Continuous Quality Assurance Research Articles

The cytopathologist's role in developing and evaluating artificial intelligence in cytopathology practice

Artificial intelligence (AI) technologies have the potential to transform cytopathology practice, and it is important for cytopathologists to embrace this and place themselves at the forefront of implementing these technologies in cytopathology. This review illustrates an archetypal AI workflow from project conception to implementation in a diagnostic setting and illustrates the cytopathologist's role and level of involvement at each stage of the process. Cytopathologists need to develop and maintain a basic understanding of AI, drive decisions regarding the development and implementation of AI in cytopathology, participate in the generation of datasets used to train and evaluate AI algorithms, understand how the performance of these algorithms is assessed, participate in the validation of these algorithms (either at a regulatory level or in the laboratory setting), and ensure continuous quality assurance of algorithms deployed in a diagnostic setting. In addition, cytopathologists should ensure that these algorithms are developed, trained, tested and deployed in an ethical manner. Cytopathologists need to become informed consumers of these AI algorithms by understanding their workings and limitations, how their performance is assessed and how to validate and verify their output in clinical practice.

Cancer Registry Survival Data for Metrics of Continuous Quality Improvement and Quality Assurance

Purpose: The purpose of this article is to illustrate how cancer registry data can be used to address questions of quality assurance and continuous quality improvement, and to generate contemporary cohorts of patients for retrospective studies. The history and purpose of hospital cancer registries is reviewed and examples of use of registry data provided. Methods: Cancer Registry information, manuals, and definitions were reviewed. The 25-year experience of the lead author in collaborating with registrars and using the cancer registry of a large community hospital in southern California is described. The strengths and weaknesses of such data are discussed. Examples of completed studies are provided to illustrate how such data was organized, analyzed, and presented to physicians and administrators, and for peer reviewed publications. Results: The strengths of such data are the large numbers of patients, validity of date of diagnosis, histologic diagnosis, general stage, and date of death. The major limitations of the data are due to incomplete reporting of specific treatment regimens, especially after the initial 4-month period of management. The quality assurance and quality improvement studies generated proved to be of great interest to local physicians and administrators. Several such studies were used in peer-reviewed publications. The interest and job satisfaction of registrars, and data quality all improved when registry data was being used and reported locally rather than merely being submitted to a national data repository. Conclusion: In the absence of comprehensive integrated medical care data bases, high-quality cancer registries can be used to address local issues related to quality improvement and quality assurance and provide data for peer-reviewed publications.

Developing a comprehensive APPE-readiness plan with a focus on skills, attitudes, and behaviors

Background and purposePharmacy schools must have a framework to ensure students have the necessary knowledge, skills, attitudes, and behaviors to be successful during advanced pharmacy practice experiences (APPEs). Educational activity and settingTen summative assessments, called APPE-readiness assessments (ARAs), were developed based on eight competencies encompassing skills, behaviors, and attitudes that must be demonstrated prior to APPEs. All eight competencies were assessed in the course Case Studies in Pharmacotherapy IV, which is offered in the final semester of the didactic curriculum immediately prior to APPEs. A 15-question pre- and post-survey was conducted to assess student confidence in performing each APPE-readiness competency. Cohort data was evaluated by the curriculum and assessment committee to assess curriculum effectiveness and areas for improvement. FindingsUpon completion of the course, the average first-attempt pass rate across all ARAs was 92.4%. All students who failed on the first attempt passed on the second attempt, thereby demonstrating APPE-readiness. Out of 62 students, 45 and 44 completed the pre- and post-survey, respectively. Prior to the ARAs, the overall average of students who felt (strongly) confident about their ability to perform each competency was 82.2 ± 2.1%. This increased to 92.6 ± 1.6% after the ARAs. SummaryThe development of an APPE-readiness assessment plan focusing on skills, attitudes, and behaviors provides insight into student and cohort performance and allows for continuous quality assurance of the pre-APPE curriculum.

