1、1,ISO15189認可和CAP認證的流程和體會,浙江大學(xué)醫(yī)學(xué)院附屬第二醫(yī)院 譚運年 2013.11.08,一、為什么要做？ 二、認證認可差別 三、體系建立和檢查手段 四、申請流程和體會,3,HELP ! FREE,一、為什么要做？,4,為什么不想做？據(jù)說 聽說 傳說,文件工作多 學(xué)習任務(wù)重 硬件達不到要求 軟件達不到要求 只按部分要求做，不評,5,推動的因素,外部： 國內(nèi)：優(yōu)質(zhì)醫(yī)院、等級醫(yī)院、衛(wèi)生部重點?？圃u審。 國外：JCI (Joint Commission on Accreditation of Healthcare Organizations ,JCAHO) ，CAP（ Colleg

2、e of American Pathologist） 內(nèi)部： 自身發(fā)展的需要、自重、自尊。,6,歸根到底：高品質(zhì)醫(yī)療服務(wù)的需要,質(zhì)的需要：深度提供項目的質(zhì)量 量的需要：廣度覆蓋面（提供多少項目、服務(wù)人群、對口支援單位）,7,回歸到正確的服務(wù)軌道上,過去：體系不完善、服務(wù)質(zhì)量有待提高 現(xiàn)在：提倡服務(wù)對象至上、服務(wù)契合對象需要,8,實驗室如何證明自己的能力,第一方證明-自我聲明 第二方證明-客戶的證明 第三方證明-公正權(quán)威的證明,9,浙二醫(yī)院檢驗科,ISO15189 初次評審 20-25 現(xiàn)場評審 20 獲得認可（編號121） CAP （Laboratory Accreditation Progr

3、am, LAP) 200-12 現(xiàn)場評審 200 獲得認證（中國大陸第6家公立醫(yī)院） ISO15189 監(jiān)督擴項評審 2013.10.11-13 現(xiàn)場評審,10,背景簡介,認可認證依據(jù),11,12,二、認證認可差別Certification Accreditation,13,發(fā)個證先，你們符合結(jié)婚的條件,14,區(qū)分重點,誰組織檢查：第三方還是權(quán)威機構(gòu)？ 檢查是體系要求符合性認定還是能力的認定？ 區(qū)別是建立在有一定內(nèi)涵聯(lián)系基礎(chǔ)上 CAP 英文中稱Accreditation,15,ISO I5189 實驗室文件體系,ISO15189:2007醫(yī)學(xué)實驗室-質(zhì)量和能力的要求 CNAS-CL02：200

4、8醫(yī)學(xué)實驗室質(zhì)量和能力認可準則 ISO15189:2012醫(yī)學(xué)實驗室-質(zhì)量和能力的要求于2012年11月1日發(fā)布。國際實驗室認可合作組織（ILAC）要求各國認可組織于2016年3月1日前完成標準轉(zhuǎn)換工作。,準則核查表 20實施的專業(yè)組核查表,三、體系建立和檢查手段,16,CAP 實驗室文件體系,CLIA 88美國臨床實驗室改進修正法規(guī)88 Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinic

5、al laboratory testing performed on humans in the United States, except clinical trials and basic research. 2003 CDC and CMS modified CLSI美國臨床和實驗室標準協(xié)會 Clinical and Laboratory Standards Institute is a volunteer driven, membership supported, nonprofit, standards organization. CLSI promotes the developm

6、ent and use of voluntary laboratory consensus standards and guidelines within the health care community.,CAP 3000 Checklist,17,評審依據(jù)的內(nèi)容,18,ISO 15189 4.1 組織和管理,對比舉例一、組織和管理,注：包括實驗室負責人和普通員工要求（ISO中未見一般員工要求）,19,CAP PERSONNEL REQUIREMENT BY TESTNG COMPLEXITY,DIRECTORS（MD or DO） SECTION DIRECTORS/TECHNICAL

7、SUPERVISORS （ MD or DO） SUPERVISORS/GENERAL SUPERVISORS ALL PERSONNEL,CAP 組織和管理,*REVISED* 07/31/2012 TLC.10100 Laboratory Director Qualifications Phase II The laboratory director satisfies the personnel requirements of the College of American Pathologists. The director must: a. Be an MD or DO licens

8、ed to practice (if required) in the jurisdiction where the laboratory is located, and b. Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent to those required for certification OR

9、 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 year 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 che

10、mical, physical, biological, or clinical laboratory science from an accredited institution, and b. Be certified and continue to be certified 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. Laborator

