Analytical evaluation of the VITROS® 5600 Integrated System in a pediatric setting and determination of pediatric reference intervals

ObjectivesTo evaluate the VITROS^® 5600 Integrated System in a pediatric setting and to determine age- and gender-specific pediatric reference intervals for several common analytes.Design and methodsThe instrument was evaluated using QC material and patient samples. Reference intervals were determined using samples obtained from children attending select outpatient clinics.ResultsImprecision analysis for 25 analytes and serum indices, the turnaround time for a simulated workload, and MicroSensor performance were assessed in our pediatric laboratory. Pediatric reference intervals for 25 analytes were also determined according to the CLSI/IFCC C28-A3 guidelines using 770 samples and over 15,000 analyses.ConclusionThe VITROS 5600 Integrated System is suitable for use in a pediatric setting. Age- and gender-partitioned pediatric reference intervals for 25 common analytes were also determined as a pilot to the ongoing CALIPER project. These reference intervals are valuable for all VITROS^® users as well as any laboratory assessing these analytes once they demonstrate the acceptability of transference to their laboratory.     

Falsely elevated tacrolimus concentrations measured using the ACMIA method due to circulating endogenous antibodies in a kidney transplant recipient

BackgroundTherapeutic monitoring of whole-blood concentration of tacrolimus, a potent immunosuppressive drug used after organ transplantation, is essential to avoid toxic effects and to maintain the correct dosage. Although the reference method for the determination of tacrolimus concentrations is LC-MS/MS, several certified immunoassays are widely used for routine examinations. We report falsely elevated blood tacrolimus concentrations using the antibody-conjugated magnetic immunoassay (ACMIA) from Siemens Healthcare Diagnostics for the analysis of a patient who had undergone renal transplantation.MethodsWhole-blood samples from a patient with elevated tacrolimus concentrations not consistent with the clinical picture were analysed with an alternative immunoassay and were investigated for interference by performing double dilution tests, by incubating in heterophilic blocking tubes and by evaluating plasmatic interfering factors.ResultsDouble dilution tests showed a clear nonlinearity, suggesting that antibody interference not related to heterophilic antibodies had occurred; false-positive concentrations of cyclosporin obtained when using an antibody-conjugated to β-galactosidase suggested the presence of endogenous antibodies directed against β-galactosidase.ConclusionIn patients receiving tacrolimus, continued surveillance by laboratory staff and clinicians is necessary when using a method not requiring external pre-treatment, such as the Siemens ACMIA method.     

Application of a six sigma model to evaluate the analytical performance of urinary biochemical analytes and design a risk‐based statistical quality control strategy for these assays: A multicenter study

BackgroundThe six sigma model has been widely used in clinical laboratory quality management. In this study, we first applied the six sigma model to (a) evaluate the analytical performance of urinary biochemical analytes across five laboratories, (b) design risk‐based statistical quality control (SQC) strategies, and (c) formulate improvement measures for each of the analytes when needed.MethodsInternal quality control (IQC) and external quality assessment (EQA) data for urinary biochemical analytes were collected from five laboratories, and the sigma value of each analyte was calculated based on coefficients of variation, bias, and total allowable error (TEa). Normalized sigma method decision charts for these urinary biochemical analytes were then generated. Risk‐based SQC strategies and improvement measures were formulated for each laboratory according to the flowchart of Westgard sigma rules, including run sizes and the quality goal index (QGI).ResultsSigma values of urinary biochemical analytes were significantly different at different quality control levels. Although identical detection platforms with matching reagents were used, differences in these analytes were also observed between laboratories. Risk‐based SQC strategies for urinary biochemical analytes were formulated based on the flowchart of Westgard sigma rules, including run size and analytical performance. Appropriate improvement measures were implemented for urinary biochemical analytes with analytical performance lower than six sigma according to the QGI calculation.ConclusionsIn multilocation laboratory systems, a six sigma model is an excellent quality management tool and can quantitatively evaluate analytical performance and guide risk‐based SQC strategy development and improvement measure implementation.     

