National Health Regulatory Authority Kingdom of Bahrain THE NHRA GUIDANCE ON SERIOUS ADVERSE EVENT MANAGEMENT AND REPORTING THE PURPOSE OF THIS DOCUMENT IS TO OUTLINE SERIOUS ADVERSE EVENTS THAT SHOULD BE REPORTED AND THE REPORTING AND MONITORING PROCESSES INVOLVED. VERSION 1.0 - EFFECTIVE: 14 September 2013 THIS GUIDANCE WAS LAST UPDATED IN 14 September 2013 PLEASE ENSURE YOU READ THE MOST UP-TO-DATE GUIDE AVAILABLE ON OUR WEBSITE
1 INTRODUCTION 2 PURPOSE The NHRA guidance for Serious Adverse Events Management and Reporting sets out the definitions, requirements and approach to be applied to improve patient safety and quality of care by: Advocating the requirement to develop and implement a management and reporting system in all healthcare facilities for all nonstandard incidents and adverse events; and Identifying the criteria for and means by which to collect, notify and report on serious adverse/ sentinel events defined in the guideline. 3 Scope 3.1 The process is identified for all NHRA licensed healthcare facilities. 3.2 All healthcare facilities are encouraged to follow the guideline and implement processes for the management and reporting of serious adverse / sentinel events to the NHRA. 3.3 All healthcare facilities are encouraged to record and monitor all adverse events, near misses and incidents internally, including those related to all aspects of direct patient care, occupational health and safety, equipment and medications. 4 Definitions 4.1 Safety: Freedom from accidental injuries. 4.2 Error: The failure of a planned action to be completed as intended (i.e. error of execution) or the use of a wrong plan to achieve an aim (i.e. error of planning) Errors may be errors of commission or omission, and usually reflect deficiencies in the systems and processes of care. 4.3 Hazard: Any threat to safety, e.g. unsafe practices, conduct, equipment, labels, names. 4.4 System: A set of interdependent elements (people, processes, equipment) that interact to achieve a common aim. 4.5 Adverse Event an event that causes harm, or has potential to cause harm to a patient. 4.6 Serious Adverse/ Sentinel Event Any unanticipated adverse event or Near Miss event in a healthcare setting resulting in death or serious physical or psychological injury to a patient or patients, not arising from the natural course of the patient's illness, includes events that: 4.6.1 Are life threatening 4.6.2 Requires in-patient hospitalization or prolongs an existing hospitalization 4.6.3 Results in persistent or significant disability or incapacity 4.6.4 Is any medically significant event that may put the patient at risk or may require medical or surgical intervention to prevent one of the outcomes listed above 4.7 Near Miss: circumstances or events that had the capacity to cause an adverse event, but which did not reach the patient.
4.8 Adverse Event Severity 4.8.1 Mild: discomfort noticed but no disruption of normal activity 4.8.2 Moderate: discomfort sufficient to reduce or affect normal daily activity 4.8.3 Severe: interferes significantly with the subject s normal activity or course of illness. All Serious Adverse Events should be classified as severe. 4.9 Pattern of Events 4.9.1 Single event: The event occurred just once, and has ended by the time of reporting. 4.9.2 Continuous: The event began just once, and is still ongoing at the time of reporting. 4.9.3 Intermittent: The event has gone through at least one cycle of starting, stopping, and starting again. 4.10 Root cause analysis A process for identifying the basic or causal factors that underlie variation in performance and that may have caused or contributed to an adverse event. It focuses primarily on systems and processes, not on individual performance. It progresses from special causes in clinical processes to common causes in organizational processes and systems and identified potential improvements that would decrease the likelihood of recurrence. 5 Requirements of the Healthcare Facilities 5.1 To develop an adverse events management system in accordance with the NHRA guidance based on the following principles: quality and safety continuous improvement, Transparency Accountability 5.2 A system and process should be identified within the healthcare facility and should: 5.2.1 Set out in writing the details of the system in a policy and supporting standard operating procedures and documentation; 5.2.2 Establish a governance mechanism to oversee, manage, monitor and report on the effectiveness of this system and any corrective actions; 5.2.3 Use the definitions identified by the NHRA in the guidance for the purposes of categorization of all events and actions including corrective actions; and 5.2.4 Include delineated roles, responsibilities and accountabilities for staff, and as well as provide appropriate training and orientation plans and materials for all staff.
