Guidance

Procedures for the approval of independent sector places for termination of pregnancy (abortion) in England

Updated 30 March 2023

Applies to England

Introduction

The Secretary of State for Health and Social Care has a power under section 1(3) of the Abortion Act 1967 to approve places or a ‘class of places’ in England where treatment for termination of pregnancy (‘abortion’) may be carried out. The purpose of the required standard operating procedures (RSOPs) is to set out the relevant legislation and make explicit the conditions and requirements for all independent sector places to be approved for undertaking termination of pregnancy.

Schedule 1 to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 provides that the termination of pregnancy is a regulated activity. All providers of regulated activities must be registered with the Care Quality Commission (CQC) and meet fundamental standards of quality and safety as set out in Part 3 to the 2014 regulations. Registered providers must also meet the requirements set out in the Care Quality Commission (Registration) Regulations 2009. A CQC visit may form part of the registration procedure and will be arranged for a time and date mutually convenient to the applicant and the visiting teams.

CQC registration must be in place before the Secretary of State will consider an application for approval for the provider’s clinic as a place for the treatment of termination of pregnancy. It is unlawful for an independent provider to carry out termination of pregnancy without this approval of their clinic or independent hospital.

Approval of independent sector places is based on a core set of principles which aims to:

• ensure compliance with all legal requirements
• ensure provision of the best quality of care for patients
• provide sound management, organisational and clinical governance arrangements

Failure to comply with the legislation and/or the relevant requirements in the RSOPs may lead to withdrawal of the Secretary of State’s approval. The CQC may also take independent enforcement action under the Health and Social Care Act 2008, which includes the power to suspend or cancel registration and pursue prosecution.

A copy of the application form for the approval of places may be obtained from the Department of Health and Social Care (DHSC) Abortion Team (details below). The department will consider all applications. The application process may include visits to the premises by CQC staff.

Department of Health and Social Care
Abortion Team
39 Victoria Street
London
SE1H 0EU

Email: [email protected]

A list of approved clinics is available and updated on a regular basis.

Section 1: working with termination of pregnancy providers

The Department of Health and Social Care (DHSC) aims to give effective help and advice to those providing abortion services to comply with the requirements of the Abortion Act 1967, the Abortion Regulations 1991 and the RSOPs.

Providers are entitled to expect DHSC to:

• help understand how and when the Abortion Act 1967, the Abortion Regulations 1991 and the RSOPs apply
• set out the approval process and make this policy available to those wishing to apply for approval to carry out treatment for termination of pregnancy under the Abortion Act 1967
• notify applicants of the Secretary of State’s decision within 2 working days of the decision being taken and in writing within 14 days. Notification of the Secretary of State’s decision following application for re-approval will be sent before the start of the new period of approval

DHSC will be objective by handling enquiries fairly, treating all providers impartially and acknowledging general or specific enquiries, written or oral, within 5 working days, and dealing with these as quickly as possible.

If you are not satisfied, you can ask us to look at your complaint and for it to be examined at a senior level elsewhere in DHSC. You can also ask your MP to put your case to the Parliamentary Commissioner for Administration (the Ombudsman).

Section 2: regulatory framework

Abortion in Great Britain is governed by the Abortion Act 1967, which defines the criteria under which abortions can take place. All independent sector places undertaking termination of pregnancy are required to comply with:

• the Abortion Act 1967
• the Abortion Regulations 1991
• the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
• the Care Quality Commission (Registration) Regulations 2009
• the required standard operating procedures (RSOPs) set out in this document

Compliance with the Abortion Act 1967

The Abortion Act 1967 regulates the provision of abortion services. If an abortion is performed which does not comply with the terms of the act, then an offence will have been committed under the Offences Against the Person Act 1861 and/or the Infant Life (Preservation) Act 1929.

Section 1(4) of the act provides that, except in emergencies, 2 doctors must certify that in their opinion, which must be formed in good faith, at least one and the same grounds for abortion set out in the act is met.

Certification and notification

Schedule 1 to the Abortion Regulations 1991 sets out the forms for the purpose of certifying the opinion of a registered medical practitioner (RMP) under the act (forms HSA1 and HSA2 and EMA1). Schedule 2 to the regulations also set out the form (HSA4) for notification of abortions to the Chief Medical Officer (CMO). Completion of these forms is the responsibility of the RMP.

View abortion notification forms for England and Wales.

HSA1 must be completed by both RMPs certifying their opinion, formed in good faith, that at least one and the same ground for abortion in section 1(1) of the Abortion Act exists. The form must then be signed and dated by 2 RMPs before an abortion is performed. The HSA1 form must be kept with the patient notes for 3 years from the date of termination.

