The International Patient Summary is a “Minimal and non-exhaustive Patient Summary, specialty-agnostic, condition-independent, but readily usable by all clinicians for the unscheduled (cross-border) care of a patient.”

The IPS templates aim to:

• Serve for both cross-jurisdictional (through adaptation/extension for multi-language and realm scenarios, including translation) and national (through localization) patient summaries.
• Support emergency care and unplanned care in any country (home and foreign), regardless of language
• Define value sets based on international vocabularies that are usable and understandable in any country  

The medication summary section contains a description of the patient’s medications relevant for the scope of the patient summary. The actual content could depend on the jurisdiction, it could report:

• the currently active medications; 

• the current and past medications considered relevant by the authoring GP; 

• the patient prescriptions or dispensations automatically extracted by a regional or a national EHR.

In all those cases however medications are documented in the Patient Summary as medication statements.

This section requires either an entry indicating the subject is known not to be on any medications; either an entry indicating that no information is available about medications; or entries summarizing the subject’s medications.

The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

This section documents the relevant allergies or intolerances (conditions) for that patient, describing the kind of reaction (e.g. rash, anaphylaxis,..); preferably the agents that cause it; and optionally the criticality and the certainty of the allergy. 

At a minimum, it should list currently active and any relevant historical allergies and adverse reactions.

If no information about allergies is available, or if no allergies are known this should be clearly documented in the section.

The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The IPS problem section lists and describes clinical problems or conditions currently being monitored for the patient. This section can record different kinds of  problems as, but not limited to,  chronic diseases (e.g. COPD, diabetes, hypertension); contagious diseases; nutritional problems (e.g. metabolic diseases); and so on.The optional author and informant elements are used, when necessary, to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The History of Procedures Section contains a description of the  patient past procedures that are pertinent to the scope of this document.

Procedures may refer for example to:

1. Invasive Diagnostic procedure:e.g. Cardiac catheterization; (the results of these procedure are documented in the results section)

2. Therapeutic procedure: e.g. dialysis; 

3. Surgical procedure: e.g. appendectomy

All those are represented in this template as procedures.

The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

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 includes current immunization status, and may contain the entire immunization history that is relevant to the period of time being summarized. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The medical devices section contains narrative text and coded entries describing the patient history of medical device use. Medical devices include, but are not limited to, implanted devices and devices for nutrition.  The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The History of Past Illness section contains a narrative description and coded entries of the conditions the patient suffered in the past.  The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The functional status section shall contain a narrative description of capability of the patient to perform acts of daily living, including possible needs of the patient to be continuously assessed by third parties. The invalidity status may in fact influence decisions about how to administer treatments. Coded clinical statements will be specified by future versions of this template. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The care plan section contains a narrative description of the expectations for care including proposals, goals, and order requests for monitoring, tracking, or improving the condition of the patient. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The social history section contains a description of the person’s Health related “lifestyle factors” or “lifestyle observations” (e.g. smoke habits; alcohol consumption; diets, risky habits.) The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The history of pregnancy section shall contain information about whether the patient is currently pregnant (optional with the Expected Delivery Date) or not. It may contain addition summarizing information about the outcome of earlier pregnancies. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.

The advance directive section shall contain a narrative description of patient’s advance directive. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header. Entries for references to consent and advance directive documents when known will be specified by future versions of this template.

This section assembles relevant observation results collected on the patient or produced on in-vitro biologic specimens collected from the patient. Some of these results may be laboratory results, others may be anatomic pathology results, others, radiology results, and others, clinical results. The structured, machine-processable content of this section is sorted out between as many Result Organizer entries as needed. One Result Organizer entry groups results, which have a common context of production:

• common specialty (imaging, bacteriology, serology, chemistry,  surgical pathology, clinical, radiology …), 
• common overall interpretation, (which interprets the set of results of the Organizer),
• common biologic specimen for in vitro diagnostic observations, 
• common associated illustrative image.

The optional author and informant elements of the section are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header. In case this section assembles results from multiple authors (e.g.; results authored by a clinical laboratory, and results produced by a radiology center), the authors are listed in the section, and each Result Organizer of the section indicates its own author(s).

Template CDA Section to carry the translations of a Parent Section

The ‘Alert’ Section brings the most important healthcare information to the fore.  

This section highlights extreme problem(s).  Previously, ‘alerts’ were just reported as ‘problems’, which carried the risk of losing the immediacy and importance of information to the attending clinician.

