R11, R11.1, R11.2 - Convalescent Plasma Program (Serum trial)

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Covid-19 UK Non-hospital Antibody Testing Results (Pillar 3)

Objective for processing

[57 paragraphs unchanged] ************************ v3 - Pillar 3 Data and updates to existing feeds NHS Blood and Transplant request an amendment to their existing feed of data to include supplementary fields that will help with the prioritisation of calling donors. In addition to the existing data feeds - NHS Digital will amend the SGSS data feed to include Ethnicity. NHS BT will also now receive Pillar 3 data - this is data that gives information on those who have had a positive antibody test. Overall, the rationale for requesting this new data is that as the second wave grows, NHS Blood and Transplant are getting an increasingly high volume of potential contacts to sift through, and believe it’s imperative to be able to measure which contacts are most likely to successfully give high-titre convalescent plasma. There is a significant body of evidence showing that certain clinical, treatment and demographic markers are highly predictive of the level of autoimmune response and therefore likelihood to give a High-Titre CVP donation The following is a list of discoveries relating to High-Titre CVP: . June 2020 paper from the University of Chicago (Madariaga et al.) found that a number of the items (e.g. patient BMI, smoking history and blood type) were predictive of donor antibody titre for COVID-19 as well as a number of symptoms . September 2020 paper (Dadovic Rose et al.) showed that symptomatic severity of illness in COVID-19 patients is predictive of later antibody response and concentration . Internal NHSBT data has been effectively leveraged already to show that certain measures of severity for COVID-19 among donors is predictive of likelihood to be High Titre: e.g. hospitalised patients are 4-5X more likely than those with a positive test only . Internal NHSBT data also shows that some simple demographic factors such as age, ethnicity, gender are also predictive of being High Titre . Scottish National Blood Transfusion Service research has found a number of predictive markers: o Patients with symptom duration >14 days have an average titre level 2X as high as those with 1-3 days duration o Patients that received oxygen treatment had 20% higher average titre level than those that did not The request is for a number of markers, where available, (such as ethnicity, symptomatic flags, antibody levels) to be included with the contact data currently being shared. Once these are received and tracked, within a short number of weeks NHSBT will be able to establish how predictive different factors are of a donor being High-Titre, by tracking the yield rates for different segments of donors. The approach to converting these donors can then be shifted, ensuring NHSBT is maximising the conversion rates for the most valuable donor segments, and that resources are being allocated optimally. These results and insights can also then be shared back with NHSD, other international blood services etc to improve the recruitment of CVP donors. Email Addresses: Email addresses will be provided to NHSBT from NHS Digital where available in the data feeds (Testing data) NHSBT proposes to use emails to contact potential convalescent plasma donors in two ways. Firstly, because many people do not answer when NHSBT try to call them (from the 0300 number), NHSBT would like to send an email to let people know NHSBT have been passed their contact details, the reasons why and that NHSBT will be ringing them (and give them the number) to talk about potential donation. NHSBT will be able to include a link for further information that they can read before NHSBT speak to them. NHSBT hope that this will improve the call answer rate and therefore the number of people able to donate - therefore potentially increasing stocks of plasma for future treatments. Secondly, after trying to call people over two weeks without success, NHSBT would like to be able to email people with a similar message to that above. This would be focussed primarily on those potential contacts that NHSBT have not yet been able to speak to after trying to call them over recent months, but would also be used prospectively. NHSBT feels that email addresses are a more effective means of communication of this type than text or letter given the need to get across more information than can easily be done by text, and have a website link that people can easily click on which is not possible by letter.

