N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-2.12 - Records to be kept when blood, blood components or derivatives are issued for allogeneic or autogeneic transfusion
(a) For blood and blood components, records
of the following information, as applicable, shall be kept in the blood bank
and made available to the department for inspection:
(1) source;
(2) unit identification code upon receipt
and, if different, upon issuance;
(3) unit ABO and Rh groups;
(4) expiration date;
(5) results of all pretransfusion
testing;
(6) disposition of the
unit, including remote storage location, if any, and intended recipient's name
or, if the name is unknown, identification code;
(7) identification of the station code or
person taking possession of the unit;
(8) documentation of visual
inspection;
(9) date and time of
issuance; and
(10) results of all
tests associated with the investigation of all transfusion reactions, with the
conclusions reached and the report signed, or approved by electronic
equivalent, by the director of the blood bank or a qualified physician
designated by the director of the blood bank.
(b) For coagulation factor concentrates,
logbook records of the following information shall be kept and made available
to the department for inspection:
(1)
manufacturer;
(2) lot
number;
(3) expiration
date;
(4) disposition, including
recipient's name if administered; and
(5) date of issue.
(c) For all derivatives, records associated
with the investigation of all reactions, with the conclusions reached and the
report signed, or approved by electronic equivalent, by the director of the
blood bank or a qualified physician designated by the director of the blood
bank, shall be kept and made available to the department for
inspection.
(d) These recordkeeping
requirements shall also apply to blood components issued to limited transfusion
services and to blood components issued to ambulance transfusion
services.
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.