Serious Incident Report Public Board Meeting 28 July 2016 Presented for: Presented by: Author Previous Committees Governance Dr Yvette Oade, Chief Medical Officer Louise Povey, Serious Incidents Investigations & Learning Manager None Trust Goals The best for patient safety, quality and experience The best place to work A centre for excellence for research, education and innovation Seamless integrated care across organisational boundaries Financial sustainability Key points 1. This report includes a summary of new serious incidents that have been reported in May and June 2016 and the initial actions that have been taken to mitigate the risks. 2. The report includes a summary of the 3 completed investigations which have been submitted to NHS Leeds West CCG in May and June 2016; it outlines the root cause(s) of the incidents and summarises the actions agreed to address the care and service delivery problems identified during the investigations. 3. There has been a reduction in patient falls resulting in serious injury in May and June 2016 Information Information Information 1
1. SUMMARY This report summarises the serious incidents that have been reported to Commissioners at NHS Leeds West CCG in May and June 2016 with information about the initial actions taken to mitigate the associated risks. 2. BACKGROUND The Trust is committed to identifying, reporting and investigating serious incidents and ensuring that learning is shared across the organisation and actions taken to reduce the risk of recurrence. The Trust seeks, where at all possible, to prevent the occurrence of serious incidents by taking a proactive approach to the reporting and management of risk to ensure safe care is provided to patients through the promotion of a positive reporting and investigation culture. A serious incident is defined where a patient, member of staff or member of the public has suffered serious injury, major permanent harm, unexpected death or where there is a pattern of incidents or actions which have caused or are likely to cause significant concern. Patients are not always harmed as a result of a serious incident. Near misses may also constitute a serious incident, where the contributory causes are serious and may have led to significant harm. These are reported and investigated in line with our Serious Incident Procedure to help us learn and take action to prevent patients, staff and members of the public from being harmed. A detailed review of serious incidents and the associated learning from completed investigations is undertaken at the Trust s Quality Assurance Committee. The number of serious incidents reported for this period to NHS Leeds West CCG, as the agreed responsible commissioners representing all of our CCGs, was 10; this has been included in figure 1. Fig 1 Total number of Serious Incidents reported by month 2
3. Pressure Ulcers The decision to include the development of category 3 pressure ulcers as serious incidents and report these on STEIS (serious incident reporting system) in addition to category 4s is directly linked to our programme for improvement, focussing on reducing the incidence of harm from more severe pressure ulcers. In the publication of the revised serious incident framework by NHS England in April 2015, a recommendation was made that the process for reporting category 3 pressure ulcers should be reviewed locally to identify the most serious pressure ulcers that were considered to be avoidable and led to longer-term or permanent harm. The Trust agreed with commissioners that a category 3 pressure ulcer would be reported as a serious incident to the CCG where the Root Cause Analysis investigation concludes it could have been prevented and led to longer-term or permanent harm. This has resulted in a reduction of the numbers of category 3 pressure ulcers reported on STEIS. Figure 2 illustrates the total number of category 3 pressure ulcers reported since April 2014 on Datix (incident reporting system) compared to the amount of category 3 pressure ulcers reported to the CCG via STEIS. Fig 2 Total number of Category 3 Pressure Ulcers reported as serious incidents on STEIS compared to the total number of Category 3 Pressure Ulcers reported 12 Category 3 Pressure Ulcers 10 8 6 4 2 0 Datix STEIS 4. Falls Reducing the number of patient falls within the Trust is a priority in our quality improvement programme. These incidents are subject to a detailed Root Cause Analysis to help us identify the causes and to agree actions that we need to take to reduce the risk. This process is led by the specialty team and CSU and the reports are reviewed by a central group. The chart below shows the numbers of patient falls resulting in serious injury. There were higher numbers of falls resulting in harm in January - March 2016; there was a further increase during April 2016. It is encouraging to note a reduction in falls in May and June 2016. 3
Fig 3 Total number of falls reported as serious incidents on STEIS compared to the total number of falls reported 5. NEW INCIDENTS A total of 10 serious incidents were reported to Commissioners at NHS Leeds West CCG in May and June 2016. These are currently being investigated and are summarised below along with details of the immediate actions taken. 5.1 Category 3 pressure ulcers No category 3 pressure ulcers were reported to the commissioners in May or June 2016 and no potential category 3 pressure ulcers were reported to Risk Management in May or June 2016. 4
