Clinical and financial impact of removing creatine kinase-MB from the routine testing menu in the emergency setting.

CONTEXT: Cardiac troponins T and I have replaced creatine kinase-MB (CK-MB) as the criterion standard for diagnosing myocardial injury. However, many laboratories still routinely perform a high volume of CK-MB testing in conjunction with troponin. PURPOSE: The purpose of this study is to study the clinical and financial impact of removing CK-MB from the routine emergency department (ED) test menu at a large academic medical center. METHODS: Creatine kinase-MB was removed from ED ordering templates and laboratory requisitions (ie, intervention), although the test could still be manually ordered. Data for creatine kinase (CK), CK-MB, and troponin T (TnT) specimens ordered during a 12-month period (6 months preintervention and 6 months postintervention) (n = 14571) was downloaded from our laboratory information system. All specimens with (1) normal TnT (ie, <0.01 ng/mL), (2) elevated CK-MB (ie, >6.6 ng/mL), and (3) elevated CK-MB index (ie, >5) were considered discrepant and independently reviewed by 2 ED clinicians for the presence of an acute coronary syndrome and for documentation of final diagnosis. Creatine kinase, CK-MB, and TnT ED volumes preintervention and postintervention were analyzed to assess laboratory cost savings. RESULTS: Of the 6444 cases included in the analysis, only 17 were discrepant. Of all 17 cases, no patients were diagnosed with acute coronary syndrome. After removing CK-MB from the templates and requisitions, CK-MB and CK volumes decreased by 80% and 76%, respectively, translating to annual reagent cost savings of approximately $47000. CONCLUSIONS: Creatine kinase-MB can be removed from the routine ED test menu without adversely affecting patient care. In addition, substantial cost savings can be achieved by reducing unnecessary CK-MB testing and associated CK orders.

Lessons learned: A look back at the performance of nine COVID-19 serologic assays and their proposed utility.

BACKGROUND: Serologic assays for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been proposed to assist with the acute diagnosis of infection, support epidemiological studies, identify convalescent plasma donors, and evaluate vaccine response. METHODS: We report an evaluation of nine serologic assays: Abbott (AB) and Epitope (EP) IgG and IgM, EUROIMMUN (EU) IgG and IgA, Roche anti-N (RN TOT) and anti-S (RS TOT) total antibody, and DiaSorin (DS) IgG. We evaluated 291 negative controls (NEG CTRL), 91 PCR positive (PCR POS) patients (179 samples), 126 convalescent plasma donors (CPD), 27 healthy vaccinated donors (VD), and 20 allogeneic hematopoietic stem cell transplant (HSCT) recipients (45 samples). RESULTS: We observed good agreement with the method performance claims for specificity (93-100%) in NEG CTRL but only 85% for EU IgA. The sensitivity claims in the first 2 weeks of symptom onset was lower (26-61%) than performance claims based on > 2 weeks since PCR positivity. We observed high sensitivities (94-100%) in CPD except for AB IgM (77%), EP IgM (0%). Significantly higher RS TOT was observed for Moderna vaccine recipients then Pfizer (p-values < 0.0001). A sustained RS TOT response was observed for the five months following vaccination. HSCT recipients demonstrated significantly lower RS TOT than healthy VD (p < 0.0001) at dose 2 and 4 weeks after. CONCLUSIONS: Our data suggests against the use of anti-SARS-CoV-2 assays to aid in acute diagnosis. RN TOT and RS TOT can readily identify past-resolved infection and vaccine response in the absence of native infection. We provide an estimate of expected antibody response in healthy VD over the time course of vaccination for which to compare antibody responses in immunosuppressed patients.

Glucose meter standardization across a large academic hospital system.

