28 Pa. Code § 30.31 - Collection, processing, storage and distribution of blood products

(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.

(k) Before issuing blood from the blood bank, all data on the label shall be carefully checked and ascertained to be clear and legible.

(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.

Notes

28 Pa. Code § 30.31