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Title: Section 58-2.7 - Immunohematology testing

Effective Date


58-2.7 Immunohematology testing.

(a) Blood specimens intended for pre-transfusion testing shall be labeled at the patient’s side at the time of collection. Such labeling shall include the patient’s name, patient’s identification number, and date of collection. Identification of the person collecting the specimen shall be recorded. (b) All tests, including, but not limited to, ABO and Rho(D) grouping, antibody detection and identification, and compatibility testing, shall employ methods, techniques or procedures which have been approved or recommended for the particular reagent in use by the F.D.A. or the American Association of Blood Banks, and which have been demonstrated to be effective in a manner acceptable to the department in conformance with generally accepted laboratory principles. All grouping antisera, reagents, devices, methods, and procedures for blood unit processing or transfusion-related testing shall be approved by the F.D.A. or conform to the recommended minimum requirements of the F.D.A.

(c) All reagents shall be stored in labeled containers under conditions appropriate for each reagent as directed by the manufacturer and shall be removed from use after their expiration date. The reactivity and specificity of each reagent shall be determined whenever a new lot is employed. All methods shall conform to manufacturers' instructions unless otherwise approved by the department. (d) Negative controls run on each day of use are not required for anti-human globulin and antibody screening cells, provided manufacturers’ instructions are followed. New lots of reagents shall be thoroughly evaluated, but antibody identification cell panels need not be tested with a known antibody. All test procedures to be used shall be determined by the blood bank director and shall be documented in the standard operating procedure manual. If no negative reactions are observed on a given test run, an investigation shall be performed and controls run. All quality control records shall be retained for five years.

(e) Centrifuges used for testing of red blood cell agglutination shall undergo revolutions per minute (RPM) and timer checks quarterly. Functional calibration that determines optimal centrifugation conditions shall be performed prior to initial use, after adjustments or repairs, and at least annually thereafter, and shall be documented. The procedure shall specify the speed and duration of centrifugation to be used. A microscope shall be located in the work area designated for immunohematology testing, if use of a microscope is specified by the facility’s standard operating procedure manual or by a test kit manufacturer’s package insert. Microscopic examination shall be performed for red blood cell agglutination tests whenever indicated for the procedure in use.


VOLUME A-1 (Title 10)