• Title/Summary/Keyword: standard operating procedure

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Clinical Microscopy: Performance, Maintenance and Laser Safety (임상에서의 현미경: 작동, 유지보수 및 레이저 안전)

  • Lee, Tae Bok
    • Korean Journal of Clinical Laboratory Science
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    • v.51 no.2
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    • pp.125-133
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    • 2019
  • A microscope is the fundamental research and diagnostic apparatus for clinical investigation of signaling transduction, morphological changes and physiological tracking of cells and intact tissues from patients in the biomedical laboratory science. Proper use, care and maintenance of microscope with comprehensive understanding in mechanism are fully requested for reliable image data and accurate interpretation for diagnosis in the clinical laboratory. The standard operating procedure (SOP) for light microscopes includes performance procedure, brief information of all mechanical parts of microscopes with systematic troubleshooting mechanism depending on the laboratory capacity. Maintenance program encompasses cleaning objective, ocular lenses and inner optics; replacement and calibration of light source; XY sample stage management; point spread function (PSF) measurement for confocal laser scanning microscope (CLSM); quality control (QC) program in fluorescent microscopy; and systematic troubleshooting. Laser safety is one of the concern for medical technologists engaged in CLSM laboratory. Laser safety guideline based on the laser classification and risk level, and advisory lab wear for CLSM users are also expatiated in this overview. Since acquired image data presents a wide range of information at the moment of acquisition, well-maintained microscopes with proper microscopic maintenance program are impulsive for its interpretation and diagnosis in the clinical laboratory.

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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Estimation of Exhaust NOx Emission for Marine Engines (선박엔진의 NOx 배출량 산정)

  • 김대식;엄명도
    • Journal of Advanced Marine Engineering and Technology
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    • v.24 no.4
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    • pp.441-445
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    • 2000
  • Considering international status of our country as world class ship builder and geographical characteristics encircled by sea in three facets, controlling of air pollutants emission from marine engines becomes more and more important issue in recent days. Implementation of immediate pollutants emission control regulation and standardization of test and certification procedure are required to reduce air pollution from marine engines. But cost increments due to additional equipment of emission control device and development and certification test expenses as well as depreciation of fuel economy should be considered. To satisfy those air pollution reduction and economic requirements, we should make our own interpretation of IMO standard and implementation schedule depending on our country's status. For this purpose we measured NOx emission from small and middle class marine engines to calculate emission factor and total pollutant emission in our country. With the comparison and analysis of other countries emission control regulation we proposed basic data of total emission from marine engine and future emission control standard in our country. According to our estimation, 62% of total NOx emission of marine engines comes from fishing boat and 38% from commercial vessels. The portion of NOx emission from marine engine is 18.6% of whole country NOx emission. Due to the voyage characteristics of middle and large vessel and necessity of international harmonization of marine engine pollutants emission control standard, it is inevitable to adopt IMO standard for middle and large marine engines. But considering technological and cost effect of fishing boat operating in near sea, it is resonable to set a standard within 80% of measured value at the moment and gradually implement the same IMO standard in near future.

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Development and Validation of Crocidolite Quality Control Samples for Proficiency Analytical Testing (청석면 분석 정도관리용 표준시료 개발 및 평가)

  • Lee, Ji-Hyun;Kim, Eun-Young;Noh, Su-Jin;Park, Yong-Jin;Jeong, Jee-Yeon
    • Journal of Environmental Health Sciences
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    • v.37 no.1
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    • pp.57-63
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    • 2011
  • Crocidolite quality control (QC) sampling created by the wet generation method has been validated by validation tests such as the accuracy, precision, and storage tests. For this study we designed and developed a manufacturing apparatus and standard operating procedure for making these QC samples. The most important step in the procedure of making QC samples was the stage eliminating static electricity in asbestos fibers. This static electricity hampers the fibers clog functioning. In accuracy and precision tests by phase contrast microscopy analysis, the difference between the reference values and the studied values was at maximum 17.8%. This satisfies the AIHA proficiency analytical test criteria for asbestos. We could confirm the nearly even distribution of crocidolite fibers on the membrane filter. Also, there was no loss of fibers in the storage test after the one month.

