Guidance

Consent and ceasing guidance

Published 4 January 2023

Applies to England

The NHS Bowel Cancer Screening Programme (NHS BCSP) currently invites eligible people aged between 60 and 74 to participate. This age range is being gradually extended so that by 2025 people will receive invitations every 2 years from the age of 50 to 74. People aged 75 or over can self-refer into the programme once every 2 years.

The initial test is a faecal occult blood test (FOBt) kit, posted to the invitee or self-referrer. The screening process differs from other screening programmes in that the first stage is completed by participants in their own homes, without the intervention or assistance of a health professional. If diagnostic tests are needed following the test kit result, these are carried out in local screening centres.

1. Informed choice

The NHS offers screening using the principle of informed choice. All prevalent screening invitations (not reminders) include a supporting information leaflet. This leaflet is also sent to anyone who self refers (those aged 74 or over) and late responders. The leaflet provides information about the possible benefits and risks of screening to help people decide whether or not they wish to take part. Incident screening invitations contain a link to an online version of the leaflet.

If a kit recipient chooses to complete and return the test kit, valid consent to the first stage of screening is demonstrated. Written consent is required from them for any subsequent diagnostic tests.

Some people who need help to make an informed decision about bowel cancer screening - for example, people with a learning difficulty - may also need additional help to use the FOBt kit. This is because the test is completed by the individual at home rather than being carried out by a screening practitioner. See section 3 below for more information about screening and making a best interests decision for someone lacking mental capacity.

2. Consent

If a test kit result shows a diagnostic test is needed, the individual is offered an appointment with a specialist screening practitioner (SSP) to discuss the test kit result and next steps.

At the SSP appointment the person’s fitness for further investigations is assessed. If the person is assessed as fit, they are offered a diagnostic test, usually a colonoscopy. If the individual is deemed unfit for colonoscopy, a CT scan may be offered instead.

All individuals offered a diagnostic test must be informed about the possible benefits and risks of the examination. This information is provided in the national information leaflet included with all result letters advising further tests are needed.

The SSP explains the appropriate diagnostic test, and should accurately and honestly answer any questions that the individual has. In addition, the individual must be assessed as being medically suitable for the procedure, either by the SSP or by a relevant responsible clinician (should a further opinion be required).

If an individual chooses to proceed with a diagnostic test, written consent is obtained before the procedure takes place.

All endoscopy units should have a withdrawal of consent policy, which must be adhered to. Everyone undergoing a diagnostic test should be told, and understand, that they can ask for the procedure to be paused or stopped completely. They should, however, have been made fully aware prior to the diagnostic test of the implications of abandoning the procedure.

If a patient asks that the procedure is abandoned there should always be a discussion with them regarding their options, for example more sedation, switching to sedation if unsedated or more pain relief. If, following this, the patient still withdraws consent then the testing clinician must recognise this and end the procedure as soon as is safe to do so.

2.1 Surveillance colonoscopy

In line with the British Society of Gastroenterology guidelines for post-polypectomy and post-colorectal cancer resection surveillance, some individuals who have polyps removed are offered a polyp site check and/or surveillance within the screening programme. Fitness to proceed and appropriateness is assessed on each occasion together with written consent.

3. Choosing not to take part in screening

There are 3 ways in which someone can choose not to participate in the bowel cancer screening programme. These are:

• non-response (not returning a test kit)
• opting out (temporary)
• ceasing (permanent)

3.1 Opting out

Opting out is temporary. It means the individual does not wish to take part in (or complete) their current screening episode, but does wish to be invited again in 2 years’ time (if still within the eligible age range).

If an individual decides to decline screening at any point in the pathway, their decision should be respected. The programme does not require a reason for their decision.

3.2 Ceasing (permanently opting out)

This is managed by a NHS BCSP hub and should not be carried out by a screening centre.

Ceasing is permanent (although the decision can be reversed). It means the individual chooses not to receive any further invitations for screening (and not to complete any current screening episode). Again, no reason for this decision is required by the programme.

Anyone who wishes to be ceased (withdraw permanently) from the screening programme must be:

• given or signposted to sufficient information, in an appropriate and accessible format, to support them making an informed decision
• informed that being ceased from the programme means they will not receive any future invitations or reminder letters regarding bowel cancer screening
• asked to put their withdrawal request in writing, ideally using a standard form provided by the screening programme, signed and dated (see note below)
• notified in writing when the ceasing has been completed, and a copy sent to their GP
• advised they can return to the programme at any time as long as they remain eligible for screening, following the process in section 3.3 below

Note: if it is not possible to get the withdrawal request in writing, or the individual refuses, a verbal request can be accepted. The hub director must agree the request (usually having listened to the call recording from the helpline). The director then completes episode notes and may sign the ceasing form on the subject’s behalf. A disclaimer letter is sent to the person explaining they have been ceased at their request. This letter includes the option for them to return confirmation of their request. The appropriate hub should receive and retain a copy of the disclaimer letter, and the call recording, as evidence.

