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BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads, Incorrect Module Types and/or Sizes, and Channel Error

FDA MedWatch -

Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or d

The discontinuation of contact precautions for methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus: Impact upon patient adverse events and hospital operations

Quality and Safety in Health Care Journal -

Background

Contact precautions for endemic methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) are a resource-intensive intervention to reduce healthcare-associated infections, potentially impeding patient throughput and limiting bed availability to isolate other contagious pathogens. We investigated the impact of the discontinuation of contact precautions (DcCP) for endemic MRSA and VRE on patient outcomes and operations metrics in an acute care setting.

Methods

This is a retrospective, quasi-experimental analysis of the 12 months before and after DcCP for MRSA and VRE at an academic medical centre. The frequency for bed closures due to contact isolation was measured, and personal protective equipment (PPE) expenditures and patient satisfaction survey results were compared using the Wilcoxon signed-rank test. Using an interrupted time series design, emergency department (ED) admission wait times and rates of patient falls, pressure ulcers and nosocomial MRSA and VRE clinical isolates were compared using GEEs.

Results

Prior to DcCP, bed closures for MRSA and/or VRE isolation were associated with estimated lost hospital charges of $9383 per 100 bed days (95% CI: 8447 to 10 318). No change in ED wait times or change in trend was observed following DcCP. There were significant reductions in monthly expenditures on gowns (–61.0%) and gloves (–16.3%). Patient satisfaction survey results remained stable. No significant changes in rates or trends were observed for patient falls or pressure ulcers. Incidence rates of nosocomial MRSA (1.58 (95% CI: 0.82 to 3.04)) and VRE (1.02 (95% CI: 0.82 to 1.27)) did not significantly change.

Conclusions

DcCP was associated with an increase in bed availability and revenue recovery, and a reduction in PPE expenditures. Benefits for other hospital operations metrics and patient outcomes were not identified.

Impact of multidisciplinary team huddles on patient safety: a systematic review and proposed taxonomy

Quality and Safety in Health Care Journal -

Background

Despite significant advances, patient safety remains a critical public health concern. Daily huddles—discussions to identify and respond to safety risks—have been credited with enhancing safety culture in operationally complex industries including aviation and nuclear power. More recently, huddles have been endorsed as a mechanism to improve patient safety in healthcare. This review synthesises the literature related to the impact of hospital-based safety huddles.

Methods

We conducted a systematic review of peer-reviewed literature related to scheduled, multidisciplinary, hospital-based safety huddles through December 2019. We screened for studies (1) in which huddles were the primary intervention being assessed and (2) that measured the huddle programme’s apparent impact using at least one quantitative metric.

Results

We identified 1034 articles; 24 met our criteria for review, of which 19 reflected unit-based huddles and 5 reflected hospital-wide or multiunit huddles. Of the 24 included articles, uncontrolled pre–post comparison was the prevailing study design; we identified only two controlled studies. Among the 12 unit-based studies that provided complete measures of statistical significance for reported outcomes, 11 reported statistically significant improvement among some or all outcomes. The objectives of huddle programmes and the language used to describe them varied widely across the studies we reviewed.

Conclusion

While anecdotal accounts of successful huddle programmes abound and the evidence we reviewed appears favourable overall, high-quality peer-reviewed evidence regarding the effectiveness of hospital-based safety huddles, particularly at the hospital-wide level, is in its earliest stages. Additional rigorous research—especially focused on huddle programme design and implementation fidelity—would enhance the collective understanding of how huddles impact patient safety and other targeted outcomes. We propose a taxonomy and standardised reporting measures for future huddle-related studies to enhance comparability and evidence quality.

Emotionally evocative patients in the emergency department: a mixed methods investigation of providers reported emotions and implications for patient safety

Quality and Safety in Health Care Journal -

Background

Emergency department (ED) physicians and nurses frequently interact with emotionally evocative patients, which can impact clinical decision-making and behaviour. This study introduces well-established methods from social psychology to investigate ED providers’ reported emotional experiences and engagement in their own recent patient encounters, as well as perceived effects of emotion on patient care.

