Page 1 of 16 DISCLOSURE OF INCIDENTS, ADVERSE, AND SENTINEL EVENTS Formerly Disclosure DEFINITION Disclosure includes the acknowledgement and discussion of the incident, potential or actual outcomes, and the necessary treatments/actions required to improve the client s condition and prevent further harm on a case by case basis in consultation with respective supervisor. PURPOSE 1. To provide a framework for disclosure of serious events that ensures optimal communication processes for clients/families. (or to facilitate the disclosure process for clients and families when harm occurs 2. To promote an open culture that moves away from an environment of individual blame and that promotes actions to prevent future harmful events 3. To remove barriers to disclosure so that information is disclosed in a manner that is respectful, helpful, and informative 4. To establish a consistent approach and mechanisms to identify, report, investigate, resolve and monitor serious events that occur during service or as a result of service provided by CHATS. 5. To promote improvements to the client care process on an ongoing basis 6. To ensure alignment with provincial legislation INTRODUCTION When a client experiences an adverse event (see Definitions for various incidents), it affects the client, relatives, and potentially the staff, support worker, and/or volunteer. Clients need to be informed of what has happened, the consequences, receive an appropriate apology, and understand what steps are being taken to prevent a similar reoccurrence. Benefits of open and timely disclosure: Permits informed choices to be made regarding the client s care Enables the client to receive treatment to mitigate complications resulting from the experience Promotes trust, honesty, and transparency between the organization and the client
Page 2 of 16 Promotes a culture of safety that values learning from adverse events and improving practices, and places importance on providing clients with the information they need Aligns with CHATS Code of Ethics and framework ( Policy 1-200) Reduces the likelihood of legal action being taken POLICY CHATS will promptly (not longer than twenty four business hours following the incident as per Incident and Adverse Event Policy 3-D-23) provide full disclosure to clients, families, and/or substitute decision makers (SDM) of a serious incident that has occurred in the course of a client s care. CHATS will analyze such incidents to prevent their recurrence. This policy aligns with the spirit of Ontario s Apology Act 2009. The Act facilitates timely apologies, which are an important step in the healing process, a potential springboard to discussions to settle disputes, and which promote humane and civil personal relationships. This policy is also in keeping with CHATS commitment to provide quality care and service to its clients and the communities it serves, its commitment to respect the right of clients and their families to be informed about such events, its Code of Ethics which guides situations and relationships which may be encountered with clients, staff, volunteers, partners and the public, and its philosophy of client-centered care. SCOPE AND APPLICATION This policy applies to all CHATS staff, support workers, volunteers, and partners. The policy and accompanying procedure set out guidelines and documentation requirements for disclosure of adverse events. Policy and Procedures will include: Roles and responsibilities Procedures Education and Training Risks and potential barriers Compliance and feedback Definitions References
Page 3 of 16 Person Responsible Quality of Care and Client Safety Committee Supervisors Actions 1. Review outcomes of root cause analyses and investigations of significant incidents 2. Make recommendations to prevent recurrence including education and change of practice 3. Identify trends and update disclosure practices to support a safety culture Supervisors are responsible for ensuring that the disclosure policy is implemented and observed in their particular areas and that it is understood and followed by staff, support workers, volunteers, and partners. Duties of the Supervisor include: Knowing the policy and procedures Reinforcing the policy s importance and staff/support worker/volunteer/partner obligation to follow procedures Providing clear protocols for disclosure Monitoring and evaluating compliance with respect to incidents Educating staff/support workers/volunteers/partners on the importance of disclosure, and helping to make decisions and disclose, as required Following up with clients and family to ensure that a proper plan is in place to follow up the initial disclosure Reporting to the director and documenting any incidents and investigations related to the disclosure as required Monitor implementation to ensure that policy is correctly followed in accordance with procedures Evaluate any feedback or data (investigations, incident reports) and
Page 4 of 16 provide recommendations Training and Development Coordinator Incorporate and deliver training on disclosure into the orientation and continuing professional development of staff, support workers, volunteers, and partners Staff, Support Workers, Volunteers, and Participate in all training. Partners Comply with disclosure procedures Report concerns May participate in disclosure meetings with client, family, or SDM as required POTENTIAL BARRIERS AND CHALLENGES CHATS will consider the following list of potential barriers/challenges during development of procedures, implementation, and evaluation: Fear of potential legal action by the client Preference to avoid upsetting the client and/or family Difficulty in admitting that an incident has occurred Fear of disciplinary action Fear of implicating others Uncertainty about the reporting process Concerns re self-image Concerns re colleague perception of skills PROCEDURE Immediate Action Any necessary life-saving or harm-reducing treatment within the scope of practice of the staff, support workers, volunteers, or partners present with the client should be undertaken immediately after the occurrence of discovery of the event. Adverse or Sentinel events should be reported verbally immediately after occurrence or discovery (and after providing care as described above) to the immediate supervisor who will inform the Director of Client Care & Services in order to get advice and assistance with respect to client care and with respect to the manner of informing the client or substitute decision-maker/family.
