Integrating quality assurance in autoimmunity: the changing face of the automated ANA IIF test

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Lieve Van Hoovels ◽  
Xavier Bossuyt ◽  
Mariangela Manfredi ◽  
Valentina Grossi ◽  
Maurizio Benucci ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Quality Indicators ◽  
Performance Criteria ◽  
Internal Quality ◽  
Routine Practice ◽  
Total Quality ◽  
Fluorescent Intensity ◽  
Cad Systems ◽  
Target Values ◽  
And Performance

Abstract Objectives Currently available computer-aided diagnosis (CAD) systems for the detection of anti-nuclear antibodies (ANA) by indirect immunofluorescence (IIF) assay enable a standardized measurement of system-specific fluorescent intensity (FI) measures. We aimed to evaluate an internal quality control (iQC) program that controls the total ANA IIF process in routine practice. Methods In addition to the kit iQC materials, supplemental quality indicators were integrated in a total quality assurance (QA) program: patient-derived iQC’s samples (negative, 1/160 fine speckled and 1/160 homogeneous), median sample FI per run and percentage of ANA IIF positive samples per run. Analytical rejection criteria were based on the imprecision of the positivity index (PI) measure of the Zenit PRO system (Menarini). Clinical rejection criteria were based on changes in FI that correspond to a change in ANA IIF titer of ≥2. To evaluate the QA program, different artificial errors were introduced during the ANA IIF process. After every run, quality indicators were evaluated and compared to the pre-set target values. Results Rescanning the ANA IIF slides five times, using an old conjugate and a needle obstruction resulted in analytically and even clinically relevant errors in ANA IIF results. All errors were correctly detected by the different defined quality indicators. Traditional Westgard rules, including analytically (and clinically) defined rejection limits were useful in monitoring quality indicators. Conclusions The integration of a total process iQC program in CAD systems, based on the specific FI measurands and performance criteria of the system, adds value to QA.

scholarly journals Harmonizing by reducing inter-run variability: performance evaluation of a quality assurance program for antinuclear antibody detection by indirect immunofluorescence

2019 ◽  
Vol 57 (7) ◽  
pp. 990-998 ◽  
Author(s):  
Laura Bogaert ◽  
Stefanie Van den Bremt ◽  
Sofie Schouwers ◽  
Xavier Bossuyt ◽  
Lieve Van Hoovels
Keyword(s):  
Quality Assurance ◽  
Quality Indicators ◽  
Indirect Immunofluorescence ◽  
Positive Sample ◽  
Antibody Detection ◽  
Quality Assurance Program ◽  
Internal Quality ◽  
Routine Practice ◽  
Daily Routine ◽  
Acceptance Criteria

Abstract Background The introduction of automated anti-nuclear antibody (ANA) indirect immunofluorescence (IIF) analysis may allow for more harmonized ANA IIF reporting, provided that a thorough quality assurance program controls this process. The aim of this study was to evaluate various quality indicators used for ANA IIF analysis with the final goal of optimizing the iQC program. Methods In an experimental setup, we introduced artificial errors, mimicking plausible problems during routine practice on a QUANTA-Lyser-NOVA View® system (Inova Diagnostics, San Diego, CA, USA). Predetermined quality indicators were evaluated against predefined acceptance criteria. In addition, we retrospectively investigated the applicability of the selected quality indicators in the daily routine practice during three pre-defined periods. Results Both the experimental as the retrospective study revealed that pre-analytical, analytical and post-analytical errors were not highlighted by company internal quality control (iQC) materials. The use of patient derived iQC samples, median fluorescence intensity results per run and the percentage of positive ANA IIF results as additional quality indicators ensured a more adequate ANA IIF quality assurance. Furthermore, negative and moderate positive sample iQC materials merit clinical validation, as titer changes of >1 correspond to clinically important shifts. Traditional Westgard rules, including a clinically defined stop limit, revealed to be useful in monitoring of the supplemental quality indicators. Conclusions A thorough ANA IIF quality assurance for daily routine practice necessitates the addition of supplemental quality indicators in combination with well-defined acceptance criteria.

