Internal Quality Assurance Program Research Articles

Assistance in the Implementation of the Internal Quality Assurance System

This study aims to map one of the internal quality assurance programs in an effort to improve the quality of schools seen from the 8 National Education Standards (SNP), the ability of school residents to carry out 5 cycles of the Internal Quality Assurance System (SPMI) at SMP Islam Cikal Harapan 01 and SMP Islam Cikal Harapan 02. Data collection techniques in this study were through questionnaires, interviews, observations, and discussions. The results showed that there was an increase in the ability to understand and implement SPMI at SMP Islam Cikal Harapan 01 and SMP Islam Cikal Harapan 02, East Jakarta. In the percentage value of quality mapping, there was an increase from 2.51% in the Pre Cycle phase to 4.21% in the first cycle phase, and the second cycle, namely quality fulfillment planning, an increase from 2.76% in the Pre Cycle phase. The results of the second cycle are quality fulfillment planning with a value of 3.87%. From the percentage value of the third cycle of quality fulfillment implementation, there was an increase from 2.4% in the pre-cycle phase to 3.2%. From the percentage value of the fourth cycle of monitoring and evaluation of the implementation of quality there was an increase from 2.7% in the pre-cycle phase to 3.8%. From the percentage value of the fifth cycle of the new quality strategy, there was an increase from 2.42% in the pre-cycle phase to 3.52%. The implication of this research for the mentoring activities carried out by the abdimas team of Unindra PGRI Jakarta is that this mentoring activity can be carried out further by involving all school members. This is needed to be able to improve the quality of education in the two schools.

PENDAMPINGAN UNTUK PENINGKATKAN MUTU KINERJA SEKOLAH

The quality of public elementary school (SDN) performance is an internal problem that is a significant concern because the performance of schools is not going well, as evidenced by the A accreditation but does not match the school performance based on the results of the quality report card for the last two periods. Assistance to improve the quality of school performance aims to map with an internal quality assurance program to improve the quality of school performance, seen from the eight national standards of education. Assistance is provided through observation, training, interviews, and discussions. The mentoring results showed an increase in the ability to understand and implement the stages of the SPMI cycle at SDN Batu Ampar 06 East Jakarta. After regular mentoring and monitoring every month for six months. It is evident from the results of the second cycle when assistance is made plans to improve quality, to reach the percentage value of the fifth cycle of the new quality strategy with an increase as an implication of the assistance carried out by the Indraprasta PGRI University Jakarta Community Service Lecturer Team

Assessment of Extractability and Accuracy of Electronic Health Record Data for Joint Implant Registries

Implant registries provide valuable information on the performance of implants in a real-world setting, yet they have traditionally been expensive to establish and maintain. Electronic health records (EHRs) are widely used and may include the information needed to generate clinically meaningful reports similar to a formal implant registry. To quantify the extractability and accuracy of registry-relevant data from the EHR and to assess the ability of these data to track trends in implant use and the durability of implants (hereafter referred to as implant survivorship), using data stored since 2000 in the EHR of the largest integrated health care system in the United States. Retrospective cohort study of a large EHR of veterans who had 45 351 total hip arthroplasty procedures in Veterans Health Administration hospitals from 2000 to 2017. Data analysis was performed from January 1, 2000, to December 31, 2017. Total hip arthroplasty. Number of total hip arthroplasty procedures extracted from the EHR, trends in implant use, and relative survivorship of implants. A total of 45 351 total hip arthroplasty procedures were identified from 2000 to 2017 with 192 805 implant parts. Data completeness improved over the time. After 2014, 85% of prosthetic heads, 91% of shells, 81% of stems, and 85% of liners used in the Veterans Health Administration health care system were identified by part number. Revision burden and trends in metal vs ceramic prosthetic femoral head use were found to reflect data from the American Joint Replacement Registry. Recalled implants were obvious negative outliers in implant survivorship using Kaplan-Meier curves. Although loss to follow-up remains a challenge that requires additional attention to improve the quantitative nature of calculated implant survivorship, we conclude that data collected during routine clinical care and stored in the EHR of a large health system over 18 years were sufficient to provide clinically meaningful data on trends in implant use and to identify poor implants that were subsequently recalled. This automated approach was low cost and had no reporting burden. This low-cost, low-overhead method to assess implant use and performance within a large health care setting may be useful to internal quality assurance programs and, on a larger scale, to postmarket surveillance of implant performance.

