헌혈혈액 혈액형검사 외부 숙련도조사 결과보고(2011)

임영애,차영주,김진규,이미남,신지연 대한수혈학회 2012 大韓輸血學會誌 Vol.23 No.1

Background:To ensure safety of blood transfusion, accuracy in performance of blood grouping tests (BGT) is essential. External proficiency testing (PT) for BGT has not been conducted in Korea. The first PT for BGT in domestic blood centers was conducted in order to evaluate the domestic status of accuracy of BGT in blood centers and to aid in improving the quality of blood centers. Methods:Whole blood survey specimens consisting of three panels for ABO grouping and two panels for Rh typing were sent to 81 blood centers. Evaluation criteria for BGT were as follows: ‘Good’ for answers with 100% referee consensus, ‘Acceptable’ for correct answers other than those of the referee, and ‘Unacceptable’ for answers other than those of ‘Good+acceptable’ as correct answers. Results:Rates of correct answers on three panels for ABO grouping were all 100%; however, that of cell typing for the panel with BW was 61.7%, and 31 blood centers incorrectly reported normal ‘B’ type as an answer. The rate of correct answers for the Rh negative panel was 100%; however, that for the weak D panel was 84%, and 13 blood centers incorrectly reported Rh negative type as an answer. Conclusion:Findings from this study demonstrated that some hospital blood centers were not able to correctly detect blood groups with weak antigens. Therefore, to improve the quality of blood centers, intensive education for blood center staff and continued PT for BGT should be required. Background:To ensure safety of blood transfusion, accuracy in performance of blood grouping tests (BGT) is essential. External proficiency testing (PT) for BGT has not been conducted in Korea. The first PT for BGT in domestic blood centers was conducted in order to evaluate the domestic status of accuracy of BGT in blood centers and to aid in improving the quality of blood centers. Methods:Whole blood survey specimens consisting of three panels for ABO grouping and two panels for Rh typing were sent to 81 blood centers. Evaluation criteria for BGT were as follows: ‘Good’ for answers with 100% referee consensus, ‘Acceptable’ for correct answers other than those of the referee, and ‘Unacceptable’ for answers other than those of ‘Good+acceptable’ as correct answers. Results:Rates of correct answers on three panels for ABO grouping were all 100%; however, that of cell typing for the panel with BW was 61.7%, and 31 blood centers incorrectly reported normal ‘B’ type as an answer. The rate of correct answers for the Rh negative panel was 100%; however, that for the weak D panel was 84%, and 13 blood centers incorrectly reported Rh negative type as an answer. Conclusion:Findings from this study demonstrated that some hospital blood centers were not able to correctly detect blood groups with weak antigens. Therefore, to improve the quality of blood centers, intensive education for blood center staff and continued PT for BGT should be required.

국내 적십자혈액원 혈액성분제제의 품질관리 현황

김종암,서동희,황병갑,김상인 대한임상검사정도관리학회 2001 臨床檢査와 精度管理 Vol.23 No.2

일본 혈액관리 현황

김이경,이동한,박경운 대한수혈학회 2014 大韓輸血學會誌 Vol.25 No.3

Information on the blood safety management system in Japan was collected by visiting the Ministry of Health, Labour and Welfare (MHLW), Japanese Red Cross Blood Service Headquarter, Kanto-Koshinetsu Block Blood Center, and Yurakucho Blood Room of Tokyo Metropolitan Blood Center, in July 2014, to improve the quality of the blood management system in Korea. In Japan, all blood products are supplied by the Japanese Red Cross Blood Service. In April 2012, the function of screening tests and blood product production of the provincial blood centers was transferred to the block blood centers. Donor suitability is assessed by medical doctors and EKG was tested for donors over 40 years old annually. To prevent bacterial contamination, the shelf life of platelets was shortened to 4 days after production, but routine bacterial screening test was not performed. Adverse reactions and infection following transfusions are reported to MHLW through the Red Cross Blood Service, and the case was reviewed by Pharmaceuticals and Medical Devices Agency (PMDA). Before transfusion, HBsAg, anti-HBs, anti-HBc, anti-HCV, and HCVcAg of the recipient is tested, and testing for HIV antigen is performed if the recipient has risk factors for HIV infection. Even when hepatitis B NAT is positive, look back is not performed if anti-HBc is negative and there is no history of blood donation within 125 days before the current donation. Good Manufacturing Practice (GMP) for blood centers was introduced in the 1990s and PMDA performs the test every 5 years. In introduction of GMP in Korea, it is necessary to decide how to absorb the expense.

