Synopsis:
The 10th edition of Standards for Immunohematology Reference Laboratories relies on a matrix of quality management system and detailed operational requirements, such as those defining minimum antisera resources. Significant changes in the 10th edition include: A new standard, 1.3.1, has been added allowing for there to be exceptions to existing policies, processes, and procedures on a case-by-case basis with the approval of the laboratory director. A new standard, 2.3, requires that all laboratories have a written plan for the implementation of allele determinations for RHCE variants. Standard 4.1.2.2 is new and has been included to allow facilities located outside of the United States to use testing centers in their country that have been approved by their Competent Authority. A new standard, 5.1.5.2.1, requires that laboratories who receive oral requests for blood components are recorded and maintained.
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