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This file is created on 2020-10-26 06:04:29am

About the ISA


ISA Structure


Interoperability for COVID-19 Novel Coronavirus Pandemic


Comment


Vocabulary/Code Set/Terminology

Allergies and Intolerances

Representing Patient Allergic Reactions


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Allergic Reactions. The Allergy and Clinical Immunology CPT codes (95004 – 95199) identify patient assessment and intervention for allergy testing, ingestion challenge testing, and allergen immunotherapy. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Representing Patient Allergies and Intolerances; Environmental Substances


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Allergies and Intolerances; Environmental Substances. The Allergy and Clinical Immunology CPT codes (95004 – 95199) identify patient assessment and intervention for allergy testing and allergen immunotherapy, including environmental substances. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Representing Patient Allergies and Intolerances; Food Substances


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Allergies and Intolerances; Food Substances. The Allergy and Clinical Immunology CPT codes (95004 – 95199) identify patient assessment and intervention for allergy testing, ingestion challenge testing, and allergen immunotherapy, including food substances. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Representing Patient Allergies and Intolerances; Medications


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Allergies and Intolerances; Medications. The Allergy and Clinical Immunology CPT codes (95004 – 95199) identify patient assessment and intervention for allergy testing, ingestion challenge testing, and allergen immunotherapy, including medications. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Clinical Notes

Representing Clinical Notes


Comment

Clinical Content and Context - See Attached Document

See attached document
USCDI-ONDEC-Submission-Context-GLD-20201023.docx

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Cognitive Status

Representing Patient Cognitive Status


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Cognitive Status. The CPT code set contains Evaluation and Management code 99483, which identifies a comprehensive cognitive assessment of the patient, including, but not limited to:
  • Cognition-focused evaluation,
  • Functional assessment, including decision-making capacity,
  • Use of standardized instruments for staging of dementia,
  • Evaluation of safety,
  • Identification of caregivers, and
  • Creation of a written care plan.
CPT codes 96105-96146 identify neuro-cognitive assessments and tests, including cognitive performance testing, interactive feedback, neurobehavioral status examination, and neuropsychological testing evaluation services. Cognitive skills are also identified in the Occupational Therapy Evaluations codes, 97165 – 97167, and Therapeutic Procedures, 97129. In addition, CPT Category II codes 3720F and 3755F identify assessment and screening for cognitive impairment or dysfunction within the treatment of other clinical conditions. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Demographics

Representing Patient Contact Information for Telecommunications


Comment

Representing Nutrition Assessment, Diagnosis, Interventions and Monitoring/Evaluation


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Nutrition Assessment, Diagnosis, Interventions and Monitoring/Evaluation. CPT codes 97802 – 97804 identify patient assessment and intervention of medical nutrition therapy. In addition, CPT Category II codes 3759F and 3760F identify assessment and screening for nutrition within the treatment of another clinical condition. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Emergency Medical Services

Representing Health Care Data for Emergency Medical Services


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Health Care Data for Emergency Medical Services. CPT codes 99281 – 99285 identify patient evaluation, examination, and medical decision making for emergency department services. CPT code 99288 identifies the direction of emergency care to emergency medical services personnel by a physician or other qualified health care professional. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Encounter Diagnosis, Assessment and Plan

Representing Assessment and Plan of Treatment


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Assessment and Plan of Treatment. The CPT Evaluation and Management codes specifically address multiple categories and subcategories for the broad range and levels of assessing and planning treatment for the patient. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Representing Patient Dental Encounter Diagnosis


Comment

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Representing Patient Medical Encounter Diagnosis


Comment

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, allergies, medications, vaccinations, assessments, 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 and determine/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.

Family Health History

Representing Patient Family Health History


Comment

Wrong code system referenced for Problem Type

2.16.840.1.113883.3.88.12.3221.7.2 - this code system is not LOINC as referenced above...it is SNOMED.

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Family Health History. The CPT Evaluation and Management codes specifically address capturing the patient’s family health history. The E/M codes specifically provide information about:
  • The health status or cause of death of parents, siblings, and children;
  • Specific diseases related to problems identified in the chief complaint or history of the present illness, and/or system review
  • Diseases of family members that may be hereditary or place the patient at risk
Also, CPT code 96040 identifies medical genetics and genetic counseling services. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, 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 and determine/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.

