Lifestyle Questionnaire

For STD testing results, see: http://trentdonor.org/std

Below are Trent's answers to a questionnaire.  This questionnaire is completed approximately every six months as specified in the online STD Policy and Procedures.

The most current questionnaire was completed on: Nov 1, 2011

 Additional Information for reference:

• The FDA website provides risk factor guidance to industry:
  ^{http://www.fda.gov/Guidances/Tissue/ucm073964.htm#DONORSCREENING1271.75}
  Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
   
• Who makes the donor-eligibility determination?
  The following is from the FDA website:  In accordance with CFR § 1271.50(a), a “responsible person” must determine and document the eligibility of a cell or tissue donor. A responsible person is one who is authorized to perform designated functions for which he or she is trained and qualified (§ 1271.3(t)). A responsible person should have appropriate medical training and adequate knowledge of relevant Federal regulations and guidances.
   
• Donor Eligibility:
  The following is from FDA CFR § 1271.50(b):  A donor is eligible under these provisions only if: (1) Donor screening in accordance with 1271.75 indicates that the donor:(i) Is free from risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases; and (ii) Is free from communicable disease risks associated with xenotransplantation; and (2) The results of donor testing for relevant communicable disease agents in accordance with 1271.80 and 1271.85 are negative or nonreactive, except as provided in 1271.80(d)(1).
   
• What physical evidence to look for?
  The following is from the FDA website: Relevant medical records (§ 1271.3(s)) include the report of the physical assessment of a cadaveric donor (§ 1271.3(o)) or the physical examination of a living donor. For living donors, you may examine only those parts of the body that are necessary to evaluate for RCDADs (Relevant Communicable Disease Agent or Disease) based upon relevant donor history that has been obtained during the interview and review of available records. You may rely on records of a recent report of a physical examination by other health professionals.
   
• Other records to consider:
  The following is from the FDA website: If they are available, the following other records also meet the definition of relevant medical records (§ 1271.3(s)).
    - Laboratory test results (other than the results of testing required for the donor-eligibility determination);
    - Medical records;
    - Coroner and autopsy reports; and
    - Records or other information received from any source pertaining to risk factors for relevant communicable disease (e.g., social behavior, clinical signs and symptoms of relevant communicable disease, and treatments related to medical conditions suggestive of risk for relevant communicable disease). Examples of these records include: medical examiner reports, police records, and information from other tissue or medical establishments, if applicable.
   
• FDA Web site: Donor Eligibility Final Rule and Guidance Questions and Answers
  _{http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm102842.htm}