BACKGROUND: To select and standardize point-of-care (POC) glucose meters across a multi-hospital system. METHODS: We formed a multidisciplinary POC glucose standardization working group including key stakeholders from each site. A set of selection criteria: usability, clinical and laboratory performance, indications for use, interface connectivity, ease of implementation and ongoing operational costs were used to develop a scoring schemato facilitate a consensus-driven selection process. RESULTS: Method comparison and consensus error grid evaluation against the clinically validated reference methods demonstrated that the analytical performance for all candidate meters was comparable for both the laboratory and clinical evaluation. However, Meter 1 ranked highest in usability evaluations, implementation and streamlined interface connectivity. The meter selection process and implementation were staggered across sites due to complexity of transitioning to a new manufacturer's meter and limitations in vendor support for training and ongoing troubleshooting of interface connectivity. CONCLUSIONS: Standardization of POC glucose meters in a large multi-hospital system is a complex undertaking requiring robust, multidisciplinary organizational structure both system-wide and locally, development of consensus-driven selection tools, usability evaluation by end-users, laboratory and clinical evaluation of the analytical performance, and a strong vendor-laboratory partnership during the implementation process.

Significant Operational Improvements with Implementation of Next Generation Laboratory Automation.

OBJECTIVES: To investigate the benefits and challenges of introducing next generation chemistry and coagulation automation. METHODS: We replaced the Roche modular preanalytic system attached to Roche Cobas 6000 analyzers with the Roche 8100 preanalytical line attached to the Roche Cobas 8000 and Stago STA R Max analyzers. The system included 2 add-on buffers (AOBs) for automated specimen archival and retrieval and primary-tube specimen processing. We measured turnaround time (TAT) from specimen receipt to result for chemistry and coagulation tests before, during, and after system implementation. TAT for add-on tests was also measured. RESULTS: We completed the system implementation during a 17-month period using existing laboratory space. The TAT for chemistry, coagulation, and add-on tests decreased significantly (P <.005, P <.001, and P <.005, respectively). We encountered several challenges, including barcode-label errors, mechanical problems, and workflow issues due to lack of bidirectional track for coagulation testing. CONCLUSIONS: Next generation laboratory automation yielded significantly shortened and less-variable TAT, particularly for add-on testing. Our approach could help other laboratories in the process of implementing and configuring automated systems.

How SARS-CoV-2 Transformed the Clinical Laboratory: Challenges and Lessons Learned.

The COVID-19 pandemic has made a devastating impact on global health and continues to challenge healthcare infrastructure and delivery. The clinical laboratories were no exception as they are responsible for diagnostic testing that dictates many clinical, infection control, and public health decisions. Information technology and laboratory management tools are critical assets for maintaining and adapting operations in response to crises. When utilized effectively, they promote the integration between the clinical laboratory specialties (e.g., chemistry, hematology, microbiology, and molecular pathology). During the COVID-19 pandemic, our systems and processes were strained due to high testing volumes, demand for rapid turnaround times, supply chain constraints, and constantly evolving testing algorithms and result interpretations as our knowledge of the virus and of diagnostics increased over time. In this report, we describe those challenges and subsequent adaptations made by each clinical laboratory section. We hope these details help to provide potential solutions and approaches for other hospitals facing COVID-19 surges or other future pandemics.

A Novel Automated Slide-Based Technology for Visualization, Counting, and Characterization of the Formed Elements of Blood: A Proof of Concept Study.

CONTEXT: - A novel automated slide-based approach to the complete blood count and white blood cell differential count is introduced. OBJECTIVE: - To present proof of concept for an image-based approach to complete blood count, based on a new slide preparation technique. A preliminary data comparison with the current flow-based technology is shown. DESIGN: - A prototype instrument uses a proprietary method and technology to deposit a precise volume of undiluted peripheral whole blood in a monolayer onto a glass microscope slide so that every cell can be distinguished, counted, and imaged. The slide is stained, and then multispectral image analysis is used to measure the complete blood count parameters. Images from a 600-cell white blood cell differential count, as well as 5000 red blood cells and a variable number of platelets, that are present in 600 high-power fields are made available for a technologist to view on a computer screen. An initial comparison of the basic complete blood count parameters was performed, comparing 1857 specimens on both the new instrument and a flow-based hematology analyzer. RESULTS: - Excellent correlations were obtained between the prototype instrument and a flow-based system. The primary parameters of white blood cell, red blood cell, and platelet counts resulted in correlation coefficients (r) of 0.99, 0.99, and 0.98, respectively. Other indices included hemoglobin (r = 0.99), hematocrit (r = 0.99), mean cellular volume (r = 0.90), mean corpuscular hemoglobin (r = 0.97), and mean platelet volume (r = 0.87). For the automated white blood cell differential counts, r values were calculated for neutrophils (r = 0.98), lymphocytes (r = 0.97), monocytes (r = 0.76), eosinophils (r = 0.96), and basophils (r = 0.63). CONCLUSIONS: - Quantitative results for components of the complete blood count and automated white blood cell differential count can be developed by image analysis of a monolayer preparation of a known volume of peripheral blood.

