final report of the investigation into the circumstances … · 2020-01-23 · 1 . health service...

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HEALTH SERVICE EXECUTIVE

Final Report of the Investigation into the circumstances surrounding the unexpected death of a male patient who had been an inpatient in the paediatric unit SERIAL NO 50325

Strictly Private and Confidential

Investigation Commencement and Completion Dates: The investigation commenced on the 4th February 2013 and was completed on the 2nd June 2014. This investigation including the terms of reference was commissioned by the Area Manager HSE Kerry Area

Strictly Private and Confidential: ------------------------------------------------------------------------------------------------

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Table of Contents ACKNOWLEDGEMENT ................................................................................................................................... 3

GLOSSARY OF TERMS AND ACRONYMS .................................................................................................. 4

EXECUTIVE SUMMARY .................................................................................................................................. 6

BACKGROUND TO THIS INVESTIGATION ................................................................................................ 8

METHODOLOGY ............................................................................................................................................. 11

CHRONOLOGY OF EVENTS ......................................................................................................................... 14

KEY CAUSAL FACTORS, CONTRIBUTORY FACTORS, INCIDENTAL FACTORS AND LINKED RECOMMENDATIONS ................................................................................................................................... 23

INCIDENTAL FINDINGS ................................................................................................................................ 27

REFERENCES: .................................................................................................................................................. 29

APPENDIX A: TERMS OF REFERENCE ..................................................................................................... 30

APPENDIX B: SOURCES OF INFORMATION REVIEWED .................................................................... 32

APPENDIX C: FRAMEWORK OF CONTRIBUTORY FACTORS ........................................................... 32

APPENDIX D: HIERARCHY OF HAZARD CONTROLS........................................................................... 33


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Acknowledgement The review team would like to extend their sympathies to the family. The review team wish to acknowledge the co-operation of all involved in the initiation of this review. It was evident at interviews with employees who cared for this patient that they were deeply saddened and shocked by the patient’s tragic and untimely death. The Review team would also like to re-iterate that this review has been completed in advance of the Coroner’s Inquest in order to achieve the necessary safety measures to reduce the likelihood of this incident occurring in the future. In the course of the preparation of the report, the review team members note the intention of the HSE to offer an apology to the relatives of the deceased patient.


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Glossary of Terms and Acronyms BP Blood pressure

CRP

C Reactive protein

Crash Call Notification of an emergency in a clinical area

CXR Chest x-ray ECG Electrocardiograph ED Emergency Department FBC

Full Blood Count

Glasgow Coma Scale (gcs)

A neurological scale that aims to provide a reliable, objective method of recording the conscious state of a patient. It comprises of assessment of the eye, verbal and motor responses

HR Heart rate HSE Health Service Executive Hirschsprungs Disease

Hirschsprung’s disease is a rare disorder of the bowel, most commonly the large bowel (colon) which can lead to severe constipation and intestinal obstruction.

INR ITU

International Normalised Ratio-this is an investigation used to determine clotting tendencies of blood. Intensive Care Unit

ISBAR Communication Tool Key Causal Factors Key Incidental Findings

Issues that arose in the process of delivering and managing health services which had an effect on an eventual adverse outcome. Issues identified in the course of the review which did not impact on the outcome but are system development issues.

NCHD Non Consultant Hospital Doctor

NIMT Nitrofurantoin

National Incident Management Team Antibiotic

NOCTE At night O2 Sat Open Disclosure

Oxygen saturations This is an open consistent approach to communication with service users when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patien tor their relatives informed and providing feedback on investigations and the steps taken to prevent recurrence of the adverse event.


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P Pulse PFA Plain Film of Abdomen Ranitidine REG

Medication used in the treatment of peptic ulcer disease Registrar

SHO Senior House Officer T Temperature Triage A professional assessment process that aids in the

identification of the priority of the patient for clinical intervention.

U&E Urea and Electrolytes Vitamin K A fat soluble vitamin required by the body for modification of

certain proteins required for blood coagulation


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Executive Summary This is the report of an investigation conducted into the circumstances surrounding the unexpected death of a male adolescent who had been an inpatient in the paediatric ward. At that particular time adolescents aged 16 were admitted under the care of the paediatric team-the criteria and admission age has since been altered and adolescents are now admitted under the care of medical teams. The aim of the review is to identify precisely what happened and whether any failures occurred in relation to the care and management received by patient X during his contact with the services of Kerry General Hospital from 29/09/2012 to 30/09/2012. The purpose of this review is where system failures are identified, the causes of these system failures and the actions necessary to remedy them are delineated so as to prevent, or if prevention is impossible, to reduce the likelihood of recurrence of such failures as far as practicable. A systems analysis methodology was used in the conduction of this review as per HSE guidance. The review was conducted by internal reviewers as requested by the Area Manager for the area. An external reviewer was appointed with the support of the Regional Manager for Quality and Patient Safety and NIMT (National Incident Management Team). As requested by the family, a separate report was requested from Southdoc which was forwarded to the family. The reviewers who undertook this investigation were: The internal reviewers were - Ms Helena Butler Risk Manager Kerry Area, Chairperson of the review team. -Mr Richard Walsh, Director of Nursing and Midwifery, Kerry General Hospital. - Dr Rizwan Khan, Paediatric Consultant Kerry General Hospital - Dr Martin Boyd, Consultant in Emergency Medicine, Kerry General Hospital. External Reviewer

- Professor Alf Nicholson, Professor of Paediatrics at the Children’s University Hospital, Temple Street, Dublin, external reviewer, appointed through the National Forum with the assistance of the National Incident Management Team (NIMT). (Appendix F)

HSE Systems analysis guidance was adhered to in order to ensure the safe management of sensitive material and to ensure fairness and factual accuracy to all concerned. The review team sought to complete its work in as timely a manner as was possible.


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Summary of key causal factors and contributory factors Key causal factors are defined by the HSE Guidelines for Systems Analysis Investigation of Incidents and Complaints (HSE, November 2012)1

This investigation identified the following four key causal factors and two incidental findings:

as issues that arise during the process of delivering and managing health services that are considered by the investigation team to have had an effect on the eventual adverse outcome.

The key causal factors identified included failure to recognise the deteriorating paediatric patient, failure in communication processes both in relation to informing those at a higher level of the clinical situation and transmission of information and inadequate serious adverse event management processes. The incidental finding related to lack of adherence to local and national documentation policies.The relevant contributory factors included the following factors -Individual staff factors, team factors, work environment factors and task technology factors Key Causal Factor 1: Failure to recognise the deteriorating paediatric patient. Key Causal Factor 2: Failure in Communication processes: Key Causal Factor 2 (a): -Failure to achieve the necessary level of professional communication and disclosure of information prevented a more in depth formulation of the patient’s care plan. Key Causal Factor 2 (b): - Lack of documented process to govern handover of patient care. Key Causal Factor 3: Failure to identify and report a serious incident according to local and national policy. Key Causal Factor 4: Deviation from Documentation Policy. Key Incidental Finding 1: Deviation from End of Life Care Guidance

