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

Question 1

1. Organising a VHR programme

Accepted Answer

VHR screening must be organised by a named VHR coordinator (VHRC) 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 and have adequate protected time to undertake the role based on the size of the VHR cohort. The VHRC is responsible for the coordination of the VHR pathway, including communicating with clients and sending invitations and reminders.

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
issuing the LT009 PROTO1 letter
client communication and invitation
liaison with MRI department, including referral for renal function blood test
updating NBSS with invitation information, to include LT011 initial communication letter
completion of SCR MRI record with details of booked/attended/rebooked MRI appointment
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 over the age of 70 years
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.

Question 2

2. Externally provided services

Accepted Answer

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 HealthcareServiceDesk@hitachids.com for this advice. Doing so will reduce the need for the transfer of information, reduce transcription error and allow for real-time information input.

Question 3

3. Out of area screening

Accepted Answer

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, with Appendix 3 and 4 clarifying the VHR pathway.

The out of area guidance must be followed at every screening episode at the woman’s request.

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). The inviting service must continue to create an episode each time the woman is due even if she requests to be screened at another service.

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 and NTDD.

The VHR woman must have a registration created on 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 see Appendices 3 & 4.

The VHR woman will continue to appear on the SPNTD of the receiving service, but it is the responsibility of the responsible service to invite her on an annual basis in accordance with her NTDD from BS Select. Once invited by the responsible service it is the responsibility of the VHR woman to request screening by the receiving service.

Question 4

4. Receiving new referrals and confirming eligibility

Accepted Answer

Genetic referrals are via an electronic pdf generated from the National Inherited Cancer Predisposition Register (NICPR) database. The pdf referral form will be sent to a nominated generic email address for the appropriate breast screening service. Radiotherapy referrals will continue to be sent via the NHS BSP referral form.

BSO’s must communicate with treating clinician (oncologist or surgeon) and BARD to make sure they:

are aware of the referral process
have the current version of the NHSBSP referral form
have the correct details for the BSO generic email address to which all referrals must be sent

The breast screening service must make sure that the generic email inbox is accessible to more than one person and is monitored daily. There must be an agreed process for acknowledging receipt of referrals via email. 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 received by a non-responsible BSO in error, the BSO must forward the referral to the responsible BSO via NHS secure email and include the referrer into the email. The receiving (responsible) BSO must acknowledge receipt of the email to both the non-responsible BSO and referrer. The BSO forwarding on the referral must monitor the situation until an email acknowledgement is received.

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. It is recommended that the NBSS Referrer Report is run on NBSS at least monthly. The referrer report must be run by the referring service and the output sent to each appropriate referring service. This report can be found on NBSS, within the Clinical Information Processing (SIL) function. Training slides can be found on www.nbss.nhs.uk – see Managing a very high risk organising a screening programme slide set.

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

Services must update NBSS and BS Select with any changes in a client’s clinical history. The consultant radiologist, consultant radiographer or breast clinician must review and agree any changes to a woman’s protocol on NBSS.

Administration checks

On receipt, each referral must be transferred to the named VHRC(s) who should make sure that the woman is the responsibility of their screening service and check whether she is already registered on BS Select. Referral documentation must be uploaded for VHR women onto BS Select. This will provide evidence for their eligibility for VHR screening.

Originals should never be destroyed until the scanning and indexing processes have been completed properly, quality assurance checks are complete, and the data has been backed-up.

If the woman is found on BS Select, a check should be made to see whether they:

are registered with a GPP which belongs to your service
are already flagged as VHR

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

are moving in from a previous BSO
have already been screened by the NHS BSP for VHR

In these instances, it is necessary to manage these women as a new referral. Check that all referral paperwork is already held in BS Select, if not request the documentation from the previously responsible BSO. Register on NBSS as appropriate.

Women are assigned to a responsible BSO according to the GPP they are registered with on BS Select. If a woman is not found on BS Select at the receiving BSO the search criteria can be expanded by removing the BSO cipher. 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 a woman is not found on BS Select at any BSO the service should use the BS Select registration request form (FM001) to register her .

