The Care Quality Commission
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Archived: Shadwell Medical Centre

Overall: Inadequate read more about inspection ratings

137 Shadwell Lane, Leeds, West Yorkshire, LS17 8AE (0113) 237 1914

Provided and run by:
Shadwell Medical Centre

All Inspections

06 July 2021

During an inspection looking at part of the service

Due to concerns we had received, we undertook an announced responsive inspection of Shadwell Medical Centre, 137 Shadwell Lane, Leeds, West Yorkshire LS17 8AE, which commenced on 7 June 2021. We also carried out an unannounced site visit on 18 June 2021.

As a result of that inspection, the practice was rated inadequate overall and inadequate for the keys questions of safe, effective, responsive and well-led. We did not inspect or rate caring.

Due to significant safety concerns, we imposed an urgent suspension of the provider’s registration under Section 31 of the Health and Social Care Act 2008. The suspension took effect from 23 June 2021 and will remain in place until 22 September 2021. Leeds Clinical Commissioning Group (CCG) arranged for another GP practice to provide services for patients in the interim.

The full reports for previous inspections can be found by selecting the ‘all reports’ link for Shadwell Medical Centre on our website at www.cqc.org.uk

Leeds CCG informed us of additional concerns they had identified following our inspection in June 2021. These concerns specifically related to delays in some two week wait referrals being processed, vaccine refrigerator temperature anomalies and the storage of vaccines. We, therefore, undertook a further focused on site inspection of Shadwell Medical Centre on 6 July 2021, and a further review of clinical records on 14 July 2021.

We are mindful of the impact of the COVID-19 pandemic on our regulatory function. This meant we took account of the exceptional circumstances arising as a result of the pandemic, when considering what enforcement action was necessary and proportionate to keep people safe. We will continue to discharge our regulatory enforcement functions required to keep people safe and to hold providers to account where it is necessary to do so.

Our findings

Two week wait referrals:

We reviewed a total of ten patient records where they had been a delay in processing; nine of which related to two week wait referrals. The key issues we found were:

  • There were delays in seeing or reviewing patients after abnormal pathology results
  • There were delays of at least seven days, between seeing a patient and sending the fast-track urgent referral.
  • Urgent tasks sent to administration staff regarding referrals were not completed in a timely way.
  • There was no mention of safety netting patients, informing them of what to do if they had not received an appointment.
  • Not all locum GPs had access rights on the electronic system to make referrals

Vaccine refrigerator:

  • The vaccine refrigerator was not up to date with calibration and had not been calibrated since purchased in 2010. The cold chain policy stated that the vaccine refrigerator should be calibrated on an annual basis. In addition, there was no evidence of any service history for the refrigerator.
  • There was evidence of over-stocking of vaccines stored in the vaccine refrigerator. This had resulted in some packaging being damaged by water, making it difficult to read important information such as the batch number and expiry date.
  • Vaccine refrigerator temperatures had not been checked each working day or any abnormalities acted on appropriately. For example, from 8 April 2021 to 23 June 2021, the refrigerator had gone out of temperature range on 10 separate occasions.
  • All of the stock contained in the refrigerator was subsequently destroyed. The NHS England Screening and Immunisations Team were informed by Leeds CCG Medicines Risk Manager. This was treated as a serious untoward incident with a patient recall process to be instigated.

Following this inspection, due to significant safety concerns and risk of harm to patients, we issued a notice of proposal to cancel the provider’s registration under Section 31 of the Health and Social Care Act 2008.

The local Clinical Commissioning Group arranged for another GP practice to provide services for patients in the interim.

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

Dr Rosie Benneyworth BM BS BMedSci MRCGP

Chief Inspector of Primary Medical Services and Integrated Care

18 June 2021

During a routine inspection

We carried out an announced focused inspection of Shadwell Medical Centre, 137 Shadwell Lane, Leeds, West Yorkshire LS17 8AE, which commenced on 7 June 2021. During that inspection, we undertook an unannounced site visit on 18 June 2021.

Overall, the practice is rated as Inadequate.

We have rated the practice as follows:

Safe - Inadequate

Effective - Inadequate

Caring - Not rated

Responsive - Inadequate

Well-led - Inadequate

We had undertaken a previous inspection in October 2020, as a result of concerns received. This inspection did not result in a rating. The last rated inspection was in April 2018 when the practice was rated as good overall, with some identified areas for improvement.

