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Summary of blood donor SAR seriousness assessment, pilot study in 2023 Background: The voluntarily submitted data on serious adverse reactions (SAR) in blood and component donors shows a more than 100-fold difference in rates in different member states (MS), ascribed primarily to differences in severity (seriousness) assessment. An international tool to support harmonisation of severity grading has been published, the Severity Grading Tool for blood Donor Adverse Events, SGTDAE. The tool has been endorsed by the European Blood Alliance. The Vigilance Expert Subgroup (VES) of the national competent authorities (NCA) for blood, tissues and cells, encourages careful reporting and evaluation of all relatively serious adverse reactions in donors at member state (MS) level. However for the annual EU data submission, homogeneity of data is necessary in the interests of cross-border data collection. It is possible that homogeneity of the data will be improved by a strict application of the tool’s criteria for seriousness by all MS when selecting cases for submission to the European Commission in the annual reporting exercise. This would mean that they only submit the more serious cases even though a larger number is reported to the NCA at national level. For this reason, the VES invites the NCA to participate in a pilot study, applying the criteria of the international SGTDAE to select (filter) cases of Grade 3 or higher. The data collected on blood donor SAR in 2023 will be used for this. A model letter containing information about the pilot accompanied by details of the criteria is provided below. The VES recommends that they should be circulated to the blood establishments in 2022, in time for them to collect the necessary data when assessing cases of serious donor adverse reactions in 2023. The data collection using the SGTDAE criteria will take place along with the 2024 SARE reporting exercise (2023 data collected according to each country’s usual methods). Methods: • Voluntary basis • Pilot of voluntary European level submission of nationally collected Serious Adverse Reactions in blood and component donors, using the validated Severity Grading tool for Donor Adverse Events • Note that for most MS this means that a smaller number of SAR in donors will be submitted to the Commission in the pilot i.e. people won’t need to collect/submit additional cases. • The (voluntary) provision of data according to the tool will be in addition to the (voluntary) provision of data in the way to which each MS is accustomed. • There will be dual data preparation and submission. Legal interpretation of the donor SAR definition can differ between MS according to healthcare organisation; there is no attempt to discuss or change these different interpretations. • At end of data collection: simple survey of all MS about their practices re data on SAR in donors, experiences with tool, current use of donor SAR information in monitoring/improving donor safety. EU Pilot of Donor SAR seriousness assessment (2023) 1 using international tool Pilot Summary, October 2022 Time line Preparation period in 2022: NCA were informed of pilot (May 2022), voluntary participation requested. Before end of 2022: NCA to receive pilot description and SGTDAE to inform blood establishments and enable them to prepare their pilot data collection. • Collection of data throughout 2023; note that BE staff need to be aware of criteria in tool, e.g. duration of donor symptoms affecting activities of daily living. • Submission of pilot data by NCAs in spring 2024 alongside the annual SARE reporting exercise. Objectives of the pilot • Evaluate the applicability of the SGTDAE for national level SAR data to be submitted within a legal framework (recognising that the data submission is voluntary). • Primary outcome measure: MS donor SAR rates (denominator: whole blood and apheresis donations) using tool, in comparison to rates using the MS customary assessment. Analyse homogeneity of total data collected with the tool, comparing to when MS use their customary methods. • Secondary outcomes: user (MS NCA) Survey results regarding difficulties applying tool (provide as input to the international group for potential future revision); overview of current MS use of donor SAR information in monitoring/improving donor safety. Coordination: Vigilance Expert Subgroup of the NCA (VES) EU Pilot of Donor SAR seriousness assessment (2023) 2 using international tool Pilot Summary, October 2022 