Radiopharmaceutical Radiation Dose SR IOD Templates

Radiopharmaceutical Radiation Dose SR IOD Templates
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The templates that comprise the Radiopharmaceutical Radiation Dose SR are interconnected as in Figure A-17.

Figure A-17. Radiopharmaceutical Radiation Dose SR IOD Template Structure

TID 10021 Radiopharmaceutical Radiation Dose

This template defines a container (the root) with subsidiary content items, each of which corresponds to a single Radiopharmaceutical Administration Dose event entry. There is a defined recording observer (the system and/or person responsible for recording the assay of the radiopharmaceutical, and the person administered the radiopharmaceutical). Multiple Radiopharmaceutical Radiation Dose objects may be created for one study. Radiopharmaceutical Start DateTime in TID 10022 “Radiopharmaceutical Administration Event Data” will convey the order of administrations.

Type:: Extensible
Order:: Significant
Root:: Yes

Table TID 10021. Radiopharmaceutical Radiation Dose

	NL	Rel with Parent	VT	Concept Name	VM	Req Type	Value Set Constraint
1			CONTAINER	EV (113500, DCM, "Radiopharmaceutical Radiation Dose Report")	1	M
2	>	HAS CONCEPT MOD	CODE	EV (G-C2D0, SRT, "Associated Procedure")	1	M	DCID 3108 “NM/PET Procedures”
3	>>	HAS CONCEPT MOD	CODE	EV (G-C0E8, SRT, "Has Intent")	1	M	DCID 3629 “Procedure Intent”
4	>	CONTAINS	INCLUDE	DTID 10022 “Radiopharmaceutical Administration Event Data”	1	M
5	>	CONTAINS	INCLUDE	DTID 10024 “Radiopharmaceutical Administration Patient Characteristics”	1	U
6	>	CONTAINS	TEXT	EV (121106, DCM, "Comment")	1	U

Content Item Descriptions

Row 2

The associated procedure is the procedure performed, or if no procedure was performed the procedure that was ordered.

TID 10022 Radiopharmaceutical Administration Event Data

The Radiopharmaceutical Administration Event conveys the dose and assay and time information of a single radiopharmaceutical event. A Radiopharmaceutical Administration event is one radioactive pharmaceutical administered to a patient.

Type:: Extensible
Order:: Significant

Table TID 10022. Radiopharmaceutical Administration Event Data

	NL	Rel with Parent	VT	Concept Name	VM	Req Type	Condition	Value Set Constraint
1			CONTAINER	EV (113502, DCM, "Radiopharmaceutical Administration")	1	M
2	>	CONTAINS	CODE	EV (F-61FDB, SRT, "Radiopharmaceutical agent")	1	M		DCID 25 “Radiopharmaceuticals” DCID 4021 “PET Radiopharmaceutical”
3	>>	HAS PROPERTIES	CODE	EV (C-10072, SRT, "Radionuclide")	1	M		DCID 18 “Isotopes in Radiopharmaceuticals” DCID 4020 “PET Radionuclide”
4	>>	HAS PROPERTIES	NUM	EV (R-42806, SRT, "Radionuclide Half Life")	1	M		UNITS = EV (s, UCUM, "seconds")
5	>	CONTAINS	NUM	EV (123007, DCM, "Radiopharmaceutical Specific Activity")	1	U		UNITS = EV (Bq/mmol, UCUM, "Bq/mmol")
6	>	CONTAINS	UIDREF	EV (113503, DCM, "Radiopharmaceutical Administration Event UID")	1	M
7	>	CONTAINS	CODE	EV (113505, DCM, "Intravenous Extravasation Symptoms")	1-n	U		DCID 10043 “Intravenous Extravasation Symptoms”
8	>	CONTAINS	NUM	EV (113506, DCM, "Estimated Extravasation Activity")	1	U		UNITS = EV(%, UCUM, "percent")
9	>	CONTAINS	DATETIME	EV (123003, DCM, "Radiopharmaceutical Start DateTime")	1	M
10	>	CONTAINS	DATETIME	EV (123004, DCM, "Radiopharmaceutical Stop DateTime")	1	U
11	>	CONTAINS	NUM	EV (113507, DCM, "Administered activity")	1	M		UNITS = EV (MBq, UCUM, "MBq")
12	>	CONTAINS	NUM	EV (123005, DCM, "Radiopharmaceutical Volume")	1	U		UNITS = EV (cm3, UCUM, "cm3")
13	>	CONTAINS	NUM	EV (113508, DCM, "Pre-Administration Measured Activity")	1	U		UNITS = EV (MBq, UCUM, "MBq")
14	>>	HAS OBS CONTEXT	CODE	EV (113540, DCM, "Activity Measurement Device")	1	U		DCID 10041 “Source of Radioisotope Activity Information”
15	>>	HAS OBS CONTEXT	INCLUDE	DTID 1002 “Observer Context”	1-n	U
16	>	CONTAINS	NUM	EV (113509, DCM, "Post-Administration Measured Activity")	1	U		UNITS = EV (MBq, UCUM, "MBq")
17	>>	HAS OBS CONTEXT	CODE	EV (113540, DCM, "Activity Measurement Device")	1	U		DCID 10041 “Source of Radioisotope Activity Information”
18	>>	HAS OBS CONTEXT	INCLUDE	DTID 1002 “Observer Context”	1-n	U
19	>	CONTAINS	INCLUDE	DTID 10023 “Organ Dose”	1-n	U
20	>	CONTAINS	CODE	EV (G-C340, SRT, "Route of administration")	1	M		BCID 11 “Route of Administration”
21	>>	HAS PROPERTIES	CODE	EV (G-C581, SRT, "Site of")	1	MC	IF Row 22 equals (G-D101, SRT, "Intravenous route") or (G-D103, SRT, "Intramuscular route")	DCID 3746 “Percutaneous Entry Site”
22	>>>	HAS CONCEPT MOD	CODE	EV (G-C171, SRT, "Laterality")	1	MC	IF Row 23 has laterality	DCID 244 “Laterality”
23	>	HAS OBS CONTEXT	INCLUDE	DTID 1020 “Person Participant”	1-n	M		$PersonProcedureRole = EV (113851, DCM, "Irradiation Administering")
24	>	CONTAINS	CODE	EV (121147, DCM, "Billing Code(s) ")	1-n	U
25	>	CONTAINS	CODE	EV (113510, DCM, "Drug Product Identifier")	1-n	U
26	>	CONTAINS	TEXT	EV (111529, DCM, "Brand Name")	1	U
27	>	CONTAINS	TEXT	EV (113511, DCM, "Radiopharmaceutical Dispense Unit Identifier")	1	U
28	>>	CONTAINS	TEXT	EV (113512, DCM, "Radiopharmaceutical Lot Identifier")	1-n	U
29	>>	CONTAINS	TEXT	EV (113513, DCM, "Reagent Vial Identifier")	1-n	U
30	>>	CONTAINS	TEXT	EV (113514, DCM, "Radionuclide Identifier")	1-n	U
31	>	CONTAINS	TEXT	EV (113516, DCM, "Prescription Identifier")	1	U
32	>	CONTAINS	TEXT	EV (121106, DCM, "Comment")	1	U

