When Pigs Fly: A Multidisciplinary Approach to Navigating a Critical Heparin Shortage.

A recent outbreak of African swine fever (ASF) in China has claimed the lives of millions of pigs, and although this virus has no health impacts on humans, the disruption of the global pig population has far-reaching negative impacts on economic and pork-derived products, including the creation of the critical drug heparin. The active pharmaceutical ingredient in heparin is derived from pig intestines, and because of the ASF outbreak, the U.S. faces an imminent shortage of heparin. This drug shortage has the potential for profound implications, as heparin is used in a substantial and varied number of medical conditions. In response to notification of the heparin shortage crisis, our institution, Massachusetts General Hospital, activated its Hospital Incident Command System to streamline organization of major stakeholders and oversee operational and clinical activities required to mitigate the potential risks and optimize alternative effective strategies. This article describes the essential elements of our institution's emergency response plan, including detailed clinical algorithms developed by our experts for maximal heparin conservation and waste reduction by promoting safe and effective alternative strategies. Through this practice, we have also identified opportunities to change providers' prescribing and utilization behaviors for the better. As the ASF has not yet been contained and this crisis continues, the strategies and policies employed by our institution can provide a framework for other institutions to tackle this ongoing challenge and future drug shortage crises. IMPLICATIONS FOR PRACTICE: A detailed description of how one institution addressed the current heparin crisis, to support heparin conservation and waste reduction, is provided. The strategies used helped decrease heparin use by 80% in less than 2 months of establishing the task force. This accomplishment can be credited to the development of a task force and strategic plan in which experts and stakeholders were quickly identified, offered a part in the decision-making process, and frequently updated. Furthermore, the response system was dynamic, accessible, and one in which challenges were recognized and acted upon. The key to any crisis management is respect for one another and constant and open communication. Heparin is such a widespread drug that this shortage can potentially affect every patient population and provider. Understanding one's institutional needs and the effect of this crisis on those needs is one of the first steps when developing a strategic plan. Continually evaluating and adjusting that approach in response to the needs of the institution are critical to its success. Moreover, as it did for the authors' institution, a constant appraisal of the strategies can lead to opportunities for improvements in organization and practice that can be sustained well beyond the crisis.

Effect of an Intervention Package and Teamwork Training to Prevent Healthcare Personnel Self-contamination During Personal Protective Equipment Doffing.

BACKGROUND: More than 28 000 people were infected with Ebola virus during the 2014-2015 West African outbreak, resulting in more than 11 000 deaths. Better methods are needed to reduce the risk of self-contamination while doffing personal protective equipment (PPE) to prevent pathogen transmission. METHODS: A set of interventions based on previously identified failure modes was designed to mitigate the risk of self- contamination during PPE doffing. These interventions were tested in a randomized controlled trial of 48 participants with no prior experience doffing enhanced PPE. Contamination was simulated using a fluorescent tracer slurry and fluorescent polystyrene latex spheres (PLSs). Self-contamination of scrubs and skin was measured using ultraviolet light visualization and swabbing followed by microscopy, respectively. Doffing sessions were videotaped and reviewed to score standardized teamwork behaviors. RESULTS: Participants in the intervention group contaminated significantly fewer body sites than those in the control group (median [interquartile range], 6 [3-8] vs 11 [6-13], P = .002). The median contamination score was lower for the intervention group than the control group when measured by ultraviolet light visualization (23.15 vs 64.45, P = .004) and PLS swabbing (72.4 vs 144.8, P = .001). The mean teamwork score was greater in the intervention group (42.2 vs 27.5, P < .001). CONCLUSIONS: An intervention package addressing the PPE doffing task, tools, environment, and teamwork skills significantly reduced the amount of self-contamination by study participants. These elements can be incorporated into PPE guidance and training to reduce the risk of pathogen transmission.

Development and Comparison of Complementary Methods to Study Potential Skin and Inhalational Exposure to Pathogens During Personal Protective Equipment Doffing.

