HomeMy WebLinkAboutM-80-0120fl:A
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FROM
l»U I'1:1. I ;,rI •
Chief H. Brice, Director
Fire Department
dt
G. Salman, Di ector
Building & Z' ping;
Inspection Department.
311 4,
1
February
,.
2 P:F 5i2[�lCeia:
8 1980,
Blood Banks & Centers
Further research indicates that the following --
is a list of all known blood plasma centers
within the municipality of Miami:
Southern Florida Blood
Components, Inc. 5 0 N. W. 11 Street
Continental Blood
Components, Inc.
1334 N
•
6 Street.
Knickerbocker Biologicals
Inc. 1675 (1677) N. W..27 Avenue
All above listed are licensed by our City License
Division.
We. again wish to call attention to the fact that the
Dade .County Health Department is the regulatory power
delegated to,. inspecting and controlling, the facilities.
and- individuals who participate as donors at these
facilities.
The address previously listed at 161 NE. 4 Street is
no longer in existence, as the License Division reported
they inspected on February 7th and the building has
been demolished.
'GSg
ec: Director's file
Zoning Division
Reading file
•
-120
Copy of original application
Name of Applicant: Charles S. Hunter
South'Florida Blood'Components
50`N. W. 11, Street
'Plasma Bank
NAME op '
APPLICANT
COMPANY
NAME
APPLICATION FOR CERTIFICATE OF USE AND OCCUPANCY
• • CITY OF MIAMI
ZONING DIVISION • BUILDING DEPARTMENT ,
• AUDITNO
t• ' •' • . •"' • •0' e-AJ: C O. NO
• (g ,
LOCATION
TYPE OF BUSINESS
PHONE
S 40- 4-0
LOT
SUBDIVISION
• • ' • - JV1'1.9 173
.. .
••41.‘ CERTIFICATE ; NO. ISSUED
73° )451 ISSUED
. '
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••••
7 •ZONING INSPECTION SUPERVISOR
APPLICANT
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MAILING ADDRESS ' 33/ A i
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JONING APPROVAL, l/*�
_
DATE OF RE -CHECKS:
•
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Title 21—Food and Drugs
Subparts D through E—(Reserved)
Subpart F-Cryoptccipitatcd Antlhemophille
Factor (Human)
CC,
640.50 Cryoprcclpftated Antthemophtlie
Factor (liftman),
640.51 General requirements,
640.52 Processing.
Subpart G—Source Plasma (Human)
640.60 Source Plasma (Human).
640.61 Informed consent,
640.62 Medical` supervision,
_ .:640.63 Suitability of donor.
640.64 'Collection of >"blood
Plasma (Human).
640,65 Plasmnpherests.
640.66 Imnunlzatlon of donors.
640.67 Test for hcpatlti- B antigen."
640.68 Processing.
640.69 General requirements.
640.70 Tfodlfication of Source
(Human).
Subparts H and t—tReservedj
Subpart! —immune Scrum CIt.bulln(Human)
610.300 Immune Serum Globulin (human)'
040.101 General requirements.
640,102 Idanufacturc of Immune Serum
Globulin (Ili:man). lated into one or _more test vessels in a
640.103 The final product.: ratio of blood to edium of 1 to 10 for
640.104 Potency. each vessel, nixed thoroughly. Incubated
Subpart K-Meastes immune Giobuttn (Human) " for seven to nine days at a temperature
6.10,110 measles Immune Gicbulln (flu- of30' to 32' C., and examined for evi-
man). Bence of growth of microorganisms every
640.111 "General requlten eats. workday throughout the test period. On
640.112 l.fanufacture of Measles immune the third, fourth, or fifth day at least 1
Globulin;;(1=::man). till. of material front each test vessel
640.113. The final product. shall be subcultured In edditional test
6�0.114 Potency. t•es eLs containing the same culture me-
AuTuoatrv: Sec. 215, 58 Stnt. C90. as .,(Mint and 1!t such proportion es \vllj Per -
as Sec.'351, 56'Stat. 702,
rrit s1 n11cant visual 111Speet!Oit, mixed
as'mliended; 42 U.S.C. 202, unless otherwise thorouhhly, incubated for seven to nine
noted. days at a temperature of 30' to`32' C.
SueRct: -es FR 2oaa, Nor. 20, 1973, unless and examined for evidence of growth of
etherwLe noted. rnicrl-)organlsins every wori:day._tltrotlgh-'
Cnoss nrr-r:r.r.,cces: For U.S. Customs Serf.- out the test period. if growth is ob-
ice'regulations 'relating to vlrtises, r,Mutns, served in any test vessel. the test Shall
and 'tc,:ins.see 19.i;I°lt 12.21-12.23. For U.S. be 1'tr,;eated to rule out faulty test
Pr ;tat Service regulations relating to the nd-see procedure." using another sample of
fin sslhnny to .L1 and 125, States malts see blood front either, (I) the container
33 Crli�'arts 12-1 and (•sp. 4 f25a,� from which the initial test snntple was >.
Subpart A--Whoic Blood (Human) \taken, (2) the residual cells or plasma
(rout that Mucci, or (3) two different
ontalnersof blood, each 18 to 24 days
id ` and each tested separately. The
(orntula for fluid tl:ioglycollat.e medium'
shall be as prc•scribcci in § 610.12(e) (1) of
this chapter and the fortnuia forthiogly-
colllat.e broth medium shall be as prca•
610.2 General`rec((.ir(•:penis. scribed in: 610 12(f) (5) of this chapter.
n)__,anufnctttn iv respc,nsi)ility. All Media and design of container shall meet
traa, h t.urittg-of--tVTln`le Blued (lfu the tcquirrinc'nts prescribed in ; 610.12
than); 1nchul[ng donor examination'; 'e)(2)(i) of this chapter Tn lieu of per-
' blood collection, to ;p:atory tests, label forming one test using an hicubation
§ 6111.1 . \\'hulc Moor! (f iuntnn).
The proper name of this product 5h01
be NVho)e Blood (Iiuntan). \note'Iaood
(Iruman) Is defined as blood collected
rom human donors for-ti'aiiEffill'on to
hulnali rc 115le its.
ing, storage and issue, shall be done
under the supervision and controlof the
same licensed establishment except:, that
the Commissioner of Food and Drugs .:
may approve arrangements, Upon'` joint
request of tv:o or more licensed establish-
ments, which he finds are of such a na-
ture as to assure compliance otherwise
with the provisions of this subchapter.
(b) Periodic': check on sterile tech-
nigue. Where blood is collected in an
open system, that is, where the blood
container is entered, at least one con-
tainer of such, blood that upon visual
examination appears normal shall be
tested each month between the 18th and
29th day after collection, as a continu-
ing check on technique of blood collec-
tion, as fellows:
The stest " shall be performed with a
total sample of no less than 10 ml.
of blood' and a total volume of fluid
thtoglycolir.te or thioglycollatc broth me-
dium 10 times the volume of the sample
of blood. The test sample shall be lnocu
C
temperature of 30' 1.
may be performed,
as prescribed in th
an incubation tamp
C. and one at an inc
of 35' to 37' C. A
performed providec
performance of sue:
turer submits data
sioner of Food and I
to establish that
equal or superior to
scribed as a check
and makes the findir
recor)d.
(cFinal contai
blood container sha
tainer and shall not
issue for any purpc,
^ollection Such col.:.
colored and transpa:,
inspection cf the co
sure shall be such
hermetic seal and
tion of the cuntents
aerial : shall not Int(
tents under the cost
;tot age and use. In
have an adverse ciTt.
purity.or potency o.
(d) [Reserved)
(e) , reissue of bit
been rcnto•: ed from s
a licensed est a.,lishr.
issued by a licensed (
the following conditi
1) 'rite contr:incr
seal when originally
remains unbroken:
(2) An original pi
oily attached and ha
except that blood lac
may be rei-sued In
vided it is accompsl
for sampling and 1
hours after entering
sampling:
(3) 'The blood he
ronti:1UOUSly at 1' Lo
(4) The blood is 1.
until a significant it
with the requhcmeI)
be made.
(f) .Issue prior to
test results. Ntwitl
visions of § 610.1 of
may be issued by the
quest of a physician
medical facility, bfo;
Prescribed in ; 640.5
hepatitis assoclated
Prescribed In ! 610.
10.64 Title 21—Food and Drugs
•
illy derivative of human blood which
Food and Drug Administration Iias
.:.cc the licensed establishment is a
:We source of viral hepatitis. except
specific immunization performed in
irdance with 1 640.6G of this part.