scholarly journals A Primer on Quality Assurance and Performance Improvement for Interprofessional Chronic Kidney Disease Care: A Path to Joint Commission Certification

Pharmacy ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 83 ◽  
Author(s):  
Linda Awdishu ◽  
Teri Moore ◽  
Michelle Morrison ◽  
Christy Turner ◽  
Danuta Trzebinska
Keyword(s):  
Chronic Kidney Disease ◽  
Quality Assurance ◽  
Kidney Disease ◽  
Performance Improvement ◽  
Quality Indicators ◽  
Joint Commission ◽  
Dialysis Access ◽  
Advanced Directives ◽  
Interprofessional Care ◽  
And Performance

Interprofessional care for chronic kidney disease facilitates the delivery of high quality, comprehensive care to a complex, at-risk population. Interprofessional care is resource intensive and requires a value proposition. Joint Commission certification is a voluntary process that improves patient outcomes, provides external validity to hospital administration and enhances visibility to patients and referring providers. This is a single-center, retrospective study describing quality assurance and performance improvement in chronic kidney disease, Joint Commission certification and quality outcomes. A total of 440 patients were included in the analysis. Thirteen quality indicators consisting of clinical and process of care indicators were developed and measured for a period of two years from 2009–2017. Significant improvements or at least persistently high performance were noted for key quality indicators such as blood pressure control (85%), estimation of cardiovascular risk (100%), measurement of hemoglobin A1c (98%), vaccination (93%), referrals for vascular access and transplantation (100%), placement of permanent dialysis access (61%), discussion of advanced directives (94%), online patient education (71%) and completion of office visit documentation (100%). High patient satisfaction scores (94–96%) are consistent with excellent quality of care provided.

Quality Indicators for Cervical Cancer Screening Programs

2014 ◽  
Vol 3 (4) ◽  
pp. 19-37 ◽  
Author(s):  
Elena Athanasiadi ◽  
Abraham Pouliakis ◽  
Evripidis Bilirakis ◽  
Vassilis Fragoulakis ◽  
Constantinos Bilirakis ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Quality Assurance ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Quality Indicators ◽  
Performance Indicators ◽  
Screening Programs ◽  
European Guidelines ◽  
Screening Services ◽  
And Performance

Cervical cancer is the malignancy most succesfully monitored by screening programs. Although most counties offer screening services, outcomes differ. It is clear that incidence reduction is achieved when quality assurance is implemented. Quality indicators are essential audit tools when implementing screening policies. Uniform indicators are used to monitor general performance and to identify potential problems that may occur and jeopardise efforts. That way quality management is enabled and the assessment of deviation from goals is facilitated. In this paper the authors present the workflow of cervical cancer screening programs in respect to the quality and performance indicators required by the European Guidelines for Quality Assurance in Cervical Cancer Screening. The authors also propose the appropriate data structures and entities that are required for a computerised system to support their calculation. Additionally the authors highlight important interconnections of the computerised system with other systems; these interconnections are vital for the calculation of the proposed quality indicators.

scholarly journals Academicians Satisfy of The Faculty of Economics, in Universitas Negeri Surabaya Throught on Total Quality Management

2017 ◽  
Vol 2 (01) ◽  
pp. 52
Author(s):  
Susi Handayani ◽  
Pujiono Pujiono
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Service Quality ◽  
Total Quality Management ◽  
Student Satisfaction ◽  
Monitoring And Evaluation ◽  
Total Quality ◽  
Study Program ◽  
And Performance

<p>The Faculty of Economics in Universitas Negeri Surabaya had certified of International standard operating (ISO) for quality management since 2015. This certification prosecutes management of faculty of economics to increase service quality to academicians. The important aspects of ISO have to determine TQM implemented. Therefore, it had created quality assurance team that exist gradually at university to study program. A service quality must be guarantied by internal and external audit. However, it improves continuous improvement that based on audit results, especially low students satisfaction, officer alacrity to give a service, ability to explanation, handling of complaints, courtesy and friendliness, and support infrastructures for learning process. All cost of quality assurance conduct to prepare an audit internal implementation, to up-date accreditation forms and performance of study program, and monitoring and evaluation for learning and curriculum, improve a quality procedure, prepare and evaluation a quality target, and follow up on audit finding.</p><p><br />Keywords: ISO, service quality, student satisfaction, total quality management</p>

scholarly journals Implementation of the Internal Quality Assurance System at UIN Malang Indonesia

