혈액제제의 콜드체인 점검 및 평가

김이경,김나미,장충훈,김준년,김현옥 대한수혈학회 2022 大韓輸血學會誌 Vol.33 No.1

Background: Due to the importance of the cold chain related to vaccine transportation, it is necessary to establish a blood cold chain operation strategy by checking the status of blood transportation from blood donation to transfusion. Methods: The blood transportation system and blood storage facilities were checked by inspecting the Korean Red Cross (KRC) Blood Centers and its affiliated supplier and Hanmaeum Blood Center. The status of the cold chain was evaluated through an interview with the quality control manager or blood supply team leader. For the hospital, the status was investigated from the perspective of the 30-min rule. A questionnaire survey was conducted for medical technicians and nurses working at the hospital. Results: Data on temperature during transport of blood components were computerized, and all standards were met. A nationwide network that could supply blood from the blood supply center to the hospitals within 2 hours was established. The frequency of temperature monitoring in the blood transport box and constant temperature check in the transport box during long-distance transport were evaluated. Conclusion: This study confirmed that blood storage and transportation in Korea complied with the cold chain standards of high-income countries or higher. The evaluation of the cold chain is a constantly evolving process requiring continuous attention. When standards for storage and transportation of blood products are established, strict regulations and examinations will be required. (Korean J Blood Transfus 2022;33:1-13)

의료기관 혈액원 혈액관리업무 향상을 위한 질병관리본부 교육 프로그램에 대한 평가 -설문조사 결과 분석(2015∼2017년)-

엄태현,김현옥,이미남,장충훈,김민주,김준년 대한수혈학회 2017 大韓輸血學會誌 Vol.28 No.3

Background: The Korea Centers for Disease Control and Prevention (KCDC) has been providing a nationwide, one-day training program for workers of hospital blood centers once a year since 2013. We evaluated the achievement levels of the program through surveys. Methods: The survey was conducted immediately after the program in 2015, 2016, and 2017. Respondents’ occupations, institutions, program contents, and operational aspects were asked. Results: The response rate was 56.2%∼73.2%. The occupations of respondents were medical technologists 66.9%∼75.7%, nurses 16.1%∼22.1%, and others (administrators, et al.) 1.5%∼11.3%. About 86.1%∼88.2% of respondents answered that the program as a whole was satisfactory or very satisfactory; 88.9%∼94.7% thought that it is necessary or very necessary; 77.9%∼84.1% answered that the appropriate length of the program was one day; 53.8%∼69.1% answered that the appropriate number of program is once per year; and 23.4%∼53.8% or 40.3%∼61.4% answered that the appropriate season for the program by the KCDC should be the first or the second quarter, respectively. Conclusion: This study suggests that the training program plays a useful role in meeting the needs of workers for hospital blood centers.

혈액원 대상 ABO 및 D 혈액형 외부 숙련도 조사사업 보고(2012, 2013)

임영애,김현옥,최영실,이동한,장충훈,이미남,권정란 대한수혈학회 2014 大韓輸血學會誌 Vol.25 No.1

Background: It was reported that a continuous education program and external proficiency testing (PT) for bloodgrouping test (BGT) might be necessary because some blood centers of medical institutions could not correctlyexamine ABO subtype and D variant, according to the results of the first year project in 2011. Therefore, theresults of PT for BGT in blood centers in 2012 and 2013 were compared to those in 2011 in order to assessthe impact of projects during a period of three years and to help in planning the future PT for BGT. Methods: Whole blood survey samples composed of three panels for ABO grouping and three panels for D typingwere sent to 74 and 71 institutes in 2012 and 2013, respectively. Evaluation criteria for BGT were as follows:‘Good’ for the answers matched with intended results, ‘Acceptable’ for the correct answers other than that of‘Good’, and ‘Unacceptable’ for the answers other than those of ‘Good+acceptable’ as correct answers. Results: The answer rates of ‘Unacceptable’ for ABO subtype were 1.4% in 2012 and 4.2% in 2013. However,the answer rate of ‘Good’ increased from 44.6% in 2012 to 83.1% in 2013. The answer rate of ‘Unacceptable’for D variants showed a marked decrease, from 16.2% in 2012 to 1.4% in 2013. Conclusion: Projects for PT for BGT during a period of three years have improved laboratory quality in bloodcenters. However, the acquisition and change of the materials for PT would be necessary in order to continuouslyand practically provide help to blood centers

혈액원 대상 ABO 및 D 혈액형 외부 숙련도 조사사업 보고(2015)

