Pour copie papier seulement : Le document original est approuvé avec signature numérique sous la responsabilité de CFA. TABLE OF CONTENTS 1. PURPOSE... 2 2. SCOPE AND RESPONSIBILITIES... 2 3. REQUIRED BACKGROUND DOCUMENTS... 2 4. FORMS AND LABELS... 2 5. REQUIRED MATERIAL... 2 6. PROCEDURE... 3 6.1. GENERAL POINTS... 3 6.2. UMBILICAL CORD DISINFECTION... 3 6.3. COLLECTION... 4 7. REFERENCE(S)... 5 8. AUTHOR/REVIEWER... 5 9. APPENDIX... 5 10. LIST OF MODIFICATIONS... 5 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. Effective date : 17-06-2013 Page 1 of 5
1. PURPOSE To describe the procedure to perform a cord blood collection. 2. SCOPE AND RESPONSIBILITIES Scope : Responsibilities : All cord blood collections. Maternity ward physicians. 3. REQUIRED BACKGROUND DOCUMENTS N/A 4. FORMS AND LABELS EdgeCell generated documents Collecte de sang de Cordon Collecte de Sang de Cordon Dirigé 5. REQUIRED MATERIAL Collection device Page 2 of 5
6. PROCEDURE 6.1. GENERAL POINTS Delivery must occur no earlier than the 34th week of pregnancy. All material required for a cord blood collection must be on a sterile field prior to use. Collection may take a few minutes, and is performed after the delivery, before the delivery of the placenta. When handling the collection device, pay special attention to the needle protector to prevent having it from sliding against the needle. 6.2. UMBILICAL CORD DISINFECTION After the birth of the baby, place a sterile field on the mother s perineal area and place the umbilical cord on this field. Open the plastic bag containing the collection device and remove only the tubing. Visually inspect the tubing. Disinfect the cord from the clamp and moving towards the placenta. Page 3 of 5
Disinfect the clamp. 6.3. COLLECTION Insert needle into the cord vein at an angle of approximately 45 as close to the clamp as possible. Lower the collection bag as much as possible. After all the cord blood has been drained, milk the cord by squeezing it from the placenta towards the clamp. Withdraw the needle from the vein. Push the needle protector up, making sure it covers the needle and is locked into position. Lock the clamp on the tubing as close to the needle as possible. Hand the blood bag to the nurse. In section 2 of Collecte de sang de cordon form (or the Collecte de Sang de Cordon Dirigé), sign with your name and medical license number. In the event that collection must be interrupted or any problems arise during collection, document the situation in the «Commentaire» section of Collecte de sang de cordon form. Page 4 of 5
7. REFERENCE(S) Foundation for the accreditation of cellular therapy (FACT): International standards for cord blood collection, processing, testing, banking, selection and release, 4 e édition, 2010. Articles B2.6.6.7, C3.1, C3.3.6, C3.3.8, C6.3, D3.1.2. 8. AUTHOR/REVIEWER Reviewer : Maryse Hamel, Stem cells Counselor Christine Milot, Specialist compliance and licensing 9. APPENDIX N/A 10. LIST OF MODIFICATIONS SECTION MODIFICATIONS JUSTIFICATION ORIGIN OF INFORMATION 4 & 6.3 8 th Addition of the form Collecte de Sang de Cordon Dirigé. This form has been created to facilitate distinction with the Collecte de Sang de Cordon form, rendering it easier to identify product at its reception in the laboratory. CC-12-5041 Lot 18.21 5 & 6.2, 2 th 6.2 4 th 6.3, 2 th 6.3, 9 th Ref. CFA : OC-01134 Withdrawal of the following sections : changing sterile gloves and rinsing sterile gloves in the case of a caesarian section Reformulation of disinfection technique. Withrawal of using proper aseptic techniques Addition: or a problem arising during cord blood collection. To reflect current practice. Cord blood collection is an aseptic technique and not a sterile one therefore changing the gloves or rinsing them is not necessary. In addition, no raise of contaminated units has been observed over time, which confirm that this practice is acceptable. Also, the fact that the gloves are not changed maximized the volume collected. To reflect current practice. Useless information. Precision for doctors participating in cord blood collection. Medical Director Verbal comments audits AUD-I- 00009 and AUD- I-00010. Page 5 of 5