HSA2 is in relation to abortion performed in an emergency under section 1(4) of the Abortion Act. It must be completed before an abortion is performed or, if that is not reasonably practicable, within 24 hours of an emergency abortion and kept for 3 years from the date of termination.

RMPs to certify in ‘good faith’ that the gestation period is below 10 weeks if the doctor terminating the pregnancy prescribes the abortion pills from their home, or if one or both pills for early medical abortion are to be taken by the pregnant woman at her home. This certification must be recorded on form EMA1 or a similar certificate and must be kept for 3 years from the date on which the medicine for the treatment of the pregnancy is prescribed.

As a matter of best practice, we expect forms HSA1 and HSA2 and EMA1 to be kept with the patient’s notes. The HSA1 and HSA2 forms can be photocopied using a PDF of the form.

HSA4 must be sent to the CMO within 14 days (electronically or by post). This form is used by DHSC to check compliance with the Abortion Act. DHSC strongly encourages the use of electronic reporting as this is a more secure system and reduces the risk of lost or misplaced forms or missing data.

The Abortion Regulations 1991 have been amended to require additional information to be sent to DHSC in relation to the use of abortion medicines at home. Abortion providers will be legally required to submit this additional data where the prescription for EMA was prescribed on or after 1 April 2023 using the HSA4 form. There will be a 3-month transition period (between 31 December 2022 and 31 March 2023) during which it will be optional for practitioners or providers to submit the additional information if your systems allow for this.

DHSC has updated both the HSA4 paper form and the electronic version of the form on the Abortion Notification System to enable this additional information to be provided. The additional information required is:

• where both or one of the medicines is taken at home
• where treatment is entirely in hospital or clinic
• whether any part of the patient pathway (consultation and treatment) was provided face to face (in person) by an RMP, nurse or midwife
• an optional question on which organisation provided the termination

For further information on accessing and using the online system, please contact [email protected]. Supplies of HSA4 forms can be ordered by completing the online order form.

Delegation of duties - termination of pregnancy

The Abortion Act 1967 enables an RMP to carry out an abortion in certain circumstances. However, in relation to terminations, the courts, in 1981 have decided that, provided the RMP personally decides upon, initiates and takes responsibility throughout the process, the protection provided by the act will apply to the RMP and to any other person participating in the termination under his or her authority. The RMP is not required to personally perform every action. Certain actions may therefore be undertaken by registered nurses or midwives provided they are trained and where the provider has agreed protocols in place. For example, a nurse or midwife may administer the drugs used for medical abortions once these have been prescribed by a doctor.  

Early medical abortion

The legal framework allows women having an abortion during the first 10 weeks of pregnancy (up to 9 weeks and 6 days gestation) to take one or both medicines for early medical abortion at home. The legal framework also permits RMPs to prescribe from their usual place of residence. Home use must be carried out in line with the clinical guidelines published by the Royal College of Obstetricians and Gynaecologists (RCOG).

Conscientious objection

Section 4 of the Abortion Act 1967 allows those with a conscientious objection to refuse to participate in treatment authorised by the act unless that treatment is immediately necessary to save the life, or to prevent grave permanent injury to the physical or mental health of a pregnant woman.

Compliance with the Care Quality Commission legislation

The CQC registers the service provider of the regulated activity (in this case termination of pregnancy) once they can demonstrate that they meet the requirements of registration. CQC may also place conditions on the registration, for example, about where the regulated activity may be carried out or managed from.

Regulation 20 of the Care Quality Commission (Registration) Regulations 2009 sets out requirements relating to providers carrying out the regulated activity of abortions, in particular the registered person who (a) carries on or manages the regulated activity consisting of the termination of pregnancies; and (b) is not an English NHS body must ensure that no termination of a pregnancy is undertaken after the 20th week of gestation unless:

• the service user is treated by persons who are suitably qualified, skilled and experienced in the late termination of pregnancy
• appropriate procedures are in place to deal with any medical emergency which occurs during or as a result of the termination

The registered person must ensure that no termination of a pregnancy is undertaken after the 24th week of gestation.

Further guidance and details of the application process are available from the CQC website.

Section 3: required standard operating procedures (RSOPs)

Patient care

RSOP 1: access to timely abortion services

Providers should have arrangements in place to minimise delays in women accessing services and a choice of method should be offered where clinically appropriate.

Terminations should always be performed as early as possible after having received the woman’s informed consent to the procedure being performed.

