CARE PLAN FRAMEWORK

A Care Plan (including Home Health Plan of Care (HHPoC)) is a consensus-driven dynamic plan that represents a patient’s and Care Team Member’s 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 patient’ss 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 patients 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 CDA Care Plan represents an instance of this dynamic Care Plan at a point in time. The CDA document itself is NOT dynamic.

Key differentiators between a Care Plan CDA and CCD (another snapshot in time document): There are 2 required sections:

• Health Concerns
• Interventions

There are 2 optional sections:

• 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

A care plan document can include entry references from the information in these sections to the information (entries) in other sections.

Please see Volume 1 of this guide to view a Care Plan Relationship diagram and story board.

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).

This document type 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) 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 ServiceEvent is constrained to “PCPR”. This means it does not function to report new ServiceEvents 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 documents in this guide.

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.

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.

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.

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 patient’s tolerance for the procedure. It should be detailed enough to justify the procedure, describe the course of the procedure, and provide continuity of care.

This template 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.

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 or when patient is sent by a cardiologist to an emergency department for angina or when a patient is referred by a nurse practitioner to an audiologist for hearing screening or when a patient is referred by a hospitalist to social services.

This document describes constraints on the Clinical Document Architecture (CDA) header and body elements 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.

An Unstructured Document (UD) document type can (1) include unstructured content, such as a graphic, directly in a text element with a mediaType attribute, or (2) reference a single document file, such as a word-processing document using a text/reference element.

For guidance on how to handle multiple files, on the selection of media types for this IG, and on the identification of external files, see the examples that follow the constraints below.

IHEs XDS-SD (Cross-Transaction Specifications and Content Specifications, Scanned Documents Module) profile addresses a similar, more restricted use case, specifically for scanned documents or documents electronically created from existing text sources, and limits content to PDF-A or text. This Unstructured Documents template is applicable not only for scanned documents in non-PDF formats, but also for clinical documents produced through word processing applications, etc.

For conformance with both specifications, implementers need to ensure that their documents at a minimum conform with the SHALL constraints from either specification.

This template defines constraints that represent common administrative and demographic concepts for US Realm CDA documents. Further specification, such as ClinicalDocument/code, are provided in document templates that conform to this template.

This template is designed to be used in conjunction with the US Realm Header. It includes additional conformances which further constrain the US Realm Header. The Patient Generated Document Header template is not a separate document type. The document body may contain any structured or unstructured content from C-CDA.

This template represents Activities. Activities are actions taken to maximize the prospects of the goals of care for the patient, including the removal of barriers to success. Activities 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 Activities Section, containing the Intervention Act containing the Instruction entry, when instructions are part of a structured care plan.

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.

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

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.

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.

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.

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: templateId 2.16.840.1.113883.10.20.22.2.8 and Plan of Treatment Section: templateId 2.16.840.1.113883.10.20.22.2.10:2014-06-09

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.

The Care Team Section is used to share historical and current Care Team information.

The Care Team Section may be included in any type of C-CDA structured document that is an open template.

An individual can have more than one Care Team. A Care Team can exist over time such as a longitudinal care team which includes historical members that may be active or inactive on the care team as needed. Or a Care Team, such as a rehabilitation team, may exist to address a person’s needs associated with a particular care event, or a team can be based on addressing a specific condition.

The Care Team Organizer entry template used in the C-CDA Care Teams Section is meant to support the foundation of effective communication, interaction channels and maintenance of current clinical context awareness for the patient, caregivers and care providers to promote care coordination.

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.

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

The Hospital Discharge Instructions Section records instructions at discharge.

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

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.

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.

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

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.

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 template. Equipment supplied to the patient (e.g., pumps, inhalers, wheelchairs) is represented by the Non-Medicinal Supply Activity 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.

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.

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.

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)

The Notes Section allow for inclusion of clinical documentation which does not fit precisely within any other C-CDA section. Multiple Notes sections may be included in a document provided they each include different types of note content as indicated by a different section.code. The Notes Section SHOULD NOT be used in place of a more specific C-CDA section. For example, notes about procedure should be placed within the Procedures Section, not a Notes Section. When a Notes Section is present, Note Activity entries contain structured information about the note information allowing it to be more machine processable.

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.

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.

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

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.

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.

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.

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.

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.

This section may also contain information about ongoing care of the patient, clinical reminders, patient’s values, beliefs, preferences, care expectations, and overarching care goals.

Clinical reminders are placed here to provide prompts for disease prevention and management, patient safety, and healthcare quality improvements, including widely accepted performance measures.

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.

The plan may also indicate that patient education will be provided.

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

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

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

This template represents the medications taken by the patient prior to and at the time of admission.

This clinical statement represents Advance Directive Observation findings (e.g., “resuscitation status is Full Code”) rather than orders. It should not be considered a legal document or a substitute for the actual Advance Directive document. The related legal documents are referenced using the reference/externalReference element.

The Advance Directive Observation describes the patient’s directives, including but not limited to:

• Medications
• Transfer of Care to Hospital
• Treatment
• Procedures
• Intubation and Ventilation
• Diagnostic Tests
• Tests

The observation/value element contains the detailed patient directive which may be coded or text. For example, a category directive may be antibiotics, and the details would be intravenous antibiotics only.

This clinical statement groups a set of advance directive observations.

This Age Observation represents the subject’s age at onset of an event or observation. The age of a relative in a Family History Observation at the time of that observation could also be inferred by comparing RelatedSubject/subject/birthTime with Observation/effectiveTime. However, a common scenario is that a patient will know the age of a relative when the relative had a certain condition or when the relative died, but will not know the actual year (e.g., “grandpa died of a heart attack at the age of 50”). Often times, neither precise dates nor ages are known (e.g., “cousin died of congenital heart disease as an infant”).

This template reflects a discrete observation about a patient’s allergy or intolerance. Because it is a discrete observation, it will have a statusCode of “completed”. The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago.

The effectiveTime of the Allergy - Intolerance Observation is the definitive indication of whether or not the underlying allergy/intolerance is resolved. If known to be resolved, then an effectiveTime/high would be present. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of “UNK”.

The agent responsible for an allergy or adverse reaction is not always a manufactured material (for example, food allergies), nor is it necessarily consumed. The following constraints reflect limitations in the base CDA R2 specification, and should be used to represent any type of responsible agent, i.e., use playingEntity classCode = “MMAT” for all agents, manufactured or not.

This template reflects an ongoing concern on behalf of the provider that placed the allergy on a patient’s allergy list. As long as the underlying condition is of concern to the provider (i.e., as long as the allergy, whether active or resolved, is of ongoing concern and interest to the provider), the statusCode is “active”. Only when the underlying allergy is no longer of concern is the statusCode set to “completed”. The effectiveTime reflects the time that the underlying allergy was felt to be a concern.

The statusCode of the Allergy Concern Act is the definitive indication of the status of the concern, whereas the effectiveTime of the nested Allergy - Intolerance Observation is the definitive indication of whether or not the underlying allergy is resolved.

The effectiveTime/low of the Allergy Concern Act asserts when the concern became active. This equates to the time the concern was authored in the patient’s chart. The effectiveTime/high asserts when the concern was completed (e.g., when the clinician deemed there is no longer any need to track the underlying condition).

This template represents the clinical status attributed to the allergy or intolerance. There can be only one allergy status observation per allergy - intolerance observation.

An assessment scale is a collection of observations that together can yield a calculated or non-calculated summary evaluation of a one or more conditions. Examples include the Braden Scale (assesses pressure ulcer risk), APACHE Score (estimates mortality in critically ill patients), Mini-Mental Status Exam (assesses cognitive function), APGAR Score (assesses the health of a newborn), Glasgow Coma Scale (assesses coma and impaired consciousness), and WE CARE (Well Child Care, Evaluation, Community Resources, Advocacy, Referral, Education - a clinic-based screening and referral system developed for pediatric settings).