11、y Director shall be an MD, DO, PhD or shall have commensurate education and experience necessary to meet personnel requirements as determined by the CAP .,*REVISED* 07/31/2012 GEN.53400 Section Director/Technical Supervisor Qualifications/Requirements Phase II Section Directors/Technical Supervisors

12、 meet defined qualifications and fulfill the expected responsibilities. NOTE: The section director/technical supervisor in each high complexity laboratory section can be a licensed MD or DO with certification in anatomic and/or clinical pathology, or qualifications equivalent to those required for b

13、oard certification. The section director/technical supervisor responsible 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 clinical pathology

14、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 specialties supervised. For laboratories subject to US regulations, alternate qualifications for the fo

15、llowing specialty areas can be found in Fed Register. 1992(Feb 28): 7177-7180 42CFR493.1449: bacteriology, mycobacteriology, mycology, parasitology, virology, diagnostic immunology, chemistry, hematology, cytology, ophthalmic pathology, dermatopathology, oral pathology, radiobioassay, immunohematolo

16、gy. Additional requirements for the section directors of the clinical cytogenetics, histocompatibility and transfusion medicine services are found in the Cytogenetics, Histocompatibility and Transfusion Medicine Checklists, respectively.,22,HEM.40000 Personnel - Bench Testing Phase II The person in

17、charge of bench testing in hematology has education equivalent to an associates degree (or beyond) in a chemical, physical or biological science or medical technology and at least 4 years experience (one of which is in clinical hematology) under a qualified director. Evidence of Compliance: Records

18、of qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field,CHM.25800 Personnel - Bench Testing Phase II The person in charge of bench testing in chemistry has education equivalent to an associates degree (or beyond) i

19、n chemical, 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 including degree or transcript, certification/registration, current license (if

20、required) and work history in related field in toxicology、blood gas testing (or certified or registered respiratory therapist ）,GEN.54750 Testing Personnel Qualifications Phase II All testing personnel meet the following requirements. 1. Personnel performing high complexity testing must have at a mi

21、nimum an earned associate degree in a laboratory science or medical laboratory technology from an accredited institution, or equivalent laboratory training 2. Personnel performing moderate complexity testing must have at a minimum an earned high school diploma or equivalent and documented training E

22、vidence of Compliance: Records of qualifications including degree or transcript, certification/registration, current license (if required) and work history in related field,CAP 普通員工資質(zhì)要求很具體,23,所有員工的資質(zhì)證明,24,對比舉例二、人員能力評價,生化： 應(yīng)制定員工能力評審的內(nèi)容和方法，每年評審員工的工作能力；對新進員工在最初2個月內(nèi)應(yīng)至少進行2次能力評審（間隔為30天），并記錄。當職責變更時，或離崗6個月以

23、上再上崗時，或政策、程序、技術(shù)有變更時，應(yīng)對員工進行再培訓(xùn)和再評審。沒有通過評審的人員需經(jīng)再培訓(xùn)和再評審，合格后才可繼續(xù)上崗，并記錄。 血液： 應(yīng)制定員工能力評審的內(nèi)容和方法，每年評審員工的工作能力；對新進員工，尤其是從事血液學(xué)形態(tài)識別的人員，在最初2個月內(nèi)應(yīng)至少進行2次能力評審（間隔為30天），評審內(nèi)容包括： 培訓(xùn)內(nèi)容和過程； 現(xiàn)場考核； 檢驗結(jié)果的分析與判斷； 檢查工作單與各種記錄。 當職責變更時，或離崗6個月以上再上崗時，或政策、程序、技術(shù)有變更時，應(yīng)對員工進行再培訓(xùn)和再評審。沒有通過評審的人員應(yīng)經(jīng)再培訓(xùn)和再評審，合格后才可繼續(xù)上崗，并記錄。,ISO 15189 人員能力評價,25,GE

24、N.55500 Competency Assessment Phase II The competency 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

25、 be assessed annually. Retraining and reassessment 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

26、 identification and preparation; and specimen 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 testin

27、g results, and preventive maintenance records 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

28、of problem-solving skills 。 。,CAP 人員能力評價,(誰來評估？怎樣評估？明確間隔時間？） 比ISO15189 要求更細,ISO 15189 未對 PT 做出規(guī)定 整合在準則核查表條款 4.9不符合項的識別和控制 4.10 糾正措施 4.11 預(yù)防措施,CAP 對PT 有非常具體規(guī)定 有非常多的Checkllist,舉例三、PT數(shù)據(jù)的上報、分析、強制要求,28,CHM.10300 PT Evaluation Phase II There is ongoing evaluation of PT and alternative assessment results,

29、with prompt 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 documentation 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 unacceptable PT and alternative assessment results inc