An alert in meant to be “Information used to warn or call to a state of preparedness. Information flagged (or intended) to raise awareness of a potential danger to/from the subject of the IPS or to/from another individual or awareness of a potential obstacle to care.”

A concise narrative from the patient’s perspective about their present health state. This is a record of the things that a person feels it is important to communicate about their needs, strengths, values, concerns and preferences to others providing support and care.

Patients unable to communicate can be supported by a proxy author. The patient’s story, provided here, may be told by the patient or by a proxy.

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 gives an 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”.  It is recommended that the agent responsible for an allergy or adverse reaction would be used for describing the allergy, however the possibility that pre-coordinate codes (e.g. “allergy to nuts”) will be used has been here also considered. The agent responsible for  an allergy or adverse reaction it is not always a manufactured material (for example, food allergies), nor is it necessarily consumed; however  the playingEntity classCode = “MMAT” for all agents, manufactured or not is expected to be used. This choice depends on thecharacteristics of the base CDA R2 specification.

An IPS Medication entry describes a medication statement, that is a substance administration that has 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 to 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.

The source of this information can be the patient, significant other (such as a family member or spouse), or a clinician. A common scenario where this information is captured is during the history taking process during a patient visit or stay, but it could be derived from the medications information recorded into a GP’s EHR-system, in form of prescribed medication, or administration statements.

The medication information may come from sources such as the patient’s memory, from a prescription bottle, or from a list of medications the patient, clinician or other party maintains.

A medication statement is usually less specific than an a prescription or a medication administration record.  

This entry is composed by a main substanceAdministration act and a subordinate substanceAdministration act, unless it is asserted that there are no medications data. 

The first conveys information as the product, the period of administration and the route of administration; the latter is used to provide dosage information as the frequency of intakes or the amount of the medication given.

This template reflects an ongoing concern on behalf of the person that placed the allergy on a patient’s allergy list. A concern may refer to one or more allergies or intolerances. There are different kinds of status that could be related to an allergy, or more in general to a condition:

• The status of the concern (active, inactive,..)
• The status of the condition (e.g. active, inactive, resolved,..)
• The confirmation status [clinical workflow status, certainty] (e.g. confirmed, likely, unlikely,…)

Not all of them can be represented in a CDA using the statusCode elements of the concern (ACT) and observation (condition).

As long as the underlying condition is of concern to the author (i.e., as long as the allergy, whether active or resolved, is of ongoing concern and interest to the author), the statusCode is “active”.

In case the clinician deems that there is no longer any need to track the underlying conditions then the concern is inactive and the statusCode is set to “completed”. 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 became inactive, and it is present if the statusCode of the concern act is “completed”

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

This template reflects an ongoing concern on behalf of the provider that placed the concern on a patient’s problem list.  The purpose of the concern act is that of supporting the tracking of a problem or a condition.

There are different kinds of status that could be related to a condition:

• The status of the concern (active, inactive,..) 

• The status of the condition (e.g. active, inactive, resolved,..) 

• The confirmation status [clinical workflow status, certainty] (e.g. confirmed, likely, unlikely,…) 

Not all of them can be represented in a CDA using the statusCode elements of the concern (ACT) and observation (condition). 

So long as the underlying conditions are 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 conditions are 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 effectiveTime/low of the Problem 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 become inactive, and it is present if the statusCode of the concern act is “completed”.

A Problem Concern Act can contain many Problem Observations.

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”.

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”. However, the results selected for a patient summary are most often final results, with status “completed”. So in most cases, the statusCode of the Organizer is “completed”.

The  result observations contained within the organizer may use either of these templates:

• Laboratory Result Observation

• Radiology Result Observation

• Pathology Result Observation
• Result Observation (most generic template used whenever none of the above is applicable)

One Result Organizer entry groups results, which have a common context of production:

• common specialty (imaging, bacteriology, serology, chemistry,  surgical pathology, clinical, radiology …), 
• common overall interpretation, (which interprets the set of results of the Organizer),
• common biologic specimen for in vitro diagnostic observations, 
• common associated illustrative image (ObservationMedia).

The ultimate choice for sorting out results between Organizer entries belongs to the authoring person or system of the section.

This generic template is the basic set of constraints, which apply to any kind of observation grouped in a Result Organizer. The IPS Result Observation template is generic. It is further specialized by child templates, which  constrain  clinical laboratory observations or radiology observations or anatomic pathology observations. The generic IPS Result Observation template is usable in a patient summary for observations, which do not fall within one of the specialized categories.   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. However, in most cases, observations selected for an international patient summary are  results that are final and approved, and thus, have a “completed” statusCode. The result of the observation may be commented through an entryRelationship introducing an “IPS Comment activity” template.

