We carried out an announced focused inspection at Fiveways Health Centre on 8 November 2018 to confirm that the practice had carried out their plan to meet the legal requirements in relation to the breaches in regulations we identified in our previous inspections in January 2018, June 2018 and September 2018 where breaches of the Health and Social Care Act 2008 were identified. You can read the report from our last focused inspection on 20 and 25 September 2017; by selecting the ‘all reports’ link for Fiveways Health Centre on our website at www.cqc.org.uk. Our inspection team was led by a CQC inspector and included a GP specialist advisor and a second CQC inspector.

The breaches of regulations identified at previous inspections were as follows:

A comprehensive inspection was carried out on 9 January 2018. Significant failings were identified in the care and treatment of patients and the practice was rated as inadequate overall and placed into special measures. Under Section 29 of the Health and Social Care Act 2008 two warning notices were issued in respect of the following regulated activities: Treatment of Disease, Disorder or Injury and Diagnostic and Screening Procedures. The provider was required to submit an action plan of planned improvements to mitigate the risks identified. A Section 64 letter was also issued, where the provider was required to provide the Care Quality Commission with specified information and documentation under Section 64 of the Health and Social Care Act 2008.

A focused unannounced inspection was carried out on 6 June 2018 to review the actions the practice had taken and to check whether the provider had implemented their action plan. Following this inspection, we found further significant failings in the management of patient care and treatment and urgent action was taken to protect the safety and welfare of people using this service. Under Section 31 of the Health and Social Care Act 2008 a temporary suspension of four months was imposed on the registration of the provider and registered manager in respect of the following regulated activities: Diagnostic and screening procedures, Treatment of disease, disorder or injury, Family planning, Maternity and midwifery services and Surgical procedures. The suspension took effect from Friday 8 June 2018 until 8 October 2018.

A focused announced inspection was carried out on the 20 and 25 September 2018 to review the actions the practice had taken during the suspension to ensure all failings and associated risks had been mitigated and processes had been implemented for the safe care and management of patients. Findings from the inspection showed the provider had failed to address the issues we had highlighted as being necessary for the suspension to be lifted. In addition, we found additional failings that will or may expose any person to the risk of harm. An extended suspension took effect from Monday 8 October 2018 for a period of 28 days.

At this inspection on 8 November 2018 we found some improvements had been made, but failings in the management of safety alerts and patients with safeguarding concerns still had not been addressed effectively to ensure the safe care and treatment of patients. Following this inspection, the suspension finished on 12 November 2018 and we served a Notice of Decision under Section 31 of the Health and Social Care Act 2008 to impose urgent conditions on the registration of the service provider in relation to the regulated activities as we believe a person will or may be exposed to the risk of harm if we do not do so.

Our judgement of the quality of care at this service is based on a combination of what we found when we inspected, information from our ongoing monitoring of data about services and information from the provider, patients, the public and other organisations.

The practice remains inadequate overall.

We concluded that:

• People were not adequately protected from avoidable harm and abuse.
• The delivery of high quality care was not assured by the leadership, governance and culture of the practice.
• Systems and processes in place did not mitigate risk to patients.

We rated the practice as inadequate for providing well-led services because:

• While some improvements had been made since our previous inspection on 20 and 25 September 2018 in that the provider had addressed the breaches in relation to the monitoring and recording of significant events, however at this inspection we continued to identify concerns that put patients at risk. This included a clear and effective process for the management of safety alerts.
• Due to a change in the management of the practice, the provider was unable to demonstrate they had considered the impact this would have on the overall leadership and governance arrangements
• The practice did not have clear systems, practices and processes to keep people safe and safeguarded from abuse.
• The practice did not always act on appropriate and accurate information. Furthermore, we found that the practices overall approach to service improvement was reactive rather than proactive.
• There was little evidence of systems and processes for learning, continuous improvement and innovation.

The areas where the provider must continue to make improvements are:

• Ensure that care and treatment is provided in a safe way to patients.
• Establish effective systems and processes to ensure good governance in accordance with the fundamental standards of care.

Insufficient improvements have been made such that there remains a rating of inadequate overall. With the suspension period completed, we have taken urgent action to impose conditions on the registration of the service provider under Section 31 of the Health and Social Care Act 2008 in respect of the following regulated activities: Diagnostic and screening procedures, Treatment of disease, disorder or injury, Family planning, Maternity and midwifery services and Surgical procedures. We have taken this urgent action as we believe a person will or may be exposed to the risk of harm if we do not do so.