The impact of pre-analytical variations on biochemical analytes stability: A systematic review

ObjectiveA common problem in clinical laboratories is maintaining the stability of analytes during pre‐analytical processes. The aim of this study was to systematically summarize the results of a set of studies about the biochemical analytes stability.MethodsA literature search was performed on the Advanced search field of PubMed using the keywords: “(stability) AND (analytes OR laboratory analytes OR laboratory tests OR biochemical analytes OR biochemical tests OR biochemical laboratory tests).” A total of 56 entries were obtained. After applying the selection criteria, 20 articles were included in the study.ResultsIn the 20 included references, up to 123 different analytes were assessed. The 34 analytes in order of the most frequently studied analytes were evaluated: Alanine aminotransferase, aspartate aminotransferase, potassium, triglyceride, alkaline phosphatase, creatinine, total cholesterol, albumin, lactate dehydrogenase, sodium, calcium, γ‐glutamyltransferase, total bilirubin, urea, creatine kinase, inorganic phosphate, total protein, uric acid, amylase, chloride, high‐density lipoprotein, magnesium, glucose, C‐reactive protein, bicarbonate, ferritin, iron, lipase, transferrin, cobalamin, cortisol, folate, free thyroxine, and thyroid‐stimulating hormone. Stable test results could be varied between 2 hours and 1 week according to the type of samples and/or type of blood collection tubes on a basic classification set as refrigerated or room temperature.ConclusionsBiochemical analytes stability could be improved if the best pre‐analytical approaches are used.     

Centralization of multisite reagent lot-to-lot validation for Ortho Clinical Vitros chemistry instruments

ObjectiveReagent lot-to-lot comparisons are recommended by accreditation bodies to ensure that the performance of each reagent lot meets acceptable standards for quality patient results. The general approach is comprised of performing quality control (QC) and patient comparison between the old and new reagent lots and evaluating against a pre-defined criteria. Reagent lot comparison practices are often variable despite using the same instrument across different laboratories. This is costly, time consuming, and can lead to variability in acceptance criteria. While Clinical & Laboratory Standards Institute (CLSI) has a recommended guideline for reagent lot validation, it is often difficult to execute for small and rural laboratories due to limited resources. Defining the analytes required for detailed validation is important to allocate appropriate resources to ensure quality patient results. The goal of this study was to develop a standardized approach to reagent lot validation and optimize lab resources on Vitros chemistry instruments.Design and MethodThis study consists of a retrospective and prospective analysis of reagent lot changes in dry slide chemistry analyzers (Ortho Clinical Diagnostics Vitros). Two years of retrospective reagent lot comparison data was obtained at a single site. A prospective study was conducted by assessing aliquots of 10 patient sample pools at 9 sites with Vitros analyzers.ResultsOf the 19 chemistry analytes evaluated, albumin, sodium, and total protein showed significant differences between reagent lots and also exceeded the pre-defined acceptance criteria.ConclusionFor these analytes, our recommendations are to perform a comprehensive lot validation with QC and patient samples. A simple lot validation with a reflex approach comprised of initially assaying QC can be adapted for the more stable analytes to allow achieving quality patient result in a resource constraint rural environment.     

Quantification of serum free light chain kappa and lambda by the SPAPLUS analyser

ObjectiveClinical assessment of the SPA_PLUS® system for the determination of the serum free light chains kappa (κ FLC) and lambda (λ FLC) compared to the BNII®.Design and methods126 serum specimens from our routine activity were analysed on two different analysers: the BNII® (immunonephelometry, Siemens) and the SPA_PLUS® (turbidimetry, Binding Site). We compared the absolute values of the serum κ FLC and λ FLC, as well as the FLC κ/λ ratio on both analysers. These results were further evaluated together with the clinical history of the patients.ResultsRegression analysis between the BNII® and the SPA_PLUS® for κ FLC and λ FLC did not display any significant differences between both methods in the normal and pathological ranges. Nevertheless, some differences have been observed for some patients in the absolute value of the involved light chain, with potential clinical implications.ConclusionThe results show overall good concordance between both methods. However, it is recommended that the monitoring of patients affected by monoclonal gammapathies by measuring FLC, be performed in the same laboratory and by the same method. Moreover, the FLC results should always be interpreted together with other laboratory tests taking into account the patient's diagnosis.     

