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1、CAP实验室认可的挑战与应对,浙江大学医学院附属第二医院 谭运年 2013.12.13,1,浙二医院检验科,ISO15189 2012.4.23-25初次现场评审 JCI (Joint Commissions hospital ) 2013.2.18-23 现场评审 CAP （Laboratory Accreditation Program, LAP) 2013.7.10-12 现场评审 2013.9.10 卫计委三甲年度评审 （全国首家） 2013.7.23-7.27 ISO15189 监督扩项评审 2013.10.11-13 现场评审,2,3,一、为什么要做认可认证？,为什么不想做？,文件
2、工作多 学习任务重 硬件达不到要求 软件达不到要求 只按部分要求做，不评,4,浙二启动认可的缘由： 对外交流越来越广，越来越频繁 特殊的地位：建设一流大学附属医院的需要 医院历史：百年老院，辉煌过去，重塑历史的要求 三甲医院复审、JCI评鉴、卫生部重点专科 临床药物研究基地 实验室内部发展要求,为什么选择CAP? 与美国的合作交流最多 JCI 认可CAP实验室的能力 FDA认可CAP实验室提供的临床药物实验数据 医院卓越战略之一 CAP是第三方认可机构,2012.3月底正式院务会启动 2012.9月提交CAP 认可申请 2013.7.10-12 CAP 现场评审（3位美国专家，1位台湾同胞，2
3、位国内专家 2013.9.10 获得CAP 认可,浙二CAP 认证时间表 CAP Accreditation Chronological Table,二、所有实验室项目性能符合要求 （Method Performance Specifications ）,一、组织架构要清晰、岗位职责要明确、人员资质要阳光 Organization Chart Job Responsibility personnel requriement by testing Complexity,对策： 制定合乎要求的组织架构图、岗位职责以及人员资质政策。 困难点： 组织结构怎样体现合理高效？ 岗位职责如何落实到每一个人？
4、 人员资质如何同CLIA88法规规定及CAP要求统一？,岗位职责如何落实到每一个人？,现状： 科主任 副主任 组长 普通员工 是岗位吗？ 专业组（生化、免疫、微生物、分子、血液，)是岗位吗？ 岗位匹配是按职称还是按学历？,人员资质如何同CLIA88法规规定及CAP要求统一？,组织结构怎样体现合理高效？,管理框架：专业组设置 人员框架： 具体到人,记录 和 总结评估,准入和维持,CAP Personnel Requirements by Testing Complexity,* an annual test volume 500,000 must be directed by a high co
5、mplexity-qualified director While CLIA may allow for non-physician or non-doctoral degreed individuals to direct Waived and Moderate Complexity laboratories, CAP does not. CAP accredited laboratories must be directed by a physician or doctoral degreed individual. Refer to CLIA88 for grandfather prov
6、isions. CLIA requires at minimum a bachelor degreed individual for technical supervisor of most laboratory sections. CLIA requires special qualifications for technical supervisor in certain specialties (Transfusion Medicine, Cytopathology, Cytogenetics, Histopathology, Oral Pathology, Histocompatibi
7、lity) (493.1449). For these specialties, required qualifications include being a physician and/or doctoral scientist, and having specified training/experience. Refer to CLIA for further details. For these specialties, the technical supervisor may be referred to as the section director.,准入,Directors（
8、MD or DO） Clinical Consultant/Technical Consultant(Waived and high complexity not applicable ) Section Directors/Technical Supervisors （ MD or DO） Supervisors/General Supervisors Testing Personnel,14,A clinical consultant is only required if the director is not a physician or a board certified docto
9、ral scientist. The clinical consultant must be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; or a doctoral scientist certified by an HHS-approved Board. A
10、technical consultant is only required if the laboratory director is not qualified as a high complexity director. The technical consultant must be qualified as a high complexity laboratory director.,介于Director and testing personnel 之间人员学历要求,*REVISED* 07/31/2012 TLC.10100 Laboratory Director Qualifica
11、tions Phase II The laboratory director satisfies the personnel requirements of the College of American Pathologists. The director must: a. Be an MD or DO licensed to practice (if required) in the jurisdiction where the laboratory is located, and b. Be certified in anatomic or clinical pathology, or
12、both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent to those required for certification OR a. Be an MD, DO or DPM licensed to practice (if required) in the jurisdiction where the laboratory is located, and b. Have at least one yea
13、r of laboratory training during residency, or at least two years of experience supervising high complexity testing OR a. Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution, and b. Be certified and continue to be certified
14、 by a board approved by HHS* (or, for non-US laboratories, by an equivalent board) OR, for non-US laboratories (not subject to US regulations) only a. Laboratory Director shall be an MD, DO, PhD or shall have commensurate education and experience necessary to meet personnel requirements as determine