To minimise delays, in line with NICE guidelines, service arrangements should be in place so that:

• women are offered an assessment within one week of the request
• women are offered the abortion procedure within one week of the assessment for those who decide to go ahead with the abortion

The planning and scheduling of appointments should be responsive to women’s needs. Women can choose to delay appointments or booked procedures. The NICE guidance is clear that for women who would prefer to wait longer for an abortion, providers can help them to make an informed decision by explaining the implications, including:

• the legal limit for abortions as stated in the Abortion Act
• that delaying the abortion will increase the risk of complications, although the overall risk is low

Appointments, care and treatment should only be cancelled or delayed by the provider when absolutely necessary. Women should be supported to access care and treatment again as soon as possible.

The RCOG recommends that appointments should be expedited for women who present beyond 12 completed weeks of gestation or who require abortion for urgent medical reasons, to minimise further risk to health.

For all gestations, women must be given a choice of surgical and medical terminations up to the legal limit as part of a care pathway.

Services that do not provide abortions at all gestations up to 23 weeks and 6 days should ensure arrangements are in place to quickly transfer women to appropriate providers through robust care pathways.

Where there are women with complex needs or significant co-morbidities, the provider must ensure that they have clinical pathways and protocols in place for referral to NHS specialist centres for abortion.

RSOP 2: contraception and sexually transmitted infections (STIs) screening

Providers should ensure that the full range of reversible contraceptive options are available, including long-acting reversible contraception (LARC) methods, and offer testing for STIs as appropriate.

Providers should ensure that the full range of reversible contraceptive options are available for women on the same day as their abortion, and that healthcare professionals have the knowledge and skills to provide all contraceptive methods. Healthcare professionals should initiate a discussion about contraception at the initial consultation, where women should be provided with information about all their contraceptive options. As far as possible, the chosen method should be initiated on the same day as their abortion, or as soon as possible as a follow-up. If the chosen method is not available, women should be provided with an interim bridging method that they can start immediately, and they should be referred to a service where the preferred method can be provided.

Advice should be given on the greater effectiveness and duration of LARC methods, for example implants and IUDs, and of their safety, but no pressure should be put on the woman to choose a particular method. Healthcare professionals fitting LARC methods must have the appropriate training and qualifications, in other words, the Faculty of Sexual and Reproductive Health Care’s Letters of Competency (LoCs).

Women who choose not to start a contraceptive method immediately should be given information about local contraception providers as well as their GP. Providers should have an agreed pathway of care to local sexual health services for initiation or continuation of contraception in the community. Other local pathways will also be relevant, for example assertive outreach for support and review for teenagers or those who have had more than one abortion.

All women should be offered an STI risk assessment and screening if appropriate, for example for chlamydia, gonorrhoea and for blood-borne viruses such as HIV and syphilis, if such testing is available. A system for partner notification and follow-up or referral to a sexual health service should also be in place. Where providers are unable to offer NHS-funded STI screening, women should be provided with information and clear pathways to be able to access sexual health testing services.

RSOP 3: counselling

Women are not required to have compulsory counselling or compulsory time for reflection before the abortion. However, providers should provide emotional support and counselling or refer women for support if they request this. For women who require formal therapeutic counselling, services should have referral pathways in place with access to trained counsellors with appropriate expertise.

Women should be advised to access support if they need it throughout the care pathway and be given information on how to access it (if relevant). This should include how to access counselling or for mental health interventions. Women who are unsure about whether to continue with the pregnancy or have an abortion should be offered counselling or decision-making support.

Counselling must be non-directive and non-judgemental and should not create barriers or delays. Counsellors should undergo continuous professional development and training similar to other professionals. Any woman who remains ambivalent after accessing pre-abortion counselling or support can be given a provisional appointment for treatment but must be told that the procedure can be postponed or cancelled and that she remains free to continue with the pregnancy if she so wishes.

Care pathways to antenatal services for those who choose to continue their pregnancy, and for women considering adoption, should be in place.

Post-abortion counselling, as outlined in the NICE abortion care recommendations, should also be available for those women who requested it. Providers should tell women that this support is available if they need it.

Providers must have robust safeguarding processes to identify those who require more support than can be provided in routine abortion service settings, for example children and young people, those with a mental health condition, those who may be experiencing sexual and/or domestic violence and abuse (physical and emotional), including where there is evidence of coercion, or poor social support. Services must have appropriate referral pathways to support services in place.

For women who require formal therapeutic counselling, services should have referral pathways in place with access to trained counsellors with appropriate expertise. Counselling must be impartial and put women’s needs first, irrespective of the employer or contractor of the counsellor.

RSOP 4: payment of fees

Providers must not request fees are paid for an abortion either directly or indirectly until 2 certificates of opinion necessary for a legal abortion under the act have been provided.

This requirement ensures that women are free of any fear of exploitation when accessing termination of pregnancy services. Where the abortion provider has a contract to provide abortion services on behalf of the NHS, the woman should be informed and should therefore not be charged a fee.

DHSC has published guidance on charging for overseas visitors in England, including any exemptions.

