Marie Stopes International Manchester Centre (MSI Manchester) is part of the Marie Stopes International group and was acquired in November 2004. The service provides surgical termination of pregnancy procedures (SToP) up to 23 weeks and six days gestation and early medical termination of pregnancy (MToP) up to nine weeks and four days gestation. Treatments can be provided under no-anaesthesia, sedation anaesthesia and general anaesthesia. The service does not carry out manual vacuum aspiration procedures. The service also provides advice on contraceptive options, provides oral contraception, long acting reversible contraception (LARC) and male sterilisation (vasectomy).
In terms of medical abortions, the provider offers three 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. The service had previously offered simultaneous medical abortions (whereby both stages of medication are administered without a gap between each stage) but had suspended this treatment at the time of our inspection until more outcome data has been collected.
The clinic is open Tuesday to Saturday and alternate Thursdays for vasectomy patients. In addition MSI Manchester has 10 satellite clinics 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.
We carried out this inspection as part of our comprehensive inspection programme of termination of pregnancy services. As part of our inspection we reviewed medical and surgical termination of pregnancy services carried out at the MSI Manchester clinic only. At the time of inspection there were no vasectomy lists.
The announced inspection of MSI Manchester took place on 19 May 2016 and we visited all areas within the service including the theatre, recovery areas, consultation rooms and waiting areas. We also carried out an unannounced inspection on 16 June 2016 to see how patients were cared for during a busy surgery day.
We have not provided ratings for this service. We have not rated this service because we do not currently have a legal duty to rate this type of service or the regulated activities which it provides.
Although we do not currently have the powers to rate these services, we report on whether they are safe, effective, caring, responsive to people's needs and well-led. We highlight areas of good practice and areas for improvement.
Our key findings across all the areas we inspected were as follows:
Are services safe at this service
- There was an electronic system in place to report incidents, with triggers to alert senior management. Staff we spoke with were aware of the process and understood their responsibilities. Serious incidents had been investigated at local level, with identified actions to prevent reoccurrence. It was clear from the reports and resulting action plans that the identified actions had been completed in a timely manner.
- Staff we spoke with understood the requirements of duty of candour. A duty of candour policy had been introduced in April 2016.
- The service had clear systems in place to identify and report any safeguarding concerns. However, records showed only 57% of staff had completed level two training in safeguarding children and adults. Staff were not routinely trained to level three in children’s safeguarding. The regional manager informed us that a new head of safeguarding had been appointed in the last six months and was reviewing training requirements in line with intercollegiate guidelines.
- There was a clear transfer policy agreement in place with the local NHS trust. If a patient required an emergency transfer to the local NHS provider, patients would be transferred by a member of clinical personnel and the theatre list would be stopped until staff were available.
- There was little reliance on agency staff to cover nursing shifts and two shifts had required agency cover in the last three months. Registration with the Nursing and Midwifery Council and General Medical Council was monitored by the central human resources team and quarterly reports were sent to the registered manager flagging any issues.
- Medical staffing was provided by doctors working both remotely and within the centre. The service employed one surgeon to work at the centre on a full time basis. There were no vacancies for medical staff and surgeons; staff working at other MSI centres provided cover if necessary.
- However, we were not assured that staffing in theatres met the recommended staffing standard identified by the Association for Perioperative Practice (AFPP).
- The provider’s schedule of services for anaesthetists and surgeons states that they should “assess all remaining clients and liaise with the senior nurse before leaving the centre”. This meant that they were able to leave the centre before all patients have been discharged and potentially leave the clinic with no staff trained in advanced life support should a patient deteriorate post-operatively.
- At the time of our inspection we observed syringes containing an induction agent (drug used to help patients relax before and during general anaesthesia) in a kidney dish on the anaesthetic machine in theatre. The tips of the syringes were not covered to protect them from the risk of cross infection. We asked the anaesthetist if this presented a risk of infection and they told us they usually placed the tip of the syringe back into the sterile wrapping. At the time of our inspection we observed additional syringes being prepared and the tips were covered in the sterile packaging until used.
