Failure Mode and Effects Analysis (FMEA) at the preanalytical phase for POCT blood gas analysis: proposal for a shared proactive risk analysis model.

OBJECTIVES: Proposal of a risk analysis model to diminish negative impact on patient care by preanalytical errors in blood gas analysis (BGA). METHODS: Here we designed a Failure Mode and Effects Analysis (FMEA) risk assessment template for BGA, based on literature references and expertise of an international team of laboratory and clinical health care professionals. RESULTS: The FMEA identifies pre-analytical process steps, errors that may occur whilst performing BGA (potential failure mode), possible consequences (potential failure effect) and preventive/corrective actions (current controls). Probability of failure occurrence (OCC), severity of failure (SEV) and probability of failure detection (DET) are scored per potential failure mode. OCC and DET depend on test setting and patient population e.g., they differ in primary community health centres as compared to secondary community hospitals and third line university or specialized hospitals. OCC and DET also differ between stand-alone and networked instruments, manual and automated patient identification, and whether results are automatically transmitted to the patient's electronic health record. The risk priority number (RPN = SEV × OCC × DET) can be applied to determine the sequence in which risks are addressed. RPN can be recalculated after implementing changes to decrease OCC and/or increase DET. Key performance indicators are also proposed to evaluate changes. CONCLUSIONS: This FMEA model will help health care professionals manage and minimize the risk of preanalytical errors in BGA.

The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis.

BACKGROUND: Administration of convalescent plasma, serum, or hyperimmune immunoglobulin may be of clinical benefit for treatment of severe acute respiratory infections (SARIs) of viral etiology. We conducted a systematic review and exploratory meta-analysis to assess the overall evidence. METHODS: Healthcare databases and sources of grey literature were searched in July 2013. All records were screened against the protocol eligibility criteria, using a 3-stage process. Data extraction and risk of bias assessments were undertaken. RESULTS: We identified 32 studies of SARS coronavirus infection and severe influenza. Narrative analyses revealed consistent evidence for a reduction in mortality, especially when convalescent plasma is administered early after symptom onset. Exploratory post hoc meta-analysis showed a statistically significant reduction in the pooled odds of mortality following treatment, compared with placebo or no therapy (odds ratio, 0.25; 95% confidence interval, .14-.45; I(2) = 0%). Studies were commonly of low or very low quality, lacked control groups, and at moderate or high risk of bias. Sources of clinical and methodological heterogeneity were identified. CONCLUSIONS: Convalescent plasma may reduce mortality and appears safe. This therapy should be studied within the context of a well-designed clinical trial or other formal evaluation, including for treatment of Middle East respiratory syndrome coronavirus CoV infection.

Point-of-care testing in the overcrowded emergency department--can it make a difference?

Emergency departments (EDs) face several challenges in maintaining consistent quality care in the face of steadily increasing public demand. Improvements in the survival rate of critically ill patients in the ED are directly related to the advancement of early recognition and treatment. Frequent episodes of overcrowding and prolonged waiting times force EDs to operate beyond their capacity and threaten to impact upon patient care. The objectives of this review are as follows: (a) to establish overcrowding as a threat to patient outcomes, person-centered care, and public safety in the ED; (b) to describe scenarios in which point-of-care testing (POCT) has been found to ameliorate factors thought to contribute to overcrowding; and (c) to discuss how POCT can be used directly, and indirectly, to expedite patient care and improve outcomes. Various studies have shown that overcrowding in the ED has profound effects on operational efficiency and patient care. Several reports have quantified overcrowding in the ED and have described a relationship between heightened periods of overcrowding and delays in treatment, increased incidence of adverse events, and an even greater probability of mortality. In certain scenarios, POCT has been found to increase the number of patients discharged in a timely manner, expedite triage of urgent but non-emergency patients, and decrease delays to treatment initiation. This review concludes that POCT, when used effectively, may alleviate the negative impacts of overcrowding on the safety, effectiveness, and person-centeredness of care in the ED.

Intensive care following in-hospital cardiac arrest / periarrest calls-experience from one Scottish hospital.