This template constrains the results of an  anatomic pathology observation. 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 repnresented as “active” ActStatus.

This template represents an observation produced as one of the results of a radiology or other imaging study performed on a patient.  In most cases, in the context of a patient summary this observation is final and validated, which is recorded with the value “completed” in the statusCode element. Should  the observation be not final, the statusCode would indicate “active”, instead.

This template constrains the results of a clinical laboratory observation. 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.

An Immunization entry describes immunization substance administrations that have actually occurred. 

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 procedure entry is used to record procedures that have occurred, or which are planned for in the future.

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 observation represents the verification status to support the clinical status of the condition.

This subordinated observation used by the problem observation records information about the current status of a condition, for example, whether it is active, in remission, resolved, et cetera.

This subordinated observation used by the allergy observation records information about the current status of an allergy or intolerance, for example, whether it is active, in remission, resolved, et cetera.

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

This clinical statement represents the subjective assessment of the severity of the condition as evaluated by the clinician.

The Severity Observation can be associated with a Reaction Observation.  When the Severity Observation is associated with a Reaction Observation it characterizes a reaction. A person may manifest many symptoms in a reaction to a single substance, and each reaction to the substance can be represented. However, each reaction observation can have only one severity observation associated with it. For example, someone may have a rash reaction observation as well as an itching reaction observation, but each can have only one level of severity.

The medical devices entry content module describes the kind of device that is, or has been used by the patient

A pregnancy status observation records whether the patient is currently pregnant or not. If pregnant, an Expected Delivery Date may be specified as an subordinate observation.

A pregnancy outcome observation records a summary over all pregnancies.

This observation records the Pregnancy Expected Delivery Date for pregnant patients, expressed as a time stamp. The code reflects the method (operationalisation) of how the date was determined, e.g. clinically estimated, estimated from last menstruation date or last ovulation date.

Specimen Collection is used when a set of laboratory or pathology observations  produced on one or more specimens need to be associated with the minimal characteristics of the specimen(s): specimen source site and type of specimen. In addition this template enables to convey when the specimen was collected.
In a patient summary there is no need to provide more data than these 4:

• collection method, 

• source site, 

• type of specimen and 

• time of collection.

An occurrence of this template describes one specimen collected, used by the set of observations present in the same Result Organizer.

This template is used to reference (point to) information contained in other entries within the same document.

This template is a specialization of the Social History Observation that may be used to represent smoking or tobacco habits.

This template is a specialization of the Social History Observation that may be used to represent alcohol consumption habits.

A pregnancy observation is a Simple Observation that uses a specific vocabulary to record observations about a patient’s current or historical pregnancies.

This clinical statement represents Advance Directive Observation findings (e.g., “resuscitation status is Full Code”) rather than orders. It should not be considered a legal document or a substitute for the actual Advance Directive document. The related legal documents are referenced using the reference/externalReference element. The Advance Directive Observation describes the patient’s directives, including but not limited to: • Medications • Transfer of Care to Hospital • Treatment • Procedures • Intubation and Ventilation • Diagnostic Tests • Tests The observation/value element contains the detailed patient directive which may be coded or text. For example, a category directive may be antibiotics, and the details would be intravenous antibiotics only.

The procedure entry is used to record procedures which are planned for in the future.

This template represents a Planned Act. It may be a wrapper for intervention-type activities considered to be parts of the same intervention; or it could be used to describe planned acts not represented by the other care plan entry templates.

An Encounter is an interaction between a patient and care provider(s) for the purpose of providing healthcare-related service(s). Healthcare services include health assessment. Examples: outpatient visit to multiple departments, home health support (including physical therapy), inpatient hospital stay, emergency room visit, field visit (e.g., traffic accident), office visit, occupational therapy, or telephone call.

The observation request entry is used to record goals, plans or intention for an observation to be performed (e.g., assessment, laboratory test, imaging study, et cetera).

A survey panel collects related survey observations.

Survey observations are used to record responses to assessment instruments. They are simple observations conforming to the CCD Result template. The vocabulary and data type constraints on survey observations is specified elsewhere, either in the specializations of the survey observation template, or by the template that makes use of it.

This clinical statement groups a set of advance directive observations.