1 Systems analysis is a method of investigating patient safety incidents, based on the “London Protocol” (2004) which involves collection of data from the literature, relevant records, interviews with those involved in delivering care where the incident occurred, and analysis of this data to establish the chronology of events that led up to the incident, and to identify the key causal factors that are considered to have had an effect on the eventual adverse outcome, the contributory factors, and recommended control actions to address the contributory factors to prevent future harm arising as far as is reasonably practicable. The systems analysis method acts as an aid to conducting serious patient safety incident investigations. At the time of the incident with which this investigation is concerned the version of the guidelines for systems analysis investigations were the version in the “Toolkit of Documentation to Support the Health Services Executive Incident Management” (HSE 2009). Prior to the decision to establish this investigation team a process of administrative review of these guidelines, in consultation with external systems safety and patient safety experts, service users and staff was concluding. The updated Systems Analysis Guidelines were concluded and adopted on the 18th of November 2012 during the early stages of this investigation and prior to establishing this investigation team. HSE Guidelines of “Systems Analysis Investigation of Incidents and Complaints” (HSE, November 2012 can be downloaded at http://www.hse.ie/eng/about/Who/qualityandpatientsafety/Quality_and_Patient_Safety_Documents/QPSDGL5211.pdf

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/Quality_and_Patient_Safety_Documents/QPSDGL5211.pdf�

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/Quality_and_Patient_Safety_Documents/QPSDGL5211.pdf�


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Key Incidental Finding 2: Feedback to Regional Office of Quality and Patient Safety on advice on potential post operative complications from surgery for Hirschsprung’s Disease. Summary of Recommendations Recommendation 1: The service must implement a Paediatric Early Warning Score and Sepsis protocol followed by a schedule of audit of compliance. Recommendation 2: The service must implement improvements to Communication Structures-structured handovers. Recommendation 3: The service must audit the operationalisation of the Serious Adverse Event policy in conjunction with the HSE South Escalation procedure and make any amendments required. Recommendation 4: The Paediatric service must review its admission criteria to the paediatric ward. Recommendation 5: The service must implement a regular audit of Documentation in accordance with local and national policies. Recommendation to address Incidental finding 1: End of Life care guidance to be issued to all staff. Recommendation to address incidental finding 2: Feedback to Regional Office of Quality and Patient Safety regarding examination of advice to parents on potential post operative complications from surgery for Hirschsprung’s Disease. Background to this Investigation Patient X, a 16 year old adolescent was admitted to the Emergency Department on 29/09/12 complaining of being unwell since 27/09/12 with acute abdominal pain and abdominal distension. On examination, the abdominal findings were noted to be soft, generalised tenderness with bowel sounds present. He had attended the GP in the previous 48 hours on 27/09/12 and was taking Nitrofurantoin 100mgs for UTI. His past medical history included surgery for Hirschsprungs Disease as a baby. He was noted to have some food intolerances. He was admitted to the paediatric ward with instructions in relation to iv fluids and monitoring of his oxygen saturations as the provisional diagnosis was one of pneumonia or a urinary tract infection (UTI). His mother who accompanied him to the ward, went home in the early hours of the morning. His condition deteriorated significantly and at 05.30hrs suffered an episode of haemoptysis,


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and a small epistaxis with a requirement for intubation. The crash call was activated. The patient was intubated and transferred to ITU. His parents were advised of the deterioration in the patient’s condition. The crash call was put out again in ITU and the patient passed away at 08.00hrs. A systems analysis methodology was used for this review. It was noted that the cause of death from the post mortem report which was in the patient notes was septic shock due to an acute suppurative pyelonephritis. Limitations to the review: At the time of the interviews, due to the time lapse of seven months since the incident, a limitation of the review was the recall of some interviewees since the incident. The time period for conduction of the review was lengthened due to the availability of the external reviewer to be sourced and difficulty making contact with the representative from the Irish Patients’ Association . The external reviewer joined the review team on 3rd May 2013. An alternative point of contact was appointed for the family in April 2014. Already Implemented. Due to the incident, the following measures have already been implemented to ensure that the likelihood of recurrence of this incident is greatly reduced as itemised in the Management Plan in (Appendix E). A Clinical Governance group has been established in the Paediatric Department to oversee the introduction of quality and safety improvement measures. The criteria for admission to the paediatric ward has been altered in that paediatric admissions aged 16 and over are now cared for by the medical teams when they are admitted to the paediatric ward. The Paediatric Registrar rota previously involved on call duty for Friday, Saturday and Sunday but this has now been decreased to a duty of 24 hours on call. An evidence based Paediatric Early Warning score is in development with material having been sourced from other sites in Ireland and the UK. The review team is aware at the time of this report of a national initiative to develop and introduce a standardised observation and warning score and have received advice from HIQA to await the introduction of the score nationally (Appendix G) The paediatric patients aged 16 and over are assessed and monitored using the National Early Warning Score Tool. The Serious Adverse Event policy for the Kerry Area has been redistributed to all medical staff and on induction to the organisation. Further briefing sessions have been delivered on this policy. Incident forms are now sent directly to the Risk Manager’s office in order to enhance the notification of incidents and appropriate escalation in a timely manner.


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Implementation of the National Open Disclosure Policy: Kerry General Hospital has adopted the national policy on Open Disclosure and has initiated training and information workshops and this process is ongoing. The website for Kerry General Hospital is currently at an advanced stage of development.


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Methodology The investigation was undertaken using the methodology for incident investigation as outlined in the HSE Guideline for Systems Analysis Investigation of Incidents and Complaints (Nov. 2012). Systems analysis is an internationally recognised methodology for investigating adverse incidents in healthcare. A systems analysis investigation is a structured investigation that aims to identify the systems cause(s) of an incident or complaint and the actions necessary to eliminate the recurrence of the incident or complaint or where this is not possible to reduce the likelihood of recurrence of such an incident or complaint as far as possible. Healthcare services carry out incident investigations using systems analysis to find out what happened, how it happened, why it happened, what the organisation can learn from the incident and what changes the organisation should make to prevent it happening again. This is the report of a review conducted into the circumstances of an unexpected death of a male patient who had been an inpatient on the paediatric ward. The purpose of this investigation was to: → Establish the factual circumstances leading up to the incident → Identify any key causal factors that may have occurred → Identify the contributory factors that may have caused the key causal factors → Recommend actions where necessary that seek to address the contributory factors so that the risk of future harm arising from these factors is eliminated or if this is not possible, is reduced as far as is reasonably practicable.

While carrying out this investigation the reviewers examined relevant literature and documentation including the following: • Patient X’s healthcare record ( Appendix B ) • Local policies and procedures • Kerry Area Serious Adverse Event Policy • KGH Antimicrobial Guidelines • KGH Medication framework • KGH Modified Early Warning Score (MEWS) Policy(now replaced by the National Early Warning Score for persons aged 16 and over) • KGH Documentation guidelines

The review team sought to arrange a meeting with the patient’s family through their advocate, and acknowledge the written account that was provided initially from the family as input to the review prior to the family meeting with members of the review team. Consent was provided by the family for access to the medical notes for the purpose of the review. A total of 10 staff members were interviewed as part of the investigation.


