Patient Safety Standards Book V.0.1 PDF

Patient Safety Standards Book Version 0.1 “Raising the Bar for Safer Healthcare” Introduction The Saudi Patient Safety Center is pleased to present the first draft of the Patient Safet...

Patient Safety Standards Book Version 0.1 “Raising the Bar for Safer Healthcare” Introduction The Saudi Patient Safety Center is pleased to present the first draft of the Patient Safety Standards, a significant step forward in the shared commitment to delivering safer healthcare. These standards are an essential milestone aligned with the Centre’s core business under article 3—mandate number 2, which is to issue patient safety standards, best practices, and approaches to be employed by healthcare practitioners and organizations. The Patient Safety Standards took into account the most recent evidence-based practices and the recommended actions and tactics from local and global patient safety institutions, the global patient safety action plan, peer-reviewed patient safety journals, and insights from subject matter experts and healthcare organizations when developing the content of this book. The skeleton of this standards book is a 10*5*5 framework comprising ten patient safety domains. Five primary criteria characterize each domain, and each criterion is supported by five pieces of evidence contributing to achieving the primary criteria. The standards book devised a logical and progressive sequence of required evidence to support and advance your patient safety excellence journey. This sequence is designed to help you maintain your current practice by considering each criterion's structure, process, and outcome requirements. Sharing this draft emphasizes maximizing the extensive collaboration with many stakeholders united by the goal of reducing preventable harm in healthcare settings. Therefore, we invite you to review the document and share your feedback. Together, we can co-create a set of standards that will drive meaningful improvements in patient safety, benefiting patients, families, and healthcare providers alike. Disclaimer All rights reserved to the Saudi Patient Safety Center. This document or any part of it is not for printing, sharing, or dissemination for any purpose except the official aim and purpose of having your official insight for enhancement and feedback. Alteration of the contents of this book or using it in any commercial context without prior approval from the publisher is prohibited. Domain 1: Quality and Patient Safety Tools In healthcare, ensuring the safety of patients is a responsibility that permeates every aspect of care delivery. Yet, healthcare organizations face ever-evolving challenges in delivering safe and effective care. Using evidence-based quality and patient safety tools is essential to enhancing patient safety and enabling health professionals to protect those entrusted to their care. The importance of performance improvement tools and models rests on their systematic approach of identifying areas for improvement, prioritizing actions, and monitoring performance progress. Hence, incorporating models such as Lean, Six Sigma, and the Plan-Do-Study-Act (PDSA) cycle can improve patient safety by continually assessing and refining the care processes. Health organizations strive to enhance patient safety through evidence-based tools. Therefore, it becomes imperative to investigate the underlying factors contributing to adverse events. This connection between patient safety tools and root cause analysis forms a crucial synergy, where the insights gleaned from improvement tools guide the in- depth exploration of systemic contributing conditions. Patient safety investigations such as Root Cause Analysis (RCA) is a structured approach to investigate safety events by drilling into the underlying factors that lead to an incident. The goal is to uncover the root causes that, when addressed, can prevent the recurrence of similar events and facilitate lasting improvements. In the academic literature, many other quality and safety tools appear of great impact on patient safety and outcomes. For instance, implementing a standardized communication approach, such as the SBAR (Situation, Background, Assessment, Recommendation), I-PASS (Introduction, Patient, Assessment, Situation, Safety Concerns), or SOAP (Subjective, Objective, Assessment, Plan) promotes clarity, consistency, and accuracy in transmitting patient information [9-11]. This approach can reduce the risk of critical information being lost, miscommunicated, or misinterpreted, leading to improved patient safety and reduced errors during care transitions. Safety huddles are another tool that facilitates regular safety discussions among team members, providing an opportunity to share observations, voice concerns, and propose solutions. Regular huddles help organizations address issues promptly and create a culture that prioritizes vigilance and continuous improvement. It should be acknowledged, however, that acting to avoid failures prospectively is more valuable compared to reacting to a specific event retrospectively. Therefore, in the pursuit of patient safety excellence, organizations must adopt a proactive improvement approach. This involves identifying, prioritizing, and mitigating potential risks before they escalate into adverse events. Models, such as failure mode and effect analysis (FMEA) and DMADV (Define, Measure, Analyze, Design, Verify) assist healthcare organizations in predicting failures and minimizing the occurrence of preventable safety errors. In conclusion, evidence-based quality and patient safety tools play a critical role in optimizing patient safety. By embracing these tools, healthcare organizations can establish a culture of continuous improvement, open communication, and proactive risk mitigation, ultimately saving more patients and fostering a safer healthcare environment. Page 2 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 1.1: the organization uses evidence-based performance improvement models to enhance patient safety. Description: This criterion highlights the organization's commitment to utilizing evidence-based performance improvement models, such as Lean, Six Sigma, PDSA (Plan-Do-Study-Act), or DMAIC (Define-Measure- Analyze-Improve-Control) as a means to enhance patient safety continuously. This subsequently demonstrates a commitment to staying abreast of advancements in the patient safety field and utilizing evidence-based performance improvement approaches as a cornerstone to enhance the quality of service, patient safety, and health outcomes. Healthcare organizations can adhere to these requirements by establishing a written program, policy, or plan outlining their improvement processes, models, prioritizations, and stakeholders involved. Such a document serves as a roadmap to mitigate risks and enhance safety systematically. This plan should be accompanied by records of staff (i.e. clinical and non-clinical) training on performance improvement processes and models. The training on performance improvement is intended for staff as determined by the healthcare organization. Moreover, organizations must provide written evidence of at least two completed patient safety-related improvement projects, with evidence of implementation and involvement of the right interdisciplinary team in these projects. Therefore, patients may be involved in the co-design of these projects. Lastly, there should be evidence of reviewing and monitoring safety practices changes based on the improvement project's findings. This could be through a set of performance indicators, inspection reports, audit rounds, dashboards, committee discussions, leadership discussions, or customer feedback. Evidence: 1.1.1 A written performance improvement plan outlines the process, procedure, and models used to enhance the performance. 1.1.2 Records of performance improvement training for the staff involved in performance improvement on improvement processes, models, and tools. 1.1.3 Documentation of at least two completed and implemented patient safety improvement projects using models such as lean, PDSA, or DMAIC. 1.1.4 Evidence of involving a relevant interdisciplinary team in patient safety improvement projects. 1.1.5 Evidence of reviewing and monitoring changes in safety practices following performance improvement projects at least quarterly. Page 3 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 1.2: the organization deploys a systematic approach for investigating patient safety events. Description: This criterion highlights the importance of adopting a systematic approach in investigating patient safety events to identify areas for improvement and implement preventive and corrective measures to mitigate the risk and prevent similar incidents in the future. The organization goes beyond merely addressing the immediate factors contributing to an event. It delves deeper into the underlying systemic issues and human factors that may have played a role. A written policy, plan, guideline, or protocol outlining the event investigation process is a foundational guide for healthcare institutions to understand factors contributing to safety incidents. Also, organizations must train the staff involved in the investigation on the processes to equip them with the skills needed to conduct thorough and effective investigations. Such training might be conducted just on time when an event that requires investigation occurs. Safety event reports, completed by interdisciplinary teams using tools like brainstorming, Fishbone diagram, 5-Whys analysis, or tree diagram, serve as tangible evidence of the commitment to pinpointing the root causes. It is required also to submit evidence of developing a corrective and preventive action plan following the investigation. These actions need to be regularly monitored for accomplishment to ensure that the identified improvements are effectively integrated and closed. Such monitoring could be through a set of performance indicators, inspection reports, audit rounds, dashboards, or customer feedback. Evidence: 1.2.1 A written policy outlines the indications, processes, tools, reporting, responsibilities, and documentation of investigating safety events. 1.2.2 Records of training for staff who are involved in the processes of investigating safety events. 1.2.3 A report of completed safety event investigation (i.e. within 30 days) by the relevant team using tools such as Fishbone, 5-Whys, or tree diagram. 1.2.4 Evidence of developing a corrective action plan following safety event investigation. 