Item | DT | Card | Conf | Description | Label |
---|
hl7:substanceAdministration
| | | R | The general model is to record each prescribed medication in a <substanceAdministration> intent (moodCode='INT'). To record medications which were taken in the past, the moodCode shall be set to 'EVN'. The <substanceAdministration> element may contain subordinate <substanceAdministration> elements in a related component entry to deal with special cases (see the following sections below on Special Cases). These cases include split, tapered, or conditional dosing, or combination medications. The use of subordinate <substanceAdministration> elements to deal with these cases is optional. The comment field should always be used in these cases to provide the same information as free text in the top level <substanceAdministration> element. There are a variety of special cases for dosing that need to be accounted for. These are described below. Most of these special cases involve changing the dosage or frequency over time, or based on some measurement. When the dosage changes, then additional entries are required for each differing dosage. The last case deals with combination medications.
For the purposes of WP3.5 only the normal, the split dosing and the combination medications are addressed. - Normal Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.7.1
This template identifier is used to identify medication administration events that do not require any special processing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. Medications that use this template identifier shall not use subordinate <substanceAdministation> acts. - Combination Medications 1.3.6.1.4.1.19376.1.5.3.1.4.11
This template identifier is used to identify medication administration events that require special processing to handle combination medications. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A combination medication is made up of two or more other medications. These may be prepackaged, such as Percocet, which is a combination of Acetaminophen and oxycodone in predefined ratios, or prepared by a pharmacist, such as a GI cocktail. In the case of the prepackaged combination, it is sufficient to supply the name of the combination drug product, and its strength designation in a single <substanceAdministation> entry. The dosing information should then be recorded as simply a count of administration units. In the latter case of a prepared mixture, the description of the mixture should be provided as the product name (e.g., "GI Cocktail"), in the <substanceAdministration> entry. That entry may, but is not required, to have subordinate <substanceAdministration> entries included beneath it to record the components of the mixture. - Split Dosing 1.3.6.1.4.1.19376.1.5.3.1.4.9
This template identifier is used to identify medication administration events that require special processing to handle split dosing. The parent template is 1.3.6.1.4.1.19376.1.5.3.1.4.7. A split dose is often used when different dosages are given at different times (e.g., at different times of day, or on different days). This may be to account for different metabolism rates at different times of day, or to simply address drug packaging deficiencies (e.g., and order for Coumadin 2mg on even days, 2.5mg on odd days is used because Coumadin does not come in a 2.25mg dose form). In this case a subordinate <substanceAdministration> entry is required for each separate dosage.
Other template IDs exist for the tapered doses, split dosing, conditional dosing, and combination medications. The reader is pointed to the PCC-TF:2 section 6.1.4.16.5. For the epSOS purposes, only the normal, the combination and the split dosing are described. | MediItem |
@classCode
| cs | 1 … 1 | F | SBADM |
@moodCode
| cs | 1 … 1 | R | |
| CONF | @moodCode shall be "INT" | or | @moodCode shall be "EVN" |
|
hl7:templateId
| II.EPSOS | 0 … 1 | R | (CCD) | MediItem |
@root
| uid | 1 … 1 | F | 2.16.840.1.113883.10.20.1.24 |
hl7:templateId
| II.EPSOS | 0 … 1 | R | IHE PCC templateId Note: The usage of statusCode values different from “completed” makes this specification not formally compliant with the current IHE PCC specification of the Medication Item Entry Content Module. All the requirements of conformance assertion with these IHE PCC templates cannot therefore be applied until the revision – if any - of the referenced IHE PCC templates. | MediItem |
@root
| uid | 1 … 1 | F | 1.3.6.1.4.1.19376.1.5.3.1.4.7 |
hl7:templateId
| II.EPSOS | 1 … 1 | R | (epSOS) | MediItem |
@root
| uid | 1 … 1 | F | 1.3.6.1.4.1.12559.11.10.1.3.1.3.4 |
hl7:templateId
| II.EPSOS | 0 … 1 | R | A "normal" <substanceAdministration> act that may not contain any subordinate <substanceAdministration> acts | MediItem |
@root
| uid | 1 … 1 | F | 1.3.6.1.4.1.19376.1.5.3.1.4.7.1 |
hl7:templateId
| II.EPSOS | 0 … 1 | R | A <substanceAdministration> act that records combination medication component information in subordinate <substanceAdministration> acts. | MediItem |
@root
| uid | 1 … 1 | F | 1.3.6.1.4.1.19376.1.5.3.1.4.11 |
hl7:templateId
| II.EPSOS | 0 … 1 | R | A <substanceAdministration> act that records split dose information in subordinate <substanceAdministration> acts. | MediItem |
@root
| uid | 1 … 1 | F | 1.3.6.1.4.1.19376.1.5.3.1.4.9 |
hl7:id
| II.EPSOS | 1 … 1 | M | A top level <substanceAdministration> element must be uniquely identified. This can be the prescription item ID if appropriate. Although HL7 allows for multiple identifiers, one and only one shall be used. | MediItem |
hl7:code
| CD.EPSOS | 0 … 1 | R | The <code> element is used to supply a code that describes the <substanceAdminstration> act, not the medication being administered or prescribed. This may be a procedure code, such as those found in ICD-10, or may describe the method of medication administration, such as by intravenous injection. The type of medication is coded in the consumable; do not supply the code for the medication in this element. This element is optional.