People may also be ceased without requesting it if they lack the capacity to consent, and are ceased under a best interests decision (see section 4.3 below for further information).

The relevant programme hub ceases the individual on the bowel cancer screening system (BCSS).

3.3 Ceasing documentation

Requests for ceasing should ideally be made in writing and where possible using the form generated by BCSS. This is to ensure there is no misunderstanding, and no one is ceased from call and recall in error.

The national standard template form contains the information needed to support a ceasing request and is the preferred method of communication. The relevant hub sends the ceasing request form to the individual and an episode note is created. It is also acceptable for the person to send a clear and unambiguous signed letter. Email is also an accepted method of requesting ceasing, following the hub’s standard operating procedures.

In some circumstances it may be more appropriate to send a ‘sensitive’ ceasing form to complete. This may apply if the person has a terminal prognosis or confirmed no functioning colon, or it is deemed that the person may be upset by the standard ceasing letter (for whatever reason). The ‘sensitive’ letter does not include any references to cancer.

The withdrawal request is an important part of a person’s screening record and must be fully and accurately documented. For people who do not wish to sign any documentation, a hub director can listen to the call and confirm the ceasing decision.

3.4 Return to call and recall

Anyone who has previously opted out or asked to be ceased from screening can contact the bowel cancer screening programme to be reinstated. This process can be carried out by the:

• programme hub for reinstating screening invitations
• screening centre to rearrange previously-declined diagnostic tests

Someone who has previously chosen to be ceased from screening does not have to provide a written request to be reinstated – they can call the free programme helpline (0800 707 60 60).

If the person is over the age range for invitations (75 or older), they are not sent an invitation, but can request a test kit via the programme helpline. Anyone within the current invitation age range will be reinstated to receive invitations again every 2 years.

If a person is returned to call and recall within 2 years of their previous invitation, they receive their next invitation 2 years after their previous one (at their next test due date (NTDD).

If they are returned to call and recall 2 years (or more) after their previous invitation, the programme sends them a test kit as soon as they are reinstated on the screening system.

4. Circumstances that may prevent screening

4.1 Physical conditions and disabilities

Physical conditions and disabilities are not necessarily a valid reason for ceasing. Screening is often achievable with appropriate support and preparation. It is essential to consider what support and resources can be put in place to help support equitable access to screening.

Hubs can advise individuals and or family or carers of ways in which screening may be made more accessible, for example signposting to appropriate resources relevant to their needs, their GP practice or local screening centre.

Anyone who does not wish to receive regular invitations, or who believes that they will never be suitable for screening, should be offered the option to withdraw from the screening programme using the process for voluntary withdrawal (ceasing) described in section 3.2 above. If a person’s circumstances change, they can re-join the programme at any time. Those who do not wish to be ceased from screening can remain in the programme and continue to receive regular invitations.

4.2 Life limiting illnesses

Someone with a life limiting illness remains eligible for screening. It is an individual’s decision whether to complete the test kit or not. However, they should consider that a kit result may indicate further tests are necessary (such as colonoscopy or possibly a CT scan).

Those with life limiting illnesses who do not wish to receive regular invitations, or who feel that they will never benefit from screening, may withdraw (be ceased) from the screening programme using the process for voluntary withdrawal described in section 3.2. They can choose to re-join the programme at any time. Alternatively, you may advise an individual to simply opt out of their current screening episode, as this does not require completion of the (permanent) ceasing process.

4.3 Mental capacity

Issues of mental capacity are subject to the Mental Capacity Act 2005, with guidance laid out in the Code of Practice for the act. Mental Capacity Act advice specifically for healthcare workers is also available.

There are different physical and mental health conditions and learning disabilities which can affect an individual’s mental capacity. It is important to ensure that all people who are eligible for bowel cancer screening have equality of access to the service.

People with learning disabilities can often understand and consent to screening with adequate support and preparation. Learning disability alone is not a valid reason for ceasing. BCSP guidance on helping people with learning disabilities is available.

Individuals must always be presumed to have capacity to make their own decisions unless it is proved otherwise. Some people can, with appropriate support, make their own decisions about attending for screening, declining individual screening invitations while remaining in the programme, or withdrawing permanently from the screening programme. People who do wish to withdraw from the programme may follow the process for voluntary withdrawal described in section 3.

If a ceasing decision has to be made on behalf of a person who lacks capacity, the person who makes the decision is known as the ‘decision-maker’. This will usually be a healthcare professional such as the person’s GP, or other responsible clinician if there is no GP. The decision-maker may only act if the person cannot make their own decision even with support and assistance. The decision-maker is legally accountable for any decision made which affects the person now or in the future.