Content Item Descriptions

Row 4	The value of Half-life that was used for computing the decay of the administered radiopharmaceutical. It is not intended for use by the receiver for any further computation.
Row 5	Activity per unit mass of the radiopharmaceutical at Radiopharmaceutical Start Time
Row 6	Unique identification of a single radiopharmaceutical administration event.
Row 8	The estimated percentage of administered activity lost at the injection site. The estimation includes extravasation, paravenous administration and leakage at the injection site.
Row 9	The time the radiopharmaceutical was administered to the patient for imaging purposes.
Row 11	Total amount of radioactivity administered to the patient at Radiopharmaceutical Start Time. It is a computed field from the TID 10022 Pre-Administration Measured Activity Row 13, TID 10022 Post-Administration Measured Activity Row 17, Radionuclide Half Life Row 4 and Radiopharmaceutical Start Time Row 9. Does not include estimated extravasation activity.
Rows 13, 16	Observation DateTime (0040,A032) shall be used to record when the measurement was taken.
Row 23	Identifies the person administering the product.
Row 24	The billing codes for the preparation and administration of the radiopharmaceutical. It does not include performance and interpretation of the imaging.
Row 25	Registered drug establishment code for the product. A coding scheme example is NDC, WHO-DDE or RxNorm. Multiple entries can be used for equivalent drug product codes.
Row 27	The human readable identification of the specific radiopharmaceutical quantity (dose) administered to the patient.
Row 28	Identifies the vial, batch or lot number from which the individual radiopharmaceutical quantity (dose) was produced. Row 27 the Radiopharmaceutical Identifier records the identification for each individual dose.
Row 29	Identifies the lot or unit serial number for the reagent component for the radiopharmaceutical identified in row 27.
Row 30	Identifies the lot or unit serial number for the radionuclide component for the radiopharmaceutical identified in row 27.

TID 10023 Organ Dose

This template conveys the information about the dose to a single organ.

Type:: Extensible
Order:: Significant

Table TID 10023. Organ Dose

	NL	Rel with Parent	VT	Concept Name	VM	Req Type	Condition	Value Set Constraint
1			CONTAINER	EV (113517, DCM, "Organ Dose Information")	1	M
2	>	HAS CONCEPT MOD	CODE	EV (G-C0E3, SRT, "Finding Site")	1	M		DCID 10044 “Radiosensitive Organs”
3	>	HAS CONCEPT MOD	CODE	EV (G-C171, SRT, "Laterality")	1	MC	IFF anatomy has laterality	DCID 244 “Laterality”
4	>	CONTAINS	NUM	EV (G-D701, SRT, "Mass")	1	U		UNITS = EV (g, UCUM, "grams")
5	>>	HAS CONCEPT MOD	TEXT	EV (G-C036, SRT, "Measurement Method")	1	M
6	>	CONTAINS	NUM	EV (113518, DCM, "Organ Dose")	1	M		UNITS = EV (mGy, UCUM, "mGy")
7	>>	HAS PROPERTIES	CODE	EV (121406, DCM, "Reference Authority")	1	MC	XOR Row 8	BCID 10040 “Radiopharmaceutical Organ Dose Reference Authority”
8	>>	HAS PROPERTIES	TEXT	EV (121406, DCM, "Reference Authority")	1	MC	XOR Row 7

