Présentation des Standards JACIE 15/11/2018

Programme de transplantation Généralités Programme de transplantation Prélèvement Préparation Clinique Bloc opératoire CTS LTCG -3 AB US HDJ Autres services 15/11/2018

The JACIE Standards Clinical Programme Collection (BM / PBPC) c 200 items Collection (BM / PBPC) Processing c 300 items General Facilities Personnel Quality Management Policies and Procedures Donor selection, evaluation and management Donor care during collection Process Controls Therapy administration Collection procedure (BM/PBPC) Labels Clinical Research Distribution Data management Storage Transportation Disposal Records 15/11/2018

B2.000 Clinical Unit Ward /OP A designated inpatient unit that minimises airborne microbial contamination. Guidance: all patients must be nursed in single rooms. Air handling is not essential but advisable for high-risk patients. A designated area for outpatient care that reasonably protects the patient from transmission of infectious agents and can provide appropriate patient isolation, administration of intravenous fluids etc Provisions for prompt evaluation and treatment by a transplant consultant/senior physician available on a 24-hour basis. Nurses experienced in the care of transplant patients. A nurse/patient ratio satisfactory to cover the severity of the patients’ clinical status. Note - Inspector must make a judgement on these issues. 15/11/2018

B2.100 Other required services A Collection Facility and Processing Facility that meet the Standards with respect to their interaction with that clinical programme Not possible to enforce for HPC from unrelated donors A transfusion service providing 24-hour availability of CMV appropriate and irradiated blood products A pharmacy providing 24-hour availability of medications For allogeneic programmes, HLA testing laboratories accredited by the European Federation for Immunogenetics (EFI) 15/11/2018

B2.00 Clinical Unit -Evidence Facilities - On site tour signage isolation facilities air handling (for high risk patients) hand washing designated OP area - Can it be used for infusions? Nurse staffing Are there enough nurses available to cover the patients’ needs? Can nursing staff provide for >1nurse/patient if required? documentation / Interview senior nursing staff Safety issues Documentation (SOPs, training logs) Observation and Interview (safety training) 15/11/2018

Other Staff - Evidence interview Other staff- Evidence of Nurses qualifications in haematology in-service training log personal CPD record centrally kept competency record SOPs for nursing procedures interview Other staff- Evidence of transplant co-ordinator pharmacy staff Dietetics social support physiotherapy staff data management staff 15/11/2018

B 4.000 Quality management Quality manual Audit Reporting of errors, accidents and adverse reactions (AEs) 15/11/2018

B 7.000 Therapy administration High dose chemotherapy-TBI Administration of HPC 15/11/2018

B7.000 Therapy Administration B7.100 There must be a written policy to ensure that the preparative regimen is administered safely.* B7.110 The treatment orders must include the patient height and weight, specific dates, daily doses (if appropriate) and route of each agent. Pre-printed orders should be used for protocols and standardised regimens. B7.120 The pharmacist preparing the chemotherapy must verify the doses against the protocol or standardised regimen listed on the orders. B7.130 Prior to administration of chemotherapy, two persons qualified to administer chemotherapy must verify the drug and dose in the bag or pill against the orders and the protocol, and the identity of the patient to receive the chemotherapy. 15/11/2018

B7.000 Therapy Administration B7.200 There must be a written policy to ensure safe administration of haematopoietic cell products. B7.210 Two qualified persons must verify the identity of the recipient and the product prior to the infusion of the product. B7.220 There must be documentation in the patient’s medical record of the unit identifier for all infused products. 15/11/2018

Therapy Administration Evidence Ask to see protocols in the Unit and Pharmacy Review patient charts to confirm treatment given Interview pharmacist and nurses about normal practice Ask nursing staff about chemotherapy training May watch treatment being given to check practice against SOP 15/11/2018

Engagement de JACIE/EBMT Le EBMT-Nursing Group est convaincu que les staffs infirmiers doivent être impliqués dans le processus d'accréditation Préparation des standards Préparation du centre pour l'accréditation Le processus d'inspection Le rapport d'inspection Actuellement le Board de JACIE comprend un membre infirmier 15/11/2018

JACIE Standards & Nurses/AHPs 9 direct references to Nurses/Nursing in Standards 39 direct references in the Accreditation Manual B2.140 -Nurses & Personnel requirements B3.700 covers Nurses specifically B3.800 covers Other Staff specifically 15/11/2018

Direct Mention B2.100 The Programme must have: B2.140 Nurses experienced in the care of transplant patients B2.150 A nurse/patient ratio satisfactory to cover the severity of the patient’s clinical status 15/11/2018

Other Staff B3.830 Dietary staff capable of providing dietary consultation regarding the nutritional needs of the transplant recipient, including enteral and parenteral support, and appropriate dietary advice to avoid food-borne illness. B3.840 Social Services staff. Very little said Help with funding if the unit does not have access to these professional B3.850 Physical Therapy staff. B3.860 Data Management staff sufficient to comply with Section B9.000 (records/audits). 15/11/2018

Structure générale des documents Standard Operating Procedure = organisation (qui, quoi, où?) Workflow Modes Opératoires (techniques) Formulaires (supports d'enregistrement, lettres…) Annexes (Textes légaux, manuels, validations) MO 01 Form 01 MO 02 Form 02 MO 03 Form 03 Ann 01 Ann 02 Ann 03 + MO 04 + Form 04 + 15/11/2018

Traçabilité? 15/11/2018

Enregistrements 15/11/2018

Enregistrements-2 15/11/2018

Fiche amélioration 15/11/2018

Fiche amélioration-2 15/11/2018

Les pour et les contre On a fait sans jusqu'ici, pourquoi changer? On ne nous dit jamais rien C'est inutile On va nous surveiller M'en fous je ferai comme avant C'est fastidieux Chacun fait à sa manière C'est ce qu'on fait déjà sans le dire On travaille mal alors? 15/11/2018

Les pour et les contre C'est essentiel et bénéfique pour les équipes-le service-l'hôpital Une documentation fiable accessible à tous On surveille le programme, pas les gens Les formations sont systématiques-formalisées La mise en place est fastidieuse, ensuite on gagne du temps Tout le monde travaille de la même manière On travaillait bien, on, travaillera mieux On formalise ce qu'on faisait avant 15/11/2018