机构名称：卫生部临床检验中心

1、机构名称：卫生部临床检验中心 注册号：pt0016地址：a：北京市东城区东单大华路1号获准认可能力索引序号地址能力范围评审类型更新时间1a授权签字人（中文）初评2012年11月22日2授权签字人（英文）初评2012 年 11 月 22 口3授权签字人（中文）监督+扩项2014 年 01 j1 14 li4授权签字人（英文）监督+扩项2014年01月14日5a能力范围（中文）初评2012年11月22日6能力范围（英文）初评2012 年 11 刀 22 口7能力范1韦1（屮文）监督+扩项2014 年 01 月 14 |_|8能力范围（英文）监督+扩项2014年01月4日name： national

2、 center for clinical laboratoriesregistration no.： pt0016address：a: no.1, dahua road, dongdan, dongcheng district, beijing,chinaindex of accredited signatoriesno.addressrangetypeupdate date1aapproved signatories (chinese)initialassessment2012-11-222approved signatories (english)initialassessment2012

3、-11-223approved sianatories (chinese)surveillance+e xtending assessment2014-01-144approved signatories (english)surveillance+e xtending assessment2014-01-145ascope ofaccreditation(chinese)initialassessment2012-11-226scope ofaccreditation(enolish)initialassessment2012-11-227scope ofaccredltatlon(chin

4、ese)surveillance+e xtending assessment2014-01-148scope ofaccreditation(english)surveillance+e xtending assessment2014-01-14中国合格评定国家认可委员会认可证书附件（注册号：cnas pt0016）名称：卫生部临床检验中心 地址：北京市东城区东单大华路1号签发日期：2012年11月22日有效期至：2015年11月21日更新日期：2012年11月22日附件1 认可的授权签字人及领域序号姓名授权签字领域备注1陈文祥细菌学(0703)、病毒学(0705)、血清学(0708)、 血液

5、学(0711)、化学病理学(0720)、医学应用 病理学(0726)检测领域2王治国细菌学(0703)、病毒学(0705)、血清学(0708)、 血液学(0711)、化学病理学(0720)、医学应用 病理学(0727)检测领域3李金明病毒学(0705)、血清学(0708)检测领域4彭明婷血液学(0711)检测领域5张传宝化学病理学(0720)检测领域6胡继红细菌学(0703)检测领域cnaschina national accreditation service for conformity assessmentappendix of accreditation certificate(reg

6、istration no. cnas pt0016)name: national center for clinical laboratoriesaddress:no.1, dahua road, dongdan, dongcheng district, beijing, chinadate of lssue:2012-11 -22date of expiry:2015-11 -21date of update： 2012-11-22appendix 1 accredited signatories and scopej2nameauthorized scope of signaturenot

7、e1chen wenxianginspection： bacteriology(0703), virology(0705), serology(0708), hematology(0711), chemical pathology(0720), medical applied pathology(0726)2wang zhiguoinspection： bacteriology()7()3), virology(0705), serology(0708), hcmatology(0711), chemical pathology(0720), medical applied pathology

8、(0727)3li jinminginspection： virology(0705), serology(0708)4feng mingtinginspection： hematology(0711)5zhang chuanbcioinspection： chemical pathology(0720)6hu jihonginspection： bacteriology(0703)cnas中国合格评定国家认可委员会认可证书附件（注册号：cnas pt0016）名称：卫生部临床检验中心地址：北京市东城区东单大华路1号认可依据：iso/iec17043: 2010以及cnas特定认可要求签发日期

9、：2012年11月22日 有效期至：2015年11月21日更新日期：2012年11月22日附件2认可的能力范围序号样品名称项目/参数领域代码备注序号名称1全血1红细胞计数0711.012白细胞计数0711.013血小板计数0711.014血红蛋口测定0726. 015红细胞比容0711.266糖化血红蛋口 ale0720. 182血清基质制备物1钠0720. 012钾0720. 013氯0720. 014磷0720. 015铁0720. 016镁0720. 01序号样品名称项目/参数领域代码备注序号名称2血清基质制备物7总钙0720. 018总蛋口0720. 029白蛋口0720. 022血清

