Guidance

Guidance on opting out (cease) from breast screening

Updated 13 July 2023

Forms A to F, as well as the standard template letters health professionals need to perform their duties, can be found online.

It is vital that women are only permanently opted out (cease) from the NHS Breast Screening Programme (BSP) when there is appropriate documentary evidence in line with BSP guidance.

Failure to comply with the guidance could result in women not receiving an invitation to screening when due, which could lead to a serious screening incident.

Eligible women are invited for breast screening every 36 months. The call and recall system is operated by local services using the breast screening select (BS Select) system. BS Select supports the invitation process in the national breast screening system (NBSS) and identifies eligible women for invitation at the correct time.

Women who choose to permanently opt out (cease) from the programme, and those who are no longer eligible due to medical reasons, can be permanently opted out (cease) from the call and recall process.

A woman who is permanently opted out (cease) from call and recall will not receive any invitation or reminder letters from the BSP unless she chooses to opt back into the programme.

To make sure that a woman is permanently opted out (cease) from the BSP, action is required on both BS Select and NBSS.

Separate practical training articles are available on the NBSS website to take you through the process.

A woman may want to temporarily opt out. This can be done by the individual contacting the screening service to inform them that she does not want to be screened following the recent invitation. She will be re-invited for screening in 36 months’ time when due for routine screening, if she remains eligible.

1. Reasons for temporarily opting out

Women may choose to opt out of an individual screening episode, rather than permanently opt out (cease). In this case, the woman will continue to be invited for breast screening while in the eligible age range.

The rest of the information in this section relates to how the NBSS episode should be managed.

1.1 Recent screen

Sometimes women will be invited for screening when they have already been screened in the last 6 months.

If a woman informs the service that this is the case, the screening appointment should be closed as recently screened (RS) on NBSS. Doing so will send an end code of PC (premature closure) to BS Select.

The woman’s next invitation will be either:

• when her GP practice is due to be screened
• via a failsafe batch if it is 36 months since her previous invitation

1.2 Pregnancy

Women can be screened during pregnancy following guidance on mammographic aspects.

There is no significant radiation dose to the foetus from mammography from a radiation protection perspective.

There is no requirement to ask about pregnancy before imaging.

1.3 Breast feeding

If a woman is breast feeding, screening can start again 3 months after lactation has ended.

The screening appointment should be closed as OT (opt out temporarily) on NBSS once the woman has informed the service. This will send an end code of PC to BS Select.

If women are breast feeding, screening can start again 3 months after lactation has ended.

1.4 Women in the high-risk programme who are pregnant or breast feeding

Women in the high-risk programme should not be screened with magnetic resonance imaging (MRI) while pregnant. In these circumstances, the screening appointment should be closed as OT on NBSS once the woman has informed the service, which will send an end code of PC to BS Select.

1.5 Under care and/or treatment

Women who have been referred for treatment following a malignant assessment outcome or malignant surgical biopsy will not be removed from the BSP. As a failsafe measure, they will continue to be invited in 36 months following a previous screening invitation.

When a woman contacts the service to inform them that they are undergoing follow-up, the service should close the episode with a CT (under care) on NBSS. This translates to PC on BS Select.

Services must continue to send an invitation to the woman even if they are aware that the woman is under care.

2. Permanently opting out (cease) due to informed choice

The NHS offers breast screening using the principle of informed choice.

Women can choose to permanently opt out (cease themselves) from the BSP at any time, and do not have to give a reason for their decision.

All initial screening invitations are accompanied by the helping women decide leaflet, which provides accurate and balanced information.

If a woman decides to opt out of screening, either temporarily or permanently, screening service staff should respect this.

Individuals must always be presumed to have capacity to make their own decisions, unless it is proved otherwise.

Some women can be supported to make their own decisions about attending, not attending temporarily or permanently opting out (cease) from the screening programme.