The full reports for previous inspections can be found by selecting the ‘all reports’ link for Shadwell Medical Centre on our website at www.cqc.org.uk

Why we carried out this inspection

We commenced this announced focused inspection on 7 June 2021 as a result of concerns we had received. However, during the inspection process we received further concerns regarding staffing levels and undertook an unannounced site visit on 18 June 2021.

This was a focused inspection responding to specific areas of concern, which resulted in not all areas within safe, effective, responsive and well-led being reviewed or reported upon. We did not review or report on caring. Therefore, we have carried forward the rating from the inspection undertaken in 2018, meaning that caring currently remains good.

How we carried out the inspection

Throughout the pandemic CQC has continued to regulate and respond to risk. However, taking into account the circumstances arising as a result of the pandemic, and in order to reduce risk, we have conducted our inspections differently.

This inspection was carried out in a way which enabled us to spend a minimum amount of time on site. This was with consent from the provider and in line with all data protection and information governance requirements.

This included:

  • Conducting staff interviews using either telephone or video calls.
  • Completing clinical searches on the practice electronic patient records system.
  • Reviewing patient records to identify issues and any clarify actions taken by the provider.
  • Requesting evidence from the provider.
  • Speaking to staff from external health care organisations.
  • Undertaking an unannounced site visit.

Our findings

We based our judgement of the quality of care at this service on a combination of:

  • what we found during the inspection and on the site visit
  • information from our ongoing monitoring of data about services and
  • information from the provider, patients, the public and other organisations.

We have rated this practice as inadequate overall and inadequate for all population groups.

We rated the practice as inadequate for providing safe services because:

  • Systems and processes relating to safety, including infection prevention and control and patient safety alerts, were not developed and implemented in a way that kept people safe.
  • Risks assessments relating to the premises and staff were not always undertaken or identified actions addressed.
  • The provider did not have clear safeguarding processes in place to keep patients safe. Not all staff were up-to-date with the appropriate level of safeguarding training for their role and safeguarding meetings were not held.
  • There was little evidence of an effective system for managing patient referrals to other services. For example, safety-netting urgent two week wait referrals.
  • There were a large number of outstanding tasks relating to patients to be actioned, such as medicine changes, dealing with abnormal pathology results and arranging for a patient to be seen by a doctor.
  • There was no clear process for managing changes in medication and the review of patients on prescribed medication. Clinical record searches identified patients who had not received appropriate monitoring in line with guidance, such as those who were prescribed high-risk medicines.
  • There was no clinical supervision, or auditing, of non-medical prescribers to ensure they were competent in their role and prescribing appropriately.
  • Incident reporting and management processes were not effective. There was no evidence of identifying any actions and learning from incidents, or sharing information with staff.
  • Patients’ paper records were not always kept secure and managed appropriately.
  • Recruitment checks and processes were not undertaken in accordance with guidance and the practice policy. There was no clear induction system for new or temporary staff.
  • There was not an effective approach to managing staff absence and busy periods in the practice.

We rated the practice as inadequate for providing effective services because:

  • There was no clear system to ensure that clinicians were up-to-date with evidence-based practice.
  • There was not an effective system in place for the recall and review of patients. Clinical record searches identified patients who had not been fully assessed or reviewed in line with guidance. For example, those patients who had a long-term condition or prescribed high-risk medicines.
  • There was limited monitoring of the outcomes of pathology results, care and treatment. Clinical record searches identified patients who had possible missed diagnoses, which included diabetes and chronic kidney disease.
  • There was an absence of care management plans in place for patients, particularly relating to those requiring palliative care or who were living with dementia.
  • Cervical screening uptake was lower than local and national averages and there was little evidence of an effective practice recall system or enough nursing hours to cope with demand.
  • There was little evidence of a programme of quality improvement in place, which included clinical audits, or sharing audits and outcomes with staff.
  • The provider was unable to demonstrate that all non-clinical and clinical staff had the skills, knowledge and experience to carry out their roles. Some staff were asked to work outside their role or competency. Not all staff were not up-to-date with mandatory training. Staff did not receive annual appraisals or training and development assessments.
  • There was little evidence of coordination of patient care with other services. There was a lack of clinical meetings within the practice or with other health and social care professionals.

