Search

Background: Cryopreserved whole blood, all-cell pellets (ACPs), and buffy coats in biobanks are widely used to obtain DNA for genetic testing. However, there are few studies concerning the quality ...

This work aims to establish a quality control method and evaluate the effects in glucose and lipids for fruit body of Isaria cicadae Miquel from strain Ic-17-7(Ic-17-7fb) in type 2 diabetes (T2DM) rat model. Random amplified polymorphic DNA, sequence-characterized amplified region, and high-performance liquid chromatography (HPLC) were used for the quality control of Ic-17-7fb. The pharmacological effects on streptozocin (STZ)-induced high-fat diet-fed Albino Wistar rats, divided into model, metformin, fruiting body of Ic-17-7fb (0.166 g/kg and 0.5 g/kg) and control group were evaluated. The fasting blood glucose (FBG), blood glucose, total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL-c), and low-density lipoprotein (LDL-c) were measured. The Ic-17-7fb could amplified a single specific band by S11-2-F3 and S11-2-R3 primers to validate. An HPLC-based quality and quantity was established and used for industrial application. The content of adenosine and N6-(2-hydroxyethyl) adenosine (HEA) of the cultivated Ic-17-7fb were analyzed. All of the validation lots of cultured Ic-17-7fb passed the quantity control of the training set (0.90 mg/g of adenosine and 0.89 mg/g of HEA). The average FBG in the 2ed -week were 4.89 ± 0.42 (control), 26.10 ± 5.77 (model), 23.63 ± 6.15 (metformin), 17.96 ± 9.36 (Ic-17-7fb for 0.166 g/kg), and 19.69 ± 8.71 mmol/L (Ic-17-7fb for 0.5 g/kg). The fruit body of Ic-17-7 (0.166 g/kg) treatment significantly was reduced by 31.19% compared with the model in the 2ed-week (p < 0.01). Ic-17-7fb (0.166 g/kg) significantly decreased the fasting blood glucose after 2 weeks of administration. Metformin, Ic-17-7fb (0.166 g/kg), and Ic-17-7fb (0.5 g/kg) reduced the TC, TG, HDL-c, and LDL-c compared with the T2DM model treatment at the 6th week of treatment (p < 0.05). This study established the first quality standard for Ic-17-7fb and has an effective application in the treatment of T2DM. The reliable method and pharmacological effect can be generalized to a broader population and possibility study for future research.

Incomplete reporting of key information on patient-reported outcomes (PROs) in randomized controlled trials (RCTs) in oncology has been highlighted repeatedly as a major barrier to the use of study findings in clinical practice. We investigated whether the quality of reporting of PRO data in cancer RCTs has improved over the last 15 years.We identified all cancer RCTs with PRO endpoints conducted across the most prevalent solid tumor types worldwide published between 2004 and 2019. The quality of PRO reporting was assessed using the International Society for Quality of Life Research recommended standards, which include important aspects related to assessment methodology, statistical analyses, and interpretation of data.We assessed a total of 631 cancer RCTs in breast (n = 187), lung (n = 131), prostate (n = 120), colorectal (n = 107), and gynecological (n = 86) cancer. We observed a higher adherence to the International Society for Quality of Life Research reporting criteria in the more recently published studies. In a multivariable linear regression analysis, we observed a statistically significant improvement in the quality of PRO reporting over time (P.001), and this relationship was independent of other measured confounding factors, such as sample size and study sponsorship. Overall, the quality of PRO reporting was higher for studies published after the publication of the Consolidated Standards of Reporting Trials-PRO Extension.The quality of PRO reporting in cancer RCTs published in the last 15 years has improved significantly. Our findings are encouraging because better reporting of PRO results may translate into a greater impact of study findings on real-world practice.

New pipelines are required to automate the quantitation of emerging high-throughput electrophoretic (EP) assessment of DNA damage, or proteoform expression in single cells. EP cytometry consists of thousands of Western blots performed on a microscope slide-sized gel microwell array for single cells. Thus, EP cytometry images pose an analysis challenge that blends requirements for accurate and reproducible analysis encountered for both standard Western blots and protein microarrays. Here, we introduce the Summit algorithm to automate array segmentation, peak background subtraction, and Gaussian fitting for EP cytometry. The data structure storage of parameters allows users to perform quality control on identically processed data, yielding a ~6.5% difference in coefficient of quartile variation (CQV) of protein peak area under the curve (AUC) distributions measured by four users. Further, inspired by investigations of background subtraction methods to reduce technical variation in protein microarray measurements, we aimed to understand the trade-offs between EP cytometry analysis throughput and variation. We found an 11%-50% increase in protein peaks that passed quality control with a subtraction method similar to microarray "average on-boundary" versus an axial subtraction method. The background subtraction method only mildly influences AUC CQV, which varies between 1% and 4.5%. Finally, we determined that the narrow confidence interval for peak location and peak width parameters from Gaussian fitting yield minimal uncertainty in protein sizing. The AUC CQV differed by only ~1%-2% when summed over the peak width bounds versus the 95% peak width confidence interval. We expect Summit to be broadly applicable to other arrayed EP separations, or traditional Western blot analysis.

Cigarette smoking is an established risk factor for oral cancer. The health effects of e-cigarettes are still under investigation but may disturb oral cavity homeostasis and cause lung and cardiovascular diseases. Carcinogens and toxicants in tobacco products and e-cigarettes may damage DNA, resulting in the formation of apurinic/apyrimidinic (AP) sites, and initiation of the carcinogenic process. In this study, we optimized a liquid chromatography-nanoelectrospray ionization-high resolution tandem mass spectrometry method to analyze AP sites in buccal cell DNA of 35 nonsmokers, 30 smokers, and 30 e-cigarette users. AP sites in e-cigarette users (median 3.3 per 10(7) nts) were significantly lower than in smokers (median 5.7 per 10(7) nts) and nonsmokers (median 6.0 per 10(7) nts). AP sites in smokers were not significantly different from nonsmokers (p > 0.05). The e-cigarette vaporizing solvents propylene glycol and glycerin were tested and did not protect against AP site formation in in vitro control and carcinogen exposed rat liver homogenates. However, propylene glycol may inhibit bacteria in oral cells, resulting in reduced inflammation and related effects, and reduced AP site levels in e-cigarette user DNA. This is the first study to examine AP site formation in e-cigarette users and to evaluate AP sites in human oral cell DNA.

BACKGROUND Although quality control standards are recommended to ensure accurate test results, the coefficient of variation for the FVC and FEV1 biologic quality control (BioQC) is not specified. The primary aim of this study was to evaluate variations in spirometry BioQCs in a large and diverse cohort of individuals to determine an acceptable standard for the coefficient of variation. METHODS The FVC and FEV1 biologic control data were secondary analyses from an inhaled medication trial that was conducted over 3 y ending in 2018 that included 114 laboratories. Results were sent to a central repository for expert review. The FVC and FEV1 coefficients of variation were based upon a minimum of 10 spirometry values annually separated by at least 5 d. A second method of computing the coefficient of variation used 10 values within 28 d. Descriptive statistics were computed. Wilcoxon signed-rank tests were conducted to compare whether the median coefficient of variation values between the 2 methods differed, tested at α = 0.05 using SPSS. RESULTS Of 249 biologic control participants, 170 met the first year's inclusion criteria. The coefficient of variation for the 5-d separated method was < 5% for 94.1% of FVC and 93.5% of FEV1 values in the first year. By year 3, 90% of FVC and FEV1 coefficient of variation values were < 4%. The medians for the 5-d separated and the 28-d measure showed no difference for either FVC coefficient of variation or FEV1 coefficient of variation, Z = -1.764, P = .78, and Z = -0.980, P = .33, respectively. CONCLUSIONS Interlab biologic control variation values of < 4% for FVC and FEV1 are achievable; however, individual labs should strive to attain lower values. Acceptable coefficients of variation can be achieved within 28 d.

