Leeds Screening Centre

On this page

• 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

This means we looked for evidence that patients were protected from abuse and avoidable harm. 

At our last inspection, we rated this key question as requires improvement. At this assessment, it remained requires improvement. 

Patients were not consistently protected from avoidable harm. We identified significant and widespread shortfalls in safeguarding, infection prevention and control, environmental safety, risk assessment and management, recruitment, staff training and competency, and referral and triage arrangements. These shortfalls increased the risk of patient’s receiving unsafe care and treatment.

The service remained in breach of Regulation 13 (Safeguarding), Regulation 12 (Safe Care and Treatment) in relation to infection prevention and control, and Regulation 19 and Schedule 3 (Fit and Proper Persons Employed) in relation to recruitment.

We identified further breaches of Regulation 12 (Safe Care and Treatment) relating to referral and triage arrangements, the communication of Non-invasive prenatal testing (NIPT) results, chaperone arrangements, emergency equipment and fire safety. 

The service was also in breach of Regulation 18 (Staffing) because it had not established effective arrangements for staff supervision, training, appraisal, competency assessment and workforce development, or systems to monitor training compliance.

Although staff described some safe practices and the registered manager acted in response to concerns raised during the onsite inspection, the service’s systems had not identified or addressed a number of significant risks. This limited assurance that patients were consistently protected from avoidable harm.

We have not awarded this service a score for Safe.

Find out about when we will not publish a key question score and what we look at when we assess Safe.

The service could not provide sufficient assurance that safety events were consistently captured, reviewed, monitored and used to support organisational learning.

Staff told us incidents and learning could be discussed during sonographer audit and team meetings, which provided opportunities to discuss service issues and review actions

Staff told us there had been no incidents within the previous 12 months. Staff told us they felt able to raise concerns and understood local reporting arrangements. They were able to describe the immediate actions they would take following a safety event, including escalating concerns to senior staff where required. However, they explained that incidents would be recorded within individual patient records rather than within a centralised incident management system. This limited the service's ability to effectively monitor incidents for trends, themes and emerging risks. As a result, the service could not provide sufficient assurance that safety events were systematically analysed and used to support continuous learning and improvement.

Following the onsite inspection, the service submitted a serious incident reporting template and incident reporting form. However, staff did not refer to these documents. 

Not all staff demonstrated a clear understanding of Duty of Candour requirements and some staff confused Duty of Candour with general incident reporting processes. Following the assessment, the service submitted a Duty of Candour policy. However, staff did not refer to this policy. 

The service did not consistently establish or maintain safe systems of care. Gaps in referral vetting, triage arrangements and staff guidance reduced assurance that risks to patients were consistently assessed, monitored and managed.

There were inconsistent processes for assessing referrals and confirming clinical information before appointments. The service did not demonstrate a consistently applied triage or booking assessment process for private diagnostic scan referrals and relied heavily on patient-provided information, clinic list reviews and face-to-face assessments to identify unsuitable referrals.

Clinical information was not always reviewed before appointments took place. Sonographers reviewed clinical histories either when receiving clinic lists the day before appointments or during appointments before deciding whether a scan should proceed. As a result, patients whose symptoms, gestation, allergies, clinical circumstances or requested investigation made the referral unsuitable may not have been identified until attendance. This increased the risk of inappropriate investigations, delayed onward referral and inefficient use of appointment capacity.

Online booking arrangements did not ensure key clinical information was obtained before appointments were booked. Private, self-funding patients booked appointments through an online portal which relied on optional free-text information and did not prompt patients to provide key clinical information.

Staff did not have access to clearly defined and accessible triage criteria. Staff told us they “just knew how to triage”, relying on their own knowledge when covering for the practice manager, who normally made triage decisions. However, on the first day of the onsite inspection they were unable to access the referral criteria used to support referral and booking decisions. They reported that patients often arrived having already researched scans and tests and knew which investigation they wanted. In addition, patient feedback evidenced staff making decisions about the appropriateness of scans without reference to agreed criteria. This reduced assurance that referral, booking and triage decisions were being made consistently against clearly defined and accessible criteria.

GP referral bookings were reviewed by patient coordinators who manually transferred referral information onto the service's booking system. They completed additional demographic checks, including confirming age, address and GP details, and said these referrals had already undergone clinical assessment by the referring clinician. They described using guidance to determine whether referrals fell within the scope of the service and returned inappropriate referrals such as those relating to physiotherapy, back or disc conditions, bowel-related concerns, patients under 18 years of age, referrals with insufficient clinical information, and requests that fell outside the service specification.

