The journey of Malaysian external quality assurance program for general diagnostic histopathology

@#International Academy of Pathology, Malaysian Division has initiated and run the external quality assurance program for general diagnostic histopathology since the year 2017. This article introduces the educational philosophy of this external quality assurance program and the technicalities in running such a national program. Challenges in ensuring the successful running of this program to gain wide acceptance by histopathology laboratories in Malaysia as well as experience in overcoming these challenges are detailed. This article charts the future direction of this external quality assurance program.

The Results of External Proficiency Tests to Prevent Transfusion-transmitted Virus Infection: There Is a Need for a Quality Assurance Program for Donor Screening Tests to Prevent Blood-borne Virus Infections / 대한수혈학회지

BACKGROUND: We analyzed the results of external proficiency tests for HBsAg, anti-HCV and anti-HIV, and these tests are currently used for blood donor screening in Korea. METHODS: The external proficiency testing (EPT) data was retrospectively collected from 2001 to 2009 from the Korean Association of Quality Assurance for Clinical Laboratories, and this association includes those institutes that have blood centers. The pooled patient sera or converted sera from the plasma were used for EPT. The year 2004 data includes the Recombinant HBsAg variant (Gly/Arg 145). RESULTS: A total 806 institutes participated in this evaluation. The average discordant rate for HBsAg, anti-HCV and anti-HIV in the blood centers was 0.2%, 0.6% and 1.0%, respectively for the years 2001~2009. For the HBsAg test, the discordant rate was less than 0.5% in 2009, yet there was a much higher rate (1.6~22.2%) in 2004 when using the recombinant HBsAg variant. CONCLUSION: HBV variants or low positive antigen or antibody titers were problematic in the current clinical laboratory, and so a systematic quality assurance program should be conducted with using control materials.

External Quality Assurance Survey for the Blood Donor Screening Tests Performed in 2010 / 대한수혈학회지

BACKGROUND: To prevent blood-borne infections and guarantee safe transfusion, we proposed a quality assurance program for donor screening tests, such as hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus antibody (anti-HCV), by introducing external proficiency testing for the laboratories that perform donor screening tests. METHODS: The materials for external proficiency testing (PT) were prepared from the HBsAg Standard Panels and anti-HCV Reference Panels provided by the Korea Food and Drug Administration (KFDA), and the normal Human Serum was provided by the Serum Bank of the Korea National Research Resource Center. The external PT materials were sent to 83 laboratories that performed donor screening tests after evaluating their quality. RESULTS: The results of evaluating the quality of the PT materials were acceptable. All the laboratories receiving the materials answered with a 100% response rate. All the laboratories answered that they obtained positive results for the HBsAg Standard Panel E, H, I and J; however, one laboratory answered in the gray-zone and that lab had negative results for HBsAg Standard Panel C and G. Seventy laboratories (84%) and 42 laboratories (51%) among the total 83 laboratories answered they had positive results for HBsAg Standard Panel B and D, suggesting that many laboratories could not detect a low level of HBsAg. All 83 laboratories answered that they had concordant results for the external PT for anti-HCV. CONCLUSION: Donor screening laboratories can detect low levels of HBsAg and anti-HCV without any errors and the performance of the laboratories that could not detect low levels of HBsAg remains to be improved. Quality assurance program using external PT with materials that contain various genotypes and mutants should be conducted to maintain the quality of donor screening tests.

A Proposal for Developing a National Quality Assurance Program for Donor Bloodassays / 대한수혈학회지

BACKGROUND: Viral screening assays performed for blood donors are required to have high sensitivity because false negative results can lead to transfusion-transmitted infections. To minimize the number of false negative cases, a systematic quality assurance program is required to verify donor screening tests. METHODS: The current status of quality assurance (QA) for blood donor screening tests in Korea and other countries was reviewed. A quality assurance program using the national standards of the Korea Food and Drug Administration (KFDA) was done as a pilot study to evaluate both the need for such a program and the feasibility of such a program. RESULTS: Singapore had a national quality assurance programs for the anti-HIVdonor screening tests. In the United Kingdom, all laboratories use the NIBSC working standards as QA materials for the donors screening. Ninety-five % (84/80) of blood centers replied that they would participate in a national quality assessment program and 92% (84/77) of the blood centers also felt that an independent organization should be designated to operate the program. Quality control materials with a weak reactivity should be included in a quality assessment program for donor screening. CONCLUSION: We propose 2 models for a National Quality Assurance Program (NQAP). In the first model, an independent national reference laboratory (NRL) needs to be established that operates the national quality assurance program. The second model involves the integration of the national quality assurance program for donor screening into the External Quality Assurance Survey run by the Korean Association of Clinical Assurance for Clinical Laboratory (KAQACL) using the national standards.

The Development of Quality Assurance Program for CyberKnife / 대한방사선종양학회지

PURPOSE: Standardization quality assurance (QA) program of CyberKnife for suitable circumstances in Korea has not been established. In this research, we investigated the development of QA program for CyberKnife and evaluation of the feasibility under applications. MATERIALS AND METHODS: Considering the feature of constitution for systems and the therapeutic methodology of CyberKnife, the list of quality control (QC) was established and divided dependent on the each period of operations. And then all these developed QC lists were categorized into three groups such as basic QC, delivery specific QC, and patient specific QC based on the each purpose of QA. In order to verify the validity of the established QA program, this QC lists was applied to two CyberKnife centers. The acceptable tolerance was based on the undertaking inspection list from the CyberKnife manufacturer and the QC results during last three years of two CyberKnife centers in Korea. The acquired measurement results were evaluated for the analysis of the current QA status and the verification of the propriety for the developed QA program. RESULTS: The current QA status of two CyberKnife centers was evaluated from the accuracy of all measurements in relation with application of the established QA program. Each measurement result was verified having a good agreement within the acceptable tolerance limit of the developed QA program. CONCLUSION: It is considered that the developed QA program in this research could be established the standardization of QC methods for CyberKnife and confirmed the accuracy and stability for the image-guided stereotactic radiotherapy.

