(a) The containers
shall be pyrogen-free, sterile and free of foreign material and shall contain
sufficient anticoagulant for the quantity of blood to be collected.
(b) Only anticoagulants which meet standards
of Federal regulations shall be used, in the amounts necessary to give optimal
proportion of blood to anticoagulant.
(c) Both donor and future recipient shall be
protected by proper preparation of the site of the venipuncture. Preparation of
the skin shall provide maximum assurance of an aseptic procedure and a sterile
product. Care shall be taken to prevent contamination of the phlebotomy needle
and the phlebotomy site.
instruments used in the bleeding and processing of blood shall be sterile and
dry prior to use.
(e) Pilot samples
shall be attached to the container and identified by a numerical system to
relate directly to the donor or to the container.
(f) Specific instructions and appropriate
materials for the handling and treatment of adverse donor reactions shall be
readily available to all personnel in the blood bank.
(g) Blood shall be stored at temperatures
between 1° and 6°C with avoidance of fluctuations of more than 2°C.
The temperature of blood during shipment should be maintained between 1°C
(h) All equipment
used in processing blood and blood products shall be in optimal working
condition, checked, and calibrated. Maintenance and control data shall be
recorded and available for inspection by the Department.
(i) The refrigerator in which blood is stored
shall contain only blood and blood components. It shall be provided with a fan
for circulating air or be of such capacity and design to ensure adequate
circulation of air.
rules shall be as follows:
(1) The expiration
date for ACD or CPD whole blood (human) and red blood cells (human) shall be 21
days from date of collection. Expiration date for heparinized blood shall be 48
hours after collection provided the product is collected in a closed system and
remains in the same bleeding container. If the seal is broken, blood must be
transfused within 24 hours.
expiration date for platelet concentrate, room temperature storage, shall be 72
hours from time of collection, with storage at temperatures between 20° and
(3) The expiration date
for fresh frozen plasma and cryoprecipitate is 12 months from donation of
original pint of blood, with storage at -18°C or lower.
(4) The expiration date for frozen blood
cells is 3 years from the date of donation, stored at -65°C or colder.
After reconstitution, expiration date is within 24 hours, stored at
temperatures between 1° and 6°C.
The expiration date for single donor
plasma (human) is 6 weeks, stored at temperatures between 1° and 6°C.
These expiration dates are in effect until modified by Federal Regulations.
Reference should be made to 21 CFR Part 640
(k) Before issuing blood from the blood bank,
all data on the label shall be carefully checked and ascertained to be clear
(l) All procedures for
the preparation of blood products shall meet standards acceptable to the
Department. Complete protocols for these procedures shall be submitted to the
Department at the time of license application or when any protocol is modified
and when any amendment to the license is requested.