Fire Hazard Analysis and Performance Based Fire safety Design for the Clean Room in Semiconductor Factory (반도체공장 Clean Room에 대한 화재요인 분석 및 성능위주 화재안전설계)

  • Han, Su-Jin;Kang, Kyung-Sik
    • Proceedings of the Safety Management and Science Conference
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    • 2006.11a
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    • pp.325-336
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    • 2006
  • This research analyzes clean room major fire prevention standard of clean Room (FM, IRI, and NFPA Code), the structure of Performance-Based Fire Safety Design (PBD) applied the korean fire industry situation. Performance-Based Fire Safety can operate effectively the performance of fire protection equipment & building design, so the fitness of fire safety system can be embodied by operating this. moreover, cost to be consume fire safety of real building can reduce and Performance-Based Fire Safety is considered to important technique in fire protection field. A fire in a clean room may cause a serious loss by spreading smoke particles. We will be investigated by using a computational fluid dynamics, for loss prevention by smoke spreading from one fire area to another for clean room and compared the Performance-Based Fire Safety Design with the prescriptive code design. The methodology of fire safety performance-based fire safety design and guarantee of many kinds design skill of fire system and developing design procedure will be very serious one in order to improve efficiency of domestic system. Therefore, This research will be contributing to secure safety of clean room and to set up the performance-based fire safety design in Korea by regulation for the performance-based fire safety design effectively.

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Fire Hazard Analysis and Performance Based Fire safety Design for the Clean Room in Semiconductor factory(1) (반도체공장 Clean Room에 대한 화재요인 분석 및 성능위주 화재안전설계(1))

  • Han, Su-Jin;Kang, Kyung-Sik
    • Journal of the Korea Safety Management & Science
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    • v.8 no.5
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    • pp.211-229
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    • 2006
  • This research analyzes clean room major fire prevention standard of clean Room(FM, IRI, and NFPA Code), the structure of Performance-Based Fire Safety Design(PBD) applied the korean fire industry situation. Performance-Based Fire Safety can operate effectively the performance of fire protection equipment & building design, so the fitness of fire safety system can be embodied by operating this. moreover, cost to be consume fire safety of real building can reduce and Performance-Based Fire Safety is considered to important technique in fire protection field. A fire in a clean room may cause a serious loss by spreading smoke particles. We will be investigated by using a computational fluid dynamics, for loss prevention by smoke spreading from one fire area to another for clean room and compared the Performance-Based Fire Safety Design with the prescriptive code design. The methodology of fire safety performance-based fire safety design and guarantee of many kinds design skill of fire system and developing design procedure will be very serious one in order to improve efficiency of domestic system. Therefore, This research will be contributing to secure safety of clean room and to set up the performance-based fire safety design in Korea by regulation for the performance-based fire safety design effectively.

Advanced Indentation Studies on the Effects of Hydrogen Attack on Tensile Property Degradation of Heat-Resistant Steel Heat-Affected Zones

  • Choi, Yeol;Jang, Jae-il;Lee, Yun-Hee;Kwon, Dongil;Kim, Jeong-Tae
    • Corrosion Science and Technology
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    • v.2 no.6
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    • pp.266-271
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    • 2003
  • Safety diagnosis of various structural components and facilities is indispensable for preventing catastrophic failure of material by time-dependent and environment accelerating degradation. Also, this diagnosis of operating components should be done periodically for safe maintenance and economical repair. However, conventional standard methods for mechanical properties have the problems of bulky specimen, destructive procedure and complex procedure of specimen sampling. So, a non-destructive and simple mechanical testing method using small specimen is needed. Therefore, an advanced indentation technique was developed as a potential method for non-destructive testing of in-field structures. This technique measures indentation load-depth curve during indentation and analyzes the mechanical properties related to deformation such as yield strength, tensile strength and work-hardening index. In this paper, we characterized the tensile properties including yield and tensile strengths of the V-modified Cr-Mo steels in petro-chemical and thermo-electrical plants. And also, the effects of hydrogen-assisted degradation of the V-modified Cr-Mo steels were analyzed in terms of work-hardening index and yield ratio.