When an Assessment Scale Observation is contained in a Problem Observation, a Social History Observation or a Procedure instance that is Social Determinant of Health focused, that Assessment scale MAY contain assessment scale observations that represent question and answer pairs from SDOH screening instruments that are represented in LOINC. Note that guidance on the use of LOINC in assessment scales already exists in Assessment Scale Observation constraints and Assessment Scale Supporting Observations constraints.

An Assessment Scale Supporting Observation represents the components of a scale used in an Assessment Scale Observation. The individual parts that make up the component may be a group of physical, cognitive, functional status, social observations or answers to questions.

An Authorization Activity represents authorizations or pre-authorizations currently active for the patient for the particular payer.

Authorizations are represented using an act subordinate to the policy or program that provided it. The authorization refers to the policy or program. Authorized treatments can be grouped into an organizer class, where common properties, such as the reason for the authorization, can be expressed. Subordinate acts represent what was authorized.

This template represents a simple observation about the type of business that compensates for work or assigns work to an unpaid worker or volunteer (e.g., U.S. Army, cement manufacturing, children and youth services). Multiple occupation industry observation instances in a single document or derived from multiple documents, represent a basic historical industry record.

Implementers should use the Basic Industry Observation template for conveying Industry in support of USCDI v3. It is recommended systems include the Basic Industry Observation in the Social History section. Implementers wishing to convey more advanced Industry detail may consider using HL7 CDA R2 Implementation Guide: C-CDA R2.1 Supplemental Templates for Occupational Data for Health in addition to this Observation.

This template represents a simple observation about the type of work (e.g., infantry, business analyst, social worker) of a person. The effectiveTime low and high represent the start and end times of a particular observation about an occupation. Multiple occupation observation instances in a single document or derived from multiple documents, represent a basic historical occupation record. Implementers should use the Basic Occupation Observation template for conveying occupation information in support of USCDI v3. It is recommended systems include the Basic Industry Observation in the Social History section.

Implementers wishing to convey more advanced Occupation detail, such as employer, usual work (longest held), or other work related observations may consider using HL7 CDA R2 Implementation Guide: C-CDA R2.1 Supplemental Templates for Occupational Data for Health in addition to this Observation.

This observation represents the sex of the patient at birth. It is the sex that is entered on the person’s birth certificate at time of birth.

This observation is not appropriate for recording patient gender (administrativeGender).

This observation is not appropriate for recording Gender Identity (GI).

It is recommended systems include the Birth Sex observation in the Social History section.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Brand Name. The UDI-DI of the medical device may be used to retrieve the Brand Name in accessGUDID, which should be considered the source of truth.

This template is used to represent a member of the care team. Care team members can include healthcare and community services providers, caregivers, relatives, the patient themselves, etc. A care team member can be another care team or an organization. Care team member attributes include the following: Care team member status on the care team Care team member time (e.g. duration, point-in-time, etc.) on the care team Schedule of the care team member describing when the care team member usually participates on the care team Care team member function on the care team such as the care team member specialty, relationship to the patient, and also role on the care team Care team member name, address, telecom, organization, etc. Care team member information (narrative description about the care team member)

The performer/assignedEntity/id may be set equal to (a pointer to) an id on a performer elsewhere in the document (header or entries) or a new performer can be described here. If the id is pointing to a performer already described elsewhere in the document, assignedEntity/id is sufficient to identify this performer and none of the remaining details of assignedEntity are required to be set. Application Software must be responsible for resolving the identifier back to its original object and then rendering the information in the correct place in the containing section’s narrative text.

This id must be a pointer to another Performer.

This template represents the schedule of when the care team member participates on the care team. Examples include: An oncologist who participated on the care team for one week. A primary care provider who participated on a care team during one summer (e.g. in the case of patients who are snow-birds). A crisis team who participated on the care team for the patient during an inpatient stay (e.g. in the case of children with special needs).

This organizer template contains information about a single care team. The author of the organizer is the person who documented the care team information. The participants of the organizer are the care team lead(s) and the care team organization.

The components of the organizer contain the following information:

• The encounter that caused the care team to be formed
• Narrative information about the care team
• The care team members
• Reasons for the care team
• The care team type(s) - a care team can have multiple care team types

This template is used to express the care team type. A care team can have multiple care team types. Examples include but are not limited to:

• Condition focused, longitudinal care team
• Event focused, Home & Community Based Services care team
• Condition focused, clinical research care team
• Public health focused, Longitudinal care-coordination care team

This clinical statement represents a caregiver’s willingness to provide care and the abilities of that caregiver to provide assistance to a patient in relation to a specific need.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Catalog Number. The UDI-DI of the medical device may be used to retrieve the Catalog Number in accessGUDID, which should be considered the source of truth.

This template represents the patient’s home environment including, but not limited to, type of residence (trailer, single family home, assisted living), living arrangement (e.g., alone, with parents), and housing status (e.g., evicted, homeless, home owner).

Comments are free text data that cannot otherwise be recorded using data elements already defined by this specification. They are not to be used to record information that can be recorded elsewhere. For example, a free text description of the severity of an allergic reaction would not be recorded in a comment.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Company Name. The UDI-DI of the medical device may be used to retrieve the Company Name in accessGUDID, which should be considered the source of truth.

A Coverage Activity groups the policy and authorization acts within a Payers Section to order the payment sources. A Coverage Activity contains one or more Policy Activities, each of which contains zero or more Authorization Activities. The sequenceNumber/@value shows the policy order of preference. The Member Identifier is described in the contained Policy Activity Template 2.16.840.1.113883.10.20.22.4.61.

This observation represents the gravity of the potential risk for future life-threatening adverse reactions when exposed to a substance known to cause an adverse reaction in that individual. When the worst case result is assessed to have a life-threatening or organ system threatening potential, it is considered to be of high criticality.

This template represents a patient’s spiritual, religious, and cultural belief practices, such as a kosher diet or fasting ritual. religiousAffiliationCode in the document header captures only the patient’s religious affiliation.

This template represents the earliest date of diagnosis, which is the date of first determination by a qualified professional of the presence of a problem or condition affecting a patient. An encounter diagnosis date may be different than this Date of Diagnosis.

The date of diagnosis is usually not the same date as the date of condition onset. A patient may have a condition for some time before it is formally diagnosed.

This template represents the observation that a patient has died. It also represents the cause of death, indicated by an entryRelationship type of CAUS. This template allows for more specific representation of data than is available with the use of dischargeDispositionCode.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Device Identifier (also known as the “Primary DI Number”) for a medical device marketed in the US. The device identifier is parsed from the UDI value.

The Device Identifier number can be used as a key to look-up device identification information in the publicly available version of the US FDA Global UDI Database (GUDID) - the AccessGUDID: https://accessgudid.nlm.nih.gov/resources/home

This template represents an assessment of patients perception of their physical, cognitive, intellectual, or psychiatric disabilities. It may contain an Assessment Scale Observation that holds the six-item set of questions used on the American Community Survey (ACS) to gauge disability, defined here: HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status This template SHOULD be included zero or more times [0..*] in the Functional Status Section or the Functional Status Organizer.

This template represents medications that the patient is intended to take (or stop) after discharge.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Distinct Identification Code for an HCT/P product regulated as a device as cited in 21 CFR 1271.290(c). The distinct identification code is parsed from the UDI value, if present.

The distinct identification code may be equivalent to the serial number, lot or batch number, or the donation identification number. The appropriate value should be provided as the distinct identification code.

This template represents the act of monitoring the patient’s medication and includes a participation to record the person responsible for monitoring the medication. The prescriber of the medication is not necessarily the same person or persons monitoring the drug. The effectiveTime indicates the time when the activity is intended to take place.