Registration requests for women referred who are not registered with a GPP will be assigned to a responsible breast screening service based on the woman’s registered postcode by the National Service desk. The women will be registered on BS Select under a dummy (ZZZ) GPP code.

4.2 Eligibility for screening

PDF Referrals received from the National Inherited Condition Predisposition Register (NICPR) must be accepted as eligible for VHR screening by all BSOs provided they are aged 18 or over. The NBSS protocol record “Authorised By” field, should contain either the consultant radiologist, consultant radiographer or breast clinician initials to confirm that the referral has been received and the woman will be invited.

Referrals accepted as eligible for screening via the NHSBSP referral form will require authorisation from the consultant radiologist, consultant radiographer or breast clinician on NBSS to confirm that the referral has been received and the woman will be invited.

In the rare occurrence where women fulfil more than one risk criteria for very high risk screening (for example, BRCA1 likely pathogenic variant and previous radiotherapy to breast tissue when aged 15), their screening protocol should be determined on a case by case basis and reviewed by a consultant radiologist, consultant practitioner or breast clinician. They will require authorisation from the consultant radiologist, consultant radiographer or breast clinician on NBSS to confirm that the referral has been received and the woman will be invited.

4.3 Referrals for women of protocol screening age

Once the referral is received at the relevant BSO, the VHRC must complete a number of steps, in the order set out below.

Identifying the woman as VHR on BS Select

The subject record in BS Select should be updated by:

setting the higher risk status,
adding the correct referral reason
uploading all supporting NHS BSP referral documentation to BS Select

If the woman has previously been registered with a higher risk status, it is necessary to check the referral reason and end date. If the new referral confirms a greater risk than currently held, the BS Select reason for referral should be updated to the higher risk referral reason.

Confirming age eligibility

The service should confirm that the woman is currently aged between 18 years of age or less than 45 years. If she is, the ssd.nationalservicedesk@nhs.net should be emailed requesting for her to be added to BS Select, using BS Select registration request form (FM001). Otherwise, if registered with a GPP, she will appear on BS Select.

Registering the woman’s details on NBSS

The woman’s required surveillance protocol must be included 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, but 18 years or over at referral must be managed differently (see section 4.4 below). NHSE cannot hold data for women below the age of 18. If a referral is made for a woman below this age, the referral must be returned to the referrer.

Up to 5 multiple referral reasons can be entered on NBSS. The selected protocol should be based on the greatest risk to ensure that the woman is offered the appropriate screening modalities, for the appropriate length of time and at the earliest starting age.

Setting the woman up with a NTDD on NBSS

NBSS will set the NTDD for a new referral in accordance with the woman’s age and the protocol start date. If the woman is already older than the protocol start age the NTDD will be set at the date of creation of the protocol record in NBSS.

If the woman has had prior screening or family history mammograms within the previous 6 months, the initial MRI should be booked and can be read against the previous images. The NTDD will be automatically calculated 12 months from the MRI attendance date or episode creation date if she fails to attend.

There is no minimum time period between repeat MRI procedures.

Sending an introduction letter

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 “Your guide to Breast Screening” leaflet and the higher risk screening leaflet. Women who have been referred due to having had radiotherapy to breast tissue must also be sent a copy of the BARD leaflet. A copy of the LT009 letter must also be sent to the woman’s GPP.

The letter is automatically created within NBSS when a protocol is initially set up. Letter (LT009) should also 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

Some referrals may be made when a woman is below the lowest eligible age for her screening protocol but is currently aged 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.

Due to her age, it is unlikely that the woman will be registered on BS Select, however this must be checked to confirm that she is not registered.
Once confirmed that she is not on BS Select, send an email request to the National service helpline for her to be added. This must be done using the BS Select registration request form (FM001).
Once the woman has been registered on BS Select, she should be identified as VHR 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 if applicable. All supporting documentation should be scanned and uploaded into BS Select.
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.

