Effective Quality Control Research Articles

Applying the total survey error framework to PIAAC

PurposeSurveys in multinational, multiregional and multicultural contexts (or “3MC” surveys) are becoming increasingly important to global and regional decision-making and theory building. To serve this purpose, the surveys need to be well managed, with an awareness of key sources of survey error and how to minimize them, mechanisms in place to control the implementation process and an ability to intervene in that process when necessary in a spirit of continuous improvement (Pennell et al., 2017). One key approach for managing and assessing the quality of 3MC surveys is the total survey error (TSE) framework and associated survey process quality. This paper aims to examine the application of the TSE framework and survey process quality to the Programme for the International Assessment of Adult Competencies (PIAAC).Design/methodology/approachThe authors begin with a background on TSE and discuss recent adaptations of TSE and survey process quality for 3MC surveys. They then presents a TSE framework tailored with examples of potential contributions to error for PIAAC and ways to address those through effective quality assurance (QA) and quality control (QC) approaches.FindingsOverall, the authors find that the design and implementation of the first cycle of PIAAC largely reflect the current best practice for 3MC surveys. However, the authors identify several potential contributions to error that may threaten comparability in PIAAC and ways these could be addressed in the upcoming cycle.Originality/valueWith a view toward continuous improvement, the final section draws on the survey process quality approach adapted from Hansen et al.’s study (2016) to summarize the recommendations in terms of additional QA elements (inputs and activities) and associated QC elements (measures and reports) for PIAAC’s consideration in the next cycle.

An Aptamer‐Based Approach to Assess the Human Plasma Proteome for Pre‐Analytical Variability

The quality of clinical samples is of utmost importance when conducting biomedical research with OMICS‐based assays as the variability introduced before sample analysis is a potential confounder in the results. In this study, we used the aptamer‐based SOMAscan® proteomic technology to characterize pre‐analytical variability in human EDTA plasma. The goal of the study was to investigate how variation in the pre‐analytical steps during processing of whole blood to plasma impacts the plasma proteome. Whole blood was obtained from apparently healthy individuals and was collected in a randomized sequence of six EDTA tubes. The pre‐analytical variables included prolongation of the processing start time, storage temperature of whole blood or plasmaprior to and after processing, and variation in applied centrifugal force. The SOMAscan® assay was performed to measure the relative abundance of 1305 proteins. To determine the effects of variations inpre‐analytical processing, the data was statistically analyzed and the results were used to identify significant changes in protein abundance under each study condition relative to the control condition (samples processed without delay and immediately stored at −80°C). Both low centrifugation force(1300 × g compared to 2500 × g) and blood storage at 0°C for 6 hours resulted in the most significant changes in protein abundance (200 and 148 proteins, respectively, fold change ≥ 1.2, P < 0.05, and FDR < 0.05), while storing immediately processed plasma for 24 hours at 4°C yielded the least changes (28 proteins). The results indicate that blood samples should be immediately processed to plasma and frozen in −80°C without delay in order to preserve sample integrity and to minimize any proteome abundance alterations. The results also provide important information on the discovery of protein abundance changes due to pre‐analytical variability that can be useful in performing effective quality control assessments.Support or Funding InformationThis study was supported with funds from the National Center for Toxicological Research, Food & Drug Administration, Jefferson, Arkansas.This abstract is from the Experimental Biology 2018 Meeting. There is no full text article associated with this abstract published in The FASEB Journal.

