A-210 Time, waste, and error efficiency assessments of InteliQ Multiqual tube-based quality control material

Background Clinical laboratory operations generate large amounts of waste despite several initiatives for implementation of sustainable practices in laboratory medicine. The basic metabolic panel (BMP) is one of the most routinely performed tests in clinical chemistry. This study evaluated identifiable waste generated to perform BMPs across major chemistry analyzer platforms for a period of one year and estimated the waste that would be produced for running 1 million BMPs. Methods Measurements for readily identifiable consumable waste for BMPs were performed across five academic medical centers encompassing four different wet chemistry platforms (Abbott Alinity, Beckman AU5800, Roche cobas c502 and Siemens Atellica) and one dry chemistry platform (Ortho Vitros 4600). For each study site, vendor purchases during the calendar year 2022 were used to calculate annual consumable consumption for materials required for a BMP. Consumable waste was defined as any quality control (QC), calibrator, reagent, dry slides, package insert paperwork and associated packaging material required for the analysis of the BMP and were separated into plastic, cardboard, paper, glass, and rubber solid waste categories. Each of these components were weighed separately. To account for à la carte, comprehensive metabolic panel (CMP) and other panel orderings, a correction factor (45%) was applied across all reagent consumables. The projected solid waste for 1 million BMPs was estimated for each study site. Results The total amount of waste generated from 1 million BMPs across the four sites using wet chemistry platforms was 3337 kg and 160593 kg for the dry chemistry platform. Total estimated solid waste for the wet chemistry analyzer systems (n=4) to perform 1 million BMPs were 995 kg, 1274.4 kg, 579.2 kg and 488.6 kg out of which 298 kg, 379 kg, 163.3 kg, and 60 kg accounted for QC waste processes on the Abbott Alinity, Beckman AU5800, Roche cobas c502 and Siemens Atellica automated analyzers, respectively (Figure A). Similarly, total waste generation for the dry chemistry analyzer (Ortho Vitros 4600) for 1 million BMPs was estimated to be 160593 kg, which included 160.5 kg for QC materials (Figure B). Variations in QC practices (2 vs 3 levels) as well as conventional and tube-based QC materials used were noted at each site. Conclusion Analysis of BMPs generates enormous amounts of solid waste across major diagnostic platforms. These findings emphasize the urgent need for recycling and waste-reduction strategies in diagnostic laboratories to reduce their environmental footprint.

Verification of new lot reagent's suitability is necessary to ensure that results for patients' samples are consistent before and after reagent lot changes. A typical procedure is to measure results of some patients' samples along with quality control (QC) materials. In this study, the results of patients' samples and QC materials in reagent lot changes were analysed. In addition, the opinion regarding QC target range adjustment along with reagent lot changes was proposed. Patients' sample and QC material results of 360 reagent lot change events involving 61 analytes and eight instrument platforms were analysed. The between-lot differences for the patients' samples (ΔP) and the QC materials (ΔQC) were tested by Mann-Whitney U tests. The size of the between-lot differences in the QC data was calculated as multiples of standard deviation (SD). The ΔP and ΔQC values only differed significantly in 7.8% of the reagent lot change events. This frequency was not affected by the assay principle or the QC material source. One SD was proposed for the cutoff for maintaining pre-existing target range after reagent lot change. While non-commutable QC material results were infrequent in the present study, our data confirmed that QC materials have limited usefulness when assessing new reagent lots. Also a 1 SD standard for establishing a new QC target range after reagent lot change event was proposed.

Quality control methods and materials are widely used to monitor each and every facet of clinical chemistry laboratory performance. Quality control materials are also used in evaluation of methods and as secondary standards. A wide range of liquid and lyophilized materials are available from commercial sources and are prepared in individual laboratories. Many problems arise in the use of quality control materials. Problems discussed in this review include the use of nonhuman based materials and additives of animal origin, the physical and chemical characteristics of quality control materials that differentiate such samples from those from patients, attempts to generate quality control materials with elevated levels of particular analytes, the difficulties in handling and storage of quality control materials, the dangers of hepatitis, and the stability of quality control materials both during storage in the laboratory and after their reconstitution. The advantages and disadvantages of liquid and lyophilized quality control materials are discussed. The assignation of analyte values is of particular importance as the current trend is to consider inaccuracy of laboratory methods in addition to imprecision. This review assesses relevant publications in an area of fundamental importance to quality control in clinical chemistry.

