• Title/Summary/Keyword: 허용 기준

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A Study on the Establishment of Acceptable Range for Internal Quality Control of Radioimmunoassay (핵의학 검체검사 내부정도관리 허용범위 설정에 관한 고찰)

  • Young Ji, LEE;So Young, LEE;Sun Ho, LEE
    • The Korean Journal of Nuclear Medicine Technology
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    • v.26 no.2
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    • pp.43-47
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    • 2022
  • Purpose Radioimmunoassay implement quality control by systematizing the internal quality control system for quality assurance of test results. This study aims to contribute to the quality assurance of radioimmunoassay results and to implement systematic quality control by measuring the average CV of internal quality control and external quality control by plenty of institutions for reference when setting the laboratory's own acceptable range. Materials and Methods We measured the average CV of internal quality control and the bounce rate of more than 10.0% for a total of 42 items from October 2020 to December 2021. According to the CV result, we classified and compared the upper group (5.0% or less), the middle group (5.0~10.0%) and the lower group (10.0% or more). The bounce rate of 10.0% or more was compared by classifying the item of five or more institutions into tumor markers, thyroid hormones and other hormones. The average CV was measured by the overall average and standard deviation of the external quality control results for 28 items from the first quarter to the fourth quarter of 2021. In addition, the average CV was measured by the overall average and standard deviation of the proficiency results between institutions for 13 items in the first half and the second half of 2021. The average CV of internal quality control and external quality control was compared by item so we compared and analyzed the items that implement well to quality control and the items that require attention to quality control. Results As a result of measuring the precision average of internal quality control for 42 items of six institutions, the top group (5.0% or less) are Ferritin, HGH, SHBG, and 25-OH-VitD, while the bottom group (≤10.0%) are cortisol, ATA, AMA, renin, and estradiol. When comparing more than 10.0% bounce rate of CV for tumor markers, CA-125 (6.7%), CA-19-9 (9.8%) implemented well, while SCC-Ag (24.3%), CA-15-3 (26.7%) were among the items that require attention to control. As a result of comparing the bounce rate of more than 10.0% of CV for thyroid hormones examination, free T4 (2.1%), T3 (9.3%) showed excellent performance and AMA (39.6%), ATA (51.6%) required attention to control. When comparing the bounce rate of 10.0% or more of CV for other hormones, IGF-1 (8.8%), FSH (9.1%), prolactin (9.2%) showed excellent performance, however estradiol (37.3%), testosterone (37.7%), cortisol (44.4%) required attention to control. As a result of measuring the average CV of the whole institutions participating at external quality control for 28 items, HGH and SCC-Ag were included in the top group (≤10.0%), however ATA, estradiol, TSI, and thyroglobulin included in bottom group (≥30.0%). Conclusion As a result of evaluating 42 items of six institutions, the average CV was 3.7~12.2% showing a 3.3 times difference between the upper group and the lower group. Cortisol, ATA, AMA, Renin and estradiol tests with high CV will require continuous improvement activities to improve precision. In addition, we measured and compared the overall average CV of the internal quality control, the external quality control and the proficiency between institutions participating of six institutions for 41 items excluding HBs-Ab. As a result, ATA, AMA, Renin and estradiol belong to the same subgroup so we require attention to control and consider setting a higher acceptable range. It is recommended to set and control the acceptable range standard of internal quality control CV in consideration of many things in the laboratory due to the different reagents and instruments, and the results vary depending on the test's proficiency and quality control materials. It is thought that the accuracy and reliability of radioimmunoassay results can be improved if systematic quality control is implemented based on the set acceptable range.

