key: cord-0714592-jrgylazf
authors: Hagle, Mary; Snyder, Kate; Janicek, Karen; Bell, Kimberly; Dietz, Beth; Gundacker, Nathan; Kinter, Angelina; Severson, Annette
title: Using a Patient Safety Analysis to Guide Infusion Therapy for Patients With COVID-19
date: 2021-09-11
journal: J Infus Nurs
DOI: 10.1097/nan.0000000000000438
sha: 13584dc72da49ea918cb9b2271b8477e473f2768
doc_id: 714592
cord_uid: jrgylazf

In the United States, during the Coronavirus Disease 2019 (COVID-19) pandemic, patients with COVID-19 overwhelmed available intensive care beds, staffing levels were unpredictable, and personal protective equipment was limited. The safety of situating electronic infusion pumps outside patient rooms was evaluated using an internal risk assessment. Based on a low level of risk, a procedure was developed to direct clinicians as to when this process is appropriate during a national crisis. A standardized analysis, Healthcare Failure Mode and Effects Analysis, was conducted to identify all potential risks and implement actions that would eliminate or control the risk. No adverse events were reported. Safe systems and preparation can protect patients.

She has worked within critical care for more than 35 years and has served as a clinical nurse specialist in both a community medical center and at the Zablocki VA Medical Center. Ms Dietz has led numerous initiatives that focused on improving patient care for the critical care population. Topics have included decreasing infection rates, reducing clinical alarms, ensuring evidence-based practice, and decreasing hospital-acquired pressure injuries. She also provides education on a variety of topics for clinicians working with critically ill patients. Nathan Gundacker, MD, is an infectious disease staff physician and COVID-19 lead physician at the Zablocki VA Medical Center. He is also an assistant professor at the Medical College of Wisconsin Division of Infectious Diseases in Milwaukee, Wisconsin. Angelina Kinter, MSN, RN, CCRN-K, was the intensive care unit (ICU) nurse manager of the COVID-19 unit at the Zablocki VA Medical Center at the time of this project. Her roles within critical care have included staff nurse, charge nurse, preceptor, and assistant nurse manager. Ms Kinter provided strong nursing leadership as the medical center established a new and separate COVID-19 ICU while continuing to manage the existing medical-surgical ICU. She supported the interdisciplinary team around the clock with the challenges that arose during the COVID-19 surge and remained committed to providing quality patient care and promoting professional development of all staff. Annette Severson, EdD, RN, is currently the nurse executive/ associate director of patient care services for the academic medical center and community-based outpatient clinics at the Zablocki VA Medical Center. More than 250 000 veterans are served for primary, secondary, and tertiary care including all-encompassing inpatient and outpatient mental health and spinal cord injury/disorder services. Dr Severson has oversight for all nursing practice, as well as several other clinical departments. Her experience in academic medical centers is broad, including the roles of clinical nurse specialist, manager, and administrator. She was also associate vice president/chief academic officer for the Wisconsin Technical College System. D uring national and world health crises, such as the coronavirus disease 2019 (COVID-19) pandemic, emergency measures in health care processes are often necessary. In the United States in 2020, COVID-19 patients overwhelmed available intensive care unit (ICU) beds; staffing levels were unpredictable; and personal protective equipment (PPE), critical medications, and supplies were limited. The situation was so dire that there was a national call for ideas to conserve PPE from the editors of the Journal of the American Medical Association on March 20, 2020. 1 Additionally, industry documents, anecdotal descriptions on social media, and professional websites provided resources and novel practices to care for patients with COVID-19. The national COVID-19 bed capacity, clinical staff shortage, and medication/supply shortage were echoed at the authors' Midwestern academic medical center.

Because the SARS-CoV-2 virus, which causes the COVID-19 disease, can be airborne, critically ill patients with COVID-19 were placed in negative pressure rooms, formally known as airborne infection isolation rooms. These rooms contain contaminated air from the patient that is filtered before it is blown outside. The door must be kept closed to maintain the negative air pressure. With all existing negative pressure rooms in use, additional rooms were converted to negative air pressure using free-standing improvised air filtration and fan systems. However, several challenges were noted. First, the fan systems were often noisy. Second, with room doors constantly closed, alarms were difficult to hear outside of the room.

