Introduction... 1 Focus... 1 Interim Audit... 2 Auditors... 2 Scope... 2 Format... 3 Consequences... 3 Fees... 3 Appendix

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1 Title: Interim audit descriptin Created n 09/06/ :17:00 Intrductin... 1 Fcus... 1 Interim Audit... 2 Auditrs... 2 Scpe... 2 Frmat... 3 Cnsequences... 3 Fees... 3 Appendix Intrductin 1. The change f the duratin f the accreditatin cycle frm 3 t 4 years was the result f a prpsal by the JACIE Bard n 30 March 2008 and adpted n 10 Octber The 4-year accreditatin cycle was intrduced with effect frm 1 January 2009 and affects nly centres awarded accreditatin r reaccreditatin frm that date nwards. Centres accredited befre 1 January 2009 will nt underg an interim audit until they are reaccredited under the terms f the 4 year cycle. 3. The intrductin f the interim audit will als bring JACIE int line with the tw-year cycle utilised by many Eurpean cmpetent authrities. 4. There will be n changes t the prcedure fr requesting and preparing fr accreditatin/reaccreditatin and the inspectin prcess will remain as it is. Fcus 5. The interim audit fcuses primarily n the Clinical Units. Cell cllectin and prcessing facilities are subject t their natinal regulatins (based n the EU Tissue and Cell Directives 1 ) and will therefre nt receive a dedicated nsite visit frm JACIE. 6. Nnetheless, the auditr will expect t find evidence in the clinical prgramme f regular interactins with the cllectin and prcessing services. 7. There will be n requirement fr the Clinical facilities t submit dcumentatin in advance f the visit althugh JACIE reserves the right t request dcumentatin frm centres n a case-by-case basis. 7.1 Where they frmed part f the riginal accreditatin, the Cllectin and Prcessing facilities will be requested in advance f the interim audit t prvide dcumentatin demnstrating that: The Cllectin Facility is registered and/r accredited as required by the apprpriate gvernmental authrity fr the activities perfrmed The Cllectin Quality Management Plan includes, r summarizes and references, a prcess fr validatin and/r verificatin f critical prcedures 1 EU 2004/23/EC, 2006/17/EC and 2006/86/EC 1/7

2 Title: Interim audit descriptin Created n 09/06/ :17: The Cllectin Facility is perfrming validatin/verificatin The Prcessing Facility is registered and/r accredited with the apprpriate gvernmental authrity fr the activities perfrmed The Prcessing Facility perfrms envirnmental mnitring fr micrrganisms There is dcumentatin f review and acceptance f validatin studies by the Prcessing Facility See the checklist in Appendix 1 belw. Interim Audit 8. At the end f the 2 nd year f accreditatin, the centre will receive an interim audit visit by ne r mre auditrs. 9. The audit will be scheduled by the JACIE Accreditatin Office wh will ntify the centre with 3 mnths ntice. 10. The interim audit will be based n a cndensed checklist f questins taken frm the full Inspectin Checklist i.e. the audit des nt intrduce any new requirements r questins nt already addressed by the Standards. See Appendix The checklist is cmpleted nly by the auditr the audited centre des nt have t submit a checklist in advance althugh they may wish t use the checklist fr a self-audit prir t the nsite visit. Auditrs 12. Auditrs will be assigned by JACIE. Scpe 13. The audit will be based n a cndensed versin f the JACIE Inspectin Checklist. It is available fr dwnlad frm the Dcument Centre n the JACIE web site at The audit will fcus n the functining f the quality system. The auditr may ask t see: Evidence f cntinuus educatinal and training activity Quarterly reprts n quality management activities and/r minutes f meetings where these activities were reprted Internal annual reprts n the perfrmance f the quality management system Evidence f regular review and apprval f SOPs and ther dcumentatin Evidence f internal audits Evidence f regular meetings e.g. minutes, agenda 2/7

