Rule 111-8-10-.21 - Quality Control for Histocompatibility(1) Mechanical refrigerators and freezers with recording thermometers must have an audible alarm that is monitored 24 hours a day. If liquid nitrogen is used for storage of frozen cells, the level of liquid nitrogen in the cell freezers must be monitored periodically. Sera and reagents must be stored at an acceptable temperature range. Reagents, solutions, culture media, controls, calibrators or other materials must be labeled to indicate identity and when significant, titer, strength or concentration, recommended storage requirements, preparation and expiration date and other pertinent information. Reagents typing area (locally constructed trays) must indicate source, bleeding date, identification number and volume remaining.(2) The laboratory must have available and follow written policies and procedures regarding specimen collection:(a) Requisitions must include patient's first and last name or unique identifier, name and address of the authorized person who ordered the test, date and time of specimen collection and source of specimen.(b) All specimens must be properly identified and easily retrievable. Blood samples must be labeled with the patient's first and last name or unique identifier, date of collection, and must be obtained in a manner which does not compromise aseptic techniques.(3) The laboratory must maintain a system to ensure reliable specimen identification and document each step in the processing and testing of patient specimens. If "chain of custody" is a requirement, the laboratory must maintain records of the "chain of custody" of the sample, the phlebotomist who collected the sample, documentation to identify each specimen, and a signature to verify information submitted. (a) Computer assisted analysis and all reports must be reviewed and verified by the supervisor or director. Records may be saved in a computer file if back-up files are maintained to ensure against loss of data.(b) The laboratory must, at least once a month, give each individual performing tests a characterized specimen as an unknown to verify his or her ability to reproduce results.(4) Records of the results for each individual must be maintained for a minimum of two (2) years. In addition, the laboratory must participate in at least one national or regional cell exchange program, if available, or develop an exchange system with another licensed/ certified laboratory in order to validate interlaboratory reproducibility. (a) The laboratory must maintain records of each result, including preliminary reports, for at least two (2) years. Worksheets must clearly identify the subject whose cells were tested, the typing sera used, date of test and the person performing the test. For each cellserum combination, the results must be recorded in a manner which indicates the approximate percent of cells killed.(b) Membranes or autoradiography from nucleic acid analysis must be retained as a permanent record.(c) For marrow transplantation, the donor must give his/her informed consent before blood is taken for typing and before the donor is placed on a list of donors available to be called. Donor records for marrow transplantation must be maintained so that donors can be rapidly retrieved according to HLA type. The report must contain the date of collection, name, street address, city and state of the testing facility, patient's name or unique identifier, date of testing, date of final report, test results, control values and normal ranges where appropriate, interpretation, and signature of the director or his/her designee.(5) Renal and Bone Marrow Transplantation. The laboratory must have established policies for selecting appropriate patient samples for crossmatching, preparing donor lymphocytes for crossmatching, and reporting crossmatch results; having available results of final crossmatches before an organ or tissue is transplanted, documenting efforts to obtain specimens for all potential transplant recipients at initial typing, for periodic screening, for pre-transplantation crossmatch and following sensitizing events such as transfusion and transplant loss. If transplantation is deferred, a new serum sample must be obtained from the patient at monthly intervals, screened for antibodies and stored in the frozen state for possible use in crossmatch tests. Serum used for crossmatching must be tested undiluted and with one or more dilutions. Crossmatching must use techniques documented to have increased sensitivity in comparison with the basic microlymphocytotoxicity test such as prolonged incubation, washing or augmentation with antiglobulin or flow cytometry. Final crossmatches performed prior to transplantation must utilize a serum sample collected within the past 48 hours before transplant if the recipient has class I lymphocytotoxic antibodies or has had a recent sensitizing event, otherwise, a serum collected within seven days may be used. Donors and recipients must be ABO and Rh typed according to blood bank standards.(a) The laboratory must HLA type all potential transplant recipients and organ donors, and follow a policy that establishes when antigen redefinition and retyping are required.(b) The laboratory must have and follow criteria for the preparation of lymphocytes for HLA-A, B and DR typing; select typing reagents which are made in-house or purchased commercially, assignment of HLA antigens and assure that reagents used for typing recipients and donors are adequate to define all major and International Workshops HLAA, B and DR specificities for which reagents are readily available.(6) Potential transplant sera must be screened for HLA-A, B and DR antibodies with a suitable lymphocyte panel on sera collected, at the time of the recipient's initial HLA typing and thereafter, following sensitizing events and upon request. A suitable cell panel, which contains all the major HLA specificities and common splits for screening patient sera, must be used.(7) Transfusion and Non-Renal Transplantation. All requirements specified in (5)(a) must be met. (a) The laboratory must check each typing tray using positive and negative control sera and must use positive controls for specific cell types (i.e., T cells, B cells and monocytes) when applicable. Controls must be used to monitor the test components and each phase of the test system to ensure an acceptable performance for each compatibility test, i.e., mixed lymphocyte cultures, homozygous typing cells for DNA analysis.(b) Compatibility tests for cellularly-defined antigens must use techniques such as the mixed lymphocyte culture test, or homozygous typing cells for DNA analysis. If the laboratory uses immunologic reagents such as antibodies or complement to remove contaminating cells during the isolation of lymphocytes or lymphocyte subsets, the methods must be verified with appropriate controls.(8) Non-Renal Solid Organ Transplantation. The results of final crossmatches must be available before transplantation when the recipient has demonstrated presensitization by prior screening, except for emergency situations. The laboratory must document the circumstances, if known, under which emergency transplants are performed, and records must reflect any information concerning the transplant provide d by the patient's physician to the laboratory.Ga. Comp. R. & Regs. R. 111-8-10-.21
O.C.G.A. § 31-22-1et seq.
Original Rule entitled "Quality Control for Histocompatibility" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.