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The adolescent’s parents were interviewed on 29/05/14 and the review team is grateful to the family for that meeting. Those interviewed included:

• Nursing staff who cared for Patient X during the time period covered by the scope of this review both in the ED department and the paediatric ward

• The Night Superintendent in charge of the hospital on the night of the incident. AD0ON

• The Shift Leader for ED on the night of the incident. • NCHDs-SHO and Registrar • Consultant Paediatrician

A written account was also obtained from the Consultant Anaesthetist who attended the patient on the paediatric ward and subsequent transfer to ITU. The main sources of information were the healthcare record and interviews with relevant staff. The interviews were conducted in a manner that aimed to ensure that the optimal levels of information were obtained whilst ensuring that the individuals being interviewed were treated with dignity and respect. The Terms of Reference for the review were provided to all interviewees prior to their attendance at interview. (Appendix A ) In addition as the review was carried out using a systems analysis methodology, everyone interviewed received information about the interview process and systems analysis investigations. All information gathered during the documentation and interview stages of the investigation process was treated confidentially. Information gathered was maintained securely, electronic documents were password protected and codes have been used to replace the names of individuals involved in the incident. The investigation process was conducted in a manner that was respectful of the rights of all to privacy, confidentiality, due process and natural justice. Each individual interviewed was informed in advance of the interview that the interviews would be recorded for the purpose of ensuring accuracy and consented to same. The interviews were used as an opportunity to establish the facts of the incident, to clarify information presented to the Review Team and as an opportunity for parties involved in the incident to present information that they wished to the Review Team. If staff had any concerns about the interview process, they are invited to communicate these concerns to the interviewers or to the investigation commissioner. Each individual interviewed was advised that they could bring their personal written account of the incident which could be used as an Aide Memoir by the interviewee or could be submitted to the Review Team for consideration. In advance of interview all parties were informed of their entitlement to be accompanied at interview. In order to ensure the confidentiality of the interview process for all


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involved, accompanying individuals not employed by the HSE were asked to sign a confidentiality agreement. Prior to the interviews each individual was informed of the opportunity to review their interview transcript and the draft report whereby they would have an opportunity to review and comment on/check the factual accuracy of the draft report. On completion of the interview and documentation review process, a Draft Report was prepared and the Draft Report was shared with all of those individuals who were interviewed as part of the investigation to ensure that the report was factually accurate; amendments were made to the Draft Report following receipt of submissions by relevant stakeholders. The Draft Report identified recommendations to address those issues which were identified as contributing to the incident and feedback was sought on the recommendations identified from. On this basis the Final Report of the investigation was developed. The Review team would also like to re-iterate that this review has been completed in advance of the Coroner’s Inquest in order to achieve the necessary safety measures to reduce the likelihood of this incident occurring in the future. The reviewers would like to thank all who participated in this review for their invaluable contribution to the process.


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Chronology of Events2

Saturday 29th September 2012 21.50 hrs ( Time noted on Triage Sheet) A male adolescent was admitted to the ED (DOB 09/01/96) complaining of being unwell since the previous Thursday with abdominal pain, pyrexia, cough. His abdomen was noted to be soft, with generalised tenderness and bowel sounds were present. He had attended his GP 24 hours earlier and the antibiotic Nitrofurantoin was commenced for a Urinary Tract infection (UTI). He was admitted as a triage category 2 which meant his condition warranted review within ten minutes and he was reviewed promptly. Feedback from the patient’s family indicates that initially their letter of referral to ED was not taken by the receptionist for approximately half an hour. Feedback from the patient’s family indicates that he was seen by a doctor from South Doc at 1am on Friday 28th September, he saw another doctor at 9.45am on Friday 28th September and he also saw another doctor from South Doc approximately one hour prior to admission to ED. He had a past medical history of Hirschsprung’s Disease having had surgery at 10 days old and 3 months and from the written account from the patient’s family he attended Our Lady’s Hospital Crumlin on an outpatient basis and his past medical history never affected the patient’s daily activities. Feedback from the interview with his parents indicated one episode of pain when he was 7 years old, he was treated by surgeons at that time, received medication for constipation and was discharged and never had a problem after this. He had enterocolitis as a baby and his mother had been advised to monitor any unusual bloody diarrhoea. He also suffered from migraines. The only other past history was that he developed a food intolerance which did not impact on his activities such as breeding birds, model machinery and other entrepreneurial pursuits. On this occasion it was noted that he had an epistaxis (a nose bleed)-the time of it was not specified. Feedback from the Paediatric SHO indicates that on discussing this event with the patient’s mother on admission ,the epistaxis occurred sometime prior to the attendance at Southdoc and ED and was not a lengthy incident. The patient’s mother related that the nosebleed was nothing unusual. There was no history of vomiting or diarrhoea at the time of this admission. Feedback from the patient’s mother also itemised that the GP from Southdoc had not rang ED to advise them of the impending attendance The Paediatric SHO initially took the history from the Southdoc letter of referral, the ED triage notes and from both the patient and his mother and she examined the patient. The findings were noted, investigations ordered while attempting to stabilize the patient with oxygen. She also prescribed the fluid regime. The Paediatric SHO then contacted the Paediatric Registrar.

2 Bold Italics used throughout the chronology of events section indicate direct quotes from all interviewees.


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The documentation of the patient’s clinical observations at this time indicated that his observations were recorded as follows: → 33.6 Temperature degrees Celsius → 131 Pulse rate beats per minute → 90/52 Blood pressure mmHg. Glasgow Coma Scale 15/15 IV Line sited, oxygen administered as oxygen saturations on room air were 73%., Bloods were taken as itemised below . Chest x-ray requested. Entry in nursing notes reflects that the patient’s hands were discoloured and blankets were applied. Feedback from the patient’s parents also related that the patient could not sign for his treatment when asked that night because his hands were numb and that as he was permitted to sign for his treatment, he should have been treated as an adult in accordance with the policy of other hospitals as he was over 16 years old at the time of admission. 21.30hrs The SHO initially took the history from the Southdoc letter of referral, the ED triage notes and from both the patient and his mother and she examined the patient. The findings were noted, investigations ordered while attempting to stabilize the patient with oxygen.She also prescribed the fluid regime. The SHO then contacted the Registrar and waited for his arrival, staying with the patient in view of his condition. Entry in medical notes from Paediatric SHO who recorded provisional diagnosis of pneumonia. Treatment plan was urine to be tested and sent for Mid Stream Specimen of Urine (MSU) for culture and sensitivity. Blood tests to be done and chest x ray result noted –basal consolidation. Blood Results noted as follows: Serum Lactate 3.8 (1.0-2.5mmol/L) WCC 14 ( 4-11), HB10.1 ( 13-18 ), Neutrophils-13.7 (1.8-8), Platelets 363 (140-440) CRP 55 ( 0-5 mg/L ), U&Es-Na 132 (135-145),K 3.7 (3.5-5.0),Urea 7.4 (1.7-8.3), Creatinine-98 (44-106), Calcium-1.91 (2.15-2.55), Albumin 31 (32-45) , Blood sugar 8.3mmol/l (3.5-10.0). Chest x-ray revealed left basal consolidation, X-ray Plain Film of Abdomen (PFA) ordered, Venous blood gas- PH 7.41 (7.32-7.42 ), Serum Lactate 3.8 (1.0-2.5mmol/L) , Diagnosis: Pneumonia, 0.9% saline and intravenous cefotaxime administered Medical record plan of care indicated intravenous fluids were to be continued, oxygen saturations were to be maintained in excess of 95% and this doctor (SHO) was to be contacted if the saturations dropped overnight. PFA result noted- a single dilated loop of bowel in the right upper quadrant. No evidence of advice being sought in relation to this finding.