RSOP 5: fetal awareness and abnormality

Providers should have in place policies and procedures to manage the specific needs of patients seeking abortion for fetal abnormality which reflect guidance from the Royal College of Obstetricians and Gynaecologists (RCOG).

The RCOG published 2 reports:

• Fetal Awareness
• Termination of Pregnancy for Fetal Abnormality

These 2 reports contain information for clinicians, researchers and healthcare professionals. Abortion for fetal abnormality is more commonly performed in specialist NHS centres. However, providers should have in place policies and procedures to manage the specific needs of patients seeking abortion for fetal abnormality which reflect the RCOG guidance. There should also be a designated care pathway and referral arrangements to specialist support organisations.

All staff caring for patients must adopt a non-directive, non-judgemental and supportive approach. While in most cases the abnormalities will have been detected and confirmed in other settings, if scanning for abnormalities is performed, appropriate training should be undertaken by all staff involved.

Feticide

The RCOG recommends that feticide be performed before delivery, unless the fetal abnormality is lethal, on abortions performed after 21 weeks and 6 days gestation.

Providing information

RSOP 6: information for women

Women must be given impartial, accurate and evidence-based information (verbal and written) delivered in a clear, understandable and non-judgemental way.

Women should be informed about their options so that they can make an informed choice about their preferred course of action. Their choice should be respected without any unnecessary delay. As early as possible, women should be provided with detailed information covering the following:

• alternatives to abortions, for instance, adoption and motherhood
• the choice of abortion methods available and appropriate to their gestation, the potential adverse effects and complications and their clinical implications
• informed consent needs to address benefits, risks and options of methods including surgical abortion or pre-treatment ultrasound
• the range of emotional responses that may be experienced during and following an abortion
• for medical abortion, women should be informed that they may see the products of pregnancy as they are passed, and what the products of pregnancy will look like
• what pain management options are available
• what to expect during and after the abortion and how to identify signs and symptoms that indicate they need to seek medical attention and who to contact if they do
• that there is a small risk of failure to end the pregnancy
• options for disposal of pregnancy remains and women should be given verbal or written information about the options
• full discussion of the range of contraceptive options and how they can be accessed
• other available services, such as screening for sexually transmitted infections, including HIV

Alongside the above information, women having an early medical abortion at home should be given the following information:

• the implications (health and otherwise) of taking the abortion medicine beyond the legal limit of 9 weeks and 6 days gestation
• advice on self-management, including how to take the pills, expected effects, side effects and how to manage them, signs and symptoms of concern, how and when to obtain healthcare support
• how to dispose of or return the abortion pills if they are not used
• how they can be sure that the pregnancy has ended

Information should be available in a variety of languages and formats (for example, braille). Women must be given the opportunity to take the information away with them if they so wish, to inform their decision-making. Services should make use of the patient information by NICE and tailored local information.

Providers should make women aware that the contents of the statutory HSA4 form sent to the Chief Medical Officer will be used for statistical purposes by DHSC and that the data published is anonymised.

A suggested privacy notice is below:

‘Abortions in Great Britain must be carried out under the legal requirements set by the Abortion Act 1967. This Act requires abortion care services to send some information on the abortions they undertake to either the:

Chief Medical Officer at the Department of Health and Social Care (DHSC) for abortions that take place in England; or the

Chief Medical Office at the Welsh Government for abortions that take place in Wales.

The following information is sent:

• patient reference number (this could be your hospital clinic number or NHS number) or if this is not available your full name
• date of birth
• postcode
• ethnicity
• marital status
• number of previous pregnancies
• treatment details

This information is also used to produce abortion care statistics with the aim of monitoring and improving services. DHSC follows extremely robust procedures to avoid the possibility of individuals being identified from the data.

The anonymised data may also be shared with the Office for National Statistics to produce conceptions data and research organisations for statistical and research purposes.’

RSOP 7: post procedure

All providers should have protocols in place covering the support for women following an abortion procedure.

Women should be informed as early as possible of the most common physical and emotional or psychological symptoms following an abortion, including after use of pills at home for early medical abortion. Information provided to women should include what to do in an emergency situation as well as routine follow-up.

On discharge, women must be given a letter providing sufficient information about the procedure to allow another healthcare practitioner to manage any complications and/or ongoing care. A 24-hour dedicated support line which specialises in post-abortion support and care, staffed by individuals trained in offering support in this speciality, should be made available.

Irrespective of method or gestation, all women having an abortion should be informed of routine follow up and/or post-abortion support or counselling. This does not have to be face-to-face with a counsellor or provided directly by the abortion provider. Pathways to services should be available for any woman who may require additional psychological support or whose mental health is perceived to be at risk.

