Marie Stopes International Manchester Centre (MSI Manchester) is part of the Marie Stopes International group. The service provides surgical termination of pregnancy procedures (SToP) up to 23 weeks and six days gestation along with medical termination of pregnancy and early medical termination of pregnancy (MToP) up to nine weeks and four days gestation.

Treatment can be provided under no-anaesthesia, conscious sedation and general anaesthesia, according to patient choice and needs but the service does not carry out manual vacuum aspiration procedures. Women are provided with advice on contraceptive options, oral contraception and long acting reversible contraception (LARC). The service also provides male sterilisation (vasectomy).

In terms of medical abortions, the provider offers four treatment options. Medication can be administered at the clinic in two stages with six hours, 24 hours, 48 hours or 72 hours in between each stage. At the time of inspection the service did not currently offer simultaneous medical abortions, but plans were in place to pilot the reintroduction of simultaneous administration in August 2017 (whereby both stages of medication are administered at the same appointment with a 30 minute gap between each stage). This would prevent women from having to attend twice for treatment.

In addition, MSI Manchester has 10 satellite clinics, (early medical units EMU) across Greater Manchester and Lancashire, where they carry out consultations and early medical abortions up to nine weeks and four days. Staff work on a rotational basis between the satellite clinics and MSI Manchester.

To get to the heart of patients’ experiences of care and treatment, we ask the same five questions of all services: are they safe, effective, caring, responsive to people's needs, and well-led? Where we have a legal duty to do so, we rate services’ performance against each key question as outstanding, good, requires improvement or inadequate.

Throughout the inspection, we took account of what people told us and how the provider understood and complied with the Mental Capacity Act 2005.

We regulate termination of pregnancy services, but we do not currently have a legal duty to rate them when they are provided as a single specialty service. We highlight good practice and issues that service providers need to improve and we take regulatory action as necessary.

Since our last inspection in 2016, we have noted the following improvements at MSI Manchester Centre:

• There had been changes to the way syringes containing an induction agent were stored. Each syringe was covered with a cap to reduce the risk of cross infection.

• Daily cleaning schedules had been fully completed.

• The service had implemented a system to ensure chair covers in the recovery area were checked and cleaned between each patient

We found the following areas of good practice:

• Staff demonstrated they understood the principles of safeguarding adults and children and knew what actions they needed to take in cases of suspected abuse.

• World Health Organisation (WHO) and five steps to safer surgery checklists were completed for all patients undergoing surgical procedures.

• There were locally agreed and up to date policies and standards that referred to evidence based practice and against which performance was audited.

• Records indicated that pain was assessed and treated in accordance with national guidelines.

• Staff treated patients attending for consultation and procedures with compassion and respect; staff were non-directive and non-judgemental.

• The service worked towards key performance indicators to assess and monitor performance. These were reported each month via the governance and quality dashboard.

• All new staff, were inducted and followed a training programme; this included a competencies framework and continuous assessments by their mentor and senior manager.

• Ultrasound scanning was undertaken by staff who received a bespoke ultrasound training course to date pregnancy provided by a qualified external sonographer delivered in line with the requirements of MSI policy.

• Staff across the service were aware of appropriate procedures in obtaining consent. They were familiar with guidance, such as Fraser guidelines.

• People could access the service when they needed it. Waiting times from treatment and arrangements to admit, treat and discharge patients were in line with good practice.

• A governance framework supported staff to deliver good quality care through the identification and monitoring of risks. As part of the wider corporate organisation, the clinic had a clear governance and committee structure in place, including clinical governance, medical advisory and health and safety committees.

However, we also found the following issues that the service provider needs to improve:

• The registered manager had not reported a notifiable serious incident to the CQC.

• Two nursing staff were not up to date with either basic life support training or immediate life support training.

• Although the April 2016 hand hygiene audit showed 100% of staff complied with infection prevention control protocols, observations whilst on inspection indicated that staff did not always follow protocols when performing patient care.

• The clinic’s counsellor was not trained to safeguarding level three. We raised this as a concern and all face to face counselling sessions for patients were immediately changed to telephone sessions.

• There was a lack of local oversight for training and revalidation for surgeons and anaesthetists attending the clinic. The senior manager was unable to show us hard copies or electronic personnel files that belonged to doctors who worked at the clinic. At the time of inspection the Registered Manager was unware how to access these documents.

• Records showed not all nursing and medical staff had received an appraisal in 2016.

• Contraception arrangements included long acting reversible contraceptive (LARC); the clinic did not achieve their target of 50% between the reporting period of April – June 2017.

• Evidence of discussion in relation to disposal of pregnancy remains was not always documented in records.

• Women were not routinely informed and did not receive a discussion to explain to them that their details were sent to the Department of Health.