A Planned Immunization entry describes the intent of administrating immunization substance. 

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 observation represents the certainty associated with a propensity, or potential risk, of a reaction to the identified substance.

IPS Radiology Result Observation Component

The component carries additional detailed radiological results. Depending on it’s type the code and value have different constraints to reflect proper results.

| Type of result | Constraints for code (Value Set) | Value Domain value type | | Observation Text | IPS Results Radiology Textual Observations | String | | Observation Code | IPS Results Radiology Observation | Code | | Observation Measurement, including linear, area and volume quantity measurements | IPS Results Radiology Measurement Observation | Quantity | | Observation Measurement, including linear, area and volume range measurements | IPS Results Radiology Measurement Observation | Interval of quantity | | Observation Measurement, including linear, area and volume ratio measurements | IPS Results Radiology Measurement Observation | Ratio of quantity | | Observation Measurement, including linear, area and volume sampled data measurements | IPS Results Radiology Measurement Observation | Sample Data (Binary) |

International Patient Summary Overview (2.16.840.1.113883.10.22.1.2)

Universal Subordinate Substance Administration to convey information about dosages

Absent or Unknown Devices

ActStatusActiveCompletedAbortedCancelled

ActStatusActiveCompletedAbortedSuspended

Allergy or Intolerance Type

**description: **
Recommended values for criticality observations

DRUGActCode

IPS Allergy Reaction Value Set.

IPS Allergy Status Code

IPS Allergy Verification Status

IPS Allergy intolerance codes value set with focus on Conditions.

IPS Allergy intolerance codes value set with focus on Substances.

IPS body site value set.

This is a placeholder for the condition status code based on SNOMED CT

IPS Condition Verification Status

HL7 IPS SNOMED value set for smoking status.

IPS Healthcare Professional Roles

IPS Medical device codes value set.

IPS Medication codes value set.

IPS Medicine active substance codes value set.

EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes. This Value Set includes all the EDQM Standard Terms having: [Concept Status] = ‘Current’ AND [Concept Class] IN (‘PDF’, ‘CMT’, ‘CDF’, ‘PFT’) AND [Domain] = ‘Human and Veterinary’

PDF = ‘Pharmaceutical dose form’; CMT = ‘Combined terms’; CDF = ‘Combined pharmaceutical dose form’; PFT = ‘Patient Friendly’

EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes. This Value Set includes all the EDQM Standard Terms having: [Concept Status] = ‘Current’ AND [Concept Class] = ‘ROA’ AND [Domain] = ‘Human and Veterinary’

ROA = ‘Route of administration’

The Value Set is used (optionally) to code the type of contact relationship between a person and the patient.

IPS Pregnancies Summary

IPS Expected Delivery Date Method

IPS Pregnancy Status

This value set indicates the level of medical judgment used to determine the existence of a problem.

IPS Problem (Condition) codes value set. 

IPS Procedure codes value set. 

IPS Results Coded Values Laboratory/Pathology value set.

IPS Results Values Laboratory/Pathology value set.

Value Set Definition: LOINC {STATUS in {ACTIVE}, CLASSTYPE in {Laboratory class (1)}, CLASS exclude {LP62148-9 (NR STATS), LP175679-2 (H&P.HX.LAB), LP7785-1 (CHALSKIN), LP94892-4 (LABORDERS)}}

IPS Results Observation

IPS Results Organizer

Value Set Definition: LOINC {STATUS in {ACTIVE}, CLASS in LP29684-5 (“RAD”)}

IPS Results Radiology Textual Observation

IPS Results Specimen Collection Method

IPS Specimen Type codes value set.

IPS Vaccine codes value set.

IPS Vaccine codes value set. This value set includes codes from the World Health Organization Anatomical Therapeutic Chemical (ATC) classification system: all descendants of J07 “VACCINES”

IPS WHO ATC

Laterality (qualifier)

** Value Set Definition: **

Value Set Definition   DrawnFromCodeSystem 0.4.0.127.0.16.1.1.2.1 (EDQM)   PropertyBasedContentSet.IncludeWithProperty.Expression  (               ([Concept Status] = ‘Current’)    AND  ([Concept Class] IN (‘Administration device ; ‘Container ‘;’Closure’ )    AND  ([Domain] = ‘Human and Veterinary’)  ) 

The list of values reported hereafter is provided only as example

Medicine Strength Denominator

Medicine Strength Numerator

Problem Severity

Quantity Units