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.

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.

CARE PLAN FRAMEWORK

A Care Plan (including Home Health Plan of Care (HHPoC)) is a consensus-driven dynamic plan that represents a patients and Care Team Members prioritized concerns, goals, and planned interventions. It serves as a blueprint shared by all Care Team Members (including the patient, their caregivers and providers), to guide the patients care. A Care Plan integrates multiple interventions proposed by multiple providers and disciplines for multiple conditions.

A Care Plan represents one or more Plan(s) of Care and serves to reconcile and resolve conflicts between the various Plans of Care developed for a specific patient by different providers. While both a plan of care and a care plan include the 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: o Health Concerns o Interventions There are 2 optional sections: o Goals o 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.

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 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).

A Diagnostic Imaging Report (DIR) is a document that contains a consulting specialists interpretation of image data. It conveys the interpretation to the referring (ordering) physician and becomes part of the patients medical record. It is for use in Radiology, Endoscopy, Cardiology, and other imaging specialties.

A Procedure Note encompasses many types of non-operative procedures including interventional cardiology, gastrointestinal endoscopy, osteopathic manipulation, and many other specialty fields. Procedure Notes are differentiated from Operative Notes because they do not involve incision or excision as the primary act. The Procedure Note is created immediately following a non-operative procedure. It records the indications for the procedure and, when applicable, postprocedure diagnosis, pertinent events of the procedure, and the patients tolerance for the procedure. It should be detailed enough to justify the procedure, describe the course of the procedure, and provide continuity of care.

This template represents a patients clinical status during a hospitalization, outpatient visit, treatment with a LTPAC provider, or other healthcare encounter.

Tabers 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.

Mosbys 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.

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.

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.

This section contains data defining the patients 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.

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 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 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 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.

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.

This section, formerly known as “Plan of Care”, contains data that define pending orders, interventions, encounters, services, and procedures for the patient. It is limited to prospective, unfulfilled, or incomplete orders and requests only. These are indicated by the @moodCode of the entries within this section. All active, incomplete, or pending orders, appointments, referrals, procedures, services, or any other pending event of clinical significance to the current care of the patient should be listed. Clinical reminders are placed here to provide prompts for disease prevention and management, patient safety, and healthcare quality improvements, including widely accepted performance measures. The plan may also indicate that patient education will be provided. When used in a document that includes a Goals Section, all the goals (whether narrative only, or structured Goal Observation entries) should be recorded in the Goals Section, rather than in the Plan of Treatment Section, to avoid confusion as to which/whose goals should be in which section? When used in a document that does not include a Goals Section, the Plan of Treatment section may also contain information about care team members goals, including the patients values, beliefs, preferences, care expectations, and overarching care goals. Values may include the importance of quality of life over longevity. These values are taken into account when prioritizing all problems and their treatments. Beliefs may include comfort with dying or the refusal of blood transfusions because of the patients 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.

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.

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.

This section contains the results of observations generated by laboratories, imaging and other procedures. The scope includes observations of hematology, chemistry, serology, virology, toxicology, microbiology, plain x-ray, ultrasound, CT, MRI, angiography, echocardiography, nuclear medicine, pathology, and procedure observations. This section often includes notable results such as abnormal values or relevant trends. It can contain all results for the period of time being documented.

Laboratory results are typically generated by laboratories providing analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology, microbiology, and/or virology. These observations are based on analysis of specimens obtained from the patient and submitted to the laboratory.

Imaging results are typically generated by a clinician reviewing the output of an imaging procedure, such as where a cardiologist reports the left ventricular ejection fraction based on the review of a cardiac echocardiogram.

Procedure results are typically generated by a clinician to provide more granular information about component observations made during a procedure, such as where a gastroenterologist reports the size of a polyp observed during a colonoscopy.

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 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.

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

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 contains social history data that influence a patients 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.

This section lists and describes any healthcare encounters pertinent to the patients 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 patients condition. It may include visits, appointments, or non-face-to-face interactions. It is also a contact between a patient and a practitioner who has primary responsibility (exercising independent judgment) for assessing and treating the patient at a given contact. This section may contain all encounters for the time period being summarized, but should include notable encounters.

