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Provider: Marie Stopes International

We are carrying out checks on locations registered by this provider using our new way of inspecting services. We will publish the reports when our checks are complete.

Reports


Inspection carried out on 27-28 February 2017

During an inspection to make sure that the improvements required had been made

Marie Stopes International (MSI) performs in the region of 70,000 abortions (both medical and surgical) a year, which represents around a third of abortions performed in England.

CQC inspected 12 of Marie Stopes International’s registered locations in England during a series of inspections between April and August 2016, as part of CQC’s planned comprehensive inspection programme. Whilst the inspections identified a number of positive factors they also identified some concerns linked to the provider’s governance arrangements which led to an unannounced inspection of Marie Stopes International’s UK administrative offices in Conway Mews, London on 28 July 2016 and 8 August 2016. These inspections concluded in August 2016 and led to Marie Stopes International voluntarily restricting its practice in the following areas to address CQC’s most serious concerns:

  • Suspensions of termination of pregnancy provision for under-18s and vulnerable groups of women.

  • Suspensions of terminations under general anaesthetic or conscious sedation.

  • Suspensions of all surgical terminations at their Norwich centre.

Marie Stopes International resumed its practice in the above areas over a phased restart programme between 7 and 30 October 2016 as CQC was satisfied that it had taken action to make improvements to address the areas of highest risk to patients.

CQC served four Warning Notices on Marie Stopes International in September 2016 for breaches of the CQC regulations in relation to requirements concerning consent, safeguarding, care and treatment of patients, and governance. CQC served three Requirement Notices in relation to safe care and treatment of patients, governance and compliance with Regulation 20 of the CQC (Registration) Regulations 2009 relating to termination of pregnancy. The Warning Notices served were applied at provider level and at those locations where we found breaches in regulation. The provider was required to make improvements.

As a consequence of the serious concerns identified and the subsequent regulatory action (described above) the CQC undertook an unannounced follow up inspection at the provider’s UK administrative offices on 27 and 28 February 2017 to check on the steps taken in relation to the breaches in regulations. Since the inspection in February 2017 we have been informed that significant changes have occurred within the senior management team resulting in further review of management, leadership and governance aspects. We will be continuing to follow up through our ongoing monitoring and regulatory process.

We have not published a rating for this service. CQC does not currently have a legal duty to award ratings for those services that provide solely or mainly termination of pregnancy services.

Our key findings at the time of our follow up inspection on 27 and 28 February 2017 were as follows:

  • A new electronic incident reporting system had been implemented across all MSI locations on 1 February 2017, to enable improved reporting, data analysis and focused improvement and learning.

  • A process for the review of serious incidents and safety concerns had been created with the establishment of a serious incident group, a safeguarding committee, infection prevention and control group, medicines management group and resuscitation and deteriorating patient group at provider level. These groups were introduced between October 2016 and February 2017.

  • The provider had reviewed and updated a large number of policies and procedures, such as the consent policy, anaesthetic policies, safeguarding policies and the incident policy. The provider had sought external review of its anaesthetic policies, by the Royal College of Anaesthetists in order to benchmark and ensure best practice. Following external review a number of revisions were required which were in process at the time of inspection.

  • In October 2016 the provider had held a number of roadshows for staff and had organised training, some of which had taken place including safeguarding training at adult and children level 3 and level 4 where applicable, consent training, basic life support (BLS) and immediate life support (ILS). Advanced Life Support (ALS) competence for anaesthetists had been reviewed and compliance recorded. At this inspection we found that there were variable training completion rates across locations.

  • There was an ongoing recruitment strategy for registered nurses, vasectomy nurses, sessional anaesthetists and gynaecology surgeons. HR processes had been strengthened and now included appropriate recruitment checks, registration and revalidation monitoring for clinical staff and fit and proper person checks at director level.

  • The provider had recently established processes within the UK administrative offices to monitor compliance with the Department of Health Required Standard Operating Procedure (RSOP) standards.

  • A clinical practice guide for registered nurses and midwives had been introduced in October 2016 through roadshows to staff. However, there were limited systems in place to ensure that staff were following this guidance.

  • The counselling process and policies had been reviewed and updated. Counselling, by trained counsellors, was mandatory for patients under 16 years of age and booked on a different day to treatment to enable patients’ reflection time. All women and young people were offered counselling. There was conflicting information in relation to the counselling age requirements which could be confusing for staff. The booking pre-abortion counselling and counselling call flow chart referred to 16 years and below whereas the policy refers to 15 years.

  • The senior management team, at the time of inspection, was aware of the detail of issues raised at the revised governance meetings. The new integrated governance committee (IGC) had a number of sub committees which fed information into the IGC. However it was unclear if the senior teams awareness was more due to the fact they had been actively attending locations rather than via effective reporting mechanisms as the sub committees were in their infancy. They had been cohesive in expressing their vision for the service, current concerns and risks to the service. However a formal strategy was yet to be put in place.

