Attachment 1 Uniform Donor History Questionnaire

Attachment 1: Uniform Donor History Questionnaire to be cognitively tested

The Public Health Service Act provides us with the authority to do this research (42 United States Code 242k). All information which would permit identification of any individual, a practice, or an establishment will be held confidential, will be used for statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or the establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).

Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0920-0222).

OMB #0920-0222; Expiration Date: 06/30/2015

Uniform Donor History Questionnaire

* The interviewer should mix the appropriate pronoun with other terms with which the historian can relate: the donor’s given name; their nickname; inserting “your” father, mother, husband, wife, sister, brother, daughter, son, or child (as indicated).

Donor Name: ___________________________________________________________________________________ First Middle Last Person Interviewed: ______________________________________________________________________________ Name Relationship Contact Information: __(____)______________________________________________________________________ Phone Address City State Zip The interview was conducted: by telephone  in person  Person Interviewed: ______________________________________________________________________________ Name Relationship Contact Information: __(____)______________________________________________________________________ Phone Address City State Zip The interview was conducted: by telephone  in person  Person conducting interview and completing this form: Print Name Signature Date/Time
I want to advise you of the sensitive and personal nature of some of these questions. They are similar to those asked when someone donates blood. We ask these questions for the health of those who may receive her/his* gift. I will read each question and you will need to answer to the best of your knowledge with a “Yes” or “No.”
Where was she/he* born?
What was her/his* occupation?
3. Did she/he* have any health problems due to exposure to toxic substances such as pesticides, lead, mercury, gold, asbestos, agent orange, etc.?	No Yes	3a. Describe toxic substance and treatment.
4. Did she/he* have a family physician, a specialist, or visit a medical facility, which can include, for example, a clinic or urgent care center?	No Yes	4a. When? 4b. Why? 4c. Provide any contact information (e.g., name, group, facility, phone number, etc.):
5. Did she/he* take any medication recently or on a regular basis such as those prescribed, non-prescribed, dietary supplements, etc.?	No Yes	5a. What was it and/or what was it used for? If a steroid, such as prednisone, ask: 5a(i) How long? 5a(ii) What was the dose?
6. Did she/he* recently have any symptoms such as: 6a. a fever? 6b. cough? 6c. diarrhea? 6d. swollen lymph nodes? 6e. weight loss?	No Yes No Yes No Yes No Yes No Yes	If any answer in question 6. is “yes,” ask “when” this occurred and “describe symptoms and reasons,” if known. 6a(i). When? 6a(ii). Describe the fever and reasons. 6b(i). When? 6b(ii). Describe the cough and reasons. 6c(i). When? 6c(ii). Describe diarrhea and reasons. 6d(i). When? 6d(ii). Describe swollen lymph nodes and reasons. 6e(i). When? 6e(ii). Describe how much weight loss and reason(s).
6f. a rash? 6g. sores in the mouth or on the skin? 6h. night sweats? 6i. severe headache? 6j. rapid decline in mental ability? 6k. seizures? 6l. tremors?	No Yes No Yes No Yes No Yes No Yes No Yes No Yes	6f(i). When? 6f(ii). Describe the rash and reasons. 6g(i). When? 6g(ii). Describe the sores and reasons. 6h(i). When? 6h(ii). Describe night sweats and reasons. 6i(i). When? 6i(ii). Describe the severe headache and reasons. 6j(i). When? 6j(ii). Describe rapid decline in mental ability and reasons. 6k(i). When? 6k(ii). Describe seizures and reasons. 6l(i). When? 6l(ii). Describe tremors and reasons.
6m. difficulty walking?	No Yes	6m(i). When? 6m(ii). Describe difficulty walking and reasons.
7. Did she/he* know anyone who had a smallpox vaccination?	No Yes	7a. Did she/he* have contact with this person which includes touching the vaccination site, handling bandages that cover it, or handling bedding, clothing, or any other material that came in contact with the vaccination site? No Yes If yes, 7a(i). When did this contact occur? If in the past 8 weeks, 7a(ii). Did she/he* experience any symptoms or complications such as a rash, fever, muscle aches, headaches, nausea, or eye involvement? No Yes If yes, 7a(ii)a. Explain:
8. In the past 12 months was she/he* in lockup, jail, prison, or any juvenile correctional facility?	No Yes	8a. How long? 8b. Where? 8c. Why?
9. In the past 12 months was she/he* bitten or scratched by any animal?	No Yes	9a. What kind of animal; such as a pet, stray, or wild animal? 9b. When? 9c. Did she/he* receive any medical treatment? No Yes If yes, 9c(i). By whom? 9d. Was the animal suspected of having rabies? No Yes 9e. Was the animal quarantined or tested? No Yes 9e(i). Which one? If yes to tested, 9e(ii). What was the result?
