Thursday June 6, :30-3:00pm Juan A. Merayo-Rodríguez, MD Medical Director LifeSouth Community Blood Centers

Case #1.1 DOB 1991 (21 yo) Male Location Florida First time whole blood donor (mobile) Vitals satisfactory Donor educational material read Questionable motivation for blood donation

Case #1.2 On donation day Donor dressed with woman’s shirt Answered “no” to question - from 1977 to present had sexual contact with another male, even once? While signing consent he said “it is stupid that we don’t accept gay males to donate blood” Donor continued asking about what tests we perform

Case #1.3 Donor was informed that Blood Banks are not considered testing facilities, there are other places (State Dep. of Health) where he could get a “free test” Donor stated he should be acceptable to donate because he always uses “protection” Asked to have his picture taken because his “friend would be jealous”

Case #1.4 Donated unit was placed into “quarantine” and put on “hold” until Medical Office determined final disposition and donor eligibility status Donor was contacted for further clarification He admitted having sexual contact with another male, but did not agree with deferral reason

Case #1.5 During the call donor was informed about FDA regulations and high risk behavior relationship with acquiring STD’s including HIV Donor still did not agree and felt this was discrimination against all gays Donor did not believe any explanation given and did not want to be contacted any more and hung up

Case #1.6 Final determination: –An indefinite deferral was put on donor’s record for MSM after 1977

Case #1.7 Joint Statement before Advisory Committee on Blood Safety and Availability from AABB, ABC and ARC June 15, 2010 Since 2006 these organizations have recommended a change in the FDA deferral criteria for prospective blood donors who have had sexual contact with another male (MSM) Change proposed 12 month since last MSM

Case #1.8 Health Canada approved on May 22, 2013 the proposal to change the indefinite deferral on MSM after 1977 to a 5 year deferral proposed by Canadian Blood Services (CBS) and Héma-Quebec (HQ) accessed May 24, 2013

Case #1.9 Questions and Comments? Next case !!!

Case #2.1 DOB 1996 (16 yo) Male, student Parental (mother) consent obtained Location Alabama First time whole blood donor Screening satisfactory Vitals satisfactory

Case #2.2 2 days post-donation Reactive Tests –NAT and EIA HIV –HIV NAT discriminated –Non reactive HCV and HBV individual NAT

Case #2.3 Report submitted to Alabama DOH Called donor’s mother to inform her about status of her son, but could not be reached, after several attempts Within next 2 weeks Certified Letters were submitted to minor donor and parent informing that donor is not eligible to donate in the future and to call within 30 days

Case #2.4 Mail returned Called donor again, sister confirmed address Re-sent Certified letter with tests 6 weeks post results No calls received from donor or parent Follow-up 12 weeks post donation: Finally able to speak to donor’s grandmother. She gave a new contact number to reach donor’s mother

Case #2.5 Donor’s mother contacted via phone, she explained they went to physician and donor is receiving therapy and follow-up She also mentioned they are looking for the “guy” that did this to the donor

Case #2.6 Alabama Administrative code –Ch Notifiable diseases Code of Alabama Section 22-11A-19 (Acts 1987, No , p. 904, §19) 21 CFR FL Statue Testing requirements FL Adm. Code DOH rule 64D Diseases or conditions to be reported and 65C Services for HIV infected children

Case #2.7 Lesson learned Code of Alabama Section 22-11A-19 (Acts 1987, No , p. 904, §19) Alabama State minors of 12 years of age above can be notified without obligation of informing parents of STD test results “a minor 12 years of age or older who may have come into contact with any STD …may give consent to the furnishing of medical care related to the diagnosis or treatment of such disease…diagnostic procedures or treatment to a minor patient who has come into contact with any designated STD, may, but shall not be obligated to, inform the parent, parents or guardian of any such minor as to the treatment given or needed”

Case #2.8 Questions / Comments? Next case !!!

Case #3.1 DOB 1967 (45 yo) Male Location Alabama Repeat donor since 2003 (2 times allogeneic) Therapeutic donor since 2011 (5 times) Diagnosis Polycythemia (erythrocytosis)

Case #3.2 Donor gave two whole blood donations as allogeneic volunteer donor, during the third attempt his hemoglobin was above 19.0 g/dL Deferred until a physician provides diagnosis or order for therapeutic phlebotomy Donor returned with doctor’s order for therapeutic phlebotomies for “Polycythemia”

Case #3.3 After a year donor changed physician and presented to a donor center to give blood with a note from new physician The note states: –“please be advised that my patient can be a routine blood donor, this is not for a therapeutic phlebotomy”

Case #3.4 Medical office was contacted when donor presented to donate as “allogeneic” Explained to donor that since there is a diagnosis of polycythemia in his record, an extensive explanation must be provided in order to allow him to donate as allogeneic. Otherwise he can donate therapeutically with a new prescription

Case #3.5 Donor was upset, but contacted his physician to send more information to the Donor Center for clarification and documentation of diagnosis Several phone calls later and after speaking with physician, a document was obtained stating that “JAK2 mutation is negative, no evidence of primary polycythemia. H/H 15.6/48. Dx HTN, sleep apnea, obesity. No follow-up needed”

Case #3.6 A letter was sent to donor a week after documentation was received stating he is now eligible to donate blood as volunteer donor.

Case #3.7 In contrast, there are many other cases of therapeutic donors and their physicians who are unable to provide evidence that the original diagnosis is not present on further evaluations

Questions/Comments? Thank you !!! Office (352)