We rated the practice as inadequate for providing responsive services because:

  • The provider could not demonstrate that care was consistently delivered and coordinated with other services for some population groups.
  • There was an ineffective rota system to support the numbers and type of appointments available on a daily basis for patients to access. Patients complained of long waits for the practice telephone to be answered by a member of staff.
  • There were no clear systems in place to manage patients with urgent needs. On some days there was no clinician working on site, should a patient need a face-to-face appointment or a baby require immunising. We saw evidence of delayed access to patient care and treatment.
  • Feedback from patients about accessing the practice was negative.
  • Complaints were not dealt with in line with the practice policy. There was no identified learning or sharing with staff.

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

  • The provider could not demonstrate they had the capacity and skills to deliver high quality, sustainable care.
  • There was a lack of leadership in the practice leading to a risk of patient harm. Staff reported that the lead GP was rarely visible in the practice.
  • The overall governance arrangements were ineffective. There was no clear vision and strategy for the practice. There was little evidence of systems in place to ensure compliance with the requirements of the duty of candour.
  • There was little evidence of continuous improvement and innovations, including any shared learning within the practice.
  • There was no evidence of a succession plan or leadership and development programme in place for staff.
  • There was a lack of awareness of a Freedom to Speak Up Guardian available for staff to access.
  • Staff reported a culture of bullying, intimidation and a fear of the lead GP.

We found breaches of regulations. The areas the provider must improve 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.
  • Ensure sufficient numbers of suitably qualified, competent, skilled and experienced persons are deployed to meet the fundamental standards of care.
  • Ensure that persons employed in the provision of regulated activities received the appropriate support, training, professional development, supervision and appraisals necessary to enable them to carry out their duties.

Following our site visit on 18 June 2021, due to significant safety concerns and risk of harm to patients, we issued a notice of decision to urgently suspend the provider’s registration under Section 31 of the Health and Social Care Act 2008. The suspension took effect from 23 June 2021 and will remain in place until 22 September 2021.

The local Clinical Commissioning Group arranged for another GP practice to provide services for patients in the interim.

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

Dr Rosie Benneyworth BM BS BMedSci MRCGP

Chief Inspector of Primary Medical Services and Integrated Care

23 October 2020

During an inspection looking at part of the service

We carried out a short notice announced focused inspection at Shadwell Medical Centre on 23 October 2020, in response to information of concern received from a number of sources. This inspection did not result in any new ratings.

The practice was previously inspected in April 2018 and was rated good overall.

We based our judgement of the quality of care at this service 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.

We found that:

  • Staff had access to appropriate training and support.
  • Staff files were kept up to date with a record of training completed and competency checks carried out.
  • Cardiopulmonary Resuscitation (CPR) training for staff had been due recently, but we saw evidence that this was booked to take place in November 2020.
  • Feedback from staff about the leadership and management within the practice was positive.
  • Staff told us they were aware of how to raise a concern should they need to, had access to a Whistleblowing policy and felt comfortable to do so. The Freedom to Speak Up Guardian was a member of the nursing team.
  • Patients had access to appointments with a GP and we saw evidence that a GP was present within the practice on a daily basis.
  • Staff had access to appropriate Personal Protective Equipment (PPE). The provider had purchased additional equipment above and beyond the minimum recommendations outlined by Public Health England.
  • The practice had responded to challenges faced during the COVID-19 pandemic, in order to keep staff and patients safe.
  • At the time of the inspection the practice had been unable to arrange an external Infection, Prevention and Control audit as the organisation the practice usually used had stopped undertaking audits due to the COVID-19 pandemic.
  • We carried out targeted searches of the clinical system to review patient consultations and saw evidence that appropriate reviews had been carried out and documented in the patient records.

Whilst we found no breaches of regulations, the provider should:

  • Consider identifying an external Freedom to Speak Up Guardian.
  • Ensure that all necessary internal infection prevention and control audits are carried out as planned.

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

Dr Rosie Benneyworth BM BS BMedSci MRCGP

Chief Inspector of Primary Medical Services and Integrated Care

17 April to 17 April 2018

During a routine inspection

This practice is rated as Good overall. The practice was previously inspected on 17 January 2017 when it was rated good overall with a rating of requires improvement for providing safe services.

The key questions are rated as:

Are services safe? – Good

Are services effective? – Good

Are services caring? – Good

Are services responsive? – Good

Are services well-led? – Good

We carried out an announced comprehensive inspection at Shadwell Medical Centre on 17 April 2018. This was part of our inspection programme and also to follow up on areas identified for improvement during the previous inspection.

