Implementation of Quality Systems in Nuclear Medicine: Why It Matters. An Outcome Analysis (Quality Management Audits in Nuclear Medicine Part III).

The International Atomic Energy Agency (IAEA) developed a comprehensive program-Quality Management Audits in Nuclear Medicine (QUANUM). This program covers all aspects of nuclear medicine practices including, but not limited to, clinical practice, management, operations, and services. The QUANUM program, which includes quality standards detailed in relevant checklists, aims at introducing a culture of comprehensive quality audit processes that are patient oriented, systematic, and outcome based. This paper will focus on the impact of the implementation of QUANUM on daily routine practices in audited centers. Thirty-seven centers, which had been externally audited by experts under IAEA auspices at least 1 year earlier, were invited to run an internal audit using the QUANUM checklists. The external audits also served as training in quality management and the use of QUANUM for the local teams, which were responsible of conducting the internal audits. Twenty-five out of the 37 centers provided their internal audit report, which was compared with the previous external audit. The program requires that auditors score each requirement within the QUANUM checklists on a scale of 0-4, where 0-2 means nonconformance and 3-4 means conformance to international regulations and standards on which QUANUM is based. Our analysis covering both general and clinical areas assessed changes on the conformance status on a binary manner and the level of conformance scores. Statistical analysis was performed using nonparametric statistical tests. The evaluation of the general checklists showed a global improvement on both the status and the levels of conformances (P < 0.01). The evaluation of the requirements by checklist also showed a significant improvement in all, with the exception of Hormones and Tumor marker determinations, where changes were not significant. Of the 25 evaluated institutions, 88% (22 of 25) and 92% (23 of 25) improved their status and levels of conformance, respectively. Fifty-five requirements, on average, increased from nonconformance to conformance status. In 8 key areas, the number of improved requirements was well above the average: Administration & Management (checklist 2); Radiation Protection & Safety (checklist 4); General Quality Assurance system (checklist 6); Imaging Equipment Quality Assurance or Quality Control (checklist 7); General Diagnostic (checklist 9); General Therapeutic (checklist 12); Radiopharmacy Level 1 (checklist 14); and Radiopharmacy Level 2 (checklist 15). Analysis of results related to clinical activities showed an overall positive impact on both the status and the level of conformance to international standards. Similar results were obtained for the most frequently performed clinical imaging and therapeutic procedures. Our study shows that the implementation of a comprehensive quality management system through the IAEA QUANUM program has a positive impact on nuclear medicine practices

Usage-Based Reading for Inspections of Requirements

Software inspection has proven to be an effective way to increase the quality of software products. A new reading technique suggested for software inspection, usage-based reading (UBR), has been tested in previous studies, where it showed good defect detection efficiency during inspection of design documents. This study addresses the question whether this is true also for inspections of requirements documents. The idea behind UBR is to let prioritized use-cases direct the reviewer’s focus on important parts of the document. Using graduate students as subjects, the UBR approach for inspection of requirement specification was compared with a checklist approach. All defects were classified according to their severity for the function of the final software. The result shows that reviewers using UBR do not find more defects and use more time than those using a checklist. In conclusion, in comparison with a checklist approach, UBR does not make the inspection of requirements specifications more efficient

Analisis Kesiapan Sertifikasi Iso 9001:2015 pada PT. Wijara Nagatsupazki dengan Menggunakan Metode Gap Analysis

Analysis of ISO 9001:2015 Certification Readiness in PT. Wijara Nagatsupazki using Gap Analysis, global economic competition and market demand, requires companies to establish and develop the internal management system in accordance with International standards. Due to the world economic competition intensifies, many organizations adopt and implement effective quality improvement programs. The quality improvement program is contained in the Quality Management of System (QMS), which are developed in ISO 9001 standard certification. ISO 9001 is a standard that contains the requirements for quality management systems published by the International Organization for Standardization (IOS). Companies that become the research object is PT. Wijara Nagatsupazki, the company is engaged in manufacturing. The company suffered some losses in the form of withdrawal of orders from customers, on the other hand there were also complaints from customers because the products are not in accordance with the standards that have been approved, this is one of the indirect impact of the absence of the ISO 9001 certification in PT. Wijara Nagatsupazki. his study aimed to evaluate the condition of PT. Wijara Nagatsupazki today and how prepared PT. Wijara Nagatsupazki preparation for ISO 9001: 2015 and providing recommendations and prepare a document for the quality of the company in accordance with the requirements of ISO 9001 2015. Gap Analysis was used to evaluate the state of the PT. Wijara Nagatsupazki and assessing the readiness of companies for preparing the company for ISO 9001:2015 certification. The calculations on the Gap Analysis using the checklist will be made under the existing requirements of ISO 9001: 2015. The results of calculations using the checklist will show how prepared PT. Wijara Nagatsupazki to perform a certification ISO 9001: 2015

Checklist for Assessing Graduate Student Competencies in Voice Disorders

Low-incidence clinical disorders such as voice, nasal resonance, and fluency present challenging areas for graduate-level speech-language pathology training programs to help students acquire necessary knowledge and skills. A checklist of competencies for fluency disorders exists in the literature. The authors are presently collecting pretest/posttest data on the fluency disorders checklist over several cohorts of graduate students to determine student level of proficiency and confidence regarding these competencies. Preliminary data analysis suggests significant student perception of growth as a result of completing course requirements. These data have been useful to the second author, who teaches a course in fluency disorders and utilizes the checklist for purposes of course design and case-based project development to help students gain competence. The authors observed that a similar checklist of competencies for voice disorders would be useful for training programs as well as for other reasons described throughout this paper. Consequently, the authors compiled a checklist for assessing graduate student competencies for voice disorders. This checklist provides academic and clinical faculty with a comprehensive tool to guide the education of graduate clinicians and assist in the assurance of educational quality for speech-language pathologists