Effective Protocols and Channel Quality Control Mechanisms for Cooperative ARQ With Opportunistic AF Relaying

Incorporating relaying techniques into automatic repeat reQuest (ARQ) in general will provide diversity and throughput enhancements. However, when opportunistic amplify-and-forward (AF) relaying is applied to cooperative ARQ, the system design becomes much more involved. First, our capacity outage analysis shows that the temporal diversities of ARQs with a single AF relay cannot be exploited unless the channel quality to the relay exceeds a threshold. This notion of selective AF relaying is extended to systems with multiple relays in an attempt to jointly explore the temporal and spatial diversities with ARQ. Two types of selective and opportunistic AF relaying schemes are then developed for such kinds of relay-assisted ARQ. And our analysis further shows that the temporal and spatial diversities cannot be fully exploited without the use of overhearing among relays and a proper link quality control mechanism to prescreen the overheard signals. This quality control mechanism is implemented with a set of thresholds designed for each hop of the relaying path. Feasible threshold setting methods are also developed for the proposed ARQ protocols to achieve their potential diversities. In contrast to our designs, the ARQ scheme with the typical opportunistic AF relaying method suffers from severe diversity losses. Simulations also show that the proposed ARQ schemes are more effective in throughput enhancement, and can provide cell-edge users almost three times the throughput gain in comparison with ARQ with no relay-assisted forwarding.

Quality assessment of porous CFRP specimens using X-ray Computed Tomography data and Artificial Neural Networks

Despite their extensive use and the quality amelioration, CFRPs remain susceptible to a variety of manufacturing defects such as the pores. Predictive tools capable of correlating the mechanical properties of CFRP parts with the characteristics of defects as derived from NDT techniques or with the manufacturing parameters could serve as an effective tool for the quality control of CFRP structural parts. The present work contributes towards the development of effective quality control tools for composite materials. Within this context, the characteristics of pores, as evaluated by X-ray Computed Tomography (CT), are correlated with the matrix-dominated mechanical properties of unidirectional porous CFRP specimens using an Artificial Neural Network (ANN). The ANN model has been trained by using a multi-scale numerical model. For the training of the ANN, 30 porosity scenarios have been created and given as input to the numerical model. The predictions of the ANN agree very well with results obtained from mechanical tests. Moving one step forward, a second ANN has been developed to correlate the autoclave pressure directly with the mechanical properties of the CFRP specimens. The validity of this ANN depends on the accuracy of the relation between the autoclave pressure and the characteristics of the pores.

Analytical perspectives of chemical adulterants in herbal sexual enhancer drugs

Context: Detection of active pharmaceutical ingredients in herbal drugs has been described in numerous studies. However, few reports have been published in relation to the analysis of counterfeit herbal supplements for the detection of synthetic drugs in Iran. Aims: To analyze herbal drugs used as sexual performance enhancer from forensic and analytical toxicology point of view. Methods: Eighty herbal drugs gathered from herbal shops in Bushehr city, Iran were analyzed. High-performance liquid chromatography and gas chromatography/mass spectrometry were used for detecting and identifying the chemical structures of probable active pharmaceutical ingredients as adulterants. Results: Among 80 samples, 23% contained only sildenafil. Three samples contained sildenafil, tramadol, and diazepam in combination with each other reported for the first time. Conclusions: This study substantiates regular analysis of purported herbal drugs is needed for more effective quality control and health promotion.

Proposal of Quality Management in Clinical Trials based on the Concept of ICH Guideline Q8

We investigated whether the basic concepts of ICH guideline Q8 “ Pharmaceutical Development” relating to the effective and efficient control of quality in drug development can be applied as a means for the effective and efficient implementation of audits carried out as a part of the quality assurance program for clinical trials in clinical development. We divided the clinical trial into 12 processes. Pharmaceuticals and Medical Devices Agency (PMDA) Inquiries from GCP On-site Inspections and Document-based Conformity Inspections, obtained from the PMDA on the basis of the information disclosure system, were categorized into the 12 processes. As our analysis targets, we chose the “ Revision of written informed consent form with regard to serious adverse events (SAEs)” process, which relates to patient safety, and the “ Examination/Observation/Assessment” process, which generates the highest number of inquiries. These two processes were further divided into several sub-processes. The inquiries were analyzed to tabulate the number of harms in each sub-process and to identify the nature of those events. We then identified the process parameters (PPs) of each process as well as deviations from said PPs (hazards), and tabulated the number of these incidences. We found that the number of harms attributable to said two processes were localized in specific sub-processes. Localization was likewise observed in the nature of the harms, the PPs relating to said harms, and deviations from said PPs. We also identified which sub-processes, the nature of harms,the PPs relating to said harms, and deviations from said PPs require management. Our findings suggest that the basic concepts of the ICH-Q8 guidelines can be applied to the quality assurance programs for clinical trials for the effective and efficient implementation of audits.