Acute liver failure with thrombotic microangiopathy due to sodium valproate toxicity: A case report

BACKGROUNDSodium valproate is widely used in the treatment of epilepsy in clinical practice. Most adverse reactions to sodium valproate are mild and reversible, while serious idiosyncratic side effects are becoming apparent, particularly hepatotoxicity. Herein, we report a case of fatal acute liver failure (ALF) with thrombotic microangiopathy (TMA) caused by treatment with sodium valproate in a patient following surgery for meningioma.CASE SUMMARYA 42-year-old man who received antiepileptic treatment with sodium valproate after surgery for meningioma exhibited extreme fatigue, severe jaundice accompanied by oliguria, soy sauce-colored urine, and ecchymosis. His postoperative laboratory values indicated a rapid decreased platelet count and hemoglobin level, severe liver and kidney dysfunction, and disturbance of the coagulation system. He was diagnosed with drug-induced liver failure combined with TMA. After plasma exchange combined with hemoperfusion, pulse therapy with high-dose methylprednisolone, and blood transfusion, his liver function deteriorated, and finally, he died.CONCLUSIONALF with TMA is a rare and fatal adverse reaction of sodium valproate which needs to be highly valued.     

Pharmacokinetics and Safety of Sodium Benzoate,a d-Amino Acid Oxidase (DAAO) Inhibitor,in Healthy Subjects: A Phase I,Open-label Study

PurposeN-methyl-d-aspartate receptor (NMDAR)-mediated neurotransmission plays a critical role in cognition and memory, and d-serine is a co-agonist of the receptor. d-serine is metabolized by d-amino acid oxidase (DAAO). Sodium benzoate is a DAAO inhibitor that leads to the elevation of d-serine levels and enhances NMDAR functions as a therapeutic for wide-spectrum central nervous system (CNS) disorders, including schizophrenia and dementia. For therapeutic application of sodium benzoate in CNS disorders, we conducted a Phase I study to evaluate its safety, tolerability, and pharmacokinetic profile after single-dose oral administration in healthy volunteers. In contrast to the accumulation in the CNS, sodium benzoate has a rapid pharmacokinetic profile when measured peripherally.MethodsIn this Phase I study, subjects were randomized into 4 different dose groups after a single oral administration. The pharmacokinetic parameters of sodium benzoate were assessed after exposure to 250, 500, 1000, and 2000 mg of sodium benzoate. All adverse events were investigated and recorded.FindingsThe C_max and AUC of sodium benzoate exhibited a higher than dose-proportional increase within the dose range from 250 to 2000 mg under fasting conditions. The slopes were 1.78 and 2.61 and the 90% CIs were 1.41 to 2.15 and 2.20 to 3.03 for C_max and AUC, respectively. Sodium benzoate was absorbed and converted to benzoic acid rapidly, reaching C_max after ～0.5 hour and elimination t_1/2 after ～0.3 hour. No subjects reported adverse events that were sodium benzoate related.ImplicationsThe nonlinear pharmacokinetic response was observed within the dose range up to 2000 mg. Sodium benzoate treatment exhibited a favorable safety profile and was well tolerated at all dose levels. The study results serve as a foundation that should be useful for investigating efficacy and safety in the drug's subsequent clinical development. Trial registration: TFDA-103607047.     