Processing activities

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). [33 paragraphs unchanged] New Request: v2: GDPPR Data All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). [2 paragraphs unchanged] The same processing activities outlined above for the PDS, SGSS, CHESS and SUS data will apply to the GDPPR data data. GDPPR data will be provided on a monthly basis. [4 paragraphs unchanged] ************************** v3 - P3 Data/Additional Data Fields NHS Digital will amend the existing flow of SGSS data to include ethnicity fields. This will help in prioritising the call list for potential donors. NHS Digital will provide the Pillar 3 iEliza Data. This is 'Antibody Testing Data'. This also includes ethnicity and some symptomatic flag data - which will again help in prioritising the call list for potential donors. Email addresses will be provided in the feeds where available. NHSBT has confirmed to NHS Digital that activities will be compliant with PECR (Privacy and Electronic Communications Regulations) and has sought further advice from the NHSX IG team in relation to how NHSBT will be complying with PECR for the proposed activities. NHS X and NHS BT have confirmed they are content with the compliance on Data Protection and PECR regarding the convalescent plasma activity. The same filters that apply for the existing data feeds (as described above) will be applied to this data set. The same processing activities outlined above for the PDS, SGSS, CHESS and SUS data and GDPPR data will apply to the P3 data.

Benefits reported

• 23,756 people have attended to provide a Convalescent Plasma donation (please note that this figure does include people who have attended more than once) Yielded benefits (as of 15/11/20) • From this NHS Blood and Transplant have been able to collect 16,242 donations. • 33,994 people have attended to provide a Convalescent Plasma donation (please note that this figure does include people who have attended more than once) As of 01/09/2020 - in terms of the trials that CV Plasma is being used as a treatment arm the following statistics are available: • From this NHS Blood and Transplant have been able to collect 24,530 donations. As of 12/11/2020 - in terms of the trials that CV Plasma is being used as a treatment arm the following statistics are available: [2 paragraphs unchanged] • Number of hospitals open: 157 214 • Number of patients randomised: 369 3925 [2 paragraphs unchanged] • Number of hospitals open: 112 120 • Number of patients randomised: 107 665

Unchanged: Expected output, Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + COVID-19 General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR)

Objective for processing

Not stated in the previous version; added here.

Initial Request - Approved under v0 and v1 of this agreement.

NHSBT require the support of NHS Digital in providing contact details for individuals who fit the criteria for collection of convalescent plasma which is being explored as a possible treatment to Covid-19. NHSBT routinely collects plasma from donors who have registered directly with them as part of their statutory functions.

 NHSBT collect plasma according to Blood and Safety Quality Regulations (BSQR 2005) which they are monitored against by their regulator, the MHRA. This applies to manufacturing the plasma component FFP or Fresh Frozen Plasma. Convalescent Plasma (CP) is manufactured to the same regulations as FFP and is the same component. The only difference is that the donors being sought here will have had COVID 19 themselves and their plasma contains antibodies that may help a patient with COVID 19. The MHRA agrees that the collection of CP is within NHSBT’s regulatory framework.

 For this activity NHSBT requires a larger pool of donors so therefore needs to contact potential donors who have not directly registered with NHSBT or consented to receive communications. NHSBT will inform Donors that they are contacting them to talk about whether they would consider donating plasma, to help treat patients who currently have COVID-19. If they are not interested, then NHSBT will update the data supplied to them from NHS Digital to record this fact.

 Where individuals consent and provide donations, those donations will be used to treat patients, including those with COVID-19. The donations may be used within the context of a clinical trial to prove the efficacy, may be given after the trial has proven efficacy or on a compassionate basis to a patient. Some plasma may in the future be given to a third party fractionation company to make a different pooled convalescent plasma medicine but only used to treat UK patients. If any plasma remains after the pandemic it may be frozen for use in future infections or may be used for another sick patient in the NHS – plasma is usually used for treating people after a major haemorrhage or major trauma. NHSBT is committed to using the plasma for the benefit of patients in the NHS.

 The use of this CP is not dependent on any R&D or ethics approval as it can be prescribed and given by any doctor as with any blood component NHSBT manufacture, however NHSBT supports the advice of the CMO, Chris Whitty, that treatment for COVID19 should be done in the context of a trial wherever possible. If the CP is used in a trial, then NHSBT would only do this on the basis that the trial has full research and ethical approval and a sponsor organisation and would require a copy of these prior to agreeing to supply. NHSBT would not itself be part of the Clinical Trial and no data about the patients who donated the CP would be passed on to any Clinical Trial.