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22.30hrs On examination the Registrar notes the abdominal examination was soft, no mottling, no guarding, no rigidity with bowel sounds. Entry in medical notes from the Registrar with provisional diagnosis of UTI or bronchopneumonia. The Registrar noted the patient’s age as 14 years. The SHO asked the Registrar what the appropriate antibiotic would be to cover this infection. Cefotaxime was prescribed as it is a broad spectrum antibiotic and effective for pneumonia or infections of the urinary tract. Capillary refill of less than 3 seconds noted. Management plan for maintenance IV fluids 80 mls/hr and intravenous Claforan and oral Azithromax. Calpol 4 hourly, Nurofen 6 hourly also ordered. Note entered to keep oxygen saturations greater than 92%.The SHO recalls agreeing with the Registrar the requirement to monitor the oxygen saturation levels .The SHO asked if the Consultant on call should be contacted for further advice but the Registrar indicated that he did not believe this was required . Both x-rays were reviewed by the Registrar. The PFA was reviewed by the SHO and the Registrar, and the SHO pointed out the dilated loop of bowel. The Registrar decided against contacting a surgeon to assess the patient. At the end of her discussion with the Registrar, the SHO finalised her admission note and setting out the management plan including the direction that oxygen saturation levels be kept above 95%. The patient’s mother related that the Registrar checked her son for meningitis and got him to stand up, and bend down but that her son was able to do this due to the fact he was strong willed and determined despite being so sick. Feedback from the patient’s parents relates that there was a nurse present at all times in the room in ED and they felt it was the same nurse that accompanied her son to transfer to the paediatric ward. Interview with the nurse who transferred the patient to the ward indicates that she met the patient and his mother at the lift bay to facilitate the transfer. The patient’s mother relates that her son was not speaking a lot in ED, he generally was not fond of hospitals or doctors but he answered when questioned. The patient’s mother recalls the registrar informing her of the strong antibiotics which were to be commenced which she felt gave her great faith. 00.00hrs Patient x admitted to Paediatric ward and noted to be alert and orientated. From interviews with staff, the ward activity revealed that the paediatric ward was not busy that night, and all three nurses on duty assisted with the admission and ongoing observation overnight. On admission Nurse A took the hand over report at the nurses’ station from the ED nurse transferring the patient, adjacent to the patient’s room. Blood gas results were noted in notes by the SHO. No coagulation screen was done on this patient. Instructions documented in notes to contact Paediatric SHO if oxygen saturations went below 95%. No instruction to monitor urinary output. No evidence that earlier episode of epistaxis recorded by ED admitting nurse had been noted in ward handover. Vital Signs- recorded by Nurse A as indicated on paediatric respiratory assessment chart. Temp: 38.2, degrees Celsius Pulse 129, beats per minute Respiratory Rate 38 Oxygen Saturation 95% on 5Litres of oxygen The following blood results were noted in the patient’s admission- HB 10.1G/L Sodium 132 (135-145) Chloride 90 (98-107) CRP 55


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Calcium 1.91 (2.15-2.55) WBC 14.97 N 13.77 MSU Result noted in nursing notes as wbc 10,000, RBC 16,900 per cmm-time noted as nocte. The administration of IV claforan in ED was noted and that the patient was charted for Zithromax. Feedback from the patient’s mother recalls Nurse A being with them on her own taking admission details at the bedside in the third bed in the ward area close to the nurses’ station within clear view of the nurses’ station- another patient was in the room but the curtains were around that bed. Feedback from the patient’s mother reveals that feedback to her from Nurse A was critical in relation to her son’s dietary requirements and pyjamas.-he had been on Neutremagen and Prejestamil and at times of sickness his diet usually reverted to one of back to basics such as having his own bread Sunday 30th September 2012 01.00hrs Patient’s mother went home at this time. There are variations in the account of admission to the ward in relation to the patient’s mother staying. The patient’s mother relates that the reaction to her request to stay was not received favourably by Nurse A and that her tone of reply was not said in a light hearted manner, that the patient was a ‘big boy’ and the patient’s mother relates that she left it up to the patient as to whether she would stay or not. Feedback from the patient’s family relates that the patient’s mother never made a request to stay the night as she assumed that she would be staying. One of the nursing staff did say that she could stay beside her son but this was overridden by nurse A. The patient’s mother relates that she did not say she had to go home but that she could go home to make bread for her son as his diet in hospitals from previous experience was poor-Her older children are adults and there was no need to rush home. The patient’s mother relates that she felt the nurse made her feel she was worrying needlessly and along with the registrar, she was reassured that her son was going to be fine and she would leave it up to her son to decide if she should go home. When the patient’s mother was leaving she stated she made it clear that she was to be rang if there was any change whatsoever in her son’s condition and when she left at 1am her son was sleeping peacefully. The account from the nursing staff on the ward relates that the parent was advised she was welcome to stay in the bed next to the patient overnight as the ward was quiet, but that the patient’s mother related she had to return home and she was advised to ring the ward at any time if she had concerns. The nursing staff recall that the patient’s mother asked the patient if he wanted her to stay but he did not wish her to stay. Entry in nursing notes noted as nocte-no time entered as per 24 hour clock. Entry noted iv infusion in progress, oxygen administration instructions, and details regarding


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investigations. Blood results noted and that first dose of IV Claforan had been administered in ED. During interviews with nursing staff it is noted that they went into the room where the patient was frequently during the night as part of their regular checks on patients and when his IV machine alarmed, and he appeared to be asleep most of the time and he drank water on a number of occasions but these checks were not documented in the nursing notes. 02.00hrs Vital signs chart recorded by Nurse B Vital Signs- Temp:38.5 degrees Celsius .Nurofen administered at this time. Pulse 121 beats per minute Respiratory Rate 38 (depth noted to be shallow) Oxygen Saturation 90% on 8 Litres of Oxygen 03.00hrs recorded by Nurse B Vital Signs- Temp 37.7 degrees Celsius Pulse 109 beats per minute Respiratory Rate 34 Oxygen Saturation 91% on 8 Litres of Oxygen 04.00hrs recorded by Nurse B Vital Signs- Temp degrees Celsius -not recorded Pulse 100 beats per minute Respiratory Rate 40 Oxygen Saturation 90% on 10 litres of Oxygen. Nurse B who remembers recording the vital signs noted in her interview that the patient remained responsive. 05.00hrs SHO contacted in relation to Oxygen Saturation of 88%. Nebuliser ordered. SHO came to the ward and contacted the registrar. 05.15hrs recorded by Nurse A Vital Signs- Temp 36.8 degrees Celsius Pulse 105 beats per minute Respiratory Rate 38 Oxygen Saturation 88% on 10 Litres of Oxygen 05.30hrs Vital Signs- Temp –not recorded Pulse - not recorded Respiratory Rate 40 Oxygen Saturation 58% Entry in nursing notes itemising episode of haemoptysis and small epistaxis while the patient was having Salbutamol (ventolin) nebuliser administered. The episode of haemoptysis progressed to continuous bleeding from the oral cavity.Interviews with staff reveal concerns regarding the patient’s condition were acted upon by Nurse A


