N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-5.8 - Required records
(a)
Complete and accurate records of hematopoietic progenitor cells released for
transplantation shall be kept for seven 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.
Notes
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