 The data received from NHS Digital will be merged with the NHSBT database of blood donors (PULSE) by extracting relevant PULSE data and linking by NHS number (with suitable checks on name and DoB) where possible, but using other identifiable data where necessary, so that they can prioritise any existing blood donors for whom the donation process will be easier and quicker. NHSBT will also undertake further processing to prioritise the list of patients based on those with a confirmed test, those treated in hospital, proximity to donor centres where specialist equipment needed is located and male donors.

They will screen against their suppression list ie those people who have previously indicated that they do not wish to be contacted.

NHS Digital is able to share Disclosed Data with the Recipient for the Agreed Purposes under a notice issued to NHS Digital by the Secretary of State for Health and Social Care under Regulation 3(4) of the Health Service Control of Patient Information Regulations (COPI) dated 17 March 2020 (the NHSD COPI Notice), as the Recipient is an organisation covered by Regulation 3(3) of COPI and the Agreed Purposes for which the Disclosed Data is being shared is covered by Regulation 3(1) of COPI. NHS Digital is also able to share the Disclosed Data under section 261(5)(d) of the Health and Social Care Act 2012 as it is necessary for NHSBT to have the information for the purposes of exercising their statutory functions. It is substantially in the public interest to share the Disclosed Data with NHSBT for the Agreed Purposes in light of the current COVID-19 outbreak and the current lack of treatment for the virus.

Legal Basis for the Recipient to receive the Disclosed Data

The Recipient is able to receive and process the Disclosed Data under a notice issued to the Recipient by the Secretary of State for Health and Social Care under Regulation 3(4) of COPI dated 20th March (the Recipient COPI Notice). It is also able to receive and use the Disclosed Data under its statutory functions and considers the need for the Disclosed Data for the Agreed Purposes to be substantially in the public interest for the same reasons given above.

Under GDPR, the Recipient can rely on Article 6(1)(c) – Legal Obligation and Article 6(1)(e) public task to receive and process the Disclosed Data from NHS Digital for the Agreed Purposes. As this is health information and therefore special category personal data the Recipient can also rely on Article 9(2)(g) – substantial public interest and para 6 of Schedule 1 DPA – statutory purpose; and Article 9(2)(h) – healthcare purposes, plus Part 1 Sched 1DPA18, para 2 health or social care purpose

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New Request: GDPPR Data

DHSC have requested NHSBT to supply a component for clinical trials to test the efficacy of Convalescent Plasma, and simultaneously investigate how to rapidly scale the collection, manufacture and distribution of Convalescent Plasma to ICU and other hospital patients across the UK (with other blood services) as part of its COVID-19 response.

Currently, NHSBT is collecting COVID-19 convalescent plasma (CP) for major coronavirus treatment trials, and if the trial is successful, widespread use in hospitals. Anyone who has had coronavirus or the symptoms can offer to donate at a donor centre by calling 0300 123 23 23 or completing the online form at www.nhsbt.nhs.uk.

Blood plasma is a yellowish liquid that makes up about half your blood volume. After a virus, plasma contains antibodies that are used to help fight infection.

Convalescent plasma is the antibody-rich plasma of someone who has recovered from a virus, in this case COVID-19.

Recovered patients’ plasma may contain antibodies that their immune systems have produced in fighting the virus. That plasma can be transfused to patients whose immune systems are struggling to develop their own antibodies. Plasma is also being collected and frozen ahead of any second wave of COVID-19, as it is very important to try to build up stocks to ensure as many people as possible in any second wave can receive this treatment, if shown to be effective in the trials. As it is frozen, it can be safely stored to facilitate this, whenever a second peak may occur.

NHSBT is leading the collection programme on behalf of the Government. NHSBT’s Clinical Trials Unit is collaborating with the REMAP-CAP and RECOVERY trials and all donated plasma is currently going to one of these two important trials. The trials are investigating whether transfusions of convalescent plasma may improve a patient’s speed of recovery and chances of survival. All patients in these studies can be randomised to receive CP or not, in addition to any other treatments they may be randomised to, due to the adaptive nature of the trial designs.