Functional Status/Disability

Representing Patient Functional Status and/or Disability


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Functional Status and/or Disability. CPT codes 99455 and 99456 identify the completion of medical history, examination, diagnosis, development of a treatment plan, and completion of necessary documents for a patient with a work related or medical disability.  Functional status and disability are also identified in the Physical Therapy Evaluations codes, 97161 – 97164, and Occupational Therapy Evaluations codes, 97165 – 97167, which include patient history, examination, clinical decision making, and development of a treatment plan. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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, 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 and determine/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.

Goals

Representing Patient Goals


Comment

The AMA requests that the…

The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Goals. CPT Category II codes for Health and Well-Being Coaching (0591T – 0593T) identify services for goal setting, education, and monitoring related to those goals.   CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

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 and determine/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.

Health Care Providers, Family Members, and Other Caregivers

Representing Health Care Providers


Comment

NUCC letter re: Health Care Provider Taxonomy code set

See attached letter.
NUCC Taxonomy Code Set in ISA_0.pdf

Representing Provider Role in Team Care Settings


Comment

NUCC letter re: Health Care Provider Taxonomy code set

See attached letter
NUCC Taxonomy Code Set in ISA.pdf

Representing Relationship Between Patient and Another Person


Comment

Imaging (Diagnostics, Interventions and Procedures)

Representing Imaging Diagnostics, Interventions and Procedures


Comment

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 and determine/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.

Immunizations

Representing Immunizations – Administered


Comment

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 and determine/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.

Representing Immunizations – Historical


Comment

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. 

    Industry and Occupation

    Representing Patient Industry and Occupation


    Comment

    Laboratory

    Representing Laboratory Tests


    Comment

    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.

      Representing Laboratory Values/Results


      Comment

      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.

      Medications

      Representing Patient Medications


      Comment

      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.

      Nursing

      Representing Clinical/Nursing Assessments


      Comment

      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, outcomes, 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.

      Representing Nursing Interventions


      Comment

      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, outcomes, 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.

      Representing Outcomes for Nursing


      Comment

      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, outcomes, 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.

      Representing Patient Problems for Nursing


      Comment

      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, outcomes, 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.

      Patient Clinical “Problems” (i.e., conditions)

      Representing Patient Clinical “Problems” (i.e., Conditions)


      Comment

      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, outcomes, 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.

      Preferred Language

      Representing Patient Preferred Language (Presently)


      Comment

      Adding Cantonese to preferred language set

      I serve a large population of Cantonese speaking Chinese patients in Northern California. The prior EHR version of Centricity allowed me to pick Cantonese as a preferred language so as to facilitate identification of those patients in verbal communications from the office. Now they have adopted the list from ONC, Cantonese is no longer an option. Please add Cantonese to the list. Thank you.

