ACLA ISA comment re: clarifications to laboratory test performed

Please clarify that “laboratory test performed” refers to the result(s) reported by the laboratory.

Please clarify the 1st bullet; are you trying to state that additional information, such as the IVD equipment (Abbott, etc.), the way the test is resulted, etc. is the level of granularity necessary? We suggest this bullet should be removed.

Please clarify the term “harmonization status”?  We suggest this term be removed until it can be further clarified for expected implementation, clearly measured, etc.  It is too nebulous as currently stated.  For example, can it be measured and if so, how is it validated and how does it relate to the laboratory test performed or provider’s EHR system laboratory test performed.