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Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements

FDA MedWatch -

Fusion Health and Vitality LLC is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that

Diagnostic error in hospitals: finding forests not just the big trees

Quality and Safety in Health Care Journal -

Diagnostic errors in hospital medicine have mostly remained in uncharted waters.1 This is partly because several factors make measurement of diagnostic errors challenging. Patients are often admitted to hospitals with a tentative diagnosis and need additional diagnostic investigations to determine next steps. This evolving nature of a diagnosis makes it hard to determine when the correct diagnosis could have been established and if a more specific diagnosis was needed to start the right treatment.2 Hospitalised patients also may have diagnoses that are atypical or rare and pose dilemmas for treating clinicians. As a result, delays in diagnosis may not necessarily be related to a diagnostic error. Furthermore, what types of diagnostic errors occur in the hospital and their prevalence depends on how one defines them. Different approaches to define them have included counting missed, wrong or delayed diagnoses regardless of whether there was a process...

Devil in the details: understanding the effects of providing electronic health record access to patients and families

Quality and Safety in Health Care Journal -

Patient advocates have long called for patients to have access to all of their healthcare data, including electronic health records (EHRs).1 In parallel, experts have suggested that providing patients with access to EHRs will improve patient engagement, care quality, and, by extension, health/healthcare outcomes.2 Prior observational studies have supported some of these claims—for example, documenting that patients are overwhelmingly interested in and satisfied with receiving their healthcare data electronically,3 to finding that patients do identify errors when they read physician notes in the EHR.4 Because studies of EHR access for patients have been conducted and disseminated across disparate clinical conditions and settings and often using varied methodologies, the systematic review by Neves et al in this issue of BMJ Quality & Safety provides a valuable contribution in assessing the impact of patients’ EHR access specifically within the randomised controlled trial (RCT)...

Home care after elective vascular surgery: still more questions than answers

Quality and Safety in Health Care Journal -

Home care services support the goal of many patients and caregivers to live independently at home and to ‘age in place’. Home care referrals in the USA have increased nearly 60% from 2002 to 2016 resulting in an over 88% increase in spending to over US$18 billion for Medicare beneficiaries.1 In a recent 2015–2016 survey in Canada, an estimated 881 800 households, or just over 6% of all households, used home care services including nursing and personal/home support services.2 Despite the widespread use of home care services in many countries, relatively little is known about how to optimise patient outcomes in home care. Many questions remain about which patients are most likely to benefit, which services (eg, nursing, therapies, personal care) are most beneficial for which patients and what intensity and duration of services are ideal for different patient populations.

Recently, de Mestral and colleagues identified that...

Prevalence and characterisation of diagnostic error among 7-day all-cause hospital medicine readmissions: a retrospective cohort study

Quality and Safety in Health Care Journal -

Background

The prevalence and aetiology of diagnostic error among hospitalised adults is unknown, though likely contributes to patient morbidity and mortality. We aim to identify and characterise the prevalence and types of diagnostic error among patients readmitted within 7 days of hospital discharge.

Methods

Retrospective cohort study at a single urban academic hospital examining adult patients discharged from the medical service and readmitted to the same hospital within 7 days between January and December 2018. The primary outcome was diagnostic error presence, identified through two-physician adjudication using validated tools. Secondary outcomes included severity of error impact and characterisation of diagnostic process failures contributing to error.

Results

There were 391 cases of unplanned 7-day readmission (5.2% of 7507 discharges), of which 376 (96.2%) were reviewed. Twenty-one (5.6%) admissions were found to contain at least one diagnostic error during the index admission. The most common problem areas in the diagnostic process included failure to order needed test(s) (n=11, 52.4%), erroneous clinician interpretation of test(s) (n=10, 47.6%) and failure to consider the correct diagnosis (n=8, 38.1%). Nineteen (90.5%) of the diagnostic errors resulted in moderate clinical impact, primarily due to short-term morbidity or contribution to the readmission.

