C-CDA on FHIR Implementation Guide STU 1 (v1.0.0)

This page is part of the C-CDA on FHIR Implementation Guide (v1.0.0: STU 1) based on FHIR R3. The current version which supercedes this version is 1.1.0. For a full list of available versions, see the Directory of published versions

C-CDA on FHIR Implementation Guide (IG)

Summary

C-CDA is one of the most widely implemented implementation guides for CDA and covers a significant scope of clinical care. Its target of the 'common/essential' elements of healthcare is closely aligned with FHIR's focus on the '80%'. There is significant interest in industry and government in the ability to interoperate between CDA and FHIR and C-CDA is a logical starting point. Implementers and regulators have both expressed an interest in the ability to map between FHIR and C-CDA.

This Implementation Guide (IG) defines a series of FHIR profiles on the Composition resource to represent the various document types in C-CDA. This release does not directly map every C-CDA template to FHIR profiles, rather tries to accomplish the C-CDA use case using Composition resource profiles created under this project (the equivalent of Level 2 CDA documents), and begins by linking to the profiles created under the US Core project for any coded entries that would normally be included in C-CDA sections. To have a simpler, more streamlined standard that reuses existing work and focuses on the 80% that implementers actually need in production systems, the resources of US Core represents a portion of the 80% needed for coded entries for coded entries of CCD, Care Plan & Discharge Summary).

The Composition profiles in this IG do not require coded data in any section. This is a departure from C-CDA, which requires coded data for Problems, Results, Medications, etc. This departure is intentional, as the C-CDA requirement for one or more coded entries in these sections resulted in some very complicated workarounds using nullFlavors to handle the fact that sometimes a patient is not on any medications, or has no current problems. In general, FHIR takes the approach that if something is nullable, it should simply be optional to ease the burden on implementers, thus C-CDA on FHIR does not require any coded entries, but rather uses the "required if known" approach, meaning that if an implementer's system has data for a section that requires data under Meaningful Use, they need to send it, but if they have no data there is no need for a null entry.

We encourage feedback on these Composition profiles, and the general approach to the project as a whole. We also encourage implementers who wish to see more of the coded data from C-CDA mapped to FHIR to comment on the US Core project and make their requests known there. Once US Core creates new profiles, this project can reference them.

Authors

Author NameEmail
Rick Geimerrick.geimer@lantanagroup.com
Sarah Gauntsarah.gaunt@lantanagroup.com
Brett Marquardbrett@riverrockassociates.com
Corey Spearsspears.corey@gmail.com
Meenaxi Gosaimeenaxi.gosai@lantanagroup.com

Scope

To represent Consolidated CDA Templates for Clinical Notes (C-CDA) 2.1 templates using FHIR profiles.

This first stage of the project defines all the C-CDA document-level profiles on the Composition resource and contained sections.

Any coded data used by sections will be represented using relevant U.S. Core FHIR profiles where they exist. FHIR profiles defined by other work groups or unconstrained FHIR resources may also be referenced if no appropriate US Core Profile exist.

Implementation Notes

Implementers moving from C-CDA to FHIR need to be aware that the goal of this project is to address the same use case as Consolidated CDA (clinical documentation for primary and transfer of care scenarios in the US), but the syntax, methodologies, and value sets in FHIR are often quite different from those in C-CDA. In particular, implementers need to be aware of the issues listed below:

  • The value sets used in US Core and FHIR in general are not fully aligned with those in C-CDA.
  • The approaches for negation used in C-CDA and the Core FHIR specification are quite different.
  • The level of granularity between C-CDA templates and FHIR resources/profiles is often different, so there will not be a 1:1 mapping between templates and profiles. Some examples include:
    • Multiple templates like Health Concern and Problem Observation map to a single US Core Condition
    • C-CDA has 3 kids of procedure templates that all map to the single US Core Procedure profile
    • In C-CDA the use the moodCode attribute can differentiate between events and planned acts using a single template but in FHIR these are often separate resources (event vs. request resources)
    • In C-CDA multiple observations such as lab results are wrapped in an Organizer, whereas in FHIR the Observation resource itself can contain multiple Observations as subcomponents

Implementers need to follow the rules and apply the value sets used by the target specification, and this will often require significant data and vocabulary mapping. implementers moving from C-CDA to C-CDA on FHIR will need to review the US Core profiles and value sets in core FHIR resources and ensure that their instances FHIR instances are compliant. We hope that ongoing work in HL7 will better align US Core, C-CDA, and the Core FHIR specifications in the future.

We encourage implementers to refer to the ongoing C-CDA to FHIR mapping work that is described on the C-CDA on FHIR wiki page for assistance when moving from C-CDA to FHIR.

References

Name Definition
HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes The Consolidated CDA (C-CDA) implementation guide contains a library of CDA templates, incorporating and harmonizing previous efforts from Health Level Seven (HL7), Integrating the Healthcare Enterprise (IHE), and Health Information Technology Standards Panel (HITSP). It represents harmonization of the HL7 Health Story guides, HITSP C32, related components of IHE Patient Care Coordination (IHE PCC), and Continuity of Care (CCD). C-CDA Release 1 included all required CDA templates in Final Rules for Stage 1 Meaningful Use and 45 CFR Part 170 Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule.
U.S. Core FHIR Implementation Guide A U.S. Realm guide for making use of FHIR resources to support queries between systems within an enterprise and across enterprises

This guide defines the following profiles.