BackgroundEvaluation of specimen suitability for downstream analytical testing and identification of potential interferents in the clinical laboratory is critical for the generation of actionable clinical results. Within the clinical laboratory, hemolysis, icterus, and lipemia are commonly assessed spectrophotometrically. While clinical laboratories rely on analyte-specific quality control (QC) materials to monitor test or instrument performance, QC materials evaluating specimen integrity checks are infrequently implemented. MethodsUsing commercially available specimen integrity materials, we evaluated the Bio-Rad Liquichek™ Serum Indices product on Roche cobas® c701 analyzers at a large academic medical center. Target arbitrary values for the hemolysis, icterus, and lipemia QC materials were 200, 20, and 500, respectively. Means, standard deviations (SD), and coefficients of variation (%CV) were established for hemolysis, icterus, lipemia, and non-interfered QCs, and performance was monitored over a 60-day period. ResultsAcross four c701 instruments, all QC materials performed well, with %CVs ≤ 1.76%, 4.51%, and 3.46% for hemolysis, icterus, and lipemia QC, respectively. ConclusionsThe Bio-Rad Liquichek Serum Indices product can serve as an effective means of monitoring specimen integrity checks in a manner congruous with existing QC programs.

Background A comprehensive Quality Management System starts with performing a daily Quality Control (Q.C.) process. The daily Q.C. process monitors the Instrument’s optimal performance and detects shifts and trends. However, the existing traditional daily Q.C. process is not only prone to manual errors, but also time consuming, costly and labor intensive. We evaluated a Bio-Rad InteliQTM Load and go Quality Control that comes in a barcoded tube ready to be loaded. We monitored the workflow efficiency gained in comparison to the traditional quality control material that comes in glass vials. Methods We evaluated the new quality control material ready to load on the instrument. This new Q.C. (Bio-Rad InteliQ Assayed Multiqual Control - 3 levels) were processed in parallel with our routine Q.C. (Bio-Rad Assayed Chemistry Lyphocheck vials - 2 levels). We performed the evaluation on Abbott Architect c8000 Chemistry analyzers in our central Laboratory (NGHA-Jeddah). The Q.C. was stored frozen. Before testing it was thawed at room temperature as per the insert instruction. Over a 5 days period, in parallel with our routine quality control, we run the new Q.C. Two times per day for 33 analytes. We monitored the processing time difference between the new and current approaches. We monitored the stability of all the analytes in the tube after Two days and again after Five days. We also monitored the cost effectiveness, labor intensiveness, probability of operator error and the overall improvement in workflow and Turn Around Time. Results Over the evaluation period, we observed the following: - Saving 40 minutes in average per week only for chemistry Q.C (time spent in reconstituting, mixing and aliquoting old Q.C) - 100% reduction in waste of plastic consumables such as pipette and plastic tubes. - Save an average of 1.0 ml dead volume in every 5.0 ml old Q.C. vial (20% of the volume, hence saving 20% of the total Q.C. cost). The dead volume wasted due to aliquoting step using the old Q.C. - 100% Eliminated delays caused by operator error such as wrong reconstitution, inadequate mixing and wrong Q.C. aliquoting. Not needed for the InteliQ. - High score of staff satisfaction. - Stability of the 32 analytes was excellent except that of Co2, which deteriorated by 14% after Two days as indicated in the insert package. Co2 day five result deteriorated by 34%. Conclusions Bio-Rad InteliQ is easy to use. It saves time and cost. When combined with Unity Q.C. data management solution it can streamline Q.C. workflow, eliminate operator errors, reduce T.A.T. and increase the overall laboratory performance. It may also work optimally with Instruments that have on-board fridge for Q.C.

Protein containing quality control (QC) material in ampoules for blood gas, pH and electrolyte analysers has been manufactured using buffered protein (Bovine Serum Albumine, BSA) solution with sodium bicarbonate and chloride salts. For comparison a similar QC material but without protein was manufactured. Results obtained with ampouled QC material depend on pre-analytical effects, on matrix effects and on the stability of the material. Pre-analytical variation occurs with closed and/or opened ampoules. The shaking rate of the ampoule must be high (vortexing) and the duration of shaking long enough (15 seconds) to give good reproducibility. Temperature coefficients of protein containing controls are equal to those of protein free controls when incubated at different temperatures. Vigorously shaking of the ampoule gives a protein foam layer resulting in stable values for pH, pCO2 and pO2 during maximally 6 minutes after opening of the ampoule. Concerning matrix effects the CO2 buffer capacity of protein containing QC material is slightly higher compared to that of protein free QC materials as determined by tonometry with CO2/air gas mixtures and measuring pH and plotting log pCO2 vs. pH. The O2 buffer capacity measured as the bias on a properly functioning blood gas analyser is smaller than the bias of protein free QC material. The protein containing quality control is stable for at least 12 months when stored refrigerated at 2-6 degrees C and 28 days at room temperature.

