| TEMPLATE ID | Diagnostic tests in the DR screening service |
|---|---|
| Concept | Diagnostic tests in the DR screening service |
| Description | Manage the acquisition and validation of diagnostic tests involved in the DR screening service. |
| Purpose | Manage the acquisition and validation of diagnostic tests involved in the DR screening service. |
| References | |
| Authors | name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-25 |
| Other Details Language | name: Aitor Eguzkitza; organisation: Universidad Pública de Navarra - Complejo Hospitalario de Navarra; email: aitor.eguzkiza@unavarra.es; date: 2016-07-25 |
| Other Details (Language Independent) |
|
| Language used | en |
| Citeable Identifier | 1013.26.165 |
| Root archetype id | openEHR-EHR-COMPOSITION.progress_note.v1 |
| Progress Note | Progress Note: Document used to record details of health-related events that have occurred as part of the subject's care, and/or the subject's health status, findings, opinions and plans that are current at the time of recording. |
| Intraocular pressure study | Intraocular pressure study: Defines the process which involves the intraocular pressure acquisition and its study. |
| Procedure | Procedure: A clinical activity carried out for screening, investigative, diagnostic, curative, therapeutic, evaluative or palliative purposes. |
| Description | |
| Procedure name | Procedure name: Identification of the procedure by name. Coding of the specific procedure with a terminology is preferred, where possible. |
| Description | Description: Narrative description about the procedure, as appropriate for the pathway step. For example: description about the performance and findings from the the procedure, the aborted attempt or the cancellation of the procedure. |
| Method | Method: Identification of specific method or technique for the procedure. Use this data element to record simple terms or a narrative description. If the requirements for recording the method require more complex modelling then this can be represented by additional archetypes within the 'Procedure detail' SLOT in this archetype. If the method is included in the 'Procedure name' via precoordinated codes, this data element becomes redundant. |
| Urgency | Urgency: Urgency of the procedure. Coding with a terminology is preferred, where possible. |
| Scheduled date/time | Scheduled date/time: The date and/or time on which the procedure is intended to be performed. Only for use in association with the 'Procedure scheduled' pathway step. |
| Final end date/time | Final end date/time: The date and/or time when the entire procedure, or the last component of a multicomponent procedure, was finished. Only for use in association with the 'Procedure performed' pathway step, and in situations where the procedure is repeated on multiple occasions before being completed or there are multiple components to the whole procedure. This may be the same as the RM time attribute for the 'Procedure completed' pathway step. |
| Reason | Reason: Reason that the activity or care pathway step for the identified procedure was carried out. For example: the reason for the cancellation or suspension of the procedure.
|
| Comment | Comment: Additional narrative about the activity or care pathway step not captured in other fields. |
| Protocol | |
| Requestor order identifier | Requestor order identifier: The local ID assigned to the order by the healthcare provider or organisation requesting the service. This is equivalent to Placer Order Number in HL7 v2 specifications.
|
| Receiver order identifier | Receiver order identifier: The ID assigned to the order by the healthcare provider or organisation receiving the request for service. This is also referred to as Filler Order Identifier. This is equivalent to Filler Order Number in HL7 v2 specifications.
|
| Intraocular pressure | Intraocular pressure: The local measurement of intraocular pressure, most commonly using a tonometry device. |
| Data | |
| Any event | Any event: Default, unspecified point in time or interval event which may be explicitly defined in a template or at run-time. |
| Data | |
| Eye examined | Eye examined: Identification of the eye under examination.
|
| Pressure | Pressure: Measured intraocular pressure. 0..90 mmHg |
| Applanation time | Applanation time: The time taken for a non-contact tonometer to flatten the cornea, used to calculate intraocular pressure. >=0 millisec |
| Clinical interpretation | Clinical interpretation: Single word, phrase or brief description that represents the clinical meaning and significance of the physical examination findings. |
| Comment | Comment: Additional narrative about the measurement, not captured in other fields. |
| State | |
| Confounding factors | Confounding factors: Description of any incidental factors related to the state of the subject which may affect clinical interpretation of the measurement. |
| Protocol | |
| Tonometry Method | Tonometry Method: Type of tonometery used to measure intracoular pressure.
