Leeds General Infirmary

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

Safe – this means we looked for evidence that people were protected from abuse and avoidable harm. At this inspection we rated the key question as Inadequate.

The service was in breach of regulations relating to managing risk, staffing, safe environments and infection prevention and control, and medicines management.

The service did not always have a culture of safety and learning. Learning was not always evident following incident reviews. Babies were not always transferred in line with the neonatal unit criteria. There were not always enough staff with the right qualifications and skills to meet the needs of babies. The environment was not always safe and medicines were not always stored correctly.

There were clear safeguarding processes in place and staff knew how to protect babies and adults from harm.

This service scored 38 (out of 100) for this area. Find out what we look at when we assess this area and How we calculate these scores.

The service did not always have a proactive and positive culture of safety based on openness and honesty. Staff did not always listen to concerns about safety and did not always investigate and report safety events. Lessons were not always learnt to continually identify and embed good practice.

Staff told us they knew how to and would report incidents using the trust system.

We asked staff about learning from incidents. All staff told us that incidents would get reported, however, staff were unable to give specific examples of any recent incidents or learning. We heard about one incident through the patient safety lead. We saw this was included in a newsletter; however, staff did not tell us about this learning. We did not find evidence that staff were proactively engaged in learning or rationale for learning by sharing of incidents. For example, we saw that group text message reminders were sent regarding learning from unplanned extubations, but few staff read these. There continued to be repeated incidents of accidental extubations reported via the trust incident reporting system and shared with staff via a newsletter. Following the inspection the Trust informed us the team

Senior staff provided examples of learning disseminated through safety huddles, presentations and newsletters. These included information on actions taken, but did not include details about individual or groups of incidents to provide staff with context or background information. There was no specific reason regarding the need for learning or to prevent future incidents. Nursing staff were unable to recall any examples of learning following recent incidents.

Staff were not always able to implement learning from training in their day to day duties. For example, infection prevention and control (IPC) audits showed staff did not follow correct hand hygiene processes and we observed during our site visit that staff were not following correct processes. One parent told us their baby required 2 staff to turn them. In spite of asking the nurse to stop, and raising their concerns with the lead nurse, another nurse attempted to do this single handed.

The service did not always work well with people and health system partners to establish and maintain safe systems of care. Staff did not always manage or monitor people’s safety. They did not always make sure there were clear pathways of care, including when people moved between different services.

There were joined up working processes in place to support babies and families within the neonatal services. We saw continuity of care across services and appropriate handover of care between services, for example, with the specialist transport service. There were clear transition arrangements for babies being discharged from the neonatal unit or transitional care unit. The family care and outreach teams supported the smooth transition. For planned transitions teams would meet families in advance and explain their role.

However, babies were transferred inappropriately to SCBU at St James’ to make cots available at LGI. There was no clear pathway in place to ensure these babies received care on the most appropriate unit. The babies discussed and observed by the inspection team did not meet the criteria for care in a SCBU, being too small or having specific ventilation needs.

Following the inspection, we raised concerns with the trust regarding the transfer of babies to the neonatal unit when their needs were over and above the criteria for the unit at the St James site. We asked the trust to provide details of the MDT input when considering identification of babies who were patients at the neonatal unit at Leeds General Infirmary site to be candidates for transfer to St James Hospital neonatal unit. The trust created an action plan which provided assurances that they would work to embed monitoring and oversight of transfers and to ensure a risk stratification process was adhered to.

Pre and post operative safety huddles were in place for all professionals involved in the care of infants going into theatre. This supported improved communication, more efficient transfer and reduced risk of errors caused by multiple handover.

The service did not always work with people and healthcare partners to understand what being safe meant to them and the best way to achieve that. Staff concentrated on improving people’s lives while protecting their right to live in safety, free from bullying, harassment, abuse, discrimination, avoidable harm and neglect. The service shared concerns quickly and appropriately.

All staff we spoke to were aware of safeguarding procedures and how to make a safeguarding referral. Staff were knowledgeable about signs of abuse or neglect. Community based staff were aware of processes to follow should they witness any concerns whilst visiting families in the community. Staff told us supervision took place regularly.

There was an up-to-date children's safeguarding policy in place. This provided guidance for recording safeguarding alerts for pregnant women. Safeguarding alerts were recorded on the trusts electronic record system. However, maternity, and neonatal services used a second electronic recording system that required an upload of information. Inspectors noted the completeness of safeguarding records. However, there was a risk that information could be missed if both systems were not updated.