Methods

Ninety-four experienced ED providers (50 physicians and 44 nurses) vividly recalled and wrote about three recent patient encounters (qualitative data): one that elicited anger/frustration/irritation (angry encounter), one that elicited happiness/satisfaction/appreciation (positive encounter), and one with a patient with a mental health condition (mental health encounter). Providers rated their emotions and engagement in each encounter (quantitative data), and reported their perception of whether and how their emotions impacted their clinical decision-making and behaviour (qualitative data).

Results

Providers generated 282 encounter descriptions. Emotions reported in angry and mental health encounters were remarkably similar, highly negative, and associated with reports of low provider engagement compared with positive encounters. Providers reported their emotions influenced their clinical decision-making and behaviour most frequently in angry encounters, followed by mental health and then positive encounters. Emotions in angry and mental health encounters were associated with increased perceptions of patient safety risks; emotions in positive encounters were associated with perceptions of higher quality care.

Conclusions

Positive and negative emotions can influence clinical decision-making and impact patient safety. Findings underscore the need for (1) education and training initiatives to promote awareness of emotional influences and to consider strategies for managing these influences, and (2) a comprehensive research agenda to facilitate discovery of evidence-based interventions to mitigate emotion-induced patient safety risks. The current work lays the foundation for testing novel interventions.

Impact of an education and multilevel social comparison-based intervention bundle on use of routine blood tests in hospitalised patients at an academic tertiary care hospital: a controlled pre-intervention post-intervention study

Quality and Safety in Health Care Journal -

Background

Repetitive inpatient laboratory testing contributes to waste in healthcare. We evaluated an intervention bundle combining education and multilevel social comparison feedback to safely reduce repetitive use of inpatient routine laboratory tests.

Methods

This non-randomised controlled pre-intervention post-intervention study was conducted in four adult hospitals from October 2016 to March 2018. In the medical teaching unit (MTU) of the intervention site, learners received education and aggregate social comparison feedback and attending internists received individual comparison feedback on routine laboratory test utilisation. MTUs of the remaining three sites served as control units. Number and cost of routine laboratory tests ordered per patient-day before and after the intervention was compared with the control units, adjusting for patient factors. Safety endpoints included number of critically abnormal laboratory test results, number of stat laboratory test orders, patient length of stay, transfer rate to the ICU, and 30-day readmission and mortality.

Results

A total of 14 000 patients were included. Pre-intervention and post-intervention groups were similar in age, sex, Charlson Comorbidity Index and length of stay. From the pre-intervention period to the post-intervention period, significantly fewer routine laboratory tests were ordered at the intervention MTU (incidence rate ratio=0.89; 95% CI 0.79 to 1.00; p=0.048) with associated costs savings of $C68 877 (p=0.020) as compared with the control sites. The variability in the ordering pattern of internists at the intervention site also decreased post-intervention. No worsening was noted in the safety endpoints between the pre-intervention and post-intervention period at the intervention unit compared with the controls.

Conclusions

Combination of education and multilevel social comparison feedback significantly and safely led to cost savings through reduced use of routine laboratory tests in hospitalised patients.

What do emergency department physicians and nurses feel? A qualitative study of emotions, triggers, regulation strategies, and effects on patient care

Quality and Safety in Health Care Journal -

Background

Despite calls to study how healthcare providers’ emotions may impact patient safety, little research has addressed this topic. The current study aimed to develop a comprehensive understanding of emergency department (ED) providers’ emotional experiences, including what triggers their emotions, the perceived effects of emotions on clinical decision making and patient care, and strategies providers use to manage their emotions to reduce patient safety risks.

Methods

Employing grounded theory, we conducted 86 semi-structured qualitative interviews with experienced ED providers (45 physicians and 41 nurses) from four academic medical centres and four community hospitals in the Northeastern USA. Constant comparative analysis was used to develop a grounded model of provider emotions and patient safety in the ED.

Results

ED providers reported experiencing a wide range of emotions in response to patient, hospital, and system-level factors. Patients triggered both positive and negative emotions; hospital and system-level factors largely triggered negative emotions. Providers expressed awareness of possible adverse effects of negative emotions on clinical decision making, highlighting concerns about patient safety. Providers described strategies they employ to regulate their emotions, including emotional suppression, distraction, and cognitive reappraisal. Many providers believed that these strategies effectively guarded against the risk of emotions negatively influencing their clinical decision making.

