DHQ v2.0, February 2016 Table Detailing Changes from v1.3 v1.3 Revised language in v2.0 Rationale Question 1: Are you

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1 DHQ v2.0, February 2016 Table Detailing s from v1.3 v1.3 Revised language in v2.0 Rationale Question 1: Are you Q 1, No Feeling healthy and well today? Question 2: Are you Q 2, No change Currently taking an antibiotic? Question 3: Are you Currently taking any other medication for an infection? Q 3, Revised to replace antimicrobial in v1.3 with medication in to read: Question 4: Are you now taking or have you ever taken any medications on the Medication Deferral List? No change Q 4, Revised: Have you taken any medications on the Medication Deferral List in the time frames indicated? (Review the Medication Deferral List.) Clarifies timeframes for drugs taken. Directive to read the medication deferral list added for clarity. Questions 5: Have you read the educational materials? Question 6: In the past 48 hours Have you taken aspirin or anything that has aspirin in it? Question 7: In the past 6 weeks Female donors: Have you been pregnant or are you pregnant now? (Males: check I am male. ) Questions 8: In the past 8 weeks, have you Donated blood, platelets or plasma? Question 9: In the past 8 weeks, have you Had any vaccinations or other shots? Question 10: In the past 8 weeks have you Had contact with someone who had a smallpox vaccination? Question 11: In the past 16 weeks Have you donated a double unit of red cells using an apheresis machine? UNDER HEADING IN THE PAST 12 MONTHS, HAVE YOU Question 12: Had a blood transfusion? Question 13: Q5, Revised: Have you read the educational materials today? Q 6, No to content See v2.0 Q 32 below Renumbered as Q 7, No Renumbered as Q 8, No Renumbered as Q 9, revised: In the past 8 weeks have you: Had contact with someone who was vaccinated for smallpox in the past 8 weeks? Renumbered as Q 10, No Renumbered as Q 11, No Renumbered as Q 12, No Added today to ensure the material is read on the day of donation. Moved to assessment category: Have you EVER. Clarifies that the time period for risk is 8 weeks after vaccination for smallpox. 1 DHQ v2.0 Table eff. February 2016

2 Had a transplant such as organ, tissue, or bone marrow? Question 14: Had a graft such as bone or skin? Question 15: Come into contact with someone else s blood? Question 16: Had an accidental needle-stick? Question 17: who has HIV/AIDS or has had a positive test for the HIV/AIDS virus? Question 18: Had sexual contact with a prostitute or anyone else who takes money or drugs or other payment for sex? Question 19: who has ever used needles to take drugs or steroids, or anything not prescribed by their doctor? Question 20: who has hemophilia or has used clotting factor concentrates? Question 34: From 1977 to the present, have you (Male donors) had sexual contact with another male, even once? (Females: check I am female. ) Question 21: Female donors: Had sexual contact with a male who has ever had sexual contact with another male? (Males: check I am male. ) Renumbered as Q 13, No Renumbered as Q 14, No Renumbered as Q 15, No Renumbered as Q 16, No Renumbered as Q 17, No Renumbered as Q 18, No Not retained in v2.0 Renumbered as Q 19, revised: In the past 12 months, have you Male donors: Had sexual contact with another male? Removed: (Females: check I am female. ) and corresponding box. Renumbered as Q 20, revised: Female donors: Had sexual contact with a male who had sexual contact with another male in the past 12 months? Removed: (Males: check I am male. ) and corresponding box. December 2015 guidance: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products (December 2015 HIV Risk ) Assessment category updated per No longer used as attention question based on findings from National Center for Health Statistics (NCHS) study. Clarifies that the time frame for MSM sexual contact is 12 months. Based on findings of National Center for Health Statistics study. 2 DHQ v2.0 Table eff. February 2016