10. In the past 12 months was she/he* told by a healthcare professional that they had a West Nile virus infection?	No Yes	10a. When was she/he* diagnosed? If this occurred within the past 4 months ask: 10a(i). What was the name of the doctor/clinic?
11. In the past 12 months did she/he* have any shots or immunizations, such as MMR, yellow fever, hepatitis B, flu, etc.?	No Yes	11a. When? 11b. What kind was it? If smallpox/vaccinia is named, ask these questions: 11b(i). Did she/he* experience any symptoms or complications such as a rash, fever, muscle aches, headaches, nausea, or eye involvement? No Yes If yes,   11b(i)a. When did these symptoms resolve? 11b(ii). Did the scab fall off or was it picked off? 11b(ii)a. When?
12. In the past 12 months did she/he* get a tattoo, touch up of an old tattoo, or permanent makeup?	No Yes	12a. Were shared or non-sterile instruments, needles or ink used? No Yes 12b. Was the procedure performed outside of the United States or Canada? No Yes If yes, 12b(i). Where?
13. In the past 12 months did she/he* have acupuncture, ear or body piercing?	No Yes	13a. Were shared or non-sterile instruments or needles used? No Yes 13b. Was the procedure performed outside of the United States or Canada? No Yes If yes, 13b(i). Where?
14. In the past 12 months did she/he* live with a person who has hepatitis?	No Yes	14a. What type of hepatitis did that person have? 14b. Was that person sick from the virus during that time, such as having abdominal pain, joint pain, exhaustion, fever, nausea, vomiting, diarrhea, or yellowing of the eyes or skin? No Yes
15. In the past 12 months did she/he* come into contact with someone else’s blood?	No Yes	15a. Describe what happened and when: 15b. Was the other person involved known to have had, or suspected of having, HIV or hepatitis? No Yes
16. In the past 12 months did she/he* have an accidental needle-stick?	No Yes	16a. Describe what happened and when: 16b. Was the needle contaminated with blood from someone known to have had, or suspected of having, HIV or hepatitis? No Yes
As I described before, I want to remind you of the sensitive and personal nature of some of these questions. We are required to ask these questions about all potential donors. Next, I will ask you about her/his* sexual history.
17. In the past 12 months did she/he* have a sexually transmitted infection such as syphilis, gonorrhea, chlamydia, genital herpes, or genital warts?	No Yes	17a. What was it?
For the next part, sexual activity and sex refer to any method of sexual contact including vaginal, anal, and oral.
18. In the past 5 years was she/he* sexually active, even once?	No Yes	If yes, complete the following questions (18a. to 18g.) 18a. Did she/he* have sex in exchange for money or drugs? No Yes If yes, 18a(i) When? 18b. MALE DONOR only: Did he have sex with another male?  (N/A) Donor is Female No Yes If yes, 18b(i). When? 18c. Did she/he* have sex with a person who has had sex in exchange for money or drugs? No Yes If yes, 18c(i). When? 18d. FEMALE DONOR only: Did she have sex with a male who had sex with another male?  (N/A) Donor is Male No Yes If yes, 18d(i). When? 18e. Did she/he* have sex with a person who used a needle to inject drugs that were not prescribed by their own doctor? No Yes If yes, 18e(i). When? 18f. Did she/he* have sex with a person who has received clotting factors for a bleeding problem? No Yes If yes, 18f(i). What was it and when was it used? 18g. Did she/he* have sex with a person who had a positive test for, or was suspected of having, Hepatitis B, Hepatitis C, or HIV? No Yes If yes, 18g(i). Which virus and when? 18g(ii). Was that person sick from the virus during that time, such as having abdominal pain, joint pain, exhaustion, fever, nausea, vomiting, diarrhea, or yellowing of the eyes or skin? No Yes 18h. In the past 12 months, how many sexual partners did she/he* have? _____
19. In the past 5 years did she/he* receive clotting factors for a bleeding problem?	No Yes	19a. When? 19b. What was the reason? 19c. Was it human derived? No Yes
20. Did she/he* EVER use or take drugs, such as steroids, cocaine, heroin, amphetamines, or anything NOT prescribed by her/his* doctor?	No Yes	20a. What was it? 20b. How often and how long was it used? 20c. When was it last used? 20d. Were needles used? No Yes If no, 20d(i). How was it taken?
21a.Did she/he* EVER have a transplant or medical procedure that involved being exposed to live cells, tissues or organs from an animal? 21b.Did she/he* live with, or have sex with, a person who had?	No Yes No Yes	21a(i). Explain: 21b(i). Explain:
22. Was she/he* EVER told by a physician that she/he* had a disease of the brain or a neurological disease such as Alzheimer’s, Parkinson’s, multiple sclerosis, or epilepsy?	No Yes	22a. What was she/he* told by a physician?
23. Was she/he* EVER refused as a blood donor or told not to donate?	No Yes	23a. What was the reason?
24. Was she/he* EVER a U.S. military member, a civilian military employee, or a dependent of either?	No Yes	24a. Did she/he* ever live or work on a U.S. military base outside the United States? No Yes If yes, 24a(i). In which country or countries? 24a(ii). When? If this occurred between 1980 and 1996 in Europe: 24a(ii)a. How long? (estimate total time)