1.2.5 Evidence of reviewing and monitoring the implementation of the developed action plan based on the investigation findings at least quarterly. Page 4 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 1.3: the organization establishes a standardized, evidence-based communication approach to reduce handoff errors. Description: This criterion highlights the importance of establishing a standardized, evidence-based handoff approach such as SBAR (Situation, Background, Assessment, Recommendation), I-PASS (Introduction, Patient, Assessment, Situation, Safety Concerns), or SOAP (Subjective, Objective, Assessment, Plan), for exchanging patient care information accurately within healthcare organizations at the provider level (i.e. staff to staff) and patient level (i.e. site to site or unit to unit) to mitigate the risk of handoff errors, promote seamless information exchange, and promote patient safety subsequently. A comprehensive policy delineating the process and tools employed for handoff assists in establishing a standardized language in which healthcare teams communicate, preventing misunderstandings and omissions that can have major consequences. Healthcare organizations need to maintain documented evidence of using such structured handoff tools to promote consistency and thoroughness in conveying critical patient information. Further, An analysis report of reported handoff errors followed by a detailed action plan to reduce them would enable healthcare organizations to learn from mistakes and proactively prevent their recurrence. Lastly, monitoring adherence to handoff policy and documentation helps ensure that established protocols are consistently followed. Such monitoring could be through performance indicators, audit rounds, or chart reviews. Evidence: 1.3.1 A policy that outlines handoff processes, procedures, tools, and responsibilities at the provider and patient levels. 1.3.2 Evidence of integrating communication and handoff tools in the orientation program of newly hired staff. 1.3.3 Documented evidence of using structured, evidence-based tools routinely during handoffs. 1.3.4 An analysis report of reported handoff errors and process violations, followed by an action plan to reduce such concerns. 1.3.5 Evidence of reviewing and monitoring adherence to handoff policy and documentation at least quarterly. Page 5 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 1.4: the organization utilizes a structured safety huddle tool to facilitate raising and reporting patient safety concerns. Description: This criterion emphasizes adopting a structured safety huddle tool at the organizational and departmental levels to facilitate identifying, raising, and reporting patient safety concerns. The tool serves as a purposeful communication mechanism to enable health professionals to share their observations, potential hazards, and other safety-related issues in a focused, coordinated, and transparent manner to lead a safer healthcare delivery. A policy outlining the purpose, procedure, frequency, and participants of safety huddles is a cornerstone to ensure clarity and consistency of safety huddle implementation. Also, healthcare organizations should invest in training encouraging active participation from all relevant interdisciplinary teams in safety huddles. Such training is essential to ensure all participants have the knowledge and skills to contribute effectively. Further, keeping documented evidence of training records and evidence of using safety huddle tools is important for tracking and analysis purposes. An analysis report of raised safety concerns through safety huddles, followed by action plans, signifies a commitment to addressing and preventing identified existing vulnerabilities promptly. Lastly, monitoring adherence to safety huddle practices using performance indicators, audit rounds, or staff feedback reports is crucial in ensuring the sustainability and effectiveness of this safety initiative. Evidence: 1.4.1 A written policy outlines the safety huddle's purpose, process, procedure, responsibilities, and frequency. 1.4.2 Records of safety huddle training for staff involved in the safety huddle process. 1.4.3 Documented evidence (i.e. report, log, meeting minutes) of using safety huddles tool or procedure. 1.4.4 An analysis report of raised safety concerns through safety huddles, followed by documented action plans. 1.4.5 Evidence of reviewing and monitoring adherence to safety huddles policy and documentation at least quarterly. Page 6 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 1.5: the organization employs a systematic, proactive approach to identify, prioritize, and mitigate potential risks. Description: This criterion emphasizes the importance of establishing a systematic risk management framework to identify, evaluate, prioritize, and effectively reduce or mitigate potential risks in healthcare settings. This framework assists in identifying potential risks that may impact patient safety or compromise operational efficiency or the overall quality of care. After risk identification, the healthcare organization adopts an evidence-based grading/scoring system that is based on the likelihood and consequences of these risks to help in prioritizing them, such as risk priority number (RPN), hazard and operability study (HAZOP) or severity assessment code (SAC). Thereafter, a methodical prospective approach such as Failure Mode and Effects Analysis (FMEA) or DMADV (Define, Measure, Analyze, Design, Verify) is employed to develop decisive actions addressing these risks systematically. To streamline risk management and proactive risk reduction processes, healthcare organizations need to train the involved personnel to detect risks and use such proactive approaches. Such training is anticipated to equip personnel involved in risk reduction projects with the necessary knowledge and skills. Lastly, the ongoing review and monitoring of implemented risk reduction strategies ensure that the organization's risk management efforts remain relevant and effective. The monitoring could be through a set of performance indicators, inspection reports, audit rounds, dashboards, or customer feedback. Evidence: 1.5.1 A written risk management plan or guideline outlines the processes of risk identification, evaluation, prioritization, and treatment. 1.5.2 Records of risk management training for relevant staff involved in risk evaluation and reduction processes and projects. 1.5.3 A report outlines organizational risks that are identified and prioritized based on their severity and likelihood using a risk scoring tool. 1.5.4 Evidence of employing a proactive risk reduction approach, such as FMEA or DMADV, by a relevant interdisciplinary team with implemented actions. 1.5.5 Evidence of reviewing and monitoring risk reduction strategies implemented based on the prioritized risks at least quarterly. Page 7 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Domain 2: Leadership Commitment to Patient Safety In rapidly evolving healthcare, the great concern for health organizations is the safety and well-being of their patients. Leaders play a pivotal role in shaping a culture of dedication to patient safety that stimulates the successful implementation of patient safety initiatives. Leaders dedicated to patient safety demonstrate a steadfast commitment to safety as a top priority, openly communicating safety goals and actively engaging with staff and patients in safety initiatives. Through their dedication and guidance, leaders establish a solid foundation for providing safe care, create a resilient culture of safety that safeguards patients, inspires trust, fosters a sense of purpose among staff, and drives continuous improvement in healthcare delivery, which ultimately leads to better outcomes and satisfaction. Effective leadership commitment to safety starts with ensuring that patient safety is a central priority. In this, leaders set the tone by officially designating patient safety as a strategic priority, reflected in mission statements, strategic plans, and policies emphasizing patient safety. Further, dedication to patient safety translated this strategic priority into fundamental actions such as participating in a structured safety leadership WalkRoundsTM program. In this program, leaders establish open and transparent communication with frontline staff, fostering an environment where safety concerns are identified, discussed, and acted upon collaboratively. In addition to patient safety concerns revealed during WalkRoundsTM sessions, excellent practices are noticed and should not be overlooked without being rewarded. Therefore, healthcare organizations need to create a rewarding system to recognize staff members who actively contribute to patient safety through reporting or participation in patient safety initiatives. At the individual and departmental levels, the reward system encourages and motivates staff to engage in patient safety efforts. The reward might be achieved at the organizational level by pursuing and obtaining a recognized national or international patient safety award and certificate. These criteria demonstrate the organization's dedication to meeting and exceeding patient safety standards, inspiring confidence among patients, families, and the broader healthcare community. It should be acknowledged, however, that leaders hold various levels of patient safety competency. Hence, healthcare organizations need to clearly define the knowledge and skills necessary for leaders to communicate, collaborate, and lead by example in promoting patient safety in every aspect of care delivery. In conclusion, leadership commitment to patient safety goes beyond words; it is exemplified by taking actions and initiatives that prioritize the safety of patients and the excellence of care. By designating patient safety as a central strategic priority, implementing structured WalkRoundsTM programs, creating a rewarding system, addressing leadership competencies, and pursuing patient safety recognition, leadership promotes a culture where patient safety is not just a goal but a shared commitment that resonates throughout the organization. Page 8 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 2.1: the organization demonstrates its commitment to safety by designating patient safety as a central strategic priority. Description: This criterion highlights the mechanism in which the organization exemplifies dedication to patient safety by designating patient safety as a central strategic priority to enhance safety culture at all levels, from the organizational board to the frontline staff members. In this, healthcare organizations strategically prioritize patient safety in their projects, plans, meetings, and daily business operations. Developing a patient safety plan aligned with the organizational strategic priority is essential to further reinforce patient safety. This plan outlines the organizational efforts to improve patient safety and reduce errors. The plan must be reviewed and approved by the organizational director/chief executive officer (CEO) to underscore the significance of patient safety from the highest levels of leadership. Furthermore, regular discussions of safety reports and proactive solutions during leadership and board meetings are vital. These discussions and participation of leaders in the patient safety journey promote a transparent and responsive approach to addressing safety concerns, fostering a learning environment, and assisting leaders in supporting patient safety projects and initiatives. Lastly, the routine review of patient safety indicators by relevant leaders at least quarterly provides continuous monitoring and insight into the organization's safety performance, enabling timely adjustments to strategies and interventions. Evidence: 2.1.1 A written strategic plan that integrates patient safety as an organizational strategic priority. 2.1.2 A written organizational patient safety plan that is reviewed and approved by the organizational director/chief executive officer (CEO). 2.1.3 Evidence of discussing or suggesting solutions based on safety reports or major patient safety events in leadership and board meetings. 2.1.4 Evidence of leadership participation in at least two patient safety projects, events, or initiatives. 