  • There was recognition by the senior management team that the culture of the organisation needed to change to ensure that staff were empowered and engaged to drive improvements at location level. This work had commenced at the roadshows but it was unclear how this work was to be continued.

However whilst there had been an impetus to drive improvement to enable the restart in October 2016 of those services that MSI voluntarily ceased in August 2016, there had then been a period of less momentum once those services had recommenced. The pace of change had slowed from November 2016 and only increased again once the new managing director had been appointed in January 2017. Unfortunately this individual then resigned from position at the end of March 2017. We were concerned that further instability of the senior team would impact significantly on the organisation and tentative progress that had been made would fail to be embedded.

There remained areas where the provider needed to make improvements:

  • The senior management team at the UK administrative offices had undergone significant change since our inspection in July and August 2016. There were a number of posts still awaiting appointment within the senior management team.

  • Senior key clinical roles at the UK administrative offices remained vacant or had interim appointments or were extended to cover dual roles. At the time of inspection, vacant roles included the safeguarding lead, infection prevention lead, risk & governance lead, quality and safety lead and medical director.

  • Clinical and corporate processes had been developed and strengthened but needed to be embedded as they had been implemented but had not been operational for long. The regional structure included a number of levels between the board and locations and reporting was inconsistent across the regions. Governance sub committees were in their infancy and we found that some regions had yet to hold their first governance meetings at the time of our inspection.

  • Newly formed systems and processes, such as incident reporting and a process for applying the duty of candour had been put in place. At the time of our inspection in February 2017 several incident investigations were ongoing which meant that the effectiveness and impact of these new process had not yet been measured

  • We found that there remained some inconsistency across MSI locations in clinical practice and oversight to ensure quality of care. There had been a system for peer review in place that the provider used to monitor clinical practice and to highlight issues at locations. The format, methodology and consistency of peer reviews had been recognised by the senior management team as ineffective and had been discontinued. At the time of our February 2017 inspection no other mechanisms for achieving oversight and monitoring were in place.

  • The provider had introduced formal competency assessments of nursing staff alongside the introduction of the clinical practice guide in October 2016. However, there was a lack of oversight of the numbers of staff assessed as competent in areas outlined within the guide or following training in anaesthetic and recovery training. No nursing staff appraisals, which would enable competency review, had taken place.

  • The balanced score card measured safety measures, such as incidents and infection control issues. It had been implemented but had yet to be approved through the UK board. Since the inspection in February 2017, and subsequent change of managing director, we have been informed that the implementation of the balance scorecard is being reviewed.

  • A clinical dashboard based around the requirements from various clinical commissioning groups had been drafted but had yet to be approved through the UK board.

  • An audit programme had been implemented however this was only commenced in January 2017 and consisted of a rolling programme of audits with a staggered introduction.

  • At the time of inspection, the audit template for the World Health Organisation (WHO) Five Steps to Safer Surgery checklist was still in draft format and was yet to be introduced.

  • Revised infection prevention and control audits were due to be introduced in March 2017, despite known concerns being highlighted through the peer review process between November 2016 and February 2017.

  • There had been no further planned resuscitation scenario training at locations. We were not assured that the proposed oversight of monitoring and learning from scenarios was effective due to the infrequent meetings of the resuscitation

  • No significant changes had been made regarding training and competency of staff to undertake ultrasound scanning. We raised concerns at this inspection with senior staff that the ultrasound policy still lent towards staff requiring skills, beyond date scanning competency, in regard to identifying various conditions that would require escalation. Senior managers acknowledged that this required review.

  • Further training was required in relation to female genital mutilation (FGM), child sexual exploitation (CSE) and Prevent. It was unclear how the senior management team took reassurance from the data supplied as they were given three different figures in respect of training.

  • External review of anaesthetic and medicine management policies had highlighted that policies did not reference the latest guidelines and further amendments were required. However, these policies remained in place whilst amendments were being made. Policies in place had been improved and mitigated risks but still required further amendments to bring into line with national guidance.

  • MSI was not meeting the Required Standard Operating Procedure (RSOP) standard 11 where the total time from access to a termination of pregnancy procedure should not exceed 10 working days. For patients with a pregnancy over 14 weeks, waits could be as high as 32 days or 4.5 weeks. For pregnancies over 19 weeks waits were between 18 and 45 days. The provider was working with others to address these delays to reduce the impact to women.

  • There had been no formal staff survey to evaluate the impact of the changes made and to highlight areas of further improvement in staff wellbeing

  • An ageing IT system was still affecting the provider’s ability to ensure submission of HSA 4 forms to the Department of Health within the legislative time frame. MSI UK was working with the Department of Health to address this.