The woman must not be registered on NBSS until 12 months prior to when she is eligible for VHR screening. No communication is made with the woman until her introductory letter (LT009) which is automatically generated when the woman is registered on NBSS. At this point the woman can inform the service if her circumstances have changed since her referral.

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 will be automatically updated from ‘Pending’ to ‘Yes’ on BS Select.

4.5 Self referrals

There is no maximum age of eligibility within the VHR programme. Anyone referred after their 71st birthday will be invited for their initial screen, however thereafter they must self refer. Women are eligible to self-refer on an annual basis from the age of 71 onwards, 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.

Question 5

5. Liaison with MRI services

Accepted Answer

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.

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. The responsible service should make an NBSS access request to the Hitachi helpdesk for this access.

Question 6

6. Invitation

Accepted Answer

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.

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 on NBSS, with a cross check against BS Select. Women should not be invited who are deducted from BS Select.

A non-batch referral (NBR) H episode should be created on NBSS to show that the episode is for a VHR screening. A new episode should be created every time a woman’s NTDD identifies she is due her VHR screening. If the episode has been prematurely closed it can be reopened up to 6 months after date of episode creation.

6.1 Mammography only

VHR mammograms can be taken within routine screening clinics.

A standard VHR timed invitation letter (LT010) should be sent 4 weeks before the appointment date, not including 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.

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

Women on a mammography only VHR protocol 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, including the time to first offered assessment appointment (recall to assessment (RC) timed appointment letter (LT020)).

6.2 MRI only

Services must create the VHR H episode on NBSS 2 months before a woman’s NTDD in order to send an MRI initial communication letter (LT011) This will allow enough time for the woman to get in touch and arrange her VHR screening appointment.

NHS BSP leaflets should not be included 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 the PROTO1 letter on registration. This is sent to the service from BARD directly with the referral or is available online

On NBSS, the date the initial communication letter (LT011) was sent should be entered within the SCR MRI record. A second initial communication letter (LT011) must be sent at 4 weeks if the woman does not respond to the first communication. Services should also try to contact the woman by telephone after sending the second initial communication letter. The date can be added in the notes free-text box within NBSS, next to the initial communication field without amending 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. Closure of the VHR episode will reset the NTDD to 12 months in advance. The MRI did not respond (DNR) letter template (LT015) is used 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. Closure of the VHR episode 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.

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. Once agreed, the MRI booked appointment date must be recorded on NBSS in the SCR MRI record, appointment history field. Part B of the SIF1 form 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 SCR MRI record appointment history on 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.

Women who do not attend their initial MRI appointment should be contacted to re-book using the first timed MRI did not attend (DNA) letter template (LT012). All rebooking of MRI appointments must be added to the SCR MRI appointment history record.

If the woman still does not attend, then the VHR 2x DNA letter (LT014) must be sent to the woman and to her GPP.

The NBSS episode should be closed no later than 8 weeks after the first initial invitation letter was sent using reason episode closed ‘NA’.

6.3 MRI plus mammography

The processes outlined below should be followed for the management of appointments and non-responders / 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 the 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.

A VHR H episode on NBSS should be created 2 months before a woman’s NTDD in order to send an MRI initial communication letter (LT011) This will allow enough time for the woman to get in touch and arrange her VHR MRI screening appointment.

NHS BSP leaflets do not need to be included 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 the PROTO1 letter on registration. This is sent to the service from BARD directly with the referral or is available online

On NBSS:

If a woman attends her mammogram appointment and does not have an MRI appointment booked, the VHR coordinator must contact the woman within 4 working days of attendance at the mammogram appointment by telephone to arrange the MRI appointment. If the woman declines to book an MRI, the VHR Coordinator must enter a deviation reason to protocol and result the mammogram using Incomplete protocol MRI declined RR result (LT016) if the woman’s outcome is return to routine recall.

The episode should be closed using NA episode closure code if the woman does not attend her two timed mammogram appointments and has not booked an MRI appointment. Closure of the VHR episode will reset the NTDD to 12 months in advance. The 2XDNA VHR letter (LT014) must be sent 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 appointments. Closure of the VHR episode 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.

