PFD report

Anne BRADLEY · Prevention of Future Deaths report

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Issued 20 Jun 2021•West Sussex

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
2

Raised in this report

Recipients
5

Named on the report

Responses found
4

Of 5 recipients

Stated actions
3

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised2

  1. Lack of a formal system for surgeons to provide endoscopists with information about tumour localisation errors and tattooing problems
  2. Failure to require or recommend equipment that increases tumour localisation accuracy in routine colonoscopies
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. Action

    Put a Local Safety Standard for Invasive Procedures document in place to support the standardised tattooing process.

    Stated by University Hospitals Sussex NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 28 June 2021.
  2. Action

    Extend use of scope guides across all Trust sites.

    Stated by University Hospitals Sussex NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 28 June 2021.
  3. Action

    Operate a system documenting, monitoring and feeding back tattooing information, using a dedicated theatre-care-plan sticker and incident-report escalation.

    Stated by University Hospitals Sussex NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 28 June 2021.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.8

  1. Position

    Specific colonoscopy equipment, techniques and training fall outside the remit of clinical guidelines.

    Stated by National Institute for Health and Care ExcellenceOutside remitThe respondent said that this matter was outside its role or authority.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of a formal system for surgeons to provide endoscopists with information about tumour localisation errors and tattooing problems

Wider context from the report

“(2) Feedback to endoscopists at St Richards Hospital I heard evidence that at St Richards Hospital surgeons do not necessarily feedback information regarding tattooing problems or incorrect localisation of tumours to endoscopists. The concern that I therefore have is that there is no formal system at St Richards Hospital which requires surgeons to provide information about the incorrect localisation of tumours or tattooing problems which is then shared with endoscopists. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to require or recommend equipment that increases tumour localisation accuracy in routine colonoscopies

Wider context from the report

“(1) Use of scope guides/scope pilots The colonoscopy was carried out without the use of a scope guide or scope pilot as none were available in the room used for Anne Bradley’s procedure. A scope guide or scope pilot is an additional piece of equipment which assists the endoscopist in carrying out a colonoscopy. I heard evidence from the endoscopist and 3 consultant colorectal surgeons who all agreed that the use of scope guides or scope pilots assist in accurately recording the location of a tumour. The accuracy of this information is important in assisting the surgeons to locate the tumour especially during laparoscopic (keyhole) surgery with early stage tumours. I heard evidence that there are limited markers within the colon to assist the endoscopist to know the location and that tattoos used to mark the location of a tumour can, and in this case did, pierce through the colon and mark multiple areas. Whilst St Richards Hospital explained that they have now equipped all rooms with scope guides or scope pilots I heard that use of such equipment is not required by quality assurance organisations. The concern I have is that equipment which increases the accuracy of the localisation of a tumour is not required or recommended for use in routine colonoscopies. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Put a Local Safety Standard for Invasive Procedures document in place to support the standardised tattooing process.

Verbatim wording from the response

“We are pleased to confirm that the Trust has instigated a robust system to ensure information in relation to tattooing is documented, monitored and, where appropriate, fed back to endoscopists. The system involves the introduction of a dedicated sticker into the colorectal theatre care plan for the operating surgeon to confirm the tumour was correctly identified by the tattoo. A negative answer will trigger completion of a Ditex incident report. A Local Safety Standard for Invasive Procedures (LocSSIP) document will be put in place which supports and describes the standardised process. All incident reports will continue to be subject to regular monitoring by the Surgical and Medical Divisional governance processes.”

Source location

2021-0214-Response-from-St-Richards-Hospital_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Extend use of scope guides across all Trust sites.

Verbatim wording from the response

“Scope guides are already in place on the St Richard’s site with a move to using scope guides across all sites. We are pleased to note that the Regulation 28 report was also addressed to four national bodies who will be best placed to consider your concerns and to implement guidance and recommendations at a national level as currently scope guides are only available from certain manufacturers.”

Source location

2021-0214-Response-from-St-Richards-Hospital_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Operate a system documenting, monitoring and feeding back tattooing information, using a dedicated theatre-care-plan sticker and incident-report escalation.