There was a trust wide safeguarding team in place for support and advice. There was a named safeguard lead nurse based on the unit and named consultant lead. There was regular liaison between the neonate team and maternity team. Neonatal safeguarding team meetings were planned when time allowed, however, there was no designated time given for this.

The trust target for compliance with children and adult safeguarding was 80%. Staff on the neonatal unit met the trust target for compliance with safeguarding adults and safeguarding children level 1, 2 and 3. However, transitional care staff were 73% compliant for both and medical staff were 69% compliant with safeguarding children level 3 and 65% complaint with adult safeguarding.

The service worked well with most people to understand and manage risks. Staff did not always provide care to meet people’s needs that was safe, supportive and enabled people to do the things that mattered to them.

We reviewed notes and saw risk assessments were completed and clear plans of care were in place. Ward rounds and daily handovers took place to support risk review. We observed a weekly multi-disciplinary (MDT) meeting and heard that family involvement was considered.

Staff told us that family involvement at ward rounds and with care of babies on the unit was encouraged. We saw some families present during ward rounds and they confirmed they were informed and involved in their baby’s care. However, we reviewed feedback from the parent and staff survey from 2024 and saw that timely encouragement to attend ward rounds was not always given, therefore families were not always supported to feel part of the team and be involved in managing risk. One comment was that ‘more staff education was required to empower staff to feel confident in supporting families’.

Because allied health professionals were understaffed, they were not able to provide the amount of time recommended to each individual baby. This meant that families were not always involved in supporting and managing the needs of their baby.

The neonatal service was involved in a working group regarding the implementation of Marthas rule. Marthas rule supports families to have a voice and raise concerns regarding deterioration of their babies and children whilst in hospital.

Basic life support videos were provided for families prior to discharge from the neonatal unit.

The service did not always detect and control potential risks in the care environment. Staff did not make sure that equipment, facilities and technology supported the delivery of safe care.

The service did not ensure the environment and equipment used within the environment were managed safely. This included the storage of general supplies and medicines.

Supplies were overstocked in cupboards and in inappropriate settings, such as the decontamination room, at the time of inspection. This was a room set aside to decontaminate equipment and store it ready for use by the next patient. During the inspection we found staff food, drinks and crockery stored in the decontamination room.

Inspectors found cupboards on a corridor were overstocked with many out of date items. Staff said they had not been aware these items were stored there until we escalated these concerns with the team at the time of inspection. The concerns were addressed, and we saw excess stock items were being removed the following day.

We found equipment was overdue for service and calibration checks including thermometers. A number of stock items had expired in the decontamination room. These included supplies of surgical scrub liquid which expired in February and October 2024.

We escalated these concerns with the team at the time of inspection. The concerns were addressed, and stock items were removed.

Medicines fridges were stocked with out of date and named prescription medicines for babies that had left the unit. There were empty medicines boxes piled on top of the bin lid. The medicines fridge, although in a locked room, was unsecured and we found non-medical staff accessed items routinely.

IV fluids were stored on the floor in opened boxes.

We found an uncovered and unattended breast milk trolley in the corridor during deliveries to parents and families. This posed a risk of loss or tampering. Even after raising our concerns with senior staff this practice continued during the inspection.

Access cards provided for families were kept in an office but not locked away. When we asked staff at the end of the inspection for further detail about security of the cards, they said some had not been returned to the unit after babies had been discharged. This meant cards may have gone astray and staff did not know where they were. Although security protocol was to delete permission via the cards when a baby was discharged, it was not clear if staff had followed this, meaning inappropriate persons could have had unrestricted access to the unit. It was not clear what action would be taken to improve the process and make the unit safe.

The service did not always make sure there were enough qualified, skilled and experienced medical staff at night. Staff did not always work together well to provide safe care that met people’s individual needs. The service ensured staff received effective support, supervision and development.

Medical staffing

Leaders had identified safety concerns regarding the medical cover available for the service. Medical cover at weekends had been shared between St James hospital site and Leeds General Infirmary. At the time of inspection there had been improvements made and each site had a separate rota. We saw that the number of consultants had been increased to support this and had improved cover. However, we saw there were still gaps on rotas and consultants worked long hours to cover these gaps.

Consultant cover was variable. A review completed in May 2024 identified that the medical staff numbers did not meet the requirements specified within the British Association of Perinatal Medicine (BAPM) standards for tier 3 doctors due to cross site working and lack of separate on call arrangements at weekends for each site. This risk was documented on the risk register.

There was insufficient higher level specialist trainee cover at night. The trust told us there were 3 specialty staff at night including 1 higher level specialty trainee and that this was in line with BAPM guidance. However, staff told us there were regularly only 2 lower level (Tier 1) specialty staff at night.”

