Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
Section 180.410 - Standard - Immunohematology: Quality Control

(1) ABO grouping shall be performed by testing patient red cells with anti-A and anti-B serums licensed under 42 CFR Part 73, using the technique for which the serum is specifically designed to be effective. For confirmation of ABO grouping, the patient serum shall be tested with known Group A red cells or a red cell pool prepared from at least five known Group A individuals and Group B red cells.

(2) Any discrepancy between results of patient red cell and serum typings shall be resolved before the blood type is reported.

(1) The D type shall be determined by testing patient red cells with anti-D typing serum licensed under 42 CFR Part 73, using the technique for which the serum is specifically designed to be effective. All D negative donor cells shall be tested for the Du variant. A control system of the patient's cells suspended as for the D test and reagent control serum produced by the anti-D manufacturer shall be employed for each D test and Du variant test.

(2) If the D test is negative, the Du test shall be reported as positive, negative, or not performed.

(1) The potency and reliability of reagents (antisera, known test cells and antihuman globulin which are used for ABO grouping, RH typing, anti body detection and antibody identification) shall be tested for reactivity on each day of use. If a new lot of reagents is opened after the daily testing has been completed, the quality control testing must be repeated using the new lot of reagents.

(2) Determination of optimum time of centrifugation for each media or procedure employed (i.e. saline, and albumin, and saline washing) shall be made semi-annually.

(3) Coombs control cells shall be added to each tube giving a negative reaction in the antihuman globulin (coombs) phase and shall give a macroscopically positive reaction.

(4) Patient samples obtained within the previous 48 hours shall be used if the test is for complement dependent antibodies.

(5) Any laboratory performing immunohematologic testing and cross-matches on samples or units which will be used for transfusion purposes shall be in compliance with 105 CMR 135.000: Use of Blood, Blood Components, and Derivatives for the Purpose of Transfusion.