1.Evaluation and Countermeasures of the Implementation of Forensic Clinical Identification Standards Based on the Perspective of Accreditation.
Yan Bin WANG ; Dan Zhou TANG ; Jun Wei GAO ; Ya Hui WANG ; Yao CHEN ; Cheng Tao LI ; Xiao Dan HE
Journal of Forensic Medicine 2019;35(4):467-471
The new Standardization Law, implemented in 2018, has added a standard post-implementation evaluation system, aiming to continuously improve the quality of standards through post-implementation evaluation. Standards in the forensic science field are closely related to accreditation activities. Forensic science standards are not only the criteria on which accreditation activities are carried out, but also one of the key contents of the inspection of forensic science institutions in accreditation activities. Since 2018, the certification and accreditation policies in the forensic science field have also been changed, which has brought impacts on the construction of a standard system based on accreditation.This paper analyzes the standard data from China National Accreditation Center from Conformity Assessment on forensic clinical identification accreditation assessment. It points out that the current coverage of laboratory accreditation activities is limited, the development in different provinces is unbalanced, and there is overlap and crossover in the standards in use. It is emphasized that the construction of the national forensic science standardization technical committee, the improvement of the forensic science standard system, the establishment of the standard implementation evaluation index system, and promotion of the coordination of standards, and the certifications and accreditations should be accelerated, in order to continue to promote the standardization and accreditation activities in the field of forensic science.
Accreditation/legislation & jurisprudence*
;
China
;
Forensic Sciences/standards*
2.Brief introduction to accreditation of pathology laboratory.
Chinese Journal of Pathology 2015;44(7):471-472
3.Working Towards Accreditation by the International Standards Organization 15189 Standard: How to Validate an In-house Developed Method an Example of Lead Determination in Whole Blood by Electrothermal Atomic Absorption Spectrometry.
Carine GARCIA HEJL ; Jose Manuel RAMIREZ ; Philippe VEST ; Denis CHIANEA ; Christophe RENARD
Annals of Laboratory Medicine 2014;34(5):367-371
Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.
Accreditation
;
Humans
;
Laboratories/standards
;
Lead/*blood/standards
;
Reference Standards
;
*Spectrophotometry, Atomic/standards
;
*Validation Studies as Topic
4.Clinical Image Evaluation of Film Mammograms in Korea: Comparison with the ACR Standard.
Yeon Joo GWAK ; Hye Jung KIM ; Jin Young KWAK ; Eun Ju SON ; Kyung Hee KO ; Jin Hwa LEE ; Hyo Soon LIM ; You Jin LEE ; Ji Won PARK ; Kyung Min SHIN ; Yun Jin JANG
Korean Journal of Radiology 2013;14(5):701-710
OBJECTIVE: The goal of this study is to compare the overall quality of film mammograms taken according to the Korean standards with the American College of Radiology (ACR) standard for clinical image evaluation and to identify means of improving mammography quality in Korea. MATERIALS AND METHODS: Four hundred and sixty eight sets of film mammograms were evaluated with respect to the Korean and ACR standards for clinical image evaluation. The pass and failure rates of mammograms were compared by medical facility types. Average scores in each category of the two standards were evaluated. Receiver operating characteristic curve analysis was used to identify an optimal Korean standard pass mark by taking the ACR standard as the reference standard. RESULTS: 93.6% (438/468) of mammograms passed the Korean standard, whereas only 80.1% (375/468) passed the ACR standard (p < 0.001). Non-radiologic private clinics had the lowest pass rate (88.1%: Korean standard, 71.8%: ACR standard) and the lowest total score (76.0) by the Korean standard. Average scores of positioning were lowest (19.3/29 by the Korean standard and 3.7/5 by the ACR standard). A cutoff score of 77.0 for the Korean standard was found to correspond to a pass level when the ACR standard was applied. CONCLUSION: We suggest that tighter regulations, such as, raising the Korean pass mark, subtracting more for severe deficiencies, or considering a very low scores in even a single category as failure, are needed to improve the quality of mammography in Korea.
Accreditation/*standards
;
Female
;
Humans
;
Mammography/*standards
;
*Quality Improvement
;
ROC Curve
;
Republic of Korea
;
Retrospective Studies
6.Management of Chinese materia medica market based on information asymmetry.
Guang YANG ; Nuo WANG ; Lan-Ping GUO ; Yong-Yan WANG ; Lu-Qi HUANG ; Jin-Xin LIU
China Journal of Chinese Materia Medica 2013;38(23):4168-4173
Pharmaceutical market is a typical market with information asymmetry, and which can lead to "lemons" problem. In all developed countries, firms must receive regulatory approval to market a pharmaceutical product. Such administrative department including SFDA, EMA, FDA and so on. Chinese materia medica is a special part of pharmaceutical market in China. The management of Chinese materia medica is a special challenge in China.
Accreditation
;
Materia Medica
;
economics
;
standards
;
Medicine, Chinese Traditional
;
economics
;
standards
;
Reference Standards
;
Social Control, Formal
7.Experience on equipment supervision and inspection in food and drug control agency.