It is recommended that, wherever possible, the woman’s GP should be informed about any treatment for abortion. Providers should explain the reason; that in the event of a woman requiring post-abortion emergency care or related care in the longer term, the GP would be aware of all treatments provided and be in a better position to determine the appropriate therapy. All women should be told of their right to confidentiality and their decision must be respected if they do not want their GP to be informed.

Safeguarding

RSOP 8: service provision for children, young people and vulnerable adults

All providers must comply with legal requirements and have regard to any statutory guidance relating to children, young people and vulnerable adults. All providers must have policies and protocols in place for dealing with these groups, including robust safeguarding processes.

The Sexual Offences Act 2003 provides a framework of offences to protect children of all ages from sexual abuse and exploitation. The law makes clear that the age of consent is 16, and that sexual activity involving children under 16 is not lawful.

Managing suspected child abuse or exploitation in abortion services can be complex. The need for a decision on an abortion may be urgent because of advanced gestation. However, managing the clinical aspects of care must not prevent staff from being alert to the possibility of abuse. This may be relevant particularly where a young woman refuses to involve a responsible adult.

It is recommended that providers use the Spotting the Signs pro forma developed by the British Association for Sexual Health and HIV and Brook, to support health professionals to identify young people attending sexual health and abortion services who may be at risk of or experiencing sexual exploitation.

Providers should have regard to the statutory guidance Working Together to Safeguard Children. This guidance is issued under section 11 of the Children Act, which places duties on a range of organisations and individuals to ensure their functions, and any services that they contract out to others, are discharged having regard to the need to safeguard and promote the welfare of children.

These duties extend to NHS England, integrated care boards (ICBs), NHS trusts and NHS foundation trusts. NHS England and ICBs are accountable for the services they commission from all provider organisations. The guidance sets out obligations on healthcare and other professionals who work with children, and how various agencies and organisations involved should work together in the interests of the child.

The NHS England’s Safeguarding accountability and assurance framework complements the statutory guidance and sets out the safeguarding roles and responsibilities of all individuals working in providers of NHS-funded care settings and NHS commissioning organisations. All health providers are required to have robust arrangements in place to safeguard all children and young people and to assure themselves, regulators and their commissioners that these are working effectively. These arrangements include safe recruitment, effective training of all staff, effective supervision arrangements, working in partnership with other agencies and identification of a named doctor and a named nurse for safeguarding children, who should work closely with the organisation’s safeguarding lead.

Healthcare professionals are required to be competent in child safeguarding and are expected to participate in regular training to update their skills. All healthcare staff working in abortion services should be trained to at least level 3 of the Royal College of Nursing intercollegiate framework Safeguarding Children and Young people: Roles and Competences for Healthcare Staff.

Children and young people aged under 16

A doctor or health professional is able to provide contraception, sexual and reproductive health advice and treatment, including abortion, without parental knowledge or consent, to a young person aged under 16 years, provided that the doctor or health professional is satisfied that the conditions set out in the Fraser Guidelines are met. As a matter of best practice, every effort should be made to encourage young women aged under 16 to involve or inform a responsible adult (over 18 years old) during and after treatment. If they do not want to inform a responsible adult, this should be considered in the safeguarding and risk assessment.

Under-13s

The total number of abortions performed on girls aged under 13 years of age tends to be very small (less than 10 a year) and are carried out by both the NHS and independent providers funded by the NHS. Children aged under 13 seeking an abortion, including EMA, must have a safeguarding risk assessment and an in-person appointment arranged as soon as possible.

It is essential that the medical, psychological and social needs of such children are met in an appropriate environment, for example, a facility for clinical assessment to confirm gestation and safeguarding action. The inpatient health facility caring for children under 13 accessing abortion must inform their named doctor or nurse for safeguarding children and the designated doctor or nurse for safeguarding children for the local authority area.

Account should also be taken of guidance to doctors from the General Medical Council (GMC) that ‘you should usually share information about sexual activity involving children under 13, who are considered in law to be unable to consent. You should discuss a decision not to disclose with a named or designated doctor for child protection and record your decision and the reasons for it’.

Guidance

DHSC expects all abortion providers to have due regard to the Royal College of Paediatrics and Child Health national guidance on safeguarding under-18s accessing early medical abortion services specifically. The guidance sets out that all children and young people under 18 seeking early medical abortion should be offered an in-person consultation at some point in the care pathway and that providers and commissioners should ensure that if this is desired, that any barriers to in-person attendance are mitigated.

The General Medical Council’s guidance for doctors includes advice on safeguarding and how to deal with confidentiality issues, including disclosing information without consent.