MEASUREMENT OF NITROUS OXIDE IN A NITROGEN MATRIX USING GAS CHROMATOGRAPHY WITH MICROELECTRON CAPTURE DETECTION: VALIDATION OF ANALYTICAL METHOD

Atmospheric nitrous oxide (N2O) as one of the most potent greenhouse gases significantly contributes to the global warming effect. Therefore, an accurate and valid measurement method for monitoring its environmental release is of great importance. In this study, an analytical method for the measurement of N2O in a nitrogen (N2) matrix using gas chromatography and microelectron capture detection (GC‐μECD) has been validated. The analytical method was validated in terms of some performance parameters such as system suitability, precision (repeatability and reproducibility), linearity, limit of detection (LoD) and limit of quantitation (LoQ), accuracy and method robustness. The results show that the GC system was found to be suitable for the measurement of N2O in the N2 matrix. The repeatability and reproducibility of the method were found to have %RSD of 1.42 and 0.71, respectively, indicating that the method is repeatable and reproducible for N2O measurement. The linearity of the method was excellent, having the R2 value of 0.9998. The LoD and LoQ of the method were found to be 0.10 and 0.34 µmol mol-1, respectively. Evaluation of method accuracy showed that the method is also accurate for the measurement of N2O in the N2 matrix. The method’s roughness indicated that the method was quite stable and unaffected by slight changes in the experimental conditions. From this study, it can be concluded that the validated method can be used in testing laboratory for internal quality assurance programs purposes related to the measurement of N2O in N2 matrix.

Building an Internal Quality Assurance Program

Any academic medical center nurturing a research program must take practical steps to safeguard compliance. Instead of relying solely on pharmaceutical monitoring to preserve compliance, the establishment of an internal quality assurance (QA) system may be considered as an extra step toward meeting compliance goals. Commitment from upper levels of management can set up the audit program to be a key element of a Good Clinical Practice quality system within an organization. If internal QA is viewed as an essential, cohesive element of research programs, it would nurture constructive interactions between the research team and QA professional, thereby building higher standards of quality into the program.

Narrow-band imaging in the prediction of surveillance intervals after polypectomy in community practice.

It has been proposed that the use of narrow-band imaging (NBI) for real-time histological assessment to determine postpolypectomy surveillance intervals is a cost-effective approach to the management of diminutive polyps. However, significant discrepancies in NBI performance have been observed among endoscopists; hence, professional societies recommend training, monitoring, and auditing. The aim of the present study was to evaluate the performance of real-time optical diagnosis for diminutive polyps after the inclusion of this approach in an internal quality assurance program, in order to assess its applicability in clinical practice Patients and methods: Four endoscopists attended periodic training sessions on NBI assessment of polyp histology before and during the study. Performance was audited and periodic feedback was provided. The accuracy of high-confidence NBI evaluation for polyps ≤ 5 mm in predicting surveillance intervals according to the European and US guidelines, and the negative predictive value (NPV) for adenoma in the rectosigmoid were calculated and compared with recommended thresholds (90 % agreement and 90 % NPV, respectively). Overall, 284 outpatients (mean age 61.3 ± 18.2 years; 63 % males) were enrolled. A total of 656 polyps were detected, 465 of which (70.9 %) were diminutive (70.5 % adenomas). Sensitivity, specificity, positive and negative predictive values, and accuracy of high-confidence NBI predictions for adenoma in diminutive lesions were 95.3 %, 83.5 %, 93.5 %, 87.6 %, and 91.9 %, respectively. High-confidence characterization of diminutive polyps predicted the correct surveillance interval in 95.8 % and 93.3 % of cases according to European and American guidelines, respectively. NPV for adenoma in the rectosigmoid was 91.3 % For community settings in which endoscopists are adequately trained and performance is periodically audited, real-time optical diagnosis for diminutive polyps is sufficiently accurate to avoid postpolypectomy histological examination of resected lesions, or to leave rectosigmoid hyperplastic polyps in place. Trial registered at ClinicalTrials.gov (NCT02196402).