The decision-maker is required to consider all the relevant factors which affect the ceasing decision, and consult with all relevant patient representatives at ‘best interest meetings’. The team must always act in the person’s best interests, and make objective decisions without imposing their own views. Any decision should usually be the least restrictive of all options unless a restrictive option (such as withholding all future screening invitations) is in the person’s best interests. The decision should be reviewed regularly by the decision-maker to ensure that it remains appropriate, since a person’s best interests may change over time.

Decision-makers are required to document the decision-making process and retain an auditable record of this. Ceasing from bowel cancer screening recall in a person’s best interests is likely to be appropriate only where the individual would never be suitable for screening, or for further investigations and/or treatment in the event of a positive screening result. In most cases the least restrictive alternative is for the person to remain in recall and receive screening invitations at routine intervals.

The main requirements for ceasing under a ‘best interests’ decision are that:

• efforts to support the person to make their own decision must be exhausted, and their 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 person concerned
• the decision and all supporting evidence must be fully documented and stored with the person’s medical record
• ceasing documentation (see section 3.3) should be signed by the decision-maker and returned to the relevant hub
• the relevant hub must send a letter to confirm the ceasing to the person’s registered address so that it can be kept with their personal records, copied to the GP (if applicable); the letter should also explain how to re-join the programme if this is appropriate
• the person’s representatives must confirm that the situation will be reconsidered if the individual’s circumstances change

4.4 Health and welfare lasting power of attorney

A health and welfare lasting power of attorney (LPA) is a legal authority given by a person for someone else to make medical decisions for them in the future should they lack the capacity to do so for themselves.

The person can enact their LPA at any time, or it comes into force if they lose the capacity to make decisions for themselves.

An LPA has to be registered with the Office of the Public Guardian for it to be valid. The registration mark is clearly visible on the document.

Health and welfare LPAs clearly show what decisions can be made such as:

• receiving healthcare treatment
• not receiving a particular healthcare treatment
• stop receiving a particular healthcare treatment

There are some decisions which cannot be made, including:

• refusing any medication prescribed by a responsible clinician if the person has been sectioned or is on leave from hospital
• deciding about life-sustaining treatment without checking whether the person has made an advance decision about this

The relevant hub should record on BCSS that a health and welfare LPA has been seen and accepted as valid.

5. Ceasing screening invitations due to ineligibility

There are 2 reasons why someone may be ceased from screening invitations due to being ineligible for screening:

• age
• lack of functioning large bowel

5.1 Ceasing due to age

Individuals are automatically ceased from call and recall (and any screening surveillance programme) if their next invitation is due on or after their 75th birthday.

If a person requires ongoing surveillance after their 75th birthday, the screening programme makes arrangements for follow up in the symptomatic service according to local agreed pathways.

All result letters from the screening programme closing a screening episode includes information that the recipient will not be invited for screening beyond the age of 75 (but can still request screening every 2 years).

A person is also automatically ceased from recall if they fail to respond to a routine invitation sent on or after their 73rd birthday. This is because their next routine invitation would be due on or after their 75th birthday.

Anyone who has been ceased automatically due to age can still request screening regardless of age, once every 2 years.

5.2 Ceasing due to no functioning large bowel

A small number of people do not have a functioning bowel. Screening is not possible for these individuals in the current NHS BCSP. The programme hub should (permanently) cease such individuals from call and recall when the absence of bowel is notified to them. Obtain confirmation of the person’s condition from their GP or consultant before ceasing. Reference to content and source of any relevant correspondence should be recorded in a subject note on BCSS. The hub writes to the individual (copied to their GP) to confirm that he or she has been taken out of the screening programme.

A person should not be (permanently) ceased from screening if their bowel is only temporarily compromised, for example pending restorative surgery. It may be appropriate to temporarily opt them out of their current screening episode, depending on the likely length of time before they will be able to participate.

5.3 Ceasing (permanent opt out) audits

All screening hubs are required to carry out an annual audit of people who are ceased/ permanently opted out from recall. This is to ensure that all those who are ceased from recall have been managed correctly. All documentation related to a person’s ceasing requests must be retained in a secure and accessible location.

Where audit identifies a ceased individual whose screening status cannot be verified, that person must be returned to call and recall as a failsafe measure.

All hubs should have a ceasing standard operating procedure (SOP) in place, detailing how the ceasing audit is performed. The SOP should include checking for whether:

• the person was provided with or signposted to information to help them make an informed choice about whether to accept screening
• the appropriate actions/steps been taken on BCSS
• the person was sent all the correct and relevant information including letters and leaflets where appropriate
• confirmation of ceasing was sent to the person and their GP
• appropriate episode notes have been made on BCSS
• there is a copy of all signed paperwork held securely at the hub