10、基质制备物10葡萄糖0720.0111肌酹0720.0112尿素氮0720. 0113尿酸0720. 0114总胆红索0720.0115直接胆红素0720. 0116总胆固醇0720. 0117廿油二酯0720.0118内氨酸氨基转移酶0720. 0219天冬氨酸氨基转移酶0720. 0220肌酸激酶0720. 0221y -谷氨酰基转移酶0720. 0222乳酸脱氢酶0720. 0223淀粉酶0720. 0224乙型肝炎病毒表面抗原0708. 0125乙型肝炎病毒表而抗体0708. 0126乙型肝炎病毒e抗原0708. 0127乙型肝炎病毒0抗体0708.0128乙型肝炎病毒核心抗体0708

11、.0129丙型肝炎病毒抗体0708. 01序号样品名称项目/参数领域代码备注序号名称2血清基质制备物30乙型肝炎病毒表面 抗原（确认试验）0708. 0131丙型肝炎病毒抗体（确认试验）0708. 012血清基质制备物32乙型肝炎病毒脱氧 核糖核酸0705. 0333内型肝炎病毒核糖核酸0705. 033冻干菌株1尿培养及鉴定0703. 042血培养及鉴定0703. 043需氧菌药敏试验0703. 064新鲜冰冻血 清1内氨酸氨棊转移酶0720. 022天冬氨酸氨基转移酶0720. 023肌酸激酶0720. 024y -谷氨酰基转移酶0720. 025乳酸脱氢酶0720. 026淀粉酶0720

12、. 027总胆固醇0720.018高密度脂蛋口胆固醇0720. 019低密度脂蛋白胆固醇0720. 0110甘油三酯0720. 0111葡萄糖0720.0112肌酹0720.0113尿素0720. 0114尿酸0720.01china national accreditation service for conformity assessmentappendix of accreditation certificate(registration no. cnas pt0016)name: national center for clinical laboratoriesaddress:no.1

13、, dahua road, dongdan, dongcheng district, beijing, chinaaccred i tat i on criteria: i so/1ec17043:2010 and re ievant requ i rements of cnasdate of lssue:2012-11 -22date of expiry:2015-11 -21date of update： 2012-11 -22appendix 2 scope of accreditationjx®sampleitem/parametercode of fieldnotejxoi

14、tem/parameter1whole blood1red blood cell0711.012white blood cell0711.013platelet0711.014hemoglobin0726.015hematocrit0711.266glycated haemoglobinale0720.182serum-basedmaterial1sodium0720.012potassium0720.013chloride0720.014phosphate0720.015iron0720.016magnesium0720.017calcium0720.018total protein0720

15、.02j2sampleitem/parametercode of fieldnotejnsitcm/paramcter9albumin0720.022serum-basedmaterial10glucose0720.0111creatinine0720.0112urea0720.0113uric acid0720.0114total bilirubin0720.0115direct-bilirubin0720.0116cholesterol0720.0117glyceride0720.0118alanine aminotransferase0720.022serum-basedmaterial

16、19asparate aminotransferase0720.0220creatine kinase0720.0221g-glutamyltransferase0720.0222lactate dehydrogenase0720.0223amylase0720.0224hbsag0708.0125anti-hbs0708.0126hbeag0708.0127anti-hbe0708.0128anti-hbc0708.0129anti-hcv0708.0130hbsag (confirm test)0708.0131anti-hcv (confirm test)0708.0132hbv dna

17、0705.0333hcv rna0705.033lyophilizedstrains1urineculture&i dentification0703.042bloodculture&i dentification0703.043aerobic ast0703.06j2sampleitem/parametercode of fieldnotejnsitcm/paramcter4fresh frozen serum1alanine aminotransferase0720.024fresh frozen serum2a sparate aminotransferase0720.0

18、23creatine kinase0720.024g-glutamyltransferase0720.025lactate dehydrogenase0720.026amylase0720.027cholesterol0720.018high density lipo-protein cholesterol0720.019low density lipo-protein cholesterol0720.0110glyceride0720.0111glucose0720.0112creatinine0720.0113urea0720.0114uric acid0720.01中国合格评定国家认可委

19、员会认可证书附件（注册号：cnas pt0016）名称：卫生部临床检验中心地址：北京市东城区东单大华路1号签发日期：2012年11月22日有效期至：2015年11月21日更新日期：2014年01月14日附件1 认可的授权签字人及领域序号姓名授权签字领域备注1王治国细菌学、病看学、血清学、血液学、化学病 理学、医学应用病理学、免疫学项冃2李金明病毒学、血清学项目3彭明婷血液学、医学应用病理学项冃4张传宝化学病理学、免疫学项冃5胡继红细菌学项目china national accreditation service for conformity assessmentappendix of accr

