Test Menu Research Articles

The utility of second single antigen bead assay: Clearing the water or stirring up mud?

Though solid-phase single antigen bead (SAB) testing has provided major advances to the HLA community and organ allocation, it has not been without limitations. In particular, false-positive reactions lead to interpretative challenges and the potential to preclude a transplant if the corresponding antigens are deemed unacceptable. Two different vendor platforms are commercially available for SAB testing, one more recent than the other. The aim herein was to assess the benefit of using the newer SAB platform in situations where the primary platform yielded suspicious (specifically, false positive) reactions. Therefore, 42 serum samples with commonly encountered false-positive patterns observed in our laboratory were tested with the newer platform. Cases were classified as resolved, equivalent, or divergent based on whether the second platform produced no reactivity, the same pattern, or a distinctly different pattern compared to the primary platform, respectively. Approximately 33% of cases were resolved, 46% were equivalent, and 21% were divergent. The project revealed advantages of adding a second SAB platform to the laboratory’s test menu including resolving challenging samples and including broader coverage of different alleles and unique class II alpha/beta subunit combinations. However, the challenges of validating, maintaining, and billing for another test method in the laboratory may be barriers to routine use.

Analytical performance evaluation of a commercial next generation sequencing liquid biopsy platform using plasma ctDNA, reference standards, and synthetic serial dilution samples derived from normal plasma

BackgroundCirculating tumor (ct) DNA assays performed in clinical laboratories provide tumor biomarker testing support for biopharmaceutical clinical trials. Yet it is neither practical nor economically feasible for many of these clinical laboratories to internally develop their own liquid biopsy assay. Commercially available ctDNA kits are a potential solution for laboratories seeking to incorporate liquid biopsy into their test menus. However, the scarcity of characterized patient samples and cost of purchasing validation reference standards creates a barrier to entry. In the current study, we evaluated the analytical performance of the AVENIO ctDNA liquid biopsy platform (Roche Sequencing Solutions) for use in our clinical laboratory.MethodIntra-laboratory performance evaluation of AVENIO ctDNA Targeted, Expanded, and Surveillance kits (Research Use Only) was performed according to College of American Pathologists (CAP) guidelines for the validation of targeted next generation sequencing assays using purchased reference standards, de-identified human plasma cell-free (cf) DNA samples, and contrived samples derived from commercially purchased normal and cancer human plasma. All samples were sequenced at read depths relevant to clinical settings using the NextSeq High Output kit (Illumina).ResultsAt the clinically relevant read depth, Avenio ctDNA kits demonstrated 100% sensitivity in detecting single nucleotide variants (SNVs) at ≥0.5% allele frequency (AF) and 50% sensitivity in detecting SNVs at 0.1% AF using 20–40 ng sample input amount. The assay integrated seamlessly into our laboratory’s NGS workflow with input DNA mass, target allele frequency (TAF), multiplexing, and number of reads optimized to support a high-throughput assay appropriate for biopharmaceutical trials.ConclusionsOur study demonstrates that AVENIO ctDNA liquid biopsy platform provides a viable alternative for efficient incorporation of liquid biopsy assays into the clinical laboratory for detecting somatic alterations as low as 0.5%. Accurate detection of variants lower than 0.5% could potentially be achieved by deeper sequencing when clinically indicated and economically feasible.