MODEL LETTER EU pilot of seriousness assessment tool for member state blood donor serious adverse reactions in 2023 To all blood establishments This is to inform you that we, as competent authority, intend to participate in an EU-level pilot of a validated, EBA endorsed international tool for seriousness assessment of blood donor adverse reactions. This has the potential to improve the homogeneity and usefulness of data collected by the European Commission, but needs to be tested first. A summary of the pilot and the actual tool are attached. We request you to conduct your 2023 data collection in such a way that the criteria of the tool can be applied select the cases for submission to the European Commission in this pilot. This is in addition to your normal data collection methods. For your information, the EU data submission table is below. If you have any questions, we will forward them to the vigilance expert subgroup of the Competent Authorities who are coördinating this pilot. Thank you for your cooperation. EU Pilot of Donor SAR seriousness assessment (2023) 3 using international tool Pilot Summary, October 2022 Annual notification for Serious Adverse REACTION(S) Comments regarding this notification for Serious Adverse Reaction(s) in donors Total number of serious adverse reactions in donors of blood and blood components: (See section 2.1 of the Common approach) Please provide additional detail about any reported death in a donor of blood or blood components (NB please also include any deaths in the total numbers of donor SAR above.) EU Pilot of Donor SAR seriousness assessment (2023) 4 using international tool Pilot Summary, October 2022 Saatja: <[email protected]> Saadetud: 11.11.2022 17:36 Adressaat: <[email protected]> Koopia: Jo Wiersum <[email protected]>; <[email protected]> Teema: RE: Blood donor SAR: pilot of seriousness assessment tool, information for informing the blood establishment(s) Dear all, As the title of the word file attached to the email below (sent on 27 October) could be misleading (it mentions nearly ready), we would like to reassure you that the file you have received was already in its final version. However, we have attached in this message a new copy (which was accidentally not included as annex in the latest newsletter sent on Monday 7 November). Many thanks for your understanding and enjoy the weekend, Massimo &amp; the SoHO team European Commission DG SANTE (Health and Food Safety) Unit D2 Medical Products: quality, safety, innovationOffice address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium From: SANTE SOHO Sent: Thursday, October 27, 2022 2:51 PMTo: SANTE SOHO &lt;[email protected]&gt;Cc: 'Jo Wiersum' &lt;[email protected]&gt;; SANTE DL SOHO &lt;SANTE-DL- [email protected]&gt;Subject: Blood donor SAR: pilot of seriousness assessment tool, information for informing the blood establishment(s) Dear competent authorities on blood and blood components, The attached document summarises the planned pilot (in 2023) of the European Blood Alliance endorsed tool for seriousness assessment of blood donor adverse reactions. The Vigilance Expert Subgroup (VES) is conducting this study so that together we can evaluate the tool (attached) and determine whether it improves homogeneity of the data submitted to the European Commission. Participation is voluntary, but it is hoped that many of you will participate so that the value of our EU- level data will improve. There is no attempt to change existing national level practices. We recommend that you inform your blood establishment(s) at this time, in order that they can to prepare to use the tool in 2023 when evaluating the serious reactions. A model letter (in English) is provided in the pilot summary, which may be used if helpful. Thanking you in advance for your participation. Best regards, The SoHO team and VES rapporteurs. European Commission DG SANTE (Health and Food Safety) Unit D2 Medical Products: quality, safety, innovationOffice address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium General factors to Severity consider in assigning severity (DAE) Examples Grade Donor Adverse Event (DAE) Severity Tool No Outside Medical Care (OMC) Arterial puncture, pressure bandage AND applied, resolved without intervention or Severity Grading Tool for Short duration ≤ 2 weeks sequelae AND Blood Donor Adverse Events Grade 1 No limitation on Activities of Daily Living Vasovagal event that resolves with comfort (ADL) care and/or oral hydration AND A User Brochure Resolved with no or