2.1 When a woman chooses to permanently opt out (cease)

Every woman who wants to permanently opt out (cease themselves) from the screening programme must:

• have already been invited for screening
• have been informed that permanently opting out (cease) from the programme will stop her from receiving any future invitations or reminder letters unless she changes her mind and decides to opt back in
• be asked to put her request in writing using the permanently opt out (cease) Form A, which must be signed and dated
• be notified in writing when the permanent opt out (cease) process has been completed using the standard template confirmation letter receipt of Form A

The service should cease the woman on NBSS and on BS Select and then scan Form A and confirmation of receipt of Form A onto the woman’s record within BS Select as a record of permanently opt out (cease).

Once successfully uploaded to BS Select, the documentation can then be confidentially destroyed.

2.2 Request to opt out in personal communication

Where the request to permanently opt out has been made by the woman in a personal communication, the woman should be asked to complete, sign and return Form A.

The service should cease the woman on NBSS and on BS Select and then scan Form A and confirmation of receipt of Form A onto the woman’s record within BS Select as a record of permanently opt out (cease).

If Form A is not received, the current NBSS episode should be marked OT and the clients’ screening status remain as ‘normal’ in NBSS and BS Select. This makes sure that she will continue to be invited.

2.3 Exceptional circumstances

In exceptional circumstances, a woman will write to the service and request to be ceased while refusing to sign and return Form A. If so, the director of breast screening and local trust/host organisation can authorise the ceasing of the woman.

Confirmation of ceasing must then be sent to the woman in writing. Verbal requests to cease must not be accepted.

Once successfully uploaded to BS Select, the documentation can then be confidentially destroyed.

2.4 Women who have moved into a new breast screening service and whose status is permanently opted out (ceased) by informed choice

When a woman is identified by a service as moving in with a status of permanently opted out (cease) due to informed choice, the new service must contact the woman using the national template ‘introductory letter’ moved in (cease) due to informed choice.

This letter informs the woman that she will not receive routine invitations but can request to opt back into screening at any point. If there is no response from the woman her status must remain permanently opted out (cease) by informed choice. The service must not issue an invitation unless the woman chooses to opt back in.

2.5 Women who go on to have a bilateral mastectomy

In the situation where a woman who has opted out of screening goes on to have a bilateral mastectomy, there is a requirement to update the reason for ceasing to bilateral mastectomy.

Documentation to support this change must be scanned into BS Select following the process for Form B.

Confirmation must be sent to the woman and copied to her GP using the standard template letter ‘confirmation of receipt of Form B’. This must then be scanned into BS Select.

3. Permanently opting out (cease) due to medical reasons

Women can be permanently opted out (cease) from the BSP for the following medical reasons.

3.1 Bilateral mastectomy

A woman can be permanently opted out (cease) from the BSP if she has had a bilateral mastectomy and is aged 18 or over.

This may be identified at a multidisciplinary team (MDT) meeting, alternatively the woman may contact the service and inform them of her bilateral mastectomy.

A discharge summary or pathology report is needed to make sure that screening is not appropriate. The evidence must be double checked by a medical professional to make sure the documentation supports the permanent opt out (cease).

Form B must then be completed, signed and dated and scanned onto the woman’s record within BS Select as a record of permanently opting out (cease). Confirmation must be sent to the woman and copied to her GP using the standard template letter ‘confirmation of receipt of Form B’. This must then be scanned and uploaded to the woman’s BS Select record.

This process can be applied to women before they are eligible for invitation to high risk or routine screening.

Due to the legal basis to hold information on BS Select, this can only be applied to women aged 18 or over.

Where the woman has not been invited for routine or high-risk screening, there is no need to create an NBSS registration to record the ceasing of the woman.

The registration and ceasing process should be completed on BS Select only. Women younger than 45 not already registered on BS Select, will need to be added to the system before being permanently opted out (cease). This is done using the new registration request form.

3.2 Mental capacity

Some women lack the mental capacity to consent to screening. Because of this, a decision has been made that it is in her best interests to remove her from the screening programme.

Double check the evidence within the breast screening office (BSO) and get it signed by a medical professional to make sure documents support the permanent opt out (cease).

