天美影院

This聽guidance has been updated to include the following revisions:

• process of 鈥渁uthorising鈥� referrals on NBSS has changed
• clarification of the out of area screening process for VHR women (with links to appendix 3 & 4 in the Out of Area guidance)
• NTDD is automatically set when women are registered on BS Select as pending and in NBSS if they are within 12 months of their protocol start date
• mammograms taken within the previous 6 months may be read in conjunction with a new MRI image to reduce the delay in screening and reporting results. The date the MRI image is taken is used to calculate the Next Test Due Date (NTDD) in 12 months鈥� time.
• the requirement to send out a timed mammogram appointment at 4 weeks if there has been no response to the initial communication where MRI (plus mammography) is required聽
• clarification for the management of VHR Short Term Recall 鈥淭鈥� episodes
• ability to enter the breast density review record in SIRI/SIRE and update the protocol as required
• requirement to conduct local reconciliation audits of referrals between the screening service and referrers is no longer required, as it is being undertaken at the national level by NHS 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聽NHS Breast Screening Programme聽(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聽eligible for聽VHR聽screening.

A large proportion of the VHR聽letters referred to in this guidance are available on the聽National Breast Screening System (NBSS)聽IT system. The remainder of letters and forms are available for download from the .

It is essential to invite聽VHR聽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 by a consultant clinical geneticist, genetic counsellor or an appropriately trained individual nominated by them
• the treating clinician (surgeon or oncologist) - for cancer patients found to carry a genetic mutation that meets the eligibility criteria for very high risk screening
• Breast cancer After Radiotherapy Database (BARD) - for women who received radiotherapy to sites involving breast tissue during treatment for lymphoma and non-lymphomas (where appropriate)

Oncologists wishing to refer women who received radiotherapy to sites involving breast tissue for cancers other than lymphoma, must complete a聽聽and send to聽BARD聽on聽chn-tr.bard@nhs.net聽to confirm eligibility for very high risk screening, and subsequent referral if appropriate.

Direct referrals from a聽GPP聽will not be accepted.

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

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

Breast screening services should not use聽NBSS聽to manage the invitation process for women at moderate risk and being seen in an NHS trust family history service. NBSS must be used for routine breast screening and VHR screening only.

This guidance does not go into the detail of how the IT systems are operated.聽聽for reference.

Due to the complexity of the聽VHR聽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聽VHR聽programme

VHR聽screening must be organised by a named聽VHR coordinator (VHRC) within the聽BSO, with at least one supporting deputy. These should be senior members of the聽BSO聽with a thorough understanding of the聽VHR聽process and have adequate protected time to undertake the role based on the size of the VHR cohort.聽 罢丑别听VHRC聽is responsible for the coordination of the聽VHR聽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聽BS Select聽and聽NBSS聽and protocol and聽NTDD聽setting
• issuing the LT009 PROTO1 letter
• client communication and invitation
• liaison with聽MRI聽department, including referral for renal function blood test
• updating聽NBSS聽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聽NBSS聽by image readers
• updating聽NBSS聽with all clinical procedures and treatment where appropriate
• monitoring reports to make sure that results are sent in accordance with聽NHS BSP聽standards
• closing the episode as appropriate depending on the outcome
• managing cancellations and non-attenders
• managing women breast feeding or under care
• managing聽VHR聽self-referrals over the age of 70 years
• handling out of area referrals
• setting and monitoring next test due dates
• maintaining聽NBSS聽and聽BS Select聽records

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

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

2. Externally provided services

There are various programme delivery models for聽VHR聽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聽MRI)
• where all elements are delivered by an external organisation

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

天美影院 providing a contracted聽VHR聽service on behalf of another service can have direct access to the responsible services鈥櫬燦BSS聽system. The Hitachi service desk can advise on information governance requirements. The responsible service should make an聽HealthcareServiceDesk@hitachids.com聽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 鈥榦ut of area鈥� screening). Wherever possible, services should try to accommodate these requests. This must include screening and assessment if required.

罢丑别听out of area guidance聽is applicable to聽VHR聽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鈥檚 request.

天美影院 have a responsibility to screen women who ask for breast screening at their unit. 罢丑别听聽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聽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鈥櫬燦BSS聽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聽VHR聽referral documentation from the inviting聽BSO. This will include details of her existing protocol and NTDD.

罢丑别听VHR聽woman must have a registration created on NBSS聽at the receiving service with the correct protocol.

