• Title/Summary/Keyword: assessment standards

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Legal Issues for the Implementation of Non-Face-to-Face Treatment (비대면진료 실행을 위한 법적 쟁점)

  • Kwon, Ohtak
    • The Korean Society of Law and Medicine
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    • v.23 no.3
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    • pp.47-87
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    • 2022
  • Due to the COVID-19 pandemic, non-face-to-face treatment was temporarily permitted. A lot of consensus has been formed on the need to continuous non-face-to-face treatment. However, the current 「Medical Service Act」 only permits telemedicine between doctors and medical personnel. On the other hand, as a result of legal interpretation, there is an opinion that non-face-to-face treatment is allowed. But considering the overall legal system, non-face-to-face treatment is not allowed. Nevertheless, we have to consider the reality such as the development of science and technology and the outbreak of infectious diseases. Therefore, it is not advisable to allow face-to-face treatment only. Ultimately, it is necessary to find ways to ensure that non-foce-to-face treatment can be performed in a safe and effective manner. And it should be institutionalized. This is strategically necessary and important. Therefore, we must look over ahead legal issues to be discussed. First of all, the scope, the target disease and the subject of implement have to be clear. Also, structurally, the standards of facilities and equipment must be prepared for non-face-to-face treatment to be implemented. Functionally, communication and information exchange between doctors and patients should be well conducted. In addition, the information protection management system that occurs in the process of non-face-to-face treatment should be materialized. Lastly, the issue of responsibility and cost of non-face-to-face treatment should be decided in detail. When these problems materialize, it can be expected that a safe non-face-to-face treatment environment will be established.

Analysis of the Disposal Rate of Fresh Frozen Femoral Head in the Bone Bank of a Single Hospital (단일 병원 인체조직은행에서 채취한 신선 동결 대퇴골두의 폐기율 분석)

  • Lee, Jaeyoung;Lee, Donghun;Jeon, Jinhwa;Lee, Kee Haeng
    • Journal of the Korean Orthopaedic Association
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    • v.56 no.4
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    • pp.305-309
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    • 2021
  • Purpose: This study analyzed the increase in disposal rate of femoral heads in the bone bank of a single hospital from medical disease and drug history, as assessed by the Korean health insurance review and assessment service. Materials and Methods: The disposal rate and cause of 340 femoral heads were analyzed according to the regulations of the bone bank based on the standard model of the Ministry of food and drug safety. Results: One hundred and seven (33%) of 323 femoral heads collected from 2009 to 2018, and 65 (46%) of 142 femoral heads collected from 2015 to 2018 were discarded. The most common causes were related to the history of dementia and the administration of radioisotope for nuclear medicine. Conclusion: The current methods and screening tools can lead to errors in disposing of the available tissues in a bone bank. Thus, improved standards and screening methods are needed.

Safety management of living modified plants: A review (유전자변형 식물체 연구에서의 안전관리 고찰)

  • Lee, Bumkyu
    • Journal of Plant Biotechnology
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    • v.49 no.3
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    • pp.163-170
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    • 2022
  • There is a continuous rise in the commercialization of living modified (LM) organisms worldwide. While LM plants have not yet been cultivated in South Korea, research, development, import of products, and registration of related research facilities are progressing. LM plants should be tested in greenhouses and fields during development. Furthermore, environmental risk assessment and safety management should be performed before their release into the environment. Research on LM plant development is conducted in laboratories as well as confined greenhouses and fields. Safety management regulations are provided as combination standards for the LMO Act in each research district. The accidental release of the LM petunia in Japan was a significant incident related to LM plant research. It implies that normal plants within the distance of crossing should be regarded as LM plants. In the United States, LM creeping bentgrass was released into the environment, thus necessitating the establishment of stringent measures to prevent the scattering of LM plant seeds by wind or other mediums. In South Korea, LM Zoysia and LM cotton were released through rainwater. Therefore, safety measures that prevent LM seed mixing and plant vegetative propagules escaping into the environment via rainwater must be established. Preventing the dispersal of unapproved LM plants requires significant time, expenditure, and effort. Researchers should first identify the impact of LM plants on the ecosystem, and steps to avert their environmental release must be implemented.

Assessment of Dental Noise Environment of a Pediatric Dentist (소아치과의사의 치과 소음 환경에 대한 평가)

  • Cho, Hyeonmin;Kim, Ik-Hwan;Cho, Seunghyun;Song, Je Seon;Lee, Jaeho
    • Journal of the korean academy of Pediatric Dentistry
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    • v.48 no.2
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    • pp.209-220
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    • 2021
  • The noise is defined as unwanted sound that causes discomfort and physical changes. This study was conducted to evaluate intensity of noise in the pediatric dental clinic and to investigate noise environment of a pediatric dentist. Human ear shaped microphone and mobile noise level meter were used for recording noise and calculating intensity of noise. By recording according to the method specified by Korea Occupational Safety and Health Agency (KOSHA) of Korea Ministry of labor and employment, the following results were obtained. For 16 experimental days, 8 hour time weighted average (8hr-TWA) was 49.33 dBA (A-weighted deci-Bell) on daily average with maximum 58.54 dBA and minimum 33.97 dBA. And Dose was 0.49% on daily average with maximum 1.28%, minimum 0.04%. These values are less than criteria of KOSHA standard (85 dBA, 100%). Comparing the highest noise level for each patient, pulp therapy group and Frankel grade I group were the highest. The intensity of dental noise of pediatric dental clinic didn't meet standard of KOSHA. It is necessary to re-evaluate noise environment by establishing new standards considering environment of pediatric dental clinic.

