Laboratory Performance Research Articles

Assessment of hematology laboratory performance in the total testing process using quality indicators and sigma metrics in the northwest of Ethiopia: A cross-sectional study.

Assuring laboratory quality by minimizing the magnitude of errors is essential. Therefore, this study aimed to assess hematology laboratory performance in the total testing process using quality indicators and sigma metrics. A cross-sectional study was conducted from April to June 2022. The study included a total of 13,546 samples. Data on included variables were collected using a checklist. Descriptive statistics were used to present the overall distribution of errors. Binary logistic regression models were applied. Furthermore, using a Sigma scale, the percentage of errors was converted to defects per million opportunities to assess laboratory performance. Finally, the defect per million opportunities was converted to a sigma value using a sigma calculator. Of the 13,546 samples and corresponding requests, the overall error rate was 123,296/474,234 (26%): 93,412/47,234 (19.7%) pre-analytical, 2364/474,234 (0.5%) analytical, and 27,520/474,234 (5.8%) post-analytical. Of the overall errors, 93,412/123,296 (75.8%), 2364/123,296 (1.9%), and 27,520/123,296 (22.3%) were pre-analytical, analytical, and post-analytical errors, respectively. The overall sigma value of the laboratory was 2.2. The sigma values of the pre-analytical, analytical, and post-analytical phases were 2.4, 4.1, and 3.1, respectively. The sample from the inpatient department and collected without adherence to the standard operating procedures (SOPs) had a significantly higher (p < 0.05) rejection rate as compared to the outpatient department and collected with adherence to SOPs, respectively. In addition, an association between prolonged turnaround times and manual recording, inpatient departments, and morning work shifts was observed. The current study found that the overall performance of the laboratory was very poor (less than three sigma). Therefore, the hospital leadership should change the manual system of ordering tests and release of results to a computerized system and give need-based training for all professionals involved in hematology laboratory sample collection and processing.

Effect of the Pătârlagele Diatomite on Seed Germination and Growth of Sunflower Plants

Sunflower (Helianthus annuus L.) is the third largest agricultural crop in Romania, after corn and wheat. In 2021 Romania cultivated 1112 thousand ha of sunflower with a production of 2818 thousand tons, ranking first among EU countries both in terms of production and cultivated area. Diatomite, also called diatomaceous earth or kieselguhr, is a natural sedimentary rock with a high content of silicon dioxide and clay minerals, widely used in agriculture for its insecticidal and fungicidal properties, stimulating the process of seed germination and plant growth, as well as the ability to absorb and retain nutrients and water. The paper presents preliminary results regarding the effect of diatomite from Pătârlagele deposit (Buzău County) on seed germination and growth of young sunflower plants in laboratory conditions and on seeds production in the field at three sowing dates as well. A semi-early hybrid P64LE99 was used in experiments. Our data showed that the Pătârlagele diatomite improves sunflower seed performances both in laboratory and field conditions. In the laboratory, an increase in seed germination and stimulation of plant growth and development were observed in the diatomite treated samples compared to the untreated control. In the field under climatic and soil conditions of the Moara Domnească area (Southern Romania), the diatomite treated samples performed better than the control, both in terms of plant growth and development as well as production elements, in three sowing dates, middle and late April and early May. The highest yields were when sowing was in the first week of May for both variants.

Prerequisites for the Innovation Performance of Artificial Intelligence Laboratory: A Fuzzy-Set Qualitative Comparative Analysis

Prerequisites for the Innovation Performance of Artificial Intelligence Laboratory: A Fuzzy-Set Qualitative Comparative Analysis

Analysis of Imprecision for Internal Quality Control of Newborn Screening by Tandem Mass Spectrometry in China, 2015 - 2021.

This study aimed to assess the performance of the newborn screening laboratories in China through retrospective analysis of the coefficient of variation (CV) of the internal quality control (IQC) data in the national tandem mass spectrometry screening for inherited metabolic disorders in newborns. From 2015 to 2021, the IQC data of amino acid and acylcarnitine test were collected twice each year. CVmonthly in-control was calculated by excluding outliers for the current month and its discrete distribution and changes in trend were comprehensively evaluated for both normal and high concentration levels. The proportion of laboratories meeting both 1/3 and 1/4 quality criteria of the total error allowable (TEa), based on the CVmonthly in-control for each testing item, was calculated. The analysis of CVmonthly in-control for the two concentration levels for the amino acids and acylcarnitine parameters showed that CVmonthly in-control for the normal concentration levels were more discrete before 2018, while CVmonthly in-control for the high concentration levels were less discrete than the normal concentration levels, but there were relatively more outliers. More than 80% of laboratories were able to meet the 1/3 TEa standard for each test at the high concentration level, while the pass rate for the 1/4 TEa standard was significantly lower than 80% (except for C2). According to the current status of testing in China, it is recommended to use 1/3TEa as the imprecision level standard; for laboratories with relatively high precision, the 1/4TEa standard can be used.