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

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

4. Receiving new referrals and confirming eligibility

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 .

BSO鈥檚 must communicate with treating clinician (oncologist or surgeon) and聽BARD聽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聽BARD聽which issued the referral. They are responsible for following up with the聽BSO聽if an acknowledgement of the referral is not received.

If a referral has been received by a non-responsible聽BSO in error, the BSO must forward the referral to the responsible聽BSO聽via NHS secure email and include the referrer into the email. The receiving (responsible)聽BSO聽must acknowledge receipt of the email to both the聽non-responsible BSO聽and referrer. 罢丑别听BSO聽forwarding on the referral must monitor the situation until an email acknowledgement is received.

4.1 Liaison with referring services

Each聽BSO聽must develop links with genetics, oncology services and聽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 鈥� 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聽NHS BSP聽VHR聽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聽VHR聽screening
• will test negative for a high risk gene mutation at a later date, having been recorded as equivalent risk

天美影院 must update聽NBSS聽and聽BS Select聽with any changes in a client鈥檚 clinical history. The consultant radiologist, consultant radiographer or breast clinician must review and agree any changes to a woman鈥檚 protocol on聽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聽VHR聽women onto聽BS Select. This will provide evidence for their eligibility for聽VHR聽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聽BS Select,聽a check should be made to see whether they:

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

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

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

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

Women are assigned to a聽responsible BSO聽according to the聽GPP聽they are registered with on聽BS Select. If a woman is not found on聽BS Select聽at the receiving BSO the search criteria can be expanded by removing the聽BSO聽cipher. If checks find that the woman is the responsibility of another聽BSO, the referral must be sent to the correct聽BSO聽via NHS secure email (copying the referrer into the email). The receiving聽BSO聽must acknowledge receipt of the email to both the聽BSO聽and referrer. 罢丑别听BSO聽forwarding on the referral must monitor the situation until an email acknowledgement is received.

If a woman is not found on聽BS Select聽at any BSO the service should use the New Registration for Breast Screening (BS) Select form, which is accessed via the

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鈥檚 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 鈥淎uthorised By鈥� 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 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 聽on a case by case basis and reviewed by聽 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聽VHRC聽must complete a number of steps, in the order set out below.

Identifying the woman as聽VHR聽on聽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聽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,聽the New Registration for Breast Screening (BS) Select form should be submitted via the requesting her to be added to BS Select. Otherwise, if registered with a GPP, she will appear on BS Select.

Registering the woman鈥檚 details on聽NBSS

The woman鈥檚 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).聽 NHSE cannot hold data for women below the age of 18.聽 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聽NTDD聽on NBSS

NBSS will set the NTDD for a new referral in accordance with the woman鈥檚 age and the protocol start date.聽 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, 聽the聽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聽MRI聽procedures.

Sending an introduction letter

罢丑别听聽must be sent out to the woman on the day she is registered on聽NBSS. It must include the 鈥淵our guide to Breast Screening鈥� 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聽. A copy of the LT009 letter must also be sent to the woman鈥檚 GPP.

The letter is automatically created within NBSS聽when a protocol is initially set up.聽聽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

聽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.

1. Due to her age, it is unlikely that the woman will be registered on聽BS Select, however this must be checked to confirm that she is not registered. Once confirmed that she is not on聽BS Select, visit the in order to submit the New Registration for the Breast Screening (BS) Select form requesting for her to be added.
2. Once the woman has been registered on BS Select, she should be identified as聽VHR聽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.
3. The next test due date (NTDD) for her first screening invitation will be automatically calculated according to the information entered. 罢丑别听NTDD聽will be set as her birthday when she reaches the correct age for her protocol.

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

罢丑别听BS Select聽alert 鈥楬igher Risk subjects a Year or Less From Their Higher Risk Screening Start Date鈥� will identify women whose聽NTDD聽is within 12 months of her protocol start date. The alert must be checked and actioned immediately. The woman must be added to聽NBSS聽with the same聽VHR聽NTDD聽as on聽BS Select. Once the woman is registered on聽NBSS聽her higher risk status will be automatically updated from 鈥楶ending鈥� to 鈥榊es鈥� on聽BS Select.

4.5 Self referrals

There is no maximum age of eligibility within the聽VHR聽programme.聽 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聽VHR聽protocol. This is an automatic change within NBSS聽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聽BS Select聽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聽. A copy of LT019 must be scanned and uploaded to聽BS Select聽as part of her聽VHR聽documentation.

