Represents a request for a patient to employ a medical device. The device may be an implantable device, or an external assistive device, such as a walker.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

An Extension

The preferred location(s) where the device should actually be used. Location is captured via a coded (e.g., SNOMED-CT) or free text. Examples:

• Code: SNOMED-CT 42665001 (Nursing Home)
• Free text: “At the patient’s residence”

Identifies the person(s) using the device, their role in using the device and, optionally, the nature of their relationship(s) to the device during use. The user is captured using a profile (e.g., HL7 RelatedPerson profile) and the relationship is indicated as Custodian, Maintainer, Patient, or Operator.

Example Users:

• Patient
• Related Person: Spouse, child
• Practitioner: Home Health Aide, Nursing Aid, Occupational Therapist, Physical Therapist, Speech-Language Pathologist

Groups information that supports the clinical justification for the device request. These can include assessment findings, and goals that may influence fulfillment of the device request.

• assessments documenting the patient’s ability to use/interact with the device related to:
  • Cognition: If the patient has the cognitive capacity to use the device via the Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8)
  • Physical Functioning: If the patient is physically able to use the device via the 9-Hole Pegboard Dexterity Test (LOINC 83141-2)
  • Vision: If the patient's visual capabilities are aligned with the device features via the Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003)
  • Health Literacy: If the patient has the ability learn how to use the device via the BRIEF health literacy screening tool (LOINC 95866-0)
  • Disability: If the patient has a disability that would need to be accommodated in the selection of a device via an indication in the patient’s demographic record of having a disability (ICD-10 Z73.6)
• Documented observation of the patient’s usage of the requested device during an assessment that may influence the fulfillment of the device.
  • Example: A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile).
• Supporting information about the patient's goals that may influence fulfillment of the device request.
  • Example: A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include: Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element).
  • Example: A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include: Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element), Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element)

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A Plan, proposal, order/service request, and/or goal order that is fulfilled by this device request.

Examples:

• A care plan that describes how the device will be used by the patient to support their participation in daily activities and care activities (captured via the US Core Care Plan profile)
• A service request for physical, occupational, or speech-language therapy that includes a description of the medical necessity for, appropriateness of, and use of the device during therapy sessions (captured via the PFE Service Request profile)
• A nutrition order that requires a device to provide nutritional support to a patient (via the PFE Nutrition Order profile)
• A goal participate in a community event that is supported an order of a portable oxygen pack (captured via the PFE Goal profile)

Composite request this is part of.

Examples:

• An alphanumeric string that is used as a group identifier for a composite request for.
• A motorized wheelchair, a seat cushion, a communication device, and accessories used to attach the cushion and communication device to the wheelchair
• A knee brace and a grabbing tool to support independent living for a patient who had knee surgery and is being discharged home from an inpatient rehab facility

The status of the request.

This element is labeled as a modifier because the status contains the codes cancelled and entered-in-error that mark the request as not currently valid.

Codes representing the status of the request.

Whether the request is a proposal, plan, an original order or a reflex order.

The kind of diagnostic request.

Indicates how quickly the {{title}} should be addressed with respect to other requests.

Identifies the level of importance to be assigned to actioning the request.

A code that indicates the device being requested. Example code systems include Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes

Examples:

• Wheelchair seat cushion: HCPCS E2601 “General use wheelchair seat cushion, width less than 22 inches, any depth”
• Splint: HCPCS A4570 “Splint”
• Brace: HCPCS L3224 “Orthopedic footwear, woman's shoe, oxford, used as an integral part of a brace (orthosis)”
• Enteral feeding pump and supplies: HCPCS B4035 “Enteral feeding supply kit; pump fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape”
• TENS device with 2 leads: HCPCS E0720 “Transcutaneous electrical nerve stimulation (tens) device, two lead, localized stimulation”
• Wheeled walker: HCPCS E0143 “Walker, folding, wheeled, adjustable or fixed height”
• Hot or cold pack: HCPCS A9273 “Cold or hot fluid bottle, ice cap or collar, heat and/or cold wrap, any type”

Codes for devices that can be requested.

The details of the device to be used.

Specific parameter(s) for the requested device.