КОНТРОЛЬ ЯКОСТІ ТА БЕЗПЕЧНОСТІ М’ЯСНОЇ СИРОВИНИ ЗА ЗАСТОСУВАННЯ ЕКСПРЕСНОГО МЕТОДУ

Effective food quality control and quality control systems are essential for protecting the health of consumers. They are necessary to create conditions in which the state can guarantee the safety and quality of meat raw material entering into the implementation, check compliance with its national requirements. Domestic meat processing enterprises are strategically important in the context of ensuring Ukraine's security in relation to food. Meat products are irreplaceable in the human diet and their consumption affects the health of the population. In the countries of the European Community, considerable attention is paid to the improvement of the legislative framework for controlling the traceability of meat raw material throughout the entire food chain – from field to table. Market operators are required to ensure the introduction of procedures for the withdrawal of meat products that poses a potential risk to consumers' health and to keep the suppliers of raw materials properly accounted for in order to identify the source of the problem. Particularly topical issues are state control of livestock products in modern conditions in connection with the development of the agro-industrial complex of Ukraine. One of the requirements for the prevention of the implementation of hazardous and poor-quality meat raw materials is the complex control system taking in to account commonly accepted and developed new express methods for determining the degree of freshness of meat raw material coming from the power for food production or sold in the trading network. The research establishes the degree of freshness of meat raw material obtained from various types of slaughtered animals by conventional methods and an express photometric method using the Nessler reagent, based on the determination of the optical density of the intensity of the coloration of meat and water extraction due to the accumulation of ammonia and ammonium salts in meat, which reacts with Nessler's reagent to form a compound from olive-yellow to yellow-orange. The degree of freshness of meat raw material according to generally accepted methods is established. It was determined that the highest optical density of fresh and doubtful freshness of minced meat was in the meat raw material of the horse - 1,302±0,004 and 1,413±0,005 B; from beef, respectively 1,262 ± 0,001 and 1,320±0,007 B, from veal, respectively, 1,253±0,003 and 1,287±0,003 B, respectively, and the lowest according to the degree of freshness – in the minced meat from urkey meat - 0,504 ± 0,001 B and 0,695 ± 0,005 B; in the meat of chicken (breast fillet) - respectively, 0,572±0,001 and 0,770±0,013 B; in the broiler chicken fillet ("Nasha Ryaba") - respectively 0,604±0,001 and 0,805 ± 0,004B. It was determined that the highest optical density from extraction of fresh and doubtful freshness of meat minced meat was in the minced meat "Chicken", respectively, 1,109 ± 0,001 and 1,331±0,050 B; "Kotletnoy" respectively - 0,947 ± 0,001 and 1,213 ± 0,003 B, and the lowest, respectively, in minced meat "Home" - 0,822 ± 0,001 and 1,003 ± 0,006 B respectively. Patented express photometric method for determining the degree of freshness of meat raw material, which has a reliability in the test of 99.9%, should be used in conjunction with other generally accepted methods for determining the quality and safety of this meat raw material.

UHPLC-ESI-Q-TOF-MS/MS analysis, antioxidant activity combined fingerprints for quality consistency evaluation of compound liquorice tablets.