Role of Endoscopic Ultrasound-Guided Fine-Needle Aspiration in the Evaluation of Abdominal Lymphadenopathy of Unknown Etiology

  • Nonthalee Pausawasdi;Kotchakon Maipang;Tassanee Sriprayoon;Phunchai Charatcharoenwitthaya
    • Clinical Endoscopy
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    • v.55 no.2
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    • pp.279-286
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    • 2022
  • Background/Aims: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a standard procedure for obtaining tissue from lesions near the gastrointestinal lumen. However, there is a scarcity of information on the diagnostic performance of EUS-FNA for abdominal lymphadenopathy of unknown causes. To assess the accuracy of EUS-FNA in diagnosing abdominal lymphadenopathy of unknown etiology. Methods: The EUS records of patients with undiagnosed abdominal lymphadenopathy between 2010 and 2015 were reviewed. Results: A total of 42 patients were included in this study. Adequate specimens were obtained from 40 patients (95%). The final diagnoses were metastatic cancer (n=16), lymphoma (n=9), tuberculosis (n=8), inflammatory changes (n=6), and amyloidosis (n=1). For diagnosing malignancy, EUS-FNA had a sensitivity of 84.6%, specificity of 95.7%, positive predictive value of 91.7%, negative predictive value of 91.7%, and area under the receiver operating characteristic curve (AUROC) of 0.901. For the diagnosis of lymphoma, EUS-FNA was 100% accurate when combined with cytologic evaluation and immunohistochemical staining. The diagnostic sensitivity decreased to 75%, whereas the specificity remained 100%, for tuberculosis. The overall AUROC was 0.850. No procedure-related complications occurred. Conclusions: EUS-FNA showed high diagnostic performance for abdominal lymphadenopathy of unknown causes, especially malignancy, lymphoma, and tuberculosis. Therefore, it is a crucial diagnostic tool for this patient population.

Modeling and Performance Analysis of MAC Protocol for WBAN with Finite Buffer

  • Shu, Minglei;Yuan, Dongfeng;Chen, Changfang;Wang, Yinglong;Zhang, Chongqing
    • KSII Transactions on Internet and Information Systems (TIIS)
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    • v.9 no.11
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    • pp.4436-4452
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    • 2015
  • The IEEE 802.15.6 standard is introduced to satisfy all the requirements for monitoring systems operating in, on, or around the human body. In this paper, analytical models are developed for evaluating the performance of the IEEE 802.15.6 CSMA/CA-based medium access control protocol for wireless body area networks (WBAN) under unsaturation condition. We employ a three-dimensional Markov chain to model the backoff procedure, and an M/G/1/K queuing system to describe the packet queues in the buffer. The throughput and delay performances of WBAN operating in the beacon mode are analyzed in heterogeneous network comprised of different user priorities. Simulation results are included to demonstrate the accuracy of the proposed analytical model.

Posterior Microscopic Lesionectomy for Lumbar Disc Herniation with Tubular Retraction Using $METRx^{TM}$ System

  • Choi, Yu-Yeol;Yoon, Seung-Hwan;Ha, Yoon;Kim, Eun-Young;Park, Hyung-Chun;Park, Chong-Oon
    • Journal of Korean Neurosurgical Society
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    • v.40 no.6
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    • pp.406-411
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    • 2006
  • Objective : The authors have developed a procedure, termed posterior microscopic lesionectomy, that creates a minimal laminotomy site according to the location of the shifted disc using the $METRx^{TM}$ system in the lumbar spine. This study compared the usefulness and surgical outcomes of this procedure with those of traditional standard lumbar discectomy. Methods : From June 2003 to June 2004, Twenty-two patients with one-level radiculopathy due to lumbar disc herniation underwent posterior microscopic lesionectomy with the assistance of an operating microscope and the $METRx^{TM}$ tubular retractor. Surgical results of the new procedure were compared to those of 39 patients who underwent traditional lumbar discectomy from April 2003 to September 2004. All patients were evaluated for pain score, clinical assessment according to the VAS, and Roland-Morris scores pre-operatively and at 1, 3, 6, and 12 months post-operatively. Results : Mean blood loss, operation time, and admission date showed significant improvements for microscopic lesionectomy compared to traditional lumbar discectomy [P < 0.001]. Also, both measures of short-term functional improvement, the Visual Analogue Scale[VAS] and Roland-Morris[RM] scores, were statistically better for microscopic lesionectomy than for traditional discectomy [P < 0.001]. Conclusion : Posterior microscopic lesionectomy can be performed more safely and provide greater benefit than traditional discectomy. The procedure is associated with less post-operative pain, shorter hospital stays, and quicker rehabilitation.