Formaldehyde Monitoring of Hygiene Products in Domestic Market (국내 유통 위생용품 중 포름알데히드 잔류량 모니터링)

  • Na, Young-Ran;Kwon, Hyeon-Jeong;Cho, Hyun-Nho;Kim, Hyeon-Jin;Park, Yon-Koung;Park, Sung-Ah;Lee, Seong-Ju;Kang, Jung-Mi
    • Journal of Food Hygiene and Safety
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    • v.35 no.3
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    • pp.225-233
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    • 2020
  • By the standards and specifications for hygiene products, three test methods for formaldehyde are specified for each item type of hygiene product. After derivatization using acetylacetone and 2,4-dinitrophenylhydrazine (2,4-DNPH), formaldehyde is analyzed by spectrophotometer and high-performance liquid chromatography (HPLC). Validation of the three test methods was performed on tissue, diaper lining and waterproof layer, and panty liner products. The results of linearity (R2), limit of detection (LOD), limit of quantification (LOQ), recovery rate (%) and reproducibility (%), showed that all three methods are suitable for analyzing formaldehyde in hygiene products. After derivatization with 2,4-DNPH and cetylacetone, formaldehyde was analyzed at 0, 3, 6, 9, 24 and 48 hours by HPLC. Formaldehyde derivatized with 2,4-DNPH showed no statistically significant change in formaldehyde peak area over time (P>0.05). But, acetylacetone-derivatizated formaldehyde showed a negative correlation coefficient (r) over time (P<0.01). We investigated the residual amounts of formaldehyde in 205 hygiene products distributed in Busan. Among 74 disposable diaper products tested, 73 had low concentrations of formaldehyde (0.13-29.87 mg/kg). Moreover, formaldehyde was not detected in any of 78 tissue, 27 disposable paper towel, 12 disposable dishcloth, 7 paper cup, one brand of paper straw and 6 disposable napkin products.

Effect of Application Level of Swine Slurry on Agronomic Characteristics and Yield of Corn and $NO_3-N$ Content of Corn Field (돈분액비 시용수준이 사료용 옥수수의 생육특성과 수량 및 토양 중 $NO_3-N$ 함량에 미치는 영향)

  • Lim, Young Chul;Yoon, S. H.;Kim, J. G.;Choi, G. J.;Kim, W. H.;Seo, S.;Lee, S. J.;Yook, W. B.
    • Journal of Animal Environmental Science
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    • v.11 no.2
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    • pp.117-124
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    • 2005
  • Livestock manure has been utilized as fertilizer, and trying to make resources natural circulation of organic material. This experiment was conducted to investigate the effect of application level of swine slurry on agronomic characteristics and yield of silage corn and $NO_3-N$ content of soil for three years in the experimental field of Grassland and Forage Crops Division, National Livestock Research Institute. Summary of the results were as follows. The experiment was conducted according to a randomized complete block design. Six treatments were non fertilizer(NF), chemical fertilizer(CF), $100\%$ swine slurry(SS100), $150\%$ swine slurry(SS150), $200\%$ swine slurry(SS200) and mixture fertilizer(MF, $100\%$ swine slurry + $50\%$ chemical fertilizer) with three replications. The application level of swine slurry(SS) $100\%$ was highest in Brix as $8.6^{\circ}$ and stay green was as swine slurry application increased. Deficiency of plant, plant height, ear height and lodging were increased in above $100\%$ swine slurry application level. Dry matter yield was decreased in SS 100 but increased in SS 150 and SS 200. Significant effect was observed for all treatments. The content of $NO_3-N$ in infiltration water was high in above swine slurry nitrogen $150\%$ but that content in run off water was very small. Conclusively, application to swine slurry below $150\%$ would be recommended to produce higher yield and to conserve environment in corn field.

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Comparison of the Efficacy of 2D Dosimetry Systems in the Pre-treatment Verification of IMRT (세기조절방사선치료의 환자별 정도관리를 위한 2차원적 선량계의 유용성 평가)