Verbatim wording from the response

“We are pleased to confirm that the Trust has instigated a robust system to ensure information in relation to tattooing is documented, monitored and, where appropriate, fed back to endoscopists. The system involves the introduction of a dedicated sticker into the colorectal theatre care plan for the operating surgeon to confirm the tumour was correctly identified by the tattoo. A negative answer will trigger completion of a Ditex incident report. A Local Safety Standard for Invasive Procedures (LocSSIP) document will be put in place which supports and describes the standardised process. All incident reports will continue to be subject to regular monitoring by the Surgical and Medical Divisional governance processes.”

Source location

2021-0214-Response-from-St-Richards-Hospital_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Specific colonoscopy equipment, techniques and training fall outside the remit of clinical guidelines.

Verbatim wording from the response

“While we have guidelines covering recognition and referral for suspected cancer [NG12], and the management of colorectal cancer [NG151], we have not made recommendations on colonoscopy. Guidance on specific equipment, techniques, and training are outside the remit of our clinical guidelines and it would be more appropriate for the professional societies, to whom I note you have also sent your report, to comment on this.”

Source location

2021-0214-Response-from-NICE-_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Professional societies are considered the appropriate bodies to comment on colonoscopy equipment, techniques and training.

Verbatim wording from the response

“While we have guidelines covering recognition and referral for suspected cancer [NG12], and the management of colorectal cancer [NG151], we have not made recommendations on colonoscopy. Guidance on specific equipment, techniques, and training are outside the remit of our clinical guidelines and it would be more appropriate for the professional societies, to whom I note you have also sent your report, to comment on this.”

Source location

2021-0214-Response-from-NICE-_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

National bodies are best placed to consider concerns and implement guidance on scope guides, which are available only from certain manufacturers.

Verbatim wording from the response

“Scope guides are already in place on the St Richard’s site with a move to using scope guides across all sites. We are pleased to note that the Regulation 28 report was also addressed to four national bodies who will be best placed to consider your concerns and to implement guidance and recommendations at a national level as currently scope guides are only available from certain manufacturers.”

Source location

2021-0214-Response-from-St-Richards-Hospital_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

MEI does not precisely localise tumours, so mandatory use would overstate its utility for precise lesion localisation.

Verbatim wording from the response

“4. An MEI, does not provide precise localisation of a tumor as appears to have been suggested. MEIs can certainly help to negotiate a difficult colon, they can demonstrate if loops are formed in the scope and whether they have been removed, and for these reasons, MEIs are invaluable in training and also improve comfort for the patient. In the case of bowel cancer screening, where patients are voluntary and asymptomatic, MEIs have been extensively used to ensure the maximum success rate in visualising the whole colon. Their use in bowel cancer screening, however, was not primarily to provide a precise localisation of polyps or tumors which is why tattoos are extensively applied.”

Source location

2021-0214-Response-from-British-Society-of-Gastroenterology_Published
Page 2 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Mandatory MEI use would create substantial manufacturer-compatibility and cost constraints without a clear benefit in every case.

Verbatim wording from the response

“9. MEIs are manufacturer specific, so the “Scope Guide” will only work with Olympus scopes and “Scope Pilot” with Pentax scopes. Many units use Fujinon scopes, and whilst there was a similar system available in the past I am not aware at present whether it is still marketed. Mandating the statutory use of MEI effectively sanctions compulsory purchase without any competition, and might preclude a number of other commercial companies that manufacture scopes. The cost of an MEI is very significant, and therefore a mandatory obligation that they should be used in all cases could run into a cost of millions of pounds without there being a clear benefit in all cases.”

Source location

2021-0214-Response-from-British-Society-of-Gastroenterology_Published
Page 3 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Published evidence-based guidelines do not support compulsory MEI use in all colonoscopies.

Verbatim wording from the response

“6. A paper by ████████ et al. Colonic tumour localization using an endoscope positioning device. Eur J Gastroenterol Hepatol 2011;23:488-9, did suggest that MEI can improve accuracy of location to the correct segment of bowel, but as far as we are aware compulsory use of MEI in all colonoscopy is not recommended by any published evidence based guidelines because as many other factors, as we have indicated, can have a bearing on tumour localisation in an individual case.”

Source location

2021-0214-Response-from-British-Society-of-Gastroenterology_Published
Page 2 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Magnetic imaging should not be mandated because it is unavailable for some systems, unsuitable for some patients, and unnecessary to complete colonoscopy.