Convalescent plasma is being collected at NHSBT’s 23 donor centres around the country. Donation takes about 45 minutes and antibody levels are quickly replaced, meaning that people can donate plasma as often as every two weeks, although NHS BT know that antibody levels fall over the weeks and months after illness, so it is important not to delay plasma donation beyond the required 28 day recovery period.

To date, donors have been identified and called through PHE data supplied by NHSD from Pillars 1 and 2 (in hospital and national testing programmes) and through people signing up to donate on the NHSBT webform. NHSBT has relied upon the contact details for positive tested people as NHS BT know from analysing data, that people who became more ill with COVID-19 are more likely to have high antibody levels that are suitable to treat others. NHS BT also know that men, in particular, are more likely to provide the plasma donations that are suitable to treat others.

The number of people infected and the number hospitalised due to Covid-19 has been falling since the first wave, and NHSBT is starting to struggle to fill the available plasma collection capacity using existing data feeds. NHSBT require access to the GPDRR data set to find potential new plasma donors, capturing the end of the first peak and preparing for the second. This data stream is potentially really important to provide new donors at a time when NHSBT are otherwise under-collecting relative to it's full capacity, thereby limiting the number of people who it will be possible to treat in any second wave.

NHSBT request the use of the data to support outbound calling to contact individuals who have been given a diagnosis of COVID-19. The purpose of these calls are to:

• Discuss whether the individual would consider donating Convalescent Plasma

• If so, whether the individual is eligible to donate plasma

• If so, book an appointment.

NHSBT is already in receipt of Pillar 1 and 2 data. Pillar 1 data is data relating to swab testing in Public Health England (PHE) labs and NHS hospitals for those with a clinical need, and health and care workers

Pillar 2 data is data relating to swab testing for the wider population, as set out in government guidance

As part of that data sharing agreement, NHS BT have in place processes to ensure that an individual is able to consent to the conversation taking place (or otherwise) NHSBT would seek to map these processes across to the GPES data.

In the future there are plans for data from Pillar 3 - serology testing to show if people have antibodies from having had COVID-19 - to be made available as a dataset. There is not an established process in place to request this dataset at this time.

This work will support the Re-map Cap and Recovery trials. The Recovery trial has already been given access to GPES to monitor/evaluate patient outcomes.

NHS Blood & Transplant (NHSBT) has received c.128k Pillar 1 and 2 contacts via SGSS. This data has been used alongside contacts NHSBT have generated via marketing campaigns to book appointments.

Whilst the data via SGSS has been valuable in supporting Convalescent Plasma donation bookings, NHSBT is finding that, as the number of positive cases reduces, it is becoming increasingly more difficult to find eligible donors to book appointments.

NHSBT has been increasing the urgency of it's marketing campaigns, which has generated a number of new contacts to try to fill the gap left by diminishing numbers of potential donors from Pillars 1 and 2.

However, NHSBT has seen a recent reduction in the number of appointments booked overall, and believe that the GDPPR data will provide additional opportunities for NHSBT to book donors into appointments and collect Convalescent Plasma (CP) donations.

It is useful to understand that only 3% of the eligible population in England give blood, a rate that is experienced by other Blood Donation operators around the world. This demonstrates that it is hard to encourage individuals to donate blood, and this is a pattern that NHS BT are seeing with Convalescent Plasma donation too.

NHSBT would like to draw attention to how the c.128k potential CP donors have been progressed. Only a small proportion of contacts consent to and are eligible to book a CV Plasma appointment.

The analysis that NHS BT have conducted shows:

• Of the c.87k who were in close proximity to an NHSBT Donor Centre and who hadn’t been screened out due to blood donation history:

o 48% did not answer a call (NHSBT sends letters to these individuals and has recently been given permission to send an SMS)

o Of the c.45k who did answer:

 22k do not give permission to continue to the conversation.