Assessment of mass spectrometry-based pain management testing in clinical laboratories across North America

BackgroundUrine drug testing (UDT) is a useful tool in monitoring compliance to prescribed medication and can also help identify behaviors of drug misuse, abuse, and diversion. Mass spectrometry (MS)-based screening is recommended as the first-line of UDT for pain management patients; however, this testing comes with an inherent lack of standardization in methodologies and various analytical challenges. The objective of this study was to assess the current state of UDT for pain management in a cross-section of clinical laboratories in North America. Materials and methodsA total of 10 blinded urine samples were sent to 6 laboratories across the United States and Canada. Urine samples containing drugs and/or metabolites of interest were included to represent different clinical scenarios commonly seen in pain management settings. Assessment was based on the ability of the laboratories to correctly identify drugs and provide a meaningful interpretation of the findings (when offered by the performing laboratory). ResultsAcross the laboratories involved in the study, 85% of tests correctly identified and appropriately reported the drugs present in the urine samples. Similarly, 84% of samples were considered to have an accurate interpretation included in the UDT report. Out of the total number of drugs included in the samples, 11% were not offered on every test menu. ConclusionsThis study revealed the lack of standardization in pain management UDT performed in a limited cross-section of clinical laboratories across North America.

Iron studies and transferrin, a source of test ordering confusion highly amenable to clinical decision support

IntroductionAn important cause of laboratory test misordering and overutilization is clinician confusion between tests with similar sounding names or similar indications. We identified an area of test ordering confusion with iron studies that involves total iron binding capacity (TIBC), transferrin, and transferrin saturation. We observed concurrent ordering of direct transferrin along with TIBC at many hospitals within our health system and suspected this was unnecessary. MethodsWe extracted patient test results for transferrin, TIBC and other biomarkers. Using these data, we evaluated both patterns of test utilization and test result concordance. We implemented a clinical decision support (CDS) alert to discourage unnecessary orders for direct transferrin. ResultsUsing linear regression, we were able to predict transferrin from either TIBC alone or TIBC with other analytes with a high degree of accuracy, demonstrating that in most cases, direct transferrin in combination with TIBC provides little if any additional diagnostic information beyond TIBC alone. The CDS alert proved highly effective in reducing transferrin test utilization at four different hospitals. ConclusionsConcurrent ordering of direct transferrin and TIBC should usually be avoided. Removal of transferrin or TIBC from the test menu or implementation of CDS may improve utilization of these tests.

Operational considerations and challenges of biochemistry laboratories during the COVID-19 outbreak: an IFCC global survey.

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 conducted a global survey to understand how biochemistry laboratories manage the operational challenges during the coronavirus disease 2019 (COVID-19) pandemic. An electronic survey was distributed globally to record the operational considerations to mitigate biosafety risks in the laboratory. Additionally, the laboratories were asked to indicate the operational challenges they faced. A total of 1210 valid submissions were included in this analysis. Most of the survey participants worked in hospital laboratories. Around 15% of laboratories restricted certain tests on patients with clinically suspected or confirmed COVID-19 over biosafety concerns. Just over 10% of the laboratories had to restrict their test menu or services due to resource constraints. Approximately a third of laboratories performed temperature monitoring, while two thirds of laboratories increased the frequency of disinfection. Just less than 50% of the laboratories split their teams. The greatest reported challenge faced by laboratories during the COVID-19 pandemic is securing sufficient supplies of personal protective equipment (PPE), analytical equipment, including those used at the point of care, as well as reagents, consumables and other laboratory materials. This was followed by having inadequate staff, managing their morale, anxiety and deployment. The restriction of tests and services may have undesirable clinical consequences as clinicians are deprived of important information to deliver appropriate care to their patients. Staff rostering and biosafety concerns require longer-term solutions as they are crucial for the continued operation of the laboratory during what may well be a prolonged pandemic.

COVID-19 in adults: test menu for hospital blood science laboratories.

IntroductionCoronavirus disease 2019 (COVID-19), is a respiratory illness caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Clinical Blood Sciences Laboratory (CBSL) plays a key role in supporting the monitoring and management of patients with COVID-19 disease.ObjectiveTo provide a comprehensive CBSL testing protocol to support the medical management of SARS-CoV-2 infection.MethodsDescription of the biochemical, haematological and immunological tests that have a role in the assessment and monitoring of patients with COVID-19 infection.ResultsWe provide a test menu for clinical laboratories to ensure the effective monitoring, management and prognostication of COVID-19 patients in hospital.ConclusionGiven the rapidity with which patients with COVID-19 disease can deteriorate, we recommend regular testing with vigilance paid to the rate and trajectory of change in each of these parameters.