5.2 Patient Falls In May 2016, two of the serious incidents reported were in relation to a patient fall. In June 2016, one of the serious incidents reported were in relation to a patient fall. 5.3 Cardiac arrest following transfusion A baby was born prematurely and underwent a blood transfusion. Following the transfusion the baby suffered a cardiac arrest and after extensive resuscitation subsequently died. Results of the post mortem examination are awaited. The incident was reviewed at the specialty governance meeting and discussed within the clinical team to raise awareness of the incident. A verbal apology has been given to the family. The incident has been reviewed by the Chief Medical Officer and Chief Nurse, and a Level 3 serious incident has commenced. This incident has been declared to Leeds West CCG. 5.4 Wrong Tooth Extraction - Never Event A patient attended the dental student teaching clinic for several tooth extractions. A clinical tutor was supervising the extractions. The consent form and checklist had been completed and two upper extractions took place uneventfully. The dental student then made preparations to extract a further tooth but unfortunately the student removed the wrong tooth. The fact the wrong tooth had been extracted was explained to the patient and the option was given to leave the tooth for another appointment or to remove it. The patient preferred for the tooth to be removed and the correct was removed without incident. The incident was discussed with the patient, and a verbal apology was given. The patient opted to have the correct tooth removed at the same appointment. The incident was reviewed by the Chief Medical Officer and Chief Nurse, and declared as a Level 3 serious incident with Leeds West CCG, a lead investigator has been appointed to conduct the investigation. There is work on-going within the dental hospital regarding the use of checklists and the team are also implementing a verbal timeout immediately prior to an extraction taking place. 5.5 Wrong Test Result The Trust was notified by Bradford Royal Infirmary about a possible biopsy specimen process error that may have led to two patients having the incorrect breast surgery. The screening and biopsies were performed in Bradford, the pathology specimens processed at Leeds, and the surgery performed at a third trust. Investigations are ongoing at this time to determine where the specimen process error occurred. 5
The relevant general managers and clinical directors have been informed. The biopsies have been sent for further analysis. The incident was reviewed by the Chief Medical Officer and Chief Nurse and declared as a Level 3 serious incident investigation to be conducted jointly with Bradford Royal Infirmary. This incident has been declared to Leeds West CCG. The patients have both received an apology and have been informed that an investigation is being undertaken. The patients have had the appropriate treatments. 5.6 Delay in Treatment A patient was seen in a post-operative outpatient clinic following an operation on his hip. During a clinic visit the patient was seen by a Specialist Consultant who planned to undertake some revision surgery on the patient s hip and a preassessment appointment was booked. An ultrasound scan was performed which showed a large hip effusion (swelling) and the patient appeared unwell with signs of infection. The patient was immediately admitted to hospital and treated for sepsis but subsequently died. A decision was made by the Chief Nurse and Chief Medical Officer that this incident should be declared a Level 3 serious incident investigation. The patient s family have been contacted and a full apology given. A lead investigator has been appointed to conduct the investigation. 5.7 Treatment in the Emergency Department A patient attended the Emergency Department (ED) after taking an intentional overdose. The patient was assessed and an ECG was completed and reviewed by a doctor. One hour after admission cardiac monitoring had not commenced and the patient was found unresponsive and resuscitation was carried out. The patient was transferred to ICU and subsequently died 6 days later. The incident was reviewed by the urgent care clinical team, including the process for assessment and treatment (triage process). A verbal apology was given to the patient s next of kin. The incident was reviewed by the Chief Medical Officer and Chief Nurse, and declared as a Level 3 serious incident with Leeds West CCG, a lead investigator has been appointed to conduct the investigation. 5.8 Delay in diagnosis There was a delay in diagnosis of meningitis in a child who had previously been reviewed in the Trust s ED department and by the GP. When the child re-presented to hospital he was admitted to PICU. Sadly, despite maximal support, the patient subsequently died. The incident was reviewed by the Chief Medical Officer and Chief Nurse, and declared as a Level 3 serious incident and reported to Leeds West CCG. An 6
investigator and co-investigator have been appointed and on-going discussions are taking place with the family who are being supported by Trust staff. 5.9 Failure to escalate - Stillbirth A patient was receiving midwifery led antenatal care. At 22 weeks gestation the patient presented with concerns about reduced foetal movement. The foetal heart was heard and a swab taken indicated that the patient had an infection. The patient was advised she would require treatment with antibiotics in labour. Following this, the patient attended the maternity assessment centre on two further occasions where the CTG (measure of foetal heartbeat) had abnormalities. At 29 weeks the patient presented again, but sadly an intrauterine death was confirmed. The obstetric team reviewed the case, including CTG interpretation and escalation. The family are being fully supported and have been given an apology. The incident was reviewed by the Chief Medical Officer and Chief Nurse, and declared as a Level 3 serious incident with Leeds West CCG, a lead investigator has been appointed to conduct the investigation. 