ASCO research program quality assessment tool: Basics for a quality community-based research site.

97 Background: In 2008, ASCO published a statement to identify minimum standards and exemplary attributes of clinical trial sites. Recommendations were made to assist with the development and implementation of high-quality research programs. Based on feedback from an ASCO needs assessment survey, ASCO’s Community Research Forum (CRF) sought to develop a tool to help community-based research sites exceed the minimum standards of conducting clinical research, and to identify important components for an internal quality assurance program. Methods: A tool was developed to incorporate elements of ASCO publications on minimal standards and exemplary attributes of research sites. The tool was designed to assist community-based research sites with the development and implementation of an internal quality assurance program. A checklist was also developed to help sites easily conduct an assessment of their program. Community-based researchers provided feedback on the tool’s content and utilization. Feedback was incorporated and the tool was released for widespread use in March 2014. Results: The tool was very well received by reviewers. All reviewers indicated that the level of detail of the tool was sufficient; 94% indicated that it presented realistic expectations, in terms of resources required to implement; and 81% indicated that it would be valuable for conducting a quality assessment of their research program. As of July 2014, the tool was downloaded by over 150 practices from 8 different countries and early feedback continued to be favorable, particularly from small and/or new research programs. Conclusions: Many community-based research programs do not have the resources to support an effective quality assurance program and rely heavily on external audits. The ASCO Research Program Quality Assessment Tool provides self-directed continual process improvement to help community-based research sites create an internal quality assurance program and exceed minimum standards of conducting clinical research. The CRF will learn more from users of the tool about the quality of research programs and processes, and key quality metrics. The tool is available for download at www.asco.org/communityresearchforum.

Immunohistochemistry Internal Quality Assurance Program Testing in Breast Cancers in Newfoundland and Labrador, Canada

Immunohistochemistry Internal Quality Assurance Program Testing in Breast Cancers in Newfoundland and Labrador, Canada

Internal quality control as a tool for planning a robustness study regarding a multiresidue method for pesticides found in olive oil

The implementation of the internal quality assurance program allows for demonstration of the performance characteristics of a method, as well as the avoidance of erroneous results. There is increasing concern in testing laboratories to ensure that the analytical process remains stable, giving reliable results under statistical control. Robustness is tested by introducing variations in experimental conditions and examining the effects on the results. The European document SANCO/12495/2011, “Method validation and quality control procedures for pesticide residue analysis in food and feed”, defines robustness as a parameter that can be derived from ongoing method verification. Internal quality control tools, such as the recovery control chart, were employed in this study to enhance the stability of the recovery rates and to investigate the experimental conditions that have a major influence on the quantification of recovery rates. The method investigated in this study permitted us to investigate eighteen pesticides in olive oil by using a gas chromatography–mass spectrometry technique. This method has been accredited to ISO/IEC 17025:2005 standards and was applied for 1 year in routine conditions for pesticide residues at the Italian National Reference Laboratory. The recovery control chart has showed that all recovery rates for 1 year were close to the maximum limit (120 %) of recovery performance criteria. Consequently, a “positive” bias has affected all data over longer periods of time. A robustness test was planned in order to investigate the grounds that most influenced the variability of the results. The robustness test involved the following three parameters: solvent used to dissolve the final extract, internal standards, and type of olive oil.

Critical Analysis of Locoregional Failures Following Intensity-Modulated Radiotherapy for Nasopharyngeal Carcinoma