For example, a cardiologist may prescribe a patient Warfarin. The patient’s primary care provider may monitor the patient’s INR and adjust the dosing of the Warfarin based on these laboratory results. Here the person designated to monitor the drug is the primary care provider.

This template represents the vehicle (e.g., saline, dextrose) for administering a medication.

This clinical statement describes an interaction between a patient and clinician. Interactions may include in-person encounters, telephone conversations, and email exchanges.

This template wraps relevant problems or diagnoses at the close of a visit or that need to be followed after the visit. If the encounter is associated with a Hospital Discharge, the Hospital Discharge Diagnosis must be used. This entry requires at least one Problem Observation entry.

This template represents the act of referencing another entry in the same CDA document instance. Its purpose is to remove the need to repeat the complete XML representation of the referred entry when relating one entry to another. This template can be used to reference many types of Act class derivations, such as encounters, observations, procedures etc., as it is often necessary when authoring CDA documents to repeatedly reference other Acts of these types. For example, in a Care Plan it is necessary to repeatedly relate Health Concerns, Goals, Interventions and Outcomes.

The id is required and must be the same id as the entry/id it is referencing. The id cannot be a null value. Act/Code is set to nullFlavor=”NP” (Not Present). This means the value is not present in the message (in act/Code).

This clinical statement represents the anticipated date when a woman will give birth.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Expiration Date of the device. The expiration date is parsed from the UDI value, if present.

Where it is necessary to reference an external clinical document, the External Document Reference template can be used to reference this external document. However, if the containing document is appending to or replacing another document in the same set, that relationship is set in the header, using ClinicalDocument/relatedDocument.

This clinical statement records whether the family member is deceased.

Family History Observations related to a particular family member are contained within a Family History Organizer. The effectiveTime in the Family History Observation is the biologically or clinically relevant time of the observation. The biologically or clinically relevant time is the time at which the observation holds (is effective) for the family member (the subject of the observation).

The Family History Organizer associates a set of observations with a family member. For example, the Family History Organizer can group a set of observations about the patient’s father.

This template represents the patient’s physical function (e.g., mobility status, instrumental activities of daily living, self-care status) and problems that limit function (dyspnea, dysphagia). The template may include assessment scale observations, identify supporting caregivers, and provide information about non-medicinal supplies. This template is used to represent physical or developmental function of all patient populations.

This template groups related functional status observations into categories (e.g., mobility, self-care).

This observation represents the gender identity of the patient, defined as:

> “Ones basic sense of being male, female, or other gender (for example, transgender or gender queer). Gender identity can be congruent or incongruent with ones sex assigned at birth based on the appearance of external genitalia. (Advancing Effective Communication, Cultural Competence, and Patient- and Family-Centered Care for the Lesbian, Gay, Bisexual, and Transgender (LGBT) CommunityA Field Guide, The Joint Commission (2011).)

This template follows the guidelines from the HL7 Gender Harmony project. This template is based on C-CDA Social History Observation template.

This observation is not appropriate for recording patient gender (administrativeGender) or birth sex.

This template represents a patient health goal. A Goal Observation template may have related components that are acts, encounters, observations, procedures, substance administrations, or supplies. A goal identifies a future desired condition or state. Goals are often related to physical or mental health conditions or diseases, but also may be related to a Social Determinant of Health (SDOH) risks or states. For example, to have adequate quality meals and snacks, gain transportation security - able to access health and social needs). SDOH data relate to conditions in which people live, learn, work, and play and their effects on health risks and outcomes. A Goal is established by the patient or provider.

A goal may be a patient or provider goal. If the author is set to the recordTarget (patient), this is a patient goal. If the author is set to a provider, this is a provider goal. If both patient and provider are set as authors, this is a negotiated goal.

A goal usually has a related health concern and/or risk.

A goal may have components consisting of other goals (milestones). These milestones are related to the overall goal through entryRelationships.

This template represents a health concern.

It is a wrapper for a single health concern which may be derived from a variety of sources within an EHR (such as Problem List, Family History, Social History, Social Worker Note, etc.).

A Health Concern Act is used to track non-optimal physical or psychological situations drawing the patient to the healthcare system. These may be from the perspective of the care team or from the perspective of the patient. When the underlying condition is of concern (i.e., as long as the condition, whether active or resolved, is of ongoing concern and interest), the statusCode is active. Only when the underlying condition is no longer of concern is the statusCode set to completed. The effectiveTime reflects the time that the underlying condition was felt to be a concern; it may or may not correspond to the effectiveTime of the condition (e.g., even five years later, a prior heart attack may remain a concern). Health concerns require intervention(s) to increase the likelihood of achieving the goals of care for the patient and they specify the condition oriented reasons for creating the plan.

This template represents information about the overall health status of the patient. To represent the impact of a specific problem or concern related to the patient’s expected health outcome use the Prognosis Observation template 2.16.840.1.113883.10.20.22.4.113.

This observation contains a description of the wound tissue of the most severe or highest staged pressure ulcer observed on a patient.

This template represents problems or diagnoses identified by the clinician at the time of the patient’s admission.

This Hospital Admission Diagnosis act may contain more than one Problem Observation to represent multiple diagnoses for a Hospital Admission.

This template represents problems or diagnoses present at the time of discharge which occurred during the hospitalization or need to be monitored after hospitalization. It requires at least one Problem Observation entry.

An Immunization Activity describes immunization substance administrations that have actually occurred or are intended to occur. Immunization Activities in “INT” mood are reflections of immunizations a clinician intends a patient to receive. Immunization Activities in “EVN” mood reflect immunizations actually received.

An Immunization Activity is very similar to a Medication Activity with some key differentiators. The drug code system is constrained to CVX codes. Administration timing is less complex. Patient refusal reasons should be captured. All vaccines administered should be fully documented in the patient’s permanent medical record. Healthcare providers who administer vaccines covered by the National Childhood Vaccine Injury Act are required to ensure that the permanent medical record of the recipient indicates:

1. Date of administration
2. Vaccine manufacturer
3. Vaccine lot number
4. Name and title of the person who administered the vaccine and the address of the clinic or facility where the permanent record will reside
5. Vaccine information statement (VIS)

a. Date printed on the VIS b. Date VIS given to patient or parent/guardian.

This information should be included in an Immunization Activity when available. (Reference: [https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/c/vis-instruct.pdf])

The Immunization Medication Information represents product information about the immunization substance. The vaccine manufacturer and vaccine lot number are typically recorded in the medical record and should be included if known.

The Immunization Refusal Reason documents the rationale for the patient declining an immunization.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to augment the parsed data from the a Unique Device Identifier (UDI). This template is used to exchange the status of the patient’s implantable medical device. This status is only relevant to medical devices implanted in the patient’s body.

This template represents the rationale for an action such as an encounter, a medication administration, or a procedure. The id element can be used to reference a problem recorded elsewhere in the document, or can be used with a code and value to record the problem. Indications for treatment are not laboratory results; rather the problem associated with the laboratory result should be cited (e.g., hypokalemia instead of a laboratory result of Potassium 2.0 mEq/L). Use the Drug Monitoring Act [templateId 2.16.840.1.113883.10.20.22.4.123] to indicate if a particular drug needs special monitoring (e.g., anticoagulant therapy). Use Precondition for Substance Administration [templateId 2.16.840.1.113883.10.20.22.4.25.2] to represent that a medication is to be administered only when the associated criteria are met.

Many templates in C-CDA R2.1 reference the Indications Template. In the next C-CDA release we will update those templates to reference the Indications template.

The Reason 2.16.840.1.113883.10.20.24.3.88:2023-05-01 should used to represent the justification for an action, or for not performing an action, such as patient, system, or non-problem/diagnosis medical-related reasons Immunization Refusal Reason 2.16.840.1.113883.10.20.22.4.53 should be used to represent the rationale for the patient declining an immunization as the value set is crafted for the immunization use case.

