N.Y. Comp. Codes R. & Regs. tit. 10 § 58-5.8 - Required Records at Hematopoietic Progenitor Cell Banks

This regulation requires that hematopoietic progenitor cell procurement services maintain complete records of all such cells released for transplantation for 7 years.  These records are required to be open to inspection by the department of health.  The regulation requires that donors' and recipients' identifying information not be disclosed or released by the bank to any person or entity, except with the written consent of the donor or to authorized employees of the department of health.
 
The regulation requires that the records maintained by hematopoietic progenitor cell procurement services include, but not be limited to:

• Donor's biographical information
• Information about the sample of cells collected
• Donor’s medical history and results of all relevant tests performed
• Medical director’s authorization for the collection

 
The requires that the records maintained by hematopoietic progenitor cell processing facility include, but not be limited to:

• Donor's ID code, and information about the sample
• Results of all clinical lab tests
• Methods used for processing, transporting and storing the samples
• Specimen location in storage
• Disposition of cells

 
Whenever these cells are released for transplantation, the following records are required to be maintained by the transplantation facility:

• Name of cell bank and description of specimen
• Any extenuating circumstances that would warrant acceptance of cells from donors who test positive
• Medical history and results of all tests performed on the donor
• Disposition of the cells
• Outcome of transplantation procedure
• If applicable, records documenting storage and temperature monitoring of cells