| TEMPLATE ID | Clinical image acquisition and validation NMR |
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| Concept | Clinical image acquisition and validation NMR |
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| Description | Register the acquisition and subsequent examination of non-mydriatic retinography test. |
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| Purpose | Register the acquisition and subsequent examination of non-mydriatic retinography test. |
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| References | |
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| Authors | name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-20 |
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| Other Details Language | name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-20 |
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| Other Details (Language Independent) | - MetaDataSet:Sample Set : Template metadata sample set
- Copyright: © openEHR Foundation
- Owner: Aitor Eguzkitza, aitor.eguzkiza@unavarra.es
- Speciality: Ophthalmology
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| Language used | en |
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| Citeable Identifier | 1013.26.116 |
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| Root archetype id | openEHR-EHR-SECTION.clinical_image_acquisition.v0 |
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| Clinical image acquisition and validation NMR | Clinical image acquisition and validation NMR: Manages the acquisition and validation of diagnostic tests based on medical imaging. |
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| Imaging examination | Imaging examination: Clinical activity about performing an imaging examination. |
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| Description | |
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| Examination name | Examination name: The name of the examination (to be) performed. Coding of the specific procedure with a terminology is preferred, where possible.
Default value: Eye fundus examination |
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| Description | Description: Narrative description about the activity or care pathway step for the identified examination, for example description about the performance and findings from the the examination, the failed attempt or the cancellation of the examination.
Default value: Carry out the funduscopic examination of eyes. |
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| Reason | Reason: Reason that the activity or care pathway step for the identified examination was carried out, for example, the reason for the cancellation or suspension of the examination.
- DR screening
- Assessment of wet AMD
- Monitor the progression of chronic glaucoma
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| Anatomical location | Anatomical location: A physical site on or within the human body. |
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| Body site name | Body site name: Identification of a single physical site either on, or within, the human body.
This data element is the only mandated data point in this archetype and should be used as the primary data point to record an anatomical location with a commonly used name. It is strongly recommended that 'Body site name' be recorded as specifically as is anatomically possible. For example: record 'upper eyelid' rather than recording 'eyelid' with 'upper' as a qualifier; 'fifth rib' rather than 'rib' with a numeric qualifier. Use the other data elements for laterality, aspect, region and anatomical line to provide more detail. This data element should be coded with a terminology capable of triggering decision support, where possible - an appropriate termset for use here could comprise individual concepts or a list of precoordinated terms. Free text should be used only if there is no appropriate terminology available.
Default value: Eye fundus |
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| Specific site | Specific site: Additional detail using a specific region or a point on, or within, the identified body site.
Use to increase precision of identification of the body site, if required. For example, the upper right quadrant or McBurney's point on the abdominal wall or interphalangeal joint of the great toe. If the 'Body site name' data element uses pre-coordinated terms that include the specific site, then this data element is redundant.
Value set: terminology:Snomed?subset=Subdivision%20of%20retina&language=en-GB |
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| Laterality | Laterality: The side of the body on which the identified body site is located.
If the identified body site has no laterality, this data element should not have a value.
If the 'Body site name' data element uses pre-coordinated terms that include laterality, then this data element is redundant.
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| Aspect | Aspect: Qualifying detail about the specific aspect of the identified body site.
Use to increase precision of identification of the body site, if required. Common aspects have been included as a value set, which can be extended over time, plus a free text option. Assumes that the body is being described while in the anatomical position. For example: proximal urethra; plantar aspect of the left thumb. Multiple aspects can also be described, if required, by allowing for 0..2 occurrences. For example: a lesion may be on the left anterior/lateral (ie anterolateral) chest wall. If the 'Body site name' data element uses pre-coordinated terms that include the aspect, then this data element is redundant.