 8.5k are not eligible to donate blood products

 4k ask for time to consider (these people are called within 14 days)

 5.5k decline to book an appointment

 5.1k book an appointment

NHSBT requests GDPPR data to make the best effort to ensure that NHSBT have access to a wide pool of individuals who can be contacted to discuss Convalescent Plasma donation. It is recognised that the GDPPR data does not have telephone numbers as part of the data set, but the request would facilitate a Direct Mail campaign to targeted individuals, providing information about plasma donation and encouraging them to contact NHSBT to discuss next steps.

The GPES data may contain information on patients that have been informally diagnosed by a GP as having COVID or having COVID-like symptoms (and it has therefore been added to their record) but they haven't then been tested so wouldn't show in SGSS

NHSBT collects Convalescent Plasma at the fixed Donor Centre sites across England. Since beginning to collect Convalescent Plasma, NHS BT have made adjustments to the donation process, to ensure that NHS BT collect high antibody titre donations in the most efficient manner, with the least impact on potential donors.

With the GDDPR contacts, NHS BT would be looking especially to target male potential donors and would encourage those individuals to follow the 'sample first'customer journey:

1. Individual books a sample first appointment at the most appropriate Donor Centre

2. At this appointment, NHSBT perform a donation eligibility assessment and, if appropriate, take a blood sample to test the level of antibodies.

3. If the individual has appropriate levels of antibodies and meets all other eligibility criteria, NHSBT will contact them to book a donation appointment.

4. At each full donation, NHSBTwill measure the level of antibodies, and will encourage the individual to continue donating (every 2 weeks as a minimum) for as long as it appropriate for them to do so.

5. If the individual does not have high enough antibodies to continue, NHSBT write to them thanking them for their time and generosity and encouraging them to continue donating other blood products.

Convalescent plasma and hyperimmune immunoglobulin may reduce mortality in patients with viral respiratory diseases, and are currently being investigated in trials as potential therapy for coronavirus disease 2019 (COVID‐19). A thorough understanding of the current body of evidence regarding the benefits and risks is required. This was highlighted by the Cochrane Collaboration - who asked for a review and to continually assess, as more evidence becomes available, whether convalescent plasma or hyperimmune immunoglobulin transfusion is effective and safe in treatment of people with COVID‐19. [https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013600.pub2/full/pl]. More CV Plasma donors will mean a larger body of evidence for this review.

Processing activities

Not stated in the previous version; added here.

ALREADY APPROVED UNDER V0 and V1 via IG Release Letters.

 NHSBT have developed call scripts and prompts to explain context, address any expected questions about where data has come from and will ask the patient for consent to continuing to speak to them about this before continuing with the call. They will make the following privacy statement on the call:

o “Your information has been provided to us by NHS Digital in these unique circumstances to help us find potential suitable donors to tackle the Covid-19 global pandemic. Your information has not and will not be shared outside the NHS and you have the right to opt out of any future communications from NSHBT should you wish to do so. NHSBT will not retain your data should you choose not to donate or register with our services”.

If the person declines, NHSBT will end the call and update their records to show the patient did not want to be contacted about this.

If the individual indicates ‘no’ and please delete my data a process would be in place to clarify whether this was for the convalescent plasma clinical trial and/or the entirety of being part of the donor database. Within NHSBT they will ensure the approach that is clear and transparent in this regard. Once the call takes place and the individual agrees to proceed, NHSBT would collect information for the purposes of the plasma donation and consent the individuals into their donor database in accordance with its usual donor process and in compliance with the NHSBT privacy policy.

 NHSBT may also write to potential donors in accordance with the letter agreed with NHS Digital on 6 May 2020 with the following wording included:

o "Your information has been provided to us by NHS Digital in these unique circumstances to help us find potential suitable donors to tackle the COVID-19 global pandemic. Please rest assured that we have not and will not share your information outside NHS Blood and Transplant. For further information about your rights and our privacy policy please visit www.nhsbt.nhs.uk/privacy"

 The minimum data necessary will be shared with the NHSBT call centre which is operated by a private company called Teleperformance. A contract and data sharing agreement are already in place for them to handle any existing NHSBT data. They are a Processer (as defined in GDPR) acting under instruction from NHSBT as the Controller. The applications that the call centre agents use are hosted in 2 data centres, one in Slough and one in Newport. All agents work in a paperless environment with no printing, saving or screen shot facilities with confidentiality agreements signed as part of their working contract. NHSBT would be the data controller for any data disseminated to them and will be bound by the terms of release letter issued to them by NHS Digital. This specifies a range of conditions around agreed purposes for use, retention and destruction - which are included at the bottom of this section of the agreement (Processing Activities).