3 Question 22: Had sexual contact with a person who has hepatitis? Question 23: Lived with a person who has hepatitis? Question 24: Had a tattoo? Question 25: Had ear or body piercing? Question 26: Had or been treated for syphilis or gonorrhea? Question 27: Been in juvenile detention, lockup, jail, or prison for more than 72 hours? Question 28: In the past three years, have you been outside the United States or Canada? Question 29: From 1980 through 1996, did you spend time that adds up to three (3) months or more in the United Kingdom? (Review list of countries in the UK) Revised in FDA review Question 30: From 1980 through 1996, were you a member of the U.S. military, a civilian military employee, or a dependent of a member of the U.S. military? Question 31: From 1980 to the present, did you spend time that adds up to five (5) years or more in Europe? (Review list of countries in Europe.) Question 32: From 1980 to the present, did you receive a blood transfusion in the United Kingdom or France? (Review list of countries in the UK.) From 1977 to the present, have you Renumbered as Q 21, No Renumbered as Q 22, No Renumbered as Q 23, No Renumbered as Q 24, No. Renumbered as Q 25, No Renumbered as Q 26, revised: Been in juvenile detention, lockup, jail, or prison for more than 72 consecutive hours? Renumbered as Q 27, No Renumbered as Q 28, No Comma added to header to read: From 1980 through 1996, Renumbered as Q 29, No Renumbered as Q 30, No Renumbered as Q 31, revised: From 1980 to the present, did you receive a blood transfusion in the United Kingdom or France? (Review country lists.) The assessment category From 1977 to the present, have you was not retained in v2.0. Revision added consecutive for clarity. The update to the parenthetical statement corresponds to the requirement to assess against transfusion in the UK and France. 3 DHQ v2.0 Table eff. February 2016

4 Question 33: From 1977 to the present, have you received money, drugs, or other payment for sex? Question 34: From 1977 to the present, have you (Male donors) had sexual contact with another male, even once? (Females: check I am female. ) UNDER THE HEADING Have you EVER Question 7: In the past 6 weeks: Female donors: Have you been pregnant or are you pregnant now? (Males: check I am male. ) Question 35: Had a positive test for the HIV/AIDS virus? Question 36: Used needles to take drugs, steroids, or anything not prescribed by your doctor? Question 37: Used clotting factor concentrates? Question 38: Had hepatitis? DRAFT UPDATED Question 33: From 1977 to the present, have you received money, drugs, or other payment for sex? Question 39: Had malaria? Question 40: Had Chagas disease? Question 41: Had babesiosis? Renumbered as Q 35, see below Renumbered as Q 19, see above Renumbered as Q 32, revised: Have you EVER (Female donors) Been pregnant or are you pregnant now? Removed: (Males: check I am male. ) and corresponding box. Renumbered as Q 33, No Renumbered as Q 34, No Not retained in v2.0 No longer renumbered as Q 44, no longer required. Question not retained in v2.0 Renumbered as Q 35, revised: Have you Ever Received money, drugs, or other payment for sex? Renumbered as Q 36, No Renumbered as Q 37, No Renumbered as Q 38, No Relocation and revision provides for assessment for TRALI mitigation AND deferral for pregnancy in the past 6 weeks. No longer used as attention question based on NCHS study findings NOTE: The May 2015 Final Rule, effective May 23, 2016, no longer requires this assessment. 4 DHQ v2.0 Table eff. February 2016

5 Question 42: Received a dura mater (or brain covering) graft? Question 43: Had any type of cancer, including leukemia? Question 44: Had any problems with your heart or lungs? Question 45: Had a bleeding condition or a blood disease? Question 46: who was born in or lived in Africa? Question 47: Been in Africa? Question 48: Have any of your relatives had Creutzfeldt-Jakob disease? Question 38: Have you ever had hepatitis? UPDATED DRAFT Renumbered as Q 39, revised: Received a dura mater (or brain covering) graft or xenotransplantation product? Renumbered as Q 40, No Renumbered as Q 41, No Renumbered as Q 42, No Not retained in v2.0. Not retained in v2.0. Renumbered as Q 43, No Additional Question Q44 is removed, no longer required. Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use, Final Rule, effective May 23, Blood centers use tests for HIV Group O Blood centers use tests for HIV Group O NOTE: The May 2015 Final Rule, effective May 23, 2016, no longer requires this assessment. 5 DHQ v2.0 Table eff. February 2016