Examples:

• Wheelchair: Seat cushion requirements, such as material and width
• Splints or braces: Range-of-motion setting
• Device weight limits
• Enteral feeding device: Number of connections
• TENS units: Settings, such as frequency and duration
• Walkers: Dimension parameters, such as width
• Hot or cold pack: Temperature

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A code that identifies the device parameter(s).

Examples:

• Wheelchair seat cushion: Material = SNOMED 260769002, width = SNOMED 103355008
• Splints or braces: Range-of-motion = SNOMED 364564000
• Enteral feeding device connections = SNOMED 711341009
• TENS units: Frequency = SNOMED 278269003, duration = SNOMED 762636008
• Walker: Width = SNOMED 103355008
• Hot or cold pack: Temperature = SNOMED 722490005

The value(s) of the device parameter(s).

Examples:

• Wheelchair seat cushion: Filled with silicone gel = SNOMED 860705001, width = “21 inches”
• Splints or braces: Range-of-motion = “50 degrees”
• Enteral feeding device connections = “2”
• TENS units: Frequency = “30 pps”, duration = “10 minutes”
• Walker: Width = “24 inches”
• Hot or cold pack: Temperature = “35°C” or “10°C”

The patient for whom the device is being requested.

An encounter that provides additional context in which this request is made.

The timing schedule for the use of the device. The Schedule data type allows many different expressions, for example. "Every 8 hours"; "Three times a day"; "1/2 an hour before breakfast for 10 days from 23-Dec 2011:"; "15 Oct 2013, 17 Oct 2013 and 1 Nov 2013".

The Schedule data type allows many different expressions, for example:

• Times per day: "Every 8 hours"; "Three times a day"
• Duration: “Up to 2 hours per day”; “Between 4 and 6 hours per day”
• Specific times: "1/2 an hour before breakfast for 10 days from 23-Dec 2011"
• Date range: "15 Oct 2013, 17 Oct 2013 and 1 Nov 2013”
• “As needed”

When the request transitioned to being actionable.

The individual or entity who initiated the device request and has responsibility for its activation.

Carries DeviceRequest.requester when the requester is a CareTeam, Group, Patient, or RelatedPerson, which are allowed in FHIR R6 but not in FHIR R4.

Desired type of performer for doing the diagnostic testing.

DO NOT USE THIS DATA ELEMENT. It will be removed from version R6 of the FHIR Device Request Profile. To capture the device performer role, use DeviceRequest.extension:device-user extension

Indicates specific responsibility of an individual within the care team, such as "Primary physician", "Team coordinator", "Caregiver", etc.

The desired performer for doing the diagnostic testing.

System SHALL use the device-user extension to record the person(s) who will be using the device

Codes indicating the reason or justification for requesting the device. This can be a code for a diagnosis, problem, or condition that necessitates use of the requested device. Complements the DeviceRequest.extension:clinical-justification.extension:note and DeviceRequest.reasonReference data elements.

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: ICD-10-CM J96.11 “Chronic respiratory failure with hypoxia”
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: ICD-10-CM I61.1 “Nontraumatic intracerebral hemorrhage in hemisphere, cortical”; ICD-10-CM I69.320 “Aphasia following cerebral infarction”; ICD-10-PCS F06Z1KZ “Speech-Language Pathology and Related Disorders Counseling Treatment using Audiovisual Equipment”
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: ICD-10-CM S83.261 “Peripheral tear of lateral meniscus, current injury, right knee”; ICD-10-PCS 0SQC4ZZ “Repair Right Knee Joint, Percutaneous Endoscopic Approach”; SNOMED 8510008 “Reduced mobility (finding)”; SNOMED 301572006 “Does mobilize using aids (finding)”; ICD-10-CM Z73 “Problems related to life management difficulty”
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: ICD-10-CM C50.811 “Malignant neoplasm of overlapping sites of right female breast”; ICD-10-CM C50.812 “Malignant neoplasm of overlapping sites of left female breast”; SNOMED 367336001 “Chemotherapy (procedure)”; ICD-10-CM R11.0 “Nausea”; SNOMED 18846006 “Chemotherapy-induced nausea and vomiting (disorder)”; ICD-10-CM R63 “Symptoms and signs concerning food and fluid intake”; ICD-10-CM R63.6 “Underweight”; SNOMED 404923009 “Weight gain advised (situation)”; SNOMED 229912004 “Enteral feeding (regime/therapy)”

Reason or justification for the request or use of this device. Complements the DeviceRequest.extension:clinical-justification.extension:note and DeviceRequest.reasonCode data elements.

