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临床检验标准化及质量控制研究团队

2017/7/1 10:41:29字号:T|T

临床检验标准化及质量控制研究团队通过建立能够溯源到国际单位的校准测量程序,研制参考物质,实现不同检测系统或医疗机构间检验结果的标准化,从而实现患者检验结果准确、可靠。

Clinical Laboratory Standardization and Quality Control team was established to develop the calibration measurement procedure which can be traced to the international unit. The goal of our team is to achieve standardization for the results from different detection systems or the laboratory of medical institutions, and further to achieve the accuracy and reliable of patients’ detect results.

团队拥有的医学系准实验室于20133月通过了中国合格评定国家认可委员会(CNAS)认可,并于20161月进入国际检验医学溯源联合委员会(JCTLM)参考实验室服务名录,能够为国内外医疗机构提供校准服务。医学校准实验室于201610月成为JCTLM的下属成员。

We have established a medical calibration laboratory which accredited by China National Accreditation Service for Conformity Assessment (CNAS) in March 2013, and it was listed in Joint Committee for Traceability in Laboratory Medicine (JCTLM) in January 2016. So we can provide calibration measurement services for domestic and foreign medical institutions. Department of Laboratory Medicine Guangdong Provincial Hospital of Chinese Medicine joined to JCTLM in October 2016, which is the only Chinese medicine hospital laboratory in the world.

近年来获广东省科技进步二等奖2项、三等奖2项,广州市科技进步三等奖2项;代表华南地区与其他五大地区一起实施国家项目“中国人权中药常规临床检验项目参考区间的建立”;主持国家自然科学基金12项,科研经费超过700万元,发表SCI论文40多篇,主编专著、教材15本。

In recent yearswe have awarded 2 the second prize and 2 third prize of science and technology of Guangdong province, and 2 third prize of science and technology of Guangzhou University of Traditional Chinese Medicine. On behalf of the South China region and the other five regions with the implementation of national key projects “Establishment of reference intervals for important routine clinical test items in Chinese population”, mainly responsible for 12 national fund projects, research funding of more than 700 million, has published more than 40 SCI papers, edited fifteen monographs and textbooks.

团队主攻方向Main direction

1.校准方法的研究 The development of calibration measurement procedure

国内率先建立了20个项目的检验“金标准”。为临床相关项目的检测提供了可靠的校准方法。

1)建立了13个临床常规生化检验项目的校准方法。包括血清丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、淀粉酶(AMY)、γ谷氨酰基转移酶(GGT)、肌酸激酶(CK)、乳酸脱氢酶(LDH)总蛋白(TP)、葡萄糖(Glu)、总胆红素(Tbil)、尿素(Urea)、肌酐(Cr)、尿酸(UA)肌酐(Cr)等。

2)建立的激素校准方法:雌二醇(estradiol-17β)、雌三醇(estriol)

(3)建立的血细胞校准方法:红、白细胞计数(RBC/WBC),血红蛋白(Hb),血小板(PLT),红细胞比容(Hct)

We have established the "gold standard" of those 20 projects in China. The goal of this study is to provide the calibration method for the relevant projects in normal laboratory medicine.

(1) We mainly developed the calibration measurement procedure for some clinical diagnostic criteria, such as ALT, AST, ALP, AMY, GGT, CK, LDH, TP, Glu, Tbil, Urea, UA, Cr.

(2) Development and evaluation of the calibration measurement procedure for the determination of estradiol-17β and estriol in human serum by using ID-LC-MS/MS.

(3) The calibration methods of Blood cell are also established: RBC/WBC, Hb, PLT and Hct.


2. 校准物质和参考区间的研究 The study of standard materials andreference interval

研制国家二级标准物质,为检验结果准确提供标准砝码

检验项目的参考区间是疾病诊断和健康评估最主要的依据。参考区间的准确性、适用性直接影响着疾病的诊治效率,参考区间的不确定甚至会导致错误的医学判断或医学干预,给患者造成心理和经济负担,同时还会造成医疗卫生资源的浪费。建立中国人群参考区间具有重要意义。根据美国CLSIC28-A3 Defining, establishing, and verifying reference intervals in the clinical laboratory》,建立了相关项目中国人群的参考区间。

We have developed and evaluated of some national secondary standard materials for those projects. It can provide "standard weight" for the accuracy of the normal laboratory medicines’ result.