Strict isolation protocols were in place for staff safety. Clinicians working in COVID-19 ICU rooms were observed while they donned appropriate PPE to ensure that they were protected when they entered a patient room and again while they doffed PPE after coming out of the room. This process took time but was critical in protecting staff. Often, nurses remained in the ICU rooms for 4 or more hours at a time because of the PPE shortage and time to don and doff. Other issues arose while working in these rooms. Clinicians became very warm while they worked, face masks or shields chafed their skin, and the powered air-purifying respirators dried their eyes. Frequent medication and/or rate changes also kept nurses in the room for extended periods of time.

Several clinicians saw journal comments and posts on social media about nursing staff situating electronic infusion pumps for intravenous (IV) therapies outside COVID-19 ICU patient rooms. In the interest of conserving PPE supplies and increasing staff efficiency, questions were raised as to whether this strategy could safely be adopted at the authors' medical center. Although the immediate benefits appeared to be clear, a taskforce was formed to validate the feasibility and safety of this new practice and then develop a procedure if indicated. An internal health and safety risk assessment was compiled with related risk control measures. A formal risk analysis, known as a Healthcare Failure Mode and Effects Analysis (HFMEA), was also conducted. Electronic infusion pumps were approved to be situated outside the COVID-19 ICU patient rooms, and a procedure was developed for use during the national crisis. The purpose of this article is to describe the procedure, report the findings of an HFMEA, and share outcomes of this procedural change.

In response to questions about situating electronic infusion pumps outside COVID-19 ICU patient rooms, an interdisciplinary taskforce was convened to examine risks and processes of this procedure. The taskforce was led by a nurse infection preventionist and consisted of an ICU clinical nurse specialist, managers, nurse scientist, pharmacists, an infectious disease physician, and other ancillary staff. The 10 taskforce members represented the following departments: biomedical engineering, facility management, industrial hygiene, infectious disease, nursing, pharmacy, and quality management (which includes infection control, medication management, and patient safety).

Several virtual and face-to-face meetings were held over the course of 3 weeks to identify known or foreseeable hazards and to describe these risks using an internal health and safety risk assessment tool. Global questions included: "What could happen?"; "How could it happen?"; and "Are there any particular factors or issues that contribute to the risk(s)?" During the meetings and via email, taskforce members considered possible adverse outcomes that could occur from situating infusion pumps outside COVID-19 ICU patient rooms. Potential adverse outcomes involved events related to, for example, trip hazard, tubing disconnection, infection, delay of medication administration, inaccurate infusion rates, medication waste, and depletion of IV extension tubing. It was noted by some taskforce members that the practice of running IV extension tubing under a door had been used infrequently but safely for patient care during magnetic resonance imaging services.

Discussion with facilities management staff helped the taskforce decide that having IV extension tubing run under the door would have no impact on negative air pressure.

After deliberating, the taskforce agreed that the likelihood of an adverse event occurring was minimal and the consequences should an event occur would likely be minor. Furthermore, the taskforce brainstormed actions to eliminate or control other risks. Logistics ensured that a 2-month supply of extension tubing would be on hand, and pharmacy identified medications with critical shortages that would not be infused outside the room. Based on the summary of the risk assessment and the risk control measures, the procedure of situating infusion pumps outside COVID-19 ICU patient rooms was supported by clinical and administrative leadership.

Following leadership endorsement, a procedure was swiftly developed and promptly initiated. It outlined the process for implementation in patient rooms and identified risk control measures with available evidence, including alerts from the ECRI Institute, Infusion Nurses Society, and the Institute for Safe Medication Practices. [2] [3] [4] [5] The procedure was indicated only for COVID-19 ICU patient rooms (Table 1) .

