Joint Meeting EBMT (UK) NAP & EBMT NG Friday October 5th 2012, London What do you know about JACIE? - An Interactive Workshop Eoin Mac Hale Senior Consultant & Trainer

Answering Questions = A/Yes = B/No = C/Don’t know

Question 1. Do you work in a JACIE Accredited Centre? Question 2. In addition to nursing responsibilities how many hold a quality management role? Question 3. Were you involved in the development and implementation of the quality management system?

Question 1 Which edition of the JACIE Standards is currently in use ? A = 4 th edition B = 5 th edition C = 6 th edition

1 st edition – nd edition – rd edition – th edition – th edition – March 2012

Question 2 The JACIE Medical Director is based in which country? A = Spain B = Italy C = None of the above

The JACIE Medical Director is: Dr. John Snowden Sheffield, UK

Question 3 Who is responsible for issuing the JACIE Inspection Report (post onsite inspection) ? A = JACIE Office in Barcelona B = JACIE Medical Director C = JACIE Accreditation Committee

Question 4 What is the format of the current JACIE Standard? A = Clinical, Collection & Processing B = Clinical, BM Collection, Apheresis Collection & Processing C = Clinical Adults, Clinical Paeds, Collection & Processing

Question 5 Is JACIE Accreditation of HSCT Programmes a legal requirement in the UK? A = Yes B = No C = Don’t know

JACIE Accreditation is a requirement in the following countries : Regulations France Engagement with JACIE a requirement for allogeneic transplant centres according to Arrêté du 3 avril 2009 relatif au contenu du document d’évaluation des activités de greffes d’organes et de greffes de cellules hématopoïétiques Switzerland Accreditation required to receive reimbursement from Social Insurance for treatments Italy Decreto Legislativo 25 gennaio 2010, n.16 implementing the European Directives on Tissues and Cells cites a 2003 agreement recognising JACIE The Netherlands Accreditation required to receive authorisation to transplant from Ministry of Health

Guidelines o European Directorate The Quality of Medicines & HealthCare Guide to the Safety and quality assurance for the transplantation of organs, tissues and cells, 4th edition (2010) o Italy Piano Oncologico Nazionale cites JACIE accreditation o United Kingdom : - JACIE cited in National Institute for Health and Clinical Excellence (NICE) guidelines Improving Outcomes in Haematological Cancer - The Future of Unrelated Donor Stem Cell Transplantation in the UK. A Report from the UK Stem Cell Strategic Forum (July 2010). NHSBT - JACIE cited in Specialised Services National Definitions Set (3rd edition) SSNDS Definition No.2, Specialised Services for Blood and Marrow Transplantation (all ages) - Certain health funding regions of the UK insist that all centres (allogeneic and autologous) must be JACIE accredited in order to receive reimbursement of treatment costs

Question 6 What does JACIE stands for ? A = Joint Accreditation Committee International and European B = Just Act Cool It’s Easy C = Joint Accreditation Committee ISCT and EBMT

Question 7 According to the JACIE Standards (5 th edition) what is the recommended nurse/patient ratio for a BMT Unit (clinical facility) ? A = 2:3 B = 1:3 C = none of the above

Question 8 If the Clinical Programme requests accreditation for allogeneic transplantation a minimum of ten (10) new allogeneic patients shall have been transplanted during the 12 months preceding accreditation. TRUE or FALSE ? A = True B = False

Question 9 The transplant programme must have an intensive care unit located on the same site as the Clinical Facility. TRUE or FALSE ? A = True B = False

ICU within the institution Multisystem support capabilities with the inpatient programme Arrangements with a neighbouring institution (established/documented/audited)

Question 10 Mid-level practitioners (CNS) shall have received specific training and maintain competency in both: Donor and recipient informed consent Diagnosis and management of HPC graft f failure TRUE OR FALSE ?? A = True B = False

Question 11 According to standard B3.6 nurses working on the BMT Unit in a senior position must have undertaken formal education/training in haematology i.e. recognised postgraduate haematology course TRUE OR FALSE ?? A = True B = False

Question 12 According the standard B3.6.3 nurse training shall only include: - neutropenic fever - infectious procedures - mucositis - nausea and vomiting - pain management TRUE OR FALSE ?? A = True / B = False

B requires training in : B – Haematology/oncology patient care B – Administration of preparative regimens B – Administration of blood products B – Care interventions (neutropenic fever, infectious procedures, mucositis, nausea and vomiting and pain management) B – Recognition of cellular therapy complications and emergencies requiring rapid notification to the clinical team

Question 13 The minimum required nursing SOPs according to B3.6.4 are: B – Care of immunocompromised patients B – Administration of preparative regimens B – Administration of cellular therapy products B – Central venous access device care B – Administration of blood products TRUE OR FALSE ??

Question 14 Standard B4.8 (qm/audits) requires the following nurse specific audits: 1. Hand hygiene 2. Administration of chemotherapy 3. Central venous catheter hygiene TRUE OR FALSE ??

Question 15 Standard B7.3 Extracorporeal Photopheresis (ECP) is a standard to be achieved by the Apheresis Facility staff ? TRUE OR FALSE ??

Standard B7.3 requires: B7.3.1 – there shall be a consultation with the facility the performs the ECP prior to therapy B7.3.2 – there shall be a written order from the physician B7.3.3 – a final report of the details of ECP administration B7.3.4 – ECP SOP in place B7.3.5 – outcomes of ECP administration should be discussed annually (*relates directly to the clinical programme – physicians and nurses)

Nurses & JACIE Join your hospital QM Group/Committee Take part in the consultation for 6 th edition Link to the EBMT Quality Management Group Train as Inspector (Apheresis Collection) Develop your role in Quality and Audits

REMEMBER Nurses comprise the largest workforce population in every department – use that voice!! (In UK Nurses make up the largest part of the entire NHS workforce, at just under 30% - Department of Health Nov 2011)

QUESTIONS & THANK YOU