Appropriate vascular access is an integral component in providing care to the hospitalized patient and a necessary element of the plan of care for the patient requiring longer-term intravenous (IV) access after hospitalization. The decision to obtain vascular access is based on a range of clinical indications and therapy duration.1 Vascular access is required for the administration of solutions into the body or for acquiring blood for laboratory testing. Vascular access may either be peripheral or be central based on need.2
There are advantages and disadvantages to each type of vascular access, and each must be weighed for the benefit to the patient. Potentially serious complications may occur with any of these devices, such as blood stream infections, thrombosis, and retained foreign bodies.2 The decision to obtain vascular access must be carefully evaluated and implemented by skilled, trained professionals with advanced knowledge and technical expertise.3–5 In many organizations, the decision to place a venous access device is assigned to a team or group of skilled individuals with demonstrated competency for vascular access placement. Physicians or registered nurses, who have been trained and credentialed to place central venous catheters, peripherally inserted central catheters (PICCs), or other venous access devices, have the requisite skill set to provide this service.
It is imperative that there are clearly established processes for care delivery that ensure successful vascular access. Process improvement and the establishment of safe care delivery is a highly desirable skill for any quality professional and deemed two of the six Healthcare Quality (HQ) Essential Competencies by the National Association for Healthcare Quality (NAHQ).6 The purpose of this article was to describe the use of the failure modes and effects analysis (FMEA) process7 to provide evidentiary support and proactive risk mitigation for the establishment of a comprehensive vascular access team (CVAT).
Failure Modes and Effects Analysis Overview
The FMEA is an assessment tool that was developed in the industrial sector to proactively evaluate failure points or potential gaps in a proposed process or workflow. Within the past decade, the use of the FMEA or healthcare FMEA approach has been increasingly used as a risk mitigation tool to proactively evaluate patient care delivery and workflow processes with the goal of ensuring patient safety.7–9 It is desirable to complete the FMEA before the establishment of a process to mitigate risks before implementation of a process and to identity apparent or latent failure points that may exist in a potential process. The FMEA allows a team to determine whether a process or the steps in a process have unintended consequences other than those desired or expected. If failure points or “failure modes” are identified on paper proactively, a team will be able to test a workflow and reduce or eliminate steps that may cause harm or produce poor outcomes.
Steps 1–6: Preparation
The steps of the FMEA process are provided in Table 1. The initial step in the FMEA process is to define the topic. What process or workflow is being evaluated for potential implementation? In step 2, an individual must define the process and document all the steps in the workflow. The documentation of the process steps may either take a broad or detailed perspective depending on the nature of the process being evaluated. In fact, there may be a need to define subprocesses within a broader or more global section of a process and to further evaluate and analyze the more specific aspects or steps. A visual process map may be developed, and then in Step 3, each one of the process actions is converted to a written document.
Once the process actions are defined, in steps 4–6, an FMEA template or tool with defined rating scales should be identified, and the written process steps are transferred to the tool. The FMEA process is more easily understood and followed using a standardized template or improvement tool, many of which are publically available from organizations such as the Institute for Healthcare Improvement (IHI).8
Step 7: Getting Started
In Step 7, a facilitator is identified to convene an FMEA team to evaluate each process step for failure points or failure modes and determine any causes and subsequent effects of the failures identified. The facilitator is specifically assigned to the leadership and management of the FMEA process. The team should consist of enough subject matter experts to ensure that the process workflow is evaluated appropriately but not so large that the FMEA is overcomplicated. An effective guideline for team size is the inclusion of enough individuals to allow for diffusion of thought and expertise surrounding a process and to ensure a range of perspectives. Including an individual with no knowledge of the process is also helpful, as those closest to a process may be at risk of failing to recognize gaps that an individual outside the process or workflow may readily identify.
The FMEA process has a unique terminology. Table 2 provides a list of definitions and terms used in describing the FMEA.
Step 8: Scoring
In the FMEA, the failure modes are scored for how risky or the severity of the outcome of the failure to the patient and organization, and probability or how likely is each failure to occur. Each failure mode is evaluated by the FMEA team using the defined scales. Once the scoring is completed, the team evaluates the findings.
Steps 9–12: Evaluation and Process Completion
In steps 9–11, assessments are also created for criticality, single-point failures, system controls, and detection. The numerical scoring in the FMEA is completed using standardized scales or rating tools. Figure 1 provides an example of an FMEA template with two 4-point scales for severity and probability. The standardized rating scales provide a more objective dimension to a subjective process because the scoring does occur in a team of individuals with varying perspectives.
