Guidance

Breast screening: guidance for organising a Very High Risk (VHR) screening programme

Updated 30 November 2021

Applies to England

Certain women have been found to be at very high risk of developing breast cancer in comparison to the general population. This guidance informs breast screening service staff how to organise very high risk (VHR) screening for such women as part of the NHS Breast Screening Programme (NHS BSP).

Each screening service is expected to have arrangements in place for managing women who are registered with a GP practice (GPP) in their catchment area and who are eligible for VHR screening.

All the VHR letters and forms referred to in this guidance are available on the National Breast Screening System (NBSS) IT system.

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It is essential to invite VHR women as close as possible to their next test due date (NTDD) due to their annual recall.

These women must be referred for screening by:

• a genetics service
• an oncology service
• a breast cancer after radiotherapy database (BARD)

Direct referrals from a GPP will not be accepted.

The referrer is responsible for telling the women why she has been referred into the NHS BSP for VHR screening.

Magnetic resonance imaging (MRI) services providing VHR screening in the NHS BSP need to meet the relevant NHS BSP MRI technical standards.

Breast screening services should not use NBSS to manage the invitation process for women not eligible for VHR screening (including women at moderate risk and being seen in a trust family history service).

This guidance does not go into the detail of how the IT systems are operated. Training articles are available on NBSS for reference.

A flowchart giving an overview of the VHR pathway can be found in the national breast screening service specification (number 24).

Due to the complexity of the VHR programme, which involves a range of age cohorts and protocols, close attention must be given to the right results process. Breast screening office (BSO) quality management systems must be robust and adhere strictly to this guidance.

1. Organising a VHR programme

VHR screening must be organised by a named VHR screening coordinator (HRC) within the BSO, with at least one supporting deputy. These should be senior members of the BSO with a thorough understanding of the VHR process. HRC’s are responsible for communicating with clients and sending invitations and reminders. The HRC is responsible for the coordination of the VHR pathway.

A detailed quality management system must be in place, outlining all processes involved and responsibilities for each function. As a minimum, this should include:

• receiving new referrals and verifying eligibility
• client registration on BS Select and NBSS and protocol and NTDD setting
• client communication and invitation
• liaison with MRI department, including referral for renal function blood test
• updating NBSS with invitation information
• recording of screening procedure(s) and reporting of images on NBSS by image readers
• updating NBSS with all clinical procedures and treatment where appropriate
• monitoring reports to make sure that results are sent in accordance with NHS BSP standards
• closing the episode as appropriate depending on the outcome
• managing cancellations and non-attenders
• managing women breast feeding or under care
• managing VHR self-referrals
• handling out of area referrals
• setting and monitoring next test due dates
• maintaining NBSS and BS Select records

BSOs must have a good working relationship with their MRI department to deliver a timely and robust VHR screening programme. This will help ensure MRI appointments are arranged in the appropriate timescales.

BSOs need to anticipate the demand for MRI screening and make arrangements with the MRI department well in advance.

2. Externally provided services

There are various programme delivery models for VHR screening. These are:

• where all elements are delivered in-house within the local breast screening service/trust
• where delivery is carried out partly in-house (for example, where women needing mammography only are invited to the local breast screening service, but then referred to an external organisation for MRI)
• where all elements are delivered by an external organisation

There should be a formal agreement when parts, or all elements, of the VHR service are provided externally. The agreement should clearly outline the responsibilities of both organisations.

Services providing a contracted VHR service on behalf of another service can have direct access to the responsible services’ NBSS system.

The Hitachi service desk can advise on information governance requirements. The responsible service should make an NBSS access request to the Hitachi helpdesk for this advice. Doing so will reduce the need for the transfer of information, reduce transcription error and allow for real-time information input.

3. Out of area screening

A small percentage of women ask to be screened at another screening service (described as ‘out of area’ screening). Wherever possible, services should try to accommodate these requests. This must include screening and assessment if required.

The out of area guidance is applicable to VHR screening.