The past decade has seen widespread advances in quality control (QC) materials and software tools focused specifically on mass spectrometry-based proteomics, yet the rate of adoption is inconsistent. Despite the fundamental importance of QC, it typically falls behind learning new techniques, instruments, or software. Considering how important QC is in a core setting where data is generated for non-mass spectrometry experts and confidence in delivered results is paramount, we have created this quick-start guide focusing on off-the-shelf QC materials and relatively easy-to-use QC software. We hope that by providing a background on the different levels of QC, different materials and their uses, describing QC design options, and highlighting some current QC software, implementing QC in a core setting will be easier than ever. There continues to be development in each of these areas (such as new materials and software), and the current generation of QC for mass spectrometry-based proteomics is more than capable of conveying confidence in results as well as minimizing laboratory downtime by guiding experimental, technical, and analytical troubleshooting from sample to results.

The Metabolomics Society Data Quality Task Group (DQTG) developed a questionnaire regarding quality assurance (QA) and quality control (QC) to provide baseline information about current QA and QC practices applied in the international metabolomics community. The DQTG has a long-term goal of promoting robust QA and QC in the metabolomics community through increased awareness via communication, outreach and education, and through the promotion of best working practices. An assessment of current QA and QC practices will serve as a foundation for future activities and development of appropriate guidelines. QA was defined as the set of procedures that are performed in advance of analysis of samples and that are used to improve data quality. QC was defined as the set of activities that a laboratory does during or immediately after analysis that are applied to demonstrate the quality of project data. A questionnaire was developed that included 70 questions covering demographic information, QA approaches and QC approaches and allowed all respondents to answer a subset or all of the questions. The DQTG questionnaire received 97 individual responses from 84 institutions in all fields of metabolomics covering NMR, LC-MS, GC-MS, and other analytical technologies. There was a vast range of responses concerning the use of QA and QC approaches that indicated the limited availability of suitable training, lack of Standard Operating Procedures (SOPs) to review and make decisions on quality, and limited use of standard reference materials (SRMs) as QC materials. The DQTG QA/QC questionnaire has for the first time demonstrated that QA and QC usage is not uniform across metabolomics laboratories. Here we present recommendations on how to address the issues concerning QA and QC measurements and reporting in metabolomics.

Background The emergence of Point of Care tests that detect Sexually Transmitted Infections (STIs) is critical for screening and diagnostic programs in low-resource settings. Point of Care tests that are designed to simultaneously detect Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) promote rapid diagnosis and early treatment of the most common etiological agents causing STIs. Along with the roll-out and use of these tests, there is a growing need for complex multi-analyte quality control materials that are stable at room temperature and challenge test performance by identifying result deviations, lot-to-lot variability, and routine laboratory workflow errors. Microbix developed a whole-workflow multiplex quality control desiccated on a Copan FLOQSwab® that is stable at 2–30°C and contains inactivated whole-genome target pathogens. The objective of this study is to evaluate sample performance with multiple Point of Care diagnostic platforms that are currently in development and commercial IVD tests that are routinely used in the laboratory. Methods Microbix designed an inactivated STI whole-workflow control that contains whole-genome CT, NG, TV, MG, and human cells to satisfy sample adequacy control requirements. The formulation is desiccated on a Copan FLOQSwab® to mimic patient specimen formats and ensure sample compatibility with all assay workflows and elution buffers. Sample performance was evaluated with Cepheid Xpert® CT/NG assay, Cepheid Xpert® TV assay, Abbott Alinity m STI assay, BD MAX™ CT/GC/TV assay, Seegene Novaplex™ CT/NG/TV/MG assay, EliTechGroup STI PLUS ELITe MGB®Kit, and commercial Point of Care assays currently in development. Results The STI positive swab formulation demonstrated acceptable performance when tested with various nucleic acid amplification tests that detect CT, NG, TV, and MG targets. The formulations also behaved as useful quality management tools by highlighting design limitations for commercial Point of Care assays that are currently in development. Conclusion CT/NG/TV/MG whole-genome multiplex formulation desiccated on a Copan FLOQSwab® is an advantageous prospective quality control material that is stable at room temperature and supports the clinical use and accuracy of emerging STI assays, including the most challenging Point of Care test formats. The formulations showed acceptable performance on multiple platforms, demonstrating excellent commutability. Additionally, the dry swab format offers great practicality for monitoring assay performance in low-resource settings.