Introduction: The high incidence of thrombotic events in patients with COVID-19 affects health care worldwide and results in an increased workload in haemostasis laboratories due to more frequent testing of D-dimer, haemostatic parameters and anti-Xa tests. However, the impact of this increase in assay requests on the quality of performance in haemostasis laboratories remains unclear. In this study, the impact of the COVID-19 pandemic on the quality of performance and management of haemostasis laboratories was evaluated.Methods: The impact on the quality of performance was studied using external quality assessment data from 2019 to 2020 derived from ECAT surveys. A questionnaire was sent to Dutch haemostasis laboratories to identify challenges and management strategies. Furthermore, the number of assays performed in 2019 and 2020 was supplied by four Dutch hospitals, located in regions with different disease incidence.Results: No differences in response rate nor the quality of the measurements were observed between the EQA surveys in 2019 and 2020. The questionnaire results showed a large increase of >25% in the number of test requests for anti-Xa, D-dimer and fibrinogen assays in 2020 compared to 2019. Extreme peaks in test requests were also observed in the four evaluated hospitals. Additionally, 84% of the respondents indicated that they had experienced increased work pressure, and increased sick leave was observed in 71% of the participating laboratories.Conclusions: The enormous increase in test requests, especially for D-dimer assays and anti-Xa activity, did not affect the quality of performance within haemostatic laboratories during the COVID-19 pandemic.

Chimeric antigen receptor T cells (CAR-T), especially against CD19 marker, present in lymphomas and acute B leukemia, enabled a revolution in the treatment of hematologic neoplastic diseases. The manufacture of CAR-T cells requires the adoption of GMP-compatible methods and it demands the collection of mononuclear cells from the patient (or from the donor), generally through the apheresis procedure, T cell selection, activation, transduction and expansion ex vivo, and finally storage, usually cryopreserved, until the moment of their use. An important aspect is the quality control testing of the final product, for example, the characterization of its identity and purity, tests to detect any contamination by microorganisms (bacteria, fungi, and mycoplasma) and its potency. The product thawing and intravenous infusion do not differ much from what is established for the hematopoietic progenitor cell product. After infusion, it is important to check for the presence and concentration of CAR-T cells in the patient's peripheral blood, as well as to monitor their clinical impact, for instance, the occurrence of short-term, such as cytokine release syndrome and neurological complications, and long-term complications, which require patient follow-up for many years.

Purpose The assessment of low-contrast-details is a part of the quality control (QC) program in digital radiology. It generally consists of evaluating the threshold contrast (Cth) detectability details for different-sized inserts, appropriately located in dedicated QC test tools. This work aims to propose a simplified method, based on a statistical model approach for threshold contrast estimation, suitable for different modalities in digital radiology. Methods A home-made low-contrast phantom, made of a central aluminium insert with a step-wedge, was assembled and tested. The reliability and robustness of the method were investigated for Mammography, Digital Radiography, Fluoroscopy and Angiography. Images were analysed using our dedicated software developed on Matlab®. The Cth is expressed in the same unit (mmAl) for all studied modalities. Results This method allows the collection of Cth information from different modalities and equipment by different vendors, and it could be used to define typical values. Results are summarized in detail. For 0.5 diameter detail, Cth results are in the range of: 0.018–0.023 mmAl for 2D mammography and 0.26–0.34 mmAl DR images. For angiographic images, for 2.5 mm diameter detail, the Cth s median values are 0.55, 0.4, 0.06, 0.12 mmAl for low dose fluoroscopy, coronary fluorography, cerebral and abdominal DSA, respectively. Conclusions The statistical method proposed in this study gives a simple approach for Low-Contrast-Details assessment, and the typical values proposed can be implemented in a QA program for digital radiology modalities.

The spread of carbapenem-resistant Gram-negative bacteria poses a substantial threat to morbidity and mortality worldwide, which is mainly attributed to the overuse of carbapenem. This study aimed to evaluate the use of a quality control circle (QCC) in controlling the overuse of carbapenems and improving the state of carbapenem resistance at a Chinese tertiary teaching hospital.A pharmacist-led multidisciplinary QCC project was carried out and the plan-do-check-act (PDCA) method was applied for 12 months. The data on carbapenem consumption, bacterial identification, and antibacterial susceptibility testing were collected to evaluate the effect of this project.The antibiotics use density (AUD) of carbapenems exhibited a decreasing trend over time (P0.001), and the AUD of meropenem, imipenem, and biapenem decreased by 30.20%, 42.45%, and 78.05% after the intervention, respectively. The total AUD of carbapenems decreased from 7.37 to 3.96, which included the decrease in the irrational use of carbapenems by 1.61, accounting for 47.21% of the total. Moreover, the positive correlations were discovered between the resistance rate of carbapenem-resistant Klebsiella pneumonia (CRKP)/Acinetobacter baumannii (CRAB) and the AUD of carbapenems (P0.05). The resistance rate of CRKP and CRAB decreased from 51.93% and 89.21% to 32.94% and 60.66%, respectively, following QCC project implementation.This is the first study to highlight the success of a multifaceted intervention QCC project and PDCA method, which led to a significant reduction in the AUD and resistance rate of carbapenems. QCC is a feasible and effective management tool for improving the quality of carbapenem use in medical institutions.

Jianhong Ji,1,&ast; Li Wang,2,&ast; Haiyang Guan,2 Yaqiong Jiang,1 Sanlian Zhou,2 Junhua Sheng,3 Lihua Wang4 1Intensive Care Unit, The Second Affiliated Hospital of Nantong University, Nantong, People’s Republic of China; 2Department of Emergency, The Second Affiliated Hospital of Nantong University, Nantong, People’s Republic of China; 3Department of Medical, The Second Affiliated Hospital of Nantong University, Nantong, People’s Republic of China; 4Department of Nursing, The Second Affiliated Hospital of Nantong University, Nantong, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Lihua WangDepartment of Nursing, The Second Affiliated Hospital of Nantong University, Nantong, 226001, People’s Republic of ChinaTel +86 13815219995Email lihua_wangdr@outlook.comObjective: This study was designed to verify the effect of group random quality control on the first aid ability of ward doctors and nurses with regard to the resuscitation of patients with in-hospital cardiac arrest (IHCA).Methods: The first aid quality control team of our hospital was established in December 2018, when the number, qualifications, organizational structure, quality control methods, and responsibilities of the team and team members were determined. The baseline data and assessment results of examinees, the rates of return of spontaneous circulation (ROSC), and the discharge survival rate of IHCA patients in 2019 and 2020 were compared.Results: There were no significant differences in the baseline data of examinees at each stage (p > 0.05). As time went on, the results of the four practical examinations were significantly improved (pairwise comparison, p < 0.05). The number of problems in examinations was significantly higher for physicians than for nurses. After guidance in department relearning, the incidence of related problems was significantly reduced, but the mastery of the frequency and depth of extracorporeal cardiac compression were not always up to standard. The proportion of critically ill patients and the incidence of IHCA in the hospital in 2020 was higher than in 2019 (p < 0.05), and the ROSC rate was also significantly higher than it was in 2019 (p < 0.05), but the difference in the survival rate at discharge was not statistically significant (p > 0.05).Conclusion: Group random quality control meets the needs of IHCA emergencies, and it can improve the first aid skills and organizational coordination of doctors and nurses on the ward through continuous discovery and problem solving so that the ultimate goal of improving the success rate of resuscitation can be achieved.Keywords: in-hospital cardiac arrest, cardiopulmonary resuscitation, quality control, patient outcomes, survival, ability

Objectives Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution. We present the results of the first three years of the program. Methods The use of four different quality control materials with different concentrations in three alternate months allows an annual evaluation of the participant’s accuracy. Assigned values are established by consensus among homogeneous groups, considering necessary at least 10 participants for a comparison at instrument level. The average percentage difference results per instrument allow the assessment of bias among groups. Results The imprecision of the three indices ranges between 3 and 9%, with no major differences among instruments. Significant differences were observed in all indices among instruments with more than 10 participants (Roche Cobas, Abbott Architect, Abbott Alinity and Siemens Advia). The 90th percentile of the distribution of percentage differences was used as the analytical performance specification (APS). An improvement in performance was observed in the first three years of the program, probably due to the learning curve effect. In 2020, APS of 7.8, 12.2 and 9.7% were proposed for hemolytic, icteric and lipemic indices, respectively. Conclusions Serum indices have a great impact on the quality and the reliability of laboratory test results. Participation in proficiency testing programs for serum indices is helpful to encourage harmonization among providers and laboratories.