.1 General. Any donor Who, in the
ion of the interviewer, appears to be
-r the influence of any drug. alcohol,
it any reason does not appear to be
iding reliable answers to medical his -
questions. shall not be considered
.table donor.
0.64- Collection of blood for Source
Plasma (I) in).
) Supervision. Ali blood for tilt col-
on of Source Plasma (Human) shall
rawn from the donor by a qualified
scd physician or by persons under
upervision trained in the proced
) Blood containers. i3lood cont.N hers
donor sets shall be gyro,-; . roc.
le and identified by lot num))cr. Tlic
int of anticoagulant required for
uantity of blood to be colic.: cd shall
z the blood container wh 1 it is
.izcd.
The anticoagulant solution. &hc
oaguiant solution shall be stern,.
pyrogc n-free. One of the :following;
ulae shall be used in the indicated
005:
Anticoagulant acid citrate dextrose
-7on (ACD) .
Kltun citrate
,C,H O_•2ii3O) 23.0 grams
sewn (C•11,O;4r,O) __ 0.0 grains
)sc (C,H„O,It,O) 24,5 grains
for injection (II.S.P.)
nake 1,000 milliliters
le per 100 milliliters
d 15 milliliters
; Anticoapufant.citrate. phosphate
' 1(0 solution (CPD).
Shim citrate
26.3 grams
nclti:(CiS,G-IliO) -- 3'.27 grants
sc.:(C„Ii O,Si,01- 2b.5grams
axle sodinro phosphate
l',PO.-H O) 222 grams
for injection (0SP.)'.
lake _.-_ __-__ 1,000 m1111ilters
100 milliliters -
f -----' 34 milliliters
Anticoagulant sodium citrates solu-
1 Sum citrate
3„I3,0,•2iT,O) 40 grams
for Injection (U.S.P.)
Sake 1.000 mounters
: par 100 milliliters
(d) Donor identification. Each unit of
blood and plasma shall be so marked or
identified by number or other symbol so
as to relate it directly to the donor.
(el Prcueuliwt of contamination of lltc
blood and plasma. The skin of the donor
at the site of phlebotomy shall be pre-
pared thoroughly and carefully by a
method that gives maximum a55uranee
of a sterile container of blood. The blood
shall be collected, tile plasma separated.
and the cells returnMi'to the cane • by
aseptic methods in a sterile system which
may be closed, or may be veined if the
vent protects the blood cells and plasma
against. contamination.
1311 Yit 22009. -Nos. 20. 1873: 33 FIt 13532.
Apr.1c.13-4
Plasmaplicresi •
14 Ca)Procedure-general.: The, plasm
pheiesis procedure which is cleaned as
that procedure in winch blood is removed
from. a donor, the plasma separated from
the formed elements and the formed ele-
ments returned to the donor. during a
Single visit to the establishment. shali
be described in detail in the; product
license application.
tb) Procedures -specific requirements:
T.1c piasmapiieresis procedure shall meet
the following f(1 'iremcnts. - —_
tL_A sample of blood shall be drawn
from each donor by a qualified licensed
physician or by persons ur.dcr his super-
vision and and trained in such procedure or.'
the day of the first piasmaphcresis and
at least every four months thereafter
on which a serologic test for syphilis and
a serum) protein elcrtrophoresis or quan-
titative nmmlulociifusion test for ini-
munoulobutins to determine the lminuno-
I.lobulin composition of the scrum shall
be performed. The results of the tests
shall be reviewed by a qualified licensed
physician within 10 daysafter the sample
is drawn to determine whether or not the
donor may continue on the program. If
the plasm. protein composition is r.ot
within normal limits established by the
testing Iaboratory. the donor shail be
removed from the program until these.
values return to normal. A cio..or . with a
reactive serologic test for syphilis shall
not be plasmapheresed again until his
scrum tests nonreactive to a serologic
test for syphilis.
(2) At icast every four months. the
accumulated laboralory data and collec-
tion records of each donor shall be rc-
Chapter I —Food and Drag Administration § 640.69
to determine continuing suitability of the for lmmunizatbon shall be
either
her oprd-
the
Publie.Health Service Act for such pur-
pose or one specifically approved by the
Director, Bureau of Biologics. Food and
donor. Only those donors found suitable uct Itccnsec
upon such a review shall remain in the
plasmapileresis program. Such a review
shall ; be signed by the reviewing
physician. Drug Administration. Immunization pro-
(3) A donor identification system shall ccdures shall be on file at each plasma- .
be established that positively identifies pl:eresis center where immunizations are -
each donor- and relates such donor performed.
directly to his blood and its components fr10,G7 Test for liepatius l; antigen.
as well as to his accumulated records Each unit of Source Plasma (Human)
and laboratory data. Such system shall shall be nonreactive to a test for the
include' either a photograph of each hepatitis B antigen a5' prescribed fn
donor which shah be used to each visit 5; 610.40 and610.41 of this chapter.
to confirm the donor's =
identity, or some
other methods that provides equal or § 640.63 Processing.
greater assurance of positively Identify- (a) Sterile system. All- surfaces that
in;; the donor. come in contact with the plasma shaU be
i4> The
amount of whole blood: not both` sterile and pyrogen-free. If the
.
a donor during a plasmapheresls procc- system (i.e., where an alnvaY must be
dare or .0 any l6-hour
tless
t shall nothe donor's inserted into a container for withdrawal
uccd 1.000 milliliters unof the plasma), the airway and vent shall
1n
including ticoagulant removed from method of separation involves a vented
i ;lit is 175 pounds or greater, in which
case the amount of whole blood. not in-
cluo ••)g anticoagulant, rcmeved from the
dono\cluring a plasmaphcresis procedure
or in ny 43-hour period shall not exceed
1,200 milliliters.
,.5) The amount' of whole blood, not
ncluding anticoagulant, removed from
a donor within a seven-day period: shall
not exceed 2.000 milliliters unless the
donor's weight is 175 pounds or greater,
In which case the amount of whole blood,
not including anticoagulant, removed
frori the donor during a seven-day period
shall not exceed 2,400 milliliters.
(6) No more than 500 milliliters of
whole blood shall be removed from a
donor at one time. unless the donor's
weight is 175 pounds or greater, in which
case no more than G00 milliliters of whole
blood shall be removed' from the. donor .
at one time.
(7) The plasma shall be separated from
the red blood cells Immediately after
blood collection. Tne maximum Sensible
volume of red blood cells shall be re-
. turned to the donor before another unit
Is collected.
§'640.66 Inununizntion of donors.
If specific immunization of a donor Ls
to be performed. the selection and sched-
uling of the injection of the antigen, and
the evaluation of each donor's clinical
response, shall be by a qualified licensed
physician or physicians. The admtnislra-
tion of the antigen may be performed by
ia licensed physician or a trained person
imrl/`r his 'imrry Ginn. Anv material used
be sterile and constructed so as to ex-
clude microorganisms and maintain a
sterile system-
(b)' Final containers. Final containers
used for Source Plasma (Human),
whether integrally attached or separated
from the original blood container, shall
not be entered prior to issuance for any
purpose except for filling with the
plasma. Such containers shall be uncol-
ored and hermetically sealed. and shall
Permit clear visibility of the contents.
Final containers and their components
shall not interact with the plasma con-
tents under conditions oC storage and use
so as to alter the safety. quality. purity.
or potency of the plasma and shall pro-
vide adequate protection against external
factors that may cause deterioration or
contamination. Prior 'to filling. the final
container shall be marked or identified
by, number or other symbol which will
relate it directly to the donor.
(c):Preservative. Source Plasma (Hu-
man) shall not co-itain a preservative.
§ 640.69 ' General requirements.
(a) Pooling. Pooling of plasma by the
manufacturer of Source Plasma (Hu-
man) from two or more donors is not
Permitted. Two units of plasma from the
salve donor may be pooled if such units
arc collected during one piasmapheresls
procedure. provided the pooling is done
by a procedure that gives maximum as-
surance of a sterile container of Plasma.
lb) Storage. Immediately after filling.
the plasma shall be stored at not warmer
•
•h
stcd as prescribm
(rr).
uircaients.
lent shall be addm
manufacturer.
ciately after pm.
shall be placed in
zed at
•edition to the itet:.t,
•;•visions of this sub_
label shall bear C;
of blood group ea:
:load.
mast using the pry.
::i:c of that:•ing dee
to thaw Cryopre •;••,,
_lie Factor (Minix,
t.iatntanted at
C.
to store the pit•?::,
lure after thav!•inr
within 6 hoots ••-
_In 2hours of'nt•'`
e•t.
in '
•• r� n r, •
it
,- •
:.LrYrC'Y'a..i•171a.a..XV,....:.Y.L"4.1,-4+wT
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'vim.``•+,-'':s,�vri' ;+..,� titir�+..1_.,:a:.���1"iG
••1' •ir. ,♦ !.