      Pregnancy Status

      Representing Patient Pregnancy Status


      Comment

      ACOG Comments RE: Proposed Representing Pregnancy Status

      For full formatted version, please see the attached word document.   Pregnancy Status Class Comment on the class: ACOG supports the comment already made supporting HL7s CCDA “Pregnancy Status” as it is comprehensive in this area and would better support both clinical research and public health use cases. https://www.hl7.org/implement/standards/product_brief.cfm?product_id=494   1. PREGNANCY STATUS 1A. Requirement Level: Must Have 1A. Value set: Yes, No, Unknown, currently pregnant or confirmed pregnant, not currently pregnant or pregnancy refuted, recently pregnant, possibly pregnant. 1A. Comments
      • Values have unnecessary overlap.  Clinically the importance is around confirmation of pregnancy.  ACOG recommends five values in this value set:  
      • Yes, confirmed pregnant;
      • No, confirmed not pregnant;
      • Unknown, possibly pregnant;
      • Recently pregnant within the last 12 months
      ACOG recommends that “recently pregnant” be defined as within the last 12 months to capture pregnancy related complications. Importantly, pregnancy-related deaths may occur well beyond the early postpartum period.  Per the CDC:  “A pregnancy-related death is defined as the death of a woman while pregnant or within 1 year of the end of a pregnancy –regardless of the outcome, duration or site of the pregnancy–from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes.”
      • ACOG supports a new data class called “Pregnancy Episode” of which pregnancy status would be a data element.  Pregnancy Episode would have data elements that include a start and end date, pregnancy status, postpartum period, and a lactation period if relevant. End date of pregnancy would be defined both by an actual known date and be defined by a calculation off EDD such that the Pregnancy Episode would automatically close at a specified period of time post the EDD.
      1A. Use Case: The Use Case for Pregnancy Episode is to ensure that a status of pregnancy is accurate and not reflective of a pregnancy that took place in the past.  It is also important to ensure that multiple pregnancies within a given time period are accurately reflected. This is important for clinical care as well as for both research and public health use cases. 1A. ACOG Related MaterialsCO736 | Optimizing Postpartum Care (05/2018)   1B. Requirement Level: Nice to Have 1B. Value set: Patient reported, pregnancy test, urine-based pregnancy test, serum-based pregnancy test, ultrasound, clinical impression, history of hysterectomy other. 1B. Comments: ACOG questions the need for these ‘nice to have’ values under pregnancy status as they are duplicative of values that exist elsewhere. Pregnancy tests and ultrasound are already covered in the Laboratory and Procedures Class and thus do not have a need to be restated here. History of hysterectomy more appropriately belongs with a designation of medically unable to conceive. Patient reported is a general health concern.  Clinical impression is covered by yes, confirmed pregnant.       2. DATE PREGNANCY STATUS Requirement Level: Must Have Value Set: Date No ACOG comments.       3. ESTIMATED DELIVERY DATE (EDD) Requirement Level: Must Have if pregnant, preferred Value Set: Date Comments
      • The correct clinical terminology is Estimated Due Date, not Estimated Delivery Date
      • EDD and GA are calculations of one another and thus appropriately belong together as in that if you have one, you have the other.  As such they need to be treated the same by USCDI in terms of “must have”/”nice to have”, the difference being that they have two different value sets.  EDD is a “Must Have” as an alternative to GA; GA is a “Must Have” as an alternative to EDD. 
      ACOG Related Materials (ReVITALize): Obstetrics Data Definitions: Estimated Due Date (EDD): The best EDD is determined by last menstrual period if confirmed by early ultrasound or no ultrasound performed, early ultrasound if no known last menstrual period or the ultrasound is not consistent with last menstrual period, or known date of fertilization (e.g., assisted reproductive technology).       4. EDD DETERMINATION METHOD Requirement Level: Nice to have if EDD used Value Set: LMP, ultrasound first trimester, ultrasound second trimester, ultrasound third trimester, ultrasound, Ovulation date, Embryo transfer, Other. Comments
      • The determination method is a “Must Have” for both EDD and GA.  The method reflects on the accuracy of the resulting date and is critical information to capture.  Being able to assess the reliability of the EDD/GA directly impacts clinical management of a pregnant individual; being unable to assess reliability represents a patient safety issue for both the mother and fetus.
      Value set comments:
      • ACOG recommends the following value set for EDD determination method:
        • LMP
        • Earliest ultrasound date and gestation age in weeks/days
        • First trimester ultrasound
        • Second trimester ultrasound
        • Third trimester ultrasound
        • Ultrasound, unknown trimester
        • Ovulation date
        • Embryo transfer date