Staff used patient record alerts to identify factors requiring additional consideration, such as a history of miscarriage, previous negative experiences or difficulties with venepuncture.

Procedures supporting NIPT sample management were not fully governed. The blood sample-taking protocol did not describe the NIPT sample transport process or the system used to verify that the correct samples were packaged and dispatched. In addition, the document was not version controlled, dated or subject to formal governance arrangements. This reduced assurance that staff were working to an up-to-date and clinically governed procedure.

These concerns reduced assurance that risks to patients were systematically assessed, monitored and managed throughout referral, booking and triage processes and contributed to a breach of Regulation 12 (Safe Care and Treatment).

The service could not demonstrate that effective safeguarding systems and processes were in place to protect people from abuse and improper treatment.

Despite previous regulatory action relating to safeguarding, the service could not demonstrate that an appropriately trained Level 3 safeguarding lead was available to oversee and complete safeguarding referrals in line with the Intercollegiate Safeguarding Roles and Competencies Framework. Not all staff were able to identify who the safeguarding lead was. Following the onsite inspection, the registered manager, who was the safeguarding lead, submitted evidence of Level 3 adult safeguarding training. However, this evidence was not available at the time and therefore could not provide assurance regarding safeguarding arrangements. 

Not all staff were able to consistently identify safeguarding concerns, describe how safeguarding issues would be escalated, or provide examples of safeguarding concerns that had required escalation. Although the service had safeguarding policies and procedures in place, these had not been effectively embedded as staff could not consistently demonstrate an understanding of safeguarding arrangements or escalation processes.

The service did not have systems to effectively monitor safeguarding training completion and compliance. Training records were incomplete for some sonographers because the service did not hold evidence of their safeguarding training. In addition, there was variation in safeguarding training levels among staff undertaking similar roles. 

As a result, the service could not provide assurance that staff had completed safeguarding training appropriate to their role or had the required knowledge, skills and competence to recognise, respond to and escalate safeguarding concerns which meant the service remained in breach of Regulation 13 (Safeguarding).

The service did not consistently identify, assess and manage risks

We identified several concerns relating to the identification, assessment and management of risk, including repeat scanning, NIPT processes, deteriorating patients and chaperone arrangements. These concerns increased the risk of avoidable harm.

Staff were unable to reliably access key operational information, including policies and procedures. This created dependence upon individual managers and reduced assurance that staff could readily access the information necessary to undertake their roles safely and consistently.

Repeated abdominal ultrasound scanning was being undertaken over extended periods. Abdominal ultrasound is not generally intended for routine surveillance. This increased the risk that underlying conditions may not be appropriately investigated or managed in a timely way.

Staff could describe the immediate actions they would take if a person became acutely unwell. However, not all staff were aware of the onward referral process outlined in the service’s Standard Operating Procedure (SOP), reducing assurance that staff would respond consistently to escalating clinical deterioration and medical emergencies.

Arrangements for communicating NIPT results were not fully defined, including the absence of documented escalation arrangements to support staff in managing complex, unexpected or sensitive results. Non-clinical staff were communicating fetal sex and genetic screening results directly to patients by telephone. These responsibilities were not reflected within their job descriptions and staff had not received the formal counselling training required by the SOP, which stated that NIPT results should be communicated by appropriately trained staff. Staff had not received training in communication skills, delivering sensitive information or supporting patients receiving unexpected or distressing news. This reduced assurance that significant or unexpected results would be managed appropriately and that patients would consistently receive appropriate support and clinical escalation when required. These concerns contributed to a breach of Regulation 12 (Safe Care and Treatment).

The service could not demonstrate how non-clinical staff acting as chaperones were selected, trained, supported or assessed as competent to undertake the role. Although patients were informed that chaperones were available on request, the service did not have a formal chaperone policy outlining staff responsibilities, training requirements or competency expectations. There was no formal process for offering or providing chaperones during intimate examinations. The registered manager told us that patient coordinators acted as chaperones and had received guidance on where to stand during examinations. However, staff told us they had not received formal chaperone training, the service was unable to provide evidence of training or competency assessments, and staff demonstrated a limited understanding of the role of a chaperone, believing chaperones were only required when specifically requested by a patient. The service had not assessed whether Disclosure and Barring Service (DBS) checks were required for patient coordinators undertaking chaperone duties and had not completed role-based risk assessments to support this decision. Chaperoning responsibilities were not included within job descriptions. This reduced assurance that chaperone arrangements were appropriately governed, consistently applied and subject to effective oversight, and that staff undertaking chaperone responsibilities were appropriately trained, assessed and supported to undertake the role safely. These concerns contributed to a breach of Regulation 12 (Safe Care and Treatment).