Use of a Lean Six Sigma approach to investigate excessive quality control (QC) material use and resulting costs

Background Illicit fentanyl use is endemic in the United States, yet availability of commercial FDA-approved assays is limited and typically relegated to automated chemistry platforms. Until recently, there were no FDA-approved point of care tests (POCT), despite the extremely common practice of POCT-based drug screening. The Abbott iCassette Fentanyl Urine Drug Screen assay is FDA-approved, CLIA-waived, for the detection of fentanyl in human urine (limit of detection: 1.0 ng/mL); the assay is reported to not detect fentanyl metabolites such as norfentanyl. Unfortunately, a commercial quality control (QC) product is not provided nor recommendations for one given, rather the manufacturer recommends the end user produce their own QC material using certified reference material. As manufacturing one’s own QC material in a setting that requires POCT assays is not generally feasible nor advisable, here we identified an appropriate commercial QC product and subsequently evaluated the assay manufacturer’s sensitivity claims. Methods Thermo Scientific DRI Fentanyl II High and Low Control Set, UTAK Fentanyl Analogs and UTAK Certified Drug Free Urine commercial QC products were evaluated for their ability to reliably produce a positive test result. Cerilliant fentanyl analytical reference standard material (F-013) was spiked into certified drug free urine at various concentrations to investigate the detection limits of the assay. Spiked concentrations were verified by mass spectrometry (LC-MS/MS). Further, the assay sensitivity was challenged with authentic fentanyl-positive urine specimens with known concentrations, as determined by LC-MS/MS. Results The DRI Fentanyl II High Control Set QC material with a claimed fentanyl concentration of 1.5 ng/mL failed to produce a clear positive (test line still visible, interpreted as negative) when dosing 100 µL and 200 µL on the cassette. UTAK Fentanyl Analogues QC material, with a fentanyl concentration of 3.5 ng/mL, reliably produced clear positive results (complete absence of test line). Cerilliant fentanyl standard spiked into drug free urine at 4.5 ng/mL produced a clear positive result while a faint test line was still visible (negative interpretation) at 0.6 ng/mL. Authentic patient urines with known fentanyl concentrations, as determined by LC-MS/MS, were unequivocally positive at fentanyl concentrations of 0.86 ng/mL and greater. An authentic specimen containing 0.05 ng/mL fentanyl produced a very faint test line (negative interpretation). Conclusion The iCassette Fentanyl assay may not produce reliable positive results when using QC material with fentanyl concentrations close to the claimed detection limit of 1.0 ng/mL. However, we found the assay’s sensitivity to be greater in authentic patient specimens versus QC material. This suggests either the assay sensitivity is variable across matrices (i.e. less sensitive in an artificial QC matrix) or the assay detects at least some fentanyl metabolites in addition to fentanyl. Ultimately we concluded that the assay was adequate for clinical use and we implemented with the UTAK material as the positive control.

Background and Objectives: Point of care test (POCT) is generally performed by non-laboratory staff who often lack an understanding on the quality control and quality assurance programs. The purpose of this study was to understand the current status of quality management of point of care (POC) blood glucose testing in a single institution where non-laboratory staff perform the tests. Materials and Methods: From July to August 2020, management status of glucometer, test strips, quality control (QC) materials, quality assurance program, and operators’ response to processing of displayed results was monitored in all Soonchunhyang University Bucheon hospital departments that performed POC blood glucose test. Results of the POC blood glucose test conducted from January 2019 to May 2020 were analyzed retrospectively. Results: A total 124 glucometers were monitored in 47 departments. Insufficient management of approximately 50% of blood sugar, test strips, and QC materials was observed. Although daily QC was conducted by 95.7% of the departments, the QC records were inaccurate. The method of recording test results varied with departments and operators. Various judgments and troubleshooting were performed on the unexpected or out of measurable range results, including some inappropriate processes. In POC blood glucose test results review, 4568 atypical results were identified from a total of 572,207 results. Conclusions: Sufficient training of the non-laboratory staff and ongoing assessment of competency through recertification is needed to maintain acceptable levels of POCT quality. In this study, various problems were identified in glucometer and reagent management, QC and post-analytic phase. We believe that these results provide meaningful basal information for planning effective operators’ training and competency evaluation, and the development of an efficient POCT quality management system.

