Procedures surrounding cord blood collection. Table of contents

Transcription

1 Effective date : Page 1 de 9 Table of contents 1. Purpose Scope Responsibilities Required material Identifiers Procedure General Collection preparation Completion or interruption of Collection Labeling Packaging and shipping Appendices References List of modifications... 9 Pour copie papier seulement : Le document original est approuvé avec signature numérique sous la responsabilité de l AQ. Tous droits réservés. Aucune partie du présent document ne peut être reproduite, conservée en mémoire ou transmise, sous quelque forme que ce soit ou par quelque moyen que ce soit, photocopie, enregistrement, procédés électroniques et mécaniques ou autres, sans la permission écrite préalable d Héma-Québec. GAB-00068[1]

2 Page 2 de 9 1. PURPOSE To describe all procedures surrounding cord blood collection: preparation of material, labeling, packaging and sending of the cord blood bag 2. SCOPE All cord blood collections 3. RESPONSIBILITIES Maternity ward nurses 4. REQUIRED MATERIAL Collection kit including : Plastic (Ziploc) bags (2) Padded shipping envelope Collection file including : Copy of ENR Consent to cord blood donation and human milk form or ENR Consent to Directed Cord Blood Donation Collecte de sang de cordon (Cord blood collection form) or Collecte de sang de Cordon Dirigé (Directed Cord Blood Collection) Étiquette Prélèvement (Collection Label) or Étiquette Prélèvement Dirigé (Directed Collection Label) Donation number labels Waybill (depending on courier service used by Héma-Québec) Collection bag Shipping box Tamper-evident seal Thermoregulator bags (4) Sterile field (participating hospital centers) Additional material required (not provided) Disinfectant solution (2% chlorhexidine / 70% alcohol)

3 Page 3 de 9 Sterile field 5. IDENTIFIERS N/A

4 Page 4 de 9 6. PROCEDURE 6.1. GENERAL Héma-Québec ensures that the mother has consented to donate and is 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 documents should be kept in a restricted area at room temperature COLLECTION PREPARATION 1 Document preparation 1.1 Verify the content of the collection file : - Copy of the consent - Collecte de sang de cordon (dirigé) - Étiquette prélèvement (dirigé) - Donation number labels 1.2 If incomplete, notify Héma-Québec s Cord Blood Bank 1.3 Adressograph and make sure it matches the information ENR (or ENR-00140) Collecte de sang de cordon (dirigé) 1.4 Transfer the consent form to the mother s hospital file ENR (or ENR-00140)

5 Page 5 de 9 2 Collection material preparation 2.1 Verify the content of the collection kit : - 2 plastic (Ziploc) bags - 1 padded shipping envelope 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 is not expired 2.5 Tear open the aluminum envelope and, if possible, keep the collection bag in its transparent plastic overwrap during the collection

6 Page 6 de COMPLETION OR INTERRUPTION OF COLLECTION 1 Collection bag 1.1 Ensure that the needle protector is locked in place, covering the needle 1.2 Make sure the clamps are closed 1.3 Gently invert the bag, back and forth, 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 infant during birth - Physical anomalies of the infant such as additional digits (toes or fingers), missing digits or any visible congenital anomalies. Anomalies concerning 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 that might alter the quality and safety of the cord blood product 2.3 Document any incident (adverse event or deviation to this procedure) Collecte de sang de cordon (dirigé) Collecte de sang de cordon (dirigé)

7 Page 7 de LABELING 1 Verification 1.1 Verify concordance of Collecte de sang de cordon (dirigé) Étiquette prélèvement (dirigé) 2 Labeling 2.1 Complete the information Étiquette prélèvement (dirigé) 2.2 In the mother s presence, affix the cord blood bag label without covering the bar code lot number with as little contact as possible with the plastic of the bag Étiquette prélèvement (dirigé) 6.5. 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)

8 Page 8 de 9 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 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 the Héma-Québec facility in Québec City IND APPENDICES N/A

9 Page 9 de 9 8. REFERENCES Cord blood collection bag REF MSC1200PU MacoPharma NOTEURO LIST OF MODIFICATIONS SECTION MODIFICATIONS JUSTIFICATION Step Steps 2.4 and Step Step Step Step 2.2 Reference : OC Removal of the mobile clamp Pictures of MacoPharma s collection bag Do not let flow down the blood into the bag Make sure the clamps are closed, instead of closing them close to the needle The label must touch as little as possible to the plastic of the bag Fenwal s collection bag will be discontinued as of March 2017; For the MacoPharma s collection bag, there will be 3 clamps on the tubing, including a permanent red clamp The collection line will be rinsed with the anticoagulant from the rinsing pouch by the maternity ward physician, to preserve product sterility (closed clamps), get a larger volume of cord blood and prevent clot formation The clamps will be closed by the maternity ward physician to preserve product sterility and make sure the collection line is rinsed immediately after collection (the red clamp is permanent); The collection line will not be used at Hema-Quebec anymore The HQ label is larger than the one from the MacoPharma s collection bag, so it is impossible not to touch at all to the plastic. No adverse impact, food save adhesive. ORIGIN OF INFORMATION CC-PRB Previous version: 6.3, Step 1.2 Product insert CC-PRB Product insert CC-PRB-00686