        • Intrauterine insemination date
        • Other
      ACOG Related Materials
      • ACOG Committee Opinion #700 Methods for Estimating the Due Date (05/2017)
      • ACOG Committee Opinion #688 Management of Sub-optimally Dated Pregnancies (03/2017)
      • ACOG Committee Opinion #671 Perinatal Risks Associated with Assisted Reproductive Technology (09/2016)
            5. GESTATIONAL AGE Requirement Level: Must Have if Pregnant alternative to EDD Value Set: Number with units = weeks or days Comments: Should be weeks AND days, not weeks OR days ACOG Related Materials (ReVITALize): Obstetrics Data Definitions:  Gestational age  (written with both weeks and days; e.g., 39 weeks and 0 days) is calculated using the best obstetrical EDD based on the following formula: gestational age = (280 - (EDD - Reference Date))/ 7         6. DATE GESTATIONAL AGE DETERMINED Requirement Level: Must have if GA is used Value Set: Date No ACOG comments.       7. GESTATIONAL AGE DETERMINATION METHOD Requirement Level: Must have if GA is used Value Set: Ultrasound, EDD, ovulation date, OTHERS? Comments: Dates should be supplied with the determination method as done with EDD determination method.  The same value set may be used as EDD determination method:  Embryo transfer, Ovulation date, ultrasound, ultrasound third trimester, ultrasound second trimester, ultrasound first trimester, LMP, Other, with the same comment above with dates added (embryo transfer date, ultrasound dates).  Intrauterine Insemination needs to be added to the value set.       8. PREGNANCY OUTCOME Requirement Level: Nice to have if postpartum status is yes Value Set: Molar pregnancy, elective termination, spontaneous termination <20 weeks gestation, still birth, ectopic/tubal, live birth, unknown, other, not a live birth Comments
      • This should be a “Must Have” as pregnancy outcome impacts care both in the short term and management of future pregnancies
      • ACOG proposes the current proposed value set be replaced with: Live birth, Gestational Trophoblastic Disease, elective termination, early pregnancy loss (<13 weeks), early second trimester loss[1] (loss <20 weeks), stillbirth/fetal death (20 weeks or greater), ectopic/tubal, term birth, preterm birth, unknown, other. Justification:
        • Molar pregnancy should be replaced with Gestational Trophoblastic Disease as the more correct clinical terminology.
        • “Not a live birth” should be removed as other values cover this value.
        • In the first trimester, the terms miscarriage, spontaneous abortion, and early pregnancy loss are used interchangeably; ACOG prefers the term ‘early pregnancy loss’ to reflect these events, and recommends it be added to the value set.  “Spontaneous termination < 20 weeks gestation” should be removed.
        • Fetal death is widely used and thus ACOG recommends that the value be stillbirth/fetal death to reflect this.
        • The value set should add premature delivery and term birth as both are important to clinical care, research and public health use cases.
      • The Pregnancy Outcome must have the outcome date associated with it as metadata.  A stand-alone Outcome Date risks not associating the correct pregnancy episode with that outcome.  As such they must be linked together.
      ACOG Related Materials
      • ACOG Practice Bulletin #200 | Early Pregnancy Loss (08/2018): Early pregnancy loss is defined as a nonviable, intrauterine pregnancy with either an empty gestational sac or a gestational sac containing an embryo or fetus without fetal heart activity within the first 12 6/7 weeks of gestation.
      • ACOG Obstetric Care Consensus #10 | Management of Stillbirth (03/2020): The U.S. National Center for Health Statistics defines fetal death as the delivery of a fetus showing no signs of life as indicated by the absence of breathing, heartbeats, pulsation of the umbilical cord, or definite movements of voluntary muscles. There is not complete uniformity among states with regard to birth weight and gestational age criteria for reporting fetal deaths. However, the suggested requirement is to report fetal deaths at 20 weeks or greater of gestation (if the gestational age is known), or a weight greater than or equal to 350 grams if the gestational age is not known. The cutoff of 350 grams is the 50th percentile for weight at 20 weeks of gestation. To promote the comparability of national data by year and state, U.S. vital statistics data are collected for fetal deaths with a stated or presumed period of gestation of 20 weeks or more. Terminations of pregnancy for life-limiting fetal anomalies and inductions of labor for previable premature rupture of membranes are specifically excluded from the stillbirth statistics and are classified as terminations of pregnancy
      • ACOG Practice Bulletin #143 | Medical Management of First-Trimester Abortion (03/2014)
      • ReVITALize: Gynecology Data Definitions  
      [1] The term ‘early’ second trimester loss is being used to reflect the time period of 13 weeks to 19 6/7 weeks during the second trimester.  Prior to 13 weeks ‘early loss’ should be used and after 20 weeks ‘stillbirth/fetal death’ applies.       9. PREGNANCY OUTCOME DATE Requirement Level: Must have if postpartum status is yes Value Set: Date Comments