Continual Improvement in Clinical Bacteriology Laboratory with Quality Indicators: A Retrospective Observational Study

Introduction: Healthcare management is undergoing significant changes with the evolution of new and re-emerging infections. A clinical microbiologist plays an important role in giving an accurate and timely report to the clinicians. Quality Indicators (QIs) act as a measure of the quality of services offered by the laboratory and are tools to monitor and evaluate the laboratory’s performance throughout the Total Testing Process (TTP). Aim: To measure the performance of the clinical bacteriology laboratory using QIs. Materials and Methods: A retrospective study was conducted in the Department of Microbiology at Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Maharashtra, India. The study evaluated QIs from the records of 94,624 samples received in the bacteriology section of the clinical Microbiology laboratory between January 2018 and March 2021. Data analysis was conducted over a six-month period from December 2021 to May 2022. In 2018, one QI was identified for each phase, with an additional QI added in each phase to the pre-existing QI in 2019. In 2020, a QI was added in the preanalytical phase only. In 2021, the acceptable limit for one preanalytical QI was reduced from 2% to 1%. Data analysis was performed using an Excel sheet. Results: Data from records of 94,624 clinical bacteriology samples collected over 39 months were analyzed retrospectively. The preanalytical indicators included the number of samples rejected (135, 0.14%) and the number of requisition forms with three patient identifiers (59,645, 93.95%). Analytical phase QIs consisted of the average External Quality Assurance Scheme (EQAS) performance score (97.44% from January 2018 to March 2021) and outliers in the Internal Quality Control (IQC) (25 from January 2019 till March 2021). Failures in the IQC were not assessed in 2018. Postanalytical phase QIs included Turnaround Time (TAT) (average of 2.55 days for aerobic growth) and reporting time for critical alerts, which was within 24 hours of alert finding (100% for smear and culture-positive results). Conclusion: Regular monitoring of QIs helps to identify potential errors. This laboratory chose to analyse and monitor its processes using practically feasible QIs. It was found that the laboratory consistently maintained its performance throughout the study period.

Laboratory Characteristics, Performance Evaluation, and Agency Cost Analysis of Cold-Recycled Asphalt Mixtures

Laboratory Characteristics, Performance Evaluation, and Agency Cost Analysis of Cold-Recycled Asphalt Mixtures

Verification Study of the Detection Method for Unauthorized Genetically Modified Papaya by Combining DNA Polymerases and Real-time PCR Instruments

In the Japanese official detection method for unauthorized genetically modified (GM) papayas, one of two types of real-time PCR reagents with DNA polymerase (TaqMan Gene Master Mix [TaqMan Gene] or FastGene QPCR Probe Mastermix w/ROX [FastGene]) is primarily used for measurement. In 2022, we conducted a laboratory performance study on the unauthorized GM papaya line PRSV-YK, and the results revealed that high threshold cycle (Cq) values for the PRSV-YK detection test were obtained using TaqMan Gene with the 7500 Fast & 7500 Real-Time PCR System (ABI7500) and QuantStudio 12K Flex (QS12K), indicating the possibility of false negatives. The possibility of similar problems with all unauthorized GM papaya lines detection tests needs to be evaluated. In this study, we performed detection tests on unauthorized GM papaya lines (PRSV-YK, PRSV-SC, and PRSV-HN), the cauliflower mosaic virus 35S promotor (CaM), and a papaya positive control (Chy), and examined how the limits of detection (LOD) for each test are affected by two types of DNA polymerases (TaqMan Gene and FastGene) and three types of real-time PCR instruments (ABI7500, QS12K, and LightCycler 480 Instrument II [LC480]). In the PRSV-YK and PRSV-SC detection tests using ABI7500 and QS12K, measurement with TaqMan Gene showed a higher LOD than FastGene. In this case, an exponential amplification curve was confirmed on the amplification plot; however, the amplification curve did not cross the ΔRn threshold line and the correct Cq value was not obtained with a threshold line=0.2. The other tests (PRSV-HN, CaM, and Chy with ABI7500 and QS12K, and all detection tests with LC480) showed no important differences in the LOD for each test using either DNA polymerase. Therefore, when performing PRSV-YK and PRSV-SC detection tests with the ABI7500 or QS12K, FastGene should be used to avoid false negatives for foods containing GM papaya lines PRSV-YK and PRSV-SC at low mixing levels.