Conclusion

The role of emotions in patient safety is in its early stages and many opportunities exist for researchers, educators, and clinicians to further address this important issue. Our findings highlight the need for future work to (1) determine whether providers’ emotion regulation strategies are effective at mitigating patient safety risk, (2) incorporate emotional intelligence training into healthcare education, and (3) shift the cultural norms in medicine to support meaningful discourse around emotions.

Do bedside whiteboards enhance communication in hospitals? An exploratory multimethod study of patient and nurse perspectives

Quality and Safety in Health Care Journal -

Objective

To understand patient and nurse views on usability, design, content, barriers and facilitators of hospital whiteboard utilisation in patient rooms.

Design

Multimethods study.

Setting

Adult medical-surgical units at a quaternary care academic centre.

Participants

Four hundred and thirty-eight adult patients admitted to inpatient units participated in bedside surveys. Two focus groups with a total of 13 nurses responsible for updating and maintaining the whiteboards were conducted.

Results

Most survey respondents were male (55%), ≥51 years of age (69%) and admitted to the hospital ≤4 times in the past 12 months (90%). Over 95% of patients found the whiteboard helpful and 92% read the information on the whiteboard frequently. Patients stated that nurses, not doctors, were the most frequent user of whiteboards (93% vs 9.4%, p<0.001, respectively). Patients indicated that the name of the team members (95%), current date (87%), upcoming tests/procedures (80%) and goals of care (63%) were most useful. While 60% of patients were aware that they could use the whiteboard for questions/comments for providers, those with ≥5 admissions in the past 12 months were significantly more likely to be aware of this aspect (p<0.001). In focus groups, nurses reported they maintained the content on the boards and cited lack of access to clinical information and limited use by doctors as barriers. Nurses suggested creating a curriculum to orient patients to whiteboards on admission, and educational programmes for physicians to increase whiteboard utilisation.

Conclusion

Bedside whiteboards are highly prevalent in hospitals. Orienting patients and their families to their purpose, encouraging daily use of the medium and nurse–physician engagement around this tool may help facilitate communication and information sharing.

Effects of CPOE-based medication ordering on outcomes: an overview of systematic reviews

Quality and Safety in Health Care Journal -

Background

Computerised provider order entry (CPOE) systems are widely used in clinical settings for the electronic ordering of medications, laboratory tests and radiological therapies. However, evidence regarding effects of CPOE-based medication ordering on clinical and safety outcomes is mixed. We conducted an overview of systematic reviews (SRs) to characterise the cumulative effects of CPOE use for medication ordering in clinical settings.

Methods

MEDLINE, EMBASE, CINAHL and the Cochrane Library were searched to identify published SRs from inception to 12 February 2018. SRs investigating the effects of the use of CPOE for medication ordering were included. Two reviewers independently extracted data and assessed the methodological quality of included SRs.

Results

Seven SRs covering 118 primary studies were included for review. Pooled studies from the SRs in inpatient settings showed that CPOE use resulted in statistically significant decreases in medication errors and adverse drug events (ADEs); however, there was considerable variation in the magnitude of their relative risk reduction (54%–92% for errors, 35%–53% for ADEs). There was no significant relative risk reduction on hospital mortality or length of stay. Bibliographic analysis showed limited overlap (24%) among studies included across all SRs.

Conclusion

SRs on CPOEs included predominantly non-randomised controlled trials and observational studies with varying foci. SRs predominantly focused on inpatient settings and often lacked comparison groups; SRs used inconsistent definitions of outcomes, lacked descriptions regarding the effects on patient harm and did not differentiate among the levels of available decision support. With five of the seven SRs having low to moderate quality, findings from the SRs must be interpreted with caution. We discuss potential directions for future primary studies and SRs of CPOE.

Empowering patients and reducing inequities: is there potential in sharing clinical notes?