Reference interval of clinical testing projectis the most important basis for disease diagnosis and health assessment. The accuracy and applicability of reference intervaldirect impact on the efficiency of diagnosis and treatment of diseases. The uncertainty of reference interval even lead to erroneous medical judgment or medical intervention, causing psychological and economic burdento patients, while also resulting in a waste of health resources. The establishment of the Chinese population reference intervals is important. According to the document CLSIC28-A3: “Defining, establishing, and verifying reference intervals in the clinical laboratory” we developed some of projects’ Chinese population reference interval.

3. 临床检验质量控制技术的研究 The investigate of Quality Control System

保证分析中的质量,为临床提供准确可靠的检验结果检验人员及质量管理人员的迫切任务。通过加强对分析中每个环节的质量控制,对室内质量控制、检测系统分析性能、能力验证进行系统的评价与研究,研究合理、有效的质量控制方案。从而保证常规实验室测量结果的准确、可靠。 

The urgent task of clinical Laboratory staff and quality management personnel is to assure quality in the process of analysis and provide accurate and reliable test results for clinical. By strengthening the quality control of every aspects in the analysis, and systematic evaluate the analysis performance, reasonable and effective quality control programs can ensure accurate and reliable results in routine laboratory measurements. We have prepared the “Written guide of Medical laboratory quality system documentation”and “Write Examples of Medical laboratory quality system documentation”.

4. 获得的奖励

2016“临床常规化学检验结果互认技术平台的建立与推广”获广东省科学技术奖励二等奖。

In 2016, we awarded second prize of provincial science and technology by The establishment and promotion of clinical routine chemical test results mutual recognition technology platform”.

 

5. 实验室设备Lab equipment

团队主要成员Members of the team

学术带头人Academic leaders

庄俊华:研究员、主任技师、博士生导师,广东省中医院检验医学部学术带头人、主任导师。

社会任职:中国中西医结合学会检验医学专业委员会名誉主任委员,中华中医药学会检验医学分会名誉主任委员,全国卫生产业企业管理协会医学检验专家委员会副主任委员,中国医学装备协会检验分会常务委员,中国合格评定国家认可委员会医学实验室认可主任评审员,广东省中西医结合学会检验医学专业委员会名誉主任委员,广东省医学会检验分会顾问,广东省医院管理学会临床检验管理专业委员会副主任委员,广东省优生优育协会新生儿疾病筛查专业委员会副主任委员,广东省中西医结合学会中西医结合标准化专业委员会副主任委员,广东省临床检验质量控制中心专家组专家,广东省医疗器械审评专家,广东省医学会医学鉴定专家库专家。

学术成果1完成者获广东省科技进步二等奖2项、三等奖1项,广州中医药大学科技一等奖1项、二等奖1项,中华中医药学会科学技术二等奖1项(第9)国家发明专利1项;国家食品药品监督管理局医疗器械(诊断试剂)生产批文1项。主持和主要完成国家级(包括863计划、十一五重大专项)省级和厅局级等课题10多项;第1主编出版专著7本,副主编/参编专著多本。发表第一和通讯作者论文60多篇,其中SCI收录论著8篇。第一导师培养博士后1名,博士生4名,硕士生16名。

Professor Zhuang Junhua, Research professor, senior technologist, doctoral supervisor, the academic leaders of Laboratory Science of Guangdong Provincial Hospital of Chinese Medicine.

Social Headships: Professor Zhuang is the chief member of a numbers of professional committees, such as Clinical Laboratory Management Association of China Hospital, Clinical Laboratory Equipment Technical committee of China Medical Equipment Association, Laboratory Medicine Professional committee of Chinese association of integrative Medicine, and so on. In addition, she is the chief judge of China National Accreditation Service for Conformity


Assessment (CNAS) and the expert of Guangdong Provincial Control Center of Laboratory Medicine.  

