Redesigning the Workflow Process to Upload Paper Consents into the Electronic Health Record

Background: Before starting cellular therapy treatment, patients and their physicians must sign consent forms for Standard of Care (SoC) treatment plans as well as ancillary protocols. To avoid delay in patient care, signed SoC consents are scanned into the Electronic Health Record (EHR) in a timely manner, and protocol consents are handed off to the research team to manage as needed. The COVID-19 pandemic forced our large academic center to adapt this consent management workflow to function with fewer onsite staff, which resulted in prolonged turnaround time for consents to be uploaded into the patient's EHR, and operational inefficiencies (e.g. lost consents requiring re-signing, increase workload for staff, etc.). The process involved 4 cross-functional teams, and handoffs spanning multiple physical locations. Combined with the increasing patient volume of our center, the consents process was unsus-tainable and inadequate. Method(s): Our first redesigned process involved physicians dropping off signed consents directly in the clinic workroom.A Research Coordinator would then sort out the protocol consents and hand off SoC consents to the Health Information Systems (HIS) team for EHR scanning. This new process reduced the number of stakeholders handling the consents and consolidated the handoff location to one location. While this allowed for marked improvement in turnaround times for SoC consent scanning, there were additional opportunities to integrate the workflow with the HIS team's existing processes to allow for further efficiencies. After 4 months, we implemented our second redesigned process: after drop-off in the clinic workroom by physicians, the HIS team would collect all consents three times per day and scan SoC consents while setting aside protocol consents for the Research team to pick up. This allowed for SoC consents to be scanned without delay and reduced workload for the Research team all while streamlining our workflow into existing HIS processes. See Figure 1 for workflow iteration details. Result(s): The new processes reduced the average turnaround time for SoC consents scanned into the EHR from 8 to 2 busi-ness days. Furthermore, we have increased the number of consents scanned same day into the EHR from 18% under the 1st redesign, to 52% with the 2nd redesign (see Figure 2). We have also diminished the error rate (including lost consents) to 1% of consents processed. (Figure Presented)(Figure Presented) Conclusion(s): The redesigned consents workflow resulted in quicker uploads into the EHR, increased same day uploads and has made lost consents statistically insignificant. Timely uploads of consents into EHRs have also allowed us to flag and resolve any issues earlierCopyright © 2023 American Society for Transplantation and Cellular Therapy

Mitigating the Impact of Covid-19 on Hiv Viral Load Access among Key Populations

Background: Monitoring of HIV-infected individuals on antiretroviral treatment requires periodic viral load(VL) measurements to ascertain adequate response to treatment. While plasmaVL is widely available in health facilities, it is difficult for use among key populations(KPs) due to their high mobility and sophisticated sample storage and transport requirements, which are not available for community VL sample collection. Use of Dried Blood Spot(DBS) VL measurement has shown promise as an alternative to plasma specimens for KPs. Studies to investigate the performance of DBSVL quantification against the standard plasma VL assay has proven to be within acceptable range. DBSVL was introduced for sample collection among KPs when it became difficult to safely and appropriately collect, store and transport samples during COVID-19 lockdown. This study assessed the usefulness of the use of DBSVL deployed by USAID to ensure access to HIV VL services among KPs in 7 states of Nigeria during COVID-19 lockdown Methods: To mitigate the impact of COVID-19 lockdown, virtual trainings were conducted for one-stop-shops and community VL champions of USAID partners providing KPs services in seven states of Nigeria on DBS sample collection, storage and transportation and remote test ordering was activated for service providers. Standard operating procedures and job aids were deployed to points of service and laboratory equipment were verified for DBSVL testing. VL sample collection rate(SCR), VL coverage(VLC), VL suppression(VLS), turnaround time (TAT) and cost savings for the program between March2019 and February2021 were compared using the two-sample independent t test pre-COVID (March2019- February2020) and during-COVID lockdown (March2020 -February2021) at 95 confidence interval and < 0.05 level of significance. Result(s): There was a significant increase (p< 0.05) in SCR from 73% to 94%, VLC 44% to 85%, and VLS 78% to 95% pre-COVID to during-COVID respectively despite increase in number of clients eligible for VL. However, the median TAT remained unchanged at 29 days. There was a 60% cost savings for the program due to reduction in consumables needed for sample collection and processing and convenience in sampling among KP clients. Conclusion(s): Implementation of DBSVL resulted in increases in both VLC and VLS with an improved TAT for KPs clients in seven states of Nigeria. KPs Program implementers should consider introduction of DBSVL sampling among KPs for a better VL access and clinical outcome.