20、editation certificate(registration no. cnas pt0016)name: national center for clinical laboratoriesaddress:no.1, dahua road, dongdan, dongcheng district, beijing, chinadate of lssue:2012-11 -22date of expiry:2015-11 -21date of update： 2014-01-14appendix 1 accredited signatories and scopej2nameauthori

21、zed scope of signaturenote1wang zhiguoaccredited items on bacteriology(0703),virology(0705), serology(0708), hematology(0711), chemical pathology(0720), medical applied pathology(0727) and immunology(0712)2li jinmingaccredited items on virology(0705) andserology(0708)3peng mingtingaccredited items o

22、n hematology(0711) and medical applied pathology(0727)4zhang chuanbcioaccredited items on chemicalpathology(0720) and immunology(0712)5hu jihongaccredited items on bacteriology(0703)中国合格评定国家认可委员会认可证书附件（注册号：cnas pt0016）名称：卫生部临床检验中心地址：北京市东城区东单大华路1号认可依据：iso/iec17043: 2010以及cnas特定认可要求签发日期：2012年11月22日 有效

23、期至：2015年11月21日更新日期：2014年01月14日附件2认可的能力范围序号样品名称项目/参数领域代码备注序号名称1全血1红细胞计数0711.012白细胞计数0711.013血小板计数0711.014血红蛋口测定0726. 015红细胞比容0711.266糖化血红蛋口 ale0720. 182血清基质制备物1钠0720. 012钾0720. 013氯0720. 014磷0720. 015铁0720. 01序号样品名称项目/参数领域代码备注序号名称2血清基质制备物6镁0720. 017总钙0720. 018总蛋口0720. 029口蛋口0720. 0210葡萄糖0720. 0111肌酊0

24、720. 0112尿素氮0720. 0113尿酸0720. 0114总胆红索0720.0115直接胆红素0720. 0116总胆固醇0720. 0117甘油=酯0720. 0118丙氨酸氨基转移酶0720. 0219天冬氨酸氨基转移酶0720. 0220肌酸激酶0720. 0221y-谷氨酰基转移酶0720. 0222乳酸脱氢酶0720. 0223淀粉酶0720. 0224乙肝表面抗原试验070& 0125乙肝表而抗体试验0708. 0126乙肝e抗原试验0708. 0127乙肝e抗体试验070& 0128乙肝核心抗体试验070& 0129丙肝抗体试验0708. 013

25、0乙肝表面抗原确认试验0708. 0131丙肝抗体确认试验0708. 0132hbv dna0705. 03序号样品名称项目/参数领域代码备注序号名称2血清基质制备物33hcv rna0705. 0334游离t30720. 0935总t30720. 0936游离t40720. 0937总t40720. 0938tsh0720. 0939皮质醇0720. 0940雌二醇0720. 0941fsh0720. 0942lh0720. 0943孕酮0720. 0944催乳素0720. 0945睾酮0720. 0946c-肽0720. 0947叶酸0720. 1548胰岛素0720. 0949维牛:素b

26、120720. 155025-症维牛:素d20720. 225125-症维牛:素d30720. 2252总维生索d0720. 2253iga0712.0154ige0712. 0255igg0712.0156igm0712.0157c30712. 0358c40712. 0359crp0712. 0760re0712. 0561aso0712. 07序号样品名称项目/参数领域代码备注序号名称2血清基质制备物62转铁蛋门0720. 0263iju白蛋白0720. 0264总psa0720. 2665cea0720. 2166afp0720. 2667hcg0720. 2668ca1990720.

27、 2669ca1250720. 2670ca1530720. 2671b2-微球蛋口0720. 2672铁蛋口0720. 2673总b-hcg亚单位0720. 2674游离psa0720. 263冻干菌株1尿培养及鉴定0703. 042血培养及鉴定0703. 043需氧菌药敏试验0703. 064新鲜冰冻血清1丙氨酸氨基转移酶0720. 022天冬氨酸氨基转移酶0720. 023肌酸激酶0720. 024y-谷氨酰基转移酶0720. 025乳酸脱氢酶0720. 026淀粉酶0720. 027总胆固醇0720. 018高密度脂蛋白胆固醇0720. 019低密度脂蛋口胆固醇0720. 01序号样品

