Introduction and General Overview
Objective
The objective of this guidebook is to provide Patient Safety Managers (PSMs) and Patient Safety Officers (PSOs) with an understanding of the fundamental steps of conducting Healthcare Failure Mode and Effect Analysis (HFMEA).
Background
The ability to proactively identify and account for potential vulnerabilities is a fundamental aspect of high reliability and the delivery of safe patient care. Failure Mode and Effect Analysis (FMEA) is one of the most widely adopted techniques for conducting a proactive risk assessment. FMEA is a systematic process used to help identify product and process problems before they occur (Mikulak, McDermott, & Beauregard 2008). The FMEA process may be used to define, identify, and eliminate known or potential failures, problems, or errors in a system, design, process, or service line. The VA National Center for Patient Safety (NCPS) adopted and modified FMEA for use in the healthcare environment in 2001, incorporating concepts from other quality and safety tools (e.g., Root Cause Analysis (RCA), Hazard Analysis and Critical Control Point (HACCP). The tool was named Healthcare Failure Mode and Effects Analysis (HFMEA) and is uniquely suited to proactive risk assessment of healthcare processes.
Why HFMEA?
HFMEA is a healthcare focused tool for proactive risk assessment. Unlike RCA, HFMEA is prospective, considering possible risks before they occur. HFMEA has its origin in FMEA methods taken from manufacturing, however, HFMEA has key differences. For example, the processes for assigning severity and probability, actions and outcomes, and lines of responsibility and accountability are present in FMEA but were substantially modified in the HFMEA process. HFMEA adds a decision tree algorithm and borrows the hazard scoring matrix from the RCA process.
NCPS requires facilities to complete at least one proactive risk assessment every 12 months. However, The Joint Commission (TJC) requires facilities to select one high risk process and conduct a proactive risk assessment every 18 months, at a minimum to comply with the Hospital Accreditation Program requirements (The Joint Commission, 2017). The HFMEA process, when successfully implemented, meets the requirement.
***Note: The facility should submit the completed Healthcare Failure Mode and Effect Analysis (HFMEA) or proactive risk assessment (PRA) as soon as possible, but no later than 3 months after analysis completion, onto the NCPS intranet site http://vaww.ncps.med.va.gov/Dialogue/HFMEATopics/submit.asp.
TJC outlines several key strategies for effective proactive risk assessment, all of which are incorporated in the HFMEA process. These include describing a chosen process, identifying ways in which a process might fail, describing the effects of potential failures on patient safety, prioritizing potential process failures, determining why such potential failures could occur, redesigning processes and/or underlying systems, and testing and monitoring redesigned processes (The Joint Commission, 2017). For the most critical risks, proactive risk assessments allow participants to develop a plan to identify probable causes, redesign the process, and test changes to confirm desired outcomes (The Joint Commission, 2017). HFMEA was originally developed for potential risks to patient safety but is also an effective technique to consider issues of timeliness, efficiency, effectiveness, patient-centeredness, or other healthcare system priorities. HFMEA is intended for users of all skill levels to identify important problems and high- yield solutions.
HFMEA Steps
The 5-steps to a successful HFMEA are described below.
1. Define the topic with a clear definition of the process to be studied.
2. Assemble a multidisciplinary team that includes subject matter experts (SME), an advisor, a recorder, and a team leader. A multidisciplinary team ensures relevant knowledge is available and various viewpoints are considered.
3. Graphically describe the process. Team members will develop and verify a diagram of the process flow, which is the Process Flow Diagram. Each step in the process is numbered, sub-processes are identified, and areas within the process that need attention are identified.
4. Conduct a hazard analysis and list all possible/potential failure modes under the sub-processes identified in step 3. The team will determine the probability and severity of the failure modes, determine their potential causes when warranted, and consider each one using the HFMEA decision tree.
5. Develop actions and outcome measures that will eliminate or control each failure mode.
Define the Topic
The first step in conducting an HFMEA is to identify and define the topic to be analyzed. The topic should represent a high-risk and/or vulnerable area and needs to include a clear definition of the process to be studied. This section provides guidance on identifying a suitable topic, which includes examples to assist in the selection of a topic that is within an appropriate scope.
1.1 HFMEA Project Types
The following list represents one way to initiate conceptualizing systems within healthcare facilities.
• System – Analyze system-wide functions that can impact patient safety, i.e. delays with diagnosis and treatment.
• Design – Focus on initial design processes using systems thinking and a multidisciplinary approach.
• Process – Consider processes such as medication administration and discharge planning.
• Service – Standardize services when variability of a product or service performance poses a patient safety risk.
• Software – Assess electronic health record (EHR) software vulnerabilities.
1.2 Identifying Potential HFMEA Topics
There are many sources available to help the team identify topics to analyze. For example, the ECRI Institute publishes an annual list of the "Top 10 Patient Safety Concerns," which highlights potential risks across the continuum of care (2019); this list may help identify high priority topics or concerns. Topics may also be identified using the following list of sources:
• Topics may be identified during the RCA process
• Review and/or trending of patient safety event reports or other event reporting systems
• Review of readmission and patient advocate data
• Solicit ideas from leaders and staff about hazards which are likely to cause injury or illness if they are not effectively controlled
• Evaluate risks with new or existing products, processes, and systems that have a potential to fail (Preferably, this is done prior to implementation of a new product, process, or system)
• Review TJC sentinel event list
• Consider vulnerabilities reported via other channels
1.3 Determining the Scope of the HFMEA Topic
After the topic is identified, consider the following strategies to further investigate whether the appropriate scope was identified. The team should define clear boundaries for the process to be examined. The complexity of the process and the availability of the team members should be considered. For example, if the process is facility-wide, the team may choose to focus on high priority or high-risk areas. If the process is complex or lengthy, the team may choose to focus on one or more of the process steps (See Chapter 3 for additional information). The subject matter experts may be helpful in refining the scope.
