20 December 2016
Termination of pregnancy (TOP) refers to the treatment of termination of pregnancy, by surgical or medical methods. Marie Stopes UK International (MSI) Norwich is part of the provider group Marie Stopes International. MSI Norwich was commissioned and commenced services on the 1 October 2013 in line with a tender award for Norwich clinical commissioning group (CCG), North Norfolk CCG, South Norfolk CCG and West Norfolk CCG.
MSI Norwich 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 Norwich also provides services via three early medical abortion units (EMU) known as satellite units situated in Cambridge, Kings Lynn and Thetford. These are located in the community where medical termination and consultations in the early stages of pregnancy are provided in a private consulting room.
All locations hold a license from the Department of Health (DH) to undertake termination of pregnancy services in accordance with The Abortion Act 1967. Services are provided to both NHS and privately funded patients. An additional EMU unit in Peterborough is planned and due to open in June 2016 to provide a vasectomy service bi–monthly, a further EMU in Cambridge is licenced but is not currently being utilised.
Patients of all ages, including those aged less than 18 years are seen and medically treated at all of the locations, however surgical intervention only takes place at MSI Norwich, with one surgical list a week. Counselling services are offered to all patients, before and after treatment, and are provided face to face or by telephone. Appointments are made through a 24hour registered pregnancy advisory centre (MSI One call centre).
The building is based in Norwich community hospital and the premises was originally shared with Norfolk foot surgery service. MSI currently have sole use of the building, however this may change in the future. They currently have two consulting rooms, one theatre, one screening room and nine day couches. A small car park is available on site and there are facilities in place to support people with a physical disability.
20 December 2016
The Care Quality Commission (CQC) carried out an announced comprehensive inspection at Marie Stopes International Norwich on 6 May 2016. This service was inspected as part of a wider programme to inspect providers of acute independent healthcare.
MSI Norwich 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 Norwich also provides services via three early medical abortion units (EMU) known as satellite units.
Our key findings across all the areas we inspected were as follows:
Are services safe at this service?
There was an inconsistent approach to action planning and ensuring that lessons learnt from incidents were shared with all relevant staff locally. There were no effective systems to monitor and manage risks. Incidents were not a standard agenda item on staff meetings to heighten awareness and enable shared learning.
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, and 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.
Staff did not have the appropriate level of safeguarding training to manage safeguarding issues. There were no staff trained at level three working at the centre which meant that there were insufficient numbers of appropriately trained staff to appropriately assess, plan, intervene and evaluate the needs of children and young people attending the service.
Satellite units had no processes in place to ensure the safety of staff. Staff had not received any training for dealing with situations of violence and aggression.
Regional staff from other Marie Stopes centres made up approximately 50% of the workforce. Staff we spoke with highlighted long working hours as a frustration at times although they recognised the need for flexibility due to the clinical demands of the service. The managers recognised that recruiting more local staff for continuity and stability would be beneficial and were currently advertising.
Infection control audit results were poor and there was no clear action plan available to improve scores and lower the risk of infection.
Staff were not trained to recognise and respond to a deteriorating patient. The resuscitation policy stated that resuscitation drills, delivered by an external company, should be carried out every three months. A simulation had taken place in MSI Norwich on the 25 February 2016 and the result had been significantly poor, with a score of 14 out of 34. This indicated a high risk with urgent action required. It was recommended that a repeat scenario take place in two weeks however, this was not undertaken until May 2016.
There were no effective systems in place for equipment maintenance. There were no visible labels on equipment to identify service dates and no records were held of any equipment checks at the satellite units.
There were systems in place for medicine management that included obtaining, recording, handling, storing and security of medicines.
Are services effective at this service?
Policies were accessible for staff but were not 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.
There was limited accessible evidence on site or from requests to the corporate HR department to show how competent and qualified the centre staff and regional staff working at the centre were to carry out their roles effectively in line with best practice.
The number of staff receiving continual professional development was unclear because mangers could not access information from the corporate system and there was no data provided regarding clinical appraisal rates.
Only 40% of the centre staff had received consent training. None of the staff had received safeguarding training at level 3. This meant that 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.