Performance of multiplex bead based assay for detection of neutralizing antibodies in SARS CoV-2 infected and vaccinated individuals

Background: After the pandemic of SARS COV2 it is evolving and causing a threat and concern worldwide. Studies on variants are crucial in understanding the change in virulence and transmissibility of the virus and further vaccine efficacy. Plaque reduction neutralization test (PRNT) is the gold standard to detect neutralizing antibodies. Consequently, it is essential to explore other neutralization platforms which give promising results with quick turnaround time and safety compared to live neutralization assay. Objective(s): To compare and evaluate the neutralizing antibody responses of a multiplex bead-based assay (MBA), using the SARSCoV- 2 Variants Neutralizing Antibody Human 5-Plex ProcartaPlexTM Panel, with PRNT and further evaluate it to estimate the neutralizing responses in infected and vaccinated individuals. Material(s) and Method(s): Confirmed RT PCR covid positive and serum samples from vaccinated individuals (Covaxin and Covishield) were assesssed for the presence of neutralizing antibodies using Multiplex bead assay Human 5-Plex ProcartaPlexTM kit. Result(s): The sensitivity and specificity of MBA was less as compared to PRNT. In our study, we observed that qualitative assay was more comparable than quantitative assay. Conclusion(s): This study demonstrated the utility of MBA for simultaneous measurement of neutralizing antibodies against multiple SARS-CoV-2 strains in serum. The qualitative assay performance was imparted excellent with high sensitivity and specificity but variation in quantitative titres was observed compared to live neutralization assay titres.

Value of Biofire Filmarray pneumonia panel in evaluating secondary infection in critically ill patients with Coronavirus disease 2019.

Objective To explore the application value of Biofire Filmarry pneumonia panel (PN) in detection of secondary and concomitant pathogen among critically ill patients with coronavirus disease 2019(COVID-19). Methods We consecutively included and analyzed the clinical data of critically ill patients with COVID-19 transferred to the ICU from February to April 2020 in the Sino-French Campus of Wuhan Tongji Hospital. Samples of Bronchoalveolar lavage fluid obtained by bedside bronchoscopy were sent for Biofire Filmarray PN and standard culture concomitantly. We compared the results of two methods and evaluated their concordance. Results In total, 21 critically ill patients with COVID-19 were included and 54 samples were tested, including 33 (61.1%) Biofire Filmarray PN tests (21 patients) and 21 (38.9%) standard cultures (14 patients), in which 19 pairs (38 samples) underwent both tests simultaneously. In Biofire Filmarray PN group, the turnaround time was about 1 hour. There were 74 positive results in 32 samples (97.0%) from 20 patients, including 29 cases(39.2%) of Acinetobacter baumannii complex, 21 cases (28.4%) of Pseudomonas aeruginosa, 16 cases (21.6%)of Klebsiella pneumoniae, 5 cases (6.8%) of Escherichia coli, 1 case (1.4%)each of Enterobacter cloacae, Haemophilus influenzae, and respiratory syncytial virus. In the standard culture group, the turnaround time was about 3 days. 19 positive results returned in 16 (76.2%) samples from 11 patients, including 8 cases (42.1%) of Pseudomonas aeruginosa, 6 cases (31.6%) of Acinetobacter baumannii, 4 cases (21.1%) of Stenotrophomonas malt and 1 case (5.3%) of Myxobacterium. Among the 19 pairs of "back-to-back" specimens, 15 pairs were concordant, and the agreement ratio was 78.9%. Conclusions Acinetobacter baumannii and Pseudomonas aeruginosa may be the common pathogens of secondary or concomitant infection in critically ill patients with COVID-19. Biofire Filmarray PN is a rapid diagnostic test and has application value in such patients;its sensitivity and accuracy require further investigation with larger sample sizes.Copyright © 2021, Peking Union Medical College Hospital. All rights reserved.

