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The measurement of photovoltaic PV performance with respect to reference conditions requires measuring current versus voltage for a given tabular reference spectrum, junction temperature, and total irradiance. A rigorous uncertainty analysis of these procedures is presented, which follows the International Organization for Standardization ISO Guide to the Expression of Uncertainty in Measurement. Intercomparison of Laboratory Radiance Calibration Standards.
Several standards for radiometric calibration were measured repeatedly with a spectroradiometer in order to understand how they compared in accuracy and stability. The tested radiance standards included a NIST W bulb and halon panel, two calibrated and stabilized integrating spheres, and a cavity blackbody. More detailed measurements am underway to investigate the discrepancy. Preparation and accreditation of anti-doping laboratories for the Olympic Games. Could accreditation bodies facilitate the implementation of medical guidelines in laboratories?
Several studies have shown that recommendations related to how laboratory testing should be performed and results interpreted are limited in medical guidelines and that the uptake and implementation of the recommendations that are available need improvement. The results showed that most countries have guidelines that are specifically related to laboratory testing; however, not all countries have a formal procedure for accepting such guidelines and few countries have guideline committees.
King Laboratories , Inc. Harmonization of anti-doping rules in a global context World Anti-Doping Agency- laboratory accreditation perspective. This article provides a review of the leading role of the World Anti-Doping Agency WADA in the context of the global fight against doping in sport and the harmonization of anti-doping rules worldwide through the implementation of the World Anti-Doping Program.
Particular emphasis is given to the WADA- laboratory accreditation program, which is coordinated by the Science Department of WADA in conjunction with the Laboratory Expert Group, and the cooperation with the international accreditation community through International Laboratory Accreditation Cooperation and other organizations, all of which contribute to constant improvement of laboratory performance in the global fight against doping in sport.
A perspective is provided of the means to refine the existing anti-doping rules and programs to ensure continuous improvement in order to face growing sophisticated challenges. A viewpoint on WADA's desire to embrace cooperation with other international organizations whose knowledge can contribute to the fight against doping in sport is acknowledged. Introduction The World Health Organization Regional Office for Africa WHO AFRO introduces a step wise incremental accreditation approach to improving quality of laboratory and it is a new initiative in Ethiopia and activities are performed for implementation of accreditation program.
Methods Descriptive cross sectional study was conducted in 30 laboratory facilities including 6 laboratory sections to determine their status towards of accreditation using WHO AFRO accreditation checklist and laboratory professionals were interviewed to assess their knowledge on quality system essentials and accreditation in Addis Ababa Ethiopia. The assessment finding from each section indicate that 2 Clinical chemistry The average score for government laboratories was Of respondents Conclusion Although majority of the laboratory professionals had knowledge on quality system and accreditation , laboratories professionals were not able to practice the quality system properly and most of the laboratories had poor status towards the WHO accreditation process.
Thus government as well as stakeholders should integrate accreditation program into planning and health policy. The World Health Organization Regional Office for Africa WHO AFRO introduces a step wise incremental accreditation approach to improving quality of laboratory and it is a new initiative in Ethiopia and activities are performed for implementation of accreditation program. Descriptive cross sectional study was conducted in 30 laboratory facilities including 6 laboratory sections to determine their status towards of accreditation using WHO AFRO accreditation checklist and laboratory professionals were interviewed to assess their knowledge on quality system essentials and accreditation in Addis Ababa Ethiopia.
Although majority of the laboratory professionals had knowledge on quality system and accreditation , laboratories professionals were not able to practice the quality system properly and most of the laboratories had poor status towards the WHO accreditation process. Notice of accreditation and approval of Chem Gas Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies. Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up.
Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO standard. The French group of molecular biologists GBMHM provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical methods validation procedures, quality controls, reagents , and post-analytical conditions.
In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated. A calibration service for biomedical instrumentation maintenance laboratories. An in-house calibration laboratory for the Biomedical Instrumentation Maintenance Services of the hospitals in the West of Scotland was established in This paper describes the development of this calibration service in the context of an overall quality system and also estimates its costs. Not only does the in-house service have many advantages but it is shown to be cost effective for workloads exceeding items per annum.
The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO as accreditation criteria. ISO was a new standard published in for accrediting medical laboratories. We believe that some requirements of the ISO standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during to Nonconformities reported in assessments based on ISO were analyzed in two periods - from to and in They are categorized according to the ISO clause numbers.
The performance of 27 laboratories initially assessed between and was compared to their performance in the second reassessment in For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods.
The total number of nonconformities reported in the second reassessment of 27 laboratories in was almost halved compared to their initial assessments. Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that contributed to quality improvement of accredited laboratories. Calibration Laboratory Capabilities Listing as of April Some of the parameters reported are: Alternating current, direct current, dimensional, mass, force, torque, pressure and vacuum, safety, and thermodynamics parameters.
Some centers reported other parameters. Electronic laboratory quality assurance program: A method of enhancing the prosthodontic curriculum and addressing accreditation standards. An electronic quality assurance eQA program was developed to replace a paper-based system and to address standards introduced by the Commission on Dental Accreditation CODA and to improve educational outcomes. This eQA program provides feedback to predoctoral dental students on prosthodontic laboratory steps at New York University College of Dentistry. The purpose of this study was to compare the eQA program of performing laboratory quality assurance with the former paper-based format.
Additionally, data extracted from the eQA program were analyzed to identify areas of weakness in the curriculum. The study findings revealed that The average number of treatments that did not pass quality assurance standards was This indicated a 6. Further analysis of these data revealed that The eQA program was favored by dental students who have experienced both electronic and paper-based versions of the system. Error type analysis can yield the ability to create customized faculty standardization sessions and refine the didactic and clinical teaching of the predoctoral students.
This program was also able to link patient care activity with the student's laboratory activities, thus addressing the latest requirements of the CODA regarding the competence of graduates in evaluating laboratory work related to their patient care. Published by Elsevier Inc. Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. We report the development of a stepwise process for quality systems improvement in the Caribbean Region. This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country.
The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement. Secondary standards laboratories for ionizing radiation calibrations: The national laboratory interests.
The national laboratories are probable candidates to serve as secondary standards laboratories for the federal sector. Representatives of the major Department of Energy laboratories were polled concerning attitudes toward a secondary laboratory structure.
Generally, the need for secondary laboratories was recognized and the development of such a program was encouraged. The secondary laboratories should be reviewed and inspected by the National Bureau of Standards. They should offer all of the essential, and preferably additional, calibration services in the field of radiological health protection. A consolidation of information has been provided that can be used to define procedures for enhancing and maintaining accuracy in temperature measurements in materials testing laboratories.
These studies were restricted to type R and K thermocouples TCs tested in air. Thermocouple accuracies, as influenced by calibration methods, thermocouple stability, and manufacturer's tolerances were all quantified in terms of statistical confidence intervals. By calibrating specific TCs the benefits in accuracy can be as great as 6 C or 5X better compared to relying on manufacturer's tolerances. The results emphasize strict reliance on the defined testing protocol and on the need to establish recalibration frequencies in order to maintain these levels of accuracy.
Accredited laboratories have an established quality system covering the administrative and technical issues specified in the standard. Services, LLC, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes for the next three years as of February 20, Laboratory calibration of pyrgeometers with known spectral responsivities. A methodology is presented to calibrate pyrgeometers measuring atmospheric long-wave radiation, if their spectral dome transmission is known. The new calibration procedure is based on a black-body cavity to retrieve the sensitivity of the pyrgeometer, combined with calculated atmospheric long-wave spectra to determine a correction function in dependence of the integrated atmospheric water vapor to convert Planck radiation spectra to atmospheric long-wave spectra.
Nonconformities reported in assessments based on ISO were analyzed in two periods — from to and in The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that ISO contributed to quality improvement of accredited laboratories.
Stolthaven Terminal, Houston, TX , has been accredited to test petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR Anyone wishing to employ The accreditation of a laboratory will be revoked for the following reasons: Background Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge.
Objectives We report the development of a stepwise process for quality systems improvement in the Caribbean Region. Results This approach consists of a three-tiered framework. Conclusion This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement. Services, LLC, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes for the next three years as of September 21, How reliable are efficiency measurements of perovskite solar cells?
