ACLA ISA comment re: clarification to section title, ‘actors’, a

The title of this section is more limited than what is covered in this section; please clarify the actors this section applies to, e.g., Electronic Health Record (EHR) systems, Laboratory Information Systems (LIS), laboratories, exchanges, etc.  Refer to the IHE LAW and LTW profiles “Intended Audience”; is the target audience the same for this section? Some of these statements should be in the “Content/Structure” section of the ISA, not the “Vocabulary/Code Set/Terminology” section; there is overlap with the “Exchanging InVitro Diagnostics (IVD) Test Orders & Results” Content /Structure section of the ISA. 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 values/results or provider’s EHR system laboratory values/results? Do these terms, such as “standard scales” or “grading schemes” represent the end result of using of standard terminology such as LOINC or SNOMED CT? Please clarify.    

Preserving Clinical Context

General Comments: USCDI specifies lots of clinical data classes and data elements
  • Resolving to myriad de-coupled fragments
  • With vanishingly little focus on:
    • Clinical context and vital inter-relationships, e.g., between problems, diagnoses, complaints, symptoms, encounters, history and physical findings, allergies, medications, vaccinations, assessments, goals/objectives, clinical decisions, orders, results, diagnostic procedures, interventions, observations, treatments/therapies, referrals, consults, protocols, care plans and status...
    • Elements and context + purpose of capture:  e.g., blood pressure, its measurement (systolic, diastolic), its unit of measure (mm/Hg), its reason for capture, its context of capture (sampling site, sampling method, patient position, at rest/during/post exercise...
It is crucial to consider, determine and resolve how clinical content and context are bound together and preserved in USCDI.  The ultimate end user (often a clinician) must be able to readily discern context and inter-relationships – otherwise USCDI places an undue (and often unresolvable) burden on this user.  Only the source EHR/HIT system can structure clinical content and context properly.  Once data is stuffed into the USCDI framework and related exchange artifact (e.g., FHIR resources) this opportunity is forever lost.