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Privacy statement - Terms and conditions

checklist for NHS Organisations when commissioning external reviews

5 August 2020

Consider taking legal advice on the Terms of Reference (ToR) to ensure that all parties comply with legal obligations and avoid the many potential pitfalls that can beset external reviews Where the ToR are defective or inadequate it can be difficult to put right once the review is underway, resulting in avoidable distress to patients and staff and extensive reputational damage. Key issues to be addressed in the ToR are:

Consider a Royal College Review. If not, research the External Reviewer carefully. Take references, look at previous reviews they have produced, obtain CVs and check their expertise is appropriate for the review.

Ensure you are assured that the External Reviewer is independent of the Trust and does not have a conflict of interest. Keep a written record of how/why the particular reviewer was chosen so you can demonstrate this later.

Options include a thematic review or an individual case/clinician/department review.

These may include regulators, commissioners, governors, NHS Resolution, Secretary of State for Health as well as individuals such as staff, patients and clinicians.

As a matter of law, the consent of patients (and clinicians) to use their information is not strictly required but that does not minimise the importance of patient engagement. Given the likely stress that could be caused by a review, it may be decided only to proceed with patient consent obtained at the outset.

Careful consideration should be given to how engagement will take place. There is a balance between securing patient buy in / transparency and not disclosing confidential information that could have an adverse impact on the welfare of individuals.

Where it is anticipated the External Reviewer will be contacting individual clinicians and/or other colleagues, write to them in advance, provide them with the ToR, explain what will be expected of them and give them an indication of timeframes and likely next steps.

Ensure robust security systems are in place for the External Reviewer to access data. Electronic access to records can be provided using secure icloud storage/data room.

Reviewers are unlikely to need to see all of a patient’s record e.g. they may only need to see the records from a defined period of time, treatment episode or department. Identifiable data should be kept to a minimum. Pseudonymised data (staff and patients) should be used where possible but this still represents the processing of personal data for the purposes of Data Protection legislation.

Remember that documents generated during the review may be disclosable to the Coroner or in any future compensation claim, and that it may be several years before you are asked to produce them. Ensure they can be easily found.

Do you want the review to be limited to a review of the medical records/papers or will the External Reviewer interview patients and staff or consider written statements from them? If there are to be interviews, be open with interviewees at the outset as to how the information they provide will be used and who it will be shared with, to avoid any allegations of breach of confidence later on. Also record and transcribe interviews, again avoids any dispute over the accuracy of statement produced.

Set a timescale that is realistic and achievable to address quality concerns and inform improvements quickly.

Plan from the start how the report will be shared internally and externally – what is the management plan for this? There may be two reports (one for publication, one not) or a publishable executive summary. If suboptimal care is found, how will this be shared with affected patients, staff and media? In high profile cases, a robust media and communications plan should be agreed with key stakeholders, including the regulators, to ensure consistent, transparent public messaging.

Any organisation or individual who is the subject of adverse comment in the report should be given the right to respond and produce evidence in reply before the report is finalised.

If the finding is that there has been sub-optimal care, how will that be managed? What is the Trust going to do about it and how will any systemic issues which arise be addressed? Will the final report pass through the Trust’s usual quality process for learning purposes?

Involve your Freedom to Speak Up Guardian. Consider inviting the whistleblower to contribute to the ToR so they cannot suggest later that they were not involved. Ensure the complainant receives adequate feedback (subject to confidentiality obligations).

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The content on this page is provided for the purposes of general interest and information. It contains only brief summaries of aspects of the subject matter and does not provide comprehensive statements of the law. It does not constitute legal advice and does not provide a substitute for it.

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