A summary of the Care Quality Commission s Report into Marie Stopes International Life 1 Mill Street Leamington Spa CV31 1ES 01926 312 272 www.lifecharity.org.uk SPUC Unit B, 3 Whitacre Mews Stannary Street SE11 4AB 020 7091 7091 www.spuc.org.uk
The Care Quality Commission s Report into Marie Stopes International Summary: On December 20 2016, the Care Quality Commission (CQC) released a number of reports on Marie Stopes International (MSI), which performs around a third of abortions in England. This followed a letter sent by the CQC to MSI in August, highlighting concerns serious enough for the abortion provider to suspend abortions for a number of particularly at risk groups. The CQC Report The CQC published 12 reports based on findings from inspections of ten of Marie Stopes International's registered locations in England, its call centre and its UK administrative offices between April and August 2016. Background & Timeline The CQC has been inspecting all independent providers of stand-alone termination of pregnancy services as part of its wider inspection programme of independent healthcare services in England. As part of this, CQC inspected Marie Stopes International's registered locations in England, which identified a number of concerns. These led CQC to carry out an unannounced focused inspection of Marie Stopes International's UK administrative offices and of its call centre. 1 Date Event 1 "CQC Publishes Inspection Reports On Marie Stopes International Care Quality Commission", Cqc.Org.Uk, 2016 <http://www.cqc.org.uk/content/cqc-publishes-inspection-reports-marie-stopesinternational> [accessed 30 December 2016].
April-August 2016 CQC inspected 12 MSI locations in England as part of its planned inspection programme. This identified concerns linked to governance arrangements. 28 July 2016, 8 August 2016 Unannounced inspection of MSI s UK administrative offices in London. CQC writes to MSI setting out significant concerns and the fact that they would have to take urgent action unless the provider immediately addressed the identified risks. 19 August 2016 In response, MSI voluntarily suspends a number of services with immediate effect- termination of pregnancy for under 18s and vulnerable people, suspension of all terminations using general anaesthesia or conscious sedation, suspension of all surgical terminations at Norwich Centre. This negated the requirement for CQC to take urgent enforcement action. 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. 2 7 October 2016 20 Dec 2016 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 3 CQC publishes 12 inspection reports, which summarise findings from 10 of MSI s registered locations in England, its call centre and its UK administrative office. 2 Professor Sir Mike Richards, Chief Inspector of Hospitals, Letter from the Chief Inspector of Hospitals, Marie Stopes International Quality Report, (Care Quality Commission, 20 December 2016) <http://www.cqc.org.uk/sites/default/files/new_reports/aaaf9029.pdf> (accessed 30 December 2016), p.2 3 Ibid.
Concerns for MPs What improvements have Marie Stopes made that persuaded the CQC that MSI should be allowed to resume abortion services? Can these improvements be listed? What steps will the CQC take to ensure that there is no repetition of the events that caused MSI to suspend its abortion services? What steps are the Government taking to ensure that the Abortion Act is being interpreted correctly by MSI? What steps do the Department of Health plan to take to ensure that MSI are not contravening the provisions of the Abortion Act? How will the Department of Health regularly update Parliament on their overseeing of MSI? How much is being spent by the Department of Health on overseeing the operation of the Abortion Act and ensuring its provisions are not being flouted? What action does the Government plan to take against those individuals employed at MSI who are found to be flouting the Government s regulations regarding abortion, such as by pre-signing the abortion notification form HSA1? What happens next? The CQC is now continually monitoring Marie Stopes International and plans to inspect its centres and UK administrative offices again in the near future to ensure that ongoing improvements are made and maintained. Professor Edward Baker, deputy chief inspector of hospitals at the CQC, stated: "We will not hesitate to take further action, if necessary, in order to guarantee this provider meets the standard of care we expect and that its patients deserve. 4 4 "CQC Publishes Inspection Reports On Marie Stopes International Care Quality Commission", Cqc.Org.Uk, 2016 <http://www.cqc.org.uk/content/cqc-publishes-inspection-reports-marie-stopes-international> [accessed 3 Jan 2017]
Media Coverage The catastrophic criticisms contained in the reports resulted in widespread print and broadcast media coverage. A selection of the coverage on the reports is detailed below.: BBC: 'Serious concerns' over Marie Stopes abortion services The Guardian: Marie Stopes UK abortion clinics put women at risk, says CQC The Telegraph: Watchdogs release damning reports on Marie Stopes abortion clinics The Times: Marie Stopes boss was paid 420,000 The Daily Mail: The 2,600 safety flaws at Marie Stopes abortion clinics including doctors going home with women under sedation and foetuses being put in waste bins rather than cremated. CQC report findings which fuel concerns In addition to the criticisms which secured media attention, the CQC issued warning notices to MSI in response to regulatory breaches on matters relating to consent, safeguarding, care and treatment and governance, with several other areas of detailed concerns. These are listed below. The page numbers refer to the report (Marie Stopes International Quality Report, Care Quality Commission, 20 December 2016) http://www.cqc.org.uk/sites/default/files/new_reports/aaaf9029.pdf) unless otherwise stated. Consent Consent is supposed to be obtained by a clinician or delegated person with knowledge of procedure - but is being taken by people without an understanding of the risks involved (p.29) - "this gave risk of harm to patients" (p.30) Consent forms were only being signed by healthcare assistants in some places, despite policy stating they should be countersigned by a clinician. (p.29) Only 38.5% of staff were trained in line with MSI policy on consent (p.28)