Trends of radiology caseload and report turnaround time before and after COVID-19 pandemic at the tertiary teaching hospital, Addis Ababa, Ethiopia

Background: Coronavirus pandemic has drastically change health institutions due to modifications to the health service delivery system. In line with this, patients visiting health institutions have markedly reduced numbers resulting in a reduced caseload of practicing physicians. Objective: This paper assessed the caseload in the radiology department of Tikur Anbessa Specialized Hospital and reported turnaround times before and after the COVID-19 pandemic in a tertiary teaching hospital. Methods: Institution-based Cross-sectional study design was employed for the radiology caseload. All patients' groups seen in radiology department in all the modalities 6 months before and after the announcement of the COVID-19 in Ethiopia. For the evaluation of radiology report turnaround time, simple random sampling was employed using the source population as those 6 months before in 6 months after the declaration of Covid in Ethiopia. Data entry and analysis were done using SPSS version 16 statistical software. Time series analysis with 95% CI was used to determine the association between different variables for radiology caseloads. Result: The trend of patient load showed a marked decrease after the COVID-19 pandemic in the radiology department. The turnaround time from study time to residents' report time (ST-RT) - after COVID-19 for MRI was increased by 17 hours. But resident report time to consultant verification time (RRT-CVT) was decreased by 1 day after the COVID-19 pandemic. For computed tomography [CT], ST-RT has decreased by 1 day and 4 hours but RRT-CVT time showed a slight increment by 1 hour and 30 min as compared to before COVID-19. This resulted in reduced exposure of residents and delays of verified patient reports. Conclusion: there is a decrease in patient load and an increase in turnaround time of radiology case reports after the COVID-19 pandemic compared with the trend before the pandemic. This will affect patient care and resident teaching. The department should look for ways of improving patient care and resident teaching through different innovative methods like the introduction of virtual education and teleradiology © 2022, Ethiopian Journal of Health Development.All Rights Reserved.

Impact of the loss of Laboratory Developed Mass Spectrometry testing at a major academic medical center.

Background: Our laboratory historically performed immunosuppressant and definitive opioid testing in-house as laboratory developed (LDT) mass spectrometry-based tests. However, staffing constraints and supply chain challenges associated with the COVID-19 pandemic forced us to refer this testing to a national reference laboratory. The VALID Act could impose onerous requirements for laboratories to develop LDTs. To explore the potential effect of these additional regulatory hurdles, we used the loss of our own LDT tests to assess the impact on patient care and hospital budgets. Methods: Laboratory information systems data and historical data associated with test costs were used to calculate turnaround times and financial impact. Results: Referral testing has extended the reporting of immunosuppressant results by an average of approximately one day and up to two days at the 95th percentile. We estimate that discontinuing in-house opioid testing has cost our health system over half a million dollars in the year since testing was discontinued. Conclusions: Barriers that discourage laboratories from developing in-house testing, particularly in the absence of FDA-cleared alternatives, can be expected to have a detrimental effect on patient care and hospital finances.

Modelling the impact of timelines of testing and isolation on disease control.

Testing and isolation remain a key component of public health responses to both persistent and emerging infectious diseases. Although the value of these measures have been demonstrated in combating recent outbreaks including the COVID-19 pandemic and monkeypox, their impact depends critically on the timelines of testing and start of isolation during the course of disease. To investigate this impact, we developed a delay differential model and incorporated age-since-symptom-onset as a parameter for delay in testing. We then used the model to compare the outcomes of reverse-transcription polymerase chain reaction (RT-PCR) and rapid antigen (RA) testing methods when isolation starts either at the time of testing or at the time of test result. Parameterizing the model with estimates of SARS-CoV-2 infection and diagnostic sensitivity of the tests, we found that the reduction of disease transmission using the RA test can be comparable to that achieved by applying the RT-PCR test. Given constraints and inevitable delays associated with sample collection and laboratory assays in RT-PCR testing post symptom onset, self-administered RA tests with short turnaround times present a viable alternative for timely isolation of infectious cases.

Factors affecting turnaround time of SARS-CoV-2 sequencing for inpatient infection prevention and control decision making: analysis of data from the COG-UK HOCI study.

BACKGROUND: Barriers to rapid return of sequencing results can affect the utility of sequence data for infection prevention and control decisions. AIM: To undertake a mixed-methods analysis to identify challenges that sites faced in achieving a rapid turnaround time (TAT) in the COVID-19 Genomics UK Hospital-Onset COVID-19 Infection (COG-UK HOCI) study. METHODS: For the quantitative analysis, timepoints relating to different stages of the sequencing process were extracted from both the COG-UK HOCI study dataset and surveys of study sites. Qualitative data relating to the barriers and facilitators to achieving rapid TATs were included from thematic analysis. FINDINGS: The overall TAT, from sample collection to receipt of sequence report by infection control teams, varied between sites (median 5.1 days, range 3.0-29.0 days). Most variation was seen between reporting of a positive COVID-19 polymerase chain reaction (PCR) result to sequence report generation (median 4.0 days, range 2.3-27.0 days). On deeper analysis, most of this variability was accounted for by differences in the delay between the COVID-19 PCR result and arrival of the sample at the sequencing laboratory (median 20.8 h, range 16.0-88.7 h). Qualitative analyses suggest that closer proximity of sequencing laboratories to diagnostic laboratories, increased staff flexibility and regular transport times facilitated a shorter TAT. CONCLUSION: Integration of pathogen sequencing into diagnostic laboratories may help to improve sequencing TAT to allow sequence data to be of tangible value to infection control practice. Adding a quality control step upstream to increase capacity further down the workflow may also optimize TAT if lower quality samples are removed at an earlier stage.