Code Critical: Improving Care Delivery for Critically Ill Patients in the Emergency Department

ProblemAlthough certain critically ill patients in emergency departments—such as those experiencing trauma, stroke, and myocardial infarction—often receive care through coordinated team responses, resource allocation and care delivery can vary widely for other high-acuity patients. The absence of a well-defined response process for these patients may result in delays in care, suboptimal outcomes, and staff dissatisfaction. The purpose of this quality improvement project was to develop, implement, and evaluate an ED-specific alert team response for critically ill medical adult and pediatric patients not meeting criteria for other medical alerts.MethodsLean (Lean Enterprise Institute, Boston, MA) principles and processes were used to develop, implement, and evaluate an ED-specific response team and process for critically ill medical patients. Approximately 300 emergency nurses, providers, technicians, unit secretaries/nursing assistants, and ancillary team members were trained on the code critical process. Turnaround and throughput data was collected during the first 12 weeks of code critical activations (n = 153) and compared with historical controls (n = 168).ResultsAfter implementing the code critical process, the door-to-provider time decreased by 62%, door to laboratory draw by 76%, door-to-diagnostic imaging by 46%, and door-to-admission by 19%. A year later, data comparison demonstrated sustained improvement in all measures.DiscussionEmergency nurses and providers see the value of coordinated team response in the delivery of patient care. Team responses to critical medical alerts can improve care delivery substantially and sustainably.     

Pediatric critical values: Laboratory–pediatrician discourse

ObjectivesTo review pediatric critical values after consultation with departmental pediatricians.MethodsAn electronic survey with the critical value list of 26 high or low abnormal chemistry laboratory values of 12 analytes was circulated to pediatricians. The survey results were presented to a focus group of 3 pediatricians for comments and review.ResultsThirty-one of 125 pediatricians affiliated with the Department of Pediatrics responded. Sixteen of 26 (61.5%) current values met the agreement criteria. The procedures for calling high glucose levels in neonates and children, and the low magnesium and low ionized calcium critical values were revised after discussion with the focus group.ConclusionsThis survey among the hospital's pediatricians resulted not only in a revised list of critical values, but also the procedure for calling the user. The use of unique critical values for different areas of clinical practice within the children's hospital was identified as an area for future development.     

Establishment of reference intervals of 24 chemistries in apparently healthy adult Han population of Northern China

BackgroundThe availability of reference intervals is essential for physicians to interpret laboratory results. Most of our laboratory reference intervals are derived from data on the foreign population. We have studied the reference intervals of 24 common laboratory biochemical tests in an apparently healthy adult Han population of Northern China.Methods1364 healthy individuals between 20 and 79 years old were recruited. 24 different chemical analytes were tested by the Roche Modular P 800 analyzer. We stratified the populations by gender and age through applying exclusion criteria, and the reference intervals were obtained by statistical analysis.ResultsReference intervals for 24 common analytes in a gender and age appropriate adult Han population of Northern China are reported.ConclusionOur study provides adequate laboratory data on reference intervals. The results emphasize the significance of establishing population-based reference intervals for a clinical laboratory.     

Code labs: expediting laboratory test results during a code

BACKGROUND Knowing a patient's "laboratory picture" is crucial in any code blue situation. Having no streamlined method for collecting and processing laboratory specimens during codes leads to staff frustration and critical delays in patient care. OBJECTIVE To simplify collection and testing of laboratory specimens during codes. METHODS Staff nurses led an initiative through which (1) code laboratory tests were placed in a computerized order set, thereby simplifying ordering; (2) prepackaged bags of supplies for the new order set were placed in each code cart; (3) the laboratory department supervisor began carrying a code pager to ensure that laboratory staff are prepared for incoming "code labs"; (4) a protocol was created for laboratory staff to follow after receiving code labs; and (5) processes were developed for units that are not integrated in the organization's electronic ordering system. RESULTS The mean turnaround time (the time from when laboratory tests are ordered to when results are posted) was reduced from 52.0 minutes to 31.3 minutes (P = .002). Laboratory staff improved their processing time (the time from when specimens are received by laboratory staff to when results are posted) from 34.9 minutes to 21.5 minutes (P = .01). Survey responses indicated that staff across disciplines were significantly more satisfied with the new process. CONCLUSIONS Because the changes are basic, they can be implemented easily in any hospital setting to improve turnaround time for laboratory tests during codes.     

