External Quality Assurance Program Research Articles

Abstract PO4-25-12: Improving HER2 Low Scoring Consistency and Accuracy: Insights from the Australian HER2 Low Concordance Study for Invasive Breast Cancer

Abstract Introduction: The Destiny Breast-04 Trial (DB-04) demonstrated the survival benefits of Trastuzumab Deruxtecan (T-DXd) for women with metastatic HER2 Low breast cancer, characterised by 1+ or 2+ IHC staining without amplification. While the DB-04 study applied the standard 2018 ASCO CAP IHC scoring criteria, in clinical practice, distinguishing HER2 0 from 1+ cancers is challenging as i) HER2 Low is not a biologically distinct subset of breast cancer, ii) there are no reference standards for HER2 Low cancers, iii) second-tier test, like ISH, are not applicable, and iv) there are no known controls for cases that have 0 or 1+ HER2 scores. For two decades this distinction was clinically immaterial, but now differentiating between HER2 0 and 1+ has now become crucial for determining patient eligibility for T-DXd therapy. Concerns regarding the subjectivity, imprecision and poor concordance between pathologists in scoring IHC in HER2 Low cancers raise the potential for misalignments in patient treatment. Ensuring pathologists have access to focused training for interpreting IHC scores at the low end of the HER2 expression spectrum, quality assurance procedures and reference sets are essential steps to help pathologists assess HER2 Low breast cancers more accurately and consistently. Design: In this study, a group of 9 experienced breast pathologists compiled a deidentified set of 60 breast cancer core biopsies from 3 laboratories. The Ventana 4B5 HER2 assay had been used for evaluation and the local laboratories had scored the samples as HER2 0 or 1+. We teased out the ASCO CAP 2018 criteria and used our collective expertise of reporting HER2 IHC for many years to specify HER2 Low-focused scoring conventions, including some potential pitfalls. Subsequently, using these conventions, each pathologist reviewed digitized whole slide images of the IHC slides and scored HER2 expression for each case. At a consensus workshop, the cases were jointly reviewed to establish consensus scores and determine the percentage of HER2-expressing tumor cells in each case. We then evaluated the concordance between individual pathologists' HER2 scores and the consensus opinion and ascertained reasons for discordance. Results: Among the cases discussed during the consensus conference, 43 out of 60 (71.7%) were classified as HER2 Low, with 40 cases designated as 1+ and three as 2+ (known to be not amplified). The consensus score matched the majority opinion of the pathologists' independent scores in 93.3% (56 out of 60) of the cases. Utilizing the HER2 Low-focused IHC scoring conventions, 7 out of 17 (41.2%) cases locally reported as HER2 0 were reclassified as HER2 Low. Conversely, among the 32 cases with local scores of 1+, 7 (21.8%) were reclassified as ultralow or null. When compared to the consensus score, individual pathologists' scores demonstrated concordance levels ranging from 71.7% to 91.7%, with a mean concordance rate of 81.3%. Cases with less than 20% of tumor cells expressing HER2 had lower inter observer concordance. This reference set of cases with expert consensus HER2 scores obtained through our study will be invaluable for peer training and the development of external quality assurance programs for HER2 Low cancers, including the quality assurance program of the Royal College of Pathologists of Australasia. Conclusion: This study revealed that when breast pathologists were provided explicit instructions on scoring pitfalls and HER2 Low-focused scoring conventions, their HER2 scores were concordant with expert consensus scores in 71.7% to 91.7% of cases. Discordant cases primarily involved cases with less than 20% of tumor cells expressing HER2. Utilising such an approach, peer training and quality assurance procedures will improve the accuracy and consistency of HER2 IHC assessment for better patient care. Reassessing older cases using HER2 Low focused scoring conventions may result in revisions of HER2 scores from HER2 Low to zero, and vice versa. Table. Individual pathologists' concordance with the consensus HER2 IHC score Applying our HER2 Low-focused IHC scoring conventions in a set of 60 core biopsies of invasive breast cancer with low or 0 HER2 protein expression. Citation Format: Gelareh Farshid, Beena Kumar, Nirmala Pathmanathan, Hema Mahajan, Ben Dessauvagie, Jane Armes, Cameron Snell, Amardeep Gilhotra. Improving HER2 Low Scoring Consistency and Accuracy: Insights from the Australian HER2 Low Concordance Study for Invasive Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-25-12.

