External Program Research Articles

Clinic-based evaluation of the dual Xpert CT/NG assay on the GeneXpert System for screening for extragenital chlamydial and gonococcal infections amongst men who have sex with men

BackgroundChlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections have increased globally. Asymptomatic infections represent a significant risk of long-term complications. Men who have sex with men (MSM) are disproportionally affected, underscoring the need to offer screening programmes to this population. CT/NG Point of Care Testing (POCT) constitutes a strategic tool to improve the continuum of STI care, however extensive real-life evaluations amongst at risk populations are lacking. The aim of this study is to estimate the GeneXpert CT/NG assay performance and usability for CT and NG at genital and extragenital sites for screening amongst MSM.MethodsThis study was a multi-site sexual health clinic-based evaluation (Italy, Malta and Peru) with consecutive enrolment. A first void urine sample (divided in two aliquots), two oropharyngeal and two anorectal swabs were collected for each study participant. One specimen set (one for each anatomical site) was tested with the dual index test (Cepheid) at the clinics by the healthcare staff, the other set with FDA/CE approved Nucleic Acid Amplification Tests (NAATs) at the laboratory. Clinical sites and reference laboratories participated in an internal and external quality control programme. Sensitivity, specificity, positive and negative likelihood ratios, positive and negative predictive values for each anatomical site were estimated using a meta-analytic approach.ResultsOne thousand seven hundred two MSM were recruited across all clinical sites for a total of 5049 biological specimens. NG and CT were respectively detected in 274 and 287 of samples. Overall, the NG POCT sensitivity and specificity was 91.43% and 99.75% in urine (LR + 372.80, LR- 0.09), 89.68% and 99.55% in rectal specimens (LR + 197.30, LR- 0.10) and 75.87% and 98.77% at the pharynx respectively (LR + 61.94, LR- 0.24). The CT component of the POCT sensitivity was 84.82% and specificity 99.63% in urine (LR + 228.68, LR- 0.15), 78.07% and 99.19% respectively on rectal site (LR + 96.23, LR-0.22), 67.79% and 99.88% respectively at pharyngeal site (LR + 554.89, LR- 0.32). 95.95% of MSM reported to be willing to wait for POCT results and no provider reported difficulties in terms of performance or interpretation of the results of the Xpert CT/NG.ConclusionRapid turnaround time, ease of use and high acceptability make the Xpert CT/NG testing system a strategic tool for increasing testing frequency, reaching those not yet tested and offering the possibility of immediate treatment if needed. The assay showed good negative likelihood ratios and confirms its use to rule out CT/NG infections. Sensitivity varied across sites and pathogens. Periodic staff training at the testing sites should be mandatory.

Remote support of an external quality assessment program in 10 laboratories in Bhutan, Uganda, and Malawi: Pathologists Overseas experience between 2009 and 2017.

This article describes Pathologists Overseas (PO) experience supporting external quality assessment (EQA) programs in 10 clinical laboratories across 3 countries between 2009 and 2017. Laboratories were enrolled in the condensed chemical pathology EQA program provided by the Royal College of Pathologists of Australasia Quality Assurance Program. Participants were given an initial 2- to 4-day in-person training, followed by 1 year of active feedback on performance via emails or phone calls by a PO volunteer. There were 2 performance metrics: percentage of reported results as a measure of compliance and percentage of acceptable reported results as a measure of accuracy. Laboratories demonstrated high compliance with result reporting, with medians of 69.9%, 71.7%, and 81.3% before, during, and after feedback, respectively. Concomitant medians for the percentage of acceptable reported results were 41.2%, 57.3%, and 53.5%, respectively. Six laboratories had low performance in terms of accuracy at baseline (<60%). Active feedback improved the percentage of acceptable reported results for these lower-performing laboratories. External quality assessment programs can be successfully adopted long term by laboratories in low-resource settings. Active feedback requires significant time and effort but could be especially beneficial for laboratories with poor baseline performance.

Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study.