Physicians' satisfaction with clinical laboratory services at public hospitals in Ethiopia: A national survey.

Physician is a central figure in the client list of clinical laboratory. Monitoring physicians' satisfaction with laboratory service is an important indicator of the quality management system and required by international laboratory standards. However, there is no national data on physician satisfaction with laboratory services in Ethiopia. Therefore, the aim of this national survey was to assess satisfaction level of physicians with laboratory services at public hospitals in Ethiopia. Institutional based cross-sectional study design was employed from November 1-30/2017. A total of 327 physicians were randomly selected from 60 public hospitals from all regions of Ethiopia. Data was collected using pre-tested self-administered questionnaire and analyzed with SPSS version 23 software. Logistic regression model was fitted to identify predictors of physician satisfaction with laboratory services. A p-value of less than 0.05 was taken as statistically significant. Overall, 55% of physicians were satisfied with the clinical laboratory services. More than half of the physicians were satisfied with the existing laboratory request form (69%), legibility and completeness of laboratory report (61%), notification of new test (78%) and test interruption (70%). On the other hand, many physicians were dissatisfied with the absence of laboratory hand book (87.5%), the existing test menu (68%), lab-physician interface (62%), availability of referral and/or back up service (62%), notification of Turn Around Time (TAT) (54%), timely notification of panic result (55%), long TAT (33.1%), provision of urgent service (67%), and timely advisory service (57%). Most of the physicians perceived that consistent quality of service was not delivered at all working shifts (71%). At 5% level of significance, we did not find enough evidence to conclude that sex, age, marital status, education level, and experience were statistically associated with physician satisfaction (p-values > 0.05). This national survey revealed nearly half of the physicians were unsatisfied with laboratory service at public hospitals in Ethiopia, which mainly related to lack of adequate test menu, laboratory hand book, on time notification of panic result, provision of urgent service, timely advisory service, delivery of quality services in all working shifts and weak lab-physician interface. Therefore, hospital management should address the gaps and improve the needs of physicians for better patient health care. In addition, laboratories should evaluate and monitor physician satisfaction level at regular interval.

Current Status of Noninvasive Prenatal Testing and Counselling Considerations: An Indian Perspective

AbstractUptake of noninvasive prenatal testing (NIPT) is rapidly expanding around the world. Here, we provide an overview of the current global state of NIPT, describe the expansion of the test menu, highlight alternative prenatal test service delivery, and discuss NIPT counseling considerations. We also provide a perspective on utilisation of NIPT in India, which has unique challenges for implementing NIPT given its large population, vast territory, and diverse ethnic groups. The barriers to implementation of NIPT in India are also discussed. Current recommendations regarding use of NIPT made by professional societies vary in different regions and such recommendations for NIPT in India will be helpful to provide general guidance to the health care providers, but will likely require modifications for implementation in India.

Prioritising pathogens for the management of severe febrile patients to improve clinical care in low- and middle-income countries