Mold-level prediction based on long short-term memory model and multi-mode decomposition with mutual information entropy

The mold is referred to as the heart of the continuous casting machine. Mold-level control is one of the keys to ensuring the quality of a high-efficiency continuous casting slab. This article addresses the failure of the mold-level prediction model in the actual production process to overcome the impact of noise. To improve the accuracy of mold-level prediction, a novel method for mold-level prediction based on the multi-mode decomposition method and the long short-term memory model is proposed. First, empirical mode decomposition of the mold-level data is performed. The actual eigenmode component number K is obtained through the calculation of the mutual information entropy of the eigenmode components. Then, we perform a K-based variational mode decomposition on the mold-level data. The noise dominant component is denoised by the calculation of the mutual information entropy of the eigenmode components. Moreover, the long short-term memory model is used to predict the noise dominant component and the information dominant component after denoising. Finally, the predicted result is subjected to variational mode decomposition reconstruction to obtain the predicted mold-level data. The experimental results show that compared with the other methods tested, the model has better prediction efficiency, prediction accuracy, and generalization ability. It provides a new idea for mold-liquid-level prediction and continuous casting blank quality assurance.

Effect of Best Practice Advisories on Sedation Protocol Compliance and Drug-Related Hazardous Condition Mitigation Among Critical Care Patients.

To determine whether best practice advisories improved sedation protocol compliance and could mitigate potential propofol-related hazardous conditions. Retrospective observational cohort study. Two adult ICUs at two academic medical centers that share the same sedation protocol. Adults 18 years old or older admitted to the ICU between January 1, 2016, and January 31, 2018, who received a continuous infusion of propofol. Two concurrent best practice advisories built in the electronic health record as a clinical decision support tool to enforce protocol compliance with triglyceride and lipase level monitoring and mitigate propofol-related hazardous conditions. The primary outcomes were baseline and day 3 compliance with triglyceride and lipase laboratory monitoring per protocol and time to discontinuation of propofol in the setting of triglyceride and/or lipase levels exceeding protocol cutoffs. A total of 1,394 patients were included in the study cohort (n = 700 in the pre-best practice advisory group; n = 694 in the post-best practice advisory group). In inverse probability weighted regression analyses, implementing the best practice advisory was associated with a 56.6% (95% CI, 52.6-60.9) absolute increase and a 173% relative increase (risk ratio, 2.73; 95% CI, 2.45-3.04) in baseline laboratory monitoring. The best practice advisory was associated with a 34.0% (95% CI, 20.9-47.1) absolute increase and a 74% (95% CI, 1.39-2.19) relative increase in day 3 laboratory monitoring after inverse probability weighted analyses. Among patients with laboratory values exceeding protocol cutoffs, implementation of the best practice advisory resulted in providers discontinuing propofol an average of 16.6 hours (95% CI, 4.8-28.3) sooner than pre-best practice advisory. Findings from alternate analyses using interrupted time series were consistent with the inverse probability weighted analyses. Best practice advisories can be effectively used in ICUs to improve sedation protocol compliance and may mitigate potential propofol-related hazardous conditions. Best practice advisories should undergo continuous quality assurance and optimizations to maximize clinical utility and minimize alert fatigue.

Information and Communication Technology Applied to Continuing Quality Improvement for the Care and Cure of Childhood Severe Hematological Disorders in India

