Jim Case

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Jim Case

No conflicts noted

Paul Amos

Jeremy Rogers

James R. Campbell

Inactivation of Ambiguous Concepts - examples and updated proposal

Document attached to the agenda Meeting Files above.

Requirement to ensure adequate advice and guidance to vendors and users - JRC 

Discussion:

Decision:

• EAG members to review document related to AMBIGUOUS issues 
• Paul Amosto present summary document at the EAG meeting 20210630

Inquiries from Germany outlined inconsistencies in terming in the Specimen hierarchy.  A background document with proposed changes is available for review and comment by the EAG prior to broader circulation: 

Specimen term change proposal

Discussion:

Group generally felt that historically and clinically, specimen and sample were used interchangeably.  There was unanimous agreement on the changing of FSNs and PTs to use the term "specimen". James R. Campbellobjected to the universal addition of "sample" descriptions to terms that already had "Specimen" in their FSNs

Update 6/14/2021:

From UNMC via Jim Campbell: "I asked Scott to poll our anatomic pathologists (and also lab pathologists) whether Specimen and Sample can be considered synonyms. The answer was clearly NO. Anatomic pathology is arguably the clearest example where the surgical Tissue Specimen is examined visually by the pathologist who then dissects the tissue into component Samples representing important aspects of the case Specimen. The samples are processed in Blocks for histologic examination and results are reported with reference to the Sample Block. In this way examination of Margins, lymphatic invasion, regional invasion and spread of the malignancy can be assessed and reported. "

Note: Additional clarification on the James R. Campbell proposed solution was sought. 

From the LIVD Community via John Snyder: "I brought this up to the LIVD team for discussion as it includes members from LOINC, APHL, Abbott laboratories, and FDA. In general, everyone agreed that the two terms are used synonymously across the implementation level and are in favor of the work listed under Next Steps section being completed. While they did recognize that there were some edge cases where differentiation between the two may be useful, at this time the group did not think the edge cases were significant enough to out-weigh the general benefit."

Comments from James R. Campbell 6/22/2021

"In response to your previous message, we are attempting to affirm that “sample” and “specimen” are NOT always equivalent. A “Sample” is “a small part or quantity intended to show what the whole is like”. A “Specimen” is “an entity or independent continuant obtained by some procedure for scientific study”. As we have agreed, the procedure is an important feature defining the Specimen concept and it SOMETIMES includes sampling in accruing the specimen, but that is not always true as Scott and I have attempted to demonstrate with our anatomic pathology exemplars.

The oncologic surgeon may remove an entire breast mass, being careful to preserve good tissue margins, and provides the excisional breast mass specimen to pathology specimen receiving for examination, preparation and sampling into tissue blocks. The blocks are further sampled and prepared as slides which are examined microscopically in order to make a useful set of observations about the excisional specimen, even though examining the individual samples prepared for study are steps in that process. These actions are to organized and executed to answer basic questions such as “Was the mass excised completely and cleanly?”

When asked the question: “What would you call this mass the surgeon excised?” The pathologists responded as Specimen and rejected Sample which they thought did not apply."

6/30/2021

Questions remain as to the resolution of the existing content.  

• Do we need to have a separate "sample" hierarchy to meet the needs of the pathology community?
• What are the criteria for when specimen and sample are synonymous? when they are not?

Decision: 

EAG consensus was that changes to FSNs may be made without inactivation and replacement of concepts.

• Jim Case to revise proposal as needed.

Based on international consensus pressure ulcer stages are now referred to as pressure injuries. A new model and terming is required

• Pressure injuries.pptx