The observation/test result is interpreted as being outside the inclusion range for a particular protocol within which the result is being reported.

Example: A positive result on a Hepatitis screening test.

Open Issue: EX, HX, LX: These three concepts do not seem to meet a clear need in the vocabulary, and their use in observation interpretation appears likely to be covered by other existing concepts (e.g., A, H, L). The only apparent significant difference is their reference to use in protocols for exclusion of study subjects. These concepts/codes were proposed by RCRIM for use in the CTLaboratory message. They were submitted and approved in the November 2005 Harmonization cycle in proposal "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". However, this proposal was not fully implemented in the vocabulary. The proposal recommended creation of the x_ClinicalResearchExclusion domain in ObservationInterpretation with a value set including those three concepts/codes, but there is no subdomain of that name or equivalent with a binding to either of the value sets that contain these concepts/codes. Members of the OO WG have recently attempted to contact members of RCRIM regarding these concepts, both by email and at the recent WGM in Atlanta, without response. It is felt by OO that the best course of action to take at this time is to add this comprehensive Open Issue rather than deprecate these three concepts at this time, until further discussion is held.

The observation/test result is interpreted as being outside the inclusion range for a particular protocol within which the result is being reported.

Example: A positive result on a Hepatitis screening test.

Open Issue: EX, HX, LX: These three concepts do not seem to meet a clear need in the vocabulary, and their use in observation interpretation appears likely to be covered by other existing concepts (e.g., A, H, L). The only apparent significant difference is their reference to use in protocols for exclusion of study subjects. These concepts/codes were proposed by RCRIM for use in the CTLaboratory message. They were submitted and approved in the November 2005 Harmonization cycle in proposal "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". However, this proposal was not fully implemented in the vocabulary. The proposal recommended creation of the x_ClinicalResearchExclusion domain in ObservationInterpretation with a value set including those three concepts/codes, but there is no subdomain of that name or equivalent with a binding to either of the value sets that contain these concepts/codes. Members of the OO WG have recently attempted to contact members of RCRIM regarding these concepts, both by email and at the recent WGM in Atlanta, without response. It is felt by OO that the best course of action to take at this time is to add this comprehensive Open Issue rather than deprecate these three concepts at this time, until further discussion is held.

The numeric observation/test result is interpreted as being below the low threshold value for a particular protocol within which the result is being reported.

Example: A Total White Blood Cell Count falling below a protocol-defined threshold value of 3000/mm^3

Open Issue: EX, HX, LX: These three concepts do not seem to meet a clear need in the vocabulary, and their use in observation interpretation appears likely to be covered by other existing concepts (e.g., A, H, L). The only apparent significant difference is their reference to use in protocols for exclusion of study subjects. These concepts/codes were proposed by RCRIM for use in the CTLaboratory message. They were submitted and approved in the November 2005 Harmonization cycle in proposal "030103C_VOCAB_RCRIM_l_quade_RCRIM Obs Interp_20051028154455". However, this proposal was not fully implemented in the vocabulary. The proposal recommended creation of the x_ClinicalResearchExclusion domain in ObservationInterpretation with a value set including those three concepts/codes, but there is no subdomain of that name or equivalent with a binding to either of the value sets that contain these concepts/codes. Members of the OO WG have recently attempted to contact members of RCRIM regarding these concepts, both by email and at the recent WGM in Atlanta, without response. It is felt by OO that the best course of action to take at this time is to add this comprehensive Open Issue rather than deprecate these three concepts at this time, until further discussion is held.