The first inter-comparison, between two accredited and eight non- accredited laboratories. Perovskite materials have generated significant interest from academia and industry as a potential component in next-generation, high-efficiency, low-cost, photovoltaic PV devices. However, due to their complex dynamic behaviour, the process of measuring the efficiency of perovskite solar cells appears to be much more complicated than for other technologies. It has long been acknowledged that this is likely to greatly reduce the reliability of reported efficiency measurements, but the quantitative extent to which this occurs has not been determined.
We find that the inter- laboratory measurement variability can be almost ten times larger for a slowly responding perovskite cell than for a control silicon cell. We show that for such a cell, the choice of measurement method, far more so than measurement hardware, is the single-greatest cause for this undesirably large variability.
We provide recommendations for identifying the most appropriate method for a given cell, depending on its stabilization and degradation behaviour. Moreover, the results of this study suggest that identifying a consensus technique for accurate and meaningful efficiency measurements of perovskite solar cells will lead to an immediate improvement in reliability.
This, in turn, should assist device researchers to correctly evaluate promising new materials and fabrication methods, and further boost the development of this technology. An automated calibration laboratory - Requirements and design approach. NASA's Dryden Flight Research Facility Ames-Dryden , operates a diverse fleet of research aircraft which are heavily instrumented to provide both real time data for in-flight monitoring and recorded data for postflight analysis.
Ames-Dryden's existing automated calibration AUTOCAL laboratory is a computerized facility which tests aircraft sensors to certify accuracy for anticipated harsh flight environments. Recently, a major AUTOCAL lab upgrade was initiated; the goal of this modernization is to enhance productivity and improve configuration management for both software and test data.
The new system will have multiple testing stations employing distributed processing linked by a local area network to a centralized database. The current study provides the remote sensing community with important high accuracy laboratory -based BRDF calibration of radiometric tarps. The results illustrate the dependence of tarps' weft and warp threads orientation on BRDF.
The study was done at incident angles of 0deg, 10deg, and 30deg; scatter zenith angles from 0deg to 60deg, and scatter azimuth angles of 0deg, 45deg, 90deg, deg, and deg. The wavelengths were nm, nm, nm and nm. The dependence is well defined at all measurement geometries and wavelengths. The fitted BRDF data show a very small discrepancy from the measured ones. New data on the forward and backscatter properties of radiometric tarps is reported.
The backward scatter is well pronounced for the white samples. The black sample has well pronounced forward scatter. The BRDF characterization of radiometric tarps can be successfully extended to other structured surface fabric samples. The results are NIST traceable. Introduction Strengthening Laboratory Management Toward Accreditation SLMTA is a competency-based management training programme designed to bring about immediate and measurable laboratory improvement.
Methods The study used an Institutional based cross sectional study design that employed a secondary and primary data collection approach on the participated institution of medical laboratory in SLMTA. Results The assessment finding indicate that there was a significant improvement in average scores Laboratory facilities respondents which thought getting adequate and timely manner mentorship were found 2. Conclusion At the end of SLMTA implementation,3 laboratories score 3 star, 6 laboratories were at 2 star, 11 were at 1 star. The most important contributing factor for not scoring star in the final outcome of SLMTA were not conducting their customer satisfaction survey, poor staff motivation, and lack of regular equipment service maintenance.
Mentorship, onsite and offsite coaching and training activities had shown a great improvement on laboratory quality management system in most laboratories. Strengthening Laboratory Management Toward Accreditation SLMTA is a competency-based management training programme designed to bring about immediate and measurable laboratory improvement. The study used an Institutional based cross sectional study design that employed a secondary and primary data collection approach on the participated institution of medical laboratory in SLMTA.
The study was conducted in Addis Ababa city government and the data was collected from February 'April and data was entered in to EPI-data version 3. The assessment finding indicate that there was a significant improvement in average scores At the end of SLMTA implementation,3 laboratories score 3 star, 6 laboratories were at 2 star, 11 were at 1 star. Background The increase in disease burden has continued to weigh upon health systems in Africa.
The role of the laboratory has become increasingly critical in the improvement of health for diagnosis, management and treatment of diseases.
Laboratories were evaluated by auditors trained and certified by the African Society for Laboratory Medicine. Ninety-eight auditors from 17 African countries, competent in the Portuguese 3 , French 12 and English 83 languages, were trained and certified. Political commitment, ownership and investment in continuous quality improvement are integral components of the process. The increase in disease burden has continued to weigh upon health systems in Africa. Two laboratory methods for the calibration of GPS speed meters. The set-ups of two calibration systems are presented to investigate calibration methods of GPS speed meters.
The GPS speed meter calibrated is a special type of high accuracy speed meter for vehicles which uses Doppler demodulation of GPS signals to calculate the measured speed of a moving target. Three experiments are performed: The evaluation of measurement results validates both methods for calibrating GPS speed meters. The relative deviations between the measurement results of the GPS-based high accuracy speed meter and those of the optical speed meter are analyzed, and the equivalent uncertainty of the comparison is evaluated. The comparison results justify the utilization of GPS speed meters as reference equipment if no fewer than seven satellites are available.
This study contributes to the widespread use of GPS-based high accuracy speed meters as legal reference equipment in traffic speed metrology. Both provide SPRT calibrations using similar equipment and procedures, and at similar levels of uncertainty. These uncertainties are among the lowest available commercially.
To achieve and maintain low uncertainties, it is required that the calibration procedures be thorough and optimized. However, to minimize customer downtime, it is also important that the instruments be calibrated in a timely manner and returned to the customer. Consequently, subjecting the instrument to repeated calibrations or extensive repeated measurements is not a viable approach. These designs behave differently, yet predictably, when subjected to calibration measurements.
To this end, an evaluation strategy involving both statistical process control and internal consistency measures is utilized to provide confidence in both the instrument calibration and the calibration process. This article describes the calibration facilities, procedure, uncertainty analysis, and internal quality assurance measures employed in the calibration of SPRTs. Data will be reviewed and generalities will be presented.
Finally, challenges and considerations for future improvements will be discussed. Reese, Executive Director, Laboratories and Reese, Executive Director, Laboratories Rose, LA , has been approved to gauge and Customs and Border Protection by calling Reese, Executive Director, Laboratories and Scientific Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO The original printouts of the test results from laboratory analyzer s were compared with the data obtained from LIS and entered into the provided template.
The accuracy of data transfer from laboratory analyzers to LIS was We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose. Calibrations by four U. A second comparison was made of the calibrations by two U. Results did not permit conclusive determination of whether differences were due to the laboratories or to changes in the gauges. Accreditation and training on internal dosimetry in a laboratory network in Brazil: In recent years, Brazilian Nuclear Programme has been reviewed and updated by government authorities in face of the demand for energy supply and its associated environmental constraints.
The immediate impact of new national programmes and projects in nuclear field is the increase in the number of exposed personnel and the consequent need for reliable dosimetry services in the country. However, standard bioassay procedures and methodologies for bioassay data interpretation are still under discussion and, in some cases, both in routine and emergency internal monitoring, procedures can vary from one laboratory to another and responses may differ markedly among Dosimetry Laboratories. Thus, it may be difficult to interpret and use bioassay data generated from different laboratories of a network.
The main goal of this work is to implement a National Network of Laboratories aimed to provide reliable internal monitoring services in Brazil. Please reference the Web site listed Reports on conference convened by Association for Library and Information Science Education for discussion of library school accreditation by 17 library-related associations and agencies. Highlights include accreditation models, accrediting information science, records management, special librarians, certification for archivists, M. Experiences of a medium sized accredited laboratory. We put forth our experiences of EQAS, analyzed the result discrepancies, reviewed the corrective actions and also put forth strategies for risk identification and prevention of potential errors in a medical laboratory.
For hematology, EQAS samples - blood, peripheral and reticulocyte smears - were received quarterly every year. For clinical chemistry, lyophilized samples were received and were processed on Siemens Dimension Xpand and RXL analyzers. For microbiology, EQAS samples were received quarterly every year as lyophilized strains along with smears and serological samples. In hematology no outliers were noted for reticulocyte and peripheral smear examination. Only one outlier was noted for CBC. Thirteen of these parameters were analyzed as random errors, 3 as transcriptional errors and seven instances of systemic error were noted.