Validating laboratory results in a national observational cohort study without field centers: The Reasons for Geographic and Racial Differences in Stroke cohort

ObjectivesThe REasons for Geographic and Racial Differences in Stroke (REGARDS) study is a prospective cohort of 30,239 Americans in the contiguous United States; the first of this scale to use home visits to obtain, process, and ship biologic samples to a core laboratory. Pre-analytical factors resulting from this study design may affect the results of some laboratory assays. We investigated the impact of REGARDS processing on a variety of analytes.Design and methodsIn REGARDS, blood samples were processed in the field by technicians who were trained on standardized methods for phlebotomy and sample processing. Field processing included centrifugation using varying non-uniform equipment and shipping overnight on ice to the University of Vermont, where samples were re-centrifuged for 30,000 ×g-minutes and stored at  −80 °C. We assessed the effects of REGARDS sample handling by processing split samples from 20 volunteers using either ideal procedures or simulated REGARDS procedures. Assays for 19 analytes for potential study in REGARDS were then run on both samples and results compared.ResultsSpearman correlation coefficients for analytes measured in ideal versus REGARDS processed samples ranged from 0.11 to 1.0. Thirteen of 19 analytes were highly correlated (> 0.75), but platelet proteins were more variable.ConclusionsSimulation of non-optimal field processing and shipment to a central laboratory showed high variability in analytes released by platelets. The majority of other analytes produced valid results, but platelet contamination in REGARDS samples makes measurement of platelet proteins unadvisable in these samples. Future analytes considered by REGARDS or similar studies should undergo similar pilot testing.     

Establishing critical care nursing research priorities for three Australian regional public hospitals: A mixed method priority setting study

ObjectiveTo determine key priorities for critical care nursing research in three Australian regional public hospitals, representing the shared priorities of healthcare professionals and patient representatives.MethodsA three phase priority setting study, including consensus methods (nominal group), survey, qualitative interviews and focus groups were conducted between May 2021 and March 2022. Healthcare professionals and patient representatives from critical care units in regional public hospitals in Australia participated. A patient representative contributed to research design and co-authored this paper.ResultsIn phase one, 29 research topics were generated. In phase two, during a nominal group ranking process, the top 5 priority areas for each site were identified. In the final phase, three themes from focus groups and interviews included patient flow through intensive care, patient care through intensive care journey and intensive care patient recovery.ConclusionIdentifying context specific research priorities through a priority setting exercise provides insight into the topics that are important to healthcare professionals and to patients in critical care. The top research priorities for nursing research in critical care in regional Australian hospitals include patient flow, patient recovery, and evidence based patient care through the intensive care journey, such as delirium management, pain and sedation, and mobilisation. These shared priorities will be used to guide future nursing research in critical care over the next 3–5 years.Implications for Clinical PracticeThe method we used in identifying the research priorities can be used by other researchers and clinicians; close collaboration among researchers and clinicians will be beneficial for practice improvement; and how we can be reassured that our practice is evidence based is worthy of attention.     

Physicians’ and nurses’ perceptions of patient safety risks in the emergency department

The emergency department has been described as a high-risk area for errors. It is also known that working conditions such as a high workload and shortage off staff in the healthcare field are common factors that negatively affect patient safety. A limited amount of research has been conducted with regard to patient safety in Swedish emergency departments. Additionally, there is a lack of knowledge about clinicians’ perceptions of patient safety risks. Therefore, the purpose of this study was to describe emergency department clinicians’ experiences with regard to patient safety risks.MethodSemi-structured interviews were conducted with 10 physicians and 10 registered nurses from two emergency departments. Interviews were analysed by inductive content analysis.ResultsThe experiences reflect the complexities involved in the daily operation of a professional practice, and the perception of risks due to a high workload, lack of control, communication and organizational failures.ConclusionThe results reflect a complex system in which high workload was perceived as a risk for patient safety and that, in a combination with other risks, was thought to further jeopardize patient safety. Emergency department staff should be involved in the development of patient safety procedures in order to increase knowledge regarding risk factors as well as identify strategies which can facilitate the maintenance of patient safety during periods in which the workload is high.     