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reviewing the patient with Nurse C. Nurse C asked Nurse A to get assistance. Nurse C remained with the patient throughout, maintaining the patient’s airway while waiting for medical assistance. Suction was applied and the patient was coughing intermittently. During this time Nurse C explained all interventions to the patient who was responsive at this stage. Nurse B came to assist Nurse C. At interview it was related that approximately 700mls of blood was suctioned at this time. Nurse A contacted the doctors and the Consultant on call. Episode of oxygen desaturation to 46% recorded. Emergency response crash call initiated and the Anaesthetic registrar and Anaesthetic consultant and night superintendent also attended. Patient coughing up fresh blood and suction applied. Vitamin K 10mgs IV and Zantac (Ranitidine) given IV. Patient was intubated at 06.30 hrs with rapid sequence induction with anaesthetic agents propofol and suxemethonium, and fresh blood continued to appear through the trachea. Suctioning continued through the endotracheal tube. Having been stabilised with difficulty with positive pressure ventilation and 100% oxygen, the patient was transferred to ITU-Blood pressure on intubation 95/37 m Hg. Four units of blood ordered for transfusion at 06.36. The Consultant Paediatrician on interview revealed he was not aware of the patient until contacted by the nurse on the ward. He was staying onsite for his on call duty. Exact time of transfer to ITU-07.00 hrs HB 7.3 PH Venous 7.32 Lactate 5.1 05.41hrs Patient’s mother relates in their written account that they were contacted to inform them of the deterioration in the patient’s condition. She relates that they were told he had a bad turn and she was used to this from when he was an inpatient in the paediatric hospital but he always bounced back-when she arrived on the ward she was not able to touch her son as there were doctors all around him and he had been intubated at that stage-she rang her husband and asked him to bring their eldest son with him. The Consultant spoke to her and advised of the imminent transfer to ITU but she was not let sit near her son. The patient’s mother relates Nurse C accompanied her to ITU and sat with her in the small room adjacent to ITU and she is appreciative of this. Her husband then joined them and he had not seen his son. She stated she did not receive any indication of difficulties encountered in stabilising her son. 07.00hrs Patient transferred to ITU- written account from Consultant Anaesthetist revealed that on admission the patient noted to be very pale, tachycardia persisting and appeared to be shut down peripherally. Nurse C assisted in the transfer of the patient to ITU. Temp 35.4 degrees Celsius Pulse 130 beats per minute Blood pressure 110/45mmHg Oxygen Saturation 88% on 10 Litres of Oxygen 07.05hrs Haematology contacted but blood was not ready. Blood recorded as being administered from 07.15 to 07.25 hrs. 07.15hrs Right brachial line inserted. Patient bleeding from Endotracheal tube. Bronchoscopy attempted on three occasions by the Consultant Anaesthetist but abandoned each time due to low heart rate and low Blood pressure. Another attempt to stop the bleeding was made by the Anaesthetist by an injection of Lidocaine with epinephrine through the


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Endotracheal tube without success. Bleeding persisted from the Endotracheal tube. First and second units of Red Cell concentrates given stat. 07.25hrs 3rd and 4th unit of blood commenced. Cardiac output not obtained-full cardiorespiratory resuscitation initiated with cardiac massage and ionotropic support. The patient’s parents were called in to the Intensive Care Unit by the resuscitation team. INR noted to be great than 10. The written account from the patient’s parents relates that they were advised to go in having asked a nurse without any explanation of what was happening and they found the resuscitation very upsetting to watch. From interview, the patient’s mother reveals they appeared to be in that room for ages, they were not told anything and their oldest son was with them-she went out to ask and a sister told them to come in and there they saw the resuscitation in progress in the single room in ITU-her oldest son nearly collapsed. She felt the Night Superintendent and priest followed them in. After approximately half an hour resuscitation ceased without any communication and the Consultant Paediatrician came over to them and advised that their son had passed 08 00hrs Resuscitation efforts ceased. Time of death noted in notes - The Coroner and Gardai were contacted in accordance with procedures. Pastoral care team were in attendance and said prayers with the patient’s family. Afterwards in the room adjacent to ITU, the Registrar came in, shook hands with them but never sympathised and asked immediately that they complete the form for the post mortem. Both parents related that they found this very cold. The family were appreciative of the care of the ITU staff and the Hospital Chaplain who even accompanied them to the canteen and chapel while their daughter was en route from Dublin -the patient’s mother did not want her to hear the news before she arrived. 01/10/2012 2012 Head of Paediatric department notified of incident. Case conference/ review to take place after receiving result of post mortem Incident form completed as per date on incident form. Serious Adverse Event policy not activated. Feedback from the patient’s mother relates that she believes they would not have received any further contact if they had not sought the advice of the Patient Advocacy association and she also expressed the regret that they did not receive an apology and an admission that something was missed-she related she would admire anyone for doing that as she doesn’t ‘want to get mad at anyone. They want honesty’. She also related that they have sought counselling services for their family but indicated that the absence of a website for Kerry General Hospital with such information and other general information was not helpful. Feedback from the patient’s mother indicates that the PFA result was not evident in the copy of the notes they have-from the records the PFA is noted as not being reported until 18.23 hrs on 17/10/12 the evening before the meeting with the patient’s mother.


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02/10/2012 Incident form signed off by Divisional Nurse Manager for Paediatrics and forwarded to a clerical officer to be sent to the office of the Risk Manager. 18/10/2012 Entry in medical notes denotes that a meeting took place at 15.00hrs between the Consultant Paediatrician and the mother of the late patient who was accompanied by a friend to discuss the case in detail and explain the sequence of events. Autopsy report was not available that day and the family were told verbally the likely cause of death. The family were offered another meeting at any time in order to answer any questions. Hospital management were not aware of this meeting. Feedback from the patient’s mother relates that there were variations in the account from the Consultant and the medical notes- she was advised that her son had been nebulised several times that night yet she noted from the notes he was nebulised once at 5am. She also asked him how her son was at 5am when he was called as there was no documentation in the nursing notes to relate how her son was in the immediate time before intubation and this was difficult for her to hear. She was also informed of the case conference. The Consultant did offer to meet her again as they never actually got through the entire meeting as she found it too difficult. The patient’s mother also indicated that after her son’s surgery as a baby that she was not advised of potential complications and would like to see this feedback highlighted. /11/2012 Case conference into case conducted by paediatric team and one of the nursing staff involved and this was regarded as a review of case. This was not communicated to senior management. 29/11/2012 Incident form received by Risk Manager who questioned requirement for review with Divisional Nurse Manager. It was decided that a review would be conducted. Incident forms at that time were sent to a secretary prior to sending to Risk Management office contributing to a delay in notification and follow up. The Risk Manager discussed requirement for review with the Divisional Nurse Manager. It was decided that a review would be conducted. 07/01/2013 Verbal Communication between Risk Manager and Divisional Nurse Manager for the area to arrange that review.


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04/02/2013 Risk Manager received communication from Regional Quality and Risk Office in Cork to elicit if the incident requires escalation to NIMT following communication from the patients’ representative association representing the family. 06/02/2013 Internal review conducted into the serious adverse event by Risk Manager, Divisional Nurse Manager and Head of Paediatric Department. This revealed that the Medical and Nursing teams felt the incident had been reviewed in the context of the case conference and this is why it had not been pursued actively with the Risk Manager. Serious Adverse Event policy activated and incident escalated to NIMT for their attention, support and oversight in conjunction with the support of the Regional Manager for Quality and Risk for HSE South. Aftermath of Incident Immediately following this patient’s tragic and untimely death those caring for him offered their sympathies and condolences to the patient’s family. Feedback from the patient’s family was that the only staff who offered their sympathies and condolences were the youngest nurse from the paediatric ward and a member of the ITU staff who had come on duty after their son had passed away. When the registrar approached them he concentrated on filling up the form for the post mortem-the family thought he was coming to sympathise with them and they perceived his demeanour to be cold towards them. The Coroner was advised of the case by the Registrar in paediatrics and the gardai attended as specified in these guidelines in relation to referral to coroner. The following day the ward sister of the paediatric unit communicated with the nursing staff involved. All staff were made aware of the facility of additional supports such as the Employee Assistance programme and the process of self referral. The paediatric teams subsequently held a case conference/review of the case whereby they elicited recommendations on management of sepsis. The patient’s mother was met by the consultant having requested this meeting on 18/10/12 but the scheduling of this meeting was not disclosed to senior management as this would have afforded senior management an opportunity to offer condolences to the relatives, offer them any support required and communicate with them regarding an investigation into the care pathway for their son. Feedback from the patient’s family in relation to this meeting was that there were discrepancies between what he was telling them and what was in the medical notes when they read them at home-The Consultant informed them that the case conference had already been held. They also note the communication sent to the family GP from the Consultant dated 23/11/12 giving brief details of what had happened but there are discrepancies between the letter and the medical notes. The Serious Adverse Event Policy for the area does not appear to have been operationalised in a timely manner.