Top ten challenges when interfacing a laboratory information system to an electronic health record: Experience at a large academic medical center.

BACKGROUND: Recent U.S. government regulations incentivize implementation of an electronic health record (EHR) with computerized order entry and structured results display. Many institutions have also chosen to interface their EHR to their laboratory information system (LIS). Reported long-term benefits include increased efficiency and improved quality and safety. In order to successfully implement an interfaced EHR-LIS, institutions must plan years in advance and anticipate the impact of an integrated system. It can be challenging to fully understand the technical, workflow and resource aspects and adequately prepare for a potentially protracted system implementation and the subsequent stabilization. OBJECTIVES: We describe the top ten challenges that we encountered in our clinical laboratories following the implementation of an interfaced EHR-LIS and offer suggestions on how to overcome these challenges. METHODS: This study was performed at a 777-bed, tertiary care center which recently implemented an interfaced EHR-LIS. Challenges were recorded during EHR-LIS implementation and stabilization and the authors describe the top ten. RESULTS: Our top ten challenges were selection and harmonization of test codes, detailed training for providers on test ordering, communication with EHR provider champions during the build process, fluid orders and collections, supporting specialized workflows, sufficient reports and metrics, increased volume of inpatient venipunctures, adequate resources during stabilization, unanticipated changes to laboratory workflow and ordering specimens for anatomic pathology. A few suggestions to overcome these challenges include regular meetings with clinical champions, advanced considerations of reports and metrics that will be needed, adequate training of laboratory staff on new workflows in the EHR and defining all tests including anatomic pathology in the LIS. CONCLUSION: EHR-LIS implementations have many challenges requiring institutions to adapt and develop new infrastructures. This article should be helpful to other institutions facing or undergoing a similar endeavor.

Increased Patient Satisfaction and a Reduction in Pre-Analytical Errors Following Implementation of an Electronic Specimen Collection Module in Outpatient Phlebotomy.

BACKGROUND: Patient satisfaction in outpatient phlebotomy settings typically depends on wait time and venipuncture experience, and many patients equate their experiences with their overall satisfaction with the hospital. METHODS: We compared patient service times and preanalytical errors pre- and postimplementation of an integrated electronic health record (EHR)-laboratory information system (LIS) and electronic specimen collection module. We also measured patient wait time and assessed patient satisfaction using a 5-question survey. RESULTS: The percentage of patients waiting less than 10 minutes increased from 86% preimplementation to 93% postimplementation of the EHR-LIS (P ≤.001). The median total service time decreased significantly, from 6 minutes (IQR, 4-8 minutes), to 5 minutes (IQR, 3-6 minutes) (P = .005). The preanalytical errors decreased significantly, from 3.20 to 1.93 errors per 1000 specimens (P ≤.001). Overall patient satisfaction improved, with an increase in excellent responses for all 5 questions (P ≤.001). CONCLUSIONS: We found several benefits of implementing an electronic specimen collection module, including decreased wait and service times, improved patient satisfaction, and a reduction in preanalytical errors.

The Benefits and Challenges of an Interfaced Electronic Health Record and Laboratory Information System: Effects on Laboratory Processes.