Smart Pipette: Elevating Laboratory Performance with Tactile Authenticity and Real-Time Feedback.

Mastering the correct use of laboratory equipment is a fundamental skill for undergraduate science students involved in laboratory-based training. However, hands-on laboratory time is often limited, and remote students may struggle as their absence from the physical lab limits their skill development. An air-displacement micropipette was selected for our initial investigation, as accuracy and correct technique are essential in generating reliable assay data. Handling small liquid volumes demands hand dexterity and practice to achieve proficiency. This research assesses the importance of tactile authenticity during training by faithfully replicating the micropipette's key physical and operational characteristics. We developed a custom haptic training approach called 'Smart Pipette' which promotes accurate operation and enhances laboratory dexterity training. A comparative user study with 34 participants evaluated the effectiveness of the Smart Pipette custom haptic device against training with off-the-shelf hardware, specifically the Quest VR hand controller, which was chosen because it is held mid-air similar to a laboratory micropipette. Both training conditions are integrated with the same self-paced virtual simulation displayed on a computer screen, offering clear video instructions and realtime guidance. Results demonstrated that participants trained with the Smart Pipette custom haptic exhibited increased accuracy and precision while making fewer errors than those trained with off-the-shelf hardware. The Smart Pipette and the Quest VR controller had no significant differences in cognitive load and system usability scores. Tactile authentic interaction devices address challenges faced by online learners, while their applicability extends to traditional classrooms, where real-time feedback significantly enhances overall training performance outcomes.

Does early adversity predict executive functioning difficulties among undergraduates? Dissociations among self-report, performance, and EEG measures.

The present research aimed to determine whether self-reports of early adversity predicted individual differences in self-reported and laboratory-measured executive functioning in college-aged samples. Two studies with young adult samples (n = 231 and n = 61) measured endorsement of adverse childhood experiences (ACEs), self-reported executive functioning difficulties on the Behavior Rating Inventory of Executive Function (BRIEF), and self-report measures of depression and emotion regulation. The second sample also completed laboratory performance tasks of working memory, inhibitory control, and selective attention while electroencephalogram (EEG) was recorded. In both samples, greater self-reported ACEs predicted greater reports of executive functioning difficulties on the BRIEF (rs = 0.378 and 0.322), relationships of medium effect size that remained significant when controlling for depression and emotion regulation variables. In the second sample, despite robust EEG/event-related potential (ERP) task findings in the group as a whole, neither lab task performance nor EEG/ERP measures were reliably correlated with individual differences in ACEs. We consider multiple alternative explanations for why early adversity predicted self-reported executive functioning difficulties but not lab task performance or neural measures in the same sample. These findings may reflect a propensity for negative self-evaluation among those with early adverse experiences, leading to inflated estimates of their own executive function problems. Alternatively, the findings may indicate that the lab tasks are insufficient in tapping aspects of executive functions that are relevant outside the lab context. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Laboratory Performance Study of the Japanese Official Method to Detect Genetically Modified Papaya Line PRSV-YK

Since the establishment of procedures for the safety assessment of food products that use recombinant DNA technology, the manufacture, import, and sale of genetically modified (GM) foods that have not undergone safety assessment are prohibited under the Food Sanitation Act. Therefore, a performance study to confirm the GM food testing operations of each laboratory is very important to ensure the reliability of the GM food monitoring system. In 2022, GM papaya line PRSV-YK-which has not yet been authorized in Japan-was selected for testing, and a papaya paste and a DNA solution were used as the test samples. With these samples, a laboratory performance study of the DNA extraction and real-time PCR operations was conducted. This confirmed that the 18 participating laboratories were generally performing the DNA extraction and real-time PCR operations correctly. However, some laboratories using certain DNA amplification reagent with some real-time PCR instruments were not able to determine the PRSV-YK detection test. This suggests that the PRSV-YK detection test may not be able to correctly detect samples containing GM papaya when performed with these combinations of instruments and reagent. In order to ensure the reliability of the PRSV-YK detection test, it is necessary to examine in detail how the combination of DNA polymerase reagents and real-time PCR instruments affects the detection limit, and to implement an appropriate solution.