Analysis of immunogenetics interlaboratory comparisons' success rates. External quality assurance system of the Spanish Society for Immunology GECLID-SEI.

For many years, transplantation outcomes were uncertain and not hopeful, until histocompatibility testing spread. Common criteria for histocompatibility assays and communications' improvement allowed an efficient organ sharing system. The possibility of organ exchanges is closely linked to the importance of interlaboratory comparisons for histocompatibility and immunogenetics methods. The external proficiency testing (EPT) systems are the most powerful quality assurance tools. They help achieve harmonization of analyses, set a standard of performance, and a common interpretation. The external quality assurance program for diagnostic immunology laboratories (Garantía Externa de Calidad para Laboratorios de Inmunología Diagnóstica, GECLID) program nowadays runs 13 external quality assurance (EQA) histocompatibility and immunogenetics schemes, with the first of them from 2011 to date: serological and molecular: low- and high-resolution human leukocyte antigen (HLA), human platelet antigen (HPA), and killer inhibitory receptor (KIR) typing(HLA-B*27, HLA-B*57:01, and coeliac disease-related HLA), cell-dependent cytotoxicity (CDC) and flow cytometry (FC) crossmatches, anti-HLA and anti-HPA antibodies, and chimerism. A total of 85 laboratories participated in this subprogram in the last 12years reporting over 1.69M results: 1.46M for anti-HLA and anti-HPA antibodies, 203.810 molecular typing data (HLA, HPA, and KIR genes), 2.372 for chimerism analyses, and 39.352 for crossmatches. Based on the European Federation for Immunogenetics (EFI) standards for EPT providers, the mean success rates ranged from 99.2% for molecular typing schemes and antibodies and 94.8% for chimerism, was 96.7% regarding crossmatches, and was 98.9% in serological typing. In 2022, 61.3% of the participating laboratories successfully passed every HLA EQA scheme, although 87.9% annual reports were satisfactory. Most penalties were due to nomenclature errors or misreporting of the risk associated to HLA and disease. This EQA confirms the reliability of HLA and immunogenetics assays in routine care. There is little heterogeneity of results of different assays used by participating laboratories, even when in-house assays are used. Reliability of test results is reasonably granted.

External quality assurance program for diagnostic complement laboratories: evaluation of the results of the past seven years.

The complement external quality assurance (EQA) program was first organized in 2010 by a group of researchers working in diagnostic complement laboratories. Starting in 2016, INSTAND e.V., a German, non-profit interdisciplinary scientific medical society dedicated to providing expert EQA programs for medical laboratories, started organizing the EQAs for complement diagnostic laboratories together with the same group of experienced scientists and doctors who also work as EQA experts. The aim of the current work is to provide descriptive analysis of the past seven years' complement EQA results and evaluate timeline changes in proficiency testing. Each year, in March and October, blinded samples (normal, pathological) were sent to the participating diagnostic laboratories, where complement parameters were evaluated exactly as in daily routine samples. Since no reference method/target values exist for these parameters, and participants used different units for measurement, the reported results were compared to the stable mean (Algorithm A) of the participants using the same method/measurement units. A reported result was qualified as "passed" if it fell into the 30-50% evaluation/target range around the mean of reported results (depending on the given parameter). While the number of participating laboratories has increased in the past years (from around 120 to 347), the number of complement laboratories providing multiple determinations remained mostly unchanged (around 30 worldwide). C3, C4, C1-inhibitor antigen and activity determinations provided the best proficiency results, with >90% passing quotas in the past years, independent of the applied method. Determination of the functional activity of the three activation pathways was good in general, but results showed large variance, especially with the pathological samples. Complement factor C1q and regulators FH and FI are determined by only a few laboratories, with variable outcomes (in general in the 85-90% pass range). Activation products sC5b-9 and Bb were determined in 30 and 10 laboratories, respectively, with typical passing quotas in the 70-90% range, without a clear tendency over the past years. With these accumulated data from the past seven years, it is now possible to assess sample-, method-, and evaluation related aspects tofurtherimprove proficiency testing and protocolize diagnostic complement determinations.

