Preventing and Responding to Sentinel Events in Surgery Beverly Kirchner, BSN, RN, CNOR, CASC April 2014 Financial Disclosure I DO NOT have an actual, potential or perceived conflict of interest to disclose Learning Objectives: 1. Define the term Sentinel Event. 2. Identify potential Sentinel Event hazards in the Operating Room 3. Discuss ways to prevent a Sentinel Event in the OR 4. Describe the process to follow if a Sentinel Event occurs 1
Definition of Sentinel Event A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious 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. Definition of Sentinel Event Such events are called sentinel because they signal the need for immediate investigation and response. The terms sentinel event and medical error are not synonymous; not all sentinel events occur because of an error and not all errors result in sentinel events. http://www.jointcommission.org/sentinel_event_policy_and_procedures/ Sentinel Events Reportable to Joint Commission Invasive procedures, including surgery, on the wrong patient, on the wrong site, or the wrong procedure# Unintended retention of a foreign object in a patient after surgery or other invasive procedures http://www.jointcommission.org/assets/1/6/camobs_2012_update2_21_se.pdf 2
Sentinel Events Reportable to Joint Commission Prolonged fluoroscopy with cumulative dose >1,500 rads to a single field or any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities (ABO, Rh, other blood groups) Abduction of any patient receiving care, treatment, or services http://www.jointcommission.org/assets/1/6/camobs_2012_update2_21_se.pdf Sentinel Events Reportable to Joint Commission Rape, assault (leading to death or permanent loss of function), or homicide of any patient receiving care, treatment, or services** Rape, assault (leading to death or permanent loss of function), or homicide of a staff member, licensed independent practitioner, visitor, or vendor while on site at the health care organization http://www.jointcommission.org/assets/1/6/camobs_2012_update2_21_se.pdf Sentinel Events That Are Not Reviewable Under Joint Commission s Under Joint Commission s Policy Note: This list may not apply to all settings. Any close call ( near miss ) Any sentinel event that has not affected a patient of the organization Medication errors that do not result in death or major permanent loss of function http://www.jointcommission.org/assets/1/6/camobs_2012_update2_21_se.pdf 3
Sentinel Events That Are Not Reviewable Under Joint Commission s Under Joint Commission s Policy Full or expected return of limb or bodily function to the same level as prior to the adverse event by discharge or within two weeks of the initial loss of said function, whichever is the longer period http://www.jointcommission.org/assets/1/6/camobs_2012_update2_21_se.pdf Sentinel Events That Are Not Reviewable Under Joint Commission s Under Joint Commission s Policy Minor degrees of hemolysis not caused by a major blood group incompatibility and with no clinical sequelae A death or loss of function following a patient leaving the organization against medical advice (AMA) Serious Events Defined in CMS Memo to Marilyn Tavenner as: Events resulting in prolonged hospitalization, permanent disability, life sustaining intervention, or death OIG Memo to Marilyn Tavenner Acting Administrator Centers for Medicare and Medicaid Services, dated July 2012 4
1. SURGICAL OR INVASIVE PROCEDURE EVENTS 1A. Surgery or other invasive procedure performed on the wrong site (updated) ambulatory practice settings/office based practices, long term care/skilled nursing facilities 1B. Surgery or other invasive procedure performed on the wrong patient (updated) ambulatory practice settings/office based practices, long term care/skilled nursing facilities http://www.qualityforum.org/topics/sres/list_of_sres.aspx 1C. Wrong surgical or other invasive procedure performed on a patient (updated) ambulatory practice settings/office based practices, long term care/skilled nursing facilities 1D. Unintended retention of a foreign object in a patient after surgery or other invasive procedure (updated) ambulatory practice settings/office based practices, long term care/skilled nursing facilities 1D. Unintended retention of a foreign object in a patient after surgery or other invasive procedure (updated) ambulatory practice settings/office based practices, long term care/skilled nursing facilities http://www.qualityforum.org/topics/sres/list_of_sres.aspx 1E. Intraoperative or immediately postoperative/post procedure death in an ASA Class 1 patient (updated) Applicable in: hospitals, outpatient/office based surgery centers, ambulatory practice settings/officebased practices http://www.qualityforum.org/topics/sres/list_of_sres.aspx 5
2. PRODUCT OR DEVICE EVENTS 2A. Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting (updated) ambulatory practice settings/office based 2B. Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (updated) ambulatory practice settings/office based 2C. Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a healthcare setting (updated) long term care/skilled nursing facilities http://www.qualityforum.org/topics/sres/list_of_sres.aspx 3. PATIENT PROTECTION EVENTS 3A. Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person (updated) ambulatory practice settings/office based practices, long term care/skilled nursing facilities 3B. Patient death or serious injury associated with patient elopement (disappearance) (updated) ambulatory practice settings/office based practices, long term care/skilled nursing facilities 3C. Patient suicide, attempted suicide, or self harm that results in serious injury, while being cared for in a healthcare setting (updated) ambulatory practice settings/office based practices, long term care/skilled nursing facilities CARE MANAGEMENT EVENTS 4A. Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration) (updated) centers, ambulatory practice settings/office based 4B. Patient death or serious injury associated with unsafe administration of blood products (updated) centers, ambulatory practice settings/office based 6