2021 ◽  
Vol 12 (6) ◽  
pp. 941-949
Author(s):  
Mulyono, Et. al.
Keyword(s):  
Quality Assurance ◽  
Quality Standards ◽  
Internal Quality ◽  
Quality Assurance System ◽  
Total Quality ◽  
Study Program ◽  
Stakeholder Satisfaction ◽  
Assurance System ◽  
Internal Quality Assurance ◽  
The University

This study aims to examine the implementation of the internal quality assurance system (IQAS) at the State Islamic University of Maulana Malik Ibrahim Malang Indonesia (called UIN Malang). This research uses qualitative methods, data obtained through interviews, document review and observation, and data analysis techniques using interactive analysis models. The results of the research can be concluded as follows: 1) The University established a Quality Assurance Institute (QAI) at the university level, the Quality Assurance Unit (QAU) at the Faculty level, Postgraduate Program, Language Development Center, and Ma’had (campus dormitories) and Quality Control Groups (QCG) at the Department/Study Program level. 2) Compiling quality assurance system planning in documents: quality policy, quality manual, quality standards, quality forms, monitoring, measurement and self-evaluation, internal quality audits, and Management Review Meetings (MRM). 3) Applying the PDCA (Plan, Do, Check, Action) model which is the application of Total Quality Management (TQM) to produce a cycle of continuous quality improvement. 4) Establish idealized academic service quality standards based on benchmarking results. 5) Ensure the stages of implementation, evaluate and revise quality standards according to benchmarking on an ongoing basis. 6) Establish quality indicators to achieve stakeholder satisfaction, productivity, and efficiency. 7) Internalizing the values ​​and quality culture in the entire campus community. This research produces a strategy for implementing a comprehensive quality assurance system to build UIN Malang as the Center of Excellence and the Center for Islamic Civilization.

scholarly journals Guideline-based quality assurance: a conceptual framework for the definition of key elements

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elena Parmelli ◽  
Miranda Langendam ◽  
Thomas Piggott ◽  
Jan Adolfsson ◽  
Elie A. Akl ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Conceptual Framework ◽  
Quality Indicators ◽  
Performance Measures ◽  
Performance Indicators ◽  
Guideline Development ◽  
Research Centre ◽  
And Performance ◽  
The Way

Abstract Background In 2017, the European Commission’s Joint Research Centre (JRC) started developing a methodological framework for a guideline-based quality assurance (QA) scheme to improve cancer quality of care. During the first phase of the work, inconsistency emerged about the use of terminology for the definition, the conceptual underpinnings and the way QA relates to health questions that are answered in guidelines. The objective of this final of three articles is to propose a conceptual framework for an integrated approach to guideline and QA development and clarify terms and definitions for key elements. This work will inform the upcoming European Commission Initiative on Colorectal Cancer (ECICC). Methods A multidisciplinary group of 23 experts from key organizations in the fields of guideline development, performance measurement and quality assurance participated in a mixed method approach including face-to-face dialogue and several rounds of virtual meetings. Informed by results of a systematic literature review that indicated absence of an existing framework and practical examples, we first identified the relations of key elements in guideline-based QA and then developed appropriate concepts and terminology to provide guidance. Results Our framework connects the three key concepts of quality indicators, performance measures and performance indicators integrated with guideline development. Quality indicators are constructs used as a guide to monitor, evaluate, and improve the quality of the structure, process and outcomes of healthcare services; performance measures are tools that quantify or describe measurable elements of practice performance; and performance indicators are quantifiable and measurable units or scores of practice, which should be guided by guideline recommendations. Conclusions The inconsistency in the way key terms of QA are used and defined has confused the field. Our conceptual framework defines the role, meaning and interactions of the key elements for improving quality in healthcare. It directly builds on the questions asked in guidelines and answered through recommendations. These findings will be applied in the forthcoming ECICC and for the future updates of ECIBC. These are large-scale integrated projects aimed at improving healthcare quality across Europe through the development of guideline-based QA schemes; this will help in implementing and improving our approach.