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: Documentation of a plan to support the patient’s participation in the community event via the US Core CarePlan
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: Documentation of an order for therapy sessions via the US Core ServiceRequest profile
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: Documentation of the use of the brace and grabber to support mobility and independent living via the US Core CarePlan profile
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: Documentation of an enteral nutrition order via the PFE NutritionOrder profile

Insurance plans, coverage extensions, pre-authorizations and/or pre-determinations that may be required for delivering the requested service.

Additional clinical information about the patient that may influence the request fulfilment. For example, this may include where on the subject's body the device will be used (i.e. the target site).

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: Documentation of their chronic lung disease and hypoxia in an HL7 Condition profile
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: Documentation of stroke via the HL7 DiagnosticReport profile; and aphasia via the PFE ConditionEncounterDiagnosis profile
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: Documentation of the surgery via the HL7 Procedure profile; and limited ability to live independently captured during activities of daily living (ADL), instrumental activities of daily living (iADL), and pain assessments conducted with and without the devices via the PFE Collection profile
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: Documentation of cancer via the HL7 DiagnosticReport profile; chemotherapy via the HL7 Procedure profile; nausea via the via the ConditionEncounterDiagnosis profile; and weight loss via US Core BodyWeight profile

Knowing where the device is targeted is important for tracking if multiple sites are possible.

Details about this request that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.

A Plan, proposal, order/service request, and/or goal order that is fulfilled by this device request.

Examples:

• A care plan that describes how the device will be used by the patient to support their participation in daily activities and care activities (captured via the US Core Care Plan profile)
• A service request for physical, occupational, or speech-language therapy that includes a description of the medical necessity for, appropriateness of, and use of the device during therapy sessions (captured via the PFE Service Request profile)
• A nutrition order that requires a device to provide nutritional support to a patient (via the PFE Nutrition Order profile)
• A goal participate in a community event that is supported an order of a portable oxygen pack (captured via the PFE Goal profile)

Examples:

• An alphanumeric string that is used as a group identifier for a composite request for.
• A motorized wheelchair, a seat cushion, a communication device, and accessories used to attach the cushion and communication device to the wheelchair
• A knee brace and a grabbing tool to support independent living for a patient who had knee surgery and is being discharged home from an inpatient rehab facility

A code that indicates the device being requested. Example code systems include Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes

Examples:

• Wheelchair seat cushion: HCPCS E2601 “General use wheelchair seat cushion, width less than 22 inches, any depth”
• Splint: HCPCS A4570 “Splint”
• Brace: HCPCS L3224 “Orthopedic footwear, woman's shoe, oxford, used as an integral part of a brace (orthosis)”
• Enteral feeding pump and supplies: HCPCS B4035 “Enteral feeding supply kit; pump fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape”
• TENS device with 2 leads: HCPCS E0720 “Transcutaneous electrical nerve stimulation (tens) device, two lead, localized stimulation”
• Wheeled walker: HCPCS E0143 “Walker, folding, wheeled, adjustable or fixed height”
• Hot or cold pack: HCPCS A9273 “Cold or hot fluid bottle, ice cap or collar, heat and/or cold wrap, any type”

Specific parameter(s) for the requested device.

Examples:

• Wheelchair: Seat cushion requirements, such as material and width
• Splints or braces: Range-of-motion setting
• Device weight limits
• Enteral feeding device: Number of connections
• TENS units: Settings, such as frequency and duration
• Walkers: Dimension parameters, such as width
• Hot or cold pack: Temperature

A code that identifies the device parameter(s).