Note: One of the values from the Value Set epSOSCodeNoMedication shall be used in the <code> element to record that a patient is either not on medications, or that medications are not known. | MediItem |
| CONF | |
hl7:text
| ED | 0 … 1 | R | | MediItem |
| |
| Example | <text>...</text> |
hl7:reference
| | 0 … 1 | R | The URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. | MediItem |
| Example | <reference value="#eP_as_text"/> |
hl7:statusCode
| CS | 1 … 1 | M | The status of all <substanceAdministration> elements must be either "active" or "completed". Status of "active" indicates a currently valid prescription, status of completed indicates a previously taken medication. | MediItem |
| CONF | @code shall be "active" | or | @code shall be "completed" |
|
| Example | <statusCode code="active"/> |
hl7:effectiveTime
| IVL_TS | 1 … 1 | R | The first <effectiveTime> element encodes the start and stop time of the medication regimen. This an interval of time (xsi:type='IVL_TS'), and must be specified as shown. This is an additional constraint placed upon CDA Release 2.0 by this profile, and simplifies the exchange of start/stop and frequency information between EMR systems. The <low> and <high> values of the first <effectiveTime> element represent the start and stop times for the medication. The <low> value represents the start time, and the <high> value represents the stop time. If either the <low> or the <high> value is unknown, this shall be recorded by setting the nullFlavor attribute to UNK.
The <high> value records the end of the medication regime according to the information provided in the prescription or order. For example, if the prescription is for enough medication to last 30 days, then the high value should contain a date that is 30 days later then the <low> value. The rationale is that a provider, seeing an un-refilled prescription would normally assume that the medication is no longer being taken, even if the intent of the treatment plan is to continue the medication indefinitely.
| MediItem |
where [1] | |
| |
| Example | <effectiveTime xsi:type="IVL_TS"> <low value="20130321"/> <high value="20140321"/></effectiveTime> |
hl7:effectiveTime
| | 1 … * | R | The second <effectiveTime> element records the frequency of administration. This <effectiveTime> element must be intersected with the previous time specification (operator='A'), producing the bounded set containing only those time specifications that fall within the start and stop time of the medication regimen. Several common frequency expressions appear in the table below, along with their XML representations. This effectiveTime has a xsi:type of either TS, PIVL_TS, EIVL_TS, or SXPR_TS. Frequency | Description | XML Representation | b.i.d. | Twice a day | <effectiveTime xsi:type='PIVL_TS' institutionSpecified='true' operator='A'> <period value='12' unit='h' /></effectiveTime> | q12h | Every 12 hours | <effectiveTime xsi:type='PIVL_TS' institutionSpecified='false' operator='A'> <period value='12' unit='h' /></effectiveTime> | Once | Once, on 2005-09-01 at 1:18am. | <effectiveTime xsi:type='TS' value='200509010118'/> | t.i.d. | Three times a day, at times determined by the person administering the medication . | <effectiveTime xsi:type='PIVL_TS' institutionSpecified='true' operator='A'> <period value='8' unit='h' /></effectiveTime> | q8h | Every 8 hours | <effectiveTime xsi:type='PIVL_TS' institutionSpecified='false' operator='A'> <period value='8' unit='h' /></effectiveTime> | qam | In the morning | <effectiveTime xsi:type='EIVL' operator='A'> <event code='ACM'/></effectiveTime> | | Every day at 8 in the morning for 10 minutes | <effectiveTime xsi:type='PIVL_TS' operator='A'> <phase> <low value="198701010800" inclusive="true"/> <width value="10" unit="min"/> </phase> <period value='1' unit='d'/></effectiveTime> | q4-6h | Every 4 to 6 hours. | <effectiveTime xsi:type="PIVL_TS" institutionSpecified="false" operator="A"> <period xsi:type="PPD_PQ" value="5" unit="h"> <standardDeviation value="1" unit="h"/> </period></effectiveTime> |
The mean (average) of the low and high values is specified for the period. The mean of 4 and 6 is 5. The standard deviation is recorded as one half the differences between the high and low values, with an unspecified distribution. The type attribute of the <effectiveTime> element describes the kind of frequency specification it contains. More detail is given for each type in the table below.