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. Once agreed, the MRI booked appointment date must be recorded on NBSS in the SCR MRI record, appointment history field. Part B of the SIF1 form 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 SCR MRI record appointment history on 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.

Women who have not attend their initial MRI appointment should be re-contacted and re-booked. Use the first timed MRI did not attend (DNA) letter template (LT012). All rebooking of MRI appointments must be added to the SCR MRI appointment history record.

Question 7

7. Women with an unproven genetic mutation

Accepted Answer

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. For more information see Eligibility criteria and test requirements for women at very high risk of breast cancer

7.2 After the age of 50

A woman without a proven genetic mutation will be returned to the routine screening programme following the completion of her invitation at the age of 50. This is an automatic step within NBSS on closure of her episode and the reason withdrawn code XFER will be set to return her to triennial screening.

The untested age 50 letter template (LT018) is used 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.

BS Select must be manually updated and her higher risk status returned to normal. A copy of the LT018 letter must be scanned and uploaded to BS Select as part of the woman’s VHR documentation.

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 new referrals should be followed.

The woman will be registered on NBSS and BS Select with the new referral reason, protocol and NTDD. Introduction to VHR screening letter (LT009) must be sent to the woman. The woman must then be screened in accordance with the NHS BSP protocol guidance.

Question 8

8. VHR women in routine batches

Accepted Answer

VHR invitations must continue when a woman reaches the age for inclusion in the routine screening programme. The woman should remain on her VHR protocol and must not be invited to a routine screening appointment.

Any VHR women who have been included in a routine screening batch will be identified within the batch completion report when the batch is completed. The routine screening NBSS episode must be closed prematurely with the reason for closure of HR and this invitation must not be sent.

Question 9

9. Temporary protocol deviations

Accepted Answer

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 deviation 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.

Question 10

10. Deviations to protocols

Accepted Answer

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

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. This will be required to be actioned each year when screened. The consultant radiologist, consultant practitioner or breast clinician must approve all ongoing protocol deviations.

The incomplete protocol RR letter template (LT016) should be used when issuing a RR result following a protocol deviation.

Question 11

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

Accepted Answer

Screening with mammography can be safely performed during pregnancy but as mammographic density increases during pregnancy and lactation, its effectiveness is reduced. Women can be screened during lactation but are advised to breastfeed or express milk prior to the examination. Shielding is not considered necessary due to the low radiation dose of mammography. See guidance on using shielding on patients for diagnostic radiology applications.

MRI during pregnancy is not recommended due to the high level of background parenchymal enhancement during pregnancy and lactation. However, each woman should be reviewed and Royal College of Radiologists (RCR) symptomatic breast screening imaging guidance covering imaging surveillance in pregnancy and lactation should be followed.

If women opt to postpone screening due to pregnancy or lactation, MRI screening should resume 3 months both postpartum and following cessation of lactation. The NBSS episode must be closed OT with an appropriate cancellation comment, this will automatically advance the NTDD by 12 months, at which point the woman will be re-invited. The woman should be advised to call back to arrange an appointment as soon as she is ready to be screened.

She must be invited at her NTDD if she does not make contact.

Question 12

12. Screening transgender people

Accepted Answer

Transgender (trans) and non-binary people who have breast tissue and fulfil the criteria to be eligible for very high risk screening will be invited for screening if they are registered with a GPP with a gender marker of female, indeterminate or unknown. If they are registered with a gender marker of male, they will not be automatically invited. They will need to speak to their GP who can arrange for a referral to a local hospital for the appropriate imaging on an annual basis.

For more information, see NHS population screening: information for trans and non-binary people.

Question 13

13. Image reporting and results issuing

Accepted Answer

If a woman has had both MRI and mammograms, reading expectations are that they must be 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, 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 (see section 20). The NBSS episode cannot be closed until all expected modalities have results entered. Use the VHR RR normal results letter template (LT017).