Conclusion

The prevalence of diagnostic error among 7-day medical readmissions was 5.6%. The most common drivers of diagnostic error were related to clinician diagnostic reasoning. Efforts to reduce diagnostic error should include strategies to augment diagnostic reasoning and improve clinician decision-making around diagnostic studies.

Going the extra mile -- cross-border patient handover in a European border region: qualitative study of healthcare professionals perspectives

Quality and Safety in Health Care Journal -

Background

Cross-border healthcare is complex, increasingly frequent and causes potential risks for patient safety. In this context, cross-border handovers or the transfer of patients from one country to another deserves particular attention. Although general handover has been the topic of extensive research, little is known about the challenges of handover across national borders, especially as perceived by stakeholders. In this study, we aimed to gain insight into healthcare professionals’ perspectives on cross-border handover and ways to support this.

Methods

We conducted semistructured interviews with healthcare professionals (physicians, nurses, paramedics and administrative staff) in a European border region to investigate their perspectives on cross-border handover. The interviews were aimed to investigate settings of acute and planned handover. Informed by the theory of planned behaviour (TPB), interviews focused on participant perspectives. We summarised all interviews and inductively identified healthcare professionals’ perspectives. We used elements of the TPB as sensitising concepts.

Results

Forty-three healthcare professionals participated. Although respondents had neutral to positive attitudes, they often did not know very well what was expected of them or what influence they could have on improving cross-border handover. Challenges covered five themes: information transfer, language barriers, task division and education, policy and financial structures and cultural differences. To overcome these challenges, we proposed strategies such as providing tools and protocols, discussing and formalising collaboration, and organising opportunities to meet and get to know each other.

Conclusion

Healthcare professionals involved in cross-border handovers face specific challenges. It is necessary to take measures to come to a shared understanding while paying special attention to the above-mentioned challenges. Meeting in person around meaningful activities (eg, training and case discussions) can facilitate sharing ideas and community building.

Identical or similar brand names used in different countries for medications with different active ingredients: a descriptive analysis

Quality and Safety in Health Care Journal -

Objective

To identify US drug brand (proprietary) names that are identical or similar to drug brand names used in other countries containing different active ingredients and name confusion medication errors associated with these drugs.

Methods

We compared a list of brand names approved by the US Food and Drug Administration from 2006 through 2018 with a list of brand names from other countries generated by Uppsala Monitoring Centre using the WHODrug Dictionary. We evaluated drug name pairs that were identical or highly similar and had different active ingredients and searched for name confusion medication errors with these drugs.

Results

A total of 27 US brand names were found to be identical to 38 drug brand names in other countries with different active ingredients. A total of 74 US drug brand names were highly similar to 93 brand names in other countries for drugs containing different active ingredients. We identified name confusion medication errors for one similar name pair.

Conclusions

US drug brand names that are identical to or highly similar to brand names in other countries may cause confusion that can lead to medication errors such as wrong drug errors and wrong drug information being consulted. Manufacturers should consider this risk prior to submitting proposed brand names to regulatory authorities. Regulatory authorities may consider incorporating this check in their brand name reviews and work with manufacturers to eliminate the use of the same or similar brand names for products with different ingredients. Consumers filling prescriptions at foreign pharmacies should also be aware of potential name confusion.

Estimating misclassification error in a binary performance indicator: case study of low value care in Australian hospitals

Quality and Safety in Health Care Journal -

Objective

Indicators based on hospital administrative data have potential for misclassification error, especially if they rely on clinical detail that may not be well recorded in the data. We applied an approach using modified logistic regression models to assess the misclassification (false-positive and false-negative) rates of low-value care indicators.

Design and setting

We applied indicators involving 19 procedures to an extract from the New South Wales Admitted Patient Data Collection (1 January 2012 to 30 June 2015) to label episodes as low value. We fit four models (no misclassification, false-positive only, false-negative only, both false-positive and false-negative) for each indicator to estimate misclassification rates and used the posterior probabilities of the models to assess which model fit best.