Following this inspection, we told the provider that it MUST take action to improve:

• The provider must ensure that the layout of the day room, where patients recover following surgical treatment, does not compromise patients’ privacy and dignity.

• Ensure effective medicines management processes are in place and improve recording of controlled drugs to ensure stock levels and doses administered are recorded accurately

• The provider must ensure an effective process for complaints handling, sharing information and taking actions to identify areas for development to improve services.

• Ensure an effective appraisal process is embedded, involving full participation and discussion to enable staff development.

• Ensure improvements in corporate and location level communication and engagement to ensure an effective process for governance, quality and risk oversight of services at local level

The provider must ensure records for the disposal of pregnancy remains are completed and available

In addition, we told the provider it should make other improvements, even though a regulation had not been breached, to help the service improve. Details are at the end of the report.

Ellen Armistead

Deputy Chief Inspector of Hospitals

We spoke with two women who used the service. They told us they were very satisfied with the care and treatment they had received at Marie Stopes Manchester. One person told us, “I couldn’t ask for more care and support”.

We found people were consulted about their treatment and their rights to privacy and dignity were respected.

People’s needs were assessed and care and treatment delivered in a safe and appropriate manner.

Staff had access to policies and procedures which were in place to safeguard children and vulnerable adults. They were able to tell us what action they would take should they have any concerns about anyone who attended the service.

Staff told us they felt well supported. We found staff had the necessary skills and training to undertake their role in a safe and appropriate manner.

We found suitable arrangements were in place to manage an effective process for identifying, receiving and handling complaints for people who used the service.

Marie Stopes International Clinic Manchester is based in a residential street off a main road into Manchester city centre. There was limited parking both on site and on surrounding streets.

We found a secure entry system on the front door managed by the reception staff. there were two waiting areas on the first floor for people and their partners to use. The people accessing the service were taken to the first floor for their consultation and pre procedure scan. This area was limited to the person accessing the service only.

We spoke to two people who told us: "I feel that the staff have been compassionate towards me, they have been understanding and informative". "This was not what I expected, I was very nervous but the staff have taken me through every aspect in a calm and caring way. They have been great with me". "I was considered at every point in my treatment, they asked me if I understood everything and did not mind repeating if asked". "There is a very professional manner here but they manage to remain personal and don't talk down to you at any time. They involve you all the time and keep asking if you are all right and happy to continue".

We did not speak to people who used this service as part of this review. We looked at a random sample of medical records. This was to check that current practice ensured that no treatment for the termination of pregnancy was commenced unless two certificated opinions from doctors had been obtained.

Marie Stopes International (MSI) Manchester Centre is operated by Marie Stopes International. Facilities include a treatment room, outpatient and ultrasound facilities. There are three consulting rooms and eight day care beds.

The service provides surgical termination of pregnancy procedures (SToP) up to 23 weeks and six days gestation along with early medical abortion (EMA) and medical termination of pregnancy (MToP) up to nine weeks and four days gestation. Treatment can be provided under no-anaesthesia, conscious sedation and general anaesthesia, according to patient choice and needs. The service also provides consultations, ultrasound scans, long acting reversible contraception and sexually transmitted infection screening services. In addition to these services, they also provide vasectomy (male sterilisation) under local anaesthetic.

In addition, MSI Manchester has eight satellite clinics, (early medical units EMU) across Greater Manchester and Lancashire, where they carry out consultations and early medical abortions.

We inspected this service using our comprehensive inspection methodology. We carried out unannounced inspections on 6 August 2018 and 17 August 2018.

To get to the heart of patients’ experiences of care and treatment, we ask the same five questions of all services: are they safe, effective, caring, responsive to people's needs, and well-led? Where we have a legal duty to do so we rate services’ performance against each key question as outstanding, good, requires improvement or inadequate.

Throughout the inspection, we took account of what people told us and how the provider understood and complied with the Mental Capacity Act 2005.

At our previous inspection on 19 June 2017 we found breaches in regulations and we served requirement notices in respect of:

• Regulation 10 Health and Social Care Act (Regulated Activities) Regulations 2014 Dignity and respect.
• Regulation 12 Health and Social Care Act (Regulated Activities) Regulations 2014 Safe care and treatment.
• Regulation 17 Health and Social Care Act (Regulated Activities) Regulations 2014 Good governance.

At this inspection we checked that actions had been implemented to address these breaches. We found that some improvements had been made but not all concerns had been fully addressed in relation to Regulation 10 for privacy and dignity.

Services we rate

We rated it as good overall.