Services have a responsibility to screen women who ask for breast screening at their unit. The national breast screening service specification reinforces this responsibility.

Accepting women from out of area should not compromise the provision of screening at a service. This means it should not have a significant impact on capacity.

3.1 Inviting service (responsible)

The inviting service must make sure that all referral documentation is shared with the receiving BSO. This is to make sure that the receiving service can review and create the correct protocol for the woman.

Once the receiving service has agreed to screen the woman, her episode on the inviting services’ NBSS must be closed opted out temporarily (OT).

3.2 Receiving service (non-responsible)

The receiving service must request the VHR referral documentation from the inviting BSO. This will include details of her existing protocol.

The VHR woman must have a registration created in NBSS at the receiving service with the correct protocol.

Create a high risk non-batch referral (H-NBR) episode and follow the VHR pathway.

Record all appointment, screening and treatment details on NBSS in the receiving service. Breast screening: guidance for providers on out-of-area screening gives further details.

4. Receiving new referrals and verifying eligibility

Referrals must only be accepted on the national NHS BSP referral form with sufficient supporting evidence as required in the surveillance protocols for women at VHR.

BSO’s must communicate with local genetics departments, oncology units and BARD to make sure they are aware of the referral process.

There should be an agreed process for acknowledging receipt of referrals. This will make sure that all referrals can be recorded as having been received and dealt with appropriately.

Responsibility for making sure a receipt is received lies with local genetics departments, oncology units and BARD which issued the referral. They are responsible for following up with the BSO if an acknowledgement of the referral is not received.

If a referral has been sent to the incorrect BSO, the referral must be sent to the correct BSO via NHS secure email and the referrer included.

4.1 Liaison with referring services

Each BSO must develop links with genetics, oncology services and BARD, with the aim of making sure that referrals for all eligible women are received and offered appropriate screening.

The status of some women may change after they are registered in the NHS BSP VHR programme. For example, some women:

• will choose to have a risk reducing (prophylactic) bilateral mastectomy and must be ceased from the programme
• may decide not to continue with VHR screening
• will test negative for a high risk gene mutation at a later date, having been recorded as equivalent risk

Update NBSS and BS Select with any changes in a client’s clinical history. As a minimum, annual contact with the referring services to review and audit client lists must be agreed locally.

Review and agree any changes to a woman’s protocol on NBSS with the director of screening.

Administration checks

On receipt of a new referral, the BSO should make sure that the woman is eligible to be screened by your service.

Women are assigned to a BSO according to the GPP they are registered with on BS Select. Expand the search criteria by removing your BSO cipher if a woman is not found on BS Select at your BSO.

If checks find that the woman is the responsibility of another BSO, the referral must be sent to the correct BSO via NHS secure email (copying the referrer into the email). The receiving BSO must acknowledge receipt of the email to both the BSO and referrer. The BSO forwarding on the referral must monitor the situation until an email acknowledgement is received.

If the woman is found on BS Select at your BSO, check whether:

• they are already flagged as VHR
• they have not been deducted and have a live status

Upload documents on VHR women onto BS Select. This will provide evidence for their eligibility for VHR screening. Request the documentation from the previous BSO if it is not already there.

It is not expected that many new referrals will be already registered on BS Select as VHR, unless they:

• are new to the area
• have already been screened by the NHS BSP for VHR

In this instance, it is not necessary to handle these women as a new referral. All referral paperwork should already be held in BS Select.

4.2 Checking eligibility

Review the referral form once you know the woman is registered with a GPP within the catchment area of the service. Review the referral form and any clinical evidence as to the woman’s eligibility for VHR screening in the NHS BSP using the VHR screening protocols criteria. This must be carried out by either a consultant radiologist, a consultant practitioner or a breast clinician experienced in the full range of triple assessment.

The woman must meet the criteria of the programme to be eligible for VHR screening within the NHS BSP.

The referral can be accepted or rejected at this stage. Receipt of referral to registration on NBSS or issue of referral rejection notice must be within 2 weeks.

