N.Y. Comp. Codes R. & Regs. Tit. 10 § 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;
(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, social security number, birth date 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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.