28、名称项目/参数领域代码备注序号名称4新鲜冰冻血 清10甘汕-酯0720. 0111葡萄糖0720. 0112肌酊0720. 0113尿素0720. 0114尿酸0720. 0115总蛋口0720. 025血浆1凝血酶原时间0711. 142激活部分凝血活酶时间0711. 143纤维蛋门原0711. 146尿液1尿液葡萄糖0726. 022尿液蛋口质0726. 023尿液隐血0726. 024尿液亚硝酸盐0726. 025尿液恫体0726. 026尿液白细胞0726. 027尿液胆红素0726. 028尿液酸碱度0726. 029尿液比重0726. 0210尿液尿胆原0726. 0211钾072

29、0. 0112钠0720. 0113氯0720. 0114钙0720. 0115镁0720. 0116磷0720. 0117葡萄糖0720. 0118尿素0720. 0119肌酎0720. 01序号样品名称项目/参数领域代码备注序号名称6尿液20尿酸0720. 0121总蛋门0720. 0122微量口蛋口0720. 0123淀粉酶0720. 017冰冻全血1糖化血红蛋门0720. 188溶液1血氧分压(p02)0720. 042二氧化碳分压(p02)0720. 043酸碱度(ph)0720. 04china national accreditation service for conformi

30、ty assessmentappendix of accreditation certificate(registration no. cnas pt0016)name: national center for clinical laboratoriesaddress:no.1, dahua road, dongdan, dongcheng district, beijing, chinaaccred i tat i on criteria: i so/1ec17043:2010 and re ievant requ i rements of cnasdate of lssue:2012-11

31、-22date of expiry:2015-11 -21date of update： 2014-01-14appendix 2 scope of accreditationjvfisampleitem/parametercode of fieldnoteitem/parameter1whole blood1red blood cell711.012white blood cell711.013platelet711.014hemoglobin726.015hematocrit711.266glycated hemoglobin720.182serum-basedmaterial1sodiu

32、m720.012potassium720.013chloride720.014phosphate720.015iron720.016magnesium720.017calcium720.018total protein720.029albumin720.02j2sampleitem/parametercode of fieldnoteitem/parameter2serum-basedmaterial10glucose720.0111creatinine720.0112urea720.0113uric acid720.012serum-basedmaterial14total bilirubi

33、n720.0115direct-bilirubin720.0116cholesterol720.0117glyceride720.0118alanine aminotransferase720.0219asparate aminotransferase720.0220creatine kinase720.0221g-glutamyltransferase720.0222lactate dehydrogenase720.0223amylase720.0224hbsag708.0125anti-hbs708.0126hbeag708.0127anti-hbe708.0128anti-hbc708.

34、0129anti-hcv708.0130hbsag (confirm test)708.0131anti-hcv (confirm test)708.0132hbv dna705.0333hcv rna705.0334free triiodothyronine0720.0935total triiodothyronine0720.0936free tetraiodothyronine0720.0937total tetraiodothyronine0720.092serum-basedmaterial38thyrotrophin0720.09j2sampleitem/parametercode

35、 of fieldnoteitem/parameter2serum-basedmaterial39cortisol0720.0940estradiol0720.0941follicle stimulatinghormone0720.0942luteinizing hormone0720.0943progesterone0720.0944prolactin0720.0945testesterone0720.0946c-peptide0720.0947folic acid0720.1548insulin0720.0949vitamin b120720.155025-hydroxyvitamin d

36、20720.225125-hydroxyvitamin d30720.2252vitamin d0720.2253immunoglobulin a0712.0154immunoglobulin e0712.0255immunoglobulin g0712.0156immunoglobulin m0712.0157complement 30712.0358complement 40712.0359c-reactive protein0712.0760rheumatoid factor0712.0561antistreptolysin o0712.072scrum-bascdmaterial62t

37、ransferrin0720.0263prealbumin0720.0264total prostate specific antigen0720.2665carcinoembryonic antigen0720.2166alpha-fctoprotcin0720.26j2sampleitem/parametercode of fieldnoteitem/parameter2serum-basedmaterial67human chorionicgonadotropin0720.2668carbohydrate atigen 19-90720.2669carbohydrate atigen 1250720.2670carbohydrate atigen 1530720.2671beta2-microglobulin0720.2672fenitin0720.2673total beta-hcg0720.2674free prostate specific antigen0720