Developing and validating a checklist for assessing the performance of air ambulance services

Objective: The purpose of this study was to develop a checklist for assessing the performance of air ambulance services. Method: This is a qualitative study. The first phase involved a review of existing documentation about air emergency standards to create a checklist of the most critical factors and components affecting the performance of air ambulance services. The second phase required experts to complete a performance evaluation checklist from the previous phase. The third phase utilized the Delphi technique to validate the performance evaluation checklist for air ambulance services. The experts in this study were 24 pundits with a vested interest in the subject. Results: A total of 31 items exist in the area of helipad-related facilities, 17 items in the area of process requirements for medical centers with helicopter landing areas, 15 items in the category of human resources for air ambulances, 10 items in the category of human resources for receiving or delivering patients from air ambulances to medical centers, 27 items in the area of base equipment, 17 items in the area of helicopter equipment, and requirements, 14 items in the category of technical, communication, and safety equipment for use inside the helicopter, 1o items dealing with time standards, 11 items dealing with road and urban base requirements for air ambulance operations. Experts approved two items in the area of utilizing other rescue and law enforcement agencies to assist and cooperate with air emergency flights and two items in the area of comfort for conscious patients to alleviate stress during flight. Conclusion: A performance evaluation checklist is an effective tool for evaluating the quantity and quality of emergency helicopter services provided and measuring their performance

Enterprise information security policy assessment - an extended framework for metrics development utilising the goal-question-metric approach

Effective enterprise information security policy management requires review and assessment activities to ensure information security policies are aligned with business goals and objectives. As security policy management involves the elements of policy development process and the security policy as output, the context for security policy assessment requires goal-based metrics for these two elements. However, the current security management assessment methods only provide checklist types of assessment that are predefined by industry best practices and do not allow for developing specific goal-based metrics. Utilizing theories drawn from literature, this paper proposes the Enterprise Information Security Policy Assessment approach that expands on the Goal-Question-Metric (GQM) approach. The proposed assessment approach is then applied in a case scenario example to illustrate a practical application. It is shown that the proposed framework addresses the requirement for developing assessment metrics and allows for the concurrent undertaking of process-based and product-based assessment. Recommendations for further research activities include the conduct of empirical research to validate the propositions and the practical application of the proposed assessment approach in case studies to provide opportunities to introduce further enhancements to the approach

College of American Pathologists\u27 Laboratory Standards for Next-Generation Sequencing Clinical Tests

Context.-The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. Objective.-To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or \u27\u27 dry bench\u27\u27 analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. Design.-To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results.-A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP\u27s molecular pathology checklist (MOL). Conclusions.-This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality

Quality programming for learning-disabled students : a comparison of microcomputer-assisted IEPS, manual-assisted IEPS, and teacher written IEPS

The purpose of this study was to determine which IEPs are of greater quality for learning-disabled students: teacher-written IEPs (those developed without the aid of microcomputers or manuals of goals and objectives); manual-assisted IEPs (those developed with the aid of manuals of goals and objectives); or microcomputer-assisted IEPs (those developed with the aid of both manuals of goals and objectives and microcomputers). This study investigated the question: What effect does the use of microcomputers and manuals of goals and objectives have upon the quality of IEPs developed for learning-disabled students?;The sample consisted of 120 IEPs of students categorized as learning-disabled by the North Central Regional Education Sevice Agency (RESA 7) of West Virginia. Forty of the IEPs were teacher-written, forty of the IEPs were manual-assisted, and forty of the IEPs were microcomputer-assisted. Three trained raters examined and evaluated, individually, all of the IEPs involved in the study with regard to legal requirements, relevance, and clarity using the Checklist For Documenting Appropriateness of the IEP.;A statistical analysis of the data collected regarding each hypothesis revealed the following findings: (1) A t test indicated that the microcomputer-assisted IEPs in this study received a significantly higher mean total score (p \u3c .01) on the Checklist For Documenting Appropriateness of the IEP than did the teacher-written IEPs in this study. as a result, the null hypothesis (that there was no difference in quality between microcomputer-assisted IEPs and teacher-written IEPs as evaluated using the Checklist For Documenting Appropriateness of the IEP) was rejected. (2) A t test indicated that the manual-assisted IEPs in this study received a significantly higher mean total score (p \u3c .01) on the Checklist For Documenting Appropriateness of the IEP than did the teacher-written IEPs in this study. as a result, the null hypothesis (that there was no difference in quality between manual-assisted IEPs and teacher-written IEPs as evaluated using the Checklist For Documenting Appropriateness of the IEP) was rejected. (3) A t test indicated that the microcomputer-assisted IEPs in this study received a significantly higher mean total score (p \u3c .01) on the Checklist For Documenting Appropriateness of the IEP than did the manual-assisted IEPs. as a result, the null hypothesis (that there was no significant difference in quality between manual-assisted IEPs and microcomputer-assisted IEPs as evaluated using the Checklist For Documenting Appropriateness of the IEP) was rejected