Introduction: Continued quality improvement systems are necessary not only to maintain minimum quality standards, but also contribute to improved outcomes (Snowden et al. 2017; Hashmi et al. 2017). In-spite of its importance, the implementation of a functional Quality Management System (QMS) in the routine daily activity oh health professionals may be a challenge, especially in resource limited settings (Hashmi et al. 2017). Methodology: BMTPlus is an information and communication technology (Agarwal et al. 2014) platform that has been used for knowledge management by Sankalp-People Tree Centre for Paediatric BMT, Bangalore (PTH) from July 2015 and Sankalp-CIMS Centre for Paediatric BMT, Ahmedabad (CIMS) from March 2017. BMTPlus brings together all aspects of transplant data management including clinical data management, personal records and QMS. The usage of these tools which directly relate to the continued quality improvement process was reviewed. Clinical outcomes for patients who underwent transplant for thalassemia in these centres from matched related donors were summarised using R statistical package (version 3.5.x) as an indicator of the effectiveness of the continued quality improvement process. Results: Table 1 summarises the program information, utilisation of various quality management-related records, staff turnover, outcomes and costs. Information technology-driven QMS provided the unique advantage of being able to audit all the data instead of sample data sets and thus widening the potential to detect issues. The inventory management and prescriptions system was audited in 2019 at PTH and the findings are that there were only 3 events in 4 years where important drugs/supplies came close to a critical shortage. Automated treatment plan imports contributed to 2 of the 1570 drug orders being detected with inaccuracies (0.13%). The PTH BMT service has been using BMTPlus for auto submission of data to CIBMTR; data audit in July 2019 showed that 92% of the 1263 due forms were successfully submitted. CIMS is catching up with 39% forms submitted so far. The impact of this quality improvement system on clinical outcomes of the program was measured on 172 successive first matched related transplants (103 from PTH and 69 from CIMS) upto April 15 2019. Outcomes were compared across 3 successive transplant protocols, all patients were transplanted at-least 100 days prior to this analysis. Both overall and disease-free survival improved significantly from protocol 1 to 3, i.e. from 88% to 100% (p = 0.002) and from 77% to 98% (p < 0.0001) respectively. Transplant-related mortality and rejection significantly dropped from 10% to 0% (p = 0.01) and from 22% to 3% (p < 0.0001) respectively. The outcomes achieved at this lower-middle income centre compared favourably with the 96.9% day-100 survival reported in USA for thalassemia ("U.S. Patient Survival Report" 2017). Progressively improved outcomes and good utilisation of quality management features were seen in spite of the fact that PTH had an attrition rate as high as 44% for physicians and 78% for nurses while in CIMS this was 74% and 57% respectively. The impact of quality management on the cost and sustainability of the program can be seen from the cost of the transplants. Though the programs experienced a 10% increase in operational costs on a year on year basis, the ongoing quality improvements led to fewer complications and cost escalations as a result of which the program at PTH and CIMS continue to offer matched-related transplants at USD 12.500 and USD 13.300 respectively which was the bundled cost set at the beginning of the programs in July-2015 and March-2017 respectively. Thanks to the use of online platform, only one quality/data manager is the only additional resource specific to continued quality improvement, quality assurance, outcome reporting and participation in international registries. Conclusion: Information and communication technology enabled comprehensive knowledge management and facilitated continuous quality improvement. This contributed to the delivery of cost-efficient and effective transplantations with progressively improving outcomes, which finally are at par with the best centres in the world in spite of the challenges of high staff turnover. Disclosures No relevant conflicts of interest to declare.

Harnessing the Power of Machine Learning for Accurate and Efficient Linear Accelerator Beam Data Commissioning

Linear accelerator (linac) commissioning is a fundamental process in the safe introduction of new linacs into the clinical workflow of any radiation oncology department. Commissioning data is vital not only for verification of proper linac operation, but also for the continuing quality assurance process and as input to the treatment planning software. Current commissioning of a new linac is a highly reparative and time-consuming task performed under time pressure but with great need for high precision. The process lacks in clear operational standards and no validation tools are commercially available. In this study, we propose a fast and robust linac beam data commissioning method to significantly save time and manpower in the process of linac commissioning. Routine linac commissioning/annual beam data, including percentage depth dose (PDD) and depth dose profile (DDP) at various beam energies and field sizes, were extracted from three medical linear accelerators at our institution. The datasets were split into training and testing data. For each beam energy, we formulated the PDD or DDP as an output of least square optimization problem, which is solved by a multivariate linear regression model with an input of a few point data measurements at a different field size. Using data augmentation technique, we use 1000 sets of data to train the linear regression model. PDD and DDP were predicted using models trained with and without Ridge Regularization and a few measured sampling points. The predicted PDD and DDP were evaluated using percentage relative error (pRE). Both PDD and DDP were accurately predicted at different beam energies and field sizes. The pRE for predictions of field sizes of 4×4 cm2 and 30×30 cm2 based on 10x10 cm2 beam data was less than 0.8% for both 6 MV and 15 MV beams. Three data points sampled along the PDD was needed to obtain this accuracy; no further increase in accuracy was found with increased number of sample points. For model trained without Ridge Regularization, the pRE was reduced by up to 50%. For model training with Ridge Regularization, data augmentation showed only marginal improvement on pRE. We propose a fast and accurate machine learning-based method to generate linac commissioning beam data for routine radiation therapy. With this method, beam data related to PDD and DDP can be accurately generated using only a few measured sampling points. We envision that this approach will significantly simplify the tedious linac commissioning procedure, save time and manpower, while increasing the safety and precision of the commissioning process.