 Coded Text- Medial
- Lateral
- Superior
- Inferior
- Anterior
- Posterior
- Proximal
- Distal
- Palmar
- Plantar
- Mid
- Oral
- Anal
 Text
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| Anatomical Line | Anatomical Line: Additional detail using theoretical lines drawn through anatomical structures used to provide a consistent reference point on the human body.
Common anatomical lines have been included as a value set, which can be extended over time, plus a free text option. The additional use of this data element allows for recording of the typical position of the heart's apex beat at 5th intercostal space, left side, and mid-clavicular line. If the 'Body site name' data element uses pre-coordinated terms that include anatomical line, then this data element is redundant.
- Coded Text
- Midline
- Midaxillary line
- Anterior axillary line
- Posterior axillary line
- Mid-clavicular line
- Mid-pupillary line
- Mid-scapular line
- Text
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| Description | Description: Narrative description that can be used to further refine and support the 'Body site name'.
For example: adjacent to the vermilion border; a tattoo covers the bottom half of this area. |
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| Mydriasis application | Mydriasis application: Defines the characteristics of mydriasis procedure when carried out on a patient. |
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| Pupil dilated | Pupil dilated: Whether or not the patient’s pupils were pharmacologically dilated for the current acquisition.
Matches to DICOM (0022,000D) attribute. |
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| Degree of dilation | Degree of dilation: The degree of the dilation in mm.
Matches to DICOM (0022,000E) attribute.
0..3 mm
Assumed value: 0 mm |
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| Mydriatic delivery method | Mydriatic delivery method: The method of delivery if this should be specified (e.g. via a nebuliser or drops). |
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| Mydriatic agent | Mydriatic agent: Chemical name of the compound used to apply midriasis.
Matches to DICOM (0022,0058) attribute. Values permitted are defined by DICOM standard (PS 3.16) inside the table with Context ID 4208 (Mydriatic agent)
Value set: terminology:Snomed?subset=Mydriatic%20agents&language=en-GB |
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| Medication supply amount | Medication supply amount: Details related to the amount of a medication, vaccine or other therapeutic item to be supplied or supplied to the patient, as part of authorisation, dispensing or administration. |
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| Amount description | Amount description: A narrative representation of the amount The amount of medication, vaccine or therapeutic good intended to be supplied or actually supplied. |
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| Amount | Amount: The amount of medication, vaccine or therapeutic good intended to be supplied or actually supplied.
For example: 1, 1.5, or 0.125.
>=0 (UCUM: 1) |
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| Units | Units: The dose unit or pack unit associated with the dispense amount.
For example: 'tablets', 'packs', ml'. |
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| Duration of supply | Duration of supply: The period of time for which the medication should be dispensed or for which a suppy was dispensed.
The dispenser is asked to supply sufficient quantity of medication to cover the defined period.
>=P0D
Units: |
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| Comment | Comment: Additional narrative about the activity or care pathway step not captured in other fields. |
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| Protocol | |
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| Start date/time | Start date/time: The start date and/or time for the procedure. This will indicate the scheduled date/time when recorded against the 'Appointment scheduled' care pathway step or the actual Start date/time in the 'Examination performed' step. |
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| Fundoscopic examination of eyes | Fundoscopic examination of eyes: Record of clinical findings on fundoscopy of eyes |
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| Data | |
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| Any event | Any event: * |
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| Data | |
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| Clinical Description | Clinical Description: Descriptive overview of examination findings |
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| Test Result | Test Result: Details of the funduscopic examination test result for each eye. |
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| Side | Side: Determines the eye on which the test was performed.Matches to DICOM Laterality (0020,0060) attribute.
