Transcript Document

Thursday June 6, 2013
1:30-3:00pm
Juan A. Merayo-Rodríguez, MD
Medical Director
LifeSouth Community Blood Centers
Case #1.1
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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)
http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-65fs-eng.php accessed May 24, 2013
Case #1.9
Questions and Comments?
Next case !!!
Case #2.1
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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 420-4-1
Notifiable diseases
• Code of Alabama Section 22-11A-19 (Acts
1987, No. 87-574, p. 904, §19)
• 21 CFR 630.6
• FL Statue 381.0041 Testing requirements
• FL Adm. Code DOH rule 64D-3.029 Diseases
or conditions to be reported and 65C-13.017
Services for HIV infected children
Case #2.7
• Lesson learned
• Code of Alabama Section 22-11A-19 (Acts 1987, No. 87-574, 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
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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 !!!
[email protected]
Office (352) 224-1747