Clinical and analytical evaluation of an immunoturbidimetric heart-type fatty acid-binding protein assay

Abstract

Background. Heart-type fatty acid-binding protein (H-FABP) is a low molecular weight protein involved in the intracellular uptake and buffering of long chain fatty acids in the myocardium. It is an early marker for ACS. We have evaluated the Randox Laboratories immunoturbidimetric assay on a Siemens Advia 1800 analyzer. The assay employs latex particles coated with mouse monoclonal anti-HFABP antibodies to generate turbidity. Methods. We used redundant patient samples and pools to assess precision, functional sensitivity, limit of detection, linearity, recovery of recombinant H-FABP and interference. We evaluated the 99th centile values and compared H-FABP with troponin in samples routinely received from chest pain patient samples. Results. Precision was typically < 10% and 12.5% at all concentrations for within and between batches. The functional sensitivity was 2.4 μg/L. The assay was linear on dilution over the range 2.76–115 μg/L. Recovery of recombinant H-FABP was approximately 20–25%. No interference was seen with haemoglobin concentrations <1.5 g/L, bilirubin < 250 μg/L and triacylglycerol < 5 mmol/L or rheumatoid factor. The 99th centile value in a reference population with eGFR > 60mL/min/1.73m² was 9.1 μg/L with no significant gender difference. H-FABP was measured in routine clinical samples (N = 1310) received for troponin I measurement. Using Siemens TnI > 50 ng/L as an indicator of myocardial damage, the ROC area under curve for H-FABP was 0.82. Conclusions. The immunoturbidimetric H-FABP assay is robustly designed and shows good analytical performance. It is therefore well suited for use in a routine clinical laboratory.     

Ion Selective Electrodes (ISEs) and interferences—A review

Ion Selective Electrodes (ISEs) are used to measure some of the most critical analytes on clinical laboratory and point-of-care analysers. These analytes which include Na⁺, K⁺, Cl^?, Ca²⁺, Mg²⁺ and Li⁺ are used for rapid patient care decisions. Although the electrodes are very selective, they are not free of interferences. It is important for laboratories to have an understanding of the type and extent of interferences in order to avoid incorrect clinical decisions and treatment.     

Positive Beliefs and the Likelihood of Successful Community Discharge From Skilled Nursing Facilities

ObjectivesTo examine the association of patient and direct-care staff beliefs about patients’ capability to increase independence with activities of daily living (ADL) and the probability of successful discharge to the community after a skilled nursing facility (SNF) stay.DesignRetrospective cohort study of SNF patients using 100% Medicare inpatient claims and Minimum Data Set resident assessment data. Linear probability models were used to estimate the probability of successful discharge based on patient and staff beliefs about the patient’s ability to improve in function, as well as patient and staff beliefs together. Estimates were adjusted for demographics, health status, functional characteristics, and SNF fixed effects.ParticipantsFee-for-service Medicare beneficiaries (N=526,432) aged 66 years or older who were discharged to an SNF after hospitalization for stroke, hip fracture, or traumatic brain injury.InterventionsNot applicable.Main Outcome MeasuresSuccessful community discharge (discharged alive within 90d of SNF admission and remaining in the community for ≥30d without dying or health care facility readmission).ResultsPatients with positive beliefs about their capability to increase independence with ADLs had a higher adjusted probability of successful discharge than patients with negative beliefs (positive, 63.8%; negative, 57.8%; difference, 6.0%, 95% confidence interval [CI], 5.4-6.6). This remained true regardless of staff beliefs, but the difference in successful discharge probability between patients with positive and negative beliefs was larger when staff had positive beliefs. Conversely, the association between staff beliefs and successful discharge varied based on patient beliefs. If patients had positive beliefs, the difference in the probability of successful discharge between positive and negative staff beliefs was 2.5% (95% CI, 1.0-4.0). If patients had negative beliefs, the difference between positive and negative staff beliefs was –4.6% (95% CI, –6.0 to –3.2).ConclusionsPatients’ beliefs have a significant association with the probability of successful discharge. Understanding patients’ beliefs is critical to appropriate goal-setting, discharge planning, and quality SNF care.     