The current consultant WTE is 16 from the beginning of October 2024. As the team increase in WTEs the Trust will gradually separate out the weekend on call arrangements to facilitate single site responsibility. On call Consultant cover is increasingly provided at both locations as the Consultant recruitment plan is progressed. From November 2024, 18 out of 26 weekends had been scheduled to have on call consultant cover on each site.

Nurse staffing

The unit had the required number of registered nurses and non-registered staff in post to meet the national guidance and there was an escalation process to maintain safe staffing. However, there was not always sufficient staff qualified in their specialty to make sure people received consistently safe and good quality care. The nurse staffing levels did not meet the required percentage of staff qualified in speciality (QIS). At the time of inspection there were 61% across both sites with QIS. This was due to increase to 64% in February 2025 as staff completed the qualification. We raised this concern with the trust following the onsite inspection. Leaders provided an action plan to increase the number of nurses able to complete the QIS training. The Trust told us the QIS toolkit stated that every baby who required high dependency (HDU) and intensive care (ICU) required a QIS nurse, however, due to the complexities and acuity of the patients on the LGI site, this meant the establishment would need 95% of the nurses to be QIS qualified. To mitigate the requirement, there was a supernumerary QIS nurse within the ICU area to support and educate the non-QIS nurses. Within the other clinical areas, there was always a QIS nurse on shift for the area.

All new neonatal nurses were supported to compete a recognised foundation training programme. Senior staff said this equipped them to be ready to start the QIS training.

There was a plan with the local university to increase the QIS training offer from two to three cohorts annually to provide more spaces to complete the qualification and increase the percentage of trained staff.

Staffing levels per shift were reviewed throughout the day. Staff would move between sites as needed. Bank staff were employed by the trust and used to cover shifts as required. Bank staff received the same training as required by the substantive nursing team. There was an escalation process in place when staffing levels were below what was required. There was guidance in place to determine when the unit may be closed to admissions, for example, where staffing skill mix was not sufficient. This was in line with regional guidance set out for all regional neonatal units. During inspection the unit was at OPEL 4 and should have been closed to admissions. However, calls to admit babies to cots and high levels of care continued to come in and we saw babies admitted to meet regional needs. At this time, we saw staff decide to transfer a baby to SJUH who had higher level needs than that unit was commissioned for.

Senior staff showed inspectors a bay stocked full of equipment that they said could be used for a further 4 cots which the service was keen to use. However, they said the service could not provide sufficient nurses to staff it so it remained unused. Staff told us they would take a further 1 or 2 babies up to an increased total of 26 if and when the local and regional networks required this.

Not all staff had timely appraisals. Appraisal numbers for the neonatal unit were 81.53%. The trust expected this would meet full compliance by the end of March 2025. However, the figure for transitional care across both sites was 65.52%, which was below the trust target.”

Turnover rates for nurse staffing had improved from 7.65% in March 2022 to 4.04% in 2024. Although an action plan to put together a staff retention survey was proposed, we did not see evidence of its completion at the time of inspection.

Sickness rates for registered and unregistered nursing staff were consistently recorded as red on the ward dashboard for the past year with the exception of three months of reduced sickness during the year for registered nurses. This was reflected in the planned versus actual staffing levels. We saw that staffing did not always meet planned levels.

The transitional care unit was staffed by midwifery staff, registered nurses, and nursery nurses.

Allied Health Professionals (AHP)

The service had specialist AHPs with time specified for neonatal care, however, there are significant gaps in the provision due to underfunding. There were significant gaps in AHP provision and levels did not meet the requirements set out in the Neonatal service specification. The team were understaffed in dietetics, physiotherapy, occupational therapy and speech and language therapy due to underfunding. Lack of AHP provision not only impacts on compliance National Institute for Health and Care Excellence (NICE) guidance for the neonatal follow up programme and early intervention needs for these infants, but this could also seriously compromise neurodevelopmental outcomes for babies having a long-term impact on their care needs for the future.

This was on the children’s service risk register. Ockenden funding had been invested to support this staff group, however, the team had struggled to recruit and did not meet the required levels.

Training

Staff told us nurses at band 6 and above completed Advanced Resuscitation of the Newborn Infant (ARNI) course. All staff further enhanced their neonatal life support skills and knowledge through attendance at regular simulation sessions and clinically based training.

We reviewed mandatory training figures and saw that the service did not always achieve the trust target for mandatory training. For example, adult resuscitation training level 1 was 66.67% compliant. Neonatal basic life support level 1 was noted as 67.16% compliant on one list provided to us, and 90.5% compliant on the unit training spreadsheet.