Doctor for Every Citizen: Telehealth Visits at Dubai Health Authority during COVID-19 Pandemic in Dubai, United Arab Emirates.

BACKGROUND: Digital health significantly affects healthcare delivery. Moreover, empirical studies on the utilization of telehealth in Dubai are limited. Accordingly, this study examines the utilization of telehealth services in Dubai Health Authority (DHA) facilities and the factors associated with telehealth appointment completion and turnaround time. METHODS: This cross-sectional study examines patients who used telehealth services in DHA from 2020 through 2021 using 241,822 records. A binary logistic regression model was constructed to investigate the association between appointment turnaround time as a dependent variable and patient and visit characteristics as independent variables. RESULTS: Of the total scheduled telehealth visits, more than three-quarter (78.55%) were completed. Older patients, non-Emiratis, patients who had their visits in 2020, patients who had video visits, and those who sought family medicine as a specialty had a shorter turnaround time to receive their appointment. CONCLUSIONS: This study identifies several characteristics associated with the turnaround time. Moreover, technological improvements focusing on specialties that can readily be addressed through telehealth and further research in this domain will improve service provision and support building an evidence-base in the government sector of the emirate of Dubai.

Quality improvement of outpatient clinical chemistry tests through a novel middleware-laboratory information system solution.

OBJECTIVES: Rapid and accurate laboratory tests are essential to support clinical decision-making. Despite the various efforts to control quality in the laboratory, our outpatient chemistry turnaround time (TAT) has deteriorated since 2018. Moreover, these difficulties have accelerated further due to the COVID-19 pandemic. Therefore, we aimed to improve laboratory work efficiency by identifying and eliminating the causes of reduced laboratory work efficiency. DESIGN & METHODS: We surveyed to identify tasks that reduce work efficiency. Based on our survey, a new-concept of work assistance middleware linked to laboratory information system (LIS) was developed. The middleware supports test end-time prediction, automatic real-time TAT monitoring, and urgent test requests so that medical technologists can focus on their chemistry tests. The developed middleware was used for 6 months in laboratory and outpatient clinics, and its effectiveness was evaluated. RESULTS: The median TAT for outpatient chemistry tests was reduced by 6.6 min, from 72.4 min to 65.8 min. And not only did the maximum TAT for the sample decrease from 353 min to 214 min, but the proportion of samples exceeding the TAT target (120 min) also decreased by 77%; from 2.00% in 2010 (1,905 out of 94,989 samples) to 0.46% in 2021 (453 out of 98,117 samples). 2,199 samples were urgently requested through middleware, and they were processed about 15% faster than other samples, effectively performing urgent tests. The test end-time prediction showed an error of 8.6 min in the evaluation using the MAE (Mean Absolute Error) index. CONCLUSIONS: Through this study, the quality and efficiency of the laboratory were improved, and while reducing the workload of medical staff, it contributed to enhancing patient safety and satisfaction.

Mitigation Tactics Discovered During COVID-19 with Long-Term Report Turnaround Time and Burnout Reduction Benefits.

RATIONALES AND OBJECTIVES: The purpose is to describe a hybrid teleradiology solution utilized in an academic medical center and its outcomes on radiology report turnaround time (RTAT) and physician wellness. MATERIALS AND METHODS: During coronavirus disease 2019, we utilized an alternating teleradiology solution with procedural and education attendings working in the hospital and other faculty remote to keep the worklist clean. RTAT data was collected for remote vs. in house emergency department (ED) and inpatient cases over a 6-month period. Pre and post implementation burnout surveys were administered. RESULTS: RTAT significantly improved for ED and inpatient MR and CT, and inpatient US and radiographs when interpreted remotely compared to in-hospital. Physician wellness scores improved and open-ended comments reflected positive feedback about the hybrid work solution. 74% enjoyed the autonomy and flexibility, and 51% said the solution positively influences my desire to remain in my current institution and improves their clinical and/or academic productivity. CONCLUSION: Hybrid work from home solutions allow faculty autonomy and flexibility with work-life balance, improving wellness. It is important to alternate the at-home faculty to maintain interdepartmental relations, particularly for junior faculty, and prevent isolation. The hybrid solution also demonstrated improved patient care metrics, possibly due to decreased distractions at home compared to the reading room.