The harmonization status of most tumor markers (TMs) is unknown. We report a feasibility study performed to determine whether external quality assessment (EQA) programs can be used to obtain insights into the current harmonization status of the tumor markers α-fetoprotein (AFP), prostate specific antigen (PSA), carcinoembryonic antigen (CEA), cancer antigen (CA)125, CA15-3 and CA19-9. EQA sample results provided by 6 EQA providers (INSTAND [Germany], Korean Association of External Quality Assessment Service [KEQAS, South Korea], National Center for Clinical Laboratories [NCCL, China], United Kingdom National External Quality Assessment Service [UK NEQAS, United Kingdom], Stichting Kwaliteitsbewaking Medische Laboratoriumdiagnostiek [SKML, the Netherlands], and the Royal College of Pathologists of Australasia Quality Assurance Programs [RCPAQAP, Australia]) between 2020 and 2021 were used. The consensus means, calculated from the measurement procedures present in all EQA programs (Abbott Alinity, Beckman Coulter DxI, Roche Cobas, and Siemens Atellica), was used as reference values. Per measurement procedure, the relative difference between consensus mean for each EQA sample and the mean of all patient-pool-based EQA samples were calculated and compared to minimum, desirable, and optimal allowable bias criteria based on biological variation. Between 19040 (CA15-3) and 25398 (PSA) individual results and 56 (PSA) to 76 (AFP) unique EQA samples were included in the final analysis. The mean differences with the consensus mean of patient-pool-based EQA samples for all measurement procedures were within the optimum bias criterion for AFP, the desirable bias for PSA, and the minimum bias criterion for CEA. However, CEA results <8 µg/L exceeded the minimum bias criterion. For CA125, CA15-3, and CA19-9, the harmonization status was outside the minimum bias criterion, with systematic differences identified. This study provides relevant information about the current harmonization status of 6 tumor markers. A pilot harmonization investigation for CEA, CA125, CA15-3, and CA19-9 would be desirable.

Ten years of an external quality program control in clinical microbiology: a statistical analysis of the results

AbstractExternal quality assessment data of clinical microbiology obtained over ten years by the Colombian company PROASECAL in laboratories of seven countries in Central and South America are analyzed. The objective is to describe the quality of clinical microbiology results of the participants in the study period (2010–2021). This analysis includes the results of genus and species identification and proper reporting of both Gram staining and susceptibility testing. Data from 195 laboratories, which processed 31 bacteria, were analyzed. In this study, 32 % of laboratories were classified as good because they successfully determined the genus and species, 36 % fair, 12 % poor, and 20 % critical, to which recommendations for improvement were sent as part of the reports. In the analysis conducted for concordance between Genus, Morphology, and Gram, the success rates obtained are between 83 % and 94 %. Regarding antibiograms, the performance observed in Gram-positive bacteria ranges from 57 to 98 %, while in Gram-negative bacteria, it is between 82 and 98 %. The descriptive tools to explain external quality assessment results in clinical microbiology are limited to the percentage of successes in each item to be reported. For the analysis of the population data set, in this article, we propose to use contingency tables (including estimates of sensitivity, specificity, and predictive values) and equality of proportions tests as techniques that facilitate the interpretation of the data. On the other hand, the statistical analysis described here can be used as an analysis methodology for similar studies.

Моделирование особенностей работы дистанционной защиты резервных трансформаторов собственных нужд энергоблоков атомной станции при самозапуске мощных двигательных нагрузок

In the article, using computer modeling, an analysis of the operation of distance protection of backup transformers is carried out, providing alternative power supply for the own needs of a nuclear power plant through a backup busbar when disconnected from the power system. During the transition from the main network to the backup network, there is a short period of power off to the sections. At the same time, the powerful motor loads of the sections that have received power begin to operate in the freewheel braking mode. Then the reserve is automatically switched on, which can occur at a more or less favorable moment. At an unfavorable moment, self-starting may be electrically more severe than a short circuit on the busbar. When combining a new network from a backup auxiliary transformer and an autonomous circuit of running machines, transient processes of electromagnetic interaction between machines switching to generator mode and the new network arise. There are some optimal favorable moments for merging networks when it is advisable to carry out self-starting. Due to the complexity of the mathematical description with a high order system of equations and a large number of interaction objects, it is advisable to study these processes using computer modeling. A practical question, which is answered by the calculations and computer modeling, concerns the value of the distance protection setting for the backup transformer for auxiliary needs. Using the developed structural simulation model in MatLab, a series of experiments was carried out on the run-down and self-starting of auxiliary sections with their given composition and load. The range of self-start time corresponded to the operation of automatic switching on of the reserve sections by distance protection. Calculations and modeling show that the adopted setting can be adjusted, ensuring protection of a larger length of the busbar with possible options for connecting auxiliary sections to it. The model is supplemented with an add-on in the form of an external program for detailed processing and visualization of data obtained from oscilloscopes of the MatLab structural model.