5. Liaison with聽MRI聽services

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

Where聽MRI聽procedures are provided by an external hospital, robust secure procedures must be in place for the exchange of information. Remote access to the聽NBSS聽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聽for this access.

6. Invitation

This exact process will vary based on whether the聽VHR聽screening is delivered in-house, partly in-house or all externally.聽BSOs聽will have different arrangements with the聽MRI聽departments for scheduling and inviting women.

The screening protocols will dictate whether a woman needs:

• mammography only
• 惭搁滨听辞苍濒测
• MRI聽and mammography

Women will be identified for invitation by running the next test due (SPNTD) report on NBSS, with a cross check against聽BS Select. Women should not be invited who are deducted from聽BS Select.

A non-batch referral (NBR) H episode should be created on NBSS聽to show that the episode is for a聽VHR聽screening. A new episode should be created every time a woman鈥檚 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.聽

6.1 Mammography only

VHR聽mammograms can be taken within routine screening clinics.

听础听聽should be sent 4 weeks before the appointment date, not including any聽NHS BSP聽leaflets with invitations as they are referenced within the invitation letter. The woman should have already received the leaflets with her聽.

If a woman does not attend her appointment, she should be sent a聽聽within 4 weeks of her聽VHR聽initial invitation.

If the woman still does not attend, a聽聽is sent to the woman and to her聽GPP. 罢丑别听NBSS聽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聽VHR聽screening appointment must be handled as per routine screening episodes.

Breast screening programme standards聽apply to聽VHR聽women when issuing results, including the time to first offered assessment appointment ().

6.2 惭搁滨听辞苍濒测

天美影院 must create the VHR H episode on NBSS 2 months before a woman鈥檚聽NTDD in order to send an聽聽 This will allow enough time for the woman to get in touch and arrange her聽VHR聽screening appointment.

NHS BSP聽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聽.

Women who have been referred due to having had radiotherapy to breast tissue must be sent a copy of the聽 with the PROTO1 letter on registration. This is sent to the service from聽BARD聽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. 天美影院 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聽NA聽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聽NTDD聽to 12 months in advance. 罢丑别听聽is used to send to the woman and to her聽GPP.

The episode must be closed as聽OT聽if a woman responds to the initial communication letter but declines the appointment. Closure of the VHR episode will reset the聽NTDD聽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聽MRI聽appointment. This appointment must be made in accordance with her聽NTDD. 罢丑别听MRI聽appointment must be made between days 6 and 16 of the woman鈥檚 menstrual cycle.

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

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

Women who do not attend their initial聽MRI聽appointment should be contacted to re-book using the聽. All rebooking of MRI appointments must be added to the SCR MRI appointment history record.

If the woman still does not attend, then the聽VHR 聽must be sent to the woman and to her聽GPP.

罢丑别听NBSS聽episode should be closed no later than 8 weeks after the first initial invitation letter was sent using reason episode closed 鈥楴A鈥�.

6.3 MRI聽plus mammography

The processes outlined below should be followed for the management of appointments and non-responders / non-attenders and the inputting into聽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聽MRI聽are booked for the same date, the woman needs to have the mammogram first. 天美影院 may wait for confirmation that the聽MRI聽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鈥檚聽NTDD in order to send an聽聽 This will allow enough time for the woman to get in touch and arrange her聽VHR聽MRI screening appointment.

NHS BSP聽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聽.

Women who have been referred due to having had radiotherapy to breast tissue must be sent a copy of the聽 with the PROTO1 letter on registration. This is sent to the service from聽BARD聽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
• a timed mammogram appointment should be booked in line with her NTDD and this appointment included in with 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. If a woman does not attend her mammogram appointment, she should be sent a聽聽within 4 weeks of her聽VHR聽initial timed mammogram invitation

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鈥檚 outcome is return to routine recall.

The episode should be closed using聽NA聽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聽NTDD聽to 12 months in advance. 罢丑别听 2XDNA VHR letter (LT014) must be sent to the woman and to her聽GPP.

The episode must be closed as聽OT聽if a woman responds to the initial communication letter but declines the appointments. Closure of the VHR episode will reset the聽NTDD聽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聽MRI聽appointment. This appointment must be made in accordance with her聽NTDD. 罢丑别听MRI聽appointment must be made between days 6 and 16 of the woman鈥檚 menstrual cycle.