대한 적십자사 헌혈의 집 공간구성 특성에 관한 연구 : 서울지역을 중심으로 Focusing on the Area of Seoul

한명흠 부천대학 2002 論文集 Vol.23 No.-

본 연구는 혈액원 산하에 있는 헌혈의 집의 실태를 파악하여 채혈 과정과 간호사의 능률에 맞는 공간구성의 유형을 찾아보고 그에 따른 현재 실태의 문제점과 개선안을 제시하여 계속되는 국내 각 혈액원 산하의 헌혈의 집 공간 설계에 기본적인 자료가 될 수 있도록 하는데 그 목적을 두고 있다. 이러한 결과를 정리하면, 첫째, 실제 휴게공간에 있어 전체 면적에 비해 비교적 큰 공간으로 많이 나타나고 있으나 좀더 안정적이고 지속적인 혈액 수급을 위한 방법으로 휴게 공간과 부대영역의 통합 및 확충, 이벤트성 공간의 신설 등으로 일반인들을 쉽게 끌어들여 헌혈의 집이 지역사회 속에서 대중의 공간 역할을 할 수 있도록 해야 할 것이다. 둘째, 채혈 공간의 구성은 ㅡ자형 배치를 지양하고 ㄷ자형의 배치를 두어 공간의 기능성과 간호사의 작업 효율을 늘릴 수 있도록 해야할 것이다. 셋째, 채혈 공간 내에서 채혈의자 주위에 수납시설의 확대와 효율적인 배치로 간호사의 업무 향상에 기여해야 할 것이다. 끝으로 혈액사업이 사회 전체 이익을 위한 효용 및 이익창출 사업이라면 헌혈의 집은 상업 공간적인 경영 마케팅적 기술과 함께 좀더 체계적인 접근 방법이 마련되어야 할 것이다 따라서 이로 인한 작업자들의 복지 및 사업장 근로조건향상으로 경영효과의 극대화를 꾀하여야 할 것이다. The purpose of this study shall be basic materials for space planning of the blood donation center in Korea. It is therefore required to propose the problem and the reform measure of the actual condition of the blood donation processing and construction of the blood donation center in which efficiency of work of staff. Study results presented for this purpose are as follows: First, the space of resting room of the blood donation center was large. But it is necessary to make integration and expansion of resting room space and affiliated facilities for stabilization of blood supplying system. And there is necessity for making event area in the blood donation center for take place of interest of the public. On that ground the blood donation center plays an important part in the local society as a public place. Second, construction of the blood-gathering room has to be not ㅡ type but ㄷtype. Because ㄷtype can make of increasing the space-function and work-efficiency of staffs. Third, the blood-gathering room has to be enlarging the storage space for the work-efficiency of staffs. Finally, the blood donation center ought to be approached with the mind of commercial space and management marketing understanding. For the reason, it is necessary to make of welfare program of staff and increase of working conditions by the maximum management effect.

