Amvale Medical Transport – Ambulance Station is operated by Amvale Limited. The service is an independent medical transport provider based in Scunthorpe. The company provides an urgent and emergency care service for a NHS ambulance trust which the service sub-contracts, it also transports national organ retrieval service teams, organs, blood and tissue. They are an accredited service provider for NHS blood and transplant services. Amvale medical transport has two locations, the main headquarters at Scunthorpe and a hub location based at a hotel near Leicester. The service was staffed by paramedics and ambulance technicians and commissioned by a regional NHS ambulance service.

The Care Quality Commission (CQC) carried out an unannounced focussed inspection on the 11th January 2017. The purpose of the inspection was to follow up concerns from the last inspection on July 31st 2015, and check the necessary improvements had been made. The concerns we had from the last inspection of which we issued requirement notices were the storage arrangements for medicines including medical gases and controlled drugs were not secure: the procedure for the transfer of controlled drugs between locations were not always followed: management of key storage provided unrestricted access to ambulance vehicles: procedures for handling documents which included patient identifiable information were not robust.

We found on this inspection that the management and audit of controlled drugs were not robust. Controlled drugs were not checked in and out of the safe at the beginning and end of the paramedics shift. The transportation of medicines form was not completed at all stages during the transportation of controlled drugs and we found one drug in use required a patient group direction as it was not covered in the Schedule 17, and 19 of the Human Medicines Regulations. There was improvement in the management of the key storage and the procedures for handling documents which included patient identifiable information.

Services we do not rate

We regulate independent ambulance services but we do not currently have a legal duty to rate them. We highlight good practice and issues that service providers need to improve and take regulatory action as necessary.

We found the following issues that the service provider needs to improve. The provider must ensure that:

• Controlled drugs (CDs) are checked in and out of the safe at the beginning and end of each paramedics shift.

• The transportation of medicines form is completed at all stages during the transportation of CDs.

• A patient group direction is in place for drugs not covered in the Schedule 17, and 19 of the Human Medicines Regulations.

• The storage and management of clinical waste is in line with infection prevention and control procedures.

The provider should ensure that:

• The provider should ensure the effective management and oversight of the cleaning materials store room to maintain cleanliness and infection prevention and control.

Following this inspection, we told the provider that it must take some actions to comply with the regulations, and some actions it should take even though a regulation had not been breached, to help the service improve. We also issued the provider with one requirement notice that affected urgent and emergency services. Details are at the end of the report.

Ellen Armistead

Deputy Chief Inspector of Hospitals (North)

Amvale Medical Transport - Ambulance Station (Amvale) is an independent medical transport provider based in Scunthorpe. The company transports patients, national organ retrieval service teams, organs, bloods and tissue. They are the accredited service provider for NHS blood and transplant services. Amvale has a number of remote locations including a hub location based at a hotel in Leicester. The services provided from that location include 999 emergency services. Services are staffed by trained paramedics and ambulance technicians and commissioned by regional NHS ambulance services.

The Care Quality Commission (CQC) carried out an unannounced focussed inspection on 31 July 2015. The reason for undertaking this inspection was because the CQC had received concerning information about the operation of some aspects of the service. The inspection was therefore focused on limited aspects of the safe, effective and well-led key questions. We have not rated this inspection because independent ambulance services are not currently rated by CQC. During our inspection we spoke with the provider, and eight members of staff of various grades. We reviewed records, and inspected five vehicles. We did not meet patients during this inspection.

The on-site inspection was conducted by the Head of Hospital Inspections, an inspection manager, two CQC inspectors, and the CQC National Professional Advisor for Ambulance and Urgent Care.

Our key findings at inspection were that storage arrangements for medicines including medical gases and controlled drugs were inappropriate and unsecure. Whilst there was a procedure and audit trail to account for the transfer of controlled drugs between locations we found that this was not always followed. The procedures to store keys meant that there was unrestricted access to ambulance vehicles. The procedures for handling documents which included patient identifiable information were not robust.