Page 5 of 16 Emotional Support CHATS recognizes that acknowledgement of the emotional experience is key to building a culture of safety. Along with the health care needs of the client, emotional support for the client, family, staff, support workers, volunteers, and partners must be addressed. Examples of such support include the availability of another team member who knows the client well, a social worker, employee assistance program (EAP), counseling services, a chaplain, and support groups. Both short and long-term support may be necessary. Following a disclosure meeting, staff/support workers/volunteers/partners often experience sadness, failure and guilt. It is important, therefore, that those involved in the disclosure process have the emotional support to help them cope with the situation e.g. in a confidential debriefing session, through private counseling. Staff/support workers/volunteers/partners who do not participate in the disclosure process, and who were involved in the incident, may also need support. They often experience fear for the client s well-being, self-doubt regarding their ability to provide care, symptoms of depression, disappointment, self-blame, shame and fear. Opportunities to share experiences can help reduce feelings of isolation and can contribute to developing a culture of safety. What Should Be Disclosed Major, adverse, or sentinel incidents (see definitions in Appendix) that result in client harm including injury, complication or death to the client must be disclosed. Different types of information will be available during initial and subsequent disclosure meetings. Information should: describe what happened (sequence of events) be factual opinions and statements of blame should not be made relate to the event, not about individuals involved relate to the client s diagnosis, treatment and care Events where disclosure is not required Disclosure is not required for a near miss incident or an incident that did not result in harm to the client. Disclosure is discretionary and will need to be determined on a case-by-case basis Who should receive the disclosure? Disclosure should be made to: The client, if the client is stable and/or able to comprehend the information
Page 6 of 16 The client s family or substitute decision-makers (in accordance with The Health Care Consent Act (1996), if the client is not capable of understanding a discussion of this nature Where disclosure should take place The setting should be comfortable, facilitate communication, and limit distractions. To the extent possible, the setting should be: Private Quiet Not subject to interruptions e.g. pagers, cell phones When disclosure should be made Disclosure is a process and not usually a one-time event. Disclosure should take place as soon as possible after the serious event has occurred or has been identified. Generally, initial communications may be brief and touch on immediate events/findings. At the time of the initial disclosure meeting, not all facts about what happened to the client may be known. Fuller disclosure may follow an investigation and/or follow-up action. Disclosure to the client should occur when the patient is stable and/or able to comprehend the information. Disclosure to the client s family or decision-maker may occur sooner depending on the situation. Written documentation must be initiated within twenty-four hours business hours, including initiation of an incident report in the GoldCare Incident Reporting Module. Disclosure Discussion Meeting The supervisor and the staff person/support worker/ volunteer/partner involved in the incident should be present. (If the person involved in the adverse incident does not attend, the client/family may believe that information is being withheld.) In some circumstances, further investigation may be required to determine which individual(s) should be present during the discussion. The Director of Client Care & Services may consider involving a Client Care Supervisor, faith based support, social worker, staff member(s), or someone from the community support network known to and trusted by the client/family to provide support to the client/family and staff.