CONTEXT: - A recent government regulation incentivizes implementation of an electronic health record (EHR) with computerized order entry and structured results display. Many institutions have also chosen to interface their EHR with their laboratory information system (LIS). OBJECTIVE: - To determine the impact of an interfaced EHR-LIS on laboratory processes. DESIGN: - We analyzed several different processes before and after implementation of an interfaced EHR-LIS: the turnaround time, the number of stat specimens received, venipunctures per patient per day, preanalytic errors in phlebotomy, the number of add-on tests using a new electronic process, and the number of wrong test codes ordered. Data were gathered through the LIS and/or EHR. RESULTS: - The turnaround time for potassium and hematocrit decreased significantly (P = .047 and P = .004, respectively). The number of stat orders also decreased significantly, from 40% to 7% for potassium and hematocrit, respectively (P < .001 for both). Even though the average number of inpatient venipunctures per day increased from 1.38 to 1.62 (P < .001), the average number of preanalytic errors per month decreased from 2.24 to 0.16 per 1000 specimens (P < .001). Overall there was a 16% increase in add-on tests. The number of wrong test codes ordered was high and it was challenging for providers to correctly order some common tests. CONCLUSIONS: - An interfaced EHR-LIS significantly improved within-laboratory turnaround time and decreased stat requests and preanalytic phlebotomy errors. Despite increasing the number of add-on requests, an electronic add-on process increased efficiency and improved provider satisfaction. Laboratories implementing an interfaced EHR-LIS should be cautious of its effects on test ordering and patient venipunctures per day.

Validation of a formula that calculates the estimated risk of respiratory distress syndrome.

OBJECTIVE: Several groups, including ours, have developed probabilistic models that incorporate both the surfactant-to-albumin ratio (TDx-FLM II) and gestational age to more accurately predict the risk of neonatal respiratory distress syndrome (RDS) and eliminate the current categorical "immature"/"indeterminate"/"mature" interpretation. We validate our model using a separate data set, with the goal of providing the clinician with a risk score. METHODS: The medical records of all women who had TDx-FLM II testing performed at Brigham and Women's Hospital between January 1, 2003, and December 31, 2005, were reviewed to gather a population upon which to validate our previous logistic regression model. Receiver operating characteristic curve and Hosmer-Lemeshow analysis was conducted to determine the performance of our model and another model in this new population. RESULTS: A total of 233 mother-neonate pairs (21 RDS, 212 non-RDS) met criteria for analysis. The receiver operating characteristic analysis illustrated that our previous formula was a strong predictor of the risk of RDS with an area under the curve of 0.902 (95% confidence interval 0.849-0.955). In addition, using the Hosmer-Lemeshow analysis, our formula produced an excellent overall fit (P=.95), whereas another published model was a poor fit to our data (P=.002). CONCLUSION: Our previously derived logistic regression model formula incorporating TDx-FLM II results and gestational age to predict risk of neonatal respiratory distress syndrome was robust and stable over time in an independent data set. The results suggest that the equation can be implemented clinically to assist physicians and patients and used by other institutions after their own internal validation. LEVEL OF EVIDENCE: III.

Significant Reduction in Preanalytical Errors for Nonphlebotomy Blood Draws After Implementation of a Novel Integrated Specimen Collection Module.

OBJECTIVES: Most preanalytical errors at our institution occur during nonphlebotomy blood draws. We implemented an electronic health record (EHR), interfaced the EHR to the laboratory information system, and designed a new specimen collection module. We studied the effects of the new system on nonphlebotomy preanalytical errors. METHODS: We used an electronic database of preanalytical errors and calculated the number and type of the most common errors in the emergency department (ED) and inpatient nursing for 3-month periods before (August-October 2014) and after (August-October 2015) implementation. The level of staff compliance with the new system was also assessed. RESULTS: The average monthly preanalytical errors decreased significantly from 7.95 to 1.45 per 1,000 specimens in the ED (P < 0001) and 11.75 to 3.25 per 1,000 specimens in inpatient nursing (P < 0001). The rate of decrease was similar for mislabeled, unlabeled, wrong specimen received and no specimen received errors. Most residual errors (80% in the ED and 67% in inpatient nursing) occurred when providers did not use the new system as designed. CONCLUSIONS: Implementation of a customized specimen collection module led to a significant reduction in preanalytical errors. Improved compliance with the system may lead to further reductions in error rates.

Laboratory diagnosis of acute myocardial injury.