Profile Name Description
C-CDA on FHIR US Realm Header This profile defines constraints that represent common administrative and demographic concepts for US Realm clinical documents. Further specification, such as type, are provided in document profiles that conform to this profile.
C-CDA on FHIR Continuity of Care Document This profile was originally based on the Continuity of Care Document (CCD) Release 1.1 which itself was derived from HITSP C32 and CCD Release 1.0. The Continuity of Care Document (CCD) profile represents a core data set of the most relevant administrative, demographic, and clinical information facts about a patient's healthcare, covering one or more healthcare encounters. It provides a means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another to support the continuity of care. The primary use case for the CCD is to provide a snapshot in time containing the germane clinical, demographic, and administrative data for a specific patient. The key characteristic of a CCD is that the Composition.event.code is constrained to "PCPR". This means it does not function to report new services associated with performing care. It reports on care that has already been provided. The CCD provides a historical tally of the care over a range of time and is not a record of new services delivered. More specific use cases, such as a Discharge Summary, Transfer Summary, Referral Note, Consultation Note, or Progress Note, are available as alternative profiles.
C-CDA on FHIR Discharge Summary The Discharge Summary is a document which synopsizes a patient's admission to a hospital, LTPAC provider, or other setting. It provides information for the continuation of care following discharge. The Joint Commission requires the following information to be included in the Discharge Summary (http://www.jointcommission.org/): The reason for hospitalization (the admission) The procedures performed, as applicable The care, treatment, and services provided The patients condition and disposition at discharge Information provided to the patient and family Provisions for follow-up care The best practice for a Discharge Summary is to include the discharge disposition in the display of the header.
C-CDA on FHIR Consultation Note The Consultation Note is generated by a request from a clinician for an opinion or advice from another clinician. Consultations may involve face-to-face time with the patient or may fall under the auspices of telemedicine visits. Consultations may occur while the patient is inpatient or ambulatory. The Consultation Note should also be used to summarize an Emergency Room or Urgent Care encounter. A Consultation Note includes the reason for the referral, history of present illness, physical examination, and decision-making components (Assessment and Plan).
C-CDA on FHIR Referral Note A Referral Note communicates pertinent information from a provider who is requesting services of another provider of clinical or non-clinical services. The information in this document includes the reason for the referral and additional information that would augment decision making and care delivery. Examples of referral situations are: * When a patient is referred from a family physician to a cardiologist for cardiac evaluation. * When patient is sent by a cardiologist to an emergency department for angina. * When a patient is referred by a nurse practitioner to an audiologist for hearing screening. * When a patient is referred by a hospitalist to social services.
C-CDA on FHIR Care Plan

CARE PLAN FRAMEWORK A Care Plan (including Home Health Plan of Care (HHPoC)) is a consensus-driven dynamic plan that represents a patient and Care Team Members prioritized concerns, goals, and planned interventions. It serves as a blueprint shared by all Care Team Members (including the patient, their caregivers and providers), to guide the patients care. A Care Plan integrates multiple interventions proposed by multiple providers and disciplines for multiple conditions. A Care Plan represents one or more Plan(s) of Care and serves to reconcile and resolve conflicts between the various Plans of Care developed for a specific patient by different providers. While both a plan of care and a care plan include the patient's life goals and require Care Team Members (including patients) to prioritize goals and interventions, the reconciliation process becomes more complex as the number of plans of care increases. The Care Plan also serves to enable longitudinal coordination of care. The Care Plan represents an instance of this dynamic Care Plan at a point in time. The composition itself is NOT dynamic. Key differentiators between a Care Plan profile and CCD profile (another snapshot in time document):

  • Requires relationships between various concepts:
    • Health Concerns
    • Interventions
    • Goals
    • Outcomes
  • Provides the ability to identify patient and provider priorities with each act
  • Provides a header participant to indicate occurrences of Care Plan review
C-CDA on FHIR Procedure Note A Procedure Note encompasses many types of non-operative procedures including interventional cardiology, gastrointestinal endoscopy, osteopathic manipulation, and many other specialty fields. Procedure Notes are differentiated from Operative Notes because they do not involve incision or excision as the primary act. The Procedure Note is created immediately following a non-operative procedure. It records the indications for the procedure and, when applicable, postprocedure diagnosis, pertinent events of the procedure, and the patients tolerance for the procedure. It should be detailed enough to justify the procedure, describe the course of the procedure, and provide continuity of care.
C-CDA on FHIR History and Physical A History and Physical (H&P) note is a medical report that documents the current and past conditions of the patient. It contains essential information that helps determine an individual's health status. The first portion of the report is a current collection of organized information unique to an individual. This is typically supplied by the patient or the caregiver, concerning the current medical problem or the reason for the patient encounter. This information is followed by a description of any past or ongoing medical issues, including current medications and allergies. Information is also obtained about the patient's lifestyle, habits, and diseases among family members. The next portion of the report contains information obtained by physically examining the patient and gathering diagnostic information in the form of laboratory tests, imaging, or other diagnostic procedures. The report ends with the clinician's assessment of the patient's situation and the intended plan to address those issues. A History and Physical Examination is required upon hospital admission as well as before operative procedures. An initial evaluation in an ambulatory setting is often documented in the form of an H&P note.
C-CDA on FHIR Diagnostic Imaging A Diagnostic Imaging Report (DIR) is a document that contains a consulting specialist's interpretation of image data. It conveys the interpretation to the referring (ordering) physician and becomes part of the patient's medical record. It is for use in Radiology, Endoscopy, Cardiology, and other imaging specialties.
C-CDA on FHIR Operative Note The Operative Note is a frequently used type of procedure note with specific requirements set forth by regulatory agencies. The Operative Note is created immediately following a surgical or other high-risk procedure. It records the pre- and post-surgical diagnosis, pertinent events of the procedure, as well as the condition of the patient following the procedure. The report should be sufficiently detailed to support the diagnoses, justify the treatment, document the course of the procedure, and provide continuity of care.
C-CDA on FHIR Progress Note This profile represents a patient's clinical status during a hospitalization, outpatient visit, treatment with a LTPAC provider, or other healthcare encounter. Taber's medical dictionary defines a Progress Note as An ongoing record of a patient's illness and treatment. Physicians, nurses, consultants, and therapists record their notes concerning the progress or lack of progress made by the patient between the time of the previous note and the most recent note. Mosby's medical dictionary defines a Progress Note as Notes made by a nurse, physician, social worker, physical therapist, and other health care professionals that describe the patient's condition and the treatment given or planned. A Progress Note is not a re-evaluation note. A Progress Note is not intended to be a Progress Report for Medicare. Medicare B Section 1833(e) defines the requirements of a Medicare Progress Report.
C-CDA on FHIR Consent This profile represents information about the patients consent. The type of consent is conveyed in type. Consents in the header have been finalized and should be on file. This specification does not address how 'Privacy Consent' is represented, but does not preclude the inclusion of Privacy Consent. The authorization consent is used for referring to consents that are documented elsewhere in the EHR or medical record for a health condition and/or treatment that is described in the document.
C-CDA on FHIR Transfer Summary This profile describes constraints for a Transfer Summary. The Transfer Summary standardizes critical information for exchange of information between providers of care when a patient moves between health care settings. Standardization of information used in this form will promote interoperability; create information suitable for reuse in quality measurement, public health, research, and for reimbursement.