Vulnerable adults

Considerations around safeguarding may arise in the case of adult women who may be vulnerable to abuse or coercion because of a range of issues. These may include a learning disability, dementia, mental health problem or other difficulty, women who have been raped or experienced domestic violence and/or intimate partner abuse. Providers must ensure that all staff are trained in recognising the signs of potential abuse and coercion in adult women and know how to respond.

The Domestic Abuse, Stalking and Honour Based Violence (DASH) risk identification model accredited by the National Police Chief Council is a useful resource to identify risk, intervention and prevention. Providers must have written guidance that staff are aware of and can easily refer to. Staff must have easy access to a named lead in the organisation for guidance and advice.

Protocols must be in place for onward referral to specialist services. Providers must follow agreed inter-agency policies and procedures developed by the relevant Safeguarding Adult Boards, where they have reason to suspect someone has experienced abuse.

Guidance

The Domestic Abuse Statutory Guidance is issued under section 84 of the Domestic Abuse Act 2021. It provides clear information on what constitutes domestic abuse and how to recognise it, supporting frontline professionals and improving the institutional response to domestic abuse by conveying best practice and standards. It aims to ensure that domestic abuse is properly understood and that all public agencies and relevant parties are applying a common definition in seeking to tackle this abhorrent crime and provide support services to survivors and their children.

RSOP 9: confidentiality

Providers must have measures in place to safeguard patient confidentiality and all staff must be familiar with them.

As a matter of law, women seeking an abortion have the right to confidentiality from all clinical and ancillary staff. NHSEI published the Confidentiality Policy in 2019. It is recommended that providers consider this document and any subsequent supplementary guidance, which sets out required practice for those who work within or under contract to NHS organisations.

We recognise that aggregated, anonymised patient information needs to be shared with commissioners and public health staff to inform the planning and commissioning of abortion services. However, information disclosed for these purposes must not include any information which could identify a patient.

RSOP 10: consent

Providers must have pathways and protocols in place for obtaining consent and support for all women and young people who lack capacity to consent.

Women must be given adequate and accurate information concerning the procedure that allows them to reach a considered decision, and good practice principles should be followed at all times when obtaining consent.

All women aged 18 or over are considered to have capacity to give consent unless there is evidence to the contrary (see section 1(2) of the Mental Capacity Act 2005). Consent provided by a 16- or 17-year-old woman has the same legal effect as consent provided by an adult (see section 8 Family Law Reform Act 1969).

Consent must be:

• provided voluntarily and without undue pressure on the woman to accept or refuse treatment
• based on sufficient and accurate information (informed consent)

An adult will lack the capacity to consent where they are unable to make the decision because of an impairment of, or disturbance in the functioning of, the mind or brain; see section 2 of the Mental Capacity Act 2005. A person is unable to make a decision where they are unable to:

• understand the information relevant to the decision
• retain that information
• use or weight that information as part of the process of making the decision
• communicate their decision by any means (see section 3 of the Mental Capacity Act 2005)

If a woman has learning disabilities, this does not automatically mean that she is unable to make a decision and to consent. Professionals must provide information and support to assist her to understand and weigh up the issues. Where she nevertheless remains unable to consent, then a capacity assessment needs to be carried out. If she is found to lack the capacity to make the decision, then a decision about abortion needs to be made by the Court of Protection. The court has its own website with information about how to make an application, including procedures for urgent applications. Neither family members nor professionals can consent on behalf of a person who lacks capacity.

A young woman who is under 16 years of age can consent and be provided with advice and treatment, including an abortion, without parental consent or knowledge, provided she meets the requirements following assessment under the Fraser Guidelines. This assessment should be undertaken by health professionals with appropriate training and experience in working with this age group.

Under-13s

Whilst there is no lower age limit for Fraser Guidelines to be applied, it would rarely be appropriate or safe for a child under 13 to consent to treatment without a responsible adult’s involvement. Children under 13 are not legally able to consent to any sexual activity, and therefore any information that such a person was sexually active would need to be acted on, regardless of whether the Fraser Guidelines had been met.

In complex situations regarding consent, professional and legal advice should be sought urgently to ensure that the timeframes are met for accessing legal abortions.

Guidance

The principles of good practice which all health professionals are expected to follow when seeking patients’ informed consent to examination or treatment are set out in the GMC’s guidance Decision making and consent.

Providers are expected to have regard to GMC publications:`0-18 Years: Guidance for all doctors’ (paragraphs 63 to 65), which provides information for doctors dealing with young people and abortion and Protecting children and young people: the responsibilities of all doctors (2020).

The British Medical Association’s (BMA’s) The law and ethics of abortion and the department’s comprehensive reference guide to consent for examination or treatment are additional resources for good practice in this area.

