MSI Reproductive Choices District Treatment Centre - Leeds

Marie Stopes International (MSI) Leeds is part of Marie Stopes International UK founded in 1976 to make family planning services available to women and men around the world. Marie Stopes is a specialist reproductive healthcare organisation and registered charity. The Leeds Centre opened in 2006.

MSI Leeds provided medical and surgical termination of pregnancy services, pre and post termination counselling as well as contraception advice and screening for sexually transmitted diseases. The service was providing medical abortions up to nine weeks and four days gestation and surgical termination of pregnancy until 18 weeks and six days gestation. The service also carried out non-scalpel vasectomies. The service treated NHS and private patients.

We made an announced inspected of the service on 16-18 May 2016 and an unannounced inspection on 26 May 2016 as part of our independent healthcare inspection programme.

We have not rated this service because we do not currently have a legal duty to rate this type of service or the regulated activities, which it provides.

Whilst this inspection identified a number of positive factors it also identified someconcerns linked to the provider’s governance arrangements[WT1].[OL2][OL3]

Due to the number of concerns arising from the inspection of this and other MSI locations, we inspected the governance systems at the MSI corporate (provider) level in late July and August 2016. We identified serious concerns and MSI undertook the immediate voluntary suspension of the following services as of 19 August 2016 across its locations, where applicable:

• Suspension of the termination of pregnancy for children and young people aged under 18 and those aged 18 and over who are vulnerable, to include those with a learning disability

• Suspension of all terminations using general anaesthesia or conscious sedation

• Suspension of all surgical terminations at the Norwich Centre

MSI responded to the most serious patient safety concerns we raised and was able to lift the restrictions on the provision of its termination of pregnancy services at this location on 7 October 2016.

CQC has also undertaken enforcement action for breaches of the following regulations, which are relevant to this location.

Regulation 12 Care and treatment must be provided in a safe way for service users.

Regulation 13 Service users must be protected from abuse and improper treatment in accordance with this regulation.

Regulation 17 Systems or processes must be established and operated effectively to ensure compliance with the requirements in this Part. (Good governance)

Regulation 20 of the Care Quality Commission (Registration) Regulations 2009

CQC is actively monitoring compliance with the above enforcement action taken in order to ensure that services are operated in a manner, which protects patients from abuse and avoidable harm.

Are services safe at this service?

Staff understood their responsibilities to raise concerns and report incidents and near misses. Record keeping was of a consistently high standard and records were stored safely and securely. Staff we spoke with demonstrated they understood the principles of safeguarding adults and children and knew what actions they needed to take in cases of suspected abuse. We saw that all patients received a private initial consultation without anyone else present to safeguard against possible coercion or abuse and to give patients the opportunity to disclose such information in a safe environment.

However, we did not see evidence that local staff received regular information and learning messages from elsewhere in the organisation. Staff were trained to safeguarding adults and children level two, which was not in line with the ‘Intercollegiate Document’ (Royal College of Paediatrics and Child Health 2014) which recommends level three training for staff working in this type of service. At a national level we found that the in-house training provided was not tailored for the specific needs of patients seeking termination of pregnancy, or to educate and enable staff to meet safeguarding requirements of their patient group. Staff did not always follow procedures in line with medicines management policies.

Are services effective at this service?

Policies and pathways were in line with national best practice guidelines. We saw that patient assessments were thorough and staff followed pathway guidance. Records indicated that surgical patients received appropriate pain relieving medications and pain-relieving medications were routinely prescribed for patients to take at home following their procedures or initiation of medical treatment. We observed in consultations and records that staff always made sure patients gave their consent in writing and adhered to Fraser guidelines in respect of children and young people.

However, not all consultation staff had received training on giving oral contraception advice and dispensing. There were a number of policies requiring review and updating.

Are services caring at this service?

We observed that patients were treated with respect and compassion while they received care and treatment. Patients told us how they had been listened to, that they felt safe and were treated with kindness.

We were concerned that staff did not provide patients with full access to privacy and dignity when being cared for in the recovery area following surgical procedures. Staff did not inform patients of the requirement to submit abortion data to the DH.