We are taking action in line with our enforcement procedures to begin the process of preventing the provider from operating the service. This will lead to cancelling their registration or to varying the terms of their registration if they do not improve. The service will be kept under review and if needed could be escalated to further urgent enforcement action.

We have shared our findings with the Clinical Commissioning Group (CCG) and the CQC and CCG are working together to address the concerns identified.

Details of our findings and the evidence supporting our ratings are set out in the evidence tables.

Professor Steve Field CBE FRCP FFPH FRCGP

Chief Inspector of General Practice

At the previous inspection in January 2018 the practice was rated as inadequate overall and placed into special measures.

We carried out a comprehensive inspection of Five Ways Health Centre on 9 January 2018. Significant failings were identified in the management of hospital correspondence and there was no system in place to ensure the appropriate management and actioning of safety alerts. During the inspection we reviewed the QOF clinical registers, where we identified several patients who had been inappropriately excluded from the registers and therefore had not received the appropriate care and treatment. We found that the practice administrator was making decisions concerning the exception reporting of patients on the clinical registers without any supervision or clinical support. We found the management of significant events and the sharing of learning needed to be strengthened and governance arrangements were not embedded. There were no systems or processes to assess and monitor patients’ outcomes and the practice were unable to demonstrate quality improvements, this also included having no effective system in place to obtain patients’ views.

Under Section 29 of the Health and Social Care Act 2008 two warning notices were issued in respect of the following regulated activities: Treatment of Disease, Disorder or Injury and Diagnostic and Screening Procedures. The provider was required to submit an action plan of planned improvements to mitigate the risks identified. A Section 64 letter was also issued, where the provider was required to provide the Care Quality Commission with specified information and documentation under Section 64 of the Health and Social Care Act 2008.

We carried out this focused unannounced inspection on 6 June 2018 to review the actions the practice had taken following the warning notices and the Section 64 letter and to confirm the provider had implemented their action plan. As a result, there was no rating awarded following this inspection.

Our key findings at this inspection were as follows:

• At the inspection in January 2018 we identified significant failings in the management of hospital correspondence. At this inspection we found that there was still no effective process in place and from the letters and patients records we viewed we found significant concerns demonstrating that patients had not received the appropriate care and treatment.
• From the sample of correspondence and patients records we viewed on the day of inspection, we found significant concerns in the lack of systems in place to review children and young people who had attended Accident and Emergency (A&E) and who were on the child protection register.
• Clinical staff did not always assess patients’ needs and deliver effective care in line with current evidence based guidance.
• Some of the patient records we reviewed showed care and treatment was not delivered in line with recognised professional standards and guidelines, including National Institute for Health and Care Excellence (NICE) best practice guidelines.
• The practice told us they had introduced a system to ensure safety alerts were actioned appropriately by clinical staff, however we identified failings in the current system as two alerts concerning potential risks to patients had not been received and there was evidence that alerts had been shared with the wider clinical team.
• The practice was unable to demonstrate that all staff working within the practice had the necessary skills, knowledge and where appropriate training to work within the competencies of their specific role.
• The practice had implemented a system for significant events and updated their policy, however we found the new system had not been embedded and learning from significant events and incidents had not been documented, discussed or shared with the whole team.
• The practice had set up an action plan to gather patient feedback, this included conducting an internal survey to gather patients’ views, however this had not been implemented and the practice was unable to demonstrate any improvements in obtaining patient feedback through internal surveys or the existence of a patient participation group.
• The lead GP had commenced quality improvement through clinical audit, however we saw little evidence that audits were driving improvement in performance or patient outcomes.
• A review of patients on high risk medicines had been completed and the lead GP had implemented a system to ensure patients on these medicines were reviewed regularly.

Due to the significant failings we identified in the management of patient care and treatment on the unannounced inspection on 6 June 2018 urgent action was taken to protect the safety and welfare of people using this service. Under Section 31 of the Health and Social Care Act 2008 a temporary suspension of four months was imposed on the registration of the provider and registered manager in respect of the following regulated activities: Diagnostic and screening procedures, Treatment of disease, disorder or injury, Family planning, Maternity and midwifery services and Surgical procedure from Five Ways Health Centre, Ladywood Middleway, Birmingham B16 8HA.