Consent requirements for providers of regulated activities are also set out under regulation 11 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

Providers offering online counselling and preventive services must comply with the General Data Protection Regulation and the Data Protection Act 2018.

The Royal College of Obstetricians and Gynaecologists provides a good practice clinical framework for obtaining valid consent in obstetrics and gynaecology.

Service organisation

RSOP 11: patient feedback and complaints

All providers must establish and effectively operate an accessible system for identifying, receiving, recording, handling and responding to complaints by service users and other persons in relation to the termination of pregnancy service. Providers must also have systems in place to undertake post-care patient satisfaction surveys and feedback on the treatment they have received. Surveys and feedback are generally agreed with local commissioners.

RSOP 12: notification of change of provider

All providers must inform DHSC of any change in the ownership of the controlling business or in the premises.

A new approval is required in every case where the ownership of an approved place changes, for example, change of address of the clinic. Providers must also notify any significant deviation from the design, layout or operation of the premises or business arrangements applicable when the approval was granted.

RSOP 13: notification of death of a patient

Arrangements must be in place to immediately notify the CQC and DHSC in the event of the death of a patient while abortion was being provided or may have been a result of the abortion.

Regulation 20(10) of the Care Quality Commission (Registration) Regulations 2009 requires that the registered person must give notice in writing to the CQC information concerning the death of a service user who has undergone termination of a pregnancy during the period of 12 months ending on the date on which the information is received and has reason to believe that the service user’s death may be associated with the termination. The registered person must give notice in writing to the CQC of that information, within the period of 14 days beginning on the day on which the information is received.

CQC has issued guidance for non-NHS trust providers on how to notify them of a death of a patient.

If the notification has been provided verbally over the telephone to DHSC, information should be confirmed in writing to the DHSC within 24 hours.

RSOP 14: performance standards and audit

In addition to national clinical standards, all providers should have in place clear locally agreed standards against which performance and care quality can be audited, with specific focus on outcomes and processes. These local standards are generally agreed with local commissioners.

RSOP 15: confirmation of professional status

Providers must have a named senior manager or director who is responsible for ensuring that qualifications, experience, GMC registration and/or NMC PIN reference are confirmed for all medical, midwifery, nursing staff and counsellors.

The senior manager or director is also responsible for ensuring that all medical, midwifery, nursing and counselling staff have their qualifications, knowledge and skills reviewed on a regular basis to ensure that they are kept up-to-date with current practice.

Robust methodologies should be in place to ensure professional requirements are met.

RSOP 16: maintaining standards

The approval process provides a framework for maintaining the safety and quality of care in a fully integrated independent sector abortion service. In keeping with the concept of clinical governance, the CQC will be responsible for ensuring that the requirements under the Health and Social Care Act 2008 are maintained through a system of monitoring and, where appropriate, inspection visits.

The CQC takes account of the RSOPs when interpreting the requirements on providers of terminations and there is also overlap between the requirements; meaning that the department can monitor compliance with the RSOPs by communication with the CQC.

It is the responsibility of providers, in consultation with their commissioners, to develop good clinical practice within their local setting, reflecting evidence-based guidelines from relevant professional bodies.

Workforce

RSOP 17: staffing and emergency medical cover

Providers must ensure that staff have the relevant skills and training and are competent to carry out abortions.

Abortion providers must ensure there is a sufficient number of staff with the right competencies, knowledge, qualifications, skills and experience to safeguard the health, safety and welfare of all who use the service and meet their routine and non-routine needs.

Abortions, particularly those at later gestations, require additional training and particular skills for medical, midwifery and nursing staff. Therefore, they must be conducted by healthcare professionals who can demonstrate that they have sufficient, regular and recent experience to ensure that their specialist skills are maintained.

NHS-funded care is expected to meet guidance on staffing levels provided by the National Quality Board where this is applicable. In addition, staff at all levels should be able to demonstrate awareness of the recommendations in relevant NICE guidance.

Procedures and protocols must be in place to deal with emergencies underpinned by regular training in emergency procedures, especially basic resuscitation. Evidence must be available that training has taken place. Protocols should also cover transfer to specialist services including intensive care and dealing with anaesthetic emergencies. Anaesthetics and conscious sedation must be administered in line with guidance from the Royal College of Anaesthetists. The monitoring of patients under sedation or anaesthetic must be undertaken in line with national guidance.

Registered medical practitioners

Registered medical practitioners should take account of guidance published by professional bodies and the appropriate Royal Colleges. In the case of general anaesthesia being administered or intravenous sedation, this should include guidance issued by the Academy of Medical Royal Colleges.