In microbiology, one discrepancy was noted in isolate identification and in the grading of smears for AFB by Ziehl Neelsen stain. Verification of the test stand for microbolometer camera in accredited laboratory. Microbolometer belongs to the group of thermal detectors and consist of temperature sensitive resistor which is exposed to measured radiation flux. Bolometer array employs a pixel structure prepared in silicon technology. The detecting area is defined by a size of thin membrane, usually made of amorphous silicon a-Si or vanadium oxide VOx.
The difference in sensitivity and offset among detectors which is called non-uniformity additionally with its high sensitivity, produces fixed pattern noise FPN on produced image. Fixed pattern noise degrades parameters of infrared cameras like sensitivity or NETD. Additionally it degrades image quality, radiometric accuracy and temperature resolution.
In order to objectively compare the two infrared cameras ones must measure and compare their parameters on a laboratory test stand. One of the basic parameters for the evaluation of a designed camera is NETD. In order to examine the NETD, parameters such as sensitivity and pixels noise must be measured. To do so, ones should register the output signal from the camera in response to the radiation of black bodies at two different temperatures. The article presets an application and measuring stand for determining the parameters of microbolometers camera.
This test stand consists of IR collimator, IR standard source, rotating wheel with test patterns, a computer with a video grabber card and specialized software. The parameters of thermals cameras were measure according to norms and method described. A brief description of the electrical and mechanical instrument configuration, followed by an extensive discussion of laboratory tests and results are contained herein.
This information is required to provide parameters for data reduction, and a basis for analysis of the measurement errors in data taken with this instrument. Upon a determination by the Administrator, a laboratory will be refused accreditation for the following reasons: The accreditation of a This value is the lowest reported Pmax uncertainty of any accredited test. Phytoplankton Productivity numerical model: The primary production module of the "Biogeochemical Flux Model" BFM has been used to replicate results from laboratory phytoplankton cultures of diatoms, dinoflagellates and picophytoplankton.
The model explicitly solve for the phytoplankton, chlorophyll, carbon, phosphorus, nitrogen and diatoms only silicon content. Simulations of the temporal evolution of the cultured phytoplankton biomass, have been carried out in order to provide a correct parameterization of the temperature role in modulating the growth dynamics, and to gain insight in the process of chlorophyll turnover, with particular reference to the phytoplankton biomass decay in condition of nutrient stress. Results highligthed some limitation of the Q10 approach in defining the temperature constraints on the primary production particularly at relatively high temperature This required a modification of such approach.
Moreover, the decay of the chlorophyll concentration under nutrient stress, appeared as expected significantly decoupled from the evolution of the carbon content. The implementation of a specific procedure based on the laboratory culture results adressing such decoupling, allowed for the achievement of better agreement between model and observations. Optimized star sensors laboratory calibration method using a regularization neural network.
High-precision ground calibration is essential to ensure the performance of star sensors. However, the complex distortion and multi-error coupling have brought great difficulties to traditional calibration methods, especially for large field of view FOV star sensors. Although increasing the complexity of models is an effective way to improve the calibration accuracy, it significantly increases the demand for calibration data.
In order to achieve high-precision calibration of star sensors with large FOV, a novel laboratory calibration method based on a regularization neural network is proposed. A multi-layer structure neural network is designed to represent the mapping of the star vector and the corresponding star point coordinate directly. To ensure the generalization performance of the network, regularization strategies are incorporated into the net structure and the training algorithm.
Simulation and experiment results demonstrate that the proposed method can achieve high precision with less calibration data and without any other priori information. The proposed method can satisfy the precision requirement for large FOV star sensors. Border Protection, Department of Homeland Security. Notice of re-approval of Intertek Testing Spectral multivariate calibration without laboratory prepared or determined reference analyte values. An essential part to calibration is establishing the analyte calibration reference samples.
These samples must characterize the sample matrix and measurement conditions chemical, physical, instrumental, and environmental of any sample to be predicted. Calibration usually requires measuring spectra for numerous reference samples in addition to determining the corresponding analyte reference values.
Both tasks are typically time-consuming and costly. This paper reports on a method named pure component Tikhonov regularization PCTR that does not require laboratory prepared or determined reference values. Instead, an analyte pure component spectrum is used in conjunction with nonanalyte spectra for calibration.
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Nonanalyte spectra can be from different sources including pure component interference samples, blanks, and constant analyte samples. The approach is also applicable to calibration maintenance when the analyte pure component spectrum is measured in one set of conditions and nonanalyte spectra are measured in new conditions. The PCTR method balances the trade-offs between calibration model shrinkage and the degree of orthogonality to the nonanalyte content model direction in order to obtain accurate predictions.
The flexibility of PCTR also allows including reference samples if such samples are available. Optimisation of the methods enabled the chromatographic separation of the analytes in less than 4 min. A correlation coefficient of 0. The uncertainty values of sodium benzoate and potassium sorbate were found as 0. Proficiency testing performance of Turkish accredited laboratories between the years and was evaluated and reported herein. The aim of the proficiency testing scheme was to evaluate the performance of the laboratories , analysing benzoate and sorbate in tomato ketchup.
The accreditation of a laboratory will be suspended if the laboratory or any individual or entity responsibly connected with the laboratory is indicted or has charges on information brought against them in a Federal or State court for any Historically, the traceability of the laboratory calibration of Earth-observing satellite instruments to a primary radiometric reference scale SI units is the responsibility of each instrument builder. For the NASA Earth Observing System EOS , a program has been developed using laboratory transfer radiometers, each with its own traceability to the primary radiance scale of a national metrology laboratory , to independently validate the radiances assigned to the laboratory sources of the instrument builders.
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The EOS Project Science Office also developed a validation program for the measurement of onboard diffuse reflecting plaques, which are also used as radiometric standards for Earth-observing satellite instruments. Summarized results of these validation campaigns, with an emphasis on the current state-of-the-art uncertainties in laboratory radiometric standards, will be presented. We collected data on the performance of 2 commonly used rapid tests Determine and Unigold in Malawi between and or at the University of North Carolina between and We also assessed the utility of each rapid test to diagnose incident HIV infection during the breastfeeding period.
Among HIV -exposed infants who were negative at age 6 weeks, 21 At 3 months of age, both rapid tests had minimal clinical value with specificity values of 7. Starting at age 6 and 9 months, the Unigold test could be used as a screening tool in the follow-up of HIV -exposed infants with specificity values of Starting at age 12 months, the type of test became less important as both tests performed well in identifying HIV -free children, although both tests failed to detect some incident HIV infections.
Updated guidelines for the use of rapid tests in young HIV -exposed children that explicitly take type of test and infant age into account are urgently needed to ensure optimal care for the 1. The cost of implementing rapid HIV testing in sexually transmitted disease clinics in the United States.
Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected. We determined the cost to sexually transmitted disease STD clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in Costs included counselor and trainer time, supplies, and clinic overhead.
We applied national labor rates and test costs. We calculated median clinic start-up costs and mean cost per patient tested, and projected incremental annual costs of implementing universal rapid HIV testing compared with current testing practices. Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial.
Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics, if brief risk reduction counseling is not offered. HIV testing in dermatology - a national audit. Forty percent of individuals have late-stage HIV at the time of diagnosis, resulting in increased morbidity. Identifying key diseases which may indicate HIV infection can prompt clinicians to trigger testing, which may result in more timely diagnosis. This audit showed that HIV testing in key indicator diseases remains below the standard set out by the national guidelines, and that GPs with special interest in dermatology have a lower likelihood for testing, and lower confidence when compared to consultants, registrars and associate specialists.
Large proportions of respondents believed further training in HIV testing would be beneficial. Although researchers can uncover patterns and insights associated with HIV trends and transmission, the review process is time consuming and resource intensive. Machine learning methods derived from computer science might be used to assist HIV domain experts by learning how to rapidly and accurately identify patterns associated with HIV from a large set of social data.
Using an existing social media data set that was associated with HIV and coded by an HIV domain expert, we tested whether 4 commonly used machine learning methods could learn the patterns associated with HIV risk behavior. We used the fold cross-validation method to examine the speed and accuracy of these models in applying that knowledge to detect HIV content in social media data.
