cap 實驗室認可的挑戰(zhàn)與應對

1、CAP實驗室認可的挑戰(zhàn)與應對,浙江大學醫(yī)學院附屬第二醫(yī)院譚運年2013.12.13,,1,浙二醫(yī)院檢驗科,ISO15189 2012.4.23-25初次現(xiàn)場評審JCI (Joint Commission's hospital ) 2013.2.18-23 現(xiàn)場評審 CAP （Laboratory Accreditation Program, LAP) 2013.7.10-12 現(xiàn)場評審 2013.9.10衛(wèi)計

2、委三甲年度評審 （全國首家） 2013.7.23-7.27ISO15189 監(jiān)督擴項評審 2013.10.11-13 現(xiàn)場評審,,2,,3,一、為什么要做認可認證？,為什么不想做？,文件工作多學習任務重硬件達不到要求軟件達不到要求只按部分要求做，不評,,4,浙二啟動認可的緣由：對外交流越來越廣，越來越頻繁 特殊的地位：建設一流大學附屬醫(yī)院的需要 醫(yī)院歷史：百年老院，輝煌過去，重塑歷史的要求三甲醫(yī)

3、院復審、JCI評鑒、衛(wèi)生部重點專科臨床藥物研究基地實驗室內部發(fā)展要求,為什么選擇CAP?與美國的合作交流最多JCI 認可CAP實驗室的能力FDA認可CAP實驗室提供的臨床藥物實驗數據醫(yī)院卓越戰(zhàn)略之一CAP是第三方認可機構,2012.3月底正式院務會啟動2012.9月提交CAP 認可申請2013.7.10-12 CAP 現(xiàn)場評審（3位美國專家，1位臺灣同胞，2位國內專家2013.9.10 獲得CAP 認可,浙二C

4、AP 認證時間表CAP Accreditation Chronological Table,二、所有實驗室項目性能符合要求（Method Performance Specifications ）,一、組織架構要清晰、崗位職責要明確、人員資質要陽光Organization Chart ＆Job Responsibility ＆ personnel requriement by testing Complexity,對策：制定合乎要

5、求的組織架構圖、崗位職責以及人員資質政策。困難點：組織結構怎樣體現(xiàn)合理高效？崗位職責如何落實到每一個人？人員資質如何同CLIA88法規(guī)規(guī)定及CAP要求統(tǒng)一？,崗位職責如何落實到每一個人？,現(xiàn)狀：科主任 副主任 組長 普通員工 是崗位嗎？專業(yè)組（生化、免疫、微生物、分子、血液，…)是崗位嗎？崗位匹配是按職稱還是按學歷？,人員資質如何同CLIA88法規(guī)規(guī)定及CAP要求統(tǒng)一？,組織結構怎樣體現(xiàn)合理高效？,管理框架：專業(yè)組設置

6、人員框架： 具體到人,,記錄 和 總結評估,準入和維持,CAP Personnel Requirements by Testing Complexity,*** an annual test volume ＞500,000 must be directed by a high complexity-qualified directorWhile CLIA may allow for non-physician or non-docto

7、ral 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 pro

8、visions.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 Medi

9、cine, Cytopathology, Cytogenetics, Histopathology, Oral Pathology, Histocompatibility) (493.1449). For these specialties, required qualifications include being a physician and/or doctoral scientist, and having specified

10、training/experience. Refer to CLIA for further details. For these specialties, the technical supervisor may be referred to as the section director.,準入,Directors（MD or DO）Clinical Consultant/Technical Consultant(Waived

11、and high complexity not applicable )Section Directors/Technical Supervisors （ MD or DO）Supervisors/General SupervisorsTesting Personnel,,14,A clinical consultant is only required if the director is not a phy

12、sician or a board certified doctoral 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 podiatr

13、y in the State in which the laboratory is located¹; or a doctoral scientist certified by an HHS-approved Board.A technical consultant is only required if the laboratory director is not qualified as a high complexit

14、y director. The technical consultant must be qualified as a high complexity laboratory director.,介于Director and testing personnel 之間人員學歷要求,**REVISED** 07/31/2012TLC.10100 Laboratory Director Qualifications

15、 Phase IIThe 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 ju

16、risdiction where the laboratory is located, andb. Be certified in anatomic or clinical pathology, or both, by the American Board ofPathology or American Osteopathic Board of Pathology, or possess qualificationsequival