Nursing and midwifery staff

One first level registered general nurse or registered midwife should be on duty in the clinic or hospital at all times when there are patients who will need their care. The person in charge of each shift throughout the 24-hour period should be a first-level registered nurse or registered midwife able to accept professional responsibility for the smooth running of the clinic, of other staff and of patients. The first-level nurse or registered midwife should be supported by appropriately qualified registered nurses or midwives.

There should be an adequate number of appropriately trained and competent nurses or midwives available from the time treatment commences to the time treatment ends. Midwifery and nursing staff must be competent in the use of all the equipment they may be called upon to use as part of their duties.

Each registered nurse or midwife should have the appropriate knowledge, training and confidence to initiate immediate action in the event of an emergency and before further medical help arrives.

Registered midwives and nurses should not be asked to undertake duties for which they are not clinically trained and competent. Nursing or maternity support workers are not nurses or midwives, and therefore should not be expected to carry out duties or responsibilities in excess of their competence or which are those of a registered nurse or midwife. Arrangements must be in place to ensure that all auxiliary support staff and operating department practitioners are aware of the principles of good quality care and the need to respect patient confidentiality.

Records of duty and shift rotas must be kept for 4 years after the year to which they relate. A named senior manager should be responsible for ensuring that these are complete and accurate, and that staff attend according to the rota.

RSOP 18: professional guidelines

Providers should have regard to relevant clinical and professional guidance.

Good-quality clinical practice is guided by authoritative clinical guidelines and professional opinion, such as that provided by relevant Royal Colleges. In relation to abortion, the guidelines published by the Royal College of Obstetricians and Gynaecologists, and the National Institute for Health and Care Excellence (NICE) are of particular relevance.

In particular, and in line with NICE guidelines, abortion care should be delivered within a robust clinical governance framework to assure accessibility, clinical quality and patient safety in line with CQC regulations. Health professionals working within the service must be appropriately trained and experienced. Clinical appraisal and revalidation procedures also ensure that staff keep up-to-date with the continuing professional development requirements set down by their professional body and registered persons must monitor compliance with these standards.

Safety

RSOP 19: risk management and patient safety

All providers must have in place a formal risk management system and a risk register to identify and minimise any risks to patients and staff within their premises. Protocols in line with the NHS Patient Safety Strategy must exist on action to be taken when patient safety incidents occur.

Within 6 months of its launch, providers should be using the NHS Patient Safety Incident Response Framework (PSIRF) to inform their response to patient safety incidents. PSIRF replaces the current Serious Incident Framework (2015). Providers should have agreed protocols in place for reporting patient safety incidents and outcomes of investigations to the CQC and their local integrated commissioning boards.

All providers must have a governance structure in place that identifies and mitigates risk and ensures that lessons are learnt from incidents that occur. An adverse event reporting system must be in place so that recurring themes can be addressed across their service.

Providers should have a system of learning from regulators findings and from reports from professional bodies. Providers should ensure that there are systems in place to review such reports and to identify learning across the service provided.

Regulation 15(1) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 states that premises must be “appropriately located for the purpose for which they are being used”.  Providers should agree the location of the abortion service in consultation with the relevant integrated care board, to ensure local population needs are met. Providers must remain cognisant of issues around privacy and public sensitivity and ensure the location of the abortion service provides comfortable and safe access to service users. 

RSOP 20: disposal of pregnancy remains

All providers should have policies on disposal of pregnancy remains which take account of relevant guidance. Information about disposal should be available for women setting out their choices.

The Human Tissue Authority (HTA) regulates activities concerning the removal, storage, use and disposal of human tissue. It has issued practical guidance to professionals carrying out activities which fall within its remit to help establishments develop appropriate policies. To inform policies and procedures governing the disposal of pregnancy remains resulting from pregnancy loss or termination of pregnancy in a clinical setting, including NHS and independent hospitals and abortion clinics, the HTA has guidance on the disposal of pregnancy remains following pregnancy loss or termination.

Regulation 20 (11) of the Care Quality Commission (Registration) Regulations 2009 sets out that the registered person must prepare and implement appropriate procedures to ensure that fetal tissue is treated with respect.

The Stillbirths and Neonatal Society position statement on pregnancy loss and the death of a baby also highlight the need for sensitive disposal:

‘Parents should always be given the choice of cremation, burial or making their own arrangements following a pregnancy loss prior to 24 weeks. However, sensitive incineration should remain an option.’

Women may decide to arrange disposal themselves and they are free to do so. The Royal College of Nursing’s document, Managing the disposal of pregnancy remains, highlights the options.

RSOP 21: maintenance of equipment

Providers must minimise risks of harm caused by equipment failure through regular checking and servicing of equipment.

All equipment must be properly maintained and suitable for its purpose. This is particularly the case with anaesthetic and patient monitoring equipment. Guidelines for checking anaesthetic machines are available from the Association of Anaesthetists.