  • Hong, Chae-Seon;Lim, Jong-Soo;Ju, Sang-Gyu;Shin, Eun-Hyuk;Han, Young-Yih;Ahn, Yong-Chan
    • Radiation Oncology Journal
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    • v.27 no.2
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    • pp.91-102
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    • 2009
  • Purpose: To compare the accuracy and efficacy of EDR2 film, a 2D ionization chamber array (MatriXX) and an amorphous silicon electronic portal imaging device (EPID) in the pre-treatment QA of IMRT. Materials and Methods: Fluence patterns, shaped as a wedge with 10 steps (segments) by a multi-leaf collimator (MLC), of reference and test IMRT fields were measured using EDR2 film, the MatriXX, and EPID. Test fields were designed to simulate leaf positioning errors. The absolute dose at a point in each step of the reference fields was measured in a water phantom with an ionization chamber and was compared to the dose obtained with the use of EDR2 film, the MatriXX and EPID. For qualitative analysis, all measured fluence patterns of both reference and test fields were compared with calculated dose maps from a radiation treatment planning system (Pinnacle, Philips, USA) using profiles and $\gamma$ evaluation with 3%/3 mm and 2%/2 mm criteria. By measurement of the time to perform QA, we compared the workload of EDR2 film, the MatriXX and EPID. Results: The percent absolute dose difference between the measured and ionization chamber dose was within 1% for the EPID, 2% for the MatriXX and 3% for EDR2 film. The percentage of pixels with $\gamma$%>1 for the 3%/3 mm and 2%/2 mm criteria was within 2% for use of both EDR2 film and the EPID. However, differences for the use of the MatriXX were seen with a maximum difference as great as 5.94% with the 2%/2 mm criteria. For the test fields, EDR2 film and EPID could detect leaf-positioning errors on the order of -3 mm and -2 mm, respectively. However it was difficult to differentiate leaf-positioning errors with the MatriXX due to its poor resolution. The approximate time to perform QA was 110 minutes for the use of EDR2 film, 80 minutes for the use of the MatriXX and approximately 55 minutes for the use of the EPID. Conclusion: This study has evaluated the accuracy and efficacy of EDR2 film, the MatriXX and EPID in the pre-treatment verification of IMRT. EDR2 film and the EPID showed better performance for accuracy, while the use of the MatriXX significantly reduced measurement and analysis times. We propose practical and useful methods to establish an effective QA system in a clinical environment.

Assessment of 1,4-Dioxane Removal in Polyester Wastewater by Activated Sludge and Its Microbial Property by 16S rDNA (폴리에스테르 중합폐수의 활성슬러지 공정에서의 1,4-다이옥산 제거 및 16S rDNA에 의한 미생물 군집특성 평가)

  • Han, Ji-Sun;So, Myung-Ho;Kim, Chang-Gyun
    • Journal of Korean Society of Environmental Engineers
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    • v.30 no.4
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    • pp.393-400
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    • 2008
  • 1,4-Dioxane($C_4H_8O_2$), which is used as a solvent stabilizer, could make harmful effects on ecosystem because of its higher solubility, toxicity and carcinogenic by US EPA. From 2011, its discharge limit to waterbody will be regulated at 5 mg/L by Ministry of Environment Republic of Korea. It was thus to investigate that the currently operating activated sludge in polyester manufacturing processes in Gumi can properly treat it to meet with the regulation standard. For that purpose, the removal rate of 1,4-dioxane and its microbial properties were assessed for a few companies(i.e. K, H and T). Its removal efficiency was the most highly recorded in H as 98% and then 77% for K, which met with the regulation standard. However, concentration of 1,4-dioxane of T was 23 mg/L in the effluent, which is more than the regulation standard. Aside from, microbial degradation test was done for 100 ppm of 1,4-dioxane in BSM (Basal salt medium) inoculated with each of activated sludge. After 7 days, 1,4-dioxane was completely removed in the test bottle inoculated with H sludge, 67% in T and 52% in K, which could confirm that the given activated sludge might have different biodegradability against the amount of 1,4-dioxane. Therefore, microbial diversity in each company was investigated by 16s rDNA cloning methods where a species, e.g. Methylibium petroleiphilum PM1, was the greatest observed from H and in lesser from K, but it was not detected from T. Methylibium petroleiphilum PM1 is known to efficiently degrade ether like methyl tertiary-butyl ether(MTBE). It is concluded that the activated sludge in H can be most effectively adopted for a biodegradation of 1,4-dioxane in the concern of industrial sector.