BACKGROUND: In-hospital cardiac arrest/periarrest is a recognised trigger for consideration of admission to the intensive care unit (ICU). We aimed to investigate the rates of ICU admission following in-hospital cardiac arrest/periarrest, evaluate the outcomes of such patients and assess whether anticipatory care planning had taken place prior to the adult resuscitation team being called. METHODS: Analysis of all referrals to the ICU page-holder within our district general hospital is between 1st November 2018 and 31st May 2019. From this, the frequency of adult resuscitation team calls was determined. Case notes were then reviewed to determine details of the events, patient outcomes and the use of anticipatory care planning tools on wards. RESULTS: Of the 506 referrals to the ICU page-holder, 141 (27.9%) were adult resuscitation team calls (114 periarrests and 27 cardiac arrests). Twelve patients were excluded due to health records being unavailable. Admission rates to ICU were low - 17.4% for cardiac arrests (4/23 patients), 5.7% (6/106) following periarrest. The primary reason for not admitting to ICU was patients being "too well" at the time of review (78/129 - 60.5%). Prior to adult resuscitation team call, treatment escalation plans had been completed in 27.9% (36/129) with Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) forms present in 15.5% of cases (20/129). Four cardiac arrest calls were made in the presence of a valid DNACPR form, frequently due to a lack of awareness of the patient's resuscitation status. CONCLUSIONS: This study highlights the significant workload for the ICU page-holder brought about by adult resuscitation team calls. There is a low admission rate from these calls, and, at the time of resuscitation team call, anticipatory planning is frequently either incomplete or poorly communicated. Addressing these issues requires a collaborative approach between ICU and non-ICU physicians and highlights the need for larger studies to develop scoring systems to aid objective admission decision-making.

Performance of bedside tools for predicting infection-related mortality and administrative data for sepsis surveillance: An observational cohort study.

BACKGROUND: Measuring sepsis incidence and associated mortality at scale using administrative data is hampered by variation in diagnostic coding. This study aimed first to compare how well bedside severity scores predict 30-day mortality in hospitalised patients with infection, then to assess the ability of combinations of administrative data items to identify patients with sepsis. METHODS: This retrospective case note review examined 958 adult hospital admissions between October 2015 and March 2016. Admissions with blood culture sampling were matched 1:1 to admissions without a blood culture. Case note review data were linked to discharge coding and mortality. For patients with infection the performance characteristics of Sequential Organ Failure Assessment (SOFA), National Early Warning System (NEWS), quick SOFA (qSOFA), and Systemic Inflammatory Response Syndrome (SIRS) were calculated for predicting 30-day mortality. Next, the performance characteristics of administrative data (blood cultures and discharge codes) for identifying patients with sepsis, defined as SOFA ≥2 because of infection, were calculated. RESULTS: Infection was documented in 630 (65.8%) admissions and 347 (55.1%) patients with infection had sepsis. NEWS (Area Under the Receiver Operating Characteristic, AUROC 0.78 95%CI 0.72-0.83) and SOFA (AUROC 0.77, 95%CI 0.72-0.83), performed similarly well for prediction of 30-day mortality. Having an infection and/or sepsis International Classification of Diseases, Tenth Revision (ICD-10) code (AUROC 0.68, 95%CI 0.64-0.71) performed as well in identifying patients with sepsis as having at least one of: an infection code; sepsis code, or; blood culture (AUROC 0.68, 95%CI 0.65-0.71), Sepsis codes (AUROC 0.53, 95%CI 0.49-0.57) and positive blood cultures (AUROC 0.52, 95%CI 0.49-0.56) performed least well. CONCLUSIONS: SOFA and NEWS best predicted 30-day mortality in patients with infection. Sepsis ICD-10 codes lack sensitivity. For health systems without suitable electronic health records, blood culture sampling has potential utility as a clinical component of a proxy marker for sepsis surveillance.

Association of out of hospital paediatric early warning score with need for hospital admission in a Scottish emergency ambulance population.