Academic Achievements: She has awarded two of the second prize (Ranking 1st.) and one of third prize of science and technology of Guangdong province (Ranking 1st.) as well as 2 of Guangzhou University of TCM. She obtained national invention patent 1 item. She was mainly responsible for 10 national and provincial science fund projects. She has published 7 monographs as the chief editor as well as more than 60 papers (6 for SCI) as the first/correspondent author in national and international journals , has trained 16 graduate students, 5 doctoral students,1 post-doctor student .

团队学术骨干Academic backbone=


黄宪章:博士,教授,主任技师,博士生导师,广东省中医院检验医学部主任、检验教研室主任。

社会任职:中华医学会检验分会青年委员会副主任委员、临床生化学组委员,中国医院协会临床检验管理专业委员会委员中国中西医结合学会检验医学专业委员会副主任委员中华中医药学会检验医学分会名誉主任委员,中国医师协会检验医师分会个体化医疗分子诊断检验医学专家委员会和肾脏疾病专家委员会副主任委员,中国生物化学与分子生物学会脂质与脂蛋白专业委员会委员,广东省医学会检验分会副主任委员兼管理学组组长、生化学组顾问,广东省中西医结合学会检验专业委员会主任委员,,广东省中医药学会检验医学专业委员会名誉主任委员。中国合格评定国家认可委员会医学实验室认可主任评审员、医学参考实验室评审员。

学术成果:获省科技进步二等奖2项(第2和第3)、三等奖2项(第2和第3),广州市科技进步三等奖1项(第2);负责制定国家标准1项、国家计量标准1项,参与制定国家卫生标准15项;主持国家自然科学基金面上项目、国家十二五课题华南分中心课题、国家十一五课题子课题各1项、省自然基金3项、省科技计划项目4项;副主编教材1本、参编教材1本,主编专著6本(第1主编1本,第2主编4本,第3主编1本),副主编专著3本,参编专著5本;发表第1作者和通讯作者论文78篇,其中SCI论文21篇。第一导师培养博士后2名,博士生5名,硕士生9名。

Professor Huang Xianzhang, PhD Tutor, senior technologist, director of Laboratory Medicine in Guangdong Provincial Hospital of Chinese Medicine.

Social Headships: Professor Huang is the vice chairman of Laboratory Medicine Branch of Guangdong Medical Association Youth Council, clinical Laboratory Management Committee members of the Chinese Hospital Association, vice chairman of Integrative Medicine Laboratory Medicine committee of China Association, lead auditor of China National Accreditation Service for Conformity Assessment (CNAS), expert of clinical laboratory quality control center in Guangdong Province and so on. He is the reviewer of “Cellular & Molecular Immunology”, “Chinese Journal of Laboratory Medicine” and “Journal of Southern Medical University”, Editorial of “Chinese Journal of Microcirculation”.

Academic Achievements: He was awarded two of the second prize (Ranking 2 and 3st.), two of the third prize of science and technology of Guangdong province (Ranking 2 and 3st.), and one of the third prize of science and technology of Guangzhou (Ranking 2st.). He mainly responsible for 10 national and provincial science fund projects, has published more than 60 papers (15 for SCI) in national and international journals (such as Clinical Chemistry, Clinical Chemistry and Laboratory Medicine), edited six monographs and edited a textbook, has trained 9 graduate students, 5 doctoral students, ,2 post-doctor students .


柯培锋:男,医学硕士,主任技师,广东省中医院大院检验科主任。

社会任职:中国合格评定国家认可委员会实验室认可主任评审员;中国老年医学学会检验医学分会常委、代谢与肾病学组成员;广东省医学会检验分会青年委员会副主任委员;中国医药生物技术协会组织生物样本库分会中医药学组委员。

学术成果:获广东省科技进步二等奖2项(排名分别为第5和第8),广州市科技进步三等奖1项(排名第5),广州中医药大学科技进步一等奖1项(排名第9),广东省医疗成果一等奖1项(排名第9)。近几年以第一作者或通讯作者发表论文20多篇(其中SCI 2篇)。副主编专著2本(分别为第1副主编和第4副主编,人民卫生出版社),主持各级课题研究5项,获国家专利2项(第1和第3)。


Professor Ke peifeng, chief technologist, director of Laboratory Medicine in Institute of Guangdong Provincial Hospital of Chinese Medicine 

Social Headships: Professor Ke is the lead auditor of CNAS, Standing Committee of Laboratory Medicine of Chinese Geriatrics Society, and vice chairman of Guangdong Province Medical Association branch of the Youth Committee. He is the standing Committee and Secretary of the professional group of biochemical of Guangdong Provincial Institute of Integrated Traditional and Western Medicine Professional Committee.

