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Grupo Asimex De Mexico Sa De CV Issues Voluntary Nationwide Recall of All Lots of Florence Morris Antiseptic Hand Sanitizer Due to Presence of Methanol (Wood Alcohol) and Sub-Potent Ethanol

FDA MedWatch -

Grupo Asimex de Mexico SA de CV is voluntarily recalling all lots of FLORANCE MORRIS Antiseptic Hand Sanitizer, 70% Alcohol, packaged in 8 fl oz bottles and 1L bottles to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol conte

Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

FDA MedWatch -

Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer lev

Correction: Value of small sample sizes in rapid-cycle quality improvement projects

Quality and Safety in Health Care Journal -

Etchells E, Ho M, Shojania KG. Value of small sample sizes in rapid-cycle quality improvement projects. BMJ Qual Safe 2016;25:202–6.

The article has been corrected since it was published online. The authors want to alert readers to the following error identified in the published version. The error is in the last paragraph of the section "Small samples can make ‘rapid improvement’ Rapid", wherein the minimum sample size has been considered as six instead of eight.

For this first (convenience) sample of 10 volunteer users, 5/10 (50%) completed the form without any input or instructions. The other five became frustrated and gave up. Table 1 tells you that, with an observed success rate of 50% and a desired target of 90%, any audit with a sample of six or more allows you to confidently reject the null hypothesis that your form is working at a 90% success rate.

Sounds good: the bright future of clinical alarm management initiatives

Quality and Safety in Health Care Journal -

For decades, those working in hospitals normalised the incessant alarms from medical devices as a necessary, almost comforting, reality of a high tech industry. While nurses drowned in excessive, frequently uninformative alarms, other members of the healthcare team often paid little attention. Fortunately, times are changing and managing alarm fatigue is now a key patient safety priority in acute care environments.1

Adverse patient events from alarm fatigue, particularly related to excessive physiological monitor alarms, have received widespread attention over the last decade, including from the news media.2–5 In the USA, hospitals redoubled alarm safety efforts following the 2013 Joint Commission Sentinel Event Alert and subsequent National Patient Safety Goals on alarm safety.1 2 6 We are now beginning to understand how to reduce excessive non-actionable alarms (including invalid alarms as well as those...

Allowing failure so trainees can thrive: the importance of guided autonomy in medical education

Quality and Safety in Health Care Journal -

The delicate balance between resident autonomy and patient safety is an essential topic in medical education. Without a doubt, it is imperative to preserve the quality and safety of care for patients. As a result, clinician educators are constantly challenged by their obligation to provide the best possible patient care while educating the next generation of trainees. How are educators who are committed to patient safety but also want to prepare trainees for independent practice expected to educate within these constraints? Said differently, is it acceptable for an educator to allow a trainee to make a mistake under supervision to teach them to avoid mistakes in the future?

In this issue of BMJ Quality and Safety, Klasen et al1 summarise their findings from 19 semistructured interviews with clinical supervisors who allow their trainees to commit errors for educational purposes. The supervisors, who practice in a variety of...

Leveraging electronic health record data to improve sepsis surveillance

Quality and Safety in Health Care Journal -

Sepsis, the syndrome of life-threatening organ dysfunction that complicates severe infection, is a leading cause of death and disability worldwide.1 A growing recognition of the enormous burden of sepsis has spurred numerous awareness campaigns, quality improvement initiatives and regulatory measures in recent years. Reliably tracking the burden of sepsis is challenging, however, because sepsis is a clinical syndrome based on a constellation of non-specific signs and symptoms and lacks a gold standard for diagnosis.2 Given the substantial resources being dedicated to improving sepsis care and outcomes, a parallel investment in developing robust, high-quality surveillance tools is necessary to understand which initiatives are effective and where best to allocate future resources.

Until recently, sepsis surveillance has primarily been conducted using hospital discharge diagnosis codes. Epidemiological studies using these data have consistently shown dramatic increases in sepsis incidence and declines in case fatality rates over the past...

Coproduction: when users define quality

Quality and Safety in Health Care Journal -

Introduction

If the core aim of a healthcare system is to minimise both illness and treatment burden while reducing the costs of care delivery, then we must accept, however reluctantly, that our efforts are largely failing.

Life expectancy in highly developed countries is declining for the first time in decades. Long-term conditions and obesity are replacing infectious diseases as the most prominent health problems in developing nations. Meanwhile, average per capita healthcare expenditures are increasing despite efforts to restrain them. For example, in the USA, the average per capita healthcare expenditures are approaching $10 000 a year and consuming over 18% of its gross domestic product. Innovations in biomedicine, information technology and healthcare delivery systems may help address some of the challenges, but instead of containing costs these innovations tend to expand services.

There are indications that interest in a concept called coproduction in healthcare is increasing. The core...

