TABLE 6.

Checklist of relevant elements of interpretation

Element(s) of interpretation
Qualitative statement
Quantitative statement
Semiquantitative statement
Database (with an understanding of its relevance and representativeness and the quality of data in the database. The issue of rarity is an essential part of any possible source attribution statement of the interpretation process. Inferences of rarity are based on the sample population analyzed and assumptions of relevance and representativeness are basic to the degree of certainty. Therefore, the reference population data used should be defined. Documentation of the construct of an appropriate reference database must be maintained.)
Endemicity or background data (environmental and/or laboratory normal values and reference ranges, etc.)
Criteria for deciding whether a result requires follow-up or further analysis (includes temporal/spatial analysis and effect of passage, etc.)
Determination of alternate (reasonable) explanations
Limits of interpretation based on extant science and context
Statistical approaches used to reach conclusions, such as match, presence or absence, similarity, most recent common ancestor, and identity, etc.
Interpretation thresholds
Software reliability (should include the inherent assumptions underlying the computations that the software performs and the justifications of the assumptions; appropriate citations of prior studies regarding these elements should be made)