Logistic regression and random forest resulted in the highest accuracy in detecting HIV -related social data Logistic regression yielded the fastest processing time Machine learning can enable social big data to become a new and important tool in HIV research, helping to create a new field of "digital HIV epidemiology. However, according to the WHO, these tests need to be assessed before they can be used in routine. We assessed 9 RDT in routine clinical use between and Two tests had performances inferior to WHO recommendations: Seven of 9 RDT had excellent performances.
Nevertheless, they can be used only after training staff, and taking into account national algorithm for their safe use. In resource-limited settings, HIV infection is often diagnosed using 2 rapid tests. If the results are discordant, a third tie-breaker test is often used to determine HIV status.
This study characterized samples with discordant rapid tests and compared different testing strategies for determining HIV status in these cases. Samples were previously collected from African adults in a population-based survey who had discordant rapid test results. Tie-breaker tests were evaluated, including rapid tests 1 performed in-country , a third-generation enzyme immunoassay, and two fourth-generation tests. Selected samples were further characterized using additional assays. Antiretroviral drugs were detected in 1 sample. Specificity was lower for the fourth-generation tests than the other tests.
Accuracy ranged from In this population-based survey, most HIV -infected adults with discordant rapid tests were virally suppressed without antiretroviral drugs. Use of individual assays as tie-breaker tests was not a reliable method for determining HIV status in these individuals. More extensive testing algorithms that use a fourth-generation screening test with a discriminatory test and HIV RNA test are preferable for determining HIV status in these cases. Can trained lay providers perform HIV testing services? A review of national HIV testing policies. Delivery of HTS by lay providers may help close this testing gap, while also increasing uptake and acceptability of HIV testing among key populations and other priority groups.
Data regarding lay provider use for HTS was extracted and collated. Our search had no geographical or language restrictions. Given the low uptake of lay provider use globally and their proven use in increasing HIV testing, countries should consider revising policies to support lay provider testing using rapid diagnostic tests.
Summary A review of published and unpublished data indicates the prevalence of high-risk behaviours for HIV transmission in segments of the Bangladeshi population. These include casual unprotected sex, heterosexual as well as between males, prior to and after marriage. Intravenous drug use IVDU exists though illicit drugs are more commonly inhaled.
There is a fear, however, that inhalers may turn to injecting drugs, as is common in neighbouring countries. This proximity will only be a risk factor, however, if high-risk contacts occur between nationals of these countries. Primary HIV infection PHI refers to the first six months following HIV acquisition and represents a unique opportunity for expedited diagnosis, and consideration of rapid antiretroviral therapy ART initiation to improve immune function, reduce the size of the viral reservoir and limit the risk of onward viral transmission.
Failure to diagnose and rapidly treat individuals with PHI has significant individual and public health implications. The Strategic Timing of AntiRetroviral Treatment trial recently identified a clinical benefit of immediate ART over deferral of treatment according to CD4 count threshold, and has led to rapid changes in World Health Organization and specialist national guidelines. For all individuals living with HIV , the offer of immediate therapy irrespective of CD4 count is now recommended.
This paper summarises the presentation and management of PHI, incorporating current research and guideline changes and discusses the role of PHI in onward transmission. Effectiveness of the U. Characteristics associated with testing during NHTD week compared with control weeks were identified using Chi-square analyses. Results In , an average of 15, more testing events were conducted and more new HIV -positive diagnoses were identified during NHTD week than during the control weeks p rapid HIV test, or 6 tested in a non-health-care setting.
HIV testing programs increased the use of rapid tests and returned a high percentage of test results. NHTD campaigns reached populations disproportionately affected by HIV and further expanded testing to people traditionally less likely to be tested. Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with limited personnel and laboratory infrastructure.
We conducted further testing on this subgroup of samples using qualitative DNA PCR to assess the potential for false positive tests in this situation. Although this study was not primarily designed to assess the validity of rapid HIV tests and thus only a subset of the samples were retested, the findings show a potential for false positive HIV results in the subset of individuals who test positive when a tiebreaker test is used in serial testing. These findings highlight a need for confirmatory testing for this category of individuals.
Background Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with limited personnel and laboratory infrastructure. Conclusion Although this study was not primarily designed to assess the validity of rapid HIV tests and thus only a subset of the samples were retested, the findings show a potential for false positive HIV results in the subset of individuals who test positive when a tiebreaker test is used in serial testing. The Centers for Disease Control and Prevention CDC recommends routine nontargeted opt-out HIV screening in health care settings, including emergency departments EDs , where the prevalence of undiagnosed infection is 0.
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The utility of this approach in EDs remains unknown. To determine whether nontargeted opt-out rapid HIV screening in the ED was associated with identification of more patients with newly diagnosed HIV infection than physician-directed diagnostic rapid HIV testing. Quasi-experimental equivalent time-samples design in an urban public safety-net hospital with an approximate annual ED census of 55, patient visits. Patients were 16 years or older and capable of providing consent for rapid HIV testing. Nontargeted opt-out rapid HIV screening and physician-directed diagnostic rapid HIV testing alternated in sequential 4-month time intervals between April 15, , and April 15, Ten of patients 0.
In the diagnostic phase, of 29, eligible patients, 0. Of these, 4 patients 1. The prevalence of new HIV diagnoses in the opt-out phase including those diagnostically tested and in the diagnostic phase was 15 in 28, 0. Little is known about the performance of oral fluid based HIV testing in Zambia. The aims of this study are two-fold: A cost analysis of four algorithms from health systems perspective were performed: Operational feasibility of using whole blood in the rapid HIV testing algorithm of a resource-limited settings like Bangladesh.
This study explored the operational feasibility of using whole blood as alternative to serum for rapid HIV testing in Bangladesh. Whole blood specimens were collected from two study groups. The sensitivity and specificity of the test results, and the operational cost were compared with current serum-based testing.
Considering the similar sensitivity and specificity of the two specimens, and significant cost reduction, rapid HIV testing with whole blood is feasible. Organizational HIV monitoring and evaluation capacity rapid needs assessment: To identify these gaps and opportunities for improvement, the U. The project included an in-depth desk review of national documents, policies, tools, and international best practices. National , regional, and district officials from government agencies, development partners, and implementing partners participated in key informant interviews and focus group discussions.
Given the large number of regions and districts, purposive sampling was used to select 16 facilities in 8 districts across 2 regions based on the general quality of the reported HIV data and the number of partners supporting the regions. RNA findings revealed tremendous improvements at the national level and in the various subsystems that contribute to the overall HIV strategic information. To ensure success further, capacity building for subnational levels should be conducted and feedback channels to subnational staff should be established and maintained.
Uptake of HIV tests is a challenging issue in vulnerable populations including immigrants, normally using standard diagnostic tools. All patients with risky sexual behaviours or with a recent diagnosis of STIs were invited to come back after months and a post-counselling questionnaire was offered. Out of the total sample, Immigrants have lower perception of sexual risk and higher prejudice than Italians. Our study showed high acceptance of rapid test in this specific vulnerable population and this allowed to identify new HIV diagnoses in unaware people.
The cost-effectiveness of rapid HIV testing in substance abuse treatment: Fewer than half of US community-based substance abuse treatment programs make HIV testing available on-site or through referral. We measured the cost-effectiveness of three HIV testing strategies evaluated in a randomized trial conducted in 12 community-based substance abuse treatment programs in Data from the trial included patient demographics, prior testing history, test acceptance and receipt of results, undiagnosed HIV prevalence 0.
Referral for off-site testing is less efficient dominated compared to offering on-site testing with information only. A strategy of on-site rapid HIV testing offer with information only in substance abuse treatment programs increases life expectancy at a cost-effectiveness ratio rapid HIV testing in substance abuse treatment programs for those not recently tested.
David; Walensky, Rochelle P. Many men who have sex with men acquire HIV while in a same-sex relationship. Studies with gay male couples have demonstrated that relationship characteristics and testing behaviors are important to examine for HIV prevention. However, HIV -negative partnered men's attitudes toward using an HT and whether characteristics of their relationship affect their use of HTs remain largely unknown. To assess HIV -negative partnered men's attitudes and associated factors toward using an HT, a cross-sectional Internet-based survey was used to collect dyadic data from a national sample of HIV -negative and 58 HIV -discordant gay male couples.