Specifically, the procedure contained an initial checklist of applicable needs or conditions to situate the infusion pump outside the COVID-19 ICU patient room. If the decision was made to situate the infusion pump outside the room, the procedure stated that the patient must have a central venous catheter. The remaining procedure document was grouped into 3 topics: IV tubing considerations, infusion pump considerations, and medication directions. For example, regarding medication directions, infusing propofol outside the room generated much discussion because of safety concerns and a medication shortage at that time; it was decided not to infuse propofol outside the room.

The procedure was not a plan for total patient care: it did not address expected nursing practices such as appropriate and timely patient assessments, cautions when administering a medication the first time, and actions to take for patient responses to medications or procedures. The procedure was revised slightly after 1 month for readability and to acknowledge a new patient safety notice from the Department of Veterans Affairs to all patient safety managers. 6 This safety notice warned that situating infusion pumps outside of patient rooms should only be used as a last resort to conserve PPE. The conservation of PPE was already a condition of implementation; thus, no other changes were needed.

Soon after approval of the practice, nurses in the COVID-19 ICU successfully situated 1 pump outside a patient's room without any adverse events. To consider all potential vulnerabilities and gaps associated with situating infusion pumps outside COVID-19 ICU patient rooms, the patient safety managers recommended completing an HFMEA. Although this analysis is best performed before starting a new practice, the taskforce supported conducting this standardized patient safety analysis even after implementation of the procedure because there was minimal evidence to support this practice and benefits seemed to outweigh the risk.

An HFMEA is a tool and an approach that is often utilized to proactively assess vulnerabilities and identify potential problems in health care, particularly those relating to patient safety, before they occur and reach the patient. 9, 10 The Failure Mode and Effects Analysis (FMEA) model has been used within the engineering community for >30 years. 11 Within the Department of Veterans Affairs, the National Center for Patient Safety adapted the FMEA model specifically for health care, resulting in the HFMEA acronym.

An HFMEA for a new process is composed of a series of activities that are systematically conducted to arrive at actions for mitigating risks. Although different numbers of actions have been reported, from 5 steps to 9 phases, the activities of HFMEA are similar. 10,12 Irrespective of how many steps or phases, all HFMEA activities are needed to complete the hazard or risk analysis and identify appropriate actions to be taken.

In brief, the following 5 steps represent the HFMEA that was conducted by the authors:

1. Define the HFMEA topic 2. Assemble the team 3. Graphically describe the process 4. Conduct the hazard analysis 5. Determine actions and outcome measures.

One of the authors (K.S.) was a patient safety fellow at the time and initiated the HFMEA on this procedure change for taskforce review. First, the topic was defined as situating electronic infusion pumps outside of COVID-19 ICU patient rooms with long IV extension sets and/or multiple IV extension sets. This procedure was done in an effort to conserve PPE during the COVID-19 pandemic by minimizing entry into the patient room and to decrease caregiver exposure by reducing the amount of time in patient rooms.

Second, the HFMEA pump team was composed of the original taskforce members with additional experts from the medical center. In step 3, starting with the written procedure, a detailed description of the process was outlined. The procedure within the HFMEA was separated into 5 sections, starting with a decision to situate the infusion pump outside the room and ending with preparation to infuse medications and follow-up actions ( Table 2 ).

In step 4 of the HFMEA, a hazard analysis was conducted; this consists of 2 parts. First, potential failure modes or hazards need to be identified; second, the failure mode is evaluated to determine the likelihood of its occurrence 

Step 3. Describe the process in detail: based on the procedure for situating IV infusion pumps outside COVID- 19 A recent article was reviewed outlining central vascular access device complications and preventive actions to determine whether any failure modes were missed in the procedure that was developed. 13 No changes were needed. Additionally, a team from China used FMEA to improve their catheter-related bloodstream infection rates in the ICU. 14 Their report of 25 failure modes and recommended actions were reviewed by the HFMEA pump team with no changes needed in the procedure or HFMEA. Last, 2 clinicians conducted an HFMEA to prevent harm from tubing misconnections. 15 They looked at all types of tubing: enteral feeding, oxygen, and vascular. No outcomes were reported. The HFMEA pump team reviewed the published failure modes and actions for possible changes in the procedure; as no changes were needed, work continued.