4.3 Accepted referrals for women of protocol screening age

When eligibility for VHR screening is confirmed and the referral is accepted, the VHR screening coordinator must complete a number of steps, in the order set out below.

Identify the woman as VHR on BS Select

Do this by setting the higher risk status and uploading all supporting referral documentation to BS Select.

Confirm the woman is currently aged less than 45 years

If she is, email the Exeter helpdesk for her to be added to BS Select, using BS Select registration request form (FM001).

Register the woman’s details on NBSS

You must include the woman’s required surveillance protocol when registering her details. Care should be taken to make sure the referral reason and surveillance protocol selected are correct. This determines future screening the woman will be offered. Women aged below protocol screening age at referral must be managed differently (see section 4.4 below).

Set the woman up with a NTDD in NBSS

This will depend on various circumstances.

For a brand new referral, the NTDD should be set for no more than 2 months after the NBSS registration.

If the woman has had prior screening or family history images, the NTDD should be set in accordance with the date of last images taken. Checks should be made on the local hospital system, such as the radiology information system (RIS), to assist with this decision.

Check if the date of MRI and mammogram differ

If this is the case, calculate the NTDD from the date of the mammogram, with consideration to the minimum 6-month time period between mammograms as stipulated within IR(ME)R 2017 regulations.

There is no minimum time period between repeat MRI procedures.

Where a mammogram was taken 2 months ago, but the MRI is due more imminently, a clinical decision will need to be made on a case by case basis where this will cause a delay in her next procedure.

Set the woman’s VHR NTD date within BS Select to match that set in NBSS

The date should be set by the BSO.

Send an introduction letter to women accepted and set up on surveillance

The introduction to VHR screening letter (LT009 PROTO1) must be sent out to the woman on the day she is registered on NBSS. It must include the helping you decide leaflet and the higher risk screening leaflet.

This letter is created within NBSS when a protocol is initially set up. Letter (LT009) should be issued whenever a new protocol is created, for example alteration in breast density.

4.4 How to manage referrals for women before their protocol screening age

The referral should be accepted if:

• evidence confirms that the woman meets the higher risk criteria
• the woman is below the lowest eligible age for her screening protocol but is 18 years or over

Although accepted, she will not be eligible for screening until she reaches her protocol screening start age.

The following steps will need to be taken.

1. Due to her age, it is unlikely that the woman will be registered on BS Select, however always check to confirm.
2. Once confirmed that she is not on BS Select, send an email request to the Exeter helpdesk for her to be added. This must be done using the BS Select registration request form (FM001).
3. Confirm the woman is registered on BS Select.
4. Identify the woman as VHR on BS Select by setting the higher risk status to pending and selecting the appropriate referral reason. The specific gene mutation, or a date first irradiated will also need to be added where applicable.
5. The next test due date (NTDD) for her first screening invitation will be automatically calculated according to the information entered. The NTDD will be set as her birthday when she reaches the correct age for her protocol.

No communication is made with the woman until her introductory letter (LT009). This is generated when the woman is registered on NBSS. At this point the woman can inform you if her circumstances have changed since her referral.

Do not register the woman on NBSS until 12 months prior to when she is eligible for VHR screening.

The BS Select alert ‘Higher Risk subjects a Year or Less From Their Higher Risk Screening Start Date’ will identify women whose NTDD is within 12 months of her protocol start date. The alert must be checked and actioned immediately. The woman must be added to NBSS with the same VHR NTDD as on BS Select. Once the woman is registered on NBSS her higher risk status should be changed from ‘Pending’ to ‘Yes’ on BS Select.

4.5 Rejecting referrals

Reject the referral if the documentary evidence does not confirm that the woman meets the NHS BSP criteria for VHR screening. All rejected referrals must be confirmed by the director of breast screening or their nominated representative.

Send a response to the referrer to explain the reason for rejection. A copy must be to the GPP and the woman. The BSO must not retain any information on women who have had their referral rejected for VHR screening and there must be no information added to NBSS or BS Select.