Multivariate multilevel modeling was used to identify behavioral and relationship factors associated with HIV -negative partnered men's attitudes toward using an HT. HIV -negative partnered men were "very likely" to use an HT. More positive attitudes toward using an HT were associated with being in a relationship of mixed or nonwhite race and with one or both men recently having had sex with a casual male partner.
Less positive attitudes toward using an HT were associated with both partners being well educated, with greater resources investment size in the relationship, and with one or both men having a primary care provider. These findings may be used to help improve testing rates via promotion of HTs among gay male couples. Rapid hiv testing in urban outreach: Opportunities for timely HIV therapy were lost; valuable resources were wasted. This study tested the hypothesis that rapid HIV testing enables a high percentage of high-risk outreach clients to learn their serostatus. We did on-site counseling and rapid HIV testing at community-based organizations e.
The project tested persons. All but one Rapid testing has a role to play in HIV outreach. It is useful in populations who are at high risk of HIV infection, who currently are not accessing HIV testing, and who have high failure to return rates. Future developments in rapid testing technology will make this testing option more convenient and cost-effective.
HIV and injecting drug use in Indonesia: Indonesia is facing one of the most rapidly growing HIV -epidemics in Asia. Risk behaviour associated with injecting drug use, such as sharing contaminated needles, is the main risk factor for HIV infection. Among the general population the prevalence of HIV -infection is still low 0. Overrepresentation of injecting drug users and continued risk behavior inside Indonesian prisons contribute to spread of HIV.
The national response targeted to limit spread of HIV through injecting drug use has included needle and syringe program NSP , methadone maintenance treatment MMT , voluntary counseling and testing VCT , and outreach program as priority programs. However coverage and utilization of the harm reduction services is still limited, but effective integration with HIV testing and treatment is expanding. Nevertheless, utilization of these services has been less satisfactory and their effectiveness has been questioned.
Besides effective prevention, HIV - testing and earlier treatment of HIV -seropositve individuals, including those with a history of injecting drug use, will help control the growing HIV -epidemic in Indonesia. An anonymous questionnaire survey was conducted among subjects in the 7 groups selected by different sampling methods, and valid questionnaires were collected.
The majority of subjects were males Among the subjects, Univariate logistic regression analysis indicated that subject group, age, education level, employment status, monthly expenditure level, HIV test experience and willingness to receive HIV saliva test were correlated statistically with willingness to pay for HIV antibody saliva rapid test. Multivariate logistic regression analysis showed that subject group and monthly expenditure level were statistically correlated with willingness to pay for HIV antibody saliva rapid test.
The willingness to pay for HIV antibody saliva rapid test and acceptable price of HIV antibody saliva rapid test varied in different areas and populations. Different populations may have different willingness to pay for HIV antibody saliva rapid test;the affordability of the test could influence the willingness to pay for the test. Cost-effectiveness of rapid syphilis screening in prenatal HIV testing programs in Haiti.
New rapid syphilis tests permit simple and immediate diagnosis and treatment at a single clinic visit. We compared the cost-effectiveness, projected health outcomes, and annual cost of screening pregnant women using a rapid syphilis test as part of scaled-up prenatal testing to prevent mother-to-child HIV transmission in Haiti. A decision analytic model simulated health outcomes and costs separately for pregnant women in rural and urban areas. We compared syphilis syndromic surveillance rural standard of care , rapid plasma reagin test with results and treatment at 1-wk follow-up urban standard of care , and a new rapid test with immediate results and treatment.
Health outcomes were projected using historical data on prenatal syphilis treatment efficacy and included disability-adjusted life years DALYs of newborns, congenital syphilis cases, neonatal deaths, and stillbirths. Results are sensitive to regional syphilis prevalence, rapid test sensitivity, and the return rate for follow-up visits. In Haiti, integrating a new rapid syphilis test into prenatal care and HIV testing would prevent congenital syphilis cases and stillbirths, and is cost-effective. A similar approach may be beneficial in other resource-poor countries.
Antiretroviral therapy during the earliest stage of acute HIV infection Fiebig I might minimize establishment of a latent HIV reservoir and thereby facilitate viremic control after analytical treatment interruption. We show that 8 participants, who initiated treatment during Fiebig I and were treated for a median of 2.
Countries were divided into 4 groups according to the HDI distribution. Addressing unmet need for HIV testing in emergency care settings: HIV testing in emergency departments EDs remains underutilized. The authors assessed intervention acceptability and compared noted HIV risks. In the standard arm, one HIV test and two referrals for testing occurred.
Future research should assess cost-effectiveness compared with staff-delivered approaches. Assessed intervention acceptability and compared noted HIV risks. In standard arm, one HIV test and 2 referrals for testing occurred. A cross sectional survey of the barriers for implementing rapid HIV testing among French general practitioners. In France, almost 30, people are unaware of their HIV -positive status. Innovative screening strategies are essential to reach this population. The aim of this study was to describe the acceptability of rapid HIV testing RHT among French general practitioners GPs working in the south of France and barriers for implementing this strategy.
We analysed an anonymous questionnaire sent by mail to GPs about demographic data, routine practice, knowledge of RHT and barriers to its use. Between 1 April and 30 September , out of the GPs contacted, 78 returned the questionnaires. The GPs' mean age was 52 years; 49 were men. Fifty-one GPs reported that their registered patients included at least one HIV -infected person and 70 GPs reported taking care of high-risk patients. The main reasons reported by uninterested GPs were: French National Authorities for Health propose to screen the population at least once in their lifetime and high-risk people at least once a year.
If specific and adapted training is developed, and if solutions to barriers reported by GPs are found, RHT could be implemented in to their routine activity. Published by Elsevier Ltd. We evaluated the impact of early vs. A pre-ART sample was analyzed if the follow-up sample had a false-negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection false-recent result.
Baseline samples had stronger rapid test and WB bands, higher fourth-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection. The sensitivity of this assay for HIV -1 antibody positive sera was Bionor's confirmatory test detected HIV -1 seropositivity earlier than the WB in longitudinal seroconversion panels and could discriminate between HIV -1 and -2 infection. The number of indeterminate responses was generally reduced significantly using Bionor's confirmatory test compared to the HIV -1 WB. The greater specificity, speed and ease of interpretation of Bionor's confirmatory test renders it an attractive and cost effective alternative to the WB for confirming HIV serological status worldwide.
Programmatic cost evaluation of nontargeted opt-out rapid HIV screening in the emergency department. Cost effectiveness is critical when considering potential screening methods. This was a prospective cohort study nested in a larger quasi-experiment. Over 16 months, nontargeted rapid HIV screening intervention and diagnostic rapid HIV testing control were alternated in 4-month time blocks.
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During the intervention phase, patients were offered HIV testing using an opt-out approach during registration; during the control phase, physicians used a diagnostic approach to offer HIV testing to patients. Each method was fully integrated into ED operations. Direct program costs were determined using the perspective of the ED. Time-motion methodology was used to estimate personnel activity costs.
Costs per patient newly-diagnosed with HIV infection by intervention phase, and incremental cost effectiveness ratios were calculated. During the control phase, 29, eligible patients were included, 0. More effective and less costly testing. Methods This was a prospective cohort study nested in a larger quasi-experiment.
In Kansas City, testing was performed in a clinic and in outreach settings. In Detroit, testing was performed in outreach settings only. Both CBOs used mobile testing vans. Measures of effectiveness were the number of HIV tests performed and the number of people notified of new HIV diagnoses, based on rapid tests. We retrospectively collected program costs, including those for personnel, test kits, mobile vans, and facility space.
The CBO in Kansas City tested a mean of people a year in its clinic and people a year in outreach settings. The number of people notified of new HIV diagnoses was 19 2. The cost of providing a new HIV diagnosis was considerably higher in the outreach settings than in the clinic.