There is no universal rating scale available to match all FMEA needs. However, each FMEA team should identify or develop a standardized scoring system applicable to the project. The scoring allows for the assignment of a quantifiable number that potentially highlights the most problematic failure in a process, creating what is called a risk priority number or RPN. Creating an RPN provides an actionable dimension to the scoring, often labeled as the criticality analysis. This RPN is determined by multiplying together each scale scored severity and probability numbers assigned by the FMEA team to the failure modes identified. In some FMEA models, the score may also include detectability, or how likely would an individual be able to detect the failure should it occur. Figure 1 provides an example of an FMEA template using only severity and probability. Criticality scores greater than or equal to eight should be evaluated before implementation of the process, as these score may indicate a risk to the process.
Although severity and probability are assessed by the FMEA team using a standardized rating scale, there are other elements that may be associated with the analysis. These elements are rated using binary (Yes/No) responses of the team to important failure-point assessments. Is the failure mode considered a “single-point failure”? A single-point failure will result in the failure, sometimes catastrophic, of the entire process. Subsequently, if the single-point failure response is a “Yes,” the implementation would be aborted until the process step was remedied. Similarly, responses to questions of “is there a system control in place to remedy a potential failure point,” and “is the failure mode so apparent that it would be detected” should be critically evaluated for each failure mode before implementation of the process or planned action. On completion of the FMEA analysis components, the final step (12) is to develop an action plan to mitigate the risks determined in the process.
Background: Case Study
In 2016, the chief nursing officer (CNO) and the chief medical officer (CMO) requested an analysis of the current state of the provision of vascular access services within an acute care healthcare organization. This organization is a 1,157 bed urban, academic, teaching hospital located within a university campus in the Southeastern United States spanning approximately 100 city blocks, with two geographically distinct inpatient sites.
At the inception of the process assessment, the responsibility for the delivery of vascular access services crossed primarily three service lines/departments within the organization. The department of nursing provided vascular access services through two teams—the PICC team and the hospital's rapid response (STAT) team. These two teams covered PICC access and difficult IV sticks.
The organization's hospitalist–proceduralist team also provided vascular access services, although these services were primarily limited to central line access. In addition to these three groups of providers, there were also various other medical/surgical departments, such as anesthesia, vascular surgery, and radiology that also provided varying types of vascular access procedures. Each department/service line provided vascular services through processes defined with the department/service line, without coordination across the organization, and using varying types of organizationally approved devices and equipment.
Failure Modes and Effects Analysis Application
An organizational improvement team was composed and championed by the CMO and CNO to redesign the delivery of vascular services, and this same improvement team served as the FMEA team. The goal of the improvement team was to design a single, integrated care delivery team, named “the Comprehensive Vascular Access Team (CVAT).” The CVAT would coordinate care delivery for all the vascular access needs of the patients across all the inpatient areas. With such a massive undertaking, the improvement team wanted to ensure that proactive risk mitigation was completed. The FMEA was selected as the process to determine whether latent or apparent failure points were identified in the redesign of the CVAT initiation process. The FMEA was completed over the course of two meetings with the improvement team and the total implementation time for the CVAT spanned 6 months. This approach allowed for the appropriate redesign of identified failure modes and resource development for staffing of the team.
Using the FMEA process, the improvement team evaluated the redesign of the CVAT initiation process. For this project, an algorithm was developed to visually depict the CVAT initiation workflow, highlighting the global aspects of the process (Figure 2). When this algorithm was completed, the workflow process steps were transferred to the organization's FMEA template (Figure 1). The template served as a checklist for the organizational FMEA team to walk through each step of the FMEA analysis and also allowed for the organization to develop action items for failure-point mitigation within a second phase of the project.
Each step of the CVAT initiation process workflow was evaluated by the FMEA improvement team using the FMEA template and scoring scales. The first step of the CVAT initiation workflow will be used for demonstrating the completion of the FMEA.
The FMEA team evaluated the “failed attempt at vascular access at the patient bedside.” Typically, the FMEA process does not begin with a failed attempt at a process step, but rather, a failed attempt is one of the gaps or failure points in a process. In this case, the cascading event to initiate the deployment of the CVAT begins with a failed attempt at the bedside for achieving vascular access. The failure points for this step were perceived by the FMEA team to have two causes. First, the unit leadership may fail to determine staff competency and skill, resulting in an increasing number of failed attempts and an overutilization of the CVAT service. This may result in a negative effect on the patient clinical– and patient satisfaction–related outcomes. Second, the staff may fail to recognize a need to secure assistance with vascular access also resulting in the same deleterious effects of overutilization of services and poor patient outcomes. The FMEA team determined that the two failure modes highlighted may be caused by related factors. The first factor is potentially a failure to ensure the appropriate skill level of the provider attempting the vascular access procedure. The second and related factor is that the unit leadership may play a role in causation by failing to ensure that the competency and skills of the staff are evaluated and appropriate for the patient population. The failure mode was scored by the improvement team for severity and probability, achieving a “2” for both severity and probability, creating a criticality score of “4.” The failure mode was deemed to be detectable, controllable, and not a single-point failure. Note that the FMEA may be scored at the cause/effect level if there are factors within these items, which pose a risk to the patient or the process that may be masked by a single score. Using the criticality analysis score of eight or higher as the determination for highest priority failure modes, these two items were both scored as 4s, resulting in lower prioritization of system fixes or process redesign.