Results

False-positive rates were low for most indicators—if the indicator labels care as low value, the care is most likely truly low value according to the relevant recommendation. False-negative rates were much higher but were poorly estimated (wide credible intervals). For most indicators, the models allowing no misclassification or allowing false-negatives but no false-positives had the highest posterior probability. The overall low-value care rate from the indicators was 12%. After adjusting for the estimated misclassification rates from the highest probability models, this increased to 35%.

Conclusion

Binary performance indicators have a potential for misclassification error, especially if they depend on clinical information extracted from administrative data. Indicators should be validated by chart review, but this is resource-intensive and costly. The modelling approach presented here can be used as an initial validation step to identify and revise indicators that may have issues before continuing to a full chart review validation.

Fall prevention implementation strategies in use at 60 United States hospitals: a descriptive study

Quality and Safety in Health Care Journal -

Background

To guide fall prevention efforts, United States organisations, such as the Joint Commission and the Agency for Healthcare Research and Quality, have recommended organisational-level implementation strategies: leadership support, interdisciplinary falls committees, electronic health record tools, and staff, family and patient education. It is unclear whether hospitals adhere to such strategies or how these strategies are operationalised.

Objective

To identify and describe the prevalence of specific hospital fall prevention implementation strategies.

Methods

In 2017, we surveyed 80 US hospitals participating in the National Database of Nursing Quality Indicators who volunteered for the study. We conducted descriptive statistics by calculating percentages for categorical variables and the median and IQR for count variables.

Results

A total of 60/80 (75%) of hospitals completed the survey. The majority of hospitals were not-for-profit (98%) and urban (90%); more than half were Magnet (53%), small (53%) and teaching (52%). Hospitals were more likely to use leadership strategies, such as updating fall policies in the past 3 years (98%) but less likely to reward staff (40%). Hospitals commonly used interdisciplinary falls committees (83%) but membership rarely included physicians. Hospitals lacked access to electronic health record tools, such as high-risk medication warnings (27%). Education strategies were commonly used; 100% of hospitals provided fall education at staff orientation, but only 22% educated all employees (not just nursing staff).

Conclusions

Our study is the first to our knowledge to examine which expert-recommended implementation strategies are being used and how they are being operationalised in US hospitals. Future studies are needed to document fall prevention implementation strategies in detail and to test which implementation strategies are most effective at reducing falls. Additionally, research is needed to evaluate the quality of implementation (eg, fidelity) of fall prevention interventions.

Prevalence of harmful diagnostic errors in hospitalised adults: a systematic review and meta-analysis

Quality and Safety in Health Care Journal -

Background

Diagnostic error is commonly defined as a missed, delayed or wrong diagnosis and has been described as among the most important patient safety hazards. Diagnostic errors also account for the largest category of medical malpractice high severity claims and total payouts. Despite a large literature on the incidence of inpatient adverse events, no systematic review has attempted to estimate the prevalence and nature of harmful diagnostic errors in hospitalised patients.

Methods

A systematic literature search was conducted using Medline, Embase, Web of Science and the Cochrane library from database inception through 9 July 2019. We included all studies of hospitalised adult patients that used physician review of case series of admissions and reported the frequency of diagnostic adverse events. Two reviewers independently screened studies for inclusion, extracted study characteristics and assessed risk of bias. Harmful diagnostic error rates were pooled using random-effects meta-analysis.

Results

Twenty-two studies including 80 026 patients and 760 harmful diagnostic errors from consecutive or randomly selected cohorts were pooled. The pooled rate was 0.7% (95% CI 0.5% to 1.1%). Of the 136 diagnostic errors that were described in detail, a wide range of diseases were missed, the most common being malignancy (n=15, 11%) and pulmonary embolism (n=13, 9.6%). In the USA, these estimates correspond to approximately 249 900 harmful diagnostic errors yearly.

