| Item |
DT |
Card |
Conf |
Description |
Label |
hl7:substanceAdministration
|
|
|
|
R |
|
(epSOSCDASubstanceAdministration) |
 |
@classCode
|
|
|
1 .. 1 |
F |
SBADM |
|
@moodCode
|
|
|
1 .. 1 |
F |
INT |
| |
Example |
<substanceAdministration classCode="SBADM" moodCode="INT">
<templateId root="2.16.840.1.113883.10.20.1.24"/>
<templateId root="1.3.6.1.4.1.12559.11.10.1.3.1.3.2"/>
<templateId root=""/>
<!-- Prescription Item ID -->
<id root="" extension=""/>
<code code="" codeSystem="" displayName="" codeSystemName=""/>
<!-- Reference to narrative text of prescription, e.g.
Pyrimon, Chloramphenicol/ Dexamethasone 1% w/v/ 0.1% w/v 5 ml Eye Drops – three
drops -->
<text>
<reference value="#med-1"/>
</text> <statusCode code="active"/>
<effectiveTime xsi:type="IVL_TS">
<low value=""/>
<high value=""/>
</effectiveTime> <effectiveTime operator="A" xsi:type="TS|PIVL_TS|EIVL_TS|SXPR_TS">
<!-- ... -->
</effectiveTime> <routeCode code="20051000" codeSystem="1.3.6.1.4.1.12559.11.10.1.3.1.44.1" displayName="Ocular use" codeSystemName="EDQM"/>
<doseQuantity value="3"/>
<!-- Optional -->
<approachSiteCode code="" codeSystem="" displayName="" codeSystemName=""/>
<rateQuantity value="" unit=""/>
<consumable>
<!-- ... -->
</consumable> <participant typeCode="AUT">
<participantRole classCode="LIC">
<id root=" " extension=" "/>
<scopingEntity classCode="ORG">
<id root=" " extension=" "/>
<desc>...</desc> </scopingEntity> </participantRole> </participant> <author>
<time/>
<assignedAuthor>
<id/>
<assignedPerson>
<name/>
</assignedPerson> </assignedAuthor> </author> <!-- 0..* entries describing the components -->
<entryRelationship typeCode="COMP">
<sequenceNumber value=""/>
</entryRelationship> <!-- Optional instructions for Pharmacist -->
<entryRelationship typeCode="SUBJ">
<!-- ... -->
</entryRelationship> <!--Optional Substitution information -->
<entryRelationship typeCode="SUBJ">
<!-- ... -->
</entryRelationship></substanceAdministration> |
|
hl7:templateId
|
|
II.EPSOS |
1 .. 1 |
M |
CCD templateId |
(epSOSCDASubstanceAdministration) |
 |
|
@root
|
|
|
1 .. 1 |
F |
2.16.840.1.113883.10.20.1.24 |
|
hl7:templateId
|
|
II.EPSOS |
1 .. 1 |
M |
epSOS templateId |
(epSOSCDASubstanceAdministration) |
|
|
@root
|
|
|
1 .. 1 |
F |
1.3.6.1.4.1.12559.11.10.1.3.1.3.2 |
|
hl7:templateId
|
|
II.EPSOS |
1 .. 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.
|
(epSOSCDASubstanceAdministration) |
|
|
@root
|
|
|
1 .. 1 |
F |
1.3.6.1.4.1.19376.1.5.3.1.4.7 |
|
hl7:templateId
|
|
II.EPSOS |
0 .. 1 |
R |
A "normal" <substanceAdministration> act that may not contain any subordinate <substanceAdministration>
acts
|
(epSOSCDASubstanceAdministration) |
|
|
@root
|
|
|
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.
|
(epSOSCDASubstanceAdministration) |
|
|
@root
|
|
|
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.
|
(epSOSCDASubstanceAdministration) |
|
|
@root
|
|
|
1 .. 1 |
F |
1.3.6.1.4.1.19376.1.5.3.1.4.9 |
|
hl7:id
|
|
II.EPSOS |
1 .. 1 |
M |
The following must be true for the prescription item ID:
- The prescription item ID must be globally unique
- In countries where there can be only one item per prescription, the prescription
item ID must be the same as the prescription ID
- The prescription item ID can be used by the prescribing system or provider to identify
the prescription to which it belongs. This provides the link from the dispensed medicine
to the prescription.
