Performance Acceptance Criteria Research Articles

Immediate loading with fixed full-arch prostheses in the maxilla: review of the literature.

Objectives: To critically review the evidence-based literature on immediate loading of implants with fixed full-arch prostheses in the maxilla to determine 1) currently recommended performance criteria and 2) the outcomes that can be expected with this procedure. Study Desing: Studies from 2001 to 2011 on immediate loading with fixed full-arch maxillary prostheses were reviewed. Clinical series with at least 5 patients and 12 months of follow-up were included. Case reports, studies with missing data and repeatedly published studies were excluded. In each study the following was assessed: type of study, implant type, number of patients, number of implants, number of implants per patient, use of post-extraction implants, minimum implant length and diameter, type of prosthesis, time until loading, implant survival rate, prosthesis survival rate, marginal bone loss, complications andmean follow-up time. Criteria for patient selection, implant primary stability and bone regeneration were also studied. Results: Thirteen studies were included, reporting a total of 2484 immediately loaded implants in 365 patients. Currently accepted performance criteria regarding patient and implant selection, and surgical and prosthetic procedures were deduced from the reviewed articles. Implant survival rates went from 87.5% to 100%, prosthesis survival rates from 93.8% to 100% and radiographic marginal bone loss from 0.8 mm to 1.6 mm.No intraoperative complications and only minor prosthetic complications were reported. Conclusions: The literature on immediate loading with fixed full-arch prostheses in the maxilla shows that a successful outcome can be expected if adequate criteria are used to evaluate the patient, choose the implant and perform the surgical and prosthetic treatment. Lack of homogeneity within studies limits the relevance of the conclusions that can be drawn, and more controlled randomized studies are necessary to enable comparison between the immediate and the conventional loading procedures. Key words:Immediate loading, full-arch, dental implants, loading protocols.

Test performance study of diagnostic procedures for identification and detection of Gibberella circinata in pine seeds in the framework of a EUPHRESCO project

Gibberella circinata (anamorph Fusarium circinatum) is a harmful fungus infecting pine trees that has been subject to European Union emergency phytosanitary measures since 2007. This fungus is spread over long distances primarily via pine seeds, consequently reliable detection tools and methods are needed to test pine seed lots imported and marketed in the EU. Several detection methods are available in the scientific literature but very limited validation data is available. For that purpose, one European EUPHRESCO project called ‘Gibcir‐Diagseed’ was launched, involving 10 countries. This project aimed to select and validate one or more diagnostic procedures targeting this pest via inter‐laboratory tests, as well as a suitable sampling method. Performance criteria were calculated for three procedures chosen by participants: isolation followed by morphological characterization, isolation followed by conventional PCR and biological enrichment followed by real‐time PCR. The results showed that all three procedures provided acceptable performance criteria but also demonstrated that none of them could generate 100% of correct results. Regarding the sampling issue, the National Plant Protection Organizations consultation enabled an agreement to be reached on the number of seeds to be tested: 400 per sample, for a 95% confidence level that an infection of at least 1% will be detected.

Performance monitoring and transfusion QAP performance levels

This presentation will endeavour to provide an understanding of Performance Monitoring in Quality Assurance of Transfusion as measured by a project undertaken by the Royal College of Pathologists of Australasia (RCPA) Quality Assurance Program (QAP) in 2012. In 2001 the Commonwealth Department of Health and Ageing (DoHA) sought proposals to undertake an evaluation of Australian pathology laboratory accreditation arrangements. Recommendations from the report were that (1) the DoHA and the Health Insurance Commission seek the cooperation of the RCPA QAP to establish explicit external quality assurance performance criteria and a mechanism for the RCPA QAP to identify relatively poorly performing laboratories; (2) RCPA QAP and other external quality assurance providers regularly submit to the National Association of Testing Authorities (NATA) reports identifying laboratories that are poorly performing according to these agreed performance criteria. The review process included establishment of a methodology/scoring system; a retrospective data analysis; establishment of criteria for acceptable performance based on the retrospective data analysis and reasonable expectations for completing a corrective action. Information and results from QAP surveys was used to assess individual participant data against established criteria to provide laboratories of an objective measure of their performance relative to their peers whilst meeting the needs of the performance review process.