The Instruction template can be used in several ways, such as to record patient instructions within a Medication Activity or to record fill instructions within a supply order. The template’s moodCode can only be INT. If an instruction was already given, the Procedure Activity Procedure template (instead of this template) should be used to represent the already occurred instruction. The act/code defines the type of instruction. Though not defined in this template, a Vaccine Information Statement (VIS) document could be referenced through act/reference/externalDocument, and patient awareness of the instructions can be represented with the generic participant and the participant/awarenessCode.

This template represents an Intervention Act. It is a wrapper for intervention-type activities considered to be parts of the same intervention. For example, an activity such as “elevate head of bed” combined with “provide humidified O2 per nasal cannula” may be the interventions performed for a health concern of “respiratory insufficiency” to achieve a goal of “pulse oximetry greater than 92%”. These intervention activities may be newly described or derived from a variety of sources within an EHR.

Interventions are actions taken to increase the likelihood of achieving the patient’s or providers’ goals. An Intervention Act should contain a reference to a Goal Observation representing the reason for the intervention.

Intervention Acts can be related to each other, or to Planned Intervention Acts. (E.g., a Planned Intervention Act with moodCode of INT could be related to a series of Intervention Acts with moodCode of EVN, each having an effectiveTime containing the time of the intervention.)

All interventions referenced in an Intervention Act must have a moodCode of EVN, indicating that they have occurred.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Latex Safety Status of the patient’s medical device. The UDI-DI of the medical device may be used to retrieve the Latex Safety status in accessGUDID, which should be considered the source of truth.

This template represents acquired or surgical wounds and is not intended to encompass all wound types. The template applies to wounds such as pressure ulcers, surgical incisions, and deep tissue injury wounds. Information in this template may include information about the wound measurements characteristics.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Lot or Batch Number of the device. The Lot or Batch Number is parsed from the UDI value, if present.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Manufacturing Date of the device. The manufacturing date is parsed from the UDI value, if present.

This template represents a set of current or historical medical devices, supplies, aids and equipment used by the patient. Examples are hearing aids, orthotic devices, ostomy supplies, visual aids, diabetic supplies such as syringes and pumps, and wheelchairs.

Devices that are applied during a procedure (e.g., cardiac pacemaker, gastrosomy tube, port catheter), whether permanent or temporary, are represented within the Procedure Activity Procedure template (templateId: 2.16.840.1.113883.10.20.22.4.14.2).

A Medication Activity describes substance administrations that have actually occurred (e.g., pills ingested or injections given) or are intended to occur (e.g., “take 2 tablets twice a day for the next 10 days”). Medication activities in “INT” mood are reflections of what a clinician intends a patient to be taking. For example, a clinician may intend that a patient be administered Lisinopril 20 mg PO for blood pressure control. If what was actually administered was Lisinopril 10 mg., then the Medication activities in the “EVN” mood would reflect actual use.

A moodCode of INT is allowed, but it is recommended that the Planned Medication Activity template be used for moodCodes other than EVN if the document type contains a section that includes Planned Medication Activity (for example a Care Plan document with Plan of Treatment, Intervention, or Goal sections).

At a minimum, a Medication Activity shall include an effectiveTime indicating the duration of the administration (or single-administration timestamp). Ambulatory medication lists generally provide a summary of use for a given medication over time - a medication activity in event mood with the duration reflecting when the medication started and stopped. Ongoing medications will not have a stop date (or will have a stop date with a suitable NULL value). Ambulatory medication lists will generally also have a frequency (e.g., a medication is being taken twice a day). Inpatient medications generally record each administration as a separate act.

The dose (doseQuantity) represents how many of the consumables are to be administered at each administration event. As a result, the dose is always relative to the consumable and the interval of administration. Thus, a patient consuming a single “metoprolol 25mg tablet” per administration will have a doseQuantity of “1”, whereas a patient consuming “metoprolol” will have a dose of “25 mg”.

This profile represents whether a medication has been consumed according to instructions.

This template records the act of supplying medications (i.e., dispensing). The moodCode equaling “EVN” (Event), signals that the “supply” has occurred and thus has been dispensed.

The template is available to explicitly identify the free text Sig within each medication.

An example free text sig: Thyroxin 150 ug, take one tab by mouth every morning.

A medication should be recorded as a pre-coordinated ingredient + strength + dose form (e.g., “metoprolol 25mg tablet”, “amoxicillin 400mg/5mL suspension”) where possible. This includes RxNorm codes whose Term Type is SCD (semantic clinical drug), SBD (semantic brand drug), GPCK (generic pack), BPCK (brand pack).

The dose (doseQuantity) represents how many of the consumables are to be administered at each administration event. As a result, the dose is always relative to the consumable. Thus, a patient consuming a single “metoprolol 25mg tablet” per administration will have a doseQuantity of “1”, whereas a patient consuming “metoprolol” will have a dose of “25 mg”.

This template records the intent to supply a patient with medications.

The Mental Status Observation template represents an observation about mental status that can come from a broad range of subjective and objective information (including measured data) to address those categories described in the Mental Status Section. See also Assessment Scale Observation for specific collections of observations that together yield a summary evaluation of a particular condition.

The Mental Status Organizer template may be used to group related Mental Status Observations (e.g., results of mental tests) and associated Assessment Scale Observations into subcategories and/or groupings by time. Subcategories can be things such as Mood and Affect, Behavior, Thought Process, Perception, Cognition, etc.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Model Number associated with the device. The UDI-DI of the medical device may be used to retrieve the Model Number in accessGUDID, which should be considered the source of truth.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the MRI Safety Status of the patient’s medical device. The UDI-DI of the medical device may be used to retrieve the MRI Safety Status in accessGUDID, which should be considered the source of truth.

This template represents equipment supplied to the patient (e.g., pumps, inhalers, wheelchairs). Devices applied to, or placed in, the patient are represented with the Product Instance entry contained within a Procedure Activity Procedure (identifier: urn:hl7ii: 2.16.840.1.113883.10.20.22.4.14)

The Note Activity represents a clinical note. Notes require authorship, authentication, timing information, and references to other discrete data such as encounters. Similar to the Comment Activity, the Note Activity permits a more specific code to characterize the type of information available in the note. The Note Activity template SHOULD NOT be used in place of a more specific C-CDA entry. Note information included needs to be relevant and pertinent to the information being communicated in the document. When the note information augments data represented in a more specific entry template, the Note Activity can be used in an entryRelationship to the associated standard C-CDA entry. For example, a Procedure Note added as an entryRelationship to a Procedure Activity Procedure entry). The Note Activity template can be used as a standalone entry within a standard C-CDA section (e.g., a note about various procedures which have occurred during a visit as an entry in the Procedures Section) when it does not augment another standard entry. It may also be used to provide additional data about the source of a currently narrative-only section, such as Hospital Course. Finally, if the type of data in the note is not known or no single C-CDA section is appropriate enough, the Note Activity should be placed in a Notes Section. (e.g., a free-text consultation note or a note which includes subjective, objective, assessment, and plan information combined). An alternative is to place the Note Activity as an entryRelationship to an Encounter Activity entry in the Encounters Section, but implementers may wish to group notes categorically into a separate location in CDA documents rather than overloading the Encounters Section.

This template represents the number of pressure ulcers observed at a particular stage.

This template represents the patient’s nutrition abilities and habits including intake, diet requirements or diet followed.

This template represents nutrition regimens (e.g., fluid restrictions, calorie minimum), interventions (e.g., NPO, nutritional supplements), and procedures (e.g., G-Tube by bolus, TPN by central line). It may also depict the need for nutrition education.

This template describes the overall nutritional status of the patient including findings related to nutritional status.