To analyze the patterns of locoregional failure following intensity-modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC) at our institution, as part of an internal quality assurance program. We aimed to investigate the potential existence of a correlation between any part of the IMRT process and clinical outcome. A total of 106 non-metastatic NPC patients consecutively treated with IMRT (with or without chemotherapy) were analyzed. Radiotherapy was administered using a sequential or simultaneous integrated boost approach at the total prescribed dose of 66-70 Gy (2.00-2.12 Gy per fraction). MRI studies of recurrences were recorded with the planning computed tomography studies to identify volume of failure. Recurrence-related characteristics were analyzed with respect to the original treatment. Failures were classified as 'in-field', 'marginal' or 'out-field' if at least 95, 20-95 or less than 20% of the volume of failure, respectively, was within 95% of the total prescription dose. With a median follow-up of 43.4 months, 5-years local control, regional control, locoregional control and overall survival rates were 87.7, 88.0, 83.5 and 81.3% respectively. A total of 21 failures were registered in 15 patients. In particular, ten failures (47.6%) were classified as 'in-field' (seven local failures and three regional failures [RFs]), nine failures (42.9%) as 'marginal' (five local failures and four RFs) and only two failures (9.5%) as 'out-field' (both RFs). The most relevant causes of failures were suboptimal target definition and target coverage as well as a longer than planned overall treatment time. IMRT determines excellent outcome in NPC patients. However, great attention in all IMRT steps is necessary to reduce potential causes of failure.

Internal Quality Assurance Program for ERBB2 (HER2) Testing Improves the Selection of Breast Cancer Patients for Treatment with Trastuzumab

International guidelines for ERBB2 (HER2) testing procedures in breast cancer patients highlight the importance of external quality control. In contrast, internal quality assurance programs have been poorly defined, and their clinical significance has not yet been investigated. We developed a quality assurance scheme by performing HER2 FISH on 724 patients randomly selected out of 1996 patients with breast cancer presenting at our institute. We collected samples monthly for tissue microarray analysis and correlated HER2 gene status with IHC scores. The concordance was excellent (κ = 0.92, P < 0.0001). HER2 amplification characterized 25% of score 2+ but also 13% of score 1+, thus expanding the number of patients eligible for trastuzumab. Based on these findings, the FISH test is now recommended at our institution for score 1+ and 2+ patients. Adherence to internal assurance program improves patient selection and may lead to the definition of in-house tailored diagnostic algorithms different from those proposed in international guidelines.

Developing an Internal Quality Assurance Program for Immunohistochemistry Interpretation of Her–2/neu

The purpose of this initiative was to develop an in-house program that allows a comparison of pathologist interpretations of human epidermal growth factor receptor 2 gene (Her-2/neu) performed by immunohistochemistry (IHC). This comparison would drive uniformity in reporting between pathologists in the greater medical community and improve the precision of Her-2/neu interpretations and its utility as a predictive marker. The technical variance behind the process of Her-2/neu interpretations may lead to interpretative variability between pathologists. The technical variables were minimized by passing a single slide with a tissue microarray stained for Her-2/neu by IHC between pathologists at different laboratory sites for interpretation. The pathologist identities remained anonymous to the group. The results were reported by the pathologists to a single assessor. The results were compiled and distributed with each pathologist knowing only his/her own identification number as designated by the single assessor; 100% pathologist participation was achieved. The findings indicate a relatively consistent pattern of reporting between pathologists for Her-2/neu. By developing an internal quality assurance program to function in conjunction with external quality assurance testing, the technical staff and pathologists can collaboratively ensure optimal performance, interpretation, and reporting of results. (The J Histotechnol 33(2):85–92, 2010)Submitted December 22, 2009; accepted with revisions May 12, 2010.

Developing an Internal Quality Assurance Program for Immunohistochemistry Interpretation of Her–2/neu

The purpose of this initiative was to develop an in-house program that allows a comparison of pathologist interpretations of human epidermal growth factor receptor 2 gene (Her-2/neu) performed by immunohistochemistry (IHC). This comparison would drive uniformity in reporting between pathologists in the greater medical community and improve the precision of Her-2/neu interpretations and its utility as a predictive marker. The technical variance behind the process of Her-2/neu interpretations may lead to interpretative variability between pathologists. The technical variables were minimized by passing a single slide with a tissue microarray stained for Her-2/neu by IHC between pathologists at different laboratory sites for interpretation. The pathologist identities remained anonymous to the group. The results were reported by the pathologists to a single assessor. The results were compiled and distributed with each pathologist knowing only his/her own identification number as designated by the single assessor; 100% pathologist participation was achieved. The findings indicate a relatively consistent pattern of reporting between pathologists for Her-2/neu. By developing an internal quality assurance program to function in conjunction with external quality assurance testing, the technical staff and pathologists can collaboratively ensure optimal performance, interpretation, and reporting of results. (The J Histotechnol 33(2):85–92, 2010)Submitted December 22, 2009; accepted with revisions May 12, 2010.