|
| 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. |
| 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. |
| 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. |
| Description | Description: Narrative description of the medical device. |
| 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. |
| Manufacturer | Manufacturer: Name of manufacturer. |
| Date of manufacture | Date of manufacture: Date the device was manufactured. |
| 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. |
| Organisation identifier | Organisation identifier: Organisation identifier for device. May be a text string or an IEEE EUI-64 identifier.
|
| Owner | Owner: Organisation responsible for the medical device. |
| Location | Location: Physical location where device is kept. |
| Network address | Network address: Network address to contact the device. |
| Part number | Part number: The part number of the device. |
| 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. |
| Hardware revision | Hardware revision: The hardware revision number. |
| Protocol revision | Protocol revision: The protocol revision number. |
| Sampling frequency | Sampling frequency: The sampling frequency limits of the device.
|
| Range | Range: The range limits of the device.
|
| Accuracy | Accuracy: The accuracy limits of the device.
|
| Resolution | Resolution: The resolution limits of the device.
|
| Date last cleaned/sterilized | Date last cleaned/sterilized: Date the device was last cleaned or sterilized. |
| Date last calibrated | Date last calibrated: Date the device was last calibrated. |
| Date last serviced | Date last serviced: The date the device was last serviced. |
| Comment | Comment: Additional narrative about the device not captured in other fields. |
| Central corneal thickness details | Central corneal thickness details: Measurement details about of the central corneal thickness. |
| Central Corneal Thickness (CCT) | Central Corneal Thickness (CCT): Value measured of the central corneal thickness. 400..700 μm |
| Measurement Method | Measurement Method: Method used to measure the corneal thickness parameter. Value set: ac0001 |
| Correction parameter | Correction parameter: Parameter obtained from tables provided by manufacturers, to correct the intraocular pressure value according to the central corneal thickness obtained. -7..7 mmHg Assumed value: 0 mm[Hg] |
| Clinical image acquisition and validation NMR | Clinical image acquisition and validation NMR: Manages the acquisition and validation of diagnostic tests based on medical imaging. |
| Imaging examination | Imaging examination: Clinical activity about performing an imaging examination. |
| Description | |
| Examination name | Examination name: The name of the examination (to be) performed. Coding of the specific procedure with a terminology is preferred, where possible. |
| 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. |
| 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.
|
| Anatomical location | Anatomical location: A physical site on or within the human body. |
| 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. |
| 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 |
| 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.
|
| 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.
|
| 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.
|
| 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. |
| Mydriasis application | Mydriasis application: Defines the characteristics of mydriasis procedure when carried out on a patient. |
| Pupil dilated | Pupil dilated: Whether or not the patient’s pupils were pharmacologically dilated for the current acquisition. Matches to DICOM (0022,000D) attribute. |
| 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 |
| Mydriatic delivery method | Mydriatic delivery method: The method of delivery if this should be specified (e.g. via a nebuliser or drops). |
| 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 |
| 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. |
| 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. |
| 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 |
| Units | Units: The dose unit or pack unit associated with the dispense amount. For example: 'tablets', 'packs', ml'. |
| 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:
|
| Comment | Comment: Additional narrative about the activity or care pathway step not captured in other fields. |
| Protocol | |
| 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. |
| Fundoscopic examination of eyes | Fundoscopic examination of eyes: Record of clinical findings on fundoscopy of eyes |
| Data | |
| Any event | Any event: * |
| Data | |
| Clinical Description | Clinical Description: Descriptive overview of examination findings |
| Test Result | Test Result: Details of the funduscopic examination test result for each eye. |
| Side | Side: Determines the eye on which the test was performed.Matches to DICOM Laterality (0020,0060) attribute.