Implementation of competency-based medical education in a Canadian medical oncology training program: Lessons from our first year.

10514 Background: As part of a university wide initiative, CBME was implemented in our MO training program in July 2017. Stages, Entrustable Professional Activity (EPA) assessments and Required Training Experiences established by the Royal College of Physicians and Surgeons of Canada were adopted. MedTech Central, the electronic portfolio developed at our university was used for assessment collection. We share here observations and experiences from our first year of implementation. Methods: Assessment metrics were obtained through MEdTech. Ethics was granted by Queen’s University as part of an ongoing research study on feedback. Lessons learned were compiled from discussions between the Program Director, Residents, Program Administrator, CBME Education Consultant and CBME lead. Results: A total of 195 assessments were completed July 2017-November 2018. 81% were EPA assessments and the remainder multisource feedback, rubrics and field notes. The median number of assessments per faculty was 17 (0-42). 52% of assessments included written “Comments” or “Next steps”. A median of 6 assessments per faculty member included specific or actionable feedback. Lessons learned centered on: 1) Faculty and Resident development and engagement (critical before, during and after implementation); 2) Value of sharing work of CBME (CBME Education Consultant, CBME Lead, Academic Advisors, Competence Committee); 3) Importance of effective communication strategy with stakeholders 4) Importance of collaboration with other training programs at institutional and national levels; 5) Culture change (a slow process); 6) Resident concerns regarding lack of global assessment; 7) Assessment plan challenges (How many observations required?); 8) Burden of CBME (Resident driven assessments or a better balance?) ; 9) Limitations of e-portfolio (How to live track and by whom?); 10) Costs 11) Value of continuous quality assurance and improvement. Conclusions: Our first year of implementation was successful in introducing CBME concepts, work based assessments and e-portfolios. Ongoing work is needed, including increasing the number of assessments and quality of feedback.

Best Practices for Occupational Therapy Fellowship and Physical Therapy Residency Programs: A Mixed Method Study

Purpose: The purpose of this sequential mixed methods study was to investigate occupational therapy fellowship and physical therapy residency directors’ perceptions of components of a successful residency program. Methods: A pilot survey was administered to occupational therapy fellowship and physical therapy residency directors prior to the study. A 17-item self-report survey was used to gather fellowship and residency director perceptions on the success of their respective programs. Directors of approved occupational therapy fellowship programs and accredited physical therapy residency programs were invited to participate. Following completion of the survey, follow-up interviews were conducted to deepen the understanding of director perceptions. Quantitative data was entered into Statistical Package for the Social Sciences (SPSS) and descriptive statistics were conducted. Qualitative data underwent thematic analysis. Results: Fellowship and residency director surveys (n=76) and interviews (n=7) highlighted program components that attributed to program success. While engagement in research was reported as only somewhat important, the other six components examined were rated as either important or very important. Research was not valued as highly as other components due to the nature of fellowship and residency programs and their focus on practical application of didactic components translating to clinical skill enhancement. Components not highlighted by the authors in the survey were then supplied by program directors in interviews: administration time, resident feedback, networking opportunities, rotation through the healthcare continuum, the opportunity to assist with teaching in an entry level program, and consistent feedback from mentors. Three themes emerged from interview data: importance of program components, fellow/resident characteristics, and program evaluation/changes. Conclusion: While some differences between occupational therapy fellowship and physical therapy residency programs were found, there were more similar components that contributed to program and participant success. Further research is necessary for the continued development and quality assurance of fellowship and residency programs.