Factors Impacting Time from Biopsy to Initiation of Treatment for Advanced NSCLC at an Academic Hospital and Affiliate Hospitals

Introduction: Delays in initiation of treatment for advanced cancers are associated with poorer outcomes. In advanced NSCLC, one factor impacting time of treatment initiation is next-generation sequencing (NGS) testing. In our hospital system, Northwestern Medicine, the standard for NGS testing at Northwestern Memorial, the 894-bed academic hospital, is in-house reflex testing on all histologies and stages for a 50-gene panel of mutations and fusions. At affiliate hospitals, there is no set protocol so testing is sent to private vendors. The purpose of this study was to compare time from biopsy to treatment between the academic center and two affiliate hospitals evaluating for impact of NGS testing, radiation therapy, repeat biopsies, and the COVID-19 pandemic. Methods: We queried the Northwestern Medicine Enterprise Data Warehouse for patients with a new diagnosis of lung cancer between January 1, 2019 and December 31, 2020 at Northwestern Memorial Hospital (NMH), Central DuPage Hospital (CDH), and Delnor Hospital. This yielded a total of 864 patients - 623 (72.1%) diagnosed in 2019 and 241 (27.9%) diagnosed in 2020. Inclusion criteria for analysis: new diagnosis of stage IV NSCLC with diagnostic evaluation conducted at one of the three aforementioned hospitals. Results: 191 patients with stage IV NSCLC met inclusion criteria, 68.6% (131/191) diagnosed in 2019 and 31.4% (60/191) diagnosed in 2020. 148/191 patients received systemic therapy, 102 diagnosed in 2019 (44 NMH / 58 CDH and Delnor), and 46 diagnosed in 2020 (27 NMH / 19 CDH + Delnor). 59/148 patients had radiation prior to systemic therapy (29 NMH, 30 CDH + Delnor), and 20/148 required repeat biopsy (10 NMH, 10 CDH + Delnor). Median time from first biopsy to treatment was 30 days at Northwestern and 37 days at CDH + Delnor overall;in 2019, these times were 35 days at Northwestern and 38 days at CDH + Delnor, and in 2020, these times were 26 days at Northwestern and 37 days at CDH + Delnor (Figure 1). [Formula presented] Conclusions: Time from biopsy to treatment decreased between 2019 and 2020 at Northwestern but not at CDH + Delnor, and was shorter overall at Northwestern compared with CDH + Delnor. Radiation therapy and need for repeat biopsy did not differ between the two sites, suggesting that reflex NGS may be associated with faster turnaround times. Fewer patients presented with lung cancer in 2020 than 2019, highlighting the impact of the COVID pandemic on cancer care. Keywords: NGS, Time to treatment

Thromboelastographic method for early decision on anticoagulant therapy in moderate to severe COVID-19 patients

BACKGROUND Coagulopathy is a serious COVID-19 complication that requires rapid diagnosis and anticoagulation. This study aimed to determine the role of coagulation examination using thromboelastography (TEG) on the decision-making time of anticoagulant therapy in COVID-19 patients and its clinical outcomes. METHODS A prospective observational study was conducted in Cipto Mangunkusumo Hospital, Indonesia, from October 2020 to March 2021. We consecutively recruited moderate and severe COVID-19 patients in the high and intensive care units. Turnaround time, time to anticoagulant therapy decision, and clinical outcomes (length of stay and 30-day mortality) were compared between those who had a TEG examination in addition to the standard coagulation profile examination (thrombocyte count, PT, APTT, D-dimer, and fibrinogen) and those who had only a standard coagulation profile laboratory examination. RESULTS Among 100 moderate to severe COVID-19 patients recruited, 50 patients had a TEG examination. The turnaround time of TEG was 45 (15–102) min versus 82 (19– 164) min in the standard examination (p<0.001). The time to decision was significantly faster in the TEG group than the standard group (75 [42–133] min versus 184 [92–353] min, p<0.001). The turnaround time was positively correlated with time to decision (r = 0.760, p<0.001). However, TEG did not improve clinical outcomes such as length of stay (10.5 [3–20] versus 9 [2–39] days) and 30-day mortality (66% versus 64%). CONCLUSIONS The TEG method significantly enables quicker decision-making time for moderate to severe coagulation disorder in COVID-19 patients.

