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.

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.

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.

Clinical Benefits of Direct-to-Definitive Testing for Monitoring Compliance in Pain Management.

BACKGROUND: The technical advantages of direct-to-definitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) urine testing for monitoring patient compliance in pain management are well known. However, the design and implementation of LC-MS/MS methods are more controversial, including factors such as determining appropriate cutoffs, specimen processing (e.g., specimen hydrolysis), reporting of qualitative and/or quantitative results, and test menu. OBJECTIVES: The objective of the research was to compare the clinical performance of our previous urine pain toxicology panel, a combination of immunoassay (IA) screens and LC-MS/MS, to our current pain toxicology panel, which features direct-to-definitive LC-MS/MS for 34 drugs and metabolites. STUDY DESIGN: Six months of results from our previous pain toxicology panel were compared to 5.5 months of results from our current pain toxicology panel, enabling us to make conclusions regarding clinical performance. SETTING: The research took place at Brigham and Women's Hospital in Boston, MA. METHODS: The percentage of false positive IA results was evaluated for our previous pain toxicology panel. The positivity rates for each drug and/or metabolite were calculated for both the previous and current panels, including rates of detection of both prescribed and illicit drugs. The turnaround time (TAT), direct and send-out costs associated with each approach, as well as projected cost savings were also determined. RESULTS: False positive rates with IA ranged from 0% to 29%; the highest false positive rate was seen for 6-acetylmorphine (6-AM). The elimination of IA, addition of metabolites, and/or lowering of cutoffs increased the detection rate of 6-AM, benzoylecgonine (cocaine metabolite), fentanyl, morphine, and oxycodone. The ability to differentiate compliance from simulated compliance improved after eliminating specimen hydrolysis. The TAT improved significantly and projected yearly cost savings with the current panel was $95,003 (USD). In our opinion, qualitative results appeared sufficient to assess compliance in the majority of cases. LIMITATIONS: Our study was performed in a single academic center in a specific geographic region; therefore, our results may not be generalizable to other types of centers or regions. CONCLUSION: Direct-to-definitive LC-MS/MS testing has several clinical benefits, including reduction of false positive results, improved assessment of patient compliance, decreased TAT, and increased detection of drug use and abuse. Cost savings were also realized using this approach. KEY WORDS: Direct-to-definitive, LC-MS/MS, immunoassay, sensitivity, cost, pain management, turnaround time, patient compliance.

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.

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.

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.

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.

Impact of a prospective review program for reference laboratory testing requests.

OBJECTIVES: To control the cost of reference laboratory testing, to ensure that its usage is medically appropriate, and to review the contribution of reference testing to patient care at our institution. METHODS: A multidisciplinary institutional committee was convened to manage the utilization of reference testing. A subset of tests was designated to be reviewed in real time by a team of clinical pathologists in consultation with clinical subject matter experts. RESULTS: Twelve percent of testing requests, accounting for approximately 18% of send-out costs, were determined to be clinically unnecessary or would not produce actionable results at that point during that patient's care and were therefore not performed. This intervention, combined with insourcing of frequently requested tests, resulted in a reduction in the costs of reference testing to less than half of that predicted by the rate of growth from 2005 to 2009. Molecular diagnostic tests displayed a higher cost per test than other forms of testing but had a similar degree of clinical impact. CONCLUSIONS: Formal prospective review of reference laboratory testing requests resulted in substantial cost containment and improved the efficiency of patient care.

Effectiveness of practices for improving the diagnostic accuracy of Non ST Elevation Myocardial Infarction in the Emergency Department: A Laboratory Medicine Best Practices™ systematic review.

OBJECTIVES: This article is a systematic review of the effectiveness of four practices (assay selection, decision point cardiac troponin (cTn) threshold selection, serial testing, and point of care testing) for improving the diagnostic accuracy Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) in the Emergency Department. DESIGN AND METHODS: The CDC-funded Laboratory Medicine Best Practices (LMBP) Initiative systematic review method for quality improvement practices was used. RESULTS: The current ACC/AHA guidelines recommend using cardiac troponin assays with a 99th percentile upper reference limit (URL) diagnostic threshold to diagnose NSTEMI. The evidence in this systematic review indicates that contemporary sensitive cTn assays meet the assay profile requirements (sensitivity, specificity, PPV, and NPV) to more accurately diagnose NSTEMI than alternate tests. Additional biomarkers did not increase diagnostic effectiveness of cTn assays. Sensitivity, specificity, and NPV were consistently high and low PPV improved with serial sampling. Evidence for use of point of care cTn testing was insufficient to make recommendation, though some evidence suggests that use may result in reduction to patient length of stay and costs. CONCLUSIONS: Based on the review of and the LMBP(TM) A-6 Method criteria, we recommend the use of cardiac troponin assays without additional biomarkers using the 99th percentile URL as the clinical diagnostic threshold for the diagnosis of NSTEMI. We recommend serial sampling with one sample at presentation and at least one additional second sample taken at least 6h later to identify a rise or fall in the troponin level. No recommendation is made either for or against the use of point of care tests. DISCLAIMER: The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry (CDC/ATSDR).

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.

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.

An intervention to improve the timing of vancomycin levels.

OBJECTIVES: Blood samples for vancomycin levels are often drawn too early, leading to potential misinterpretation of results. However, only a few studies describe interventions to reduce mistimed vancomycin levels. METHODS: We implemented an information technology (IT)-based intervention that provided educational instructions to nurses and determined the percentage of levels drawn too early for 27 months before (n = 6,291) and 14 months after (n = 3,608) the intervention. In addition, we conducted nurse interviews (n = 40) and dataset analysis to assess the root causes of mistimed levels. RESULTS: The percentage of vancomycin timing errors decreased from 39% (2,438/6,291) to 32% (1,137/3,608), though in a time series analysis this decrease was not statistically significant (P = .64). Four common causes of mistimed levels were found: (1) unclear provider orders, (2) scheduling levels to be drawn with morning laboratory tests, (3) lack of communication between providers, and (4) failure to adjust the blood draw in relation to the previous dose. CONCLUSIONS: A real-time, IT-based intervention that links the timing of levels with medication administration might have a more substantial impact.

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.

Effectiveness of barcoding for reducing patient specimen and laboratory testing identification errors: a Laboratory Medicine Best Practices systematic review and meta-analysis.

OBJECTIVES: This is the first systematic review of the effectiveness of barcoding practices for reducing patient specimen and laboratory testing identification errors. DESIGN AND METHODS: The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used. RESULTS: A total of 17 observational studies reporting on barcoding systems are included in the body of evidence; 10 for patient specimens and 7 for point-of-care testing. All 17 studies favored barcoding, with meta-analysis mean odds ratios for barcoding systems of 4.39 (95% CI: 3.05-6.32) and for point-of-care testing of 5.93 (95% CI: 5.28-6.67). CONCLUSIONS: Barcoding is effective for reducing patient specimen and laboratory testing identification errors in diverse hospital settings and is recommended as an evidence-based "best practice." The overall strength of evidence rating is high and the effect size rating is substantial. Unpublished studies made an important contribution comprising almost half of the body of evidence.