5.2.5 Each licensed healthcare facility should be able to demonstrate that an adverse events management system is implemented and managed in the facility in accordance with NHRA guidance. To do so, a facility should make available to the NHRA, if and when directed to: 5.2.5.1 The adverse events management policy and supporting documents that set out in detail the process and operating procedures and the governance system in place; 5.2.5.2 Documentary evidence of identified and reported adverse events, their causes or suspected causes, trends, actions and improvements planned or implemented to prevent recurrence, as well as training activities undertaken or planned within specified timelines. 5.2.6 To comply with NHRA directions: 5.2.6.1 The NHRA reserves the right within its role as regulator to investigate any and/or all events and apply sanctions in accordance with its remit under the regulatory legislation that is in force in Bahrain. 5.2.7 All healthcare facilities and employees should: 5.2.7.1 Comply with all applicable NHRA policies and licensing standards; and 5.2.7.2 Comply with NHRA inspection requirements, and cooperate with the NHRA licensure inspectors. 5.2.7.3 Assist the NHRA with its requests for information and/or documentation, and submit requested information within the identified timeframes. 6 Requirements of the NHRA 6.1 The NHRA will set out the definitions and types of serious adverse events/sentinel events to be reported externally and the requirements for reporting. 6.2 Reviews and from time to time revises the list of events that should be reported and investigated in accordance with evidence and reported information to ensure the safety and quality of care for patients is continuously assured and improved. 6.3 The NHRA should share learning from serious adverse events reported, patient safety and quality issues, whilst maintaining confidentiality at all times.
6.4 The NHRA should investigate and may commission its own investigations, by independent third party, of certain cases if necessary. 6.5 The NHRA can receive information on serious adverse events via the complaints system and, where necessary, will investigate any complaint in accordance with the NHRA Policies and Standard for Complaints management.(this can be found on the NHRA website) 6.6 Where it finds evidence of noncompliance with the legislation, standards and regulations, NHRA may impose sanctions consistent with its remit and the NHRA Policy on Noncompliance and Sanctions. 6.7 The NHRA will analyze investigations, RCAs and any reports submitted by health care facilities and may direct them to: 6.7.1 Provide additional information; 6.7.2 Undertake further investigations into cases; 6.7.3 Develop/revise action plans to address issues identified. 6.8 Facilities should also be prepared for unannounced visits from the NHRA Licensure inspectors, which can be triggered not only by the serious adverse event reports but also by reports in the media, calls from the patient or family, or calls from concerned health care staff from the affected organization. 7 The Reporting Process Research has shown that focused reporting systems are more valuable for deepening the understanding of particular issues of care. These guidelines focus on reporting systems related to serious adverse events only. The process for reporting to the NHRA is outlined in the flowchart below. Template forms and defined data elements are contained in the appendices to this guide. 7.1 For serious adverse / sentinel events defined in this guide, see appendix 3, Healthcare facilities are requested to: 7.1.1 Report occurrence of an identified serious adverse event to the NHRA within 48 hours; 7.1.2 Submit an initial SAE report (see appendix 1)of the event within seven days of its occurrence to NHRA with details of the investigation and actions taken including minimizing risk of recurrence; and 7.1.3 Submit a full RCA report (see appendix 2) to NHRA with details of the investigation, root cause analysis and action plan to minimize risk of recurrence (within 45 working days).
8 NHRA Reporting Reporting of events is of little value unless the data are analyzed. Regardless of the objective of the system whether to identify new and previously unsuspected hazards, discover trends, prioritize areas for remedial efforts, uncover common contributing factors, or develop strategies to decrease adverse events and patient harm neither the act of reporting nor the collection of data will accomplish that objective unless the data are analyzed and recommendations are made for change. Classification of the event is the first step in the analysis.