Examples:

• Wheelchair seat cushion: Material = SNOMED 260769002, width = SNOMED 103355008
• Splints or braces: Range-of-motion = SNOMED 364564000
• Enteral feeding device connections = SNOMED 711341009
• TENS units: Frequency = SNOMED 278269003, duration = SNOMED 762636008
• Walker: Width = SNOMED 103355008
• Hot or cold pack: Temperature = SNOMED 722490005

The value(s) of the device parameter(s).

Examples:

• Wheelchair seat cushion: Filled with silicone gel = SNOMED 860705001, width = “21 inches”
• Splints or braces: Range-of-motion = “50 degrees”
• Enteral feeding device connections = “2”
• TENS units: Frequency = “30 pps”, duration = “10 minutes”
• Walker: Width = “24 inches”
• Hot or cold pack: Temperature = “35°C” or “10°C”

The patient for whom the device is being requested.

The Schedule data type allows many different expressions, for example:

• Times per day: "Every 8 hours"; "Three times a day"
• Duration: “Up to 2 hours per day”; “Between 4 and 6 hours per day”
• Specific times: "1/2 an hour before breakfast for 10 days from 23-Dec 2011"
• Date range: "15 Oct 2013, 17 Oct 2013 and 1 Nov 2013”
• “As needed”

The individual or entity who initiated the device request and has responsibility for its activation.

Carries DeviceRequest.requester when the requester is a CareTeam, Group, Patient, or RelatedPerson, which are allowed in FHIR R6 but not in FHIR R4.

DO NOT USE THIS DATA ELEMENT. It will be removed from version R6 of the FHIR Device Request Profile. To capture the device performer role, use DeviceRequest.extension:device-user extension

System SHALL use the device-user extension to record the person(s) who will be using the device

Codes indicating the reason or justification for requesting the device. This can be a code for a diagnosis, problem, or condition that necessitates use of the requested device. Complements the DeviceRequest.extension:clinical-justification.extension:note and DeviceRequest.reasonReference data elements.

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: ICD-10-CM J96.11 “Chronic respiratory failure with hypoxia”
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: ICD-10-CM I61.1 “Nontraumatic intracerebral hemorrhage in hemisphere, cortical”; ICD-10-CM I69.320 “Aphasia following cerebral infarction”; ICD-10-PCS F06Z1KZ “Speech-Language Pathology and Related Disorders Counseling Treatment using Audiovisual Equipment”
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: ICD-10-CM S83.261 “Peripheral tear of lateral meniscus, current injury, right knee”; ICD-10-PCS 0SQC4ZZ “Repair Right Knee Joint, Percutaneous Endoscopic Approach”; SNOMED 8510008 “Reduced mobility (finding)”; SNOMED 301572006 “Does mobilize using aids (finding)”; ICD-10-CM Z73 “Problems related to life management difficulty”
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: ICD-10-CM C50.811 “Malignant neoplasm of overlapping sites of right female breast”; ICD-10-CM C50.812 “Malignant neoplasm of overlapping sites of left female breast”; SNOMED 367336001 “Chemotherapy (procedure)”; ICD-10-CM R11.0 “Nausea”; SNOMED 18846006 “Chemotherapy-induced nausea and vomiting (disorder)”; ICD-10-CM R63 “Symptoms and signs concerning food and fluid intake”; ICD-10-CM R63.6 “Underweight”; SNOMED 404923009 “Weight gain advised (situation)”; SNOMED 229912004 “Enteral feeding (regime/therapy)”

Reason or justification for the request or use of this device. Complements the DeviceRequest.extension:clinical-justification.extension:note and DeviceRequest.reasonCode data elements.

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: Documentation of a plan to support the patient’s participation in the community event via the US Core CarePlan
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: Documentation of an order for therapy sessions via the US Core ServiceRequest profile
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: Documentation of the use of the brace and grabber to support mobility and independent living via the US Core CarePlan profile
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: Documentation of an enteral nutrition order via the PFE NutritionOrder profile

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: Documentation of their chronic lung disease and hypoxia in an HL7 Condition profile
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: Documentation of stroke via the HL7 DiagnosticReport profile; and aphasia via the PFE ConditionEncounterDiagnosis profile
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: Documentation of the surgery via the HL7 Procedure profile; and limited ability to live independently captured during activities of daily living (ADL), instrumental activities of daily living (iADL), and pain assessments conducted with and without the devices via the PFE Collection profile
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: Documentation of cancer via the HL7 DiagnosticReport profile; chemotherapy via the HL7 Procedure profile; nausea via the via the ConditionEncounterDiagnosis profile; and weight loss via US Core BodyWeight profile

Represents a request for a patient to employ a medical device. The device may be an implantable device, or an external assistive device, such as a walker.