Content Item Descriptions

Row 3	For paired organs,use (G-A102, SRT, "Right and Left") to report the estimated absorbed dose for both organs.
Row 4	The estimated mass of organ in grams used when calculating the organ dose.
Row 5	Method used to obtain the estimate. This could include a method that does not involve performing a measurement (e.g., Standard Organ Mass Tables).
Row 6	Organ dose (in units of mGy). Organ is specified by row 2.

TID 10024 Radiopharmaceutical Administration Patient Characteristics

This template describes the characteristics of the patient that are specific to the current clinical presentation (visit). The characteristics noted may affect the activity received, and how dose is calculated for the patient. Patient Characteristic concepts in this template, which may replicate attributes in the Patient Study Module, are included here as possible targets of by-reference relationships from other content items in the SR tree.

Type:: Extensible
Order:: Significant

Table >TID 10024. Radiopharmaceutical Administration Patient Characteristics

	NL	Rel with Parent	VT	Concept Name	VM	Req Type	Value Set Constraint
1			CONTAINER	EV (121118, DCM, "Patient Characteristics")
2	>	CONTAINS	CODE	EV (109054, DCM, "Patient state")	1-n	U	DCID 10045 “Radiopharmaceutical Patient State”
3	>	CONTAINS	NUM	EV (121033, DCM, "Subject Age")	1	U	UNITS = DCID 7456 “Units of Measure for Age”
4	>	CONTAINS	CODE	EV (121032, DCM, "Subject Sex")	1	U	DCID 7455 “Sex”
5	>	CONTAINS	NUM	EV (8302-2, LN, "Patient Height")	1	U	UNITS = EV (cm, UCUM, "cm")
6	>	CONTAINS	NUM	EV (29463-7, LN, "Patient Weight")	1	U	UNITS = EV (kg, UCUM, "kg").
7	>	CONTAINS	NUM	EV (8277-6, LN, "Body Surface Area")	1	U	UNITS = EV (m2, UCUM, "m^2")
8	>>	INFERRED FROM	CODE	EV (8278-4, LN, "Body Surface Area Formula")	1	U	BCID 3663 “Body Surface Area Equations”
9	>	CONTAINS	NUM	EV (F-01860, SRT, "Body Mass Index")	1	U	UNITS = EV (kg/m2, UCUM, "kg/m^2")
10	>>	INFERRED FROM	CODE	EV (121420, DCM, "Equation")	1	U	DT (122265, DCM, "BMI = Wt/Ht^2")
11	>	CONTAINS	NUM	EV (14749-6, LN, "Glucose")	1	U	UNITS = EV ("mmol/l", UCUM, "mmol/l")
12	>	CONTAINS	NUM	EV(113550, DCM, "Fasting Duration")	1	U	UNITS = DT (h, UCUM, "hours")
13	>	CONTAINS	NUM	EV(113551, DCM, "Hydration Volume")	1	U	UNITS = DT (ml, UCUM, "ml")
14	>	CONTAINS	TEXT	EV (113552, DCM, "Recent Physical Activity")	1	U
15	>	CONTAINS	NUM	EV (2160-0, LN, "Serum Creatinine")	1	U	UNITS = DT (mg/dl, UCUM, "mg/dl")
16	>	CONTAINS	NUM	EV (F-70210, SRT, "Glomerular Filtration Rate")	1-n	U	UNITS = DT (ml/min{1.73_m2}, UCUM, "ml/min/1.73m2")
17	>>	HAS CONCEPT MOD	CODE	EV (G-C036, SRT, "Measurement Method")	1	U	DCID 10047 “GFR Measurement Methods”
18	>>	HAS CONCEPT MOD	CODE	EV (121050, DCM, "Equivalent meaning of concept name")	1	M	DCID 10046 “GFR Measurements”

Content Item Descriptions

Row 3	Defaults to value of Patient's Age (0010,1010) in Patient Study Module
Row 5	Patient height may differ from Patient's Size (0010,1020). Row 4 is the height value used for any height based protocols. Observation DateTime (0040,A032) may be used to record when the measurement was taken.
Row 6	Patient weight may differ from Patient's Weight (0010,1030). Row 5 is the weight value used for any weight based protocols. Observation DateTime (0040,A032) shall be used to record when the measurement was taken.
Row 11	Patient's Blood Glucose level. Observation DateTime (0040,A032) shall be used to record when the measurement was taken.
Row 15	Serum Creatinine level. Observation DateTime (0040,A032) shall be used to record when the measurement was taken.
Row 16	Glomerular Filtration Rate Observation DateTime (0040,A032) shall be used to record when the measurement was taken. The formatting of the UCUM units is aligned with LOINC. See http://unitsofmeasure.org/trac/ticket/98

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