SENTINEL EVENTS AND ROOT CAUSE ANALYSIS

HOSPITAL NAME INSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section: TITLE/DESCRIPTION POLICY NUMBER SENTINEL EVENTS AND ROOT CAUSE ANALYSIS EFFECTIVE DATE REVIEW DUE REPLACES NUMBER NO. OF PAGES APPROVED BY APPLIES TO PURPOSE It is the policy of to identify Sentinel Events, to make appropriate individuals within the institution aware of Sentinel events, to take immediate action to investigate and understand the causes that underlie Sentinel events, and to make changes in the hospital systems and processes to reduce the probability of Sentinel Events in the future. This Policy establishes a process for identifying and responding appropriately to all Sentinel Events and near misses occurring within the hospital or associated with services that the hospital provides or provides for. An appropriate response to a Sentinel Event or near miss requires the: (1) completion of a thorough and credible Root Cause Analysis that focuses on progress and system factors, (2) determination of a risk reduction strategy and Action Plan that measures the effectiveness of process and system improvements and, (3) implementation of appropriate changes to the Center s systems and processes. DEFINITION 1. Action Plan The Action Plan is the product of the Root cause Analysis that identifies the strategies the Center intends to implement to reduce the probability of Sentinel Events occurring in the future. The Action Plan addresses responsibility for implementation, oversight, pilot testing (as appropriate), timeliness, and strategies for measuring the effectiveness of the actions. 2. UUUUUUUUUUUUUUUUUUCommittee The Committee is the Center s Sentinel Event Committee. 3. Central Board of Accreditation for Healthcare Institutions, the national accrediting body for hospitals and other health care organizations. 4. Policy The Policy is this Sentinel and Root Cause Analysis policy. 5. Root Cause Analysis A Root Cause Analysis is a process for identifying the basic or causal factor(s) that underlie variation in performance including the occurrence or possible occurrence of a Sentinel Event. A Root Cause Analysis focuses primarily on systems and processes not individual performance. A Root Cause Analysis progresses from special causes in clinical processes to common causes in Center processes and identifies potential improvements in processes or system that would tend to decrease the likelihood of Sentinel Events in the future. 6. Sentinel Event: A Sentinel Event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof, not related to the natural course of a patient s illness or underlying condition. The phrase serious physical or psychological injury specifically includes loss of limb or function. The phrase or the risk thereof includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome and includes delays in diagnosis and treatment. The following events are considered Sentinel Events even if the outcome is not death or major permanent loss of function: Suicide Homicide Surgery on the wrong patient or body part Impairment (major/permanent loss of bodily function i.e. serious physical or psychological injury or the risk thereof) that is not the result of the patient s underlying medical condition. Any unexpected death that is not the result of the patient s underlying medical condition Rape Child Abduction or discharge to the wrong family Standards Page 1 of 6

Hemolytic Blood Transfusion 7. Task Force The Task Force is the subcommittee appointed by the Committee to: (1) investigate an occurrence or process variation. (2) determine whether such occurrence or process variation meets the definition of a Sentinel Event, and (3) complete a thorough and credible Root Cause Analysis and resulting Action Plan describing the hospital s risk reduction strategies when a Sentinel Event occurs in the hospital or is associated with service that the hospital provides, or provides for. RESPONSIBILITY DUTIES AND COMPOSITION OF THE COMMITTEE 1. Creation of Committee The hospital shall form a committee called the Sentinel Event Committee. The Committee shall be organized and conduct its proceedings in accordance with the bylaws of the Committee. The Chairman of the Committee shall be the Administrator. This Committee is a medical peer review committee and its proceedings and communications are privileged under applicable Hospital Bylaws 2. Composition of Committee The Sentinel Event Committee shall be composed of the following: Administrator Medical Director Director of Nursing Assistant Administrator for Clinical Services Ex-officio members - Chief Legal Officer - Healthcare Risk Manager - Risk manager Designated staff persons 3. Duties of the Committee The Committee shall: (a) Investigate an occurrence or process variation (b) Determine whether such occurrence or process variation meets the definition of a Sentinel Event (c) Ensure completion of a thorough and credible Root Cause Analysis and resulting Action Plan describing the hospital s risk reduction strategies when a Sentinel Event occurs in the hospital or is associated with services that the hospital provides, or provides for. In its sole discretion, the Sentinel Event Committee may appoint a Task Force to perform some or all of these functions or may serve as the Task Force performing these functions. CROSS REFERENCES POLICY PROCEDURE PROCEDURE FOR IDENTIFYING AND RESPONDING APPROPRIATELY TO SENTINEL EVENTS 1. Application of Policy Any Sentinel Event occurring within the hospital or associated with services that the Center provides, or provides for, shall be handled as described in this policy. 2. Identification of Sentinel event If any individual in the hospital (including, but not limited to, any individual employed by the hospital, any individual who independently contracts with the hospital to provide health care services to patients at the hospital, any member of the hospital s Medical Staff, and any allied health care professional) discovers, Standards Page 2 of 6