4D. Death or serious injury of a neonate associated with labor or delivery in a low risk pregnancy (new) centers 4E. Patient death or serious injury associated with a fall while being cared for in a healthcare setting (updated) centers, ambulatory practice settings/office based 4F. Any Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation to a healthcare setting (updated) centers, long term care/skilled nursing facilities 4G. Artificial insemination with the wrong donor sperm or wrong egg (updated) ambulatory practice settings/office based practices 4H. Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen (new) ambulatory practice settings/office based practices, long term care/skilled nursing facilities 4I. Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results (new) ambulatory practice settings/office based practices, long term care/skilled nursing facilities ENVIRONMENTAL EVENTS 5A. Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a healthcare setting (updated) centers, ambulatory practice settings/office based 5B. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or are contaminated by toxic substances (updated) centers, ambulatory practice settings/office based 7
5C. Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a healthcare setting (updated) Applicable in: hospitals, outpatient/office based surgery centers, ambulatory practice settings/officebased 5D. Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a healthcare setting (updated) Applicable in: hospitals, outpatient/office based surgery centers, ambulatory practice settings/officebased. RADIOLOGIC EVENTS 6A. Death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area (new) Applicable in: hospitals, outpatient/officebased surgery centers, ambulatory practice settings/office based practices POTENTIAL CRIMINAL EVENTS 7A. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider (updated) centers, ambulatory practice settings/office based 7B. Abduction of a patient/resident of any age (updated) centers, ambulatory practice settings/office based 8
7C. Sexual abuse/assault on a patient or staff member within or on the grounds of a healthcare setting (updated) centers, ambulatory practice settings/office based 7D. Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a healthcare setting (updated) centers, ambulatory practice settings/office based Facts About Sentinel Events or Serious Events Hospitals must report in 27 states ASCs must report in 21 states Self reporting is not working according to OIG report to CMS Internal healthcare facility risk reporting systems are broken OIG Memo to Marilyn Tavenner Acting Administrator Centers for Medicare and Medicaid Services, dated July 2012 National Academy for State Health Policy http://www.nashp.org/pst state list FREQUENTLY REVIEWED SENTINEL EVENTS / SERIOUS EVENTS Unintended retention of a Foreign Body in Healthcare (estimated 39 times per week stated in John Hopkins Report and Dr. Makary s book Unaccountable stated 40 times per week) 9
FREQUENTLY REVIEWED SENTINEL EVENTS / SERIOUS EVENTS Wrong Patient, Wrong Site, Wrong Procedure (estimated wrong procedure 20 times per week and wrong body site 20 times per week stated in John Hopkins Report) Reporting Sentinel Events Internally Immediate Manager Director of Surgery (if you have one) Risk Management Safety Officer Quality Assessment Performance Improvement Committee Administrator Medical Executive or Medical Advisory Committee Board Reporting Sentinel Events Externally State Health Department or any other State department required under your state law Accrediting body FDA Med Watch OSHA CMS OIG CDC Law Enforcement Agencies 10
Tips on Preventing Sentinel Events Set Safety goals such as: Provide accurate patient identification Create effective communication paths for caregivers Reduce safety risk for administering high alert medications Eliminate wrong site, wrong patient, wrong procedure, wrong implant. Use Universal Protocol for Time Out Process Tips on Preventing Sentinel Events Focus on what is right for each patient Use technology to help you track and document sentinel events Do not get stuck in We have always done it this way Make sure change helps the team give better care. Do not add steps that increase workload. Tips on Preventing Sentinel Events Develop teamwork among the OR team. No one is a superstar! Work on communication Clearly define roles of each team member Understand teams weaknesses and work to make them strengths Educate the team on identifying errors Educate the team on how to properly report errors Make it safe to speak up Develop team related competencies 11
Tips on Preventing Sentinel Events Develop a strong core of ethical behavior Develop strong leaders Reveal your medical errors Chicago hospital adopted the Seven Pillars and reduced their Sentinel Event/Serious Event Report incidents Investigate and fix problem Communicate the error Apologize and make it right waive fees Fix gaps in system when identified Track data, report data, share data Educate staff Tips on Preventing Sentinel Events Focus on value of patient outcome based on patient s point of view and standard of care Trust your nurses. They have the answers. Leadership should be about nurturing and enhancing the teams skills of caring and compassion Becker Hospital Review, Quality Care and Infection Control, ://www.beckershospitalreview.com /quality/5 tips onhow to improve patient safety with the help of technology. Last reviewed May 12, 2013. C. Nucci. Healthleaders Media, To Err is Human, to Get it Right Takes a Village, October 20, 2010. Agency for Healthcare Research and Quality. Navigating the Health Care System. http://ahrq.gov/news/columns/navigating the health care system/071012.html. Last accessed May 20, 2013. Tips on Preventing Sentinel Events Leaders must build trust with team Leaders must be willing to see and make the hard choices through process improvement Leaders are the culture of the organization Kronos, Nursing s Time to Lead, Enabling true leadership in a Time of Crisis, Pillar 1 In Nursing We Trust. Copy righted in 2013 12