Page 7 of 16 Since not all staff/support workers/volunteers/partners involved in the client s care will participate in the disclosure, they should be informed when the meeting will take place and briefed afterwards if appropriate, to ensure consistency and sensitivity for the client/family. Documentation of the disclosure discussion/meeting(s) The following information should be included: Date, time, location of discussion Who was invited, who attended and their relationship to the client Known material facts regarding the incident that were presented Consequences for the client Options considered or actions taken, or actions recommended to be taken to address consequences, including health care or treatment Offers of support and responses from the client/family, substitute decision-maker If Quality of Care and Client Safety Committee has conducted review, identified (systemic) steps to be taken to avoid or reduce the risk of similar incidents Reactions of the client, family, substitute decision-maker(s) Questions raised by the client, family substitute decision-maker, and responses provided Changes to the care plan that were discussed Plans agreed to for the ongoing disclosure process including key contact information Confirmation that the client, family, substitute decision-maker(s) to be kept informed of new facts Refusals of client, family, substitute decision-maker(s) to receive information regarding the incident. A record of the incident and actions taken in response, a summary of the disclosure, including attendees present, will be documented in the permanent client record. Note: Providing the client, family substitute decision-maker with a copy of the documentation of the meeting may promote openness and transparency of the disclosure process. Disclosure Discussion - How to Disclose-see Appendix for additional material on how to disclose, and for a communication checklist Disclosure should be made in person as soon as possible after the incident has occurred. The following guidelines for discussion may be helpful: 1. Choose an appropriate setting 2. Present information in a straightforward, non-judgmental and sympathetic fashion - Use non-technical and jargon-free language
Page 8 of 16 - Avoid blame and speculation - Speak slowly and provide enough information for the client and family to understand without overwhelming them 3. Be sensitive to body language (sit down and hold the hand of the client/family member if appropriate 4. Be aware of cultural differences 5. Resist interruptions and accept moments of silence in the conversation 6. Ensure that all relevant information and the permanent client record are available to use during the discussion 7. Promptly acknowledge that the event occurred 8. Express feelings of regret/sympathy/empathy/remorse to the client and family 9. Make an appropriate apology based on whether the expected standard of care was met (benevolent apology) or not met (full apology). Avoid an apology of accountability (liability) e.g. it s my fault Note: One of the most critical elements of disclosure is the apology. An apology demonstrates compassion and that the health care provider cares about the client and the harm that occurred. The nature of the apology depends on whether or not there was deviation from the expected standard of care. 10. Find out what the client and family already know 11. Describe the facts relating to the event including: - the nature, severity and cause (if known) - consequences of the harm, including short and long-term effects - what, if anything can be done to mitigate the consequences of the serious event 12. Offer assistance from social work, a religious advisor, second opinion, the involvement of outside assistance, or transfer of care to another provider if the client requests or prefers it 13. Describe the corrective actions that were and will be taken to prevent reoccurrence at the system level 14. If all the facts are not known, confirm that they will be disclosed as they become known 15. Give a brief overview of the investigative process that will follow and what the client and family can expect to learn, with appropriate timelines 16. Pause frequently and allow time for client and family to digest the information 17. Allow time for clarification and questions by the client and family 18. Offer future meetings and indicate who will be the contact for such requests 19. Review and reinforce the complaint process with the client/family and provide a copy of the complaint fact sheet. A record of the incident and actions taken in response, a summary of the disclosure, including attendees present, must be documented in the permanent client record.