The medicine was given to the target site with a pressurized topical spray (aerosol pharmaceutical) and a non-pressurized topical spray solution by gently pressing the spray container against the skin and initiating the spray. Formulation components consists of product concentrate (one or more pharmaceutical drugs with relevant excipient) and packaging components (valves, pump, actuator, container). After formulation process development various quality control test like spray pattern, spray content uniformity and geometry, particulate matter, droplet size distribution, microbial limit, net content, pH, osmolarity, weight loss, leachability, viscosity, valves, actuators, diptubes, weight checking, leak test, valve discharge rate, dosage with valves, therapeutic activity, and toxicity studies to check the quality and efficacy. The benefit of Topical Spray Life Cycle Management (post-approval adjustments, 30-day supplements, annual report, Food and Drug Administration inspection and enforcement, cover letter, risk management standard and related information from the International Organization for Standardization) is that it covers the entire lifecycle of a topical spray, from conception through formulation design development to marketing. The product lifecycle management data offers regulatory bodies with a significant financial benefit. Topical non-pressurized sprays have been developed for a variety of applications due to their ease of use, environmental friendliness, low cost, and innovative technology. This review give details about meter dose topical spray of Estradiol, 1% tolnaftate, 2% Miconazole nitrate spray, 0.5% w/w Voriconazole spray, Clotrimazole transdermal apray, Lopinavir meter dose transdermal spray are studied by researcher. This review also enlisted patents and marketed formulation on topical spray from year 2007 to 2020.

Introduction It is common for patients to switch between several healthcare providers. In this context, the long-term follow-up of medical conditions based on laboratory test results obtained from different laboratories is a challenge. The measurement uncertainty in an inter-laboratory context should also be considered in data mining research based on routine results from randomly selected laboratories. As a proof-of-concept study, we aimed at estimating the inter-laboratory reference change value (IL-RCV) for exemplary analytes from publicly available data on external quality assessment (EQA) and biological variation. Materials and methods External quality assessment data of the Reference Institute for Bioanalytics (RfB, Bonn, Germany) for serum creatinine, calcium, aldosterone, PSA, and of whole blood HbA1c from campaigns sent out in 2019 were analysed. The median CVs of all EQA participants were calculated based on 8 samples from 4 EQA campaigns per analyte. Using intra-individual biological variation data from the EFLM database, positive and negative IL-RCV were estimated with a formula based on log transformation under the assumption that the analytes under examination have a skewed distribution. Results We estimated IL-RCVs for all exemplary analytes, ranging from 13.3% to 203% for the positive IL-RCV and - 11.8% to - 67.0% for the negative IL-RCV (serum calcium - serum aldosterone), respectively. Conclusion External quality assessment data together with data on the biological variation - both freely available - allow the estimation of inter-laboratory RCVs. These differ substantially between different analytes and can help to assess the boundaries of interoperability in laboratory medicine.

At present, there are not much data on the clinical use of live recombinant viral vector vaccines. Characteristics of new vaccines should be factored into requirements/recommendations for quality control, preclinical and clinical studies of vaccines in order to enable further risk/benefit assessment. The aim of this study was to analyse current approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines. The paper provides an overview of the licensed live viral vector vaccines and those at various stages of clinical trials. The authors analysed Russian, European, American, and Japanese guidelines related to quality issues, preclinical and clinical studies of live viral vector vaccines. The analysis demonstrated that the regulatory requirements for live recombinant viral vector vaccines include assessment of a detailed rationale for vaccine development, including information on the choice of the vector, the origin of the heterologous antigen gene(s), elements related to the transgene(s) expression, as well as assessment of the genetic and phenotypic stability of the recombinant virus, the risk of reversion to virulence or recombination with wild type strains, the potential for virus genome integration into the host cell chromosome, the pre-existing immunity to the vector, the intensity of the immune response elicited by the vector, and the reusability of the vector. The choice and number of applicable toxicological and pharmacological models will depend on these aspects. The results of the analysis of approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines may be used in the development of Russian regulatory guidelines harmonised with the international norms and regulations.

Objectives Curcumae Radix, the medicinal part is radix, commonly called as Yujin (Chinese:郁金), is a widely used traditional Chinese medicine for its high medicinal value and health benefits. Curcumae Radix has been used to treat conditions such as syndrome of heat disease and unconsciousness, epilepsy and internal stagnation of phlegm, qi stagnation and blood stasis, dysmenorrhoea, jaundice, cholelithiasis caused by dampness heat of liver and gallbladder. This review aims to summarize the botany, traditional usages, processing, phytochemistry, quality control, pharmacology and toxicology of Curcumae Radix to better understand its therapeutic potential. Key findings So far, a variety of chemical constituents have been isolated and identified from Curcumae Radix, mainly including volatile oil and diphenylheptanes. Modern research shows that the extracts and compounds from Curcumae Radix possess wide-ranging pharmacological effects, including anti-tumour, hepatoprotective, anti-inflammatory and analgesic, anti-thrombosis, as well as effects on the nervous system and others. Summary Curcumae Radix holds an important position in traditional system of medicine. It is cost-effective and an important plant with curative application in contemporary medicine. However, further in-depth studies are also needed to determine the medical uses of this plant and its chemical constituents, pharmacological activity, quality control and toxicology.

Phenol is used as a preservative in a number of biological products. Methods that are used for quantitative determination of phenol differ a lot. Current requirements for accredited laboratories include continuous internal quality control. Reference standards with a certified content of the analyte are an effective metrological tool for ensuring such control. The aim of the study was to develop and certify reference standards for phenolic content in biological products, based on comparison of results obtained by GLC, HPLC, spectrophotometric, and colorimetric methods. Materials and methods: diluent for allergens by (candidate reference standard), 2.5 and 5 mg/mL phenol solutions, and 2.5 mg/mL 2-phenoxyethanol solution were used in the study. The experiments were performed using spectrophotometric, colorimetric, HPLC, and GLC procedures. The statistical analysis of results included calculation of the arithmetic mean, standard deviation, coefficient of variation, and analysis of variance with Student’s t-test and Fisher’s F-test. Results: the results of phenolic content determination by the spectrophotometric, colorimetric, and HPLC methods were statistically comparable. The F value obtained for equal sample sizes (n = 40) was F = 0.9343, given the critical value Fcrit = 3.96. A reference standard certified by one of these methods can be used to control the consistency of phenol determination by a relevant method. The results of phenolic content determination by the GLC method showed statistically significantly differences: F = 17.47, given Fcrit = 3.96, which demonstrated the need for certification of another reference standard. Conclusions: two reference standards were certified in the study: reference standard 42-28-449 with the certified phenolic content of 2.56‒3.32 mg/mL, to be used with the spectrophotometric, colorimetric, and HPLC methods; and reference standard 42-28-451 with the certified phenolic content of 2.92‒3.28 mg/mL, to be used with the GLC method.