임영애,조현수,최영실,장충훈,이미남,권정란,김준년,김현옥 대한수혈학회 2016 大韓輸血學會誌 Vol.27 No.1

배경: 혈액안전사업단에서는 2011년도부터 혈액형 외부 숙련도조사를 시행해 왔다. 이에 ABO 혈액형 검사시의 혈구 응집강도를 포함한 2015년도 혈액형 외부 숙련도조사 결과를 분석하여 국내 혈액원의 질향상에 기여하고자 하였다. 방법: 3개의 ABO 혈액형과 3개의 D 혈액형으로 구성된 2종류의 전혈 검체를 68개 혈액원에발송하였다. 혈액형 검사결과 분석시는 의도한결과와 일치할 경우에는 ‘Good’, 이외의 허용 가능한답변은 ‘Acceptable’, 정답인 ‘Good+Acceptable’ 이외는 ‘Unacceptable’로 간주하였다. 결과: ‘Unacceptable’의 비율은 A(A1)형 0%, B 형 4.5%, ABW(A2BW)형 1.5%였으나, ABW(A2BW) 형의 경우 혈액원의15%에서 BW형을 검출하지 못하여 ‘Acceptable’로 평가되었다. D형 양성과 음성 결과를 바꾸어 잘못 입력한 1기관이 ’Unacceptable’ 로 평가된 것을 제외하고는 모두 ‘Good’ 이었다. ABO 혈액형의 응집강도는 77.2%∼100% 까지 혈액형과 검사실마다 다양하였다. 결론: 일부 의료기관 혈액원들은 BW형 항원을검출하지 못하고, 사무적 착오도 발생하여 지속적인 교육이 필요하고, 각 혈액원의 ABO 혈액형검사의 응집강도 비교도 혈액원의 질향상에 도움을 줄 것으로 여겨졌다. Background:The Korean Blood Safety Commission has implemented external proficiency testing (PT) for blood grouping test (BGT) since 2011. We analyzed the results of 2015 PT for BGT including hemagglutination grade for ABO BGT to help in planning the future PT for BGT and improving the quality of blood centers (BC). Methods:Two kinds of whole blood survey samples composed of three panels for ABO grouping and three panels for D typing were sent to 68 institutes. Evaluation criteria for BGT were as follows: ‘Good’ for the answers matched with intended results, ‘Acceptable’ for the consensus answers other than that of ‘Good’, ‘Unacceptable’ for the answers other than those of ‘Good+acceptable’ as correct answers. Results:The answer rates of ‘Unacceptable’ for ABO BGT were 0% for A(A1) antigen (Ag), 1.5% for B Ag, and 1.5% for ABW (A2BW) Ag, 15% of blood centers were graded as ‘Acceptable’ for ABW (A2BW) Ag because they could not detect BW Ag. All answers for D typing were ‘Good’ except one institute reported wrong switched results as D positive and D negative. Hemagglutination grade for ABO BGT varied from 77.2%∼100% depending on blood groups and laboratories. Conclusion:Because some hospital BC could not detect BW Ag and there was a clerical error, continuous education should be required, and comparison of hemagglutination grade for ABO BGT of each BC would be helpful in improving quality of BC.

혈액원 대상 ABO 및 D 혈액형 외부 숙련도 조사사업 보고(2014)

임영애,김현옥,오진숙,최영실,장충훈,이미남,권정란,이동한 대한수혈학회 2015 大韓輸血學會誌 Vol.26 No.1

Background: Korean Blood Safety Commission has implemented external proficiency testing (PT) for blood grouping test (BGT) to help improve the quality of blood centers since 2011. We analyzed the results of 2014 PT for BGT to help in planning the future PT for BGT and to improve the quality of blood centers. Methods: Whole blood survey samples including three panels for ABO grouping and three panels for D typing were sent to 69 institutes. Evaluation criteria for BGT were as follows: ‘Good’ for answers matched with intended results, ‘Acceptable’ for correct answers other than that of ‘Good’, ‘Unacceptable’ for answers other than those of ‘Good+acceptable’ as correct answers; and ‘Not graded’ for answers in case of different answers in the two standard laboratories. Results: All of the answer rates of ‘Good’ for D typing were 100%. However, the answer rates of ‘Good’ for cell typing, serum typing and interpretation for 14-ABO-2 samples with discrepant result between cell typing and serum typing were 39.1%, 29%, and 47.8%, respectively. Those of ‘Unacceptable’ for cell typing and interpretation for 14-ABO-2 samples were 2.8% and 1.4%. Conclusion: Because the answer rates of ABO grouping for samples with discrepant result between cell typing and serum typing were not high, education for this case is needed. Diversity of materials for PT would be necessary for more accurate evaluation of the performance of BGT in blood centers. 배경: 혈액안전사업단에서는 국내 혈액원의질향상에 도움을 주기 위하여 2011년도부터 혈액형 외부 숙련도조사를 시행해 왔다. 이에 2014년도 혈액형 외부 숙련도조사 결과를 분석하여 향후 외부숙련도 조사를 진행하는데 도움을 주고국내 혈액원의 질향상에 기여하고자 하였다. 방법: 3개의 ABO 혈액형과 3개의 D 혈액형 패널용 전혈 검체를 69개 혈액원에 발송하였다. 혈액형 검사결과 분석시는 의도한 결과와 일치할경우에는 ‘Good’, 이외의 정답은 ‘Acceptable’로, 정답인 ‘Good+Acceptable’ 이외는 ‘Unacceptable’, 2개 시험소의 답변이 다를 경우에는 ‘Not graded’ 로 간주하였다. 결과: D형 혈액형 검체는 ‘Good’으로 평가된기관의 비율이 100%였으나, 혈구형과 혈청형에불일치를 보이는 14-ABO-2 검체의 경우 ‘Good’ 으로 평가된 기관의 비율은 혈구형 39.1%, 혈청형 29%), 그리고 종합판정은 47.8%이었으며, ‘Unacceptable’으로 평가된 기관의 비율은 혈구형2.8%과 종합판정이 1.4%였다. 결론: 혈구형과 혈청형의 불일치를 보이는 검체에 대해서는 ABO 혈액형의 정답율이 높지 않으므로 이에 대한 교육이 필요하고, 혈액원의 혈액형 검사 수행능을 더 정확하게 평가하기 위해서는 외부숙련도 검체의 다양화가 필요할 것으로여겨졌다.