Plasma first: Accelerating lung cancer diagnosis through liquid biopsy

Background: Molecular profiling of tumor tissue is the gold standard for treatment decision making in advanced non-small cell lung cancer. Results may be delayed or unavailable due to insufficient tissue samples or prolonged wait times for biopsy, pathology assessment and testing. We piloted the use of plasma molecular testing as part of the initial diagnostic work-up for patients with suspected advanced lung cancer (NCT04863924). Methods: Patients with radiologic evidence of advanced lung cancer referred to the lung rapid diagnostic program underwent plasma circulating tumor DNA (ctDNA) testing using InVisionFirst-Lung, a next-generation sequencing (NGS) assay targeting 37 genes. Standard tissue testing was performed with comprehensive NGS (Oncomine). The primary endpoint was time to treatment in stage IV NSCLC patients compared to an historical pre-COVID-19 cohort (2018-9). Secondary endpoints included actionable targets identified in plasma, % of patients starting targeted therapy based on liquid biopsy and result turnaround time (TAT). Results: Between July 1 to December 31, 2021, 60 patients were enrolled. Median age was 70 years (range 33-91), 52% were female, 57% Caucasian, 48% never smokers. Of these, 73% had NSCLC, 12% small cell, 10% non-lung pathology and 5% declined tissue biopsy. Of 44 NSCLC patients, 5 (11%) had early-stage disease and underwent curative therapy. Most stage IV patients (79%) had systemic treatment. Median time to treatment initiation in the study cohort was 34 days (n = 31, range 10-90) versus 62 days (n = 101, range 13- 159) in the historical cohort (p<0.0001). Two thirds (N = 23) of stage IV NSCLC patients had actionable alterations identified, (30% in current/ex-smokers);18 started targeted therapy including 10 based on plasma results before tissue results were available. Median TAT was 7 days for plasma from blood draw to reporting (range 4-14) and 26 days for tissue molecular testing (range 11-42), p<0.0001. Concordance was high between plasma and tissue testing (70%). Liquid biopsy identified actionable alterations for 3 patients not identified by tissue NGS. In 4 cases, plasma testing failed to identify actionable alterations detected in tissue, due to undetectable plasma ctDNA. Conclusions: Liquid biopsy in the initial diagnostic workup of patients with suspected advanced NSCLC leads to faster molecular results and shortens time to treatment compared to tissue testing alone. Supplementing the current standard of tissue molecular testing with a plasma-first approach during the diagnostic work up of patients with suspected advanced lung cancer may increase access to precision medicine and improve patient outcomes. (Table Presented).

Field performance of rapid antigen test for SARSCoV- 2 in western Kenya

Introduction/ Background: Testing for SARS-CoV-2 is a key pillar in combating COVID-19. Whilst testing using real-time polymerase chain reaction is the current gold standard, rapid antigen tests are an attractive alternative. This study assessed the field performance of the NowCheck COVID-19 antigen kit in selected healthcare facilities in Kisumu County - western Kenya. Methods: This was a prospective multi-facility field evaluation study using the NowCheck COVID-19 antigen test (Ag-RDT) compared to standard SARS-CoV-2 realtime polymerase chain reaction (RT-PCR). Paired oropharyngeal and nasopharyngeal swabs were collected from 997 all persons suspected to have COVID-19 and subjected to both antigen and RT-PCR testing. The testing algorithm followed the Ministry of Health, Kenya COVID-19 testing protocol. The results of both methods were captured using an electronic digital application and analyzed. Results: A total of 997 suspected COVID-19 cases were recruited. The median age of study participants was 39 years and 54% were male. T he NowCheck COVID-19 Antigen test (BioNote, Hwaseong-si, South Korea) had a sensitivity of 84.8% (95% CI: 75.8-91.4) and specificity of 94.4% (95% CI: 92.7-95.8) and overall accuracy of 93.5% (95%CI: 91.8- 94.9) when a cycle threshold (Ct value) of ≤35 was used. When a Ct value <40 kit sensitivity was 71.5% (63.2- 78.6) with a specificity of 97.5% (96.2-98.5). The highest sensitivity of 87.7% (77.2-94.5) was observed in samples with Ct values ≤30, corresponding with samples with higher viral loads. Impact: N/A [This was submitted before the CPHIA organizing committee added an “Impact” section.] Conclusion: The NowCheck COVID-19 antigen test showed good field performance in this evaluation. Operational specificity and sensitivity were close to WHOrecommended thresholds. Faster turnaround time to results, lower cost, simple analytical steps requiring no equipment or infrastructure make antigen testing an attractive screening method in the fight against the SARS-CoV-2 pandemic.