The team has 0.8 whole time equivalent (WTE) band 7 perinatal resuscitation officers. This role was to focus on resuscitation training and governance around resuscitation equipment / crash call attendance and delivery of the resuscitation algorithm.

The service did not always assess or manage the risk of infection. Staff did not always detect and control the risk of it spreading or share concerns with appropriate agencies promptly.

The service did not always ensure staff, or the environment provided effective infection prevention and control. There had been a recent outbreak of Serratia (an invasive bacterial infection) on the unit and a range of environmental measures had been put in place. However, staff did not always follow good hand hygiene practice during and after providing care to babies.

We saw information for families and visitors regarding infection, prevention and control (IPC) practices as they entered the unit. There were hand washing stations and hand gel was available immediately on entering the unit.. Visitors were let into the unit through a door entry system before walking down a corridor and through two further doors to access the unit. This required visitors to be vigilant at each area regarding hand hygiene. We entered the unit multiple times during our inspection and were not verbally prompted to wash or gel hands on entering. We were not aware of any staff member taking responsibility for ensuring visitors to the unit did carry out hand hygiene. Staff told us families were educated around the importance of infection prevention and control by the matrons or band 7 staff. However, we did not see evidence on how effective this communication was.

There was a trust wide IPC policy in place. There was a process in place for additional actions where an outbreak was suspected.

We reviewed IPC audits for the previous six months. We saw mixed results. Some areas of practice scored consistently high for IPC compliance. Some areas scored consistently below 90% of the expected standard, for example, line IPC booklet daily reviews and terminal cleaning. We did not see any evidence of action plans for these areas that scored consistently below standard.

We saw hand hygiene audits were completed monthly as per the policy and most showed 100% compliance. These included a L43 Isolation audit from March 2024. However, where comments were made regarding non-compliance there were no actions noted. Senior nurses told us results of audits were discussed at safety huddles.

An ICU audit from May 2024 showed 87.5% compliance but no actions were noted, and a separate audit recorded a junior doctor had not decontaminated their hands after locating items needed and returning to the patient.

During the inspection we observed, and parents told us, staff did not follow good hand hygiene practices when providing care. A senior doctor had to prompt a colleague to wash their hands after carrying out a clinical examination, and a report was made about 2 occasions of poor hand hygiene practice during nursing care.

Cleaning audits showed 100% compliance with no actions required. However, the inspection team found areas and items that were not clean such as dusty surfaces. Inspectors informed senior staff regarding excess and out of date stock and saw some areas being cleared of excess stock, and cleaned before they left site. However, an environmental audit completed 2 weeks after the inspection found the same areas that the inspection team had raised had not been addressed and were non-compliant. These included cluttered surfaces, excess equipment stored in cupboards, wardrobes, and in the decontamination room. Dust was found on a computer within a cot space and equipment was stored within splash zones of sinks and hand wash basins. The audit team also noted not all staff attending ward rounds were bare below the elbow and computers on wheels were not cleaned between patients. One audit found 12 staff attended a ward round and the numbers of staff attending were overflowing to stand in other patients’ cot spaces. This raised the risk of cross-contamination whilst also preventing staff accessing other patients quickly and efficiently. This audit also showed that toys that should be clean or cleanable were not inspected because they were seen to be parents’ own property and were managed by parents. Inspectors had observed cuddly toys were kept in cots during our visit. The trust website gave information encouraging parents and families to bring soft toys. This practice did not meet IPC standards.

The service did not always make sure that medicines and treatments were safe and met people's needs, capacities and preferences. Staff did not always involve people in planning.

Staff did not always follow systems and processes in the safe and secure storage of medicines.

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We were not assured that stock control systems were effective as we found medicines and surgical scrub that were out of date. Several items were pointed out to ward staff on the first day of our inspection and removed. On the second day we found a further 3 medicines were out of date and 9 items prescribed for named babies no longer on the ward. These included vaccines, infusions and parenteral nutrition, with one item dating back to 2022. We asked staff why these were still stored and their response was that it was easier to use these as stock medicines rather than order them from pharmacy. We reported this to senior leaders during the inspection.

The Safe & Secure Handling of Medicines Audit from July 2024 showed some medicines had been found to be out of date. The audit stated these had been removed and reported at "Neonatal governance". During the inspection we found medicines to be out of date and staff were not aware medicines stored on the ward were out of date. We also found a tablet crusher full of excess tablet residue.

