Patient Safety II: RCA and FMEA Overview

An unexpected and undesirable event that results in death or serious injury to a patient.

An event that could have resulted in harm to a patient but did not.

A serious, unexpected event that results in death or permanent harm to a patient.

A review conducted after an adverse event or sentinel event to identify the cause of the event and recommend changes to prevent similar events from occurring in the future.

Conducting interviews or gathering written accounts from people directly involved in an event, ideally close to when it occurred.

A structured approach to identifying the root cause of an issue by repeatedly asking "Why?" five times, delving deeper with each answer.

A question aimed at understanding the reason or explanation behind an event or action.

The primary cause of an issue, the underlying factor that triggered the problem.

A team of individuals working together to understand and resolve an issue using the 5 Whys approach.

A serious event, like a death or permanent harm to a patient, needs a thorough investigation to prevent it from happening again.

Sometimes a Root Cause Analysis is also done for near misses, which are incidents that could have caused harm but thankfully didn't.

The process of gathering information about what happened, usually by talking to those involved as soon as possible.

Asking "Why?" five times to get to the core reason for an issue, like a bad decision or faulty equipment.

It helps to understand the root cause of an issue because it's a collaborative effort to think through the problem and find the real answer.

A visual representation of the steps in a process, showing their order and connections. It's like a map of how things flow.

Each individual step in a process is assigned a sequential number, from top to bottom, to show the order in which they occur.

The flowchart should include every step in the process being studied, ensuring a complete picture.

It helps to understand the entire process and identify any potential issues or areas for improvement.

Analyze the process by breaking it down into manageable steps, making it easier to identify areas for improvement.

A method for analyzing potential failure points in a process to prevent problems before they occur.

A numerical value that reflects the likelihood of a failure occurring, its potential severity, and the ease of detecting it. This is often calculated by multiplying the ratings for each factor: occurrence, detection, and severity.

A structured process of reviewing steps in a process, identifying potential failure modes, analyzing their causes and effects, and estimating their risk using likelihood of occurrence, detection, and severity rankings.

A proactive approach to risk assessment, aiming to prevent problems before they arise, often used in engineering and manufacturing, but can also be applied to other areas like healthcare.

A reactive approach to problem-solving, aimed at analyzing the cause of an incident after it has already occurred, often used in the context of accidents or safety investigations.

A systematic approach to identifying, prioritizing, and mitigating potential risks before they escalate into adverse events.

A structured improvement methodology that involves defining, measuring, analyzing, designing, and verifying a process or product to optimize its performance.

This criterion mandates healthcare organizations to use evidence-based performance improvement models like Lean, Six Sigma, PDSA, or DMAIC to enhance patient safety.

Models such as Lean, Six Sigma, PDSA, and DMAIC help organizations identify and eliminate inefficiencies and improve patient safety.

Healthcare organizations should have a written program, policy, or plan outlining their improvement processes, models, prioritizations, and stakeholders involved.

Training on performance improvement processes and models is essential for staff, including both clinical and non-clinical personnel.

Senior leaders and clinical department heads regularly meet with frontline staff to review safety culture, identify potential safety concerns, and encourage transparent reporting of safety issues.

This document outlines the objectives, scope, frequency, and responsibilities of Patient Safety Leadership WalkRoundsTM.

Executives and leaders receive training to understand the purpose behind Patient Safety Leadership WalkRoundsTM and how to properly conduct them.

A schedule for monthly Patient Safety Leadership WalkRoundsTM is created. This includes details on dates, participants, and areas to be visited.

Documenting discussions and action plans to address safety issues raised during the rounds.

Healthcare organizations must review and monitor the implementation of action plans using performance indicators, inspection reports, audit rounds, dashboards, or customer feedback.

Evidence of leadership participation in at least two patient safety projects, events, or initiatives.

Leaders review and monitor the results of patient safety indicators at least quarterly.

Evidence of discussing or suggesting solutions based on safety reports or major patient safety events in leadership and board meetings.

A written plan that describes how a healthcare organization will prevent and manage risks to its staff's health and safety.

Assessing potential hazards in the workplace to identify and control risks, protecting staff and patients.

Regular training that equips healthcare staff with knowledge and skills to identify and reduce workplace risks.

Regularly monitoring and reviewing incidents, injuries, and near misses in the workplace to identify patterns and prevent future occurrences.

A program designed to help employees balance their work and personal lives, promoting well-being and sustainability.

A program aimed at promoting the well-being of staff, reducing burnout, and improving retention.

Pre-employment health screenings and vaccinations are integral components of the OHS program.

Healthcare organizations should prioritize incorporating work-life balance programs to support staff members' well-being.

The OHS program encompasses a range of initiatives to ensure the health and safety of staff.

Work-life balance programs enhance staff satisfaction, reduce burnout, and improve retention rates.

Communication strategies employed to inform staff about the availability and benefits of a work-life balance program.

Initiatives like flexible work arrangements, stress management workshops, and fitness programs that promote employee well-being within a work-life balance program.

Policies that regulate time off for employees, including vacation, sick leave, and parental leave, as a core element of a work-life balance program.

The regular evaluation of a work-life balance program's effectiveness and participation rates to identify areas for improvement and ensure its positive impact.

Using nationally or internationally recognized patient safety awards or certifications, like the SPSC National Patient Safety Award (NPSA) or Patient Safety-Friendly Hospital Initiative (PSFHI), demonstrates a healthcare organization's dedication to patient safety. This criterion emphasizes the value of pursuing and achieving external recognition in patient safety.

Healthcare organizations that obtain patient safety awards need to go beyond simply applying or participating. They need to demonstrate a higher level of dedication and unique implementation of safety rules to truly earn the award.

Healthcare organizations should inform their staff about the specific requirements for patient safety awards or certifications. This awareness campaign helps every team member understand their role in contributing to patient safety and meeting the award criteria.

Successfully pursuing and obtaining patient safety awards should be celebrated within the organization, and these achievements should be shared with patients, families, and the broader community. This transparent communication promotes trust and demonstrates the organization's commitment to patient safety.

A written competency framework outlines the essential skills and abilities required for leaders to successfully champion patient safety initiatives within an organization. This provides a clear understanding of the knowledge and expertise needed to effectively prioritize and implement patient safety measures.

Job descriptions for organizational leaders should explicitly include patient safety roles, responsibilities, knowledge, and skills. This ensures that leaders are accountable for patient safety and have the necessary training and expertise to effectively lead in this area.

Organizational leaders should demonstrate the use of patient safety-related competencies in responding to and addressing patient safety events. This means they should use their knowledge and skills to analyze situations, make informed decisions, and implement effective solutions to prevent future events.

Leaders should be evaluated annually based on patient safety metrics and indicators. This assesses their effectiveness in championing patient safety and provides an opportunity for improvement. It helps ensure that leaders are held accountable for their performance in this crucial area.

Regularly reviewing and monitoring the perception of staff and patients regarding the leadership's effectiveness in promoting patient safety is crucial. This provides valuable feedback to the organization, highlighting what's working well and areas for improvement.

Feedback is essential for the continuous improvement of leadership practices. It highlights the importance of a supportive and transparent culture, where leaders actively seek and respond to input about their patient safety initiatives. This empowers leaders to grow and learn, enhancing their effectiveness in promoting patient safety.