Laboratories that analyze the function and/or the phenotype of white blood cells (lymphocytes/leukocytes) comprising the immune system are surveyed and permitted through the Clinical Laboratory Evaluation Program (CLEP). 

Permit Category Descriptions_[1] are provided. 

Laboratories are required to demonstrate compliance with:

• General Systems Standards - Effective August 2020_[2]
• Cellular Immunology and Cytokines - Effective August 2020_[3]

For method approval_[4] and validations, please return the completed Cellular Immunology Checklist_[5] to the address indicated on the form.