      • The Pregnancy Outcome Date must have the Pregnancy Outcome linked to it. A standalone Outcome Date risks not associating the correct pregnancy episode with that outcome.  As such they must be linked together.
      • Pregnancy Outcome Date must also include the level of certainty in the date {certain, estimated, unknown} as some outcomes, particularly with ectopic and early pregnancy loss, may not have a known outcome date.  
      •  The requirement level is a “Must Have” when there is any “Pregnancy Outcome”, not just postpartum status of yes.  Not all pregnancies result in a postpartum state, such as an ectopic pregnancy.
            10. ANT PREGNANCY OUTCOME WITHIN THE LAST 42 DAYS? Requirement Level: Must have if not pregnant Value Set: Yes, no, unknown Comments
      • ACOG proposes that the data element of “Any pregnancy outcome within the last 42 days?” be replaced with the data element of “Not Pregnant”, with an expanded value set .  The data element of “Any pregnancy outcome within the last 42 days?” is covered  by data element number 8: “Pregnancy Outcome”.  What is missing from the Pregnancy Status Class is a specific data element of “Not Pregnant”
      • Value set for “Not Pregnant”: LMP, method of contraception, pregnancy intention, pregnancy prevention intention-reported, medically unable to conceive {hysterectomy, inability to conceive with current partner, bilateral oophorectomy, bilateral salpingectomy, genetically unable to conceive, menopause}.
      • ACOG recommends the Pregnancy Intention value set include the values specified by LOINC 86645-9:  Yes, I want to become pregnant; I'm OK either way; No, I don't want to become pregnant; Unsure                  
      • ACOG recommends the Pregnancy Prevention Intention -Reported value set include the values specified by LOINC 91144-6: I am already doing something to prevent pregnancy; I want to start preventing pregnancy; I don't want to prevent pregnancy;  I am unsure whether I want to prevent pregnancy;  I prefer not to answer; This question does not apply to me.
      Use Case: Support of clinical decision support (CDS) for medication prescribing; necessary data elements to support research which may require confirmation of protection against pregnancy. LOINC Details: Pregnancy prevention intention – Reported has existing LOINC codes.  LOINC Term Description: A patient’s current intentions to prevent pregnancy. This includes a male patient’s intentions to prevent pregnancy with a female partner. This term was created for, but not limited in use to, the Office of Population Affair’s (OPA’s) clinical performance measures for contraceptive provision endorsed by the National Quality Forum (NQF).     https://loinc.org/91144-6/ Pregnancy Intention is a component of the LOINC Pregnancy and Contraception Panel 86642-6 (FPAR) Family Planning Annual Report.  LOINC Term Description: A patient's intention or desire in the next year to either become pregnant or prevent a future pregnancy. This includes male patients seeking pregnancy with a female partner. Pregnancy intention may be used to help improve preconception health screenings and decisions, such as determining an appropriate contraceptive method, taking folic acid, or avoiding toxic exposures such as alcohol, tobacco and certain medications. This term was based on, but is not limited in use to, Power to Decide's One Key Question®, used by the Office of Population Affair's (OPA's) Family Planning Annual Report (FPAR).  https://loinc.org/86645-9/       11. LMP (Last Menstrual Period) Requirement Level: Nice to have alternate to EDD/GA not dependent on pregnant Value Set: Date Comments
      • Last menstrual period (LMP) should be a “Must Have” and not a “Nice to Have” as a data element.  LMP remains important in determining EDD/GA along with the first accurate ultrasound or both.
      • Value set, in addition to date, should include certain, estimated, unknown, N/A.  N/A should have the ability to include the reason for no menses {pre-menarcheal, hormonal suppression, breastfeeding, hysterectomy, endometrial ablation}.
      ACOG Related Materials
      • ReVITALize: Obstetrics Data Definitions: Estimated Due Date (EDD): The best EDD is determined by last menstrual period if confirmed by early ultrasound or no ultrasound performed, early ultrasound if no known last menstrual period or the ultrasound is not consistent with last menstrual period, or known date of fertilization (e.g., assisted reproductive technology).
      • ACOG Committee Opinion #700 Methods for Estimating the Due Date (05/2017)
            12. MULTIPLICITY OF BIRTH/PREGNANCY Requirement Level: Nice to have Value Set: Numeric Comments
      • Multiplicity of birth/pregnancy should be a “Must Have” and not a “Nice to Have” data element.  Twins and higher order pregnancies have an increase in fetal morbidity and mortality, primarily due to prematurity.  Because of the increase in adverse outcomes with non-singleton pregnancies, it is important to capture this data for both clinical research and public health use cases.  
      ACOG Related Materials
      • Practice Bulletin #169 Multifetal Gestations: Twin, Triplet, and Higher-Order Multifetal Pregnancies (10/2016)
      20200921_USCDI ACOG.docx

