R432-100-24. Blood Services

  (1) Hospital blood services are defined as follows:

  (a) A "donor center" means a facility that procures, prepares, processes, stores and transports blood and blood components.

  (b) A "transfusion service" means a facility that stores, determines compatibility, transfuses blood and blood components, and monitors transfused patients for any ill effect.

  (c) A "blood bank" means a facility that combines the functions of a donor center and transfusion service within the same facility.

  (2) The hospital blood service shall establish and maintain an appropriate blood inventory in the hospital at all times, have immediate access to community blood services or other institutions, or have an up-to-date list of donors, equipment and trained personnel to draw and process blood.

  (a) Blood or blood components must be collected, stored, and handled in such manner that they retain potency and safety.

  (b) Blood or blood components must be properly processed, tested, and labeled.

  (3) If the hospital operates a donor center, transfusion service or a blood bank the donor center, transfusion service, or blood bank must be accredited.

  (a) Hospital blood banks and donor centers must be accredited by the Food and Drug Administration (FDA).

  (b) Hospital transfusion services must be certified by the Health Care Financing Administration to meet Clinical Laboratory Improvement Amendments of 1988 (CLIA), or any accrediting organization approved by the Health Care Financing Administration.

  (4) Results of the accrediting organization survey, or current CLIA certification must be available for Department review.