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

Once completed by the聽MRI聽unit the SIF1 form should be returned to the聽BSO. The details must be entered onto the聽SCR MRI聽record appointment history on NBSS. 罢丑别听BSO聽must have a local process to identify whether there are any subsequent changes to the聽MRI聽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聽. All rebooking of MRI appointments must be added to the SCR MRI appointment history record.

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聽NHS BSP聽VHR聽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.

罢丑别听聽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聽GPP.

BS Select聽must be manually updated and her higher risk status returned to normal. A copy of the LT018 letter must be scanned and uploaded to聽BS Select聽as part of the woman鈥檚聽VHR聽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聽BSO, the process for receiving new referrals should be followed.

The woman will be registered on聽NBSS and BS Select聽with the new referral reason, protocol and NTDD. must be sent to the woman. The woman must then be screened in accordance with the聽NHS BSP聽protocol guidance.

8. VHR聽women in routine batches

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

Any聽VHR聽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聽NBSS聽episode must be closed prematurely with the reason for closure of HR and this invitation must not be sent.

9. Temporary protocol deviations

NBSS聽will create the appropriate screening records according to a woman鈥檚 set protocol, for example SCR-MRI聽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聽MRI聽for one screening episode but does have a mammogram.

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

罢丑别听聽must be used when issuing a routine recall (RR) result following a temporary protocol deviation.

10. Deviations to protocols

MRI聽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.

罢丑别听聽should be used when issuing a聽RR聽result following a protocol deviation.

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

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聽.

MRI聽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聽聽should be followed.

If women opt to postpone screening due to pregnancy or lactation,聽MRI聽screening should resume 3 months both postpartum and following cessation of lactation. 罢丑别听NBSS聽episode must be closed聽OT聽with an appropriate cancellation comment, this will automatically advance the聽NTDD聽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聽NTDD聽if she does not make contact.

12. Screening transgender people

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聽NHS population screening: information for trans and non-binary people.

13. Image reporting and results issuing

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

Breast screening: using聽MRI聽with higher risk women聽outlines reporting requirements within the聽VHR聽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聽NBSS聽for both mammography images and MRIs, at the time of reporting. To make sure that the women receive the right outcome,聽BSOs聽should develop a process to audit all results entered into聽NBSS (see section 20). 罢丑别听NBSS聽episode cannot be closed until all expected modalities have results entered. Use the聽.

14. Recall to assessment

Abnormalities detected by聽MRI聽and/or digital mammography should be assessed by the local聽NHS BSP聽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聽NHS BSP聽screening assessment unit, the assessing team must satisfy聽clinical guidelines for screening assessment.

If assessment takes place outside of the聽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.

罢丑别听using聽MRI聽with higher risk women guidance聽stipulates requirements for services to be able to perform聽MRI-guided biopsies. Each screening service should have an identified site where women requiring聽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聽routine programme consolidated standards.

Staff involved in the assessment clinic should be made aware of聽VHR聽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聽VHR聽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聽NBSS聽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. 聽The episode must contain at least 1 assessment procedure for the episode to be closed routinely.

Following the attendance at聽STR聽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 鈥榠ncludes screening鈥� tick box and 鈥榬esponsible clinician鈥� field completed. This will advance the NTDD date by 12 months from the screening date within the STR episode

15. Breast density

Some of the聽VHR聽women surveillance protocols聽state that women aged 50 or over require mammography with or without an聽MRI. The decision for continuing聽MRI聽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聽),聽MRI聽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聽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聽MRI聽due to a breast density classification of BI-RADS A (non-dense), her new protocol should be created within the client record on聽NBSS聽to show mammography only is required for her subsequent screening appointments. An 聽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鈥檚 breast density is likely to reduce over time. If the initial breast density review indicated that the woman should continue to have聽MRI聽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 . There is also information in the Protocols for the surveillance of women at higher risk of developing breast cancer 听辞苍濒颈苍别.

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

NHS BSP guidance on opting-out (ceasing)聽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聽VHR聽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聽NHS BSP聽guidance on opting-out (ceasing).

17. Women who change聽GPP

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

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

The new responsible service must send an email聽to the previous聽BSO聽to acknowledge that they have seen the woman on the聽BS Select聽report. This is the opportunity for the newly responsible receiving聽BSO聽to request any additional supporting documentation be uploaded to聽BS Select聽by the previous聽BSO.

The previous聽BSO聽must continue to invite the woman and manage her in accordance with the聽VHR聽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鈥檚 care has transferred to another聽BSO.

