The Gamma Knife Centre at The National Hospital for Neurology and Neurosurgery

The Gamma Knife Centre at The National Hospital for Neurology and Neurosurgery is operated by QSRC Limited. QSRC Limited is an independent health care service and a wholly owned subsidiary of Medical Equipment Solutions Ltd (MESL). The Gamma Knife service is delivered by the centre working in partnership with University College London Hospitals NHS Foundation Trust (UCLH) as the host trust.

This service provides outpatient and day case treatment to both NHS and private patients using stereotactic radiosurgery (SRS) to treat tumours or lesions within the brain. This can include secondary brain tumours (metastases), other tumours (malignant and benign), as well as vascular and functional conditions.

We inspected this service using our comprehensive inspection methodology. We carried out the announced part of the inspection on 22 and 23 November 2016 and returned on 1 December 2016. We inspected this service under the medical care core service.

To get to the heart of patients’ experiences of care and treatment, we ask the same five questions of all services: are they safe, effective, caring, responsive to people's needs, and well-led? Where we have a legal duty to do so we rate services’ performance against each key question as outstanding, good, requires improvement or inadequate.

Throughout the inspection, we took account of what people told us and how the provider understood and complied with the Mental Capacity Act 2005.

Services we rate

We rated this service as requires improvement overall because:

• We were not assured that clinical governance and risk management processes were robust. We found that whilst plans for the centre’s governance structure had been developed, in practice governance structures were not yet fully embedded and the reporting structure and responsibilities within the service and the partnership with the host trust were not clear.

• We found a failure to implement recruitment procedures to provide assurance that employees and consultants working under practising privileges complied with the Health and Social Care Act 2008, to employ fit and proper persons. Managers lacked oversight of the practising privileges process. The centre did not have its own policy for granting and reviewing practising privileges and could not provide evidence that all appropriate recruitment checks had been carried out. This meant there was a lack of oversight of the recruitment process for consultants applying for practising privileges.
• There was no formal process to ensure staff working under practising privileges had an appropriate level of valid professional indemnity insurance in place. We found insurance documents for two consultants were out of date and that there was no formal system in place to review this.
• The centre’s risk register did not reflect all corporate and clinical risks and did not record any controls or actions to mitigate the risks that were identified. Regular management review of the risk register was not evident and plans to introduce a new risk register had not yet been actioned.
• There was no clear strategy for the development of the service following the award of the NHS England (NHSE) contract. We were unable to see a strategic plan setting out how the service would expand to meet the contract requirements. The leadership team could articulate their plans for the future but did not have this written down as a strategy agreed by the host trust. The business plan for 2017 did not include any plans to meet delivery of an expanded service.

• The service did not fully meet the NHS England service specification for stereotactic radiosurgery. There was no oncology input during the planning and treatment stage of the patient pathway. There was no oncology representation at the specific gamma knife multidisciplinary team (MDT) meetings and the oncologist had not received specific gamma knife training. After the inspection, the provider told us that they had introduced a further planning meeting involving all members of the MDT, including the clinical oncologist.
• There were inconsistencies in staff understanding of how incidents were reported and investigated. We heard several different versions of the incident reporting system and how this operated in practice from the staff. Learning from incidents was not always consistently shared with all staff.
• Although there were clearly defined service level agreements for medical physics input the capacity of this service was limited. The service level agreement for continuity of treatment should the machine break down had expired. There were no contingency plans in place if the equipment broke down or if a medical physicist was unavailable at short notice.
• The service collected patient comments and complaints but we did not see any evidence of changes following feedback.

However:

• We observed staff delivering excellent patient care and they clearly responded to individual patient needs.
• Feedback we received from patients and relatives about the service was consistently positive.
• Staff told us they enjoyed their work and felt well supported by the leadership team.
• We saw record keeping was of a good standard and processes had improved to ensure all notes were available during treatment.
• The multi-disciplinary team meetings were well attended and clearly documented to ensure a robust referral process
• Equipment was well maintained and the environment was clean. Internal infection control audits indicated compliance with national guidance standards.
• The arrangements and systems to ensure patient safety before the gamma knife surgery took place were used consistently.

Following this inspection, we told the provider that it must take some actions to comply with the regulations and that it should make other improvements, even though a regulation had not been breached, to help the service improve. We also issued the provider with a Warning Notice for breach of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 19 (1)(a)(b)(2)(a)(3)(a) to employ fit and proper persons. Details are at the end of the report. After the inspection we carried out a return visit to the provider on 31 January 2017 and found that the provider had made significant improvements towards meeting the requirements of the Warning Notice.

Action the provider MUST take to meet the regulations:

• The provider must ensure that there is a robust process for ensuring that consultants and all 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.
• The provider must ensure that there are effective governance, reporting and assurance mechanisms that provide timely information so that performance and outcomes are monitored effectively and in line with hospital policy and risks can be identified, assessed and managed. Reporting structures and responsibilities should be clearly set out and adhered to.
• The provider must ensure that the risk register is up to date and fit for purpose and reflects current clinical and corporate risks. There should be clear controls and review timescales identified for each risk.
• The provider must ensure that incidents are reported in-line with the relevant incident reporting policy. The provider must ensure that the incident reporting process is clear and consistently applied and understood by staff. Learning and feedback from incidents should be shared with staff.
• The provider must ensure that the service meets the NHS England service specification for stereotactic radiosurgery including the additional standards for tier 3 and 4 conditions requiring a gamma knife trained clinical oncologist to be part of the planning and treatment team.