의료기관 혈액원의 변화 및 대한적십자사혈액원에 대한 만족도 조사

최계령,김현옥,김신영,장충훈,최영실,김준년 대한수혈학회 2015 大韓輸血學會誌 Vol.26 No.2

배경: 지난 수년간 한국의 혈액제제 수급상황은 공급혈액원의 다변화와 의료기관 혈액원의 수적 정리 등으로 인해 많은 변화가 있었다. 본 연구에서는 현재 의료기관 헌혈혈액원의 기능현황을 파악하고 적십자사 혈액원이 제공하는 서비스에 대한 의료기관의 만족도를 조사하여 이전 결과와 비교하였다. 방법: 2014년 11월 총 64개 의료기관 혈액원 혈액은행 담당자에게 이메일을 통해 설문지를 발송하였으며 이 중 62기관으로부터 설문결과에 대한회신을 받아 내역을 분석하였다. 결과: 의료기관 혈액원의 수는 2004년 129개에서 2014년 64개로 감소하였다. 의료기관 혈액원을 운영하는 기관은 도서지역 의료기관 2곳을 제외하고 모두 총 병상 수 400병상 이상의 규모였다. 이들의 80% 이상은 대한적십자사의 헌혈자정보조회서비스 및 핵산증폭검사(Nucleic Acid Amplification Test) 검사결과 회신서비스에 대하여 만족하였다. 모든 1000병상 이상의 의료기관에서는 혈액원 업무를 이관할 의사가 없다고 답하였으며 혈액원 기능을 유지하려는 이유로는 지정헌혈 및 자가헌혈을 지속적으로 받기 위해서와응급시 신속한 혈액공급을 대비하기 위해서였다. 결론: 혈액관리업무의 주체는 국가임을 재확인하고, 대한 적십자사 혈액원과의 공조하에 국가혈액사업의 종합적이고 일관된 국가혈액관리정책을 수행하기 위한 구성된 위원회 및 정책실행기구를 설치해야 한다. Background: Blood supply circumstances in Korea have changed in recent decades because of blood supplier diversification and restructuring of hospital blood donation centers. The purpose of this study is to understand the current status of hospital blood donation centers and their satisfaction levels with the Korean Red Cross Blood Center (KRCBC) and compare with the previous results for sustainable development of the blood supply system. Methods: During one month in November 2014, we conducted a questionnaire survey through e-mail in 64 hospital blood donation centers which are approved by government. The response rate was 97% (62/64 hospitals). Responses from 62 hospitals were analyzed. Results: The number of hospital blood donation centers were reduced by half from 129 in 2004 to 64 in 2014. There was no blood donation center in hospitals less than 400 beds, except 2 hospitals; 23 hospital (37.1%) blood banks collected no blood components. More than 80% of hospitals were satisfied with the KRCBC service such as donor record lookup and nucleic acid amplification Test (NAT) results lookup. Hospitals with more than 1,000 beds replied that they would not take account of transferring the collection services to KRCBC because of the directed and autologous donation and unexpected emergency blood transfusion. Conclusion: The government should be the subject of national blood policy and establish a committee or agency for its comprehensive and consistent execution through close cooperation with the KRCBC and hospitals.

채혈금지대상자 기준에 대한 국내 혈액원 의사의 의견수렴을 위한 설문조사 연구

박서진,김명희,김선형,신정원,김현경,이상원,신영희,임영애 대한수혈학회 2010 大韓輸血學會誌 Vol.21 No.3

Background: The donor selection criteria should ensure the safety of both the donors and the recipients of blood products. However, modifications may help promote more blood donors in keeping with the rapidly aging Korean population. Our goal was to gather opinions of the medical staff at blood centers on the current donor selection criteria. Methods: A survey was sent out via email to 55 medical staff at hospital blood banks, the Korean Red Cross and Hanmaeum blood centers. The survey included 14∼16 questions regarding age, weight, donation volume, donation interval and frequency, hemoglobin, blood pressure, pulse rate, and the level of alanine aminotransferase (ALT). Results: Survey responses from 38 out of 55 (69.1%) medical staff were analyzed. The donor selection criteria that showed significantly higher acceptable rates included the upper age limit (71%, P=0.009) and whole blood donation frequency and intervals (68%, P=0.023). The ALT level showed the highest unacceptable rate (84%, P<0.0001) and other criteria with significantly higher unacceptable rates included donor weight (68%, P=0.023) and donation volume (76%, P=0.001). Responses from medical staff at supply blood banks and hospital blood banks showed a significant difference regarding the use of parent/guardian consent forms in blood donors that were 16 years or younger (75% versus 41%, respectively; P=0.0368). Conclusion: This study outlines the perspectives of medical staff at blood centers regarding the current donor selection criteria. According to the survey, the ALT level, donor weight, and donation volume should be considered for revision. These results can be referenced in the future when proposing modifications to the donor selection criteria. 배경: 헌혈자 선별기준은 헌혈자와 수혈을 받는 헌혈자의 안전성을 최대한 보장하는 것이 가장 중요하다. 특히 국내도 고령화 사회로 접어들면서 헌혈자원 확대에 대한 검토가 필요하다. 따라서 본 연구에서는 현재의 헌혈자 선별기준 항목의 적절성에 대하여 설문조사를 통하여 국내혈액원 의사들의 의견을 수렴하였으며 외국 기준들과 비교분석하여 선별기준 개선에 도움을 주고자 하였다. 방법: 대한적십자사 및 한마음 혈액원과 연간50단위 이상 제조하는 의료기관혈액원에 근무하는 의사 55명을 대상으로 헌혈자 선별기준에 대한 14∼16개의 문항에 대하여 적절 또는 부적절여부를 묻는 설문조사를 이메일을 통하여 실시하고 통계처리를 하여 자료를 분석하였다. 결과: 회신율은 69.1% (38/55)로 현재 선별기준중 상한연령(71%, P=0.009)과 전혈 헌혈빈도 및간격(68%, P=0.023)은 적절하다는 의견이 우세하였고, ALT(84%, P<0.0001)는 부적절하다는 의견이 가장 높았으며, 그 밖에 체중(68%, P=0.023)과채혈량(76%, P=0.001)도 현재 기준이 부적절하다는 의견이 유의하게 높게 나타났다. 또한 16세 이하의 헌혈자에 대해서 부모 또는 보호자 동의서를추가에 동의하는 의견은 의료기관혈액원(41%)에비해 공급혈액원(75%)에서 월등히 높게 나타났다(P=0.0368). 결론: 현재의 헌혈자 선별기준에 대한 설문조사를 통해 헌혈자 상한연령, 전혈 헌혈빈도 및 간격과 같이 적절하다고 생각하는 항목과 ALT 수치, 헌혈자 체중, 그리고 채혈량과 같이 개선을고려해야 하는 항목들에 대한 혈액원 의사들의의견을 수렴할 수 있었다. 이는 향후 헌혈자 선별기준 개선(안)을 제시하는데 도움을 줄 것으로 여겨졌다.