A phased strengthening of laboratory capacity in the Eastern Mediterranean Region during the COVID-19 pandemic.

The Eastern Mediterranean Region (EMR) faces ongoing challenges in its public health system due to limited resources, logistical issues, and political disruptions. The COVID-19 pandemic accelerated the need for stronger laboratory capacities to handle the increased demand for testing. In a phased response, EMR countries utilized the National Influenza Centers to rapidly establish and scale molecular testing for SARS-CoV-2, the causative agent of COVID-19. The expansion of capacity included strong collaborations between public health bodies and private and academic sectors to decentralize and expand testing to the subnational level. To ensure that the quality of testing was not impacted by rapid expansion, national and subnational laboratories were enrolled in external quality assurance programs for the duration of the response. Implementation of genomic surveillance was prioritized for variant tracking, leading to the establishment of regional sequencing reference laboratories and the distribution of MinION sequencing platforms to complex emergency countries who previously had limited experience with pathogen sequencing. Challenges included a lack of technical expertise, including in implementing novel diagnostic assays and sequencing, a lack of bioinformatics expertise in the region, and significant logistical and procurement challenges. The collaborative approach, coordinated through the WHO Eastern Mediterranean Regional Office, enabled all 22 countries to achieve SARS-CoV-2 diagnostic capabilities, highlighting the pivotal role of laboratories in global health security.

CaRE@ELLICSR: Effects of a clinically integrated, group-based, multidimensional cancer rehabilitation program.

Although oncology clinical practice guidelines recognize the need and benefits of exercise, the implementation of these services into cancer care delivery remains limited. We developed and evaluated the impact of a clinically integrated 8-week exercise and education program (CaRE@ELLICSR). We conducted a mixed methods, prospective cohort study to examine the effects of the program. Each week, participants attended a 1-h exercise class, followed by a 1.5-h education session. Questionnaires, 6-min walk tests (6MWT), and grip strength were completed at baseline (T0), 8 weeks (T1), and 20 weeks (T2). Semi-structured interviews were conducted with a sub-sample of participants about their experience with the program. Between September 2017 and February 2020, 277 patients enrolled in the program and 210 consented to participate in the research study. The mean age of participants was 55 years. Participants were mostly female (78%), white/Caucasian (55%) and half had breast cancer (50%). Participants experienced statistical and clinically meaninful improvements from T0 to T1 in disability, 6MWT, grip strength, physical activity, and several cancer-related symptoms. These outcomes were maintained 3 months after program completion (T2). Qualitative interviews supported these findings and three themes emerged from the interviews: (1) empowerment and control, (2) supervision and internal program support, and (3) external program support. This study demonstrates the impact of overcoming common organizational barriers to deliver exercise and rehabilitation as part of routine care. CaRE@ELLICSR demonstrated clinically meaningful improvements in patient-reported and functional outcomes and was considered beneficial and important by participants for their recovery and wellbeing.

Re-testing as a method of implementing external quality assessment program for COVID-19 real time PCR testing in Uganda.