witnesses, has knowledge of or otherwise becomes aware of any unexpected occurrence that is a possible Sentinel event must verbally report as follows: Monday-Friday, 8:00 AM 5:00 PM immediately report to the supervisor or designee as well as the Administrator or designee All other hours, to the Nursing Supervisor who immediately reports the event to the administrator on-call (see also procedure entitled, Administrative Alert After Hours/Weekends ) If any of the above are unavailable, verbally report to the Administrator or designee After the verbal report, a completed patient care variance report should be submitted. 3. Appointment of Task Force As soon as practicable after the Committee Chairman is notified of an occurrence or process or process variation that could constitute a Sentinel Event, but not later than forty-eight (48) hours after the occurrence or process variation is reported to the Committee Chairman, the Committee Chairman shall call a meeting of the Sentinel Event Committee to investigate the occurrence or process variation and to determine whether such occurrence or process variation meets the definition of a Sentinel Event. If the Committee determines that a reasonable possibility of a Sentinel Event has occurred, the committee shall appoint a Task Force composed of hospital personnel at all levels including, but not limited to, personnel closest to the issue(s) involved and personnel with decision-making authority. 4. Completion of Root Cause Analysis and Action Plan The Task Force shall investigate and understand the causes that underlie the event within seventy-two (72) hours and complete a thorough and credible Root analysis and resulting Action Plan describing the hospital s risk reduction strategies in accordance with Sections IV and V of this Policy within forty-five (45) days of the known occurrence of the Sentinel Event. 5. Report to Committee After completing the Root Cause Analysis and Action Plan, the Task Force shall produce full documentation of the Root Cause Analysis and Action Plan to the Sentinel Event Committee. The Committee shall subsequently direct the Root Cause Analysis and Action Plan to be reported to and thoroughly reviewed by the hospital s relevant clinical committees (e.g. if the Sentinel Event involves a medication error, the Root Cause Analysis and Action Plan shall be reported to and reviewed by the Pharmacy and Therapeutic Committee). The Committee shall further direct the Root Cause Analysis and Action Plan to be reported to and thoroughly reviewed by any other hospital committee the Committee deems appropriate. ROOT CAUSE ANALYSIS 6. Purpose of Root Cause Analysis The purpose of the Root Cause Analysis is to understand how and why a Sentinel Event occurred and to prevent the same or similar Event from occurring in the future. Because the immediate cause of most Sentinel Events is human fallibility, the Root Cause Analysis is expected to uncover any underlying hospital systems and processes that can be changed to reduce the likelihood of human fallibility in the future. 7. Action Plan The Task Force shall create a high-level work plan that clearly defines the issues surrounding the Sentinel Event and that includes target dates for accomplishing specific objectives. The Task Force shall brainstorm for all possible or potential contributing factors, and sort and analyze the list of contributing factors. The Task Force may use a cause-and-effect diagram to assist in the sorting process and a flowchart to chart the processes involved and to determine with which process or system each factor is associated. 8. Consultation of Framework The Task Force shall review the Joint Commission s Framework for Sentinel Event Root cause Analysis ( Framework ) in developing its Root cause Analysis. The Framework contains certain questions designed to elicit both the immediate causes and any underlying systemic and process causes of the Sentinel Event that can be changed to reduce the likelihood of a Sentinel Event in the future. 9. Focus on Systems and Processes The Root cause Analysis must: Focus primarily on systems and processes, not individual performance Standards Page 3 of 6