2.1.5 Evidence of reviewing and monitoring the results of patient safety indicators by relevant leaders at least quarterly. Page 9 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 2.2: the organization develops and implements a structured patient safety leadership WalkRoundsTM program to promote safety. Description: This criterion highlights the importance of strategically employing patient safety leadership WalkRoundsTM to strategically advance patient safety in healthcare organizations. This initiative entails the active participation of senior leaders and clinical department heads in regular rounds, engaging with frontline staff to assess safety culture, identify potential safety concerns, and promote free reporting of safety concerns. For consistency, it is essential to establish a policy that outlines the objectives, scope, frequency, and assigned responsibilities of patient safety leadership WalkRoundsTM. This policy serves as the foundational document that clarifies the entire process. Moreover, healthcare organizations must train their executives and leaders on leadership WalkRoundsTM to equip them with the necessary knowledge and skills to conduct these rounds without drifting from the intended purpose. To ensure the regularity of these rounds, organizations must also prepare a schedule for monthly patient safety leadership WalkRoundsTM. Such a schedule may include details on dates, participants, and areas planned to be visited. Moreover, healthcare organizations must maintain documented evidence that details the discussions and action plans developed to address the safety issues raised during these rounds. Subsequently, healthcare organizations must review and monitor action plans to ensure they are effectively implemented. This monitoring could be through a set of performance indicators, inspection reports, audit rounds, dashboards, or customer feedback reports. Evidence: 2.2.1 A policy outlines the process, procedure, frequency, and responsibilities of the patient safety leadership WalkRoundsTM. 2.2.2 Records of training organization’s executives and leaders on patient safety leadership WalkRoundsTM. 2.2.3 Records of conducting patient safety leadership WalkRoundsTM at least monthly, including participants, visited areas, and the voiced safety issues. 2.2.4 Documented evidence of developing and implementing action plans following leadership WalkRoundsTM to address voiced safety issues. 2.2.5 Evidence of reviewing and monitoring the implementation of action plans that were developed following patient safety leadership WalkRoundsTM. Page 10 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 2.3: the organization's leaders create a rewarding system to recognize staff members who actively contribute to patient safety. Description: This criterion highlights the dedication of leaders toward patient safety by instituting an internal reward policy designed to commend staff members who are actively engaged in advancing the quality of care. The organization must integrate patient safety contributions as a recognized effort that requires acknowledgment and appreciation. The policy aims to enhance the safety culture and motivate healthcare professionals by identifying individuals who consistently and positively contribute to promoting patient safety. For fairness and understanding purposes, the policy shall include the selection and evaluation criteria for recognizing patient safety contributions. Also, this policy shall be communicated to all staff members to encourage widespread participation. Moreover, healthcare organizations should show instances where leadership has formally recognized staff members who have acquired advanced patient safety certifications, actively reported safety concerns, or consistently engaged in safety initiatives. This recognition acknowledges individual commitment to enhancing patient safety and sets a precedent for others. Furthermore, healthcare organizations should review and monitor compliance with and the impact of implementing the rewarding policy. This monitoring could be through assessment reports, culture surveys, satisfaction surveys, or staff feedback reports. Compliance with this criterion is an administrative necessity that promotes a patient-centric ethos within healthcare organizations. Evidence: 2.3.1 A written rewards policy that integrates patient safety contributions as an effort requires organizational acknowledgment and appreciation. 2.3.2 Evidence of communicating the selection and evaluation criteria of recognizing patient safety contributions to all organizational staff. 2.3.3 Evidence on instances demonstrates leadership recognition for staff who acquired advanced patient safety certification. 2.3.4 Evidence on instances demonstrates leadership recognition for staff active in reporting safety concerns or consistently involved in safety initiatives. 2.3.5 Evidence of reviewing and monitoring compliance with and impact of implementing the rewarding policy at least quarterly. Page 11 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 2.4: the organization defines the competencies required for its leaders to champion patient safety initiatives effectively. Description: This criterion underscores the necessity of reviewing and evaluating the skills and competencies of its leaders to ensure their ability to drive patient safety initiatives effectively. In this, healthcare organizations need to establish a framework that outlines the competencies required for leaders to champion patient safety initiatives effectively. This competency framework serves as a strategic roadmap, defining the skills, knowledge, and responsibilities leaders need to lead by example, ensuring patient safety remains a core priority. Hence, integrating these competencies into the job descriptions of organizational leaders would foster patient safety as a fundamental part of their duties. Similarly, organizations should utilize patient safety-related competencies in organizational leaders' recruitment and evaluation process. For instance, assessing leader candidates based on patient safety competencies during interviews ensures that the leader possesses the qualifications and mindset to drive patient safety initiatives forward. Lastly, healthcare organizations must regularly review and monitor the perceptions of both staff and patients regarding the leadership's effectiveness in championing patient safety. Such monitoring could be obtained through a designated survey or part of other surveys such as staff satisfaction, patient satisfaction, and safety culture surveys. The feedback allows for the continuous improvement of leadership practices and highlights the importance of a culture of accountability and transparency. Evidence: 2.4.1 A written competency framework outlines the required competencies for leaders to champion patient safety initiatives. 2.4.2 Evidence of integrating patient safety roles, responsibilities, knowledge, and skills in the job descriptions of organizational leaders. 2.4.3 Documented evidence that leaders use patient safety-related competencies in addressing and responding to patient safety events. 2.4.4 Evidence of appraising leaders' performance annually based on patient safety metrics and indicators. 2.4.5 Evidence of reviewing and monitoring the perception of staff and patients regarding the leadership's effectiveness in championing patient safety. Page 12 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 2.5: the organization demonstrates its dedication to patient safety by pursuing and achieving external patient safety recognition. Description: This criterion emphasizes the value of dedication to patient safety through pursuing and accomplishing national or international patient safety awards or certifications, such as the SPSC National Patient Safety Award (NPSA) and Patient Safety-Friendly Hospital Initiative (PSFHI). Participation or applying for patient safety certificates or awards is an initial level demonstrating a commitment to patient safety. However, obtaining such certificates or awards is a step ahead of the level of dedication and unique implementation of safety rules. Healthcare organizations need to keep documented evidence of applying for, participating in, and obtaining such certificates or awards. Equally important, organizations need to conduct awareness campaigns for staff regarding the specific requirements of these safety awards or certificates, ensuring that every team member understands their role in meeting the criteria and contributing to patient safety. Furthermore, healthcare organizations should transparently communicate the pursuit and achievement of patient safety recognition internally and externally, celebrating these accomplishments with staff and sharing them with patients, families, and the broader community. Last but not least, maintaining the performance gains preceding or following the attainment of safety recognition is important. Hence, regular review and monitoring of metrics that demonstrate ongoing improvements in patient safety outcomes provide a quantifiable measure of the positive impact of these certificates or awards. Evidence: 2.5.1 Documented evidence of applying for or participating in national or international patient safety awards or certificates. 2.5.2 Records of providing training or awareness sessions to the staff regarding safety awards or certificate requirements. 2.5.3 Evidence of obtaining a national or international patient safety award or certificate. 2.5.4 Evidence of communicating the pursuit and achievement of patient safety recognition internally and externally. 2.5.5 Evidence of reviewing and monitoring improvements in patient safety outcomes preceding or following the safety recognition. Page 13 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Domain 3: Patient Safety Culture Patient safety culture has emerged as a guiding path toward safer and more compassionate care in healthcare. Patient safety culture represents the collective values, beliefs, and behaviors that shape the safety-conscious mindset of an organization. A positive patient safety culture is vital in saving lives, promoting outcomes, and enhancing how healthcare is practiced and perceived. Therefore, assessing safety culture helps organizations identify areas for improvement and enable the evolution of meeting patient safety challenges. In patient safety, the influence of leadership cannot be overstated. From boardrooms to bedside, leaders play a role in setting the tone, aligning priorities, and empowering frontline caregivers, subsequently nurturing a safety culture. In addition, other factors assist in shaping the safety culture, such as organizational structure, safety policies, communication, and patient engagement. It should be acknowledged, however, that patient safety culture is confronted by diversified barriers and challenges, such as time pressures, workload, and resistance to change. Hence, healthcare organizations need to adopt measures to enhance the culture of patient safety, such as developing a patient safety plan, forming an interdisciplinary committee overseeing quality and patient safety, and conducting periodic patient safety awareness campaigns. Using validated tools for measuring staff perceptions of patient safety culture is important. It ensures that the healthcare organization understands its safety culture, areas of strength, and areas that require improvement. Furthermore, an incident reporting system encourages open communication about safety concerns and allows organizations to identify potential risks. However, voluntary incident report systems may not detect