Value Sets

This guide defines the following value sets. Note: value sets defined in the base Composition resource or in US Core are not included in this list.

Name Definition
DischargeSummaryDocumentTypeCode http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.11.20.4.1
A value set of LOINC document codes for discharge summaries. Specific URL Pending
ConsultDocumentType http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.11.20.9.31
Specific URL Pending
ReferralDocumentType http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.1.11.20.2.3
A referral note provides a consulting physician specified patient information about the patient referred. Specific URL Pending
ProcedureNoteDocumentTypeCodes http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.11.20.6.1
A value set of LOINC document codes for Procedure Notes. Specific URL Pending
HPDocumentType http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.1.11.20.22
Specific URL Pending
LOINC Imaging Document Codes http://hl7.org/fhir/ccda/ValueSet/1.3.6.1.4.1.12009.10.2.5
A value set of LOINC document type codes for Diagnostic Imaging Reports.
DIRSectionTypeCodes http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.11.20.9.59
The Section Type codes used by DIR are all narrative document sections. The codes in this table are drawn from LOINC (http://www.loinc.org/) and DICOM (http://medical.nema.org/). The section/code should be selected from LOINC or DICOM for sections not listed in this table.
SurgicalOperationNoteDocumentTypeCode http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.11.20.1.1
Specific URL Pending
ProgressNoteDocumentTypeCode http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.11.20.8.1
Specific URL Pending
TransferDocumentType http://hl7.org/fhir/ccda/ValueSet/2.16.840.1.113883.1.11.20.2.4
A transfer document is exchanged between care providers when a patient transfers from one care setting to another. This value set includes all LOINC codes whose Component = Transfer Summary Note* and SCALE_TYPE = Doc.

US Core Value Sets

The value sets used in US Core are not fully aligned with those in C-CDA, though the differences are often minor. The C-CDA on FHIR project will not attempt to address such alignment issues. Rather, implementers moving from C-CDA to C-CDA on FHIR will need to review the US Core profiles and value sets and ensure that their instances FHIR instances are compliant. We hope that ongoing work in HL7 will better align US Core, C-CDA, and the Core FHIR specifications in the future.

Full details on US Core value sets can be found on the US Core Terminology page

Code Systems

See the FHIR terminology section for a complete discussion on code systems and a list of codes system names used in FHIR. The following additional names (URIs) have been identified for this implementation guide, If a URI is listed here, it SHALL be used in the US Core profiles in preference to any other code system name.

This guide references the following extensions.

Name Definition
C-CDA on FHIR Data Enterer http://hl7.org/fhir/ccda/StructureDefinition/CCDA-on-FHIR-Data-Enterer
C-CDA on FHIR Informant http://hl7.org/fhir/ccda/StructureDefinition/CCDA-on-FHIR-Informant
C-CDA on FHIR Information Recipient http://hl7.org/fhir/ccda/StructureDefinition/CCDA-on-FHIR-Information-Recipient
C-CDA on FHIR Participant http://hl7.org/fhir/ccda/StructureDefinition/CCDA-on-FHIR-Participant
C-CDA on FHIR In Fulfillment Of Order http://hl7.org/fhir/ccda/StructureDefinition/CCDA-on-FHIR-In-Fulfillment-Of-Order
C-CDA on FHIR Performer http://hl7.org/fhir/ccda/StructureDefinition/CCDA-on-FHIR-Performer
C-CDA on FHIR Authorization http://hl7.org/fhir/ccda/StructureDefinition/CCDA-on-FHIR-Authorization
CCDA-on-FHIR-VersionNumber http://hl7.org/fhir/ccda/StructureDefinition/CCDA-on-FHIR-VersionNumber

Section Descriptions

The section descriptions below are taken from Consolidated CDA R2.1, and are listed here for quick reference. In some cases minor modifications have been made where CDA specific concepts were mentioned that are not appropriate for FHIR.