OBJECTIVE: Physiological derangement, as measured by paediatric early warning score (PEWS) is used to identify children with critical illness at an early point to identify and intervene in children at risk. PEWS has shown some utility as a track and trigger system in hospital and also as a predictor of adverse outcome both in and out of hospital. This study examines the relationship between prehospital observations, aggregated into an eight-point PEWS (Scotland), and hospital admission. METHODS: A retrospective analysis of all patients aged less than 16 transported to hospital by the Scottish Ambulance Service between 2011 and 2015. Data were matched to outcome data regarding hospital admission or discharge and length of stay. RESULTS: Full data were available for 21 202 paediatric patients, of whom 6340 (29.9%) were admitted to hospital. Prehospital PEWS Scotland was associated with an odds ratio for admission of 1.189 [95% confidence interval (CI): 1.176-1.202; P < 0.001]. The area under receiver operating curve of 0.617 (95% CI: 0.608-0.625; P < 0.001) suggests poorly predictive ability for hospital admission. There was no association between prehospital PEWS Scotland and length of hospital stay. CONCLUSION: These data show that a single prehospital PEWS Scotland was a poor predictor of hospital admission for unselected patients in a prehospital population. The decision to admit a child to hospital is not solely based on the physiological derangement of vital signs, and hence physiological-based scoring systems such as PEWS Scotland cannot be used as the sole criteria for hospital admission, from an undifferentiated prehospital population.

Superior performance of National Early Warning Score compared with quick Sepsis-related Organ Failure Assessment Score in predicting adverse outcomes: a retrospective observational study of patients in the prehospital setting.

BACKGROUND: Early intervention and response to deranged physiological parameters in the critically ill patient improve outcomes. A National Early Warning Score (NEWS) based on physiological observations has been developed for use throughout the National Health Service in the UK. The quick Sepsis-related Organ Failure Assessment Score (qSOFA) was developed as a simple bedside criterion to identify adult patients outwith the ICU with suspected infection who are likely to have a prolonged ICU stay or die in hospital. We aim to compare the ability of NEWS and qSOFA to predict adverse outcomes in a prehospital population. PATIENTS AND METHODS: All clinical observations taken by emergency ambulance crews transporting patients to a single hospital were collated along with information relating to mortality over a 2-month period. The performance of the NEWS and qSOFA in identifying the endpoints of 30-day mortality, ICU admission and a combined endpoint of 48 h. ICU admission or 30-day mortality was analysed. RESULTS: Complete data were available for 1713 patients. For the primary outcome of ICU admission within 48 h or 30-day mortality, the odds ratio for a qSOFA score of 3 compared with 0 was 124.1 [95% confidence interval (CI): 13.5-1137.7] and the odds ratio for a high NEWS category, compared with the low NEWS category was 9.82 (95% CI: 5.74-16.81). Comparison of qSOFA and NEWS performance was assessed using receiver operating characteristic curves. The area under the receiver operating characteristic curve for the primary outcome for qSOFA was 0.679 (95% CI: 0.624-0.733), for NEWS category was 0.707 (95% CI: 0.654-0.761) and for NEWS total score was 0.740 (95% CI: 0.685-0.795). Comparison of the receiver operating characteristic curves between NEWS total score and qSOFA using DeLong's test showed NEWS total score to be superior to qSOFA at predicting combined ICU admission within 48 h of presentation or 30-day mortality (P = 0.011). CONCLUSION: Our study shows qSOFA can identify patients at risk of adverse outcomes in the prehospital setting. However, NEWS is superior to qSOFA in a prehospital environment at identifying patients at risk of adverse outcomes.

The development of a consensus definition for healthcare improvement science (HIS) in seven European countries: A consensus methods approach.

INTRODUCTION: There is a limited body of research in the field of healthcare improvement science (HIS). Quality improvement and 'change making' should become an intrinsic part of everyone's job, every day in all parts of the healthcare system. The lack of theoretical grounding may partly explain the minimal transfer of health research into health policy. METHODS: This article seeks to present the development of the definition for healthcare improvement science. A consensus method approach was adopted with a two-stage Delphi process, expert panel and consensus group techniques. A total of 18 participants were involved in the expert panel and consensus group, and 153 answers were analysed as a part of the Delphi survey. Participants were researchers, educators and healthcare professionals from Scotland, Slovenia, Spain, Italy, England, Poland, and Romania. RESULTS: A high level of consensus was achieved for the broad definition in the 2nd Delphi iteration (86%). The final definition was agreed on by the consensus group: 'Healthcare improvement science is the generation of knowledge to cultivate change and deliver person-centred care that is safe, effective, efficient, equitable and timely. It improves patient outcomes, health system performance and population health.' CONCLUSIONS: The process of developing a consensus definition revealed different understandings of healthcare improvement science between the participants. Having a shared consensus definition of healthcare improvement science is an important step forward, bringing about a common understanding in order to advance the professional education and practice of healthcare improvement science.

