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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

What proportion of vancomycin trough levels are drawn too early?: frequency and impact on clinical actions.

Vancomycin trough levels are recommended to predict vancomycin efficacy, and inaccurate levels may lead to inappropriate clinical actions. However, the frequency of timing errors and associated clinical impact is unknown. We retrospectively analyzed vancomycin levels (n = 2,597) measured during 13 months at a large academic medical center.

A strategy for optimizing staffing to improve the timeliness of inpatient phlebotomy collections.

Context: The timely availability of inpatient test results is a key to physician satisfaction with the clinical laboratory, and in an institution with a phlebotomy service may depend on the timeliness of blood collections. In response to safety reports filed for delayed phlebotomy collections, we applied Lean principles to the inpatient phlebotomy service at our institution. Our goal was to improve service without using additional resources by optimizing our staffing model.

Serial serum free light chain measurements do not detect changes in disease status earlier than electrophoretic M-spike measurements in patients with intact immunoglobulin myeloma.

Background: Serum free light chains (SFLC) are used to manage patients with light chain or hyposecretory myeloma, and may also be useful in patients with intact immunoglobulin myeloma (IIMM), because their shorter half-life may enable earlier indication of relapse/response than electrophoretic M-spikes or heavy chain (IgGA) immunonephelometry.

Methods: One thousand five SFLC, M-spike, and IgGA concentrations were compared at multiple time points during the treatment of 17 myeloma patients, followed over 7.7-63.

Reduction in specimen labeling errors after implementation of a positive patient identification system in phlebotomy.

Ensuring accurate patient identification is central to preventing medical errors, but it can be challenging. We implemented a bar code-based positive patient identification system for use in inpatient phlebotomy. A before-after design was used to evaluate the impact of the identification system on the frequency of mislabeled and unlabeled samples reported in our laboratory.

Applying Lean/Toyota production system principles to improve phlebotomy patient satisfaction and workflow.

Our goals were to improve the overall patient experience and optimize the blood collection process in outpatient phlebotomy using Lean principles. Elimination of non-value-added steps and modifications to operational processes resulted in increased capacity to handle workload during peak times without adding staff. The result was a reduction of average patient wait time from 21 to 5 minutes, with the goal of drawing blood samples within 10 minutes of arrival at the phlebotomy station met for 90% of patients.