External Quality Assurance Helps Improve Infrastructure for Testing Breast Biomarkers Across a Lower- and Middle-Income Country: Our Experience With Breast Biomarker Testing in the National Cancer Grid External Quality Assurance System in India.

Biomarkers in breast cancer need strict monitoring given their role in patient management. To study the impact that regular participation in the National Cancer Grid (NCG) external quality assurance (EQA) system has on concordance rates for biomarkers in breast carcinoma. Tissue microarray (TMA) containing breast carcinomas was circulated to participating laboratories that performed immunohistochemistry for breast biomarkers. The returned TMAs were then assessed for test concordance. A total of 105 laboratories participated in the estrogen receptor (ER) and progesterone receptor (PR) EQA system cycles, and 99 centers participated in the human epidermal growth factor 2 (HER2) EQA system. In the ER EQA in the first cycle only 1 laboratory had a 100% concordance, which improved to 59 of 77 (76.6%) and 85 of 97 (85.9%) in the fourth and fifth cycles, respectively. In the PR EQA the 100% pass rate jumped from zero to 52 of 76 (68.4%) in the fourth cycle and 86 of 97 (88.6%) in the last cycle. For HER2 EQA, the 100% pass rates were seen in 7 of 23 laboratories (30.4%) in the first cycle, 49 of 78 laboratories (62.8%) in the fourth cycle, and 48 of 94 laboratories (51.1%) in fifth cycle of EQA. Centers who participated in the NCG EQA system for a longer period often changed testing methodology, with consequent improvement in their laboratory concordance rates. An increasing trend for the use of automated platforms and of the US Food and Drug Administration-approved antibody for HER2 testing was observed. Our experience demonstrates that laboratory performances improve with participation in an EQA system even in less perfect settings, and this drives the placement of more proficient practices across the country.

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.

Impact of the COVID-19 Pandemic on Laboratory Services

The positive impact of the coronavirus disease 2019 (COVID-19) pandemic is that hospital laboratory services are excellent when other services are declining. Aside from molecular biology laboratory (polymerase chain reaction, PCR) services for COVID-19 diagnostics, public demand has dramatically increased. It is a retrospective descriptive study that uses data on the total number and types of results of laboratory examination orders that have been verified from the laboratory information system of a hospital from 2018 to 2022. Data analysis is presented in the frequency of the number and type of results of laboratory examination orders and differences in requests for laboratory services before and during the pandemic since the government established it on March 8, 2020. The total number of laboratory requests between January 2018 and December 2022 was 1,943,539 services. The highest increase in laboratory examination services was in molecular biology (98.4%). As the need for community services increases for the PCR severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) examination, which is used in addition to diagnosing confirmed COVID-19 patients, it is also necessary for the community to conduct tracing if a family member has a COVID infection or travel requirements and follow-up for hospital employee exit tests who contracted COVID-19. In conclusion, the COVID-19 pandemic has positively impacted laboratory performance. There have been changes and an increase in the number and types of laboratory examination services and personal performance and management in laboratories.

Evaluation of Low- and Intermediate-Temperature Cracking Performance of Fiber-Reinforced Asphalt Mixtures

This study was conducted to assess the impact of aramid fiber reinforcement on the fatigue and thermal cracking performance of asphalt mixtures at intermediate and low temperatures, respectively. The study also involved evaluating the experimental consistency and ranking fiber-reinforced asphalt mixtures (FRAMs) based on their performance. One aggregate (diabase stone), one binder type (PG 76-22), and two combinations of aramid fibers, added at different dosages, were used to produce three FRAMs. These fibers included polyolefin/aramid (PFA) fibers at 0.05% dosage by mix weight and Sasobit-coated aramid (SCA) fibers at 0.01% and 0.02% dosages. An unreinforced (control) mix was also produced without any reinforcement. All mixtures were produced at a batch plant by keeping their binder content constant (at 5.5%). The manufacturer recommended dry and wet mixing times were used for better fiber distribution and represent actual mixing conditions. The laboratory performance of plant-produced FRAMs was assessed to characterize the low- and intermediate-temperature cracking performance. The indirect tension asphalt cracking test, semi-circular bend test, three-point bending beam tests, and uniaxial fatigue tests were performed at intermediate temperature; the disk shape compact tension test and thermal stress restrained specimen test tests were performed at low temperature. Fibers were successful at improving the fatigue cracking of asphalt mixtures based on intermediate-temperature testing results. In addition, fiber reinforcement, regardless of dosage and combination, showed improvements in low-temperature (thermal) cracking performance. Furthermore, based on ranking analysis for selected performance indicators from each experiment, the SCA 0.02% reinforced mix on average showed the highest cracking resistance.