This section lists and describes any healthcare encounters pertinent to the patients 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 patients 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 patients genetic relatives in terms of possible or relevant health risk factors that have a potential impact on the patients healthcare risk profile.

This template represents Interventions. Interventions are actions taken to maximize the prospects of the goals of care for the patient, including the removal of barriers to success. Interventions can be planned, ordered, historical, etc.

Interventions include actions that may be ongoing (e.g., maintenance medications that the patient is taking, or monitoring the patients 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 individuals condition, what to do at home, when to call for help, any additional appointments, testing, and changes to the medication list or medication instructions, clinical guidelines and a summary of best practice.

Instructions are information or directions to the patient. Use the Instructions Section when instructions are included as part of a document that is not a Care Plan. Use the Interventions Section, containing the Intervention Act containing the Instruction entry, when instructions are part of a structured care plan.

The Functional Status Section contains observations and assessments of a patient’s physical abilities. A patients functional status may include information regarding the patients 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.

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

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.

The Mental Status Section contains observations and evaluations related to a patients 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 Payers Section contains data on the patients 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 patients 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 patients 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 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 Course of Care section describes what happened during the course of an encounter.

This section contains a narrative description of the problems or diagnoses identified by the clinician at the time of the patients 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 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.

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 patients current complaint or reason for seeking medical care.

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.

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 patients 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 patients 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.

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.

This section represents the clinicians 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 (V2): templateId 2.16.840.1.113883.10.20.22.2.10:2014-06-09

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

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 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 contains data defining the patients 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 records the patient’s chief complaint (the patients own description).

The Hospital Discharge Physical Section records a narrative description of the patients physical findings.

This section records a narrative description of the expectations for diet and nutrition, including nutrition prescription, proposals, goals, and order requests for monitoring, tracking, or improving the nutritional status of the patient, used in a discharge from a facility such as an emergency department, hospital, or nursing home.

THIS TEMPLATE HAS BEEN DEPRECATED IN C-CDA R2 AND MAY BE DELETED FROM A FUTURE RELEASE OF THIS IMPLEMENTATION GUIDE. USE OF THIS TEMPLATE IS NOT RECOMMENDED.

Reason for deprecation: This template has been replaced by the Nutrition Section (2.16.840.1.113883.10.20.22.2.57).

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

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.

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

This section records the patient’s chief complaint (the patients own description) and/or the reason for the patient’s visit (the providers 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.

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

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

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

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

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.

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 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 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.

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.

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

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.

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.

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.

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 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.

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.

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 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 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.

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 patients prescription history and indicate the source of the medication list.

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 patients prescription history and indicate the source of the medication list.

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

The Hospital Discharge Instructions Section records instructions at discharge.

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.

THIS TEMPLATE HAS BEEN DEPRECATED IN C-CDA R2 AND MAY BE DELETED FROM A FUTURE RELEASE OF THIS IMPLEMENTATION GUIDE. USE OF THIS TEMPLATE IS NOT RECOMMENDED.

Reason for Deprecation: Replaced by the Procedure Implants Section (2.16.840.1.113883.10.20.22.2.40)

THIS TEMPLATE HAS BEEN DEPRECATED IN C-CDA R2 AND MAY BE DELETED FROM A FUTURE RELEASE OF THIS IMPLEMENTATION GUIDE. USE OF THIS TEMPLATE IS NOT RECOMMENDED.

Reason for deprecation: This template has been replaced by the Procedure Description Section (2.16.840.1.113883.10.20.22.2.27).

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 patients 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 patients 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.

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 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 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).

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 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 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 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.

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.

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 (V2) template be used for moodCodes other than EVN if the document type contains a section that includes Planned Medication Activity (V2) (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 template records the act of supplying medications (i.e., dispensing).

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.

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.

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 reflects an ongoing concern on behalf of the provider that placed the concern on a patients 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 (V2) template.

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 patients 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 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 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 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 reaction. The Severity Observation characterizes the Reaction Observation. 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.

Note the severity observation is no longer recommended for use with the Allergy and Intolerance Observation. The Criticality Observation is preferred for characterizing the Allergy and Intolerance.