4.6 Self referrals

The maximum age of eligibility within the VHR programme is up to the 71st birthday. Women are eligible to self-refer on an annual basis from the age of 71 onward, in accordance with their VHR protocol. This is an automatic change within NBSS and will be displayed within the banner. It will display the date at which she is next eligible to self-refer.

Higher Risk status should remain in BS Select for these women and they will continue to appear on the higher risk list.

The higher risk list can be sorted by age to be able to identify the women 71 or over by their date of birth. The HR005 self-referral crystal report must be run monthly to identify women that have reached 71 and will no longer be routinely invited. These women must be sent the 71 or over self-referral letter (LT019). A copy of LT019 must be scanned and uploaded to BS Select as part of her VHR documentation.

5. Liaison with MRI services

A local process must be established to send the details of women who require MRI from the BSO to the identified MRI provider services. There needs to be good communication between the MRI department and the BSO to make sure there is appropriate timing in relation to MRI and mammography.

All results must be entered onto the NBSS system of the inviting service (see section 3.1 above) regardless of where the MRI is undertaken. This will allow consistent monitoring and reporting, correct allocation of NTDD and will make sure that messages are routinely sent to BS Select.

Where MRI procedures are provided by an external hospital, robust secure procedures must be in place for the exchange of information. Remote access to the NBSS of the inviting service can be requested to allow direct entry by reporting radiologists.

6. Invitation

This exact process will vary based on whether the VHR screening is delivered in-house, partly in-house or all externally. BSOs will have different arrangements with the MRI departments for scheduling and inviting women. If some, or all, of the surveillance procedures are being completed externally, the BSO must have a formal agreement with this organisation to clearly outline all expectations and responsibilities. This agreement must have supporting standard operating procedures.

The screening protocols will dictate whether a woman needs:

• mammography only
• MRI only
• MRI and mammography

Women will be identified for invitation by running the next test due (SPNTD) report in NBSS, with a cross check against BS Select. Do not invite women who are deducted from BS Select.

Create a non-batch referral (NBR) H episode in NBSS to show that the episode is for a VHR screening.

6.1 Mammography only

VHR mammograms can be taken within routine screening clinics.

Send a standard VHR timed invitation letter (LT010) 4 weeks before the appointment date. Do not include any NHS BSP leaflets with invitations as they are referenced within the invitation letter. The woman should have already received the leaflets with her introduction to VHR screening letter (LT009).

If a woman does not attend her appointment, she should be sent a second timed invitation letter (LT013) within 4 weeks of her VHR initial invitation.

Use the 2 non-attended mammography appointments letter template (LT014) to send to the woman and to her GPP if she still does not attend. The NBSS episode should be closed as non-attender (NA) no later than 8 weeks after the initial invitation letter was sent.

Women who attend their VHR screening appointment must be handled as per routine screening episodes.

Breast screening programme standards apply to VHR women when issuing results, as does the recall to assessment (RC) timed appointment letter (LT020).

6.2 MRI only

Send an MRI initial communication letter (LT011) 2 months before a woman’s NTDD. This will allow enough time for the woman to get in touch and arrange her VHR screening appointment.

Do not include NHS BSP leaflets as links to the online versions are in the invitation letter and the woman should have already had copies with her introduction to VHR screening letter (LT009).

Women who have been referred due to having had radiotherapy to breast tissue must be sent a copy of the BARD leaflet with each invitation.

Add the date the initial communication letter was sent as part of the woman’s NBSS episode. A second communication must be sent within 4 weeks if the woman does not respond to the first communication. Add the date in the notes free text box within NBSS. Do not amend the first initial communication date.

The episode should be closed using NA episode closure code if the woman is a non-responder. This should be no later than 8 weeks after the first initial communication letter was sent. This will reset the NTDD to 12 months in advance. Use the MRI did not respond (DNR) letter template (LT015) to send to the woman and to her GPP.

The episode must be closed as OT if a woman responds to the initial communication letter, but declines the appointment. This will reset the NTDD to 12 months in advance.