Pooling sample can increase SARS-CoV-2 capacity testing in resource limiting settings

Introduction/ Background: The global spread of SARS-CoV-2 and high demand for reagents may cause a challenge in procurement and the testing process, impacting turnaround times and the epidemiological data for optimal response mainly in low-income countries. To overcome this bottleneck, evaluating pooling system in the testing could be a solution Methods: For pooling strategy, 100 ul of each sample were pooled for up to 4 samples and extract using the same technology. The swabs were Oropharyngeal and nasopharyngeal swabs collected from individual attending clinic at Thies région and tested by Real-Time PCR after inactivation and RNA extraction using KingFisher Flex machine from ThermoFisher according to the manufacturer. SARS-CoV-2 detection were done using AllplexTM 2019-nCoV assay from Seegene targetting N, E, RdRp Gene in Biorad CFX96. All Samples are test individually and pooled. Ct values were compared between positives samples and result obtained with pooling. Results: We include in this analysis 43 pool of 4 samples each including 54 positive SARS-CoV-2 pooled with 114 negative samples and 40 pool of 4 negatives samples. Among positives sample included in the pool, 19 had Ct between 17 and 25, 23 between 25 to 30 and 12 had more than 30. Our result confirms that all 54 positives samples pooled in negatives samples were detected by pooling. The pooling was associated with a loss of 0.8 average of Ct ranging between -1.2 to 2.8. All samples individually negatives were also negatives in the pooling. The complete analysis is ongoing. Impact: This study indicates that pooling sample is practical and can be used for community surveillance, testing of low-risk populations, and in resourcelimited settings to mitigate reagent stock out. This can allow to reduce testing turnaround times and faster public health authorities' response to the global pandemic, especially in low-income countries. Conclusion: Our preliminary data confirms that pooling sample correctly identifies SARS-CoV-2 infected individual in 100% of our sample with an expected average of loss of ct of 0.8. This strategy can increase testing throughput in RLS and reduce turnaround time.

Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection

Objective: development and validation of a reverse transcription polymerase chain reaction (RT-PCR) test kit for SARS-CoV-2 ribonucleic acids (RNA) qualitative detection adapted for using with automated station for RNA extraction. Material and methods. Assessment of clinical performance was carried out on biological samples (nasal and oropharyngeal swabs and sputum) obtained during the diagnostic procedure. The presence of novel coronavirus RNA was established using a reference kit. Sensitivity was evaluated on standard SARS-CoV-2 sample (EDX SARS-CoV-2 Standard, Bio-Rad Laboratories, USA). Results. Presence of SARS-CoV-2 RNA is detected by two genome regions. Sensitivity determined by testing SARS-CoV-2 standard was 250 copies/ml. Coefficient of variation during the testing of samples with the concentration of 104 copies/ml did not exceed 5% in different conditions. Diagnostic sensitivity against reference test was 100% (95% confidence interval (CI) 95.6–100) for nasal and oropharyngeal swabs and 100% (95% CI 94.8–100) for sputum. Diagnostic specificity was 100% (95% CI 95.6–100) for nasal and oropharyngeal swabs and 100% (95% CI 94.8–100) for sputum. The turnaround time for test from RNA extraction till obtaining results was about 3 hours when testing 96 samples using automated stations for RNA extraction. Conclusion. Using the kit together with automated station for RNA extraction will increase laboratory testing capacity in pandemic conditions.

Quality Improvement Project to Reduce Turnaround Times to Improve Vascular Theatre Efficiency