Inspectors witnessed a woman with a learning disability being treated improperly: Consent to treatment for this patient was not carried out in a way they could understand and we observed the situation was poorly and insensitively handled by doctors. (p.29) We were therefore not assured that those staff undertaking the consent procedure had the appropriate training in consent for children and young people and those with learning difficulties. We were also not assured that those staff taking consent had the necessary knowledge of the procedure proposed to be carried out, so as to ensure that an informed discussion could be held, as is required. The provider was also not taking into account best practice guidance, in respect of consent being obtained by the person undertaking the procedure or through effective delegation. This gave rise to a risk of harm to patients (p.29) Staff obtaining consent were not appropriately trained to explore issues such as child sexual exploitation (p.30, and see below) Safeguarding There were delays in reporting safeguarding incidents - CQC were concerned that the safeguarding committee was aware of deficits and delays but took no action to resolve the issue. Staff were not appropriately trained in child safeguarding (detail p10) No training in child sexual exploitation (p12) "There was no evidence that MSI was taking the necessary steps to mitigate the risks to children and young people in relation to safeguarding them from abuse and improper treatment" (p13) Staff were not properly trained in safeguarding for people with learning disabilities (p.28)
Care and treatment Access to counselling services were not properly managed (p.30), especially for children. Staff competency Professional registration of doctors and nurses was not being properly checked, "the lack of governance in relation to the competency and training of staff had resulted in an immediate risk to patients due to lack of assurance that staff working at MSI have appropriate qualifications (p.27) Absence of clinical leadership e.g. the uncertainty that the lead anaesthetist was clinically competent (p.39). The lead anaesthetist was not on the General Medical Council (GMC) Specialist Register. The lead anaesthetist was responsible for providing clinical leadership and oversight of the One Call centre. We were not assured how the provider ensured the lead anaesthetist was clinically competent (p.39) Lead anaesthetist and lead surgeon both part time - The lead surgeon was employed for half a session a week with MSI and we raised concern regarding the level of oversight that would be possible with such limited time on site. Following us raising concerns, the provider immediately doubled the input from the lead surgeon. "we were concerned that the leaders of the organisation did not have the skills, experience or competence to fulfil their roles" (p.39 and more the next few pages) Limited oversight of staff training (p.3) Staff were unaware about management of deteriorating patients - medical staff left before patients were discharged and nursing staff were not trained to deal with emergency situations. (p.16) Not all staff had the required level of life-support training and couldn t provide assurances that staff in Early Medical Abortion units had the correct level of resuscitation training (p.6, detail p.9)
Nurses were not trained to assist in anaesthesia - "The risk of this is significant in that if a patient deteriorates during anaesthesia and requires emergency intubation, nursing staff may not be competent to assist. " (p.15) No one was present who could prescribe and administer medication in respect of conditions such as haemorrhage. There was no procedure for what to do if there was no doctor present (p.16) Staff were not given proper accredited ultrasound training they were diagnosing potential medical issues for the patient without assurances around competence to do so. They were trained internally through a non-accredited course, with limited assessment of their understanding or competence (p.17, detail p.22-24). We were concerned that there was no minimum entry requirement for staff to undertake this course and that staff attending may not have the anatomical knowledge to understand the abnormalities discussed at this course (p.23) It seems that staff were diagnosing fetal abnormality Having reviewed the course content submitted by the provider, the theory module explores abnormalities of gestation, gestational age, abnormalities of adnexa (uterine appendages) and recognition of whether the pregnancy is viable or nonviable (p.23) Surgical standards Staff didn t carry out the World Health Organisation Five Steps to Safer Surgery checklist appropriately - completing all steps before surgery had even started. Staff stated this was due to the speed of throughput of patients. At Sandwell and Birmingham, the steps were completed in advance by a healthcare worker with no clinicians involved (p14) Staff were not complying with the required monitoring of the service under Department of Health Required Standard Operating Procedure (RSOP) Staff could not assure the CQC that treatment was evidence based (p.17) - meaning in compliance with the Abortion Act and other legislation and RSOPs (p.18) "RSOP standards require that policies and procedures are in place to ensure that termination of pregnancy is in line with legislation and national guidance. The provider could not provide assurance that policies were up to date with the
legislation, current guidance and that staff were appropriately trained to undertake their roles." (p18) The simultaneous administration of abortifacient medication procedure was not introduced properly, there was no assurance it was evidence based, they hadn t informed patients it was a trial, there were no new consent forms, and there was a rise in patients requiring follow up surgery (p.19). This was not reported to insurers (p.20) There was no effective oversight system for the maintenance of equipment (p.6) Governance: Risk Management The incident reporting process was not effective and the provider could not be assured that all incidents were being reported. Staff did not have access to the incident reporting system and had to make paper records which were uploaded onto an electronic system by governance administrators, which created a delay in reporting and responding to concerns. There were plans in place to bring in a new incident reporting system to improve the process later in the year (p.7) Incidents increased from 704 in 2014/15 to 2634 in 2015/16 there was no evidence that this trend or how to learn from it had been discussed (p.7). They were not investigating incidents immediately but one or two months later (p8). There was no analysis of clinical complication data, despite incidents such as incorrect drugs being given, and perforated uterus (p.20). Data for clinical complications was unclear - This document stated that the clinical complication rate for surgical procedures in 2016 to July was 0.02%. The complication rate nationally is around 0.09%. Therefore the provider allegedly performed better than the national average. However, it was not clear how that figure was determined. CQC witnessed a patient who was very distressed and inappropriate behaviour from a surgeon was observed - despite writing to MSI for an update, this was not reported through their incident reporting system (p.8)
Governance: Legal issues There was no process to ensure that HSA1 forms signed by two doctors, were submitted within the legal timeframe (p.33) The bulk signing of forms (p.36) There was a lack of assurance that two signatories had been obtained before prescribing abortifacient medicine (p.36) They were using policies that had not been ratified (p.37)