Considerable effort by clinicians and scientists focuses on the utility of biomarkers to prevent, diagnose and manage adverse cardiac events as well as provide information on a specific patient's underlying pathology. Although troponins I and T (TnI and TnT) are cardiac specific markers that yield diagnostic and prognostic value in patients with myocardial injury, troponins cannot be utilized in all clinical settings. Troponins have limited utility for the diagnosis of early ischemia and preoperative myocardial infarction. Troponin T also lacks specificity in patients with renal failure. New markers, such as ischemia modified albumin (IMA) and CD40 ligand, and new technologies, such as proteomics, are under investigation to advance our knowledge of heart disease.

A computer-based intervention for improving the appropriateness of antiepileptic drug level monitoring.

We designed and implemented 2 automated, computerized screens for use at the time of antiepileptic drug (AED) test order entry to improve appropriateness by reminding physicians when a potentially redundant test was ordered and providing common indications for monitoring and pharmacokinetics of the specific AED. All computerized orders for inpatient serum AED levels during two 3-month periods were included in the study. During the 3-month period after implementation of the automated intervention, 13% of all AED tests ordered were canceled following computerized reminders. For orders appearing redundant, the cancellation rate was 27%. For nonredundant orders, 4% were canceled when information on specific AED monitoring and pharmacokinetics was provided. The cancellation rate was sustained after 4 years. There has been a 19.5% decrease in total AED testing volume since implementation of this intervention, despite a 19.3% increase in overall chemistry test volume. Inappropriateness owing to repeated testing before pharmacologic steady state was reached decreased from 54% of all AED orders to 14.6%. A simple, automated, activity-based intervention targeting a specific test-ordering behavior effectively reduced inappropriate laboratory testing. The sustained benefit supports the idea that computerized interventions may durably affect physician behavior. Computerized delivery of such evidence-based boundary guidelines can help narrow the gap between evidence and practice.

Neonatal respiratory distress syndrome as a function of gestational age and an assay for surfactant-to-albumin ratio.

OBJECTIVE: Neonatal respiratory distress syndrome (RDS) affects approximately 1% of live births, and the probability of RDS continues to be a major determinant in the timing of delivery. This study was designed to investigate the optimal gestational age-specific cutoff value for a surfactant-to-albumin ratio assay for predicting RDS. METHODS: Amniotic fluid surfactant-to-albumin ratio data were collected prospectively for a 2-year period. Women were included in the study if they delivered within 72 hours of surfactant-to-albumin ratio estimation. RDS was defined by the presence of 2 or more of the following criteria: evidence of respiratory compromise shortly after delivery and a persistent oxygen requirement for more than 24 hours, administration of exogenous pulmonary surfactant, and/or radiographic evidence of hyaline membrane disease. RESULTS: A total of 415 mother-neonate pairs (28 RDS, 387 non-RDS) met criteria for analysis. Both gestational age and surfactant-to-albumin ratio values were independent predictors of RDS. By modeling the odds of RDS by using a logistic regression with gestational age and surfactant-to-albumin ratio values as continuous variables, a probability of RDS of 15% or less can be achieved with a surfactant-to-albumin ratio cutoff of 60 mg or more surfactant/g albumin at 28 weeks of gestation, 50 or more at 30 weeks, 40 or more at 33 weeks, 30 or more at 35 weeks, and 20 or more at 37 weeks. CONCLUSIONS: These data describe a means of stratifying the probability of neonatal RDS using both gestational age and surfactant-to-albumin ratio value and may be a useful model for clinical decision-making. LEVEL OF EVIDENCE: II-2

Noninvasive testing in the clinical laboratory.

We have chosen to provide a brief review of only three of the numerous existing, emerging or future applications of novel technologies that provide noninvasive testing. Clinical laboratory testing over the recent decades has been characterized by a remarkable increase in the variety and volume of [figure: see text] information made available to assist physicians in the practice of medicine. Among current trends that facilitate prompt delivery of results, noninvasive testing holds great promise. Technologies that already exist or that have not yet been developed may extend the opportunities to exploit this approach. Noninvasive testing has other obvious attractive features; safety, painlessness and adaptability to special care situations. Our profession may well enjoy additional vitalization from the further evolution of this facinating and important field.

