Transvaginal Mesh Case Record Review

Chapter 4 - The Case Record Retrieval Process

Introduction

4.1 Once the documents were drafted and meetings had started to take place as described in Chapters 2 and 3, we were ready to progress to the next stage and to start requesting and retrieving case records. This chapter describes to whom these requests were made, the challenges that we encountered, and the steps we took in an effort to resolve and overcome them. Unsurprisingly, the most significant requests for records in terms of volume went to the Health Boards in Scotland followed by Scottish general practices. We were also required, for a small number of cases, to request records from English Trusts and from overseas. Some retrieval requests involved us asking the participants themselves for copies of their case records. We shall consider each of these groups in turn.

Engagement with Scottish Regional Health Boards

4.2 There are fourteen regional National Health Service (NHS) Boards that report to the Scottish Government and who have the responsibility for the delivery of frontline healthcare services in Scotland.^[87] Where we directed our requests was based on a combination of where the participants resided (or had previously resided) and location(s) of where the treatments occurred. These factors required us to approach nine regional Health Boards.^[88] These were:

• NHS Ayrshire and Arran;
• NHS Borders;
• NHS Fife;
• NHS Forth Valley;
• NHS Greater Glasgow and Clyde;
• NHS Highland;
• NHS Lothian;
• NHS Lanarkshire;
• NHS Tayside.

Data sharing agreements-

4.3 Four months after the launch of the Review, in late June 2021, we were advised by the Scottish Government that Clinco would be unable to request any records from Health Boards until a separate ‘Data Sharing Agreement’ was put in place between the Scottish Government and each of the nine Health Boards involved. From the Panel’s perspective this was unexpected and unnecessary.

4.4 The Scottish Government agreed that whilst such Data Sharing Agreements were not legally required, it was felt that they served to document the transfer of information between two data controllers (in this case, the Scottish Government and the Health Boards). The suggestion was that the Agreement allowed the parties involved to have a shared understanding and expectation of the use of the data by the other, as well as helping both parties comply with accountability principles detailed in the UK General Data Protection Regulations (UKGDPR). Since the Scottish Government was the data controller and regarded the implementation of data sharing agreements as best practice, they required these to be put in place.

4.5 The Panel remain unconvinced for the need of such an additional agreement between the Scottish Government and Health Boards. Patients are legally entitled to request their health care records and they are not required to provide a reason for their request.^[89] It is their choice whether they choose to share any such information and with whom. This can be for any purpose without any validation from any official body. To enable the participants’ choice, we had already designed rigorous consent mechanisms and both the Panel and Clinco remain of the view that that these sufficed to satisfy the necessary legal and ethical requirements to request and obtain records on the participants behalf.^[90]

4.6 It was the middle of August 2021^[91] before Clinco had the necessary consent processes established with the first two participants, so up until that point, waiting for the additional Data Sharing Agreements to be signed off had no detrimental impact on our timescales. However, as the months progressed, this was no longer the case as the numbers of participants ready to move to the retrieval stage, grew.^[92]

4.7 It took nearly five months - from July 7 2021 until October 27 2021- to have the Data Sharing Agreements signed by all nine Health Boards. The signs-offs occurred on an incremental basis,^[93] so to expedite matters, as soon as we had intimation from the Scottish Government^[94] that each sign-off was complete, we proceeded to request case records.

4.8 Whilst this may have been something that was unforeseen, the Panel were frustrated at the delay in obtaining additional sign off from the nine Health Boards. In hindsight, this could have all been put in place with all 14 Health Boards, as soon as Clinco was engaged in March 2021 so that once it became apparent which Health Boards we needed to approach to request retrieval of case records, the agreements would have already been in place. We are of the view that such if such agreements are to be put in place in any future work, that this should be done with all Health Boards, prior to the commencement of any larger case review.

4.9 We recommend that if deemed necessary by the Scottish Government, any bespoke Data Sharing Agreements should be put in place with the remaining Boards prior to the commencement of any larger case review.

4.10 The Panel agreed that our main concern was to expedite and progress the Review. To enable this, once Clinco had received the consent forms from the participants, they then requested case records from all agencies other than the Scottish regional Health Boards ^[95] since no similar agreements were required for them. This included general practices in Scotland, Trusts in England, and overseas healthcare providers.

Accountable Officers

4.11 The Panel were advised prior to the commencement of the Review, that our primary contact from each Health Board would be the relevant Accountable Officer. They would be the named person that we would approach to assist with the retrieval of case records.