minimal intervention Citrate reaction resolved with oral calcium or reduction in infusion rate Introduction: Superficial thrombophlebitis resolved with OMC, no hospitalization oral antibiotics, no sequelae The severity assignment tool is OR designed to be used with the Standard Grade 2 Duration >2 weeks- ≤ 6 months Vasovagal event that requires transport to for Surveillance of Complications OR ER for IV hydration Limitations on ADL for ≤2 weeks Related to Blood Donation published Lacerations requiring sutures in 2014 by ISBT/AABB/IHN. Severity Not life-threatening assignment can be hampered by AND any of the following Hospitalization Arteriovenous fistula requiring surgical subjectivity; this tool was created to OR repair enhance objective assignment of Duration >6 months severity. The Severity assignment is Grade 3 OR Fracture, dental injury, or concussion patterned after an established clinical Limitations on ADL >2 weeks OR TIA and other cardiovascular events , severity scale, Common Terminology Require surgery which are not life-threatening Criteria for Adverse Events (CTCAE1) OR v 5.0, which rates severity by Grades 1- Other serious complications (Category E) LOC with fall and intracranial bleed 5 with 1 through 5 being roughly Grade 4* Immediate medical intervention required Anaphylaxis requiring intubation or associated with mild, moderate, to prevent death tracheostomy severe, life-threatening and death. Grade 5* Death Death Definitions and general considerations for severity grading include: * Grade 4 and Grade 5 are not shown in the Severity Grading Tool of Blood Donor Adverse Events . This tool has been formally endorsed by Developed by : AABB Donor Hemovigilance Working Group Please refer to Standard for Surveillance of Complications Related to Blood Donation, December 2014 for complete Donor Adverse Event Definition CTCAE v 5: Common Terminology for Adverse Events Version 5.0; published November 27, 2017; US Department of Health and Human Services, National Institutes of Health, National Cancer Institute  Instructions for Use Working Definitions and Abbreviations for Use in Grading Reactions: • Determine category of Donor Adverse Event (DAE) using ISBT/AABB/ IHN Standard for Surveillance of Complications Related to Blood Dona- • Outside Medical Care (OMC): donor is evaluated and/or tion, December 2014. treated by Emergency Medical Response (EMR), Health Care • For Grade 1, the reaction must satisfy all criteria listed Professional (HCP), urgent care, hospital emergency room • Select the highest applicable grade of severity; for example, if a vasova- (ER) without admission to the hospital. Please note that if EMR gal reaction resulted in a fall and the donor was seen in the emergency is called (an ambulance) and the donor is evaluated but not room where she required sutures (Grade 2) to repair a laceration on her transported, then it is still considered OMC. arm and was also diagnosed with a concussion (Grade 3), the final se- • Hospitalization: admission to the hospital; does NOT verity assignment would be Grade 3. include being seen and discharged from urgent care or hospital • Occasionally a donor may experience multiple adverse events. Assigning emergency department. a severity grade in such cases requires judgement. • Life-threatening: any adverse event that places the subject  If the reactions are distinct, with more than one type DAE classi- at immediate risk of death without intervention. fication, assign each DAE a separate Severity Score based on the  A DAE should be graded as life-threatening, Grade 4, Grading Tool. (Example, citrate reaction that resolves with oral only if the situation required immediate action to calcium [Gr1] plus a nerve injury that impacts ADL for more prevent death. For instance, the following interventions than 2 weeks [Gr3]). would suggest a life-threatening DAE: intubation or  If the DAEs are related or difficult to distinguish , then assign a tracheostomy for stridor, wheezing, bronchospasm or single Severity Grade based on the highest applicable Severity laryngeal edema (anaphylactic shock). Grade.  