Sharing reference intervals and monitoring patients across laboratories- findings from a likely commutable external quality assurance program.

Laboratory results are increasingly interpreted against common reference intervals (CRIs), published clinical decision limits, or previous results for the same patient performed at different laboratories. However, there are no established systems to determine whether current analytical performance justifies these interpretations. We analysed data from a likely commutable external quality assurance program (EQA) to assess these interpretations. The use of CRIs was assessed by evaluating instrument group medians against minimum specifications for bias. The use of clinical decision limits was assessed using specifications from professional bodies, and the monitoring of patients by testing at different laboratories was assessed by comparing all-laboratory imprecision to within-subject biological variation. Five of the 18 analytes with Australasian CRIs did not meet specification for all instrument groups. Among these, calcium and magnesium failed for one instrument group out of seven, while bicarbonate, chloride, and lipase failed for two instrument groups. Of the 18 analytes reviewed currently without CRIs in Australasia, 10 candidates were identified. Among analytes with clinical decision limits, i.e.lipids, glucose, and vitamin D, only triglycerides met both bias and imprecision specifications, while vitamin D met the imprecision specification. Monitoring patients by testing at different laboratories was supported for 15 of the 46 (33 %) analyte-method principles groups that met minimum imprecision specifications. Analysis of data from commutable EQA programs can provide a mechanism for monitoring whether analyticalperformance justifies the interpretations made incontemporary laboratory practice. EQA providers shouldestablish systems for routinely providing this information to the laboratory community.

Lessons learned from an external quality assurance program in applying CLSI interpretive criteria for reporting piperacillin/tazobactam susceptibility

We evaluated the performance of automated susceptibility testing for piperacillin/tazobactam (PTZ) MICs against the reference microbroth dilution method. The Minimum Inhibitory Concentration of PTZ against a clinical isolate of Klebsiella pneumoniae was determined by reference broth micro-dilution method in 10 replicates which yielded a modal MIC of 16 mg/L (susceptible dose-dependent). Out of 434 laboratories who obtained MIC of 16 mg/L correctly, only 301 interpreted the result as susceptible dose dependent as per 2022 revised CLSI criteria. Educating the clinical laboratories in validating AST methods as per latest CLSI guidelines is of utmost important.

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.

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.

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.

Compliance to specifications in an external quality assurance program: did new biological variation estimates of the European Federation of Laboratory Medicine (EFLM) affect the quality of laboratory results?

The results of external quality assurance schemes are evaluated against specifications generally based on biological variation (BV) data. This study was carried out to determine whether new BV values affected the level of compliance to specifications. Our secondary objective was to identify the conditions that would be compromised as a result of poor analytical performance in disease associated markers. This study was based on the results of the SEQCML External Quality Assurance scheme for the 2015-2022 period. Deviation of the individual result from the target value was estimated. Additionally, we calculated the percentage of results that met the pre-established specification. In 97 of the 133 analytes, the level of compliance was maintained in 80-90 % of the results obtained in the two study periods. In 23 analytes, the level of compliance ranged from 51 to 79 % in the two study periods. In ALT, AST and sodium, the level of compliance was≤50 % of the results obtained in the first study period, with sodium being the only analyte that maintained this poor level of compliance in the second study period. The level of compliance to specifications remained independent from the specification used (SEQCML or EFLM) for the majority of the analytes. The results for sodium ion were below the target value, which may lead to misdiagnosis of hyponatremia. Non-compensated alkaline picrate methods overestimate creatinine, which may produce false information suggestive of kidney failure.

