약물검사에서 관리시료의 농축을 이용한 보고 가능 범위의 설정에 대한 연구 (A Study of Reportable Range Setting through Concentrated Control Sample)
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- 대한임상검사과학회지
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- 제36권1호
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- pp.13-18
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- 2004
This study was designed to establish working range for reoportable range in own laboratory in order to cover the upper and lower limits of the range in test method. We experimented ten times during 10 days for setting of reportable range with between run for method evaluation. It is generally assumed that the analytical method produces a linear response and that the test results between those upper and lower limits are then reportable. CLIA recommends that laboratories verify the reportable range of all moderate and high complexity tests. The Clinical Laboratory Improvement Amendments(CLIA) and Laboratory Accreditation Program of the Korean Society for Laboratory Medicine states reportable range is only required for "modified" moderately complex tests. Linearity requirements have been eliminated from the CLIA regulations and from others accreditation agencies, many inspectors continue to feel that linearity studies are a part of good lab practice and should be encouraged. It is important to assess the useful reportable range of a laboratory method, i.e., the lowest and highest test results that are reliable and can be reported. Manufacturers make claims for the reportable range of their methods by stating the upper and lower limits of the range. Instrument manufacturers state an operating range and a reportable range. The commercial linearity material can be used to verify this range, if it adequately covers the stated linear interval. CLIA requirements for quality control, must demonstrate that, prior to reporting patient test results, it can obtain the performance specifications for accuracy, precision, and reportable range of patient test results, comparable to those established by the manufacturer. If applicable, the laboratory must also verify the reportable range of patient test results. The reportable range of patient test results is the range of test result values over which the laboratory can establish or verify the accuracy of the instrument, kit or test system measurement response. We need to define the usable reportable range of the method so that the experiments can be properly planned and valid data can be collected. The reportable range is usually defined as the range where the analytical response of the method is linear with respect to the concentration of the analyte being measured. In conclusion, experimental results on reportable range using concentrated control sample and zero calibrators covering from highest to lowest range were salicylate
이 연구는 '13년 국가직무능력표준 개발 매뉴얼과 국가직무능력표준 개정 분류체 계표에 근거하여 카지노운영관리 직무에 대한 국가직무능력표준(NCS)을 개발한 것이다. 연구 방법은 단계별 연구 범위와 직무분석기법인 데이컴(DACUM) 절차에 의하여 국가직무능력표준 개발전문가인 산업현장전문가, 교육훈련전문가, 자격(직무분 석)전문가, 퍼실리테이터 및 실무 검증위원인 워킹그룹과 함께 총 10차례 검토 협의 수정 보완 보고 절차 단계를 거쳐 카지노운영관리 직무의 국가직무능력표준을 개발 하였다. 이 연구의 주요 개발 결과는 다음과 같다. 첫째, 국가직무능력표준 개정 분류체계 표에 근거하여 카지노운영 직무 선정과 직무를 정의하였고 직무를 토대로 총 8개의 능력단위를 도출 개발하였다. 둘째, 개발한 능력단위를 근거로 총 27개의 능력단위별 능력단위요소를 도출 개발하였다. 셋째, 국가직무능력표준 수준 및 개정 분류체계표에 근거하여 능력단위요소별 수준 체계를 개발하였고 이들 능력단위요소별 수준 평정값을 이용하여 상위 영역인 능력단위별 수준 체계를 합의 도출하였다. 이에 카지노운영관리 직무에 관한 능력단위 및 능력단위요소에 따른 국가직무능력표준 (NCS)의 개발 지침에 근거하여 카지노운영관리 직무에 관한 국가직무능력표준(NCS)의 분류번호를 제시하였다. 넷째, 능력단위 범위를 기준으로 총 27개의 해당 능력단위요소별 수행준거와 지식 기술 태도를 도출 개발하였다. 다섯째, 카지노운영관리 직무에 기초한 총 8개의 해당 능력단위에 근거하여 적용 범위 및 작업 상황, 평가 지 침, 직업기초능력 등을 협의 도출 개발하였다.
Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.
The records system is believed to have started in Italy in the 14th century in line with trade developments in Europe. In 1491, Luca Pacioli, a mathematician, and an Italian Franciscan monk wrote the first book that described double-entry accounting processes. In many countries, including Korea, the government accounting standards used single-entry bookkeeping rather than double-entry bookkeeping that can be aggregated by account subject. The cash-based and single-entry bookkeeping used by the government in the past had limitations in providing clear information on financial status and establishing a performance-oriented financial management system. Accordingly, the National Accounting Act (promulgated in October 2007) stipulated the introduction of double-entry bookkeeping and accrual accounting systems in the government sector from January 1, 2009. Furthermore, the Korean government has also introduced International Financial Reporting Standards (IFRS), and the System of National Accounts (SNA). Since 2014, Korea owned five national accounts. In Korea, valuation began with the 1968 National Wealth Statistics Survey. The academic origins of the valuation of national wealth statistics which had been investigated by due diligence every 10 years since 1968 are based on the 'Engineering Valuation' of professor Marston in the Department of Industrial Engineering at Iowa State University in the 1930s. This field has spread to economics, etc. In economics, it became the basis of capital stock estimation for positive economics such as econometrics. The valuation by the National Wealth Statistics Survey contributed greatly to converting the book value of accounting data into vintage data. And in 2000 National Statistical Office collected actual disposal data for the 1-digit asset class and obtained the ASL(average service life) by Iowa curve. Then, with the data on fixed capital formation centered on the National B/S Team of the Bank of Korea, the national wealth statistics were prepared by the Permanent Inventory Method(PIM). The asset classification was also classified into 59 types, including 2 types of residential buildings, 4 types of non-residential buildings, 14 types of structures, 9 types of transportation equipment, 28 types of machinery, and 2 types of intangible fixed assets. Tables of useful lives of tangible fixed assets published by the Korea Appraisal Board in 1999 and 2013 were made by the Iowa curve method. In Korea, the Iowa curve method has been adopted as a method of ASL estimation. There are three types of the Iowa curve method. The retirement rate method of the three types is the best because it is based on the collection and compilation of the data of all properties in service during a period of recent years, both properties retired and that are still in service. We hope the retirement rate method instead of the individual unit method is used in the estimation of ASL. Recently Korean government's accounting system has been developed. When revenue expenditure and capital expenditure were mixed in the past single-entry bookkeeping we would like to suggest that BOK and National Statistical Office have accumulated knowledge of a rational difference between revenue expenditure and capital expenditure. In particular, it is important when it is estimated capital stock by PIM. Korea also needs an empirical study on economic depreciation like Hulten & Wykoff Catalog A of the US BEA.