Admission Diagnosis Section

This section contains a narrative description of the problems or diagnoses identified by the clinician at the time of the patient’s admission. This section may contain a coded entry which represents the admitting diagnoses.

Referenced in:

Admission Medications Section (entries optional)

The section contains the medications taken by the patient prior to and at the time of admission to the facility.

Referenced in:

Advance Directives Section (entries optional)

This section contains data defining the patient’s advance directives and any reference to supporting documentation, including living wills, healthcare proxies, and CPR and resuscitation status. If the referenced documents are available, they can be included in the exchange package. The most recent directives are required, if known, and should be listed in as much detail as possible. This section differentiates between "advance directives" and "advance directive documents". The former is the directions to be followed whereas the latter refers to a legal document containing those directions.

Referenced in:

Advance Directives Section (entries required)

This section contains data defining the patient’s advance directives and any reference to supporting documentation, including living wills, healthcare proxies, and CPR and resuscitation status. If the referenced documents are available, they can be included in the exchange package. The most recent directives are required, if known, and should be listed in as much detail as possible. This section differentiates between "advance directives" and "advance directive documents". The former is the directions to be followed whereas the latter refers to a legal document containing those directions.

Referenced in:

Allergies and Intolerances Section (entries optional)

This section lists and describes any medication allergies, adverse reactions, idiosyncratic reactions, anaphylaxis/anaphylactoid reactions to food items, and metabolic variations or adverse reactions/allergies to other substances (such as latex, iodine, tape adhesives). At a minimum, it should list currently active and any relevant historical allergies and adverse reactions.

Referenced in:

Allergies and Intolerances Section (entries required)

This section lists and describes any medication allergies, adverse reactions, idiosyncratic reactions, anaphylaxis/anaphylactoid reactions to food items, and metabolic variations or adverse reactions/allergies to other substances (such as latex, iodine, tape adhesives). At a minimum, it should list currently active and any relevant historical allergies and adverse reactions.

Referenced in:

Anesthesia Section

The Anesthesia Section records the type of anesthesia (e.g., general or local) and may state the actual agent used. This may be a subsection of the Procedure Description Section. The full details of anesthesia are usually found in a separate Anesthesia Note.

Referenced in:

Assessment Section

The Assessment Section (also referred to as “impression” or “diagnoses” outside of the context of CDA) represents the clinician's conclusions and working assumptions that will guide treatment of the patient. The assessment may be a list of specific disease entities or a narrative block.

Referenced in:

Assessment and Plan Section

This section represents the clinician’s conclusions and working assumptions that will guide treatment of the patient. The Assessment and Plan Section may be combined or separated to meet local policy requirements. See also the Assessment Section and Plan of Treatment Section

Referenced in:

Chief Complaint Section

This section records the patient's chief complaint (the patient’s own description).

Referenced in:

Chief Complaint and Reason for Visit Section

This section records the patient's chief complaint (the patient’s own description) and/or the reason for the patient's visit (the provider’s description of the reason for visit). Local policy determines whether the information is divided into two sections or recorded in one section serving both purposes.

Referenced in:

Complications Section

This section contains problems that occurred during or around the time of a procedure. The complications may be known risks or unanticipated problems.

Referenced in:

Course of Care Section

The Course of Care section describes what happened during the course of an encounter.

Referenced in:

DICOM Object Catalog Section - DCM 121181

DICOM Object Catalog lists all referenced objects and their parent Series and Studies, plus other DICOM attributes required for retrieving the objects. DICOM Object Catalog sections are not intended for viewing and contain empty section text.

Referenced in:

Discharge Diagnosis Section

This template represents problems or diagnoses present at the time of discharge which occurred during the hospitalization. This section includes an optional entry to record patient diagnoses specific to this visit. Problems that need ongoing tracking should also be included in the Problem Section.

Referenced in:

Discharge Medications Section (entries optional)

This section contains the medications the patient is intended to take or stop after discharge. Current, active medications must be listed. The section may also include a patient’s prescription history and indicate the source of the medication list.

Referenced in:

Discharge Medications Section (entries required)

This section contains the medications the patient is intended to take or stop after discharge. Current, active medications must be listed. The section may also include a patient’s prescription history and indicate the source of the medication list.

Referenced in:

Encounters Section (entries optional)

This section lists and describes any healthcare encounters pertinent to the patient’s current health status or historical health history. An encounter is an interaction, regardless of the setting, between a patient and a practitioner who is vested with primary responsibility for diagnosing, evaluating, or treating the patient’s condition. It may include visits, appointments, or non-face-to-face interactions. It is also a contact between a patient and a practitioner who has primary responsibility (exercising independent judgment) for assessing and treating the patient at a given contact. This section may contain all encounters for the time period being summarized, but should include notable encounters.

Referenced in:

Encounters Section (entries required)

This section lists and describes any healthcare encounters pertinent to the patient’s current health status or historical health history. An encounter is an interaction, regardless of the setting, between a patient and a practitioner who is vested with primary responsibility for diagnosing, evaluating, or treating the patient’s condition. It may include visits, appointments, as well as non-face-to-face interactions. It is also a contact between a patient and a practitioner who has primary responsibility (exercising independent judgment) for assessing and treating the patient at a given contact. This section may contain all encounters for the time period being summarized, but should include notable encounters.

Referenced in:

Family History Section

This section contains data defining the patient’s genetic relatives in terms of possible or relevant health risk factors that have a potential impact on the patient’s healthcare risk profile.

