Pro Medicus

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• Overview
• Learning culture
• Safe systems, pathways and transitions
• Safeguarding
• Involving people to manage risks
• Safe environments
• Safe and effective staffing
• Infection prevention and control
• Medicines optimisation

The service did not always use effective systems and processes to store medicines. The service did not control infection risk well. Vehicles and equipment were not always well-maintained and there were not always effective arrangements to monitor the safety and upkeep of the equipment and vehicles. The service did not manage patient safety incidents well. However: Staff had robust recruitment processes, with up-to-date mandatory training and additional training to work with the patient group. During our assessment of this key question, we found concerns which resulted in a breach of regulation 12 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. You can find more details of our concerns in the evidence category findings below.

This service scored 56 (out of 100) for this area. Find out what we look at when we assess this area and How we calculate these scores.

People told us they felt safe and that they felt confident to raise any concerns. None of the people spoken to as part of our assessment had experience of raising concerns with the service.

Staff knew what incidents to report and how to report them. Staff understood the principles of duty of candour. Staff and leaders said that there was no local incident reporting system in place. Staff used an incident reporting system which reported directly to the contracting agencies who employed them. Managers told us they would ensure that a local incident reporting system would be introduced for compliance purposes. Managers could not demonstrate that they investigated incidents and shared lessons learned with the whole team and the wider service. Managers did not demonstrate an understanding of the statutory obligation to report statutory notifications to the Care Quality Commission.

The service did not manage patient safety incidents well. We were not assured that the provider had robust policies to support safe incident reporting systems and processes. We requested a copy of the provider’s incident reporting policy during our assessment. The ‘serious incident policy’ that the service provided did not include guidance for staff on how to report an incident, or information about which incidents needed to be notified to external organisations such as the CQC. Following our assessment, the provider sent us an incident reporting policy which did include information about how to report an incident and the requirements to report incidents externally. However, we remained concerned that the provider’s incident policies did not include all relevant information to support safe incident reporting systems and processes. For example, there was a lack of clear guidance about how incidents should be investigated. Staff and leaders were not always following the processes set out in the provider's policy. For example, the policy described that dissemination of learning by managers would be done ‘as routine’ and that compliance with the policy would be measured through set standards and key performance indicators. Staff reported incidents on an incident reporting system which reported directly to the contracting agencies who employed them. The service did not monitor the themes, trends or learning from these incident reports. There was no effective process for learning from incidents. The meeting minutes reviewed during our assessment did not show any evidence of discussion about learning from incidents. The service did not have an effective process in place to ensure that incidents were notified to external organisations such as the Care Quality Commission when required.

We did not look at Safe systems, pathways and transitions during this assessment. The score for this quality statement is based on the previous rating for Safe.

We did not look at Safeguarding during this assessment. The score for this quality statement is based on the previous rating for Safe.

We did not look at Involving people to manage risks during this assessment. The score for this quality statement is based on the previous rating for Safe.

People said that they were cared for in safe environments that were designed to meet their needs. People said that vehicles and equipment were well-maintained.

Staff were able to describe the processes in place to monitor the safety and upkeep of the environment and equipment. Staff acknowledged that some vehicles showed signs of deterioration. Staff took immediate action to remove and replace any out-of-date consumables and fire extinguishers identified during our assessment.

Our observations showed that there were not always effective arrangements to monitor the safety and upkeep of the equipment kept within vehicles. We found multiple expired consumables on the vehicle reviewed during our assessment. We also found out-of-date fire extinguishers on the vehicle. Staff took immediate action to remove and replace these items during our assessment.