BackgroundSevere febrile illness without a known source (SFWS) is a challenge for clinicians when deciding how to manage a patient, particularly given the wide spectrum of potential aetiologies that contribute to fever. These infections are difficult to distinguish clinically, and accurate diagnosis requires a plethora of diagnostics including blood cultures, imaging techniques, molecular or serological tests, and more. When laboratory services are available, a limited test menu hinders clinical decision-making and antimicrobial stewardship, leading to empiric treatment and suboptimal patient outcomes. To specifically address SFWS, this work aimed to identify priority pathogens for a globally applicable panel for fever causing pathogens.MethodA pragmatic two-pronged approach combining currently available scientific data in an analytical hierarchy process and systematically gathered expert input, was designed to address the lack of comprehensive global aetiology data. The expert re-ranked list was then further adapted for a specific use case to focus on community acquired infections in whole blood specimens. The resulting list was further analysed to address different geographical regions (Asia, Africa, and Latin America), and Cohen kappa scores of agreement were calculated.ResultsThe expert ranked prioritized pathogen list generated as part of this two-pronged approach included typhoidal Salmonella, Plasmodium species and Mycobacterium tuberculosis as the top 3 pathogens. This pathogen list was then further adapted for the SFWS use case to develop a final pathogen list to inform product development. Subsequent analysis comparing the relevance of the SFWS pathogen list to multiple populations and geographical regions showed that the SFWS prioritized list had considerable utility across Africa and Asia, but less so for Latin America. In addition, the list showed high levels of agreement across different patient sub-populations, but lower relevance for neonates and symptomatic HIV patients.ConclusionThis work highlighted once again the challenges of prioritising in global health, but it also shows that taking a two-pronged approach, combining available prevalence data with expert input, can result in a broadly applicable priority list. This comprehensive utility is particularly important in the context of product development, where a sufficient market size is essential to achieve a sustainable commercialized diagnostic product to address SFWS.

Blood transfusion-transmissible malaria and its cost analysis in Hawassa regional blood bank, Southern Ethiopia.

Background:Blood transfusion is an intervention used to save life particularly for those patients who survive only with receiving blood. Establishing effective diagnostic test menus concerning the screening of transfusion-transmissible infections in the blood banks play a vital role to safeguard recipients from transfusion-transmissible infections.Objective:The aim of this study was to assess blood transfusion-transmissible malaria and its screening cost analysis in Hawassa regional blood bank, Hawassa, Sothern Ethiopia.Methods:An institutional-based cross-sectional study was conducted from April to May 2018 among 414 voluntary blood donors. Each participant’s blood sample was screened for most transfusion-transmissible infections using antigen/antibody tests, while rapid diagnostic test and microscopy were used for malaria screening and confirmation. In addition, the cost screening of transfusion-transmissible infections was calculated using activity-based costing method.Results:The overall seropositivity of transfusion-transmissible infections was 7.0% and the positivity rate of hepatitis B virus, syphilis, and Plasmodium falciparum was 5.6%, 1.0%, and 0.5%, respectively. The cost per test of each transfusion-transmissible infection was US$5.04 for human immunodeficiency virus, US$4.61 for hepatitis B virus, US$5.11 for hepatitis C virus, and US$4.75 for syphilis, while the cost per test of malaria rapid diagnostic test was US$4.74 and this is comparatively lower than the cost per test of other transfusion-transmissible infections except for hepatitis B virus. In addition, total cost of laboratory incurred for transfusion-transmissible infections screening is estimated to be US$213,634.5 per year, while it becomes US$265,537.5 if the malaria screening cost is added. This means 19.54% of the total cost of laboratory incurred per year or US$51,903.Conclusion:The positivity rate of malaria parasites among voluntary blood donors was 0.5%, and it might be increased if the study was conducted in high transmission seasons. A cost of malaria screening is comparatively lower than costs of other transfusion-transmissible infections except for hepatitis B virus. Therefore, the screening of malaria parasites should be considered as one of the test menus of transfusion-transmissible infections in blood banks, especially in malaria-endemic areas.

