The Care Quality Commission (CQC) carried out an announced comprehensive inspection at Marie Stopes International Essex centre on 12 April 2016. This inspection was part of a wider programme to inspect providers of acute independent healthcare.
MSI Essex provides consultations, ultrasound scans, medical and surgical termination of pregnancy, and counselling and support for people who use the service. In addition, long acting reversible contraception and sexually transmitted infection testing and screening are offered. MSI Essex also provides services via seven early medical abortion units (EMU) known as satellite units.
The centre provides medical termination to nine weeks + three days and surgical termination of pregnancy to 23 weeks + six days. Surgical termination is carried out either under general anaesthetic, conscious sedation, by vacuum aspiration or dilatation and evacuation or no anaesthetic according to patient choice and needs.
At the time of inspection there was no registered manager in place. There was a newly appointed clinical operations manager in post but they were yet to apply as registered manager. They were responsible for the day-to-day management at MSI Essex and they were being supported by the regional manager.
Our key findings across all the areas we inspected were as follows:
Are services safe at this service?
There was an inconsistent approach to categorising incidents, action planning and ensuring that lessons learnt from incidents were shared with all relevant staff locally and across the organisation.
There was no effective process to review incidents and undertake trend analysis to reduce the risk to patients subsequent to an incident.
Incidents were not a standard agenda item on staff meetings to heighten awareness and enable shared learning. A duty of candour policy was introduced in April 2016 however there was no training for staff on the duty of candour regulation
There were no staff on site that were trained and competent to assist the anaesthetist to administer anaesthesia and monitor patients undergoing conscious sedation or general anaesthesia. Marie Stopes International provides a two-day introduction to anaesthetic course however at the time of inspection no member of staff at MSI Essex had undertaken this course. We had further concerns that a two day course would not be sufficient to fully equip nursing staff with the knowledge and skills to assist in an emergency situation if a patient with a difficult airway
Staff did not carry out the World Health Organisation (WHO) 'Five Steps to Safer Surgery' checklist appropriately. Staff were completing all sections of the hard copy of the checklist, without any verbal checks, before the procedure had taken place. Local audit was not effective as it was a quantative check that the paperwork had been completed. No observational audit was undertaken to ensure compliance was in line with best practice.
Not all infection prevention and control process followed standard practice. Handwashing practices audit results in February 2016 had been poor. The appointed lead for infection prevention and control (IPC) had not received MSI infection control training. Staff were observed to rinse surgical instruments prior to decontamination in a sluice area adjacent to the theatre. This was not documented standard practice within the MSI decontamination policy.
Not all staff had the appropriate level of safeguarding training to manage safeguarding issues. Training data provided did not distinguish between adult and children safeguarding training. 52% of staff had completed level 2 training. The clinical operations manager had received level three training however records showed that they had not received level 2 training.
There was no finalised emergency patient transfer agreement in place at the time of inspection. There were no lone working safety processes in place for staff at the satellite units and staff had not received any training on dealing with violence and aggression.
However staff were confident to report serious incidents, whistle blow or challenge if they suspected poor practice. The centre had a planned preventative maintenance programme in place for equipment. Equipment was serviced and labelled appropriately to identify review dates for maintenance.
Staff were knowledgeable about what constitutes a safeguarding concern and were confident to raise incidents when there were concerns of sexual violence, poor social support, or where there was evidence of coercion.
Are services effective at this service?
Policies were not always updated to reflect practice changes in a timely manner. There was a lack of consultation and engagement of staff to support evidence based care practices. Minutes from the corporate clinical governance meetings did not consistently demonstrate effective reporting on patient outcomes to demonstrate effective practices. Quality dashboards with key performance indicators (KPI) to improve quality measurements were being introduced.
Staff were unable to provide us with an explanation or evidence of the decision making process behind the introduction of simultaneous drug administration. Staff could not assure us that the treatment was evidence–based.
Only 40% of the centre staff had received consent training and as none of the staff had received safeguarding training at level 3 we were not assured that staff taking consent had the appropriate knowledge, skills and competence to support patients who may be vulnerable or lack capacity to make a decision.
However there was evidence that when concerns around consent were recognised, that related to a safeguarding issue, incidents were reported and there was appropriate collaborative working with external agencies such as the police, social services and staff at the local NHS hospital.
Are services caring at this service?
Patients were positive about the care provided, which they noted was individually patient centred. Staff were helpful, caring and treated patients with dignity and respect.
Staff adopted a non-directive, non-judgemental and supportive approach to women receiving treatment for termination.
MSI Essex scored above the national average for rating the overall service at 96% very good or excellent. Comments were overwhelmingly positive in the 61 comments cards received in the week prior to inspection.