A comparative study of management system of unregulated agricultural pesticides in Korea, the European Union, and the United States of America: a review (비규제 농약 관리를 위한 한국, 유럽, 미국의 농약관리체계 비교분석)

  • Nam, Sun-Hwa;Kwak, Jin Il;Kim, Dasom;An, Youn-Joo
    • Journal of Applied Biological Chemistry
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    • v.61 no.2
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    • pp.195-204
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    • 2018
  • Pesticide residue in the eggs in the market has become a significant problem in Korea. In particular, the detection of fipronil indicated that unregulated pesticide residue can be present in livestock products, including eggs. Institutionally unregulated pesticides are a risk to human health and the ecosystem. In this study, we analyzed the system of agricultural pesticide management in Korea, the European Union, and the United States of America (USA) and discussed the problems of the Korean management system and the possible improvement directions. Based on the analysis, we considered three tasks: registration of pesticides, pesticide residue levels in food, and pesticide residue levels in environmental media. The registration of pesticides was conducted by the Ministry of Agriculture, Food, and Rural Affairs in Korea; the Directorate-General for Health and Food Safety in the European Commission (EC); and the US Environmental Protection Agency (USEPA) in the USA. The work regarding pesticide residue levels in food was conducted by the Ministry of Food and Drug Safety in Korea, the Directorate-General for the Health and Food Safety in the EC, and the USEPA and Food and Drug Administration in the USA. The work regarding pesticide residue levels in environmental media was conducted by the Ministry of Environment in Korea, the Directorate-General for Environment in the EC, and the USEPA in the USA. Therefore, Korea should review the extension of pesticide residue standards in the environmental media for strengthening the system of management of unregulated agricultural pesticides.

Monitoring of Patulin levels in Fruit Juices and Beverages (과실쥬스 및 음료에서 파튤린 오염실태 조사)

  • Eom, Joon-Ho;Byun, Jung-A;Park, You-Gyoung;Seo, Eun-Chae;Lee, Eun-Mi;Kim, Mi-Ra;Sun, Nam-Kyu;Kim, Chang-Soo;Jung, Woo-Young;Jung, Rae-Seok;Na, Mi-Ae;Lee, Jin-Ha
    • Journal of Food Hygiene and Safety
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    • v.24 no.1
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    • pp.56-62
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    • 2009
  • Patulin, a mycotoxin mainly produced by Penicillium and Aspergillus, is found in various foods. In the present, a maximum acceptable level for patulin is established at $50{\mu}g/kg(ppb)$ in apple juices and apple concentrates in Korea. But patulin may be detected in foods produced with other fruits. In the present study, patulin contamination was analyzed in 520 samples of fruit juices and beverages, and 50 samples of fruit juice concentrates. High performance liquid chromatography(HPLC) was applied to quantitatively analyze patulin levels in samples and liquid chromatography-mass spectrometry(LC/MS/MS) was used to remove false positive results. The results showed that three samples of 520 fruit juices and beverages and five samples of 50 fruit juice concentrates were contaminated by patulin, $9.8-18.0{\mu}g/kg$ and $4.7-18.2{\mu}g/kg$ respectively. Contaminated samples were produced with apple, orange or pear. This indicates that it is necessary to extend the regulatory range of patulin. In the other hands, the present study confirmed the effectiveness of LC/MS/MS analytical method to remove false positive results.

Long-term monitoring of heavy metal contents in paddy soils (논토양 중금속 함량의 장기변동 모니터링)

  • Kim, W.I.;Kim, M.S.;Roh, K.A.;Lee, J.S.;Yun, S.G.;Park, B.J.;Jung, G.B.;Kang, C.S.;Cho, K.R.;Ahn, M.S.;Choi, S.C.;Kim, H.J.;Kim, Y.S.;Nam, Y.K.;Choi, M.T.;Moon, Y.H.;Ahn, B.K.;Kim, H.K.;Kim, H.W.;Seo, Y.J.;Kim, J.S.;Choi, Y.J.;Lee, Y.H.;Lee, S.C.;Hwang, J.J.
    • Korean Journal of Soil Science and Fertilizer
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    • v.41 no.3
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    • pp.190-198
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    • 2008
  • There is an increasing concern over heavy metal contamination of paddy soils and the subsequent translocation of heavy metals to rice. Objective is to monitor the status and long-term trend of heavy metal contamination in paddy soils, periodically. In 2007 survey, the average concentrations of As(arsenic), Cd(cadmium), Cu(copper), Ni(nickel), Pb(lead), and Zn(zinc) in 2,010 paddy soils nationwide were 0.87, 0.08, 3.33, 1.19, 4.95 and $4.67mg\;kg^{-1}$, respectively. Few sites, which were contaminated by As in 2003 and 2007 survey and by Ni in 1999 and 2007 survey, were over the threshold level for soil contamination designated by the Soil Environmental Conservation Act in Korea. Long-term change was shown that As, Ni, and Zn were gradually increased whereas Cd and Cu were decreased. In the distribution of extractable heavy metal contents, the modes of each heavy metal content were similar with the average contents of each heavy metals. Mean value of heavy metals except copper in paddy soils was higher than median value. It means that the downward distribution of heavy metal content in paddy rice was shown against normal distribution.