4.12 Prior to its launch in February 2021, the commissioning of the Review, and its purpose, appears to have been shared with those identified as Accountable Officers. This can be evidenced by the minutes of the meetings of the Scottish Government Transvaginal Mesh Short Life Working Group.^{[96] [97]} On December 4 2020, and February 26 2021(5 days after the Review was launched), an extract from their minutes confirmed that:

“there will be an expectation that Accountable Officers assist with finding evidence and they will be contacted regarding this.”^[98]

“The Case Record Review has been discussed regularly at these meetings [and], there is an expectation that the Accountable Officers will assist in locating and providing the records for review. In discussion, it was noted that the provision of the medical records (as long as there is a signed mandate) should not be an issue for Boards.”^[99]

4.13 Given the above extracts from the minutes, on at least two occasions, the Accountable Officers had discussed the Review and their role within it.^[100] Despite the fact that we were given the names of Accountable Officers to contact, there remained confusion, which on occasion continued for several months, as to who the point of contact should be. At one point we had four live contacts for one Board, whilst others seemed to have no awareness of the Review, or their requirement for involvement with it;

“Can you please clarify what you want me to do? It will be useful to send me a hard copy with your request”

“There is not a specific person assigned to this task.”

4.14 We therefore had no option but to request that the Scottish Government intervened, and identify to whom we should be directing our requests. They assumed the responsibility for resolving this matter^[101] and by the end of November 2021, there was a significant increase in engagement. However, it did not resolve the matter of engagement from the Boards completely, and we requested further support from the Scottish Government to secure all Health Boards’ engagement. On the January 27 2022, the Director General for NHS Scotland sent out a letter to all Health Board Chief Executives encouraging them to engage with the Review. Some six months after this, Clinco received an email on July 27 2022, which noted that a Health Board’s Executive Medical Director was unaware that the Review was taking place. Resolving these matters were time-consuming for all parties concerned.

4.15 Once the named contacts were established, the process continued to be protracted as often, a single request for records did not always get acknowledged and so multiple follow-up requests had to be made to try and elicit a response. Despite these multiple requests, on further occasions, we had to ask the Scottish Government to intervene to help expedite our request for case records. Their interventions always resulted in a positive response from the Boards. All Boards ultimately provided a full response to the request made to them including any follow up requests that we made and we are grateful to all who assisted us with this task.

4.16 Clinco prepared a total of 32 progress reports for the Panel detailing that the first reports from the Boards were received by Clinco on December 2 2021 and the last set of records on January 20 2023.

4.17 The experience of engaging with the Health Boards using the approach described above was both protracted and resource-intensive for the Panel and Clinco. We conjecture, that the Health Boards also found the process to have been onerous and overly complicated. It is regrettable that they did not reflect on their role more fully when the matter was initially raised with them during the meetings of the Short Life Working Group. This may have served to address any potential concerns at the time, and would have resulted in a more workable and less cumbersome process. We recognise that this Review was taking place just as Scotland was coming out of a lockdown and the consequential pressures that this placed, and continues to place, upon the NHS. Despite this, we remain of the view that poor communication and a lack of preparedness was responsible for at least some of this. The Panel were most concerned about the impact that the delay and lack of progress had on the trust and confidence of the participants.

4.18 Given our requests involved only 18 participants, the Panel conclude that this approach to engaging with the Health Boards would not be workable should a future Case Record Review be made available to a larger group of women.

Engagement with general practices.

4.19 Our request for retrieval of case records from general practices did not require us to approach any practices outwith Scotland. Most requests from us were acknowledged promptly, and records were received by Clinco on average within six weeks. A small number of practices sought further information or wished to contact the participant directly to obtain their consent prior to sending their records, otherwise this was a straightforward part of the retrieval process.

Engagement with other case record holders

4.20 We made four requests for case records to St Louis, USA, and received all of these within five weeks of our request. One request was made to the Spire Hospital in Bristol which was received within four weeks. Two requests were made to Nuffield Health in Glasgow. With one request we were advised that the records were no longer in existence (routinely destroyed after seven years); the other request was returned to us within six days. One request was made to the University Hospital London, and the records were received within five weeks. No duplicate or follow up requests were required to be sent to any of the above.

4.21 On occasion, if we were unable to retrieve what we believed to be records which were central to the review, we approached the participants for their assistance, as many of them had their own copies. All engaged with our request.

4.22 We are grateful to all the agencies and individuals who engaged with us.