RSOP standard three requires that there are protocols in place to support women following a termination, including access to counselling and support services. Staff we spoke with stated that all women requesting a termination were offered the opportunity for emotionally support from a trained pregnancy counsellor. This would be offered at any time pre or post termination. This was completed either face to face or by telephone by staff at the One Call centre.
Staff could describe the range of emotional responses that women may experience during and following an abortion
Are services responsive at this service?
Service planning and delivery met the needs of the population. The services provided reflected the importance of flexibility, choice for patients. Commissioners and stakeholders were involved in service planning.
Between January and December 2015, no patients waited longer than 10 days from first appointment to termination of pregnancy unless they requested a delay. Staff managed patient flow through the centre well and in November 2015 the average patient time spent in the centre was 106 minutes (against a target of 110 minutes). 95.9% of patients were satisfied with the process for booking appointments and comparative analysis indicated a year on year improvement.
Translation services were available for patients who did not have English as a first language and notices were displayed in the reception areas informing patients this service was available.
There was a complaints procedure in place. Complaints advice was given in the back of the patient literature and also displayed in the patient information folder in waiting areas. The service had made changes regarding the process in place for patients arriving late in response to a number of complaints.
Are services well led at this service?
Marie Stopes International provided MSI Essex with an Integrated Governance Framework which was not being measured against the most up to date standards. The framework made reference to the CQC Essential Standards of Quality and Safety however these were replaced by the Fundamental standards in 2014.
There were gaps between the governance processes at corporate and location level in communication and engagement. Staff were not fully aware of the rationale behind a recent practice change for simultaneous administration of the medicines used to effect a medical abortion. There was no evidence based information on site to show this practice was recognised, benchmarked or systems put in place for effective measurement of patient for outcomes.
There was no effective system to ensure action plans arising from incidents, local audit or “nominated Individual visits” (NI) visits were completed, reviewed and re-audited to improve patient safety and quality of care.
Risk management arrangements were not effective to ensure that the certificate(s) of opinion HSA1 were signed by two medical practitioners in line with the requirements of the Abortion Act 1967 and Abortion Regulations 1991. We found some evidence that doctors were being requested to sign HSA1 forms in bulk without the opportunity to have full access to patient information.
Local audit process to ensure completion of HSA1 forms only included a check that the form was completed and signed. It was not a qualative check of the process.
There was no process or monitoring system in place at MSI Essex to ensure that the submission of HSA 4 forms to the Department of Health had been undertaken within the legal timeframe.
The culture was viewed as being top down and corporately led. Senior staff did not always feel they had a strong voice at corporate level.
However, the service had a vision, core values and strategy of which the staff had a general understanding.
Staff were complimentary about the current leadership team at MSI Essex. They stated they were visible and approachable and were open to new ideas and changes.
We saw areas of good practice including:
- Staff were described and observed as being non-judgemental
However, there were also areas of poor practice where the provider needs to make improvements.
Importantly, the provider must:
- Ensure that there is an effective process for incident reporting and that recording is consistent to enable analysis of data to highlight areas of improvement.
- Ensure a consistent approach to action planning and ensuring lessons learnt from incidents are shared with all relevant staff locally.
- Ensure that senior staff involved in the investigations have access to formal training in root cause analysis to support the risk management process.
- Ensure that hard copy documentation in relation to the World Health Organisation (WHO) 'Five Steps to Safer Surgery' checklist is completed accurately and used appropriately at each phase of the surgical procedure.
- Undertake improvements in corporate and location level communication and engagement to ensure evidence based care can be demonstrated at all times.
- Ensure that there are competent and appropriately trained staff on site with sufficient airway knowledge to enable prompt and competent support to the anaesthetist.
- Establish an effective system to ensure and demonstrate that staff are competent and qualified to carry out their roles safely and effectively in line with best practice.
- Ensure an effective system is in place for risk management and quality improvement. Including effective local audit process to ensure care is provided in accordance with legislation and best practice guidelines.
- Ensure that there are effective processes in place to ensure that the certificate(s) of opinion HSA1 form are signed by two medical practitioners in line with the requirements of the Abortion Act 1967 and Abortion Regulations 1991.
- Ensure that there is an effective process for submission of HSA 4 forms to the Department of Health within the legal timeframe of 14 days.
- Ensure that there are effective infection prevention controls and systems in place to lower the risk of infection and drive improvement.
- Review the practice of open storage of multiple surgical termination products in a single container and amend policy and guideline to ensure good infection control practice.
In addition the provider should:
- Ensure that specific lone worker staff safety risk assessments are in place for the satellite units. Staff should receive training on violence and aggression to safeguard them.
- The provider should have specific written information in the waiting areas regarding key risks to patients such as domestic abuse, the risk of sexual exploitation, access to support groups and contact numbers if at risk.
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 11 Consent
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.
Professor Sir Mike Richards
Chief Inspector of Hospitals