Form C must then be completed, signed and dated as appropriate and scanned onto BS Select as a record of opting out permanently (cease).

Confirmation must be sent to the woman and copied to her GP using the standard template letter ‘confirmation of receipt of Form C and D’. Scan this onto BS Select.

If a permanent opt out (ceasing) decision must be made for, or on behalf of, a woman who lacks capacity, the person who makes the decision is known as the decision-maker.

This documentation should be uploaded, with a completed, signed and dated Form C, to BS Select as a permanent record of the decision.

Confirmation must be sent to the woman and copied to her GP using the standard template letter ‘confirmation of receipt of Form C and D’. This must be scanned to BS Select.

Permanently opting out (cease) from the BSP in a woman’s best interests is likely to be appropriate only:

• where the woman would never be able to consent for screening
• for further investigations and/or treatment in the event of a positive screening result

In most cases the least restrictive alternative is for the woman to remain in recall and receive screening invitations at routine intervals.

To permanently opt out (cease) a woman under a ‘best interests’ decision:

• efforts to support the woman to make her own decision must have been exhausted, and the woman’s lack of capacity must be formally acknowledged by the decision-maker
• the case must be considered individually, including a case conference with an appropriate family member or other personal representative of the woman
• the decision and all supporting evidence must be fully documented and stored with the woman’s medical record
• a formal permanently opt out (cease) request (see national template Form C) signed by the decision-maker (and patient representative if appropriate) must be uploaded to BS Select
• confirmation must be sent to the woman’s registered address and copied to her GP using the standard template letter ‘confirmation of receipt of Form C and D’, which must be scanned to BS Select
• the woman’s representatives must confirm that the situation will be reconsidered if the woman’s personal circumstances change

3.3 Decision makers

The decision-maker will usually be a healthcare professional such as the woman’s GP or other responsible clinician if there is no GP. It could also be the individual with a signed welfare power of attorney for the woman.

The decision-maker may only act if the woman cannot make her own decision even with support and assistance. The decision-maker will be legally accountable for any decision made which affects the woman now or in the future.

The decision-maker is required to consider all the relevant factors which affect the permanently opt out (cease) decision and consult with all the relevant patient representatives at a best interest meeting. The team must always act in the woman’s best interests.

Decision-makers must make an objective decision about the woman’s best interests without imposing their own views. Any decision should usually be the least restrictive of all options unless a restrictive option (such as the withholding of all future screening invitations) is in the woman’s best interests.

The decision should be reviewed regularly by the decision-maker to make sure that it remains appropriate since a woman’s best interests may change over time. Decision-makers are also required to document the decision-making process and keep a record that can be audited.

3.4 Personal welfare lasting power of attorney

On some occasions, a woman’s personal welfare lasting power of attorney deems it in her best interests to remove her from the BSP.

Evidence of personal welfare lasting power of attorney is needed and must be scanned onto BS Select as a permanent record.

Form D must be completed, signed and dated by the attorney.

The evidence must be double checked and signed by a medical professional in the service to make sure the documentation supports the permanent opt out (cease).

The signature of the personal welfare of lasting power of attorney and form D must be scanned onto BS Select as a record of permanently opting out (cease).

Confirmation must be sent to the woman and copied to her GP using the standard template letter ‘confirmation of receipt of Form C and D’. This must be scanned onto BS Select.

Once successfully uploaded to BS Select, the documentation can then be confidentially destroyed.

4. Permanently withdrawing (cease) from the high risk BSP

Women in the high-risk screening programme are able to permanently withdraw (cease) themselves from high risk screening once they have reached the protocol age for screening.

Form E must be completed and signed by the woman and then scanned and uploaded onto the woman’s record within BS Select.

Confirmation must be sent to the woman and copied to her GP using the standard template letter ‘confirmation of receipt of Form E’.

A woman who has permanently withdrawn (cease) from high-risk will remain in the routine screening programme. Once she reaches the eligible age, 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. At this point the process to follow is opting out permanently (cease) due to informed choice using Form A.