Measuring an efficiency aggregation of medical diagnostic laboratories: A window NDEA approach

The efficiency evaluation of laboratories, as one of the most significant areas of healthcare, plays a key role in the quality of laboratory management. The classic data envelopment analysis (DEA) models have overlooked intermediate products, internal interactions and dealt with analyzing the network within the “Black Box” mode. This results in the loss of important information, and at times, a considerable modification occurs in efficiency results. This article evaluated the efficiency of some selected medical diagnostic laboratories in the city of Tehran according to the network data envelopment analysis (NDEA) approach. We considered a four-stage structure with additional inputs and undesirable outputs. We obtain the labs’ performance over a period of 6 months in 2022 by the NDEA window analysis process. To this aim, a four-stage structure model of three chief medical diagnostic laboratory processes as the pre-test, the test, and the post-test is designed. We considered sustainability criteria (economic, social, and environmental) to appraise the performance of laboratories, thus helping to improve the social, economic, and environmental problems of medical diagnostic laboratories. By using the Delphi viewpoint, the criteria for efficiency evaluation are achieved. The results showed that laboratory unit No. 22 maintained the highest average overall efficiency, since the high accuracy of this unit’s laboratory results had led to many physicians recommending this unit to their patients. We found that the only laboratory unit No. 20 had a decreasing trend, as it is located in an area that abounds with administrative and educational centers. At the beginning of the exam period, then the summer holidays, and finally the wave of end-of-summer trips, a decline occurs in efficiency over the period of six months.

Perbandingan Turnaround Time Antara Verifikasi Manual dan Verifikasi Otomatis terhadap Hasil Pemeriksaan Profil Lipid di Laboratorium Klinik Pramita Cabang Pajajaran Kota Bandung

Turnaround Time (TAT) for laboratory services is an indicator of the quality of laboratory services to meet customer satisfaction and as a benchmark for laboratory performance. Laboratory results are very important to be delivered in the shortest possible time for the rapid diagnosis and management of patients. One of the factors that causes the length of TAT in the reporting process at the analytical stage is the verification process of inspection results which is still carried out manually by ATLM personnel. Implementing automatic verification of examination results is one way to overcome the long waiting time (TAT) for laboratory services. The aim of this research is to determinate the TAT of manual verification and automatic verification of lipid profile examination results, and testing the difference in TAT between manual verification and automatic verification of lipid profile examination results at the analytical stage at the Pramita clinical laboratory, Pajajaran branch in Bandung city. The method used in this research is to use descriptive comparative method with a quantitative approach. Based on the research that has been done, the average ± standard deviation TAT for manual verification of the results of lipid profile examination was 112.44 ± 46.02 minutes, while the automatic verification TAT was 68.03 ± 28.07 minutes. The results of the independent sample t-test between TAT manual verification and automatic verification of the lipid profile examination results with a significance value of Sig.(2-tailed) 0.000 &lt;0.05. The conclusion of this research is that TAT verification of lipid profile examination results at the analytical stage decreased after automatic verification was implemented. There is a significant difference in Turnaround Time between manual verification and automatic verification of the results of lipid profile examinations at the analytical stage at the Pramita Clinical Laboratory, Pajajaran branch in Bandung city.&#x0D; &#x0D;

#242 : Correlation of Sperm DNA Fragmentation with Laboratory Performance in Good and Poor Prognosis Patient Groups at Morula IVF Jakarta