15、d by the CAP .,*REVISED* 07/31/2012 GEN.53400 Section Director/Technical Supervisor Qualifications/Requirements Phase II Section Directors/Technical Supervisors meet defined qualifications and fulfill the expected responsibilities. NOTE: The section director/technical supervisor in each high complex
16、ity laboratory section can be a licensed MD or DO with certification in anatomic and/or clinical pathology, or qualifications equivalent to those required for board certification. The section director/technical supervisor responsible for anatomic pathology must be an MD or DO certified in anatomic p
17、athology or possess qualifications equivalent to those required for certification. The section director/technical supervisor responsible for clinical pathology must be an MD or DO certified in clinical pathology or possess qualifications equivalent to those required for certification; or may be an i
18、ndividual who meets the alternate qualifications for the specialties supervised. For laboratories subject to US regulations, alternate qualifications for the following specialty areas can be found in Fed Register. 1992(Feb 28): 7177-7180 42CFR493.1449: bacteriology, mycobacteriology, mycology, paras
19、itology, virology, diagnostic immunology, chemistry, hematology, cytology, ophthalmic pathology, dermatopathology, oral pathology, radiobioassay, immunohematology. Additional requirements for the section directors of the clinical cytogenetics, histocompatibility and transfusion medicine services are
20、 found in the Cytogenetics, Histocompatibility and Transfusion Medicine Checklists, respectively.,HEM.40000 Personnel - Bench Testing Phase II The person in charge of bench testing in hematology has education equivalent to an associates degree (or beyond) in a chemical, physical or biological scienc
21、e or medical technology and at least 4 years experience (one of which is in clinical hematology) under a qualified director. Evidence of Compliance: Records of qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field,C
22、HM.25800 Personnel - Bench Testing Phase II The person in charge of bench testing in chemistry has education equivalent to an associates degree (or beyond) in chemical, physical or biological science or medical technology and at least 4 years experience (one of which must be in clinical chemistry) u
23、nder a qualified director. Evidence of Compliance: Records of qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field in toxicology、blood gas testing (or certified or registered respiratory therapist ）,GEN.54750 Testi
24、ng Personnel Qualifications Phase II All testing personnel meet the following requirements. 1. Personnel performing high complexity testing must have at a minimum an earned associate degree in a laboratory science or medical laboratory technology from an accredited institution, or equivalent laborat
25、ory training 2. Personnel performing moderate complexity testing must have at a minimum an earned high school diploma or equivalent and documented training Evidence of Compliance: Records of qualifications including degree or transcript, certification/registration, current license (if required) and
26、work history in related field,17,CAP 普通员工资质要求很具体,阳光资质,18,Team Leader Assessment of Director,资质的维持,Laboratory Director: What quality improvement initiatives have been most successful during the past two years? Which are works in progress? What educational programs have been made available to staff Ha
27、ve you had any complaints that would indicate unsafe How do you ensure the laboratory meets the expectations of hospital administration and medical staff? How do you ensure that the laboratory has adequate numbers of properly trained staff? Organization Administrator: How does the laboratory communi
28、cate important laboratory information to administration? How well does the laboratory meet the operational, financial and clinical needs of the organization? Medical Staff Representative: How is the laboratory involved in hospital-wide quality management activities, including patient care improvemen
