PROCEDURES SURROUNDING CORD BLOOD COLLECTION TABLE OF CONTENTS 1. PURPOSE SCOPE AND RESPONSIBILITIES REQUIRED DOCUMENTS...

Transcription

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 APPENDIX 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: Responsibilities: All cord blood collections. Maternity ward nurses. 3. REQUIRED DOCUMENTS S/O 4. FORMS AND LABELS ENR Consent for cord blood donation ENR Consent to directed cord blood donation IND Étiquette d identification de la poche de sang de cordon (Cord blood identification label) IND Numéro de prélèvement (Donation Number (35 labels)) Courrier 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) 5. REQUIRED MATERIAL Collection kit including: Plastic (Ziploc) bag Mobile clamp Collection file includes: Page 2 of 9

3 Copy of ENR Consent to cord blood donation 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) Cord blood identification labels IND or 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 Sterile field (participating hospital centers) Padded shipping envelope Additional material required (not provided) Disinfectant solution (Proviodine or other) Sterile bowl 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 DOCUMENT PREPARATION Upon the mother s arrival for delivery, have her file in hand and ensure that it includes: A copy of the ENR Consent to cord blood donation form (or ENR Consent to Directed Cord Blood Donation for a directed donation) The Collecte de sang de cordon collection form or Collecte de Sang de Cordon Dirigé for directed donation Donation number labels Cord blood identification labels IND or «Courrier» Étiquette Prélèvement or «Courrier» Étiquette Prélèvement Dirigé In the event anything is missing, notify a Cord Blood Bank counselor. Addressograph the collection form Collecte de sang de cordon or Collecte de sang de cordon Dirigé with the mother s hospital card making sure it matches the information previously printed on this form. Transfer the copy of the consent form to the patient s hospital file COLLECTION MATERIAL PREPARATION Verify the contents of the collection kit: Two plastic (Ziploc) bags One removable clamp Page 4 of 9

5 Using proper aseptic techniques, place a sterile field on a mobile table. On the sterile field, place a sterile bowl that contains gauze pads and disinfectant solution. Make sure the collection bag has not expired. Tear open the aluminum envelope and make sure to keep the transparent plastic bag containing the collection bag during the collection COMPLETION OR INTERRUPTION OF COLLECTION Once the collection process is complete, ensure that the needle protector is locked in place, covering the needle. Unlock the clamp and let the blood flow down into the bag (by gravity), then relock as close to the needle as possible. Clip the removable clamp on the tubing as close to the needle as possible. Gently mix the blood bag contents with the anticoagulant in order to avoid blood clots by inverting the top and bottom of the bag 4-5 times. Fill out sections 1 and 2 of the Collecte de sang de cordon or Collecte de sang de cordon dirigé form. Complete the following information on the «Commentaire» section of that form: If the collection procedure was interrupted or if a problem arose with the mother or the baby during birth. Presence of information such as: 6.4. LABELING For the mother: abnormal vital signs, signs of at-risk behaviours, signs of viral or bacterial infection (such as septicemia), past medical history or any other information which may be deemed pertinent to the cord blood collection. For the baby: presence of physical anomalies such as additional digits (toes or fingers), missing digits or any visible congenital anomalies. Labeling must be performed in the mother s presence. Verify concordance of the Donation number label already on the Collecte de sang de cordon or Collecte de sang de cordon dirigé form with the identification labels IND or «Courrier» Étiquette Prélèvement (or Courrier Étiquette Prélèvement Dirigé) and the series of Donation number labels. Page 5 of 9

6 Complete the identification label and glue it on top of the cord blood bag label without covering the bar code lot number. Make sure that no part of the identification label is pasted directly onto the plastic bag itself (see example in Appendix) PACKAGING AND SHIPPING PACKAGING OF THE CORD BLOOD BAG Place the cord blood bag into a plastic (Ziploc) bag; expel any air and seal. Put all remaining labels and the Collecte de sang de cordon form as well as any unused material into the other plastic bag. Place the bag containing the cord blood bag and the plastic bag containing the remaining labels and documents in the padded shipping envelope, then seal the envelope SHIPPING TO HÉMA-QUÉBEC Immediately place the padded shipping envelope on the thermoregulator bags provided in the shipping box (up to a maximum of five collection kits per box). Fasten the strap on the shipping box. Secure the box by affixing a tamper-evident seal to the strap. Carry the box to the location designated for outgoing parcels. Ship the box to Héma-Québec as soon as possible. For Montreal hospitals, notify the courier service (stated on the waybill) and make sure they sign the waybill. For Québec hospitals, notify Héma-Québec at Québec facility. Page 6 of 9

7 7. BIBLIOGRAPHY Foundation for the accreditation of cellular therapy (FACT): International standards for cord blood collection, processing, testing, banking, selection and release, 4 th edition, 2010, Articles B , B , C3.1, C3.3.6, C3.3.8, C3.3.9, C6.3, C6.4, C6.5, C6.6, C6.8, 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 : Maryse Hamel, Stem cells Counselor Christine Milot, Specialist quality Page 7 of 9

8 9. APPENDIX Page 8 of 9

9 10. LIST OF MODIFICATIONS SECTION MODIFICATION JUSTIFICATION 3 Withdrawal : PFN Non relevant for Collection centres staff. 4 Withdrawal : IND Étiquette d identification du sang de cordon dirigé is Replaced by EdgeCell generated label Étiquette prélèvement dirigé ORIGIN OF INFORMATION CC Lot , 6.3, 6.4 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. CC Lot et Withdrawal: sterile gloves and compresses are removed from the list of obligatory material Sterile gloves are not necessary as the procedure is aseptic and not sterile. Medical Director Ref. CFA : OC Withdrawal: 4 gauze pads. Useless information. Verbal comments following audits AUD-I et AUD-I Page 9 of 9