Question 14

14. Recall to assessment

Accepted Answer

Abnormalities detected by MRI and/or digital mammography should be assessed by the local NHS BSP screening team. The clinical guidelines for breast cancer screening assessment should be followed with all clinical records created and completed within NBSS.

If MRI guided assessment is required, this will be as a result of an MDT discussion and may not be available in the local NHS BSP screening unit.

Assessment 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

All assessment appointments must be created on NBSS, so that all procedure records are linked to an appointment.

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.

14.1 Short-term recall

Short-term recalls (STR) are defined as a further appointment to attend a screening assessment indicated before the normal screening interval (one year).

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

Consideration should be given that VHR women are invited annually, rather than every 3 years as for routine screening. Women placed on short-term recall must have her initial VHR screening episode closed as Early Recall (EC) and the episode must include an MDM record. The episode cannot be closed as EC without an MDM record.

If recall is within 6 weeks of the original assessment, then it must be part of the same NBSS episode. If recall is after 6 weeks, it must be logged on NBSS as a short-term recall (STR) T episode. The default period for a STR is 3 months from the first attended assessment appointment. This can be amended to be greater than 6 weeks and less than or equal to 6 months. The recall due date is calculated from the recall period in months field and cannot be added manually.

All women on STR must have previously attended assessment. Short-term recall should not be used as a routine outcome following assessment. Every effort must be made to obtain a definitive diagnosis at initial assessment. Short-term recall should only be made in exceptional circumstances and with fully informed consent as it is associated with significant anxiety.

All STR women can be identified in the SPNTD report and will remain on the report until the STR episode is completed and the episode closed. When due, a very high risk non-batch referral (T-NBR) episode must be created. All VHR women on short-term recall must be invited to an assessment clinic. The episode must contain at least 1 assessment procedure for the episode to be closed routinely.

Following the attendance at STR appointment, the next test due date (NTDD) is reset as follows:

if no screening is performed the NTDD on NBSS is calculated automatically from the available data held within the system as the T episode sits between 2 screening episodes. This will advance the NTDD date by 12 months from the original screening date within the screening episode.
if adequate screening is performed and recorded within the STR episode which is a clinical decision, the screening undertaken should advance the next invitation date. When the clinician wants to advance the recall date for the next invite (H episode) within NBSS the episode record must have the ‘includes screening’ tick box and ‘responsible clinician’ field completed. This will advance the NTDD date by 12 months from the screening date within the STR episode

Question 15

15. Breast density

Accepted Answer

Some of the VHR women surveillance protocols state that women aged 50 or over require mammography with or without an MRI. The decision for continuing MRI is based on an annual review of breast density.

Women on such protocols should have both procedures up to and including the age of 50. At the screen when the woman is aged between 50 and before her 51st birthday, breast density must be reviewed by the reporting image reader at the time of her breast screening. If the mammogram shows an entirely fatty breast (BI-RADS A, see the BI-RADS Atlas - Reporting System), MRI is unlikely to add value and her screening protocol should change to mammography only for the remainder of her screening invitations. The review is undertaken by one image reader and the outcome recorded on NBSS on the PROTOREV record. The breast density measurement can also be reported using an automated tool which can measure density giving a BI-RADS score. If there is uncertainty over the category of breast density, a further image reader should be consulted.

If a decision is made that a woman no longer needs MRI due to a breast density classification of BI-RADS A (non-dense), her new protocol should be created within the client record on NBSS to show mammography only is required for her subsequent screening appointments. An introductory letter (LT009) is produced and should be sent to the woman, and her GPP, to inform her of the change to her imaging. If on review her breast density BI-RADS classification is B to D (dense), the review must be recorded within the PROTOREV record and no change to her protocol is required.

The woman’s breast density is likely to reduce over time. If the initial breast density review indicated that the woman should continue to have MRI and mammography, images should be reviewed annually when a woman is screened (at the time of image reading) and a PROTOREV record completed up to her 71st birthday (or beyond on an annual basis if she opts to self-refer for screening).