A complex endeavour: an ethnographic study of the implementation of the Sepsis Six clinical care bundle.

BACKGROUND: Implementation of the 'Sepsis Six' clinical care bundle within an hour of recognition of sepsis is recommended as an approach to reduce mortality in patients with sepsis, but achieving reliable delivery of the bundle has proved challenging. There remains little understanding of the barriers to reliable implementation of bundle components. We examined frontline clinical practice in implementing the Sepsis Six. METHODS: We conducted an ethnographic study in six hospitals participating in the Scottish Patient Safety Programme Sepsis collaborative. We conducted around 300 h of non-participant observation in emergency departments, acute medical receiving units and medical and surgical wards. We interviewed a purposive sample of 43 members of hospital staff. Data were analysed using a constant comparative approach. RESULTS: Implementation strategies to promote reliable use of the Sepsis Six primarily focused on education, engaging and motivating staff, and providing prompts for behaviour, along with efforts to ensure that equipment required was readily available. Although these strategies were successful in raising staff awareness of sepsis and engagement with implementation, our study identified that completing the bundle within an hour was not straightforward. Our emergent theory suggested that rather than being an apparently simple sequence of six steps, the Sepsis Six actually involved a complex trajectory comprising multiple interdependent tasks that required prioritisation and scheduling, and which was prone to problems of coordination and operational failures. Interventions that involved allocating specific roles and responsibilities for completing the Sepsis Six in ways that reduced the need for coordination and task switching, and the use of process mapping to identify system failures along the trajectory, could help mitigate against some of these problems. CONCLUSIONS: Implementation efforts that focus on individual behaviour change to improve uptake of the Sepsis Six should be supplemented by an understanding of the bundle as a complex trajectory of work in which improving reliability requires attention to coordination of workflow, as well as addressing the mundane problems of interruptions and operational failures that obstruct task completion.

Making it easy to do the right thing in healthcare: Advancing improvement science education through accredited pan European higher education modules.

BACKGROUND: Numerous international policy drivers espouse the need to improve healthcare. The application of Improvement Science has the potential to restore the balance of healthcare and transform it to a more person-centred and quality improvement focussed system. However there is currently no accredited Improvement Science education offered routinely to healthcare students. This means that there are a huge number of healthcare professionals who do not have the conceptual or experiential skills to apply Improvement Science in everyday practise. METHODS: This article describes how seven European Higher Education Institutions (HEIs) worked together to develop four evidence informed accredited inter-professional Improvement Science modules for under and postgraduate healthcare students. It outlines the way in which a Policy Delphi, a narrative literature review, a review of the competency and capability requirements for healthcare professionals to practise Improvement Science, and a mapping of current Improvement Science education informed the content of the modules. RESULTS: A contemporary consensus definition of Healthcare Improvement Science was developed. The four Improvement Science modules that have been designed are outlined. A framework to evaluate the impact modules have in practise has been developed and piloted. CONCLUSION: The authors argue that there is a clear need to advance healthcare Improvement Science education through incorporating evidence based accredited modules into healthcare professional education. They suggest that if Improvement Science education, that incorporates work based learning, becomes a staple part of the curricula in inter-professional education then it has real promise to improve the delivery, quality and design of healthcare.

The accuracy and timeliness of a Point Of Care lactate measurement in patients with Sepsis.

