Sentinel Events Root Cause Analysis PDF

## Ministry of Health ### Administrative Policy and Procedure #### QPS-002-APP V2 - Reporting, Investigating Sentinel Events and Action Plan - Jun 24, 2021 #### 1. Statement of Purpose - To establish a system and processes for the management of sentinel events identification, reporting, investigat...

## Ministry of Health ### Administrative Policy and Procedure #### QPS-002-APP V2 - Reporting, Investigating Sentinel Events and Action Plan - Jun 24, 2021 #### 1. Statement of Purpose - To establish a system and processes for the management of sentinel events identification, reporting, investigation and corrective action plan and ensure adherence to these processes for the purpose of improving healthcare and patient safety with maintain just culture. - Ensure effective analysis (RCA) for all sentinel events and improvement of the processes to prevent reoccurrence. #### 2. Applicability - This policy applied to all healthcare facilities and staff regulated by Ministry of Health (MOH). #### 3. Definitions/Abbreviations - **Sentinel Event:** A patient safety issue that is not primarily related to the natural course of the patient's illness or underlying condition of a patient that reached the patient and resulted in death, permanent or severe temporary harm. - **Event Occurrence Date:** the date of the event happened. - **Internal Notification Date:** The date when the event notified inside the facility. - **Severe Temporary Harm:** refers to a critical, potentially life-threatening harm lasting for a limited time (less than 4 months) with no permanent residual but requires transfer to a higher level of care/monitoring for a prolonged period of time (four to six months), transfer to a higher level of care for a life-threatening condition, or additional major surgery, procedure, or treatment to resolve the condition. - **Healthcare facilities:** The facility that provide health care which include hospital, PHCs, dental care centers, and specialized care centers. - **Healthcare facilities premises:** refer to all property utilized by the facility, offices, housing, parking lots, warehouse and any other areas under the jurisdiction of the healthcare facility. - **Invasive procedure:** An invasive procedure is one where purposeful/deliberate access to the body is gained via an incision, percutaneous puncture, where instrumentation is used in addition to the puncture needle, or instrumentation via a natural orifice. It begins when entry to the body is gained and healthcare professionals perform ends when the instrument is removed, and/or the skin is closed. - **Measures of Effectiveness:** It is a measurement data to quantify the recommended action plan and the staff comply with recommended changes and if the changes made a difference. - **Newborn:** a newborn is from birth to 28 days. - **Infant:** A young baby, from 29 days to 12 months of age. - **Child:** Any person from 1 year till 14 years. - **Root cause analysis (RCA):** is a structured retrospective analysis of an event or situation that aims to identify its true causes and the actions needed to eliminate them, using a wide range of approaches, tools and techniques to uncover causes. - **Action Plan:** The product of the root cause analysis is an action plan that identifies the strategies that the organization intends to implement in order to reduce the risk of similar events occurring in the future. - **RCA team:** A multidisciplinary team consists of representation from departments such as but not limited to the following: quality, risk management, medical, nursing, & others as deemed necessary. - **Most Responsible Physician (MRP):** refers to the physician who has overall responsibility for the care and management of an individual patient during the patient's hospital stay. - **Safety Event Report (SER) /Occurrence Variance Report (OVR):** refers to any undesired incidents that may affect patients, employees, family members, visitors, facility, equipment, or property, which is not consistent with standard operations of care. These incidents may cause actual injury/damage or have the potential to cause injury, loss of function, or death. - **MOH:** Ministry of Health. - **RHD:** Regional Health Directorate. - **SE:** Sentinel Event. - **RCA:** Root Cause Analysis. - **CAP:** Corrective Action Plan. - **OVR:** Occurrence Variance Report. #### 4. Policy - Sentinel events shall be reported and managed with just culture for the purpose of continuous learning and improvement. - All Health care facilities should develop Sentinel events policy aligned with this sentinel events policy. - All Sentinel Events shall be reported within 48 hours after discovery to the MOH sentinel event portal as per facility approved policy and Minister Memorandum. - The defined sentinel events categories are the minimum categories. Health care facility can define more categories as needed per their approved policy. - The Sentinel events could be identified during providing service or during review the following but not limited to: - Safety Reporting System / Occurrence Variance Report (OVR) - Patient safety complains - Mortality and morbidity reviews - Departmental morning meeting - Social media - Direct request by high authority. - If the General Directorate of Quality and Patient safety (GD-QPS) capture sentinel event from any sources, the GD-QPS will send an email to related facility to report the event on the MOH portal. The related facility should response to the email within 24h working hours from submitted email. If the facility did not respond to the first email, the GD-QPS will activate the escalation mechanism. - The health care facility general director should be notified within 24 hours from discovery of the event. - The health care facility general director or his/her designee activate RCA review committee - The RCA review committee consists of four to six people from a mix of different professionals as per the nature of sentinel event's needs. - The RCA review committee should not include individual involved in the event. - The RCA review committee has the right to interviews individuals at all level