Time series evaluation of improvement interventions to reduce alarm notifications in a paediatric hospital

Quality and Safety in Health Care Journal -

Background10

The Joint Commission identified inpatient alarm reduction as an opportunity to improve patient safety; enhance patient, family and nursing satisfaction; and optimise workflow. We used quality improvement (QI) methods to safely decrease non-actionable alarm notifications to bedside providers.

Methods

In a paediatric tertiary care centre, we convened a multidisciplinary team to address alarm notifications in our acute care cardiology unit. Alarm notification was defined as any alert to bedside providers for each patient-triggered monitor alarm. Our aim was to decrease alarm notifications per monitored bed per day by 60%. Plan-Do-Study-Act testing cycles included updating notification technology, establishing alarm logic and modifying bedside workflow processes, including silencing the volume on all bedside monitors. Our secondary outcome measure was nursing satisfaction. Balancing safety measures included floor to intensive care unit transfers and patient acuity level.

Results

At baseline, there was an average of 71 initial alarm notifications per monitored bed per day. Over a 3.5-year improvement period (2014–2017), the rate decreased by 68% to 22 initial alarm notifications per monitored bed per day. The proportion of initial to total alarm notifications remained stable, decreasing slightly from 51% to 40%. There was a significant improvement in subjective nursing satisfaction. At baseline, 32% of nurses agreed they were able to respond to alarms appropriately and quickly. Following interventions, agreement increased to 76% (p<0.001). We sustained these improvements over a year without a change in monitored balancing measures.

Conclusion

We successfully reduced alarm notifications while preserving patient safety over a 4-year period in a complex paediatric patient population using technological advances and QI methodology. Continued efforts are needed to further optimise monitor use across paediatric hospital units.

'Whatever you cut, I can fix it: clinical supervisors interview accounts of allowing trainee failure while guarding patient safety

Quality and Safety in Health Care Journal -

Background

Learning is in delicate balance with safety, as faculty supervisors try to foster trainee development while safeguarding patients. This balance is particularly challenging if trainees are allowed to experience the educational benefits of failure, acknowledged as a critical resource for developing competence and resilience. While other educational domains allow failure in service of learning, however, we do not know whether or not this strategy applies to clinical training.

Methods

We conducted individual interviews of clinical supervisors, asking them whether they allowed failure for educational purposes in clinical training and eliciting their experiences of this phenomenon. Participants’ accounts were descriptively analysed for recurring themes.

Results

Twelve women and seven men reported 48 specific examples of allowing trainee failure based on their judgement that educational value outweighed patient risk. Various kinds of failures were allowed: both during operations and technical procedures, in medication dosing, communication events, diagnostic procedures and patient management. Most participants perceived minimal consequences for patients, and many described their rescue strategies to prevent an allowed failure. Allowing failure under supervision was perceived to be important for supporting trainee development.

Conclusion

Clinical supervisors allow trainees to fail for educational benefit. In doing so, they attempt to balance patient safety and trainee learning. The educational strategy of allowing failure may appear alarming in the zero-error tolerant culture of healthcare with its commitment to patient safety. However, supervisors perceived this strategy to be invaluable. Viewing failure as inevitable, they wanted trainees to experience it in protected situations and to develop effective technical and emotional responses. More empirical research is required to excavate this tacit supervisory practice and support its appropriate use in workplace learning to ensure both learning and safety.

Validation of automated sepsis surveillance based on the Sepsis-3 clinical criteria against physician record review in a general hospital population: observational study using electronic health records data

Quality and Safety in Health Care Journal -

Background

Surveillance of sepsis incidence is important for directing resources and evaluating quality-of-care interventions. The aim was to develop and validate a fully-automated Sepsis-3 based surveillance system in non-intensive care wards using electronic health record (EHR) data, and demonstrate utility by determining the burden of hospital-onset sepsis and variations between wards.

Methods

A rule-based algorithm was developed using EHR data from a cohort of all adult patients admitted at an academic centre between July 2012 and December 2013. Time in intensive care units was censored. To validate algorithm performance, a stratified random sample of 1000 hospital admissions (674 with and 326 without suspected infection) was classified according to the Sepsis-3 clinical criteria (suspected infection defined as having any culture taken and at least two doses of antimicrobials administered, and an increase in Sequential Organ Failure Assessment (SOFA) score by >2 points) and the likelihood of infection by physician medical record review.