Aims: Delays in turnaround time (TAT) have significant financial implications for the National Health Service, estimated to be as much as £347 327 per year. Considering this, we aimed to reduce the TAT by 25% in a vascular surgical theatre, via a Quality Improvement Project (QIP), as part of an MBBS component. We hypothesised that improvements in TAT would also lead to beneficial secondary effects, such as improved theatre utilisation, reduced on the day cancellations, and fewer minutes overrun. Methods: TAT was defined as the time between the last patient going to recovery (“wheels out”) to the next one entering the theatre (“wheels in”). Using the electronic theatre record system “Galaxy”, we established a baseline average TAT using data from October 2019 to January 2020. To identify the common issues underlying TAT delays, a group of three medical students undertook a four week research period, involving ad hoc staff interviews and review of postoperative debrief forms. From this, we constructed our interventions and implemented them over a six week period. Results: Our research period suggested ward-based preparation was a common reason for delay. To address this, we created interventions that focused on giving the ward staff more time, to promote “patient readiness”. An advanced warning system when sending for the patient (30 minutes prior to the end of surgery;previously, the ward was only notified when the patient was being closed) and a newly designed ward based checklist (shown in Fig. 1;the checklist allowing systematic review of tasks needed to be completed) were utilised. Baseline average TAT was 51.7 minutes and the pre-intervention theatre utilisation percentage was 86%. After a PDSA cycle using the interventions described above, we reduced the average TAT to 42.1 minutes, an 18.4% decrease. Figure 2 shows a run chart visualising these results. While the reduction did not meet our 25% target, it remains a significant one. Unfortunately, reduced TAT did not translate into significant improvement in theatre utilisation, on the day cancellations, or minutes overrun, all of which remained at the median of the pre-intervention period. However, improvements in these metrics were impeded by factors out of our control (e.g., surgical complications causing delays). These “unpreventable” delays had particularly significant impacts on our results when they occurred due to the intervention period being conducted over only one PDSA cycle (owing to the COVID-19 pandemic halting elective procedures). Conclusion: Our ward based interventions have shown they can reduce turnaround times in vascular surgery. Less idle theatre time and improved theatre utilisation will be imperative in reducing the backlog of surgeries the COVID pandemic has created. While this QIP was unable to translate reduced TAT to beneficial secondary effects, such as improved theatre utilisation, we hypothesise that with a larger sample size, reduced turnaround times will improve these long term, as there will be more opportunity for the interventions to have their effect without being obstructed by unpreventable delays. Therefore, we believe these interventions should be considered for further exploration on a larger scale to ascertain their true value. This will begin with the resumption of our second PDSA cycle, once surgeries resume [Formula presented] [Formula presented]

Implementation of an Asynchronous Econsult Service Between Primary Care Provider and Specialist

Background: Our health system serves a vast rural population that creates care gaps for pediatric specialty services. Ask-A-Doc is a formalized “curbside consult” e-Consult service between PCP and specialist. It uses asynchronous messaging to ask a question, and have it answered and documented in the EHR within the requested timeframe. We describe the impact Ask-ADoc has had on delivery of pediatric specialty care. Methods: We analyzed specialty enrollment, volume of consults, number of inperson clinic referrals saved by Ask-A-Doc, average turn-around time, and referring provider satisfaction. In-person referrals saved was determined by how many Ask-A-Doc questions did not incur an in-person evaluation within 60 days of Ask-A-Doc encounter. We also analyzed utilization of Ask-A-Doc prior to and after April 2020, when the COVID pandemic began to impact our clinics. Results: Twelve pediatric specialty services have adopted Ask-A-Doc since March 2018. The number of specialty services using Ask-A-Doc increased from 7 at the end of 2018 to 12 at the end of 2020. Volume of Ask-A-Doc consults increased from 50 in 2018, to 508 in 2019, to 1396 in 2020 (figure 1). Of the total pediatric specialty outpatient referrals, an average of 15% are Ask-A-Doc consults. Services with higher rates of Ask-A-Doc utilization per total referrals placed are Infectious disease (67%), Nephrology (36%), and Hematology/Oncology (35%). Average turn-around time for specialist to answer the Ask-A-Doc question is 9.6 hours. Ask-A-Doc saved a total of 33 in-person referrals in 2018, 354 in 2019, and 1013 in 2020 (figure 1). Approximately 70% of Ask-A-Doc consults did not require subsequent in-person visits which opened new slots in the pediatric specialists' schedules. Referring physicians were very pleased with Ask-ADoc consults rating an average of 4.9 stars out of 5 (n=362). Eight services had been started on Ask-A-Doc prior to April 2019. We used these 8 services to analyze Ask-A-Doc volumes 1 year prior to and 1 year after the start of the pandemic (figure 2). There was a significant increase in average Ask-A-Doc consults per month from pre to post-pandemic years (64.8 to 106.7, p=0.0002). During this same time, average days to be seen for inclinic consultations significantly decreased by 14.5 days, from 57.2 to 42.7 (p=0.003) for these services. Conclusion: Ask-A-Doc e-Consult service provided considerable value to pediatric specialties. Ask-a-Doc 1) provided timely specialty care (average turnaround time of 9.6 hours);2) avoided face to face visits that were unnecessary, opening up over 1,000 new patient slots;and 3) improved access to care, allowing sicker patients to be seen sooner. Referring providers found the service to be extremely helpful. Participation as well as use of Ask-a-Doc continues to grow in pediatrics. Ask-a-Doc has brought us one step closer to “right care, right setting, right time”.