Pour copie papier seulement : Le document original est approuvé avec signature numérique sous la responsabilité de CFA.

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1 Pour copie papier seulement : Le document original est approuvé avec signature numérique sous la responsabilité de CFA. TABLE OF CONTENTS 1. PURPOSE SCOPE AND RESPONSIBILITIES REQUIRED DOCUMENTS FORMS AND LABELS REQUIRED MATERIAL PROCEDURE GENERAL COLLECTION PREPARATION COMPLETION OR INTERRUPTION OF COLLECTION LABELING PACKAGING AND SHIPPING BIBLIOGRAPHY AUTHOR/REVIEWER LIST OF MODIFICATIONS... 9 All rights reserved. No part of this document may be reproduced, stored or transmitted in any firm or by any means, electronic, mechanical, by photocopying, recording or otherwise, without the prior written permission of Héma-Québec. GAB-00006[1] Page 1 of 9

2 1. PURPOSE To describe all procedures surrounding cord blood collection: preparation of material, labeling, packaging and sending of the cord blood bag. 2. SCOPE AND RESPONSIBILITIES Scope: All cord blood collections. Responsibilities: Maternity ward nurses. 3. REQUIRED DOCUMENTS S/O 4. FORMS AND LABELS ENR Consent to cord blood donation and human milk ENR Consent to directed cord blood donation ENR Contrôle de réception des échantillons sanguins et produits arrivant de l externe IND Numéro de prélèvement (Donation Number (labels)) IND Emballage et expédition du sang de cordon (Cord blood packaging and shipping) Courriers generated by EdgeCell : - ÉTIPRE- Étiquette Prélèvement (Cord blood identification label) - ÉTIDIR- Étiquette Prélèvement Dirigé (Directed cord blood identification label) - Collecte de sang de Cordon (Cord blood collection) - Collecte de sang de Cordon Dirigé (Directed Cord Blood Collection) Page 2 of 9

3 5. REQUIRED MATERIAL Collection kit including : Plastic (Ziploc) bags (2) Mobile clamp Collection file including : Copy of ENR Consent to cord blood donation and human milk form or ENR Consent to Directed Cord Blood Donation if directed donation Collecte de sang de cordon (Cord blood collection form) or Collecte de sang de Cordon Dirigé (Directed Cord Blood Collection) Étiquette Prélèvement or Étiquette Prélèvement Dirigé Donation number labels Waybill (depending on courier service used by Héma-Québec) Collection device Shipping box Tamper-evident seal Thermoregulator bags (4) Sterile field (participating hospital centers) Padded shipping envelope Additional material required (not provided) Disinfectant solution (2% chlorhexidine / 70% alcohol) Sterile field Page 3 of 9

4 6. PROCEDURE 6.1. GENERAL Héma-Québec ensures that the mother has consented to and has been medically qualified prior to the cord blood collection. The cord blood bag must not leave the delivery room or the operating room before all labeling has been completed. Use only one cord blood kit per collection. Thermoregulator bags must remain in the shipping box provided. Collection kits, collection bags and files should be kept in a restricted area at room temperature COLLECTION PREPARATION 1 Document preparation 1.1 Verify the content of the collection file : - ENR (or ENR-00140) (copy of the consent) - Collecte de sang de cordon (dirigé) - Étiquette prélèvement (dirigé) - IND (donation number labels) 1.2 If incomplete, notify Héma-Québec s Cord Blood Bank 1.3 Adressograph and make sure it matches the information Collecte de sang de cordon (dirigé) 1.4 Transfer the consent form to the mother s hospital file ENR (or ENR-00140) Page 4 of 9

5 2 Collection material preparation 2.1 Verify the content of the collection kit : - 2 plastic (Ziploc) bags - 1 removable clamp 2.2 Place a sterile field on a mobile table 2.3 Place gauze pads and disinfectant solution (2% chlorhexidine / 70% alcohol) on the sterile field 2.4 Make sure the collection bag has not expired 2.5 Tear open the aluminum envelope and make sure to keep the collection bag in its transparent plastic bag during the collection Page 5 of 9