|
| Acquisition details | Acquisition details: Details about acquisition obtained during the examination of eye fundus |
| Red reflex | Red reflex: True if Red Reflex is present Assumed value: false |
| Small pupil | Small pupil: True if during the acquisition, pupil diameter is smaller than normal (3,3mm) Assumed value: false |
| High refraction | High refraction: True if the refraction of the eye exceeds the range from -12D to +15D Assumed value: false |
| Cataract artifact | Cataract artifact: True if cataract obstructs the visualization of eye fundus Assumed value: false |
| Shadow artifact | Shadow artifact: True if shadow artifact is present on the border of the image Assumed value: false |
| Uncooperative patient | Uncooperative patient: True if patient doesn't collaborate during the image acquisition Assumed value: false |
| 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 |
| Visualization | Visualization: Details about image quality related to ease of visualization of structures on eye fundus |
| Quality | Quality: Levels quantifying the quality of each acquisition, based in the ease to visualize the structures on the eye fundus
|
| Comment | Comment: Comment, especially if not fully visualised |
| Structural description | Structural description: General description of the structures in the eye fundus |
| Optic Disc | Optic Disc: Description of optic disc |
| Macula | Macula: Description of macula |
| Retinal arteries | Retinal arteries: Description of retinal arteries |
| Retinal veins | Retinal veins: Description of retinal veins |
| Retinal background | Retinal background: Description of retinal background |
| Vitreous | Vitreous: Description of vitreous humour |
| Clinical results | Clinical results: Information of diagnostic interest obtained in the test |
| Other findings | Other findings: Narrative description of clinical findings not considered in the SLOT |
| State | |
| Mydriatic used | Mydriatic used: True if mydriatic is used Assumed value: false |
| Protocol | |
| Method | Method: Method chosen to perform the funduscopic examination
|
| 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. |
| 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 |
| 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. |
| Description | Description: Narrative description of the medical device. |
| 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. |
| Manufacturer | Manufacturer: Name of manufacturer. |
| Date of manufacture | Date of manufacture: Date the device was manufactured. |
| 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. |
| Catalogue number | Catalogue number: The exact number assigned by the manufacturer, as it appears in the manufacturer's catalogue, device labeling, or accompanying packaging. |
| Model number | Model number: The exact model number assigned by the manufacturer and found on the device label or accompanying packaging. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| Organisation identifier | Organisation identifier: Organisation identifier for device. May be a text string or an IEEE EUI-64 identifier.
|
| Owner | Owner: Organisation responsible for the medical device. |
| Location | Location: Physical location where device is kept. |
| Network address | Network address: Network address to contact the device. |
| Part number | Part number: The part number of the device. |
| 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. |
| Hardware revision | Hardware revision: The hardware revision number. |
| Protocol revision | Protocol revision: The protocol revision number. |
| Sampling frequency | Sampling frequency: The sampling frequency limits of the device.
|
| Range | Range: The range limits of the device.
|
| Accuracy | Accuracy: The accuracy limits of the device.
|
| Resolution | Resolution: The resolution limits of the device.
|
| Regulatory status | Regulatory status: Whether device is regulated or otherwise. |
| Date last cleaned/sterilized | Date last cleaned/sterilized: Date the device was last cleaned or sterilized. |
| Date last calibrated | Date last calibrated: Date the device was last calibrated. |
| Date last serviced | Date last serviced: The date the device was last serviced. |
| Formulae | Formulae: Details about formulae or algorithms used by the device in order to generate results/output. |
| Formula name | Formula name: Data element which is calculated or derived. |
| Formula | Formula: Formula used to calculate or derive the Calculated field. |
| Comment | Comment: Additional narrative about the device not captured in other fields. |
| Field angle | Field angle: Describes the optical acceptance angle of the lens used during the test
|
| Attempts | Attempts: Number of attempts before obtaining the acquisition (doesn't compute if test is repeated by a specific recognized technical failure) 1..3 |
| (Subdivision of the retina) | (Subdivision of the retina): Subdivision of the retina identifying eye fundus image locations |
| (ETRDS fields) | (ETRDS fields): Subdivision of the retina based on Diabetic Retinopathy Study fields
|
| Mosaic and peripherals | Mosaic and peripherals: Division of the retina in quadrants + mosaic obtained from the combination of them
|
| Next step planning | Next step planning: Decision-making concerning the planning of next assessment for the diagnostic tests carried out. |
| Diagnostic report request | Diagnostic report request: Request for a diagnostic report involving the study of specific diagnostic tests. |
| Request | Request: Current Activity. |
| Description | |
| Service requested | Service requested: Identification of the service requested. This is often coded with an external terminology.