all errors. Thus, it is recommended to use a combination of various tools to detect medical errors and learn from them. For instance, effectively employing trigger tools to capture missed or unreported safety events is critical. These tools serve as an additional layer of defense in the pursuit of patient safety, enabling organizations to detect errors that might otherwise remain hidden. Transparency and learning from errors create an environment where individuals feel comfortable reporting safety events without fear of retribution. In this, just culture guides the way toward fairness, accountability, and resilience, eventually empowering individuals to freely report errors, knowing that they will be treated fairly and that the focus is on learning and system improvement rather than blame. In the modern era of interconnected healthcare systems, collective efforts to pursue and advance patient safety culture by sharing successful models and best practices in patient safety remain a common thread that unites the global healthcare community. In Saudi Arabia, the health system has recognized the importance of integrating patient safety principles into healthcare policies and practices. Subsequently, significant strides have been taken to foster a positive safety culture across healthcare institutions. Page 14 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 3.1: the organization adopts measures to enhance patient safety culture. Description: This criterion demonstrates the organization's commitment to fostering a patient safety culture through comprehensive measures. These measures might range from launching a patient safety awareness campaign to adopting artificial intelligence technologies that complement safety practices. Therefore, documenting planned patient safety activities and initiatives in an annually revised patient safety plan encourages alignment with organizational patient safety objectives. This plan must be tailored to the emerging patient safety issues, errors, and reported safety concerns. Achieving patient safety objectives without involving relevant stakeholders appears impossible. Hence, launching patient safety campaigns annually plays a vital role in translating these objectives into actionable awareness. These campaigns raise staff awareness about patient safety goals, measures, and best practices. Furthermore, the evidence of regular discussions on patient safety policies, initiatives, and indicators within an interdisciplinary patient safety committee serves as a dynamic platform for collaboration and knowledge sharing. Crucially, allocating resources such as staffing, training, and technology to support patient safety culture and initiatives demonstrates a tangible commitment to enhancing patient safety. Finally, reviewing and monitoring adherence to patient safety practices brings a sense of accountability and continuous improvement. This monitoring could be through performance indicators, audit rounds, tracers, or chart reviews. Evidence: 3.1.1 A written annual patient safety plan that outlines the planned activities and initiatives to prioritize and enhance patient safety. 3.1.2 Records of launching patient safety campaigns to raise staff awareness of patient safety goals, measures, and practices at least annually. 3.1.3 Evidence of discussing patient safety policies, initiatives, and indicators in an interdisciplinary patient safety committee at least quarterly. 3.1.4 Evidence of allocating resources to support organizational patient safety culture and initiatives. 3.1.5 Evidence of reviewing and monitoring adherence to patient safety policies, measures, and goals at least quarterly. Page 15 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 3.2: the organization adopts a validated tool to measure staff perceptions of patient safety culture and take actions accordingly. Description: This criterion highlights how a healthcare organization is committed to providing safe care by using an evidence-based validated tool annually to assess the perceived safety culture among clinical and non-clinical staff. The evidence-based assessment allows the organization to identify strengths, areas for improvement, and trends over time, laying the foundation for focused and effective safety culture initiatives. However, healthcare organizations need to administer the assessment tool to a representative number of staff members to ensure an accurate understanding of the safety culture within the organization. After administering the survey, analyzing survey data at organizational, departmental, and professional levels and sharing the survey results with participating staff through emails, bulletin boards, posters, or meeting discussions demonstrate transparency and accountability while providing valuable insights into areas that require attention. Thereafter, healthcare organizations need to develop a time-framed action plan that addresses at least the lowest three patient safety culture domains or more to ensure that identified weaknesses are acknowledged and addressed. Lastly, reviewing and monitoring progress in implementing the patient safety culture action plan at least quarterly reflects a commitment to continuous improvement. These initiatives serve as actions to foster an environment where the culture of safety is a priority. Evidence: 3.2.1 Evidence of using an evidence-based validated tool to assess safety culture aligned with the written patient safety plan, at least annually. 3.2.2 Evidence of administering and collecting the patient safety culture survey to a representative sample from all staff (clinical and non-clinical). 3.2.3 Evidence of analyzing safety culture data and sharing the analysis results with participating staff (e.g. email, poster, meeting minutes). 3.2.4 Evidence of developing a time-framed action plan addressing at least one of the three lowest-scored patient safety culture domains. 3.2.5 At least quarterly, evidence of reviewing and monitoring the progress in implementing the patient safety culture action plan. Page 16 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 3.3: the organization utilizes an incident reporting system to promote reporting and learning safety culture. Description: This criterion highlights establishing an incident reporting system to foster a reporting and learning safety culture within the healthcare organization. Such systems (i.e. electronic or paper-based) encourage staff to report incidents, errors, and near-misses openly and transparently. These reports are instrumental in guiding targeted interventions to prevent future occurrences and learning continuously. To define this process, healthcare organizations need to establish a written incident reporting policy to standardize the reporting approach. The policy should outline reporting indications, methods, and timeframes to ensure that staff members understand the procedures and expectations for incident reporting. Furthermore, training all organizational staff on the importance of incident reporting and the use of the reporting system is vital to ensure that all staff members are aware of their role in identifying and reporting safety incidents and to encourage active reporting by all disciplines. Following reporting, healthcare organizations need to develop action plans in response to reported incidents based on a severity matrix such as the severity assessment code (SAC), followed by providing feedback to reporters to keep them informed of actions taken to address their reported event. Lastly, reviewing and monitoring the frequencies, categories, and trends of reported safety incidents and implementing action plans is crucial for data-driven improvements. Evidence: 3.3.1 A written incident reporting policy that outlines the reporting indications, methods, responsibilities, and time frame, as well as the analysis and feedback procedures. 3.3.2 Records of staff training on the importance of incident reporting and the use of the reporting system. 3.3.3 Records of active reporting by all disciplines submitted via a standardized incident reporting system (i.e. electronic or paper-based) 3.3.4 Evidence of developing action plans in response to reported incidents based on the severity matrix, followed by sending feedback to reporters. 3.3.5 Evidence of reviewing and monitoring frequencies, categories, and trends of reported safety incidents and implementing action plans quarterly. Page 17 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 3.4: the organization employs trigger tools to effectively and accurately capture missed or unreported safety events and errors. Description: This criterion underscores the importance of employing trigger tools in the error surveillance approach. The Institute for Healthcare Improvement (IHI) global trigger tools are one of the most commonly used tools. The idea is to use predefined "triggers" that suggest the possibility of an adverse event. These triggers prompt conducting a thorough medical records review to determine if an adverse event has occurred but is missed or unreported through traditional reporting systems. Healthcare organizations need to establish a written policy, protocol, or guideline that defines the triggers and the process for reviewing identified cases to ensure that staff members clearly understand the working mechanism of trigger tools. Hence, the organization must specify the selection and definition of each trigger tool to ensure consistent analysis. Further, staff members involved in the trigger process, as determined by the healthcare organization, need to be trained on the effective use, review, and validation of trigger findings to equip them with the knowledge and skills needed to optimally leverage trigger tools. Proper training ensures that potential safety incidents are not overlooked and that identified cases are thoroughly reviewed. Lastly, reviewing and monitoring trigger tool reviews to identify patterns, trends, and areas of concern provides valuable insights into recurring safety issues. It allows the organization to target its resources and efforts where they are most needed, ultimately enhancing patient safety. Evidence: 3.4.1 A written protocol or guideline defines the process, procedure, and responsibilities in which triggers are used and how identified cases are reviewed. 3.4.2 A training record on how to use, review, and validate trigger findings effectively for staff involved in the trigger process. 3.4.3 A record indicates the organization's consistent and systematic use of clinical trigger tools. 3.4.4 Evidence demonstrates instances where cases are flagged by trigger tools and reviewed to determine if an error occurred. 