• 의료법학
• /
• 제9권2호
• /
• pp.209-229
• /
• 2008

When we are totalizing the lawsrelated to the medical, as the Laboratory medical testing is a kind of the medical act, it is the regulation that the medical technologist can analyze the specimen using in vitro diagnostic devices and diagnosticdrugs under the guidance of doctor or dentist from a corresponding medical institution and can report through verification and interpretation. However, in real medical fields, 'the guidance of doctor' is seriously in-sufficient or even the person who is not the medical technologist is executing. Furthermore the cases that produce inspection results with devices or reagents which are not validated nor approved have been frequently occurred. The result of Laboratory medical testing derived from this procedure can become the important information for the disease control of a country, and also can be decisive to the definite diagnosis and the prognostic monitoring about the patient disease. In spite of its significant medical act to be applicable to an unique proof with the related expert appraisal result in the medical mal-practice lawsuit, our reality in which the quality control is not properly working due by the costs and the labor shortage related to the Laboratory medical testing is quietly in bad condition. Even from now, the government should recognize the significance of the Laboratory medical testing and must achieve more strict administrative management as well as the law maintenance.

• 한국신뢰성학회지:신뢰성응용연구
• /
• 제16권3호
• /
• pp.216-223
• /
• 2016

Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.

• Annals of Laboratory Medicine
• /
• 제38권6호
• /
• pp.585-590
• /
• 2018

Background: Although testing to detect weak D antigens using the antihuman globulin reagent is not required for D- patients in many countries, it is routinely performed in Korea. However, weak D testing can be omitted in D- patients with a C-E- phenotype as this indicates complete deletion of the RHD gene, except in rare cases. We designed a new algorithm for weak D testing, which consisted of RhCE phenotyping followed by weak D testing in C+ or E+ samples, and compared it with the current algorithm with respect to time and cost-effectiveness. Methods: In this retrospective study, 74,889 test results from January to July 2017 in a tertiary hospital in Korea were analyzed. Agreement between the current and proposed algorithms was evaluated, and total number of tests, time required for testing, and test costs were compared. With both algorithms, RHD genotyping was conducted for samples that were C+ or E+ and negative for weak D testing. Results: The algorithms showed perfect agreement (agreement=100%; ${\kappa}=1.00$). By applying the proposed algorithm, 29.56% (115/389 tests/yr) of tests could be omitted, time required for testing could be reduced by 36% (8,672/24,084 min/yr), and the test cost could be reduced by 16.53% (536.11/3,241.08 USD/yr). Conclusions: Our algorithm omitting weak D testing in D- patients with C-E- phenotype may be a cost-effective testing strategy in Korea.

• 대한유전성대사질환학회지
• /
• 제5권1호
• /
• pp.108-115
• /
• 2005

Inherited metabolic diseases (IMD) comprise a large class of genetic diseases involving disorders of metabolism. The majorities are due to defects of single genes that code for enzymes that facilitate conversion of various substances into others. Because of the multiplicity of conditions, many different diagnostic tests are used for screening of IMD. Molecular genetic diagnosis is the detection of pathogenic mutations in DNA and/or RNA samples and is becoming a much more common practice in medicine today. The purpose of molecular genetic testing in IMD includes diagnostic testing, pre-symptomatic testing, carrier screening, prenatal diagnosis, preimplantation testing, and population screening. However, because of the complexity, difficulty in interpreting the result, and the ethical considerations, an understanding of technical, conceptual, and practical aspects of molecular genetic diagnosis is mandatory.

• Genomics & Informatics
• /
• 제17권3호
• /
• pp.34.1-34.3
• /
• 2019

Direct-to-consumer (DTC) genetic testing is a controversial issue although Korean Government is considering to expand DTC genetic testing. Preventing the exaggeration and abusing of DTC genetic testing is an important task considering the early history of DTC genetic testing in Korea. And the DTC genetic testing performance or method has been rarely reported to the scientific and/or medical community and reliability of DTC genetic testing needs to be assessed. Law enforcement needs to improve these issues. Also principle of transparency needs to be applied.

• 대한임상검사과학회지
• /
• 제54권3호
• /
• pp.167-172
• /
• 2022

In clinical practice, the diagnosis of tuberculosis (TB) continues to be a challenge. The goal of this study was to evaluate the reliability and impact of adenosine deaminase (ADA) enzyme testing as a biochemical marker in the continued management of suspected tuberculosis in a limited resource setting hospital. The retrospective data were collected from 2018 to 2021 and comprised the results of all ADA test assays done in the laboratory. All types of body fluids received for ADA testing were analyzed. Over the course of two years, 1461 samples for ADA assay testing were received. The average age of the study population was 56.69±11.7 years, with males accounting for the majority of the subjects (55.72%). Pleural fluid (N=817, 55.92%) was the most common type of sample received for the ADA assay. 114 (13.95%) of the 817 pleural fluid samples were found to be positive. A survey was conducted to obtain physician's response regarding reliability on ADA testing. 100% of them reported the supportive role of ADA levels in the workup of patients with suspected tuberculosis. In a limited resource setting, the ADA test, in conjunction with clinical and other laboratory findings, can help physicians to initiate early treatment in hospitals for the benefit of patients.