BACKGROUND AND AIMS: Infertility in males contributes to about 40% of cases of infertility in couples, either as the main factor or along with female factors. Fragmentation of sperm DNA is known as a cause of male infertility, which impacts the failure of couples to undergo assisted reproductive programs, such as embryo development and recurrent miscarriage. However, some literature studies are still debating this. This research aims to determine the correlation between sperm DNA fragmentation and IVF laboratory performance. METHODS: Infertile couples undergoing an in vitro fertilization program at Morula IVF Jakarta in 2022 are the samples for this study. We divided them into two groups: good prognosis (maternal age [Formula: see text]38 years, AFC[Formula: see text]7; AMH[Formula: see text]1.1) and poor prognosis (maternal age &gt; 38 years, AFC &lt;7, AMH&lt;1.1). Sperm DNA fragmentation was examined using the sperm chromatin dispersion (SCD) assay. Correlation statistical analysis using the Spearman test (p-value &lt;0.05). RESULTS: Based on receiver operating characteristic (ROC) curve analysis, it was found that the sperm DNA fragmentation rate &gt;14.9% had a significant negative correlation with IVF laboratory performance, particularly in the fifth-day embryo quality and blastocyst rate in the good prognosis group. Whereas in the group with poor prognosis, all laboratory performance parameters were not affected by high sperm DNA fragmentation values. CONCLUSIONS: Sperm DNA fragmentation rate &gt; 14.9% correlated with fifth-day embryo quality and a lower blastocyst rate in the good prognosis group.

Enhancing particle size characterization performance through proficiency testing program: result and insights from inter-laboratory comparison

The proficiency testing (PT) for particle size characterization by inter-laboratory comparison was organized by the dimensional metrology department of the National Institute of Metrology Thailand (NIMT). This program aims to enhance and to expand the efficiency and capability of testing laboratories in the field of particle size characterization using various techniques, including atomic force microscope (AFM), transmission electron microscope (TEM), scanning electron microscope (SEM), and dynamic light scattering (DLS). The measurement range covers nanometer to micrometer scale. These instruments are importance for research and development especially to nanotechnology related industries. The PT program was conducted in 2022 where five artifacts were used: monodispersed gold nanoparticle (diameter 20 nm), monodispersed polystyrene particle (diameter 100 nm, 500 nm, and 1500 nm) and monodispersed silica oxide particle (diameter 100 nm). The monodispersed polystyrene particles, diameter 100 nm and 1500 nm are certified reference materials (CRMs). These two artefacts were used as the reference to evaluate accuracy of participant laboratories. The other 3 artefacts are reference material under development. Hence, the assigned values were calculated from consensus among all participants. To evaluate the performance of participant laboratories, En values and z-scores were calculated for each artefact and each measuring technique. The assessment of participant performance through performance scores allows the participant to determine how accurate and how appropriate the measurement results and measurement uncertainties evaluation are. From the results, unsatisfied results can be categorized into three scenarios. First, the measurement uncertainties were not appropriately evaluated. Secondly, measurands obtained from all measuring techniques are not the same. Lastly, the magnification used in microscopy techniques plays a crucial role to resolution and accuracy of size determination.

Impact of Achieving Hospital Accreditation on Assuring Quality in Clinical Laboratories: Experience of an Oncology Hospital in low middle income country

Abstract Introduction/Objective Shefaa Al-Orman Oncology Hospital (SOH) is a leading cancer care facility in Upper Egypt dedicated to providing specialized treatment to cancer patients for free. The General Authority of Healthcare Accreditation and Regulation (GAHAR, accredited from the International Society for Quality in Health Care) is the regulatory and accreditation body that ensures that healthcare facilities in Egypt comply with the highest standards of quality and safety. Here, we aim to assess the impact of GAHAR accreditation process on: Streamlining workflow, contributing to staff professional development and knowledge, increasing loyalty, and creating a more productive and fair work environment. - Optimizing turnaround time (TAT). - Compliance with the minimum retesting interval (MRI) guidelines. - Healthcare providers' satisfaction with the laboratory services. - Patients’ satisfaction. Finally, we aim to emphasize the role of building an integrated lab quality management system that addresses different lab processes/procedures as a basis for la accreditation. Methods/Case Report laboratory personnel, healthcare providers and patients responses were measured using questionnaire method to assess the impact of accreditation on various aspects of laboratory services. Comparative lab statistics were collected from laboratory information system. Results (if a Case Study enter NA) As shown by questionnaires, 95% of lab staff reported positive impact on streamlining of workflow, 100% reported in professional development and improvement in knowledge, and increased loyalty and created a fair work environment (80% in each). Healthcare providers satisfaction reached 88%, and patient satisfaction reached 93%. TAT optimization increased from 84.1% to 98.1%. Prior to accreditation, the lab had an effective internal quality control program. GAHAR mandated enrollment in External Quality Assurance Services (EQAS) to ensure reliable results. In addition, GAHAR mandated a policy/procedure to enforce minimum retesting interval. Application of this policy led to better utilization. Finally, pre and post-analytical processes were streamlined, leading to improved overall laboratory performance. Conclusion Achieving GAHAR accreditation had positive impact on laboratory workflow, staff professional development, compliance with guidelines, ensure reliable laboratory results, and overall laboratory performance. Laboratories should consider accreditation and implementing quality assurance measures to enhance the delivery of high-quality laboratory services and patient safety.