3.4.5 Evidence of quarterly reviewing and monitoring trigger tool reviews, identifying patterns, trends, and areas of concern. Page 18 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 3.5: the organization employs a just culture approach to foster a safe, fair, and more accountable healthcare environment. Description: This criterion underscores that the just culture approach is based on the belief that everyone makes mistakes but that not all are equal. In this, individuals are held accountable for their reckless or intentional behavior while providing support and learning opportunities for those who make inevitable human errors. To govern this process, healthcare organizations need to establish a just culture policy and algorithm that is aligned with the organizational priorities and the national just culture framework. This policy and algorithm provide a standardized, evidence-based approach to analyzing and categorizing individual behaviors in the context of errors. In just culture, errors are categorized into human errors that require supporting the staff (i.e. second victim), at-risk behaviors that require coaching, and reckless behaviors that require remedial and possible disciplinary actions. Further, training leaders, departmental heads, and managers on just culture is essential to equip them with the knowledge and skills needed to implement the principles of just culture, reduce subjectivity, and ensure that actions taken are proportionate to the nature of the behavior. Lastly, reviewing and monitoring the impact of implementing the just culture policy on patient safety culture and incident reporting is crucial for assessing the policy's effectiveness. The review could be based on indicators, surveys, or audits to measure the overall improvement of safety outcomes. Evidence: 3.5.1 A written just culture policy defines and regulates the analysis of individual behaviors related to errors, which aligns with the national just culture policy. 3.5.2 Records of training for leaders, departmental heads, and managers on just culture principles. 3.5.3 Evidence of adopting and utilizing an evidence-based just culture algorithm to guide the analysis of behavioral choices. 3.5.4 Evidence of using staff support programs such as the “second victim” principle to support staff experienced emotional trauma following human errors as per just culture policy. 3.5.5 Evidence of reviewing and monitoring the impact of implementing just culture principles on patient safety culture and incident reporting. Page 19 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Domain 4: Workforce Safety Workforce safety is a critical concern in healthcare settings, where health professionals tirelessly provide essential care to patients while navigating diverse challenges. Ensuring the safety and well-being of healthcare staff is not only imperative for ethical reasons but also crucial for maintaining high-quality patient care and promoting organizational effectiveness, particularly with the fast-paced and emotionally demanding nature of the healthcare industry. One of the crucial aspects of workforce safety is maintaining a safe staffing level to deliver high-quality patient care. Insufficient staffing can increase workloads, burnout, and compromised patient safety. Hence, healthcare organizations optimize staff-to-patient ratios proactively to reduce the risk of medical errors and adverse events. Therefore, safe staffing levels enable healthcare professionals to provide timely and effective care, fostering a positive work environment that prioritizes patient and staff safety. As an integral part of workforce safety, introducing programs such as the workplace violence prevention program, occupational health and safety program, and work-life balance program appears to be of great value and is linked to patient and staff outcomes. Workplace violence poses a significant threat to the safety and well-being of healthcare staff. Implementing workplace violence prevention programs is necessary to protect employees from potential harm. These programs include strategies such as training staff to recognize warning signs, de-escalation techniques, and appropriate responses to violent incidents. Organizations could create a secure environment by actively addressing workplace violence, boosting staff confidence, and ensuring they can focus on providing optimal patient care. In the same vein, the occupational health and safety program plays a vital role in safeguarding healthcare staff from work-related risks and promoting their well-being. The program involves comprehensive risk assessments to identify potential hazards and the implementation of measures to prevent injuries and illnesses. Also, introducing work-life balance programs supports staff in achieving harmony between their personal and professional lives. By promoting a positive work-life balance, organizations can retain skilled staff, improve productivity, and foster a culture of resilience. Furthermore, adopting the Practice Partnership Model of Care (PPM) contributes to workforce safety through collaboration among healthcare professionals, promoting effective communication, and coordinated efforts to deliver comprehensive patient care close to patients' bedside. In conclusion, to ensure the success of workforce safety mechanisms, healthcare organizations must integrate all these initiatives and programs cohesively. A holistic approach to workforce safety enhances overall staff satisfaction, mitigates staff turnover, and creates an environment where patient care thrives. Leadership support and ongoing evaluations are essential to continuously improve and sustain these mechanisms, creating a safe, supportive, and high-performing healthcare environment for staff and patients. Page 20 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 4.1: the organization maintains a safe staffing level to ensure the delivery of safe and efficient patient care. Description: This criterion places great importance on maintaining a safe staffing level as a fundamental pillar to ensuring the delivery of safe care. By optimizing staff-to-patient ratios, the organization seeks to uphold a healthy environment where healthcare professionals can dedicate focused attention, expertise, and time to each patient's needs. Adequate staffing levels enable timely interventions, close monitoring, and reducing the risk of errors while maximizing health outcomes. Hence, healthcare organizations should develop a written staffing plan tailored to ensure adequate staff-to-patient ratios, considering patients' acuity and care complexity. This plan should meet regulatory requirements and consider the unique needs of the patient population served. Also, the plan should be complemented by a guideline regulating staff scheduling and workload, including scheduling, overtime, work hours, and rest breaks to avoid staff overburden and fatigue-related risks. In staff shortage cases, healthcare organizations should adopt various temporary measures to overcome this shortage, such as employing overtime, cross-training, or adopting flexible staffing models. Further, healthcare organizations must verify that agency staff, if available, are appropriately trained and licensed as per applicable national regulations. Lastly, reviewing and monitoring staffing levels at least quarterly while assuming corrective actions to address shortages allows organizations to respond to staffing challenges and maintain safe care. Evidence: 4.1.1 A written staffing plan to ensure adequate staff-to-patient ratios based on patients' acuity and care complexity as per the relevant authorities. 4.1.2 A written policy, plan, or guideline that regulates staff scheduling and workload, including work hours and rest breaks. 4.1.3 Evidence of implementing measures to address the identified staffing shortages, such as overtime, cross-training, or flexible staffing models. 4.1.4 Evidence to ensure that agency (i.e. outsourced) staff are licensed, trained, and competent as per their job description, if applicable. 4.1.5 Evidence of reviewing and monitoring staffing levels at least quarterly and taking corrective actions to address staff shortage as necessary. Page 21 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 4.2: the organization develops and implements workplace violence prevention programs to protect healthcare staff. Description: This criterion highlights the multidimensional approach to protecting healthcare staff by designing and implementing a structured workplace violence prevention program. The program emphasizes zero tolerance for violence by addressing and mitigating potential risks that could affect the safety of employees. This program, which is usually overseen by the human resources department, should define the types of possible violence, the reporting procedures, and the consequences for those who engage in workplace violence. This policy serves as a guide to staff and management in recognizing, reporting, and addressing workplace violence instances. To further strengthen these efforts, healthcare organizations should conduct training or awareness campaigns to educate and empower staff in detecting, reporting, and preventing workplace violence. Moreover, it is important to conduct a risk assessment as part of the prevention program to identify potential sources of violence, followed by developing and implementing actions and measures to prevent these risks and protect the staff. In addition, security measures may include using panic buttons that staff may use in violent cases to alert others, access controls, the presence of security personnel, and the use of monitored surveillance cameras. Lastly, monitoring reported incidents related to workplace violence and taking appropriate actions to prevent reoccurrences are important to create a safe zone for the staff. Evidence: 4.2.1 A written workplace violence prevention policy that outlines types of violence, reporting procedures, and workplace violence consequences. 4.2.2 Records of training or awareness campaigns for the staff on detection, reporting, and prevention of workplace violence. 4.2.3 Evidence of conducting a risk assessment to identify potential sources of violence, with action plans to prevent or mitigate them. 4.2.4 Evidence of implementing security measures to protect the staff, such as panic buttons, access controls, security staff, and surveillance cameras. 4.2.5 Evidence of quarterly reviewing and monitoring reported incidents related to workplace violence, with actions taken to prevent reoccurrences. Page 22 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 4.3: the organization implements an occupational health and safety (OHS) program to promote a healthy work environment. Description: This criterion underlines the importance of establishing a comprehensive occupational health and safety (OHS) program with the primary objective of fostering a healthy work environment and protecting staff's physical and psychological well-being. This program is a roadmap for hazard identification, risk assessment, and mitigation strategies. To promote the program's effectiveness, healthcare organizations should train the staff on relevant occupational health and workplace safety topics to equip them with the knowledge and skills required to identify and reduce the risk of workplace incidents. The OHS program encompasses multifaceted initiatives, including but not limited to risk assessments, pre-employment assessments, vaccinations, safety training, and health and medical surveillance. For instance, conducting regular proactive workplace risk assessments to identify potential occupational hazards followed by action plans and measures (i.e. corrective and preventative) to prevent or mitigate these risks would protect the health and safety of staff. Lastly, healthcare organizations must monitor the reported and investigated workplace incidents. Such monitoring could be through performance indicators, tracking records, root cause analysis reports, or staff feedback analysis. Compliance with these requirements is a fundamental commitment to the safety of healthcare workers and patients. Evidence: 4.3.1 A written occupational health and safety (OHS) program that outlines the strategies for preventing and managing occupational health hazards. 