BACKGROUND: Fluorescent tracers are often used with ultraviolet lights to visibly identify healthcare worker self-contamination after doffing of personal protective equipment (PPE). This method has drawbacks, as it cannot detect pathogen-sized contaminants nor airborne contamination in subjects' breathing zones. METHODS: A contamination detection/quantification method was developed using 2-µm polystyrene latex spheres (PSLs) to investigate skin contamination (via swabbing) and potential inhalational exposure (via breathing zone air sampler). Porcine skin coupons were used to estimate the PSL swabbing recovery efficiency and limit of detection (LOD). A pilot study with 5 participants compared skin contamination levels detected via the PSL vs fluorescent tracer methods, while the air sampler quantified potential inhalational exposure to PSLs during doffing. RESULTS: Average PSL skin swab recovery efficiency was 40% ± 29% (LOD = 1 PSL/4 cm2 of skin). In the pilot study, all subjects had PSL and fluorescent tracer skin contamination. Two subjects had simultaneously located contamination of both types on a wrist and hand. However, for all other subjects, the PSL method enabled detection of skin contamination that was not detectable by the fluorescent tracer method. Hands/wrists were more commonly contaminated than areas of the head/face (57% vs 23% of swabs with PSL detection, respectively). One subject had PSLs detected by the breathing zone air sampler. CONCLUSIONS: This study provides a well-characterized method that can be used to quantitate levels of skin and inhalational contact with simulant pathogen particles. The PSL method serves as a complement to the fluorescent tracer method to study PPE doffing self-contamination.

Simulation of a Spontaneous Vaginal Delivery and Neonatal Resuscitation in a Biocontainment Unit.

This article describes a large-scale scenario designed to test the capabilities of a US biocontainment unit to manage a pregnant woman infected with a high-consequence pathogen, and to care for a newborn following labor and spontaneous vaginal delivery. We created and executed a multidisciplinary functional exercise with simulation to test the ability of the Johns Hopkins Hospital biocontainment unit (BCU) to manage a pregnant patient in labor with an unknown respiratory illness and to deliver and stabilize her neonate. The BCU Exercise and Drill Committee established drill objectives and executed the exercise in partnership with the Johns Hopkins Simulation Center in accordance with Homeland Security and Exercise Program guidelines. Exercise objectives were assessed by after-action reporting and objective measurements to detect contamination, using a fluorescent marker to simulate biohazardous fluids that would be encountered in a typical labor scenario. The immediate objectives of the drill were accomplished, with stabilization of the mother and successful delivery and resuscitation of her newborn. There was no evidence of contamination when drill participants were inspected under ultraviolet light at the end of the exercise. Simulation optimizes teamwork, communication, and safety, which are integral to the multidisciplinary care of the maternal-fetal unit infected, or at risk of infection, with a high-consequence pathogen. Lessons learned from this drill regarding patient transportation, safety, and obstetric and neonatal considerations will inform future exercises and protocols and will assist other centers in preparing to care for pregnant patients under containment conditions.

The Impact of High-Level Isolation Units Beyond High-Consequence Pathogen Preparedness.

In response to the 2014 Ebola outbreak, the Office of the Assistant Secretary for Preparedness and Response (ASPR) funded the creation of 10 Regional Ebola and Other Special Pathogen Treatment Centers (RESPTCs) across the United States. These high-level isolation units are designed to provide care for patients infected with high-consequence pathogens, such as viral hemorrhagic fevers, in an environment that is safe for patients, staff, the hospital, and surrounding communities. This commentary describes the impact on infection prevention and preparedness that the Johns Hopkins biocontainment unit has on the hospital and health system beyond the unit itself. Training, research projects, and collaborative partnerships conducted by a high-level isolation unit team while the unit is not activated for patient care can enhance infection prevention, multidisciplinary training and innovation, personal protective equipment design and testing, clinical skills, and infection prevention beyond the isolation setting.

Application of the Incident Command System to the Hospital Biocontainment Unit Setting.