      Procedures

      Representing Dental Procedures Performed


      Comment

      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, outcomes, 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.

      Representing Medical Procedures Performed


      Comment

      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, outcomes, 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.

      Provenance

      Representing Data Provenance


      Comment

      Provenance Elements - See Attached Documents

      See attached document.
      USCDI-ONDEC-Submission-Provenance-GLD-20201023.docx

      Race and Ethnicity

      Representing Patient Race and Ethnicity


      Comment

      Research

      Representing Data for Biomedical and Health Services Research Purposes


      Comment

      Sex at Birth, Sexual Orientation and Gender Identity

      Representing Patient Gender Identity


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Gender Identity. CPT code 55970 identifies an intersex surgery of male to female. CPT code 55980 identifies an intersex surgery of female to male. Evaluation and Management codes for a new patient (99381) and established patient (99391) include completing a gender appropriate history, exam, counseling and interventions. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Patient Sex (At Birth)


      Comment

      Representing Patient-Identified Sexual Orientation


      Comment

      Social, Psychological, and Behavioral Data

      Representing Alcohol Use


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Alcohol Use. CPT codes 99408 and 99409 identify patient screening and intervention for alcohol abuse. CPT codes 8032-80322 identify testing for alcohol. CPT code 82075 identifies an alcohol breath test. In addition, CPT Category II codes identify a patient screened for unhealthy alcohol use (3016F), patient counseled about risks of alcohol use (4158F), and patient counseled for pharmacologic treatment for alcohol dependence (4320F). CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Depression


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Depression. CPT code 96127 identifies patient screening through a behavioral assessment for depression.  CPT code 99483 includes an assessment for depression within the cognitive care plan.  CPT code 96127 includes an assessment for depression with this developmental/behavioral screening and testing. In addition, CPT Category II code 1040F, 2060F, and 3088F – 3093F identify evaluations of major depressive disorder. CPT Category II codes 1220F, 3351F – 3354F, 3725F identify a patient screened for depression within the treatment of other clinical conditions. CPT Category II codes 4060F – 4067F identify various services provided depression. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Drug Use


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Drug Use. CPT codes 99408 and 99409 identify patient screening and intervention for substance abuse. CPT codes 80320 – 80377 identify definitive drug testing. In addition, CPT Category II codes identify a patient screened for injection drug use (4290F) and counseled for pharmacologic treatment for opioid addiction (4306F). CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Exposure to Violence (Intimate Partner Violence)


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Exposure to Violence (Intimate Partner Violence). The CPT Evaluation and Maintenance services include assessing a patient’s risk and exposure to violence. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Financial Resource Strain


      Comment

      Representing Food Insecurity


      Comment

      Representing Housing Insecurity


      Comment

      Representing Level of Education


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Level of Education. The CPT Evaluation and Maintenance services include assessing a patient’s level of education. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Physical Activity


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Physical Activity. Physical activity is identified in the Physical Therapy Evaluations codes, 97161 – 97164, and Occupational Therapy Evaluations codes, 97165 – 97167. CPT codes 97169 – 97172 identify athletic training evaluations, which includes a physical activity profile. The CPT Evaluation and Maintenance services include assessing a patient’s level of physical activity. CPT codes 97750 and 97755 identify tests and measurements of physical performance. In addition, CPT Category II code 1003F identifies an assessment of patient level of activity. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Social Connection and Isolation


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Social Connection and Isolation. The CPT Evaluation and Maintenance services include assessing a patient’s social history. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Stress


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Stress. The CPT codes 90839 and 90840 are used to identify psychotherapy for a crisis. Also, the CPT Evaluation and Maintenance services include assessing a patient’s level of stress. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Transportation Insecurity