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

A human language.

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

An Extension

The preferred location(s) where the device should actually be used. Location is captured via a coded (e.g., SNOMED-CT) or free text. Examples:

• Code: SNOMED-CT 42665001 (Nursing Home)
• Free text: “At the patient’s residence”

Identifies the person(s) using the device, their role in using the device and, optionally, the nature of their relationship(s) to the device during use. The user is captured using a profile (e.g., HL7 RelatedPerson profile) and the relationship is indicated as Custodian, Maintainer, Patient, or Operator.

Example Users:

• Patient
• Related Person: Spouse, child
• Practitioner: Home Health Aide, Nursing Aid, Occupational Therapist, Physical Therapist, Speech-Language Pathologist

Groups information that supports the clinical justification for the device request. These can include assessment findings, and goals that may influence fulfillment of the device request.

• assessments documenting the patient’s ability to use/interact with the device related to:
  • Cognition: If the patient has the cognitive capacity to use the device via the Brief Cognitive Assessment Tool (BCAT®) short form (LOINC 95872-8)
  • Physical Functioning: If the patient is physically able to use the device via the 9-Hole Pegboard Dexterity Test (LOINC 83141-2)
  • Vision: If the patient's visual capabilities are aligned with the device features via the Motor Free Visual Perception test (MFVP) (SNOMED-CT 396216003)
  • Health Literacy: If the patient has the ability learn how to use the device via the BRIEF health literacy screening tool (LOINC 95866-0)
  • Disability: If the patient has a disability that would need to be accommodated in the selection of a device via an indication in the patient’s demographic record of having a disability (ICD-10 Z73.6)
• Documented observation of the patient’s usage of the requested device during an assessment that may influence the fulfillment of the device.
  • Example: A patient at a long-term care facility uses a cane to complete a walking assessment (e.g., the Centers for Medicare & Medicaid Services [CMS] Minimum Data Set [MDS] section GG items on walking distance) that is captured as observation data (via the derivedFrom data element within the PFE Use of Device profile).
• Supporting information about the patient's goals that may influence fulfillment of the device request.
  • Example: A patient at an inpatient rehabilitation facility has a goal of living independently at home after knee surgery, which requires limiting the range of motion of their knee. To support this goal, the physical therapist overseeing their rehab submits device requests for a knee brace that limits range of motion and a grabbing tool to help compensate for limited mobility due to the brace. Supporting information related to the goal can include: Independent daily dressing assessment (e.g., items GG0130.F and G from the MDS captured in the LOINC panel 108256-9) and a pain assessment (e.g., section J from the MDS captured in the LOINC panel 108256-9) that are completed by the patient while wearing a knee brace and while using a grabbing tool (captured in the PFE Goal profile via an Observation under the “addresses” data element).
  • Example: A patient in a skilled nursing facility has a goal to gain weight and maintain it. The patient’s dietitian orders an enteral nutrition-related device. Supporting information related to the goal can include: Vital sign data regarding weight to assess gain/maintenance (captured in the PFE Goal profile via LOINC code 29463-7 under the “measure” data element), Nutrition orders (captured in the PFE Goal profile via a NutritionOrder under the “addresses” data element)

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Identifiers assigned to this order by the orderer or by the receiver.

The URL pointing to a FHIR-defined protocol, guideline, orderset or other definition that is adhered to in whole or in part by this DeviceRequest.

Note: This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

The URL pointing to an externally maintained protocol, guideline, orderset or other definition that is adhered to in whole or in part by this DeviceRequest.

This might be an HTML page, PDF, etc. or could just be a non-resolvable URI identifier.

A Plan, proposal, order/service request, and/or goal order that is fulfilled by this device request.