|
(epSOSCDASubstanceAdministration) |
| |
Example |
<id extension="23" root="1.2.246.556.12001.4.93.1.1"/>
|
|
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.
|
(epSOSCDASubstanceAdministration) |
| |
CONF |
|
|
hl7:text
|
|
ED |
0 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
| |
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.
|
(epSOSCDASubstanceAdministration) |
| |
Example |
<reference value="#eP_as_text"/>
|
|
hl7:statusCode
|
|
CS |
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.
|
(epSOSCDASubstanceAdministration) |
| |
CONF |
| @code shall be "active" |
| or |
| @code shall be "completed" |
|
| |
Example |
<statusCode code="active">...</statusCode> |
|
hl7:effectiveTime
|
|
IVL_TS |
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.
|
(epSOSCDASubstanceAdministration) |
| |
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).
|
|
(epSOSCDASubstanceAdministration) |
|
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.
|
(epSOSCDASubstanceAdministration) |
| |
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, otherwise both <low> and <high> have the same value. If the dose
is in countable units (tablets, caplets, "eaches"), then the unit should be valorized
= ‘1’The unit attribute – when expresses measureable units - 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 shall be derived from the value set epSOSDoseForm, OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.2.
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.
|
(epSOSCDASubstanceAdministration) |
|
|
@unit
|
|
|
1 .. 1 |
R |
|
| |
CONF |
|
| |
Example |
<doseQuantity nullFlavor="UNK">...</doseQuantity> |
|
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.
|
(epSOSCDASubstanceAdministration) |
| |
Example |
<!-- ... -->
|
|
hl7:consumable
where
[hl7:manufacturedProduct [hl7:templateId/@root='1.3.6.1.4.1.12559.11.10.1.3.1.3.1']] |
|
|
1 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
@typeCode
|
|
|
1 .. 1 |
F |
CSM |
| |
Contains |
1.3.6.1.4.1.12559.11.10.1.3.1.3.1 epSOS CDA ManufacturedProduct (DYNAMIC)
|
| Included from 2.16.840.1.113883.3.1937.777.10.10.103 epSOS CDA author prescriber (DYNAMIC) 0..* Required
|
|
hl7:author
|
|
|
0 .. * |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
@typeCode
|
|
|
0 .. 1 |
F |
AUT |
|
|
@contextControlCode
|
|
|
0 .. 1 |
F |
OP |
| |
Example |
<author>
<time value="20121229"/>
<assignedAuthor>
<id root="2.16.840.1.113883.2.9.4.3.2" extension="RSSMRA00A01F205F" assigningAuthorityName="Ministero Economia e Finanze"/>
<addr>
<streetAddressLine>Viale della Cristallina 3</streetAddressLine> <city>Bologna</city> <state>BO</state> <postalCode>40121</postalCode> <country>IT</country> </addr> <telecom use="WP" value="tel:(+39)051-34343434"/>
<assignedPerson>
<name>
<given>Paolo</given> <family>Rossi</family> </name> </assignedPerson> </assignedAuthor></author> |
|
|
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.
|
(epSOSCDASubstanceAdministration) |
|
|
hl7:assignedAuthor
|
|
|
1 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
|
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. |
|
|
II.EPSOS |
1 .. * |
R |
HP ID number |
R1.10.5 |
|
|
|
0 .. 1 |
F |
NA |
|
|
CE.EPSOS |
0 .. 1 |
R |
HP Specialty |
R1.10.7 |
|
|
AD.EPSOS |
1 .. * |
R |
|
IHE PCC |
|
|
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 |
|
|
|
0 .. 1 |
|
|
| |
CONF |
|
|
|
|
1 .. 1 |
M |
|
(epSOSCDASubstanceAdministration) |
|
|
|
0 .. 1 |
F |
PSN |
|
|
|
0 .. 1 |
F |
INSTANCE |
|
|
PN |
1 .. 1 |
R |
HP Name |
IHE PCC |
| |
Example |
<name>
<given>John</given> <family>Español Smith</family></name> |
|
|
|
1 .. * |
R |
HP Family Name/Surname |
R1.10.1 |