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There was no clear oversight of stock, how, or if, stock rotation or controls were carried out, or who was responsible for them. Following the inspection the trust provided evidence of a process to oversee stock control and supply in clinical areas. However, evidence showed this was not always followed."

The ward benefited from clinical input with visits from at least two pharmacists per day.

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Healthcare assistants checked fridge temperatures with no specific training or awareness of what the temperatures meant. There were no actions noted to show how out of range had been escalated.

We found administrative staff handling fluids and labelling boxes. We escalated this to the lead pharmacist for neonates who stated this was not within the medicines process.

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Following this, we checked stored fluids and found strengths were mixed up in the same box (sodium bicarbonate). Staff told us differences in strengths would always be flagged at a second check but evidence on the prescriptions showed this policy was not always followed, thus leading to potential risk of incorrect administration.

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We observed a conversation between a nurse and a pharmacist to confirm if a heparin protocol shared digitally amongst the nursing staff was a draft or in use. That conversation confirmed that the protocol was not yet in use. Because of differences within the two protocols, there was a serious potential risk of incorrect dose or strength being administered.

Medicines stocks were not being rotated, with longer expiry dates being on top of medicines due to expire sooner. We found expired medicines including oral solution stored with newer medicines. This posed a risk of out of date medicines having been administered to patients.

We escalated out of date stocks to senior ward staff and they were removed immediately.

We found 9 medicines prescribed and labelled for named patients no longer on the unit being used as stock items. Ward staff said they would reuse these because it was quicker than ordering stock supplies. However, pharmacy staff said this was not pharmacy process and items should be returned to stock.

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We reviewed five patient records including medication charts and found that babies' weights were recorded and updated in line with guidance to ensure accurate prescribing.

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However, staff did not always follow trust medicines policy in relation to double signing of intravenous medicines and incomplete administration records. These were not always documented on e-med. On some occasions these were documented in the main notes. This meant patients could be at risk of unsafe medicines administration. For example, intravenous medicines, infusions were not always double signed as per policy.

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Staff did not always follow trust policy or fully document administration of controlled drugs correctly. However, pharmacy-controlled drug checks were taking place. We found gaps in the controlled drugs administration record book where second signatures were missing. Some medicines were documented as administered in the patients' main notes only and not on the electronic medicines system. This meant there was a risk of further administration of controlled drugs or a high-risk medicine such as heparin. We also found the heparin pump number and `emag number' were missing from the record. For another patient different times of administration were recorded on administration charts. Nursing staff were unable to clarify at what time this infusion was actually given. This meant there could be a risk of incorrect further administration within a specified time.

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Several staff told us of a medication error that had occurred in August 2024. The trust investigation of the incident showed due to difference in dosages used by Embrace and NNU, neonatal staff were required to be aware of these and carry out complex calculations to ensure the baby received the correct dosage. However, staff calculated the dose incorrectly. Since the incident, staff had received training on this, and an action plan stated the service would change their dosage measure for this medicine. However, at the time of the on-site inspection, 5 months later, staff told us the two organisations continued to use the different dosage measures. This meant the risk remained and a miscalculation could potentially happen again.

We identified records where staff had not followed trust policy that states when prescribing staff should fully write out nanograms and micrograms as standard. We found 2 examples where abbreviations had been used. This posed a potential risk of incorrect medicines administration due to ambiguous prescribing and the patient could receive under dosing or overdosing of medicines.

There was a risk of medicines not being suitable for use due to temperature deviations out of range. There had been extensive periods from June 2024 to January 2025 where both the aseptic and main medicines fridges had been out of range with no escalation process followed. This could affect the efficacy of medicines stored in the fridge which is a risk of harm to patients. Senior pharmacy staff escalated this late on day 2 of inspection to the trust Medicines advisory service. They reviewed the temperature logs, and the stability data available for the medicines, and deemed them safe for use.

We found room temperatures were also higher than the guidance and staff were using the incorrect form as per trust policy to record temperatures.

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Emergency trollies were in place on the ward. Data provided from the trust showed electronic checks were at 100% compliance. However, we found emergency drugs out of date within the adult resus trolley- the electronic check system contained the incorrect expiry date had been input. This had been last checked in December 2024 by the ward sister, who stated because it did not flag on the system, they did not check it separately. The system showed an expiry date of June 2025, this would have been inputted manually when replaced. This raised concerns of the robustness of this electronic system and the processes in place. We raised concerns regarding contradictory emergency medicine protocols attached to resuscitation trollies, this was acted on immediately by senior staff.

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The pharmacy team completed a safe and secure storage of medicines audit in July 2024, but this had not identified concerns we raised on inspection.