3 Title: Interim audit descriptin Created n 09/06/ :17:00 Reprts f Serius Adverse Events (SAEs), their review and evidence f crrective actins Evidence f review f dnr recrds Evidence f utcme analysis Evidence f validatin f prcedures r equipment Evidence f envirnmental mnitring See the checklist in Appendix 1 belw. 15. The auditr will receive a cpy f the mst recent Inspectin Reprt and Annual Reprt fr the centre. JACIE reserves the right t examine any issues identified in the previus inspectin reprt. Frmat 16. The visit will take place during part r all f ne day. 17. One r mre persns familiar with the quality management system shuld be available t assist the auditr. 18. The auditr may ask t interview staff members as part f the audit. 19. The auditr may als visit ther parts f the site(s) in rder t gather evidence e.g. visit t the labratry t find evidence f the use f SOPs by persnnel. 20. A rm shuld be available t the auditr 21. Refreshments shuld be made available t the auditr. Dcumentary evidence f the functining f the quality management system shuld be gathered tgether in this rm. Cnsequences 22. The audit is a check-up n the peratin f the quality management system. The audit will lead t a reprt n the actual state f quality management in the prgramme and may identify deficiencies r highlight areas that require attentin If deficiencies are reprted, the centre shuld submit crrective actins within a time perid nt exceeding 6 mnths frm receipt f the Interim Audit reprt Failure t crrect deficiencies within this time perid may result in suspensin f accreditatin Centres are still required t submit annual reprts at the end f Year 1, Year 2 and Year 3 f the accreditatin perid. Fees 23. An additinal fee f 1000 is charged at the time f applicatin fr initial accreditatin r reaccreditatin. This fee will cver the csts f the interim visit and preparing the reprt t the centre. JACIE will reimburse the auditr s travel, accmmdatin and subsistence csts. 3/7

4 Title: Interim audit descriptin Created n 09/06/ :17:00 Appendix 1 Questins frm the Interim Audit Checklist. REF STANDARD PLEASE COMPLETE A SEPARATE CHECKLIST FOR EACH CLINICAL UNIT B Clinical Units B1.2 Des the Clinical Prgram use cell cllectin facilities that meet FACT-JACIE Standards with respect t their interactins with the Clinical Prgram? B2 B2.4.4 Des the Clinical Prgram use cell prcessing facilities that meet FACT-JACIE Standards with respect t their interactins with the Clinical Prgram? CLINICAL UNIT Are facilities used by the Clinical Prgram maintained in a clean, sanitary, and rderly manner? B3 PERSONNEL B3.1 CLINICAL PROGRAM DIRECTOR B3.1.6 Des the Clinical Prgram Directr participate regularly in educatinal activities related t the field f HPC transplantatin? B3.2 ATTENDING PHYSICIANS B3.2.3 D the Clinical Prgram attending physicians participate regularly in educatinal activities related t the field f HPC transplantatin? B3.5 MID-LEVEL PRACTITIONERS (Physician Assistants, Nurse Practitiners, Advanced Practitiners) B3.5.3 D mid-level practitiners participate regularly in educatinal activities related t the field f HPC transplantatin? B4 QUALITY MANAGEMENT B4.1 Des the Clinical Prgram maintain the written Quality Management Plan? B4.2.2 B B B4.3.1 B Is the Clinical Prgram Directr respnsible fr the Quality Management Plan as it pertains t the Clinical Prgram? Des the Clinical Prgram Directr r designee reprt n quality management activities, at a minimum, quarterly? If the respnsibility f the Quality Management Plan is delegated, des the designee prvide a reprt n the perfrmance f the Quality Management Plan, at a minimum, annually t the Clinical Prgram Directr? Is there a system t dcument the fllwing fr all medical and nursing staff: Initial qualificatins and training? B B Annual perfrmance review? Prvisins fr cntinuing educatin? B4.3.2 Is there a plicy and/r prcedure fr persnnel training and cmpetency assessment? B4.4 Des the Quality Management Plan include, r summarize and reference, plicies and prcedures fr the fllwing fr critical prcesses, plicies, and prcedures: Develpment? Apprval? Implementatin? 4/7