APPENDIX ONE Licensing & Registration Office National Health Regulatory Authority PO Box 11464 Manama Kingdom of Bahrain Report No: (for official use only) REPORT OF SERIOUS ADVERSE EVENT KINGDOM OF BAHRAIN Please complete for any serious adverse event which results in death or loss of a body part, or disability or permanent loss of bodily function. All information is protected under patient confidentiality. Is this a revision of an earlier SAE report to the NHRA Yes No If Yes: provide NHRA report no: 1. GENERAL INFORMATION Facility Name Facility license No: Address: Telephone Nos. (Mobile): (Business): Fax No.: Name of Person Submitting Report:: Title or Position: Email address: Profession: License No; (if applicable) 2. SERIOUS ADVERSE EVENT Please supply a simple and clear description of the event or situation you are reporting: Incident Date: Time AM PM Date Discovered: Time: AM PM
3. HOW WAS EVENT DISCOVERED Report by staff/physician Report by family / visitor Report by patient Assessment by patient after the event Review of chart / record Other 4. PATIENT INFORMATION In Patient Out patient Day Case Medical Record No: Gender: Male Female Patient Name: Address: Date of Birth: Date of Admission: 4. EVENT DETAILS Type of serious adverse event: Care Management Events In a health care facility Patient death / harm due to medication error Patient death / harm due to a haemolytic reaction / incompatible blood or blood products Maternal death / harm due to labour / delivery in a low risk pregnancy Patient death / harm due to hypoglycaemia Stage 3 or 4 pressure ulcer acquired after admission Patient death / harm due to spinal manipulation therapy or spinal tap. Other event causing patient death / harm. CPR No: Date of Discharge: (if applicable) Product or Device Event In a health care facility Patient death / harm due to the use of contaminated drugs/devices/biologics Patient death / harm due to the use of a device which it was not intended Patient death / harm due to intravascular air embolism Patient death / harm due the use of a single use device in which the device is used other than is intended New single use device Reprocessed single use device Other event causing patient death / harm Environmental Events In a health care facility Patient death / harm due to an electric shock Patient death / harm due to oxygen / gas delivery wrong gas delivery / contaminated gas delivery. Patient death / harm due to burn incurred from any source Patient death /harm due to a fall Patient death / harm due to the use of bed / restraint rails Other event causing patient death / harm Surgery Related Events In a health care facility Surgery performed on the wrong patient Surgery performed on the wrong body part Wrong surgical procedure performed on a patient Retention of foreign object in a patient after surgery or other procedure Intraoperative or immediately post operative coma or death. Other event causing patient death / harm
6. IF 5A WAS SELECTED, COMPLETE THIS SECTION What type of medication error occurred? (check all that apply) Wrong patient Wrong drug Wrong dose Wrong route Wrong frequency Wrong time Omission Other Brand / Product Name Wrong diluent / concentration /dosage form Generic Name: monitoring error 7. WHERE WAS THE PATIENT WHEN THE EVENT OCCURRED 8. IMMEDIATE CORRECTIVE ACTION TAKEN
9. FOR NHRA USE ONLY: Acknowledgement of SAE Report Date Processed: Follow up action Required: Assigned Inspector: RCA completed: Date Inspected: (if required) Inspection Report Completed: Date Issued Learning points identified and shared:
APPENDIX TWO Root Cause Analysis Report Template Lead Investigator: Position: Date: 1. THIS REPORT SHOULD BE USED FOR LEARNING PURPOSES ONLY. IT IS NOT TO BE USED TO APPORTION BLAME. 2. DO NOT USE ANY IDENTIFYING INFORMATION, USE DR X NURSE Y E.T.C
Root Cause Analysis Report Template 1. Incident Description Use this section to describe the incident and it s consequences, using only the facts. 2. Type of Investigation Undertaken Use this section to describe the methods used during the investigation team interviews, timelines, fishbone diagrams, 5 Whys, barrier analysis etc. Further assistance can be found http://www.mindtools.com http://www.institute.nhs.uk/quality_and_service_improvement_tools www.npsa.nhs.uk/rca/ http://psnet.ahrq.gov/ www.patientsafety.gov/cogaids/rca/index.html 3. Findings Use this section to describe the care delivery or service delivery problems and what the contributing factors were found to be. 4. Positive Features and Good Practice Use this section to highlight any positive features, good practice or actions that reduced the severity of the incident. 5. Recommendations and Action Plan Use this section to list the recommendations and the action plan to implement them. Recommendation Action By Whom Due Date The action plan may not be available when the RCA report is written. In this case, the action plan may be sent at a later date so as not to delay the publication of the RCA report s findings.
6. Appendices Use this section to record: Lists of documents used Copies of any relevant documents or relevant sections Electronic versions of annotated fishbone diagrams, time lines, barrier analysis tables etc.
APPENDIX THREE Serious Adverse events that should be reported to the NHRA Care Management Events in a health care facility Patient death / harm due to medication error Patient death / harm due to a haemolytic reaction / incompatible blood or blood products Maternal death / harm due to labour / delivery in a low risk pregnancy Patient death / harm due to hypoglycaemia Stage 3 or 4 pressure ulcer acquired after admission Patient death / harm due to spinal manipulation therapy or spinal tap. Suicide of an in patient Other event causing patient death / harm. Environmental Events in a health care facility Patient death / harm due to an electric shock Patient death / harm due to oxygen / gas delivery wrong gas delivery / contaminated gas delivery. Patient death / harm due to burn incurred from any source Patient death /harm due to a fall Patient death / harm due to the use of bed / restraint rails Other event causing patient death / harm Product or Device Event in a health care facility Patient death / harm due to the use of contaminated drugs/devices/biologics Patient death / harm due to the use of a device which it was not intended Patient death / harm due to intravascular air embolism Patient death / harm due the use of a single use device in which the device is used other than is intended New single use device Reprocessed single use device Other event causing patient death / harm Surgery Related Events in a health care facility Surgery performed on the wrong patient Surgery performed on the wrong body part Wrong surgical procedure performed on a patient Retention of foreign object in a patient after surgery or other procedure Intraoperative or immediately post-operative coma or death. Other event causing patient death / harm