This notice of urgent suspension of the provider and registered manager’s registration was imposed due to the seriousness of the findings relating to lack of appropriate care and treatment and because we believed that a person would or may be exposed to the risk of harm if we did not take this action. The suspension took effect from Friday 8 June 2018. We have shared our findings with the Clinical Commissioning Group (CCG) and the CQC and CCG are working together to address the concerns identified.

The service will be kept under review and if needed further urgent enforcement action could be taken. Another inspection will be conducted within the four months suspension period and if there is not enough improvement we will move to close the service by adopting our proposal to remove this location or cancel the provider’s registration.

Professor Steve Field CBE FR FFPH FRCGP
Chief Inspector of General Practice

Letter from the Chief Inspector of General Practice

This practice is rated as Inadequate

The key questions are rated as:

Are services safe? – Inadequate

Are services effective? – Inadequate

Are services caring? – Requires Improvement

Are services responsive? – Good

Are services well-led? - Inadequate

As part of our inspection process, we also look at the quality of care for specific population groups. The population groups are rated as:

Older People – Inadequate

People with long-term conditions – Inadequate

Families, children and young people – Inadequate

Working age people (including those retired and students – Inadequate

People whose circumstances may make them vulnerable – Inadequate

People experiencing poor mental health (including people with dementia) - Inadequate

We carried out an announced comprehensive inspection at Five ways Health Centre on 9 January 2018 as part of our inspection programme.

At this inspection we found:

• The practice had a system in place to manage risk; however we found the system was not always effective and did not ensure safety incidents were acted on appropriately. For example, there was limited information to demonstrate whether actions to improve safety as a result of learning had been made following incidents.
• The practice were unable to demonstrate effective management of risks in relation to medicine safety alerts or updates from the Medicines and Healthcare products Regulatory Agency (MHRA).
• The practice did not routinely review the effectiveness and appropriateness of care provided. Care and treatment was not always delivered according to evidence- based guidelines. For example, patients on high risk medicines were not reviewed regularly and patients on the learning disability register were not offered regular health checks.
• The practice did not adopt a systematic approach to determine the number of staff required in order to meet the needs of people using the services. For example, the practice was reliant on regular locums which placed additional pressure on the principal GP.
• Non-clinical staff were exception reporting patients without clinical input or oversight. The GP reported they had no involvement in this process and were unaware of the high exception reporting rates.
• The health care assistant (HCA) was adding medicines to patients records for the prescriptions to be signed by the GP. We were told that before adding medicines the HCA discussed each patient with the GP. However when reviewing patients’ records, we found that this was not clearly documented.
• Emergency medicines were available and all staff were aware of their location. We found one medicine was not in place, however this was immediately purchased.
• The practice had systems, processes and practices in place to keep people safe and safeguarded from abuse.
• We found some clinical audits had been completed; however, audits did not demonstrate quality improvements.
• There was a leadership structure and staff felt supported by management; however effective oversight to ensure governance arrangements were embedded had not been established. For example, practice policies such as collection of prescription protocol was not being followed; systems for preventing and controlling the spread of infections was not always being carried out.
• We found limited clinical leadership within the practice and clinical tasks were being completed by administration staff. For example: the review and actioning of clinical letters.
• Uptake for childhood immunisations and national screening programmes were below national averages.
• Staff involved and treated patients with compassion, kindness, dignity and respect.
• Feedback from patients from the national GP patient survey and the CQC patient comment cards showed that they felt they were treated with compassion, kindness, dignity and respect and felt involved in their care and treatment.
• There was little evidence of innovation or service development and improvement was not being explored or discussed among staff and the management team.

The areas where the provider must make improvements as they are in breach of regulations are:

• Ensure care and treatment is provided in a safe way to patients.
• Establish effective systems and processes to ensure good governance in accordance with the fundamental standards of care.

The areas where the provider should make improvements are:

• Encourage patients to attend immunisation and national screening programmes.
• Continue to review how the practice could proactively identify carers in order to offer them support where appropriate.
• Review the current processes for engaging with the practice population to encourage patients to feedback on services.
• Monitor complaints and comments received to identify trends.