Despite the concerns identified, some aspects of risk management were managed appropriately. Sonographers were able to describe how they escalated abnormal findings, including referrals to the Early Pregnancy Assessment Unit, local maternity services or the emergency department where required, ensuring relevant clinical information was shared appropriately. They described escalating diagnostic findings to a consultant radiologist for clinical advice and referring patients back to their GP where appropriate.

The service did not consistently identify, assess, monitor and mitigate risks within the care environment. Significant concerns were identified in relation to emergency equipment, clinical consumables, sharps management, hazardous substances and fire safety arrangements, which reduced assurance that risks to patients, staff and visitors were effectively managed.

On the first day of the onsite inspection, we found several concerns relating to emergency preparedness which reduced assurance that emergency equipment would be available and effective if required.

At the previous inspection, the service was advised to ensure all staff knew the location of the Automated External Defibrillator (AED). Whilst staff were able to identify the location of the AED during our inspection, they were unaware that it was out of service, displayed a battery fault alert and contained out-of-date consumables. Staff were unclear about ownership, servicing and maintenance responsibilities. This reduced assurance that emergency equipment was subject to effective monitoring, maintenance and oversight and would be available and effective if required in an emergency. In addition, the first aid kit contained expired items, including bandages, plasters, wound cleaning wipes and sterile dressings. These concerns increased the risk of delays in responding effectively to a medical emergency.

We identified concerns relating to environmental safety and the storage of equipment and materials. Sharps boxes were unlabelled, undated and not assembled in accordance with manufacturer instructions. Lids were loose fitting and closure flaps had not been fully secured. This increased the risk of accidental injury, exposure to contaminated sharps and inappropriate access to clinical waste.

We found multiple out-of-date consumables and items of equipment, including facemasks, NIPT needles, syringes, ultrasound gel, blood sample kits and items contained within an old first aid box.

Controlled Substances Hazardous to Health (COSHH) products were not always stored safely. We found 13 cleaning products stored in an unsecured area, six of which were out of date. Sterile culture kit vials were stored in an unlocked location and were readily accessible to patients or visitors. This did not provide assurance that hazardous substances and clinical consumables were stored securely and managed appropriately.

Staff told us weekly stock checks were undertaken. However, these checks had not identified or addressed out-of-date consumables, unsecured hazardous substances, unsafe sharp box use or defective emergency equipment.

These findings demonstrated weaknesses in the services, monitoring and mitigation of risks relating to the premises, equipment and substances hazardous to health and contributed to a breach of Regulation 12 (Safe Care and Treatment).

The service did not consistently manage fire safety arrangements. Annual fire risk assessments had been completed and a fire evacuation procedure was in place. However, fire safety information was inconsistent. The fire policy and evacuation procedure identified one assembly point, while the fire action card displayed directed staff to a different location. Staff did not have immediate access to fire action flowcharts or evacuation plans because these were only available electronically. In addition, both fire extinguishers were out of date despite a fire risk assessment having been completed in January 2026. These concerns reduced assurance that fire safety arrangements were effectively maintained, communicated and understood by staff. As a result, the service could not demonstrate that fire safety risks had been consistently assessed, monitored and mitigated. These concerns contributed to a breach of Regulation 12 (Safe Care and Treatment).

We escalated these concerns during the onsite inspection. Staff took immediate action to remove out-of-date items and inform the registered manager.

Following our onsite inspection, the service submitted evidence of improvements. A replacement defibrillator had been ordered with a maintenance contract in place. A new first aid kit had been provided, out-of-date consumables had been removed and replaced, sharps boxes had been labelled and secured, and COSHH items and sterile culture vials had been stored appropriately. On the second visit, we confirmed these actions had been completed. Whilst these actions addressed the immediate concerns identified, they were implemented after the onsite inspection and therefore did not reduce the risks present at the time of inspection.

Despite the concerns identified, some aspects of environmental safety were managed appropriately. Improvements had been made since the previous inspection, including the installation of a sink within the clinical room. Waste segregation processes were in place and clinical waste bins had pedal-operated lids.

Electrical equipment had undergone portable appliance testing, daily ultrasound equipment safety checks were completed and documented, and maintenance records were available for all ultrasound machines.

The service had sufficient staff to meet patients needs, and staff worked collaboratively to deliver care. However, there were gaps in recruitment, training, competency assessment, appraisal and workforce governance arrangements. 