6 6.3. COMPLETION OR INTERRUPTION OF COLLECTION 1 Collection bag 1.1 Ensure that the needle protector is locked in place, covering the needle 1.2 Let the blood flow down into the bag 1.3 Lock the clamps as close to the needle as possible 1.4 Gently invert the top and bottom of the bag 4-5 times to mix the anticoagulant with the cord blood 2 Document 2.1 Fill out sections 1 and 2 Collecte de sang de cordon (dirigé) 2.2 If applicable, add the following comments : - Interruption of the collection procedure - Problem with the mother or the baby during birth - Physical anomalies for the baby such as additional digits (toes or fingers), missing digits or any visible congenital anomalies. For the mother: - Abnormal vital signs - Signs of at-risk behaviours - Signs of viral or bacterial infection (such as septicemia) - Past medical history - Any other pertinent information to the cord blood collection 2.3 Document any incident (adverse event or deviation to the procedure) Collecte de sang de cordon (dirigé) Collecte de sang de cordon (dirigé) Page 6 of 9

7 6.4. LABELING 1 Verification 1.1 Verify concordance of Collecte de sang de cordon (dirigé) Étiquette prélèvement (dirigé) IND Labeling 2.1 Complete the information Étiquette prélèvement (dirigé) 2.2 In the mother s presence, glue on the cord blood bag label without covering the bar code lot number or touching the plastic bag. Étiquette prélèvement (dirigé) IND PACKAGING AND SHIPPING 1 Packaging 1.1 Place the cord blood bag into a plastic (Ziploc) bag 1.2 Activate the temperature logger and place it with the cord blood bag in the plastic bag 1.3 Expel any air and seal 1.4 Put the documents, remaining labels (keep one for shipping identification) and unused material into the other plastic bag 1.5 Place both plastic bags in the shipping envelope 1.6 Seal the envelope Collecte de sang de cordon (dirigé) IND Page 7 of 9

8 2 Shipping 2.1 As soon as possible, place the shipping envelope on the 2 thermoregulator bags at the bottom of the shipping box, then cover with the 2 other thermoregulator bags 2.2 Apply a collection label for each CBU packaged ENR IND If needed, place up to a maximum of five collection kits per box, inserted between the thermoregulator bags (only one envelope will contain a temperature logger) 2.4 Fasten the strap on the shipping box and affix a tamper-evident seal 2.5 Carry the box to the location designated for outgoing parcels 2.6 Ship the box to Héma-Québec as soon as possible Montreal hospitals Notify the courier service stated on the waybill and make sure they sign it Québec hospital Notify Héma-Québec at Québec facility IND Page 8 of 9

9 7. BIBLIOGRAPHY Foundation for the accreditation of cellular therapy (FACT): International standards for cord blood collection, processing, testing, banking, selection and release, 5 th edition, 2013, Articles B , B3.1.8, B3.1.9, B3.1.12, C3.1, C3.1.3, C3.1.6, C3.1.7, C6.3, C6.4, C6.5, C6.6, C6.8, C7.5.2, C7.7.1, D3.1.2, D AABB : Standards for Cellular Therapy Products Services, 4 th edition, 2009, Articles 5.9, , 5.14, Safety of Human Cells, Tissues and Organs for Transplantation Regulations, 2007, Current to March 24, 2010, Articles 72, 74. CAN/CSA Z : Lymphohematopoietic cells for transplantation, 2012, Articles AUTHOR/REVIEWER Reviewed by : Annie Maheux, Projects and conformity coordinator 9. LIST OF MODIFICATIONS SECTION MODIFICATION JUSTIFICATION ORIGIN OF INFORMATION 5 and 6.2 Instruction 2.3 Disinfect with a 2% chlorhexidine / 70% alcohol solution; Removal of the sterile bowl To decrease the sterility positive results rate; The use of the bowl is optional FACT Management meeting report AUD-I00059 AEX-548-EXP Ref. CFA : OC Page 9 of 9