Ying MA ; Li TIAN ; Jingkun QI ; Xin YU ; Weiling TAO ; Hezhan ZHANG ; Jian ZOU
Chinese Journal of Medical Instrumentation 2013;37(5):370-372
To assure the effective operation of certification and accreditation in the laboratory management system, further strengthen the instruments and equipment management, and provide specific recommendations on improvement of internal audit, management review and continuous improvement of management system. The inspector program had been firstly established and complemented. Through the inspection, we identified many deficiencies, made many specific recommendations for improvement. After inspection, the working procedures were improved; data from department were more rigorous, scientific and just; hardware foundation was established for international mutual recognition.
Accreditation
;
Food Inspection
;
legislation & jurisprudence
;
Laboratories
;
standards
;
Pharmacy Administration
;
legislation & jurisprudence
8.How to improve the accreditation validity of medical devices testing laboratory.
Chinese Journal of Medical Instrumentation 2013;37(4):294-296
The safety and effectiveness of medical devices are directly related to human health. Therefore, how to improve the accreditation validity of medical devices testing laboratory has been the focus of attention from every corner of society. With respect to the characteristics of medical devices testing laboratory, this paper represented the existing issues during the accreditation and evaluation of testing laboratory, put forward some improvement suggestions on how to improve the validity of testing laboratory evaluation based on the practical experience.
Accreditation
;
Device Approval
;
Laboratories
;
organization & administration
;
standards
9.Outcomes-based Curriculum Development and Student Evaluation in Nursing Education.
Journal of Korean Academy of Nursing 2012;42(7):917-927
PURPOSE: A curriculum development model is presented to examine the processes necessary to develop new programs or evaluate existing programs within the philosophy of outcomes-based education in nursing, especially in the context of accreditation. The philosophy of outcomes-based education is to produce individuals who can demonstrate the evidence of competencies in designated areas of education. For nursing education, this means competencies in performing the role of professional nursing as defined by the profession and social needs at the beginning level upon completing a nursing program. METHODS: A curriculum development model has been developed analytically based on the literature and experiences. RESULTS: A 10-step process framework incorporating the tenets of outcomes-based nursing education is illustrated. CONCLUSION: This curriculum development framework can be applied in developing new educational programs in nursing or to evaluate and revise existing programs in anticipation of the accreditation process that is moving with a full force in such countries as Korea.
Accreditation/standards
;
Competency-Based Education
;
Curriculum/*standards
;
Education, Nursing, Baccalaureate/*standards
;
Humans
;
Models, Educational
;
Students/*psychology
10.American diagnostic radiology residency and fellowship programmes.
Annals of the Academy of Medicine, Singapore 2011;40(3):126-131
American Diagnostic Radiology Residency and Fellowship programmes are Graduate Medical Education programmes in the United States (US) equivalent to the Postgraduate Medical Education programmes in Singapore. Accreditation Council for Graduate Medical Education (ACGME) accredited diagnostic radiology residency programmes require 5 years total with Post Graduate Year (PGY) 1 year internship in a clinical specialty, e.g. Internal Medicine following medical school. PGY Years 2 to 5 are the core years which must include Radiology Physics, Radiation Biology and rotations in 9 required subspecialty rotations: Abdominal, Breast, Cardiothoracic, Musculoskeletal, Neuroradiology, Nuclear and Paediatric Radiology, Obstetric & Vascular Ultrasound and Vascular Interventional Radiology. A core curriculum of lectures must be organised by the required 9 core subspecialty faculty. All residents (PGY 2 to 4) take a yearly American College of Radiology Diagnostic In-Training Examination based on national benchmarks of medical knowledge in each subspecialty. Because the American Board of Radiology (ABR) examinations are changing, until 2012, residents have to take 3 ABR examinations: (i) ABR physics examination in the PGY 2 to 3 years, (ii) a written examination at the start of the PGY 5 year and (iii) an oral exam at the end of the PGY 5 year. Beginning in 2013, there will be only 2 examinations: (i) the physics and written examinations after PGY 4 will become a combined core radiology examination. Beginning in 2015, the final certifying examination will be given 15 months after the completion of residency. After residency, ACGME fellowships in PGY 6 are all one-year optional programmes which focus on only one subspecialty discipline. There are 4 ACGME accredited fellowships which have a Board Certifi cation Examination: Neuroradiology, Nuclear, Paediatric and Vascular Interventional Radiology. Some ACGME fellowships do not have a certifying examination: Abdominal, Endovascular Surgical Neuroradiology and Musculoskeletal Radiology. One year unaccredited fellowships can also be taken in Breast, Cardiothoracic or Women's Imaging.
Accreditation
;
Clinical Competence
;
statistics & numerical data
;
Communication
;
Curriculum
;
Education, Medical, Graduate
;
statistics & numerical data
;
Educational Measurement
;
Educational Status
;
Fellowships and Scholarships
;
statistics & numerical data
;
Health Knowledge, Attitudes, Practice
;
Humans
;
Internship and Residency
;
statistics & numerical data
;
Radiology
;
education
;
standards
;
Singapore
;
United States

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