6 COMPLETED INVESTIGATIONS Three serious incident investigations were completed and submitted to NHS West Leeds CCG during May and June 2016. The incidents are summarised below along with the details of the root cause and the action plan agreed to address the care and service delivery issues identified. 6.1 Death following surgery A female patient with learning disabilities and mental health problems and an established care package was admitted to St James s hospital. It was suspected that the patient had swallowed a foreign body and perforated her small bowel so she required an emergency laparotomy. Following surgery the patient was transferred to the ward and was placed in a side room. Two hours after arriving on the ward the patient was found to have suffered a respiratory arrest. Attempts were made to resuscitate the patient but this was unsuccessful. Root Cause It has not been possible to identify a specific root cause, however there were factors that contributed to the incident. This included the incomplete investigation history to assist the clinical team in making decisions about treatment, particularly during the handover on admission from the patient s care home. Learning identified and actions taken The investigation identified that preparation for major surgery requires multidisciplinary co-operation to ensure that care is cohesive and continuous. In addition to patient history and medical records, a number of alternative sources of information are available and interrogation of these may reveal significant patient related information that could influence clinical decisions. 7
The actions identified from the findings of the investigation included raising further awareness of the use of Patient Pathway Manager (PPM) as a source of clinical information and to consider how all sources of clinical information can be identified through the development of an alert page containing a short summary of known patient related risk factors. Actions were also identified to improve the patient pathway when patients are taken to the operation theatre from ED and the development of a standard set of patient information to accompany patients when they are admitted to hospital from residential care and other care providers. 6.2 Delay in treatment A patient was admitted to St James's hospital via the Emergency Department with serious health conditions. The patient had a complex medical history. Following admission a Consultant Physician referred the patient urgently to the surgical team because of increasing concerns that the patient may have developed a form of gangrene called necrotising fasciitis (a serious bacterial infection that spreads quickly and can become life threatening in a very short amount of time). Several surgical specialities became involved and a CT scan was carried out. This led to a delay of approximately 11 hours before surgical debridement (removal of infected tissue) was carried out. The patient was taken to Intensive Care for renal support but sadly died two weeks later. Root Cause This investigation has concluded that the failure to treat necrotising fasciitis (NF) as a surgical emergency was due to a failure to recognise the importance of early surgical debridement, the absence of a consultant surgeon review of the patient and a lack of clarity on clinical management of the condition and the urgency of treatment in the Trust s Guidelines. Learning identified and actions taken The importance of Consultant involvement in the assessment of patients with life threatening conditions is crucial. There must be an awareness of the seriousness of necrotising fasciitis and its associated complications. A review of the current guidance for NF is being undertaken and when completed will be disseminated across specialities. A learning bulletin will also be published to raise awareness amongst clinical staff of the potential risks associated with this condition. 6.3 Neonatal Death A pregnant woman of 26 weeks gestation was admitted to hospital with spontaneous rupture of membranes. This represents a high risk of an adverse outcome for a baby. CTG recordings were intermittently abnormal and escalation for a consultant s opinion did not take place initially. Although recordings were reassuring at one point, the tracings deteriorated and a decision was made for an urgent caesarean section to be undertaken. There was a delay in delivering the baby and when the baby was delivered she was in a poor condition and died 12 hours later. Root Cause The root cause of this incident was the premature birth of a 26 weeks neonate. This was most likely due to chorioamnionitis, (inflammation of foetal membranes due to a bacterial infection) which led to premature onset of labour. 8
Learning identified and actions taken The report identified that documentation of CTG interpretation needs to be clearer, particularly in relation to identifying the individual making the interpretation. Processes to ensure timely antibiotic delivery in the treatment of neonatal sepsis (infection) are not always reliable. Actions were identified to clarify the process for staff to escalate concerns to the consultant on call and delivery suite co-ordinator; staff to be made aware of the sepsis protocol and the importance of timely antibiotic treatment and a learning event is to be held to raise awareness of the importance of clear documentation when interpreting CTG. 7. PUBLICATION UNDER THE FREEDOM OF INFORMATION ACT This paper will be made available under the Freedom of Information Act 2000. 8. RECOMMENDATION The Trust Board is asked to receive the serious incident report, note the new serious incidents that have been reported, including initial actions taken to mitigate risks and note the closed investigations and the agreed actions. Dr Yvette Oade Chief Medical Officer July 2016 9