Design of Standard Submission Format for Underground Structures : An Automated Update of the UnderSpace Integrated Map (지하공간통합지도 자동갱신을 위한 지하구조물 제출 표준 설계)

  • Park, Dong Hyun;Jang, Yong Gu;Ryu, Ji Song
    • Journal of the Korean Society of Surveying, Geodesy, Photogrammetry and Cartography
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    • v.39 no.6
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    • pp.469-476
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    • 2021
  • The framework plan for the development of an integrated underground space map was established of preventing ground subsidence. The mapping process is expected to be completed to the level of nationwide municipal government standards by end of this year. To facilitate the utilization of the integrated underground space map, paper-based drawings for specialized organizations in underground safety impact assessment have been provided since September 2018, and services for local government officials have been provided in the underground information utilization system since May 2019. However, the map is utilized based on the information at the time of the initial development of the map, without any updates, thereby resulting in a lack of accuracy and latest information. This has led to a decrease in the utilization and reliability of the information. Therefore, in this study, for the underground structures(subway, underground shopping mall, underground passage, underground roadway, underground parking lot, utility tunnel), which are the key components of the integrated underground space map, a standard format for the submission of completed drawings is designed in accordance with Article 42 (2) of the Special Act on Underground Safety Management, which aims at laying the foundation for establishing the updated system of the integrated underground space map. In addition, through the verification of the automatically updated underground structure data based on the standard format, the reliability of the data can be assured. This format is expected to contribute to the improved utilization of the integrated underground space map in the future.

The Auditors' Responses to Management's Overconfident Tone Depending on the Level of Earnings Management (경영자의 자기과신적 어조 및 이익조정에 대한 감사인의 반응)

  • Hee-Yeon Sunwoo;Hyejeong Shin
    • Journal of East Asia Management
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    • v.4 no.1
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    • pp.23-51
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    • 2023
  • We investigate whether the association between management overconfident tone and the level of audit effort measured by audit fees and hours differs depending on the level of earnings management. Prior studies suggest that firms led by overconfident managers are likely to initiate risky investments, report low quality financial statements, and have material weaknesses in internal control system. These characteristics, combined together, result in higher audit risk. At the same time, auditors assess audit risk based on the quality of financial reporting, measured by level of earnings management. As a result, the assess audit risk is likely to reflect the combined effect of management overconfidence and the level of earnings management. In this paper, we investigate whether auditors differentiate the effects of real earnings management (REM) and accrual-based earnings management (AEM) when they assess the audit risk related management overconfident. Using the CEO's letter published in 2018, we measure the CEO's tone representing the degree of overconfidence (i.e., activity). Based on this measure, we find that the positive association between managerial overconfident tone and audit effort is more pronounced as the level of REM is higher. However, we find that the baseline association does not vary depending on the level of AEM. These results suggest that auditors consider the managerial overconfident severer when such characteristic accompany the higher level of REM, which can be outcome of aggressive business decisions possibly leading to the higher audit risks. We further find that these results are stronger for Big 4 auditors and continuing auditors. This paper contributes to the literature and practice as follows. First, we provide contextual evidence on how auditors reflect managerial characteristics in the audit process by documenting that auditors actively increase their audit efforts only when overconfident managerial characteristics are highly likely to lead to audit risk. This result suggests that auditors conduct external auditing considering both the efficiency and effectiveness of the audit process. Second, we suggest that auditors use information obtained from a wide range of sources to identify audit risks. Our results provide evidence of how the auditing standards, which do not provide detailed guidelines for audit risk assessment, are being applied in practice. Finally, our results also enhance the understanding of how audit fees are determined. Combined with the studies related to audit pricing, we provide the important reference for discussion between the auditor and the auditee about the audit fee that has created acute tension after the enforcement of the new External Audit Act.