- Cleaning schedule checklists for the theatre had not been completed consistently and there was no record of how often and when the fabric covers for chairs in the ward area had been cleaned or changed.
- Resuscitation equipment was not checked daily, which is identified as best practice by the Royal College of Anaesthetists (2012).
Are services effective at this service
- The provider had policies and guidelines in place in relation to: offering patients a choice of procedure, discussion and options for future contraception and screening for sexually transmitted disease.
- Policies were not always updated to reflect practice changes in a timely manner. Both the ultrasound policy and the medicines management policy we reviewed were out of date at the time of inspection. The ultrasound policy had been due for review in July 2015 and the medicines policy had been due for review in March 2016.
- The service had key performance indicators in place and these were reported each month via the governance and quality dashboard. The dashboard showed there had been no returns to theatre or transfers from January to March 2016.
- The service had locally agreed standards in place with commissioners. The service also reported any instances of ectopic pregnancy to the commissioners.
- Medical records audits included monitoring of pathways of care, information provision and pre-abortion assessment in line with Royal College of Obstetricians and Gynaecologists’ (RCOG) guidelines. The pre-abortion assessment was performed in conjunction with the corporate pre-existing conditions guidelines. Details about the type of abortion procedures that were carried out were captured and monitored via centrally produced capacity reports.
- For new staff, an induction and training programme was in place where competencies were assessed with mentor support and supervision. Senior staff we spoke with stated that staff were assessed against these before being allowed to practice unsupervised. Records showed all of the medical and nursing staff had received an appraisal in 2015.
- Staff across the service were aware of appropriate procedures in obtaining consent. Healthcare assistants and nurses had been trained in line with the provider’s own policy and would go through the consent process with patients during the consultation. However, none of the staff had received safeguarding training at level three, which meant 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.
Are services caring at this service
- Staff took time to interact with patients; they were attentive to their needs and spoke in a compassionate manner most of the time. Staff in theatre were supportive and tried to put the patient at ease.
- All patients were provided with a feedback questionnaire prior to discharge, to be completed in the clinic or later at home. They were anonymous, sealed, and sent to an external organisation for collation and reporting. For the period January 2015 to March 2016, service users had rated the service at 96% for the overall quality of care.
- Counselling services were available to help and support patients if required, either by telephone or face to face.
- The layout of the recovery room meant there was limited privacy for patients. Staff at the time of our inspection did not seem to be aware of this or sensitive to the need to adapt practice when required to ensure patients’ privacy and dignity was not compromised.
Are services responsive at this service
- Services were responsive to patients’ needs. Appointments were offered in a timely manner and patients were given options to choose the procedure that was the best option for them. Waiting times for consultation from initial contact and treatment from initial contact were consistently within the Royal College of Obstetricians and Gynaecologists’ (RCOG) recommended timeframes.
- Records we reviewed showed pre-existing medical conditions were considered and risk assessed in the medical review. If a patient was deemed at risk and could not be managed in the clinic they were referred to the local NHS provider.
- A 24 hour telephone line was available to provide advice and support outside service hours. In the event a patient deteriorated, the patient could be brought back to a clinic for consultation or if it was an emergency could be directed to their local accident and emergency department.
- There was disabled access on the basement level, where a patient with reduced mobility could be treated, whether receiving a medical or surgical termination of pregnancy.
- A telephone interpreter service was available for non-English speaking patients, as well as written information, in the form of leaflets and on the website.. A hearing loop had been introduced on 12 May 2016.
- Where possible any concerns raised whilst the patient was on site would be dealt with by staff. Formal complaints were reviewed and responded to by the head of quality and customer service with involvement from the registered manager.
- We were not assured that patients were given information to make an informed choice with regards to disposal of pregnancy remains. We did not see any evidence of discussions in the patient record and did not see information about options given to patients. However information was available on the provider website.
