Proficiency Testing Requirements

(A) Every blood bank subject to 105 CMR 135.000 shall participate successfully in the Comprehensive Blood Bank Series J of the College of American Pathologists (CAP) or an equivalent program approved by the Department. The extent to which a blood bank participates will be determined by the procedures performed by that blood bank. A blood bank must be enrolled in such a program to the extent necessary to cover all testing which it uses for diagnosis or treatment. Every blood bank that performs infectiousdisease testing on donor blood for the purpose of approving blood for transfusion purposes shall successfully participate in the AABB-CAP Viral Markers Series W or an equivalent program approved by the Department. (B) The Department shall set standards for successful participation that all blood banks and transfusion services shall meet. (C) Any blood bank or transfusion service subject to 105 CMR 135.000 which fails to meet any standard for successful participation specified by the Department will be required to submit such information as required by the Department. (D)(1) The Department may provide additional proficiency testing samples to a blood bank or transfusion service. (2) Any proficiency testing samples provided by the Department shall meet the same criteria as samples used by the proficiency testing programs approved by the Department.