The centre benchmarked itself against the Department of Health Abortion statistics produced annually. The centre performed 535 early medical terminations and 723 surgical terminations in the last year and the key performance indicators and monitoring systems showed effective outcomes for the vast majority of patients. However monitoring was not in line with the Required Standard Operating Procedures (RSOP) 16: performance standards and audits.
Are services caring at this service?
Patients were positive about the care provided by staff and those we spoke with felt that care was individually centred. Staff were observed to be 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.
Marie Stopes Norwich scored the national average for rating the overall service at 95% very good or excellent in patient satisfaction surveys.
RSOP standard three requires that there are protocols in place to support women following a termination. This includes the provision of sufficient information, counselling and support services and consent to share information with their GP and the Department of Health. Staff we spoke with stated that women would be offered access to a counsellor should they require it, however this was not seen in practice during the inspection. Staff were aware of the range of emotional responses that may be experienced during and following a termination of pregnancy.
Are services responsive at this service?
Services were planned and delivered in a way that met the needs of the population. The importance of flexibility, choice and continuity of care was reflected in the services provided.
Patient flow through the centre was compromised at times. There were periods of extended waiting times due to the lack of recovery space causing theatre backlogs. The average patient time spent in the centre was 107 minutes in March 2016 (against a target of 95 minutes).
Senior staff stated that future service planning included consideration of a second weekly surgical list to reduce waiting times and improve capacity management and patient flow through the centre.
Translation services were available for patients who did not have English as a first language.
There was a complaints procedure in place. Complaints advice was given in the back of the patient literature and displayed in the patient information folder in waiting areas.
Are services well led at this service?
Marie Stopes International provided the Norwich centre with an Integrated Governance Framework which they stated was in line with the NHS governance agenda and the CQC Essential Standards of Quality and Safety. There were gaps between the governance process at corporate and location level in communication and engagement which needed to be addressed to ensure evidence based care can be demonstrated at all times. The CQC Essential Standards of Quality and Safety were replaced by the fundamental standards in 2014.
There was no effective system in place to ensure action plans were completed, reviewed and audited to improve patient safety and quality of care.
Risk management arrangements were not in place to make sure 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. The local audit process was not specific enough to identify the practice. The audit results were based on a quantative measure only that HSA1 forms had two signatures.
We were informed by clinicians that bulk signing of HSA1 forms, of between 30 to 60 forms at a time, was undertaken. Surgeons and anaesthetists were requested to do this as the demand was too great for remote doctors and we were informed by doctors that HSA1 forms were being signed on the basis of the ‘reason for termination’ information only, which was printed or handwritten on the back of the form. We were not assured clinicians had access to all relevant information to enable a decision of opinion in good faith.
There was no process in place for assurance that HSA 4 forms were submitted to the Department of Health within the legal timeframe of 14 days.
Leadership had been inconsistent with six different managers at MSI Norwich in the last three years. Staff stated that this had affected continuity and stability for the clinical teams. The culture was viewed as being top down and corporately led. Teambuilding was difficult due to approximately 50% of the staff, at times, coming from other centres and the lack of leadership on site had reduced staff morale. There was evidence that this was being addressed with the introduction of new managers, attempts to recruit local staff and through communication and engagement groups. Staff told us they did not feel valued by the organisation although they found the new managers on site supportive and approachable.
Marie Stopes Norwich did not have a formal strategy although staff were clear about supporting the patients to deliver high quality care, promote good outcomes for patients, and encompass key elements such as compassion, dignity and equality.
We saw several 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.
- Ensure that all equipment at MSI Norwich and the EMU has been serviced and is in good working order.
- Ensure there is an effective system in place to record and monitor servicing and maintenance of equipment.
- Improvements in corporate and location level communication and engagement, should be addressed to ensure evidence based care can be demonstrated at all times.
- Establish a robust 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 staff have regular appraisals to establish continual professional development requirements to ensure staff have the right skills to perform their job role.
- Ensure a robust 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.
- Ensure the quality of photocopied templates (flow charts) is improved to enable clarity of patient records.
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