We decided to carry out this responsive review in response to an overall multi agency safeguarding strategy which is being coordinated by NHS Devon. At the same time NDHT also wrote to us asking us to carry out a review demonstrating their willingness to work in partnership with the Commission.

At the time of this review there are five safeguarding alerts currently being reviewed under DCC safeguarding process and involving NHS Devon and Southwest Strategic Health Authority.

The alerts which have been raised identify potential concerns around specific aspects of care provided to these patients which include:

• how pressure area care is managed

• how well the hospital works with patients with complex needs and/or patients with communications difficulties

• consent and assessing mental capacity for patients

• meeting nutritional and hydration needs

We carried out a responsive review with inspections to the hospital on 11, 12 and 14 July 2011 and because of the concerns we looked outcomes one, two, four and five.

We were not looking at the investigation of these alerts because these are being looked at in the separate safeguarding strategy meetings. The purpose of this review was to check compliance in these key outcome groups for current patients.

In our previous planned review of this hospital in March 2011, we set two compliance actions. One of them was in relation to records (outcome 21). The trust gave us a detailed action plan and this included some key changes to the documentation being used to ensure good care and treatment. They told us they would be fully compliant by the end of September 2011. We continue to monitor this with meetings and requests for further updates. We will also check this by a further unannounced visit to the hospital. However, record keeping was looked at as part of our reviewing compliance with the above outcomes and we have reported upon these under the relevant outcome groups.

Three inspectors spent three days at North Devon District Hospital (NDDH) completing this responsive review, two days on medical and surgical wards including those where issues via safeguarding had been identified; Staples ward, Glossop ward and the medical assessment unit (MAU). We looked at the records of 20 patients and 10 of those in more detail; where we spoke to the individual and or their carer. We also spoke to different staff including nurses, doctors, an occupational therapist, the community psychiatric liaison team and the complex care discharge team. We used an observational tool called SOFI

(Short Observational Framework Inspection) where for periods of time we sat and observed in detail interactions between staff and patients. The mapping tool helps us to understand positive and less positive interaction between the staff and patients. These were completed in two different wards. On the third day we spoke to the trust’s Tissue Viability Clinical Nurse Specialist and to 10 doctors from varying clinical areas to check their understanding and application of consent and the Mental Capacity Act.

Patients told us that they were consulted about their care and treatment. Some patients told us that staff in some wards were busy. In their opinion care and treatment was rushed. One patient said staff were ‘attentive and do their best, but they are very rushed and don’t have the same time.' Another patient described how doctors had spent time with them to explain their illness and the treatment options. They added that the nurses on the ward had also explained the treatment to them.

We saw that consent for care and treatment is considered and documented, but in some areas this needed improvement, particularly around the consent to use bed rails and where clinical decisions are made about emergency treatment. We did see some good examples of where patients lacked capacity to make decisions and a multidisciplinary approach had been used to look at the best interests of the individuals.The trust has training to ensure that mental capacity is assessed fully, but not all staff have completed this. Staff who were less confident in this aspect knew where they could go for support and help. We saw that the introduction of the community psychiatric liaison team has played a key part in improving consent and capacity issues.

We observed lunchtime in three wards and spoke to some people about their experiences. We also looked at records relating to nutrition and hydration, and did not find any significant issues with this. One person told us that for vegetarians on a soft diet the food choices were limited. We have passed this onto the hospital catering manager who agreed to look at this.

Patients we spoke to said that their needs were being met, but we have identified some key areas of concern where lack of assessment and care planning could place people at risk. Essentially this is around pressure damage and wound care. We did not find that outcomes for people were poor, but we did find that wound care plans were not being reviewed and monitored sufficiently to ensure appropriate treatment was consistent. We are aware that the trust are auditing and monitoring this closely. They also have a new generic wound care plan, but this was not being used during this review. We have set a compliance action in respect of this and we will be reviewing this again in the near future with further unannounced visits to the hospital.