Optimizing outpatient phlebotomy staffing: tools to assess staffing needs and monitor effectiveness.

CONTEXT: Short patient wait times are critical for patient satisfaction with outpatient phlebotomy services. Although increasing phlebotomy staffing is a direct way to improve wait times, it may not be feasible or appropriate in many settings, particularly in the context of current economic pressures in health care. OBJECTIVE: To effect sustainable reductions in patient wait times, we created a simple, data-driven tool to systematically optimize staffing across our 14 phlebotomy sites with varying patient populations, scope of service, capacity, and process workflows. DESIGN: We used staffing levels and patient venipuncture volumes to derive the estimated capacity, a parameter that helps predict the number of patients a location can accommodate per unit of time. We then used this parameter to determine whether a particular phlebotomy site was overstaffed, adequately staffed, or understaffed. Patient wait-time and satisfaction data were collected to assess the efficacy and accuracy of the staffing tool after implementing the staffing changes. RESULTS: In this article, we present the applications of our approach in 1 overstaffed and 2 understaffed phlebotomy sites. After staffing changes at previously understaffed sites, the percentage of patients waiting less than 10 minutes ranged from 88% to 100%. At our previously overstaffed site, we maintained our goal of 90% of patients waiting less than 10 minutes despite staffing reductions. All staffing changes were made using existing resources. CONCLUSIONS: Used in conjunction with patient wait-time and satisfaction data, our outpatient phlebotomy staffing tool is an accurate and flexible way to assess capacity and to improve patient wait times.

Using Lean principles to optimise inpatient phlebotomy services.

BACKGROUND: In the USA, inpatient phlebotomy services are under constant operational pressure to optimise workflow, improve timeliness of blood draws, and decrease error in the context of increasing patient volume and complexity of work. To date, the principles of Lean continuous process improvement have been rarely applied to inpatient phlebotomy. AIMS: To optimise supply replenishment and cart standardisation, communication and workload management, blood draw process standardisation, and rounding schedules and assignments using Lean principles in inpatient phlebotomy services. METHODS: We conducted four Lean process improvement events and implemented a number of interventions in inpatient phlebotomy over a 9-month period. We then assessed their impact using three primary metrics: (1) percentage of phlebotomists drawing their first patient by 05:30 for 05:00 rounds, (2) percentage of phlebotomists completing 08:00 rounds by 09:30, and (3) number of errors per 1000 draws. RESULTS: We saw marked increases in the percentage of phlebotomists drawing their first patient by 05:30, and the percentage of phlebotomists completing rounds by 09:30 postprocess improvement. A decrease in the number of errors per 1000 draws was also observed. CONCLUSIONS: This study illustrates how continuous process improvement through Lean can optimise workflow, improve timeliness, and decrease error in inpatient phlebotomy. We believe this manuscript adds to the field of clinical pathology as it can be used as a guide for other laboratories with similar goals of optimising workflow, improving timeliness, and decreasing error, providing examples of interventions and metrics that can be tailored to specific laboratories with particular services and resources.

Significant cost savings achieved by in-sourcing urine drug testing for monitoring medication compliance in pain management.

INTRODUCTION: Reference laboratory testing can represent a significant component of the laboratory budget. Therefore, most laboratories continually reassess the feasibility of in-sourcing various tests. We describe the transfer of urine drug testing performed for monitoring medication compliance in pain management from a reference laboratory into an academic clinical laboratory. METHODS: The process of implementing of both screening immunoassays and confirmatory LC-MS/MS testing and the associated cost savings is outlined. RESULTS: The initial proposal for in-sourcing this testing, which included the tests to be in-sourced, resources required, estimated cost savings and timeline for implementation, was approved in January 2009. All proposed testing was implemented by March 2011. CONCLUSIONS: Keys to the successful implementation included budgeting adequate resources and developing a realistic timeline, incorporating the changes with the highest budget impact first. We were able to in-source testing in 27 months and save the laboratory approximately $1 million in the first 3 year.