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Key Causal Factors, Contributory Factors, Incidental Factors and Linked Recommendations The aim of this investigation was to establish the circumstances regarding the unexpected death of a male patient originally admitted to the paediatric ward. Key Causal Factors Key causal factors are defined by the HSE Guidelines for Systems Analysis Investigation of Incidents and Complaints (HSE, November 2012)3

as issues that arise during the process of delivering and managing health services that are considered by the investigation team to have had an effect on the eventual adverse outcome.

Actions or omissions in the process of care where the care deviated beyond the safe limits of practice and where this deviation had a direct or indirect effect on the eventual adverse outcome for the patient. Examples of Key casual Factors are failure to monitor, observe or act, incorrect decision or action, not seeking help when necessary, failure to note faulty equipment, not following an agreed protocol) Following an analysis of the chronology, this investigation identified the following four key causal factors and two incidental finding. Key Causal Factor 1: Failure to recognise the deteriorating paediatric patient. Key Causal Factor 2: Failure in Communication processes: Key Causal Factor 2 (a): -Failure to achieve the necessary level of professional communication and disclosure of information prevented a more in depth formulation of the patient’s care plan. Key Causal Factor 2 (b): - Lack of documented process to govern handover of patient care. Key Causal Factor 3: Failure to identify and report a serious incident according to local and national policy. Key Causal Factor 4: Deviation from Documentation Policy. Key Incidental Finding 1: Deviation from End of Life Care Guidance Key Incidental Finding 2: Feedback to Regional Office of Quality and Patient Safety on advice on potential post operative complications from surgery for Hirschsprung’s Disease.

3 HSE Guidelines of “Systems Analysis Investigation of Incidents and Complaints” (HSE, November 2012 can be downloaded at http://www.hse.ie/eng/about/Who/qualityandpatientsafety/Quality_and_Patient_Safety_Documents/QPSDGL5211.pdf


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Each Key Causal Factor was analysed by the Review Team in order to identify the Contributory Factors. Contributory Factors are considered to be hazards and potential causes of future harm, if not mitigated (through appropriate recommendations being put in place). The list of Contributory Factors outlined within the Contributory Factors Framework used to analyse the Key Causal Factors in this investigation is included under Appendix C of this report. The following sections of the report analyse the Key Causal Factors specified above and the Contributory Factors identified for each. Key Causal Factor 1: Key Causal Factor 1: Failure to recognise the deteriorating paediatric patient. Contributory Factors to KCF 1 1.Task Factors e.g. Task Design, Availability and use of protocols, availability and accuracy of test results. The review team established while an early warning score system for adult patients was in operation in the hospital including the ED which serves to guide staff as a trigger system regarding recognition of the deteriorating patient and signs of impending sepsis, there is no such system nationally for paediatric patients. In view of the immediate recognition of the patient’s serious condition the triage nurse in ED contacted the paediatric team quickly and the patient was transferred to the paediatric ward as quickly as possible. Nursing staff in the ED were referring to and were knowledgeable of a paediatric triage and risk rating score on the wall in the paediatric room. Recommendation 1: Implementation of a paediatric early warning score and audit of compliance with this score as a trigger method to identify the deteriorating paediatric patient A separate sepsis protocol also has to be developed to support this guideline. The review team is aware of developments nationally to expedite a separate protocol for Sepsis which is being undertaken by the National Clinical Effectiveness committee. 2 Team Factors e.g. supervision and seeking help, written and verbal communication, team structures. The patient’s results revealed an increased serum lactate and CRP and the Consultant on call for paediatrics was not contacted about these results for advice as these clinical signs can be indicative of sepsis. In view of the patient’s past medical history of Hirschsprung’s disease, while the SHO sought advice from the Registrar, there does not appear to have been attempts to obtain Consultant advice on the result of the abdominal


25

x-ray which revealed distended bowels to rule out the possibility of colitis. This patient had no recent history of diarrhoea, vomiting or constipation. From 2am the oxygen saturations decreased and there were three missed opportunities to alert the paediatric SHO and Registrar to these parameters. The blood pressure was not recorded and there does not appear to be evidence of a documented intake and output chart to monitor fluid balance on the paediatric ward. In addition the results of the mid stream specimen of urine do not appear to have been communicated to the medical team. Key Causal Factor 2: Failure in communication processes. Key Causal Factor 2(a): -Failure to achieve the necessary level of professional communication and disclosure of information prevented a more in depth formulation of the patient’s care plan. Key Causal Factor 2(b): - Lack of documented process to govern handover of patient care . 1 Individual Factors e.g. knowledge, competence, skill, competence, physical

and mental health

The patient had a significant past history, as he had surgery for Hirschsprung’s disease as a baby and was relevant to his acute presentation. While the SHO had made an effort to elicit and document the past medical history without access to the old notes, and asked for advice from the Registrar, subsequent consideration of the patient’s past history was not taken into account in decision making on review of the x-rays where the abdominal x-ray revealed distended bowels.

Recommendations ; Due consideration be given to a patient’s past medical history with regard to the potential complications of this condition post surgery. 2 Task Factors e.g. Task Design, Availability and use of protocols, availability and accuracy of test results

The radiology report of 29/09/12 23.31hrs identifying a single dilated loop of bowel in the right upper quadrant does not appear to have been reviewed to exclude the possibility of colitis and advice on follow up of this result does not appear to have been sought from the Registrar from relevant Consultant staff.

3 Individual Staff Factors: Knowledge and Skills The staff nurse who transferred the patient to the paediatric ward that night was not caring for him in the Emergency Department-she was allocated to the majors area including paediatrics from his admission to the ED and recounted that her time with him was limited, in that she met him and his mother shortly after the x-ray procedures. While this staff nurse was working in the ED that evening, she is not rostered there continuously and is sent on relief duty throughout the rest of the hospital. During interview with this staff nurse, it became apparent that prior to transferring the patient she read the medical notes to ascertain the information required for patient handover. It


