Title: Section 58-5.7 - Hematopoietic progenitor cell processing facilities

Effective Date

07/21/2004

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 forty-eight (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 degrees Celsius to minus 80 degrees Celsius, 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 or there is indication or suspicion of microbial contamination, 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 twenty-four (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.

Volume

VOLUME A-1 (Title 10)

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