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| Acquisition details | Acquisition details: Details about acquisition obtained during the examination of eye fundus |
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| Red reflex | Red reflex: True if Red Reflex is present
Assumed value: false |
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| Small pupil | Small pupil: True if during the acquisition, pupil diameter is smaller than normal (3,3mm)
Assumed value: false |
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| High refraction | High refraction: True if the refraction of the eye exceeds the range from -12D to +15D
Assumed value: false |
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| Cataract artifact | Cataract artifact: True if cataract obstructs the visualization of eye fundus
Assumed value: false |
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| Shadow artifact | Shadow artifact: True if shadow artifact is present on the border of the image
Assumed value: false |
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| Uncooperative patient | Uncooperative patient: True if patient doesn't collaborate during the image acquisition
Assumed value: false |
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| Others | Others: Other details identified during the acquisition which may affect the results from reviewing the test
Value set: terminology:Snomed?subset=Complications%20on%20ophthalmic%20image%20acquisition&language=en-GB |
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| Visualization | Visualization: Details about image quality related to ease of visualization of structures on eye fundus |
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| Quality | Quality: Levels quantifying the quality of each acquisition, based in the ease to visualize the structures on the eye fundus
- 1: Quality inadequate for any diagnostic purpose
- 2: Unable to exclude all emergent findings
- 3: Only able to exclude emergent findings
- 4: Quality not ideal, but is possible to exclude subtle findings
- 5: Ideal quality
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| Comment | Comment: Comment, especially if not fully visualised |
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| Structural description | Structural description: General description of the structures in the eye fundus |
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| Optic Disc | Optic Disc: Description of optic disc |
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| Macula | Macula: Description of macula |
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| Retinal arteries | Retinal arteries: Description of retinal arteries |
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| Retinal veins | Retinal veins: Description of retinal veins |
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| Retinal background | Retinal background: Description of retinal background |
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| Vitreous | Vitreous: Description of vitreous humour |
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| Clinical results | Clinical results: Information of diagnostic interest obtained in the test |
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| Other findings | Other findings: Narrative description of clinical findings not considered in the SLOT |
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| State | |
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| Mydriatic used | Mydriatic used: True if mydriatic is used
Assumed value: false |
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| Protocol | |
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| Method | Method: Method chosen to perform the funduscopic examination
- Direct
- Indirect
- Contact lens biomicroscopy
- Non-contact lens biomicroscopy
- Mydriatic retinography
- Non-mydriatic retinography
- Angiography
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| Medical Device | Medical Device: An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognising that each type of device has specific data recording requirements. |
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| Device name | Device name: Identification of the medical device, preferably by a common name, a formal fully descriptive name or, if required, by class or category of device.
This data element will capture the term, phrase or category used in clinical practice. For example: <brand name><machine> (XYZ Audiometer); <size> <brand name> <intravenous catheter> (14G Jelco IV catheter); or <brand name/type> <implant>. Coding with a terminology is desirable, where possible, although this may be local and depending on local supplies available.
Value set: terminology:Snomed?subset=Ophthalmic%20photography%20devices&language=en-GB |
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| Type | Type: The category or kind of device.
Not applicable if a category is already recorded in 'Device name'.
Example: if the 'Device' is named as a 'urinary catheter'; the 'Type' may be recorded as 'indwelling' or 'condom'.Coding with a terminology is desirable, where possible. This may include use of GTIN or EAN numbers. |
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| Description | Description: Narrative description of the medical device. |
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| Unique device identifier (UDI) | Unique device identifier (UDI): A numeric or alphanumeric string that is associated with this device within a given system.
Often fixed to the device as a barcode. |
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| Manufacturer | Manufacturer: Name of manufacturer. |
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| Date of manufacture | Date of manufacture: Date the device was manufactured. |
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| Serial number | Serial number: Number assigned by the manufacturer which can be found on the device, and should be specific to each device., its label, or accompanying packaging. |
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| Catalogue number | Catalogue number: The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging. |
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| Model number | Model number: The exact model number assigned by the manufacturer and found on the device label or accompanying packaging. |
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| Batch/Lot number | Batch/Lot number: The number assigned by the manufacturer which identifies a group of items manufactured at the same time, usually found on the label or packaging material. |
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| Software version | Software version: Identification of the version of software being used in the medical device.