I am placing this service in special measures. Services placed in special measures will be inspected again within six months. If insufficient improvements have been made such that there remains a rating of inadequate for any population group, key question or overall, we will take action in line with our enforcement procedures to begin the process of preventing the provider from operating the service. This will lead to cancelling their registration or to varying the terms of their registration within six months if they do not improve.

The service will be kept under review and if needed could be escalated to urgent enforcement action. Where necessary, another inspection will be conducted within a further six months, and if there is not enough improvement we will move to close the service by adopting our proposal to remove this location or cancel the provider’s registration.

Special measures will give people who use the service the reassurance that the care they get should improve.

Professor Steve Field (CBE FRCP FFPH FRCGP) 

Chief Inspector of General Practice

This practice is rated as inadequate overall. (Previous rating January 2018 – Inadequate)

The key question is rated as:

Are services well-led? - Inadequate

We carried out a comprehensive inspection of Five Ways Health Centre on 9 January 2018. Significant failings were identified in the care and treatment of patients and the practice was rated as inadequate overall and placed into special measures. Under Section 29 of the Health and Social Care Act 2008 two warning notices were issued in respect of the following regulated activities: Treatment of Disease, Disorder or Injury and Diagnostic and Screening Procedures. The provider was required to submit an action plan of planned improvements to mitigate the risks identified. A Section 64 letter was also issued, where the provider was required to provide the Care Quality Commission with specified information and documentation under Section 64 of the Health and Social Care Act 2008.

We carried out a focused unannounced inspection on 6 June 2018 to review the actions the practice had taken following the warning notices and the Section 64 letter and to confirm the provider had implemented their action plan. Following this inspection, we found further significant failings in the management of patient care and treatment and urgent action was taken to protect the safety and welfare of people using this service. Under Section 31 of the Health and Social Care Act 2008 a temporary suspension of four months was imposed on the registration of the provider and registered manager in respect of the following regulated activities: Diagnostic and screening procedures, Treatment of disease, disorder or injury, Family planning, Maternity and midwifery services and Surgical procedures. The suspension took effect from Friday 8 June 2018 until 8 October 2018.

We carried out this inspection on the 20 and 25 September 2018 to review the actions the practice had taken during the suspension to ensure all failings and associated risks had been mitigated and processes had been implemented for the safe care and management of patients. Findings from the inspection showed the provider had failed to address the issues we had highlighted as being necessary for the suspension to be lifted. In addition, we found additional failings that will or may expose any person to the risk of harm.

At this inspection we found:

• As identified in the previous two inspections, the significant event reporting process had not been implemented effectively and the practice were unable to demonstrate a proactive approach in assessing, monitoring and mitigating risks relating to health, safety and welfare of service users.
• The practice was unable to demonstrate that learning identified from significant events had been considered in the assessment of risks.
• The practice management team were unable to demonstrate they were knowledgeable about issues and priorities relating to the quality and future of services.
• Governance arrangements continued to be ineffective in ensuring that responsibilities were clear and that quality, performance and risks were identified, understood and managed.
• The practice had not ensured the appropriate availability of flu vaccines for patients who were eligible and had not acted to protect patients from exposure to the risk of harm.
• The practice was unable to demonstrate that an appropriate system was in place to ensure safety alerts were managed effectively.
• The practice had not completed the relevant employment checks to assure themselves that newly appointed staff were fit for their role.
• The practice infection control lead was unable to demonstrate the appropriate knowledge for the role.

An extended suspension took effect from Monday 8 October 2018 for a period of 28 days. Insufficient improvements have been made such that there remains a rating of inadequate overall and we are taking action in line with our enforcement procedures to begin the process of preventing the provider from operating the service. This will lead to cancelling their registration or to varying the terms of their registration within four weeks if they do not improve. The service will be kept under review and if needed could be escalated to urgent enforcement action. Where necessary, another inspection will be conducted within four weeks, and if there is not enough improvement we will move to close the service by adopting our proposal to vary the provider’s registration to remove this location or cancel the provider’s registration.

We have shared our findings with the Clinical Commissioning Group (CCG) and the CQC and CCG are working together to address the concerns identified.

Professor Steve Field CBE FRCP FFPH FRCGPChief Inspector of General Practice