4.3.2 Records of staff training on relevant occupational health and workplace safety topics. 4.3.3 Evidence of integrating and implementing pre-employment health screening and vaccinations as part of the OHS program. 4.3.4 Evidence of conducting a workplace risk assessment, at least annually, to identify occupational hazards and take actions to prevent them. 4.3.5 Evidence of reviewing and monitoring reported, investigated and managed workplace incidents and injuries. Page 23 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 4.4: the organization introduced a work-life balance program to support staff members’ physical and psychological well-being. Description: This criterion highlights the impact of a work-life balance program on fostering a healthy and sustainable work environment. The program aims to support staff in achieving a harmonious balance between their professional responsibilities and personal lives, ensuring their physical and psychological well-being. Subsequently, it enhances staff satisfaction, reduces burnout, improves retention rates, and ultimately contributes to better patient outcomes. However, to ensure its best utilization, healthcare organizations need to communicate the program and its benefits with all staff through educational materials, announcements, posters, emails, newsletters, or any other channel to ensure that staff are aware of available work-life balance resources. The work-life balance program may include various staff wellness initiatives such as flexible work assignments, remote work policy, stress management workshops, mental health support resources, healthy eating campaigns, meditation sessions, and fitness programs. Also, the program includes implementing time-off policies, including vacation, sick, and parental leave. These initiatives help staff manage the unique stresses of healthcare and contribute to better physical and mental health. Lastly, healthcare organizations must continually review and monitor the effectiveness of the work-life balance program and assess the rate of staff participating to gauge its impact and make necessary adjustments. Evidence: 4.4.1 A written work-life balance program outlines the objectives, components, scope, procedures, and responsibilities. 4.4.2 Evidence of using communication and education materials to inform staff members about the work-life balance program. 4.4.3 Evidence of implementing staff wellness initiatives such as flexible work assignments, stress management workshops, and fitness programs. 4.4.4 Evidence of implementing time-off policies to regulate and manage staff leaves, including vacation, sick, and parental leave. 4.4.5 Evidence of reviewing and monitoring the effectiveness and participation rates in the work-life balance program at least quarterly. Page 24 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 4.5: the organization adopts the Practice Partnership Model of Care (PPM) to achieve better patient and workforce outcomes. Description: This criterion highlights the effect of the Practice Partnership Model (PPM) on patient and staff outcomes. The model emphasizes partnership among healthcare providers. It includes four main components: working in partnership with other staff; clinical handover at the bedside to promote greater patient involvement in their care; comfort rounds (i.e. conducting regular care rounds every 1-2 hours to address patient needs immediately); and environmental modifications (i.e. increasing the time that clinicians spend in the direct vicinity of their patients). These four components reflect patient-centeredness, transform care at the bedside, and improve patient and staff outcomes. Effective PPM implementation starts with educating clinical staff about PPM principles and practices. Such education equips healthcare professionals with the necessary knowledge and skills to effectively implement the model and foster a collaborative care approach. Furthermore, health organizations should integrate PPM principles into the clinical handoff process to enhance communication and cooperation during these critical transitions. Also, documenting the integration of PPM into patient care processes in the patient medical record (e.g. in the multidisciplinary care plan) is essential, as it ensures that the patient's care plan aligns with the collaborative approach. Lastly, healthcare organizations should monitor the impact of PPM on patient and workforce outcomes, such as patient satisfaction scores, staff satisfaction surveys, and clinical outcome measures. Evidence: 4.5.1 A written policy or guideline outlines the Practice Partnership Model (PPM) principles, objectives, and implementation strategies. 4.5.2 Records of training or orientation sessions designed to familiarize clinical staff with PPM principles and practices. 4.5.3 Evidence of integrating the PPM principles in the clinical handoff process across different departments or units. 4.5.4 Evidence of documenting the integration of PPM into patient care processes in the patient medical record. 4.5.5 Evidence of reviewing and monitoring the impact of PPM on patient and workforce outcomes, such as patient and staff satisfaction. Page 25 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Domain 5: Patient Safety Training Patient safety is a cornerstone of high-quality healthcare, and its significance cannot be overstated in ensuring positive health outcomes for patients. To achieve optimal and safe patient care, healthcare organizations must prioritize patient safety training and education for their staff. In fact, patient safety training equips healthcare professionals with the knowledge and skills necessary to identify potential risks, prevent errors, and enhance patient care. Hence, comprehensive patient safety training empowers staff members to adopt evidence-based practices, communication techniques, and teamwork strategies that foster a safety culture. The journey of patient safety training starts upon hiring new staff members through integrating patient safety into general orientation programs. Patient safety terminologies and other topics such as error reporting and just culture are discussed during orientation to set the foundation for a safety-oriented work environment. However, due to the progressive nature of patient safety practices, conducting a follow-up annual patient safety training is vital to reinforce patient safety principles consistently. Through regular training sessions, staff members stay updated on the latest protocols, guidelines, and advancements in patient safety, leading to improved patient outcomes and minimized medical errors. Annual training ensures that all staff members remain well-versed in patient safety concepts and continue to prioritize safe and high-quality care delivery. On top of that, the role of simulation-based training appears a promising effect in supporting patient safety. Simulation-based training offers a dynamic and realistic learning environment where clinical staff can practice and refine their skills without jeopardizing patient safety. Through simulated scenarios, healthcare professionals encounter lifelike patient care challenges, develop crisis management skills, and enhance teamwork and communication. This subsequently prepares staff to respond effectively to complex situations and ultimately improve patient safety. Several factors affect the successful implementation of patient safety training during the orientation phase and annually. Having leaders certified in patient safety and qualified in healthcare leadership appears to be among the most important affecting factors. The significance of having leaders certified in patient safety and qualified in healthcare leadership cannot be overstated. Leaders with expertise in patient safety play a pivotal role in steering patient safety initiatives, driving a proactive approach to risk management, and inspiring a safety-oriented culture among their teams. Certification and qualification ensure that leaders are equipped to make informed decisions, mentor their teams, and effectively advocate for patient safety at all levels of the organization. In conclusion, patient safety training empowers clinical staff with the knowledge and skills to provide safe and effective patient care. The commitment to ongoing education ensures that healthcare professionals remain vigilant in pursuing patient safety excellence, resulting in improved patient outcomes and enhanced trust in the healthcare system. Page 26 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 5.1: the organization integrates patient safety terminologies and practices in the general orientation program for all new hires. Description: This criterion emphasizes the importance of incorporating patient safety terminologies and practices into the orientation process of all newly recruited staff. The goal is to familiarize them with essential safety terminologies, including patient safety goals, just culture, systems thinking, patient engagement, adverse events, near misses, error reporting, and root cause analysis. Hence, healthcare organizations are required to have a written orientation policy that clearly defines patient safety content included in the orientation program to provide a structured framework for educating new staff members on patient safety fundamentals. For consistency, a written agenda, curriculum, or training materials are also vital to equip new hires with a consistent understanding of patient safety terminologies and practices. Following these orientation programs, organizations are expected to maintain orientation delivery, attendance, and evaluation records. Further, to ensure that orientation sessions are delivered correctly and using updated patient safety information, healthcare organizations must assign the orientation role to trainers qualified or experienced in patient safety. Lastly, reviewing and monitoring the enrollment rate of new hires in the orientation program is a critical indicator to ensure that the vast majority of new staff members receive this vital orientation promptly to prevent or reduce adverse events and enhance the overall patient safety. Evidence: 5.1.1 A written orientation policy integrates patient safety terminologies and practices as an integral part of the organizational orientation program. 5.1.2 A written agenda, curriculum, or training materials that integrate patient safety terminologies and practices in the orientation program. 5.1.3 Evidence of delivering orientation programs that include patient safety practices by trainers qualified or experienced in patient safety. 5.1.4 Evidence of performing a post-orientation evaluation to assess the effectiveness of the orientation program. 