Nursing workforce deployment and intensive care unit strain during the COVID-19 pandemic in Victoria,Australia

BackgroundThe COVID-19 pandemic demanded intensive care units (ICUs) globally to expand to meet increasing patient numbers requiring critical care. Critical care nurses were a finite resource in this challenge to meet growing patient numbers, necessitating redeployment of nursing staff to work in ICUs.ObjectiveOur aim was to describe the extent and manner by which the increased demand for ICU care during the COVID-19 pandemic was met by ICU nursing workforce expansion in the late 2021 and early 2022 in Victoria, Australia.MethodsThis is a retrospective cohort study of Victorian ICUs who contributed nursing data to the Critical Health Information System from 1 December 2021 to 11 April 2022. Bedside nursing workforce data, in categories as defined by Safer Care Victoria’s pandemic response guidelines, were analysed. The primary outcome was ‘insufficient ICU skill mix’—whenever a site had more patients needing 1:1 critical care nursing care than the mean daily number of experienced critical care nursing staff.ResultsOverall, data from 24 of the 47 Victorian ICUs were eligible for analysis. Insufficient ICU skill mix occurred on 10.3% (280/2725) days at 66.7% (16/24) of ICUs, most commonly during the peak phase from December to mid-February. The insufficient ICU skill mix was more likely to occur when there were more additional ICU beds open over the ‘business-as-usual’ number. Counterfactual analysis suggested that had there been no redeployment of staff to the ICU, reduced nursing ratios, with inability to provide 1:1 care, would have occurred on 15.2% (415/2725) days at 91.7% (22/24) ICUs.ConclusionThe redeployment of nurses into the ICU was necessary. However, despite this, at times, some ICUs had insufficient staff to cope with the number and acuity of patients. Further research is needed to examine the impact of ICU nursing models of care on patient outcomes and on nurse outcomes.     

Research and discussion on the evaluation scheme of reagent lot‐to‐lot differences in 16 chemiluminescence analytes,established by the EP26‐A guidelines of the CLSI

BackgroundVerification of new reagent lots is a part of the crucial tasks in clinical laboratories. The Clinical and Laboratory Standards Institute (CLSI) EP26‐A guideline provides laboratories with an evaluation method for reagent verification. The purpose of this study was to compare the performance of EP26‐A with our laboratory reagent lot verification protocol and get the final scheme.Method16 chemiluminescence analytes including estradiol (E2), progesterone (P), ferritin (FER), cortisol (COR),carbohydrate antigen 153 (CA153), and free prostate‐specific antigen (FPSA). were prospectively evaluated in two reagent lots. The laboratory''s lot verification process included evaluating 5 patient samples with the current and new lots and acceptability according to a predefined criteria. For EP26‐A, method imprecision data and critical differences at medical decision points were important factors affecting the sample size requirements and rejection limits.ResultThe number of samples required for EP26‐A was 3 to 12, of which P, CA153, and FPSA had increased by more than 5 samples compared with the current protocol. Of the 16 chemiluminescence analytes, 11 had higher rejection limits when using EP26‐A than the current laboratory scheme. Our current protocol and EP26‐A were in agreement in 32 of the 32 (100%) paired verifications.ConclusionThe EP26‐A protocol is an important tool to find the differences between reagent lots, and it makes up for the loopholes in the statistical efficiency, sample concentration and quantity, and the selection of rejection limits in the current protocol.