Bridlington NHS Dialysis Unit is operated by Fresenius Medical Care Renal Services Limited. The service opened in October 2008. It is a private medical dialysis unit in the grounds of Bridlington Hospital, in the East Riding of Yorkshire. The unit primarily serves the communities of the East Yorkshire and Hull areas. It also accepts patient referrals from outside this area.

The service provides haemodialysis from Monday to Saturday each week, with morning and afternoon sessions.

We carried out a comprehensive inspection of the unit on 5 April 2017. This included an unannounced visit to the unit on 18 April 2017. The inspection took place as part of our comprehensive inspection programme. We found that the service was in breach of regulations. We issued a warning notice to the provider in regard to specific breaches within the unit. This identified concerns and areas for improvement at Bridlington NHS dialysis clinic including:

• The process of incident reporting, investigation, escalation, and learning from incidents.
• Medicines management processes, including patient identification in order to be in line with safe standards and national guidelines.
• Infection prevention and control practices which are intended to keep patients safe.
• Processes to ensure deteriorating patients can be safely and appropriately managed in line with best practice guidance and national standards.
• The processes of monitoring and ensuring staff are competent to carry out their roles.
• The mandatory training processes, which ensure staff have had up to date training essential to their roles.
• The processes to ensure staff are aware of safeguarding procedures and comply with the Mental Capacity Act and Deprivation of Liberty Safeguards.
• Standards for keeping patient information safe, in line with national legislation. To ensure a process is in place to maintain record keeping in line with professional standards.
• To ensure a process is in place where risks are placed on the risk register, so risks can be appropriately managed and action taken.
• To improve overall leadership and governance of the unit and the process for managing performance of the staff and the unit.

We carried out an unannounced visit to the unit on 13 December 2017 to check on progress that had been made against our warning notice. This inspection focused on the specific issues we had raised following the comprehensive inspection earlier in the year.

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 do not rate

We regulate dialysis services, but we do not currently have a legal duty to rate them when they are provided as a single specialty service. We highlight good practice and issues that service providers need to improve, and take regulatory action as necessary.

In this inspection, we found the following areas of good practice:

• We saw improvements in the incident reporting culture; with staff feeling more empowered to raise concerns and report incidents.
• We saw improvements in the culture, morale and leadership within the clinic.
• We saw improvements in the training culture in the clinic, with staff given dedicated time in which to complete their training. We saw effective recording of competency assessments following training.
• We saw an effective process in place for staff checking patient identification pre-administration of dialysis treatment and additional medications.
• Systems were in place to prevent and protect people from a healthcare-associated infection, on the majority of occasions staff used these safety systems including aseptic technique and decontamination of reusable devices appropriately.
• All staff were aware of their responsibilities to report safeguarding concerns.
• All records we reviewed were stored correctly, were comprehensive, and contained detailed assessments.
• There were effective processes in place for assessing and recording a person’s mental capacity to consent to care or treatment. When patients were found to lack capacity to make a decision, staff had made ‘best interests’ decisions in accordance with Mental Capacity Act (MCA) and Deprivation of Liberty Safeguards (DoLS) legislation.
• The risk register for the clinic had been updated and now reflected risks specific to the Bridlington unit; for example, the use of incorrect disinfectant, and risk of patient prescriptions not being followed.

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

• We were not assured that sufficient progress had been made in relation to the development of protocols specific to the care of the deteriorating patient within the Bridlington clinic.
• We were not assured of sufficient oversight of the organisation when incidents occurred to enable learning to take place. We saw that the head nurse had closed incident logs on two occasions without any comment or advice recorded on the electronic incident log. We also observed that when incidents involved agency members of staff, we did not see a safe process in place to ensure the incidents were captured in all units and reported to the relevant agency so that agency staff could be offered additional competency training or support.

Following this inspection, we told the provider that it should make other improvements to help the service improve, even though a regulation had not been breached.

Ellen Armistead

Deputy Chief Inspector of Hospitals (North)

We observed care being received by patients when undertaking dialysis. We spoke with two nurses, the clinical manager and the regional manager during our visit. We also spoke with two patients who attended appointments.

Patients were seen to be treated with respect, their clinical needs were met and there was a programme available for patients to be trained to conduct many of the processes themselves, such as recording weight, connecting to and the use of the dialysis machine.

A recent patient survey suggested a high degree of satisfaction with the service. On the day of our inspection, most patients undertaking treatment were resting or watching television. Patients we spoke with told us that they were very happy with the care and treatment they received and they had confidence in the staff. One patient said “The care is first class”.

The clinical areas were clean, tidy and there were systems in place to lower the risk of spread of infection. Both patients we spoke with commented on the cleanliness of the unit. Staff were appropriately trained, supervised and supported and we saw evidence of a programme of auditing and monitoring the quality of clinical practice and records.

We were unable to speak to people regarding their care during the inspection.

Bridlington NHS dialysis unit is operated by Fresenius Medical Care UK (FMC), an independent healthcare provider. It is contracted by Hull and East Yorkshire NHS trust to provide renal dialysis to NHS patients. Patients are referred to the unit by local NHS trusts. The service is situated on the site of Bridlington and District NHS hospital which was built in 1989; dialysis services began in 2008. It is a 12 station dialysis unit (comprised of ten stations in the general area and two side rooms which can be used for isolation purposes) providing haemodialysis for stable patients with end stage renal disease/failure.

We inspected this service using our comprehensive inspection methodology. We carried out the announced part of the inspection on 5 April 2017, along with an unannounced visit to the unit on 18 April 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? 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 do not rate

We regulate dialysis 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 process of incident reporting, investigation, escalation, and learning from incidents.
• Medicines management processes including patient identification in order to be in line with safe standards and national guidelines.
• Infection prevention and control practices which are intended to keep patients safe.
• Processes to ensure deteriorating patients can be safely and appropriately managed in line with best practice guidance and national standards.
• The processes of monitoring and ensuring staff are competent to carry out their roles.
• The mandatory training processes which ensure staff have had up to date training which is essential to their roles.
• The process for managing performance of the staff and the unit.
• The processes to ensure staff are aware of safeguarding procedures and comply with the Mental Capacity Act and Deprivation of Liberty Safeguards.
• Standards for keeping patient information safe in line with national legislation.
• To ensure a process is in place to maintain record keeping in line with professional standards.
• To ensure a process is in place where risks are placed on the risk register, so risks can be appropriately managed and action taken.
• To improve overall leadership and governance of the unit.

However, we also found the following areas of good practice:

• Daily water testing was carried out by staff which was more frequent then the weekly minimum requirement for chlorine testing.
• Good standards of monitoring patients’ arteriovenous fistulas to ensure they worked safely and effectively.
• All of the patients received dialysis through high flux dialysers. High flux dialysis is a form of more effective haemodialysis; it is better quality dialysis. 
• Flexible staff who worked over when needed for the interests of patients.
• Caring and friendly staff who knew the patients well and looked after them with compassion and understanding.

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 three requirement notices that affected dialysis services. Details are at the end of the report.

On 27 April 2017 we served a warning notice under section 29 of the Health and Social Care Act 2008. The warning notice related to Regulation 17, The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014- Good governance. We had serious concerns that the governance systems and process did not provide assurance that risks were identified, recorded and acted upon, to ensure patients receive safe care and treatment and were protected from risk of harm. The warning notice requires the provider to take action to ensure systems and processes are established and operated effectively to assess, monitor, and improve the quality and safety of the services provided in the carrying on of the regulated activity.

We have given the provider three months to make the necessary improvements.

Ellen Armistead

Deputy Chief Inspector of Hospitals (North region)