Rapid Clinical Mutation Screening for AML Using the Genexus Platform

Introduction: The promise of “precision medicine” is using therapeutic agents matched to the inferred biology of a patient's particular disease. In acute myeloid leukemia this approach demands fast and accurate assessment of the mutation and cytogenetic landscape of each AML case. The NCI Myeloid Malignancies Molecular Analysis for Therapy Choice program (“myeloMATCH”) is a precision medicine clinical trial initiative across the NCI National Clinical Trials Network for patients with newly diagnosed acute myeloid leukemia and myelodysplasia. In myeloMATCH the goal is to have cytogenetic and mutation assays performed within 72 hours of central lab receipt, allowing for a rapid assignment of the appropriate clinical trial from the myeloMATCH trial portfolio. Here we report analytic performance of rapid genomic profiling laboratory developed test based on the Thermo Fisher Genexus Oncomine Myeloid Panel GXv2 (NCI Myeloid Assay version 2, or “NMAv2”) which performs rapid sequencing of SNVs, indels, and gene fusions, capturing 1,661 hotspot variants (45 genes) and 779 fusions (35 genes) with a turnaround time of &amp;lt;48 hours from specimen receipt to clinical reporting. Methods: The validation testing was performed by two harmonized laboratories; NCI Molecular Characterization laboratory (MoCha) and Fred Hutch Molecular Oncology (MO). We conducted analytical validation and harmonization experiments for CLIA/CAP and FDA regulatory compliant use in this trial across both accredited clinical laboratories with harmonized workflows. Samples are extracted with AllPrep per manufacture protocol. Library preparation with the Oncomine Myeloid Assay GX v2 and the sequencing reactions are performed on the automated Ion Torrent Genexus System. Sequencing data generated by NMAv2 was analyzed using Ion Torrent Genexus system version 6.6.2.1. The default manufacturer workflow has been customized using a custom designed hotspot browser extensible data (BED) file, sequence variant baseline (SVB) file, fusion target file, torrent variant caller (TVC) version 5.18 and Oncomine extended filter chain (OEFC) version 5.16. In NMA, the default 2.5%, and 3% VAFs were set up for calling hotspot and non-hotspots SNV/indel, 1% VAF for FLT3-ITD and 100 read counts for all fusion, except 2000 read counts for KMT2A-PTD. Results: The validation set included 148 unique samples and comprised of 76 AML/MDS patients (49 peripheral blood, 27 bone marrow aspirate), 51 healthy donor blood, 6 healthy donor bone marrow, 7 cancer cell lines, 5 normal HapMap cell lines, and 3 contrived materials encompassing 364 known mutations (143 SNPs, 132 indels, 27 fusions). 180 runs were completed for this validation (106 at FH and 74 at MoCha) with 89.44% success rate in passing run level metrics. Results of the validation testing are detailed in Table 1. High reproducibility in detecting all reportable variants was observed, with overall &amp;gt;99% mean positive percentage agreement (PPA) across both labs (Figure 1). The limit of detection for each variant type was &amp;lt;0.06% for hotspot SNVs, 0.07% for non-hotspot SNVs, 0.51% for hotspot indels, ~1% for non-hotspot indels, 0.23% for FLT3-ITDs, and 50 minimum reads at 0.1% tumor content for fusions. 99.39% concordance was observed by testing 86 blinded validation sample set with analytically validated orthogonal assays. Conclusions: The NMAv2 has high specificity, sensitivity, accuracy and reproducibility (inter-lab and intra-lab) with sequencing results generated within 48 hours of assay initiation. As such, the assay is well suited for use to rapidly categorize the genomic alteration of AML to support clinical care in patients with active myeloid malignancies, including those patients potentially enrolled in the myeloMATCH program. Table 1: Results of validation experiment results for the NMAv2 Figure 1: Harmonization results for the NMAv2 between MoCha and MO labs, Right Panel = Indel; Left panel = SNV