Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 30 - BLOOD BANKS › LICENSING, FEES AND INSPECTIONS › Section 30.31 - Collection, processing, storage and distribution of blood products

Current through Register Vol. 54, No. 28, July 13, 2024
(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.
(d) All
				  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
				  and 10°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.
(j) Expiration
				  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.
(2) The
				  expiration date for platelet concentrate, room temperature storage, shall be 72
				  hours from time of collection, with storage at temperatures between 20° and
				  24°C.
(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.
(5) 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.