For step 4, part 2, these failure modes were then transferred to another table for the hazard analysis (Table 4 ). In the analysis, the HFMEA pump team evaluated the severity of patient injury if a failure occurred and the probability or likelihood of the failure occurring. In Table 4 , the 3 potential failure modes from section 3 ( Table 3 ) are listed with their severity, probability, and hazard scores. Definitions for each level of severity and probability are in Table 4 . For example, a score of 2 (moderate) in severity means there could be an increased length of stay or increased level of care for the patient. 9 A probability score of 3 would mean it happens occasionally, that is, it could happen several times in 1 to 2 years. 9 For step 5, each potential failure mode, such as a problem, hazard, or vulnerability, has a protective or preventive action and an identified individual who will use that action to control or eliminate the problem. Many HFMEAs have a threshold at which a hazard score requires an action to control the potential problem, for example, a hazard score of ≥8. At the conclusion of an HFMEA, administrators or other decision-makers choose whether to implement the proposed process or project. The authors' completed HFMEA did not identify any other preventive actions than what was in the procedure, such as ensuring a 2-month supply of IV extension tubing.

The HFMEA for situating electronic infusion pumps outside COVID-19 ICU patient rooms was completed after implementation of the procedure; however, no new information or vulnerabilities were identified. The HFMEA was valuable from this aspect, and the patient safety managers accepted the analysis as completed.

The procedure was in practice for several months until the emergency ended with availability of PPE, other supplies, and staff. Monitoring relevant COVID-19 literature, process implementation in the COVID-19 ICU, and adverse events continued until the practice ended in spring 2021. Less TABLE 3

Step 4. part 1: identify potential failure modes-based on the detailed outline of the process for situating IV infusion pumps outside COVID- 19 than 20 patients in COVID-19 ICU patient rooms have had infusion pumps situated outside their rooms. Although this is a low frequency compared with some hospitals, patients were often hospitalized in the COVID-19 ICU for up to 4 weeks. Nurses reported that it was easier to implement this process before the patient was admitted to the room. There were mixed perceptions by nurses on whether this procedure decreased PPE usage or the number of times nurses went into the room. One nurse noted that there was no delay in titrating medication infusion rates because the nurses did not have to wait until there were several patient cares or actions needed before going into the room. This was attributed to grouping care in order to reduce PPE usage. Additionally, nurses were not in 1 room for hours at a time, reducing exposure and physical strain. Nurses' concerns included drug waste due to the extension tubing and securement of connection sites and tubing. No reports were received about infusion pump function issues if the rate was <5 mL/h or >300 mL/h. Several failure mode themes were identified in the authors' HFMEA. These included needing an interdisciplinary decision, implementation of protective or preventive actions, increased risk of infection, and increased risk of human error attributed to multiple steps. The final procedure addressed these themes. The issue of drug wastage versus scarcity was important. Propofol is a high-alert medication, and tubing needs to be changed every 12 hours. This results in 34.4 mL of additional medication waste every 24 hours, based on the standard setup. For certain patients, this may be appropriate to balance PPE conservation and worker exhaustion. However, because of the national propofol shortage at the time, propofol was administered inside the ICU patient room.

There were no reported clinician or patient falls related to IV extension tubing, no identified central line-associated bloodstream infections (CLABSI), and no reported medication events related to the use of IV extension tubing. There was 1 occurrence of a propofol infusion outside the COVID-19 ICU patient room; no adverse events occurred. Last, no policies were changed for this specific procedure; it was for 1 patient care unit only and was kept with other COVID-19 special practices.

During a health crisis or national emergency, electronic infusion pumps may be safely situated outside ICU patient rooms to conserve resources, such as PPE or other supplies. Before implementing this procedure, stakeholders conducted an internal health and safety risk assessment, developed an approved internal procedure, completed an HFMEA, and staff instituted the practice without any adverse events reported.