몰입은 관람객이 콘텐츠를 관람할 때 관람객들이 콘텐츠에 몰두하고 있는 심리적 상태를 의미하는 것으로, 관람객의 몰입경험은 콘텐츠의 만족도에 긍정적인 영향을 미친다. 따라서 공연 같은 콘텐츠를 제공하는 기업들은 콘텐츠의 흥행을 위해 관람객의 몰입도를 측정하는 것은 매우 중요하다. 설문 등의 표본조사 방법을 통해 관람객의 몰입도를 측정 연구는 방송분야 등 에서 널리 사용되고 있다. 이러한 몰입도 측정방법은 콘텐츠 관람 이후 설문을 실시하기 때문에 몰입도를 실시간으로 측정할 수 없을 뿐만 아니라 몰입도 측정의 정확성이 저하되는 문제 등이 있다. 이러한 문제를 해결하기 위하여 생리적 반응이나 얼굴 표정 분석, 그리고 움직임 관찰 방법 등을 이용하여 몰입도를 측정하는 연구가 수행되고 있다. 생체 신호를 이용하여 몰입도를 측정하는 연구의 경우, 1인을 대상으로 생체신호를 측정할 뿐만 아니라, 많은 데이터 처리 시간과 비용이 소모되는 단점이 있어 많은 관람객이 관람하는 공연장에 적용하기에는 한계가 있다. 얼굴 표정인식 통해 몰입도를 측정하는 경우도 1인을 대상으로 하고 있으며, 밝은 조명의 실험실 환경에서만 가능하다는 단점이 존재한다. 또한 관람객들의 움직인 동기화를 이용하여 몰입도를 특정한 연구는 다중관객을 대상으로 하였지만, 이는 실험실 환경에 한정하여 적용된 사례이다. 따라서 본 연구에서는 공연장, 시사회관 등 많은 관람객들이 콘텐츠를 관람하는 실제 환경에서 다중관람객이 다중몰입도의 정량적 평가를 위한 시스템을 설계하고 개발하였다. 제안된 시스템은 외부장치, 서버, 내부장치 등의 3부분으로 구성되어 있다. 서울시 마포구 상암동에 위치한 DMC 홍보관에 상설 전시장으로 운영하고 있으며, 관람객들을 대상으로 데이터를 획득하고 있다. 제안하고 있는 시스템을 활용하면 콘텐츠의 어느 구간에서 관객들이 몰입을 하고 있는지, 어느 구간에서 몰입을 하고 있지 못한지 분석가능하기 때문에, 향후 콘텐츠 제작 및 마케팅에 유용하게 활용할 수 있을 것으로 기대된다.
1974년(年) 천연(天然)소나무집단(集團)에 대한 유전적변이(遺傳的變異)를 분석(分析)하고져 먼저 경북(慶北) 청송군(靑松郡) 소재(所在) 주왕산(周王山)소나무림(林), 충남(忠南) 서산군(瑞山郡) 소재(所在) 안면도(安眠島) 소나무림(林), 그리고 강원도(江原道) 평창군(平昌郡) 소재(所在) 소나무림(林)을 대상(對象)으로하여 각(各) 집단(集團)에서 되도록 소면적(小面積)의 범위내(範圍內)에 서있는 소나무 개체(個體)를 각(各) 20주(株)씩 총 60주(株)를 택(擇)하여 그 모수(母樹)에 대한 형태학적(形態學的) 특성(特性)등을 조사측정(調査測定)하고 집단간(集團間)에 보이는 차이(差異) 그리고 한 집단내(集團內)에 있는 각개체수목(各個體樹木)의 형질(形質)을 조사보고(調査報告)한바 있다(제일보고문(第一報論文). 1974년(年) 가을에 가계별(家系別)로 종자(種字)을 채취(採取)하여서 가계별(家系別) 및 산지별(産地別)의 차이(差異)를 분석(分析)하고 동시(同時)에 그 종자(種字)를 파종하여서 1-0묘(苗) 및 1-1묘(苗)를 대상(對象)으로 생장인자(生長因子)에 대한 측정(測定)을 하고 그 유전력(遺傳力)을 계산(計算)해 보았다. 그밖에 엽록소함량(葉綠素含量) 또는 monoterpene등의 함량(含量)의 차이(差異)를 분석(分析)해 보았다. 종자(種字)의 형태학적(形態學的) 특성(特性)에 있어서는 집단간(集團間) 또 가계간(家系間)에 유의차(有意差)를 보이지 않는 것도 있었으나 대체(大體)로 유의차(有意差)가 인정(認定)되었다. 그리고 각형질간(各形質間)의 상관(相關)을 보았는데 구과폭(毬果幅)과 종자익(種字翼)의 폭(幅), 구과장(毬果長)과 종자익(種字翼)의 길이간(間), 그리고 구과(毬果) 생중량(生重量)과 종자중량간(種字重量間)에는 정(正)의 상관(相關)이 보였다. 묘고(苗高)와 근원경(根元徑)의 성장(成長)에 있어서는 가계간(家系間) 그리고 집단간(集團間)에 차이(差異)가 인정되었다. 묘고(苗高)의 유전력(遺傳力)은 집단(集團)의 평균치(平均値)를 가지고 분석(分析)하였다. 즉 집단(集團)에 관계(關係)되는 분산(分散)을 유전분산(遺傳分散)으로 보고서 유전력(遺傳力)을 계산(計算)해 보았는데 1-0묘(苗)의 묘고(苗高)에서는 0.29, 1-1묘(苗)에서는 0.14가 그리고 근원경(根元徑)에 있어서는 1-0묘(苗)는 0.15, 1-1묘(苗)에서는 0.06이였다. 기공열수(氣孔列數)에 있어서는 집단간차이(集團間差異)가 있었으나 거치밀도(鋸齒密度)에는 차이(差異)가 없었다. 침엽(針葉)의 특성(特性)에 관(關)해서는 모수(母樹)와 차대간(次代間)에 상관(相關)이 없었다. 엽록소함량(葉綠素含量)은 집단간차이(集團間差異)는 보였으나 가계간차이(家系間差異)는 없었다. monoterpene의 성분(成分)에 있어서는 myrcene과
