Thornbury Radiosurgery Centre (“the centre”) is an independent health care service providing stereotactic radiosurgery (SRS). SRS is a well-established method of treating selected tumours or lesions in the brain. This can include secondary brain tumours (metastases), other tumours (malignant and benign), vascular and functional. In this centre this is undertaken using a specialist Gamma Knife. Procedures are completed as a day case although there are arrangements in place within the hosting hospital, BMI Thornbury Hospital, for overnight stays before and after treatment on the ward.

The service is commissioned by NHS England as a specialist service and Supracentre. This means that the centre was awarded the NHS England contract to treat tier one to four patients. Tier three and four patients generally have more complex conditions and the NHS England service specification for this treatment laid out precise requirements to be met. The service is not contracted to treat children.

The centre is a joint venture between BMI Healthcare and Medical Equipment Solutions Ltd (MESL). Both parties have been shareholders since 2008.

The service provides SRS to NHS and self-funding patients from the local area and all over the UK, and for self-funding patients from elsewhere in the world.

The inspection took place on 20 and 21 September 2016. This was a planned, comprehensive inspection using our new methodology as part of our commitment to inspect and rate all independent hospitals by 31 March 2017. We conducted an unannounced visit to the service on 5 October 2016.

We have reported on the medical care received by patients, acknowledging that these were in the SRS preparation and treatment rooms only.

Overall, we rated this service as requires improvement.

Our key findings were as follows:

Safe

We rated the service as requires improvement for the safety key question.

The centre reported no clinical or non-clinical incidents, deaths or serious incidents or never events from March 2015 to April 2016. Never events are serious incidents that are wholly preventable, as guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers. However, we found that incidents that met the service’s reporting criteria were not recognised by staff as serious enough to be classified as incidents. Therefore, we were not assured that incidents were routinely formally recorded or acted upon, or that lessons were learned within the service, the wider team at BMI Thornbury Hospital, or staff at MESL’s other centre.

We were concerned about the safety of patients during their journey between the centre and the BMI Thornbury Hospital imaging centre. The route that patients had to take by wheelchair between departments for tests and treatment was difficult to manoeuvre because this was adjacent to the public car park and down a steep slope. The safety of this journey had not been risk assessed.

Compliance with mandatory training for staff at the centre was at 94%. However, there was a lack of evidence of compliance with mandatory training by the consultants working within the service.

We found that the environment was visibly clean and cleaning schedules were followed, and we observed staff following infection prevention and control practices. The centre met Ionising Radiation (Medical Exposure) Regulations (IR(ME)R) safety requirements for staff skills and practice and for equipment. Staffing levels were appropriate and there had been no sickness or staff turnover in the past year.

Effective

We rated the service as requires improvement overall for the effective key question.

For SRS/SRT nationally there has been a lack of national patient outcome data to allow patient outcomes to be effectively monitored and compared between services. This limited the ability of the centre to allow patient outcomes to be compared with other services. The new NHSE service model and service specification introduces mechanisms for reporting and monitoring of national patient outcome data, and staff at the centre have welcomed this and are working with other organisations to deliver.

We were concerned that the centre did not meet the NHS England service master specification for stereotactic radiosurgery for the additional standards for tier 3 and 4 conditions. This specification states that the composition of the SRS Treatment and Planning team will involve neurosurgeons and clinical (radiation) neuro-oncologists, supported by paediatric oncologists (where appropriate), neuro-radiologists, medical physics, health technology staff, radiographers, clinical nurse specialists, and administrative support. We found that, although the clinical oncologist attended the multidisciplinary (MDT) meetings, they were not present following repeat MRI scans or when patients received treatment.

There was an inconsistent approach to recording consultant competencies, with some staff files not containing evidence of competence. One consultant did not meet the centre’s requirement to attend MDT meetings.

We saw that policies and practice were in line with relevant professional guidance and legislation and that regular audits of the effectiveness of the equipment took place.

Patients received appropriate pain relief. We saw staff enquiring as to whether patients could feel any pain during treatment and we observed a consultant providing top up anaesthetic until the patients reported they were pain free.

Staff told us, and we saw in the patient records that we reviewed, that MDT meetings took place at the local NHS trust with consultant staff to discuss patients attending the service.

Caring

We rated the service as good for the caring key question.

We observed staff interactions with patients and saw that staff were caring and treated patients with compassion and understanding. Patient feedback cards were overwhelmingly positive and patients described their experiences of care and respect from all staff.

