Inspections and Statements of Deficiency

(A) All blood banks and transfusion services subject to 105 CMR135.000 willbe inspected by the Department to assess their compliance with 105 CMR 135.000. As evidence of such compliance, the Departmentwill accept the American Association of Blood Banks (AABB) orthe College ofAmerican Pathologists (CAP) accreditation; provided, however, that AABB or CAP, or both, if inspected by both, provide to the Department all statements of deficiencies and certification of compliance with requirement for accreditation. The Department retains the right to request a plan of correction and perform inspections as it deems necessary. (B) Upon inspection, the Department will send a deficiency statement to notify the blood bank or transfusion service of any violation of 105 CMR 135.000. The blood bank or transfusion service shall submit to the Department a written plan of correction for each violation within ten working days of receipt of the deficiency statement. The Department will notify the blood bank or transfusion service about whether the plan is acceptable or not. (C) The Department will issue a letter ofapprovalto anyblood bank or transfusion service found to be in compliance with 105 CMR 135.000 which is not part of a hospital subject to licensure by the Department.