Referenced in:

Fetus Subject Context

For reports on mothers and their fetus(es), information on a mother is mapped to recordTarget, PatientRole, and Patient. Information on the fetus is mapped to subject, relatedSubject, and SubjectPerson at the CDA section level. Both context information on the mother and fetus must be included in the document if observations on fetus(es) are contained in the document.

Referenced in:

Findings Section (DIR)

The Findings section contains the main narrative body of the report. While not an absolute requirement for transformed DICOM SR reports, it is suggested that Diagnostic Imaging Reports authored in CDA follow Term Info guidelines for the codes in the various observations and procedures recorded in this section.

Referenced in:

Functional Status Section

The Functional Status Section contains observations and assessments of a patient's physical abilities. A patient’s functional status may include information regarding the patient’s ability to perform Activities of Daily Living (ADLs) in areas such as Mobility (e.g., ambulation), Self-Care (e.g., bathing, dressing, feeding, grooming) or Instrumental Activities of Daily Living (IADLs) (e.g., shopping, using a telephone, balancing a check book). Problems that impact function (e.g., dyspnea, dysphagia) can be contained in the section.

Referenced in:

General Status Section

The General Status section describes general observations and readily observable attributes of the patient, including affect and demeanor, apparent age compared to actual age, gender, ethnicity, nutritional status based on appearance, body build and habitus (e.g., muscular, cachectic, obese), developmental or other deformities, gait and mobility, personal hygiene, evidence of distress, and voice quality and speech.

Referenced in:

Goals Section

This template represents patient Goals. A goal is a defined outcome or condition to be achieved in the process of patient care. Goals include patient-defined over-arching goals (e.g., alleviation of health concerns, desired/intended positive outcomes from interventions, longevity, function, symptom management, comfort) and health concern-specific or intervention-specific goals to achieve desired outcomes.

To satisfy the 2015 Edition Certification Criteria, Transition of Care documents should include the Assessment Section (2.7) and the Plan of Treatment Section31 (2.48), or the Assessment and Plan Section (2.6). They also should include the Goals Section (2.22). Content should be distinguished as described below when the Goals Section, and the Plan of Treatment Section or Assessment and Plan of Treatment Section, are both included within the same Transition of Care document. This guidance does not apply to the Goals Section within a Care Plan document. There is no additional guidance for the Assessment Section beyond what is already in Consolidated CDA.

Referenced in:

Health Concerns Section

This section contains data describing an interest or worry about a health state or process that could possibly require attention, intervention, or management. A Health Concern is a health related matter that is of interest, importance or worry to someone, who may be the patient, patient's family or patient's health care provider. Health concerns are derived from a variety of sources within an EHR (such as Problem List, Family History, Social History, Social Worker Note, etc.). Health concerns can be medical, surgical, nursing, allied health or patient-reported concerns. Problem Concerns are a subset of Health Concerns that have risen to the level of importance that they typically would belong on a classic “Problem List”, such as “Diabetes Mellitus” or “Family History of Melanoma” or “Tobacco abuse”. These are of broad interest to multiple members of the care team. Examples of other Health Concerns that might not typically be considered a Problem Concern include “Risk of Hyperkalemia” for a patient taking an ACE-inhibitor medication, or “Transportation difficulties” for someone who doesn't drive and has trouble getting to appointments, or “Under-insured” for someone who doesn't have sufficient insurance to properly cover their medical needs such as medications. These are typically most important to just a limited number of care team members.

The Health Concerns Section contains, when available, concerns as expressed by the patient and/or the patient's agent(s), and/or by the patient or other care team members. When the Problem Section and Health Concerns Section both appear in a single document, then the Health Concerns section is titled "Additional Health Concerns" to distinguish it from the Problem List (the author's concerns). If it were simply titled Health Concerns, some would think that it contains all concerns, including the Problem List, which could cause confusion. Also, the Health Concerns Section appears after the Problem Section in the documents. The Health Concerns Section does not duplicate the entries from the Problem List. However, it may include some of the same concerns in the Problem List. It may be formatted as a "list" but may also be free form narrative not in any particular format. Whereas the Problems Section must contain both structured entries and narrative, the 2015 Edition Certification Criteria for Health Concerns section is only narrative. C-CDA conformance requires structured entries which may be populated with relevant data or the appropriate nullFlavor. Patient concerns may be specific to an encounter, or overarching concerns not specific to an encounter. Patient concerns are not limited to medical problems. For example, they can include things like barriers (lack of transportation, lack of finances, difficulty communicating with provider) or anything else relevant to the document/care. Also, the Additional Health Concerns section may contain concerns from members of the care team other than the author/attester of the document. The author/owner of each concern or group of concerns within the Additional Health Concerns section should be clearly labeled (e.g. Patient, Nurse, Therapist).

Referenced in:

Health Status Evaluations and Outcomes Section

This template represents observations regarding the outcome of care from the interventions used to treat the patient. These observations represent status, at points in time, related to established care plan goals and/or interventions.

Referenced in:

History of Past Illness Section

This section contains a record of the patient’s past complaints, problems, and diagnoses. It contains data from the patient’s past up to the patient’s current complaint or reason for seeking medical care.

Referenced in:

History of Present Illness Section

The History of Present Illness section describes the history related to the reason for the encounter. It contains the historical details leading up to and pertaining to the patient’s current complaint or reason for seeking medical care.

Referenced in:

Hospital Consultations Section

The Hospital Consultations Section records consultations that occurred during the admission.

Referenced in:

Hospital Course Section

The Hospital Course Section describes the sequence of events from admission to discharge in a hospital facility.

