1. Dispensary and Administration Site Information Presentation

2. Background Hospitals with a licensed Laboratory -Transfusion Medicine (TM) Service must meet standards established to ensure patient safety and product efficacy Healthcare facilities that are providing TM services (administration of blood components and products) that do not carry a laboratory license must also meet the established standards and regulations Issue Facilities that receive blood components /products from a licensed laboratory services may not be peer assessed to ensure compliance to the standards set out by the accreditation bodies Patient safety may be at risk in the absence of standardized policies and procedures for blood and blood components/products

3. Definitions Hospital Transfusion Service provider: a licensed laboratory transfusion service that is providing blood components/products that are received directly from Canadian Blood Services to another facility for either storage and administration, or administration only Dispensary facility: any facility that receives, stores, distributes and administers blood components/products from a hospital transfusion service provider Administration facility: any facility that receives and administers (without storing) blood components/products for a specific patient from a hospital transfusion service provider

4. Why is this a concern? Krever Commission In 1997 Justice Krever presented his report that included 50 recommendations that would impact hospitals and facilities that provide blood and blood products to their patients. Key recommendations Safety  Informed Consent/Disclosure of Potential Risks of Transfusion Accountability  Transfusion Committees, ensuring compliance to established standards and regulations Blood Utilization  Ensuring the products that are received at the site are being used appropriately

5. National Standards CSA Z902 Blood and Blood Components Canadian Standards Association introduced 2004 revised in 2010 Purpose: Ensure critical elements of blood safety, efficacy, and quality are incorporated into facility procedures. Designed to help healthcare facilities and professionals to maintain and enhance the safety and quality of the national blood system from vein to vein Scope: Applies to blood centres, transfusion services and to any other organization that collects, processes, stores or uses human blood components or products.

6. Canadian Society for Transfusion Medicine Standards for Hospitals Version 3, 2010 – available through: www.transfusion.ca Purpose: Designed specifically for hospital transfusion services as a resource for the development of policies, processes and procedures to help them meet Canadian and International standards Scope: Applicable to hospital transfusion services, including dispensary/administration facilities

7. What Needs to Be Done All facilities involved in any type of transfusion activity should be in compliance with the applicable CSA Z902-10 standards (note: these standards will be federally legislated as of 2014) and CSTM standards There should be continual evaluation of compliance to these standards for all these facilities Ensure the standards are in place to maximize patient safety and minimize risk throughout the transportation, storage and transfusion process at the dispensary/administration sites A physician within the facility must be assigned responsibility for overseeing the Transfusion Medicine program

8. Accreditation Hospitals with licensed laboratories in Ontario must have their laboratories accredited by the Ontario Laboratory Accreditation Program (OLA). Many hospitals and healthcare facilities within Ontario are accredited by Accreditation Canada. The Qmentum accreditation program includes Transfusion Service standards. Both of these accreditation programs include assessment of Transfusion activities based on the CSA and CSTM standards and are available voluntarily Sites that are not accredited have the option to seek voluntary accreditation through either one of the two organizations listed below:

9. Dispensary/Administration Site Standards Transfusion Committee Transporting, receiving and storing blood Patient sample collection for testing Blood Administration Informed Consent Adverse reaction reporting Recalls/Lookback/Traceback Training and Competency Records and Documentation

10. Transfusion Committee Help define blood transfusion policies as appropriate to the local clinical activities; Ensure that regular evaluations of blood transfusion practices are conducted Establish criteria for the evaluation of ordering practices, usage (including the discarding of blood and blood components), administration policies, and the ability of services to meet recipient needs Recommend corrective measures, if necessary

11. Transfusion Committee cont’d Disseminate transfusion medicine information and education Evaluate reports of adverse transfusion events and all transfusion errors within the facility, as well as relevant federal and provincial or territorial reports on adverse transfusion events Review available alternatives to allogeneic blood transfusion and make appropriate recommendations on their use NOTE: The transfusion committee activities may be fulfilled under the auspices of another committee e.g. Pharmacy and Therapeutics (P&T) committee, provided that it is reflected in the terms of reference and that transfusion is a standing agenda item and receives adequate attention

12. Transporting, Receiving and Storing Ensure that the blood component/product: Was shipped without compromise in a validated shipping container that meets regulatory standards for the maintenance of appropriate temperature Meets the acceptable temperature range upon receipt Complies with established visual inspection acceptance criteria

13. Patient Sampling for Testing Ensure that the proper patient identification process is followed when collecting samples for testing Ensure that the samples collected are done so in the correct container and shipped appropriately Ensure that the appropriate sample has been collected (collected in the acceptable time frames) Ensure that the person collecting the sample is identified clearly

14. Blood Administration Ensure that: There is positive ID of the recipient, the association of the blood component/product with the recipient is verified in the physical presence of the recipient, and that this process is documented the blood component or product is transfused in the acceptable time limits vital signs are taken at the established acceptable time intervals there is written notification to the recipient of the administration of the blood component or product healthcare providers are familiar with and recognize the signs and symptoms of adverse reactions

15. Informed Consent Ensure that: The healthcare provider responsible for the request for the blood component/product has informed the patient of the benefits and the potential risks associated with the administration of the component or product, and with the consequences of refusing the blood component/product The process has been documented

16. Adverse Reactions Ensure that: the healthcare provider recognizes the signs and symptoms of adverse reactions and understands the steps that must be taken to stabilize the patient Appropriate investigation of the adverse reaction is performed and documented Root cause analysis is performed when appropriate with follow up action documented as required there is a mechanism in place for reporting the adverse reactions to the facility providing the components or products and also to the manufacturer/supplier and government agencies as required

17. Recall/Lookback/Traceback Ensure that there is a policy and procedure for the management of recall of any component or product that brings into question its safety or efficacy. Where there are cases of suspected transfusion-transmitted disease, the facility will ensure that there is a policy and procedure for both the Lookback or Traceback process to identify implicated components/products that have been transfused to recipients and to ensure proper follow up is taken

18. Training and Competency Establish a mechanism to communicate current information concerning the risks associated with transfusion, and new standards or processes to all personnel involved with transfusion activities at the facility Ensure that personnel involved in transfusion activities have access to ongoing training and competency at defined intervals

19. Records and Documentation The facility will ensure that all records associated with the transfusion are retained for the established required time frames. Records of employees signatures. Identification, initials, qualifications, training and competency also need to be retained for the required time frame.

20. Conclusion The licensed transfusion service and the dispensary/administration facilities should work collaboratively to establish a relationship and determine the expectations of each party for ongoing support, consultation and oversight in order that the standards may be met and continuously maintained A formal agreement should be in place Dispensary/Administration facilities shall comply with the regulated standards provided by CSA and OLA (Ontario Lab Accreditation) The goal is to mitigate risk and maximize patient safety