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Title: Section 58-2.10 - Required records and confidentiality

Effective Date


58-2.10 Required records and confidentiality.

(a) Complete and accurate records of blood, blood components and derivatives released for allogeneic or autogeneic transfusion shall be kept for seven years or six months after the expiration date of the individual product, whichever is later, by the blood bank preparing the product and by the institution using the product. Such records shall be open to inspection by the department and shall include the information specified in sections 58-2.11 and 58-2.12 of this Subpart. For all collected or distributed blood, blood components and derivatives, the donor's name, address, telephone number, social security number and any other information which would directly or indirectly identify the blood donor of any specific unit shall not be disclosed by the blood bank to any person or entity except upon the written consent of the donor or except to the department and other agencies which issue clinical laboratory and/or blood bank permits to the facility whose records are requested.

(b) Blood banks and transfusion services shall file a Blood Services Activity Report annually with the department.

(c) Records shall be maintained of all tests, controls, reagents and current procedures, in a manner acceptable to the department in conformance with generally accepted laboratory principles.


VOLUME A-1 (Title 10)