The variation can be largely explained by differences in the number of undiagnosed infections among the people tested and by the costs of purchasing and operating a mobile van. Acceptability of rapid HIV diagnosis technology among primary healthcare practitioners in Spain. This study investigated the acceptability of rapid HIV testing among general practitioners GP and aimed to identify perceived barriers and needs in order to implement rapid testing in primary care settings. An anonymous questionnaire was distributed online to all members of the two largest Spanish scientific medical societies for family and community medicine.
The study took place between 15 June and 31 October Completed questionnaires were returned by participants. Among all respondents, The barriers most commonly identified by respondents were a lack of time and a need for training, both in the use of rapid tests This study reveals a high level of acceptance and willingness on the part of GPs to offer rapid HIV testing in their practices. Nevertheless, the implementation of rapid HIV testing in primary care will not be possible without moving from comprehensive pre-test counselling towards brief pre-test information and improving training in the use of rapid tests.
Scaling up HIV treatment and prevention through national responses and innovative leadership. Over the past decade, there has been an unprecedented global response to the AIDS epidemic. This infusion of new funding has led to a rapid scale-up of HIV treatment and prevention and consequently has saved millions of lives and transformed communities around the world.
However, as clearly demonstrated by a review of national responses, successes have been due in large part to strong and innovative leadership from governments, the private sector, and nongovernmental organizations. Examples from Brazil, Botswana, Nigeria, Uganda, and India illustrate the vital role played by bold and collaborative leadership in the global and local scale-up of HIV prevention and treatment.
Computer-facilitated rapid HIV testing in emergency care settings: Computer tool usability and acceptability were assessed among 35 adult patients, and provider focus groups were held, in two ECSs in Washington State and Maryland. The computer tool was usable by patients of varying computer literacy. Patients appreciated the tool's privacy and lack of judgment and their ability to reflect on HIV risks and create risk reduction plans. Staff voiced concerns regarding ECS-based HIV testing generally, including resources for follow-up of newly diagnosed people.
Such tools may help circumvent some practical barriers associated with routine HIV testing in busy settings though linkages to care will still be needed. Homeless Stand Downs are outreach events that connect Veterans with services. Veterans who declined testing were asked their reasons for declining. Only "no time to test" differed significantly by Homeless Stand Down site. A national survey of organ procurement organizations. Emergency department patient perceptions and preferences on opt-in rapid HIV screening program components.
Multivariable regression models were used to compare participants on their beliefs about the program components. Of the participants, The majority of participants Overall, participants were highly accepting of the components of this opt-in rapid HIV screening program. However, concerns regarding the accuracy of the rapid HIV test might limit test acceptance and should be addressed during pre-test information procedures. Objectives Streptococcus pneumoniae is the leading cause of bacterial pneumonia and associated bacteremia during HIV infection. Rapid diagnostic assays may limit inappropriate therapy.
Methods Clinical signs and symptoms and sera and urine were collected prospectively from 70 adults with pneumococcal pneumonia, including 47 with HIV co-infection. A systematic review of 24 published studies was conducted. Results Clinical symptoms, signs, and laboratory parameters except leukocytosis, were similar in HIV -infected and HIV -seronegative pneumonia. Conclusions Urinary antigen detection provides a credible rapid diagnostic test for pneumococcal pneumonia regardless of HIV -status.
Are the investments in national HIV monitoring and evaluation systems paying off? This article explores whether those investments have made a difference in terms of data availability, quality and use for assessing whether national programs are on track to achieve the Millennium Development Goal MDG of halting and reversing the HIV epidemic. Availability of population-based survey data was assessed. The extent to which data are used for program improvement is difficult to ascertain.
Mexico's policies on antenatal HIV testing are contradictory, and little is known about social and behavioral characteristics that increase pregnant Mexican women's risks of acquiring HIV. We analyzed the association between risk behaviors reported by pregnant women for themselves and their male partners, and women's rapid HIV antibody test results from a large national sample.
Three quarters of pregnant women with a reactive test did not report risk behaviors for themselves and one third did not report risk behaviors for themselves or their male partners. In the retrospective case-control analysis, other than reporting multiple sexual partners, reactive pregnant women reported risk behaviors did not differ from nonreactive women's behaviors.
However, reactive pregnant women were significantly more likely to have reported risk behaviors for male partners. Our findings support universal offer of antenatal HIV testing and suggest that HIV prevention for women should focus on reducing risk of HIV acquisition within stable relationships. China is considered a country of low HIV prevalence , people living with HIV , however, HIV infections among high-risk populations continue to grow at alarming rates.
Dentists, as oral health experts, would be well placed to conduct ORHT. We assessed willingness of dentists to undertake ORHT in their clinical practice. A cross-sectional, paper-based survey of dentists from the Xi'an region of China was conducted from April to June Dentists were recruited from Shaanxi Stomatological Association using a stratified sampling methodology. If made available in the dental setting, Four hundred and thirty-five Female dentists felt more accepting of ORHT than males Going beyond Indicator Development and Conceptual Training.
These include the World Bank's Multi-Country…. The population was enrolled by convenience sampling after taking informed consent. Among 70, persons tested, 80 1. The prevalence rate was steady until , and then increased rapidly. The rate among male heterosexuals was significantly higher than that in females 3. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. Four regional training-of-trainers workshops have been conducted since The TB SLMTA programme has been rolled out in 37 tuberculosis laboratories in 10 countries using the Workshop approach in 32 laboratories in five countries and the Facility based approach in five tuberculosis laboratories in five countries.
Lessons learnt from early implementation of TB SLMTA suggest that a structured training and mentoring programme can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalisation of QMS into country programmes, is needed to support tuberculosis laboratories.
Five national reference laboratories from four countries participated in the SLMTA programme that incorporated classroom teaching and implementation of improvement projects. Mentors were assigned to the laboratories to guide trainees on their improvement projects and to assist in the development of Quality Management Systems QMS. At the end of each audit, a comprehensive implementation plan was developed in order to address gaps. After 18 months, one laboratory reached four stars, two reached three stars and two reached two stars.
There was a corresponding decrease in nonconformities and development of over management and technical standard operating procedures in each of the five laboratories. The tremendous improvement in these five Caribbean laboratories shows that SLMTA coupled with mentorship is an effective, user-friendly, flexible and customisable approach to the implementation of laboratory QMS. It is recommended that other laboratories in the region consider using the SLMTA training programme as they engage in quality systems improvement and preparation for accreditation.
Quality management systems for your in vitro fertilization clinic's laboratory: Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization IVF clinics and their laboratories. It is commonplace for Assisted Reproductive Technology ART laboratories to be required to have a quality control system.
However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. Full Text Available Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization IVF clinics and their laboratories.
Role of a quality management system in improving patient safety - laboratory aspects. The aim of this study is to describe how implementation of a quality management system QMS based on ISO enhances patient safety. A literature review showed that several European hospitals implemented a QMS based on ISO and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO are outlined, and the impact of the implementation of each requirement on patient safety is summarized.
Several hospitals that implemented ISO reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities.
Other standards, practices, and quality requirements may also contribute to patient safety. Implementation of a QMS based on ISO provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories.
Published by Elsevier Inc. Quality management system has been introduced to a few laboratories in the Malaysian Nuclear Agency Nuclear Malaysia for the purpose to enhance the delivery of quality services to customers. In addition, the RAS achievements including issues and challenges in implementing the quality management system in the past 10 years will also be discussed. Past efforts to improve laboratory quality systems and to achieve accreditation for better patient care in the Caribbean Region have been slow.
Importance of implementing an analytical quality control system in a core laboratory. The aim of the clinical laboratory is to provide useful information for screening, diagnosis and monitoring of disease. The laboratory should ensure the quality of extra-analytical and analytical process, based on set criteria. To do this, it develops and implements a system of internal quality control, designed to detect errors, and compare its data with other laboratories , through external quality control.
In this way it has a tool to detect the fulfillment of the objectives set, and in case of errors, allowing corrective actions to be made, and ensure the reliability of the results. This article sets out to describe the design and implementation of an internal quality control protocol, as well as its periodical assessment intervals 6 months to determine compliance with pre-determined specifications Stockholm Consensus 1. A total of 40 biochemical and 15 immunochemical methods were evaluated using three different control materials.