NHSBT will not onwardly share the full data with their data processor Teleperformance. Dialling files (ie name and telephone number only) will be derived from the data supplied from NHS Digital and will be transferred to Teleperformance in Northern Ireland via SFTP (SSH File Transfer Protocol).

The minimum data possible is shared with the agents making the calls to enable them to complete their task and the data supplied will be deleted once an outcome has been recorded and returned back to NHSBT. Any person that has not been contacted will be deleted at the end of the week with a no answer Information about the date of tests may be shared with PHE and University of Oxford for donors who have given plasma and who have consented for their data and sample to be used for research purposes, for the purpose of evaluating commercial antibody tests. Data of test is key to understanding the level of antibodies in the sample given this reduces over time.

 Secure transfer of the Disclosed Data to NHSBT will be via Message Exchange for Social Care and Health (MESH). The data will be securely transferred to NHSBT on a weekly basis via secure MESH mailbox. Once the data is transferred to NHSBT it will be saved in a secure folder on NHSBT’s internal network G: drive – with access limited to the Statistics Team.

 With the exception of the date of the COVID-19 test for individuals who donate plasma, the Disclosed Data will be kept separately from all other NHSBT patient data in a secure access-controlled environment (with a daily back-up). NHSBT will maintain a Convalescent Plasma master dataset with one robust record per person (NHSBT will ensure they mark anyone who declines the option of donation). They will keep this for the duration of the programme to avoid re-contacting anyone whose details come in through different sources, including through their own on-line call for donors. Over subsequent weeks they will check incoming data against this master dataset and update it, and delete the raw data files coming in.

 The date of the COVID-19 test will be retained by NHSBT within the NHSBT Donor Record for those that have agreed to donate and have provided plasma as this is relevant information to enable NHSBT and those with whom it may share the samples for clinical trials and research (including urgent research to be carried out by Public Health England and the University of Oxford to evaluate commercial antibody tests) to be able to evaluate the level of antibodies in the sample with reference to the test date, as the levels of antibodies may reduce over time

 The data received from NHS Digital will be merged with the NHSBT database of blood donors (PULSE) by extracting relevant PULSE data and linking by NHS number (with suitable checks on name and DoB) where possible, but using other identifiable data where necessary, so that they can prioritise any existing blood donors for whom the donation process will be easier and quicker. NHSBT will also undertake further processing to prioritise the list of patients based on those with a confirmed test, those treated in hospital, proximity to donor centres where specialist equipment needed is located and male donors. They will screen against their suppression list IE those people who have previously indicated that they do not wish to be contacted.

CONDITIONS:

1. The Recipient will ensure that it and any of its Processors (as defined in GDPR) who process the Disclosed Data comply with the GDPR, the Data Protection Act 2018, all applicable law concerning privacy or the processing of personal data and the Duty of Confidence when processing the Disclosed Data.

2. The Recipient and Processor may process the Disclosed Data for the Agreed Purposes only.

3. NHS Digital will share the Disclosed Data securely with the Recipient on 17 April 2020.

4. The Recipient will store the Disclosed Data securely and all processing will be carried out from within the UK.

5. The Recipient will only retain the Disclosed Data for as long as is necessary for the Agreed Purpose. If the individuals in the Disclosed Data indicate they do not want to donate CP and ask for their data to be deleted, the Recipient will delete their data. If the individual consents to becoming a donor, NHSBT will collect and retain information about the individual for the purposes of the plasma donation, including the date of the COVID-19 test for the individual from the Disclosed Data and consent the individuals into the donor database in accordance with its usual donor process and in compliance with the NHSBT privacy policy.