When the woman responds to the initial communication letter and requests her screening, the service should follow their internal processes for arranging an MRI appointment. This appointment must be made in accordance with her NTDD. The MRI appointment must be made between days 6 and 16 of the woman’s menstrual cycle.

Once agreed, the MRI appointment date must be recorded on NBSS. The completed MRI screening request form within NBSS (SIF1) should be downloaded and forwarded to the MRI department. Part A of the SIF1 is completed within the BSO when the MRI is requested. Part B should be completed by the MRI radiographer at the time of the procedure.

Once completed by the MRI unit the SIF1 form should be returned to the BSO. The details must be entered onto the MRI record in NBSS. The BSO must have a local process to identify whether there are any subsequent changes to the MRI appointment and ultimately whether the woman has attended or not.

Contact and re-book women that do not attend their initial MRI appointment. Use the first timed MRI did not attend (DNA) letter template (LT012).

If the woman still does not attend, then the 2 non-attended appointments letter (LT014) must be sent to the woman and to her GPP.

The NBSS episode should be closed as a NA and should be closed no later than 8 weeks after the first initial invitation letter was sent.

6.3 MRI plus mammography

All details outlined in sections 6.1 (mammography only) and 6.2 (MRI only) above should be applied to all women who need MRI plus mammography. Follow the processes outlined for the management of non-responders and non-attenders and the inputting into NBSS.

Mammography should be performed on the same day as the MRI. When this is not possible, the mammogram must be performed within 2 weeks of the MRI.

When the mammogram and MRI are booked for the same date, the woman needs to have a mammogram first. Services may wait for confirmation that the MRI appointment has been made and/or sent, and must then issue a separate invitation for a mammogram.

7. Women with an unproven genetic mutation

7.1 Up to age 50

A woman with an unproven genetic mutation who is deemed to be of equivalent risk, can be registered in the NHS BSP VHR screening programme up to, and including the age of 50.

7.2 After the age of 50

After the age of 50, a previously untested woman will be returned to the routine screening programme. Use the untested age 50 letter template (LT018) to send to the woman at this point to explain that without a proven genetic mutation she will be returned to the routine screening programme. A copy of this letter (LT018) must be sent to the GPP. It must also be scanned and uploaded to BS Select as part of the woman’s VHR documentation.

At age 51 or over, the woman must be withdrawn on NBSS using reason withdrawn code XFER to return her to triennial screening. BS Select must be updated and her higher risk status returned to normal.

The genetics service will need to complete a new referral if a result showing a gene mutation is returned. Once this is received by the BSO, the process for receiving referrals should be followed.

The woman will be registered on NBSS with the new referral reason and protocol. The woman must then be screened in accordance with the NHS BSP protocol guidance.

8. VHR women in routine batches

Any VHR women who have been included in a routine screening batch will be identified when the batch is completed. A warning report is produced within NBSS with a list of ‘clients in HR surveillance programme’.

VHR invitations must not stop when she reaches the age for inclusion in the routine screening programme. The woman should continue on her VHR protocol and must not be sent her routine appointment. The routine screening NBSS episode must be closed prematurely with the reason for closure of HR and this invitation must not be sent.

9. Temporary protocol deviations

NBSS will create the appropriate screening records according to a woman’s set protocol, for example SCR-MRI and/or SCR-FILM.

Where it is not possible for the required set of procedures to be undertaken, this is considered to be a temporary protocol deviation. For example, this may happen if a woman chooses not to have an MRI for one screening episode, but does have a mammogram.

This must be documented on NBSS with a reason entered within the annual VHR (H) non batch referral episode. This is mandatory in the form of free text.

The incomplete protocol RR letter template (LT016) must be used when issuing a routine recall (RR) result following a temporary protocol deviation.

10. Permanent protocol deviations

MRI is not possible with some medical conditions. Examples include when the woman has a pacemaker or renal function.

It is not possible to create a permanent protocol deviation within NBSS. In this situation the process for temporary protocol deviation should be followed, as described above. The consultant radiologist, consultant practitioner or breast clinician must approve all ongoing protocol deviations.