17、ent to those required for certificationORa. Be an MD, DO or DPM licensed to practice (if required) in the jurisdiction where thelaboratory is located, and b. Have at least one year of laboratory training during reside

18、ncy, or at least two years of experience supervising high complexity testingOR a. Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratoryscience from an accredited institution, andb

19、. Be certified and continue to be certified by a board approved by HHS** (or, for non-USlaboratories, by an equivalent board)OR, for non-US laboratories (not subject to US regulations) onlya. Laboratory Director shall

20、 be an MD, DO, PhD or shall have commensurate educationand experience necessary to meet personnel requirements as determined by the CAP……….,**REVISED** 07/31/2012GEN.53400 Section Director/Technical Supervisor Qualifi

21、cations/Requirements Phase IISection Directors/Technical Supervisors meet defined qualifications and fulfill the expected responsibilities.NOTE: The section director/technical supervisor in each high complexity la

22、boratory 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 resp

23、onsible for anatomic pathology must be an MD or DO certified in anatomic pathology or possess qualifications equivalent to those required for certification. The section director/technical supervisor responsible for clini

24、cal pathology must be an MD or DO certified in clinical pathology or possess qualifications equivalent to those required for certification; or may be an individual who meets the alternate qualifications for the specialti

25、es 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

26、, mycology, parasitology, virology, diagnostic immunology, chemistry, hematology, cytology, ophthalmic pathology, dermatopathology, oral pathology, radiobioassay, immunohematology. Additional requirements for the sectio

27、n directors of the clinical cytogenetics, histocompatibility and transfusion medicine services are found in the Cytogenetics, Histocompatibility and Transfusion Medicine Checklists, respectively.,HEM.40000 Personnel - Be

28、nch Testing Phase IIThe person in charge of bench testing in hematology has education equivalent to an associate's degree (or beyond) in a chemical, physical or biological science or medical technology and at l

29、east 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

30、(if required) and work history in related field,CHM.25800 Personnel - Bench Testing Phase IIThe person in charge of bench testing in chemistry has education equivalent to an associate's degree (or beyond) in chemic

31、al, physical or biological science or medical technology and at least 4 years experience (one of which must be in clinical chemistry) under a qualified director.Evidence of Compliance:? Records of qualifications includ

32、ing degree or transcript, certification/registration, current license(if required) and work history in related fieldin toxicology、blood gas testing (or certified or registered respiratory therapist ）,GEN.54750 Testing

33、 Personnel Qualifications Phase IIAll 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 medic

34、al laboratory technology from an accredited institution, or equivalent laboratory training2. Personnel performing moderate complexity testing must have at a minimum an earned high school diploma or equivalent and docume

35、nted trainingEvidence of Compliance:? Records of qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field,,17,CAP 普通員工資質要求很具體,陽光資質,,18,T

36、eam Leader Assessment of Director,資質的維持,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

37、made available to staff ● Have you had any complaints that would indicate unsafe ● How do you ensure the laboratory meets the expectations of hospital administrationand medical staff?● How do you ensure that the labo

38、ratory has adequate numbers of properly trained staff?Organization Administrator:● How does the laboratory communicate important laboratory information to administration?● How well does the laboratory meet the operati

39、onal, financial and clinical needs of theorganization?Medical Staff Representative:● How is the laboratory involved in hospital-wide quality management activities, including patient care improvements, patient safely a

40、ctivities 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

41、the organization?,GEN.55500 Competency Assessment Phase IIThe competency of each person to perform his/her assigned duties is assessed.NOTE: during the first year o

42、f an individual's 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 reassessment of employe

43、e 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

44、 applicable, patientidentification and preparation; and specimen collection, handling, processing and testing2. Monitoring the recording and reporting of test results, including, as applicable, reportingcritical resul

45、ts3. Review of intermediate test results or worksheets, quality control records, proficiencytesting results, and preventive maintenance records4. Direct observation of performance of instrument maintenance and functio

46、n checks5. Assessment of test performance through testing previously analyzed specimens, internalblind testing samples or external proficiency testing samples; and6. Evaluation of problem-solving skills。。。。。。,,20,普通