Traditional Chinese medicines (TCM)/herbal medicines (HM) are too complicated to comprehensively investigate their quality consistency effectively with a single detection technique. Hence, finding an effective, rapid, and comprehensive quality control (QC) method is of great importance for guaranteeing the safety and efficacy of TCM/HM in clinical applications. In our current research, a novel strategy of multi-wavelength fusion HPLC fingerprints and ultraviolet (UV) spectroscopic fingerprinting was proposed and successfully applied to monitor the quality consistency of compound liquorice tablets (CLT). The quality grades of 35 CLT samples from two manufacturers were successfully discriminated and evaluated by the averaged linear quantified fingerprint method (ALQFM) from a qualitative and quantitative perspective. The results showed that the UV spectroscopic fingerprints agreed well with the multi-wavelength fusion HPLC fingerprints. In addition, ultra-high-performance liquid chromatography coupled with electrospray ionization quadrupole time-of-flight mass spectrometry (UHPLC-ESI-Q-TOF-MS) was applied to investigate the chemical constituents in CLT samples, providing an important chemical structural foundation for further QC and bioactivity studies. Additionally, a simple flow injection analysis (FIA) was developed to investigate the antioxidant capacity in CLT, which was based on the scavenging of 2,2-diphenyl-1-picrylhydrazyl radicals by antioxidants. Furthermore, the fingerprint–efficacy relationship between high-performance liquid chromatography (HPLC) fingerprints and the antioxidant activities of CLT samples was established utilizing orthogonal projection to latent structures (OPLS). In conclusion, this study indicated that integrating UHPLC-ESI-Q-TOF-MS/MS, UV spectroscopic fingerprints, and multi-wavelength fusion HPLC fingerprints coupled with the antioxidant activities reported could give important clues for further pharmacological and clinical studies of CLT. Meanwhile, it provides a practical strategy for the rapid screening and identifying of TCM/HM quality consistency.

Metal–organic framework-based nanofiber filters for effective indoor air quality control

MOF-based nanofiber filters via a scalable synthetic strategy serve a dual role in removing both PM2.5 and formaldehyde effectively.

Prediction of mechanical properties of porous CFRP specimens by ANNs and X-ray CT data

Carbon fiber reinforced plastics (CFRPs) have evolved into the primary material for several lightweight structures. However, despite their extensive use and the quality amelioration, CFRPs remain susceptible to a variety of manufacturing defects, the most common of which are the pores. Predictive tools capable of correlating the mechanical properties of CFRP parts with the characteristics of defects as derived from non-destructive testing (NDT) techniques or even further with the manufacturing parameters could serve as an effective tool for the quality control of CFRP structural parts. In the present paper, the characteristics of pores as evaluated by X-ray Computed Tomography (CT) have been correlated with the matrixdominated mechanical properties of unidirectional porous CFRP specimens using Artificial Neural Networks (ANN). Thirty (30) porosity scenarios have been created and given as input to the numerical model. That multi-scale numerical model, which had been validated experimentally, has been used for training the ANN model. The predictions of the ANN agree very well with results from mechanical tests. Moving one step forward, a second ANN has been developed to correlate the autoclave pressure directly with the mechanical properties of the CFRP specimens. The validity of the latter ANN depends on the accuracy of the relation between the autoclave pressure and the characteristics of the pores. The present work represents a step towards the development of effective quality control tools for composite materials.

Strength estimation of concrete masonry units using stress-wave methods

Solid concrete masonry units (CMUs) are rapidly replacing burnt clay bricks in the construction industry, especially in the southern regions of Asia. In developing countries, the plants producing CMUs lack effective quality control for the fabricated units. They rely on destructive tests, such as those described by ASTM C140, to demonstrate compliance with compressive strength criteria. Such destructive testing is expensive and is, therefore, performed on a limited scale. A previous study concluded that a surface hardness based nondestructive test (NDT) method (rebound hammer test) is not reliable and that ultrasonic pulse velocity (UPV), which is a stress wave propagation based method, can be a useful tool for strength estimation of CMU (Sajid et al., 2016). This study compares the performance of the UPV test with that of the resonant frequency test, another stress wave propagation based method, to evaluate the compressive strength of concrete specimens. The specimens are made with materials, mixture proportions and compaction similar to those of solid CMUs. The statistical models show that the resonant frequency test is more reliable compared with the UPV test for evaluating strength of concrete for masonry units.