As part of the safeguarding strategy meeting information request, the Trust sent us

their policies and guidance for the use of two mechanical devices post operatively to help prevent the risk of a deep vein thrombosis. Our specialist advisors have assured that the guidelines are appropriate but one of the references needs updating

We carried out an unannounced inspection in November 2011 to check on compliance of standards where we had previously found improvements were needed. During this inspection we spent time observing practices with the surgical theatres and found that improvements were needed to ensure that all pre and post operative checks were being fully completed.

This inspection was carried out on 3 April 2012 to specifically check on compliance of theatres and ensuring the safety checks were being completed and that this was being reviewed and monitored by the trust on a regular basis. Prior to this inspection we had received a detailed action plan from the trust to show how they planned to achieve compliance in outcome areas we had highlighted needed improvements. These were in the regulated activity of surgical procedures and in outcomes 4, care and welfare of people and outcome 16- assessing and monitoring the quality of service provision.

Three inspectors spent time observing pre and post operative checks in theatres for planned surgery, day surgery and ophthalmic surgery. We saw the theatre teams carrying out mandatory surgical safety checks on patients undergoing surgery on that day. These checks consist of a "check in" procedure when safety checks are carried out prior to surgery, a "time out" procedure when safety checks are carried out prior to the operation starting and a "check out" procedure at the end of surgery. These are mandatory formalised checks laid down by the World Health organisation Organisation (WHO) and National Patient Safety Agency (NPSA). The checks are performed to enhance patient safety.

We also saw that since our last inspection, theatres had introduced team briefings for all theatre staff before any patients were brought in for their procedure. This included running through the patient list, what procedures were being undertaken, any anticipated equipment needs and any special requirements such as post operative pain control needs. We saw that this had a big impact on improving communication between the teams.

We found that with all 17 observations the checks were always fully completed and included the prompts listed in the WHO checklist. We saw that each theatre had laminated checklists as an aid memoire for staff. There were also laminated small check lists for staff to carry and refer to if they wished. These were used to good effect.

We saw staff perform instrument and swab checks in conjunction with the WHO checklist.

Staff that we spoke to felt that there had been improvements in the team’s commitment to ensuring that all safety checks were completed. We heard that if any staff member did not comply with the mandatory checks that they had a system to report this to senior staff. Staff felt in their view that the team brief and end of day debriefs had worked especially well. One staff member commented “There is no doubt that the team brief has empowered all staff to be able to speak out.” Another member of staff said “It has cut down on the time we spent searching for equipment at the beginning of a case.”

We asked for some additional information from the trust about how they were ensuring that they were monitoring that theatres were complying with all safety checks. We saw that regular audits had been completed and working parties set up to look at how procedures could be improved.

We did not speak to people who used this service as part of this review. We looked at a random sample of medical records. This was to check that current practice ensured that treatment for the termination of pregnancy was not commenced unless two certificated opinions from doctors had been obtained.

During our visits to the hospital we spoke to both in patients and out patients about their experiences. We spoke to a total of 50 patients during our visits either as out patients or in patients on ward areas. Overall we heard very positive comments about individuals' experiences of using the hospital. One patient whom we spoke to said they had made several complaints over the years about their treatment via PALS, but at the end of the discussion said ''I still really rate the staff here, they do a great job of looking after us.''

Another patient we spoke with said they had known the hospital over several years and felt the service it provided was ‘just getting better and better’. Other patients also reflected they felt the care services provided had improved over recent years.

One relative said ''They could not have treated my wife better, I am really impressed with all the staff here, nothing is too much trouble.'' Another person told us ''On the whole staff are smashing, you may get a personality clash with one or two, but on the whole they have been great, really caring.''

We spoke with four people who were representatives for children who were staying on the children’s ward. All described their experiences as very positive, verbalising that staff always explained to them and their children what was going to happen whilst they were on the ward.

We observed care and treatment being delivered, by a cross section of trust staff, in a kind and respectful way.