At this inspection we found:

  • The practice had systems in place to manage risk so that safety incidents were less likely to happen.
  • The practice had policies and protocols in place which were accessible to all staff.
  • The practice routinely reviewed the effectiveness and appropriateness of the care they provided. They ensured that care and treatment was delivered according to evidence-based guidelines.
  • Staff involved and treated patients with compassion, kindness, dignity and respect. The practice had taken steps to proactively identify carers and had taken steps to engage with local services to train staff.
  • The practice had made significant improvements with regard to patient satisfaction levels.
  • The practice demonstrated positive outcomes in relation to management of pre-diabetic patients and amber drugs monitoring. This achievement had been acknowledged by the Clinical Commissioning Group (CCG).
  • There was a strong focus on continuous learning and improvement; and the practice could clearly demonstrate where improvements had been made since the last Care Quality Commission inspection.

We saw areas of outstanding practice:

  • The practice proactively identified carers by undertaking a reviewing of clinical coding and opportunistically asking patients to identify their carers. For example; during long term conditions reviews and frailty assessments. The practice had identified 644 patients as carers (13% of the practice list). Carers were offered an annual seasonal flu vaccination. They were provided with information relating to local carers’ support groups and offered routine screening for anxiety, depression and other health problems. We saw evidence that the practice had carried out anxiety or depression assessments on 86 carers and 217 carers had received a flu vaccination.

The areas where the provider should make improvements are:

  • Review and develop the system for significant event reporting to ensure that learning is identified, shared with staff and documented.
  • Continue to monitor and improve medication reviews to ensure records contain clear evidence to support that compliance, ongoing indication for continuing the medication, it’s effectiveness and safety (including side effects) are considered.
  • Continue to monitor and improve the process for issuing acute medications and ensure there are adequate clinical notes to support this.
  • Review and improve mechanisms within the practice to allow staff to voice any concerns.
  • Take steps to assure themselves that all clinicians have completed safeguarding training to the appropriate level.

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

17 January 2017

During a routine inspection

Letter from the Chief Inspector of General Practice

We carried out an announced comprehensive inspection at Shadwell Medical Centre on 1 March 2016. The overall rating for the practice was requires improvement and the practice was asked to submit an action plan setting out how they would improve systems and processes within the practice and the date by which these improvement would be implemented. The full comprehensive report on the March 2016 inspection can be found by selecting the ‘all reports’ link for Shadwell Medical Centre on our website at www.cqc.org.uk.

This inspection was undertaken following confirmation from the practice that all actions were completed and was an announced comprehensive inspection on 17 January 2017. Overall the practice is now rated as Good.

Our key findings across all the areas we inspected were as follows:

  • Staff understood and fulfilled their responsibilities to raise concerns and report incidents and near misses.
  • Feedback from patients about their care was consistently positive.
  • The practice implemented suggestions for improvements and made changes to the way it delivered services as a consequence of feedback from patients and from the patient participation group. For example, reception staff had been supported with training in customer services.
  • The practice had worked with the Leeds North Clinical Commissioning Group to implement a number of recommendations, such as improving the systems for monitoring of amber drugs and ensuring nursing staff had access to appropriate clinical supervision. Amber drugs are a list of medication which require initiation by a specialist within a hospital setting but can be transferred to primary care for ongoing use.
  • The practice had good facilities and was well equipped to treat patients and meet their needs.
  • The practice reviewed complaints and how they are managed and responded to, and made improvements as a result.
  • The practice had visible clinical and managerial leadership and governance arrangements.

The areas where the provider should make improvements are:

  • Continue to assure themselves that suitable medicines and healthcare products regulatory alerts (MHRA) protocol is implemented within practice to capture any patients who do not respond and follow up for action.
  • Continue to maintain the newly implemented systems, processes and practices and ensure they are embedded into the culture of the practice.
  • Set aside regular time for GPs within the practice to communicate and discuss topics such as NICE Guidance and Safety Alert Broadcasts.

Professor Steve Field (CBE FRCP FFPH FRCGP) 

Chief Inspector of General Practice

1 March and 17 March 2016

During a routine inspection

Letter from the Chief Inspector of General Practice

We carried out an announced comprehensive inspection at Shadwell Medical Centre on 1 March 2016. We received information of concern following the inspection and returned to the practice on 17 March 2016. Overall the practice is rated as requires improvement.