29、ts, patient safely activities and teaching conferences? How does the laboratory communicate important laboratory information to medical staff? How well does the laboratory meet the patients care needs (TAT, accuracy, responsiveness) of the organization?,GEN.55500 Competency Assessment Phase II The c
30、ompetency of each person to perform his/her assigned duties is assessed. NOTE: during the first year of an individuals duties, competency must be assessed at least semiannually. After an individual has performed his/her duties for one year, competency must be assessed annually. Retraining and reasse
31、ssment of employee competency must occur when problems are identified with employee performance. Elements of competency assessment include but are not limited to: 1. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specime
32、n collection, handling, processing and testing 2. Monitoring the recording and reporting of test results, including, as applicable, reporting critical results 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance record
33、s 4. Direct observation of performance of instrument maintenance and function checks 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and 6. Evaluation of problem-solving skills 。 。,20,普通员工能力评价,(谁
34、来评估？怎样评估？明确间隔时间？）,二、所有实验室项目性能符合要求（METHOD PERFORMANCE SPECIFICATIONS ） （一）项目划分： 豁免和非豁免项目（Waived and non-waived） FDA-cleared or approved tests， 自建方法（Laboratory Develop Test，LDT) 定性/定量 （二）性能确定方法： 新项目使用前性能确认（verification not validation, LDT除外) 参加PT或替代实验方法确保性能 质控品的使用 回顾性方法使用（VMA,肌酐肌酸异常与临床匹配问题、分子诊断项目） （三）
35、现状： 大多数实验室未对新项目进行正确规范确认 PT参加项目有限，PT评估分析，预防纠正不到位；替代方法基本没做。 质控品种类、浓度水平使用不规范 需要回顾性统计分析方法没有做，有结果难以执行。,challenges and strategies,大多数实验室未对新项目性能进行正确规范确认 遵照CAP对新项目的要求进行确认： 规范新项目申请审批流程，前期调研重点强调临床需求和项目的法律法规适应性，重视与各个部门的沟通交流，并且要记录。 按项目实际情况开展性能确认，主要是核实厂家性能参数，看厂家声明的参数是否可以在实验室重现。 （难点：开放系统或非配套试剂性能验证存在困难，使用非配套分析系统时，
36、实验室应采用有证参考物质、正确度控制品等进行正确度验证或与经确认的参考方法（参考实验室）进行结果比对以证明实验室检验结果的正确度。如以上方式无法实现，可通过以下方式提供实验室检测结果可信度的证明：参加适宜的能力验证/室间质评，且在最近一个完整的周期内成绩合格；与使用相同检测方法的已获认可的实验室、或与使用配套分析系统的实验室进行比对，结果满意。 解决办法：尽量使用配套系统）,PT参加项目有限，PT评估分析，预防纠正不到位；替代方法基本没做。 CAP 规定非美国法律法规约束的实验室：只要CAP PT目录上列有申请认可实验室给病人发报告的项目，该实验室必须参加该种PT或者因为样品稳定性、所在国法律
37、法规不许可入关等影响的项目可以通过其它替代的方法对项目性能进行监督和确定。（2014开始）A laboratorys participation in proficiency testing must include all analytes on CAP catalog list for which it performs patient testing. 卫计委的临床检验中心、各省市临床检验中心提供项目数有限 浙二购买CAP产品：2013年82program ,165 package；2014年去掉线性产品（LN序列） 56 program ,124 package，覆盖96%项目 CAP
38、目录上没有的项目（GPDA, AFU ）、稳定性差的项目(糖化血红蛋白A1C)法律法规不许可的项目（结核杆菌培养），目录上有但方法学不同糖化血红蛋白 VMA 怎样处理？ 规范PT结果评估与纠正：不满意（unsatisfactory)、不成功(unsucessfull). 替代方法采用规定的比对方法，参考方法少用,24,CHM.10300 PT Evaluation Phase II There is ongoing evaluation of PT and alternative assessment results, with prompt corrective action taken f
39、or unacceptable results. Primary records are retained for two years These include all instrument tapes, work cards, computer pri ntouts, evaluation reports, evidence of review, and documentation of follow-up/corrective action. Evidence of Compliance: Records of ongoing, timely review of all PT repor
40、ts and alternative assessment results by the laboratory director or designee AND Records of investigation of “unacceptable“ PT and alternative assessment results including records of corrective action that is appropriate to the nature and magnitude of the problem,Unsatisfictory unsuccessful,PT Failu
41、re Scenarios,Type of Analytes/Procedures,CMS Regulated: BOLD TYPE Centers for Medicare & Medicaid Services (医疗保险和医疗补助服务中心) CMS Non-regualated:,28,What happens when a lab has a PT failure for : a regulated analyte?,Suspension of testing, Cessation of testing Revocation of a labs accreditation by CMS Non-regulated analytes? Each accrediting agency has different PT oversight standards.,质控品种类、浓度水平使用不规范,CAP Chemistry and Toxicology Checklist 中要求：定量2个浓度（血气除外），定性阴阳两个水平 应对： 按要求使用质控,回顾性统计分析方法没有做，有结果难以执行。,对有些特定项目如果一个项目从来没有做出阳性，考虑取消,30,关键因素：人 合格的科主任以及员工 (Qualified Directors and Staffs) 有度合理使用员工,谢谢!,31,