Page 9 of 16 If the client s care is funded by a CCAC or other source, the funder should also be notified as soon as possible. Any required written reports for the funder will be completed within the timeframes specified. Corrective Action CHATS supports and encourages reporting and disclosure of incidents. If there has been an error, CHATS focuses its efforts on attempting to rectify the situation and prevent further incidents. In situations where an investigation reveals the need for corrective action, the fact that disclosure was done promptly and according to the policy and procedures will be taken into consideration. Staff, support workers, volunteers and partners are to be commended for professional conduct and efforts to continually improve health care safety and quality. DEFINITIONS Incidents Incident An incident is an event, process, practice, outcome, occurrence or situation that is not consistent with routine agency practices that may have a negative outcome. The unusual incident has or could potentially result in harm, injury, or loss to a client. It includes any accidental injury or unusual event involving visitors. Adverse Event An incident which produces an unexpected and undesirable incident directly associated with the care or service provided to the client, occurs during the process of providing care and produces an adverse outcome for a client, including an injury, complication or death. Sentinel Event (Sometimes referred to as Critical or Major Event) An unexpected incident, related to system or process deficiencies, which leads to death or major and enduring loss of function (including loss of limb or vital organ) for a recipient of services, and/or results in the client being sent to acute care via 911. Major and enduring loss of function refers to sensory, motor, physiological impairment not present at the time services were sought or began. The impairment lasts for a minimum of two weeks and is not related to an underlying condition or a known risk inherent in providing the care or service. Near Miss An event or situation that could have resulted in an accident, injury, or illness, but did not either by chance or through a timely intervention. Harm
Page 10 of 16 An unexpected or normally avoidable outcome that negatively affects the client s health and/or quality of life, which occurs or occurred in the course of the healthcare treatment and/or service and is not due directly to the client s illness. Disclosure Disclosure to the client/family/substitute decision-maker(s) includes the acknowledgement and discussion of the incident, potential or actual outcomes, and the necessary treatments/actions required to improve the client s condition and prevent further harm. Apology A compassionate and sincere expression of regret that at times involves taking responsibility for an injury, even if systems failures are responsible for the harm rather than one person. Expression of Regret An expression of sorrow for the harm experienced by the patient Error The failure to complete a planned action as it was intended or when an incorrect plan is used in an attempt to achieve a given aim. Most Responsible Staff The staff person who is responsible for coordinating, managing and directing a client s care/services. Root Cause Analysis A systematic process of investigating a critical incident or an adverse outcome to determine the multiple, underlying contributing factors. The analysis focuses on identifying the latent conditions that underlie variation in performance an, if applicable, developing recommendations for improvements to decrease the likelihood of a similar incident in the future. REFERENCES Apology Act 2009 (Ontario) Canadian Disclosure Guidelines, Canadian Patient Safety Institute, May 2008 Review of Provincial, Territorial and Federal Legislation and Policy Related to the Reporting and Review of Adverse Events in Healthcare in Canada, Canadian Patient Safety Institute, November 15, 2007 Disclosure of Harm to Patients and Families, Health Quality Council of Alberta, July 2006 Open disclosure standard: a national standard for open communication in public and private hospitals, following an adverse event in health care, 2003 Australian Council for Safety and Quality in Health Care Toronto Rehabilitation Institute, Disclosure of Adverse Events Policy
OTHER RELATED POLICIES/FORMS: Incident and Adverse Event Reporting Policy 3-D-23 Complaint Reporting Policy 3-D-22 Client Emergency Response 3-D-120 Employee Assistance Program (EAP) Ethics Policy 1-200 Page 11 of 16
Page 12 of 16 APPENDIXA TEAM DISCUSSION *Note: Please complete form and scan in client record PLANNING FOR THE DISCLOSURE MEETING Task Have all relevant staff/support workers/volunteers/partners involved in the incident been notified and consulted Identify support person (e.g. family member) for the client: Name Relationship to client Availability for the meeting Identify person(s) responsible for initial disclosure conversation with client: Known to client Familiar with incident and care of client Good interpersonal and communication skills Willing to maintain relationship with client Received disclosure training Name(s) Establish and agree upon known facts: Avoid include speculation, opinion or blame Delegate communication of appropriate details to those staff that need to know (e.g., those managing the client or who may be questioned by the client or his/her family) to one team member. Consider appropriate timing of the initial discussion (as soon as possible after incident e.g. 48 hours): Clinical condition of client Availability of key staff and support Availability of client s support person(s) Client preference Privacy and comfort of client Emotional and psychological state of client Identify special considerations or support and offer as appropriate: For client For staff/support workers/volunteers/partners Identify location for disclosure: Private Quiet