of the organization who were involved in the sentinel event or have knowledge of the issues and processes involved in the event. - At least one member of the team has an experience in the RCA work flow process and is knowledgeable in conducting RCA. - The RCA team has the right to seek subject matter expert opinion outside facility with support of the facility general director. - If the sentinel event outcome was patient death: - The medical record file of the patient who had the sentinel event shall be secured with controlled access to avoid modification in documentation or documenting post event. - The RCA review committee shall be granted access to patient medical record file all documentation related to patient care. - If the sentinel event outcome was not patient death such as lose of organ or limb: - The patient medical record file for the episode where the sentinel event occurred copy and secured with controlled access and the original released for continuity of the patient care to avoid modification in documentation or documenting post event. - The RCA review committee shall be granted access to the copy of the patient file and all documentation related to patient care. - The health care facility shall ensure controlled and secured access to the devices involved in sentinel event and retrieve data record for the episode of patient care. - The RCA committee start to gather the information from all possible sources and not limited to: - Patient file (paper and electronic) - Other documentations such as, inspection report, letters or patient statement - Forms related to the event - Site observation - Interview, physical evidence or pictures. - Gathered information will be organized in a chronological order using one of the following tools: - Narrative chronology - Time Person Grid - Flow chart - Information matrix. - The QPS in the RHD/Cluster shall ensure the quality and appropriateness of Sentinel events Root Cause Analysis (RCA) and the corrective action plan before the final submission to MOH. - The approved Sentinel events Root Cause Analysis (RCA) and the corrective action plan shall be submitted within thirty (30) working days from discovery of event to MOH sentinel Portal. - The RCA focuses primarily on systems and processes review. The review must identify potential improvements that would eliminate or decrease the likelihood of the sentinel events reoccurrence in the future. - Quality and Patient Safety Department in the facility in coordination with the related department shall developed the measures to monitor the effectiveness of corrective action plan. - Quality and Patient Safety Department in the facility monitors the submitted actions status and the measures of effectiveness for the corrective action plan, which was created by responsible department. - The health care facility general director ensures implementation of the corrective action plan and communicate the support as needed. - The MOH specialty lead review the RCAs as a subject matter expert for appropriateness review for the recommendation and corrective action plan. - In the clustered regions, if the sentinel event involves two or more MOH facilities within the same cluster: - The sentinel events involve two or more MOH facilities within the cluster, the quality and patient safety in the cluster shall facilitate the RCA review and the team formation. - The sentinel events involve two or more MOH facilities and private sector within the same region the quality and patient safety in the RHD shall facilitate the RCA review and the team formation. - In the un-clustered regions, if the sentinel event involves two or more facilities within the same region: - The sentinel events involve two or more facilities MOH or Private sectors within the same region, the quality and patient safety in the RHD shall facilitate the RCA review and the team formation in coordination with relevant sector directorate. - The sentinel event involves two or more facilities in two different regions (Cluster, RHD, Other Governmental sectors and Private sectors), the GD-QPS shall facilitate the RCA and team formation in coordination with relevant deputyship in MOH. - The healthcare facility reporting a sentinel event must take all precautions to ensure confidentiality and security of the reported event. - The Quality and Patient Safety departments in the facility disseminate lessons learned and produce Alert. - The Quality and Patient Safety at the RHD/Clusters disseminate lessons learned between the facilities within the region/Cluster and produce Alert. - The General Directorate of Quality and Patient Safety in MOH disseminate lessons learned among all the regions/Clusters and produce Alert on regular bases. Report of lessons will disseminate to the General Directorate of Hospitals Affaires on Quarter Bases. - The disclosure of sentinel events to the patients or their families shall be conducted by understandable language as per the MOH disclosure policy. - The initial disclosure shall be conducted immediately upon discovering the incident by the attending team. - The final disclosure shall be provided to the patient upon the completeness the RCA by treating team with coordination with hospital leadership. - The health care facility should provide the needed support to the staff involved in the sentinel event such as but not limited to a legal or psychological support as per the second victim program. - The quality and patient safety in RHD/Cluster ensure providing training as needed to the staff in the health care facilities. #### 5. Procedure Flowchart - [Description of flow chart] #### 6. Performance Measurement - Measuring of Complying with 48 hours reporting time to MOH Portal. - Measuring of Complying with 30 working days of submitting time to approved MOH channel. - Percentage of sentinel event reported outside the portal. - Percentage of strong action post patient safety event from social media. - Patient perception about patient safety. - Percentage of closing recommendation from RCA. - Quality of RCA. ##### 7. Related References: - JCI 7th edition hospital standards January 2021. - СВАНІ 3rd edition Standards 2016. - Guideline for Neonatal Care, Saudi Ministry of Health. - Child protection law, Bureau of Expert at the Council of Ministries, 26/12/2014. - Munetz MR, Lidz CW, Meisel A. Informed consent and incompetent medical patients. J Fam Pract. 