This template represents the outcome of care resulting from the interventions used to treat the patient. In the Care Planning workflow, the judgment about how well the person is progressing towards the goal is based on the observations made about the status of the patient with respect to interventions performed in the pursuit of achieving that goal.

Often thought of as an “actual outcome”, the Outcome Observation may be related to goals, progression toward goals, and the associated interventions. For example, an observation outcome of a blood oxygen saturation level of 95% is related to the goal of “Maintain Pulse Ox greater than 92”, which in turn is related to the health concern of respiratory insufficiency and the problem of pneumonia. The template makes use of the Entry Reference (templateId:2.16.840.1.113883.10.20.22.4.122) to reference the interventions and goals defined elsewhere in the Care Plan CDA instance.

This template represents the type of referral (e.g., for dental care, to a specialist, for aging problems) and represents whether the referral is for full care or shared care. It may contain a reference to another act in the document instance representing the clinical reason for the referral (e.g., problem, concern, procedure).

This template represents planned acts that are not classified as an observation or a procedure according to the HL7 RIM. Examples of these acts are a dressing change, the teaching or feeding of a patient or the providing of comfort measures. The priority of the activity to the patient and provider is communicated through Priority Preference. The effectiveTime indicates the time when the activity is intended to take place.

This template represents the insurance coverage intended to cover an act or procedure.

This template represents a planned or ordered encounter. The type of encounter (e.g., comprehensive outpatient visit) is represented. Clinicians participating in the encounter and the location of the planned encounter may be captured. The priority that the patient and providers place on the encounter may be represented.

This template represents planned immunizations. Planned Immunization Activity is very similar to Planned Medication Activity with some key differences, for example, the drug code system is constrained to CVX codes. The priority of the immunization activity to the patient and provider is communicated through Priority Preference. The effectiveTime indicates the time when the immunization activity is intended to take place and authorTime indicates when the documentation of the plan occurred.

This template represents a Planned Intervention Act. It is a wrapper for planned intervention-type activities considered to be parts of the same intervention. For example, an activity such as “elevate head of bed” combined with “provide humidified O2 per nasal cannula” may be the interventions planned for a health concern of “respiratory insufficiency” in order to attempt to achieve a goal of “pulse oximetry greater than 92%”. These intervention activities may be newly described or derived from a variety of sources within an EHR.

Interventions are actions taken to increase the likelihood of achieving the patient’s or providers’ goals. An Intervention Act should contain a reference to a Goal Observation representing the reason for the intervention.

Planned Intervention Acts can be related to each other or to Intervention Acts. (E.g., a Planned Intervention Act with moodCode of INT could be related to a series of Intervention Acts with moodCode of EVN, each having an effectiveTime containing the time of the intervention.)

All interventions referenced in a Planned Intervention Act must have moodCodes indicating that that are planned (have not yet occurred).

This template represents planned medication activities. The priority of the medication activity to the patient and provider is communicated through Priority Preference. The effectiveTime indicates the time when the medication activity is intended to take place. The authorTime indicates when the documentation of the plan occurred.

This template represents planned observations that result in new information about the patient which cannot be classified as a procedure according to the HL7 RIM, i.e., procedures alter the patient’s body. Examples of these observations are laboratory tests, diagnostic imaging tests, EEGs, and EKGs. The importance of the planned observation to the patient and provider is communicated through Priority Preference. The effectiveTime indicates the time when the observation is intended to take place and authorTime indicates when the documentation of the plan occurred. The Planned Observation template may also indicate the potential insurance coverage for the observation.

This template represents planned alterations of the patient’s physical condition. Examples of such procedures are tracheostomy, knee replacement, and craniectomy. The priority of the procedure to the patient and provider is communicated through Priority Preference. The effectiveTime indicates the time when the procedure is intended to take place and authorTime indicates when the documentation of the plan occurred. The Planned Procedure Template may also indicate the potential insurance coverage for the procedure.

Planned Procedure Usage Note: Common practice in the industry has shown that Planned Procedure is the usually implemented CDA template for any type of intervention or procedure regardless of if the “immediate and primary outcome (post-condition) is the alteration of the physical condition of the patient”, or not. As a result, it is recommended to use Planned Procedure when sending procedures also thought of as “interventions” such as “Home Environment Evaluation” or “Assessment of nutritional status”.

This template represents both medicinal and non-medicinal supplies ordered, requested, or intended for the patient (e.g., medication prescription, order for wheelchair). The importance of the supply order or request to the patient and provider may be indicated in the Priority Preference. The effective time indicates the time when the supply is intended to take place and author time indicates when the documentation of the plan occurred. The Planned Supply template may also indicate the potential insurance coverage for the procedure. Depending on the type of supply, the product or participant will be either a Medication Information product (medication), an Immunization Medication Information product (immunization), or a Product Instance participant (device/equipment).

A policy activity represents the policy or program providing the coverage. The person for whom payment is being provided (i.e., the patient) is the covered party. The subscriber of the policy or program is represented as a participant that is the holder of the coverage. The payer is represented as the performer of the policy activity.

This template represents the diagnosis or diagnoses discovered or confirmed during the procedure. They may be the same as preprocedure diagnoses or indications.

A criterion for administration can be used to record that the medication is to be administered only when the associated criteria are met.

This template represents a patient’s reported intention or desire in the next year to either become pregnant or prevent a future pregnancy. The effectiveTime.low represents the date the intention was recorded and the effectiveTime.high represents the date a year from the recorded date.

This clinical statement represents current and/or prior pregnancy dates enabling investigators to determine if the subject of the case report was pregnant during the course of a condition.

This template represents the surgical diagnosis or diagnoses assigned to the patient before the surgical procedure and is the reason for the surgery. The preoperative diagnosis is, in the opinion of the surgeon, the diagnosis that will be confirmed during surgery.

This template represents priority preferences chosen by a patient or a care provider. Priority preferences are choices made by care providers or patients or both relative to options for care or treatment (including scheduling, care experience, and meeting of personal health goals), the sharing and disclosure of health information, and the prioritization of concerns and problems.

This template reflects an ongoing concern on behalf of the provider that placed the concern on a patient’s problem list. So long as the underlying condition is of concern to the provider (i.e., as long as the condition, whether active or resolved, is of ongoing concern and interest to the provider), the statusCode is “active”. Only when the underlying condition is no longer of concern is the statusCode set to “completed”. The effectiveTime reflects the time that the underlying condition was felt to be a concern; it may or may not correspond to the effectiveTime of the condition (e.g., even five years later, the clinician may remain concerned about a prior heart attack).

The statusCode of the Problem Concern Act is the definitive indication of the status of the concern, whereas the effectiveTime of the nested Problem Observation is the definitive indication of whether or not the underlying condition is resolved.

The effectiveTime/low of the Problem Concern Act asserts when the concern became active. The effectiveTime/high asserts when the concern was completed (e.g., when the clinician deemed there is no longer any need to track the underlying condition).

A Problem Concern Act can contain many Problem Observations (templateId 2.16.840.1.113883.10.20.22.4.4). Each Problem Observation is a discrete observation of a condition, and therefore will have a statusCode of “completed”. The many Problem Observations nested under a Problem Concern Act reflect the change in the clinical understanding of a condition over time. For instance, a Concern may initially contain a Problem Observation of “chest pain”:

• Problem Concern 1 — Problem Observation: Chest Pain Later, a new Problem Observation of “esophagitis” will be added, reflecting a better understanding of the nature of the chest pain. The later problem observation will have a more recent author time stamp.
• Problem Concern 1 — Problem Observation (author/time Jan 3, 2012): Chest Pain — Problem Observation (author/time Jan 6, 2012): Esophagitis Many systems display the nested Problem Observation with the most recent author time stamp, and provide a mechanism for viewing prior observations.