'`•l�ry ��ly•�
Chapter I —Food and Drug Administration 4 640.63
h^4demonstrated : potency In patients
having a factor V1U deficiency.
(d) Finel container. Pinal containers
ised for. Cryoprecipitated Antihernophilie
Factor(Human) shall be'uncolored •and
trtttsparent to permit visual inspection
of the contents and any closure shall be
such as will maintain an hermetic seal
sad prevent contamination of the con-
t•:lla. The container material shall not
Z,:tract with the contents under the cus-
toyuy conditions of storage and use, in
rich a manner as to have an adverr,e
c:lect upon the safety. purity. and
potencyof the product, , At the time of
;'•ling, the final 'container' shall be
; ed or, identified by nurxt cx o other
rtsbol so us to rclate'it to the -dono
Subpart G—Source Plasma (Human)
s to use a flit`
;uipmcnt.
_".t indicating thetheii' •. T
• : sma and
• iution present in
oit which the pea •
_ of the lest met
tied (Australia) r •
-••in¢.
:•sz of pi=fina•'1.11C, •,
..'.ed .rcm the red
1 Stcziic systcin action by ccntric
esscnti:tlly r-
•
610.60 Source Pinteni, ([rumen).
The proper name of this product shall
le Source Plasma (Human). The product
cicrited as the fluid portion of human
• •ai which has been stabilized against
eeetingi collected by p]esrapheresis,
s:.•f1s intended as source ivat.criai_for
!;;...1H riciniifriciurc into blood aeriva-
__a_aire_portion of pooled plasma sepa-
r,t:e by chemical rnc:tns) intended for
' :nt!on.
r•tC.61 Tnf,,rined consent.
e v rittcn consent of a pros a ire
11.111 be obtained after •unlined
d p+ - •:piained the
-0''• of the procedure to the prospec-
�':: 'fhe explanation shall include
of n hemolytic transfusion rcac-
tt he is given the cells of another
r, and, the hnaards involved if he
t;ec: mmu fired The explanation
the plesma.'rnc
within 2 h,
•.xabdi
�nation el
t. !tiny bo used fcr • ,
;.recc•dure has
c colvc:zt to Ptrtr
plasticl.Ict sv
the frozeCrl'Or r r
of
:;c Factor
trd Anlili t;,ti'
• au be t-A9 a i
d •drily
'-L S COn t;1nuna,..
• to produce a Prc
•
S
mining donor. suitability. Such determi-
nation shall be made on the day of col-
lection from the donor by means of a
wedical history, tests, and such physical
examination as appears necessary to the
qualified licensed physician.'
(b) Initial medical examination. Each
donor shall be examined by a qualified
licensed physician on the day of the first
donation, or no more than one week prior
to the first donation, and shall be cer-
tified to he in good health by the exatnin-
ing physician. The certification of good
health shall be on a form supplied by, the
licensed establishment that indicates the
certification is with respect to the suita-
bility of the individual to be a plasma-
phcresis donor.
(c) Qualification o1 donor. Donors
shall be in good health on the day of
.onation, as indicated in part by:
(1) Normal temperature;
(2) Demonstration that systolic and
di tstolic blood pressures are within nor-
m 1 limits, unless the examining pliysi-
ci• n is satisfied that an individual with
blood pressures outside these limits is an
of terwise qualified donor under the pro-
s': ions of this section;
(3) A blood hemoglobin level of no
css than 12.5 grams of hemoglobin per
100 milliliters of blood;
(4) A normal pulse rate:
(5) A total serum protein of no; less
than 6.0 grams per ` 100 milliliters` of
serum; - .
(6) Weight, which shall be at Ieast 110
pounds:
(7) Freedom from acute respiratory''
diseases; •
(8):;Freedom front any infectious skin
disease at the site of l hicbotorny and
4. e'en1st of such disclosure and 'be from any such disease tsei:ei tli.ed to
- in such an'cxtent s to create a ris): of con-
•ach a manner that'fntelligent tamhlat;omof the plasma;
•••fled consent be given and that
t • �t o,.,,crtunity to refuse is presented• (9) Freedom from any disease, other
tit. •i,2 ,f -( than malaria, transinisslble; by blood
ro.;cn) 5111W:1151On. transfusion, insofar as can be determined
licensed physician shall be by history and exatninatlons indicated
r tint .t•s when donor suitability is in this section;
' _ c'rn1:fled; imnrtinizations are be- (10) -Freedom of the nrms-and fore:
blood is being collected, orals from sl:1n punctures or scars in-
ro,t I,:'0i cells are being returned to .- dicativec of addiction to , self -injected
•�r. narcotics,,
i '''''•) S:loreor. (11) Freedom from a history of viral
4 t,,, hepatitis;
""t of determining. The stilt- (12) Freedom from a history of close
donor for Source Plasma contact within' six months of donation
A.t i, ' •a.til be dctcrinincd by aquelt-• with an individual having viral hepatitis;
4• •"i l'h:'sician or by persons un- (13) 'Frcedoul from a history of having
r •r'1•ion and trained in deter- received, within six months, human blood
•
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•FOOD. AND DRUG ADMINISTRATION
COMPLIANCE POLICY GUIDES : •
1••••••••• •••••••1IIIII
•
r‘t
GUIDE
. . _.. „ ...,-. •...- - ., .. •••.CHAPTER'.-:'34-:,::"BIOLOG1CALS.':•.•••••
SUBJECT --..-'.:"..110.41Strat--100--r,...-.0f„..:.--eI31-OOd::.111anks.......FandOther.,s.Firth,,,ColleCOng•:,:;--.:Ilanti.f-act-
-urin4,•'""P.-retiaritig--,:•Or„,PrOCessi iig';"-Iltiipar':;BlOOd.!:•••OrI31-070-:.Pr0-d...-..
• . .... . ... , .. ,.. . .
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. ••... : . •• ..:: .- .............,.... ..• .
„ . .. „.... .. „ .
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BACKGROUND: :::,..„-.•,:.-',;....„;.....'-•,•-•- -:-...--.•..-.i•- -.•-: ...--::::•••••••••.,-..:::-•:•-....-•.:,,,.„-..:•-•:::-,-...-...•-,---,.••,:,:•-•• •-..,....-- -:: .•-•--..--..••.,-.. - •
, . „......„ , • ......„ ....... •..••.... „......•...--.•..........,........•...,............ „.• .. ••••••-•........,•.... . .. , .
• "-The.JanUary- 31 ,-•1973t;r1Federat:.".RegiStertannOUnced•;•;•the':..'•amendthent: and -revision •
of....the.-.21-CFR,,-.Part...-.27Trly,,the---:;:additiOn.'OfSeCtion::„..273.237,** •Registration
ofblood banks and otbef•••:•.'firms.:-.C.-.01IeCting,::..,tttanUfaCtt.Jripg, preparing or pro-- 6
ceSting human. bTood'":Or-::".,"-To04:.:,:i.-poll.:14*--..-.,:j',--7-.T-."*.--.0re.o..tnbie :to . this announcement
provides guidance'-::',.as."•:•t0-,:::,1„tbetYPes:::-i-;„„Of:0"StalallShMents -.thatmutt register and
-. -the:blood compOrent's:-Iand:-•:praductS:•.•:Ithaty:Idetertine:-•eligibil.ity. for registration..
• ...- ....... ..--... ••:.--,:-...,...-...,-,--....--,.,.,...„:-..:.,..•.„.. .-.-...-.•••,--•...•• • ... •
. . • .. :. ...........•. • ...,.. .„.:....:•,..-..„....•._....•-..,,,.••.....,-,.:-,',.,'•-,,-,',".',.,-,-....,' .• •,,,, , ,7 - .• • .. , • -... :, . • •
••ExCerptsi•froM'ithe.:;preatiiabl*-"toi;:the;••:.,jantary31,-.--,.1973i,.-Federal. Register announce-
'. filelit f.0110W:::.:::-...,..'..'-'::::::::::::„..,.:.....,.......-....-..:::.:,1,;',..',1:-:'::;ti•-:-:;;:H,,-'..:'--::-:,:',..:1,:... -:::::,,...:::::,,-..'.-,,..:::',...:.i.-.--..•:;,..,.,-..,':,.-...,. ::,.-.:. „ ..,'..... - . .