Monitoring the quality of SARS-CoV-2 virus detection in molecular diagnostic laboratories in the Eastern Mediterranean Region during the COVID-19 pandemic.

The COVID-19 pandemic placed unprecedented stress on laboratories in the Eastern Mediterranean Region. Building on existing capacity for influenza diagnostics, countries introduced COVID-19 diagnostic support to ~100% regional coverage. A key challenge during the expansion was maintaining quality testing in laboratories, ensuring that correct results were shared with medical facilities. WHO organized two rounds of independently monitored severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) external quality assurance programs (EQAP). The Public Health Laboratory (PHL) division of WHO supplied external quality assurance (EQA) panels, from the Royal College of Pathologists of Australasia Quality Assurance Programme (RCPAQAP) Australia to laboratories not enrolled in recurring Global Influenza Surveillance and Response System (GISRS) quality assurance programs, in which national influenza centers routinely participate. Fifteen and 14 countries participated in PHL/EQAP for SARS-CoV-2 between 2020 and 2022. Concordance was consistent between rounds, reaching 96.4% and 89.9%. A separate assessment of GISRS/EQAP to national-level laboratories identified high levels of response and concordance for SARS-CoV-2 (100% response, 93% concordance), which was reduced for influenza (50% response rate, 80% concordance), reflecting the challenge of prioritizing pathogens during outbreaks. The proliferation of laboratories in response to COVID-19 was a success story from the pandemic. However, monitoring the quality of laboratories was challenging via existing EQAP. The addition of PHL/EQAP provided a mechanism to monitor performance of laboratories that were not designated as national influenza centers. While a high proportion of laboratories attained good results, continual emphasis on quality and enrollment in EQAP is key to ensuring sustainability of laboratory testing in future.

135 External quality assurance program for diagnostic complement laboratories: Evaluation of the past six year[StQuote]s results

135 External quality assurance program for diagnostic complement laboratories: Evaluation of the past six year[StQuote]s results

Miniaturization and Automation Protocol of a Urinary Organic Acid Liquid-Liquid Extraction Method on GC-MS.

The aim of this study was to improve the extraction method for urinary organic acids by miniaturizing and automating the process. Currently, manual extraction methods are commonly used, which can be time-consuming and lead to variations in test results. To address these issues, we reassessed and miniaturized the in-house extraction method, reducing the number of steps and the sample-to-solvent volumes required. The evaluated miniaturized method was translated into an automated extraction procedure on a MicroLab (ML) Star (Hamilton Technologies) liquid handler. This was then validated using samples obtained from the ERNDIM External Quality Assurance program. The organic acid extraction method was successfully miniaturized and automated using the Autosampler robot. The linear range for most of the thirteen standard analytes fell between 0 to 300 mg/L in spiked synthetic urine, with low (50 mg/L), medium (100 mg/L), and high (500 mg/L) levels. The correlation coefficient (r) for most analytes was >0.99, indicating a strong relationship between the measured values. Furthermore, the automated extraction method demonstrated acceptable precision, as most organic acids had coefficients of variation (CVs) below 20%. In conclusion, the automated extraction method provided comparable or even superior results compared to the current in-house method. It has the potential to reduce solvent volumes used during extraction, increase sample throughput, and minimize variability and random errors in routine diagnostic settings.

Total error in lymphocyte subpopulations by flow cytometry-based in state of the art using Spanish EQAS data.