High-consequence pathogens create a unique problem. To provide effective treatment for infected patients while providing safety for the community, a series of 10 high-level isolation units have been created across the country; they are known as Regional Ebola and Special Pathogen Treatment Centers (RESPTCs). The activation of a high-level isolation unit is a highly resource-intensive activity, with effects that ripple across the healthcare system. The incident command system (ICS), a standard tool for command, control, and coordination in domestic emergencies, is a command structure that may be useful in a biocontainment event. A version of this system, the hospital emergency incident command system, provides an adaptable all-hazards approach in healthcare delivery systems. Here we describe its utility in an operational response to safely care for a patient(s) infected with a high-consequence pathogen on a high-level isolation unit. The Johns Hopkins Hospital created a high-level isolation unit to manage the comprehensive and complex needs of patients with high-consequence infectious diseases, including Ebola virus disease. The unique challenges of and opportunities for providing care in this high-level isolation unit led the authors to modify the hospital incident command system model for use during activation. This system has been tested and refined during full-scale functional and tabletop exercises. Lessons learned from the after-action reviews of these exercises led to optimization of the structure and implementation of ICS on the biocontainment unit, including improved job action sheets, designation of physical location of roles, and communication approaches. Overall, the adaptation of ICS for use in the high-level isolation unit setting may be an effective approach to emergency management during an activation.

Evaluation of environmental cleaning of patient rooms: Impact of different fluorescent gel markers.

In this systematic evaluation of fluorescent gel markers (FGM) applied to high-touch surfaces with a metered applicator (MA) made for the purpose versus a generic cotton swab (CS), removal rates were 60.5% (476 of 787) for the MA and 64.3% (506 of 787) for the CS. MA-FGM removal interpretation was more consistent, 83% versus 50% not removed, possibly due to less varied application and more adhesive gel.

Human factors-based risk analysis to improve the safety of doffing enhanced personal protective equipment.

OBJECTIVE: To systematically assess enhanced personal protective equipment (PPE) doffing safety risks. DESIGN: We employed a 3-part approach to this study: (1) hierarchical task analysis (HTA) of the PPE doffing process; (2) human factors-informed failure modes and effects analysis (FMEA); and (3) focus group sessions with a convenience sample of infection prevention (IP) subject matter experts. SETTING: A large academic US hospital with a regional Special Pathogens Treatment Center and enhanced PPE doffing protocol experience.ParticipantsEight IP experts. METHODS: The HTA was conducted jointly by 2 human-factors experts based on the Centers for Disease Control and Prevention PPE guidelines. The findings were used as a guide in 7 focus group sessions with IP experts to assess PPE doffing safety risks. For each HTA task step, IP experts identified failure mode(s), assigned priority risk scores, identified contributing factors and potential consequences, and identified potential risk mitigation strategies. Data were recorded in a tabular format during the sessions. RESULTS: Of 103 identified failure modes, the highest priority scores were associated with team members moving between clean and contaminated areas, glove removal, apron removal, and self-inspection while preparing to doff. Contributing factors related to the individual (eg, technical/ teamwork competency), task (eg, undetected PPE contamination), tools/technology (eg, PPE design characteristics), environment (eg, inadequate space), and organizational aspects (eg, training) were identified. Participants identified 86 types of risk mitigation strategies targeting the failure modes. CONCLUSIONS: Despite detailed guidelines, our study revealed 103 enhanced PPE doffing failure modes. Analysis of the failure modes suggests potential mitigation strategies to decrease self-contamination risk during enhanced PPE doffing.

Impact of Case-Specific Education and Face-to-Face Feedback to Prescribers and Nurses in the Management of Hospitalized Patients With a Positive Clostridium difficile Test.

BACKGROUND: Approaches to changing providers' behavior around Clostridium difficile (CD) management are needed. We hypothesized that case-specific teaching points and face-to-face discussions with prescribers and nurses would improve management of patients with a positive CD test. METHODS: Charts of patients age ≥18 years with positive CD tests hospitalized July 2016 to May 2017 were prospectively reviewed to assess CD practices and generate management recommendations. The study had 4 periods: baseline (pre-intervention), intervention #1, observation, and intervention #2. Both interventions consisted of an in-person, real-time, case-based discussion and education by a CD Action Team (CDAT). Assessment occurred within 24 hours of a positive CD test for all periods; during the intervention periods, management was also assessed within 48 hours after CDAT-delivered recommendations. Outcomes included proportion of patients receiving optimized treatment and incidence rate ratios of practice changes (both CDAT-prompted and CDAT-independent). RESULTS: Overall, the CDAT made recommendations to 84 of 96 CD cases during intervention periods, and providers accepted 43% of CDAT recommendations. The implementation of the CDAT led to significant improvement in bowel movement (BM) documentation, use of proton pump inhibitors, and antibiotic selection for non-CD infections. Selection of CD-specific therapy improved only in the first intervention period. Laxative use and treatment of CD colonization cases remained unchanged. Only BM documentation, a nurse-driven task, was sustained independent of CDAT prompting. CONCLUSIONS: A behavioral approach to changing the management of positive CD tests led to self-sustained practice changes among nurses but not physicians. Better understanding of prescribers' decision-making is needed to devise enduring interventions.