Staff told us they accessed policies and guidance to support working with NHS providers. The provider worked effectively with the NHS to coordinate services with other providers. However, staff were not following best practice and legislative requirements for the management of controlled drugs and medical gases to prevent unauthorised access and use. The appraisal system for paramedic staff supported the service in working effectively with the NHS. The provider used a clinical skills record booklet for paramedic staff and staff were required to maintain registration with the Health and Care Professions Council (HCPC).

Immediately following the inspection we asked the provider to take action and sought further assurances from the provider that changes had been made in November 2015.

The provider told us in August 2015 that they had taken action following the July 2015 inspection to strengthen governance arrangements. They stated that risk assessments had been undertaken for the storage of medical gases and storage procedures had changed. We were told that standard operating procedures for medicines had been reviewed. The provider also said they had changed procedures for the handling of documents and reviewed its policy for contracting ambulance staff.

The provider must:

• Ensure risk assessments are routinely completed for all medical gas and controlled drug storage facilities, that these meet national guidance for safety and security and, restrict access to only authorised individuals.
• Maintain a standard operating procedure for the distribution of controlled drug storage keys which includes an audit trail that showing how keys are managed and used. This must include the requirement that the controlled drugs key is kept on a separate key ring to vehicle keys to ensure that access is restricted to registered paramedics.
• Ensure there is a robust audit trail for the issue, transport, receipt and recording of stock levels of medicines, controlled drugs and medical gases.
• Ensure there is regular audit of the safe and secure management of medicines and medical gases. The registered manager must act promptly on actions arising from outcomes of audit.
• Ensure medicines management training needs are routinely assessed where required provide regular training in the safe and secure management of medicines, controlled drugs and medical gases for all contracted staff.
• Ensure that there is effective on-site co-ordination and management of the remote locations to include ensuring procedures are implemented monitored and audited for key holding; access and storage of controlled drugs and medical gases.

Professor Sir Mike Richards

Chief Inspector of Hospitals

We spoke with external contractors from East Midlands Ambulance Service (EMAS) who commissioned work from the service. They told us the service worked well with them, was responsive to need and that they had overall confidence in the provider.

Systems were in place for dealing with emergencies that may impact on patients. Staff we spoke with talked about the importance of clear communication with patients to ensure their dignity was promoted and they were at ease and where possible their anxieties allayed. Staff spoke about the need to where possible, work in partnership with patients to ensure interventions were tailored to them and they were able to understand the reasons for decisions about interventions made.

The provider told us about alerts and referrals they had made to ensure vulnerable patients were protected from potential harm. Staff who we spoke with were clear of their professional roles and responsibilities in this regard.

There was evidence infection control and cross infection procedures were in place and available to staff. There was a policy for cleaning ambulance vehicles, including disinfection and cleaning of equipment and deep cleaning processes in response to high risk infections.

We found that vehicles were well maintained and that records were kept that ensured repairs were appropriately actioned.

We found staff were confident in their skills and aware of professional duties. We saw that records were kept to monitor training provided to ensure staff skill competencies were assessed and maintained.

We saw that the provider had systems in place to enable the effectiveness of the service to be monitored and ensure the health, safety and welfare of patients was assured.

Amvale Medical Transport – Ambulance Station is operated by Amvale Limited. The service provides emergency and urgent care and a patient transport services.

We inspected this service using our comprehensive inspection methodology. We carried out the announced part of the inspection on 17 October 2017.

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?

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

The main provision provided by this service was a patient transport service. Where our findings on the patient transport service for example, management arrangements – also apply to other services, we do not repeat the information but cross-refer to the patient transport core service.

Services we do not rate

We regulate independent ambulance services but we do not currently have a legal duty to rate them. We highlight good practice and issues that service providers need to improve and take regulatory action as necessary.