Referenced in:

Hospital Discharge Instructions Section

The Hospital Discharge Instructions Section records instructions at discharge.

Referenced in:

Hospital Discharge Physical Section

The Hospital Discharge Physical Section records a narrative description of the patient’s physical findings.

Referenced in:

Hospital Discharge Studies Summary Section

This section records the results of observations generated by laboratories, imaging procedures, and other procedures. The scope includes hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, nuclear medicine, pathology, and procedure observations. This section often includes notable results such as abnormal values or relevant trends, and could record all results for the period of time being documented. Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology, microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory. Imaging results are typically generated by a clinician reviewing the output of an imaging procedure, such as when a cardiologist reports the left ventricular ejection fraction based on the review of an echocardiogram. Procedure results are typically generated by a clinician wanting to provide more granular information about component observations made during the performance of a procedure, such as when a gastroenterologist reports the size of a polyp observed during a colonoscopy. Note that there are discrepancies between CCD and the lab domain model, such as the effectiveTime in specimen collection.

Referenced in:

Immunizations Section (entries optional)

The Immunizations Section defines a patient's current immunization status and pertinent immunization history. The primary use case for the Immunization Section is to enable communication of a patient's immunization status. The section should include current immunization status, and may contain the entire immunization history that is relevant to the period of time being summarized.

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Immunizations Section (entries required)

The Immunizations Section defines a patient's current immunization status and pertinent immunization history. The primary use case for the Immunization Section is to enable communication of a patient's immunization status. The section should include current immunization status, and may contain the entire immunization history that is relevant to the period of time being summarized.

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Instructions Section

The Instructions Section records instructions given to a patient. List patient decision aids here.

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Interventions Section

This template represents Interventions. Interventions are actions taken to maximize the prospects of the goals of care for the patient, including the removal of barriers to success. Interventions can be planned, ordered, historical, etc. Interventions include actions that may be ongoing (e.g., maintenance medications that the patient is taking, or monitoring the patient’s health status or the status of an intervention). Instructions are nested within interventions and may include self-care instructions. Instructions are information or directions to the patient and other providers including how to care for the individual’s condition, what to do at home, when to call for help, any additional appointments, testing, and changes to the medication list or medication instructions, clinical guidelines and a summary of best practice. Instructions are information or directions to the patient. Use the Instructions Section when instructions are included as part of a document that is not a Care Plan. Use the Interventions Section, containing the Intervention Act containing the Instruction entry, when instructions are part of a structured care plan.

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Medical (General) History Section

The Medical History Section describes all aspects of the medical history of the patient even if not pertinent to the current procedure, and may include chief complaint, past medical history, social history, family history, surgical or procedure history, medication history, and other history information. The history may be limited to information pertinent to the current procedure or may be more comprehensive. The history may be reported as a collection of random clinical statements or it may be reported categorically. Categorical report formats may be divided into multiple subsections including Past Medical History, Social History.

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Medical Equipment Section

This section defines a patient's implanted and external health and medical devices and equipment. This section lists any pertinent durable medical equipment (DME) used to help maintain the patient’s health status. All equipment relevant to the diagnosis, care, or treatment of a patient should be included. Devices applied to, or placed in, the patient are represented with the Procedure Activity Procedure (V2) template. Equipment supplied to the patient (e.g., pumps, inhalers, wheelchairs) is represented by the Non-Medicinal Supply Activity V2 template. These devices may be grouped together within a Medical Equipment Organizer. The organizer would probably not be used with devices applied in or on the patient but rather to organize a group of medical supplies the patient has been supplied with.

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Medications Administered Section

The Medications Administered Section usually resides inside a Procedure Note describing a procedure. This section defines medications and fluids administered during the procedure, its related encounter, or other procedure related activity excluding anesthetic medications. Anesthesia medications should be documented as described in the Anesthesia Section templateId 2.16.840.1.113883.10.20.22.2.25.

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Medications Section (entries optional)

The Medications Section contains a patient's current medications and pertinent medication history. At a minimum, the currently active medications are listed. An entire medication history is an option. The section can describe a patient's prescription and dispense history and information about intended drug monitoring.

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Medications Section (entries required)

The Medications Section contains a patient's current medications and pertinent medication history. At a minimum, the currently active medications are listed. An entire medication history is an option. The section can describe a patient's prescription and dispense history and information about intended drug monitoring. This section requires either an entry indicating the subject is not known to be on any medications or entries summarizing the subject's medications.

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Mental Status Section

The Mental Status Section contains observations and evaluations related to a patient’s psychological and mental competency and deficits including, but not limited to any of the following types of information:

  • Appearance (e.g., unusual grooming, clothing or body modifications)
  • Attitude (e.g., cooperative, guarded, hostile)
  • Behavior/psychomotor (e.g., abnormal movements, eye contact, tics)
  • Mood and affect (e.g., anxious, angry, euphoric)
  • Speech and Language (e.g., pressured speech, perseveration)
  • Thought process (e.g., logic, coherence)
  • Thought content (e.g., delusions, phobias)
  • Perception (e.g., voices, hallucinations)
  • Cognition (e.g., memory, alertness/consciousness, attention, orientation) – which were included in Cognitive Status Observation in earlier publications of C-CDA.
  • Insight and judgment (e.g., understanding of condition, decision making)

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Nutrition Section

The Nutrition Section represents diet and nutrition information including special diet requirements and restrictions (e.g., texture modified diet, liquids only, enteral feeding). It also represents the overall nutritional status of the patient and nutrition assessment findings.