Patients we spoke to gave a variable response about the food at the hospital. One patient reported it as ‘’lousy’’ and another said ‘’best not to mention what I think about the food.’’ Some patients gave more favourable responses. These tended to be in patient areas where stays were only for a short while, such as maternity. We saw that the hospital only have a one week menu at present and some people described this as ‘’very monotonous’’ and we were told that the week end pureed food was not appetising. We saw people being assisted to eat their meals when needed and that drinks and snacks were available.

Patients we spoke to had no complaints about the environment or cleanliness of the hospital. Most comments very positive and included ''It is kept very clean, I have no complaints.'' ''The cleaning staff work hard and do a good job.''

We heard that patients felt that staff explained their treatment to them, and that they were involved in decisions about their care and treatment. We were told that patients did feel comfortable in being able to make their concerns known.

One patient said ‘I don’t need to ask questions because they explain it so well’. Another said, ‘If there’s something I don’t quite understand, I just say so, and they explain everything.’ A third person, who had a hearing impairment, said the doctor realised the patient wasn’t understanding what he was saying because of his hearing difficulty, and then wrote everything down for him.

One patient in an acute medical ward said that ‘the staff are very good’. We saw staff engaging well with people, sometimes lightening their mood and sometimes acknowledging their distress with kindness. We heard staff ask how people were getting on with their treatment or a dressing and listening to them. One relative said ‘You can’t fault them (the staff). They jolly you along and they are lovely about everything’. They went on to say that the care in accident and emergency was ‘wonderful’.

We saw that the care and nursing staff had a good understanding of patients needs and care and treatment were being delivered appropriately, but that some records were not well maintained and this could lead to potential risk of care or treatment not being well monitored.

Staff working at the hospital told us that they have good training and that most have had an annual appraisal, but we found that regular planned support and supervision was not in place for all staff. This meant that there is no clear audit of how staff competencies are checked and that staff may not have had opportunities to discuss their skills and ongoing training needs on a regular basis.

Following our last inspection of Northern Devon Healthcare NHS Trust in October 2017, we issued the trust with a warning notice under Section 29A of the Health and Social Care Act 2008.

The warning notice set out the following areas of concern, where significant improvement was required:

Regulation 12 Safe Care and Treatment

Maternity:

• Healthcare professionals were not always following guidelines and best practice. This had led to the mismanagement of some cases, resulting in harm or death to the babies.

• There was poor collaboration and multidisciplinary team working within the maternity unit. The negative culture did not promote safe care and treatment, or effective working within the department.

• The consultant obstetrician workforce was unstable. A number of consultants had their practice restricted, so they no longer covered the labour ward. There was a potential risk with consultants who had their practice restricted continuing to work in antenatal clinics.

• Medical staff were not up-to-date with training necessary to carry out their role. They consistently did not meet trust targets for maternity mandatory training.

Outpatients:

• Patients were not being seen in a timely manner in ophthalmology due to the limited capacity within outpatient clinics.

• In ophthalmology there were 20 patients who had gone past their follow-up dates with evidence of patient harm.

• New systems were not always implemented successfully. Following migration to a new electronc health record, which incorporates a new booking system, missing information about outcomes and follow-ups was identified.

• There was historical failure to act on issues identified from previous incidents of patient harm. The trust had also failed to act in a timely manner to complete actions identified in previous investigations.

• Clinicians across outpatient specialties were not always risk-assessing patients who had been waiting a long time.

• There were ineffective processes for monitoring patients on the cardiology waiting list.

• There were an increased number of patients who were lost to follow up across all outpatient specialities because of lost contact or IT failure.

• There was a lack of oversight of training completion for medical staff.

• There were not enough staff trained to administer chemotherapy in the oncology department.

Urgent and Emergency Care:

• Oversight of infection control within the emergency department was unclear, including actions required to improve cleanliness. The major injury department was not clean and was an infection risk.

• Poor infection control within the department reflected poor compliance with infection control training.

Regulation 17 Good Governance

Maternity:

• There was not a robust and regular audit programme to monitor quality and safety within the maternity unit. Audits were reactive in response to incidents and poor performance metrics.

• The governance structure and risk management arrangements were not clear.