The design, production and adaptability to clinical routine of a patient-specific tumor and respiratory monitoring phantom (TRMP) was investigated using 3D printer technology. TRMP and GTV modelling were done using 4D-CT images of the inhalation phase. The model was converted to STL (Stereolithography) format and printed with STH (Strong Herbal) biopolymer with HU (Hounsfield Unit) suitable for imaging purposes. The assembly of TRMP motorized parts and mechanical equipment has been completed and made suitable for clinical use. In the first part of the study, the deviations of radio-opaque markers attached to the TRMP sternum to perform mechanical quality control tests and T1-7 costal vertebrae in CC, AP, and LAT directions were evaluated. In the second part of the study, in order to evaluate the usability of the TRMP in quality assurance (QA), point dose measurements with BeO OSL dosimetry and EBT3 gafchromic film measurements were taken in Trilogy® radiotherapy accelerator and CyberKnife® robotic radiosurgery accelerator. In this study, we present a highly flexible TMRP capable of performing independent internal and external motions. TRMP was successfully tested in different treatment accelerators, both mechanically and dosimetrically.

Background: Analytical information obtained from clinical tissue samples has recently become more important due to recent advancements in the clinical practice of medicine, for example, gene panel testing. However, acquiring and managing the sample quality, which greatly influences the analyses, are not sufficient and hence requires immediate attention. We introduced time stamp (TS) recording and documentation using the Standard PREanalytical Code (SPREC) for breast cancer surgery samples to monitor and control their quality. Materials and Methods: The TS recording used SPREC for quality control of each sample by recording seven factors: type of sample, type of collection, warm ischemia time (WIT), cold ischemia time (CIT), fixation type, fixation time (FT), and long-term storage. The responsibilities to record each factor were assigned among group members (breast surgeons, anesthesiologists, pathologists, operating room nurses, and medical technologists in pathology). Results: Records based on SPREC were recorded for 393 surgical cases of first-time breast cancer patients performed at the Kanagawa Cancer Center from May 2018 to April 2019. The vascular clamp time was defined as when skin flap formation was completed, regardless of the surgical procedure. An anesthesiologist recorded the vascular clamp time and sample collection time, and the pathologist recorded the fixation start time and fixation end time. WIT was 23 (3-116) minutes (breast-conserving surgery, 11 [3-38] minutes; mastectomy, 26 [5-116] minutes; and nipple-sparing mastectomy, 39 [31-43] minutes), CIT was 37 (3-1052) minutes, and FT was 43 (17-115) hours. The median CIT and FT were significantly shortened after introducing the TS system, and the variabilities were reduced. Conclusion: A TS system for quality control of breast cancer surgical sample functions well due to the establishment of highly versatile WIT and a working group consisting of multiple members of different occupations who shared roles.

The existing paired t -test under classical statistics cannot be applied when the data is obtained from the complex process, having interval, uncertainty, indeterminacy, and incompleteness. In this paper, the modification of the paired t -test under neutrosophic statistics is proposed. The testing criterion of the proposed paired t -test is given. The application of the proposed paired t -test is given using the interval quality control of clinical laboratory data. From the analysis, it can be seen than the proposed test is quite effective and informative to apply for testing the measurement tools in the clinical laboratory.

Traditionally, diagnosis of acute infections has been organism-growth based, which makes timely and actionable infection diagnosis a major challenge. In addition, traditional microbial detection methods, including direct microscopy, are not suited for outsourcing to clinical, non-laboratory-educated personnel. Optimal management of patients with known or suspected clinical infections, such as targeted (or no) antimicrobial treatment and correct use of single room contact isolation facilities, requires rapid identification of the causative infectious microorganism. We are now facing a new disruptive paradigm shift in diagnostic microbiology. The availability of small-footprint robust instruments with easy-to-use assay kits allows non-laboratory-trained nurses and physicians to perform high-quality molecular diagnostics in a near-patient setting with results available in

BACKGROUND Prostate magnetic resonance imaging (MRI) is technically demanding, requiring high image quality to reach its full diagnostic potential. An automated method to identify diagnostically inadequate images could help optimize image quality. PURPOSE To develop a convolutional neural networks (CNNs) based analysis pipeline for the classification of prostate MRI image quality. STUDY TYPE Retrospective. SUBJECTS Three hundred sixteen prostate mpMRI scans and 312 men (median age 67). FIELD STRENGTH/SEQUENCE A 3 T; fast spin echo T2WI, echo planar imaging DWI, ADC, gradient-echo dynamic contrast enhanced (DCE). ASSESSMENT MRI scans were reviewed by three genitourinary radiologists (V.P., M.D.M., S.C.) with 21, 12, and 5 years of experience, respectively. Sequences were labeled as high quality (Q1) or low quality (Q0) and used as the reference standard for all analyses. STATISTICAL TESTS Sequences were split into training, validation, and testing sets (869, 250, and 120 sequences, respectively). Inter-reader agreement was assessed with the Fleiss kappa. Following preprocessing and data augmentation, 28 CNNs were trained on MRI slices for each sequence. Model performance was assessed on both a per-slice and a per-sequence basis. A pairwise t-test was performed to compare performances of the classifiers. RESULTS The number of sequences labeled as Q0 or Q1 was 38 vs. 278 for T2WI, 43 vs. 273 for DWI, 41 vs. 275 for ADC, and 38 vs. 253 for DCE. Inter-reader agreement was almost perfect for T2WI and DCE and substantial for DWI and ADC. On the per-slice analysis, accuracy was 89.95% ± 0.02% for T2WI, 79.83% ± 0.04% for DWI, 76.64% ± 0.04% for ADC, 96.62% ± 0.01% for DCE. On the per-sequence analysis, accuracy was 100% ± 0.00% for T2WI, DWI, and DCE, and 92.31% ± 0.00% for ADC. The three best algorithms performed significantly better than the remaining ones on every sequence (P-value

Purpose In Germany, Austria, and Switzerland, pretreatment radiotherapy quality control (RT-QC) for tumor bed boost (TB) in non-metastatic medulloblastoma (MB) was not mandatory but was recommended for patients enrolled in the SIOP PNET5 MB trial between 2014 and 2018. This individual case review (ICR) analysis aimed to evaluate types of deviations in the initial plan proposals and develop uniform review criteria for TB boost. Patients and methods A total of 78 patients were registered in this trial, of whom a subgroup of 65 patients were available for evaluation of the TB treatment plans. Dose uniformity was evaluated according to the definitions of the protocol. Additional RT-QC criteria for standardized review of target contours were elaborated and data evaluated accordingly. Results Of 65 initial TB plan proposals, 27 (41.5%) revealed deviations of target volume delineation. Deviations according to the dose uniformity criteria were present in 14 (21.5%) TB plans. In 25 (38.5%) cases a modification of the RT plan was recommended. Rejection of the TB plans was rather related to unacceptable target volume delineation than to insufficient dose uniformity. Conclusion In this analysis of pretreatment RT-QC, protocol deviations were present in a high proportion of initial TB plan proposals. These findings emphasize the importance of pretreatment RT-QC in clinical trials for MB. Based on these data, a proposal for RT-QC criteria for tumor bed boost in non-metastatic MB was developed.