|
| Description of service | Description of service: A detailed narrative description of the service requested. |
| Reason for request | Reason for request: A short description of the reason for the request. This is often coded with an external terminology.
|
| Reason description | Reason description: A narrative description explaining the reason for request. |
| Intent | Intent: Stated intent of the request by the referrer. |
| Urgency | Urgency: Urgency of the request.
|
| Date &/or time service required | Date &/or time service required: The date and time that the service should be performed or completed. |
| Latest date service required | Latest date service required: The latest date that is acceptable for the service to be completed. |
| Protocol | |
| Requestor Identifier | Requestor Identifier: The local ID assigned to the order by the healthcare provider or organisation requesting the service. This is also referred to as Placer Order Identifier. |
| Receiver identifier | Receiver identifier: The ID assigned to the order by the healthcare provider or organisation receiving the request for service. This is also referred to as Filler Order Identifier. |
| Request status | Request status: The status of the request for service as indicated by the requester. Status is used to denote whether this is the initial request, or a follow-up request to change or provide supplementary information. |
| Service request | Service request: Request for a health-related service to be supplied by a healthcare provider or agency. For example equipment request. |
| Request | Request: Description of the requested service. |
| Description | |
| Service name | Service name: Identification of the service requested, by name. Coding of the 'Service name' with a coding system is desirable, if available.
|
| Service type | Service type: Category of service requested. For example: hospital vs home care delivery. |
| Description | Description: Narrative description of the service requested.
|
| Reason for request | Reason for request: A short phrase describing the reason for the request. Coding of the 'Reason for request' with a coding system is desirable, if available. |
| Reason description | Reason description: Narrative description about the reason for request. |
| Intent | Intent: Description of the intent for the request. For example a referral with the intent of having specialist care take over the care of the patient, or advice on how to proceed with an investigation or treatment. This data element allows multiple occurrences to enable multiple choice selection in user interface. |
| Urgency | Urgency: Urgency of the request for service. Specific definitions of emergency and urgent will vary between clinical contexts, clinical systems and the nature of the request itself, so have not be defined in this archetype. If explicit timing is required then the Service period should be clearly stated.
|
| Service due | Service due: The date/time, or acceptable interval of date/time, for provision of the service. In practice, clinicians will often think in terms of ordering services as approximate timing, for example: review in 3 months, 6 months or 12 months. As clinical systems need more exact parameters to operate on, this '3 months' will usually be converted to an exact date 3 months from the date of recording and stored using this data element. |
| Service period start | Service period start: The date/time that marks the beginning of the valid period of time for delivery of this service. This date/time is the equivalent to the earliest possible date for service delivery. For example: sometimes a certain amount of time must pass before a service can be performed, for example some procedures can only be performed once the patient has stopped taking medications for a specific amount of time. |
| Service period expiry | Service period expiry: The date/time that marks the conclusion of the valid period of time for delivery of this service. This date/time is the equivalent to the latest possible date for service delivery or to the date of expiry for this request. For example: a service may be required to be completed before another event, such as scheduled surgery. |
| Indefinite? | Indefinite?: The valid period for this request is open ended and has no date of expiry. Record as TRUE to record explicity that the request has no expiry date. |
| Protocol | |
| Requestor Identifier | Requestor Identifier: The local ID assigned to the order by the healthcare provider or organisation requesting the service. This is also referred to as Placer Order Identifier. |
| Receiver identifier | Receiver identifier: The ID assigned to the order by the healthcare provider or organisation receiving the request for service. This is also referred to as Filler Order Identifier. |
| Request status | Request status: The status of the request for service as indicated by the requester. Status is used to denote whether this is the initial request, or a follow-up request to change or provide supplementary information. |
| 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 |