Cancer Registry Survival Data for Metrics of Continuous Quality Improvement and Quality Assurance

Purpose: The purpose of this article is to illustrate how cancer registry data can be used to address questions of quality assurance and continuous quality improvement, and to generate contemporary cohorts of patients for retrospective studies. The history and purpose of hospital cancer registries is reviewed and examples of use of registry data provided. Methods: Cancer Registry information, manuals, and definitions were reviewed. The 25-year experience of the lead author in collaborating with registrars and using the cancer registry of a large community hospital in southern California is described. The strengths and weaknesses of such data are discussed. Examples of completed studies are provided to illustrate how such data was organized, analyzed, and presented to physicians and administrators, and for peer reviewed publications. Results: The strengths of such data are the large numbers of patients, validity of date of diagnosis, histologic diagnosis, general stage, and date of death. The major limitations of the data are due to incomplete reporting of specific treatment regimens, especially after the initial 4-month period of management. The quality assurance and quality improvement studies generated proved to be of great interest to local physicians and administrators. Several such studies were used in peer-reviewed publications. The interest and job satisfaction of registrars, and data quality all improved when registry data was being used and reported locally rather than merely being submitted to a national data repository. Conclusion: In the absence of comprehensive integrated medical care data bases, high-quality cancer registries can be used to address local issues related to quality improvement and quality assurance, and provide data for peer-reviewed publications.

Protected Spaces in Smart Cities and the Identification of New Radio Signals in their Environment using a Complex Measurement Method

This research focuses on the creation of a security boundary through the establishment of information security, more specifically by creating an environment that allows for information security for people-to-people communication. The relevance of the research is justified by the vulnerability of infocommunication tools and systems, as well as by the spread of increasingly cheaper information gathering technologies. There was a need to create an environment where personal, communication between man and man could be realized so that its information content remains protected. Analysing the problem, there are a number of security solutions for information-technology devices, but the creation of a near-human analogue environment for information security is a frontier for the subject. In this approach, the direction of the research was determined by the task of developing an environment that excludes the online operation of infocommunication technologies that create an information security gap and how to identify the spatial position of radio-based communication devices in protected spaces that may be a source of information security. In connection with the continuous quality assurance of the protection, it is necessary to identify the radio signals in the environment of the protected room, which - in the majority of cases - is a built environment with buildings. We offer a new conceptual solution. We studied the operation of the information security breaches during the preliminary research phase by designing a protected space and, by virtue of their principal exclusion, we propose a schematic layout of a protected room, excluding many information security issues. The main purpose of the research is to present an environment that can create a safer person-to-person communication and to provide a novel possible conceptual solution for determining the location of the source of a radio signal.

External Quality Assessment (EQA) for Molecular Diagnostics of Zika Virus: Experiences from an International EQA Programme, 2016⁻2018.

Quality Control for Molecular Diagnostics (QCMD), an international provider for External Quality Assessment (EQA) programmes, has introduced a programme for molecular diagnostics of Zika virus (ZIKV) in 2016, which has been continuously offered to interested laboratories since that time. The EQA schemes provided from 2016 to 2018 revealed that 86.7% (92/106), 82.4% (89/108), and 88.2% (90/102) of the participating laboratories reported correct results for all samples, respectively in 2016, 2017, and 2018. The review of results indicated a need for improvement concerning analytical sensitivity and specificity of the test methods. Comparison with the outcomes of other EQA initiatives briefly summarized here show that continuous quality assurance is important to improve laboratory performance and to increase preparedness with reliable diagnostic assays for effective patient management, infection and outbreak control.

I233] Automated treatment planning and quality assurance

In radiotherapy, there is a strong development striving at improving the quality of the treatment plans. Consequently, there is a great need for quality assurance procedures focusing on the treatment plan quality. The most fundamental aspect is perhaps the quality of a treatment plan for an individual patient (treatment plan optimization), which in turn is dependent on the quality of the underlying protocols and prioritization strategies (guidelines). However, there are also other important aspects, such as quality assurance of treatment planning algorithms and their application to specific diagnoses or treatment techniques (benchmarking), preparatory treatment planning for multi-centre clinical studies (dummy runs), and treatment planner achievements (training and competencies). The quality of a treatment plan may also encompass its deliverability at treatment (QC pass rate and plan robustness). To approach these issues in a quantitative fashion, there must be an unambiguous understanding of the concept of treatment plan quality, that can be applied in a continuous quality assurance program. While the plan quality in its fundamental sense is related to the degree of prescription fulfilment, it is also influenced by various limitations and uncertainties. In this respect, it is of foremost importance to use optimization objectives that are specific and measurable. Many of these issues can be addressed using automatically generated treatment plans, either data-base driven or protocol based, and extended to sets of multiple Pareto-optimal plans. In this presentation, we will review some of the possibilities for treatment plan quality assurance that becomes available with automated treatment planning techniques. The influence of short-cuts and limitations will be discussed.