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-7 .'-:•i;,:.'!.....egiti....4t1cip':'::,..ici::::,:':iijo,etti 0.,1,,,,.7tii*,',,,..11,c1440, s-::::thei,:-:.,.-to0104714tlon..-ii:::.:::::::.:::,,::.::,....,:::.:.......,,,, ... .
•, ..':•-•„•..,:.:-,',.:ai.p0'."•.100;,...-..„t,st...1.:0g;,..-.0e!•:i.ot.0.•.:40,tio.,-.o::.:01::C01701-1.:::...1070(0,401:1.,,..:;'i,:i4PbPr.-.2:',..',',::',i!.:-.:.-1:;,:-:...,:
'..:.-..r.40011ecl, 0.,:.':.tli0'.'.,..':frffi,d.1j..'.:i:01704(14:::.::.::'0f-,:..t.01.4eisi'-';':00tt. ,.:cif.--:,...,:ji001-Iii f.C1.,.0.1,ii'ig.,,,,:.'...7:,;T:-
0)-..,0...'co*-cil'i'-:.,,I:„....06.i':;:•i,j.1C1440*:ii1700,0,,,c*-4,..§1...n.....i.iP. '',•:.',.p..1.is0..7,1se,,,:..1)..00gi ,=..g.::,-•-.00.:.:;:..i.:::..:..:::-....:-.i,-.,.',••:.:.":
., . -:•,.-:.,-.-::::::.:-.(Or.j.t.:41:...ogit,/i,t40pe'.,i74::::of:;i.1p.1.4011,..:pg.f.;:.0ff.:OiSi:::•,,,,00.4,:::,';de:,.,b7•100d:::f..pit9:44Cts
....:':;.:,...::.:......-::::•.....-.:•'.-
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-1.11,..,YOry-,..'.9..r.'1.-141,6:::to.i:::.717.40'.E.,,,!:01oli40.-0,0.i(6dt;:::::„..;-,1t,:...:.;kh4*ii061040--•01-.11-........;,:-..--:,-.'-.'i..:,,,:.: •:.
procosi:rig:,..iand•:..411.t.:;'.91-ti..,:::;tiOjtk.,::-..t1)atipi*,-;•rpti-..f.Q0.1.7.0..ici:i:in.::"tli•.0i-•;•1)0O,::.;'..:--..,ii:.,::::-S'..-4:".....,:...H.;•,...,•••,
::,•blbiid,:-..,:oi..:;I:iloo&.0.1:704(iCt.::;',..:E;••ktiOi.i.01.e,:i•:•,-•-•tritltici..ti:ig:O.Fii:....:.-4
testing
:....*,::::::,..,...,',•:;-•.••':::,:•';':•" .; •
,...„, ,... ....,.,, ... .... . .
--•-:jo,.)iiirig .• and .typ trig •.'-:q ',-:',.....,..01.Y:1--:.;0:-• caijipa t,1b tl:..ikr:i.l'.dtt104';',t.:4001..,c,..rfor.01,9.d:-...,:•:....,.: • ,
-••••::.in -: - Co.nj until On.-:wi.thai".•-•-,-,ti-anSfili-SiOn:-,-:"Of.:.b1 060-;•.:or...,:b1,-.O.O.d.-;"CO.Mpettnti..;:-.-:',F.Or.-..:•..
purposes - of:d6teiin.i.,i)tnjeici..-Titiliit.y.;::,:ifofb106.c1:-:::140kirpg-i....*t)'74'...100.--;il.::.'.::::.::::,:.,:
blood -coriwoneiit§,::-:07e.;[,ic.tef.,:iiiedai.,:,!:;Te.,d;b1,0!*:4011'.::'1."01.-..t:01...t::::,'::concen-
trates, - platelet.,:-...ii.ci0r:::..1.1061;1'..0.P.,-si.t..,.-0.p00...,b,.,.0pci;.0i7:!-:.:1-dii#y,-,..01:::''.---r:::-'.:,..:-::::::..
. , .•:.: , '-.': filtered: blood, ::i.:•:.,:illy10:::"''-40npi..:-,:-..01.•tjila,Cst:Oti,i7..kt..6ittai.::0•-4);ii:,:i iieiio 0.11,11;'.-.:',...'...• ._
: ' • : •., .: or : any. i ploduct.-.‘4111di:.,-inastieY.,..4611i:.':.:....1-.ci',.oli..i.v:101-.6:11.:41.004:•,:::or.,i'01.•.$iiis-,_..,..,,..,,,,',..'. :•.' •
• • • • ..• ...:.. ...•. ..........._.„ ..._. . ........ ........... .., •_„..,...:... • ... .:
_ „.... .., „..
•••••••••••••••••••••••••••,•••••••
---....-1
7134.01 '
••••••••••••
)
I ""*If a blood bank processes all or even part of the blood which it col-
lects, or prepares any blood component from blood or blood products.
received from other banks it vould be re tii ed toregi -ter Further-
;_., more, if a blood bank does not collect or process any blood, but re
ceives its entire supply form other banks and then cross --matches and
transfuses such whole blood or components without any further pro?
cessing, it is also required to register. _Registration is also
•
TRANSMITTAL 140. 74(06/17/74)
ISSUING of FicE: EDR0. Divisionof FiLld OpcuitionS
AUTHORITY: Associate Commissioner for Coniplitnce
, , 1
-•.• , -••,1 "•^ • __ „
. , •
•
•
- ..' r:equ'. red.of
blood b
a.e^ss
or
other
pctabi\i•shsnents
that
rto lcollect or IsupPly
blood cells, serum 0r plasma for the manu,actureofadrug, or as a co.•
m-
non.......e.‘•.n.t • s.l—•.i•r. the e,m..an.
u.fa
crtu
.r• e„:o'—
•tf
,.z, .—a. 'o-"r
ato... . •y
• - reagents
a...,• .nd
1'controls, .' .
. t..
:..
nc
lu.
.d.
i-
n
g
those esablishnentstLatsupplY°utdatedpooied plasmatom,utacturers
offraotionat°"Produotc or laboratorycontrolreagents.FinalY,'ali
estabilshmentstha+inaoufacturePlasmaoypiasmapheresis "ill)ereqUi•e
d
toregister, rgardisofwhether tbePlasmaso manufactured is t:be
used reagnts'iiCensed
blood groupingaodtyping serums, hepatitis associated antibody, or
other diagnostic reagents made from ,lasma"***
POLICY
Thos.blood•banksand otberhunanbicoAorhloou ),oduc#estabiishmentsrequired
i.
.•r
e.
d
to register under Section510 of theFpgrAct and 21 CFR*** follow
1Blood banks and ot,erestabiishments collecting, manufacturing, relabel
1ng preparing,processing 0rtestingblood, blood conponentsor
products
2Bloodban-or other establihments that collecLurprepare blood cells
serums orplasma:forthemanufaCture °f a diug or as a component in the
ma__,ctueof labo:at0ryreagentsorcont.ols
3.Blood ban"sorestauiislnelfethat supplyoutdated3ooledp1as•ma to
manufacturers of fractionation ni.oducts0.laboratoYcentrolreaients
4 ___piasrnnleresises4abiisrits
EstablisnrnnLS that pepacoinponentS
from blood or blood
products
receivedfrom other banks _rsout.ces
6Est0blislnentS receiving their entire supplyof bloodfrom0tierbalks
Ilich the- cross -match and t ansfuse such whole components
withoUtfurdir- Pncessing
Establish
m
ents that do not engage inany of the above activities, but
toebolonprior totranfusion, are exempt fromrLgistation
January 31, 1913 I
.-
*** 21 CFR 6°1:11 •
*** ar ee dc e. dr ai lf *i Reedgas 21( E06FIR176;3714.11 ' Wednesday - Jan . . ..--..
TRAt4StAl TT AL No. 74 _14
ister volume 38, No
. 20 - —.....--- GE 2
.....,..
--•
ti:Oc t) AND DRUG ADMINISTRATION
COMPLIANCE POLICY GUIDES: •
GUIDE 7134.02
__----..,... ... ...
The January 31 197.3*�e&ier-aa- r9 er*. �nounced the amendment and: revision
of 21 GFR, ; Pad^
73.. The preamble to .this aniaiThtement—aa-s�directs `atten-
tion.to the classification Of blood and blood products. as.drugs finder the FD&C
Act gas well 73-5a-biologic nder---i:he-PubiicHealth`Service Nct.
