US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1276-1278: Meet the clinical cytogenetics and histocompatibility requirements: specimen identification through accessioning, culture, imaging and reporting, records of media, cells counted and karyotyped, banding resolution and adequate karyotypes, sex by full chromosome analysis, ISCN reporting; continuous monitored specimen and reagent storage with alarm and emergency storage, cell exchange participation, WHO HLA nomenclature, written typing and crossmatch criteria, monthly recipient sera, transplant testing protocols and a day-of-transplant recipient specimen

What does 1276-1278 require?

A clinical cytogenetics laboratory must have policies and procedures ensuring accurate specimen identification through accessioning, cell preparation, photography or other imaging, printing, reporting and storage of results, karyotypes and photographs; records of the media used, reactions observed, cells counted and karyotyped, chromosomes counted per metaphase and banding quality, of resolution appropriate to the specimen and study, and of an adequate number of karyotypes per patient; determination of sex by full chromosome analysis; and reports that summarise and interpret the observations, state cells counted and analysed and use the International System for Human Cytogenetic Nomenclature. A histocompatibility laboratory must continuously monitor and alarm the storage temperature of donor and recipient specimens and reagents, keep written storage and retention policies with easily retrievable specimens and an emergency alternate storage plan, quality control any immunologic reagents used to isolate lymphocytes, and participate in a national or regional cell exchange or an exchange with another laboratory; use WHO HLA nomenclature and written criteria for when antigen and allele typing are required; make a reasonable effort to hold monthly serum specimens from all potential transplant recipients for antibody screening, identification and crossmatch; for each crossmatch type follow written procedures and criteria covering the antigens, alleles and antibodies tested, recipient alloantibody assessment on an ongoing basis, donor typing for identified antibodies, pre- and post-transplant confirmation testing, release of results to the transplant team, reliance only on CLIA-certified test reports and time limits between recipient testing and crossmatch, with the crossmatch type stated on the report; and for infusion and transplantation keep written testing protocols by transplant type, donor type and recipient risk, the type and frequency of testing supporting clinical protocols, and a process to obtain a recipient specimen collected on the day of transplant before transplantation or to document the efforts to obtain it. All control procedures must be documented.