Our key findings across all the areas we inspected were as follows:

  • Staff understood and fulfilled their responsibilities to raise concerns, and to report incidents and near misses.
  • The practice had a disabled toilet which had no alarm to highlight if a patient was in distress. This meant there was a risk that patients may be left in the toilet for long periods without assistance if required.
  • Patients’ paper medical records were stored in the attic area of the practice. This meant that staff were put at risk when having to access the paper medical records.
  • The practice had carried out infection control audits but there were no updates to action plans to indicate that improvements had been made as a result of findings.
  • Data from the national patient survey showed patient outcomes were low compared to the national average. Comments cards we received also raised concerns in relation to the standard of care provided by the practice.
  • The majority of patients said they were treated with compassion, dignity and respect. However, not all felt cared for, supported and listened to.
  • Staff who acted as chaperones had received a Disclosure and Barring Service (DBS) check. (DBS checks identify whether a person has a criminal record or is on an official list of people barred from working in roles where they may have contact with children or adults who may be vulnerable). However; at the time of our inspection staff acting in this role had not received appropriate training. We received assurance from the practice manager following our inspection that this had been provided.
  • We identified concerns regarding staffing levels within the practice and how these were managed. In addition, we noted concerns regarding the workload of the salaried GP.
  • Blank prescription forms and pads were not securely stored and there were no systems in place to monitor their use. We saw evidence that this process had been changed during our second visit to the practice. Blank prescriptions had been relocated to a locked cupboard in the practice managers office and a logging system had been introduced.

The areas where the provider must make improvements are:

  • Ensure the necessary pre- employment checks for all staff are carried out.
  • Ensure appraisals are carried out for all staff
  • Ensure all areas of the practice which staff and patients require access to are safe and fit for purpose
  • Ensure that governance systems and processes are established and operated effectively. This includes systems to share lessons learned from complaints, to act on infection control audit findings and recommendations, to respond to and act on feedback from stakeholders and for succession planning to maintain the level of service provision.

In addition the provider should:

  • Work with the patient group in order improve services and support to patients.
  • Continue to monitor tasks undertaken by non-clinical staff. For example; pathology results received by the practice.
  • Review, monitor and maintain adequate levels of trained staff to support the running of the service.
  • Review their communication arrangements within the practice in order to enable staff to keep up to date with clinical issues and learn from incidents.
  • Consider holding regular staff meetings to allow for sharing of information amongst staff, including practice and clinical updates.

Professor Steve Field (CBE FRCP FFPH FRCGP) 

Chief Inspector of General Practice

19 November 2014

During an inspection looking at part of the service

Our inspection on the 22nd May 2014 we found the practice had not ensured patients had sufficient access to appointments with the GPs. The practice had also not followed recruitment procedures or provided adequate support and guidance to staff. Following the inspection the practice wrote to us and told us they would take action to ensure they were compliant with these essential standards.

At this inspection we found that improvements had been made. The provider now reviewed patient's access to appointments and put systems in place to ensure staff were recruited safely and had the right support and guidance in place.

22 May 2014

During an inspection in response to concerns

We visited the practice because concerns had been raised with us. The main concern was that there were not enough GPs at the surgery. We were also told that it was difficult to get an appointment to see a GP and that the appointment system was inflexible.

We spoke with seven patients during our visit, the practice manager and clinical and administration staff. We saw three GPs had recently left and that the provider had put into place locum GPs to ensure clinical support was maintained. We also saw new GPs and nursing staff were being recruited. However we found there had been some stress on the appointment schedule during the time of this transition. We found staff recruitment was not robust. We also found supervision and appraisals were out of date and staff felt unsupported and unclear about their roles.

The practice had mechanisms in place to monitor and asses the standard of care patients received. However we did find the provider had failed to notify the Care Quality Commission of important changes to their registration.

13 August 2013

During a routine inspection

We spoke with four patients, the registered provider (the lead GP), the practice manager, a health care assistant and a receptionist.

Patients' needs were assessed and care and treatment was planned and delivered in line with their individual wishes.

Staff had received training in the safeguarding vulnerable of adults and children. They were aware of the appropriate agencies to refer safeguarding concerns so patients were protected from harm.

Staff received appropriate professional development. The provider had worked continuously to maintain and improve high standards of care by creating an environment where clinical excellence could do well.

There were systems in place to gather the views of patients who used the service about the care and support provided. Patients had their comments and complaints listened to and acted on to improve the patient experience.