We found that whilst the provider had complied with the warning notices issued in September 2016 in relation to:

Regulation 13 HSCA (RA) Regulations 2014 Safeguarding

Regulation 11 HSCA (RA) Regulations 2014 Need for consent.

and complied with the requirement notice in relation to:

Regulation 20 (Registration) Regulations 2009 relating to termination of pregnancy.

It had not fully complied with the warning notices or requirement notices issued in September 2016 in relation to:

Regulation 12 HSCA (RA) Regulations 2014 Safe care and treatment

Regulation 17 HSCA (RA) Regulations 2014 Good governance.

CQC will be undertaking further enforcement action, monitoring Marie Stopes International closely, and reviewing its progress.

Importantly, the provider has been required to :

  • Ensure that there is an effective system of leadership and governance in place to monitor the service and reduce the risk of harm.

  • Ensure that all risks are assessed, monitored and that mitigations are in place to reduce the risk of harm.

  • Ensure that the implementation of an Early Warning Score (EWS) is consistent across all locations and that there is an effective system for monitoring to provide assurance that it is being used appropriately.

  • Ensure that all nursing staff are competent in their roles to ensure the safety of patients using the service. Ensure that there is an effective system for monitoring competence and a system for regular staff appraisals.

  • Ensure that there is an effective system for monitoring of training compliance across all locations.

  • Ensure that effective systems and processes are in place to monitor and improve services, providing consistency across locations

  • Ensure that the World Health Organisation (WHO) Five Steps to Safer Surgery checklist is completed accurately, used appropriately at each phase of the surgical procedure and quality audit is undertaken.

  • Ensure that effective oversight systems and processes are in place to service and maintain all equipment.

In addition the provider should:

  • Review the training, competency assessment and revalidation of ultrasound training.

Professor Sir Mike Richards

Chief Inspector of Hospitals


CQC inspections of services

Inspection carried out on 28 July 2016 and between 1 and 8 August 2016

During an inspection to make sure that the improvements required had been made

Marie Stopes International (MSI) performs in the region of 70,000 abortions (both medical and surgical) a year, which represents around a third of abortions performed in England. Most of these are carried out on behalf of the NHS. CQC inspected 12 of Marie Stopes International’s registered locations in England during a series of inspections between April and August 2016, as part of CQC’s planned inspection programme. During the quality assurance of the reports of the registered location it became clear that whilst the inspections identified a number of positive factors they also identified some concerns linked to the provider’s governance arrangements. As a result, CQC carried out an unannounced inspection of Marie Stopes International’s UK administrative offices in Conway Mews, London on 28 July 2016 and 8 August 2016.

We have not published a rating for this service. CQC does not currently have a legal duty to award ratings for those services that provide solely or mainly termination of pregnancy services. We did, however, find that the provider did not have sufficiently effective governance arrangements across registered locations so as to be assured of the safety and quality of all of the services it provided to patients. Therefore we inspected the provider in respect of these concerns and not at all domains using the key lines of enquiry. A full assessment of the caring domain can be found in the individual location reports. 

We sent the provider a letter setting out our significant concerns and the fact that we would have to take urgent action unless the provider immediately addressed the risks we had identified. In response, the provider decided to voluntarily suspend services as follows on 19 August 2016, with immediate effect:

  • 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.

This action negated the requirement for CQC to take urgent enforcement action as patient groups in relation to whom we had major safety concerns had their safety risks addressed by MSI suspending the above services.

At the time, NHS England activated ‘contingency arrangements’ to ensure that all patients seeking the services that had been suspended could receive safe quality care. This included diverting around 250 patients a week to alternative providers and setting up a helpline for anyone with any questions or concerns.

Since 19 August 2016 CQC has been monitoring Marie Stopes International very closely and reviewing its progress. CQC served four warning notices (as referred to in the section of the report entitled ‘Enforcement Action’ which is at the end of this report) in relation to consent, safeguarding, the care and treatment of patients and governance processes as the provider had breached the CQC regulations relating to these matters. The provider needed to take action to remedy the breaches identified. MSI is working to remedy these breaches. CQC continues to monitor these services with regard to compliance with the regulations and will re-inspect these services in due course. CQC  also worked with other stakeholders to ensure the provision of termination of pregnancy services are available to patients who require this service.

Having demonstrated to CQC that it has addressed the most serious areas of concern, including staff training in the key areas identified, Marie Stopes International began to lift the restrictions it placed on its termination services on 7 October 2016.

