Care Quality Commission (Registration) Regulations 2009: Regulation 20
This regulation applies only to registered persons who carry on or manage the regulated activity of termination of pregnancies and are not an English NHS body. To meet this regulation the provider must follow the requirements of the regulation and the procedures and guidance issued by the Department of Health in May 2014, which are:
- Procedures for the Approval of Independent Sector Places for the Termination of Pregnancy (Abortion).
- Guidance in Relation to Requirements of the Abortion Act 1967
The Department of Health's guidance takes account of legal requirements and best practice in relation to termination of pregnancy. We have not provided further guidance in this document as it is either self-explanatory in the regulation or is addressed in the Department of Health's guidance. See the offences section for more detail about regulatory action CQC can take.
CQC must refuse registration if providers cannot satisfy us that they can and will continue to comply with this regulation.
Note:
Termination of pregnancy deaths are notified under this regulation rather than under Regulation 16.
The regulation in full
- This regulation applies to a registered person who—
- carries on or manages the regulated activity consisting of the termination of pregnancies; and
- is not an English NHS body.
- The registered person must ensure that, unless two certificates of opinion have been received in respect of the service user—
- no termination of pregnancy is carried out; and
- no fee is demanded or accepted from a service user.
- The registered person must ensure that a certificate of opinion in respect of a service user undergoing termination of a pregnancy is completed and included with the service user's medical record.
- The registered person must ensure that no termination of 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; and
- 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.
- The registered person must ensure that a register of service users undergoing a termination of pregnancy is maintained, which is—
- completed in respect of each service user at the time the termination is undertaken; and
- retained for a period of not less than 3 years beginning on the date of the last entry.
- The registered person must ensure that a record is maintained of the total numbers of terminations of pregnancies undertaken.
- The registered person must ensure that the record referred to in paragraph (7) (which may be in paper or electronic form) is—
- accurate;
- kept securely and can be located promptly when required;
- retained for an appropriate period of time; and
- securely destroyed when it is appropriate to do so.
- The registered person must ensure that notice in writing is sent to the Chief Medical Officer of the Department of Health of each termination of pregnancy.
- If the registered person—
- receives 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 Commission of that information, within the period of 14 days beginning on the day on which the information is received.
- The registered person must prepare and implement appropriate procedures to ensure that foetal tissue is treated with respect.
- In this regulation, "certificate of opinion" means a certificate required by regulations made under section 2(1) of the Abortion Act 1967.