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Objective Section

The Objective Section contains data about the patient gathered through tests, measures, or observations that produce a quantified or categorized result. It includes important and relevant positive and negative test results, physical findings, review of systems, and other measurements and observations.

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Observer Context

The Observer Context is used to override the author specified in the CDA Header. It is valid as a direct child element of a section.

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Operative Note Fluids Section

The Operative Note Fluids Section may be used to record fluids administered during the surgical procedure.

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Operative Note Surgical Procedure Section

The Operative Note Surgical Procedure Section can be used to restate the procedures performed if appropriate for an enterprise workflow. The procedure(s) performed associated with the Operative Note are formally modeled in the header using serviceEvent.

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Payers Section

The Payers Section contains data on the patient’s payers, whether "third party" insurance, self-pay, other payer or guarantor, or some combination of payers, and is used to define which entity is the responsible fiduciary for the financial aspects of a patient’s care. Each unique instance of a payer and all the pertinent data needed to contact, bill to, and collect from that payer should be included. Authorization information that can be used to define pertinent referral, authorization tracking number, procedure, therapy, intervention, device, or similar authorizations for the patient or provider, or both should be included. At a minimum, the patient’s pertinent current payment sources should be listed. The sources of payment are represented as a Coverage Activity, which identifies all of the insurance policies or government or other programs that cover some or all of the patient's healthcare expenses. The policies or programs are sequenced by preference. The Coverage Activity has a sequence number that represents the preference order. Each policy or program identifies the covered party with respect to the payer, so that the identifiers can be recorded.

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Physical Exam Section

The section includes direct observations made by a clinician. The examination may include the use of simple instruments and may also describe simple maneuvers performed directly on the patient’s body. It also includes observations made by the examining clinician using only inspection, palpation, auscultation, and percussion. It does not include laboratory or imaging findings. The exam may be limited to pertinent body systems based on the patient’s chief complaint or it may include a comprehensive examination. The examination may be reported as a collection of random clinical statements or it may be reported categorically. The Physical Exam Section may contain multiple nested subsections.

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Plan of Treatment Section

This section, formerly known as "Plan of Care", contains data that define pending orders, interventions, encounters, services, and procedures for the patient. It is limited to prospective, unfulfilled, or incomplete orders and requests only. These are indicated by the @moodCode of the entries within this section. All active, incomplete, or pending orders, appointments, referrals, procedures, services, or any other pending event of clinical significance to the current care of the patient should be listed. Clinical reminders are placed here to provide prompts for disease prevention and management, patient safety, and healthcare quality improvements, including widely accepted performance measures. The plan may also indicate that patient education will be provided. When used in a document that includes a Goals Section, all the goals (whether narrative only, or structured Goal Observation entries) should be recorded in the Goals Section, rather than in the Plan of Treatment Section, to avoid confusion as to “which/whose goals should be in which section?” When used in a document that does not include a Goals Section, the Plan of Treatment section may also contain information about care team members’ goals, including the patient’s values, beliefs, preferences, care expectations, and overarching care goals. Values may include the importance of quality of life over longevity. These values are taken into account when prioritizing all problems and their treatments. Beliefs may include comfort with dying or the refusal of blood transfusions because of the patient’s religious convictions. Preferences may include liquid medicines over tablets, or treatment via secure email instead of in person. Care expectations may range from being treated only by female clinicians, to expecting all calls to be returned within 24 hours. Overarching goals described in this section are not tied to a specific condition, problem, health concern, or intervention. Examples of overarching goals could be to minimize pain or dependence on others, or to walk a daughter down the aisle for her marriage.

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Planned Procedure Section

This section contains the procedure(s) that a clinician planned based on the preoperative assessment.

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Postoperative Diagnosis Section

The Postoperative Diagnosis Section records the diagnosis or diagnoses discovered or confirmed during the surgery. Often it is the same as the preoperative diagnosis.

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Postprocedure Diagnosis Section

The Postprocedure Diagnosis Section records the diagnosis or diagnoses discovered or confirmed during the procedure. Often it is the same as the preprocedure diagnosis or indication.

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Preoperative Diagnosis Section

The Preoperative Diagnosis Section records the surgical diagnoses assigned to the patient before the surgical procedure which are the reason for the surgery. The preoperative diagnosis is, in the surgeon's opinion, the diagnosis that will be confirmed during surgery.

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Problem Section (entries optional)

This section lists and describes all relevant clinical problems at the time the document is generated. At a minimum, all pertinent current and historical problems should be listed. Overall health status may be represented in this section.

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Problem Section (entries required)

This section lists and describes all relevant clinical problems at the time the document is generated. At a minimum, all pertinent current and historical problems should be listed. Overall health status may be represented in this section.

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Procedure Description Section

The Procedure Description section records the particulars of the procedure and may include procedure site preparation, surgical site preparation, pertinent details related to sedation/anesthesia, pertinent details related to measurements and markings, procedure times, medications administered, estimated blood loss, specimens removed, implants, instrumentation, sponge counts, tissue manipulation, wound closure, sutures used, vital signs and other monitoring data. Local practice often identifies the level and type of detail required based on the procedure or specialty.

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Procedure Disposition Section

The Procedure Disposition Section records the status and condition of the patient at the completion of the procedure or surgery. It often also states where the patient was transferred to for the next level of care.

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Procedure Estimated Blood Loss Section

The Procedure Estimated Blood Loss Section may be a subsection of another section such as the Procedure Description Section. The Procedure Estimated Blood Loss Section records the approximate amount of blood that the patient lost during the procedure or surgery. It may be an accurate quantitative amount, e.g., 250 milliliters, or it may be descriptive, e.g., “minimal” or “none”.