Assessment of the proficiency of gram stain interpretation at QML pathology, Queensland

All Australian laboratories are required to participate in quality assurance (QA) exercises. Most have internal QA programs as well as external programs. The Gram stain is the basic stain used in the microbiology laboratory. It is fundamental to the processing of specimens and the interpretation of cultures. The aim of this study is to assess the internal proficiency of the technicians and/or scientists at QML Pathology at interpreting Gram stain. Gram stains prepared at three regional laboratories and a random number of Gram stains from the central laboratory were read by the microbiology registrar. This was compared with the reported results. Any discrepancy between the two results was reviewed by a senior scientist at the central laboratory. A total of 419 slides were read. There was 37% concordance between the registrar and the four study sites. A representative selection of slides in this study was photographed. All technicians/scientists involved in the initial reporting of the study slides reported on the photographed images. The discrepancies from the study slides were compared to the photographed slides to look for correlation. The limitations of this study and the deficiencies of the staff were identified. A new ‘Test and Teach’ kit for Gram stains was developed for internal QA. All Australian laboratories are required to participate in quality assurance (QA) exercises. Most have internal QA programs as well as external programs. The Gram stain is the basic stain used in the microbiology laboratory. It is fundamental to the processing of specimens and the interpretation of cultures. The aim of this study is to assess the internal proficiency of the technicians and/or scientists at QML Pathology at interpreting Gram stain. Gram stains prepared at three regional laboratories and a random number of Gram stains from the central laboratory were read by the microbiology registrar. This was compared with the reported results. Any discrepancy between the two results was reviewed by a senior scientist at the central laboratory. A total of 419 slides were read. There was 37% concordance between the registrar and the four study sites. A representative selection of slides in this study was photographed. All technicians/scientists involved in the initial reporting of the study slides reported on the photographed images. The discrepancies from the study slides were compared to the photographed slides to look for correlation. The limitations of this study and the deficiencies of the staff were identified. A new ‘Test and Teach’ kit for Gram stains was developed for internal QA.

Development of a cross-thesaurus with Internet-based refinement supported by UMLS.

Combinatorial terminological systems are appearing, to solve the issues related to flexibility and precision of representation requested by modern healthcare information systems and in particular by messaging standards. The development of a robust system of descriptors ('cross-thesaurus') is a crucial activity in the production of combinatorial terminological systems. We developed a tool (I-BROWSE) to produce a cross-thesaurus by analysing existing terminological corpora. To facilitate the work of experts and to produce re-usable results, our application interacts via the Internet with the UMLS Knowledge Sources Server. We applied our tool on 6372 dissections on surgical procedures produced in the project GALEN-IN-USE, as a part of the internal Quality Assurance Program. Support from UMLS seems mostly promising about descriptors on <anatomy>, <pathological structure>, <pathological process> and <physiological process>. Additional assistance can be given to domain experts on less frequent descriptors on pervasive modifiers. We plan to apply our tool also to production of terminological standards in CEN, as a part of a world-wide process of gradual convergence and transformation of coding systems into second-generation systems and terminological services.

Technical Notes: How to Submit Data to the Proficiency Analytical Testing (PAT) Program via Computer Modem

Abstract A new automated data entry system (ADES) has been developed and is now available for use with the Proficiency Analytical Testing (PAT) Program. The PAT Program is designed to evaluate laboratories performing analyses on metals, silica, asbestos, and organic solvents as well as supplement their internal quality assurance programs. This system was developed to provide a faster, more accurate method to receive PAT data from several hundred participating laboratories. The ADES has advantages over faxing and mailing, including multiple phone lines for easier access and elimination of illegible PAT report forms. All that is required is a computer, modem, communications software, and a phone line. Laboratories receive a copy of the data entry program, detailed instructions on how to operate the program and upload the data, and a security password.