• There was no multidisciplinary approach to governance.

• Clear audit trails of actions generated and how these were monitored were not evidenced in all meeting minutes.

• Processes to discuss and learn between the multidisciplinary team required improvement. Round table reviews for serious incidents were not well attended by consultant obstetricians.

• The department of health’s safer maternity care recommendations had not been implemented. There was no board level maternity champion or designated obstetrician and midwife to jointly champion maternity safety in the trust.

Outpatients:

• There was not an effective system to manage risks at a local level in outpatients. Risks were not being regularly updated or reviewed. Individual risks were not always being managed effectively.

• Managers did not receive feedback about themes and trends from incident data which were escalated to the clinical governance lead.

• The governance system did not support the delivery of good quality care and we could not identify who had overall responsibility for all outpatient areas at both clinic and board level.

• There was a systematic programme of audit, however not all managers were aware of what audits were being carried out.

End of Life Care:

• Systems did not operate effectively. There was a lack of oversight, audit and assessment of the end of life care service provided, and a poor governance structure.

• The trust had not addressed all the shortfalls in the 2015 National Care of the Dying audit.

• The end of life steering group had a list of actions at the end of each set of minutes but no timescales for when these would be addressed. The end of life strategy action plan included no timeframes.

• Local audits had taken place but there was no action plan to address the areas where improvement was needed.

• Systems for maintaining accurate and completed detailed records of patients using the end of life care service were not operating effectively. We did not see any advance care plans or an individual plan of care detailing patient choices for now and at the end of their life. Medical care plans were not complete.

We conducted an unannounced follow-up inspection on 17 and 18 July 2018. This inspection was focused solely on the improvements required as detailed within the warning notice. We did not review the ratings as part of this inspection.

The trust had made some progress in addressing our concerns and we had seen improvements. However, systems and processes were not fully embedded. The pace of change had been slow and there was further work needed to continue the improvements. The requirements of the warning notice had not been fully met.

In urgent and emergency care we found:

• There was still ineffective oversight and inconsistent cleaning in the emergency department. We identified a significant build-up of dust in some areas. However, the trust was undertaking a major building and redesign project at the time of our visit.

However:

• The infection prevention control training compliance concerns had been addressed. Both clinical and non-clinical staff training compliance had greatly improved.

In maternity we found:

• Incident investigations had improved. Specialists from different professional groups contributed to reviews and identified improvements.

• The response of medical staff to requests to review patients’ care needs had improved.

• We observed good communication and interactions between doctors and midwives.

• Leaders had begun to develop a vision and strategy for maternity care.

• An improved governance framework was in development to assure and evaluate the quality of maternity care.

• The leadership team were visible, approachable and supported staff to do their work.

• The culture within the service was improving. The results of a recent survey would be used to influence forthcoming organisational development.

However:

• Incidents and other adverse events were not used as part of service risk assessments.

• Trust targets for mandatory and service specific training were not achieved.

• Medical staffing remained fragile whilst a long-term strategy for consultant job plans were developed.

• The trust was unable to demonstrate clinical practice complied with local guidelines.

• There was no audit programme. This meant assessments of care provision and risk control measures were not co-ordinated or evaluated as part of the quality management system.

• There was no clear ownership of the risk register.

In end of life care we found:

• There was improved oversight, audit and assessment of the end of life service. There were improvements in the governance structure. Most systems were operating effectively.

• Concerns and issues could be routinely identified, and improvements had been made to the service.

• The trust was participating in the National Audit of Care at End of Life.

• There were systems for maintaining accurate and completed detailed records of patients using the end of life care service.

• We reviewed three patient records, which included comprehensive advance plans of care. These individual plans of care detailed patient choices for now and at the end of their life. Patient care needs and preferences were known and met by the service.

• The end of life strategy was due to be ratified several days after our inspection on 30 July 2018. It covered the period 2018-2020.

However:

• The trust was still addressing remaining shortfalls from the 2015 National Care of the Dying audit.