xsi:type | Description | TS | An xsi:type of TS represents a single point in time, and is the simplest of all to represent. The value attribute of the <effectiveTime> element specifies the point in time in HL7 date-time format (CCYYMMDDHHMMSS) | PIVL_TS | An xsi:type of PIVL_TS is the most commonly used, representing a periodic interval of time. The <low> element of <phase> may be present. If so it specifies the starting point, and only the lower order components of this value are relevant with respect to the <period>. The <width> element represents the duration of the dose administration (e.g., for IV administration). The <period> indicates how often the dose is given. Legal values for the unit attribute of <period> are s, min, h, d, wk and mo representing seconds, minutes, hours, days, weeks, and months respectively. | EIVL_TS | An xsi:type of EIVL_TS represents an event based time interval, where the event is not a precise time, but is often used for timing purposes (e.g. with meals, between meals, before breakfast, before sleep). Refer to the HL7 TimingEvent vocabulary for the codes to use for the <event> element. This interval may specify an <offset> which provides information about the time offset from the specified event (e.g., <offset><low value='-1' unit='h'/><width value='10' unit='min'/></offset> means 1 hour before the event. In that same example, the <width> element indicates the duration for the dose to be given. | SXPR_TS | An xsi:type of SXPR_TS represents a parenthetical set of time expressions. This type is used when the frequency varies over time (e.g., for some cases of tapered dosing, or to handle split dosing). The <comp> elements of this <effectiveTime> element are themselves time expressions (using any of the types listed above). Each <comp> element may specify an operator (e.g. to intersect or form the union of two sets). |
| MediItem |
where [position()>1] | |
| |
@operator
| cs | 1 … 1 | F | A |
hl7:routeCode
| CE.EPSOS | 0 … 1 | R | The <routeCode> element specifies the route of administration using the EDQM route of administration vocabulary. A code must be specified if the route is known, and the displayName attribute should be specified. If the route is unknown, this element shall not be sent. | MediItem |
| |
| CONF | |
hl7:doseQuantity
| IVL_PQ | 0 … 1 | R | The dose is specified in the <doseQuantity> element. If a dose range is given (e.g., 1-2 tablets, or 325-750mg), then the <low> and <high> bounds are specified in their respective elements... If the dose is in countable items (tablets, caplets, "eaches"), then the unit should be valorized = ‘1’. In this case it is allowed to used the UCUM annotations for describing the type of countable items (e.g. .{tablet}, {puff},..). The unit attribute – when expresses unit of measures- shall be derived from the Value Sets epSOSUnits, 1.3.6.1.4.1.12559.11.10.1.3.1.42.16 based on the UCUM code system. The countable units attribute is derived from the value set epSOSDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2 | MediItem |
| |
| Example | <doseQuantity nullFlavor="UNK">...</doseQuantity> |
| Example | <doseQuantity value="2" unit="{tablet}"/> |
hl7:rateQuantity
| IVL_PQ | 0 … 1 | R | The rate is specified in the <rateQuantity> element. The rate is given in units that have measure over time. In this case, the units should be specified as a string made up of a unit of measure (see doseQuantity above), followed by a slash (/), followed by a time unit (s, min, h or d). Again, if a range is given, then the <low> and <high> elements contain the lower and upper bound of the range, otherwise, they contain the same value. Any <low> and <high> elements used for <doseQuantity> or <rateQuantity> should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document.