Flow cytometry analyses of lymphocyte subpopulations (T, B, NK) are crucial for enhancing clinical algorithms and research workflows. Estimating the total error (TE) values for the percentage and absolute number of lymphocyte subpopulations using the state-of-the-art (SOTA) approach with real data from an external proficiency testing (EPT) scheme was performed. A comparison with previously published Biological Variability (BV)-based specifications was carried out. A total of 44,998 results from 86 laboratories over 10 years were analysed and divided into two five-year periods (2012-2016) and (2017-2021). Data come from the IC-1 Lymphocytes scheme of the Spanish External Quality Assurance System (EQAS) GECLID Program. This quantitative scheme includes percentages and absolute numbers of CD3+, CD3+CD4+, CD3+CD8+, CD19+, and CD3-CD56+CD16+ NK cells. The percentage of TE was calculated as: |reported value-robust mean|*100/robust mean for each laboratory and parameter. The cut-off for TE is set at 80 % best results of the laboratories. A significant reduction in the SOTA-based TE for all lymphocyte subpopulations in 2017-2021 was observed compared to 2012-2016. The SOTA-based TE fulfils the minimum BV-based TE for percentages of lymphocyte subpopulations. The parameter with the best analytical performance calculated with SOTA (2017-2021 period)-based TE was the percentage of CD3+ (TE=3.65 %). The values of SOTA-based specifications from external quality assurance program data are consistent and can be used to develop technical specifications. The technological improvement, quality commitment, standardization, and training, reduce TE. An update of TE every five years is therefore recommended. TE assessment in lymphocyte subsets is a helpful and reliable tool to improve laboratory performance and data-based decision-making trust.

Spurious Outlier in Cell Counter for Total White Blood Cell Count Parameter in Laboratory External Quality Assurance Program

Spurious Outlier in Cell Counter for Total White Blood Cell Count Parameter in Laboratory External Quality Assurance Program

Analytical variability and interpretation of results of a 3-category sperm motility assessment: 5 years’ of an Australian external quality assurance programme

Research questionHow do laboratories perform when assessing sperm motility with a 3-category system and interpreting results as per the fifth edition of the World Health Organization manual (WHO5), and will the use of a 4-category system as per the sixth edition of the WHO manual improve their performance? DesignEighty video recordings of sperm samples were sent to over 200 laboratories spanning a 5-year period for the assessment of progressive motility. The results were reviewed relative to the all-laboratory trimmed mean (ALTM) in terms of the minimum and maximum values reported, the coefficient of variation and the proportion of laboratories indicating an abnormal result. A further 20 video recordings were sent over 1 year, with 6–11 laboratories per distribution adjusting to reporting rapid progressive motility using the 4-category system. ResultsFor the 3-category system, the videos covered a mean assessed progressive motility range of 12.0–81.1%. The mean difference between the minimum and maximum values per sample was 50.3% and the coefficients of variation were negatively correlated with the ALTM (r = –0.87, P < 0.00001). Progressive motility abnormality reporting formed a sigmoid curve, and the inflection point (50% of laboratories identifying an abnormality) gave an ALTM value of 32.01%. Preliminary results for laboratories using the 4-category system showed no performance improvement but the number of laboratories was small. ConclusionsAnalytical variation can result in laboratories crossing the clinical cut-off of the lower reference limit for samples whose motility is close to the WHO5 lower reference limit, but is less important for samples with extreme values. The benefits of a 4-category motility system are yet to be shown.

Building clinical pharmacology laboratory capacity in low- and middle-income countries: Experience from Uganda.

Research and clinical use of clinical pharmacology laboratories are limited in low- and middle-income countries. We describe our experience in building and sustaining laboratory capacity for clinical pharmacology at the Infectious Diseases Institute, Kampala, Uganda. Existing laboratory infrastructure was repurposed, and new equipment was acquired. Laboratory personnel were hired and trained to optimise, validate, and develop in-house methods for testing antiretroviral, anti-tuberculosis and other drugs, including 10 high-performance liquid chromatography methods and four mass spectrometry methods. We reviewed all research collaborations and projects for which samples were assayed in the laboratory from January 2006 to November 2020. We assessed laboratory staff mentorship from collaborative relationships and the contribution of research projects towards human resource development, assay development, and equipment and maintenance costs. We further assessed the quality of testing and use of the laboratory for research and clinical care. Fourteen years post inception, the clinical pharmacology laboratory had contributed significantly to the overall research output at the institute by supporting 26 pharmacokinetic studies. The laboratory has actively participated in an international external quality assurance programme for the last four years. For clinical care, a therapeutic drug monitoring service is accessible to patients living with HIV at the Adult Infectious Diseases clinic in Kampala, Uganda. Driven primarily by research projects, clinical pharmacology laboratory capacity was successfully established in Uganda, resulting in sustained research output and clinical support. Strategies implemented in building capacity for this laboratory may guide similar processes in other low- and middle-income countries.

