Accreditation ; Laboratories ; standards ; Pathology ; standards

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

Accreditation ; organization & administration ; China ; Hospital Administration ; standards

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*

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

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

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

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

OBJECTIVE: The purpose of this study was to evaluate any improvement in the quality of abdominal CTs after the utilization of the nationally based accreditation program. MATERIALS AND METHODS: Approval was obtained from the Institutional Review Board, and informed consent was waived. We retrospectively analyzed 1,011 outside abdominal CTs, from 2003 to 2007. We evaluated images using a fill-up sheet form of the national accreditation program, and subjectively by grading for the overall CT image quality. CT scans were divided into two categories according to time periods; before and after the implementation of the accreditation program. We compared CT scans between two periods according to parameters pertaining to the evaluation of images. We determined whether there was a correlation between the results of a subjective assessment of the image quality and the evaluation scores of the clinical image. RESULTS: The following parameters were significantly different after the implementation of the accreditation program: identifying data, display parameters, scan length, spatial and contrast resolution, window width and level, optimal contrast enhancement, slice thickness, and total score. The remaining parameters were not significantly different between scans obtained from the two different periods: scan parameters, film quality, and artifacts. CONCLUSION: After performing the CT accreditation program, the quality of the outside abdominal CTs show marked improvement, especially for the parameters related to the scanning protocol.
*Accreditation ; Humans ; *Quality Improvement ; Radiography, Abdominal/*standards ; Republic of Korea ; Retrospective Studies ; Tomography, X-Ray Computed/*standards

BACKGROUND: The Korean Laboratory Accreditation Program (KLAP) by the Korean Society of Laboratory Medicine (KSLM) was started in 1999. We summarized history and achievement of KLAP for the last 8 yr. METHODS: We analyzed 8 yr data (1999-2006) of historical events, trends of participating laboratories, and scores according to the impact of the question to the outcome of the tests. Inspection check lists are for 'laboratory management', 'clinical chemistry', 'diagnostic hematology', 'clinical microbiology', 'diagnostic immunology', 'transfusion medicine', 'cytogenetics', 'molecular genetics', 'histocompatibility', 'flow cytometry', and 'comprehensive laboratory test verification report'. The laboratories with score 90 or higher got 2-yr certificate and laboratories with score between 60 and 89 got 1-yr certificate. The laboratories with score below 60 failed accreditation. RESULTS: The number of accredited laboratories was 2.4 times higher in 2006 (n=227) than in 1999 (n=96). Inspection check lists have been revised 5 times till 2006. The average accreditation rate was 99.6% during these periods and the 2-yr accreditation rate was 32.4% in 2000, 45.6% in 2001, 53.3% in 2002, 47.3% in 2003, 68.5% in 2004, 37.7% in 2005, and 47.7% in 2006. Number of participants in inspector training workshops increased from 89 in 2000 to 766 in 2006. CONCLUSIONS: The KLAP has been in place successfully and stabilized over the past 8 yr. It seemed to enhance the laboratory quality. Efforts for improvement of quality control and inspector training workshops appeared to be in the main contributing factors.
Accreditation ; Education, Medical, Continuing ; Korea ; Laboratories/*standards ; Pathology, Clinical/*standards ; *Program Evaluation