A quest for waste reduction at institutions of higher learning: Investigating the integration of Six Sigma and Lean Six Sigma methodologies with total quality management

Abstract Institutions of higher learning are required to rethink strategies to eliminate ‘institutional waste’. The sector is facing numerous challenges with resource restrictions. Factors such as the impact of the Fees-must-fall campaign in South Africa and the global tendency of government initiatives to increase student enrolment targets, while subsidies, on a continual basis, are on the decrease, places institutions in higher education under enormous financial distress. This article argues that the majority of institutions’ quality management systems in South Africa and abroad are underpinned by the principles of Total Quality Management (TQM). There is a dearth of research on the implementation of Six Sigma and Lean Six Sigma in higher education. This article investigates the integration of Six Sigma and Lean Six Sigma as mechanisms to reduce waste in the higher education sector. It reflects on how this integration can enhance a university’s core business and institutional functions through processes of continuous quality assurance, the latter is characteristic of the principles of TQM.

External Quality Assessment for Zika Virus Molecular Diagnostic Testing, Brazil.

We conducted an external quality assessment of Zika virus molecular diagnostic tests in Brazil using a new Zika virus standard. Of 15 laboratories, 73% showed limited sensitivity and specificity. Viral load estimates varied significantly. Continuous quality assurance is required for adequate estimates of Zika virus–associated disease and determination of patient care.

International Accreditations as Drivers of MBA Education Improvement

Business schools in China are now under great pressure to implement continuous improvement and quality assurance to remain competitive in a globalized higher education market. Drivers for quality improvement include external pressures such as supranational organizations, national government, marketization, and globalization. As a symbol of excellent quality of management education, MBA international accreditations play an important role in quality improvement of MBA education. A case study based on GWMBA (MBA of Guangdong University of Foreign Studies) is presented to demonstrate this impact. Future challenges include the risk of standardization and institutional isomorphism and the balance between globalization and localization.

Supporting graduate nurse transition to practice through a quality assurance feedback loop.

This mixed-method study focused on new graduate nurses and their transition to practice. Transition to practice can be a time of heightened stress and anxiety, leaving many new graduates disillusioned and dissatisfied with their work. The study explored how satisfaction levels with transition may improve during their first year, using a unique approach of a continuous quality assurance feedback loop. This assurance framework is utilised in hospitality, automotive and supply chain logistics and in health, primarily to monitor patient outcomes. However, an association with graduate nurse satisfaction has not been previously reported. Graduate nurses from two health services completed a short survey questionnaire every four weeks for 12 months. De-identified aggregated data was sent to health service management, giving them an opportunity to integrate the findings with the objective of potentially increasing graduate satisfaction ratings. Quantitative findings showed no statistical significance of graduate nurse satisfaction scores between health services, however, one health service consistently outperformed the other. Qualitative findings drawn from a seminar and interviews confirmed that one health service took a more proactive stance with the monthly reports, communicating the results to ward managers. Outcomes reflected a greater commitment of support and an overall increase of satisfaction scores.