Application of Health Technology Assessment (HTA) to Evaluate New Laboratory Tests in a Health System: A Case Study of Bladder Cancer Testing

We describe the methods and decision from a health technology assessment of a new molecular test for bladder cancer (Cxbladder), which was proposed for adoption to our send-out test menu by urology providers. The Cxbladder health technology assessment report contained mixed evidence; predominant concerns were related to the test’s low specificity and high cost. The low specificity indicated a high false-positive rate, which our laboratory formulary committee concluded would result in unnecessary confirmatory testing and follow-up. Our committee voted unanimously to not adopt the test system-wide for use for the initial diagnosis of bladder cancer but supported a pilot study for bladder cancer recurrence surveillance. The pilot study used real-world data from patient management in the scenario in which a patient is evaluated for possible recurrent bladder cancer after a finding of atypical cytopathology in the urine. We evaluated the type and number of follow-up tests conducted including urine cytopathology, imaging studies, repeat cystoscopy evaluation, biopsy, and repeat Cxbladder and their test results. The pilot identified ordering challenges and suggested potential use cases in which the results of Cxbladder affected a change in management. Our health technology assessment provided an objective process to efficiently review test performance and guide new test adoption. Based on our pilot, there were real-world data indicating improved clinician decision-making among select patients who underwent Cxbladder testing.

Users Regard Operator Training as Critical for Successful POCT Applications.

Point-of-care tests (POCT) measure analytes close to the patients and are a complementary supplement to the test menu of medical laboratories. However, the involvement of many different stakeholders makes it challenging to ensure reliable results. In a survey, we asked experienced POCT users how they control their total POCT process and what factors they consider essential for success. Results were verified in four in-depth interviews. Overall, 73 German participants from various medical disciplines completed the survey. All but one participant regarded operator training as important but only half of the participants' institutions conducted operator training on a regular basis. Participants often requested e-learning, but face-to-face teaching is still preferred. Twenty-one percent of participants already used e-learning and reported mixed satisfaction. Fifty-five percent of the participants never refer to the quality management manual. Instead, 94% stated that if a POCT error arises a contact person for POCT is always available at their workplace. The majority of participants think that external and, in particular, internal quality controls are important for POCT. Only a few difficulties for performing quality control such as "temporal expenditure" and "lack of information about the importance of internal quality control" were commonly mentioned. For future developments, participants expect evolution and improvements especially with regard to "measurement quality and reliability". The answers of the experts in the in-depth interviews largely corresponded with the participants of the survey. The importance of operator training is well established and confirmed in this work. How to conduct this training is less certain, but the answers in this survey suggest some form of blended learning with e-learning and practical elements. The discrepancy between the high importance that guidelines and other normative documents place on written information and their low practical usage was striking.

A Toxic Place to Be.

In the clinical chemistry laboratory, sporadic requests for copper and arsenic trickle in, occasionally done in-house and other times sent out to reference laboratories. It was a sunny day, the birds were chirping in the nearby park, and there was but a fresh gentle breeze. I remember on 4th May 2018, I had plans to go fishing after work with two colleagues, an emergency physician and a psychiatrist. They were joking about it earlier that week in the staff canteen with the expression “may the fourth be with you.” But still, it was to us just a day like any other day. I headed in that morning to be handed over the duty biochemist beeper. Our department possessed an inductively coupled plasma mass spectrometer (ICP-MS) and at times clinicians would phone to discuss specific test requests or results related to the ICP-MS test menu. That day we received a friendly call requesting a full heavy metal …

The Effects of a Systemwide Diagnostic Stewardship Change on West Nile Virus Disease Ordering Practices.

We report that removing the clinically insensitive West Nile virus CSF nucleic acid amplification test (NAAT) from the electronic health record (EHR) test. This diagnostic stewardship intervention decreased costs and may have improved diagnostic yield.

Reevaluating the Role of Cytogenetic Testing in Patients with Suspected Myelodysplastic Syndrome in the Era of Next Generation Sequencing