Ensure ongoing operational requirements are being met s No How to Disclose Additional Guidelines to Approach Disclosure Meetings Incidents can occur: With no deviation from the standard of care With deviation from the standard of care Page 13 of 16 Unless you are already certain, begin initial disclosure conversations on the assumption that the standard of care has been met. If an investigation should later reveal that the standard of care was not met, the organization will take responsibility for the incident and harm that occurred. Prior to the initial disclosure with the client, the disclosure team should agree on what information will be shared at the meeting. Team members may wish to role play in preparation. If the standard of care has been met, follow the steps set out below. 1. Anticipate Start with an expression of sympathy and an apology. The apology should take the form of a benevolent expression of regret e.g. I am so sorry that you and your family are having such a difficult experience. 2. Listen To understand the client and family concerns 3. Empathize Use active listening techniques and normalize their thoughts and feelings without being defensive e.g. It sounds as though this is.very difficult for you to hear. 4. Apologize I am so sorry you have had this experience. 5. Explain Offer to explain what happened to the client and family e.g. Would it help if I were to explain what happened? If it is known that the standard of care has not been met at the outset, or if it is determined subsequently, follow the process, follow the steps as outlined below. 1. Truth, transparency, teamwork Begin with truthful and transparent statement of facts
Page 14 of 16 2. Empathize with experience of client and family I can imagine this is making you feel very. 3. Apologize and take accountability to try to prevent similar situations from happening again Take responsibility for what happened Responsibility should not be confused with blame. Responsibility within a systems approach is a commitment to be open and transparent and to improve practices to try to prevent similar events from happening again I am so sorry that I. 4. Manage client care, emotional support for those involved and ongoing communication and help in recovery from the harm/incident e.g. medical, practical, financial, etc.
Page 15 of 16 APPENDIX COMMUNICATION CHECKLIST Overall approach 1. Anticipate the client s thoughts, feelings, and questions. 2. Listen to the client and family to understand their feelings and concerns; there may be strong emotions, so acknowledge them and avoid being defensive 3. Empathize with the client/family s thoughts and feelings e.g. I can understand how upsetting this must be; I can see how this doesn t make sense to you 4. Explain e.g. Would it help if we went over what happened? Environment (Physical, Cultural, Body Language) Make sure there are no barriers between you and the client If you feel nervous, put your feet together on the floor, put your knees together and put your hands, palm down on your lap (a neutral position) If addressing two people, sit them beside each other Sit with your eyes at the same level as the client s Maintain eye contact except if the client is distressed Speak slowly, clearly and in appropriate language explain medical terms If English is not the client/family s language of comfort, use an interpreter not a family member Try to look relaxed and unhurried Emotional context Identify and address emotions and their cause, and respond in a way that shows you have made the connection e.g. That must have felt awful or This information has obviously come as a shock or I wish things had turned out differently or This must be very difficult for you or We are so sorry that this happened to you Establish Agenda Introduce everyone and explain the purpose of the meeting Take charge with an opening statement e.g. I want to tell you about what happened with your mother or Something has happened that I need to speak to you about Narrate events in sequence, speak slowly and deliberately using layman s language Don t rush-it may give the impression that you are avoiding issues or crowding the client/family out
Page 16 of 16 Listening Skills Ask open-ended questions e.g. How are you? How did that make you feel? Remain silent while the client is speaking Nod, smile, request elaboration/clarification and repeat a key word from the client s comments Clarify any ambiguities Inform the client/family of any time constraints and when discussion can resume If you must answer a pager/cell, do so while acknowledging that a client is with you Summarize and strategize Schedule the next discussion to happen very soon Summarize the steps you plan to take Don t promise anything you can t deliver Before wrapping up, ask if there are other issues that should be discussed, even if you cannot address it now because of lack of time or information.