5.1.5 Evidence of reviewing and monitoring the enrollment rate of the new hires in the orientation program on an annual base. Page 27 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 5.2: the organization provides annual patient safety training to staff members to promote adherence to patient safety practices. Description: This criterion emphasizes the necessity of annual updated training on various patient safety subjects for all staff members based on the organization’s needs and priorities. The training aims to equip healthcare professionals with the necessary knowledge and skills to improve patient outcomes and reduce adverse events. The annual patient safety training is different from the general patient safety orientation as it is longer in time, has more comprehensive content, targets new and previously hired staff, and aims to reinforce and update the knowledge and skills of healthcare staff regarding patient safety. This training may cover patient safety goals, error prevention and reporting, communication strategies, infection control, and medication safety. Hence, healthcare organizations are expected to establish a written policy, plan, or guideline that outlines the content, frequency, documentation, and responsibility for this training. Additionally, having a written agenda, curriculum, and schedule demonstrates training regularity and consistency. Following this training, organizations are expected to maintain orientation delivery, attendance, and evaluation records. Also, these records should be used in the staff performance evaluations and to enhance the program content for future use. Finally, reviewing and monitoring the enrollment rate of staff in the annual patient safety training is an important indicator to ensure that a substantial percentage of the workforce is regularly exposed to patient safety education. Evidence: 5.2.1 A written policy, plan, or guideline that defines the content, frequency, documentation, and responsibility of the annual patient safety training. 5.2.2 Records or attendance reports demonstrate the regular delivery of patient safety training for all staff. 5.2.3 Evidence of integrating the annual patient safety training in the annual performance evaluations of all staff members. 5.2.4 Evidence of performing a post-training assessment or evaluation to assess the training effectiveness, with training evidence kept in staff personal files. 5.2.5 Evidence of reviewing and monitoring the enrollment rate of staff in the annual patient safety training. Page 28 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 5.3: the organization provides staff with training in teamwork, using an evidence-based teamwork tool, to enhance patient safety. Description: This criterion highlights the importance of promoting effective teamwork among healthcare staff. Teamwork training fosters a collaborative culture that reduces medical errors and enhances patient outcomes. In this, healthcare organizations must integrate teamwork training in their training plans. This integration shall be accompanied and supported by adopting an evidence-based teamwork tool such as Crew Resource Management (CRM) or Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS®). CRM and TeamSTEPPS are evidence-based teamwork tools to optimize patient outcomes by improving teamwork skills among healthcare teams. As part of this training, organizations need to ensure that staff members (i.e. clinical and non-clinical) are equipped with the knowledge and skills required for successful team collaboration, teamwork, and conflict resolution. Including clinical and non-clinical staff in this training demonstrates a commitment to enhancing teamwork and ensures that a broad spectrum of staff is prepared to engage in effective teamwork. Lastly, organizations need to review and monitor the implementation of teamwork skills within the organization, as well as the impact of teamwork training on patient safety. Such monitoring could be through performance indicators, audit rounds, leadership rounds, executive committee discussions, or staff feedback reports. Evidence: 5.3.1 Evidence indicates that teamwork training, including teamwork skills and conflict resolution, should be integrated into the organizational training plan. 5.3.2 Evidence indicates adopting an evidence-based teamwork tool to train the staff on the principles of effective teamwork. 5.3.3 Documented evidence represents the participation of clinical staff in teamwork training programs. 5.3.4 Documented evidence represents the participation of non-clinical staff in teamwork training programs. 5.3.5 Evidence of reviewing and monitoring the implementation of teamwork skills in the organization and how it impacts patient safety. Page 29 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 5.4: the organization maintains a sufficient number of leaders and managers certified or trained in advanced patient safety. Description: This criterion underscores the vital need for a sufficient number of leaders and managers certified or trained in advanced patient safety practices. Such training levels shape the culture of patient safety within healthcare organizations and equip leaders with deep knowledge and understanding of patient safety principles, error prevention strategies, and risk management. Subsequently, the training assists them in effectively leading patient safety initiatives and empowers them to make informed decisions regarding patient safety priorities. In this, healthcare organizations are expected to ensure that a sufficient number of organizational leaders and managers (i.e. 10% or more based on the organization's size, scope, and structure) have attended advanced safety training as determined by the healthcare organization. To foster the concept of advanced patient safety training, healthcare organizations need to integrate this training into the job descriptions and the performance evaluations of leaders and managers. This would emphasize the importance of patient safety as a core competency for these roles and setting clear expectations. Lastly, it is important to monitor the impact of trained leaders and managers on patient safety outcomes, such as improved reporting of incidents, improved rate of closed incidents, improved hand hygiene, and decreased error rate. These numbers provide concrete evidence of the impact of these training initiatives and subsequently enhancing patient safety. Evidence: 5.4.1 Evidence indicates that a representative number of leaders attended advanced safety training based on the organization's size and structure. 5.4.2 Evidence indicates that a representative number of managers attended advanced safety training based on the organization's size and structure. 5.4.3 Evidence of integrating patient safety training requirements in the job descriptions for leaders and managers. 5.4.4 Evidence of integrating patient safety training in the performance evaluations of leaders and managers. 5.4.5 Evidence of reviewing and monitoring the impact of trained leaders and managers on patient safety outcomes (e.g. improved reporting). Page 30 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 5.5: the organization provides simulation-based training for clinical staff to improve patient safety and reduce errors. Description: This criterion highlights the importance of simulation-based training as a method to improve patient safety. This method allows clinical staff to practice skills in a realistic, risk-free environment, learn from mistakes, and develop teamwork skills. Simulation-based training can be used to train for various patient safety-related scenarios, such as emergency response, surgical simulations, medication administration scenarios, and communication simulations. Healthcare organizations need to establish a policy that outlines the indications, frequency, and scenarios for simulation-based training to provide clear guidance on when and how to employ this powerful training method. Therefore, the availability and accessibility of such simulation facilities and equipment are imperative and allow healthcare professionals to practice and refine their skills in a controlled environment. Following the simulation-based training, organizations are expected to keep training and attendance records for that. Moreover, evidence indicating leadership support for simulation-based training underscores its organizational commitment to patient safety improvement. Finally, the monitoring and reviewing improvements in safety indicators resulting from simulation training provide tangible evidence of its impact, such as improved post-resuscitation survival rate following life support simulation-based training or decreased surgical site infection following laparoscopy simulation- based training. Evidence: 5.5.1 A written policy outlines the indications, process, frequency, and scenarios of simulation- based training. 5.5.2 Evidence that the simulation facilities and equipment are available and accessible to clinical staff. 5.5.3 Documented evidence of the participation of clinical staff in safety-related simulation- based training. 5.5.4 Evidence suggests that leadership supports the use of simulation-based training to improve safety. 5.5.5 Evidence of reviewing and monitoring improvements in safety indicators resulting from simulation training. Page 31 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Domain 6: Patient and Family Engagement Patient and family engagement is an evolving concept of modern healthcare that empowers patients to actively participate in their care journey. This engagement is an ethical necessity that may reduce the likelihood of medical errors and adverse events. Hence, healthcare organizations are encouraged to integrate patient and family engagement as a strategic priority to ensure their partnership in the care journey rather than being passive recipients of medical care. Patients and their families possess unique insights into their health conditions, preferences, and goals, making their active participation in decision- making crucial to achieving positive outcomes. The literature revealed that patient and family engagement assists in improving patient adherence to treatment plans, enhancing patient safety and outcomes, increasing patient satisfaction, and reducing healthcare costs. However, it should be acknowledged that there are hindrances to this engagement, including communication gaps, cultural barriers, health literacy disparities, and resistance from healthcare providers. Therefore, engagement is not a simple outcome that can be achieved by implementing a single initiative. Healthcare organizations adopt multifaceted models that underpin patient and family engagement, such as the health belief model, transtheoretical model, and shared decision- making model. The effect of these models relies heavily on translating them into multiple initiatives to support patient engagement. These initiatives may include initiating patient education programs, establishing communication channels, creating shared decision-making practices, and establishing a patient and family advisory council (PFAC). For instance, educational programs can empower patients and their families with essential health information, helping them better understand their conditions and the treatment options that subsequently assist them in shared decision-making. In addition to shared decision-making, organizations may opt to implement other approaches to further enhance the engagement of patients and their families. Hence, organizations gather, evaluate, and use data on satisfaction and complaints to promote patient safety by identifying areas for improvement based on patient feedback. By leveraging this feedback, healthcare organizations can implement targeted interventions to enhance patient safety and overall care quality. Furthermore, timely and transparent disclosure of harmful adverse events occurring during care provision demonstrates accountability that can foster patient engagement and enhance commitment to learning from mistakes. Finally, the establishment of a PFAC provides a platform for patients and their families to offer their perspectives and suggestions in an environment that truly values patient and family voices in shaping the delivery of healthcare services. In conclusion, “patient and family