5 Title: Interim audit descriptin Created n 09/06/ :17:00 Review? Revisin? Archival? B4.5 Des the Quality Management Plan include, r summarize and reference, a system fr dcument cntrl, including a list f all critical dcuments that shall adhere t the dcument cntrl system requirements? B4.7.1 B4.7.2 Fr HPC prducts, is there a prcess fr dcumentatin and review f time t engraftment fllwing prduct administratin? Fr ther cellular therapy prducts, is the criteria fr prduct efficacy and/r the clinical utcme determined? Is this criteria reviewed at regular time intervals? B4.8 Des the Quality Management Plan include, r summarize and reference, plicies, prcedures, and a timetable fr cnducting and reviewing audits f the Prgram's activities t verify cmpliance with elements f the Quality Management Prgram and peratinal plicies and prcedures? B4.8.2 Are the results f audits used t recgnize prblems, detect trends, and identify imprvement pprtunities? B4.8.3 Des the Clinical Prgram peridically audit data cntained in the Minimum Essential Data-A Frms f the EBMT (see Appendix IV)? Des the Prgram peridically audit at a minimum: Patient utcmes? Dnr screening and testing? Recipient Day 100 treatment related mrtality? B B B B B B B B Is cllectin and analysis f data related t the audit reviewed, reprted, and dcumented, at a minimum, n an annual basis? Are adverse events in the Clinical Prgram dcumented in a manner that cmplies with institutinal requirements and applicable laws and regulatins? Is dcumentatin f each adverse event that ccurs in the Clinical Prgram reviewed by the Clinical Prgram Directr? Is a written descriptin f an adverse event made available t the recipient's and/r dnr's physician and the Cllectin and Prcessing facilities, if apprpriate? Are deviatins frm key Standard Operating Prcedures (B5.1.1, B5.1.6, and B5.1.7) dcumented? Are planned deviatins pre-apprved by the Clinical Prgram Directr r designee? Are unplanned deviatins and assciated crrective actins reviewed by the Clinical Prgram Directr r designee? Is there a defined prcess imprvement plan that includes plicies r prcedures fr the recgnitin and investigatin f the cause f all issues that require crrective actin? B Are fllw-up activities cnducted t determine if the crrective actins were effective? 5/7

6 Title: Interim audit descriptin Created n 09/06/ :17:00 B4.11 Des the Quality Management Plan include, r summarize and reference, a prcess fr cellular therapy prduct tracking and tracing that allws tracking frm the dnr t the recipient r final dispsitin and tracing frm the recipient r final dispsitin t the dnr? B5 POLICIES AND PROCEDURES B5.2 Des the Clinical Prgram maintain a detailed Standard Operating Prcedures Manual? B5.3.1 B5.3.2 B5.3.3 B5.3.4 B5.3.5 B5.3.6 B5.3.7 B5.3.8 Des each individual prcedure include: A clearly written descriptin f the bjectives? A descriptin f equipment and supplies used? Acceptable end-pints and the range f expected results, where applicable? A stepwise descriptin f the prcedure, including diagrams and tables as needed? Reference t ther Standard Operating Prcedures r plicies required t perfrm the prcedure? A reference sectin listing apprpriate literature, if applicable? Dcumented apprval f each prcedure by the Clinical Prgram Directr r designated physician prir t implementatin and every tw years thereafter? Dcumented apprval f each prcedural mdificatin by the Clinical Prgram Directr r designated physician prir t implementatin? B5.3.9 A cpy f current versin f rders, wrksheets, reprts, labels, and frms, where applicable? B5.4 Are cpies f the Standard Operating Prcedures Manual readily available t the facility staff at all times? B5.5 D all persnnel in the facility fllw the Standard Operating Prcedures related t their psitins? B5.6 Are new and revised plicies and prcedures reviewed by the staff prir t implementatin? Is this review and assciated training dcumented? B5.7 Are archived plicies and prcedures, the inclusive dates f use, and their histrical sequence maintained fr a minimum f ten (10) years frm archival r accrding t gvernmental r institutinal plicy, whichever is lnger? B6.8 DONOR RECORDS B6.8.1 Is there a plicy fr dnr recrds cvering: Creatin Regular review Retentin C HPC, Apheresis Cllectin Facility(s) C2.1 Is the Cllectin Facility registered and/r accredited as required by the apprpriate gvernmental authrity fr the activities perfrmed? C4.14 Des the Quality Management Plan include, r summarize and reference, a prcess fr validatin and/r verificatin f critical prcedures? 6/7

7 Title: Interim audit descriptin Created n 09/06/ :17:00 D Cell Prcessing Facility(s) D2.1 Is the Prcessing Facility registered and/r accredited with the apprpriate gvernmental authrity fr the activities perfrmed? D2.4.1 D Where apprpriate, des the Prcessing Facility prvide envirnmental mnitring fr micrrganisms? Is there dcumentatin f review and acceptance f validatin studies by the apprpriate individual frm Quality Management? 7/7

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