Title: Section 58-5.8 - Required records.

Effective Date

07/21/2004

58-5.8 Required records.

(a) Complete and accurate records of hematopoietic progenitor cells released for transplantation shall be kept for seven (7) years by the hematopoietic progenitor cell procurement service, processing facility and transplantation service using the sample. Such records shall be open to inspection by the department. For all donated hematopoietic progenitor cells, the donor's name, address, and any other information that would directly or indirectly identify the donor shall not be disclosed or released by the bank to any person or entity, except upon the written consent of the donor or the person authorized by law to make the donation, or to authorized employees of the department, or as permitted by law,. The recipient's name, address, and any other information that would directly or indirectly identify the recipient shall not be disclosed or released by the hematopoietic progenitor cell bank to any person or entity, except upon the written consent of the recipient, or except to authorized employees of the department, or as permitted by law.

(b) Records to be kept by the hematopoietic progenitor cell procurement service shall include, but not be limited to, the following information:

(1) donor's full name, address, age, sex, and identification code, as well as documentation of donor or donor's mother informed consent;

(2) date and volume of hematopoietic progenitor cells collected;

(3) any adverse reaction of the donor and its outcome;

(4) medical history and results of all required clinical laboratory tests and of the physical examination performed;

(5) disposition of hematopoietic progenitor cells;

(6) documentation of sterility testing, and viability and recovery checks, if performed; and
(7) medical director's authorization for the collection.

(c) Records to be kept by the hematopoietic progenitor cell processing facility shall include, but not be limited to, the following information:

(1) donor's identification code, date and amount of cells collected;

(2) results of all clinical laboratory tests performed; (3) methods used for processing, preserving storage and transport of the hematopoietic progenitor cells, including manufacturer's name and lot numbers of all reagents used in processing or preserving the cells; (4) temperature records of the storage chamber;

(5) records of visual inspection of the hematopoietic progenitor cell specimens at the time of freezing and thawing;

(6) specimen location in the storage chamber;

(7) methods used for hematopoietic progenitor cell preservation, storage and transport; and

(8) disposition of the cells.

(d) Whenever hematopoietic progenitor cells are released for transplantation, the following records shall be maintained by the hematopoietic progenitor cell transplantation facility:

(1) name of the hematopoietic progenitor cell bank providing the cells, description of the specimen, and condition of the cells and shipping container upon receipt, including any loss noted of liquid nitrogen, dry ice or other coolant; (2) if applicable, any extenuating circumstances that warrant acceptance of hematopoietic progenitor cells from donors who test positive;

(3) medical history and results of all tests, and of the physical examination performed on the donor, if applicable;
(4) disposition of the hematopoietic progenitor cells, including date and time released, and name of recipient; (5) outcome of the transplantation procedure, including, but not limited to, any adverse outcome or infectious disease in the recipient; and (6) if applicable, records documenting storage and temperature monitoring of hematopoietic progenitor cells, in accordance with the requirements in section 58-5.7 of this Subpart.

Volume

VOLUME A-1 (Title 10)

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