We found the following areas of good practice:

• The service had improved on the majority of the issues for action highlighted in the previous inspection in January 2017. During the last inspection, we found that clinical waste was not stored in line with infection prevention and control practices. During this inspection, we found improvements and the storage of waste was in line with infection prevention guidelines.
• Staff followed infection control policies that managers monitored to improve practice. Managers were able to respond to requests to provide the service in a timely manner and had the flexibility in the resources to meet the needs of commissioners.
• We found the environment clean and tidy and the vehicles and equipment were well maintained.
• Staff recognised incidents and knew how to report them. Managers investigated incidents quickly, and shared lessons learnt and changes in practice with staff. When things went wrong patients received an apology.
• Patients records were stored securely the patient record forms we checked were all completed fully.
• Staff had received training to enable them to care for patients effectively and staff were able to identify and respond appropriately to patients if they deteriorated.
• Staff kept patients safe from harm and abuse. They understood and followed procedures to protect vulnerable adults and children.
• Staff provided care and treatment based on national guidance and evidence, and used this to develop new policies and procedures.
• New staff received an induction programme and staff received annual appraisals.
• Staff understood their roles and responsibilities under the Mental Health Act 1983 and the Mental Capacity Act 2005. They knew how to support patients experiencing mental ill health and those who lacked the capacity to make decisions about their care.
• Patients were taken to the appropriate hospital, based on their needs.
• We saw good evidence of multi-disciplinary working between staff from the hospital and the ambulance crews.
• Staff cared for patients with compassion, treating them with dignity and respect.
• Patients, families and carers gave positive feedback about their care.

• Staff provided emotional support to patients to minimise their distress.
• The service treated concerns and complaints seriously, investigated them and learnt lessons from the results.
• Staff took into consideration the individual needs of patients when each booking was made to support the safe transport of patients.
• The service had a strategic plan and service values that were resonant across all groups of staff.
• Staff described the culture within the service as open to change and supportive. Staff could raise concerns and felt listened to. They said leaders were visible and approachable.
• The service had a clear leadership structure and each member of the leadership team had clear roles and responsibilities.
• The service had effective systems and processes in place regarding recruitment of staff.
• The service has gone through periods of uncertainty over the last year with the reduction and termination of the urgent and emergency care service contract, the service and its staff showed resilience in the process and continued to support the contract and show flexibility to the demand on their services.

However, we also found the following issues that the service provider needs to improve:

• During the previous inspection in January 2017, we found that controlled drugs were not checked in and out of the safe at the beginning and end of each paramedic’s shift. During this inspection we found that this was still happening.
• We found a batch of a medicine that had passed the expiry date.
• We found that some hazardous substances were not stored in a locked cupboard. This did not comply with control of substances hazardous to health (COSHH) legislation.
• Not all staff we spoke with were aware of female genital mutilation (FGM) and had not received training regarding this. This is important, as reporting any recognised incidents of FGM is a legal requirement for all healthcare staff.
• A safeguarding lead had been appointed who had been trained to safeguarding level three. The intercollegiate document states that the identified safeguarding lead should be trained at level four for children.
• We found crews checked their vehicle daily, if a fault was found there was no audit trail as to whether this had been reported and resolved.
• Although a medicine policy was in place, there was no clear guidance for staff to follow or have consideration to when handling patients own medication, when administering patients own medication or when transferring a patient with a syringe driver (which is used to give patients medication continually over a period of time).
• An audit was in place of the patient report forms, which captured what care, and treatment had been provided in line with evidence-based practice, this audit had not taken place since August 2016.
• The service had a number of processes in place to monitor the quality and safety of the services that were provided. However, the service did not have oversight of other key areas, for example, the audit of the management and storage of controlled drugs was not robust.
• There was some duplication in the two management meetings that took place and some areas of clinical governance were not discussed within the meetings.
• The service did not have a fit and proper persons policy that all directors are required to comply with.

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 one requirement notice that affected both the emergency and urgent care and the patient transport service. Details are at the end of the report.

Ellen Armistead

Deputy Chief Inspector of Hospitals Ellen Armistead, on behalf of the Chief Inspector of Hospitals