Next, a standard operation procedure was planned to develop a system of internal quality control that included calculating the error of the analytical process, setting quality specifications, and verifying compliance. The quality control data were then statistically depicted as means, standard deviations, and coefficients of variation, as well as systematic, random, and total errors.
The quality specifications were then fixed and the operational rules to apply in the analytical process were calculated. Finally, our data were compared with those of other laboratories through an external quality assurance program. The development of an analytical quality control system is a highly structured process. This should be designed to detect errors that compromise the stability of the analytical process. The laboratory should review its quality indicators, systematic, random and total error at regular intervals, in order to ensure that they are meeting pre-determined specifications, and if not, apply the appropriate corrective actions.
The quality management systems compliant with the ISO They have also been investigated from the analytical point of view. Unfortunately, a low number of studies concerned the management system functioning in the accredited testing laboratories. The aim of following study was to assess the management system functioning in the accredited testing laboratories in Poland.
On 8 October , 1, accredited testing laboratories were present in Poland. There are more and more such laboratories that have various problems and different long-term experience when it comes to the implementation, maintenance and improvement of the management systems. The article describes the results of the conducted expert assessment survey carried out to examine the conditions for the functioning of a management system in an accredited laboratory.
It also focuses on the characteristics of the accredited research laboratories in Poland. The authors discuss the selection of the external and internal conditions that may affect the accredited management system. They show how the experts assessing the selected conditions were chosen. The survey results are also presented. An overview of Quality Management System implementation in a research laboratory. The aim of this paper is to show the advantages of implementing a Quality Management System QMS in a research laboratory in order to improve the management of risks specific to research programmes and to increase the reliability of results.
This paper also presents experience gained from feedback following the implementation of the Quality process in a research laboratory at INRA, the French National Institute for Agronomic Research and details the various challenges encountered and solutions proposed to help achieve smoother adoption of a QMS process. Practical examples illustrate the benefits and improvements observed in the laboratory.
The laboratory of body radioactivity counter has implemented IS0 standard Performance Criteria for Radio bioassay in all measured in vivo techniques of internal contamination in the human organism in monitoring programs defined by the Personal Dosimetry Service Internal CIEMAT. Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa.
Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system QMS and laboratory accreditation are key to improving patient care. An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April , regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region.
A total of 21 laboratories Most NTRLs participated in acid-fast bacilli microscopy external quality assurance Barriers to accreditation included lack of training and accreditation programmes. Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient. Quality system of the Chemical Analysis Laboratory to fulfill the requirements with Certification Organizations.
In the present work was described the Quality System established in the Chemical Analysis Department to fulfill with the Organization requirements, personnel, measurement equipment, calibration, working procedures, etc. There are described the available resources, the performance and control of each of one principal points of the system. Evaluation of the implementation of a quality system in a basic research laboratory: To evaluate the process of implementing a quality management system in a basic research laboratory of a public institution, particularly considering the feasibility and impacts of this improvement.
This was a prospective and qualitative study. In parallel, we used the PDCA tool to define the goals of each phase of the implementation process. Accordingly, documents were prepared and routines were established such as the registration of non-conformities, traceability of research data and equipment calibration. The implementation of a quality system , the setting of a laboratory focused on basic research is feasible once certain structural changes are made.
Importantly, impacts were noticed during the process, which could be related to several improvements in the laboratory routine. Isotopic power supplies for space and terrestrial systems: The Sandia National Laboratories participation in Quality Assurance QA programs for Radioisotopic Thermoelectric Generators which have been used in space and terrestrial systems over the past 15 years is summarized.
Basic elements of the program are briefly described and recognition of assistance from other Sandia organizations is included. Descriptions of the various systems for which Sandia has had the QA responsibility are also presented. In addition, the outlook for Sandia participation in RTG programs for the next several years is noted. The quality management system at the European tritium handling experimental laboratory.
The main limitations of conventional Quality Assurance QA are discussed with reference to the operational phase of a radio-chemical research laboratory. The paper suggests a broader approach utilizing a Quality Management System QMS which focuses on the operational efficiency of a R ampersand D organization in terms of reliability, reproducibility, cost effectiveness and safety. The management's role is presented with particular reference to the best fit of managerial style to the organization's mission, culture, personnel and surrounding environment. Development of a laboratory prototype water quality monitoring system suitable for use in zero gravity.
The development of a laboratory prototype water quality monitoring system for use in the evaluation of candidate water recovery systems and for study of techniques for measuring potability parameters is reported. Sensing techniques for monitoring of the most desirable parameters are reviewed in terms of their sensitivities and complexities, and their recommendations for sensing techniques are presented.
A master water monitor development schedule is included. Quality assurance manual for the Department of Energy laboratory accreditation program for personnel dosimetry systems. The overall purpose of this document is to establish a uniform approach to quality assurance. This will ensure that uniform, high- quality personnel dosimetry practices are followed by the participating testing laboratories.
The document presents guidelines for calibrating and maintaining measurement and test equipment M and TE , calibrating radiation fields, and subsequently irradiating and handling personnel dosimeters in laboratories involved in the DOE dosimetry systems testing program. Radiation energies for which the test procedures apply are photons with approximately 15 keV to 2 MeV, beta particles above 0. The quality control of equipment used in calibration from the National Laboratory of Metrology on Ionizing Radiations is presented, with results of standard measure systems and irradiation system.
Tables and graphics with the quality of systems are also shown. In order to ensure the traceability of the samples and their results through all stages of service execution, a computer system was designed as a reliable tool, in addition to the use of certified reference materials, reagent sets, periodic and constant calibration of the samples.
The new potentialities of SDA are directed towards the introduction of tumor markers. Tumor markers are currently used primarily to evaluate the cancer reaction to treatment and to control relapse, although its role in the early detection and diagnosis of cancer is still being studied. Quality management system and accreditation of the in vivo monitoring laboratory at Karslruhe Institute of Technology. The in vivo monitoring laboratory IVM at Karlsruhe Institute of Technology KIT , with one whole body counter and three partial-body counters, is an approved lab for individual monitoring according to German regulation.
In a quality management system QMS , which was successfully audited and granted accreditation, was set up at the IVM. The system itself was set up to be flexible and could be adapted to the recent organisational changes e. Next, interactive input program were designed to accomplish data collecting of the disqualification rate of samples, the mistake rate of samples and the occasions of losing samples, etc. Then, a series moment of sample collection, laboratory sample arrived, sample test, sample check, response to critical value, namely, trajectory information left on LIS were recorded and the qualification rate of TAT, the notification rate of endangering result were calculated.
Finally, the information about quality control were collected to build an internal quality control database and the KIQI, such as the out-of-control rate of quality control and the total error of test items were monitored. The mistake rates of samples was 0. We have solved the problem by optimizing the processes. We have solved the problem by changing the reagent. It is an objective and effective method to manage KIQI with the powerful management mode of database and information process capability on LIS.
Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. We report the development of a stepwise process for quality systems improvement in the Caribbean Region. This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country.
The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement.
Achieving Quality Laboratory Projects. The theme articles present strategies for achieving quality laboratory projects in vocational agriculture. They describe fundamentals of the construction of quality projects and stress the importance of quality instruction. Piloting laboratory quality system management in six health facilities in Nigeria. Full Text Available Achieving accreditation in laboratories is a challenge in Nigeria like in most African countries. Major interventions include advocacy, capacity building, mentorship and quality improvement projects. At baseline audit, two of the laboratories attained 1- star while the remaining four were at 0- star.
At follow up audit one lab was at 1- star, two at 3-star and three at 4-star. At exit audit, four labs were at 4- star, one at 3-star and one at 2-star rating. One laboratory dropped a 'star' at exit audit, while others consistently improved. The elements facility and safety was the major strength across board throughout the audit exercise.
This effort resulted in measurable and positive impact on the laboratories. Strengthening Laboratory Management Toward Accreditation SLMTA is a competency-based management training programme designed to bring about immediate and measurable laboratory improvement. The study used an Institutional based cross sectional study design that employed a secondary and primary data collection approach on the participated institution of medical laboratory in SLMTA.