An Assessment of Environmental Carrying Capacity by Analyzing the Emission and Concentration of Urban Atmospheric Pollutants (대기오염을 고려한 도시의 환경적 수용력 산정 연구)

  • Lee, Kwang-Ho;Jeong, Yeun-Woo
    • Land and Housing Review
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    • v.2 no.4
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    • pp.517-528
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    • 2011
  • Indiscreet developments cause environmental problems in major cities of Seoul Metropolitan Area. Among the environmental problems, the air pollution leads the citizens' physical and economic damages. Therefore, it needs to predict how much air pollutant which is emitted from human activities can be carried by urban environment, then to examine the reasonable level of urban development This study assumed that the air pollution is represented differently by the amount of emission. With the assumption, the acceptable air pollutant emission which keeps the air quality under the environmental standard is estimated, then the proper population is calculated in the case of Gwacheon, Gyeonggi. The result is as follow: First, air pollution concentrations of CO, $NO_2$, $SO_2$ which are estimated by using IDW interpolation of GIS don't excess the air environmental standard. Second, the result of correlation analysis between air pollutant emission and air pollution concentration shows that CO and $NO_2$ has high correlationship with total source of pollution and linear source of pollution, and $SO_2$ with linear source of pollution. Third, the results of regression analysis show that the acceptable population is bigger that the real population in the case of CO, and with the estimation of $NO_2$ and $SO_2$, the current population in the urban center and boundaries where the residential and commerce land uses are concentrated is bigger than the acceptable population. The consequence of this study is that the estimation of carrying capacity can suggest the acceptable human activities which keep the air quality under the environmental standard. This can leads the sustainable urban development by control the human activities under the carrying capacity of urban environment.

Standards of Due Diligence and Separation of Responsibilities in the Division of Labor in Medicine (분업적 의료행위에 있어서 주의의무위반 판단기준과 그 제한규칙들)

  • Choi, Hojin
    • The Korean Society of Law and Medicine
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    • v.19 no.2
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    • pp.41-72
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    • 2018
  • In the division of labor (or teamwork) in medicine, the responsibility of medical and nursing staff should be separated or distributed to justify negligent criminal offenses. The present work refers to the standards by which the due diligence and responsibility of the individual persons are to be determined and delimited. In this context, it has been proven that objective theory as a measure of due diligence is appropriate. From a moral point of view, when assessing due diligence, it makes sense to impose greater individual or higher performance demands on the perpetrator, but law and order require that due diligence should result from socially relevant human behavior. To give objective measure of negligence and to provide the highest level of personal responsibility, so that man can not be burdened too much responsibility and it is accordingly with an equality theorem. Afterwards some points are presented, which should be considered in a concrete fact in the determination of the medical negligence. Medical action has specific characteristics such as professionalism, discretionary and exclusive, unbalance of information. These characteristics distinguish medical actions from general negligence. The general level of knowledge, the urgency, working condition and working environment of the medical facility, duration of the professional practice, assessment of the medical activity are crucial in this context. As a standard of delineation of due diligence, I have used the permitted risk and the principle of trust. In the horizontal division of labor, the principle of trust applies. The principle of trust applies in principle in cases of division of labor interaction, when doctors in the same hospital exercise their own specific occupational field or everyone works in another hospital. However, this is not true for every case. In the vertical division of labor, the principle of trust does not apply and the senior physician can not trust the assistant doctors. In this case, the principle of trust is converted into a duty of supervision for assistant doctors by the senior physician. This supervision requirement could be used as a random check.