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Procedure Findings Section

The Procedure Findings Section records clinically significant observations confirmed or discovered during a procedure or surgery.

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Procedure Implants Section

The Procedure Implants Section records any materials placed during the procedure including stents, tubes, and drains.

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Procedure Indications Section

This section contains the reason(s) for the procedure or surgery. This section may include the preprocedure diagnoses as well as symptoms contributing to the reason for the procedure.

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Procedure Specimens Taken Section

The Procedure Specimens Taken Section records the tissues, objects, or samples taken from the patient during the procedure including biopsies, aspiration fluid, or other samples sent for pathological analysis. The narrative may include a description of the specimens.

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Procedures Section (entries optional)

This section describes all interventional, surgical, diagnostic, or therapeutic procedures or treatments pertinent to the patient historically at the time the document is generated. The section should include notable procedures, but can contain all procedures for the period of time being summarized. The common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM), therefore this section contains procedure templates represented with three RIM classes: Act, Observation, and Procedure. Procedure Activity Procedure (V2) is for procedures that alter the physical condition of a patient (e.g., splenectomy). Procedure Activity Observation (V2) is for procedures that result in new information about a patient but do not cause physical alteration (e.g., EEG). Procedure Activity Act (V2) is for all other types of procedures (e.g., dressing change).

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Procedures Section (entries required)

This section describes all interventional, surgical, diagnostic, or therapeutic procedures or treatments pertinent to the patient historically at the time the document is generated. The section should include notable procedures, but can contain all procedures for the period of time being summarized. The common notion of "procedure" is broader than that specified by the HL7 Version 3 Reference Information Model (RIM), therefore this section contains procedure templates represented with three RIM classes: Act. Observation, and Procedure. Procedure act is for procedures that alter the physical condition of a patient (e.g., splenectomy). Observation act is for procedures that result in new information about a patient but do not cause physical alteration (e.g., EEG). Act is for all other types of procedures (e.g., dressing change).

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Reason for Referral Section

This section describes the clinical reason why a provider is sending a patient to another provider for care. The reason for referral may become the reason for visit documented by the receiving provider.

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Reason for Visit Section

This section records the patient’s reason for the patient's visit (as documented by the provider). Local policy determines whether Reason for Visit and Chief Complaint are in separate or combined sections.

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Results Section (entries optional)

This section contains the results of observations generated by laboratories, imaging and other procedures. The scope includes observations of hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, nuclear medicine, pathology, and procedure observations. This section often includes notable results such as abnormal values or relevant trends. It can contain all results for the period of time being documented. Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology, microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory. Imaging results are typically generated by a clinician reviewing the output of an imaging procedure, such as where a cardiologist reports the left ventricular ejection fraction based on the review of a cardiac echocardiogram. Procedure results are typically generated by a clinician to provide more granular information about component observations made during a procedure, such as where a gastroenterologist reports the size of a polyp observed during a colonoscopy.

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Results Section (entries required)

The Results Section contains observations of results generated by laboratories, imaging procedures, and other procedures. These coded result observations are contained within a Results Organizer in the Results Section. The scope includes observations such as hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, nuclear medicine, pathology, and procedure observations. The section often includes notable results such as abnormal values or relevant trends, and could contain all results for the period of time being documented. Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology, microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory. Imaging results are typically generated by a clinician reviewing the output of an imaging procedure, such as where a cardiologist reports the left ventricular ejection fraction based on the review of a cardiac echocardiogram. Procedure results are typically generated by a clinician to provide more granular information about component observations made during a procedure, such as where a gastroenterologist reports the size of a polyp observed during a colonoscopy.

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Review of Systems Section

The Review of Systems Section contains a relevant collection of symptoms and functions systematically gathered by a clinician. It includes symptoms the patient is currently experiencing, some of which were not elicited during the history of present illness, as well as a potentially large number of pertinent negatives, for example, symptoms that the patient denied experiencing.

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Social History Section

This section contains social history data that influence a patient’s physical, psychological or emotional health (e.g., smoking status, pregnancy). Demographic data, such as marital status, race, ethnicity, and religious affiliation, is captured in the header.

Note: in C-CDA birth sex is recorded in the social history section, but C-CDA on FHIR uses the US Core Patient profile for patient data, which itself contains a birth sex extension, so birth sex will be found on the Patient resource, not in this section.

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Subjective Section

The Subjective Section describes in a narrative format the patient’s current condition and/or interval changes as reported by the patient or by the patient’s guardian or another informant.

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Surgical Drains Section

The Surgical Drains Section may be used to record drains placed during the surgical procedure. Optionally, surgical drain placement may be represented with a text element in the Procedure Description Section.

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Vital Signs Section (entries optional)

The Vital Signs Section contains relevant vital signs for the context and use case of the document type, such as blood pressure, heart rate, respiratory rate, height, weight, body mass index, head circumference, pulse oximetry, temperature, and body surface area. The section should include notable vital signs such as the most recent, maximum and/or minimum, baseline, or relevant trends. Vital signs are represented in the same way as other results, but are aggregated into their own section to follow clinical conventions.

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Vital Signs Section (entries required)

The Vital Signs Section contains relevant vital signs for the context and use case of the document type, such as blood pressure, heart rate, respiratory rate, height, weight, body mass index, head circumference, pulse oximetry, temperature, and body surface area. The section should include notable vital signs such as the most recent, maximum and/or minimum, baseline, or relevant trends. Vital signs are represented in the same way as other results, but are aggregated into their own section to follow clinical conventions.

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