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does not appear that the patient’s nosebleed earlier on was communicated to ward staff in the paediatric ward. Feedback from the patient’s mother was that this was not a significant nosebleed and had happened some time prior to admission. In addition, the ED department was very busy that night with a staff member gone on escort, and the staff complement depleted. This staff member though relatively junior and not rostered full time to the department, was the allocated paediatric nurse and her primary responsibility was paediatrics and majors secondary. With a very busy department that night and not being present throughout the initial treatment she was not fully aware of the child’s condition when requested to transfer him. The information transmitted verbally to the ward when the bed was requested from ED regarding diagnosis was based on the initial diagnosis (pneumonia) on the ED patient attendees list at time of arrival and not on the differential diagnosis at time of transfer to the ward. When the patient was reviewed in ED, he was unable to provide a urine specimen, the SHO did discuss the requirement for insertion of a urinary catheter with the Registrar but the conclusion was reached that at that particular time, this procedure was too invasive and the plan was for a ward urinalysis and a urine sample being sent for culture and sensitivity urgently. The decision was taken to prescribe a broad spectrum antibiotic pending the result of this urine specimen and the staff of the paediatric ward were made aware of the importance of this urine sample. The admission notes reflect a provisional diagnosis of either Pneumonia or a Urinary Tract Infection. In the process of transfer to the paediatric ward, it appears that the actual handover took place with a nurse who was not actively looking after the patient- from staff interviews, designated patient allocation on night duty was unclear and did not appear to aid the transfer of information. One nurse took the handover at the desk, another admitted him at the bedside. Recommendation 2 Standardised criteria for handover as per the SBAR 7 framework would provide consistency in handover processes (HSE Acute Medicine programme, 2013). 4 Team Factors e.g. supervision and seeking help, written and verbal communication, team structures. The Registrar having reviewed the patient following a request by the SHO who was concerned for the patient’s condition, decided not to seek the opinion of the on call consultant who was in close proximity on site. Recommendation 1. Adherence to criteria for escalation as specified in early warning score criteria, which would enhance communication processes in a timely and accurate manner against specified recognised criteria. 5 Work Environment Factors e.g. staffing levels and skill mix, workload and shift patterns, availability and maintenance of equipment The Emergency Department was very busy that night, and whilst the patient was transferred speedily to the paediatric unit, the nursing complement of the ED Department was reduced due to one nurse having to accompany a patient on a transfer to a regional specialist centre. The shift leader recalls the referral to the paediatric team but due to the busy nature of the department that particular night, does recall the paediatric team at the patient’s bedside but does not recall specific interaction with the patient. The SHO did remain with the patient while awaiting the registrar. There are


27

no paediatrically trained nurses placed in ED. Full time presence by the nurse allocated to the paediatric bay that night was not possible. At the time of decision to transfer to the ward, the nurse was in the Majors area dealing with other patients while the patient was in x-ray. The porters contacted the ED department to communicate that the x-rays had been completed and that they would meet the nurse at the lift lobby to transfer the patient to the paediatric ward. In addition, the registrar was completing the end of a 48 hours continuous duty roster. At that time period in the hospital, patients of 16 years were deemed appropriate for the care of the paediatric teams whereas in larger facilities the national guidelines set out 16 years of age as the age cut off. Recommendation 4- The Paediatric service must review its admission criteria under the care of the paediatric medical team to the paediatric ward. 6 Organisational/Management Factors e.g. organisational structure and policies, financial resources and constraints, safety culture and priorities. While communication with the patient’s relatives did occur after the serious adverse event, between the Consultant and the patient’s mother at her request, this process is not in keeping with the organisational process whereby the relatives are offered the opportunity to meet Hospital management and the Hospital manager afforded the opportunity to meet with the relatives and offer condolences, and advise of the processes of review to take place after such incidents while also ascertaining support structures for the bereaved family on their loss. Key Causal Factor 3: Failure to identify and report a serious incident according to local and national policy. 1.Task Factors e.g. Task Design, Availability and use of protocols, availability and accuracy of test results. It was noted that the policy on Serious Adverse Event Management had been distributed in July 2012 and was available in clinical areas and on the staff internal electronic library database. However the specifics and timelines in relation to notification of the incident articulated in this policy were not adhered to in relation to this serious adverse event, even though the case conference held by the Paediatric department following the death of the patient did attempt to identify corrective measures for the service in relation to the management of sepsis. The implementation of the Serious Adverse Event policy in a timely manner, would have provided the organisation with an opportunity to sympathise and communicate with the family of the deceased in a timely manner to sympathise and offer support, and to keep them informed of the investigation process into such a serious adverse event. Recommendation 3 : The service must audit the operationalisation of the Serious Adverse Event policy in conjunction with the HSE South Escalation procedure and make any amendments required.


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Key Causal Factor4: Deviation from Documentation Policy 1.Task Factors e.g. Task Design, Availability and use of protocols, availability and accuracy of test results The review team established that while the organisation has a developed multidisciplinary documentation policy which is evidence based and in line with best practice guidance, it was not adhered to in this instance. In relation to nursing entries, the use of the word nocte was used and it was difficult to ascertain definitive timelines in relation to the patient’s care on the paediatric ward and signature databases were not completed. The nursing notes do not reveal contemporaneous entries to denote the actual condition of the patient particularly in the time preceding his deterioration. The review team is mindful of the feedback from the parents of the patient in relation to this where, from reading the documentation, they are not aware of their son’s condition immediately prior to his deterioration and this has added to their grief as they were not able to speak or touch their son having been called in. The feedback from the family is that clinicians documenting care should write their notes so that anyone can read them so that it is clear to elicit specific instructions being acted upon as such documentation is required of professionals as part of their roles. Recommendation 5: Regular pattern of audit of documentation in accordance with local and national policies with proof of recommendations being implemented. Incidental Findings Key Incidental Finding 1: Deviation from End of Life Care Guidance While the organisation has previously issued End of Life care guidance to all staff disciplines, this guidance is to be re-iterated to all locum medical staff and NCHD staff particularly in relation to communication with families and the provision of advice regarding bereavement services. Key Incidental Finding 2: Post Operative Complications The review team identified valuable feedback from the family in relation to advice from the national paediatric hospitals in relation to potential post operative complications from surgery for Hirschsprung’s condition and this feedback will be progressed through the regional office of Quality and Patient Safety. Recommendations to address further incidental findings: End of Life care guidance to be issued to all staff Feedback to Regional Office of Quality and Patient Safety regarding examination of advice to parents on potential post operative complications from surgery for Hirschsprungs.


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References: An Bord Altranais (November, 2002) Recording Clinical Practice Guidance to Midwives and Nurses National Hospitals Office Code of practice for Healthcare Records Management (2007) Abbreviations Health Service Executive (2012) Guideline for Systems Analysis investigation of Incidents and Complaints. Health Service Executive (May 2011) HSE Standards and Recommended Practices for Healthcare Records Management V3.0 Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock (2008). Revised 2011. 3rd Edition Crit Care Med 2013 ; 41:580-637. (http://www.survivingsepsis.org/) Toolkit of documentation to support incident management http://hsenet.hse.ie/HSE Central/Office of the CEO/Quality and Risk/Documents /OQR008 HSE Toolkit of documentation to support incident management1. Local Policies Kerry Area Serious Adverse Event Policy

KGH Antimicrobial Guidelines KGH Medication framework KGH MEWS Policy KGH Documentation guidelines KGH Interhospital transfer guidelines

http://hsenet.hse.ie/HSE�


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Appendix A: Terms of Reference Terms of Reference

Final Terms of Reference Kerry Area Log No: 50325

Introduction These are the terms of reference for the investigation commissioned by Mr. Michael Fitzgerald, Area Manager, HSE Kerry Area into the care received by patient x in Kerry General Hospital between the 29

th September 2012 to the 30

th September 2012

inclusive. 1. Purpose of the review The purpose of the review is to: To establish precisely the factual circumstances leading up to the incident. Identify any key causal factors that might have occurred. Identify any contributory factors that caused the key causal factors to include the recognition and management of sepsis as outlined in local policy and guidance documents. Recommend actions that will address the contributory factors so that the risk of future harm arising from these factors is eliminated or if this is impossible, is reduced as is reasonably practicable. To identify reasons why the incident was not notified as a serious incident in a timely manner according to National HSE Policy. To seek a report from SouthDoc with regard to patient’s clinical management and care on presentation to its services on 27

th September 2012.