Torunn Varmdal,1,2 Ellisiv B Mathiesen,1,3 Tom Wilsgaard,1 Inger Njølstad,1 Audhild Nyrnes,1 Sameline Grimsgaard,1 Kaare Harald Bønaa,2,4 Jan Mannsverk,1 Maja-Lisa Løchen1,5 1Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway; 2Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway; 3Department of Neurology, University Hospital of North Norway, Tromsø, Norway; 4Clinic for Heart Disease, St. Olav’s University Hospital, Trondheim, Norway; 5Department of Cardiology, University Hospital of North Norway, Tromsø, NorwayCorrespondence: Torunn VarmdalDepartment of Community Medicine, UiT The Arctic University of Norway, Postboks 6050 Langnes, Tromsø, 9037, NorwayTel +47 930 28 286Email torunn.varmdal@ntnu.noPurpose: To assess whether acute myocardial infarction (MI) diagnoses in national health registers are sufficiently correct and complete to replace manual collection of endpoint data for a population-based, epidemiological study.Patients and Methods: Using the Tromsø Study Cardiovascular Disease Register for 2013– 2014 as gold standard, we calculated correctness (defined as positive predictive value (PPV)) and completeness (defined as sensitivity) of MI cases in the Norwegian Myocardial Infarction Register and the Norwegian Patient Register separately and in combination. We calculated the sensitivity and PPV with 95% confidence intervals using the Clopper-Pearson Exact test.Results: We identified 153 MI cases in the gold standard. In the Norwegian Myocardial Infarction Register, we found a PPV of 97.1% (95% confidence interval (CI) 92.8– 99.2) and a sensitivity of 88.2% (95% CI 82.0– 92.9). In the Norwegian Patient Register, the PPV was 96.3% (95% CI 91.6– 98.8) and the sensitivity was 85.6% (95% CI 79.0– 90.8). The combined dataset of the Norwegian Myocardial Infarction Register and the Norwegian Patient Register had a PPV of 96.6% (95% CI 92.1– 98.9) and a sensitivity of 91.5% (95% CI 85.9– 95.4).Conclusion: MI diagnoses in both the Norwegian Myocardial Infarction Register and the Norwegian Patient Register were highly correct and complete, and each of the registers could be considered as endpoint sources for the Tromsø Study. A combination of the two national registers seemed, however, to represent the most comprehensive data source overall. The benefits of using data from national registers as endpoints in epidemiological studies include faster, less resource-intensive access to nationwide data and considerably lower loss to follow-up, compared to manual data collection in a limited geographical area.Keywords: cardiovascular diseases, data quality, registers, data collection, quality control

In analytical quality management, target setting models that are selected by the purpose together with the error models that are applied correctly have critical importance. In our study, we aimed to compare the analytical performance characteristics of routine clinical chemistry and immunoassay tests with different target-setting models proposed by various organizations. Our study was performed with internal and external quality control data obtained using Beckman Coulter AU680 for clinical chemistry analytes and Roche Cobas 8000 autoanalyzer for immunoassay analytes. The total analytical error (TAE) was calculated by the formula TAH%=1.65×(CV%)+Bias%. Measurement uncertainty (MU) has been calculated adhering to the Nordtest guideline. Results were compared with BVEFLM, CLIA, RCPA, PRDEQA%, pUEQAS%, and permissible MU (pU%) data to investigate analytical performance qualities. When we compare the results of TAE and MU, MU was found to be higher than TAE for all analytes. ALT, AST, glucose, K, and triglycerides m

Purpose of the review Digital medicine (mHealth) aims to help patients and healthcare providers (HCPs) improve and facilitate the provision of patient care. It encompasses equipment/connected medical devices, mHealth services and mHealth apps (apps). An updated review on digital health in anaphylaxis is proposed. Recent findings In anaphylaxis, mHealth is used in electronic health records and registries.It will greatly benefit from the new International Classification of Diseases-11 rules and artificial intelligence. Telehealth was revolutionised by the coronavirus disease 2019 pandemic, and lessons learnt should be extended to shared decision making in anaphylaxis. Very few nonvalidated apps exist and there is an urgent need to develop and validate such tools. Summary Although digital health appears to be of great importance in anaphylaxis, it is still insufficiently used.

INTRODUCTION Sigma metric offers a quantitative framework for evaluating process performance in clinical laboratories. This study aimed to evaluate the analytical performance of automated analyzers in hematology unit of Alexandria Main University Hospital using the sigma metric approach. MATERIALS AND METHODS Quality control data were collected for 6 months, and sigma value was calculated from hematology analyzers SYSMEX (XN 1000, XT 1800i), ADVIA (2120i, 2120), and coagulation analyzers SYSMEX CA 1500 (3610, 6336). RESULTS For the normal control level, satisfactory mean sigma value ≥3 was observed for all of the studied parameters by all analyzers. For the high control level, red blood cell count by ADVIA 2120, and hematocrit by ADVIA (2120i and 2120) performed poorly with a mean sigma value

INTRODUCTION The lack of quality control procedures for home point-of-care (POC) international normalized ratio (INR) devices is a concern. Concomitant laboratory and POC INR testing may be proposed to overcome the lack of quality control. However, a difference between the POC INR and the laboratory INR is not necessarily due to failure of the POC device. This study aimed to identify variables associated with a significant deviation between the POC INR and the laboratory INR. METHODS Children included in this retrospective cohort study performed at least one concomitant laboratory and POC INRs. Clinical and laboratory variables were assessed for an association with significant deviation within pairs of INR. RESULTS A significant deviation was noted for 30 (15.3%) of the 196 pairs of INR measurements from 124 children. Relative to patients without deviations, patients with deviations were younger (odds ratio =0.91; P = .020), less experienced in the use of POC INR devices (odds ratio =0.89; P = .098), and more likely to have received an INR result from a laboratory using animal thromboplastin (odds ratio =2.81 vs. 0.37 for laboratories using human thromboplastin; P = .016). In a multivariate analysis, younger age and the laboratory's use of animal thromboplastin were associated with significant deviations. CONCLUSIONS Although most children had coherent pairs of INR values, the occurrence of deviations raises the question of the origin of the thromboplastin used in the laboratory and emphasizes the need to provide specific quality control procedures for POC INR devices.

The presence of 3-monochloropropane-1,2-diol (3-MCPD) esters and 2-MCPD esters in infant formulas have raised a number of food safety concerns. Here, a dietary exposure assessment was conducted for 3-and 2-MCPD esters in infant formulas available for consumption in Chinese infant and toddlers aged 0-3 years old. This work presents the occurrence data for 3-and 2-MCPD ester in 874 infant formulas purchased in China between 2015 and 2017. The concentrations of 3-MCPD esters ranged from ND to 1.469 mg/kg, with concentrations of 2-MCPD esters ranging from ND to 0.218 mg/kg. The LODs of 3-and 2-MCPD esters were 0.027-0.074 mg/kg. The mean exposures of infants and toddlers to 3-MCPD esters from formulas were lower than the tolerable daily intake (TDI, 2 μg/kg bw/day, established by EFSA), while high exposures (95th percentile) to 3-MCPD esters ranged from 0.907 to 2.520 μg/kg bw/day. On the whole, the health risk of Chinese infant and toddlers exposed to 3-MCPD esters was low, but the health risk of some infants aged 0-6 months with high formula consumption (95th percentile) raises some concern.

International audience; The structural design of spars for horizontal axis wind turbine blades to achieve satisfactory levels of performance starts with the knowledge of aerodynamic forces acting on the blades. The present paper proposes a comparative study of the geometries of three spars designed for a 48 m long composite blade. The spars are evaluated under compression, bending loads as well as on free vibration. Different Subroutines have been developed and coupled with Finite Element Analysis (FEA) software to analyze the mechanical performances and the qualities of each one of the three designed spars. In other words, it seeks not only to define the behavior and response of each one of the spars and the effect of composite materials on the improvement of the structure stiffness and weight, but also to determine the suitable spars type for the wind turbine blade and the results shows that the Box spars offers a compromise of the main parameters.