Significant milestones have been made in the development of COVID19 diagnostics Technologies. Government of the republic of Uganda and the line Ministry of Health mandated Uganda Virus Research Institute to ensure quality of COVID19 diagnostics. Re-testing was one of the methods initiated by the UVRI to implement External Quality assessment of COVID19 molecular diagnostics. participating laboratories were required by UVRI to submit their already tested and archived nasopharyngeal samples and corresponding meta data. These were then re-tested at UVRI using the WHO Berlin protocol, the UVRI results were compared to those of the primary testing laboratories in order to ascertain performance agreement for the qualitative & quantitative results obtained. Ms Excel window 12 and GraphPad prism ver 15 was used in the analysis. Bar graphs, pie charts and line graphs were used to compare performance agreement between the reference Laboratory and primary testing Laboratories. Eleven (11) Ministry of Health/Uganda Virus Research Institute COVID19 accredited laboratories participated in the re-testing of quality control samples. 5/11 (45%) of the primary testing laboratories had 100% performance agreement with that of the National Reference Laboratory for the final test result. Even where there was concordance in the final test outcome (negative or positive) between UVRI and primary testing laboratories, there were still differences in CT values. The differences in the Cycle Threshold (CT) values were insignificant except for Tenna & Pharma Laboratory and the UVRI(p = 0.0296). The difference in the CT values were not skewed to either the National reference Laboratory(UVRI) or the primary testing laboratory but varied from one laboratory to another. In the remaining 6/11 (55%) laboratories where there were discrepancies in the aggregate test results, only samples initially tested and reported as positive by the primary laboratories were tested and found to be false positives by the UVRI COVID19 National Reference Laboratory. False positives were detected from public, private not for profit and private testing laboratories in almost equal proportion. There is need for standardization of molecular testing platforms in Uganda. There is also urgent need to improve on the Laboratory quality management systems of the molecular testing laboratories in order to minimize such discrepancies.

Quality Improvement Project to Standardize a Nurse Extern Program Across A Multistate Health System.

A multistate health system updated the nurse extern policy and skills list. Because of a knowledge gap and inconsistent practices, there was a need for a standardized program. A literature review, Internet search, and focus group informed the creation of the nurse extern program. The program, which includes a toolkit and role-specific pathways, aligns training practices across the health system.

Experience of external quality assessment scheme in hematology at Shantabaa Medical College, Amreli: An observational 5-year study

Background: The complete blood count is one of the most frequently requested tests in laboratory medicine. External quality assessment programs are intended to allow medical laboratories to compare the closeness of their output (test results) to their peers through statistical evaluation against a target value. External quality assessment schemes (EQAS) are accepted around the world as an invaluable tool by laboratories to assess the performance of their testing systems. Results are objectively compared to other laboratories, using the same methodologies for every parameter. Aims and Objectives: To review EQAS results from time to time in an effort to improve the performance of the laboratory. Materials and Methods: An observational study is done for hematology EQAS test results at the hematology laboratory, Shantabaa Medical College and General Hospital, Amreli, from June 2017 to August 2021 (5 years). One ethylenediaminetetraacetic acid whole blood sample for blood cell counts and two slides for peripheral smear examination and reticulocyte count are received quarterly in a year from all India Institute of Medical Science, New Delhi. The test results of all Indices of blood samples and peripheral smears for cell morphology and reticulocyte count were analyzed and documented. Results: Satisfactory results were obtained in all the cycles except once. The discrepancy was observed in RBC, MCH, and reticulocyte count. Root cause analysis was performed and necessary action was taken. Conclusion: This participation in EQAS over the past 5 years has helped us significantly to improve our laboratory services in terms of performance evaluation, patient care, and overall quality of laboratory practices.

Improving drinking water quality through proficiency testing-the impact of testing method and accreditation status on Escherichia coli detection by Canadian environmental testing laboratories.

Water quality testing is crucial for protecting public health, especially considering the number of boil water advisories annually issued across Canada that impact daily life for residents in affected areas. To overcome these challenges, the development of drinking water safety plans and accessibility to regular testing using simple, rapid, and accurate materials are necessary. However, the significance of monitoring the accuracy of environmental microbiology testing laboratories cannot be overlooked. Participation in external quality assessment programs, such as those that include proficiency testing (PT), is a necessary risk management resource that ensures the effectiveness of these testing processes. Proficiency Testing Canada (PTC), in collaboration with the Canadian Microbiological Proficiency Testing (CMPT) program based at the University of British Columbia, have implemented a drinking-water microbiology PT program since 1996. Both PTC and CMPT are ISO/IEC 17043:2010-accredited EQA providers. The drinking water program provided PT challenges to subscribing testing laboratories twice per year. Each challenge consisted of four samples containing unknown concentrations of Escherichia coli (E. coli) and Enterobacter spp. Results from participants were assessed for accuracy based on the method of testing. This cross-sectional study evaluated 150 rural and metropolitan testing sites across Canada between 2016 and 2022. Multivariable logistic regression analysis was conducted to examine the impact of different testing methods and laboratory accreditation status on the proficiency scores. This approach enabled us to assess the association between multiple independent variables and the likelihood of achieving specific proficiency scores, providing insights into how testing methods and accreditation status affect overall performance. After adjusting for rural residence, testing time, and survey year, the membrane filtration method was positively associated with the likelihood of scoring satisfactory results compared to the enzyme-substrate method (OR: 1.75; CI: 1.37-2.24), as well as accreditation status (OR: 1.47; CI: 1.16-1.85). The potential for improvement in environmental laboratory testing performance through the implementation of regulated PT in drinking water safety plans is proposed, along with the need for reliable testing methods applicable to rapid drinking water microbiology testing.