Use the incomplete protocol RR letter template (LT016) when issuing a RR result following a protocol deviation.

11. Guidance for pregnant women, or women who are breastfeeding

Breast screening: HR women who are pregnant or lactating states that MRIs should not be carried out during pregnancy or on women who are breast feeding.

If the woman informs the BSO that she is pregnant or breast feeding, the NBSS episode should be closed OT with an appropriate cancellation comment. This will automatically advance the NTDD by 12 months, at which point she should be re-invited.

A woman should wait 3 months after giving birth before attending her appointment if she is not breast feeding. If breast feeding, she must wait for 3 months after stopping before attending her screening appointment. Advise the woman to call back to arrange an appointment when it is suitable for her to be screened. She must be invited at her NTDD if she does not make contact.

12. Image reporting and results issuing

If a woman has had both MRI and mammograms, reading expectations are that they must be independently double read. The mammography images must be available when the MRI is reported.

Breast screening: using MRI with higher risk women outlines reporting requirements within the VHR programme. Breast screening services are expected to monitor that these conditions are being met by all who report.

Readers should enter their reporting opinion directly onto NBSS for both mammography images and MRIs, ideally at the time of reporting. To make sure that the women receive the right outcome, BSOs should develop a process to audit all results entered into NBSS. The NBSS episode cannot be closed until all expected modalities have results entered. Use the VHR RR normal results letter template (LT017).

13. Recall to assessment

Abnormalities detected by MRI and/or digital mammography should be assessed by the local NHS BSP screening team. This should ideally include a radiographer familiar with breast MRI.

Although this assessment does not need to take place in an NHS BSP screening assessment unit, the assessing team must satisfy clinical guidelines for screening assessment.

If assessment takes place outside of the NHS BSP, the responsible breast screening service should be sent:

• details of the examinations performed, and of the person (or people) performing them
• the outcome of MDT discussions

The using MRI with higher risk women guidance stipulates requirements for services to be able to perform MRI-guided biopsies. Each screening service should have an identified site where women requiring MRI-guided biopsies can be referred, if they cannot be performed in-house.

Recall to assessment rates and waiting times for results and assessment are as per the routine programme consolidated standards.

Staff involved in the assessment clinic should be made aware of VHR screening patients, as their questions and the amount of support they need may be different to women recalled from routine screening.

13.1 Short term recall

As with routine screening, the decision to place a woman on short term recall from assessment should only be done in exceptional circumstances and where felt to be clinically necessary.

Consideration should be given that VHR women are invited annually, rather than every 3 years as for routine screening. The short term recall period should therefore be set accordingly, with consideration for the IR(ME)R 2017 guidance.

This will prevent a mammogram from being taken within 6 months. For example, a VHR woman placed on short term recall for 6 months, will be due her annual VHR invitation in the next 6 months.

Women placed on short term recall must have her NTDD manually amended to show the short-term recall date. When due, a high risk non-batch referral (H-NBR) episode must be created with the short-term recall box ticked. MRI appointments should be booked for days 6 to 16 of the woman’s menstrual cycle. The NTDD for a woman returned to routine recall should have her NTDD set from the date of initial screen not the date of her short-term recall.

14. Breast density

Some of the VHR women surveillance protocols state that women require mammography with or without an MRI. The decision for continuing MRI is based on an annual review of breast density.

The women on this protocol should have both MRI and mammography up to and including the age of 50. At this point, and annually after that, breast density should be reviewed based on current images until a decision is made that MRI is no longer required. If the mammogram shows an entirely fatty breast (Birads A), MRI is unlikely to add value and should not be performed.

Once the decision is made that a woman no longer needs MRI, she should have a new protocol created stating mammography only. An introductory letter (LT009) is produced and should be sent to the woman to inform her of the change to her imaging. A comment should be made in NBSS to detail the name of the clinician who made the decision and the date.

Any women who are newly referred into the programme after the age of 50 should have both MRI and mammographer performed at the initial screen to review whether the MRI is required at subsequent screens.