Results

In total 82 653 hospital admissions were included. The Sepsis-3 clinical criteria determined by physician review were met in 343 of 1000 episodes. Among them, 313 (91%) had possible, probable or definite infection. Based on this reference, the algorithm achieved sensitivity 0.887 (95% CI: 0.799 to 0.964), specificity 0.985 (95% CI: 0.978 to 0.991), positive predictive value 0.881 (95% CI: 0.833 to 0.926) and negative predictive value 0.986 (95% CI: 0.973 to 0.996). When applied to the total cohort taking into account the sampling proportions of those with and without suspected infection, the algorithm identified 8599 (10.4%) sepsis episodes. The burden of hospital-onset sepsis (>48 hour after admission) and related in-hospital mortality varied between wards.

Conclusions

A fully-automated Sepsis-3 based surveillance algorithm using EHR data performed well compared with physician medical record review in non-intensive care wards, and exposed variations in hospital-onset sepsis incidence between wards.

Logic model framework for considering the inputs, processes and outcomes of a healthcare organisation-research partnership

Quality and Safety in Health Care Journal -

Background

The published literature provides few insights regarding how to develop or consider the effects of knowledge co-production partnerships in the context of delivery system science.

Objective

To describe how a healthcare organisation–university-based research partnership was developed and used to design, develop and implement a practice-integrated decision support tool for patients with a physician recommendation for colorectal cancer screening.

Design

Instrumental case study.

Participants

Data were ascertained from project documentation records and semistructured questionnaires sent to 16 healthcare organisation leaders and staff, research investigators and research staff members.

Results

Using a logic model framework, we organised the key inputs, processes and outcomes of a healthcare organisation–university-based research partnership. In addition to pragmatic researchers, partnership inputs included a healthcare organisation with a supportive practice environment and an executive-level project sponsor, a mid-level manager to serve as the organisational champion and continual access to organisational employees with relevant technical, policy and system/process knowledge. During programme design and implementation, partnership processes included using project team meetings, standing organisational meetings and one-on-one consultancies to provide platforms for shared learning and problem solving. Decision-making responsibility was shared between the healthcare organisation and research team. We discuss the short-term outcomes of the partnership, including how the partnership affected the current research team’s knowledge and health system initiatives.

Conclusion

Using a logic model framework, we have described how a healthcare organisation–university-based research team partnership was developed. Others interested in developing, implementing and evaluating knowledge co-production partnerships in the context of delivery system science projects can use the experiences to consider ways to develop, implement and evaluate similar co-production partnerships.

Applying thematic synthesis to interpretation and commentary in epidemiological studies: identifying what contributes to successful interventions to promote hand hygiene in patient care

Quality and Safety in Health Care Journal -

Objectives

Hand hygiene is considered the most important preventive measure for healthcare-associated infections, but adherence is suboptimal. We previously undertook a Cochrane Review that demonstrated that interventions to improve adherence are moderately effective. Impact varied between organisations and sites with the same intervention and implementation approaches. This study seeks to explore these differences.

Methods

A thematic synthesis was applied to the original authors’ interpretation and commentary that offered explanations of how hand hygiene interventions exerted their effects and suggested reasons why success varied. The synthesis used a published Cochrane Review followed by three-stage synthesis.

Results

Twenty-one papers were reviewed: 11 randomised, 1 non-randomised and 9 interrupted time series studies. Thirteen descriptive themes were identified. They reflected a range of factors perceived to influence effectiveness. Descriptive themes were synthesised into three analytical themes: methodological explanations for failure or success (eg, Hawthorne effect) and two related themes that address issues with implementing hand hygiene interventions: successful implementation needs leadership and cooperation throughout the organisation (eg, visible managerial support) and understanding the context and aligning the intervention with it drives implementation (eg, embedding the intervention into wider patient safety initiatives).

Conclusions

The analytical themes help to explain the original authors’ perceptions of the degree to which interventions were effective and suggested new directions for research: exploring ways to avoid the Hawthorne effect; exploring the impact of components of multimodal interventions; the use of theoretical frameworks for behaviour change; potential to embed interventions into wider patient safety initiatives; adaptations to demonstrate sustainability; and the development of systematic approaches to implementation. Our findings corroborate studies exploring the success or failure of other clinical interventions: context and leadership are important.

How can patient-held lists of medication enhance patient safety? A mixed-methods study with a focus on user experience

Quality and Safety in Health Care Journal -

Background

Patients often carry medication lists to mitigate information loss across healthcare settings. We aimed to identify mechanisms by which these lists could be used to support safety, key supporting features, and barriers and facilitators to their use.

Methods

We used a mixed-methods design comprising two focus groups with patients and carers, 16 semistructured interviews with healthcare professionals, 60 semistructured interviews with people carrying medication lists, a quantitative features analysis of tools available for patients to record their medicines and usability testing of four tools. Findings were triangulated using thematic analysis. Distributed cognition for teamwork models were used as sensitising concepts.

