Title: Section 58-5.6 - Collection and handling of hematopoietic progenitor cells

Effective Date

07/21/2004

58-5.6 Collection and handling of hematopoietic progenitor cells.

(a) All hematopoietic progenitor cell specimens obtained by bone marrow aspiration shall be collected by the medical director of the procurement service or other qualified physician, physician's assistant, or a nurse practitioner under the supervision of the medical director. Hematopoietic progenitor cells obtained by peripheral blood apheresis shall be collected by an individual trained in pheresis in accordance with the requirements of section 58-2.15 of this Part. Cord blood collection shall be performed by staff with documented training, experience and proficiency in the techniques utilized.

(b) Hematopoietic progenitor cell collection apparatus and containers shall be clean, pyrogen-free and sterile.

(c) Phlebotomy and bone marrow aspiration puncture sites shall be prepared by a procedure which conforms to current medical standards generally accepted by leading authorities in transplantation medicine.
(d) Hematopoietic progenitor cell collection systems shall meet the following minimum requirements:

(1) hematopoietic progenitor cells shall be collected under aseptic conditions using an approved system adequately protected against contamination;

(2) additives shall be used as required to ensure the continued suitability of hematopoietic progenitor cells for transplantation and retention of viability. All changes in additives shall be validated on-site, and such validation shall be documented;

(3) each container shall be legibly labeled or tagged at the time of collection with:

(i) the donor's identification code and date of collection; and

(ii) if known, the recipient/patient's name, the name of the hospital where the patient is to be transplanted, and the patient's hospital registration number or, if unavailable, Social Security number, birthdate, or similar identifying information; (4) each final container shall be legibly labeled or tagged at the time of issuance with:

(i) if performed, the results of laboratory tests for syphilis, HBsAg, and antibodies to HBV, HCV, HIV-1, HIV-2, HTLV-I and CMV, unless the results were forwarded to the hematopoietic progenitor cell transplantation service in advance or included in records accompanying the hematopoietic progenitor cells; and

(ii) a biohazard label, if the donor has tested reactive or positive for any of the tests required in section 58-5.4(c) or (d)(1) of this Subpart; and

(5) if microbial culturing is performed, suspected contamination shall be reported to the transplantation service. (e) Prior to collection of cord blood, an access agreement/ acknowledgment shall be consummated between the administration of the hospital or other collection site and the licensed cord blood bank.

Volume

VOLUME A-1 (Title 10)

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