations it was established that a further 6 patients who had received colonoscopies at the Centre had subsequently been diagnosed with bowel cancer and to date, three of those patients have died. We are aware of at least two other patients who are extremely unwell with their bowel cancer.
Shortcomings in procedures and patient care
The review panel found short-comings in the standards applied to recruit Dr Mak in the first place, to follow up his standard of practice and in reporting the results of the poor care. The shortcomings have been identified as follows:
- the recruitment process that the Centre used when recruiting Dr Mak was not adequate enough to check that he had sufficient recent up to date experience of colonoscopy procedures.
- although Dr Mak underwent yearly appraisals there was no clinical review of his competence
- The audit procedures which were in place audited the number of procedures undertaken, routine complications which can occur during the investigation and procedures where the scope was able to reach the “terminal ileum” i.e. the last part of the colon to be examined. However, these audit procedures were not capable of identifying the problems which did later occur
- Dr Mak was the subject of 13 complaints in 3 years. This was the highest number for any clinician at the trust
- a review of the colonoscopy procedures indicated that some patients could have had their bowel condition investigated by using a less invasive procedure such as a flexible sigmoidoscopy.
The team also identified two other factors which contributed to the poor result and these were:
- owing to the small size of the treatment centre there was no medical leadership appointed for endoscopy
- the concerns about Dr Mak’s performance were not identified or reported though the routine performance review or clinical governance processes.
Recommendations
The review has identified deficiencies in The Centre’s procedures for recruitment and monitoring of its medical staff and has made the following recommendations:
- the need for external review of the quality of the endoscopies carried out at the Centre
- the appointment of a lead doctor to supervise and lead the endoscopy clinic at the Centre
- establishing routine audit procedures which would look at the clinical competence of doctors carry out endoscopy procedures at the Centre
- ensure that the DVD’s take at the time of the colonoscopies are reviewed as part of the review procedure.
- to increase the use of other doctors to assess the competence of doctors being appointed to work at the centre
- to review the process for reporting Serious Untoward Incidents at the Centre. A number of procedures have been introduced to deal with this.
- to change the system for GP’s to refer patients into the centre, to revise the GP referral form and to change the system used to notify the GP of results
for the Lead Endoscopist to triage referrals received for colonoscopy
Our Conclusions
The review has been a thorough exercise and deficiencies have been identified in the whole endoscopy procedure adopted at the Centre, from referral, to the procedure itself, the procedure for reporting back to GPs and for monitoring the clinical performance of the doctor. As a result, three patients have died from bowel cancer, which may have been diagnosed by competent examination. Further patients have had their long term health significantly compromised by the lack of care and lack of monitoring and a number of medical negligence claims are pending.
This is a traumatic outcome for the families involved. It is catastrophic for a family to lose a loved one to cancer at any time but with the knowledge of the fact that their death may have been presentable the effect on the family is very marked.