Quality and Safety in Health Care Journal -

Patients who read their clinical notes via online patient portals (‘open notes’) report that doing so engages them actively in their care, improves their sense of control over their health and enhances safety.1–3 In several surveys, patients who are older, less educated, non-white or whose first language is not English report even greater benefits than do their counterparts.2–4 However, for many reasons, persons from these demographic groups are less likely to use health portals than other patient populations.5 Drawing on promising preliminary evidence,2–4 6 we suggest that open notes may, over time, prove important in the care of patients who are at risk of experiencing healthcare disparities.

Opening notes via electronic patient portals

Consumers seek convenience, speed and security for their online data. In more than...

Whiteboards: important part of the toolbox for improving patient understanding during hospitalisation

Quality and Safety in Health Care Journal -

‘What are effective strategies to identifying and overcoming barriers to comprehension of information delivered to patients during hospitalisation and at discharge?’ This is one of 11 priority questions identified through the Improving Hospital Outcomes through Patient Engagement Study, a 2018 Patient-Centered Outcomes Research Institute (PCORI)-funded project to define a patient-centred research agenda for hospital medicine.1 In this issue of BMJ Quality & Safety, Goyal et al explored the use of whiteboards in patient rooms as one such strategy.

The article, entitled ‘Do Beside Whiteboards Enhance Communication in Hospitals? An Exploratory Multi-Method Study of Patient and Nurse Perspectives’, examined the perspectives of both patients and nurses on whiteboard use.2 Over a year, the team surveyed almost 500 adults admitted at the University of Michigan Hospital in order to elicit their views on usability and content of whiteboard information. The authors also included nurses’ perspectives gathered through...

Resilience and regulation, an odd couple? Consequences of Safety-II on governmental regulation of healthcare quality

Quality and Safety in Health Care Journal -

Introduction

The concept of resilience, or Safety-II, is finding its way into national patient safety policies. In the Netherlands, for example, hospital, professional and patient federations have named Safety-II as one of the three pillars for the new national patient safety strategy.1 In July 2019, National Health Service (NHS) England and NHS Improvement published the NHS Patient Safety Strategy which also strives to embed Safety-II principles in the national policy.2 National policies of any kind require a form of public accountability, and for quality and safety in healthcare this accountability is mostly regulated by external, often governmental, regulatory authorities. However, while most current research on Safety-II addresses activities of front-line workers and clinical leadership, the role of external regulatory systems is hardly addressed.3 The relationship between regulation and Safety-II and the role regulators could play in improving or undermining Safety-II performance, needs...

Social emotion and patient safety: an important and understudied intersection

Quality and Safety in Health Care Journal -

Until the late 1990s, models of decision making and behaviour in the psychological literature largely ignored the role of emotion. With the work of influential authors,1–3 among others, came the recognition and evidence that our decisions are not always rational. We rely on heuristics or rules of thumb that can accumulate with experience and exposure and that help us to be more efficient (most of the time) but also prone to bias.4 At the same time, social psychologists seeking to understand what drives our behaviour were also beginning to recognise that, while the costs and benefits of adopting a particular behaviour (eg, smoking or running) were important motivators, the anticipated and actual feelings associated with engaging in these behaviours were often more important predictors of future behaviours.5 For example, people who felt miserable and embarrassed when running were less...

Choosing quality problems wisely: identifying improvements worth developing and sustaining

Quality and Safety in Health Care Journal -

The years since launch of the Choosing Wisely Campaign1 2 have seen an increase in studies reporting interventions aimed at reducing low-value care, from unindicated imaging3 4 and laboratory tests3 4 to prescriptions for medicines5–7 that deliver no net benefit. Many describe use of some combination of the usual suspects of intervention types: education,5 8 performance feedback data (sometimes described as audit-feedback, social comparison or peer comparison), policy changes (eg, restricting release of blood products to 1 unit at a time based on a haemoglobin cut-off in non-haemorrhage situations)9 and computer provider order entry (CPOE)–based modifications (eg, alerts) or restrictions.10

In this issue of BMJ Quality and Safety, Ambasta and colleagues examined the impact of a social comparison and education intervention on routine...

Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame

FDA MedWatch -

The Alaris System Infusion Pump is the foundation of the infusion system. Multiple models are being recalled due to damaged IUI Connectors, loose or missing Battery Screws and broken upper and lower hinge posts and membrane frame.

Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels

FDA MedWatch -

Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred v

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