Section 180.430 - Standard - Histocompatibility: Quality ControlIn addition to the standards for quality control in immunohematology ( 105 CMR 180.410) and immunology ( 105 CMR 180.400) , which are applicable to the histocompatibility testing laboratory, the histocompatibility testing laboratory shall use the following control systems and validation methods for the performance of tests:
(A)Renal Allotransplantation(1) Crossmatching of potential recipients and donors before transplantation is performed with one or more of the more sensitive techniques using the most reactive and most recent patient sera;(2) HL-A serologic typing of both donor and recipient which include at least those antigens detectable with serum capable of defining the same antigens as those definable by the National Institutes of Health serum tray(s); and(3) All potential recipient sera shall be screened monthly for cytotoxic antibodies against histocompatibility antigens.(B) The tests in 105 CMR 180.430(A)(2) and (3) are required for transfusions and bone marrow transplants.(C) For disease associated antigens, 105 CMR 180.430(A)(2) applies only to those antigens for which testing is performed.(D) Mixed lymphocyte cultures or other recognized methods to detect cellular-defined antigens shall be performed in accordance with prescribed methods. Procedures shall be established for freezing of lymphocytes and to provide for a comprehensive panel of fresh and/or frozen lymphocytes.(E) Procedures shall be established for the performance of cell harvesting, viability testing and purity checks on lymphocyte suspensions. Such checks shall be done for each test performed.(F) Provisions for twenty-four hour laboratory coverage shall be maintained for organ transplant testing.(G) The laboratory shall also:(1) At least once each month give each individual performing tests a individual's ability to reproduce test results. The results of such testing shall be recorded, and(2) Participate in at least one national or regional cell exchange program, if available, or develop an exchange system with another laboratory in order to validate interlaboratory reproducibility.