15. Permanently opt out (withdraw) from VHR risk screening only

NHS BSP guidance on opting-out (ceasing) and withdrawing should be followed in all circumstances.

Women identified as being at higher risk of breast cancer can choose not to accept their annual screening and may want to permanently opt out (withdraw) from VHR screening only.

A woman who has permanently opted out (withdrawn) from VHR screening will remain eligible for invitation in the routine screening programme. Once she reaches the eligible age for routine screening she will be invited every 3 years. She will not be able to permanently opt out (cease) from routine screening until she has received an invitation to routine screening.

15.1 Bilateral Mastectomy

Women who have had a confirmed bilateral mastectomy should be permanently opted out (ceased) from the breast screening programme following the NHS BSP guidance on opting-out (ceasing).

16. Women who change GPP

Women who change GPP and fall under the remit of another BSO, must have their NBSS client registration screen updated with the new BSO 3-character cipher. The woman will be identified as having moved on the NBSS SPTND report initially, with a note entry stating client has transferred to XXX BSO.

These women must not be withdrawn from VHR screening on NBSS, as this will remove their NTDD and send a blank date to BS Select.

A handover email from the receiving BSO to the previous BSO must be sent to acknowledge that they have seen the woman on the BS Select report. This is the opportunity for the receiving BSO to request any additional supporting documentation be uploaded to BS Select by the previous BSO.

The previous BSO must continue to invite the woman and manage her in accordance with the VHR guidance if they:

• are not aware of the new registered BSO
• cannot be assured that the woman’s care has transferred to another BSO

There is currently no way on NBSS to record that a woman has moved abroad and has therefore not transferred her care to a BSO within the United Kingdom. If the woman de-registers from her GPP, she will be deducted from BS Select. Until that happens, the woman must continue to be invited for her VHR screening. No changes should be made to NBSS and she will continue to appear on the next test due SPNTD report. Once a woman has been deducted from BS Select she is not eligible for invitation.

17. Women diagnosed with cancer

As with routine screening, women diagnosed with cancer and under care should continue to be invited for VHR screening. This is regardless of whether the woman was diagnosed via screening or symptomatically. This is a failsafe mechanism to make sure that all women are invited and the onus is on the woman to contact the service and either attend or opt-out of this screening episode. If she opts-out, the NBSS episode should be closed as under care temporarily (CT). Her NTDD will be advanced by 12 months.

It is good practice to review previous images of VHR women who are diagnosed with screen-detected cancer. This is as an educational exercise due to the short time period between invitations. The review findings would not be subject to disclosure of audit or duty of candour processes. This is not recommended within the routine BSP.

18. Interval cancers

NHS BSP guidance on interval cancers and duty of candour is applicable to women identified as being at VHR.

19. Essential VHR monitoring and audit

It is essential that the BSOs run reports routinely, and act on their outcomes. These reports indicate VHR women who are due an invitation and where results are outstanding.

19.1 Daily reports

BS Select Home Page Alerts – Immediate Action

‘Pending Higher Risk Subjects now overdue for adding to Higher Risk Screening Programme’. Women on this alert are set to Pending Higher Risk status on BS Select and their Higher Risk NTDD is in the past. These women should be registered in NBSS immediately. The woman’s Higher Risk NTDD on BS Select must be entered as the Higher Risk NTDD on NBSS. Once the woman is added to NBSS her Higher Risk status on BS Select should be changed from Pending to Yes (Active).

‘Higher Risk Exceptions’. This report highlights that a change has been made to a Pending woman on BS Select. All exceptions should be checked and corrected if necessary. The report shows if a Pending Higher Risk woman has:

• had a DOB change or
• been added to NBSS as Higher Risk, but the Higher Risk status has not been changed on BS Select or
• a different Higher Risk NTDD on BS Select to the one on NBSS

BS Select Outcomes

Check the outcome reports on BS Select to make sure that all VHR episode transfers have been completed and there are no unmatched clients or rejected outcomes for VHR episodes.