1.4 Writing a Topic Statement
Drafting the topic statement is a straightforward process. After identifying a potential scope, PSMs can gather facts, data, and material about the scope to include consideration of events that have occurred at other facilities. The topic statement should include a description of the topic being analyzed and the scope of what will be covered. Consider the following guidelines when drafting a topic statement:
• The topic statement should describe what process is being analyzed
• The topic statement should describe the boundaries or scope of what will be analyzed
• The topic statement should be clear, definitive, concise, and leave no room for misinterpretation
• The topic statement should be brief, consisting of one or two sentences
Examples of effective topic statements are included below.
Example 1: "Medication error prevention specifically related to pharmacy assigned medication administration times."
Example 2: "Cleaning of non-critical reusable medical equipment and high touch surfaces in in-patient care areas."
Example 3: "Handoff of mental health patients from admission to arrival on acute care."
Assemble the Team
The composition of the team should be multidisciplinary and the number of people on a team depends on the scope of the process being reviewed (QAPI, 2013). There should be at least one representative from each employee group involved in the process. For example, if the HFMEA is aimed at the process of assessing residents in a Community Living Center for fall risk and protecting those residents found to be at a high risk, the team should include clinical staff such as representatives from Nursing (RN and LPN or CNA), Medicine, Environmental Management Services, Physical Medicine and Rehabilitation Services, and Behavioral Health Services.
2.1 Advisor
Typically, the facility PSM serves as the team's advisor. The primary responsibilities of the advisor are to define the project topic and scope, assemble the project team, orient team members to the process, and provide consultation to the team throughout the process. The advisor should provide the team with a clear vision of the task. The advisor initiates the process and works with hospital leadership to gain support and escalate issues as necessary. Understanding the HFMEA requirements is an important characteristic of an effective advisor. Specific responsibilities of the advisor include:
• Identifying the high-vulnerability topic/process (in consultation with the Medical Center Director)
• Obtaining leadership support to ensure the topic aligns with leadership goals
• Assembling a multi-disciplinary team with subject matter experts (and individuals who are unfamiliar with the process)
• Completing the charter memo and obtaining Director concurrence
• Requesting supervisor support for team member participation
• Providing orientation/overview of the HFMEA process to team members
• Supporting the team with ongoing consultation
2.2 Team Leader
The advisor appoints the team leader and ensures a clear understanding of the processes being reviewed. The team leader guides the team and serves as the project manager. It is important that the team leader understand the HFMEA process and can facilitate the team, as needed. The team leader's responsibilities include:
• Arranging meeting times and location
• Setting and maintaining ground rules for meetings
• Keeping the team on task and within the timeline
• Using the HFMEA tools and cognitive aides developed by NCPS
• Facilitating the use of materials (e.g., flipcharts and sticky notes) for flowcharts and diagrams
• Summarizing the work completed and identifying next steps
• Writing the final HFMEA summary for leadership review
• Consulting with the advisor
2.3 Subject Matter Experts
Subject matter experts (SME) are staff who have immediate experience with the process being analyzed or who bring additional knowledge, experience, or points of view that will benefit the team. Including SMEs who are involved directly in the process being analyzed helps the team to understand the process steps (as planned and as actually carried out). If possible, SMEs should be included from multiple shifts to gain a true perspective of topic being analyzed. The experiences of staff working during the day may be much different than what happens during the evening and night shifts (QAPI, 2013). The staff selected to serve as the SME team members should have day-to-day responsibilities for completing one or more steps in the process under analysis. Effective SME team members:
• Have personal knowledge of what happens in the process, including differences between work as performed and as planned
• Are vital to the project success
• Must be allowed a flexible schedule to participate fully in team meetings and work required outside of recurring team meetings
Team participation can be demanding, and supervisors must be made aware of the time commitment when they are selecting individuals to serve on the team.
2.4 Recorder
The recorder is responsible for documentation during the working sessions, taking minutes, and distributing the information to the team. The recorder is responsible for:
• Updating flip charts, worksheets, and process flow diagrams throughout the working sessions and between meetings
• Notating the process flow diagram and documenting the hazard analysis decisions
• Recording the actions and outcome measures
• Using the HFMEA numbering scheme
• Recording any necessary information
• Assisting the team leader to stay on the timeline
2.5 HFMEA Cover Sheet
The cover sheet is used to record the administrative information about the HFMEA. Administrative information includes the topic statement, dates started and completed, team members and designations, and other information. When completing the topic sheet, teams should include the following information:
• The final topic statement
• A list of all team members, their position titles, and contact information
• Designation of team leader and team recorder
• Self-certification that all affected areas of the process being examined are represented on the team
• Self-certification that members at various levels within the organization with different types of knowledge are included on the team
• Annotation of the official date the HFMEA was started and the date it was completed