6. The Recipient and the Processor will on completion of the processing activity for the Agreed Purposes securely destroy the Disclosed Data which an individual has not provided NHSBT with consent to continue to process it (including any copies it was necessary for it take for the Agreed Purposes) and on the request of NHS Digital shall provide a data destruction certificate signed by the Recipient’s and Processor’s Data Protection Officers.

7. The Recipient will update its privacy policy to reflect that NHS Digital is sharing the Disclosed Data and the purpose for this here: https://www.nhsbt.nhs.uk/privacy/

8. The Recipient will notify NHS Digital if it receives any complaints from individuals it contacts and the parties agree that if there are complaints they will review this data sharing arrangement and if appropriate, NHSBT will cease processing the Disclosed Data for the Agreed Purposes.

9. The Recipient may only process the Disclosed Data until 30th September 2020 (the End Date), or such earlier data where paragraph 8 applies. The End Date will be reviewed by NHS Digital and the Recipient and if the Recipient continues to need any of the Disclosed Data for the Agreed Purpose beyond the End Date, NHS Digital and the Recipient will agree in writing an extension to the End Data and any change to the legal basis for continued processing from that set out above.

10. The Disclosed Data is confidential patient information and is provided by NHS Digital in confidence to the Recipient and to its Processor. The Disclosed Data must be maintained by the Recipient and its Processor as confidential in accordance with Duty of Confidence. In particular, the Recipient must comply with its legal responsibilities under COPI when processing the Disclosed Data, including the restrictions laid down in Regulation 7 of COPI. This requires the Recipient when processing the Disclosed Data under COPI:

a. not to process the Disclosed Data more than is necessary to achieve the purposes for which the Recipient is permitted to process that information under Regulation 3(1) of COPI and the Agreed Purposes;

b. so far as it is practical to do so, to remove from the Disclosed Data any particulars which identify the person to whom it relates which are not required for the purposes for which it is, or is to be, processed;

c. not allow any person access to that information other than a person who, by virtue of their contract of employment or otherwise, is involved in processing the information for one or more of those purposes and is aware of the purpose or purposes for which the information may be processed;

d. not allow any person to process the Disclosed Data unless that person is a health professional or a person who in the circumstances owes a duty of confidentiality which is equivalent to that which would arise if that person were a health professional; and

e. to ensure that appropriate technical and organisational measures are taken to prevent unauthorised processing of the Disclosed Data.

11. The Recipient will only share the date of the COVID-19 test with other organisations for the Agreed Purposes where there is a legal basis to do so and any sharing complies with paragraph 1 of these Terms of Release above.

12. Any dispute in respect of these terms or their subject matter will be escalated to appropriately senior officers of the Recipient and NHS Digital for resolution.

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New Request: GDPPR Data

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

Weekly disseminatinons of the GDPPR data will occur in a similar fashion to the dissemination process used for the data sets that NHS BT are currently receiving.

There will be no flow of data from NHSBT into NHS Digital.

The same processing activities outlined above for the PDS, SGSS, CHESS and SUS data will apply to the GDPPR data GDPPR data will be provided on a monthly basis.

The GDPPR data will be minimised in a number of ways - including not supplying any records where an 'S-Flag' has been included. The S flag is a flag placed on the PDS (Personal Demographic Service) system for individual medical records.

The status is set to sensitive on request to restrict access to location information on a PDS record. It's removed when the restriction is no longer required.

Vulnerable patients (e.g. those suffering domestic violence, in the public eye, in witness protection programmes) can request that their PDS entry is marked as

‘sensitive’ (a process known as ‘s-flagging’ within the NHS). This process restricts access to contact information, but does not remove the information from the record itself. It is anticipated there will be around 1.6 - 1.65 million records disseminated from the GDPPR data - not taking into account any slight alterations based on applying the relevant filtering of the shielded patient list and patient objections being applied.

Expected output

Not stated in the previous version; added here.

This work is not a trial in itself - the work is a service commissioned by the NHS Blood and Tranplant Service.