Our key findings at the time of inspection were as follows:

  • There was limited clinical oversight of the quality of the service provided. There was a vacancy for the head of nursing. The medical oversight, provided by a consultant in gynaecology and obstetrics worked eight hours a week. This person reviewed policies and procedures, was responsible for the clinical quality and had responsibility for medical staff. There had been concerns about the anaesthetic leadership of the service.
  • There was no process for ensuring that the senior team were fit and proper persons to manage the service. This is a duty required by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Key documentation on the recruitment of individuals was missing from personnel files.
  • The professional registration of clinical staff, both nursing and medical staff, working at the service was routinely checked at employment. Some locations maintained their own annual checks but the provider did not ensure that professional registration was routinely checked on an ongoing basis.
  • There was limited oversight of the training required and undertaken by staff. Monitoring of competence of staff was ad-hoc.
  • Poor quality monitoring of services in areas such as consent and safeguarding, with staff not appropriately trained and practice not adhering to national guidance.
  • There was a lack of oversight as to the completion and submission of HSA1 and 4 forms respectively.
  • Whilst location staff were able to verbalise what the duty of candour meant the senior team were unaware ot their responsibilities in this respect.
  • Poor risk management arrangements have given rise to specific immediate concerns relating to the lack of assurance in MSI, in areas such as consent and safeguarding and the lack of assurance in relation to training and competence in conscious sedation and general anaesthesia.
  • The provider was not complying with the required monitoring of the service under the Department of Health Required Standard Operating Procedure (RSOP) standards and had limited understanding of these standards.
  • The provider was aware that there was an “inadequate reporting system.” However, no action had been taken to identify the cause and to mitigate the risks of non-reporting of incidents. Therefore learning from incidents was low throughout the organisation.
  • Staff taking consent from children and young persons were not appropriately trained to explore issues such as female genital mutilation or child sexual exploitation.
  • Staff were not trained to ensure that vulnerable patients had a good understanding of procedures.
  • Processes for counselling services for children and young people were not consistently described.
  • There was a policy for the management of anaesthesia and sedation however this was due for review in 2013 and had not been reviewed. The policy did not address the management of difficult airways.  At location level the staff told us that there was no policy in place.
  • Competency checking on anaesthetists, doctors and staff was ad-hoc.
  • Whilst the provider had a planned programme of maintenance, equipment there was a lack of oversight of this programme.
  • Staff were unaware about the management of deteriorating patients as there was no policy in place. Medical personnel left the premises before all patients were discharged and nursing staff were not trained to deal with emergency situations which may arise.
  • Staff had limited training in resuscitation. Unplanned simulation drills were poorly attended and staff in attendance rarely knew what the correct actions were. Feedback from these simulations was limited.
  • There was no resuscitation committee in place to ensure that policies were up to date nor to provide guidance to the provider on improvements required. This committee was incorporated into the clinical governance committee however records demonstrated a lack of discussion of resuscitation issues.
  • The policy and practice of the organisation limited who could report potential safeguarding alerts. Despite staff at location level being able to verbalise what constituted a safeguarding referral staff were not trained to the appropriate level in safeguarding in order to recognise when referral was required. The limitations on the grades of staff who could report alerts delayed reporting of some serious concerns. The provider was aware of this issue but had not taken remedial action in all of its locations.
  • Ultrasound scanning was undertaken by staff who received internal non-accredited training. Staff, whilst dating the pregnancy, were also diagnosing potential medical issues for the patient without assurances around competence to do so. Competency checking of staff undertaking scanning was limited and not in line with the provider’s policy.

As noted above, there were areas of poor practice identified where the provider needed to make improvements.

Importantly, the provider has been required to :

  • Ensure that staff taking consent have the appropriate knowledge, skills and competence and have a full understanding of the procedure for which they are taking consent.
  • Ensure that vulnerable patients are able to give informed consent.
  • Ensure that there is an effective counselling system for children and young people, and vulnerable patients, to assist in enabling informed consent.
  • Ensure that effective oversight systems and processes are in place to service and maintain all equipment.
  • Ensure that there are effective systems in place for timely reporting and management of incidents and safeguarding concerns.
  • Ensure that all risks are assessed, monitored and that mitigations are in place to reduce the risk of harm.
  • Ensure that all medical and nursing staff are competent to ensure the safety of patients using the service.
  • Ensure that effective systems and processes are in place to monitor and improve services.
  • Ensure that there is an effective system of leadership and governance in place to monitor the service and reduce the risk of harm.
  • Ensure that 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 audits undertaken in relation to the World Health Organisation (WHO) Five Steps to Safer Surgery checklist include observational audit to assess the quality of the check and embedded practice.
  • Ensure that there are effective processes in place to ensure that the certificate(s) of opinion HSA1 forms 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.
  • Review the training, competency assessment and revalidation of ultrasound training.

Professor Sir Mike Richards

Chief Inspector of Hospitals