National Healthcare Safety Network laboratory-identified Clostridium difficile event reporting: A need for diagnostic stewardship.

We describe the proportion of health care facility-onset Clostridium difficile infection (HO-CDI) National Healthcare Safety Network laboratory-identified events at our facility that were deemed nontrue HO-CDIs. Reasons included testing in a patient without significant diarrhea or with recent laxative use, or delayed testing. Standardized infection ratios using only true HO-CDI in the numerator were improved compared with publically reported standardized infection ratios. A prioritization matrix identifies which clinical services could benefit most from directed diagnostic stewardship interventions.

Improving daily patient room cleaning: an observational study using a human factors and systems engineering approach.

BACKGROUND: While playing a critical role in preventing healthcare-associated infections, patient room cleaning is often unsatisfactorily performed. To improve patient room cleaning, a human factors and systems engineering (HFSE) approach is needed to understand the complex cleaning process and associated work system factors. PURPOSE: We conducted an observational study to assess the performance of environmental care (EVC) associates during daily patient room cleaning and identify work system factors influencing their performance. METHODS: This study was conducted in eight adult medicine inpatient units at a large urban academic medical center. An HFSE researcher shadowed 10 day-shift EVC associates performing daily patient room cleanings and used a semi-structured observation form to collect quantitative data (e.g., duration of room cleaning, orders for surface cleaning) and qualitative data (e.g., challenges to patient room cleaning). Descriptive statistics (e.g., median, interquartile range) were reported for cleaning performance, and bivariate and regression analyses were conducted to identify factors influencing cleaning performance. We also performed link analyses of the workflow of EVC associates and qualitative analyses of observer notes to identify challenges to daily patient room cleaning. RESULTS: We observed 89 patient room cleanings. Median duration of cleaning a room was 14 minutes, and median percentage of surfaces cleaned in a room was 63%. High-touch surfaces that were frequently missed during daily cleaning included the bedrails, telephone, patient and visitor chairs, and cabinet. Work system factors that could influence cleaning performance included the type of unit, the presence of the patient and family members in the room, cleaning patterns and orders of EVC associates, and interruptions EVC associates encountered while cleaning. CONCLUSIONS: Daily patient room cleaning was influenced by a number of work system factors. To improve daily patient room cleaning, multifaceted interventions are needed to address these system-level factors.

Contributions of CD8 T cells to the pathogenesis of mouse adenovirus type 1 respiratory infection.

CD8 T cells are key components of the immune response to viruses, but their roles in the pathogenesis of adenovirus respiratory infection have not been characterized. We used mouse adenovirus type 1 (MAV-1) to define CD8 T cell contributions to the pathogenesis of adenovirus respiratory infection. CD8 T cell deficiency in ß2m-/- mice had no effect on peak viral replication in lungs, but clearance of virus was delayed in ß2m-/- mice. Virus-induced weight loss and increases in bronchoalveolar lavage fluid total protein, IFN-γ, TNF-α, IL-10, CCL2, and CCL5 concentrations were less in ß2m-/- mice than in controls. CD8 T cell depletion had similar effects on virus clearance, weight loss, and inflammation. Deficiency of IFN-γ or perforin had no effect on viral replication or inflammation, but perforin-deficient mice were partially protected from weight loss. CD8 T cells promote MAV-1-induced pulmonary inflammation via a mechanism that is independent of direct antiviral effects.