engagement” is a vital component of patient safety. Integrating the engagement as a strategic priority and supporting this priority with various initiatives assist healthcare organizations in tapping into patients' and families' unique perspectives and expertise, resulting in better decision-making, improved care outcomes, and enhanced patient satisfaction. Page 32 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 6.1: the organization integrates patient and family engagement as a strategic priority supported by multiple initiatives. Description: This criterion underscores the importance of patient engagement. Person-centered care and patient engagement are related concepts. However, person-centered care emphasizes tailoring healthcare services and treatments to individual needs, while engagement refers to the active involvement of patients in their healthcare journey. In this, the healthcare organization needs to explicitly integrate patient and family engagement as a central organizational priority. Such integration guides the active involvement of patients and their families in the care processes to empower them and improve overall health outcomes. To support this, organizations need to train staff members on patient engagement to ensure that healthcare professionals have the knowledge and skills to effectively engage patients and their families in the decision-making process. Further, organizations need to assess the level of patient engagement annually using validated tools such as WeCares or Patient Activation Measure (PAM) to address patient needs. The assessment shall be followed by implementing engagement initiatives such as Ask Me 3, SpeakUp, or the What Matters To You (WMTY) campaign to foster a collaborative relationship with healthcare providers. Monitoring the impact of these initiatives on improvements in patient clinical outcomes, patient satisfaction, complaint rate, and overall quality is important. Such monitoring could be through a set of performance indicators, inspection reports, staff feedback reports, or customer feedback reports. Evidence: 6.1.1 A written strategic plan that integrates patient and family engagement as an organizational strategic priority. 6.1.2 Records of training or awareness campaigns for the staff on the importance and methods of patient and family engagement. 6.1.3 Evidence of annual assessment for patient engagement using an evidence-based validated tool such as WeCares or Patient Activation Measure (PAM). 6.1.4 Evidence of implementing patient and family engagement initiatives such as Ask Me 3©, SpeakUp©or What Matters To You (WMTY) campaign. 6.1.5 Evidence of reviewing and monitoring the impact of implementing patient and family engagement initiatives. Page 33 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 6.2: the organization implements mechanisms to gather, review, and utilize patient and family satisfaction and complaint data. Description: This criterion underscores the necessity of establishing robust mechanisms to collect, review, and learn from patient and family satisfaction and complaint data. These mechanisms provide valuable insights into the quality of care, services, and overall patient experience. Further, the organization gains a deeper understanding of risks and areas that require improvement and subsequently develops strategies to address concerns aligned with patient preferences and needs. In this, healthcare organizations need to establish a written policy that clearly outlines the processes and responsibilities related to collecting and analyzing patient and family satisfaction and complaint data. Additionally, using a standardized structured platform or tool (i.e. electronic or paper-based) to collect and analyze patient satisfaction and complaint data regularly. This approach helps in identifying patterns and trends in patient and family satisfaction and complaints, and this analysis should be followed by an action plan to address issues or areas for improvement identified. For transparency and accountability purposes, the satisfaction and complaint results shall be disseminated to involved stakeholders along with the corresponding action plan. Thereafter, the organization needs to monitor action plans and improvement initiatives to address issues identified in satisfaction and complaint data. This monitoring could be through a set of performance indicators, dashboards, or customer feedback reports. Evidence: 6.2.1 A written policy outlines the processes, procedures, and responsibilities in collecting and analyzing patient & family satisfaction and complaint data. 6.2.2 A standardized structured platform or tool is available to collect and analyze patient and family satisfaction and complaint data regularly. 6.2.3 Evidence of collecting and analyzing patient and family satisfaction trends and complaint data, followed by a written action plan. 6.2.4 Documented evidence of disseminating patient and family satisfaction, complaint results, and action plans to relevant stakeholders. 6.2.5 Evidence of reviewing and monitoring action plans and improvement initiatives addressing identified issues in satisfaction and complaint data. Page 34 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 6.3: the organization engages patients and their families in the decision- making regarding their treatment and care plans. Description: This criterion emphasizes the commitment to patient-centered care and respect by actively engaging patients and their families in decision-making. Patient education and shared decision-making are related concepts. However, education provides patients with information to understand their health condition and treatment options, where information typically flows from the healthcare provider, while shared decision-making is a collaborative approach between patients and healthcare providers to make decisions, with information flows in both directions to arrive at a decision that is aligned with the patient's values, goals, and preferences. In this, health organizations need to have a policy outlining the process and structure of patient engagement and need to provide patients and their families with educational materials to assist them in making informed decisions. Further, organizations need to keep their staff aware of shared decision-making topics such as health literacy to facilitate meaningful engagement. Documenting shared decision-making related to treatment options, care plans, discharge planning, and discharge decisions in the patient's medical record is critical. Also, monitoring the impact of shared decision-making on clinical outcomes, patient satisfaction, and adherence to treatment plans is important. Such monitoring could be through a set of performance indicators, chart reviews, staff feedback reports, or customer feedback reports. Evidence: 6.3.1 A written policy outlines the process, procedure, and responsibility for engaging patients and their families in treatment and care decisions. 6.3.2 Evidence of equipping patients and their families with educational materials that assist them in shared decision-making. 6.3.3 Documented evidence demonstrates shared decision-making in treatment and care plans, including informed consent. 6.3.4 Documented evidence demonstrates shared decision-making in discharge planning and discharge decisions. 6.3.5 Evidence of reviewing and monitoring the impact of shared decision-making on clinical outcomes, satisfaction, or adherence to treatment plans. Page 35 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 6.4: the organization timely and openly discloses harmful adverse events occurring during care provision to the affected patient. Description: This criterion emphasizes the importance of informing patients of adverse events that may have occurred during their care in a transparent, timely, and factual manner. Such disclosure fosters trust, patient safety, accountability, and dedication to patient-centered care and ethical responsibility. Further, it enables patients to be informed about their care, facilitates an open dialogue between patients and healthcare providers, and supports a culture of learning and continuous improvement. In this, healthcare organizations need to establish a policy that outlines the process, timing, content, and documentation of disclosing harmful adverse events to patients. This disclosure must be conducted by an individual trained in disclosure processes to consider and accommodate the emotional and psychological needs of patients and their families. The details of the disclosure process must be documented, including a record of disclosure content, timing, the disclosing individual, and patient responses. Beyond disclosure, healthcare organizations need also to develop a post-disclosure analysis to prevent future reoccurrence. Lastly, monitoring compliance with the event disclosure policy and action plans is vital. Such monitoring could be through a set of performance indicators, chart reviews, root cause analysis reports, or customer feedback reports. These requirements prioritize patients' rights to know about adverse events and contribute to overall healthcare safety by reducing the likelihood of similar events in the future. Evidence: 6.4.1 A written policy outlines the process, procedure, timeframe, and responsibility of disclosing harmful adverse events to patients. 6.4.2 Records of training for individuals responsible for event disclosure on what, when, and how to effectively and timely disclose adverse events. 6.4.3 Documented evidence or records of events disclosed to affected patients, including disclosure content, time, disclosing individual, and response. 6.4.4 Documented evidence of developing post-disclosure analysis to document root causes, identified gaps, and actions to prevent future reoccurrence. 6.4.5 Evidence of reviewing and monitoring compliance with the event disclosure policy and the developed action plans at least quarterly. Page 36 of 68 Patient Safety Standards © SPSC 2024 DRAFT & RESTRICTED Criteria 6.5: the organization establishes a patient and family advisory council (PFAC) to enhance patient-centered care and patient safety. Description: This criterion emphasizes the crucial role of the Patient and Family Advisory Council (PFAC) in promoting patient-centered care, enhancing the patient experience, and ensuring patient safety. The PFAC comprises patients, family members, caregivers, and healthcare professionals collaborating to provide valuable insights and feedback, ensuring that health services align with patient needs, values, goals, and preferences. Hence, healthcare organizations need to establish a structured PFAC, with written terms of reference to define the council’s charges and formation order to specify involved members. The membership list must include a patient or patient representative and must be led by the organization's director or a designated leader. This leadership is crucial in effectively guiding the council's activities and aligning them with the organization's goals. Moreover, maintaining records of regular PFAC meetings, focusing on achieving at least 70% closure of discussed agenda items, demonstrates the council's commitment to making tangible progress in enhancing patient-centered care. Finally, monitoring the implementation of action plans developed based on patient feedback within the PFAC reinforces the organization's dedication to translating patient input into meaningful improvements in care delivery. Such monitoring could be through