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Transportation Insecurity. The CPT Evaluation and Maintenance services include assessing a patient’s level of transportation insecurity. Care plan services also address transportation needs. CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Tobacco Use

      Representing Patient Electronic Cigarette Use (Vaping)


      Comment

      Representing Patient Second Hand Tobacco Smoke Exposure


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Second Hand Tobacco Smoke Exposure. CPT Category II code 1032F identifies a patient who is a current smoker or currently exposed to secondhand smoke.   CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Representing Patient Tobacco Use (Smoking Status)


      Comment

      The AMA requests that the…

      The AMA requests that the Current Procedural Terminology (CPT) code set be added to the standards listed in Section I: Representing Patient Tobacco Use (Smoking Status). CPT codes 99406 and 99407 identify the patient as a tobacco user and that cessation counseling was provided. In addition, CPT Category II codes identify assessment of tobacco use (1000F), current tobacco user with asthma (1032F), current tobacco user with heart disease (1034F), tobacco use cessation counseling (4000F), tobacco use cessation pharmacologic therapy (4001F), and patient screened as a tobacco user and received cessation intervention (4004F). CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, and diagnostic services and provides for reliable communication among users. It has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. It is the most widely adopted outpatient procedure code set. Use of the CPT code set is federally required under HIPAA.

      Units of Measure

      Representing Units of Measure (For Use with Numerical References and Values)


      Comment

      Vital Signs

      Representing Patient Vital Signs


      Comment

      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, outcomes, 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.

      Section II

      Admission, Discharge, and Transfer

      Sending a Notification of a Long Term Care Patient’s Admission, Discharge and/or Transfer Status to the Servicing Pharmacy


      Comment

      Sending a Notification of a Patient’s Admission, Discharge and/or Transfer Status to Other Providers


      Comment


      Content/Structure

      Care Coordination for Referrals

      Referral from Acute Care to a Skilled Nursing Facility


      Comment

      Referral to a Specialist - Request, Status Updates, Outcome


      Comment

      Referral to Extra-Clinical Services - Request, Updates, Outcome


      Comment

      Care Plan

      Documenting and Sharing Care Plans for a Single Clinical Context


      Comment

      Documenting and Sharing Medication-Related Care Plans by Pharmacists


      Comment

      Documenting Care Plans for Person Centered Services


      Comment

      Domain or Disease-Specific Care Plan Standards


      Comment

      Sharing Patient Care Plans for Multiple Clinical Contexts


      Comment

      Clinical Decision Support

      Communicate Appropriate Use Criteria with the Order and Charge to the Filling Provider and Billing System for Inclusion on Claims


      Comment

      Provide Access to Appropriate Use Criteria


      Comment

      Sharable Clinical Decision Support


      Comment

      Clinical Quality Measurement and Reporting

      Reporting Aggregate Quality Data for Quality Reporting Initiatives


      Comment

      Reporting Patient-level Quality Data for Quality Reporting Initiatives


      Comment

      Sharing Quality Measure Artifacts for Quality Reporting Initiatives


      Comment

      Data Provenance

      Establishing the Authenticity, Reliability, and Trustworthiness of Content Between Trading Partners


      Comment

      Diet and Nutrition

      Exchanging Diet and Nutrition Orders Across the Continuum of Care


      Comment

      Drug Formulary & Benefits

      Allows Pharmacy Benefit Payers to Communicate Formulary and Benefit Information to Prescriber Systems


      Comment

      Electronic Prescribing

      Allows a Long Term or Post-Acute Care to Request to Send an Additional Supply of Medication


      Comment

      Allows a Pharmacy to Notify a Prescriber of Prescription Fill Status


      Comment

      Allows a Pharmacy to Request a Change to a Prescription


      Comment

      Allows a Pharmacy to Request a New Prescription For a New Course of Therapy or to Continue Therapy


      Comment

      Allows a Pharmacy to Request Additional Refills


      Comment

      Allows a Pharmacy to Request, Respond to, or Confirm a Prescription Transfer


      Comment

      Allows a Prescriber or a Pharmacy to Request a Patient’s Medication History