The COVID-19 pandemic forced health care organizations to balance PPE preservation, health care worker exposure and absence, drug shortages, and optimal patient care simultaneously. These stressors forced the creation of strategies to conserve PPE and work with limited numbers of clinicians in ICUs and other units. Several organizations cautioned against the placement of IV pumps outside patient rooms, stating that this should be a last resort when there are critical shortages of PPE. [2] [3] [4] [5] [6] 

Step 4. Part 2: Identify severity and probability for each potential failure mode and calculate a hazard score-related to preparing and using the infusion pump Potential failure modes in preparing and using the infusion pump Severity a Probability b Hazard score c A. Staff are unfamiliar with infusion pump manufacturer recommendations. Probability of occurring: 1-Remote: unlikely to occur (may happen sometime in 5-30 years) 2-Uncommon: possible to occur (may happen sometime in 2-5 years) 3-Occasional: probably will occur (may happen several times in 1-2 years) 4-Frequent: likely to occur immediately or within a short period (may happen several times in 1 year) c Hazard score: severity score multiplied by probability; preventive action must be identified if score ≥8

As of June 14, 2021, 5 reports related to this topic were found. The Society of Critical Care Medicine published a summary of experiences about managing patients with COVID-19 in ICUs. 16 Situating infusion pumps outside ICU rooms was addressed extensively with recommendations for nurses and pharmacists. Almost all of the recommendations were listed in the authors' COVID-19 ICU procedure, including securing tubing to the floor to eliminate a trip hazard. At the authors' institution, 2 of the operating room nurses deployed to the COVID-19 ICU recommended use of a cord protector floor mat routinely utilized in the operating room, which was put into place.

In August 2020, an interprofessional team of ICU clinicians in the United States published their process of situating infusion pumps outside COVID-19 ICU patient rooms. 17 Their detailed explanations of equipment and procedures provide guidance for implementing this practice. There were several differences between the authors' procedure and what was done by Shah et al. 17 For example, they put an identification wristband on the patient and taped a wristband to the inside of the glass door for scanning, whereas the authors' procedure directed the nurse to put a wristband on the patient and a wristband on the infusion pump pole outside the room. With no reported adverse events using either identification method, future discussion of a preferred method with rationale may be helpful. The procedure by Shah et al 17 was implemented institution-wide among various ICUs, although no specific outcomes were reported. With a current pandemic and limited resources, "This practice should be given consideration, 17 " although cautions were also offered about this practice: it is not ideal and is not recommended under typical circumstances. Shah et al 18 then studied the impact of this practice on 18 patients with COVID-19 before and after pump location inside and outside COVID-19 ICU patient rooms. They found significantly fewer nurse entries into the COVID-19 ICU rooms after pumps were situated outside the rooms (P < .0001); this was cautiously extrapolated into a corresponding decrease in PPE use. Also, there were no reports of CLABSI or extravasation for these patients, mirroring the HFMEA pump team's experience of no reported CLABSIs. 18 An interprofessional team from Italy shared their experiences in situating a variety of devices outside ICU rooms during the COVID-19 pandemic. 19 They addressed cross-contamination, technology, and regulatory issues. Information was provided for remote monitoring of a ventilator, continuous renal replacement therapy, vital signs, and drug and fluid administration. They noted that there is resistance to utilizing these remote practices in the clinical setting, but it is technologically possible. For example, when administering drugs or fluids via an electronic infusion pump, the ability to monitor pressures within the pump exists. Cautions about pump infusions were given, such as being aware of higher flow resistance attributed to longer IV tubing, knowing the internal diameter of IV tubing, and considering fluid viscosity, as well as tubing disconnection. The authors noted that it is essential to prevent transmission of infections, to keep patients safe, and to protect clinicians during a pandemic. 19 Last, implications for nurses, pharmacists, and providers when IV pumps are situated outside COVID-19 ICU patient rooms were summarized by an interprofessional team. 20 An important point was that nurses need more information and education when working with remotely situated IV pumps, although during a crisis time is at a premium.