Verbatim wording from the response

“Further comment on the use of magnetic imaging is that it is not appropriate to mandate this equipment as it is not available for all video endoscope systems, it cannot be used on all patients and is not necessary for completion of colonoscopy. It does support training and also supports regular practice. Many services use it to support patient comfort. It therefore is a highly desirable piece of equipment. JAG accreditation ensures high quality endoscopy services and measures against quality”

Source location

2021-0214-Response-from-Royal-College-of-Physicians_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The absence of magnetic imaging was only a small contributory factor and should not be treated as the single rectifiable cause of death.

Verbatim wording from the response

“Summary of response Having reviewed the detail, I would point out the multiple factors contributed to the sad demise of Mrs Bradley, including the importance of agreed protocols for tattoo placement and the responsibility of the surgeon to identify the location of the tumour per-operatively. The quality of pre-operative assessment and post-operative care should also be stressed. Placing credence on the lack of availability of a magnetic imaging device as the single rectifiable contributor to her death would be ill advised and not justifiable.”

Source location

2021-0214-Response-from-Royal-College-of-Physicians_Published
Page 1 · response
Published 28 June 2021

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.4

  1. 1

    Attributing the postoperative death solely to lack of MEI, or implying MEI would have prevented it, is unwarranted.

    Stated by British Society Of GastroenterologyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
  2. 2

    The operating surgeon remains responsible for identifying the correct bowel section, confirming the tattoo and ensuring adequate resection margins.

    Stated by British Society Of GastroenterologyRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
  3. 3

    Correct tattooing is considered the key available method for tumour localisation, rather than MEI.

    Stated by British Society Of GastroenterologyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
  4. 4

    The implication that accidental tattooing of another bowel section is common is incorrect.

    Stated by British Society Of GastroenterologyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Attributing the postoperative death solely to lack of MEI, or implying MEI would have prevented it, is unwarranted.

Verbatim wording from the response

“1. Ultimately it is always the responsibility of the surgeon carrying out an operation to identify and remove the correct section of bowel. Distances described at colonoscopy are always potentially subject to significant error, dependent on the amount of colonoscope inserted. The instrument can “loop” and as the colon itself is elastic, so measurements can vary immensely. It is not unusual to examine a resection specimen and then make a further resection. Anne Bradley's death from post-operative complications mainly reflects the quality of her postoperative care, and to imply that it relates solely to the lack of an MEI is unwarranted.”

Source location

2021-0214-Response-from-British-Society-of-Gastroenterology_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The operating surgeon remains responsible for identifying the correct bowel section, confirming the tattoo and ensuring adequate resection margins.

Verbatim wording from the response

“1. Ultimately it is always the responsibility of the surgeon carrying out an operation to identify and remove the correct section of bowel. Distances described at colonoscopy are always potentially subject to significant error, dependent on the amount of colonoscope inserted. The instrument can “loop” and as the colon itself is elastic, so measurements can vary immensely. It is not unusual to examine a resection specimen and then make a further resection. Anne Bradley's death from post-operative complications mainly reflects the quality of her postoperative care, and to imply that it relates solely to the lack of an MEI is unwarranted.”

Source location

2021-0214-Response-from-British-Society-of-Gastroenterology_Published
Page 1 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Correct tattooing is considered the key available method for tumour localisation, rather than MEI.

Verbatim wording from the response

“An MEI would probably have distinguished between the sigmoid colon and the transverse colon, but an MEI would not be able to precisely localise the position of a tumour within, for example, the sigmoid colon itself. For this reason, the position of any lesion on an MEI should always be regarded as approximate. This is why correct tattooing, rather than MEI, is the key method to localise a tumour.”

Source location

2021-0214-Response-from-British-Society-of-Gastroenterology_Published
Page 2 · response
Published 28 June 2021

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The implication that accidental tattooing of another bowel section is common is incorrect.

Verbatim wording from the response

“3. The implication that the unintentional tattooing of another section of colon is common, is not correct. The published evidence on the frequency of accidental injection of another section of the bowel should be reviewed. It is well accepted, however, that the position of a tattoo is only an approximate indicator of a polyp or tumor. Tattoos are often placed on the distal side of a tumor. The ink often spreads”

Source location

2021-0214-Response-from-British-Society-of-Gastroenterology_Published
Page 1 · response
Published 28 June 2021

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026