Excerpts from the preamble Of the January 31,1973 FedraVR�e ester announce-
menp 9
t res onding to:questions concerning-th,e classification of Flood"as a drug
follow:
"***Section 201(g) (1)definition of drug in the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321), xreveals that blood and related
blood products fall clearly within that definition. That section
states 11The term 'drug' means (A) articles recognized :in the official
United- States Pharmacopeia...; and (B) `articles intended for use
in the diagnosis, cure, mitigation, treatment, or Prevention of
disease in man or other animals:..." Blood :is coveredby both
parts of this :definition. Human blood as first recognized
the United States. Pharmacopeia, (USP), XV Edition `.;(Dec. 15, 1955),
and has been included in each USP since that edition. Indications'
for use of blood products , also fall directly within" the broad
therapeutic scope of the definition. Uhile" it is, of course, true
that blood is human living tissue, . it is i ncorrect to assume that
it must be either a living humantissue or a drug. That huiv.an
blood, and blood Products may: be characterized as `;living human
tissue for `som2 Purposes, and as biologics for purposes of r ryu-
lation,under the Public Health Service Act (sec.:351, -53 Stat. 702,
as amended; 42 U.S.C. 262) in no bray alters,; the fact that blood is
also a drug subject to regulation under applicable p}•ovisions of
the Federal Food, Drug, and Cosmetic Act. ***"
POLICY;
}lwnan blood. and blood products are. characterized,as biologics ror."Vurposes
of regulation under the;Public Health Service Act, as -amended and also as
a drug subject to relgulation-under applicable provisions of the r< <,d;'D.'rug,
and; Cosmetic, Act.
Federal :Rejjister Volume 38, No.
Pecodified as 21 CFR 600.
......
T;;AhSIM111A( NO�-74-�14 (06/17:/76i)� � ,�_
ILSui;�c ot•fii_r_: EU)}R0,.-Division of. FieldOpotations
AUTI4o6 T : A ' OCiate:Cominissionet for Ci.npli,ince
Wednesday - Janua1y 31,;? 1973
PAGE 1
OITY OF MIAMI. FLORIDA
INTER -OFFICE MEMORANDUM
TO Robert E. Ferencik, Director
Building Department
FROM: •
Michel E. Anderson
Assistant City Attorney
DATE:
March 5, 1976
FILE:
PLASMA CORPORATION OF AMERICA
v. CITY OF MIAMI
Circuit Court Case No. 76-6567
Please review the abovestyled cause and
return with your comments withinthe
next . seven " (7) days as an Answer is due
shortly thereafter.
MEA/s
Enc.
.-T• •r,_.
Chief H.'Brice ,`Director
Fire Department
a'
G. Salman, Di ector
Building & Zo ing
Inspection Department
M:115
0, February
0:FE ?NCCS•
, 1980
f ,r !r1
In response to your inquiry we are enclosing a copy
of Chapter 6 of the Code of Dade County, which
established the Dade County Department of Health as
the authorized agency to inspect, control and issue
permits for the donor facilities and the individuals
who participate as donors at these facilities.
The enactment of thispart of the Dade County Code
preempted the. prerogative of:the City_of Miami as'a
regulatory. body. (County .Ord. 73-91 and Ord. 74-4
Sec. ` 6-4.1)
A search of records of the License Division of the Cit
of Miami reveals only two facilities licensed as- blood
plasma facilities, as follows:
currently licensed
license not'. renewed
.annual inspectionsthese'.facilit es by..th
Code,Compli'ance Division of this -department:, since ;the:
Dade County Health Department is the•regulatory`power.
We ,are -enclosing also:; a memorandum: dated February 28 ,
1975 to former"City Manager P.`,W. Andrews from former
Assistant` Director of;the`Building-Department'Ronald G.
Mayer.
Enclosures`
CC:
Director's _file'
Readingfile
Zoning ;Division
-1.20
CITY OF MIAMI, FLORIDA
INTEROFFICE MEMORANDUM
• TO:
FROMt
Mr. P. W. Andrews
City; Manager
Ronald G. Mayer
Assistant; Director
Building Depa.)J nt
DATEt
SUUJECTt.
I1EFEHENGE8t':
ENCLOSUREet
February 28, 1975 Ff.c:
170 West Flagler Street
Blood Bank !_Facility
Copy 0
Code o
tChapter 6 of the
Dade County''
r drew Crouch.
At the request of Assistant City B Building Department, and
the Department of planning, regard Department,
the
the License Divsiotheave blo dnbanked with facilitylocat.ed. at
various aspects of
170 West Flagler Street.
ro erty is zoned C-4 and the use as a blood -and -
The serum facility is a p
`fie p P.. eimitted use in this zone.
1969, a Certificate of Use was granted for
On June 25, :.,
a blood -bank facility at 170 WesteFlaglerere Street.actelly ,of a
Previous occupancies' of this pp r Y' ered�mtue"
more lenient nature and would have required
park-
ing facilities ,than the present use.
license was granted:September 30, 1974,
The most recent City anization
The org
% and the current licensee number alsois 9licensed under the
which: occupies` the: premises isd
Federal GoverruneritControl Act for blood bank operations._
•
Concerning regulatory laws ,for blood donor facilities,
the City
City ` Ordinances 8224 and 8259 wereelena Ledo y197,4. How -
of Miami Commission during, the ey pa
Dade an preempted! the:;
ever, subsequent enactments by1a body' and set,forih
City'�_s,, p� �z°gative as a�regulatory.,,...
ade County Department. of Health as. tilde
t_hc D ins sect, _control, and:; issue
authority t:o'periodically i ermIts
permits for.the donor `facility, and 'a� so. to issue n
an d ideitificatioii and control; of the individuals who
Page 1 .'of 2
•
participate as donors at suc
I am enclosing two copes,of Cihapter 6 of :the Dade
County Code covering blood -bank -donor facilities:
cc : Planming ;.Department
License Division,
Building` Director's file
Building and Zoning Division
Zoning Section _
'Reading; file L
1111111111111111111111111
III 1111 1
Chapter G
BLOOD DONOR FACILITIES*
Sec. 6-1. Short title.
This chapter may be cited as the "Dade C u 3y-73ood Donor
Facility Ordinance." (Ord. No. 73-91, §
)
Sec G 2.Definitions.
As ,used in this chapter, the following terms .shall be de-
fined as hereinafter provided: 1 primary
(a) Blood` donor facility means any facility the p'l
function of''which is to obtain, by venapuncture, source
blood or plasma (human) intended for. injection. (b) Donor meansa person present at a blood donor facility
for the purpose of undergoing venapuncture in order
to extract source blood or plasma . (human) intended
for injection.
(c) Party means individuals, partnerships, or�anizationslofl anY
associations, or public or private
character. (Ord. No. 73-91, § 2, 10 30-73; Ord. No. 74-4,
§§ 1, 4, ? -i4 Ord. No. 74-53,..§ 1, 7-2-74)
Sec. 6-3. illodified reenactment of Florida Clinical Laboratory
Law.
Florida. Statutes, Chapter 483, Laws of Florida 1971, other-
wise known as The Florida. Clinical Laboratory Law, and here-
inafter referred to as the "statute," this chapter incorporated� herein
bye
reference and shall be a pprovisions:
forth herein verbatim subject to the following p'i
ter G, s§ G-1-6-7, is derived from Ord. No. 73-01,
•Editor's opted Chapprovides:
§§ 1-7, adopted EffectiveOct. 30, late. Section saidof this l ordinace shall
"Section 10. Date. The provisions the becfollow-
ing sections onof effective= on alStatut s re-enacted ately upon its rhereinxshall thatnohccore ef-
fective s , days from the date of enactment: Florida
until forty-five ( ), y (4), (5); .:S3.0u1• • `3.10i; 483.11.;
Statutes 53.1 1 (3 2 and 483 23
:E3.1•�1; d93.151; :8...101; :83..,1;
Supp. ;:o. 112 169
•
11611111
§ 6-4.1
BLOOD DONUIC•'1'i:G1Lr-1c..,
DADE COUNTY CODE
§ 6-3
(a) Wherever in the statute reference is made to a clinical
laboratory, that reference shall be,. deemed; and con-
strued to be a- reference to a blood donor facility.
(b) Whenever in the statute, except in Section 483.051(3)
thereof, reference is made to the State of Florida, that
reference, shall be deemed and construed to be a refer-
ence to Dade County.
(c) Wherever in the statute l of re t of healthde toathedivision of health of the dep..
reha-
bilitative services, that reference shall be deemed and
construed to be a reference to the Dade County De-
partment of Public Heath.