Seismic Performance Evaluation of RC Beam-Column Connections in Special and Intermediate Moment Frames

This article presents the results of a research project aimed at investigating the seismic performance criteria of beam-column connections in reinforced concrete (RC) moment frames. A total of 112 RC beam-column connection tests were examined in detail. All the test specimens were qualified as either special moment frame (SMF) or intermediate moment frame (IMF) connections, based on the design and detailing requirements of ACI 318-08 [2008, Ch. 21]. The performance acceptance criteria, originally defined for steel moment frame connections in the 1997 edition of the AISC Seismic Provisions, were employed to evaluate the seismic performance of the RC connection specimens. Most of the specimens that satisfied the ACI 318 design requirements applying for SMFs were found to be ductile up to a plastic drift of 3% without any major degradation in strength, which satisfied the AISC performance acceptance criteria. This is most likely attributed to the stringent ACI 318-08 requirements for joints in SMFs. On the other hand, more than 40% of the IMF connections were not satisfactory based on the AISC criteria applying for steel IMF connections. Joint shear stress level showed more significant effect on their seismic performance than the column-to-beam flexural strength ratio. It is believed that inadequate joint detailing prevented these connections from developing their full beam flexural capacity, which resulted in premature strength deterioration and subsequent failure. Based on the findings, it is recommended that design requirements for beam-column connections in RC IMFs should be revisited and enhanced; otherwise, the R-factor assigned for RC IMFs should be somewhat reduced to accommodate their smaller ductility than intended by the ACI 318 requirements.

213P - Results of the Second Pilot External Quality Assurance Scheme for Somatic Egfr Mutation Testing in Non-Small-Cell Lung Cancer (NSCLC)

ABSTRACT Background The External Quality Assurance (EQA) process aims at establishing performance levels and may identify systematic errors in methodology that may not be revealed by internal QA processes. The European Molecular Genetics Quality Network (EMQN), the European Society for Pathology (ESP), the European Thoracic Oncology Platform (ETOP) and the European Society of Medical Oncology (ESMO) with other leading European groups collaborated in a pilot EQA scheme for somatic EGFR gene mutational analysis in NSCLC. Material and methods Samples generated from cell lines mimicking clinical fractions of neoplastic cell content were validated by 5 laboratories and then provided to participating laboratories. Each sample was supplied with a mock clinical case. Participating laboratories registered with the EMQN, performed the analysis using their usual method(s), and submitted their results within a 6 week timeframe. Anonymous results were assessed and made available to all participants. Results Of a total of 117 labs from 30 countries registered, 91 labs returned results. Sequencing and the DxS Therascreen kit were the main methodologies used by the participants. The standard of genotyping was worrying, with a significant number of genotyping errors made. Only 42 (46.1%) participants reported the correct result for all 10 samples. The majority of errors were false-negative results (82.2%); however, 15.1% of errors were due to false-positive results and 2.7% to a combination of both errors. There were 42 (4.8%) analytical failures of which 88.1% were distributed across 6 laboratories. The performance of 18 (19.8%) labs fell below the criteria for acceptable performance (score Conclusions The technical performance of genotyping in EGFR mutation testing for NSCLC has room for improvement, evident from a high level of “true” diagnostic errors. Overall the standard of reporting was acceptable. Robust EQA can contribute to global optimization of EGFR testing. Disclosure All authors have declared no conflicts of interest.

Comparison and bias analysis of BUN, Cr and UA between two different biochemical analysis systems

Objective To discuss the comparability of blood urea nitrogen (BUN), creatinine (Cr), uric acid (UA) results and provide basis for result concordance in different biochemical systems. Methods The within-run precision and the between-day precision for the median and high values of quality control materials were tested in Beckman LX-20 and Hitachi 7600 chemistry analyzer respectively, and the evaluation criteria were according to the precision requirement of manufacturer and our laboratory.According to American Clinical and Laboratory Standards Institute (CLSI) document EP9-A2, serum BUN, Cr, UA from 40 patients were detected by Hitachi 7600 chemistry analyzer as experimental method and by Beckman LX-20 chemistry analyzer as comparative method.The relative bias (SE%) between experimental method and comparative method was calculated and the concordance of biochemical analysis system was determined according to EQA requirements and acceptable performance criteria. Results The between-run and between-day precision coefficients of variation for BUN, Cr and UA in two biochemical analysis systems were lower than the precision requirement of manufacturer and our laboratory.In Hitachi 7600 chemistry analyzer, the SE% for BUN at three levels of medical decision were 9.4%, 2.0% and 0.8%, the SE% for Cr were 7.3%, 3.8% and 2.8%, the SE% for UA were 7.9%, 1.7% and 1.2%.Two biochemical analysis systems were not comparable in BUN analysis because SE% of serum BUN levels detected by Hitachi 7600 at low medical decision level exceeded the specified range.The remaining items between two biochemical analysis systems were concordant. Conclusion While the same test is detected by more than two systems in one laboratory, it is necessary to do method comparison and bias evaluation for concordance in order to ensure the comparability among test results.（Chin J Lab Med，2012,35：550-553） Key words: Blood urea nitrogen; Creatinine; Uric acid; Clinical chemistry tests; Evaluation studies