- The post-operative area was cramped, there was little room for privacy and patients’ dignity was at risk. The area was staffed with two staff, who were also responsible for collecting patients from theatre, watching a monitor and responding to patients’ needs in a separate room.
Are services well led at this service
- The service had a clearly defined vision supported by the corporate mission statement “Children by choice, not chance”. Staff we spoke with were able to articulate this and were ‘pro-choice’ in their approach to providing patients with care and treatment.
- There was a regional management structure in place that identified lines of accountability. Staff we spoke with told us they felt supported to learn and develop and liked working at the clinic.
- There was a corporate governance framework in place supported by both a corporate central governance committee and local integrated governance committees. Local compliance with governance standards and key performance indicators was monitored via a governance and quality dashboard that was submitted to head office on a monthly basis.
- Review of best practice guidance and any changes to clinical policy were discussed and ratified during the corporate clinical leads meetings. Any decisions would then be signed off by the central governance committee. However, there was no evidence of local management involvement in decision making, with a top down approach being adopted by the provider. This was evident in the initial decision to implement simultaneous administration of medication for early medical abortions.
- There was no effective process in place to ensure policies were reviewed and updated in a timely manner.
- Staff stated that practising privileges were handled corporately and were reviewed by the medical director and lead doctor. However, there was limited oversight of this process at local level. For example, the registered manager was not involved in the decision to renew practising privileges and did not have sight of the doctor’s most recent appraisal or revalidation. Similarly, pre-employment checks were carried out and stored at head office. The provider was in the process of transferring this information onto an online system so it could be accessed from any clinic but it was not in place at the time of our inspection.
- The process for signing HSA1 forms meant that abortifacient medication could be prescribed before two signatures had been obtained on the HSA1 form, we found this in two out of eight records reviewed.
- Patients were not informed about the statutory requirement of HSA4 forms. Staff did not explain to patients that these details were sent to the Department of Health and that it was a legal requirement.
- Clinical governance reports included data on failure rate by surgery and medical treatments, infections, and the reasons for any transfers. However, the reports included data at either national or regional level and were not broken down by clinic so it was not clear how the data was used to drive local improvement.
We saw some areas of practice where the provider needs to make improvements.
Importantly, the provider must:
- Ensure all staff have received the appropriate level of safeguarding training in line with intercollegiate guidelines.
- Ensure that staffing levels in theatre have been risk assessed and adhere to recommended guidance at all times.
- Ensure staffing levels in the recovery area are sufficient to meet patients’ needs at all times.
- Consider how best to ensure patients’ privacy and dignity is maintained in the recovery area.
- Ensure patients are informed of the requirement to submit abortion data to the Department of Health and how this information is anonymised.
- Ensure syringes that are used to administer intra-venous medication are stored appropriately prior to use to prevent risk of cross infection,
- Ensure cleaning records in theatre are fully completed and that there is a clearly documented process for changing seat covers in the recovery area.
- Review how often resuscitation equipment is checked in line with best practice guidance.
- Ensure the registered manager has clear local oversight of the practising privileges review and renewal process.
- Ensure the registered manager has clear local oversight and assurance with regards to the completion of pre-employment checks prior to new members of staff commencing employment.
- Consider how data included in quarterly governance reports can be broken down to clinic level so they can be used meaningfully to identify local issues and improve local performance and patient outcomes.
- Ensure both the ultrasound policy and the medicine management policy are reviewed to ensure they contain current information in line with best practice. This should include being clear whether scanning post treatment is a routine requirement or not.
- 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 staff are appropriately trained to assess and respond to a deteriorating patient and staff with advanced life support training remain on site whilst patients are recovering from surgical termination of pregnancy.
In addition the provider should:
- Ensure there is an effective system in place to provide patients with information to make an informed choice with regards to disposal of pregnancy remains, including documentation of discussion and decision.
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 12 October 2016.
CQC also issued warning notices 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 warning notices 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