Section 493.1278 - [Effective 12/28/2024] Standard: Histocompatibility(a)General. The laboratory must meet the following requirements: (1) Use a continuous monitoring system and alert system to monitor the storage temperature of specimens (donor and recipient) and reagents and notify laboratory personnel when temperature limits are exceeded.(2) Establish and follow written policies and procedures for the storage and retention of specimens based on the specific type of specimen. All specimens must be easily retrievable. The laboratory must have an emergency plan for alternate storage.(3) If the laboratory uses immunologic reagents to facilitate or enhance the isolation or identification of lymphocytes or lymphocyte subsets, the efficacy of the methods must be monitored with appropriate quality control procedures.(4) 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.(b)Human leukocyte antigen (HLA) typing. The laboratory must do the following:(1) Use HLA antigen terminology that conforms to the World Health Organization (WHO) Nomenclature Committee for Factors of the HLA System.(2) Have available and follow written criteria for determining when antigen and allele typing are required.(c)Antibody screening and identification. The laboratory must make a reasonable effort to have available monthly serum specimens for all potential transplant recipients for periodic antibody screening, identification, and crossmatch.(d)Crossmatching. For each type of crossmatch that a laboratory performs, the laboratory must do the following, as applicable: (1) Establish and follow written policies and procedures for performing a crossmatch.(2) Have available and follow written criteria for the following:(i) Defining donor and recipient HLA antigens, alleles, and antibodies to be tested;(ii) Defining the criteria necessary to assess a recipient's alloantibody status;(iii) Assessing recipient antibody presence or absence on an ongoing basis;(iv) Typing the donor, to include those HLA antigens to which antibodies have been identified in the potential recipient, as applicable;(v) Describing the circumstances in which pre- and post-transplant confirmation testing of donor and recipient specimens is required;(vi) Making available all applicable donor and recipient test results to the transplant team;(vii) Ensuring immunologic assessments are based on test results obtained from a test report from a CLIA-certified laboratory; and(viii) Defining time limits between recipient testing and the performance of a crossmatch.(3) The test report must specify the type of crossmatch performed.(e)Transplantation. Laboratories performing histocompatibility testing for infusion and transplantation purposes must establish and follow written policies and procedures specifying the histocompatibility testing (that is, HLA typing, antibody screening and identification, and crossmatching) to be performed for each type of cell, tissue, or organ to be infused or transplanted. The laboratory's policies and procedures must include, as applicable- (1) Testing protocols that address: (i) Transplant type (organ, tissue, cell);(ii) Donor (living, deceased, or paired): and(iii) Recipient (high risk vs. unsensitized);(2) Type and frequency of testing required to support clinical transplant protocols; and(3) Process to obtain a recipient specimen, if possible, for crossmatch that is collected on the day of the transplant and prior to transplantation. If the laboratory is unable to obtain a recipient specimen on the day of the transplant, the laboratory must have a process to document its efforts to obtain the specimen.(f)Documentation. The laboratory must document all control procedures performed, as specified in this section.68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003