BACKGROUND: The aims of this study were to a) compare the lactate measurement of a Point of Care (POC) handheld device to near patient blood gas analysers, and b) determine the differential reporting times between the analysers. METHODS: A two-staged study; method comparison and prospective observational stages, was conducted. For the first stage, blood samples were analysed on the i-STAT handheld device and the near patient blood gas analysers (GEM 4000 and OMNI S). Results were compared using Pearson correlation coefficient and Bland-Altman tests. For the second stage, we examined the differential reporting times of the POC device compared to the near patient blood gas analysers in two Scottish hospitals. Differential reporting times were assessed using Mann-Whitney test and descriptive statistics were reported with quartiles. RESULTS: Highly significant Pearson correlation coefficients (0.999 and 0.993 respectively) were found between i-STAT and GEM 4000 and OMNI S. The Bland-Altman agreement method showed bias values of -0.03 and -0.24, between i-STAT and GEM 4000 and OMNI S respectively. Median time from blood draw to i-STAT lactate results was 5 min (Q1-Q3 5-7). Median time from blood draw to GEM 4000 lactate results was 10 min (Q1-Q3 7.75-13). Median time from blood draw to OMNIS lactate results was 11 min (Q1-Q3 8-22). The i-STAT was significantly quicker than both the GEM 4000 and the OMNIS (each p-value < 0.001). In addition, 18 of our study samples were sent to the central laboratory for analysis due to a defect in the lactate module of OMNI S. The median time for these samples from blood draw to availability of the central laboratory results at the clinical area was 133 min. CONCLUSIONS: The POC handheld device produced accurate, efficient and timely lactate measurements with the potential to influence clinical decision making sooner.

Validation of the National Early Warning Score in the prehospital setting.

BACKGROUND: Early intervention and response to deranged physiological parameters in the critically ill patient improves outcomes. A National Early Warning Score (NEWS) based on physiological observations has been developed for use throughout the National Health Service (NHS) in the UK. Although a good predictor of mortality and deterioration in inpatients, its performance in the prehospital setting is largely untested. This study aimed to assess the validity of the NEWS in unselected prehospital patients. METHODS: All clinical observations taken by emergency ambulance crews transporting patients to a single hospital were collated along with information relating to hospital outcome over a two month period. The performance of the NEWS in identifying the endpoints of 48h and 30 day mortality, intensive care unit (ICU) admission, and a combined endpoint of 48h mortality or ICU admission was analysed. RESULTS: 1684 patients were analysed. All three of the primary endpoints and the combined endpoint were associated with higher NEWS scores (p<0.01 for each). The medium-risk NEWS group was associated with a statistically significant increase in ICU admission (RR=2.466, 95% CI 1.0-6.09), but not in-hospital mortality relative to the low risk group. The high risk NEWS group had significant increases in 48h mortality (RR 35.32 [10.08-123.7]), 30 day mortality (RR 6.7 [3.79-11.88]), and ICU admission (5.43 [2.29-12.89]). Similar results were noted when trauma and non-trauma patients were analysed separately. CONCLUSIONS: Elevated NEWS among unselected prehospital patients is associated with a higher incidence of adverse outcomes. Calculation of prehospital NEWS may facilitate earlier recognition of deteriorating patients, early involvement of senior Emergency Department staff and appropriate critical care.

Reducing cardiac arrests in the acute admissions unit: a quality improvement journey.

BACKGROUND: In 2010, the acute admissions unit (AAU) at Stirling Royal Infirmary had the highest number of cardiac arrests of any ward. A quality improvement project was undertaken to reduce this to <1/1000 admissions by December 2011. METHODS: In January 2011, based on initial needs assessment, we selected three initiatives to improve cardiac arrest rate: (1) structured response to deteriorating patients; (2) analysis of adverse events; and (3) improved end-of-life decision-making. We performed a failure modes effects analysis to identify reasons for the failure of early recognition and response. Ward staff conducted weekly safety meetings to engage unit staff and promote a safety culture of continuous improvement. Additionally, in July 2011 the unit adopted a ward-based clinical team structure with twice daily consultant ward rounds. Our primary outcome measure, cardiac arrests per 1000 admissions, was measured from January 2011 to August 2012. RESULTS: Over 17 months, the number of cardiac arrests per 1000 admissions fell from a baseline of 2.8/1000 admissions to 0.8/1000 admissions (71% reduction), referrals to palliative care increased by 22 to 37/1000 admissions per month (68% increase) and the 30-day mortality of patients admitted to the AAU fell from 6.3% to 4.8% (24% relative reduction). CONCLUSIONS: Through adoption of a shared goal, application of improvement methodology including the model for improvement to test new innovations, and promotion of a safety culture in the AAU, cardiac arrests were successfully reduced to <1/1000 admissions per month with an associated significant fall in mortality. This was achieved with negligible cost.