This template reflects a discrete observation about a patient’s problem. Because it is a discrete observation, it will have a statusCode of “completed”. The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago. The effectiveTime of the Problem Observation is the definitive indication of whether or not the underlying condition is resolved. If the problem is known to be resolved, then an effectiveTime/high would be present. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of “UNK”.

The Problem Status records the clinical status attributed to the problem.

The common notion of “procedure” is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Therefore procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g., splenectomy). This template represents procedures whose immediate and primary outcome (post-condition) is the alteration of the physical condition of the patient. Examples of these procedures are an appendectomy, hip replacement, and a creation of a gastrostomy. This template can be used with a contained Product Instance template to represent a device in or on a patient. In this case, targetSiteCode is used to record the location of the device in or on the patient’s body. Equipment supplied to the patient (e.g., pumps, inhalers, wheelchairs) is represented by the Non-Medicinal Supply Activity template. Procedure Activity Procedure Usage Note: Common practice in the industry has shown that Procedure Activity Procedure is the usually implemented CDA template for any type of intervention or procedure regardless of if the “immediate and primary outcome (post-condition) is the alteration of the physical condition of the patient” or not. As a result, it is recommended to use Procedure Activity Procedure when sending procedures also thought of as “interventions” such as “Home Environment Evaluation” or “Assessment of nutritional status”.

This clinical statement represents a particular device that was placed in a patient or used as part of a procedure or other act. This provides a record of the identifier and other details about the given product that was used. For example, it is important to have a record that indicates not just that a hip prostheses was placed in a patient but that it was a particular hip prostheses number with a unique identifier.

The FDA Amendments Act specifies the creation of a Unique Device Identification (UDI) System that requires the label of devices to bear a unique identifier that will standardize device identification and identify the device through distribution and use.

The FDA permits an issuing agency to designate that their Device Identifier (DI) + Production Identifier (PI) format qualifies as a UDI through a process of accreditation. Currently, there are three FDA-accredited issuing agencies that are allowed to call their format a UDI. These organizations are GS1, HIBCC, and ICCBBA. For additional information on technical formats that qualify as UDI from each of the issuing agencies see the UDI Appendix.

When communicating only the issuing agency device identifier (i.e., subcomponent of the UDI), the use of the issuing agency OID is appropriate. However, when communicating the unique device identifier (DI + PI), the FDA OID (2.16.840.1.113883.3.3719) must be used. When sending a UDI, populate the participantRole/id/@root with the FDA OID (2.16.840.1.113883.3.3719) and participantRole/id/@extension with the UDI.

When sending a DI, populate the participantRole/id/@root with the appropriate assigning agency OID and participantRole/id/@extension with the DI. The scopingEntity/id should correspond to FDA or the appropriate issuing agency.

This template represents the patient’s prognosis, which must be associated with a problem observation. It may serve as an alert to scope intervention plans. The effectiveTime represents the clinically relevant time of the observation. The observation/value is not constrained and can represent the expected life duration in PQ, an anticipated course of the disease in text, or coded term.

This template represents a patient’s progress toward a goal. It can describe whether a goal has been achieved or not and can also describe movement a patient is making toward the achievement of a goal (e.g., “Goal not achieved - no discernible change”, “Goal not achieved - progressing toward goal”, “Goal not achieved - declining from goal”).

In the Care Planning workflow, the judgment about how well the person is progressing towards the goal is based on the observations made about the status of the patient with respect to interventions performed in the pursuit of achieving that goal.

For example, an observation outcome of a blood oxygen saturation level of 95% is related to the goal of “Maintain Pulse Ox greater than 92” and in this case the Progress Toward Goal Observation template would record that the related goal has been achieved.

This clinical statement represents the response to an undesired symptom, finding, etc. due to administered or exposed substance. A reaction can be defined described with respect to its severity, and can have been treated by one or more interventions.

This template describes the thought process or justification for an action or for not performing an action. Examples include patient, system, or non-problem/diagnosis medical-related reasons for declining to perform specific actions, or any reason for performing an action. Note that the parent template that calls this template can be asserted to have occurred or to not have occurred. Therefore, this template simply adds a reason to some other (possibly negated) act. As such, there is nothing in this template that says whether the parent act did or did not occur. It is expected that the primary use of this template within C-CDA is to provide the rationale for why something was not done. If this template is called by a template that is not negated, the Reason template should contain something other than a problem or a diagnosis, such as a patient preference. The Indication observation: 2.16.840.1.113883.10.20.22.4.19 should be used to represent a diagnosis or problem to indicate the diagnosis or problem is the rationale for an action. Immunization Refusal Reason: 2.16.840.1.113883.10.20.22.4.53 should be used to represent the rationale for the patient declining an immunization as the value set is crafted for the immunization use case.

This template represents the results of a laboratory, radiology, or other study performed on a patient.

The result observation includes a statusCode to allow recording the status of an observation. Pending results (e.g., a test has been run but results have not been reported yet) should be represented as active ActStatus.

This template provides a mechanism for grouping result observations. It contains information applicable to all of the contained result observations. The Result Organizer code categorizes the contained results into one of several commonly accepted values (e.g., Hematology, Chemistry, Nuclear Medicine).

If any Result Observation within the organizer has a statusCode of “active”, the Result Organizer must also have a statusCode of “active”.

This template represents a risk concern. It is a wrapper for a single risk concern which may be derived from a variety of sources within an EHR (such as Problem List, Family History, Social History, Social Worker Note, etc.). A Risk Concern Act represents a health concern that is a risk. A risk is a clinical or socioeconomic condition that the patient does not currently have, but the probability of developing that condition rises to the level of concern such that an intervention and/or monitoring is needed.

This observation represents the date and time range of the information contained in a section. It is an optional entry and may be used in any section.

This template represents a patient’s daily self-care ability. These activities are called Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL). ADLs involve caring for and moving of the body (e.g., dressing, bathing, eating). IADLs support an independent life style (e.g., cooking, managing medications, driving, shopping).

This template represents a patient’s sensory or speech ability. It may contain an assessment scale observations related to the sensory or speech ability.

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Serial Number of the device. The serial number is parsed from the UDI value, if present.

This clinical statement represents the location of a service event where an act, observation or procedure took place.

This clinical statement represents the gravity of the problem, such as allergy or reaction, in terms of its actual or potential impact on the patient. The Severity Observation can be associated with an Allergy - Intolerance Observation, Substance or Device Allergy - Intolerance Observation, Reaction Observation or all. When the Severity Observation is associated directly with an allergy it characterizes the allergy. When the Severity Observation is associated with a Reaction Observation it characterizes a reaction. A person may manifest many symptoms in a reaction to a single substance, and each reaction to the substance can be represented. However, each reaction observation can have only one severity observation associated with it. For example, someone may have a rash reaction observation as well as an itching reaction observation, but each can have only one level of severity.

This template represents sex notations that occur in various instances, such as encounters that reflect information derived from driver’s licenses or other IDs and meets the USCDI Data element Sex.

The Birth Sex Observation template is available for use in C-CDA and reflects specifically the sex assigned at birth concept present in USCDI V1 and V2.

This Sex observation MAY also mean sex at the time of birth if it was documented at the time of delivery. Future versions of the template be informed by the content of the HL7 Cross Paradigm IG: Gender Harmony - Sex and Gender Representation 1.0.0. when published.

It is recommended systems include the Sex Observation in the Social History section.

This observation represents the sexual orientation of the patient, defined as:

> A persons identification of their emotional, romantic, sexual, or affectional attraction to another person.

This template was informed by the HL7 Gender Harmony project.

This observation is not appropriate for recording patient gender (administrativeGender), Gender Identity (Gender Identity Observation), or birth sex (Birth Sex Observation).

This template represents the current smoking status of the patient as specified in Meaningful Use (MU) Stage 2 requirements. Historic smoking status observations as well as details about the smoking habit (e.g., how many per day) would be represented in the Tobacco Use template.