Progress from identifying special causes in clinical processes to common causes in organizational processes Repeatedly dig deeper by asking Why? and then, when answered, Why? again Identify changes and improvements that could be made in system and processes, either through correction of existing systems or processes or development of new systems or processes, that would reduce the risk of such events occurring in the future 10. Thoroughness and Credibility The Task Force must complete a thorough and credible Root Cause Analysis. To be thorough, the Root cause Analysis must include: A determination of the human and other factors directly associated with the Sentinel Event, and the processes and systems related to its occurrence Analysis of the underlying systems and processes through a series of Why? questions designed to determine where re-design might reduce risk Identification of risk points and their potential contributions to the particular type of Sentinel Event A determination of potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or a determination, after analysis, that no such improvement opportunities exist. To be credible, the Root Cause Analysis must: Include participation by the leadership of the Center and by the individuals most closely involved in the processes and the systems under review. The individuals closest to the processes are frequently (but not always) nurse since they spend most of their times with the patients Be internally consistent, that is, not contradict itself or leave obvious questions unanswered Include consideration of any relevant literature. For example, the most common Sentinel Events relate to adverse drug events. 11. Minimum Scope of Root Cause Analysis for Specific Types of Sentinel Events The Task Force s Root Cause Analysis shall include, at a minimum, a detailed inquiry into the areas listed on the Minimum Scope or Root Causes Analysis for Specific Types of Sentinel Events. 12. Documentation of Root Cause Analysis The Task Force shall produce full documentation of its Root cause Analysis to the Committee within forty-five (45) days of the known occurrence of the event. The Root cause Analysis shall be maintained confidentiality by the Chairman of the Committee. ACTION PLAN AND MEASUREMENT STRATEGY 13. The Purpose of the Action Plan The purpose of the Action Plan is to identify strategies that the hospital intends to implement to reduce the risk of similar Events occurring in the future and to make in the hospital s system and processes to reduce the probability of such an Event in the future. 14. Development of Acceptable Action Plan The Task Force shall develop an Action Plan that addresses responsibility for implementation, oversight, pilot testing (as appropriate), timeliness and strategies for measuring the effectiveness of the actions,. The Task Force shall include within the Action Plan an appropriate approach for evaluating the effectiveness of the improvements. The Action Plan must, at a minimum: Identify changes that can be implemented to reduce risk, or formulate a rationale for not undertaking such changes Where improvement actions are planned, identify who is responsible for implementation and when the action will be implemented, including any pilot testing, and how the effectiveness of the actions will be evaluated 15. Implementation The hospital shall implement the systems and processes identified in the Action Plan (after initial testing, if appropriate). 16. Documentation The Task Force shall produce full documentation of its Action Plan, along with the Root Cause Analysis, to the Committee within forty-five (45) days of the known occurrence of the Event. Both the Root Cause Analysis and the Action Plan shall be maintained confidentiality by the Chairman of the Committee. THE ROOT CAUSE ANALYSIS, ACTION PLAN, AND OTHER RELATED DOCUMENTS ARE PRIVILEGED AND CONFIDENTIAL Standards Page 4 of 6

17. Privileged Nature of Root Cause Analysis, Action Plan, and Other Related Documents The Root Cause Analysis, Action Plan, and other related documents produced by the Task Force are confidential and privileged. 18. Disclosure of unanticipated events to patients patients and, when appropriate their families should be informed about unanticipated outcomes of care that relate to sentinel events FORMS EQUIPMENT REFERENCES APPROVAL: Prepared by Reviewed by Approved By Approved By Latest Revision Approved By Name Signature Date Standards Page 5 of 6

INTERDISCIPLINARY PROCESS REVIEW OF SENTINEL EVENTS Sentinel event identified and immediately reported to Administrator, CEO or designees Administrator (Chair of Sentinel Event Committee) calls committee meeting to evaluate event within 48 hours of report. The committee meets and reviews case. YES Does the above committee believe that the event is sentinel? No Committee appoints interdisciplinary Task Force with the following charges: Continue Investigation Conduct Root Cause Analysis Report preliminary findings to committee within 72 Hours Complete root cause analysis Prepare record of findings and action plan Report finalized findings and actions taken as a result of review of event to the Committee within 45 days Committee makes recommendations and assignments about review and monitoring of issue. Committee: Reviews preliminary root cause analysis after 72 hours Reviews root cause analysis and action plan prepared by the Task Force after 45 days Assigns responsibilities for action steps to clinical or hospital departments after review by relevant committees Sets deadlines for completion of action steps Considers and plans actions on systems issues or hospital-wide issues Ensures reporting on results of action plan in departments Reports results to Medical Executive Committee and Performance Improvement Coordinating Council