Confirmation must be sent to the woman and copied to her GP using the standard template letter ‘confirmation of receipt of Form A’.

The process for permanently withdrawing high-risk women in NBSS and BS Select is different to the process used for permanently opt out (cease) a woman.

Screening services should make sure they follow the correct processes to make sure the woman is invited for routine screening when of the eligible age.

Women at high risk who have had a confirmed bilateral mastectomy can be ceased using Form B. Confirmation must be sent to the woman and copied to her GP using the standard template letter ‘confirmation of receipt of Form B’.

5. Reasons for not permanently opting out (cease) women from the BSP

5.1 Not having been routinely invited to take part in screening

Women can only make an informed choice to permanently opt out (cease):

• from the routine BSP once they have been routinely invited or are invited within the AgeX trial

• from high risk screening once they have been invited for high risk screening

5.2 Physical conditions and disabilities

Physical conditions and disabilities are not a valid reason for permanently opting out (cease) women.

Screening is often possible with enough support and preparation. It is essential to explore what support and resources can be put in place to make sure those in greatest need have equitable access.

There are some disabilities and conditions affecting mobility that may prevent a woman from achieving a position where the breast can be adequately imaged. This may be temporary or permanent, depending on the condition.

A longer appointment for the screening test will be required at a static screening centre.

There is further information about screening women with physical conditions and disabilities.

In some cases, progress in medications or treatment can improve a woman’s situation so that a mammogram can be obtained when this was not previously possible.

Women can consider their own circumstances at each invitation, and decide whether they can accept the invitations.

Women who do not want to receive regular invitations, or who feel that screening is not appropriate for them, can permanently opt out (cease) using Form A. If a woman’s circumstances change, she can opt in at any time by contacting the screening service.

5.3 Terminal illness

Women who have a terminal illness remain eligible for screening and should be treated no differently. They should be invited for as long as they remain eligible. It is the woman’s decision whether to attend or not.

A woman can decide to not attend an appointment and temporarily opt out. Women who do not want to receive regular invitations, or who feel that they will not benefit from screening, are able to permanently opt out (cease) using Form A. If a woman’s circumstances change, she can opt in at any time by contacting the service.

5.4 Mental capacity

A woman may be eligible for screening but there can be circumstances which affect her ability to consent to the test (mammogram). The woman should only be permanently opted out (cease) if a best interest decision is made on her behalf. She will then be managed in the same way as women who choose to permanently opt out (cease).

Issues of mental capacity are subject to the Mental Capacity Act 2005. The Code of Practice for the Act is available. Additionally, there is also advice specifically for healthcare workers.

5.5 Learning disabilities

There are different physical and mental health conditions and learning disabilities which can affect an individual’s mental capacity. It is important to make sure that all eligible women have equality of access.

Women with learning disabilities can understand and consent to screening with adequate support and preparation.

Learning disability alone is not a valid reason for ceasing.

Guidance on supporting women with learning disabilities is available.

6. Non-binary and gender reassignment

Services should familiarise themselves with information in NHS population screening: information for transgender and non-binary people.

Trans men who continue to be registered as female will receive invitations unless they choose to permanently opt out (cease) using Form A.

Trans men who are still registered as female during or after gender reassignment, should be permanently opted out (cease) if they do not have breast tissue. Form B would need to be completed once clinical confirmation of bilateral mastectomy has been obtained.

7. Opting back into the BSP

A woman who decided to permanently opt out (cease) can opt back in at any time by contacting the screening service by:

• telephone
• email
• in writing
• via the website, provided the service has one

If a woman chooses to opt back in, she must have her status returned to ‘normal’ within the client registration screen in NBSS.

It is also necessary to uncease her in BS Select, by accessing her subject details screen and clicking the ‘remove cease’ button. Her screening status will then be displayed as ‘normal’.

Form F, detailing the reason for unceasing, should be completed and uploaded as part of her BS Select record.