As a result, the service could not demonstrate that all staff had the knowledge, skills, qualifications, competence and support required to carry out their roles safely and effectively.

Recruitment and staffing

The staffing team consisted of a registered manager, who was also a sonographer, a practice manager, patient coordinators, an apprentice patient coordinator and staff trained to undertake phlebotomy. The service engaged self-employed sonographers registered with the Health and Care Professions Council (HCPC). In addition, a consultant radiologist provided ad hoc second-opinion reporting.

Recruitment records continued to contain gaps in essential information, including employment histories, references, proof of identity and role-specific documentation, despite assurances following the previous inspection that recruitment records had been reviewed and updated.

The service relied on enhanced Disclosure and Barring Service (DBS) certificates obtained through other employers for self-employed sonographers. These checks had not been obtained specifically for work undertaken on behalf of the service and did not meet Schedule 3 requirements.

There were no recruitment records, employment records or DBS checks available for the consultant radiologist.

These findings meant the service could not demonstrate it had completed all necessary recruitment checks to assure itself that staff and contractors were suitable and fit to carry out regulated activities. This represented a continued breach of Regulation 19 because the service had failed to operate robust recruitment procedures in accordance with Schedule 3 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

Patient co-ordinators were rostered to provide administrative support throughout service delivery. Staff reported workloads were manageable, breaks were taken and they were able to finish work on time. Staff consistently described effective team working, good communication and accessible management support.

Training, competency and appraisal

Oversight of staff training, competency assessment and appraisal arrangements was inconsistent and did not provide assurance that all staff had maintained the skills, knowledge and competencies required for their roles.

Staff were expected to complete mandatory training annually and reported having sufficient time to do so. However, the service did not maintain a central training matrix or effective monitoring system and could not demonstrate compliance across all staff groups.

Evidence relating to sonographer training was incomplete. The service relied on sonographers completing mandatory training through NHS employers or external providers and supplying evidence of completion to the service. However, only two of the five personnel files reviewed contained evidence of mandatory training certification. This meant the service could not demonstrate compliance with mandatory training requirements, including safeguarding training, across the workforce.

Although the registered manager had completed additional sonography-related modules, certificates had not been retained within service records and patient coordinators accessed the registered manager's NHS training account to retrieve certificates. This demonstrated weak governance arrangements and poor management of training records.

The consultant radiologist had no documented training, competency or continuing professional development records available for review.

Training records demonstrated that patient coordinators had completed core mandatory training and the practice manager had completed additional information governance training. However, governance arrangements relating to the patient coordinator role were inconsistent as it was described as receptionist, co-ordinator and screening coordinator.

Patient co-ordinators undertook additional booking triage for all obstetric patients undergoing pregnancy scans and non-invasive prenatal testing (NIPT). They contacted patients to obtain relevant clinical information, including pregnancy history, gestational age, previous screening results and known genetic conditions. The triage process included checks to ensure scans and NIPT were booked within appropriate gestational timeframes. 

Although their job descriptions included duties such as greeting patients, responding to enquiries and processing payments, they did not reflect responsibilities staff were undertaking in practice, including acting as chaperones, undertaking booking triage and communicating NIPT results directly to patients. Staff were undertaking responsibilities that were not reflected within their job descriptions, and the service had not demonstrated that these responsibilities were supported by the training and escalation arrangements required by its own procedures.

Three staff undertaking phlebotomy held venepuncture training certificates. However, certificates were dated 2003, 2005 and 2016, and the service could not provide evidence of refresher training or ongoing competency assessments. As a result, the service could not demonstrate effective oversight of staff competence in this role.

The service advised that formal appraisals for patient coordinators and the practice manager should take place every two years. However, this frequency was not specified within the employee handbook, which stated that an appraisal scheme was in place but that details were available separately. No separate appraisal scheme or supporting guidance was provided. The most recent documented appraisals had been completed in 2022, and no evidence of more recent appraisal activity was provided.

Annual performance reviews focused primarily on competency scoring and performance measures. Although training needs were recorded, there was limited consideration of wider appraisal elements, including staff wellbeing, professional development, reflective practice, career progression and support requirements.

Staff told us additional support would be implemented where training needs were identified and reviewed after six months. However, the service could not demonstrate how identified performance or development needs would be formally monitored, reviewed and resolved.

Sonographers did not receive formal appraisals because they were self-employed. However, they described participating in continuing professional development activities, including Antenatal and Reproductive Care (ARC) ultrasound training and attendance at British Medical Ultrasound Society (BMUS) conferences.