LANDASAN PEMIKIRAN IMPLEMENTASI SISTEM MANAJEMEN MUTU ISO 9001:2008 DI FITK UIN MALANG

<span class="fontstyle0">This study aims to examine the foundation of the implementation of ISO 9001: 2008 Quality Management System in improving the quality of learning in the Faculty of<br />Tarbiyah and Teacher Training (FITK) UIN Maulana Malik Ibrahim Malang, the results can be summarized as follows: 1) Making the concept of “Ulul Albab” as a jargon that would be manifested in the form of an educational program under the umbrella of “Ulul Albab”. 2) Realizing a scientific structure that integrates science and Islam with the Tree<br />of Science Metaphor. 3) Trying to anticipate the challenges of higher education both on the national macro and global competition. 4) Realizing organizational health (organization health), to develop academic freedom, innovation, creativity and knowledge sharing. 5) Applying quality assurance consistently. 6) Determined to apply quality culture by implementing QMS ISO 9001: 2008 as international standard quality standard. 7) Implementing the International Quality Management System Organization for Standardization (SSNI ISO) 9001: 2008 to achieve the quality standard of education. 8) Conduct internal audit for continuous improvement of quality (continual improvement). 9) Anticipate various organizational changes at any time and periodic. 10) The ability of leaders to have the vision and confidence to realize his vision. 11) Making the values of the Qur'an (the concept of ihsan: doing better) as the cornerstone of the implementation of the quality management system. 12) Implement the main principles of the quality management system: "Write down what is done and do what is written". 13) Implement a systematic and continuous quality assurance system. 14) The purpose of quality assurance to ensure: compliance, certainty, and relevance. 15) Stipulate the quality points refer to the quality of UIN Maulana Malik Ibrahim Malang. 16) Determined to make quality assurance in academic service.<br /></span><span class="fontstyle2">Keywords: </span><span class="fontstyle0">Platform, Thought, QMS, Quality, Learning.</span>

Nanofluidic device for continuous multiparameter quality assurance of biologics.

Process analytical technology (PAT) is critical for the manufacture of high-quality biologics as it enables continuous, real-time and on-line/at-line monitoring during biomanufacturing processes. The conventional analytical tools currently used have many restrictions to realizing the PAT of current and future biomanufacturing. Here we describe a nanofluidic device for the continuous monitoring of biologics' purity and bioactivity with high sensitivity, resolution and speed. Periodic and angled nanofilter arrays served as the molecular sieve structures to conduct a continuous size-based analysis of biologics. A multiparameter quality monitoring of three separate commercial biologic samples within 50 minutes has been demonstrated, with 20 µl of sample consumption, inclusive of dead volume in the reservoirs. Additionally, a proof-of-concept prototype system, which integrates an on-line sample-preparation system and the nanofluidic device, was demonstrated for at-line monitoring. Thus, the system is ideal for on-site monitoring, and the real-time quality assurance of biologics throughout the biomanufacturing processes.

Antiretroviral therapy supply chain quality control and assurance in improving people living with HIV therapeutic outcomes in Cameroon

BackgroundEvaluation of medication efficacy and safety is an essential guarantee to successful therapeutic outcome in public health practices. However, larger distribution chain supply in developing countries such as Cameroon is often challenged by counterfeit drugs, poor manufacturing, storage and degradation leading to health and patient adverse consequences. Yet, access to supply chain management in strengthening ARVs quality assurance and outcomes remains poorly documented. More than 53,000 patients have been enrolled on free ARVs medications, but little is documented on quality assurance and validity of safety for affected populations along the supply chain management since 2008.MethodsThe cross sectional study was conducted in ARVs distribution units and centers in central, littoral and south west regions of Cameroon. ARVs drugs samples included Nevirapine, Efavirenz, and fixed dose combinations of Zidovudine + Lamivudine, Lamivudine + Stavudine and Zidovudine + Lamivudine + Nevirapine. Drugs packaging and labeling was assessed and galenic assays were performed at National Laboratory of quality Control of Medications and Expertise (LANACOME), Yaoundé, Cameroon.ResultsThe study covered 16 structures located in eight different towns including the central ARVs store, two regional pharmaceutical procurement centers and thirteen HIV approved treatment centers and management units. A total of 35 ARVs products were collected. Only eight ARVs drugs containing Lamivudine and Stavudine presented with white stains on tablets, however these drugs were standard for all other tests performed. The others 28 ARVs products were standards to all assays performed.ConclusionWe concluded that ARVs drugs freely accessible and distributed to PLWHA are of good quality in Cameroon. However, with the increase number of patients under HAART since 2013, adoption of “Test and Treat” approach to reach the 90-90-90 goals and with the implementation of new national antiretroviral regimen guidelines and molecules such as boosted protease inhibitors, continuous quality control and assurance surveillance, monitoring and evaluation is recommended. Assessment of quality of formulations that are more susceptible to degradation such as pediatric formulations for averting the rising multidrug resistance trend is also desired.