When the medical device is an actual software application, record the version of the software using this data element. When the medical device has multiple software applications embedded within it, record each software component in a separate CLUSTER archetype within the Components SLOT - either as a nested instance of another CLUSTER.device archetype or using a CLUSTER archetype designed specifically for recording software details (but not yet available at time of this archetype development). |
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| Date of expiry | Date of expiry: Date after which the device/product is no longer fit for use, usually found on the device itself or printed on the accompanying packaging.
This date usually applies only to single use or disposable devices. |
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| Other identifier | Other identifier: Unspecified identifier, which can be further specified in a template or at run time.
Coding of the name of the identifier with a coding system is desirable, if available. |
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| Medical device details | Medical device details: Specific details that relate to asset management for any medical device that is designed for more than a single use. |
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| Organisation identifier | Organisation identifier: Organisation identifier for device.
May be a text string or an IEEE EUI-64 identifier.
- Text
 Identifier
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| Owner | Owner: Organisation responsible for the medical device. |
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| Location | Location: Physical location where device is kept. |
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| Network address | Network address: Network address to contact the device. |
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| Part number | Part number: The part number of the device. |
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| Manufacturer model name | Manufacturer model name: HL7 CDA compatible representation of device manufacture details.
May be a simple string or contain simple markup e.g. for Continua PHMR reports:
"Pulse Master 2000||584216|69854|2.1|1.1|1.0|"
repesenting Model, Unspecified, SerialNumber, PartNumber, HardwareRevision, SoftwareRevision, ProtocolRevision, and ProdSpecGMDN. |
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| Hardware revision | Hardware revision: The hardware revision number. |
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| Protocol revision | Protocol revision: The protocol revision number. |
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| Sampling frequency | Sampling frequency: The sampling frequency limits of the device.
- Text
 Quantity
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| Range | Range: The range limits of the device.
- Text
 Interval of Quantity
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| Accuracy | Accuracy: The accuracy limits of the device.
- Text
- Quantity
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| Resolution | Resolution: The resolution limits of the device.
- Text
- Quantity
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| Regulatory status | Regulatory status: Whether device is regulated or otherwise. |
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| Date last cleaned/sterilized | Date last cleaned/sterilized: Date the device was last cleaned or sterilized. |
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| Date last calibrated | Date last calibrated: Date the device was last calibrated. |
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| Date last serviced | Date last serviced: The date the device was last serviced. |
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| Formulae | Formulae: Details about formulae or algorithms used by the device in order to generate results/output. |
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| Formula name | Formula name: Data element which is calculated or derived. |
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| Formula | Formula: Formula used to calculate or derive the Calculated field. |
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| Comment | Comment: Additional narrative about the device not captured in other fields. |
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| Field angle | Field angle: Describes the optical acceptance angle of the lens used during the test
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| Attempts | Attempts: Number of attempts before obtaining the acquisition (doesn't compute if test is repeated by a specific recognized technical failure)
1..3 |
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| (Subdivision of the retina) | (Subdivision of the retina): Subdivision of the retina identifying eye fundus image locations |
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| (ETRDS fields) | (ETRDS fields): Subdivision of the retina based on Diabetic Retinopathy Study fields
- Study field 1
- Study field 2
- Study field 3
- Study field 4
- Study field 5
- Study field 6
- Study field 7
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| Mosaic and peripherals | Mosaic and peripherals: Division of the retina in quadrants + mosaic obtained from the combination of them
- Mosaic
- Central
- Nasal
- Temporal
- Superior
- Inferior
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| Other contributors | Jose Andonegui, Complejo hospitalario de Navarra (CHN), jose.andonegui.navarro@cfnavarra.es; Luis Serrano, Universidad Pública de Navarra (UPNA), lserrano@unavarra.es; Jesús D. Trigo, Universidad Pública de Navarra (UPNA), jesusdaniel.trigo@unavarra.es |
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