Method variation of cytomegalovirus IGM assays in EQA

Cytomegalovirus (CMV) is a common virus that infects people of all ages. Correctly diagnosing a primary CMV infection in pregnant women is critical to avoid congenital anomalies. CMV IgM specificity is poor in detecting primary infections due to vial reactivation or persistence following primary infection. Algorithms using CMV IgM and IgG avidity can be useful. We sought to review the performance of CMV IgM and IgG avidity assays in the RCPAQAP CMV External Quality Assurance (EQA) Program. Data sourced from an expected IgM positive consenting donor sample was assessed using RCPAQAP software. The same sample was included in four surveys over three years. Variation in the quantitative IgM data across methods was consistently noted (e.g., Roche vs Diasorin). There were also similar differences in the qualitative interpretations between the ‘negative’ and ‘positive’ groups (21 vs 92, respectively). While 120 sites reported for IgM, only 34 of these measured IgG avidity which more than 95% reported as ‘high’. In a clinical setting, access to both results may be of benefit. While the study was limited, further investigation of discrepancies between CMV methods when interpreting results should be considered. The inclusion of IgG avidity is recommended.

Introduction of a sickling test EQA program

The RCPAQAP introduced a Sickling Test External Quality Assurance (EQA) Program in 2022. The program is designed for screening and confirmatory methods for Haemoglobin S, and is suitable for solubility, reduced oxygen and ICT/kit-based methods. We sought to review the returned results from the first two surveys to determine any potential method differences.

What has been The Impact of Laboratory Accreditation in Saudi Arabia? A Cross-Sectional Survey of Laboratory Practitioners

Objectives: While laboratory accreditation has improved laboratory practices in several countries, its effectiveness in laboratories in Saudi Arabia remains unclear. This survey aims to assess the impact of laboratory accreditation on laboratory practices across the country. Materials and Methods: In this cross-sectional study, we surveyed laboratory practitioners (n = 207) across Saudi Arabia from September 21 to October 22 using an online questionnaire created over Monkey Survey. Practitioners were queried regarding their laboratory accreditation, practices, and the observed impact on patient laboratory testing. Data were analyzed using IBM Statistical Package for the Social Sciences (SPSS) software and potential associations were assessed using the Chi-square test. P &lt; 0.05 was considered statistically significant in all cases. Results: Laboratories with a higher number of accreditations were more likely to have documented standard operating procedures (SOPs) (P = 0.039) and more frequent reviews of laboratory policies and procedures (P = 0.002). Practitioners in our study were more likely to have noticed an overall improvement in patient laboratory testing if their institutes adhered to the components of the accreditation process, such as documented SOPs for testing (P = 0.017), availability of safety manuals (P &lt; 0.01), written policies of internal and external quality assurance programs (P = 0.007), regular meetings to maintain accreditations (P ≤ 0.001), and availability of a task force team to maintain the accreditation program (P ≤ 0.001). Conclusion: This survey suggests that accreditation has had an overall positive impact on laboratory practices and patient laboratory testing in Saudi Arabia.

Quality Assurance for Veterinary In-Clinic Laboratories.

Quality assurance and the implementation of a quality management system are as important for veterinary in-clinic laboratories as for reference laboratories. Elements of a quality management system include the formulation of a quality plan, establishment of quality goals, a health and safety policy, trained personnel, appropriate and well-maintained facilities and equipment, standard operating procedures, and participation in external quality assurance programs. Quality assurance principles should be applied to preanaltyic, analytic, and postanalytic phases of the in-clinic laboratory cycle to ensure that results are accurate and reliable and are released in a timely manner.