Immunogenicity of Recombinant Adenovirus Type 5 Vector-Based Ebola Vaccine Expressing Glycoprotein from the 2014 Epidemic Strain in Mice.

The 2014 Ebola outbreak in West Africa highlighted the worldwide public health threat posed by this virus and the urgent need for an Ebola vaccine. A novel recombinant adenovirus type 5 vector-based Ebola vaccine (Ad5-EBOV), based on the 2014 Zaire Guinea epidemic strain, was developed in China. A good safety profile and robust immune response elicited by Ad5-EBOV were confirmed in phase 1 and phase 2 clinical trials. Nonetheless, clinical studies of this Ebola vaccine are still at an early stage and there are still no solid efficacy data for humans. For efficacy evaluation and quality control of Ad5-EBOV, the cellular and humoral immune responses in BALB/c mice vaccinated with Ad5-EBOV were examined at various time points. ELISpot and flow cytometric analysis showed that EBOV glycoprotein (GP)-specific T cell responses were detectable early in the first week after infection and by week 4 had increased to maximum levels, which lasted through week 6. During week 1, high titers of EBOV GP-specific antibodies were found (geometric mean [GM], 1783). These titers peaked at week 10 (GM, 26,214) and lasted to 6 months (GM, 1,351). The titer of neutralizing antibodies based on pseudovirus assays also increased over time to peak at 1:16 in one mouse and 1:8 in nine mice during week 6, before decreasing to zero by week 12. These results suggest that BALB/c mice can be used to evaluate the effectiveness of Ad5-EBOV, and that the cellular immune response and humoral immune response can be used as indicators to evaluate vaccine effectiveness. Rapid determination of such methods and indicators is critical for the evaluation of Ebola vaccine efficacy, and can provide effective quality control for Ad5-EBOV.

Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization.

ESTIMACIÓN DE CALIDAD DE OBJETOS DE APRENDIZAJE EN REPOSITORIOS DE RECURSOS EDUCATIVOS ABIERTOS BASADA EN LAS INTERACCIONES DE LOS ESTUDIANTES

Los recursos educativos abiertos se han erigido como uno de los pilares fundamentales de la educacion abierta. Una de las principales barreras que esta obstaculizando su uso y adopcion es la carencia de mecanismos de control de calidad efectivos y sostenibles en los repositorios. Estrategias de evaluacion como la revision por pares no han resultado lo suficientemente escalables para afrontar el ritmo de creacion de materiales abiertos por parte de la comunidad. El presente estudio muestra una nueva estrategia basada en analiticas de aprendizaje para estimar la calidad de los objetos de aprendizaje en base a las interacciones que los estudiantes tienen con ellos en entornos abiertos. Se analizaron 146291 sesiones de interaccion de estudiantes con 256 objetos de aprendizaje distribuidos a traves de un repositorio abierto. Un total de 11 interacciones estudiante-objeto de aprendizaje fueron consideradas en el estudio. La calidad de los recursos fue medida empleando el instrumento estandar de evaluacion LORI (Learning Object Review Instrument). Para estudiar las relaciones entre las interacciones de los estudiantes con los objetos de aprendizaje y la calidad de los mismos y para construir una metrica de prediccion se utilizaron analisis de regresion lineal. Los resultados muestran que existe relacion entre las interacciones y la calidad, y que es posible estimar con un error moderado la calidad de los objetos de aprendizaje en base a las interacciones que los estudiantes tienen con ellos. Los resultados obtenidos senalan que la analitica de aprendizaje propuesta puede ser utilizada en repositorios de objetos de aprendizaje abiertos para detectar automaticamente recursos conflictivos o de baja calidad.

