PFD report

Collin Gary GRIFFITHS · Prevention of Future Deaths report

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Issued 4 Sep 2018•Inner North London

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.

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Concerns
2

Raised in this report

Recipients
1

Named on the report

Responses found
2

Of 1 recipient

Stated actions
15

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 auditing of the accuracy of nurses' medical records
    Part of recurring concern: Failure to assure the quality of clinical and care recordsPart of recurring concern: Failure to reliably review clinical records for safety deficiencies
  2. Failure to record medical conditions through a method independent of verbal communication
    Part of recurring concern: Unreliable recording of patients' clinically relevant medical history
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.5

  1. Action

    Provide clinics with a laminated copy of the medical questions for patients to review with nurses during risk assessments.

    Stated by Masta LimitedStated in progressThe respondent said that this action was in progress when they made their response on 18 January 2019.
  2. Action

    Conduct rotating face-to-face clinic audits, investigate concerns through action plans and re-audits, and maintain scheduled rolling coverage.

    Stated by Masta LimitedStated in progressThe respondent said that this action was in progress when they made their response on 18 January 2019.
  3. Action

    Produce and finalize a pre-consultation medical-question fact sheet explaining the questions and their importance.

    Stated by Masta LimitedStated in progressThe respondent said that this action was in progress when they made their response on 18 January 2019.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    A patient-completed tick-box questionnaire is considered less effective because last-minute attendance and context-free questions may cause errors.

    Stated by Masta LimitedDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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 auditing of the accuracy of nurses' medical records

Wider context from the report

“2. MASTA currently has no way of auditing whether the record a nurse makes is accurate. This could be assessed by questioning patients as they leave, or by sending in a patient specifically to test this anonymously. ”

Is this part of a recurring concern?

Yes — Failure to assure the quality of clinical and care records; Failure to reliably review clinical records for safety deficiencies.

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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 record medical conditions through a method independent of verbal communication

Wider context from the report

“1. The recording of medical conditions was entirely dependent on the verbal communication, which in this instance was sub optimal. Would there be anything to stop MASTA handing out a tick box questionnaire (similar to the ones for blood donors) for patients to fill in while they are waiting to be seen? There seems to be a need for an added layer of security, rather than just relying on patients listening to a long list of conditions being read out. ”

Is this part of a recurring concern?

Yes — Unreliable recording of patients' clinically relevant medical history.

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

Provide clinics with a laminated copy of the medical questions for patients to review with nurses during risk assessments.

Verbatim wording from the response

“• The clinics will be provided with the new medical questions in a laminated document to be given to travelers to read through with the nurse, as they go through their individual risk assessment, preventing any misunderstanding - please see enclosed document 4. The draft has been sent to the marketing team to format on the 26th October 2018”

Source location

2018-Response-by-Masta
Page 4 · response
Published 18 January 2019

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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

Conduct rotating face-to-face clinic audits, investigate concerns through action plans and re-audits, and maintain scheduled rolling coverage.

Verbatim wording from the response

“• Face to face audits have been carried out at selected clinics in October and this will be alternated monthly going forwards to ensure that all clinics are covered; then this will be reviewed and any clinics of concern will be issued with an action plan and re-audited; this will work on a rolling basis. Previously this had been a bespoke audit, but has now been written to ensure consistency, in re-audit. Re-audits of 3 clinics have been scheduled during November 2018.”

Source location

2018-Response-by-Masta
Page 4 · response
Published 18 January 2019

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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

Produce and finalize a pre-consultation medical-question fact sheet explaining the questions and their importance.

Verbatim wording from the response

“• We have written a fact sheet detailing all the medical questions that a traveler will be asked during the consultation and the reasons why the questions are important. This fact sheet will be emailed out to travelers before their consultation, along with the Travel Health Brief - please see enclosed document 3. This factsheet is currently going through final review stage before going live.”

Source location

2018-Response-by-Masta
Page 4 · response
Published 18 January 2019

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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

Test digital pads for storing patients’ signed confirmation that medical questions were understood and answered accurately.

Verbatim wording from the response

“• We are currently testing digital pads to obtain a written signature that can be stored in our bespoke medical records system. The intention is that this would be signed by the client once all the medical questions have been covered as a declaration that they have understood the questions asked and that they have read from the laminated question document.”

Source location

2018-Response-by-Masta
Page 3 · response
Published 18 January 2019

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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

Implement a standardized nurse audit covering completion and documentation of the medical risk-assessment process.

