Denial or Revocation of License or Approval

(A) Non-compliance with any of 105 CMR 135.000 may result in denial, suspensionor revocation of the license of the hospital of which the blood bank or transfusion service is a part or in the imposition of any other sanction which may be imposed on such a hospital under 105 CMR 130.000. (B) Non-compliance with any applicable provisions of 105 CMR 135.000 by a blood bank or transfusion service subject to M.G.L. c. 111, § 184B which is not part of a hospital subject to Department licensure may result in denial, suspension or revocation of any approval. (C) Non-compliance with any applicable provisions of 105 CMR 135.000 by a transfusion service which is a part of an out-of-hospital service subject to Department licensure under M.G.L. c.111, § 51A may result in denial or revocation of the license of the out-of-hospital service or temporary or permanent withdrawal of the right of the out-of-hospital service to operate a transfusion service. 135.200 Requirements All blood banks and transfusion services shall comply with the most recent AABB edition of "Standards for Blood Banks and Transfusion Services". Inaddition, for the purpose of applying 105 CMR 135.000, all AABB Standards which incorporate the word "should" will be taken to mean "shall"except upon written authorization by the blood bank director for good cause. The blood bank or transfusion service shall document the rationale for all such authorizations. The blood bank's or tranfusion service's procedure manual may serve as an acceptable form of authorization. (A) Any change in the positionofblood bank director shallbe reported to the Department within 30 days. (B) Blood donor screening and venipuncture procedures shall be performed only by suitably qualified individuals who have received appropriate training. The blood bank shall maintain records documentingthe training of such qualified individuals. Ongoing continuing education andretrainingshall be provided if applicable or as needed. Trainingmustbe provided by experienced health professionals with experience in clinical detection, measurement and analysis appropriate to the donor screener's responsibilities. The training programs must include at a minimum: (1) a thorough training on content and application of pertinent screening protocols; (2) a thorough training on venipuncture blood collection and processing procedures; (3) a thorough training on worker and patient safety including emergency procedures required to aid a distressed donor; (4) a means for testing employee technique and proficiency in performing assigned duties and responsibilities. Suchassessments shallbe made by the blood bank director (or his/her designee) on an annual basis and shall make personal inspections of the donor centers to insure suitable handling of donors and to instruct employees.