Monitoring performance of external quality control

Aim In 2010 the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPA QAP), received Quality Use of Pathology Program funding to determine if regular external quality assurance that laboratories perform could be used to identify unacceptable performance earlier than the usual 3 year NATA accreditation cycle, to help minimise risk to patients. Method Criteria for unacceptable performance have been established to identify laboratories that maybe underperforming in external quality assurance (EQA). New frameworks have also been developed that outline the process of actions to be taken by the RCPA QAP when participant results and IVDs fall outside levels of acceptable performance. The frameworks proactively notify participants or manufacturers or their sponsors to assist them early. Results When unacceptable performance is identified, according to the set criteria, a letter will be sent to the participant outlining the result(s) falling outside the criteria for acceptable performance and offer assistance to review the QAP results. Persisting unacceptable performance will be referred to a Committee for review and results referred to the National Association of Testing Authorities (NATA) or Therapuetic Goods Administration (TGA) for follow-up. Conclusion The RCPA QAP has established a performance monitoring system using the EQA results. The early warning system will identify laboratories of concern and assist them to obtain their accreditation. Conflict of interest statement This research was supported by the Department of Health and Ageing. The Department had no role in analysing the data or preparing the abstract.

Avaliando a comutatividade: importante requisito da qualidade para laboratórios clínicos

INTRODUÇÃO: Poucos laboratórios no Brasil realizam a avaliação da comutatividade dos resultados de exames, provavelmente por desconhecimento dos procedimentos para sua realização e também pela pouca importância dada a essa avaliação. OBJETIVO: Avaliar a comutatividade dos resultados de exames hematológicos realizados em três analisadores automatizados em um laboratório de um hospital público universitário, em Belo Horizonte, MG, Brasil, propondo procedimento prático, de baixa complexidade, factível de ser utilizado em laboratórios clínicos. MATERIAL E MÉTODOS: As amostras foram selecionadas visando obter valores nos níveis de decisão terapêutica. Foram processadas seis amostras por dia, durante quatro dias, em duplicata em três analisadores, totalizando 48 replicatas em cada instrumento. Foi avaliada a correlação entre os resultados de 10 dos principais parâmetros hematológicos obtidos nos instrumentos-teste e aqueles obtidos com o instrumento-referência. Foram estimados os erros sistemáticos e totais, considerando as especificações da variação biológica como limite máximo aceitável. RESULTADOS: O coeficiente de correlação (r) entre os equipamentos para os parâmetros investigados foi > 0,975. Os erros sistemático (médio) e total, obtidos para os parâmetros analisados, quando se comparam os equipamentos de teste com o de referência, atenderam às especificações da qualidade definidos. Discussão: A comutatividade é um importante processo da gestão da qualidade do laboratório clínico e visa garantir a comparabilidade de resultados de exames realizados por diferentes sistemas. CONCLUSÃO: Utilizando procedimento padronizado internacionalmente, prático e de baixa complexidade, demonstrou-se que os exames realizados nos equipamentos avaliados são equivalentes, podendo ser usados indistintamente no acompanhamento de pacientes.

