Comments – Draft 2017 Interoperability Standards Advisory
Oct 24, 2016
Submitted by:
Rachel Richesson
Associate Professor, Duke University School of Nursing
Co-Investigator, Coordinating Center for the NIH Health Care Systems Research Collaboratory (https://www.nihcollaboratory.org/Pages/default.aspx )
Nursing Informatics Researcher
These comments represent the individual views of the author. These comments do not necessarily represent the views of the NIH Health Care Systems Research Collaboratory, the NIH, Duke University, or other organizations and governmental entities collaborating in the development of the NIH Collaboratory and associated studies.
Introduction
I appreciate the opportunity to provide feedback, which I believe reflects the perspective of nursing researchers who are “secondary users” of clinical data and “pragmatic clinical trials.”
Pragmatic clinical trials (PCTs) are research investigations embedded in healthcare settings, with the goal of increasing the efficiency of research and relevance to clinical practice. One fundamental principle for successful pragmatic trials is that the trial should be minimally disruptive of existing workflows. This means that any new data necessary to collect for a given project should be parsimonious and carefully considered. For that reason, we appreciate ONC’s endorsement of standards for data collected in EHR systems as these standards can enable multi-site research. Data encoding standards that represent research needs can enable the routine conduct of PCTs, and support a national infrastructure to support evidence generating medicine that is a defining feature of Learning Health Systems.
There are some very noticeable gaps in the Draft 2017 ISA that I want to address:
Section I-D Interoperability Need: Representing Patient Functional Status and/or Disability. The Draft ISA does mention that this is a gap and is requesting community input. We’d like to reiterate the importance of this area. Standardized representation of patient functional status and disability are critical to research evaluating treatments and interventions of all types and across diseases. We encourage ONC to support work in defining standards for these areas.
A recommendation for Nursing Encounter diagnosis is not included in the current draft 2017 ISA and we feel that this is an important gap. This will be critical for research involving nurses and nurse practitioners. SNOMED CT is the reference standard that should be used for this.
Further, in response to Interoperability Need: Representing Care Team Member (Health Care Provider), we believe that all nurses (including but not limited to billable providers) should have a National Provider Identifier (NPI) in the interest of supporting research around nursing.
Nursing. A major source of health care is from nursing activities, and as such nursing is an important intervention or variable (mediator) that should be assessed for in pragmatic trials and observational research studies using EHR data. Currently, nursing procedures are not addressed in the current standards advisory. (Note that medical and dental encounter procedures are listed in Section 1, subsection O under “Procedures”, but nursing procedures are not included. The “nursing interventions” section on the current draft ISA (https://www.healthit.gov/standards-advisory/draft-2017/I-L/representing-nursing-interventions) lists observations (in LOINC), but not nursing intervention or procedures.) Without these standards being present in the advisory, it is unlikely that standardized nursing data will be available in various research networks. While there are a number of specific nursing terminologies that capture nursing procedures or intervention, they have all been mapped to SNOMED CT and therefore SNOMED CT should be considered the reference standard for nursing procedures and interventions.
The nursing big data initiative has formed for the past several years to define and promote data representation standards for various nursing data. At present, there is a strategic plan for standardized nursing data in the U.S. (https://www.ncbi.nlm.nih.gov/pubmed/25670754 ) This plan supports the use of standardized coding systems for the transmission of nursing-sensitive data across organizations: specifically, LOINC and SNOMED CT for nursing assessments and observations, and SNOMED CT for nursing problems, diagnoses and procedures. While today most nursing data is captured in flowsheets and not standardized, the LOINC and ONC standards that are named in the “national action plan for sharable and comparable nursing data to support practice and translational research” and the ONC draft 2017 ISA both have the capacity to represent the nursing concepts needed to support nursing research and to evaluate impact of nursing care on patient outcomes.
Further, I recommend a value assessment and implementation roadmap for a complete and well-maintained patient-centered problem list, that includes both nursing and medical problems.
Another critical gap in the current draft 2017 ISA is for Patient Reported Outcomes. We propose that existing standards that are have been validated and measured would be useful. In particular, we propose the Patient Reported Outcomes Management Information System be recognized (PROMIS; http://www.healthmeasures.net/explore-measurement-systems/promis). PROMIS is designed for both clinical care and research and has a strong theoretical foundation based upon on Item response theory. Further, because PROMIS is focused on functional domains rather than specific conditions, the items can potentially pertain to multiple diseases.
Interoperability Need: Documenting Patient Care Plans. In the current draft 2017 ISA, the mention of CDA to structure patient care plans does not address any semantic (i.e., coding system) standards. Specifically, we believe that the CDA should include nursing problems/diagnoses, assessments, interventions and outcomes, all using the coding systems specified in Section 1 and the National Action Plan for nursing.
Further, I advocate for a complete and well-maintained patient-centered problem list, that includes both nursing and medical problems. There are operational and regulatory challenges to achieving this, but I believe that the ONC can provide leadership toward this vision.
Conclusion
Achieving the full potential of PCTs and a learning health system will require the standardized representation of nursing data. These are necessary to support multi-site research and research of evidence-based treatments in different populations. The current draft 2017 ISA includes many recommendations that will facilitate research. However, some gaps and under specifications need to be addressed to support the evaluation and improvement of nursing practice on patient outcomes and population health. I appreciate the opportunity to comment.