Conclusion

Based on physician review, at least 0.7% of adult admissions involve a harmful diagnostic error. A wide range of diseases are missed, including many common diseases. Fourteen diagnoses account for more than half of all diagnostic errors. The finding that a wide range of common diagnoses are missed implies that efforts to improve diagnosis must target the basic processes of diagnosis, including both cognitive and system-related factors.

PROSPERO registration number

CRD42018115186.

Impact of providing patients access to electronic health records on quality and safety of care: a systematic review and meta-analysis

Quality and Safety in Health Care Journal -

Objective

To evaluate the impact of sharing electronic health records (EHRs) with patients and map it across six domains of quality of care (ie, patient-centredness, effectiveness, efficiency, timeliness, equity and safety).

Design

Systematic review and meta-analysis.

Data sources

CINAHL, Cochrane, Embase, HMIC, Medline/PubMed and PsycINFO, from 1997 to 2017.

Eligibility criteria

Randomised trials focusing on adult subjects, testing an intervention consisting of sharing EHRs with patients, and with an outcome in one of the six domains of quality of care.

Data analysis

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Title and abstract screening were performed by two pairs of investigators and assessed using the Cochrane Risk of Bias Tool. For each domain, a narrative synthesis of the results was performed, and significant differences in results between low risk and high/unclear risk of bias studies were tested (t-test, p<0.05). Continuous outcomes evaluated in four studies or more (glycated haemoglobin (HbA1c), systolic blood pressure (SBP) and diastolic blood pressure (DBP)) were pooled as weighted mean difference (WMD) using random effects meta-analysis. Sensitivity analyses were performed for low risk of bias studies, and long-term interventions only (lasting more than 12 months).

Results

Twenty studies were included (17 387 participants). The domain most frequently assessed was effectiveness (n=14), and the least were timeliness and equity (n=0). Inconsistent results were found for patient-centredness outcomes (ie, satisfaction, activation, self-efficacy, empowerment or health literacy), with 54.5% of the studies (n=6) demonstrating a beneficial effect. Meta-analyses showed a beneficial effect in effectiveness by reducing absolute values of HbA1c (unit: %; WMD=–0.316; 95% CI –0.540 to –0.093, p=0.005, I2=0%), which remained significant in the sensitivity analyses for low risk of bias studies (WMD= –0.405; 95% CI –0.711 to –0.099), and long-term interventions only (WMD=–0.272; 95% CI –0.482 to –0.062). A significant reduction of absolute values of SBP (unit: mm Hg) was found but lost in sensitivity analysis for studies with low risk of bias (WMD= –1.375; 95% CI –2.791 to 0.041). No significant effect was found for DBP (unit: mm Hg; WMD=–0.918; 95% CI –2.078 to 0.242, p=0.121, I2=0%). Concerning efficiency, most studies (80%, n=4) found either a reduction of healthcare usage or no change. A beneficial effect was observed in a range of safety outcomes (ie, general adherence, medication safety), but not in medication adherence. The proportion of studies reporting a beneficial effect did not differ between low risk and high/unclear risk studies, for the domains evaluated.

Discussion

Our analysis supports that sharing EHRs with patients is effective in reducing HbA1c levels, a major predictor of mortality in type 2 diabetes (mean decrease of –0.405, unit: %) and could improve patient safety. More studies are necessary to enhance meta-analytical power and assess the impact in other domains of care.

Protocol registration

http://www.crd.york.ac.uk/PROSPERO (CRD42017070092).

Associations of workflow disruptions in the operating room with surgical outcomes: a systematic review and narrative synthesis

Quality and Safety in Health Care Journal -

Background

Performance in the operating room is an important determinant of surgical safety. Flow disruptions (FDs) represent system-related performance problems that affect the efficiency of the surgical team and have been associated with a risk to patient safety. Despite the growing evidence base on FDs, a systematic synthesis has not yet been published.