Background: In patients with suspected myelodysplastic syndrome (MDS), ancillary tests including cytogenetics (CG) and molecular diagnostics often support the diagnosis and add prognostic value guiding treatment decisions. Frequently, high-cost new technologies such as next generation sequencing (NGS) are added to the existing test menu without consideration for redundancy or added value. In our institution most patients with suspected MDS or cytopenias of undetermined origin will have conventional CG and NGS routinely ordered in addition to bone marrow (BM) morphology and flow cytometry (FCM). In a previous retrospective study, we evaluated combined NGS and CG in 120 patients and we found that our NGS panel had enhanced diagnostic and prognostic advantages over standard karyotyping. Based on these results, we undertook a quality improvement (QI) project to streamline molecular diagnostic testing, reduce test redundancy, turnaround time and cost. Methods: Between February and June 2019 we prospectively evaluated an "NGS first approach" to investigate patients with suspected MDS or cytopenias of undetermined origin. We assessed BM morphology, FCM, NGS testing (Oncomine Myeloid Research Assay, Thermo-Fisher) and CG for all patients. To assess whether BM aspirates can be used to triage appropriate use of NGS and CG, expert morphologists assigned BM samples to either the NGS/CG group or NGS only group, based exclusively on the presence of morphological abnormalities suggesting the possibility of an MDS. Results: We included 50 patients with suspected MDS or cytopenias of undetermined origin. Of these, 33 (66%) were triaged into the NGS/CG group and the remaining 17 (34%) into the NGS only group. In the NGS/CG group NGS testing revealed DNA mutations in 27 (81.8%) patients, whereas CG showed an abnormal karyotype in 12 (36.4%). Among the 21 patients with normal karyotype, NGS revealed mutations in 17 (81%). Two patients (6%) were identified as MDS by morphological examination and had an abnormal karyotype but negative NGS. Of those assigned to the NGS/CG group, 27 (81.8%) were morphologically diagnosed as either MDS (54.5%), acute myeloid leukemia (AML) (15.2%), MDS/myeloproliferative neoplasms (MPN) (6.1%), or therapy related myeloid neoplasms (t-MNs) - MDS/AML (6.1%). Among the patients assigned to the NGS only group, NGS testing showed no abnormalities in 16 (94.1%) patients. One patient was found to carry a BRAF mutation and subsequently diagnosed with hairy cell leukemia. CG testing showed a normal karyotype in 16 (94.1%) patients. One patient was found to carry an inv(2)(p11.2q13) and was diagnosed as clonal B cell lymphocytosis. Conclusion: We proposed and validated a testing algorithm based on an "NGS first approach" with CG restricted to patients with morphological changes suggestive of MDS, in order to reduce the number of samples karyotyped. Overall, in patients with a morphological diagnosis of MDS, NGS defined genetic abnormalities in more patients (84.2%) compared to CG (47.4%) alone. Additional cytogenetic testing only detected chromosomal abnormalities in less than 10% of MDS cases. Most importantly, nearly no mutations or CG abnormalities were detected in patients without dysplastic features. Based on these results we estimated that we could reduce karyotyping by 10% to 20% for patients presenting with probable MDS or cytopenias of undetermined origin using an "NGS first approach". Further studies are warranted to validate and provide cost saving estimates of this approach. Disclosures Hsia: Amgen: Honoraria; Jansen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees.

Panther Fusion® Respiratory Virus Assays for the detection of influenza and other respiratory viruses

BackgroundNucleic acid amplification tests (NAATs), such as PCR, are preferred for respiratory virus testing, due to superior diagnostic accuracy and faster turnaround time. Panther Fusion® Respiratory Assays (Fusion), which includes FluA/B/RSV (FFABR), Paraflu and AdV/hMPV/RV, offers a modular approach to syndromic testing on a fully automated platform while improving gene targets and expanding the test menu. Objectives and study designWe evaluated Fusion using 275 consecutive nasopharyngeal specimens previously used in an analysis of five PCRs, as well as 225 archived specimens. ResultsOf the combined 500 specimens, 134 were positive for influenza A (FluA), 54 for FluB, 65 for RSV, 64 for parainfluenza (PIV), 24 for adenovirus (AdV), 21 for humanmetapneumovirus (hMPV), and 40 for rhinovirus (RV) with Fusion. Of the positive samples Fusion correlated with historical results for all but one, despite multiple freeze-thaws cycles of this collection. Fusion was positive for an additional 33 samples, including 11 FluAs, 7 RSVs, 3 PIV3s, 3 AdV, 6 hMPV and 3 RVs. These samples were retested with corresponding Prodesse (Pro) assays using quadruple sample volume. This resolver test confirmed Fusion results for an additional 4 FluAs, 4 RSVs, 1 PIV3 and 3 AdVs. The sensitivity and specificity ranges of Fusion were 99–100% and 98–100%. Limit of detection (LOD) analyses were performed on a variety of Flu isolates. The LODs ranged from 2.69 to 2.99 log copies/ml and demonstrated superior LOD as compared to previously published data for some assays or to concurrent analyses with two new commercial tests.