Results

We identified a wide range of mechanisms through which carrying medication lists can improve medication safety. These included improving the accuracy of medicines reconciliation, allowing identification of potential drug interactions, facilitating communication about medicines, acting as an aide-mémoire to patients during appointments, allowing patients to check their medicines for errors and reminding patients to take and reorder their medicines. Different tools for recording medicines met different needs. Of 103 tools examined, none met the core needs of all users. A key barrier to use was lack of awareness by patients and carers that healthcare information systems can be fragmented, a key facilitator was encouragement from healthcare professionals.

Conclusion

Our findings suggest that patients and healthcare professionals perceive patient-held medication lists to have a wide variety of benefits. Interventions are needed to raise awareness of the potential role of these lists in enhancing patient safety. Such interventions should empower patients and carers to identify a method that suits them best from a range of options and avoid a ‘one size fits all’ approach.

When do trials of diabetes quality improvement strategies lead to sustained change in patient care?

Quality and Safety in Health Care Journal -

Introduction

Health systems invest in diabetes quality improvement (QI) programmes to reduce the gap between research evidence of optimal care and current care.1 Examples of commonly used QI strategies in diabetes include programmes to measure and report quality of care (ie, audit and feedback initiatives), implementation of clinician and patient education, and reminder systems. A recent systematic review of randomised trials of QI programmes indicates that they can successfully improve quality of diabetes care and patient outcomes.2 Changes in surrogate markers such as blood glucose control, blood pressure or cholesterol levels are used to measure QI intervention effectiveness.2

However, investments in QI strategies are only worthwhile if the programmes that effectively improve care are sustained after trial completion.3 Failure to maintain QI programmes contributes to substantial research waste, resulting in suboptimal patient care since the effective interventions are not available.

Communication and resolution programmes need to be effectively marketed to leadership and stakeholders

Quality and Safety in Health Care Journal -

Dear Editor,

I am writing to comment on the recent article, ‘Making communication and resolution programmes mission critical in healthcare organisations’, authored by Gallagher et al.1

When implementing a communication and resolution programme (CRP) or disclosure programmes as they are also referred to, there are two key factors to keep in mind: (1) how to market or sell the programme to stakeholders and (2) designing and implementing the programme for long-term success. The authors of this paper seem to negate or dismiss the most important marketing tool for CRP/disclosure programmes: litigation reduction and cost savings for insurers and healthcare organisations. They stated, ‘...CRP is not premised primarily on saving money, but is a norm expected within the clinical mission’. Throughout the article, the financial implications of postevent honesty are downplayed. Instead, Gallagher et al wish for a more ‘ambitious goal’ of making CRP/disclosure ‘integral to clinical mission’...

Key marketing message for communication and resolution programmes: the authors reply

Quality and Safety in Health Care Journal -

We thank Mr Wojcieszak for his letter and his longstanding interest in supporting the principles underlying communication and resolution programmes (CRPs). We understand his belief that the best strategy for spreading CRPs is through marketing that emphasises cost savings and is directed towards those whose primary motivation is financial. In fact, over the last 20 years, many have been lured by the potential of CRPs to reduce liability costs. However, marketing CRPs by emphasising their potential cost savings has not led to widespread adoption of authentic CRPs as hoped. Worse, the emphasis on reducing payments has fuelled incomplete and often cosmetic CRP implementation—the precise concerns that motivated our editorial.

While early claims resolutions and its potential cost savings are certainly one component of CRPs, this practice is not new or unique to CRPs. Savvy risk management and insurance claims representatives have quietly settled claims without litigation for decades. However,...

Quality and safety in the literature: September 2020

Quality and Safety in Health Care Journal -

Healthcare quality and safety span multiple topics across the spectrum of academic and clinical disciplines. Keeping abreast of the rapidly growing body of work can be challenging. In this series, we provide succinct summaries of selected relevant studies published in the last several months. Some articles will focus on a particular theme, while others will highlight unique publications from high-impact medical journals.

Key points

  • In a retrospective cohort study, patients with chronic life-limiting illness and pre-existing Physician Orders for Life-Sustaining Treatment (POLST) who were hospitalised near the end of their lives frequently received care that seemed incongruent with their documented preferences. Potential discordance occurred more frequently in those admitted with traumatic injury and less frequently in those with a history of cancer and dementia. JAMA. 16 Feb 2020.

  • In a cross-sectional study of US long-stay nursing home residents with advanced illness, rates of...

  • Grupo Yacana México S.A.S De C.V. Issues Voluntary Nationwide Recall of All Lots of Yacana Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Sub-Potent Ethanol

    FDA MedWatch -

    Guadalupe, Nuevo León, Grupo Yacana México S.A.S de C.V. is voluntarily recalling All Lots of Yacana Hand Sanitizer, 70% Alcohol, 250 ml to the consumer level. The products have the potential to contain methanol (wood alcohol) and be sub-potent for the ethanol content.

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