A Comparative Evaluation of Performance Based Analysis Procedures According to 2007 Turkish Earthquake Code and Fema-440

Chapter 7 of the 2007 Turkish Earthquake Code (TEC) entitled “Assessment and Strengthening of Existing Buildings” sets standards for assessment and rehabilitation of existing buildings. Linear elastic and non-linear evaluation procedures of 2007 TEC are applied to reinforced concrete buildings. 2007 TEC gives two methods for assessment and rehabilitation of existing buildings. Linear elastic and non-linear static evaluation procedures are proposed for structural evaluation. A performance-based evaluation methodology is used under three levels of earthquake ground motion intensities with different return periods. The performance acceptance criteria are based on demand to capacity ratios at critical sections for the linear evaluation procedures (equivalent seismic load method and mode superposition method) and material strains for the non-linear evaluation procedures (the non-linear static pushover analysis). Member performance limits are described for three damage levels, considering the anticipated failure mode and ductility capacity of each member. Structural performance is then calculated by accounting for the distribution of member damages over the building.. Consistency between the results of the methods used for seismic evaluation of existing buildings is of prime importance. For this purpose, an irregular structure of in plane (A3 type) and 3 story is considered. The target performance level of the building is obtained by applying the linear and the non-linear evaluation procedures. The results are given comparatively on the target performance level of the building. Furthermore non-linear procedure results are compared between 2007TEC and FEMA-440 Capacity-Spectrum Method (CSM) and Displacement- Coefficient Method (DCM).

Limitations of Minimally Acceptable Interpretive Performance Criteria for Screening Mammography

Limitations of Minimally Acceptable Interpretive Performance Criteria for Screening Mammography

Identifying Minimally Acceptable Interpretive Performance Criteria for Screening Mammography

Identifying Minimally Acceptable Interpretive Performance Criteria for Screening Mammography

Identifying Minimally Acceptable Interpretive Performance Criteria for Screening Mammography

To develop criteria to identify thresholds for minimally acceptable physician performance in interpreting screening mammography studies and to profile the impact that implementing these criteria may have on the practice of radiology in the United States. In an institutional review board-approved, HIPAA-compliant study, an Angoff approach was used in two phases to set criteria for identifying minimally acceptable interpretive performance at screening mammography as measured by sensitivity, specificity, recall rate, positive predictive value (PPV) of recall (PPV(1)) and of biopsy recommendation (PPV(2)), and cancer detection rate. Performance measures were considered separately. In phase I, a group of 10 expert radiologists considered a hypothetical pool of 100 interpreting physicians and conveyed their cut points of minimally acceptable performance. The experts were informed that a physician's performance falling outside the cut points would result in a recommendation to consider additional training. During each round of scoring, all expert radiologists' cut points were summarized into a mean, median, mode, and range; these were presented back to the group. In phase II, normative data on performance were shown to illustrate the potential impact cut points would have on radiology practice. Rescoring was done until consensus among experts was achieved. Simulation methods were used to estimate the potential impact of performance that improved to acceptable levels if effective additional training was provided. Final cut points to identify low performance were as follows: sensitivity less than 75%, specificity less than 88% or greater than 95%, recall rate less than 5% or greater than 12%, PPV(1) less than 3% or greater than 8%, PPV(2) less than 20% or greater than 40%, and cancer detection rate less than 2.5 per 1000 interpretations. The selected cut points for performance measures would likely result in 18%-28% of interpreting physicians being considered for additional training on the basis of sensitivity and cancer detection rate, while the cut points for specificity, recall, and PPV(1) and PPV(2) would likely affect 34%-49% of practicing interpreters. If underperforming physicians moved into the acceptable range, detection of an additional 14 cancers per 100000 women screened and a reduction in the number of false-positive examinations by 880 per 100000 women screened would be expected. This study identified minimally acceptable performance levels for interpreters of screening mammography studies. Interpreting physicians whose performance falls outside the identified cut points should be reviewed in the context of their specific practice settings and be considered for additional training.

Six of Eight Hemoglobin A1c Point-of-Care Instruments Do Not Meet the General Accepted Analytical Performance Criteria