국내 헌혈자 문진에 대한 설문조사 연구

임영애,김명희,박서진,김은진,김문정,민혁기,김성배,박규은,황유성 대한수혈학회 2011 大韓輸血學會誌 Vol.22 No.1

Background: An objective and standardized interview process is important when screening for healthy blood donors. Our aims were to gather opinions of the interviewing nurses at blood centers on the current donor interview and to suggest improvements to the interview. Methods: We conducted an anonymous survey consisting of five questions regarding the donor health questionnaire, which can be found on the reverse side of the donation record card. The survey targeted the interviewing nurses with more than 1 year of experience at collection sites of the Korean Red Cross and the Hanmaum blood centers. The survey was sent out and gathered via mail, fax or email between September and October of 2010. Results: The average self-deferral rate of donors prior to interview was 7.4%, and 66.7% of the interviewing nurses considered ‘taking medicine’ as the most common reason for donor self-deferral. The past and current history of disorders was the hardest question for nurses to determine the eligibility of the donors. Having a history of blood transfusion, surgery, tattoo or a piercing procedure, etc. within a year was the most unacceptable reason for deferred donors. The nurses strongly recommended revision of redundant questions as well as re-examining the unsolvable dilemma of questions concerning malaria. Conclusion: According to the survey, this study outlines the perspectives of interviewing nurses at blood centers regarding the rate and reasons for self-deferral of blood donors, the difficulties and the suggestions for improving the current donor interview. The results will be helpful in the future when proposing modifications to the donor interview.

국내 혈액원 수혈전파성감염 선별을 위한 진단면역학적 검사의 질관리

정유나,윤승규,곽정숙,조윤정 대한수혈학회 2017 大韓輸血學會誌 Vol.28 No.3

The Korean government previously established a national blood policy and national blood system based on basic and essential legislation. This achievement was the result of collaborative efforts between the Korean Centers for Disease Control and Prevention, the Korean Society of Blood Transfusion, the Korean Society for Laboratory Medicine, the Laboratory Medicine Foundation, and/or the Korean Association of External Quality Assessment Service. To ensure a safe and effective transfusion, a comprehensive quality assurance (QA) system to assess every process from donor selection to transfusion is mandatory. From a blood safety perspective, selection of appropriate donor blood screening tests for transfusion-transmissible infections (TTI) and the QA program is of great importance. In this article, we review legislation regarding the national blood policy and national blood system as well as the selection logic regarding diagnostic immunologic tests for TTI and quality assurance efforts for TTI of each blood center.

B형간염바이러스 표면항원과 C형간염바이러스 항체 헌혈혈액선별검사 숙련도시험 결과(2012∼2015년)