Based on the completion of the described function of the FMEA, it was concluded that there were risk opportunities present in the development of the CVAT process that should be mitigated before implementation. The improvement team developed an action plan to ensure that appropriate education and competency assessments were in place for the identified failure. However, because education is typically considered a lower level redesign solution, a process engineering fix or control was also designed to ensure that a patient's condition was not compromised, awaiting the appropriate level of staff for achieving access. The development of an organizational standing order for a CVAT consult ensured that nursing staff are able to initiate a consult for vascular services within 60 minutes of the identification of a need for vascular access if there is a failure on the unit to achieve the desired outcome.
The CVAT was successfully and safely implemented on the main campus of the organization as single service, which was defined as the initial measure of success by the improvement team. The implementation on the main campus and lessons learned from this process will be evaluated for future implementation of the CVAT team across the health system. The FMEA provided the improvement team with insight into workflow gaps that needed to be addressed before implementation of the team.
Appropriate vascular access is critical for the hospitalized inpatient. Failure to achieve vascular access or poorly initiating the vascular access process may lead to poor patient outcomes that include infection, increased morbidity, and potentially mortality. It is imperative that vascular access processes within a healthcare system are safe, timely, effective, efficient, equitable, and patient-centered. Using a tool such as the FMEA before implementation of any new service may provide an effective method for ensuring the highest quality and safest patient care.
On completion of the entire FMEA process in this organization, the improvement team was prepared to implement a CVAT and ensure that risks to the process were mitigated ahead of front-line process deployment. This example has highlighted how the FMEA may be used to proactively mitigate risks before implementing a standardized organizational process. In addition, this article has provided support for the development of the NAHQ HQ Essentials for improvement and patient safety.6
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Shea Polancich, PhD, RN, is column editor for the Journal of Healthcare Quality Department titled “Translation of Research into Healthcare Quality Practice.” Dr. Polancich has been practicing in quality and patient safety for over a decade. She is currently an Assistant Professor and Assistant Dean at the University of Alabama at Birmingham (UAB) School of Nursing with a primary practice at the UAB Medical Center, Birmingham, Alabama, as a director specializing in nursing improvement, innovation, and analytics. Formerly, her roles included the Director for Quality and Patient Safety at Vanderbilt University Medical Center, Director of Data Analysis and Measurement at Texas Health Resources, NIH/NINR research intern, and health policy fellow at George Mason University. She served on an NQF advisory group specific to patient safety and adverse events.
Loring W. Rue, MD, received his medical degree in 1983 from the University of Virginia School of Medicine and went on to complete his postdoctoral training in general surgery at the University of Alabama at Birmingham. Dr. Rue served in the U.S. Army at the Institute of Surgical Research and in the 1991 Gulf War. In 1992, Dr. Rue joined the faculty of the Department of Surgery at the UAB and served as the Director of the Division of Trauma, Burns and Surgical Critical Care for 19 years before stepping down in 2014. He has held several leadership positions in the past including Senior Associate Dean for Clinical Affairs and Vice Chair for Clinical Affairs in Surgery. In 2013, Dr. Rue was appointed as Senior Vice President for Quality, Patient Safety and Clinical Effectiveness. The following year, he was named the first Chief Medical Officer for the UAB Health System.
Terri Poe, DNP, RN, NE-BC, is the Senior Associate Vice President and Chief Nursing Officer (CNO) of the University of Alabama Hospital (Birmingham). She received her Bachelor's degree of Nursing (1986), Master's degree of Public Administration (1993), and Doctorate degree of Nursing Practice (2013) all from the University of Alabama at Birmingham (UAB). Before her role as the CNO, she was the Administrative Director for Emergency Services and has served as a nursing leader for over 3 decades. Poe serves on the Board of the Alabama Chapter of AONE. She is a 2015 graduate from the America's Essential Hospital fellowship program.
Rebecca (Suzie) Miltner, PhD, RN, is an Associate Professor and the Director of Educationally Focused Practice Partnerships at the University of Alabama at Birmingham (UAB) School of Nursing. She completed a post-doctoral fellowship with the VA National Quality Scholars Program as well as an Executive Fellowship in Patient Safety at Virginia Commonwealth University. Her research areas of interest are the quality of nursing care in acute care settings, practice variation in bedside nursing and the science of quality measurement. She teaches in the Nursing Administration and Doctor of Nursing Practice graduate programs at the UAB School of Nursing.