Using radiocarbon to constrain black and organic carbon aerosol sources in Salt Lake City

AbstractBlack carbon (BC) and organic carbon (OC) aerosols are important components of fine particulate matter (PM2.5) in polluted urban environments. Quantifying the contribution of fossil fuel and biomass combustion to BC and OC concentrations is critical for developing and validating effective air quality control measures and climate change mitigation policy. We used radiocarbon (14C) to measure fossil and contemporary biomass contributions to BC and OC at three locations in Salt Lake City, Utah, USA, during 2012–2014, including during winter inversion events. Aerosol filters were analyzed with the Swiss_4S thermal‐optical protocol to isolate BC. We measured fraction modern (fM) of BC and total carbon in PM2.5 with accelerator mass spectrometry and derived the fM of OC using isotope mass balance. Combined with 14C information of end‐member composition, our data set of 31 14C aerosol measurements provided a baseline of the fossil and contemporary biomass components of carbonaceous aerosol. We show that fossil fuels were the dominant source of carbonaceous aerosol during winter, contributing 88% (80–98%) of BC and 58% (48–69%) of OC. While the concentration of both BC and OC increased during inversion events, the relative source contributions did not change. The sources of BC also did not vary throughout the year, while OC had a considerably higher contemporary biomass component in summer at 62% (49–76%) and was more variable. Our results suggest that in order to reduce PM2.5 levels in Salt Lake City to meet national standards, a more stringent policy targeting mobile fossil fuel sources may be necessary.

Developments and Challenges in Online NIR Spectroscopy for Meat Processing.

Meat and meat products are popular foods due to their balanced nutritional nature and their availability in a variety of forms. In recent years, due to an increase in the consumer awareness regarding product quality and authenticity of food, rapid and effective quality control systems have been sought by meat industries. Near-Infrared (NIR) spectroscopy has been identified as a fast and cost-effective tool for estimating various meat quality parameters as well as detecting adulteration. This review focusses on the on/inline application of single and multiprobe NIR spectroscopy for the analysis of meat and meat products starting from the year 1996 to 2017. The article gives a brief description about the theory of NIR spectroscopy followed by its application for meat and meat products analysis. A detailed discussion is provided on the various studies regarding applications of NIR spectroscopy and specifically for on/inline monitoring along with their advantages and disadvantages. Additionally, a brief description has been given about the various chemometric techniques utilized in the mentioned studies. Finally, it discusses challenges encountered and future prospects of the technology. It is concluded that, advancements in the fields of NIR spectroscopy and chemometrics have immensely increased the potential of the technology as a reliable on/inline monitoring tool for the meat industry.

Portable laser spectrometer for airborne and ground-based remote sensing of geological CO2 emissions.

A 24kg, suitcase sized, CW laser remote sensing spectrometer (LARSS) with a ~2km range has been developed. It has demonstrated its flexibility in measuring both atmospheric CO2 from an airborne platform and terrestrial emission of CO2 from a remote mud volcano, Bledug Kuwu, Indonesia, from a ground-based sight. This system scans the CO2 absorption line with 20 discrete wavelengths, as opposed to the typical two-wavelength online offline instrument. This multi-wavelength approach offers an effective quality control, bias control, and confidence estimate of measured CO2 concentrations via spectral fitting. The simplicity, ruggedness, and flexibility in the design allow for easy transportation and use on different platforms with a quick setup in some of the most challenging climatic conditions. While more refinement is needed, the results represent a stepping stone towards widespread use of active one-sided gas remote sensing in the earth sciences.