|
|
|
1 .. * |
R |
HP Given Name |
R1.10.2 |
|
|
|
1 .. * |
R |
HP Prefix |
R1.10.3 |
|
|
|
1 .. * |
R |
HP Suffix |
R1.10.4 |
|
|
|
hl7:representedOrganization
|
|
|
1 .. 1 |
R |
|
R1.10.9 |
| |
Contains |
2.16.840.1.113883.3.1937.777.10.10.111 epSOS CDA Organization (DYNAMIC)
|
| Included from 2.16.840.1.113883.3.1937.777.10.10.134 CDA Participant (Body) (DYNAMIC) 0..* Required
|
|
hl7:participant
|
|
|
0 .. * |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
@typeCode
|
|
cs |
1 .. 1 |
R |
|
| |
CONF |
|
|
|
@contextControlCode
|
|
|
1 .. 1 |
F |
OP |
|
|
hl7:time
|
|
IVL_TS |
0 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
hl7:awarenessCode
|
|
CE.EPSOS |
0 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
| |
CONF |
|
|
|
hl7:participantRole
|
|
|
1 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
|
0 .. 1 |
F |
ROL |
|
|
II.EPSOS |
0 .. * |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
CE.EPSOS |
0 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
|
1 .. 1 |
F |
2.16.840.1.113883.5.111 (RoleCode) |
|
|
AD |
0 .. * |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
TEL |
0 .. * |
R |
|
(epSOSCDASubstanceAdministration) |
Choice min 0 element(s) and max 1 element(s). Elements to choose from:
- hl7:playingDevice containing hl7:code from template CDA Device (DYNAMIC)
- hl7:playingEntity containing hl7:code from template CDA PlayingEntity (DYNAMIC)
|
|
|
|
|
R |
|
(epSOSCDASubstanceAdministration) |
| |
Contains |
2.16.840.1.113883.3.1937.777.10.10.129 CDA Device (DYNAMIC)
|
|
|
|
|
R |
|
(epSOSCDASubstanceAdministration) |
| |
Contains |
2.16.840.1.113883.3.1937.777.10.10.128 CDA PlayingEntity (DYNAMIC)
|
|
|
|
0 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
|
0 .. 1 |
F |
ENT |
|
|
|
0 .. 1 |
F |
INSTANCE |
|
|
II.EPSOS |
0 .. * |
R |
|
(epSOSCDASubstanceAdministration) |
|
|
CE.EPSOS |
0 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
| |
CONF |
|
|
|
ED |
0 .. 1 |
R |
|
(epSOSCDASubstanceAdministration) |
|
hl7:entryRelationship
where
[hl7:act [hl7:templateId/@root='2.16.840.1.113883.10.20.1.43' and hl7:templateId/@root='1.3.6.1.4.1.19376.1.5.3.1.4.3.1']] |
|
|
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'.
|
(epSOSCDASubstanceAdministration) |
|
|
@typeCode
|
|
|
1 .. 1 |
F |
SUBJ |
|
|
@inversionInd
|
|
bl |
1 .. 1 |
R |
|
| |
Contains |
1.3.6.1.4.1.19376.1.5.3.1.4.3.1 Entry Medication FulFillment Instructions (DYNAMIC)
|
|
hl7:entryRelationship
|
|
|
0 .. 1 |
R |
An entry relationship may be present to provide the substitution instructions. When
present, this entry relationship SHALL contain one and only one observation.
This observation SHALL have :
- the code element valorized with @code=‟SUBST' and @codeSystem='2.16.840.1.113883.5.6'
- the value element valorized with one of the value of the epSOSSubstitutionCode Value
Set (Vaue Set OID 1.3.6.1.4.1.12559.11.10.1.3.1.42.7). Nullflavor is not allowed.
NOTE:
Within the epSOS-I scope the “N” code shall be interpreted as No substitution allowed
excepting for the Package Size.
The presence of any other code that is not “N”, or the absence of the substitution
instructions, means that also the brand name (as well as the Package Size) can be
changed.
|
(epSOSCDASubstanceAdministration) |
|
|
@typeCode
|
|
|
1 .. 1 |
F |
SUBJ |
|
|
hl7:observation
|
|
|
|
|
|
(epSOSCDASubstanceAdministration) |
|
|
|
0 .. 1 |
F |
OBS |
|
|
|
0 .. 1 |
F |
EVN |
|
|
|
1 .. 1 |
M |
|
(epSOSCDASubstanceAdministration) |
|
|
|
1 .. 1 |
F |
SUBST |
|
|
|
1 .. 1 |
F |
2.16.840.1.113883.5.6 (ActClass) |
|
|
|
1 .. 1 |
M |
|
(epSOSCDASubstanceAdministration) |
| |
CONF |
|
Template epSOS CDA substanceAdministration