The study was conducted in Addis Ababa city government and the data was collected from February 'April and data was entered in to EPI-data version 3. The assessment finding indicate that there was a significant improvement in average scores Laboratory facilities respondents which thought getting adequate and timely manner mentorship were found 2. At the end of SLMTA implementation,3 laboratories score 3 star, 6 laboratories were at 2 star, 11 were at 1 star. The most important contributing factor for not scoring star in the final outcome of SLMTA were not conducting their customer satisfaction survey, poor staff motivation, and lack of regular equipment service maintenance.
Mentorship, onsite and offsite coaching and training activities had shown a great improvement on laboratory quality management system in most laboratories. Quality assurance in radionuclide laboratories. The authors are members of an ad-hoc working group preparing a contribution to the procedures manual ''Loseblattsammlung'' dealing with quality assurance and quality control in radionuclide laboratories. A short version of the Loseblatt is presented here. Full Text Available Biomedical science is a sensitive discipline and presents unique challenges due to its social character, continuous development and competitiveness.
The issue of quality management systems and accreditation is gaining increasing interest in this sector. All over Europe, Health Services Units have started to introduce quality management systems and harmonization of criteria for accreditation is of increasing importance. Moreover, clinical laboratories , like the Assisted Reproduction laboratories and biochemical laboratories are required to apply a Quality Management System in order to ensure their correct, scientific and effective operation.
Ultimately, it is a moral obligation for every health care organisation to supply the best possible care for the patient. The specific features and the diversity of clinical laboratories led to the introduction and, recently to the revision of the international standard ISO , which is the first international standard developed specifically to address the requirements for accreditation of this type of laboratory. The basic principles for the quality assurance in the clinical laboratories are: All these principles should be supported by the Management in order that the necessary adaptations should be made.
The Quality Assurance Lab has about Quality assurance programme for isotope diagnostic laboratories. Quality assurance systems are suggested to be introduced in laboratories , in accordance with the recommendations of IAEA and WHO, taking local circumstances into consideration.
It is emphasized that a quantitative enhancement of work must not endanger its quality ; diagnostic information must be undistorted, reproducible, and gathered with the minimum of radiation burden. National authorities are requested to strengthen their supervision.
Recommendations for quality assurance methods are given for medical isotope diagnostic laboratories. Tactical Systems Integration Laboratory. Federal Laboratory Consortium — The Tactical Systems Integration Laboratory is used to design and integrate computer hardware and software and related electronic subsystems for tactical vehicles Federal Laboratory Consortium — Purpose: The detailed requirements to quality and competence".
Particular difficulties of global nature]. The article discusses the methodological issues related to the implementation of international principles of standardization in the format of GOST R ISO " Quality management systems. Information provided by manufacturer marking ". This approach legibly assigns the responsibility concerning the support of metrological correctness of laboratory measurements. The lacking of both full-value public and sectorial normative documentation and coordinated positions of Rosstandard and Minzdrav of Russia on functioning of medical laboratories is noted.
Quality in pathology laboratory practice.
Quality refers not only to analytical quality control, a traditional area of laboratory excellence, but to the entire science of quality management. As measures of quality , structural indicators refer to staffing and physical facilities, process indicators to the institutions operations and, perhaps most importantly, outcome indicators address the ultimate patient care uses that pathology information is put to. Comparison of performance to peer laboratories , external quality control, is a practical, if limited, yardstick of performance. Customer satisfaction and turn-around-time of tests are receiving more recent attention as quality measures.
Blood banking, because of its inherently complex cycle from donor phlebotomy to product infusion, requires special considerations with regard to quality management. Reporting of anatomical pathology, where the only gold standard is a consensus of experts, also does not lend itself to classical numerical quality assessment. Quality in the molecular microbiology laboratory. In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases.
Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program.
Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered.
For most European based clinical microbiology laboratories this means following the common International Standard Organization ISO framework and ISO which sets out the quality management requirements for the medical laboratory BS EN ISO Medical laboratories -particular requirements for quality and competence. This chapter focuses on the key quality assurance and quality control requirements within the. Besides one existent accredited lab, radioactive material chemical analysis lab, five test laboratories and two calibration labs are under plan to acquire the accreditation from KOLAS.
Since it is tailored to the radioactive material chemical analysis lab, a number of requirements of the Manual are not applicable to the labs other than radioactive material chemical analysis lab. The current status of radiopharmacy laboratories in Turkey, conveniences to good radiopharmacy practice GRP and quality management systems ISO. This study ha been conducted in the Radiopharmacy Laboratories of Nuclear Medicine departments of various hospitals and private nuclear medicine laboratories. A total of 35 laboratories from 7 regions of Turkey have been selected by layered sampling method from Radiopharmacy Laboratories located in 30 different cities.
During the study, a GRP investigation list with 67 questions and direct communication technique have been used. The aim was determine the current status of the Radiopharmacy Laboratories in general and the administration of radiopharmaceuticals on patients, and good practices in radiopharmacy and conformance with quality assurance systems. In this respect, questions have been asked to determine a General status, b Information level of lab workers regarding to the GRP and ISO concepts i-Status of lab managers, ii- Responsibilities and knowledge of lab workers and iii- regarding to GRP and ISO , c Conditions of infrastructure, and lab services and its quality , d Status of organizations.
Results showed that only two of the 35 managers of laboratories were radiopharmacists, the rest were Nuclear Medicine specialists. There were less knowledge on GRP than ISO, the labs holding ISO certificate were in minority even though ISO is known concept, radiopharmacist were more knowledgeable in GRP while nuclear medicine specialists were in ISO, the labs with better GRP knowledge have better infrastructure, the GRP knowledge were better in the university and armed forces hospitals while ISO knowledge and certificates were more in private labs and hospitals, the armed forces hospitals better paraphernalia, practically almost all radiopharmaceutical kits were imported goods and there were important problems in quality control.
Diagnosis and improvement proposals for the Ezeiza Atomic Center quality management system by carrying out the third laboratories workshop. The purpose of this survey was to get information that would allow to assess the quality of the laboratories and the services they perform, including the degree of implementation of the management systems. In order to comply with this purpose fourteen EAC's laboratories were studied.
The information obtained was related to the staff, their training, the kind of tasks they perform as services or as research and development, the customers, the amount of invoicing, the premises, the equipment and the adapting and implementation of the quality management system. With the results obtained from the survey a report was issued. These workshops were to go deep into the analysis of the information obtained and to generate improvement proposals of the different subjects.
The results of quality control program of secondary standards, therapy level, and the calibration system of clinical dosemeters were analysed from , when a change in the laboratory installation occurred and new standards were obtained. The national and the international intercomparisons were emphasised. Accredited laboratories have an established quality system covering the administrative and technical issues specified in the standard. Quality assurance in medical laboratories.
The book presents a comprehensive and specified survey of the quality assurance measures and methods applied in medical laboratories in the pre-analytical phase and in the analytical and post-analytical phases. It also gives information on computer-aided procedures, cost-benefit analyses in this field, and on official requirements and standards in the fields of clinical chemistry, hematology, immunology and microbiology, and equipment testing and inspection.
One chapter of the book particularly deals with quality assurance for radioimmunological in-vitro analyses. The ideal laboratory information system. Laboratory information systems LIS are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests.
In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care.
Specific suggestions for improving the function of LIS are listed under the following sections: Analytical quality , performance indices and laboratory service. Quality assurance handbook for measurement laboratories. This handbook provides guidance in the application of quality assurance to measurement activities. It is intended to help those persons making measurements in applying quality assurance to their work activities by showing how laboratory practices and quality assurance requirements are integrated to provide control within those activities.
The use of the guidance found in this handbook should help provide consistency in the interpretation of quality assurance requirements across all types of measurement laboratories. This handbook also can assist quality assurance personnel in understanding the relationships between laboratory practices and quality assurance requirements. The handbook is composed of three chapters and several appendices. Basic guidance is provided by the three chapters.
In Chapter 1, the role of quality assurance in obtaining quality data and the importance of such data are discussed. Chapter 2 presents the elements of laboratory quality assurance in terms of practices that can be used in controlling work activities to assure the acquisition of quality data. Chapter 3 discusses the implementation of laboratory quality assurance. The appendices provide supplemental information to give the users a better understanding of the following: A Laboratory Notebook System.
Many scientists are using a laboratory notebook when conducting experiments.