Raman spectroscopy is an analytical method to identify medical samples of bacteria. Because Raman spectroscopy detects the biochemical properties of a cell, there are many factors that can influence and modify the Raman spectra of bacteria. One possible influence is a proper method for isolation of the bacteria. Medical samples in particular never occur in purified form, so a Raman-compatible isolation method is needed which does not affect the bacteria and thus the resulting spectra. In this study, we present a Raman-compatible method for isolation of bacteria from bronchoalveolar lavage (BAL) fluid using density gradient centrifugation. In addition to measuring the bacteria from a patient sample, the yield and the spectral influence of the isolation on the bacteria were investigated. Bacteria isolated from BAL fluid show additional peaks in comparison to pure culture bacteria, which can be attributed to components in the BAL sample. The isolation gradient itself has no effect on the spectra, and with a yield of 63% and 78%, the method is suitable for isolation of low concentrations of bacteria from a complex matrix. Graphical abstract Supplementary Information The online version contains supplementary material available at 10.1007/s00216-021-03488-0.

Objectives. To examine age and temporal trends in the proportion of COVID-19 deaths occurring out of hospital or in the emergency department and the proportion of all noninjury deaths assigned ill-defined causes in 2020. Methods. We analyzed newly released (March 2021) provisional COVID-19 death tabulations for the entire United States. Results. Children (younger than 18 years) were most likely (30.5%) and elders aged 64 to 74 years were least likely (10.4%) to die out of hospital or in the emergency department. In parallel, among all noninjury deaths, younger people had the highest proportions coded to symptoms, signs, and ill-defined conditions, and percentage symptoms, signs, and ill-defined conditions increased from 2019 to 2020 in all age–race/ethnicity groups. The majority of young COVID-19 decedents were racial/ethnic minorities. Conclusions. The high proportions of all noninjury deaths among children, adolescents, and young adults that were coded to ill-defined causes in 2020 suggest that some COVID-19 deaths were missed because of systemic failures in timely access to medical care for vulnerable young people. Public Health Implications. Increasing both availability of and access to the best hospital care for young people severely ill with COVID-19 will save lives and improve case fatality rates.

Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture.Methods : : We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories: facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria.Results : : Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twenty-five KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation.Conclusion : : For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.

Sepsis represents a global health priority because of its high mortality and morbidity. The key to improving prognosis remains an early diagnosis to initiate appropriate antibiotic treatment. Procalcitonin (PCT) is a recognized biomarker for the early indication of bacterial infections and a valuable tool to guide and individualize antibiotic treatment. To meet the increasing demand for PCT testing, numerous PCT immunoassays have been developed and commercialized, but results have been questioned. Many comparison studies have been carried out to evaluate analytical performance and comparability of results provided by the different commercially available immunoassays for PCT, but results are conflicting. External Quality Assessment Schemes (EQAS) for PCT constitute another way to evaluate results comparability. However, when making this comparison, it must be taken into account that the variety of EQA materials consist of different matrices, the commutability of which has not yet been investigated. The present study gathers results from all published comparison studies and results from 137 EQAS surveys to describe the current state-of-the-art harmonization of PCT results. Comparison studies globally highlight a significant variability of measurement results that nonetheless seem to have a moderate impact on medical decision-making. For their part, EQAS for PCT provides highly discrepant estimates of the interlaboratory CV. Due to differences in commutability of the EQA materials, the results from different peer groups could not be compared. To improve the informative value of the EQA data, the existing limitations such as non-harmonized conditions and suboptimal and/or unknown commutability of the EQA materials have to be overcome. The study highlights the need for commutable reference materials that could be used to properly evaluate result comparability and possibly standardize calibration, if necessary. Such an initiative would further improve the safe use of PCT in clinical routine.

Snakebite envenomation is a public health problem of high impact, particularly for the developing world. Antivenom, which contains whole or protease-digested immunoglobulin G, purified from the plasma of hyper-immunized animals (mainly horses), is the mainstay for the treatment of snakebite envenomation. The success of antivenom therapy depends upon its ability to abrogate or reduce the local and systemic toxicity of envenomation. In addition, antivenom administration must be safe for the patients. Therefore, antivenom manufacturers must ensure that these products are effective and safe in the treatment of envenomations. Antivenom efficacy and safety are determined by the physicochemical characteristics of formulations, purity of the immunoglobulin fragments and antibodies, presence of protein aggregates, endotoxin burden, preservative load, and batch to batch variation, as well as on the ability to neutralize the most important toxins of the venoms against which the antivenom is designed. In this context, recent studies have shown that laboratory-based simple analytical techniques, for example, size exclusion chromatography, sodium dodecyl sulphate polyacrylamide gel electrophoresis, mass spectrometry, immunological profiling including immuno-turbidimetry and enzyme-linked immunosorbent assays, Western blotting, immune-chromatographic technique coupled to mass spectrometry analysis, reverse-phase high performance liquid chromatography, spectrofluorometric analysis, in vitro neutralization of venom enzymatic activities, and other methodologies, can be applied for the assessment of antivenom quality, safety, stability, and efficacy. This article reviews the usefulness of different analytical techniques for the quality assessment of commercial antivenoms. It is suggested that these tests should be applied for screening the quality of commercial antivenoms before their preclinical and clinical assessment.

Ultrasound Core Laboratories (UCL) are used in multicenter trials to assess imaging biomarkers to define robust phenotypes, to reduce imaging variability and to allow blinded independent review with the purpose of optimizing endpoint measurement precision. The Household Air Pollution Intervention Network, a multicountry randomized controlled trial (Guatemala, Peru, India and Rwanda), evaluates the effects of reducing household air pollution on health outcomes. Field studies using portable ultrasound evaluate fetal, lung and vascular imaging endpoints. The objective of this report is to describe administrative methods and training of a centralized clinical research UCL. A comprehensive administrative protocol and training curriculum included standard operating procedures, didactics, practical scanning and written/practical assessments of general ultrasound principles and specific imaging protocols. After initial online training, 18 sonographers (three or four per country and five from the UCL) participated in a 2 wk on-site training program. Written and practical testing evaluated ultrasound topic knowledge and scanning skills, and surveys evaluated the overall course. The UCL developed comprehensive standard operating procedures for image acquisition with a portable ultrasound system, digital image upload to cloud-based storage, off-line analysis and quality control. Pre- and post-training tests showed significant improvements (fetal ultrasound: 71% ± 13% vs. 93% ± 7%, p < 0.0001; vascular lung ultrasound: 60% ± 8% vs. 84% ± 10%, p < 0.0001). Qualitative and quantitative feedback showed high satisfaction with training (mean, 4.9 ± 0.1; scale: 1 = worst, 5 = best). The UCL oversees all stages: training, standardization, performance monitoring, image quality control and consistency of measurements. Sonographers who failed to meet minimum allowable performance were identified for retraining. In conclusion, a UCL was established to ensure accurate and reproducible ultrasound measurements in clinical research. Standardized operating procedures and training are aimed at reducing variability and enhancing measurement precision from study sites, representing a model for use of portable digital ultrasound for multicenter field studies.

Streptokinase is a well-established cost-effective therapeutic molecule for thrombo-embolic complications. In the current study, a tag-free variant of streptokinase with a native N-terminus (N-rSK) was developed using the Pichia expression system. A three-copy clone was screened that secreted 1062 mg/L of N-rSK in the complex medium at shake flask level. The biologically active (67,552.61 IU/mg) N-rSK recovered by anion exchange chromatography was predicted to contain 15.43% α-helices, 26.43% β-sheets. The fermentation run in a complex medium yielded a poor quality product due to excessive N-rSK degradation. Therefore, modified basal salt medium was also employed during fermentation operations to reduce the proteolytic processing of the recombinant product. The concomitant feeding of 1 g/L/h soya flour hydrolysate with methanol during the protein synthesis phase reduced the proteolysis and yielded 2.29 g/L of N-rSK. The fermentation medium was also supplemented with urea during growth and induction phases. The combined feeding approach of nitrogen-rich soya flour hydrolysate and urea during bioreactor operations showed significant improvement in protein stability and resulted in a 4-fold increase in N-rSK concentration to a level of 4.03 g/L over shake flask. Under optimized conditions, the volumetric productivity and specific product yield were 52.33 mg/L/h and 33.24 mg/g DCW, respectively.