Quality assurance in clinical biochemistry

1993 ◽  
Vol 101 ◽  
pp. 251-261
Author(s):  
Callum G. Fraser
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Clinical Biochemistry ◽  
External Quality Assessment ◽  
Internal Quality ◽  
Total Quality ◽  
External Quality ◽  
Quality Management Systems ◽  
Numerical Result ◽  
Biochemistry Test

SynopsisThere are many steps in the process between the clinician requesting a clinical biochemistry test and receiving a numerical result. Each of these steps must be subject to quality assurance techniques. Clinical biochemistry laboratories now have mature, integrated systems of internal quality control, external quality assessment and quality assurance to ensure that the results issued do aid in the provision of optimum patient care. The recent advent of a professionally led laboratory accreditation scheme will stimulate further improvements in quality. Enthusiastic adoption of the techniques of quality management science, in the form of total quality management systems, will focus future attention on laboratories providing services to the standards dictated by consumers. Translation of these standards into objective operational specifications will then allow laboratories to adopt appropriate comprehensive quality assurance techniques which will guarantee the quality demanded.

Evolution of internal quality assurance at one university – a case study

2017 ◽  
Vol 25 (2) ◽  
pp. 189-205 ◽  
Author(s):  
David O’Sullivan
Keyword(s):  
Quality Assurance ◽  
Evaluation Process ◽  
Internal Quality ◽  
Research Assessment ◽  
Strategy Execution ◽  
Content Type ◽  
Study Approach ◽  
Policies And Procedures ◽  
And Performance

Purpose Quality assurance (QA) at one University has evolved over the past 15 years through emerging National and European standards, various leadership initiatives and through the engagement of key stakeholders in co-designing and implementing internal QA processes. In 2000, the QA process was focussed mainly on quality review (QR) that involved extensive reporting of information. It was characterised by stakeholders as a largely reactive culture, treated with scepticism by faculty staff and that struggled to convince both management and faculty that QA provided value. In 2016, QR is now leaner, more evidence based and focussed around creativity and enhancement. In addition to QR, additional QA processes now incorporate a variety of activities including benchmarking, structured policies and procedures and research assessment. QA is also part of a tripartite approach that links quality, strategy and performance together, with quality focusing on assuring an appropriate standard of excellence, strategy guiding faculty towards a vision of the future and performance providing evidence of quality enhancement and strategy execution. The paper provides a case study of the transformation of QA at the University. Design/methodology/approach The research uses a case study approach. It documents a methodology used to engage a wide number of stakeholders in a self-evaluation process and the results of that process, i.e. enhancements to the internal review process and various policies and procedures. Findings There are early indications that the University’s internal QA has migrated towards a more responsive culture and is increasingly endorsed by the various internal and external stakeholder groups. Research limitations/implications This paper presents the evolution of QA and potential lessons for the wider Higher Education Institutions (HEI’s) sector. Originality/value This paper provides a case study of changes to QA processes at one university that has risen significantly in various university rankings since. Some evidence is provided to show that quality initiatives have contributed to overall performance.