혈액관리업무 심사평가자 교육프로그램 개발

신정원,신희봉,노경호,허미나,장충훈,이상원,신영학 대한수혈학회 2011 大韓輸血學會誌 Vol.22 No.3

Background: Standardized management and surveillance at a national level is essential to maintain blood product safety. Officials of the Korean Division of Human Blood Safety Surveillance, Korea Centers for Disease Control and Prevention, and Korean laboratory transfusion medicine specialists, currently participate as inspectors in the Korean National Blood Inspection Program for Blood Establishments. However, lack of definitive guidelines and absence of standardized inspector training programs compromise the goal of objective and consistent safety management results. In this study, we propose establishment of written inspection guidelines and a clearly documented accreditation training program. Methods: Inspector training programs in the US and EU were reviewed online and the results of the Korean National Blood Inspection in our country performed during last 4 years were analyzed. Results: We suggested inspection guidelines for every question of inspection checklists. Also, for the questions similar to those of Laboratory Accreditation Program of the Korean Society for Laboratory Medicine (KSLM),guidelines were proposed as ‘Results of Laboratory Accreditation Program of the KSLM could be concerned if inspected laboratory obtained 2 year accreditation lately’. We suggest an 18hr-basic training program composed of lectures, e-learning and a visit to a blood center, as well as 12hr-continuing courses, should be established. Conclusion: To establish the Blood Inspection Program in a more systematic manner, thorough management and training of inspectors are essential. We expect the guidelines and training program for inspectors, suggested in our study, will be the cornerstone for creating a more professional quality management system and further ensure the safety of the national blood management system.

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.

혈액성분제제 품질관리 자료의 통계학적인 비교

김종암 ( Chongahm Kim ),서동희 ( Dong Hee Seo ),권소영 ( So Yong Kwon ),오영철 ( Yuong Chul Oh ),임채승 ( Chae Seung Lim ),장충훈 ( Choong Hoon Jang ),김순덕 ( Soonduck Kim ) 대한임상검사과학회 2004 대한임상검사과학회지(KJCLS) Vol.36 No.1

According to increase of domestic blood components use, the quality control of blood components is necessary to support good products. The purpose of this study is used to provide the producing index of the good product as compared with the accuracy and validity for the distribution of the quality control data. The value of mean, standard deviation, 95% confidence interval and degree of normal distribution of data were calculated by univariate procedure, the value of monthly mean of each blood centers per items were compared by Analysis of Variance(ANOVA) test for the degree of distribution. When there was difference among the mean values, the Duncan``s multiple range test was done to confirm the difference. Finally, methods for accessing accuracy and validity of the quality data was done by the Contingency table test. The quality data of five blood centers was showed to the normal distribution and it was in a acceptable range. For each blood centers, the monthly means of Hematocrit(Hct), Platelet(PLT) and pH were not significantly different except Hct of C center, PLT of B, D center and pH of A center. The quality data per items was graded according to quality to six level. As a result of the comparative analysis, the monthly means of Hct of C and E center was significantly different higher than that of D, B and A center. The monthly means of PLT of A center and pH of C center was significantly different higher than that of the others. In the accuracy and validity of the quality control data, C center for Hct, A center for PLT and C center for pH were better than the other. The C blood center was most satisfiable and stable in the quality control for blood component. If the quality control method used in C blood center is adopted in other blood centers, the prepared level of the blood component of the center will be improved partly.