Are services responsive at this service?

We found the service to be responsive to meeting people’s needs and requirements. Patients did not wait longer than three days for consultations although national guidance stipulated five days, not more than 10 days in total for treatment, and were offered appointments to suit them. Options were given, if requested, on the disposal of foetal remains following the guidelines as set out by the Human Tissue Authority. Complaints and concerns were acted upon and changes had been made to the service because of some comments made. Staff were involved in the learning from complaints. There was written information available to make a complaint but there were no posters displayed or leaflets available for patients to take away with them.

Appointments frequently overran due to shortage of time for staff to carry out all procedures with each patient and to ensure that the patients were sure about their decision. Patients sometimes had to wait for long periods to be seen and for prescriptions to be provided via the remote electronic system.

Are services well led at this service?

Although there was a committee and meeting structure, throughout the organisation, to facilitate governance and oversee risk and quality management there was not a structured approach for escalation of issues or information sharing. Local manager or staff representation or attendance was not evident at all relevant meetings. The corporate reporting structure enabled oversight of the whole organisation in relation to key performance indicators and allowed for performance benchmarking between units. However, it was not clear how achievement of some indicators represented quality of service for patients. We were not assured that all HSA4 forms were submitted and authorised within the Department of Health required time of 14 days following abortion.

The organisation vision of a world in which every birth is wanted and “children by choice, not chance” was well known and supported by staff at all levels. Local managers had a clear vision and strategy for their service and were keen to support services for patients. Quality of care and patient experience was seen as the responsibility of all staff. Most staff felt supported by their managers and were confident they could raise concerns and have them dealt with appropriately. There was a local risk register in place, which gave risks and mitigations, and we saw evidence that this was reviewed annually.

Our key findings were as follows:

• There were some staff vacancies and recruitment procedures were underway to increase the size of the team.

• Record keeping was good.

• Staff generally followed MSI policies and procedures.

• There was enough equipment to allow staff to carry out their duties. The service had processes in place for checking and maintaining equipment.

• Staff understood their responsibilities to raise concerns and report incidents and near misses but we were not assured that learning was shared across the organisation.

• Location staff and managers were able to verbalise what the duty of candour meant.

• Staff had not received children’s safeguarding training to an appropriate level and the training offered to staff did not meet the requirements for the patient groups they treated.

• Staff were competent in their roles, received an annual appraisal and support for revalidation.

• The service had a rolling programme of local clinical audits. Managers monitored and benchmarked performance of all units across the organisation using a performance dashboard.

• The governance structure did not provide clear processes for escalation of issues or shared learning.

• A number of policies were not in line with national guidance and required review.

• Managers were supportive and the culture encouraged candour, openness, and honesty.

We saw several areas of good practice including:

• Staff were described and observed as being non-judgemental.

• Staff were responsive to the individual needs of patients.

• Staff ensured that all patients received a private initial consultation without anyone else present to protect patients against possible coercion or abuse and to give them the opportunity to disclose such information in a safe environment.
• Staff had access to a ‘Do Not Proceed’ (DNP) team who would arrange referral to appropriate providers for patients with complex or additional medical needs, who did not meet usual acceptance criteria.
• Although we found that staff training did not meet the requirements of patient groups, staff we spoke with knew their own role and remits for safeguarding children and vulnerable adults and had a heightened awareness of the needs and vulnerabilities of children and young people using their service.

• Completion of records was consistently of a high standard

However, there were also areas of practice where the provider must make improvements. The provider must:

• Ensure that staff always follow procedures in line with medicines management policies with regard to refrigerated drugs and administration of controlled drugs.

• Review the children safeguarding training requirements for all staff to ensure the standard and level of training is in line with intercollegiate guidance 2014

• Ensure that all HSA4 forms are submitted to the DH within 14 days of abortion.

• Ensure women are informed of the requirement to submit abortion data to the DH and explain how this information is anonymised

Professor Sir Mike Richards

Chief Inspector of Hospitals