Outcomes in rectal cancer care in Uruguay: A study on quality indicators.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 234-234
Author(s):  
Santiago Fontes ◽  
Megan Berry ◽  
Ana Marín-Jiménez ◽  
Juan Carlos Sánchez ◽  
Graciela Reyes ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Overall Survival ◽  
Treatment Outcomes ◽  
Quality Indicators ◽  
Rectal Carcinoma ◽  
Cancer Care ◽  
Diagnosis And Treatment ◽  
Internal Quality ◽  
Target Values

234 Background: For years, rectal cancer has been considered a model oncologic entity and significant therapeutic improvements have been made in the last two decades. However, evidence suggests there are important differences in quality of care between countries, institutions and teams. Therefore, population-based audits are of great importance to ensure quality cancer care. Quality indicators (QIs) provide information on safety and quality of cancer screening, diagnosis and treatment. Aim: To describe and analyze quality indicators for diagnosis and treatment of rectal carcinoma at a high-volume cancer center in Uruguay. Methods: A retrospective descriptive study was performed as a sub-analysis of a cohort of 971 patients. A total of 497 rectal or rectosigmoid-junction carcinoma patients treated between 2008 and 2020 at the Uruguayan National Cancer Institute were included. Previously validated target values formed the basis of the QIs used in this study. Each QI was reported as the proportion (% 95% CI) of patients fulfilling the criteria out of eligible patients. Kaplan–Meier method was used to calculate overall survival rates. Results: Mean age was 62 years, 59.5% were male, and 78% showed no evidence of disseminated disease at diagnosis. Diagnosis and staging: combined contrast-enhanced CT TAP scan was performed in 66% of the sample, 51% of cases had a total colonoscopy before elective curative intent surgery. Locoregional c-TN staging was assessed by high resolution MRI in 64% of cases. Only 30% and 63% of patients in the preoperatively irradiated and the nonirradiated groups had a minimum of 12 lymph nodes examined. Multimodal treatment: preoperative chemo-radiation was delivered for stages II and III middle/low-third rectal cancers in 81% of the cases. Adjuvant therapy was prescribed in 75% and 47% of stages III and II receiving surgery as upfront treatment, respectively. 78% of cStage IV patients received palliative chemotherapy. Surrogate indicators of outcome: 82% had distal tumor-free margins, although only 72% had a pathological circumferential radial margin ((y)pCRM) mentioned in the pathology report. Non-curative (R1,2) resections in M0 rectal carcinoma in our cohort was below the target value of <20%. 15% of our cases had a positive (y)pCRM. Treatment-outcomes: Our cumulative overall local recurrence was 12.6% and the 3-year overall survival rate was 84.8%. Conclusions: Continuous analysis of QIs in rectal cancer is necessary for internal quality management and for external quality assessment, to improve and compare treatment outcomes. Our results highlight the positive aspects of rectal cancer care at our center and reveal the weak points in diagnosis and treatment that need special attention. They will serve as a guide in the implementation of new strategies and programs that will aim to improve safety and quality of rectal cancer care for Uruguayan patients, regardless of where they live or are treated.

scholarly journals Conceptual Framework and Development of Quality Management for Islamic Higher Education in Indonesia

2021 ◽  
pp. 43-60
Author(s):  
Khairul Azan ◽  
Kemas Imron Rosadi ◽  
Muntholib Muntholib
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
Quality Management ◽  
Internal Quality ◽  
Quality Assurance System ◽  
Total Quality ◽  
Quality Culture ◽  
Assurance System ◽  
Internal Quality Assurance

Quality is a determining indicator of the existence of Islamic higher education institutions in the future. Higher education with quality will be in demand by the community. Therefore, quality must be a priority indicator in the implementation of Islamic-based higher education. In order for the quality to continue to increase, universities should implement the concept of Total Quality Management (TQM) in all areas of university administration. Integrated quality management requires the existence of an Internal Quality Assurance System (SPMI) which aims to ensure the implementation of ducation according to standards. In order for the Internal Quality Assurance System (SPMI) to run well, it is necessary to have a quality culture that is well understood and implemented by stakeholders. The quality culture contains several aspects, namely: 1) focus on customers, 2) obsession with quality, 3) scientific approach, 4) long-term commitment, 5) teamwork, 6) continuous improvement of the system, 7) education and training, 8) controlled freedom, 9) respect for everyone, 10) unity of purpose, 11) involvement and empowerment of employees. Efforts that can be made in developing and maintaining the quality of Islamic higher education include: 1) Strategic Plan as a basis for implementing education, 2) building a higher education brand image, 3) consistency in implementing the internal quality assurance system.

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