As China is implementingquot;Healthy Chinaquot; strategy, medicinal and edible food has attracted unprecedented attention due to the dual attributes of food and medicine. However, there is a lack of the quality control standard and the existing quality control research cannot fully reflect the dual attributes of medicinal and edible food, which consequently restrict the development of medicinal and edible food industry. This study reviewed the research status and proposed the strategy of quality control in line with the dual attribu-tes of medicinal and edible food, and clarified the research contents of quality control of medicinal and edible food of different types to provide references for the follow-up quality control of medicinal and edible food.

The community-driven initiative Quality Assessment and Reproducibility for Instruments & Images in Light Microscopy (QUAREP-LiMi) wants to improve reproducibility for light microscopy image data through quality control (QC) management of instruments and images. It aims for a common set of QC guidelines for hardware calibration and image acquisition, management and analysis.

Objectives: The objective of the study was to assess the impact of an internal quality indicator (QI) audit on the quality level of colonoscopies in the National Colorectal Cancer Screening Program (NCCSP). Design: Sixty-eight colonoscopists from 29 endoscopic centres participated in the NCCSP from April 2009 to January 2015. Controlled QIs were the percentage of total colonoscopies, adenoma detection rate (ADR), mean adenoma per procedure (MAP), mean adenoma per positive procedure (MAP+), right-sided ADR, sessile serrated lesion (SSL) detection rate, and patient responses to post-procedural questionnaires. A group of 3 expert endoscopists from the NCCSP Council performed 91 inspections and provided education. Results: A total of 891.364 (58.2%) Slovenian citizens participated in the first 3 screening rounds of the NCCSP. Among 46.552 (6%) positive individuals, 42.866 (92.1%) underwent first colonoscopies. Total colonoscopies were performed in 98% of endoscopies (p = 0.459 between cycles), mean ADR was 51.8% (p = 0.872 between cycles), mean percentage of adenoma in the right colon was 37.5% (p = 0.227 between cycles), mean MAP was 1.1 (p = 0.981 between cycles), mean MAP+ was 2.0 (p = 0.824 between cycles), and mean SSL detection rate was 3% (p < 0.001). We observed great difference in QIs between endoscopists and a significant increase in MAP, ADR in the right colon, and SSL per endoscopist during the 6-year period. Due to quality underperformance, 3 endoscopic centres (10.3%) and 13 endoscopists (19.1%) were excluded from the program. Conclusions: The success of the NCCSP is related to the quality of colonoscopies performed. To ensure the proper quality level, regular audit and permanent education are needed.

OBJECTIVE Myelomeningocele (MMC) is frequently complicated by symptomatic hydrocephalus, necessitating early permanent CSF diversion and revision surgeries. Shunt infections are a common cause of shunt malfunction. This study aims to characterize long-term shunt-related outcomes of patients undergoing MMC closure. METHODS A total of 170 patients undergoing MMC closure between the years of 1995 and 2017 were identified from a retrospective review of a prospectively populated surgical database at the Children’s Hospital of Pittsburgh. Patients who underwent MMC closure and required ventriculoperitoneal (VP) shunt insertion met criteria and were included in the primary study analysis. Analysis with a Fisher exact test was performed for categorical variables, and Mann-Whitney U-tests were utilized for numerical data. RESULTS Of the 158 total patients undergoing MMC closure and meeting inclusion criteria, 137 (87%) required VP shunt insertion. These 137 patients demonstrated a shunt revision rate of 21.1% per person-year and a shunt infection rate of 2.1% per person-year over a mean follow-up of 10.8 years. Patients had a mean of 3.4 ± 0.6 shunt surgeries prior to their first infection. Patients undergoing immediate shunt removal, external ventricular drain placement, or shunt replacement after clearing the infection had lower rates of subsequent infections than patients who initially were managed with shunt externalization (p < 0.001). Placement of a shunt at the time of MMC closure was not found to be a risk factor for infection. Of patients with initial shunt placement after the implementation of the Hydrocephalus Clinical Research Network protocol in 2011, the authors’ institution has had a shunt infection rate of 4.2% per person-year and a revision rate of 35.7% per person-year. CONCLUSIONS This study describes long-term outcomes of shunted MMC patients and factors associated with shunt infections. Most patients underwent multiple revisions prior to the first shunt infection. Shunt externalization may be ineffective at clearing the infection and should be avoided in favor of early shunt removal and external ventricular drainage, followed by shunt replacement once infection is demonstrated to have cleared.

Background: Population based Cancer Registries(PBCRs) are hallmark of cancer surveillance and cancer control activity .The value of cancer registries rely heavily on underlying quality of their data. Current study assessed data quality of four new PBCRs of Chandigarh, SAS Nagar, Mansa and Sangrur covering a total population of 4.5 millions on three quality parameters i.e. comparability, validity and completeness as recommended by International Agency of Research on Cancer(IARC), Lyon, France. Methods: For assessing comparability, data of the registries were reviewed in terms of system of classification and coding, definition of incidence date and rule for multiple primaries. For assessing validity (Accuracy) four different methods i.e. re-abstraction and re-coding, percentage morphologically verified cases (MV%), percentage of death certificate only (DCO%) cases and percentage of cases with other and unspecified sites (O and U%) were used. For assessing completeness of coverage, different semi-quantitative methods were used. Results: Re-abstraction done for 10% of the total incident cases yielded overall percentage agreement of 97.4%, 97.2%, 95.4% and 94.9% for PBCR Chandigarh, SAS Nagar, Mansa and Sangrur respectively. MV% was found to be 96.3% for PBCR Chandigarh, 92.8% for PBCR SAS Nagar , 89.3% for PBCR Mansa and 82.9% for PBCR Sangrur. Percentage of DCO cases and O and U cases were 1.4% and 2.8% for PBCR Chandigarh, 3.9% and 5.3% for SAS Nagar, 6.4% and 16.4% for Mansa and 6.3% and 8.3% for Sangrur. Completeness assessed through the various methods showed good level of completeness at PBCR Chandigarh and SAS Nagar and somewhat lower but acceptable level of completeness at PBCR Mansa and Sangrur. Conclusions: All the four PBCRs are comparable internationally. PBCR Chandigarh and SAS Nagar, predominantly urban registries, have higher accuracy of their data and good completeness levels as compared to predominantly rural registries of Mansa and Sangrur. Cancer estimates given by all the four registries are reliable and data from these registries can be utilized for planning cancer prevention and control activities in the region.

The recent revision of OECD inhalation toxicology test guidelines 412 and 413 presents new challenges for both the study director (SD) and quality assurance (QA) personnel when conducting GLP (good laboratory practice) studies. In the case of nanomaterial inhalation exposure studies, GLP has rarely been applied, yet the new revisions are applicable to soluble and insoluble nanomaterials, as well as conventional chemicals. For example, the new guidelines require an additional bronchoalveolar lavage (BAL) fluid assay and lung burden measurement during the post-exposure observation (PEO) period, plus nanomaterial physicochemical characterization before and after nano-aerosol generation when exposing experimental animals. Implementing these revised guidelines will prove especially challenging for QA measures related to the physicochemical characterization and aerosolization of test nanomaterials. Therefore, this review examines the key elements involved in nanomaterial inhalation GLP testing under the revised OECD guidelines, suggests an alternative to the increased animal numbers, in consideration of animal welfare and with scientific merits, and discusses the limitation of toxicokinetic estimation using the new testing guidelines.

