CLSI approved guideline I/LA33-A, Validation of Automated Systems for Immunohematological Testing Before Implementation

The Clinical and Laboratory Standards Institute (CLSI) has recently published a newly approved guideline entitled: I/LA33-A, Validation of Automated Systems for Immunohematological Testing Before Implementation. A PDF preview of the guideline is is available. The full publication is available for purchase in either PDF or hard copy format. Automated systems for immunohematological laboratory testing may bring potential advantages to a laboratory, such as improvements in turnaround time, standardized interpretation of reactions, and positive sample identification using bar-code technology. The guideline provides key elements of the validation process, including installation qualification, operational qualification, and performance qualification. According to a representative of the CLSI, the guideline was developed by a team of highly experienced blood bankers who worked together to build consensus and ensure that most useful and practical recommendations are provided when validating automated devices prior to laboratory implementation. All current device manufacturers are reportedly represented in the I/LA33 subcommittee making the document technically accurate and applicable to all available automated immunohematological devices. In addition, the subcommittee consisted of the device-users and medical directors in-charge of validation and daily operation of their own facility, making I/LA33-A a training tool. According to Dr. Katharine Appleton Downes, the chairholder who led the document development (attribution used with permission), "I/LA33-A is beneficial to the laboratory because it is comprehensive in design and was developed based on input from a variety of stakeholders. The appendix is especially practical because it contains templates for the laboratory to apply to meet its needs for data gathering, statistical calculations, and testing of materials." Comments regarding this guideline are encouraged.

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