(d). The following sections .of the statute are inapplicable
to and specifically excluded from this chapter:
Sec-
tions ;
4183.011; 483.041 (7) ; 483.051 (6),
•
483.161 beginning with the word "microbiology" and
continuing through the word "technology"; , 483.181;
433.191;nnd 483.21. (Ord. No. 73-91, § 3„10-30-73)
Sec. 6-4. Reenactment of regulations of the United States
Food and Drug Administration.
The regulations of the commissioner of t he food and drf rug
administration of the United StatesI
tmeEducation, and -Welfare, Sections 273.3100 through 273.3103
inclusively, as set forth in the Federal Register, Volume 38,
Number 1.39, and Sections 60010, 600.11, 640.1 through 640.18
inclusively, as set forth in the Federal Register, Volume 38,
Number 223, and as may be modified from time totime here-
after are incorporated herein by reference and .shall be apart
of this chapter as though set forth blood donor facilities within Dade
regu-
lations shall be applicable to
County. (Ord. No. 73-91,> § .4, 10-30-73; Ord. No. 74-53, § 2,
7-2-74)
Sec. 6-4.1. Donor identification system for plasma donors an
plamapheresis facilities.
(a) Definitions. As used in this section the following terms
shall be defined: as hereinafterprovided:
Supp. No. 112
§ 6-4.1
(1) "Plasma donor" means an individual who undergoes
venipuncture (or phlebotomy) to obtain the liquid por-
tion of blood (plasma)
l'Plasmanheresis" meant the procedure whereby .whole ..
blood is removed from aI
,lasma donor by vcripuncture
, . .
(or phlebotomy) and - ie plasma is j
oe:�ara`edthere-
from. w
"Plasmaphcrca.sfacility" t3 y" means any; facility, labora-
tory,
.:�
or. place of business where pitsrapheresis isper-
i
formed.
(b) :plasma donor identification system. There shall be
established,; pursuant to regulations promulgated by the
director of the Dade. County Department of Public Heal h, a
system for the registration and identification o_f
dataand t
applicable to any person who shall
gathering of medical r
undergo or" attempt to undergo plasmaphe es.s in any
plas^.-la-
data
pheresis facility. in Dade County. , Theinformation,
gathering, and registration system for which provision is
herein made shallbe known as the "Piasrna. Donor Identifi-
cation System:"
Donor after provided, it shall be unlawful for ary person to
present himself for placunaphcresis and for any plas
inaiihcl es is` facility to perform plasm apheresis on any
individual, unless that iriiividual :than first present
to the: pllasiraphe esis fn cility a valid donor registra-
tion card for'which provision is made in subsection
(b) (2) of: this section.
) Application for donor registration number and dor.or
prospective plasma donor bc-
registration card. Each 1 ,; e
fore undergoing plasmaaheresis shall make applica-
tion to the- department of public health, ir. a manner
prescribed by that department, for a donor identifi-
cation number' and a donor identification card. ce and
plasmapheresis facility shall be required to place
maintain upon the premises of the facility such photo-
graphic and other identification equipment as shall
Supp. No. 112 171
• (1) D • identification card required. Except as herein
411111111101111111
§ G-4.1 DADE COUNTY CODE § G-4.1
be required by the director of the Dade County Depart-
ment .of Public Health for the- maintenance of the
plasma donor identification syAtem.
(3) Records and confidentiality. Records shall be kept by
each plasmaplieresis facility and by the department of .
public health pertaining to each plasrno.pheresis pro-
cedure performed and each attempt by an individual
to undergo plasmaplieresis. Such records shall set
forth the date of the aforementioned events, identify-
ing information pertaining to the plasma donor or
prospective plasma donor, and such other identifying
and medical data as shall be required by the depart-
rnent of public health. All of the aforementioned in-
formation shall be provided by plasrnapheresis facili-
ties to the department of public health daily and the
department of public health shall compile such infor-
mation and give prompt notification of any violation
of this section or the rules and regulations promul- •
gated pursuant hereto.
The department of public health shall keep all its TCC-
ores in a manner which protects the rights of individ-
,
uals to the confidentiality of their niedical records.
The disclosure of the identity of or other inforrnation
relating to blood donors, except as such disclosure is
directlyrelated to and necessary for enforcement of
this section is expressly prohibited.
(4) Prohibited acts. It shall be unlawful for any person
to obtain or attempt to obtain more than one plasma
donor identification card or more than one plasma
donor identification number, or for any person to at-
tempt to utilize a donor identification card or donor
identification number of another individual, or for
any person to proviae false information to a plasnia-
pheresis facility or to the departinent of public health
in connection with the application for a donor identifi-
cation card or identification number or in connection ._
with any plasmapheresis procedure.
Supp. No. 112
172
11
§ BLOOD DONOrtACILIT/ES § 4-2.1
t;
(c) Fees. The director of the Dade County Department or
Public Health shall assess a •fee.tupon each plasmapheresis
facility for the purpose of paying the expense which the de7
partment of public health shall •incur in the implementation
and maintenance of the plzsmay.J.onor identification system.
The .fee shall be based upon the number of plasma-
pheresis procedures pi..,rforrned by a pinsw.apheresis
and shall be payable monthly by the facility upon receipt of
an invoice from the Dade County Department of Public
Health. The fee shall not exceed,:the amount of fifty cent?
($0.50) for each nlasma•oheresis procedure which has been
performed by the facility during the said month. The total
of fees collected shall not exceed the cost to the dcpartment
of public health of administerir.g:tne plasma donor identifi-
cation system.
(d) Penalties. In addition to the penalties otherwise pro-
vided 1)y Ordinance 73-91 [Chapter 6], the following pen-
alties may be imposed by the director. of the department of
• public health upon his determination.that an individual has
• violated a provision of this section:
• (1) For a violation by a perin who is hot a registered .
donor, a disqualification of that:person from beconiing
a registered donor for a period not exceeding r.inety
(90) days for each violation.
(2) For the first violation bv a registered donor, suspen-
,
sion of the donor identification card and number and
all.the privileges incident.thereto for a period not ex-
ceeding ninety (90) days..
• (3) For the second violation by a registered donar, sus-
pension of the donor identification card and *number
and all the -privileges ir.cident thereto for a period .not
exceeding one year.
(4) For the third violation by a registered donor, suspen-
sion of the donor identification card and number and
all the privileges incident rnereto for a period not ex-
ceeding five (5) years, or permanent revocation of
the donor identification card and registration number
Supp. No. 112
173
hill111111
1
§ G-4.1 DADE COUNTY CODE
and all the privileges incident thereto. (Ord. No. 74-4r
§§ 2, 3, 2-5-74; Ord. No. 74-50, § 1, 7-2-74)
Editor's note —Ord. No. 74-4, §§ 2, 3, amended Ord. No. 73-91 from
which Ch. 6 is derived by adding the provisions codified herein as. § 6-4.1,
Scc. 6-4.2. Breath analysis required of commercial donors..
It shall be unlawful for any commercial blood donor facility;
in Dade County to extract whole blood or any of its products
from a commercial donor unless, immediately prior -'to said
extraction, the facility shall analyze the breath of the donor
and determine from such analysis that the blood of the donor`
does not contain alcohol in excess of 0.07 per cent, weight per
volume. For the purpose of performing the required breath
analysis, each commercial blood donor facility in Dade County
shall maintain upon the premises thereof such testing ma-
terials, equipment, supplies, and personnel as are approved
by the state division of health of the department of health
and rehabilitative services and as shall be required and an -
proved by the Dade County Department of Public Ilealth.
(Ord. No. 74-4, § 5, 2-5-74)
Editors note —Section 5 of Ord. No. 74-1 is included herein as §
6• 4.2 at the discretion of the editors.
Sec. 6-5. Reporting of communicable disease.
Any blood donor facility or employee thereof who shall dis-
cover the existence of a communicable disease in a' donor shall
immediately submit to the director of the Dade County De-
partment of Public Health a confidential report setting forth
the nature of the disease and the name and address and other
information sufficient to identify and locate the diseased per
son. (Ord. No. 73-91, § 5, 10-30-73)
Scc. 6-5.1. Procedure for the denial, revocation, suspension,
limitation annulment or denial of renewal of the
registration of any blood donor facility or license
of blood donor facility personnel.
Notice of violation. Whenever the director of the department
of public health or his duly authorized representative finds
and determines that there has been a violation of the Dade.