Hemoglobin A(1c) (Hb A(1c)) point-of-care (POC) instruments are widely used to provide rapid-turnaround results in diabetic care centers. We investigated the conformance of various Hb A(1c) POC instruments (In2it from Bio-Rad, DCA Vantage from Siemens, Afinion and Nycocard from Axis-Shield, Clover from Infopia, InnovaStar from DiaSys, A1CNow from Bayer, and Quo-Test from Quotient Diagnostics) with generally accepted performance criteria for Hb A(1c). The CLSI protocols EP-10, EP-5, and EP-9 were applied to investigate imprecision, accuracy, and bias. We assessed bias using 3 certified secondary reference measurement procedures and the mean of the 3 reference methods. Assay conformance with the National Glycohemoglobin Standardization Program (NGSP) certification criteria, as calculated from analyses with 2 different reagent lot numbers for each Hb A(1c) method, was also evaluated. Because of disappointing EP-10 results, 2 of the 8 manufacturers decided not to continue the evaluation. The total CVs from EP-5 evaluations for the different instruments with a low and high Hb A(1c) value were: In2it 4.9% and 3.3%, DCA Vantage 1.8% and 3.7%, Clover 4.0% and 3.5%, InnovaStar 3.2% and 3.9%, Nycocard 4.8% and 5.2%, and Afinion 2.4% and 1.8%. Only the Afinion and the DCA Vantage passed the NGSP criteria with 2 different reagent lot numbers. Only the Afinion and the DCA Vantage met the acceptance criteria of having a total CV <3% in the clinically relevant range. The EP-9 results and the calculations of the NGSP certification showed significant differences in analytical performance between different reagent lot numbers for all Hb A(1c) POC instruments.

Design recommendations for bond between GFRP/steel wire composite rebars and concrete

Due to significant advantages over GFRP rebars, namely high tensile strength, high elastic modulus, and good ductile properties, GFRP/steel wire composite rebars offer a superior alternative to ordinary steel rebars. However, experimental researches on this new type of rebar have been limited, especially those on the bond performance. This research is designed to investigate the bond behavior between GFRP/steel wire composite rebars and concrete. According to American Concrete Institute (ACI) code, a total of 180 pull-out specimens were tested under monotonic static loading conditions. The test parameters were the rebar rib spacing, rebar diameter, embedded length, concrete compressive strength, concrete cover thickness, and concrete cast depth. Based on the numerical analysis of the test results, new criteria for acceptable bond performance of GFRP/steel wire composite rebars to concrete were developed. Designed recommendations for the modification factor of concrete cover thickness, the modification factor of concrete cast depth, and the critical value of bond slip at both free and loaded ends were derived. The calculation formula of bond strength and the basic development length were proposed, and the calculation principle of development length of concrete structures reinforced with GFRP/steel wire composite rebars was suggested.

Draft radioanalytical water and soil performance testing: Uncertainty acceptance criteria derived from historical mixed-analyte performance evaluation program results

Radioanalytical performance testing programs provide radioassay laboratories, regulators and the public performance-based evidence that measurement capabilities are in control. Performance acceptance criteria that combine aspects of measurements difference from a known value and the associated combined uncertainty establishes a quantitative statement of statistical confidence. However, there is need for a reasonable upper limit of the reported measurement uncertainty. Evaluation of thousands of historical U.S. DOE Mixed-Analyte Performance Evaluation Program measurement results for 17 radionuclides in soil and water samples provides predictive expectations for future measurement results and a statistical basis for establishing reasonable upper limits for reported measurement uncertainties for performance evaluation programs.

Laboratory Evaluation and Field Application of Roadside Oral Fluid Collectors and Drug Testing Devices

This study was a part of a collaborative U.S./E.U. international research effort (Roadside Testing Assessment, ROSITA II) to assess illegal drug use among motor vehicle operators suspected of driving while under the influence of drugs and to evaluate the effectiveness of point-of-collection oral fluid drug detection technologies. A goal of the study was to assess commercial oral fluid drug testing devices for potential use in law enforcement. Ten devices were evaluated in the laboratory for their ability to meet manufacturers' claimed (and proposed) cutoff concentrations for the detection of amphetamine(s), cocaine/metabolite, opiates, cannabinoids, and benzodiazepines (2 devices). The field study portion of the research was conducted in major cities in the United States and Western Europe by teams of scientists working in collaboration with the local police. In Salt Lake City, Utah, the Drugwipe, Securetec, Ottobrunn, Germany (Securetec) oral fluids drug testing device was also evaluated in the field by testing suspected drug-impaired drivers. During the initial phase of the field study, 40 subjects were recruited. Drugwipe results were compared with laboratory-based immunoassay and mass spectrometry results and demonstrated that calculated sensitivities were between 75% and 100% depending on drug class. Specificities varied from 36% for cannabinoids to over 95% for opiates. During the second phase of the field study, 267 subjects were recruited. The Drugwipe sensitivities were 36.4%, 35.9%, 42.9%, and 7.7%, respectively, for amphetamine(s), cocaine, opiates, and cannabinoids. The Drugwipe specificities were 99.2%, 97.4%, 99.6%, and 99.6%, respectively, for amphetamine(s), cocaine, opiates, and cannabinoids. Drugwipe failed to meet the study criteria for acceptable device performance, required performance sensitivities, and specificities 90% or greater.