Verbatim wording from the response

“• We have written an audit for the nurses, to ensure that the assessments are being completed in full, looking at how the risk assessment is conducted, but more specifically looking to ensure the following actions are taken;”

Source location

2018-Response-by-Masta
Page 4 · response
Published 18 January 2019

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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

A patient-completed tick-box questionnaire is considered less effective because last-minute attendance and context-free questions may cause errors.

Verbatim wording from the response

“We acknowledge that the coroner has suggested each patient complete a tick box questionnaire whilst waiting for their consultation. We do not feel this would be as effective as all the improvements detailed above. From experience patients turn up last minute for their appointments and would not therefore have the required time to digest and complete the medical questions. There is also the risk that questions without the context and ability to ask questions of a medical professional could lead to errors.”

Source location

2018-Response-by-Masta
Page 3 · response
Published 18 January 2019

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Other statements in published responses

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

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.10

  1. 1

    Hold a shared-learning event for lead nurses following the incident.

    Stated by Masta LimitedStated completedThe respondent said that this action was complete when they made their response on 18 January 2019.
  2. 2

    Add a direct NaTHNaC Yellow Fever information link to the Travel Health Brief.

    Stated by Masta LimitedStated completedThe respondent said that this action was complete when they made their response on 18 January 2019.
  3. 3

    Deliver a mandatory thymus-gland training module to nurses conducting risk assessments and providing related medical advice.

    Stated by Masta LimitedStated completedThe respondent said that this action was complete when they made their response on 18 January 2019.
  4. 4

    Expand Yellow Fever vaccine side-effect information in the traveller vaccination record booklet.

    Stated by Masta LimitedStated completedThe respondent said that this action was complete when they made their response on 18 January 2019.
  5. 5

    Complete and deploy further improvements to the revised medical questions after staging-site testing.

    Stated by Masta LimitedStated in progressThe respondent said that this action was in progress when they made their response on 18 January 2019.
  6. 6

    Highlight Yellow Fever contraindications at the beginning of the Stamaril Patient Group Directive and reissue it to nurses.

    Stated by Masta LimitedStated completedThe respondent said that this action was complete when they made their response on 18 January 2019.
  7. 7

    Revise medical risk-assessment questions to identify thymus-gland conditions through separate, explicit questions.

    Stated by Masta LimitedStated completedThe respondent said that this action was complete when they made their response on 18 January 2019.
  8. 8

    Include information in patient information leaflets explaining how to report possible medicine side effects to the MHRA.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 18 January 2019.
  9. 9

    Issue a Drug Safety Update reminder about avoiding live attenuated vaccines in clinically immunosuppressed patients.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 18 January 2019.
  10. 10

    Issue a Drug Safety Update reminder about the risks of live vaccines, including yellow fever vaccine, in immunocompromised patients.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 18 January 2019.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    Existing statutory SmPC and PIL contraindications and warnings are considered adequate to minimise yellow fever vaccine risks for people with thymus dysfunction.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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

Hold a shared-learning event for lead nurses following the incident.

Verbatim wording from the response

“5. A shared learning event on the back of the incident has taken place with the lead MASTA nurses across the country. This took place at the lead nurse meeting on the 11th July 2018. They were asked to cascade this learning to their broader clinical teams by the 31st October 2018.”

Source location

2018-Response-by-Masta
Page 2 · response
Published 18 January 2019

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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

Add a direct NaTHNaC Yellow Fever information link to the Travel Health Brief.

Verbatim wording from the response

“2. A link to the NaTHNaC site for Yellow Fever was put on the MASTA Travel Health Brief. The link goes directly onto the Yellow Fever information for travellers page, which discusses areas of concerns, when they should have the vaccination, and who cannot have the vaccination. This change happened on the 6th April 2018.”

Source location

2018-Response-by-Masta
Page 2 · response
Published 18 January 2019

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

Deliver a mandatory thymus-gland training module to nurses conducting risk assessments and providing related medical advice.

Verbatim wording from the response

“4. A mandatory thymus training module on the function of the gland, disease and disorder and when and why it would be removed has been developed and completed by all MASTA nurses who carry out all the risk assessments and provide medical advice to other Health Care Professionals within the MASTA network. This was issued on the 27th July 2018.”

Source location

2018-Response-by-Masta
Page 2 · response
Published 18 January 2019

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

Expand Yellow Fever vaccine side-effect information in the traveller vaccination record booklet.

Verbatim wording from the response

“3. The traveler’s vaccination record booklet has had the Yellow Fever side effects expanded upon on the 17th August 2018.”

