N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-5.7 - Hematopoietic progenitor cell processing facilities
(a) If hematopoietic progenitor cells are to
be frozen, the following requirements apply:
(1) unless otherwise specifically authorized
in writing by the director of the hematopoietic progenitor cell processing
facility, hematopoietic progenitor cells shall be frozen within 48-hours of
collection using cryopreservation techniques generally accepted by experts in
transplantation medicine and meeting the requirements of this
Subpart;
(2) until used,
hematopoietic progenitor cells shall be stored continuously within a
temperature range of minus 196° C to minus 80° C, under one of the following
conditions:
(i) in a mechanical freezer
reserved for hematopoietic progenitor cells, equipped with an automatic
temperature recording device, an audible alarm and a back-up system in the
event of unexpected mechanical failure; or
(ii) in a liquid nitrogen freezer reserved
for hematopoietic progenitor cells, equipped with an automatic liquid nitrogen
level monitor, an audible alarm and a back-up system in the event of unexpected
liquid nitrogen loss;
(3) frozen hematopoietic progenitor cells in
transit from a processing facility to a transplantation facility or other
facility shall be:
(i) maintained, at a
minimum, on dry ice or in a liquid nitrogen dry shipper. Storage/transport
procedures for the frozen hematopoietic progenitor cells shall be validated,
and such validation shall be documented;
(ii) transported as fast as reasonably
possible and without any unnecessary delay; and
(iii) used immediately upon arrival or stored
as required in paragraph (2) of this subdivision until thawed for use;
and
(4) hematopoietic
progenitor cell specimens shall be inspected visually at the time of freezing
and thawing. If the color or physical appearance is abnormal, the cells shall
not be released for transplantation unless authorized, in writing, by the
transplantation service director.
(b) Hematopoietic progenitor cells stored in
the liquid state shall be maintained at a temperature and for a period of time
specified in a protocol approved by the director of the hematopoietic
progenitor cell procurement service and/or processing facility.
(c) Storage temperature records for
hematopoietic progenitor cells shall be maintained as required in section
58-5.8(c) and
(d) of this Subpart, and be made available
for inspection by the department for the entire period of storage and for one
year afterward.
(d) Unless needed
to meet a medical emergency, hematopoietic progenitor cells shall be
transported in a leak-resistant, crush-resistant and puncture-resistant
container featuring a prominent label which:
(1) identifies the contents as "human blood,"
"human hematopoietic progenitor cells" or "human bone marrow";
(2) describes the contents, the packing
agent, if any, and any special precautions necessary in handling such contents;
and
(3) contains the name, address
and 24-hour telephone number of the person or entity to be contacted in the
event that the container is found leaking or damaged, or is
misdirected.
Notes
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