25. Did she/he* EVER travel or live outside of the United States or Canada?	No Yes	25a. Where? 25b. When and for how long? If international travel or residency is extensive, be aware of query regarding vaccinations or other shots (within the past 12 months) at question #11.
26. Did she/he* EVER receive a blood transfusion or other medical treatment outside of the United States or Canada?	No Yes	26a. What occurred (which one)? 26b. Describe where and when:
27. Did she/he* EVER have surgery?	No Yes	27a. What kind? 27b. Where? 27c. When?
28. Did she/he* EVER use or take growth hormone?	No Yes	28a. When was it used? 28b. What kind was it?
29. Did she/he* EVER have a positive or reactive test for: 29a. the HIV/AIDS virus? 29b. hepatitis? 29c. T. cruzi or told she/he* has Chagas’ disease?	No Yes No Yes No Yes	29a(i). Explain: 29b(i). Explain: 29c(i). Explain:
30. Did she/he* EVER have liver disease or hepatitis?	No Yes	30a. What kind? 30b. When?
31. Did she/he* EVER have malaria?	No Yes	31a. When? 31b. Where was she/he* treated?
32. Did she/he* EVER have cancer?	No Yes	32a. What type? If skin cancer: 32a(i). What kind? 32b. When was it diagnosed? 32c. Describe when and where surgery, radiation, or chemotherapy occurred: 32d. Was the cancer considered cured? No Yes If yes, 32d(i). When?
33. Did she/he* EVER smoke?	No Yes	33a. What was it? If cigarettes: 33a(i). How many packs per day? 33b. How many years? 33c. Did she/he* quit? No Yes If yes, 33c(i). When?
34a. Did she/he* EVER have lung disease such as asthma, COPD, or emphysema? 34b. Did she/he* EVER have tuberculosis, or a positive skin or blood test for tuberculosis?	No Yes No Yes	34a(i). Explain: 34b(i). Did she/he* receive treatment? No Yes If yes, 34b(i)a. When? 34b(i)b. How long?
35. Did she/he* EVER drink alcohol?	No Yes	35a. What type? 35b. How often? 35c. How much? 35d. How long?
36. Did she/he* EVER have diabetes?	No Yes	36a. For how many years? 36b. Was it treated? No Yes If yes, 36b(i). How?
37a. Did she/he* EVER have kidney disease, kidney stones, or frequent kidney infections? 37b. Was she/he* EVER treated with dialysis?	No Yes No Yes	37a(i). What did she/he* have? 37a(ii). When? 37b(i). If treated with dialysis, was it peritoneal dialysis or hemodialysis? 37b(ii). When?
38. Did he/she* EVER have high blood pressure or high cholesterol?	No Yes	38a. Which one (or both)? 38b. For how many years?
39. Did she/he* EVER have heart problems or heart disease, such as a weak heart, a heart valve problem or an infection involving the heart?	No Yes	39a. Explain: 39b. How was it treated?
40. Did she/he* EVER have circulation problems of the legs, such as varicose veins, blood clots, leg ulcers, or skin discoloration of the feet or ankles?	No Yes	40a. Explain:
41. Did she/he* EVER have an autoimmune disease such as systemic lupus erythematosis, rheumatoid arthritis, sarcoidosis, etc.?	No Yes	41a. What was it? 41b. Did she/he* take steroids? No Yes If yes, complete 5a(i) and 5a(ii).
42. Did she/he* EVER have any eye problems, procedures, or surgery?	No Yes	If yes to eye problems: 42a. What kind of eye problems? If yes to eye surgery or procedures: 42b. What kind of surgery or procedure was performed and why? 42c. Which eye(s)?  left  right  unknown 42d. What is the name and/or phone number of her/his* eye doctor or eye clinic?
43. Did she/he* or any of her/his* relatives have Creutzfeldt-Jakob disease, which is also called CJD or variant CJD?	No Yes	43a. Who did? If a relative, 43a(i). Is this person a blood relative? (Note: The definition of blood relative is a person who is related through a common ancestor and not by marriage or adoption) No Yes If yes, 43a(ii). Which blood relative? 43b. Is there a physician, relative, or other person who can provide more information? (document discussion)
44. Is there a family history of: 44a. diabetes? 44b. coronary artery disease?	No Yes No Yes	44a(i). Describe type of relative, such as mother, father, sister, brother, etc.: 44b(i). Describe type of relative, such as mother, father, sister, brother, etc.:
Final Questions
45. Are there other medical conditions you are aware of that we have not discussed?	No Yes	45a. Describe:
46. Do you now have any concerns that her/his* donation should not proceed?	No Yes	46a. Can you share your concerns?
47. Regarding these questions, are there other people, including healthcare professionals, who may provide additional information?	No Yes	47a. Name(s) and contact information:
48. Do you have any questions about these questions?	No Yes	48a. Document:
Note to interviewer: Question 49, the HIV-1 Group O Risk Question, must be asked if the test kit being used for HIV-1 Ab testing is not labeled to include HIV-1 Group O. Check here if question skipped .
49. Did she/he* EVER have sex with a person who was born in or lived in Africa?	No Yes	49a. When was the person born, or when did the person live, in Africa? If since 1977: 49a(i). What country were they from?
Additional Notes

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