A breast density review with PROTOREV record must be completed on NBSS at image reading for each screen for VHR women aged 50 or older on the MRI plus mammography protocol until the clinical decision is made to change to a mammogram only protocol. When the woman is aged 50 or older at the date of image reading the breast density review will be automatically enabled if the image reader enters either Routine Recall (RR) or Review in Clinic (RC). The breast density review field is available within SIRE /SIRI to the first or subsequent image reader if it has not already been performed by another image reader in the current episode. It will only need to be completed by one image reader and once completed the field will be greyed out to subsequent readers, but the review outcome will be visible.

A PROTOREV record must be completed for all episodes if the outcome of the review is no change to protocol. This is until the outcome of review is no longer requires MRI and then the new mammogram only protocol is created.

More information is available in the NBSS R924 release training and guidance slide set. There is also information in the Protocols for the surveillance of women at higher risk of developing breast cancer online.

Question 16

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

Accepted Answer

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.

16.1 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).

Question 17

17. Women who change GPP

Accepted Answer

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.

The new responsible service must send an email to the previous BSO to acknowledge that they have seen the woman on the BS Select report. This is the opportunity for the newly responsible 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 until they receive acknowledgement of responsibility for screening the woman from the new responsible BSO. At this stage they can 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.

Question 18

18. Women diagnosed with breast cancer

Accepted Answer

As with routine screening, women diagnosed with breast cancer and under care must continue to be invited annually 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, 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 when she must be reinvited.

It is good practice to review previous images of VHR women who are diagnosed with screen-detected breast 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 for screen-detected cancers within the routine programme.

Question 19

19. Interval cancers

Accepted Answer

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

Question 20

20. Essential VHR monitoring and audit

Accepted Answer

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.

These are in addition to the reports required to monitor the breast screening programme standards.

20.1 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 on 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 registered as VHR on NBSS her Higher Risk status on BS Select will be changed from Pending to Yes (Active) within 24 hours automatically.

‘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 date of birth 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 compared to NBSS

BS Select Outcomes

BSOs should 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. Failure to action the rejections and the unmatched clients could lead to women not being invited or being invited inappropriately.

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’

20.2 Weekly reports

NBSS SASP8: “Missing MRI and ultrasound results” report needs 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 needs 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.

20.3 Monthly reports

a) 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. As an example:

Two months in advance

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

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 into 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. Services should use the Higher Risk List to make sure all women have a Higher Risk Referral reason and have confirmatory evidence added to their BS Select record.

The cross-check will identify VHR women who have moved into the area, but not registered 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.

b) The HR005 self-referral crystal report must be run monthly to identify women that have reached 71 years 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.

c) The NBSS Referrer Report needs to be run on at least a monthly basis, with the outputs sent to appropriate referring services. This report can be found on NBSS, within Clinical Information Processing (SIL) function. Training slides can be found on www.nbss.nhs.uk – see Managing a VHR screening programme training and guidance slide set.

d) 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 ‘Pending Higher Risk List’ report. All VHR women below their screening protocol age should have their higher risk status set to ‘Pending’. The Pending status can also be seen on the ‘Higher Risk List’. Further information on how to manage referrals for women before their protocol screening age is available in section 4.4 of this guidance.

e) The BS Select report ‘Higher Risk Short-Term Recall List’ will show all Higher Risk women in this category. Services should check this report to make sure the HR STR episode (episode type T) are created at the correct time. The report can be re-ordered to show the earliest STR Recall Due Date.

BS Select Home Page Alerts – Action

The report ‘Higher Risk subjects a Year or Less From Their Higher Risk Screening Start Date’, 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.

20.4 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 showing a pending status (which means they will not be registered on NBSS)
women were screened out of area
women have now been deducted from BS Select

20.5 National KC62 return

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

Data at national, regional and breast screening service level are reported on the breast screening information system (BSIS). BSIS is accessed on line.

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Applies to England

1. Organising a VHR programme