Program Report Cards: Evaluation Across Multiple Residency Programs at One Institution

The designated institution official (DIO) is responsible for monitoring all residency programs within an institution. Although program-evaluation tools have been developed for residency program directors to use, there are currently no such published evaluation tools for DIOs. This manuscript describes the development and implementation of a standardized, dimensional program report card for the more than 60 residency and fellowship programs at our institution. This report card measures the theoretical construct of residency program performance and is divided into four sections: (1) quality of candidates recruited, (2) the resident educational program, (3) graduate success, and (4) overall house officer satisfaction. Each section is measured by objective and subjective metrics that allow the DIO to record programmatic strengths and weaknesses. These results are confidentially shared with the residency program director and encourage a partnership between the DIO and the program director. It is difficult to provide concrete construct validity with this instrument. The process used to develop the report card seems valid. The authors recognize that this report card is a surrogate for each program's RRC's perception of quality. In the future, the authors hope to work closely with the Accreditation Council for Graduate Medical Education and/or the group on resident affairs of the Association of American Medical Colleges to set national benchmark criteria for acceptable residency program performance for each medical discipline. They hope that DIOs and program directors will be able to compare residency programs objectively and identify areas for improvement at a local and national level.

Automated Tecan Programming for Bioanalytical Sample Preparation with EZTecan

This paper reports the first successful automated Tecan (Tecan US, Research Triangle Park, NC) programming for bioanalytical sample analysis with an in-house developed software, called EZTecan. Based on the sample run list in the Watson Laboratory Information Management System (InnaPhase Corp., Philadelphia, PA), EZTecan can generate a Tecan program for bioanalytical sample preparation, including sample transfer, sample dilution, extraction, and reconstitution. Many built-in functions for EZTecan ensure the flexibility, quality, and efficiency of the liquid handling. It takes about 90 min to prepare two 96-well plates from sample transfer to reconstitution. Analytical results shown good inter- and intra-assay accuracy and precision, which meet the +/-15% Good Laboratory Performance acceptance criteria. With EZTecan, bioanalysts can prepare samples without writing a single line of Tecan program.

Equimolar Ammonia Interference in Potassium Measurement on the Osmetech OPTI CCA: A Reply

We agree that the Osmetech OPTI Critical Care Analyzer (OPTI) measurement of potassium ion shows a bias with samples containing extremely high plasma ammonia concentrations, as reported by Carayanopoulos et al. (1). As a result of this report we have notified all OPTI customers of this interference at these rare high ammonia concentrations. Hyperammonemia has an estimated incidence in newborns of 1 per 25 000–53 000 live births (2)(3). Urea cycle disorders are the usual cause (4), occasionally leading to ammonia concentrations >400 μmol/L, which would increase the potassium reported on OPTI by 0.5 mmol/L. Such a bias is greater than allowed under the US Healthcare Financing Administration/CLIA proficiency testing criteria for acceptable performance (5). In rare cases, newborns may also suffer hyperammonemia attributable to other pathologies (6), such as organic acidemias, fatty acid oxidation disorders, congenital lactic acidosis, lysinuric protein intolerance, hepatic or renal dysfunction, Reye syndrome, certain drugs (valproate, asparaginase, …

Development of global standards for antimicrobial susceptibility testing: The ISO initiative

The International Organization for Standardization (ISO) has recently provided an opportunity to define a global standard reference method for antimicrobial susceptibility testing and to delineate acceptable performance criteria for antimicrobial susceptibility testing devices. A working group organized under the auspices of ISO Technical Committee 212 has worked closely with a working group of the European Committee on Normalization to develop the two global standards. The global reference method is the broth microdilution method that is presently described by both the Clinical and Laboratory Standards Institute and the European Union Committee on Antimicrobial Susceptibility Testing. Experts from 13 countries that formed the membership of the working groups have endeavored over the past 3 years to agree upon the international reference method and to define for the first time an outline for objective assessment of commercial devices that can be used for routine susceptibility testing in clinical microbiology laboratories.