Quality Governance Design Good University Governance In The Education Sector: a Literature Review of Concepts Performance Models and Audit Practices From a Risk Management Perspective

This research outlines the research methodology used in a literature review on the Quality Governance Design of Good University Governance (GUG) in the education sector, with a focus on the GUG concept, performance models, and audit practices from a risk management perspective. The GUG concept is a vital framework for enhancing the quality and effectiveness of higher education institutions such as universities, with principles of transparency, accountability, participation, and ethics as its core components. This concept also emphasizes the importance of innovative ideas and the leadership capabilities of university leaders in facing global changes. Furthermore, this research discusses relevant performance models, including the Balanced Scorecard (BSC) and Key Performance Indicators (KPIs), which assist universities in measuring their performance through financial, customer, internal process, and growth and learning perspectives. These models help universities become more focused, transparent, and accountable in their governance. Audit practices, both internal and external, are also essential elements in higher education risk management. Internal audits help identify operational, financial, and reputational risks, while external audits ensure compliance with accreditation standards. Audit practices help universities manage risks efficiently and strengthen transparency and accountability in educational governance. This research also illustrates the integration of the GUG concept in higher education, including internal and external quality assurance, program accreditation, and sustainable quality improvement. Previous research indicates that many factors influence the quality of university governance, including government influence, leadership, and quality assurance priorities.

External quality assessment program for human papillomaviruses DNA testing in Thailand

BackgroundSince 2020, the National Health Security Office includes the human papillomavirus DNA testing for cervical cancer screening in the government's healthcare schemes. HPV DNA testing has become primary screening in many laboratories in Thailand. External quality assurance scheme is crucial for assessment of laboratory performance. ObjectivesThe aim of this study was to develop a pilot program using LBC samples for the EQA of molecular methods and to review the methods used by participants to detect the presence of high risk HPV genotypes. Study designFour pilot distributions were shipped between December 2021 and May 2023, six months apart of two panels, each consisting of five different specimens. ResultsAll participants achieved 100 % accuracy in correctly identifying the presence or absence of high-risk genotypes in all 5 EQA samples. The most used HPV DNA test for detecting the presence of high-risk HPV DNA was the two specific high-risk genotypes and 12 other high-risk HPV genotypes. There was an observed increase in the use of assays that could detect 14 HPV HR genotypes. It suggests expanding testing methods to include a broader range of high-risk HPV genotypes, which could improve the comprehensiveness of the testing. ConclusionsThe HPV DNA testing scheme provides a standardised, homogeneous and characterised clinical specimen. These results indicate that the LBC samples are suitable for utilisation in an EQA scheme. EQA of HPV molecular screening programme is essential for monitoring the performance of laboratory networks.

Geant4 implementation of axial channeling radiation in classical description

The progress in developing a C++ module for simulation of channeling radiation in Geant4 using classical description is being discussed. The created module is built into Geant4 as a discrete set of physical processes, which allows combining it with other physical processes of Geant4. The direct simulation of CR in Geant4 allows describing devices such as, e. g. positron sources, without using external programs for CR calculation. In previous version, the module was capable to simulate only planar channeling radiation. In this paper, the implementation of axial channeling radiation in Geant4 is shown. The module now simulates both planar and axial channeling radiation from ultra-relativistic electrons channeled in Si, C, Ge and W single crystals. The simulation results are compared with available experimental data.