• 대한임상검사과학회지
• /
• 제55권3호
• /
• pp.203-212
• /
• 2023

코로나19가 창궐한 후 임상병리사(medical technologists, MT)가 병원에서 PCR 검사를 수행하고 있을 뿐만 아니라 차세대 염기서열분석(next-generation sequencing, NGS)도 수행한다는 사실을 일반적으로 알고 있다. 하지만, 많은 사람들은 유전자검사 분야에 대한 임상병리사의 업무로 의료법에 명시되어 있지 않다는 사실을 인지하지 못하고 있는 실태이다(MT 72.5%, N=200; 학생 62.8%, N=123). 이러한 이유로, NGS에 대한 임상병리사의 업무 적절성을 검증하기 위해서 온라인 설문지를 작성하도록 설계하여 설문조사 결과를 분석하였다. NGS가 포함된 유전분야에 대한 임상병리사의 업무범위에 대한 법제화가 필요하다(MT 99.5%, N=200, 학생 86.8%, N=123)고 나타났다. 그리고 임상병리사 국가면허시험 문제은행에 세포유전학 및 분자유전학 관련 임상유전학 문항이 모두 포함돼야 한다(MT 97.5%, N=200; 학생 72.3%, N=123)고 조사되었다. 이러한 조사를 바탕으로 임상병리학 분야의 발전을 위해 임상병리사와 학생 모두를 위한 유전자 교육 및 법제화를 위해 대한임상병리사협회는 교수협의회와 적극 협력할 필요가 있겠다.

• International Journal of Oral Biology
• /
• 제35권4호
• /
• pp.185-190
• /
• 2010

Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most prevalent pathogens in hospitals. To investigate cross contamination by this bacterium in both dental and medical settings, the pathogens that cause acute pyogenic infection and one of the major microbes responsible for nosocomial infection were isolated from health care providers, nurses and patients. We used VITEK II to measure drug sensitivity, and we further performed biochemical testing, coagulase serotype testing and pulse-field gel electrophoresis (PFGE) for isolated MRSA colonies. The isolation rate of Staphylococcus aureus from nasal swabs was 75.0% from dental health care providers and 18.8% from the medical health care providers. A total of 10 MRSA strains were isolated from 40 health care providers and 2 patients and the prevalent coagulase serotype from patients and health care providers was VII. The antimicrobial drug resistance and partial PFGE types of the isolated MRSA strains showed a similar pattern. These results suggest that MRSA may be one of the principal causes of nosocomial infection in dental and medical hospitals.

• 대한임상검사과학회지
• /
• 제52권3호
• /
• pp.261-270
• /
• 2020

본 연구는 질 가산율 산출 및 적용기준을 검토하여 우수검사실 신임인증 및 전문인력영역에 있어 임상병리사를 추가 가능성을 알아보았다. 연구에 참여한 6개 기관은 1,000병상 이상의 대형병원 규모이며, 상근 진단검사의학과 전문의 평균 5명, 임상병리사는 평균 53명으로 전문의 1명당 10.6명으로 나타났다. 임상병리사의 행위분류별 소요시간에 대한 분석결과, 분석 중 행위는 낮아지고 있는 반면 검사실 운영, 정도관리 등의 강화로 포괄적 분석 전 행위의 비율이 높게 나타났다. 분석 중 행위는 생화학 검사수행 등의 비중이 높았고, 분석 후 행위는 결과분석 등이 대부분을 차지하였다. 이와 같이 검체검사 질 향상을 위해 많은 시간이 소요되며, 그에 맞는 인력이 요구된다. 결론적으로 검체검사 질 향상을 위해 임상병리사의 채용 역시 중요하며, 그에 따른 인원 규정이 필요하다 할 수 있다.

• 대한임상검사과학회지
• /
• 제55권3호
• /
• pp.213-218
• /
• 2023

일본에서 '팀 의료'는 임상병리사가 당뇨병팀, 영양지원팀, 감염관리팀, 진료지원팀 등 다양한 종류의 팀에서 활발하게 활동하고 있다. 전반적으로 최근 의료환경이 지속적으로 변화함에 따라 임상병리사는 채혈, 검체 채취, 검사, 심전도 등을 수행할 뿐만 아니라 의사, 간호사와 협력하여 '진료보조나 지원'에 적극적으로 참여할 것이 요구되고 있다. 따라서 국내 병동이나 응급실에 상주하는 임상병리사는 임상검사실과 연결고리 역할을 수행함으로써 의료의 질 향상과 의료안전 확보에 더 잘 기여할 수 있을 것이고, 의사와 간호사는 업무부담이 경감되고 보다 나은 환자관리를 위해 헌신할 수 있을 것으로 기대된다.