In a CDA document, any <low> and <high> elements used for <doseQuantity> or <rateQuantity> SHOULD contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document.
| MediItem |
hl7:consumable
| | 1 … 1 | R | The <consumable> element shall be present, and shall contain a <manufacturedProduct> element, conforming to the Medicine Entry Content module template. Contains 1.3.6.1.4.1.12559.11.10.1.3.1.3.1 epSOS CDA ManufacturedProduct (DYNAMIC) | MediItem |
@typeCode
| cs | 0 … 1 | F | CSM |
Included | 0 … * | R | from 2.16.840.1.113883.3.1937.777.11.10.103 epSOS CDA author prescriber (DYNAMIC) In the case where there is a prescriber of a medication, the prescriber is represented by the <author> element of the entry. See the Prescriber description for the structure of the <author> element. |
hl7:author
| | 0 … * | R | | epSOiber |
@typeCode
| cs | 0 … 1 | F | AUT |
@contextControlCode
| cs | 0 … 1 | F | OP |
hl7:functionCode
| CE.EPSOS | 1 … 1 | M | | R1.10.6 |
| CONF | |
hl7:time
| TS.EPSOS.TZ | 1 … 1 | R | The author/time element represents the start time of the author’s participation in the creation of the clinical document. The author/time element SHALL be present. | epSOiber |
hl7:assignedAuthor
| | 1 … 1 | R | | epSOiber |
@classCode
| cs | 0 … 1 | F | ASSIGNED |
| Schematron assert | role | error | |
| test | @nullFlavor or hl7:assignedPerson or hl7:assignedAuthoringDevice | |
| Message | If assignedAuthor has an associated representedOrganization with no assignedPerson or assignedAuthoringDevice, then the value for "ClinicalDocument/author/assignedAuthor/id/@NullFlavor" SHALL be "NA" "Not applicable" 2.16.840.1.113883.5.1008 NullFlavor STATIC. | |
hl7:id
| II.EPSOS | 1 … * | R | HP ID number | R1.10.5 |
@nullFlavor
| cs | 0 … 1 | F | NA |
hl7:code
| CE.EPSOS | 0 … 1 | R | HP Specialty | R1.10.7 |
hl7:addr
| AD.EPSOS | 1 … * | R | | IHE PCC |
hl7:telecom
| TEL.EPSOS | 1 … * | R | Attribute @value SHALL contain a URI if element telecom is used. The URI scheme SHALL be one of URLScheme | IHE PCC / R1.10.8 / R1.10.8.1 / R1.10.8.2 |
@use
| set_cs | 0 … 1 | | |
| CONF | |
hl7:assignedPerson
| | 1 … 1 | M | | epSOiber |
@classCode
| cs | 0 … 1 | F | PSN |
@determinerCode
| cs | 0 … 1 | F | INSTANCE |
hl7:name
| PN | 1 … 1 | R | HP Name | IHE PCC |
| Example | <name> <given>John</given> <family>Español Smith</family></name> |
hl7:family
| | 1 … * | R | HP Family Name/Surname | R1.10.1 |
hl7:given
| | 1 … * | R | HP Given Name | R1.10.2 |
hl7:prefix
| | 0 … * | R | HP Prefix | R1.10.3 |
hl7:suffix
| | 0 … * | R | HP Suffix | R1.10.4 |
hl7:representedOrganization
| | 1 … 1 | R | Contains 2.16.840.1.113883.3.1937.777.11.10.111 epSOS CDA Organization (DYNAMIC) | R1.10.9 |
hl7:entryRelationship
| | 0 … * | R | An entry relationship may be present to provide the fulfillment instructions. When present, this entry relationship shall contain a Medication Fulfillment Instructions entry content module. Again, a related statement is made about the medication or immunization. In CDA, this observation is recorded inside an <entryRelationship> element occurring at the end of the substance administra- tion or supply entry. The containing <act> is the subject (typeCode='SUBJ') of this new observation, which is the inverse of the normal containment structure, thus inversionInd='true'. Contains 1.3.6.1.4.1.19376.1.5.3.1.4.3.1 Entry Medication FulFillment Instructions (DYNAMIC) | MediItem |
@typeCode
| cs | 1 … 1 | F | SUBJ |
@inversionInd
| bl | 1 … 1 | R | |
hl7:entryRelationship
| | 0 … * | R | A top level <substanceAdministration> element may contain one or more related components, either to handle split dosing, or to support combination medications. In the first case, the subordinate components shall specify only the changed <effectiveTime> and/or <doseQuantity> elements. The value of the <sequenceNumber> shall be an ordinal number, starting at 1 for the first component, and increasing by 1 for each subsequent component. Components shall be sent in <sequenceNumber> order. This information is given for informative purposes as only normal or combination medications are administered in epSOS. | MediItem |
@typeCode
| cs | 1 … 1 | F | COMP |
hl7:sequenceNumber
| INT | 1 … 1 | M | | MediItem |