With the widespread application of HIV-1 nucleic acid testing (NAT) in China, particularly in the diagnosis of HIV-1 infection, ensuring the accuracy of NAT results through quality control has become critically important. However, existing HIV-1 NAT quality control materials (QCMs), such as clinical plasma samples and inactivated HIV-1 cell culture supernatants, have limitations in sustainability, biosafety risks, and costs. MS2-armed RNA (MS2) does not replicate the biological characteristics of natural viruses or the complexities of the extraction and detection processes associated with authentic viral particles. To address these limitations, this study developed a novel HIV-1 NAT QCM based on HIV-1 pseudovirus (PsV). HIV-1 PsV packaged using an improved four-plasmid lentiviral vector (LV) system could be generated with a high concentration of up to 10⁹ copies/mL. The HIV-1 PsV mimics the morphology of the real virus and is capable of only single-cycle infection, thereby ensuring biosafety. The HIV-1 PsV-based QCM demonstrated excellent homogeneity, absence of matrix effects, stability for 7 days at 4°C and -20°C, and the ability to withstand up to five freeze-thaw times. We further found that HIV-1 PsV outperformed inactivated HIV-1 and MS2 in terms of short-term stability and freeze-thaw stability, respectively. Additionally, the PsV-based QCM was successfully detected by 12 commercial HIV-1 NAT quantification kits in the Chinese market and demonstrated excellent performance in an external quality assessment (EQA) involving 60 laboratories. In summary, the novel HIV-1 PsV-based QCM can serve as a safe and sustainable alternative to existing HIV-1 NAT QCMs for EQA of HIV-1 NAT laboratories.IMPORTANCEThis study proposes a novel strategy to prepare HIV-1 nucleic acid testing (NAT) quality control material (QCM) using HIV-1 pseudovirus (PsV) packaged by an improved four-plasmid lentiviral vector (LV) system. The HIV-1 PsV-based QCM can simulate authentic virus particles and better monitor the entire HIV-1 NAT process, including nucleic acid extraction, amplification, and detection. The innovative HIV-1 NAT QCM possesses several desirable characteristics: biosafety, homogeneity, stability, and the ability to be prepared at high concentrations and on a large scale, significantly reducing production costs. Compared to commonly used QCMs such as inactivated HIV-1 and MS2, the HIV-1 PsV demonstrates superior stability and better meets the requirements for transportation, storage, and quality control applications of HIV-1 NAT laboratory. Particularly, the ability of HIV-1 PsV to accommodate the insertion of large nucleic acid sequences provides a solid technical foundation for developing more advanced quality control solutions in the future.

A hybrid quality control (QC) program was developed that integrates automated and conventional Linac QC, realizing the benefits of both automated and conventional QC, increasing efficiency and maintaining independent measurement methods. Failure mode and effects analysis (FMEA) was then applied in order to validate the program prior to clinical implementation. The hybrid QC program consists of automated QC with machine performance check and DailyQA3 array on the TrueBeam Linac, and Delta4 volumetric modulated arc therapy (VMAT) standard plan measurements, alongside conventional monthly QC at a reduced frequency. The FMEA followed the method outlined in TG‐100. Process maps were created for each treatment type at our center: VMAT, stereotactic body radiotherapy (SBRT), conformal, and palliative. Possible failure modes were established by evaluating each stage in the process map. The FMEA followed semiquantitative methods, using data from our QC records from eight Linacs over 3 years for the occurrence estimates, and simulation of failure modes in the treatment planning system, with scoring surveys for severity and detectability. The risk priority number (RPN) was calculated from the product of the occurrence, severity, and detectability scores and then normalized to the maximum and ranked to determine the most critical failure modes. The highest normalized RPN values (100, 90) were found to be for MLC position dynamic for both VMAT and SBRT treatments. The next highest score was 35 for beam position for SBRT, and the majority of scores were less than 20. Overall, these RPN scores for the hybrid Linac QC program indicated that it would be acceptable, but the high RPN score associated with the dynamic MLC failure mode indicates that it would be valuable to perform more rigorous testing of the MLC. The FMEA proved to be a useful tool in validating hybrid QC.

Quality control of construction materials is one of the entire pressure pipeline installation project an important part of quality control. The quality control includes the procurement, acceptance testing, storage, distribution and use during the installation.