These findings meant the service could not demonstrate that all staff had received appropriate support, training, competency assessment, supervision and appraisal to carry out their roles safely and effectively. This represented a continued breach of Regulation 18.

Following the onsite inspection, the service submitted an overview document stating that mandatory training certificates were now held for all staff. 

The service did not consistently identify, assess and manage infection prevention and control (IPC) risks. 

Significant concerns were identified in relation to environmental cleanliness, waste management, infection control consumables and compliance with IPC procedures. These issues increased the risk of infection transmission and did not provide assurance that infection prevention and control risks were being effectively monitored and managed.

At the previous inspection, the service was required to improve compliance with IPC procedures, including ensuring that clinic room furniture met IPC standards. Following that inspection, the service informed us that all clinic rooms contained furniture suitable for IPC requirements and that daily inspections and cleaning were undertaken between patients.

During this onsite inspection, we found these improvements had not been sustained as we identified several environmental cleanliness concerns. 

The clinic environment was not clean when opened on Monday morning following a clinic session on the preceding day, which did not provide assurance that cleaning arrangements were effective in maintaining environmental cleanliness between clinic sessions. Cleaning records demonstrated that routine cleaning was undertaken on Monday evenings.

We found two visibly unclean fabric chairs adjacent to the treatment couch, damaged and unclean furniture within reception and kitchen areas, scuffed walls and unclean flooring within the waiting area. These conditions did not support the effective prevention and control of infection.

We identified multiple out-of-date IPC consumables and equipment. There was no in-date hand sanitiser available. The urine and vomit spill kit was out of date, including the granules, spray and antibacterial wipes contained within it. Three biohazard disinfectant sprays used to clean potentially infectious materials were out of date. In addition, an ultrasound gel bottle was visibly unclean, not fully sealed and had not been date labelled.

Although the IPC policy included guidance on waste disposal, it did not fully reflect the service's operational arrangements. As a result, clinical waste was not consistently segregated or disposed of appropriately.

Despite action having been taken following the previous inspection, we identified ongoing concerns regarding waste management. Black waste bags had been placed inside yellow clinical waste bins, clinical waste items including purple gloves had been disposed of within domestic waste streams and staff were not consistently aware of cleaning schedules or the location of cleaning records. These findings indicated that waste management processes had not been effectively embedded into practice.

We identified inappropriate infection control practice following NIPT procedures. Swab wipes had been cut into quarters in advance and stored within a lunchbox for later use. Although staff stated that scissors had been cleaned with alcohol wipes before use, gloves had not been worn during the preparation process. This increased the risk of contamination and was not consistent with infection prevention and control principles.

Staff advised that routine checks and monitoring processes were in place. However, these arrangements had failed to identify or address environmental cleanliness concerns, out-of-date IPC consumables, inappropriate waste segregation practices, and unsafe preparation of clinical materials. This reduced assurance that infection prevention and control risks were being effectively identified, monitored and mitigated.

These findings demonstrated that the service had not established effective systems to assess, monitor and manage infection prevention and control risks. This was a breach of Regulation 12 (Safe Care and Treatment).

We raised these concerns with the registered manager, who took prompt action to address the issues identified. Following the first onsite inspection, the service submitted evidence demonstrating that out-of-date items had been replaced, waste management arrangements had been revised, new waste bags had been introduced, bins had been labelled appropriately, cleaning arrangements had been strengthened and environmental improvements were planned or underway.

The service also submitted revised clinical and non-clinical waste guidance. We reviewed this document and found it provided clear direction regarding waste segregation, disposal processes and staff responsibilities.

Despite the concerns identified, some aspects of infection prevention and control were managed appropriately.

Staff understood and followed key IPC principles, including effective hand hygiene, the use of personal protective equipment, maintaining bare arms below the elbows and routine handwashing practices.

During our subsequent onsite inspection, handwashing facilities and in-date hand sanitising gel were available within all areas inspected. Clear signage promoting hand hygiene was displayed.

Sonographers routinely asked pre-screening infection control questions and ensured sufficient time was allocated between patients to undertake cleaning activities.

Staff followed the required process for cleaning and disinfecting transvaginal ultrasound probes using an automated disinfection system that recorded and logged each cleaning cycle.

Patients consistently told us clinical areas appeared clean and well maintained. They reported that staff wore gloves during examinations and blood sample collection procedures and followed appropriate infection prevention and control processes.

The service used non-latex probe covers during transvaginal examinations, reducing the risk of latex-related reactions and supporting effective infection prevention and control.

The service did not store, prescribe, administer, or supply medicines. There were no controlled drugs or medicines kept within the service.