Implementation and effects assessment of precise quality control model mediated by nursing quality indexes in nursing quality management

Objective To explore the implementation methods and effects of precise quality control model mediated by nursing quality indexes in quality management. Methods Fifty-seven care units with complete quality control data were collected. From January to December 2015, the 57 using the traditional quality control mode were selected as control group, whilst from January to December 2016 57 units were chosen for the intervention group using precision quality control mode, that was, to select the number of indicators and target values, screening quality control points, unified the acquisition path of indicators, lock the key departments and monitoring points affecting the quality to carry out quality management performance. We observed the changes of the two groups of quality indicators. Results The nine process quality indicators including wards 6S management, first aid techniques, health education, primary care, first class and critical care nursing, safe treatment, operating nursing documents, drug and sterile product quality and pass rate of identity verification were significant difference between the two groups (P<0.05) . The five outcome quality indicators including hospitalized patients fall, dosing defects, hospital pressure sores, burns and urinary uncontrolled extubation rates were significant difference between the two groups (P<0.05) as well. Conclusions The quality control model, which is mediated by the nursing quality index, is helpful to improve the nursing quality. It is an effective quality control mode to achieve continuous improvement of nursing quality. Key words: Nursing quality; Target management; Quality index; Quality control point; Concise quality control

Dried tube specimens: A tool to ensure effective proficiency testing & quality control of Hepatitis B virus diagnosis in developing countries

Background: Proficiency testing (PT) is a key component of Quality assurance to evaluate the laboratory performance. Although HBV testing has rapidly expanded worldwide, but in resource limited settings (RLS) like India there is still a lacunae in PT programs to monitor and improve the quality of testing. Conventional PT programs use serum or plasma specimens that require strict settings for storage and transportation. Thus the aim was to standardize dried tube specimens (DTS) technique for stability studies of HBV specimens as has been done for PT programs in HIV-EQAS. Methods: Dried tube specimens, an unusual, simple and easy to use technique, were standardized that can help assessing the quality of Hepatitis B Surface Antigen (HBsAg) testing in RLS. DTS were prepared by drying 30l of samples mixed with 0.1% of green dye, left overnight at room temperature. The DTS were rehydrated with 250l of PBSTween buffer before testing. Twenty DTS samples (09 HBV positive and 11 negative) were used for performing ELISA and rapid tests at weekly interval for Dried tube specimens stored at 4C, 25C, 37C & 45C. Results: Stability studies showed that HBsAg in the DTS specimens were stable upto 28 days at temperature 4C, 25C, 37C & 45C. We observed consistent and expected results for all the DTS samples by ELISA and rapid tests for the different durations and temperatures. No difference in the qualitative nature of the HBV reactive and non-reactive samples were observed for Dried tube specimens over 28 days duration and stored at 4C, 25C, 37C & 45C temperatures. However, a decline in HBsAg levels were observed after four weeks (28days) for a few specimens stored at 45C. Conclusion: Stability results of this preliminary study indicate that the reactivity status was unchanged and maintained for HBV plasma samples upto 28 days at temperatures (4C, 25C 37C& 45C) in the dried tube specimens. Further we found DTS is an easy and simple method to prepare and transport quality control specimens for effective implementation of PT programs to monitor HBV testing in India.

Consequences of Low-Quality Audits for Engagement Partners

We investigate the consequences of low-quality audits for engagement partners in the US and the role audit firm quality control systems play in this process. We employ a sample period during which the identity of the engagement partner on specific audits is not publicly known to isolate the effect of quality control systems on partner management. We find that restatements result in partner changes for both restating and non-restating clients. Because the identity of the partner on an audit is not publicly known, non-restating clients may not be fully aware of the restatements associated with their engagement partners. We find that audit firms with ineffective partner quality control systems take advantage of this opaque information environment and do not replace low quality partners, especially if the partners can bring in large audit fees. Even if these audit firms replace the partner, they do not supply a new partner with higher quality. Our results highlight the importance of an effective quality control system in disciplining partners. When audit firm quality control systems fail, enhanced transparency through disclosing the identity of the engagement partner may be necessary in disciplining the auditing labor market.