Objective

Our aim was to identify, evaluate and summarise the evidence on relationships between intraoperative FD events and provider, surgical process and patient outcomes.

Methods

We systematically searched databases MEDLINE, Embase and PsycINFO (last update: September 2019). Two reviewers independently screened the resulting studies at the title/abstract and full text stage in duplicate, and all inconsistencies were resolved through discussion. We assessed the risk of bias of included studies using established and validated tools. We summarised effects from included studies through a narrative synthesis, stratified based on predefined surgical outcome categories, including surgical process, provider and patient outcomes.

Results

We screened a total of 20 481 studies. 38 studies were found to be eligible. Included studies were highly heterogeneous in terms of methodology, medical specialty and context. Across studies, 20.5% of operating time was attributed to FDs. Various other process, patient and provider outcomes were reported. Most studies reported negative or non-significant associations of FDs with surgical outcomes.

Conclusion

Apart from the identified relationship of FDs with procedure duration, the evidence base concerning the impact of FDs on provider, surgical process and patient outcomes is limited and heterogeneous. We further provide recommendations concerning use of methods, relevant outcomes and avenues for future research on associated effects of FDs in surgery.

Overly optimistic picture of current state of cross-border patient care in 'Going the extra mile study

Quality and Safety in Health Care Journal -

As international health services researchers, we read the paper by Beuken et al1 with great interest. However, in our opinion the authors are too optimistic about the actual volume of current cross-border healthcare. The study also fails to address the role of healthcare professionals to support patients in their cross-border experience, and ultimately, proposes far too modest directions for action. Consequently, it misses the opportunity to go the ‘extra mile’ needed for this important topic.

In our opinion, the authors are idealistic in writing that a relatively large number of Europeans are receiving cross-border healthcare. This lacks important nuances. Five years after the adoption of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare, still, less than 0.05% of European Union (EU) citizens receive healthcare treatments abroad under the Directive.2 Most cross-border healthcare claims are made within the context of the Regulation No...

Response to: Overly optimistic picture of current state of cross-border patient care in 'Going the extra mile by Beuken JA, Verstegen DML, Dolmans D, et al

Quality and Safety in Health Care Journal -

As authors, we were pleased to read the elaborate comments in the correspondence from Kringos et al1 regarding our study, ‘Going the extra mile—cross-border patient handover in a European border region: qualitative study of healthcare professionals’ perspectives’.2 We were happy to read that we succeeded in articulating the need for attention to professionals’ role in cross-border healthcare, especially with regards to the identified challenges (information transfer, differences in task division and education, use of tools and protocols and cultural and language differences). Kringos and colleagues make some excellent points. We would like to elaborate on some of the comments, namely the argued overestimation of cross-border healthcare use, the limited attention for patients and the modesty of proposed actions.

Overestimation of cross-border health care use

Of the overall European population, only a small proportion receives cross-border healthcare. This is, however, different in border regions. Our...

Tiered daily huddles: the power of teamwork in managing large healthcare organisations

Quality and Safety in Health Care Journal -

Successful management of large healthcare organisations has always been challenging but never more than today. We must all think, work and act differently to deliver the highest quality and safest patient care amidst the challenges of payment reform, regulatory requirements, expense growth and resource constraints.1 2 These problems are particularly challenging for non-profit academic medical centres given the need to balance financial demands with commitments to teaching, research and the communities we serve. We observed that in our large healthcare organisation (66 000 caregivers serving approximately 2 million unique patients annually), our leadership team holds immense responsibility but lacked daily insight into our performance, and as a result, took action in retrospect. In order to address this challenge we built a tiered huddle system across our hospitals and outpatient facilities that has produced significant learnings and rapid results. We now reflect and share what we...

Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

FDA MedWatch -

Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the

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