BS Select SSPI Update Warnings – Action monitoring report

BSOs should check and action (where appropriate) the ‘SSPI Update Warnings – Action’ report on BS Select for clients which have moved into their BSO with:

• the Event type of ‘Subject joined BSO’ and
• the Warning type of ‘Subject has HR status’

19.2 Weekly reports

NBSS SASP8: Missing MRI and ultrasound results reports need to be run at least weekly, with the parameters 0 to 52 weeks, to identify women with MRI or ultrasound results outstanding.

NBSS SASP5: Missing results report need to be run at least weekly, with the parameters 2 to 52 weeks, to identify women with mammogram results outstanding. This report also includes details of women attending for routine screening.

19.3 Monthly reports

NBSS SPNTD report must be run monthly within the first week of the month. This will identify all VHR women eligible for invitation. The SPNTD report should be run for 2 time periods.

Two months in advance

As an example, run on the first working day of April to cover the whole month of May and June. This will identify the women that require an invitation as part of VHR screening to make sure that NTDDs are maintained.

One month in advance

As an example, run on the last working day of April to cover the whole month of May. This will identify any additional women who may have moved in to the BSO since the prior month’s report.

The SPNTD is run on consecutive months as a failsafe to make sure that all VHR women due for screening are identified and invited in a timely manner. There will be a duplication of VHR women, but the purpose is to cross-check the results of the 2 reports to identify any additional women.

SPNTD results should be cross-checked with the VHR list on the BS Select Higher Risk List monitoring report monthly. It will reveal any discrepancies between the 2 lists, which must then be investigated and rectified.

The cross-check will identify VHR women who have moved into the area, but not shown on NBSS. In these cases, the BSO need to make sure that all referral information is available within BS Select. If not, the information must be requested from the previous BSO and uploaded to BS Select.

Women that are now eligible for self-referral are not listed in the SPNTD VHR report unless they have been placed on short term recall.

The HR005 self-referral crystal report must be run monthly to identify women that have reached 71 and will no longer be routinely invited.

Use the 71 or over self-referral letter template (LT019) for these women.

If a VHR woman transfers into the area aged 71 or over, then a check must be made on BS Select to make sure that she had her final invitation at age 70. If not, then the woman must be invited for her final VHR screening.

VHR women registered on BS Select 18 years or over, but below Higher Risk screening start age, can be identified by reviewing the BS Select ‘Higher Risk List’ monitoring report. All VHR women below their screening protocol age should have their higher risk status set to ‘Pending’.

Women with a ‘Pending’ status can be reviewed on the BS Select ‘Pending Higher Risk List’ monitoring report. Further information on how to manage referrals for women before their protocol screening age is available in section 4.4 of this guidance.

BS Select Home Page Alerts – Action

‘Higher Risk subjects a Year or Less From Their Higher Risk Screening Start Date’. The report identifies women whose higher risk status needs to be made active. These women should be registered on NBSS 12 months in advance of their eligibility for VHR screening. This will allow time for an appointment to be made in a timely manner.

19.4 Annual reports

Each BSO is responsible for annually auditing the live women on NBSS (using the crystal report HR002) and BS Select (higher risk list). This is to make sure that the same women:

• are recorded on both systems as VHR
• have all necessary documentation in place (uploaded to BS Select)

All open episodes should appropriately reflect women in active stages of the screening processes and are not overdue an invitation. All mismatches must be investigated and resolved.

The only valid reasons for the lists not matching will be that:

• women were registered on BS Select before being eligible for VHR screening (which means they will not be registered on NBSS)
• women were screened out of area
• women have now been deducted from BS Select

Annual contact (as a minimum) with the referring services to review and audit client lists. This review is to make sure that there is a reconciliation of all women referred for breast screening to mitigate against women not being screened. This process must be agreed locally.

19.5 National KC62 return

VHR women are reported in table U of the KC62. Prior to submission of the annual return, table U should be double checked to make sure that all VHR women are included and that they appear in the correct columns.