We found good practice in relation to:

• The service provided mandatory training in key skills to all staff and made sure everyone completed it. This included resuscitation and safeguarding for nursing and medical staff at appropriate levels.
• Staff kept themselves, equipment and the premises clean. They used control measures to prevent the spread of infection. We observed appropriate infection prevention and control measures in place including hand washing and use of personal protective equipment.
• The service had suitable premises and equipment and looked after them well. Equipment was well maintained and serviced. Daily checks were recorded and completed appropriately.
• Risk assessments were in place and monitoring carried out before, during and following procedures such as venous thromboembolism checks (VTE) use of the World Health Organisation (WHO) and five steps to safer surgery checklist and the termination of pregnancy early warning score (TEWS).
• The service had enough staff with the right qualifications, skills, training and experience to keep patients safe from avoidable harm and abuse and to provide the right care and treatment. Experienced staff were supporting newly appointed staff at the main clinic. . All staff had received an appraisal in the 12 months before inspection.
• The service prescribed, administered and recorded medicines in line with trust policies and procedures. Medicines, including controlled drugs and abortifacients (medicines that induce a termination of pregnancy) were managed well. Daily checks of stock were carried out. Take home medicines included pharmacy dispensing labels as well as manufacturers’ instructions.
• The service managed patient safety incidents well. Staff recognised incidents and reported them appropriately. Managers investigated incidents and shared lessons learned with the whole team and the provider.
• The service provided care and treatment based on national guidance such as the Royal College of Obstetricians and Gynaecologists (RCOG), the Department of Health Required Standing Operating Procedure (RSOP) and the National Institute for Health and Care Excellence (NICE).
• Staff monitored patients’ comfort needs and provided pain relief as required. Light refreshments were provided following surgery.
• The service monitored the effectiveness of care and treatment and used the findings to improve them and benchmarked internally. An integrated dashboard was maintained and audits were carried out routinely.
• Staff worked together as a team to benefit patients. There was effective multidisciplinary working both internally amongst staff and externally with other health professionals.
• Staff understood their roles and responsibilities under the Mental Capacity Act 2005. Consent was obtained both verbally and in writing before care and treatment. Staff understood principles of Fraser guidelines and Gillick competence in assessing mental capacity. (Fraser guidelines and Gillick competence are used specifically for patients under the age of 16 requesting contraceptive or sexual health advice and treatment.)
• Staff cared for patients with compassion. Feedback from patients confirmed that staff treated them well and with kindness. We observed respectful, sensitive and non-judgemental care for patients by all staff.
• Staff provided emotional support to patients to minimise their distress. There was telephone counselling available via the 24-hour helpline service.
• Staff involved patients and those close to them in decisions about their care and treatment. Patients were encouraged to be supported by someone close to them through the care pathway.
• The service planned and provided services in a way that met the needs of local patients. Bookings were made centrally through MSI UK One Call. This meant patients were offered a choice of appointments at MSI Manchester or alternative MSI locations to ensure treatment occurred in a timely manner.
• The service took account of patients’ individual needs at the main clinic. There was an accessible entrance for patients with reduced mobility, a hearing loop and an interpreter service for patients whose first language was not English. The website could be translated into a wide-range of languages.
• The service treated complaints seriously, investigated them and learned lessons from the results, which were shared with all staff.
• The service had managers at all levels with the right skills and abilities. The leadership structure had changed to include local leadership as well as regional.
• The service had a vision for what it wanted to achieve and workable plans to turn it into action which had been developed with involvement from staff. The service followed the provider’s vision and had regional focus.
• Managers at the service promoted a positive culture that supported and valued staff. Managers encouraged an open and transparent culture and actively engaged with staff.
• The HSA4 forms were discussed with patients during the booking process and written information was provided at the main centre. (Providers have a statutory requirement to complete HSA4 form to notify a termination of a pregnancy to the Department of Health)

We found areas of practice that require improvement:

• Whilst a governance framework was in place we found this was not fully embedded due to the introduction of a new management structure, therefore local oversight of risk was not fully effective at the time of inspection.
• The probes used for trans vaginal scans (TVS) were cleaned only to minimally accepted standards, although senior managers told us that infection control processes were being reviewed.
• The door to the cleaning cupboard was not locked and included accessible cleaning fluids.
• There were plans to reorganise the surgical treatment and recovery areas that included privacy curtains for each chair space. However; this was not in place at time of inspection.
• There was no face-to-face counsellor available at the time of inspection, although the position had been appointed into and the staff member was completing the induction process.
• The level of screening provision was dependent on a patients address and commissioning arrangements. Patients were not signposted to other health professionals if unable to access the full range of screening provision.Managers locally could access demographic details for staff, including emergency contact details and proof of professional registration, however; details provided of full records were not consistent. Complete personnel records were held centrally by the human resource department for the provider; the registered managers were not able to access all records.

Following this inspection, we told the provider that it must take some actions to comply with the regulations and it should make other improvements to help the service improve. We also issued the provider with one requirement notice in respect of Regulation 17 Health and Social Care Act (Regulated Activities) Regulations 2014 Good governance. Details are at the end of the report.

Ellen Armistead

Deputy Chief Inspector of Hospitals