A situation that is potentially life-threatening should • Not all Grades are applicable for all DAE; for instance, all DAE involving NOT be given a Grade 4; Grade 4 is reserved for only major blood vessel injury, cardiac and cerebrovascular incidents are those DAE that actually required intervention to graded at least Grade 3 ; no option for Grade 1 or 2 is given. Likewise, prevent death. DAEs involving arm pain are not life-threatening and are limited to • Surgery: Any procedure that required regional (spinal, Grades 1, 2 or 3. block), inhalation or general anesthesia. The following are NOT • Grades 4 (Life-threatening) and 5 (Death) are very rare. Neither considered surgery: simple sutures, staples, butterfly closure. Grade 4 nor Grade 5 is shown in the Severity Assessment Table/Tool, and should only be selected when the final diagnosis is • Activities of Daily Living (ADL): Include everyday confirmed in consultation with appropriate medical personnel. (See def- household chores, doing necessary business, shopping, going to inition of Life-threatening). work or school, or getting around for other purposes. ADL are • Death due to a blood donation or if donation was a contributing factor impacted if the donor should be reported to the competent authority as required by law.  Needs the help of other persons with bathing or • Imputability: This grading tool is developed to assist with assignment of showering, dressing, eating, getting in or out of bed or severity. Imputability must be assessed separately for determination of chairs, using the toilet, and getting around the home the relationship of the donation to severe DAEs, as required for fatality (Self-care ADL) reporting. Please refer to Standard for Surveillance of Complications  Cannot work, attend school or manage routine Related to Blood Donation 2014 -- ISBT/AABB/IHN. personal/family activities because of the Donor Adverse Event (Instrumental ADL).  Severity Grading Tool of Blood Donor Adverse Events Category Grade 1 Grade 2 Grade 3 A.1. Blood outside vessel • • OMC (EMR, ER, PCP, Urgent care), Hospitalization, or • No OMC no hospitalization, or • ADL >2 weeks, or --Haematoma • Localized to • ADL ≤2 weeks, or • Severe sequelae, or --Arterial puncture venipuncture site --Delayed bleeding • Generalized beyond venipuncture site • Surgical intervention • OMC (EMR, ER, PCP, Urgent care), A.2. Arm Pain • No OMC no hospitalization, or --Nerve injury/irritation • Duration > 6 months, or --Other arm pain • Duration ≤2 weeks • Duration >2 weeks to ≤6 months, or • ADL >2 weeks • ADL ≤2 weeks A.3. Localized infection/inflammation of • OMC (EMR, ER, PCP, Urgent care), • Hospitalization, or vein or soft tissue no hospitalization, or --Superficial thrombophlebitis • No OMC • ADL >2 weeks, or --Cellulitis • ADL ≤2 weeks, or • Resolved with IV treatment • Resolved with oral antibiotics A.4. Other major blood vessel injury --Deep venous thrombosis • Diagnoses medically confirmed, or --Arteriovenous fistula • Treated with anticoagulant therapy, or --Compartment syndrome • Required surgical intervention --Brachial artery pseudoaneurysm • OMC (EMR, ER, PCP, Urgent care), • Hospitalization, or B. Vasovagal reactions --Vasovagal reaction, no loss of no hospitalization, or • ADL >2 weeks, or consciousness (LOC) • No OMC • ADL ≤2 weeks, or • Fracture(s), medically confirmed concus- --Vasovagal reaction, loss of con- • Suture of laceration(s), or sion, dental injury requiring dental proce- sciousness (LOC) dure, e.g. cap/crown, dental implant, • IV rehydration bridge, tooth extraction, dentures C. Related to apheresis • No OMC • OMC (EMR, ER, PCP, Urgent care), • Hospitalization, or --Citrate reaction • Citrate toxicity no hospitalization, or • ADL >2 weeks, or --Haemolysis (including carpopedal • ADL ≤2 weeks, or • Abnormal cardiac rhythm medically --Air embolism spasm) resolved with or • Citrate toxicity requiring intravenous diagnosed --Infiltration without oral calcium calcium • OMC (EMR, ER, PCP, Urgent care), • Hospitalization, or • No OMC D. Allergic Reaction no hospitalization, or • Generalized reaction, including bron- --Local allergic reaction • Managed with • Generalized reaction including chospasm, laryngospasm or anaphylaxis, --Generalized (anaphylactic) reac- over- the- counter bronchospasm, laryngospasm managed with requiring management with intravenous tion medications—topical inhalation or oral bronchodilator and/or auto steroids and/or epinephrine, but NOT intu- steroids, antihistamine -injector (EpiPen) bation or tracheostomy E. Other serious complication --Acute cardiac symptoms --Myocardial infarction --Cardiac arrest • Diagnoses medically confirmed --Transient ischemic attack --Cerebrovascular accident (Stroke) • OMC (EMR, ER, PCP, Urgent care), • Hospitalization, or • No OMC no hospitalization, or • Duration > 6 months, or F. Other • No injury • Duration >2 weeks to ≤6 months, or • ADL >2 weeks, or • ADL ≤2 weeks • Surgical intervention