Preventing Surgical Sentinel Events Unintended retention of a Foreign Body ( estimated 39/40 times per week) Establish a system that ensures all surgical items opened are accounted for by end of case Develop a team based system approach Standardized instrument sets, count sheets, and process Transparent Preventing Surgical Sentinel Events Process needs to be verifiable Process needs to be reliable Perioperative Standards and Recommended Practices, Retained Surgical Items, AORN, 2013 pages 306 321. John Hopkins, Never Events December 2012 Office of Quality Monitoring, The Joint Commission, http://www.jointcommission.org/sentinel Event Policy and Procedure// Preventing Surgical Sentinel Events Wrong Patient, Wrong Site, Wrong Procedure (estimated wrong procedure 20 times per week and wrong body site 20 times per week) Implementation of Universal Protocol for Wrong Site Surgery (Verification of person procedure and site, Site Marking, Time Out) Implement teamwork expectations Implement patient handoff protocol 13
Preventing Surgical Sentinel Events Adequate patient assessment Stress appropriate communication Expect team members to respect each other Identify potential process failures and address Audit process in action Wrong Site Surgery: A Preventable Medical Error Patient Safety and Quality, NCBI. http://www.ncbi.nlm.nih.gov/books/nka2678/?report=printable. Preventing Surgical Sentinel Events Resources: AORN Correct Site Surgical Tool Kit AORN Just Culture Tool Kit AORN Human Factors in Health Care Tool Kit AORN comprehensive Surgical Checklist The Joint Commission Universal Protocol World Health Organization s Surgical Safety Checklist Preventing Surgical Sentinel Events Resources: Ambulatory Surgery Center Quality Collaboration ASCA 14
Create a Sentinel Event Team Be proactive and have a sentinel event team in place that is education on Investigating Sentinel Events/Serious Events Educate team members on how to conduct a Root Cause Analysis Sentinel Event Team Consider the following as the members of your Sentinel Event Team: Risk Manager Administrator Nursing, Medical, Allied Health Member Safety Officer Biomed (if equipment failure) Director of Quality Team members must be given time to work on the Investigation and Root Cause Analysis Know time frame to complete work (based on accreditation body and state law) How to Set Up a Sentinel Event Response Team, Hospital Peer Review, December, 1999. http://www.highbeam.com/doc/1g1 206904255.html 15
Investigate the Incident Create a safe environment where all staff involved in the sentinel event can feel free to speak up Begin investigation by educating the staff involved on the process to be used to investigate the event Walk through the event start to finish of to begin to understand went wrong Investigate the Incident Use the event walk through data to begin to prepare and identify the root cause of the event Create and Action Plan to ensure the event does not occur again Questions to Consider Asking after an Event What happened?(step by step from admission to event) When did the event occur? What was done for the patient the minute the event occurred and immediately after? Who was notified of the event occurring? 16
Questions to Consider Asking after an Event Why did it happen? What were the process steps taken? What steps in the process contributed to the event? What were the Human Factors that contributed to the event? Did equipment play a role in the event? Questions to Consider Asking after an Event What environmental factors affected the outcome in the event? What factors were beyond the control of the staff and the facility environment? What other areas and services are affected by the event? Questions to Consider Asking after an Event What in the current process fell apart to cause the event? Was the staff qualified and competent? Was the event caused by human resource issues? How can education improve the process? How was communication handled? 17
Questions to Consider Asking after an Event Was the environment a risk factor in the event? If so what is in place to identify and prevent environmental issues? What uncontrollable factors that contributed to the event? Identify Risk Reduction Strategies Create an Action Plan for each finding in the root cause analysis Description of action needs to be detailed with expected outcome. Expected outcomes should be one of the following: Eliminate issue, Control issue, and Accept issue. Follow up Measure Effectiveness of Plan Collect appropriate data Analysis data collected Use data to continue making corrections if needed Communicate, Communicate Educate Re educate 18
Follow up Report event to appropriate agencies based on State law and accrediting body Report event to The Medical Executive Committee (if appropriate for your facility) Report event to the legal department or malpractice carrier if expected legal action will occur Follow up Report to the Governing Board Report to the QAPI Committee Report to Risk Management Report to the Safety Officer if the event had environmental impact. Track process to ensure it is hardwired QUESTIONS? CONTACT INFORMATION: BEVKIRCHNER1@VERIZON.NET 19