This template represents a “snapshot in time” observation, simply reflecting what the patient’s current smoking status is at the time of the observation. As a result, the effectiveTime is constrained to a time stamp, and will approximately correspond with the author/time. Details regarding the time period when the patient is/was smoking would be recorded in the Tobacco Use template.

If the patient’s current smoking status is unknown, the value element must be populated with SNOMED CT code 266927001 to communicate “Unknown if ever smoked” from the Current Smoking Status Value Set.

This template represents a patient’s job (occupation and industry), lifestyle, and environmental health risk factors. Demographic data (e.g., marital status, race, ethnicity, religious affiliation) are captured in the header. Though tobacco use and exposure may be represented with a Social History Observation, it is recommended to use the Current Smoking Status template or the Tobacco Use template instead, to represent smoking or tobacco habits. There are supplemental templates and guidance for observations of Occupational Data for Health, nutrition and pregnancy that could be captured in the Social History Observation, and implementers may want to consider using those more specific templates in the Social History section.

This template represents the administration course in a series. The entryRelationship/sequenceNumber in the containing template shows the order of this particular administration in that medication series.

This template reflects a discrete observation about a patient’s allergy or intolerance to a substance or device. Because it is a discrete observation, it will have a statusCode of “completed”. The effectiveTime, also referred to as the ‘clinically relevant time’ is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago.

The effectiveTime of the Substance or Device Allergy - Intolerance Observation is the definitive indication of whether or not the underlying allergy/intolerance is resolved. If known to be resolved, then an effectiveTime/high would be present. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of “UNK”.

This template represents a patient’s tobacco use.

All the types of tobacco use are represented using the codes from the tobacco use and exposure-finding hierarchy in SNOMED CT, including codes required for recording smoking status in Meaningful Use Stage 2.

The effectiveTime element is used to describe dates associated with the patient’s tobacco use. Whereas the Smoking Status - Meaningful Use template (2.16.840.1.113883.10.20.22.4.78:2014-06-09) represents a “snapshot in time” observation, simply reflecting what the patient’s current smoking status is at the time of the observation, this Tobacco Use template uses effectiveTime to represent the biologically relevant time of the observation. Thus, to record a former smoker, an observation of “cigarette smoker” will have an effectiveTime/low defining the time the patient started to smoke cigarettes and an effectiveTime/high defining the time the patient ceased to smoke cigarettes. To record a current smoker, the effectiveTime/low will define the time the patient started smoking and will have no effectiveTime/high to indicated that the patient is still smoking.

This template represents the tribe or band that an individual associates with, within the United States. It is recommended systems include the Tribal Affiliation Observation in the Social History section. The tribe or band name is drawn from an HL7 code system that aligns with the Indian entities list, a list of tribes or bands recognized by and eligible to receive services from the United States Bureau of Indian Affairs. This template does not represent tribal enrollment. Please see Indian Entities Recognized by and Eligible To Receive Services From the United States Bureau of Indian Affairs.

This template is nested in an entryRelationship/Procedure Activity Procedure to record all the UDI-related templates to exchange the parsed UDI data elements and associated data.

• Device Identifier urn:hl7ii:2.16.840.1.113883.10.20.22.4.304: 2019-06-21 NCIt: C101722 SHALL be included in UDI Organizer
• Lot or Batch Number urn:hl7ii:2.16.840.1.113883.10.20.22.4.315: 2019-06-21 NCIt:C101672 SHOULD be included in UDI Organizer if present in UDI
• Serial Number urn:hl7ii:2.16.840.1.113883.10.20.22.4.319: 2019-06-21 NCIt: C101671 SHOULD be included in UDI Organizer if present in UDI
• Manufacturing Date
  urn:hl7ii:2.16.840.1.113883.10.20.22.4.316: 2019-06-21 NCIt:C101669 SHOULD be included in UDI Organizer if present in UDI
• Expiration Date urn:hl7ii:2.16.840.1.113883.10.20.22.4.309: 2019-06-21 NCIt: C101670 SHOULD be included in UDI Organizer if present in UDI
• Distinct Identification Code urn:hl7ii:2.16.840.1.113883.10.20.22.4.308: 2019-06-21 NCIt: C113843 SHOULD be included in UDI Organizer if present in UDI
• Brand Name urn:hl7ii:2.16.840.1.113883.10.20.22.4.301: 2019-06-21 NCIt: C71898 MAY be included in the UDI Organizer if available
• Model Number urn:hl7ii:2.16.840.1.113883.10.20.22.4.317: 2019-06-21 NCIt: C99285 MAY be included in the UDI Organizer if available
• Catalog Number urn:hl7ii:2.16.840.1.113883.10.20.22.4.302: 2019-06-21 NCIt: C99286 MAY be included in the UDI Organizer if available
• Company Name urn:hl7ii:2.16.840.1.113883.10.20.22.4.303: 2019-06-21 NCIt: C54131 MAY be included in the UDI Organizer if available
• MRI Safety urn:hl7ii:2.16.840.1.113883.10.20.22.4.318: 2019-06-21 NCIt: C106044 MAY be included in the UDI Organizer if available
• Latex Safety urn:hl7ii:2.16.840.1.113883.10.20.22.4.314: 2019-06-21 NCIt: C160938 MAY be included in the UDI Organizer if available
• Implantable Device Status urn:hl7ii:2.16.840.1.113883.10.20.22.4.305 2019-06-21 NCIt: C160939 MAY be included in the UDI Organizer if available

This template represents measurement of common vital signs. Vital signs are represented with additional vocabulary constraints for type of vital sign and unit of measure.

The following is a list of recommended units for common types of vital sign measurements:

This template provides a mechanism for grouping vital signs (e.g., grouping systolic blood pressure and diastolic blood pressure).

This template represents characteristics of a wound (e.g., integrity of suture line, odor, erythema).

This template represents the Wound Measurement Observations of wound width, depth and length.

This template represents the Author Participation (including the author timestamp). CDA R2 requires that Author and Author timestamp be asserted in the document header. From there, authorship propagates to contained sections and contained entries, unless explicitly overridden.

The Author Participation template was added to those templates in scope for analysis in R2. Although it is not explicitly stated in all templates the Author Participation template can be used in any template.

This template represents the sender (author) and receivers (participants) of a handoff communication in a plan of treatment. It does not convey details about the communication. The “handoff” process involves senders, those transmitting the patient’s information and releasing the care of that patient to the next clinician, and receivers, those who accept the patient information and care of that patient.

This template represents the organization that supported generation of a CDA document. The Assembler Organization may be different than the Author Organization, and may be different from the Organization that developed the software used to generate the document.

This Participation is only for use in the CDA Header because it applies to the entire content in the document.

This template is consistent with the prior Assembler Document Participant (2.16.840.1.113883.3.5019.1.1) in the 2016 HL7 Data Provenance guide, however, makes no claim about representing the software organization. All constraints for conformance are defined in this template.

Note: The CDA Participant does not support a software device or the organization that created the software. The Assembler role can only be expressed at the level of organization. This is a known issue with the current CDA R2 model. Note: The Provenance template title includes a version 2 to support moving from the ‘Basic Provenance’ guide to the this Companion Guide, so the templateId has not changed.

This template represents the key information to record Provenance in an Author Participation.

This Participation is appropriate at any place CDA allows an author. For example, at the CDA Header, CDA Section, CDA Entry, or within a CDA entry (e.g. Organizer and contained Observation(s)).

This template is consistent with the C-CDA Author Participation, however, it doesnt use a formal conforms to relationship. All constraints for conformance are defined in this template which specializes the Author Participation (2.16.840.1.113883.10.20.22.4.119).