County Blood Donor Facility Ordinance, he shall give notice
Surd. No. 112 ?74
6-5.1
§ 6-5.1
BLOOD DONOR FACILITIES
§ 6-5.2
of such violation to the party or parties responsible for such
violations. Such notice shall be in', writing and shallspecify
the violation and shall prescribe for a reasonable time for
compliance, and shall be serried upon the party or parties re-
sponsible for the violation. Such notice shall be deemed to be
properly.. served and binding upon = the party or parties re-
sponsible and imon:the facility involved if a copy is served
personally by certified mail, or if after diligent search and
inquiry the party or parties responsible for the violation can-
not be found or served by personal service or certified mail,: a
copy'' of the notice is posted in a conspicuous place on the fa-
cility involved. Such notice shall specify that the violation
must be corrected within the tirne specified in the notice and
thatfailure to comply within the time specified may result in
the suspension or revocation of the party or parties registra-
tion and/or license. Such notice shall inform the party or
parties to whom it is directed of the right to apply to the
health appeals board for a heath Band review of the matters
specified in the notice. (Ord. No. 74-53, § 4, t 2--74) :
Editor'o note —Ord. No. 74-53, 4, amended Ord. No. 73-91 from
which Ch. 6 is basically drivel by addin .the provisions :included herein
as §§ 6-5.1-6-5.3.
Scc. 6- .2.' Procedure for the denial, suspension or revocation'
of any donor identification card.
Notice of violation. Whenever the director of the depart -
menu of public health or his duly authorized representative
finds -and determines that there has been a violation of the
Dade County Blood Donor Facility Ordirarcc he shall give
notice of such violation to the party responsible for such viola-
tion. Such notice shall be in writing and shall be served upon
the party responsible for the violation. The notice sl,' 1l specify
the violation and the penalty i:nnosed as provided for in
section 6-4.1(d) of this chapter. S.:ch notice shall be deemed
to be properly served and binding upon the party responsible,
if a copy is served personally or se.reed by certified mail, or
if `after- diligent search •and inquiry.the party responsible for
the violation cannot be found or served by personal service
or certified mail, a copy of the notice is published once during
Sapp. No. 112
175
h .. IIII111II1II1
§ 6-5.2
DADE COUNTY CODE § 6-6
each week for four (4) consecutive weeks in some newspaper
published in Dade County. Thc_newzpaPer shall meet such re-
quirements as prescribed by law for such Purpose. Such notice
shall inform the party to whom it is directed of the right:to.::
;apply to the health appeals board for a hearing; and review, -of
the matters specified in the notice. (Ord. No. 74-53, § 4, 7-2-74)
No:c—See the editor': note following § 6-5.1."
Sec. 6-5.3. Appeals.
Any party aggrieved by any action or decision of the di-
rector of department of public health or his duly authorized
representative may appeal to the health appeals board by
filing with the board, with'n ten (10) days of the date' of
service of the notice of violation or of the action or decision
complained of, a written notice of appeal which shall set forth
concisely the action or decision appealed from and reasons or
rour.ds for the appeal. The board shall set such appeal for
hearing at the earliest possible date, and cause notice thereof
to be given to the appellant and the director of the department
of public health. The board shall hear and consider all facts
material to the appeal and render a decision promptly. The
board may affirm, reverse or modify the action or decision
appealed from providing that the board shall not take- any
action v.hicil conflicts or nullifies any. of the provisions of the
Dade County Blood_Donor Facility Ordinance. The board shall
specifically state in its decision the date by which compliance
must be made. The decision. of the board shall be final, and
no rehearing or reconsideration shall be considered. Any party
aggrieved by any decision of the board on appeal taken to it,
including, but not limited to, the director of the department of
public health or his duly authorized representative, may apply
to the circuit court of Dade County fora review by writ of
certiorari in accordance with the applicable Florida appellate
rules. (Ord. No. 74-53, § 4, 7-2-74)
Note —See the editor's note following § 6-5.1.
Sec. 6-6. Enforcement, inspection, penalties.
• It shall be the responsibility of the director of the Dade
County Department of Public Health or his duly authorized
`Supp. No. 112 176
§ 6-6 BLOOD DONOR. FACILITIES
�i.
representative to enforce the. provisior.s of this chapter
throughout Dade County and the director shall have the duty
and authority to promulgate regulations necessaryto carry
out the provisions of this chapter.
The Dade County Dep^r}n-ilnt of Public 'Health shall make
an inspection of each=blood donor facility in Dade County not
less frequently than once per month for the purpose of deter-
mining the 'existence of any violation of this chapter.
If the director of ,the department of public health or his
designee shall determine that a ; violation of this chapter or of
any regulation promulgated"hereunder has occurred, the di-
•
rector shall take one or more o` the following actions:
(a) Service upon .the person or facility in violation :of a
citation . settingforts the violation . and establishing a
time within which such violation must be corrected.
(b), Initiation of a procedure for the denial, revocation,
suspension, "•limitation, an`ni:.^.lent, or denial of renewal
of the registration of any blood donor facility or the
license of any blood don)r facility personnel.
§ G-0
(c) The initiation of a judicial procedure for injunctive
action against, any individual or organization violating
this chapter, it being hereby declared that the opera-
tion or maintenance of any unregistered blood' donor
facility or the performarcc of any blood donor procc
dure or operation in violation of this chapter or any
regulation promulgated hereunder is a nuisance inimical
to the public, health, welfare, and safety.
(d). W'henever the director ofpublic-health shall have de
termincd the existence of a violation of this. chapter
which constitutes an immediate threat to the health,
safety, or welfare of a donor, a potential recipient of
blood or plasma, or the public, and such condition can-
not..or.will not be immediately corrected, the director
of. public health may order the immediate closing of
such blood donor facility until such time as the threat
is found no longer to
Supp. No. 112
17'i:
6-6 DADE. COUNTY CODE
Referralof the matter to the state attorney for "crim-
inal action against any person in violation of this chap-
ter. (Ord. No. 73-91 § 6, 10-30-73)
Sec. 6-7. Criminal penalty.
Any person who violates any provision of this chapter shall
he guilty of a misdemeanor nunishable:by a fine or not more.
than five hundred dollars ($500.00) or by imprisonment of not
more than sixty (60) days or by both such fine and imprison-
rnent. Each day of a violation shall constitute a" separate of
fense. (Ord. No. 73-91, § 7, 10-30 73),
7
G,i/s
2/9/79
RESOLUTION NO. 7 9- 1 1 j
A RESOLUTION AUTHORIZING AND DIRECTING THE DIRECTOR
OF FINANCE TO PAY TO PLASMA CORP. OF AMERICA THE SUM
OF TWENTY TWO THOUSAND ($22 , 000) DOLLARS , AGREED. UPON
AND INCORPORATED IN THE SETTLEMENT AGREEMENT, IN FULL
AND COMPLETE SATISFACTION OF ANY AND ALL CLAIMS_AGAIrIST
THE CITY OF MIAMI ARISING OUT OF THE FINAL JUDGMENT:.
ENTERED IN THE CIRCUIT COURT IN FAVOR OF PLASMA CORP, OF
AMERICA AND AGAINST THE CITY OF MIAMI.
WHEREAS
action against the City,. of Miami in
injunctive relief due to",the "City' s refusal to issue a
Occupancy for the premises located at 161N,E. 4th Street Miami,
Florida; and
WHEREAS, the final "judgment Court
states that the City of had had wrongfully withheld said Certificate
of Occupancy; and
the. Plaintiff Plasma Corp.
1976
for
enteredby
of America filed an
declaratory judgment and
Certificate of
the Circuit
was, subsequently
WHEREAS, a"supplemental complaint for damages
filed to :-recover those losses suffered by the ,plaintiff due to :.
withholding of the said Certificate of Occupancy, and.
WHEREAS, after considerable negotiation and discussion
counsel for, the plaintiff has agreed to accept the
Thousand ($22,000) Dollars in full and.
suffered by the plaintiff arising,
\•7iiEREAS , . it is advantageous to the City of Miami
damages
Sum
the.
sure of Twenty Two
complete satisfaction o
out this .action; anc
to effect a considerable savings;
NOW, THEREFORE BE IT RESOLVED BY THE
any
ay
C011.1ISSION OF THE
this
CITY OF MIAMI, FLORIDA:
Section 1. The. Director of Finance is hereby directed to
f rr ty TW0 Thousand ($22,000)
o yen
pay to Plasma Corp. of Americathe sum
Dollars, agreed upon and incorporated in the settlement agreement,
the
in full- and coinplcte satisfactionof any and all claims against
entered in. the Circuit
ainst the City of Miami.
of
City.
Court in
Mami aris:i.ng
out of
favor of Plasma
the final judgment
Gorp. of America and ag
CITY COIAk'11SSION
MEETING OF
FEa ? 6 •,Ui`,
;tiy_urcr 7 9 -.1 1
1979.