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 ‘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 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 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 any act that cannot be classified as an observation or procedure according to the HL7 RIM. Examples of these acts are a dressing change, teaching or feeding a patient, or providing comfort measures. The common notion of “procedure” is broader than that specified by the HL7 Version 3 Reference Information Model (RIM). Procedure templates can be represented with various RIM classes: act (e.g., dressing change), observation (e.g., EEG), procedure (e.g., splenectomy).

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 that result in new information about the patient that cannot be classified as a procedure according to the HL7 RIM. Examples of these procedures are diagnostic imaging procedures, EEGs, and EKGs.

This template represents a patient’s occupations, 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.

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

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 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 (V2) 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 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 represents a patients spiritual, religious, and cultural belief practices, such as a kosher diet or fasting ritual. religiousAffiliationCode in the document header captures only the patients religious affiliation.

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).

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.

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 patients father.

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).

This clinical statement records whether the family member is deceased.

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.

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.

An assessment scale is a collection of observations that together yield a summary evaluation of a particular condition. 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), and Glasgow Coma Scale (assesses coma and impaired consciousness).

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 cognitive or functional status observations.

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 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 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.

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 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).

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 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 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.

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 Coverage Activity id is the ID from the patient’s insurance card. The sequenceNumber/@value shows the policy order of preference.

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

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 (V2) (identifier: urn:hl7ii: 2.16.840.1.113883.10.20.22.4.14)

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 (V2) template (templateId: 2.16.840.1.113883.10.20.22.4.14.2).

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

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

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 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.

The pressure ulcer observation contains details about the pressure ulcer such as the stage of the ulcer, location, and dimensions. If the pressure ulcer is a diagnosis, you may find this on the problem list. An example of how this would appear is in the Problem Section.

THIS TEMPLATE HAS BEEN DEPRECATED IN C-CDA R2 AND MAY BE DELETED FROM A FUTURE RELEASE OF THIS IMPLEMENTATION GUIDE. USE OF THIS TEMPLATE IS NOT RECOMMENDED.

Reason for deprecation: This template has been replaced by Longitudinal Care Wound Observation (2.16.840.1.113883.10.20.22.4.114).

A functional status problem observation is a clinical statement that represents a patients functional perfomance and ability.

THIS TEMPLATE HAS BEEN DEPRECATED IN C-CDA R2 AND MAY BE DELETED FROM A FUTURE RELEASE OF THIS IMPLEMENTATION GUIDE. USE OF THIS TEMPLATE IS NOT RECOMMENDED.

Reason for deprecation: Functional Status Problem Observation has been merged, without loss of expressivity, into Functional Status Observation (2.16.840.1.113883.10.20.22.4.67:2014-06-09).

A Series Act contains the DICOM series information for referenced DICOM composite objects. The series information defines the attributes that are used to group composite instances into distinct logical sets. Each series is associated with exactly one study. Series Act clinical statements are only instantiated in the DICOM Object Catalog section inside a Study Act, and thus do not require a separate templateId; in other sections, the SOP Instance Observation is included directly.

A cognitive status problem observation is a clinical statement that describes a patient’s cognitive condition, findings, or symptoms. Examples of cognitive problem observations are inability to recall, amnesia, dementia, and aggressive behavior.

A cognitive problem observation is a finding or medical condition. This is different from a cognitive result observation, which is a response to a question that provides insight into the patient’s cognitive status, judgement, comprehension ability, or response speed.

THIS TEMPLATE HAS BEEN DEPRECATED AND MAY BE DELETED FROM A FUTURE RELEASE OF THIS IMPLEMENTATION GUIDE. USE OF THIS TEMPLATE IS NOT RECOMMENDED.

Reason for deprecation: Cognitive Status Problem Observation has been merged, without loss of expressivity, into Mental Status Observation (2.16.840.1.113883.10.20.22.4.74).

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

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).

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.

A SOP Instance Observation contains the DICOM Service Object Pair (SOP) Instance information for referenced DICOM composite objects. The SOP Instance act class is used to reference both image and non-image DICOM instances. The text attribute contains the DICOM WADO reference.