Staff did not always have effective processes in place to keep the environment and equipment safe for use. The service did not carry out any audits which monitored the environment or equipment. This meant that we were not assured that the service was able to effectively monitor compliance with the processes that were in place. There was no process for auditing expiry dates of consumables. As a result, we found multiple expired consumables on vehicles. There was no process in place to record the serial number of tamper tags on kit bags. This meant that staff could not be sure whether a bag had been tampered with prior to use. Staff completed electronic daily vehicle and equipment checklists before use. All daily vehicle checklists we looked at were complete and up to date. The registered manager could access the detail to carry out compliance checks. A system was in place to monitor when vehicles needed to be serviced and all vehicles had regular safety service. The vehicles also had up-to-date MOT certificates and tax records. If there were any concerns about any equipment they were taken out of use and repaired. The service had a vehicle and equipment fault log which included details of actions taken after faults had been identified. We saw vehicles that were clearly labelled as off road and not in use. The service had registers to monitor the calibration, servicing and testing of equipment. The registers showed that all equipment was up-to-date for calibration, servicing and testing. The service also had a fire extinguisher record to monitor the date that each fire extinguisher was due to be serviced. The record showed that all fire extinguishers were up to date for servicing. However, this did not align with our observations on-site. Arrangements were in place to allow staff to use the facilities at hospital sites for disposal of clinical waste. Staff had accessible health and safety policies based on up to date health and safety legislation.

People told us they felt there were enough staff to meet their needs. People told us that staff appeared to be skilled and experienced.

The registered managed told us they had enough staff to ensure all shifts were filled. The service operated on a flexible basis responding to requests by contracting providers. This determined how many staff and the number of vehicle hours needed per day.

The service had enough staff with the right qualifications, skills, training and experience to keep patients safe from avoidable harm and to provide the right care and treatment. The service employed seven staff who worked based on their personal contracts and availability. In addition, bank staff were employed on an ad hoc basis. Staff recruitment systems and processes ensured staff had suitable safety checks. Leaders used an online enhanced Disclosure and Barring Service checks which meant they could access up to date detail relating to staff suitability. Updates were electronically flagged to ensure timely renewal of those checks. All staff files had appropriately completed paperwork. Staff received and kept up-to-date with their mandatory training. Leaders did not keep a log of staff training to ensure completion in a timely way. However, the administration team were in the process of developing a more robust management system. Our review of records demonstrated that all staff were up to date with training. The mandatory training was comprehensive and met the needs of patients and staff. Training included manual handling, health, and safety, first aid including how to use an automated external defibrillator. The clinical supervision and appraisal records reviewed during our assessment were thorough but had not been consistently completed.

Service users provided positive feedback about the cleanliness of the vehicles and equipment. People told us that they had observed staff washing their hands and using personal protective equipment when required.

Staff and leaders did not always demonstrate a clear understanding of infection control principles. Staff said that they completed daily cleaning schedules for cleaning vehicles and recorded this on an application on their hand held device. However, the service was not able to provide evidence of the completion of cleaning schedules. In addition, this was not reflected in the standard of cleanliness in the vehicles. Staff said that there was no infection prevention and control lead in the service. This demonstrated that the service did not have clear roles and responsibilities around infection prevention and control.

Our observations showed that the service did not control infection risk well. Staff had not ensured vehicles used to transport patients were clean and well maintained. For example, there was mud on the floors of some of the vehicles. One ambulance showed signs of visible wear and tear. This included visible rust and a chair with a tear. Tape had been used to repair the seatbelt and headrest. This meant the vehicle was neither safe nor compliant with infection control principles. Some vehicles not contain clinical waste bins. There was limited personal protective equipment (PPE) on the vehicles for staff to use. For example, glove sizes were missing and there were no visors or aprons present. Staff had access to handwashing gels and wipes in all vehicles. Each vehicle had accessible spill kits. The service’s base location provided staff with access to vehicle and equipment cleaning facilities. However, we did not see appropriate cleaning materials in use, including mops or disinfectants. Cleaning materials were not always visibly clean. The area used to clean vehicles did not have guidance for staff about the cleaning processes or the cleaning products that should be used. We were not able to observe any patient care during our on-site visit.