Academic Achievements: He was awarded two of the second prize (Ranking 5 and 8st.), one of the third prize of science and technology of Guangzhou (Ranking 5st.), and one of the first prize of science and technology of Guangzhou University of Traditional Chinese Medicine (Ranking 9st.), has published more than 20 papers (2 for SCI) in national and international journals, Taken part in more than 10 national and provincial science fund projects. He has mainly responsible for 5 science fund projects, awarded 2 China national invention patents (Ranking 1 and 3st.).

徐建华:男,医学博士,主任技师,硕士生导师,广东省中医院二沙检验科主任。

社会任职:中国合格评定委员会医学实验室技术评审员,广东省健康管理学会检验医学专业委员会副主任委员,广东省医学会检验医学分会信息与工程学组副组长

学术成果:广东省中医院拔尖人才、青年岗位能手;工作中一直从事临床生化与分子生物学研究;主攻方向为检验标准化及质量管理,肿瘤分子机制及标志物筛选等研究。主持省级课题4项、厅级课题2项,校级课题4项;参与国家级等课题10多项;近年在《Clinical laboratory》、《Molecular Biosystems》、《中华医学杂志》和《中华检验医学杂志》等SCI收录和专业期刊发表论文40多篇,主持国家授权专利1项。

Professor Xu Jianhua: chief technologist, director of Ersha island Branch Laboratory Medicine of Guangdong Provincial Hospital of Chinese Medicine 

Social Headships: Professor Xu is the lead auditor and assessment team leader of CNAS, Guangdong Medical Association of Laboratory Medicine Information and Engineering Group deputy head. Guangdong Provincial Institute of Health Management Professional Committee of Laboratory Medicine, vice chairman. And is the reviewer of “Chinese Journal of Clinical Rehabilitative Tissue Engineering”,Chinese Journal of Clinical Laboratory Scienceand “Journal of Tropical Medicine”.

Academic Achievements: He was mainly responsible for 4 provincial science fund projects, participate in national and other topics more than 10. And he has published more than 40 papers in national and international journals (such as Clinical laboratory, Molecular Biosystems and Chinese Medical Journal). He obtained national invention patent 1 item.

 徐宁:男,医学博士,主任技师,硕士研究生导师,广东省中医院芳村医院检验科主任。

社会任职:中华中医药学会检验医学分会常委、副秘书长,广东省免疫学会临床检验专业委员会副主任委员,广东省健康管理学会检验医学专业委员会副主任委员,中国合格评定国家认可委员会(CNAS)主任评审员。

学术成果:主编人民卫生出版社专著2本(排名23)、副主编人民卫生出版社专著2本(排名24),参编4本;先后在《中华检验医学杂志》、《临床检验杂志》等发表论文20余篇;主持省部级课题4项、厅局级课题3项、院校课题3项,参与国家、省部等各级课题10余项;先后获得省部级科技进步二等奖2项(排名46)、三等奖1项(排名5);获国家实用新型专利2项(排名第1、第2)。

Professor Xu ning: chief technologist, director of Fangcun Branch Laboratory Medicine of Guangdong Provincial Hospital of Chinese Medicine 

Social Headships: Professor Xu served as the Standing Committee of the Chinese Medical Association of Laboratory Medicine, Deputy Secretary-General. He is the vice chairman of Guangdong Provincial Institute of Immunology Clinical Laboratory Committee, and vice chairman of Guangdong Provincial Institute of Health Management Professional Committee of Laboratory Medicine. And he is the lead auditor and assessment team leader of CNAS.

Academic Achievements: He has trained seven graduate students, five doctoral students, and awarded the second prize and third prize of science and technology of Guangdong province, participate in national and other topics more than 10, edited 5 monographs as editor in chief or vice chief, has published more than 60 papers in national and international journals, edited five monographs and edited a textbook, has trained seven master degree students.