Title: Interim audit descriptin 2011-06-08 Created n 09/06/2011 15:17:00 Intrductin... 1 Fcus... 1 Interim Audit... 2 Auditrs... 2 Scpe... 2 Frmat... 3 Cnsequences... 3 Fees... 3 Appendix 1... 4 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 2008. 2. 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: 7.1.1 The Cllectin Facility is registered and/r accredited as required by the apprpriate gvernmental authrity fr the activities perfrmed. 7.1.2 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
Title: Interim audit descriptin 2011-06-08 Created n 09/06/2011 15:17:00 7.1.3 The Cllectin Facility is perfrming validatin/verificatin. 7.1.4 The Prcessing Facility is registered and/r accredited with the apprpriate gvernmental authrity fr the activities perfrmed. 7.1.5 The Prcessing Facility perfrms envirnmental mnitring fr micrrganisms. 7.1.6 There is dcumentatin f review and acceptance f validatin studies by the Prcessing Facility 7.1.7 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 1. 11. 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 www.jacie.rg. 14. 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
Title: Interim audit descriptin 2011-06-08 Created n 09/06/2011 15:17:00 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. 22.1 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. 22.1.1 Failure t crrect deficiencies within this time perid may result in suspensin f accreditatin. 22.2 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
Title: Interim audit descriptin 2011-06-08 Created n 09/06/2011 15:17:00 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 B4.2.2.3 B4.2.2.4 B4.3.1 B4.3.1.1 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? B4.3.1.2 B4.3.1.3 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
Title: Interim audit descriptin 2011-06-08 Created n 09/06/2011 15:17:00 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? B4.8.3.1 B4.10.1 B4.10.2 B4.10.3 B4.10.5 B4.10.5.1 B4.10.5.2 B4.10.6 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? B4.10.6.1 Are fllw-up activities cnducted t determine if the crrective actins were effective? 5/7
Title: Interim audit descriptin 2011-06-08 Created n 09/06/2011 15:17:00 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
Title: Interim audit descriptin 2011-06-08 Created n 09/06/2011 15:17:00 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 D4.14.2 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