The service did not have an effective approach to assessing and managing the risk of infection, which was in line with current relevant national guidance. Cleaning of the vehicle and equipment was carried out by ambulance crew members. Staff said that vehicles were cleaned daily and after every patient transfer. However, the service was not able to provide vehicle cleaning schedules to demonstrate compliance. The provider policy stated that deep cleans of the vehicles would be carried out on a monthly basis. The records reviewed during our assessment indicated that deep cleans were not always being carried out on a monthly basis as required. The service had a range of infection control audits in place. However, there were gaps in the completion of infection control audits and this meant that we were not assured that the service was able to effectively monitor infection prevention and control. In addition, it was not always clear that actions were taken in response to concerns identified during audits. The audits did not produce an overall score to assist managers to monitor compliance rates over time. The service had an infection prevention and control policy to provide guidance for staff. However, staff were not always following the infection control processes which were set out in the provider's policy. For example, the service could not provide evidence of the completion of daily cleaning checklists. There was no infection prevention and control lead in the service. This meant that the service did not have clear roles and responsibilities around infection prevention and control.

The majority of people spoken to as part of our assessment had not had experience of medicines optimisation whilst using this service. However, those who did said that they felt safe and supported to understand and manage any risks.

Staff told us that they had access to information which supported them to safely and effectively manage medicines.

Our observations showed that staff did not always store and manage all medicines safely. Medical gases were not always being stored in line with best practice. They were not stored in a secure position and were sometimes kept outside of the lockable cages. Within the base, some medicines were not stored securely. The service had retained expired controlled drugs within a training environment. These were not stored securely, and access was not limited to authorised staff only. The provider did not stock this item, they were not trained to use it. They were unable to provide assurances that they were authorised to hold this item. The provider stated that their investigation concluded that the controlled drugs had been placed in the training environment by an unknown party with the possible intent to cause reputational damage. The service made use of tamper evident seals on medicine bags. However, there was no process in place to record the serial number of these tags and ensure that a bag had not been tampered with prior to use. There were no oral syringes or measuring spoons available within drugs bags. It was therefore unclear how staff would measure oral solutions kept within the bag. Regular temperature monitoring records for medicines stored within the base or vehicles was not always accessible to staff. The service started a manual check of temperatures inside the base after our first on site-visit. Staff completed medicines records and kept them up to date. We saw evidence of these records being in place from November 2023. We were unable to review any previously completed patient record forms due to them being returned to the contracting NHS Trust but we could see reference to them within the service's own administration records. The service had carried out an audit of patient record forms, which included a review of medicines administration, before they were returned to the NHS trust. Audit results for July to October 2023 showed 100% compliance.

The provider had access to up-to-date national guidance which they followed. This was accessible on mobile devices so staff could refer to it in the field. Staff only administered medicines within their scope of competency and within approved lists of medicines set out by their NHS contracts. There was a medicines policy in place. This included information which signposted staff to refer to contracting NHS organisation's PGDs when conducting work for that organisation. However, staff were not always following that policy around the management of controlled drugs that were held and stored by the service. The service did not monitor the temperature of medicines stored inside the vehicles or garage. Medicines should be stored at temperatures in line with manufacturers recommendations to ensure efficacy. Some medical gases may separate when stored below certain temperatures. It was unclear how the service monitored to ensure that medical gases were not separated before use. The service completed medicines audits. However, these failed to measure the effectiveness of medicines management and optimisation in the service and did not identify areas for improvement. Audit results were not accessible to all members of staff and learning wasn’t always being shared within the organisation. Staff did not retain a record of the amount of oxygen administered to patients during a shift as records were returned to the NHS trust. Certain staff were subscribed to receive medicines safety alerts. However, it was unclear who took responsibility to ensure actions were taken and recorded when relevant to the service. We were told there was a process to assess what medicines a person would need to take to hospital with them when being transported on the ambulance. We could not be assured the process was robust for staff to accurately assess what would or would not be needed by a patient when attending hospital.