An Ethical Consideration on the Standard Operating Procedure Operation Status and the Ethical Review of the Vulnerable Research Subjects of Institutional Review Board, a Medical Institution in Korea (우리나라 의료기관 Institutional Review Board의 취약한 연구 대상자 관련 표준운영지침서 운영 현황과 윤리적 고찰)

  • Eun Hwa Byun;Byung In Choe
    • The Journal of KAIRB
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    • v.5 no.1
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    • pp.21-32
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    • 2023
  • Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

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High-efficiency deep geological repository system for spent nuclear fuel in Korea with optimized decay heat in a disposal canister and increased thermal limit of bentonite

  • Jongyoul Lee;Kwangil Kim;Inyoung Kim;Heejae Ju;Jongtae Jeong;Changsoo Lee;Jung-Woo Kim;Dongkeun Cho
    • Nuclear Engineering and Technology
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    • v.55 no.4
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    • pp.1540-1554
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    • 2023
  • To use nuclear energy sustainably, spent nuclear fuel, classified as high-level radioactive waste and inevitably discharged after electricity generation by nuclear power plants, must be managed safely and isolated from the human environment. In Korea, the land area is limited and the amount of high-level radioactive waste, including spent nuclear fuels to be disposed, is relatively large. Thus, it is particularly necessary to maximize disposal efficiency. In this study, a high-efficiency deep geological repository concept was developed to enhance disposal efficiency. To this end, design strategies and requirements for a high-efficiency deep geological repository system were established, and engineered barrier modules with a disposal canister for pressurized water reactor (PWR)-type and pressurized heavy water reactor type Canada deuterium uranium (CANDU) plants were developed. Thermal and structural stability assessments were conducted for the repository system; it was confirmed that the system was suitable for the established strategies and requirements. In addition, the results of the nuclear safety assessment showed that the radiological safety of the new system met the Korean safety standards for disposal of high-level radioactive waste in terms of radiological dose. To evaluate disposal efficiency in terms of the disposal area, the layout of the developed disposal areas was assessed in terms of thermal limits. The estimated disposal areas were 2.51 km2 and 1.82 km2 (existing repository system: 4.57 km2) and the excavated host rock volumes were 2.7 Mm3 and 2.0 Mm3 (existing repository system: 4.5 Mm3) for thermal limits of 100 ℃ and 130 ℃, respectively. These results indicated that the area and the excavated volume of the new repository system were reduced by 40-60% compared to the existing repository system. In addition, methods to further improve the efficiency were derived for the disposal area for deep geological disposal of spent nuclear fuel. The results of this study are expected to be useful in establishing a national high-level radioactive waste management policy, and for the design of a commercial deep geological repository system for spent nuclear fuels.

Study on the Efficient Integration of Long-term Care Facilities and Geriatric Hospitals by Using NHIC Survey Data (실태조사를 통한 장기요양시설과 요양병원의 효율적 연계방안)

  • Choi, in-duck;Lee, eun-mi
    • 한국노년학
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    • v.30 no.3
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    • pp.855-869
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    • 2010
  • The purpose of this study is to identify how to efficiently integrate long-term care facilities into geriatric hospitals. We conducted a survey on the current operations of facilities and medical services of 2009 of 192 long-term facilities and 168 geriatric hospitals in Korea between October and November. Technical statistics and chi-square test were conducted on the collected data using the SPSS 13.0/Win program. There was a difference between the two facility types in terms of the co-payment levels of the food services. Both types selected the budget deficit as their major management problem. Ease of access and the surrounding environment were critical factors used to select the location of both types of facilities. Facility users benefited from the discounted co-payments of both facility types. However, facility users wanted more frequent visits and support from their family members during their stay at the facilities. It was discovered that users in the long-term care facilities stayed longer, that is until they died, compared to their counterparts in geriatric hospitals. The two types of facilities provided their services totally separately to users. Users of the two types of facilities are poorly supported and cared for by their families. This study suggests that setting reasonable service fees, paying caretakers, introducing an integrated facility, strengthening facility assessment standards, introducing the family doctor system, and introducing the handling of long-term care insurance by geriatric hospitals would allow the integration between long- term care facilities and geriatric hospitals to be beneficial.

Okadaic Acid Group Toxins: Toxicity, Exposure Routes, and Global Safety Management (오카다익산 군 독소: 독성, 분석법 및 관리 동향)

  • Kyoungah Lee;Namhyun Kim;Jang Kyun Kim;Youn-Jung Kim;Jung Suk Lee;Young-Seok Han
    • Journal of Food Hygiene and Safety
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    • v.38 no.6
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    • pp.409-419
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    • 2023
  • Okadaic acid (OA) group toxins, including OA and its analogs, such as dinophysis toxins (DTXs), have been reported to cause diarrheal shellfish poisoning (DSP). These toxins are primarily produced by dinoflagellates and are accumulated in bivalves. Recently, the presence of Dinophysis sp., a causative alga of DSP, has been reported along the coasts of Korea, posing a potential risk of contamination to domestic seafood and exerting an impact on both the production and consumption of marine products. Accordingly, the European Food Safety Authority (EFSA) and the World Health Organization (WHO) have established standards for the permissible levels of OA group toxins in marine products for safety management. Additionally, in line with international initiatives, the domestic inclusion and regulation of DTX2 among the substances falling under the purview of management outlined by the 2022 diarrheal shellfish toxin standard have been implemented. In this study, we reviewed the physicochemical properties of OA group toxins, their various exposure routes (such as acute toxicity, genotoxicity, reproductive and developmental toxicity), and the relative toxicity factors associated with these toxins. We also performed a comparative assessment of the methods employed for toxin analysis across different countries. Furthermore, we aimed to conduct a broad review of human exposure cases and assess the international guideline for risk management of OA group toxins.