1985 Mar;20(3):273-9. PMID: 3156207. - International Labour Office ILO International Council of Nurses ICN, World Health Organization WHO. - Public Services International PSI, Joint program on Workplace Violence in the Health Sector, Geneva, 2002 ##### 8. Attachments: - Appendix – 1 Electronic Report Form and Root Cusses Analysis Electronic Form - Appendix – 2 Minister Memorandum - Appendix – 3 MOH sentinel events categories - Appendix - 4 Escalation Mechanism ##### 9. Responsibilities - General Directorate of Quality and Patient safety ensure monitor and support the implementation of the sentinel event policy by healthcare facilities regulated by Ministry of Health (MOH). - General Director in the RHD/Chief Executive Officer (CEO) in Cluster ensure monitor and support the implementation of the sentinel event policy by healthcare facilities within RHD/Cluster. - general director of health care facility ensure monitor and support the implementation of the sentinel event policy by healthcare facility. ##### Development Team - Dr. Areej Abudan - Head of Patient Safety in General Directorate of Quality and Patient Safety - Mr. Abdullah Al Zahrani - Director of Risk Management and Patient Safety Department - Mr. Assad Khalil - Director Clinical Risk Management Eastern Health Cluster - Mr.Ayed Al Reshidi - Vice President for Quality and Clinical Excellence at Qassim Health Cluster ##### Reviews - Ms. Mona Al Sarawi - GD of General Directorate of Quality and Patient Safety - Dr. Ahmed Gashgari - GD of General Directorate of Hospital Affairs - Mr. Abdullah Al Soheimi - GD of General Administration of Specialised Center Affairs ##### Approvals - Dr. Faisal Dahmashi - Assistant Deputy Minister for Hospital Services - Eng. Khalid Saud Altala - Assistant Deputy Minister for Planning and Organization Excellence - **Appendix 1 - Electronic Report Form and Root Cusses Analysis Electronic Form** [The document specifies a table to list events and follow a series of questions relating to each event] - **Appendix 2 - Cause and Effect Analysis Investigation Form** [The document specifies a table to list causes, with yes/no questions about the cause and if correction would limit reoccurrence. The table also has a column to mark root cause or contributing factor] - **Appendix 3 - Action Hierarchy** [The document specifies a table to list strength of actions (Strong, Intermediate, Weak) and provide examples of each strength category] - **Appendix 4: Sentinel Event Categories** [The document includes this list of sentinel event categories and a description of each category. This is not a full description of each event but simply a listing of criteria]. - Abduction of any patient (Newborn/Infant/Child/Adult) receiving care within a healthcare facility - Discharge or handing of a newborn or an infant to the wrong family - Discharge of a Minor or Incapacitated Patient to an unauthorized person - Suicide, attempted suicide, or self-harm (Para suicide) of any patient in a healthcare setting or within 72 hours of discharge - Staff Suicide, attempted suicide, or self-harm that results in severe temporary harm, permanent harm, or death - Invasive diagnostic or therapeutic procedure or surgery, on the wrong patient, wrong site or side, wrong implant. - Fertilizing wrong sperm to wrong ovum, or implant wrong embryo to wrong mother, or unexpected damage to embryos, sperm, eggs, or frozen tissue which is underwent fertilization in infertility centers - Administration of incompatible ABO, Non-ABO of blood/ blood products, or transplantation of incompatible organs - Unintended retention of a foreign object in a patient after invasive procedure, including surgery - Unexpected Death of a full-term Newborn - Rape cases encountered within the premises/campus of a healthcare facility. - Assault or homicide of any patient receiving care, treatment, and services at the health care facility setting - Assault or homicide of Visitor or Watcher receiving care, treatment, and services at the healthcare facility setting - Physical and Psychological violence, or homicide of a staff member, or vendor at the healthcare facility setting - Fire, flame, unanticipated smoke, or flashes occurring within a healthcare facility - Patient leaving a healthcare facility without the knowledge/authorization - Medication error leading to severe temporary harm, permanent harm, or death. - Patient severe temporary harm, permanent harm, or death associated with intravascular air embolism - Patient severe temporary harm, permanent harm, or death as a result of medical device breakdown or failure when in use - Unexpected building collapse, or malfunctioning structure or overturning of any healthcare facility load bearing part of any lift or lifting equipment when in use or during installation - Transfusing/ transplantation of contaminated blood, blood products, organ or tissue or transmission of disease as a result of using contaminated instruments or equipment provided by the healthcare facility - Death or serious disability associated with failure to manage/identify neonatal hyperbilirubinemia - Delivery of radiotherapy to the wrong body region or dose exceeds more than 25% of the total planned radiotherapy dose - Patient severe temporary harm, permanent harm, or death as a result of patient fall - Patient severe temporary harm, permanent harm, or death associated with administration/ connection of the wrong medical gas - System failure leading to service interruption and total evacuation outside healthcare facility - Unexpected death - Unexpected Loss of a limb or a function - Maternal death, permanent harm, or severe temporary harm - MR damage or Patient or staff severe temporary harm, permanent harm, or death associated with introduction of a metallic object - Loss or damage to specimen sample or tissue biopsy after invasive procedure. - [This document also includes an Arabic translation of all the above content]