We saw that staff provided patients with information on their treatment before and during their procedures with sensitivity and respect. Patients were followed by the same clinical team members from arrival in the hospital, through their treatment, and on to discharge. Staff forged good professional but friendly and appropriate relationships with patients, including those with additional or complex needs.

Responsive

We rated the service as requires improvement for the responsive key question.

We were concerned that, following fitting of head frames, the healthcare assistant took patients in wheelchairs for their scans. Patients were in full view of other private hospital patients, staff and public, and wore theatre scrubs. No blanket was provided for warmth and patients appeared uncomfortable being seen with head apparatus in public areas.

The centre provided information to patients in a number of ways including in leaflets, face-to-fac, and over the telephone. Patient information leaflets were only available in English. Translation services were available. However, staff told us that they would sometimes use patient relatives as translators. This meant that there was a risk that patients could be placed in a situation where sensitive information was shared with relatives without their consent or that fully-informed consent may not be given by the patient.

The service was planned and delivered in line with regional needs. The centre had begun recruitment of additional staff and planned to move to a day case model of treatment in order to meet an expected increase in demand for the service.

Patients were able to access the service in a timely manner. The centre met the NHS 18 week waiting time standard in the period April 2015 to March 2016 and the average waiting time for private patients from April 2015 to March 2016 was 3.9 weeks.

Staff told us, and we observed, that patients were routinely offered the opportunity to stay in the private hospital overnight following their treatment, at no extra cost. Staff explained that this was stressed as an option to patients who may be returning home alone or who may not be well enough to be discharged home following their treatment.

Well-led

We rated the service as requires improvement for the well-led key question.

Governance structures and policies were in place, and these were integrated with BMI Healthcare Ltd, BMI Thornbury Hospital, and Medical Equipment Solutions Ltd (MESL) Board. However, we were not assured that clinical governance and risk management processes were robust.

We reviewed the minutes of the BMI Thornbury Hospital clinical governance committee and the medical advisory committee in 2016, which were part of the centre’s governance structure. We found that staff from the centre did not regularly attend these meetings. However, the centre had established its own medical advisory committee, which first met in June 2016 and was attended by two of the consultant neurosurgeons together with the MESL chief executive and its registered manager. Managers advised us that this medical advisory committee would meet quarterly going forward.

The Board minutes we reviewed did not refer to discussion of operational or clinical risks or make any explicit reference to matters that required escalation from the clinical governance committee. The centre had adopted the BMI Healthcare Ltd corporate risk management policy and strategy. This policy was past its review date and was not tailored to the centre. Centre-specific risks were recorded in a risk register. Risks were rated, mitigating actions and controls were identified, and each risk was assigned a responsible person. The risk register did not state when a risk had been identified or when it was last reviewed. Therefore, it was not possible to determine how long risks had been on the risk register or how frequently they were reviewed and updated.

We were not assured that the service had robust systems in place to ensure compliance with the practising privileges policy. We found that consultant practising privileges files were not up-to-date in relation to confirmation of professional registration status, Disclosure and Barring Service checks, professional indemnity insurance, annual appraisal, and evidence of training undertaken. We raised this with managers at the time of the inspection and confirmation was subsequently received that these issues had been addressed.

The service had a vision and strategy, which staff were aware of, and which was aligned to the new NHS England service specification for stereotactic radiosurgery. Staff spoke positively about the leadership within the centre, and we observed a positive culture.

We identified areas in which action by the provider is required to improve the service.

Importantly, the provider must:

• Ensure that incidents are reported in line with the relevant incident reporting policy.

• Ensure that the service meets the NHS England service specification for stereotactic radiosurgery for the additional standards for tier 3 and 4 conditions for a clinical oncologist to be part of the planning and treatment team.
• Risk-assess the journey that patients take between the centre and the BMI Thornbury Hospital imaging centre.
• Ensure that patients’ needs are met when they are transported through public areas, including providing blankets as appropriate.

• Ensure that there are in operation effective governance, reporting, and assurance mechanisms that provide timely information so that performance and outcomes are monitored effectively and in line with the centre’s policies, and risks can be identified, assessed, and managed.
• Ensure that there is a robust process for ensuring that medical and other staff have the skills, competency, professional registration, and good character to practise in the centre, including evidence of current professional registration, indemnity insurance, up-to-date appraisal and training, and Disclosure and Barring Service checks (DBS), and that practising privileges are reviewed in line with the relevant policy.

In addition the provider should:

• Consider implementing a formal handover of patients from the centre to the ward.

• Ensure that staff are aware of the risks of asking families to act as interpreters.
• Ensure that information is available to patients, families, and carers about how to make a complaint about the service.

Professor Sir Mike Richards

Chief Inspector of Hospitals