Clinical and Laboratory Standards Institute (CLSI) standard PRE01—Patient and Laboratory Specimen Identification Processes covers procedures for patient and specimen ID, collection, transport, and handling that are applicable to most medical laboratory specimens. It discusses the critical need for accuracy in examination ordering, patient registration, patient and specimen ID, and specimen labeling and handling throughout the preexamination, examination, and postexamination phases. This standard is intended for providers and health care professionals who collect, label, and process biological specimens for laboratory testing and who train specimen-collection personnel to do so. CLSI PRE01 is also meant to serve as a resource for individuals who manage ID and labeling processes and develop, validate, and verify electronic patient ID systems, procedures, and practices. This standard seeks to harmonize patient and specimen ID processes throughout the health care industry wherever blood and nonblood specimens are collected and identified. This standard does not include information related to the collection of individual specimen types and takes precedence over all CLSI documents when patient and specimen ID are discussed, except in cases of specimen-specific requirements.

This standard replaces CLSI GP33-Ed2, published in 2019. Several changes were made in this edition, including: 
• Combining common information on patient and specimen identification to eliminate redundancy and/or potentially contradictory information across CLSI documents 
– NOTE: Detailed information for specific measurands and/or specimen types is retained in applicable CLSI documents. 
• Updating patient identification process to include obtaining patient consent 
• Adding information for general handling and transport to the laboratory or testing facility, including: 
– Packaging specimens for transport within a facility or campus 
– Packaging specimens for public transport 
– Monitoring specimens during external transport 
– Transporting specimens internationally (see Appendix B for a list of national and international agencies that regulate transport of dangerous goods) 
• Adding new table providing approaches for greeting the patient 
• Adding chapter on QSEs described in CLSI QMS01, including information on personnel management, equipment management, process management, information management, NCE management, assessments, and continual improvement 
• Updating Appendixes A and C on placement of labels on tubes and identification of irreplaceable specimens, respectively

CLSI PRE01 discusses the critical need for accuracy in examination ordering, patient registration, patient and specimen ID, and specimen labeling throughout the preexamination, examination, and postexamination phases. This standard is intended for providers and health care professionals (HCPs) who collect, label, and process biological specimens for laboratory testing and who train specimen-collection personnel to do so. It is also meant to serve as a resource for those who develop and validate electronic patient ID systems, procedures, and practices, and manage ID and labeling processes.

This standard harmonizes patient and specimen ID processes throughout the health care industry wherever blood and nonblood specimens are collected and identified. It serves as the primary source over other CLSI documents, except when there are specific requirements outlined in those documents. CLSI PRE01 does not include information related to the collection of individual specimen types.