HFMEA is a productive methodology to prevent harm to patients. However, not all reviewed HFMEA reports included outcomes. In a 2021 systematic review of 33 articles about medication safety, 31 had corrective actions recommended. 21 Anjalee et al 21 found that 6 articles reported a reduction in errors. In addition, the perceptions of FMEA participants about its advantages were reported; these included the ability to gather the collective knowledge of the team, analyze complex processes, increase clinicians' awareness of health care risks, and promote safety. Several drawbacks were listed as well, such as being a time-consuming process, subjective in nature, and having a single-institution focus. 21 In a 2020 systematic review of 158 articles about HFMEA health care projects, Liu et al 22 made recommendations for conducting future HFMEA projects and identified gaps in research. One of their recommendations was to have more than the usual 5 team members as reported in the literature because the complexity of health care systems often requires more experts on the team. The HFMEA pump team wanted the representation of all stakeholders involved in situating infusion pumps outside a patient's room. This provided diverse perspectives and the ability to consider more risks. Thus, the HFMEA pump team included 10 members from 7 departments.

Situating electronic infusion pumps outside ICU patient rooms can be safe and successful but should be a practice reserved for emergencies. Proactively using a systematic method and a step by step analysis, such as an HFMEA, to analyze a new process and prevent adverse events was a productive use of time, talent, and energy in instituting a novel procedure. In addition, monitoring outcomes of high-risk process change is important to correct failures and maintain a safe system for patients. Despite many cautions, clinicians and administrators need to be prepared for future health emergencies and possible shortages. The implementation of infusion pumps outside COVID-19 ICU rooms allowed for PPE conservation, and the protocol will be in place at the authors' institution for future pandemics, if needed. As we navigate the current pandemic and prepare for the future, a focus on system safety permits clinicians to focus on their patients.

Infusion therapy clinicians and managers need to be aware of issues addressed in this article, because they may be called on as stakeholders and experts for patient safety issues. Their familiarity with different patient populations, venues of care, and professional standards guiding practice make infusion therapy clinicians and managers essential to committees and councils that regularly develop and revise policies and procedures, let alone when a taskforce is needed during emergencies. Even when clinicians are not familiar with a venue of care, such as an ICU, principles of patient safety, infection prevention, use of best evidence, and methods for risk evaluation can be maintained with the necessary experts involved.

Note: All electronic references were accessed

Conserving supply of personal protective equipment-a call for ideas

Large-volume infusion pumps: considerations when used with long extension sets outside patient rooms to help reduce staff PPE use

Frequently asked questions related to covid-19 health care related challenges

Clinical experiences keeping infusion pumps outside the room for COVID-19 patients

Acute care ISMP medication safety alert: planning for anticipated shortage of smart infusion pumps and dedicated administration sets

Department of Veterans Affairs Veterans Health Administration National Center for Patient Safety. Patient safety notice: patient safety aspects of using infusion pumps outside of patient rooms

COVID-19 Resource Center

Institute for Safe Medication Practices. COVID-19 resources

Department of Veterans Affairs Veterans Health Administration National Center for Patient Safety. Healthcare Failure Modes and Affects Analysis (HFMEA): a simple step by step guide

Using health care failure mode and effect analysis: the VA National Center for Patient Safety's prospective risk analysis system

Proactive risk mitigation: using failure modes and effects analysis for evaluating vascular access

Central vascular access device complications

Application of failure mode and effect analysis in managing catheter-related blood stream infection in intensive care unit

Using HFMEA to assess potential for patient harm from tubing misconnections

Configuring ICUs in the COVID-19 era

Relocating IV pumps for critically ill isolated coronavirus disease 2019 patients from bedside to outside the patient room

Comparative analysis of intravenous pumps relocation for critically ill isolated COVID-19 patients from bedside to outside the patient room

Preventing infectious diseases in intensive care unit by medical devices remote control: lessons from COVID-19

Extending tubing to place intravenous smart pumps outside of patient rooms during COVID-19: an innovation that increases medication dead volume and risk to patients

Application of Failure Mode and Effect Analysis (FMEA) to improve medication safety: a systematic review

Failure mode and effects analysis for proactive healthcare risk evaluation: a systematic literature review

ACKNOWLEDGMENT Grateful appreciation is extended to all departments for their interprofessional collaboration, as well as to medical center administrators and auxiliary staff who supported the expertise and needs of frontline clinicians.