Effect of the technical variability of counting chambers upon the interpretation of sperm concentration results

Research questionDoes the choice of sperm-counting chamber affect the proportion of samples generating results with an erroneous interpretation? DesignLaboratories in an external quality assurance programme were sent 141 semen samples over a 12-year period and asked to return the sperm concentration and whether or not the result was abnormal. Only those using 5th edition of the World Health Organization manual (WHO5) interpretation criteria were included. Submissions from specialist fertility laboratories were used to calculate assigned values for each sample. Laboratory50 values determined the sperm concentration at which the laboratories reported a majority transition from abnormal to normal interpretations, i.e. the tipping point, which should coincide with the lower reference limit. ResultsThe median and range of bias from the assigned values of each sample were determined for the Makler (–3.3%; –88.6% to +332.8%), haemocytometer (10.6%; –93.3% to +645.5%), Kova (+65.3%; –71.7% to +581.8%) and Vetriplast (+72.4%; –100.0% to +709.1) chambers. Laboratory50 values for the Makler (17.3 × 106/ml), haemocytometer (13.6 × 106/ml), Kova (10.0 × 106/ml) and Vetriplast chambers (8.8 × 106/ml) reflected the under- and overestimation of the chambers and confirmed a shift in the adjusted lower reference limit then used. The proportion of laboratories reporting erroneous interpretations of the four chambers for oligozoospermic samples were 10.9%, 15.1.%, 40.1% and 44.0%, respectively, and rose as the adjusted lower reference limit decreased. ConclusionsThe between-laboratory and within-sample variation for all the chambers was high and remains a concern. The main impact of an increasing bias of the chambers was a lowering of the laboratory50 tipping point, resulting in an under-reporting of abnormal semen samples.

From Becoming to Being: how STEM teachers develop leadership identities

ABSTRACT The development of STEM teacher leadership identity empowers K–12 teachers to make changes to improve teaching and learning. Identity development might not be productively supported in all school settings, however. Hence, external professional development programs should offer opportunities to supplement this identity development. We construct and propose a Can’t-to-Becoming-to-Being model to describe STEM teacher leadership identity development as a progression of stages from weak to strong identity. Using interview data over two points in time with 127 STEM teacher leaders, we illustrate four stages of development: Can’t, Can, Should, and Being. We also elucidate the conditions that teachers identify as catalyzing or inhibiting identity development, with attention to the impacts of teacher leaders’ participation in professional development programs. Our findings indicate that the Can’t-to-Becoming-to-Being model is useful for describing how teachers may develop STEM teacher leadership identity and may provide researchers a tool for exploring this process. Professional developers might consider the catalysts (and inhibitors) we identify as a means of strengthening teacher leadership identities in the design and implementation of professional learning. External spaces separate from school communities may offer teacher leaders opportunities to try out provisional selves and provide additional motivation to propel participants to Being teacher leaders.

‘Can you put down your mission and plug into mine?’ How place-based initiatives leverage collaborations with academic institutions to enhance their ABCD and CBR potential

&#x0D; &#x0D; &#x0D; Place-Based Initiatives (PBIs) involve efforts to mobilise and coordinate local resources, services and expertise across multiple organisations and sectors in order to strengthen the social, structural, physical and economic conditions of historically disinvested neighbourhoods. While promising, these initiatives have had some documented challenges, and some are leveraging partnerships with academic institutions to address those challenges. In this article, we explore perspectives of leaders and staff from three PBI organisations in Charlotte, NC to better understand the benefits of PBI-academic partnerships and the conditions under which they are most effective. Thematic analysis of 23 semi-structured interviews revealed that PBIs leverage partnerships with academic institutions to accomplish two key goals. First, these partnerships stimulate asset- based community development (ABCD) by connecting community organisations and neighbourhood residents with academic resources and by strengthening PBI service delivery. Second, some partnerships give rise to community-based research efforts that help address external accountability challenges and inform PBI programming. The findings also illuminated several pitfalls in academic-PBI partnerships, sometimes rooted in conflicting priorities and approaches of academic researchers and non-profit practitioners. Finally, insights delineate key recommendations for improving PBI-academic collaborations, including countering academic exploitation by plugging into PBIs’ mission and respecting PBI expertise.&#x0D; &#x0D; &#x0D;

Ensuring quality in 17OHP mass spectrometry measurement: an international study assessing isomeric steroid interference.