1787. The Effects of a Systemwide Diagnostic Stewardship Change on West Nile Virus Disease Ordering Practices

BackgroundNeuroinvasive West Nile Virus (WNV) often leads to prolonged neurological deficits and carries a high case fatality rate. The CSF IgM (MAC-ELISA) is preferred over the CSF nucleic acid-based test (NAAT) by the CDC due to its higher sensitivity. However, our hospital system was observed to have an over-utilization of NAAT testing compared with MAC-ELISA testing. The primary objective was to compare the number of MAC-ELISA and NAAT WNV tests ordered before and after a diagnostic stewardship intervention. The secondary objectives were to determine whether this change to lead to any cost savings and increased detection of probable cases of WNV-ND.MethodsIn an effort to increase the use of the MAC-ELISA and to decrease unnecessary NAAT testing, the NAAT test was removed in April 2018 from the test menu in the electronic health record of a health system comprising five hospitals in the Maryland and Washington, D.C. area. NAAT testing remained possible via a paper order form. This study was a retrospective review of WNV testing done on CSF samples from July 2016 through December 2018. The seasonal and yearly number of total tests, positive tests, and total costs were determined from the period of July, 2017 to April, 2018 and were compared with May, 2018 to January, 2019. A paired t-test was performed to evaluate for differences in total testing, total positives, and total costs during non-winter months before and after the intervention.ResultsA total of 12.59 MAC-ELISA tests/month (95% CI: 10.29, 14.89) increased to 41 tests/month (95% CI: 34.35, 47.65) which was significantly different (P < 0.001). In contrast, there were 46.23 NAAT tests/month (95% CI: 39.55, 52.91) which decreased to 0 NAAT tests/month after the intervention (P < 0.001). This resulted in an average decrease in WNV test spending from $7200 per month to $471 per month (P < 0.001). Preceding the intervention in test ordering, 0.23% of WNV CSF tests were positive (NAAT+MAC-ELISA) while 2.44% WNV CSF tests were positive after the intervention (P = 0.03).ConclusionElimination of electronic WNV NAAT ordering is an effective way of decreasing inappropriate WNV NAAT testing, decreasing associated costs, and may lead to improved diagnosis of WNV-ND. Disclosures All authors: No reported disclosures.

Automated Calculation of Turnaround Times Using Data Warehouses for Publication in Online Test Menus