The wall shear stress in the vicinity of end-to end anastomoses under steady flow conditions was measured using a flush-mounted hot-film anemometer(FMHFA) probe. The experimental measurements were in good agreement with numerical results except in flow with low Reynolds numbers. The wall shear stress increased proximal to the anastomosis in flow from the Penrose tubing (simulating an artery) to the PTFE: graft. In flow from the PTFE graft to the Penrose tubing, low wall shear stress was observed distal to the anastomosis. Abnormal distributions of wall shear stress in the vicinity of the anastomosis, resulting from the compliance mismatch between the graft and the host artery, might be an important factor of ANFH formation and the graft failure. The present study suggests a correlation between regions of the low wall shear stress and the development of anastomotic neointimal fibrous hyperplasia(ANPH) in end-to-end anastomoses. 30523 T00401030523 ^x Air pressure decay(APD) rate and ultrafiltration rate(UFR) tests were performed on new and saline rinsed dialyzers as well as those roused in patients several times. C-DAK 4000 (Cordis Dow) and CF IS-11 (Baxter Travenol) reused dialyzers obtained from the dialysis clinic were used in the present study. The new dialyzers exhibited a relatively flat APD, whereas saline rinsed and reused dialyzers showed considerable amount of decay. C-DAH dialyzers had a larger APD(11.70
The wall shear stress in the vicinity of end-to end anastomoses under steady flow conditions was measured using a flush-mounted hot-film anemometer(FMHFA) probe. The experimental measurements were in good agreement with numerical results except in flow with low Reynolds numbers. The wall shear stress increased proximal to the anastomosis in flow from the Penrose tubing (simulating an artery) to the PTFE: graft. In flow from the PTFE graft to the Penrose tubing, low wall shear stress was observed distal to the anastomosis. Abnormal distributions of wall shear stress in the vicinity of the anastomosis, resulting from the compliance mismatch between the graft and the host artery, might be an important factor of ANFH formation and the graft failure. The present study suggests a correlation between regions of the low wall shear stress and the development of anastomotic neointimal fibrous hyperplasia(ANPH) in end-to-end anastomoses. 30523 T00401030523 ^x Air pressure decay(APD) rate and ultrafiltration rate(UFR) tests were performed on new and saline rinsed dialyzers as well as those roused in patients several times. C-DAK 4000 (Cordis Dow) and CF IS-11 (Baxter Travenol) reused dialyzers obtained from the dialysis clinic were used in the present study. The new dialyzers exhibited a relatively flat APD, whereas saline rinsed and reused dialyzers showed considerable amount of decay. C-DAH dialyzers had a larger APD(11.70