47、員工能力評價,(誰來評估？怎樣評估？明確間隔時間？）,二、所有實驗室項目性能符合要求（METHOD PERFORMANCE SPECIFICATIONS ）（一）項目劃分：豁免和非豁免項目（Waived and non-waived）FDA-cleared or approved tests， 自建方法（Laboratory Develop Test，LDT) 定性/定量（二）性能確定方法：新項目使用前性能確認（veri

48、fication not validation, LDT除外)參加PT或替代實驗方法確保性能質控品的使用回顧性方法使用（VMA,肌酐肌酸異常與臨床匹配問題、分子診斷項目）（三）現(xiàn)狀：大多數實驗室未對新項目進行正確規(guī)范確認PT參加項目有限，PT評估分析，預防糾正不到位；替代方法基本沒做。質控品種類、濃度水平使用不規(guī)范需要回顧性統(tǒng)計分析方法沒有做，有結果難以執(zhí)行。,challenges and strategies,大多數

49、實驗室未對新項目性能進行正確規(guī)范確認遵照CAP對新項目的要求進行確認：規(guī)范新項目申請審批流程，前期調研重點強調臨床需求和項目的法律法規(guī)適應性，重視與各個部門的溝通交流，并且要記錄。按項目實際情況開展性能確認，主要是核實廠家性能參數，看廠家聲明的參數是否可以在實驗室重現(xiàn)。（難點：開放系統(tǒng)或非配套試劑性能驗證存在困難，使用非配套分析系統(tǒng)時，實驗室應采用有證參考物質、正確度控制品等進行正確度驗證或與經確認的參考方法（參考實驗室）

50、進行結果比對以證明實驗室檢驗結果的正確度。如以上方式無法實現(xiàn)，可通過以下方式提供實驗室檢測結果可信度的證明：參加適宜的能力驗證/室間質評，且在最近一個完整的周期內成績合格；與使用相同檢測方法的已獲認可的實驗室、或與使用配套分析系統(tǒng)的實驗室進行比對，結果滿意。解決辦法：盡量使用配套系統(tǒng)）,PT參加項目有限，PT評估分析，預防糾正不到位；替代方法基本沒做。CAP 規(guī)定非美國法律法規(guī)約束的實驗室：只要CAP PT目錄上列有申請認可實驗室

51、給病人發(fā)報告的項目，該實驗室必須參加該種PT或者因為樣品穩(wěn)定性、所在國法律法規(guī)不許可入關等影響的項目可以通過其它替代的方法對項目性能進行監(jiān)督和確定。（2014開始）A laboratory's participation in proficiency testing must include all analytes on CAP catalog list for which it performs patient testi

52、ng.衛(wèi)計委的臨床檢驗中心、各省市臨床檢驗中心提供項目數有限浙二購買CAP產品：2013年82program ,165 package；2014年去掉線性產品（LN序列） 56 program ,124 package，覆蓋>96%項目CAP目錄上沒有的項目（GPDA, AFU… ）、穩(wěn)定性差的項目(糖化血紅蛋白A1C…)法律法規(guī)不許可的項目（結核桿菌培養(yǎng)…），目錄上有但方法學不同糖化血紅蛋白 VMA怎樣處理？規(guī)范

53、PT結果評估與糾正：不滿意（unsatisfactory)、不成功(unsucessfull)…. 替代方法采用規(guī)定的比對方法，參考方法少用,24,,,CHM.10300 PT Evaluation Phase IIThere is ongoing evaluation of PT and alternative assessment results, with prompt

54、corrective action taken for 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 documentatio

55、n of follow-up/corrective action.Evidence of Compliance:?Records of ongoing, timely review of all PT reports and alternative assessment results by the laboratory director or designee AND?Records of investigation of

56、 "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 Failure Scenarios,Typ

57、e of Analytes/Procedures,CMS Regulated: BOLD TYPECenters for Medicare & Medicaid Services (醫(yī)療保險和醫(yī)療補助服務中心) CMS Non-regualated:,,,,,28,What happens when a lab has a PT failure for : a regulated analyte?,Suspensi

58、on of testing,Cessation of testingRevocation of a lab’s accreditation by CMSNon-regulated analytes?Each accrediting agency has different PT oversight standards.,,質控品種類、濃度水平使用不規(guī)范,CAP Chemistry and Toxicology Checkl