She must be invited immediately, using a self-referral non-batch referral (NBR), if she was last invited more than 36 months ago.

If she was previously invited and attended less than 36 months ago, she will be invited when her GP practice is due to be screened. She may be included in the next routine failsafe batch if there are changes to her registration details.

8. Ceasing audits

Service specification number 24 requires breast screening services to audit the records of women who are permanently opted out (cease) from call and recall annually. This is to make sure these women have been managed correctly.

All documentation relating to an individual’s permanent opt out (cease) request must be retained in a secure and accessible location until scanned and uploaded to BS Select, after which it should be destroyed.

Permanently opted out (cease) women whose screening status cannot be verified must have their status returned to ‘normal’ on NBSS and BS Select as a failsafe measure.

As a minimum, the audit should confirm that all women permanently opted out (cease) have full documentation uploaded to BS Select and have a status of ‘ceased’ in both NBSS and BS Select as appropriate.

The results of this annual audit should be presented to the local screening immunisation team and SQAS at a programme board meeting. This process will be supported by an annual SQAS report presenting outcomes at breast screening service level. This will identify any services who may be required to review individual evidence for permanently opting out (cease) to reconcile records on both computer systems.

8.1 Identification of errors

Where a woman is permanently opted out (cease) from screening for any reason, and the necessary documentation or confirmation cannot be found during a ceasing audit, this must be considered an error.

8.2 Take immediate action

The case should be reviewed immediately to confirm that the woman should be returned to the programme and managed in accordance with guidance around incident management.

An invitation for screening should be sent without delay if one is due or overdue as a result of the inappropriate permanent opting out (cease). Consideration should be given as to whether a screening incident assessment form (SIAF) needs to be raised.

If there is evidence or concerns that systematic errors are being made in relation to temporary or permanent opting out (cease) by a screening service, advice should be sought from SQAS.

Managing safety incidents in NHS screening programmes explains the incident management procedures for NHS screening programme providers and commissioners and provide a form for notifying incidents to SQAS.

9. Specific responsibilities

With reference to the temporary and permanent opting out (cease) of women from the BSP, different organisations within the screening programme have several specific responsibilities. These are listed below.

9.1 GP practices

Practices need to:

• provide advice and support on request to women who want to make an informed choice to permanently opt out (cease)
• support and input into best interest meetings regarding women who may not have capacity to consent to screening or to permanently opt out (cease) from screening themselves
• inform the breast screening service when women have had a bilateral mastectomy

9.2 Breast screening services

Services must:

• make sure that documentation/forms and processes (including verification processes) meet minimum programme requirements
• provide opting out (cease) Form A to women if they request to permanently opt out (cease) from the programme
• act promptly when permanent opt out (cease) requests are made

Services must confirm to women in writing when they have been permanently opted out (ceased). They must use the appropriate national template letter confirmation of ceasing. Keep permanent opt out (cease) documentation in a secure and accessible location until it has been uploaded and saved onto BS Select. Paper documents can then be confidentially destroyed.

As a minimum, services also need to carry out annual ceasing audits at least once a year to confirm:

• appropriate supporting documentation is held
• the woman is correctly permanently opted out (cease) NBSS and BSS

The findings of the audit should be reported to the programme board.

Services must:

• make sure that women who cannot be confirmed as being permanently opted out (ceased) appropriately following a ceasing audit are returned to ‘normal’ status in NBSS and BS Select immediately and are sent an invitation if one is due or overdue as a result of the permanent opt out (cease)
• follow guidance on screening incidents and cooperate with screening incident investigations

9.3 Screening and immunisation teams (SITs) and commissioners

SITs need to obtain an overview of the annual permanent opt out (cease) ceasing audits, via the local screening programme board.

9.4 PHE SQAS

SQAS needs to have an overview of the annual permanent opt out (cease) ceasing audits via the local screening programme board. It also needs to assess, advise and oversee incident investigations involving permanently opting out (cease).

Contact the PHE Screening helpdesk with any queries about this publication, making sure you include its full title.