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

18. Women diagnosed with breast cancer

As with routine screening, women diagnosed with breast cancer and under care must continue to be invited annually for聽VHR聽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聽NBSS聽episode should be closed as under care temporarily (CT). Her聽NTDD聽will be advanced by 12 months when she must be reinvited.

It is good practice to review previous images of聽VHR聽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.

19. Interval cancers

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

20. Essential聽VHR聽monitoring and audit

It is essential that the聽BSOs聽run reports routinely, and act on their outcomes. These reports indicate聽VHR聽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聽Home Page Alerts 鈥� Immediate Action

鈥楶ending Higher Risk Subjects now overdue for adding to Higher Risk Screening Programme鈥�. Women on this alert are set to Pending Higher Risk status on聽BS Select聽and their Higher Risk聽NTDD聽is in the past. These women should be registered on NBSS聽immediately. The woman鈥檚 Higher Risk聽NTDD聽on聽BS Select聽must be entered as the Higher Risk聽NTDD聽on聽NBSS. Once the woman is registered as VHR on聽NBSS聽her Higher Risk status on聽BS Select聽will be changed from Pending to Yes (Active) within 24 hours automatically.

鈥楬igher Risk Exceptions鈥�. This report highlights that a change has been made to a Pending woman on聽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聽NBSS聽as Higher Risk, but the Higher Risk status has not been changed on聽BS Select聽or
• a different Higher Risk聽NTDD聽on聽BS Select聽compared to NBSS

BS Select聽Outcomes

BSOs should check the outcome reports on聽BS Select聽to make sure that all聽VHR聽episode transfers have been completed and there are no unmatched clients or rejected outcomes for聽VHR聽episodes. Failure to action the rejections and the unmatched clients could lead to women not being invited or being invited inappropriately.

BS Select聽SSPI Update Warnings 鈥� Action monitoring report

BSOs聽should check and action (where appropriate) the 鈥楽SPI Update Warnings 鈥� Action鈥� report on聽BS Select聽for clients which have moved into their聽BSO聽with:

• the Event type of 鈥楽ubject joined聽BSO鈥� and
• the Warning type of 鈥楽ubject has HR status鈥�

20.2 Weekly reports

NBSS聽SASP8: 鈥淢issing聽MRI聽and ultrasound results鈥� report needs to be run at least weekly, with the parameters 0 to 52 weeks, to identify women with聽MRI聽or ultrasound results outstanding.

NBSS聽SASP5: 鈥淢issing results鈥� 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聽SPNTD聽report must be run monthly within the first week of the month. This will identify all聽VHR聽women eligible for invitation. 罢丑别听SPNTD聽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聽VHR聽screening to make sure that聽NTDDs聽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聽BSO聽since the prior month鈥檚 report.

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

SPNTD聽results should be cross-checked with the聽VHR聽list on the聽BS Select聽Higher Risk List monitoring report monthly. It will reveal any discrepancies between the 2 lists, which must then be investigated and rectified. 天美影院 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聽VHR聽women who have moved into the area, but not registered on聽NBSS. In these cases, the聽BSO聽need to make sure that all referral information is available within聽BS Select. If not, the information must be requested from the previous聽BSO聽and uploaded to聽BS Select.

Women that are now eligible for self-referral are not listed in the聽SPNTD聽VHR聽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聽聽for these women.

If a聽VHR聽woman transfers into the area aged 71 or over, then a check must be made on聽BS Select聽to make sure that she had her final invitation at age 70. If not, then the woman must be invited for her final聽VHR聽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 鈥� see Managing a VHR screening programme training and guidance slide set.

d) VHR聽women registered on聽BS Select聽18 years or over, but below Higher Risk screening start age, can be identified by reviewing the聽BS Select聽鈥楶ending Higher Risk List鈥� report. All聽VHR聽women below their screening protocol age should have their higher risk status set to 鈥楶ending鈥�. The Pending status can also be seen on the 鈥楬igher Risk List鈥�. 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 鈥楬igher Risk Short-Term Recall List鈥� will show all Higher Risk women in this category. 天美影院 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聽Home Page Alerts 鈥� Action

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

20.4 Annual reports

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

• are recorded on both systems as聽VHR
• have all necessary documentation in place (uploaded to聽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聽BS Select聽before being eligible for聽VHR聽screening showing a pending status (which means they will not be registered on聽NBSS)
• women were screened out of area
• women have now been deducted from聽BS Select

20.5 National KC62 return

VHR聽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聽VHR聽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聽is accessed 聽.