Abstract Awareness of turnaround times (TATs) is important for time-sensitive clinical decision making and setting expectations for timing communications with patients. In fact, a significant number of clinicians consider the TAT as the most important measure of laboratory quality (PMID 24839360). TAT definitions vary considerably, ranging from rough estimates to more precisely defined statistics based on historical data, the former more typically provided in online test catalogs and the latter usually reserved for a limited number of tests for internal quality assurance and improvement. As data warehousing of laboratory information is becoming more commonplace, calculation of TATs can more easily be performed. Our goal in this project was to develop a generalized, automated approach to calculate expected TATs for publication in our online test catalog. We began by defining TAT as the amount of time between receipt of the specimen by the laboratory and the reporting of the finalized result in the laboratory information system (using specimen collection time increased median TATs by 21 minutes). The TAT of an order set/panel of tests was calculated using the time stamp of the last finalized test result of the set. For development purposes, a subset of warehouse data corresponding to all tests within a 1-month period was selected (170,363 accession numbers, 2,206,311 total test results). All accessions with “add-on requests” (tests requested by physicians using specimens collected for prior tests) were removed. The median and 90th percentile TATs were calculated using R for each test and panel, as these values are commonly used in quality assurance programs and are thought to be intuitively easy to understand in a test menu. Values were not reported if fewer than 100 test results were available for a given test. A summary table and TAT distribution graphs are provided for review by laboratory personnel before being published in the online test menu. Categorizing tests ordered “stat” versus “nonstat” generated some interesting insights, the most obvious being that, for the majority of our tests, the difference in median TATs is very small. In some cases, however, the median stat TAT was actually longer (eg, hemoglobin A1C), which might be due to blood draws at irregular hours by phlebotomists, then batching of samples with specimens collected later at regular blood draw times, suggesting that elimination of the stat option was appropriate. Distinct advantages of using data warehouses to calculate TATs include being able to provide clinicians with data-driven estimates of expected lab result TATs. Such data can also be used for internal quality assurance purposes. Areas of further development include developing a more rigorous mathematical theory of the precision associated with our median and 90th percentile TATs and tuning the frequency of data query and TAT recalculation.

Laboratory Test Utilization in an Expanding Regional Laboratory Network: Past Successes and Future Opportunities

Abstract Introduction The University of Rochester Medical Center developed a reference test utilization program implemented in 2011 to tackle increasing test volumes and costs. There was an initial &gt;7,000 decrease in test volumes, which equated to &gt;$1,000,000.00 in savings by year end 2012. Despite this, by the end of 2018, testing volumes had increased 34% and the cost had climbed 36%. Here we would like to discuss the methods implemented for initial success, potential reasons for continued increases in volumes and costs, and ideas to mitigate this trend in the future. Methods In 2010, the University of Rochester formed a laboratory diagnostics committee, which successfully decreased reference testing volumes and costs in both the inpatient and outpatient settings. They did this by developing a formulary for reference tests, which was divided into three tiers based on clinical utility and cost: tier 1 tests, unrestricted and available to all providers to order; tier 2 tests, restricted with only board-certified, subspecialty-trained physicians able to order; and tier 3 tests, off formulary and not available to order. The resident physician staff was also no longer allowed to order any reference testing on inpatients. Despite initial gains costs and volumes have climbed &gt;36% and 34%, respectively, since implementation. Possible explanations for this include the addition of regional affiliate hospitals and reference clients that are not following these protocols, increased testing volumes, and increasing use of molecular testing. Conclusion Despite successful implementation of a reference test utilization program, close monitoring and adaptations are necessary in our continuously changing health care environment to remain effective. Implementation of the program at the regional affiliate hospitals and a more robust molecular testing menu in-house are potential options to control rising costs while providing high-quality patient care.

Does Provider Specialty Matter?

Multiple practice guidelines discourage indiscriminate use of broad panels of allergen-specific IgE (sIgE) tests due to increased risk of false positives and misinterpretation of results. We provide an analytical framework to identify specialty-specific differences in ordering patterns and effectiveness, which can be used to improve test utilization. Test results from a tertiary pediatric hospital were analyzed by ordering specialty to evaluate size of allergen workups. Positivity rates were analyzed to determine effectiveness in selecting tests with high positive pretest probabilities. Laboratory test menu components were also evaluated. Our findings demonstrate 29% of sIgE tests are ordered as part of broad workups (>20 sIgE tests/date of service) contrary to the recommended testing approach. Detailed descriptions of ordering patterns and positivity rates are provided. This study provides a framework for using a cross-sectional analytical approach to assess test utilization patterns and evaluate components of laboratory testing menus.