2. Scope of the review The timeframe of this review will be from patient’s admission date on 29/09/2012 to 30/09/2012 inclusive. 3. Review Team Mr. Richard Walsh, Director of Nursing Kerry General Hospital Dr Rizwan Khan Consultant Paediatrician Kerry General Hospital Dr Martin Boyd Consultant in ED Kerry General Hospital Chairperson Helena Butler Risk Manager Kerry Area External Consultant Paediatrician (being requested at present) 4. Review method The investigation will follow the HSE Investigation Procedure and will be cognisant of the rights of all involved to privacy and confidentiality; dignity and respect; due process; and natural and constitutional justice.


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In compliance with HSE policy, a systems analysis methodology will be used in undertaking this incident review (Guidance for System Analysis Investigation of incidents and Complaints 2012). Interviews with the relevant staff will be carried out and a review of the medical records, diagnostic & electronic patient records will be undertaken. All who participated in the investigation will have an opportunity to give input to the extracts from the report relevant to them to ensure that they are factually accurate and fair from their perspective. The investigation will commence on 04/03/2013 and will be expected to last until 01/07/2013 provided unforeseen circumstances do not arise. 5. Report Following completion of the review an anonymised report will be prepared by the review team outlining the findings and identifying any actions required to remove or reduce as far as is reasonably practicable, the risk(s) identified by this review. The SouthDoc Service will provide a detailed report on the management and care of Patient x at Southdoc on the 27

th September 2012. This report will be attached to the

final review of this case. The final report will be shared with the family if this is in line with the family’s wishes. The anonymised report may be published and may be subject to a freedom of information request. 6. Recommendations and implementation The report when finalised will be presented to the commissioner of the review, Mr. Michael Fitzgerald, Area Manager, HSE Kerry Area. Local management will be assigned responsibility for the implementation of the review recommendations. Action plans will be developed by local management to support the implementation of the recommendations. These action plans will assign responsibility to a designated person and will include target dates for completion. Action plans will be monitored regularly to ensure that the recommendations made are fully implemented. The implementation of the recommendations (risk reduction/quality improvement strategies), presented in order of priority, will be undertaken by local managers who will oversee the implementation of the review recommendations. Action plans will be developed to support the implementation of the recommendations and these will be monitored regularly to ensure that the recommendations made are fully implemented by assigning responsibility to a designated person. with clearly identifiable dates for progress review as per the action plan template identified in the HSE Toolkit of Documentation in relation to incident management (2009). 8. Communication Strategy for the Investigation Mr. TJ O’Connor, General Manager of Kerry General Hospital will be appointed for the purpose of communicating information pertaining to the investigation to the family if this is in accordance with the wishes of the family. 9. Reference: HSE 2012 Guideline for Systems Analysis Investigation of Incidents and Complaints


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Appendix B: Sources of Information Reviewed Medical and Nursing Notes from ED and Paediatric Ward Observation charts Blood results-haematology, microbiology and biochemistry. Radiology reports. ECG recordings ITU Admission notes and continuation sheets. Incident report form. Incident escalation form. Medication prescription sheets Nursing rosters. Written accounts from family and Consultant Anaesthetist

Appendix C: Framework of Contributory Factors Table 1: Framework of Contributory Factors

Factor Types Contributory Factor Individual affected/harmed Condition (complexity & seriousness)

Language and communication Personality and social factors Psychological, existing mental health condition, Stress

Task and Technology Factors Task design and clarity of structure Availability and use of protocols, policies, standards Policies etc. relevant, unambiguous, correct and realistic Availability and accuracy of test results Decision-making aids

Individual (Staff) Factors Knowledge and skills Competence – education, training, supervision Physical, psychological and mental health illness.

Team Factors Verbal communication Written communication Supervision and seeking help Team structure (leadership, congruence, consistency etc.)

Work Environmental Factors Staffing levels and skills mix Workload and shift patterns Administrative and managerial support Environment - Physical and cognitive. Design, availability and maintenance of equipment

Organisational & Management Factors

Organisational structure Financial resources and constraints Policy, standards and goals Quality & Safety culture and priorities

Institutional Context Factors Economic and regulatory context National health service executive Links with external organisations


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Appendix D: Hierarchy of Hazard Controls Table 2: Hierarchy of Hazard Controls to support the development of recommendations Strength of control

Category of control

Comments/Examples

Strongest control

Weakest control

Elimination The work process or task is redesigned so as to remove the hazard/contributory factor. However, the alternative method should not lead to a less acceptable or less effective process e.g. stop providing service; discontinue a particular procedure; discontinue use of a particular product or service, e.g. stop using a particular type of equipment. If hazard elimination is not successful or practical, the next control measure is Substitution.

Substitution Replacing the material or process with a less harmful one. Re-engineer a process to reduce potential for ‘human error’. If no suitable practical replacement is available the next control measure is engineering controls.

Engineering controls

Installing or using additional equipment. Introduce ‘hard’ engineering controls, e.g. installation of handling devices for moving and handling people and objects, e.g. Re-engineer equipment so that it is impossible to make errors. If no suitable engineering control is available the next control measure is administrative procedures.

Administrative procedures

Ensure that administrative policies, procedures and guidelines are in place. Ensure staff are appropriately trained in these. Monitor compliance with policies, procedures and guidance through audit. If no administrative procedure is available the next control measure is work practice controls.

Work Practice Controls

This is the last control measure to be considered. Change the behaviour of staff, e.g. make staff wear personal protective equipment, etc. Work Practice Controls should only be considered after all the previous measures have been considered and found to be impractical or unsuccessful.


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Appendix E Management Plan

ISA________HSE South Kerry_______________________ Date of Incident___30/09/12___________________ ISA Manager___Mr Fitzgerald____________________ Date Notified to RDO Q&R___04/02/2013__________ Location of Incident___Kerry General Hospital__________________ Monitoring Log No.______50325______________

No. Recommendation Specific Tasks to meet Recommendation

Responsible Person

Due Date for completion

On Target (OT) OR Late (L)

Reason if Late

1 Implementation of Paediatric Early Warning Score and sepsis protocol

Paediatric Clinical Governance Committee

October 2014 Guidance received from HIQA

2 Improvements to Communication structures

Handover policy Inter-ward handover guidelines and

Clinical Director DON CGC

September 2014


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checklist using an established and recognised handover tool

3 Serious Adverse Event Policy Management

CGC Completed

4 Admission Criteria to Paediatric Ward

Paediatric Governance Committee

Completed

5 Documentation All Staff PDT

Immediately

6 End of Life Care Guidance to be redistributed to all staff

CGC Nov 2014

7 Feedback to Regional Office of Quality and Patient Safety regarding guidance issued to parents of children post surgery for Hirschsprungs Disease and potential complications post operatively

Risk Manager

Immediately

8 Hospital Website development including guidance for those relatives who have been bereaved

CGC In progress


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Appendix F QUALIFICATIONS AND EXPERIENCE OF THE EXTERNAL REVIEWER Professor Alf Nicholson is RCSI Professor of Paediatrics at the Children’s University Hospital , Temple Street , Dublin 1 and a general paediatrician with over 20 years experience at consultant level . Training in Paediatrics was undertaken in Dublin , Manchester and Melbourne where Professor Nicholson was Fellow in general and ambulatory paediatrics for a large tertiary paediatric hospital with on-call commitment for child protection at consultant level . Professor Nicholson is an executive member of the European Academy of Paediatrics and co-directs the national training programme for paediatric trainees. His main research interest is in injury prevention in children . Professor Nicholson has over 50 publications and many national and international presentations . For the past 2 years, Professor Nicholson has been working 0.5 WTE as the National Lead in Paediatrics Appendix G: HIQA Communication in relation to Paediatric Early Warning Score