Source location

2018-Response-by-Masta
Page 2 · response
Published 18 January 2019

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

Complete and deploy further improvements to the revised medical questions after staging-site testing.

Verbatim wording from the response

“As a company we treat any incident seriously and have acted swiftly to re-evaluate our policies, procedures and systems to ensure we are providing the best possible care to our patients. Set out below is our response to those specific concerns identified by Coroner ME Hassell (detailed above) in”

Source location

2018-Response-by-Masta
Page 1 · response
Published 18 January 2019

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

Highlight Yellow Fever contraindications at the beginning of the Stamaril Patient Group Directive and reissue it to nurses.

Verbatim wording from the response

“6. The contraindications to the Yellow Fever vaccine were highlighted and moved to the top of the Patient Group Directive for Stamaril (the yellow fever vaccination product name) and reissued to all MASTA nurses. This happened on the 6th April 2018.”

Source location

2018-Response-by-Masta
Page 2 · response
Published 18 January 2019

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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

Revise medical risk-assessment questions to identify thymus-gland conditions through separate, explicit questions.

Verbatim wording from the response

“1. Medical questions were reviewed, and the thymus question, which at the time of the incident read; “Do you have any current medical conditions” with the pop up prompts for the nurse highlighting that the thymus gland was a contra- indication and should be further explored.”

Source location

2018-Response-by-Masta
Page 2 · response
Published 18 January 2019

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

Include information in patient information leaflets explaining how to report possible medicine side effects to the MHRA.

Verbatim wording from the response

“On review of this information, and in relation to actions within the remit of the MHRA, we are satisfied that the statutory SmPC and PIL for yellow fever vaccine provides relevant contraindications and warnings to minimise the risk of use in those with a history of thymus dysfunction. The general view of the MHRA (in relation to all vaccines and medicines) is that PILs should be provided to patients, parents or vaccinees when a vaccine or medicine is given, and that provision of the PIL would also be valuable as part of the informed consent process and discussions with patients about the benefits and risks of their vaccines and medicines. All PILs now also carry information on how to report possible side effects to the MHRA, and patients, parents or vaccinees should be made aware of this mechanism.”

Source location

2018-0295-Response-by-MHRA
Page 2 · response
Published 18 January 2019

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

Issue a Drug Safety Update reminder about avoiding live attenuated vaccines in clinically immunosuppressed patients.

Verbatim wording from the response

“As you are aware, yellow fever vaccine is a live vaccine, containing a small amount of attenuated (weakened) virus which mimics a natural infection. Live attenuated vaccines should not be given to people who are clinically immunosuppressed due to the risks of over-replication of vaccine virus. You may wish to be aware that, following other recent reports of fatal events in immunocompromised patients who inadvertently received live shingles vaccine, the MHRA issued a reminder of this general risk of live vaccines to healthcare professionals via its Drug Safety Update (DSU) bulletin in April 2016: https://www.gov.uk/drug-safety-update/live-attenuated-vaccines-avoid-use-in-those-who-are-clinically-immunosuppressed.”

Source location

2018-0295-Response-by-MHRA
Page 3 · response
Published 18 January 2019

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

Issue a Drug Safety Update reminder about the risks of live vaccines, including yellow fever vaccine, in immunocompromised patients.

Verbatim wording from the response

“As there have now been three fatal cases reported to us we intend to issue a further reminder about the risks of live vaccines in immunocompromised patients, including Yellow Fever vaccine in Drug Safety Update.”

Source location

2018-0295-Response-by-MHRA
Page 3 · response
Published 18 January 2019

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

Existing statutory SmPC and PIL contraindications and warnings are considered adequate to minimise yellow fever vaccine risks for people with thymus dysfunction.

Verbatim wording from the response

“On review of this information, and in relation to actions within the remit of the MHRA, we are satisfied that the statutory SmPC and PIL for yellow fever vaccine provides relevant contraindications and warnings to minimise the risk of use in those with a history of thymus dysfunction. The general view of the MHRA (in relation to all vaccines and medicines) is that PILs should be provided to patients, parents or vaccinees when a vaccine or medicine is given, and that provision of the PIL would also be valuable as part of the informed consent process and discussions with patients about the benefits and risks of their vaccines and medicines. All PILs now also carry information on how to report possible side effects to the MHRA, and patients, parents or vaccinees should be made aware of this mechanism.”

Source location

2018-0295-Response-by-MHRA
Page 2 · response
Published 18 January 2019

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