Interference from isomeric steroids is a potential cause of disparity between mass spectrometry-based 17-hydroxyprogesterone (17OHP) results. We aimed to assess the proficiency of mass spectrometry laboratories to report 17OHP in the presence of known isomeric steroids. A series of five samples were prepared using a previously demonstrated commutable approach. These samples included a control (spiked to 15.0 nmol/L 17OHP) and four challenge samples further enriched with equimolar concentrations of 17OHP isomers (11α-hydroxyprogesterone, 11β-hydroxyprogesterone, 16α-hydroxyprogesterone or 21-hydroxyprogesterone). These samples were distributed to 38 participating laboratories that reported serum 17OHP results using mass spectrometry in two external quality assurance programs. The result for each challenge sample was compared to the control sample submitted by each participant. Twenty-six laboratories (68 % of distribution) across three continents returned results. Twenty-five laboratories used liquid chromatography-tandem mass spectrometry (LC-MS/MS), and one used gas chromatography-tandem mass spectrometry to measure 17OHP. The all-method median of the control sample was 14.3 nmol/L, ranging from 12.4 to 17.6 nmol/L. One laboratory had results that approached the lower limit of tolerance (minus 17.7 % of the control sample), suggesting the isomeric steroid caused an irregular result. Most participating laboratories demonstrated their ability to reliably measure 17OHP in the presence of the four clinically relevant isomeric steroids. The performance of the 12 (32 %) laboratories that did not engage in this activity remains unclear. We recommend that all laboratories offering LC-MS/MS analysis of 17OHP in serum, plasma, or dried bloodspots determine that the isomeric steroids are appropriately separated.

External quality control program in infectious diseases screening at laboratories and blood banks in Latin America: an analysis of the past 5 years.

To evaluate the screening of blood samples for infectious disease markers at laboratories and blood banks in Latin America per the findings of an External Quality Assessment Program (EQAP). This qualitative analysis used data from the EQAP coordinated by the Fundação Pro Sangue Hemocentro de São Paulo with the support of the Pan American Health Organization to assess the performance of blood screening for infectious diseases from 2014 to 2018 in Latin America. Each participating laboratory or blood bank received an identical blind panel with 24 blood samples with variable reactivity for all the screening parameters. Panels were processed at each participating facility and results were returned to the Fundação Pro Sangue Hemocentro de São Paulo for individual and joint analyses. Two types of discrepant results were potential failures: false positive results (FPRs) and false nonreactive results (FNRRs). A total of 23 136 samples were evaluated. Global rates of FPR, FNRR, and concordant results were 0.3%, 1.0% and 98.7%, respectively. Seven FNRRs were found for HBsAg (1.0%), 12 for syphilis (2.6%), and 21 for Chagas disease (2.9%). No FNRRs were found for the HIV, HCV, and HTLV viruses. The average accuracy of all the laboratories and blood banks participating in the EQAP during the study period was 99.5% (standard deviation, 0.5%). The findings of this qualitative analysis are positive for blood safety in Latin America, with an average accuracy of 99.5% among the participating laboratories and blood banks. This report reflects an important improvement in blood bank serological screening EQAP-PAHO report since the 2003.

Heart Risk Assessment Analysis and Prediction using Various Machine Learning Algorithms

In today’s world artificial intelligence plays a major and crucial role in technological development. Machine Learning is an extension of Artificial Intelligence through which accuracy and prediction rate of model is made without the assist of any external programs. The evolution andopportunity of ML is expandingeach and every day. Many organizations have made ML as one the important assets of their company.Supervised, Unsupervised and Reinforcement learning and ensemble learning’s are different types of ML through which datasets accuracy can be measured. Our current study focuses mainly on Utilizationof ML in medical industry. Based on current report of World Health Organization the most predominant cause of death is detecting most on cardiovascular disease. Myocardial infarction also said as heart attack is caused when flood flow to the heart muscles has been suddenly blocked. It should be considered as the severe one detection should be done in early stage so life can be prevented. This article presentsaexamination on machine learning for projection of heart disease. Distinct expert algorithms have been used for the evaluation and model deployment purpose