Disclosure of Adverse Patient Safety Events and Harm Kitty Grant Beth Kiley Risk Management/ Patient Safety Consultants Performance Excellence

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1 Disclosure of Adverse Patient Safety Events and Harm Kitty Grant Beth Kiley Risk Management/ Patient Safety Consultants Performance Excellence

2 Definitions: Adverse Patient Safety Event: A patient safety event which results in unintended harm to the patient and is related to the care and/or services provided to the patient rather than the patient s underlying medical condition and; May negatively impact a patient s physical and/or psychological health and/or quality of life. Adapted CPSI 2008.

3 Definitions: Adverse Patient Safety Event: Type A that affects or potentially affects a particular patient. Type B that affects or potentially affects: multi-person or groups of affected individuals; Issues that are legitimate public interest, this may involve other health organizations and districts.

4 Definitions: Disclosure: The process by which an adverse event is communicated to the patient by HC providers. Initial Disclosure is the initial communication with the patient as soon as reasonably possible. Post-analysis Disclosure is the subsequent communication with a patient about known facts related to the reasons for the harm after an appropriate analysis of the event. CPSI 2008.

5 Policy Events are discussed with the patient or with SDM when patient lacks capacity; and repeated with the patient if/when they regain capacity. Nothing precludes a provider from: disclosing minor events immediately & directly; Patient Impact Scale Level 1-4 (e.g. omitted dose). Applies to near miss events Example: patient with same name.

6 Initial Disclosure Team & Discussion Inform manager or appropriate person; Process for after-hours. Initial assessment of event is this Type A or B; Follow the Decision-making framework. Designate the initial disclosure team: Team consists of appropriate p providers, manager and Patient Representative (if available); Respect patient wishes if they have chosen not to interact with certain team members after the event; Respect the option/obligation of providers to consult with their professional organizations and/or indemnifiers prior to participating; Provide the patient the opportunity to arrange external support persons of their choice; Arrange for other potential internal support person s to be available to attend or provide subsequent support to the patient; and Inform the patient of their option to contact Ethics Support.

7 Initiating Disclosure Person known to & trusted by patient; Good interpersonal/ communication skills; Be respectful cultural, language, gender, & diversity issues; Good grasp of the relevant factual information; Well informed about the patient s needs (e.g. capacity); Willing/ able to apologize & express regret; Provide sensitive feedback; Be able to maintain medium to long-term relationship & provide support.

8 Timing & Threshold Adequate time for initial analysis & information; Timing be consistent with normal care practices around providing health care information to patients; t Clinical condition of patient (e.g. capacity); Patient/ substitute decision-maker preferences; Availability of key involved staff & appropriate communicators; Availability of patient s family/ support persons as requested; Availability of internal support staff; Privacy and patient comfort; and Patient-centered & private location for disclosure.

9 Initial Discussion Content Patient advised of identity & role of all persons attending disclosure; Empathic expression of regret and apology from the care-providers, health care team, and the organization is acceptable and encouraged as per Our Promise. If the team and organization are responsible, accept responsibility and apologize. Early expression of regret communicates concern and empathy; Subsequent apologies and regret may be important to the patient/family; An apology is not an expression of liability.

10 Initial Discussion Content Accurate explanation of what happened: All factual information that patient in the circumstances would reasonably wish to know; Potential outcomes & consequences; and Information to allow patient to make fully informed decisions about future health care and treatment. Facilitate the patient s understanding: Ample time to ask questions; Use of appropriate language and terminology; Awareness and appreciation of patient s culture, language, education level, and special needs.

11 Initial Discussion Content Offers of practical and emotional support; Anticipate need for long term support; Present an initial care plan for consideration; What steps are being taken to manage the adverse PSE and that the event has been or will be reported to the appropriate organizational authorities.

12 Discussion Content does not include: Speculation regarding the adverse PSE; Attributing ti blame to specific individuals, id health care providers and/or organizations/districts; Admission i of liability do not use the L word; Denial of responsibility; and Intentional omission of and lack of clarity regarding the known facts.

13 CDHA External Disclosure (Type B) Follow a decision-making framework: Identify and assemble relevant stakeholders Patient advocate (e.g. public participant board); Ethics, Legal support, Risk/Pt Safety, & Communications; Identify the decision makers and how recommendations Identify the decision-makers and how recommendations will be reached (e.g. consensus, vote or secret ballot); Identify and reflect on the ethics principles involved; Confirm the facts;

14 CDHA External Disclosure (Type B) Consider all relevant information & evidence; What are the disclosure options; What are the benefits and burdens of the disclosure options; Go forward recommendations; Communication strategy; and Monitor and evaluate outcomes of disclosure.

15 External Disclosure Communications designates the authorized spokesperson who has been part of the ethics decision- making process and supports other CDHA staff who are interviewed; Written permission from patient/ decision-maker is requested for public release of information We will not identify them; External timeline for release ASAP, as a third party may do it for you; The patient/family or a third party may disclose communication about an internal event without seeking your participation or approval So prepare.

16 References Canadian Patient Safety Institute Canadian Disclosure Guidelines (2008). Guidelines for Informing the Media After and Adverse Event (2010). Canadian Medical Protective Association Communicating with your patient about harm- Disclosure of Adverse Events (2008). Nova Scotia Department of Health Disclosure of Adverse Events Policy (2005). Patients for Patient Safety Canada Disclosure Principles (undated).

17 The End

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