Papers or reports will not be generated for this specific work - the output that will be created will be potential lists of donors and updated information on systems/increases in supply of potential donors.

For this activity NHSBT requires a larger pool of donors so therefore needs to contact potential donors who have not directly registered with NHSBT or consented to receive communications. NHSBT will inform Donors that they are contacting them to talk about whether they would consider donating plasma, to help treat patients who currently have COVID-19. If they are not interested then NHSBT will update the data supplied to them from NHS Digital to record this fact .

Donations will be used to treat patients, including those with COVID-19. The donations may be used within the context of a clinical trial to prove the efficacy, may be given after the trial has proven efficacy or on a compassionate basis to a patient.

NHSBT’s Clinical Trials Unit is collaborating with the REMAP-CAP and RECOVERY trials and all donated plasma is currently going to one of these two important trials. The trials are investigating whether transfusions of convalescent plasma may improve a patient’s speed of recovery and chances of survival. All patients in these studies can be randomised to receive CP or not, in addition to any other treatments they may be randomised to, due to the adaptive nature of the trial designs.

Expected measurable benefits

Not stated in the previous version; added here.

As yet there is no vaccine for COVID-19 and treatment options remain very important for those suffering and hospitalised as a result.

Convalescent plasma (CP) is one of a number of therapies being formally evaluated in national and international clinical trials. It is not yet proven effective, although it is expected that the US will imminently announce positive outcomes of their studies of CP, showing a significant reduction in mortality.

CP donations are frozen and can be stored to help treat patients in the case of regional peaks or a more widespread second wave over Autumn/winter. It is important for NHSBT to collect as much plasma from donors who have suffered from COVID-19 as possible, with an urgency to do this before antibody levels in those who have suffered diminish too far.

To date NHSBT have relied on contacting eligible individuals reported in the data disseminations from Pillar 1 and 2 data from PHE to ask them to become donors, as well as symptomatic volunteers who sign up to the NHSBT web form, who may or may not have had a positive antigen test.

As the incidence of COVID-19 has fallen, NHSBT is now facing a shortage of new contacts to fill the capacity for CP collection, despite increased marketing and web sign ups. This potential new data source is important to be able to identify and contact (by letter), people who may be eligible and willing to donate life-saving CP over coming weeks and months. Only a small proportion of people will have suitable antibody levels to donate, and, in most cases, NHSBT screen people and check their antibody level ahead of any donation, by taking a blood sample first.

With so many unknowns about vaccines and treatments, CP remains an important potential therapy which could save many thousands of lives, and so it is important to reach out to as many potential donors as possible. NHSBT appreciate that the data received may reflect a wide range of individuals with a wide range of circumstances and symptoms, and the communication sent will reflect that in a sensitive way and ask people to contact NHSBT only if they are willing and able to try to help.

Convalescent plasma and hyperimmune immunoglobulin may reduce mortality in patients with viral respiratory diseases, and are currently being investigated in trials as potential therapy for coronavirus disease 2019 (COVID‐19). A thorough understanding of the current body of evidence regarding the benefits and risks is required. This was highlighted by the Cochrane Collaboration - who asked for a review and to continually assess, as more evidence becomes available, whether convalescent plasma or hyperimmune immunoglobulin transfusion is effective and safe in treatment of people with COVID‐19. [https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013600.pub2/full/pl]. More CV Plasma donors will mean a larger body of evidence for this review.

Benefits reported

Not stated in the previous version; added here.

• 23,756 people have attended to provide a Convalescent Plasma donation (please note that this figure does include people who have attended more than once)

• From this NHS Blood and Transplant have been able to collect 16,242 donations.

As of 01/09/2020 - in terms of the trials that CV Plasma is being used as a treatment arm the following statistics are available:

RECOVERY TRIAL:

Start Date: 26/05/2020

• Number of hospitals open: 157

• Number of patients randomised: 369

REMAP-CAP

Start Date: 30/04/2020

• Number of hospitals open: 112

• Number of patients randomised: 107

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Benefits reported

Stated in the previous version and removed here.

Yielded Benefits is not a requirement for new applications.