A Purpose of Reference Observation describes the purpose of the DICOM composite object reference. Appropriate codes, such as externally defined DICOM codes, may be used to specify the semantics of the purpose of reference. When this observation is absent, it implies that the reason for the reference is unknown.

A Referenced Frames Observation is used if the referenced DICOM SOP instance is a multiframe image and the reference does not apply to all frames. The list of integer values for the referenced frames of a DICOM multiframe image SOP instance is contained in a Boundary Observation nested inside this class.

This template represents problems or diagnoses identified by the clinician at the time of the patients admission. This Hospital Admission Diagnosis act may contain more than one Problem Observation to represent multiple diagnoses for a Hospital Admission.

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

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 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).

A Boundary Observation contains a list of integer values for the referenced frames of a DICOM multiframe image SOP instance. It identifies the frame numbers within the referenced SOP instance to which the reference applies. The CDA Boundary Observation numbers frames using the same convention as DICOM, with the first frame in the referenced object being Frame 1. A Boundary Observation must be used if a referenced DICOM SOP instance is a multiframe image and the reference does not apply to all frames.

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

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

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

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

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.

This participant is the Physician Reading Study Performer defined in documentationOf/serviceEvent. It is usually different from the attending physician. The reading physician interprets the images and evidence of the study (DICOM Definition).

This encounterParticipant is the attending physician and is usually different from the Physician Reading Study Performer defined in documentationOf/serviceEvent.

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

DICOM Template 2000 specifies that Imaging Report Elements of Value Type Text are contained in sections. The Imaging Report Elements are inferred from Basic Diagnostic Imaging Report Observations that consist of image references and measurements (linear, area, volume, and numeric). Text DICOM Imaging Report Elements in this context are mapped to CDA text observations that are section components and are related to the SOP Instance Observations (templateId 2.16.840.1.113883.10.20.6.2.8) or Quantity Measurement Observations (templateId 2.16.840.1.113883.10.20.6.2.14) by the SPRT (Support) act relationship. A Text Observation is required if the findings in the section text are represented as inferred from SOP Instance Observations.

DICOM Template 2000 specifies that Imaging Report Elements of Value Type Code are contained in sections. The Imaging Report Elements are inferred from Basic Diagnostic Imaging Report Observations that consist of image references and measurements (linear, area, volume, and numeric). Coded DICOM Imaging Report Elements in this context are mapped to CDA-coded observations that are section components and are related to the SOP Instance Observations (templateId 2.16.840.1.113883.10.20.6.2.8) or Quantity Measurement Observations (templateId 2.16.840.1.113883.10.20.6.2.14) by the SPRT (Support) act relationship.

A Quantity Measurement Observation records quantity measurements based on image data such as linear, area, volume, and numeric measurements. The codes in DIRQuantityMeasurementTypeCodes (ValueSet: 2.16.840.1.113883.11.20.9.29) are from the qualifier hierarchy of SNOMED CT and are not valid for observation/code according to the Term Info guidelines. These codes can be used for backwards compatibility, but going forward, codes from the observable entity hierarchy will be requested and used.

A Study Act contains the DICOM study information that defines the characteristics of a referenced medical study performed on a patient. A study is a collection of one or more series of medical images, presentation states, SR documents, overlays, and/or curves that are logically related for the purpose of diagnosing a patient. Each study is associated with exactly one patient. A study may include composite instances that are created by a single modality, multiple modalities, or by multiple devices of the same modality. The study information is modality-independent. Study Act clinical statements are only instantiated in the DICOM Object Catalog section; in other sections, the SOP Instance Observation is included directly.

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

The ServiceEvent Procedure Context of the document header may be overridden in the CDA structured body if there is a need to refer to multiple imaging procedures or acts. The selection of the Procedure or Act entry from the clinical statement choice box depends on the nature of the imaging service that has been performed. The Procedure entry shall be used for image-guided interventions and minimally invasive imaging services, whereas the Act entry shall be used for diagnostic imaging services.

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

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

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 designed to be used in conjunction with the US Realm Header (V2). It includes additional conformances which further constrain the US Realm Header (V2). 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 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 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 (V2) [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.

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 Act 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 the insurance coverage intended to cover an act or procedure.

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.

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 (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