AT
PREPARED AND APPROVED BY:
//
G. ,iIIRIAM MAE R
ASSISTANT CITY ATTORNEY
APPRO'
GEORG
CITY AT
KN•X, J
RNEY
2.
79-115
rN
riA
INMR-OFFICE NICMORANDUM
CITY OF MIAMI, FLORIDA
rOr
Mr. Michel E. Anderson
Law Department
Cit.y of Mi,arni,
rcs
Robr-rt • e..5.nc.,s7.1-1././
ENcLosw.Es; cony of. Certificate of Use &
6.,..,1"k•P 1 Copy from Drug Administr-tion Rules
Contrary to allegations in complaint zoning approved for the property
at 161N. E. 2.1th Street vas withheld because subject operation is not
and 114s'ne\ier been a "iciod 8ank".
Subject. Corporation or its -agents misrepresented the type of business
in the original application and that.of December 2, 1975. Type of
busincss should correctly have been listed as manufacture. of Source -
PlaEma. Human (as licensed by the U. S. Food and Drug Administration).
7n:ed the original Certificate of Use can probaoly be revoked on
hearing h City .
In addition, City License was mislead in issUing,a license as, medical
laboratory. •••
The method of operation at Plasma Corporation of.._America is to draw
blood from paid donors, centrifuge it until a straw -colored liquid
containing blood components is produced. This separated and shipped
away for.treatment production of reagents.
In aaortion, certain donors are injected with tetanus vaccine to
produce re -actions whicn increase value 01 plasma.
, .
Following these descriptions and referring to' the enclosed sections
of Title 21, Plasma Corporation of 7,..merica would appear to be a
manufacturing drugcist.,
1 am informed by the local office of the Federal Drug Ar,ministrat50n
that in several court cases the difference between Blood r,anlis and
oLher operations have upheld. Contact is Randy Glover, 5695
N. W. 36th Street.
You
will nc..tice by the ;_•nclosed copy that the Certificate. of Use, for
South Florida Blood Components or said Blrloci but Was
correctly chJ..nged to indicate blood plasma bank alLhough the term
1-r,lik is erfon.aous.
DATE:
March 12, 1976
FILE.:
SIJBJEGT: 161 N. E. .4th Street
= Plasma Corpora -Lion of America VS.
L./4r-
Mr. Michel 2. Anderson
-2-
March 12, 1976
Certainlythe term. Blood. Funk, with its charitable and humanitarian
connotations, Would misi ad'nny person not. i��ini'lliyl with the
plas;naphresi s business,
4. 7ssued a Certificate of Use for a Blood .C)ccl: yi Ona1
1 1C-nS' S for MediCal Lborrtorynttorlicy for t�l : n 1ff
, recocnizes t'h.±s f f r_Uco aril cO'rIeCt1v refers to Flood P as.mia
Center.
5. Checl.. i•:hy then cic. sed ? Violation .of Federal, Drug 7,, uin1S=r a tlO;1
County 1•3ealth o::dir`anceS7 Stories, .public: recores ;.'c Est.: doubt on
p acea: l e conduct.
10. City i.T:s: ectcr. noted: Sian
a ono care at•
pick up
1.2. GOn'nC. in p'c_or who Ieject•ed ct'i c ion d n:i' s cn; t"Gscurry
1"O it City=:iii^1cyc I"S of tet" d =n±S1 and, ,tin ¶i i.On .of ' �F mo anc urn
i.... er -Oi'_ 1 C. 'c d i'5Ll: tJ si on occul d e rc;ardi nt . d i f t e:rCanc? between
bl ood ,:+ank and, anti±f' S oO i ±t cn
1 71 _C.. :dui or lied ed to City r-,rd L•1i•g- C_ rue t Se t`2�.sio.a1� or' l is d Lo
••
City: J__c•_ns - S;1- e rug- 1 as '1ic_E'ned `py U. S.
e ._ •a.l Drug _ ,dmir: st._ ation,
•u.j 1.c? na ✓ .-'_"ct.Or
1 nSi) 'lam ti on
Fading File
(gitu of Aliami, i'iarizia
BUILDING DEPARTMENT.
3319 PAN AM,ERICANDRIVE.?
33133 •
Mr. Roberto E. Ruiz
Plasma Corporation, of America
161N. E. 4th Street
Miami, Florida
Dear � Sir:
Blood'Bank at
161_N. E.:4th Street
Thisletter'will°confirm our. telephone, conversation of this
date �=in 'reference,.-to� , the .operatiOm-of"a. blood bank, at the
above location.
City ordinances require that a-.Conditi0oardUse be 'hearing
for :;the at the City o:f MiamiPlanning
in order to ,o,btath permissiaollrto operatbea blood bank at
the above address.. After pp,
:all.:other applicable Codes and inspect.ions';.complied with a
Certificate'of Use and Occupancy will.be..issued for the:
above . use .
If this fice can be of further service to you, pl
free to ntact us.
Yoursvery truly,`
Robert"E. Ferencik,:P.E.
Building Department
•
- 5
Per:
G. E List
REF:GEL:jb 'Chief Zoni.q Inspector
City Planning Board
Building Director
Zoning Inspection
Reading File
ease` feel
INTER --OFFICE . MoFANCDu:1
TO: Mr. John. S. .Lloyd
City Attorney
FROM:
Ronald G. May.er, Acting Director
. (BuildingDel. artmont
DATE:
December 5, 19,75
PILE:
Sul3JEOT: Request for Opinion
Blood', Bank, 161 N.E. 4th Street
RCFCRENCES:
ENCLOSURES:
A request for a Zoning, Certificate. of. Use ,"and: Occupant
has been denied by the Zoning Field Inspector for a
"blood . bank" at .. 161 N. E. 4th Street.
hn; 1967 .a .Certificate of 'Use for a "blood bank" was
is,sued'at subject address.., The premises have been
licensed as a medical laboratory through: September 30,
197 5
As a result of: 'a Health Department order this operation
and: -Other -similar blood-letting concerns closed.: A
sign . at 161. N. E. 4th Street says "closed 'indefinitely'
On October 16th, by letter, the Director of ' the Building
Department directed a new application for a Certificate
of Use be filed for and approved, before reliceisi.ng.
On December 2, 1975.an application was filed by .Plasma -
Corporation of America for a "blood bank".
The Field Inspector is denying the application until,
further information is presented and feels that he will
continue to do so. Reason is: 1. The term "blood bank"
is a misnomer. The operation is a commercial blood-letting
where plasma is separated from whole blood by centrifuging.
The whole blood is returned to the donor and the . residue . shipped
out of the City for processing.
The operating does not appear to be "a
rior is it a blood bank and no similar.
can be located.
"medica lros .i tor
1 l
y:.
'C-3
use allowable :in
Your office is requested to review' these"facts and provi.
us' with any other material which would substani.ate these
fInd i.ncjs
cc : • Building Director
Zoning Inspection,
Reading File
•
,n
Citu of Iartb a
I �dn"1 M t )
Of
1 11r1 ,i• t`. �t+ � !!.
i.IJb.M�i1�'�P.I tj".. ,.4.•�1.:F•� .t� •
,. /1 J �+. I '-t, i•I' 4� ' r i�.�.••••
oomm6 $.16 kin r .lr�rt.;I 1-1-0 t7 .t�i'on. if art •f � � '� i ..,.. •,
HUILDINO DEPARTMENT.::
111/ PAN A► ERICAN'DRIVE
11131
•
•
•
•
•
l •
•
•
October 16
.i }
.Plasma.Corporation o
161. N. E. 4th ,Street.
;Miami, Florida 33132
'Gentlemen:
America
1975
Re: 161 N. E.'4th Street
•
CERTIFIED MAIL
RETURN RECEIPTREQUESTED
IIt has been noted that a"painter has obtained a permit,
authorizing the redecorationof the premises designated
as 161 N. E. 4th Street.
!The records of thislDepartment_show that aZoning.Certif
•icate of use was issued `February '24, 1967 authorizing the
;operation of a blood plasma center ;in. this apace.
Recent inspection of the building has revealed. that the
premises have. not been in use and theCity.of Miami
License Division records show; that no current lice:Ise is
in existence.
You are, therefore, radvised that under the provisions or
'the Cityof Miami. Zoning Ordinance, (and prior to any tame
';..
a:business, on these premises is established) it will be
necessary that a new Zoning Certificate of;,Use be filed
and approved by , thin Departme
truly yours/
I obert E.
Director,
REF:g3
cc t City Manager
City License Divi3ion
Building Director's file i
Zoning Inspection •••
Reading file,
t1 1 a
I'e encik, P.E.
Building Department
Thy for
,.,