이미남,김준년,차영주,박규은,김현옥,권계철,최영실,권정란 대한수혈학회 2016 大韓輸血學會誌 Vol.27 No.3

Background: Donor screening test is one of the most important processes for blood safety management. Korea Center for Disease Control and Prevention (KCDC) has been conducting an annual proficiency test program that includes the distribution of specially manufactured panels for hepatitis B surface antigen (HBsAg) and antibody to hepatitis C virus (anti-HCV) to blood centers. Here, KCDC reports the results of these proficiency tests for HBsAg and anti-HCV blood donor screening for all licensed blood centers in Korea between 2012 and 2015. Methods: Panels for the proficiency tests were manufactured and distributed to blood centers by Chung-Ang University Hospital, which has been participating in the Korea Blood Safety Commission. Well-proven reactive sera and healthy donor’s sera acquired from the Human Serum Bank in Chung-Ang University were used to make the panels. To identify the S/CO ratio of the panel, three medical institutes triple-checked the results of each panel. Results: Most blood centers reported correct answers for the proficiency test with six panels. The average percentages (year) of correct answers were as follows: 98.7% (2012), 98.5% (2013), 99.1% (2014) and 99.6% (2015) for the HBsAg proficiency tests; and 97.7% (2012), 99.5% (2013), 99.1% (2014), and 99.8% (2015) for the anti-HCV proficiency tests. Conclusion: To improve the blood center’s ability for donor screening tests, KCDC will continue the proficiency test program by managing specialized panels for HBsAg and Anti-HCV tests. Furthermore, we will investigate the level of satisfaction to improve the quality of the program. 배경: 혈액원의 헌혈혈액 선별검사 능력은 혈액 안전성 확보를 위해 매우 중요하다. 질병관리본부는 혈액원을 대상으로 매년 항원성이 약하거나, 저농도의 항체를 가진 특화된 패널을 포함한B형간염바이러스 표면항원(Hepatitis B surface antigen, HBsAg) 및 C형간염바이러스 항체(anti-HCV) 검사의 숙련도시험을 실시하여 왔다. 이에 질병관리본부에서 2012년부터 2015년까지 모든 허가된 혈액원에서 실시한 헌혈혈액 선별검사인 HBsAg 과 anti-HCV 숙련도시험 결과에 대하여 보고하고자 한다. 방법: 질병관리본부는 HBsAg 및 Anti-HCV 검사의 숙련도시험 사업을 혈액안전사업단에 참여하고있는 중앙대학교병원에 위탁하여 특화된 패널을 제조하고 혈액원으로 발송하였다. 패널을제조하기 위하여, 중앙대학교 혈청검체은행으로부터 성상이 잘 밝혀져 있는 양성 검체와 음성 검체를 분양받아 사용하였고, 제조된 패널들의 설정값(S/CO) 확인을 위해 세 개의 의료기관에서 각패널마다 3회 반복 검사로 확인 후 사용하였다. 결과: HBsAg 및 Anti-HCV 검사의 숙련도시험을 실시한 혈액원은 6개 패널에 대하여 대부분정답을 보고하였다. 평균(연도) 정답률은 다음과같다: HBsAg 검사의 숙련도시험은 98.7% (2012), 98.5% (2013), 99.1% (2014) 및 99.6% (2015); anti- HCV 검사의 숙련도시험은 97.7% (2012), 99.5% (2013), 99.1% (2014), 그리고 99.8% (2015)였다. 결론: 혈액원의 선별검사 능력을 향상시키기위하여 질병관리본부는 HBsAg 및 Anti-HCV 검사에 대한 특화된 패널을 계속적으로 사용하는숙련도시험 위탁사업을 지속 운영하려한다. 또한, 프로그램의 질향상을 위하여 만족도 조사도실시할 것이다.

제대혈 관리 및 연구에 관한 법제와 개선방안

정연덕(Yeun Dek Chung) 중앙법학회 2010 中央法學 Vol.12 No.4

The purpose of this study is to develop legal standards in the field of management of umbilical cord blood. Umbilical cord blood consist of hemopoietic progenitor cell and stem cell. Recently doctors and scientist discovers many usage of cord blood. Cord Blood Act deals with cord blood transplantation, private cord blood bank and public cord blood bank. KONOS (Korean Network for Organ Sharing) is the central resource for government-funded technical, and medical related cord blood information. Private cord blood banks and public cord blood bank have invested lots of resource in gaining cord blood and related information. However, outcome of these information does not spread to patient. Thus Cord Blood Act not only regulate but also promote development of this Cord blood industry. After this enactment, the public will have benefit in cancer therapy. This paper aims to suggest a standard to deal with balance of Private Cord Blood Bank and Public Cord Blood Bank. It also deal with right of patient in using the information provide from KONOS. The public would be served by having ready access with cord blood information. Finally, it will address the need to consider issues for regulation of Cord Blood Business and distribution of information to develop a legal framework to deal with this problem.