PURPOSE: Quality assurance (QA) of ultrasound (US) equipment is currently required in only a few countries around the world. In Greece, no national or other norms exist for regulating the use of US equipment. However, to obtain accreditation for the radiology department of a Greek hospital, the establishment and implementation of a quality control (QC) protocol and a QA programme for US equipment was required. MATERIALS AND METHODS: A literature review regarding US QC/QA procedures was performed. The information collected was used as a guide to create a QC/QA protocol and to obtain an appropriate US QC phantom. Drafting and testing of the initial protocol lasted 6 months. Its final version was implemented for 18 months in two US systems and five US transducers. RESULTS: The QC tests included in the protocol evaluate mechanical and electrical safety, image display, uniformity, penetration depth, distance accuracy, greyscale display, anechoic object imaging, geometric distortion, and axial/lateral resolution. The only QC test that failed was the test for uniformity since intense non-uniformities were observed that led to the replacement of two linear transducers. CONCLUSION: US imaging is considered safe and, where appropriate, is preferred over imaging modalities that use ionizing radiation. However, the lack of QC/QA implies that US image quality is not routinely monitored. Therefore, the possibility of malfunctions that may go undetected and lead to wrong diagnosis cannot be excluded. A QC/QΑ programme can contribute to the elimination of such errors and ensure that performance is maintained over time.

Introduction The largest source of manmade ionising radiation exposure to the public stems from diagnostic medical imaging examinations. Reject analysis, a form of quality assurance, was introduced to minimise repeat exposures. The purpose of this study was to analyse projection‐specific reject rates and radiographic examinations with multiple rejects. Methods A retrospective audit of rejected radiographs was undertaken in a busy Australian metropolitan emergency digital X‐ray room from March to June 2018. The data were collected by reject analysis software embedded within the X‐ray unit. Reject rates, and reasons for rejection for each X‐ray projection were analysed. Results Data from 11, 596 images showed overall reject rate was 10.3% and the overall multiple reject rate was 1.3%. The projections with both a high number and high percentage of rejects were antero‐posterior (AP) chest (175, 18.1%), AP pelvis (78, 22.5%), horizontal beam hip (61, 33.5%) and horizontal beam knee (116, 30.5%). The projections with both a high frequency and multiple reject rate were horizontal beam knee (32, 8.4%) and horizontal beam hip (17, 9.3%). The top reasons for multiple rejects were positioning (67.1%) and anatomy cut‐off (8.4%). Conclusions The findings of this study demonstrated that projection‐specific reject and multiple reject analysis in digital radiography is necessary in identifying areas for quality improvement which will reduce radiation exposure to patients. Projections that were frequently repeated in this study were horizontal beam knee and horizontal beam hip. Future research could involve re‐auditing the department following the implementation of improvement strategies to reduce unnecessary radiation exposure., The purpose of this study was to analyse projection‐specific reject rates and radiographic examinations with multiple rejects. Data from 11,596 images showed overall reject rate was 10.3% and the overall multiple reject rate was 1.3%. Projections that were frequently repeated in this study were horizontal beam knee and horizontal beam hip. The findings of this study demonstrated that projection‐specific reject and multiple reject analysis in digital radiography is necessary in identifying areas for quality improvement which will reduce radiation exposure to patients.

Purpose The output constancy check, a basic quality control (QC) item for radiotherapy machines, is performed daily according to suggestions in technical reports by experienced experts. In this study, a patient risk model was built to determine the optimal frequency of an output constancy check for a specific radiotherapy machine. Methods and materials The method was based on the patient risk model and comprised three steps: 1) the power function graph was used to select a proper QC rule and the average number of QC measurements per QC rule evaluation. 2) The optimal QC frequency was determined by the minimum integer value of expected patients treated between QC measurements. 3) The individual control chart (I-Chart) was used to evaluate the effectiveness of the model. The model was implemented on the output constancy check of a Tomotherapy machine. Results The QC rule with the limits set to the mean ± 3 standard deviations and 5 measurements per QC were selected according to the power function graph. The optimal frequency was observed every 21 patients. The I-Chart showed that the optimal frequency detected the machine failure earlier compared to the conventional daily frequency. The model could monitor whether Tomotherapy machine was in good condition and predicted the time to adjust the machine. Conclusions The optimal output constancy check frequency of a radiotherapy machine is determined by the number of patients, which uses patient risk model. The optimal frequency is superior to the conventional daily frequency in identifying machine failure earlier.

Objectives Failure to rescue (FTR) is defined by the number of deaths among patients experiencing major complications after surgery. In this report we analyze FTR and apply a cumulative sum control chart (CUSUM) methodology for monitoring performance in a large series of operated lung carcinoma patients. Methods Prospectively stored records of cases undergoing anatomical lung resection in one center were reviewed. Postoperative adverse events were coded and included as a binary variable (major, or minor complications). The occurrence of 30-day mortality was also recorded. Patients dying after suffering major complications were considered as FTR. Risk-adjusted CUSUM graphs using EuroLung1 and 2 variables were constructed for major complications and FTR. Points of plateauing or trend inversion were checked to detect intentional or non-adverted changes in the process of care. Results 2237 cases included. 9.1% cases suffered major complications. The number of cases considered as failures to rescuing was 46 (2.1% of the total series and 22.5% of cases having major complications). The predictive performance of EuroLung1 and 2 models was as follows: EuroLung1 (major morbidity) C-index 0.70 (95%CI: 0.66–0.73); EuroLung2 (applied to FTR) C-index 0.81 (95%CI: 0.750.87). CUSUM graphs depicted improvement in rescuing complicated patients after case 330 but no improvement in the rate of non-complicated cases until case 720. Conclusions FTR offers a complementary view to classical outcomes for quality assessment in Thoracic Surgery. Our study also shows how the analysis of FTR on time series can be applied to evaluate changes in team performance along time.

Objective The quality of patient information relating to intermittent claudication (IC) and peripheral arterial disease (PAD) on the World Wide Web was assessed. Methods The quality of websites and YouTube videos was assessed using the search terms “intermittent claudication” and “peripheral arterial disease”. The first 50 hits screened for each search term from the three largest search engines by market share, and the first 20 videos from YouTube were screened. Website quality was scored using the University of Michigan Consumer Health Website tool (maximum score 80). Readability was calculated using the Flesch Reading Ease (FRE) score (maximum score 100). Videos were classified by content and upload source. Video reliability was assessed using the JAMA benchmark criteria. Video educational content was assessed using the Global Quality Score (GQS). Subjective content assessment was undertaken. Results Seventy-six websites were analysed. The majority of websites for both IC (51.7%) and PAD (72.3%) were rated as weak. The median Michigan score for IC (27; interquartile range [IQR] 15, 32.5) was lower that the score for PAD (31; IQR 25.5, 38.8; p = .030). The majority of websites for both IC (69%) and PAD (68.1%) were rated as requiring an above average reading level. The overall median FRE score was 55.9 (IQR 46.6, 60.6) for IC and 55.3 (IQR 44.6, 59.3) for PAD. Twenty-two videos were analysed. Of the 14 videos evaluated as part of the PAD search, the median JAMA score was 2 (2 – 3), the median GQS score was 3 (3 – 3) and the evaluation of content score was 8.5 (7.25 – 11.5). The equivalent scores for the IC search were 2 (2 – 2), 3 (3 – 4), and 5.5 (5 – 8). Conclusion The educational quality and reliability of information both in written and video form on the internet is low. Attention needs to focus on improving the quality of all forms of information delivery to allow proper advocacy for patients.