Factors affecting Reading Agreement of Pneumoconiotic Findings / 대한산업의학회지

To find the factors affecting reading agreement of pneumoconiotic findings of simple chest P-A films and to develop the definite quality assurance (Q.A) program for the reading of pneumoconiosis, I gathered the reading reports of the previously developed forty four chest films from nationwide thirty nine radiologists and compared those with the findings decided by the stepwise panel readings of the highly qualified eight radiologists. The reading agreement of profusion by complete or short classification was higher in the radiologists with sufficient reading experiences of pneumoconiosis during residency training. It was also higher in the radiologists with reference to ILO standard films or those working in the agencies for pneumoconiosis within one category of profusion by complete classification. Other factors were not related with the reading agreement of profusion. In small opacity and pleural thickening, there were not any consistent and meaningful findings between the reading agreement and radiologists' characteristics. From the above results, it is necessary to develop the Q.A program to improve the reading agreement of pneumoconiotic findings, especially small opacity and pleural lesions.

Factors affecting Reading Agreement of Pneumoconiotic Findings / 대한산업의학회지

To find the factors affecting reading agreement of pneumoconiotic findings of simple chest P-A films and to develop the definite quality assurance (Q.A) program for the reading of pneumoconiosis, I gathered the reading reports of the previously developed forty four chest films from nationwide thirty nine radiologists and compared those with the findings decided by the stepwise panel readings of the highly qualified eight radiologists. The reading agreement of profusion by complete or short classification was higher in the radiologists with sufficient reading experiences of pneumoconiosis during residency training. It was also higher in the radiologists with reference to ILO standard films or those working in the agencies for pneumoconiosis within one category of profusion by complete classification. Other factors were not related with the reading agreement of profusion. In small opacity and pleural thickening, there were not any consistent and meaningful findings between the reading agreement and radiologists' characteristics. From the above results, it is necessary to develop the Q.A program to improve the reading agreement of pneumoconiotic findings, especially small opacity and pleural lesions.

Círculos de calidad como, estrategia de un programa de garantía de calidad de la atención médica, en el instituto nacional de perinatología / Quality circles as strategy of a quality assurance program of medical attention in national institute od perinatology

El presente artículo muestra la metodología de implantación de un porgrama de garantía de calidad de la atención médica mediante círculos de calidad en el Instituto Nacional de Perinatología, y sus resultados. Entre ellos destacan: efectos en la estructura organizacional, en la optimización de recursos, en el porpio porceso de la atención, en la satisfacción de los pacientes y en el aprendizaje implicado en la adaptación de esta tecnología al ámbito hospitalario y a las características de una cultura diferente de la cual surgió esa tecnología. El poryecto, concebido como investigación-acción, fue asesorado por el Centro de Investigaciones en Salud Pública, y fue creado con el porpósito de asegurar que las condiciones organizacionales bajo las cuales se porporciona la atención médica fue sen aquélas que permitieran elevar la calidad tanto en la dimensión interpersonal como en la técnica, mediante la participación del personal directamente responsable de la prestación de los servicios. Ello condujo a la utilización de los círculos de calidad como técnica participativa de control de calidad y como eje de un porgrama de garantía de calidad de la atención médica. Pueden identificarse siete etapas en la implantación del porgrama de garantía de calidad mediante la utilización de círculos de calidad: 1) elaboración del documento porpositivo y portocolo de trabajo; 2) negociación; 3) diseño de una guía para la elaboración de un manual de garantía de calidad; 4) selección del punto de inicio; 5) elaboración del Manual de Garantía de Calidad por servicios; 6) operacionalización de los círculos de calidad; 7) evaluación del porgrama. Esta experiencia ha demostrado la factibilidad de utilizar los círculos de calidad como componentes fundamentales de un porgrama de garantía de calidad de la atención médica y permite asegurar que, en general, es posible utilizar esta tecnología en los servicios de salud

The present article shows the methodology of implantation of a quality guarantee program of medical attention through quality circles at the National Institute of Perinatology and it's results. Among them emphasize the following: organization's structure effects. The optimus on resources in it's own process of attention on the satisfaction of the patients and in the learning implicated in the adaptation of the technology to the hospital enviroment and the characteristics of a different culture from which that technology emerged. The proyect, conceived as investigation-action, was advised by Public Health Investigation Center and was created with the purpose to secure that the organized conditions under which the medical attention are given were those permitting to raise the quality as much in the among personal dimention as in the technical, through the participation of the personnel directly resposible of the services given. This led to the use of quality ,circles as participant technical of quality control and as main quality guarantee program of medical attention. Seven stages can be identified in the implantation of the quality assurance program using the quality circles: 1) to elaborate the proposal document and work protocol; 2) negotiation; 3) drawing of a guide for the elaboration of a quality guarantee manual; 4) selection the point of starting; 5) elaboration of the quality guarantee manual by service; 6) to operate the quality circles; 7) evaluation of the program. This experience has demostrated it's feasible using the quality circles as fundamental components of a quality guaranty program of medical attention and permits to secure that, in general, it is possible to use this technology in the health services.