This template is used to identify primary authorship for an entry. An entry may have many authors, but recipients need a single authoritative point of contact for resolving issues. This is typically the last provider to make substantive changes to the entry If two providers are simultaneously involved in that activity, the implementer must choose one, ideally in a repeatable way.

The assignedAuthor/id may be set equal to (a pointer to) an id on a participant elsewhere in the document (header or entries) or a new author participant can be described here.

Note: The Provenance template title includes a version 2 to support moving from the ‘Basic Provenance’ guide to the this Companion Guide, so the templateId has not changed.

This template represents a generic participant person that has a relationship to the patient. (e.g., parent, next-of-kin, neighbor). The related person’s name is required and it is recommended that the person’s contact information is present. The more specific CDA participant of Guardian (recordTarget/patientRole/patient/guardian) can be used to represent a legally responsible guardian of the patient within the header. This template may be used to represent a person with any relationship to the patient within the header, or at the entry level when pertinent to a particular clinical statement.

Reusable address template, for use in US Realm CDA Header.

The US Realm Clinical Document Date and Time datatype flavor records date and time information. If no time zone offset is provided, you can make no assumption about time, unless you have made a local exchange agreement.

This data type uses the same rules as US Realm Date and Time (DTM.US.FIELDED), but is used with elements having a datatype of IVL_TS.

The US Realm Clinical Document Date and Time datatype flavor records date and time information. If no time zone offset is provided, you can make no assumption about time, unless you have made a local exchange agreement.

This data type uses the same rules as US Realm Date and Time (DT.US.FIELDED), but is used with elements having a datatype of TS.

The US Realm Patient Name datatype flavor is a set of reusable constraints that can be used for the patient or any other person. It requires a first (given) and last (family) name. If a patient or person has only one name part (e.g., patient with first name only) place the name part in the field required by the organization. Use the appropriate nullFlavor, “Not Applicable” (NA), in the other field.

For information on mixed content see the Extensible Markup Language reference (http://www.w3c.org/TR/2008/REC-xml-20081126/).

The US Realm Clinical Document Person Name datatype flavor is a set of reusable constraints that can be used for Persons.

Example of an allergy to egg

Admission Diagnosis Section example

Admission Medication example

Advance Directive Observation example

Advance Directive Organizer example

Advance Directives Section example

Age Observation example

Allergies and Intolerances Section example

Allergy Concern Act example

Allergy Intolerance Observation example

Anesthesia Section example

Assessment and Plan Section example

Assessment Scale Observation example

Assessment Scale Supporting Observation example

Assessment Section example

Author Participation example

Authorization Activity example

Care Plan Caregiver participant example

Care Plan Patient authenticator example

Care Plan performer example

Care Plan relatedDocument example

BCare Plan Review example

Caregiver Characteristics example

Characteristics of Home Environment example

Chief Complaint and Reason for Visit Section example

Chief Complaint Section example

Comment Activity example

Complications Section example

Continuity Of Care Document Author example

Continuity Of Care Document Performer example

Continuity Of Care Document serviceEvent example

Consultation Note Callback participant example

Consultation Note structuredBody example

Consultation Note inFulfillmentOf example

Course of Care Section example

Coverage Activity example

Criticality Observation example

Cultural and Religious Observation example

Deceased Observation example

Diagnosis Reference example

Discharge Diagnosis example

Discharge Medications Section example

Discharge Medication example

Discharge Summary (encompassingEncounter) example

Drug Monitoring Act example

Drug Vehicle example

Encounter Activity example

tEncounter Diagnosis example

Encounters Section example

Entry Reference example

Estimated Date of Delivery example

External Document Reference example

Family History Death Observation example

Family History Observation example

Family History Organizer example

Family History Section example

Functional Status Observation example

Functional Status Organizer example

Functional Status Section example

General Status Section example

Goal Observation example

Goals Section example

Handoff Communication Participants example

Health Concern Act example

Health Concerns Section example

Health Status Evaluations and Outcomes Section example

Health Status Observation example

Highest Pressure Ulcer Stage example

History and Physical Encompassing Encounter example

History of Present Illness example

Hospital Admission Diagnosis example

Hospital Consultations Section example

Hospital Course Section example

Hospital Discharge Diagnosis example

Hospital Discharge InstructionsSection example

Hospital Discharge Physical Section example

Hospital Discharge Studies Summary Section example

Immunization Activity example

Immunization Medication Information example

Immunization Refusal Reason example

Immunizations Section example

Indication example

Instructions Section example

Instruction example

Intervention Act example

Interventions Section example

Longitudinal Care Wound Observation example

Medical Equipment Organizer example

Medical Equipment Section example

Medication Activity example

Medication Dispense example

Medication Free Text Sig example

Medication Information example

Medication Supply Order example

Medications Administered Section example

Medications Section example

Mental Status Organizer example

Mental Status Organizer example

Mental Status Section example

No Known Medications example

No Known Problem Section example

Non-Medicinal Supply Activity example

nonXMLBody Example with Compressed Content

nonXMLBody Example with Embedded Content

nonXMLBody Example with Referenced Content

Number of Pressure Ulcers Observation example

Nutrition Assessment example

Nutrition Recommendation example

Nutrition Section example

Nutritional Status Observation example

Objective Section example

Operative Note performer example

Operative Note serviceEvent example

Operative Note Fluids Section example

Operative Note Surgical Procedure Section example

Outcome Observation example

Past Medical History example

Patient Generated Document authenticator example

Patient Generated Document author device example

Patient Generated Document author example

PPatient Generated Document custodian example

Patient Generated Document dataEnterer example

Patient Generated Document informant Example informant

Patient Generated Document informant RelEnt example

Patient Generated Document informationRecipient example

Patient Generated Document inFulfillmentOf example

PPatient Generated Document legalAuthenticator example

Patient Generated Document participant example

Patient Generated Document recordTarget example

Patient Referral Act example

Payers Section example

Physical Exam Section example

Plan of Treatment Section example

Planned Act example Example

Planned Coverage example

Planned Encounter example

Planned Immunization Activity example

Planned Medication Activity example

Planned Observation example

Planned Procedure Section example

Planned Procedure example

Planned Supply example

Policy Activity example

Postoperative Diagnosis Section example

Postprocedure Diagnosis example

Postprocedure Diagnosis Section example

Precondition for Substance Administration example

Pregnancy Observation example

Preoperative Diagnosis Section example

Preoperative Diagnosis example

Priority Preference example

Problem Concern Act example

Problem Observation example

Problem Section example

Procedure Note performer example

Procedure Note serviceEvent example

Procedure Activity Procedure example

Procedure Description Section example

Procedure Disposition Section example

Procedure Estimated Blood Loss Section example

Procedure Findings Section dexample

Procedure Implants Section example

Procedure Indications Section example

Procedure Specimens Taken Section example

Procedures Section example

Product Instance example

Prognosis Coded example

Prognosis Free Text example

Progress Note encompassingEncounter example

Progress Note serviceEvent example

Progress Toward Goal Observation example

Reaction Observation example

Reason For Referral example

Reason for Visit Section example

Referral Note Callback Contact example

Referral Note Caregiver example

Referral Note informationRecipient example

Result Observation example

Result Organizer example

Results Section example

Review of Systems Section example

Risk Concern Act example

Self-Care Activities (ADL and IADL) example

Sensory Status example

Service Delivery Location example

Severity Observation example

Smoking Status - Meaningful Use example

Social History Observation example

Social History Section example

Subjective Section example

Substance Administered Act example

Surgical Drains Section example

Tobacco Use example

Transfer Summary Callback Contact example

Transfer Summary participant (Support) example

US Realm Address example

US Realm Date and Time example

US Realm Header example

US Realm Patient Name example

US Realm Person Name example

Vital Sign Observation example

Vital Signs Organizer example

Vital Signs Section example

Wound Characteristic example

Wound Measurement Observation example