• Actions in minutes from local working group meetings were still without timescales.

• Several audits of treatment escalation plans did not have action plans.

• Audits of advance plans of care were not available as completion of the audit was not due until September 2018.

In outpatients we found:

• The trust was better sighted on waiting lists and those patients who had been waiting a long time to be seen. The referral to treatment time weekly meetings reviewed patients in detail.

• The trust was formalising their harm review process, with retired clinicians identifiedto complete this exercise.

• Specialities found it easier to gain approval for additional clinics, however this was dependent on capacity.

• The ophthalmology task and finish group were reviewing how they could improve the efficiency of the ophthalmology service through different project workstreams. However, there were still actions remaining and work required to move things forward.

• There was weekly monitoring of data quality issues. Outpatient managers were fully aware of any limitations with the electronic health record which incorporates the booking system.

• Governance processes were being improved, however they were not yet embedded for us to see the impact across the service.

• There was an improved system to manage and record risks at a local outpatient level.

• The ophthalmology action plan had a person responsible for each action.

However:

• Incident reports showed the culture for incident reporting in the Seamoor chemotherapy and day treatment unit had not improved. There was a back-log of incidents which had not been signed off by a ward manager, delaying the learning for staff.

• Mandatory training compliance for medical staff had improved but was still below the trust target for some modules. Compliance with resuscitation training was poor and safeguarding training needed improvement.

• There was not capacity for regular clinician reviews in some specialities. We were not provided with evidence to show the processes had improved in cardiology.

• The in-house competency assessments on the Seamoor chemotherapy and day treatment unit were not completed in a timely way. There was still a misunderstanding between staff and the unit’s management team about what training was required to ensure competency. Some staff would soon be signed off as competent, however they were not always confident in their role.

• The trust was still underperforming against referral to treatment times and patients were waiting for long periods of time.

• Trauma and orthopaedics had a high number of patients waiting over 52 weeks. However, all patients waiting over 40 weeks were being formally reviewed and risk-assessed.

• There were concerns about the culture and morale of staff on the Seamoor chemotherapy and day treatment unit. Staff told us they had not been engaged since the issue of the warning notice with regards to the concerns raised about the unit.

Following this inspection, we told the provider that it must take some actions to comply with the regulations, and that it should make other improvements, even though a regulation had not been breached, to help the service improve.

Importantly, the trust must:

• Ensure the emergency department is cleaned to a high standard and there is not a build-up of dust.

• Meet trust targets for mandatory and practical obstetric multi-professional training in maternity and ensure the training data produced centrally is accurate.

• Develop and undertake audits to measure the effectiveness of the maternity service against patient outcomes, policies and risks.

• Consider the concerns raised in the Seamoor chemotherapy and day treatment unit and ensure the skill mix is appropriate and staff are competent to deliver a safe and effective service. Competency assessment must be completed in a timely way to ensure a competent workforce.

• Improve mandatory training compliance for medical staff across the trust, particularly for resuscitation and safeguarding training.

• Formalise clinician review processes to risk assess patients waiting a long time to be seen or overdue follow-ups across outpatient specialities.

In addition, the trust should:

• Consider the accuracy and validity of the cleaning audits completed in the emergency department.

• Complete actions and shared learning from serious incidents in maternity in a timely way.

• Consider how adverse events in maternity may impact identified risks to patient safety.

• Make the responsibility for maintaining the maternity risk register clear and regularly identify and record risks.

• Plan to audit advance care plans in the end of life service..

• Review the Overarching End of Life Action Plan to Improve the Quality of End of Life Care Provision and consider the deadlines set and whether they ensure appropriate and prompt change to the service.

• Complete timescales for meeting minutes and action plans for the end of life service.

• Complete action plans for audits in the end of life service to identify learning and improvement, for example audits of treatment escalation plans.

• Engage with staff on the Seamoor chemotherapy and day treatment unit to support and improve the culture and morale. Gain assurance incidents are being reported and learning is shared with staff in a timely manner.

Professor Edward Baker

Chief Inspector of Hospitals