Examples:

• A care plan that describes how the device will be used by the patient to support their participation in daily activities and care activities (captured via the US Core Care Plan profile)
• A service request for physical, occupational, or speech-language therapy that includes a description of the medical necessity for, appropriateness of, and use of the device during therapy sessions (captured via the PFE Service Request profile)
• A nutrition order that requires a device to provide nutritional support to a patient (via the PFE Nutrition Order profile)
• A goal participate in a community event that is supported an order of a portable oxygen pack (captured via the PFE Goal profile)

The request takes the place of the referenced completed or terminated request(s).

Composite request this is part of.

Examples:

• An alphanumeric string that is used as a group identifier for a composite request for.
• A motorized wheelchair, a seat cushion, a communication device, and accessories used to attach the cushion and communication device to the wheelchair
• A knee brace and a grabbing tool to support independent living for a patient who had knee surgery and is being discharged home from an inpatient rehab facility

The status of the request.

This element is labeled as a modifier because the status contains the codes cancelled and entered-in-error that mark the request as not currently valid.

Codes representing the status of the request.

Whether the request is a proposal, plan, an original order or a reflex order.

The kind of diagnostic request.

Indicates how quickly the {{title}} should be addressed with respect to other requests.

Identifies the level of importance to be assigned to actioning the request.

A code that indicates the device being requested. Example code systems include Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes

Examples:

• Wheelchair seat cushion: HCPCS E2601 “General use wheelchair seat cushion, width less than 22 inches, any depth”
• Splint: HCPCS A4570 “Splint”
• Brace: HCPCS L3224 “Orthopedic footwear, woman's shoe, oxford, used as an integral part of a brace (orthosis)”
• Enteral feeding pump and supplies: HCPCS B4035 “Enteral feeding supply kit; pump fed, per day, includes but not limited to feeding/flushing syringe, administration set tubing, dressings, tape”
• TENS device with 2 leads: HCPCS E0720 “Transcutaneous electrical nerve stimulation (tens) device, two lead, localized stimulation”
• Wheeled walker: HCPCS E0143 “Walker, folding, wheeled, adjustable or fixed height”
• Hot or cold pack: HCPCS A9273 “Cold or hot fluid bottle, ice cap or collar, heat and/or cold wrap, any type”

Codes for devices that can be requested.

The details of the device to be used.

Specific parameter(s) for the requested device.

Examples:

• Wheelchair: Seat cushion requirements, such as material and width
• Splints or braces: Range-of-motion setting
• Device weight limits
• Enteral feeding device: Number of connections
• TENS units: Settings, such as frequency and duration
• Walkers: Dimension parameters, such as width
• Hot or cold pack: Temperature

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

A code that identifies the device parameter(s).

Examples:

• Wheelchair seat cushion: Material = SNOMED 260769002, width = SNOMED 103355008
• Splints or braces: Range-of-motion = SNOMED 364564000
• Enteral feeding device connections = SNOMED 711341009
• TENS units: Frequency = SNOMED 278269003, duration = SNOMED 762636008
• Walker: Width = SNOMED 103355008
• Hot or cold pack: Temperature = SNOMED 722490005

The value(s) of the device parameter(s).

Examples:

• Wheelchair seat cushion: Filled with silicone gel = SNOMED 860705001, width = “21 inches”
• Splints or braces: Range-of-motion = “50 degrees”
• Enteral feeding device connections = “2”
• TENS units: Frequency = “30 pps”, duration = “10 minutes”
• Walker: Width = “24 inches”
• Hot or cold pack: Temperature = “35°C” or “10°C”

The patient for whom the device is being requested.

An encounter that provides additional context in which this request is made.

The timing schedule for the use of the device. The Schedule data type allows many different expressions, for example. "Every 8 hours"; "Three times a day"; "1/2 an hour before breakfast for 10 days from 23-Dec 2011:"; "15 Oct 2013, 17 Oct 2013 and 1 Nov 2013".

The Schedule data type allows many different expressions, for example:

• Times per day: "Every 8 hours"; "Three times a day"
• Duration: “Up to 2 hours per day”; “Between 4 and 6 hours per day”
• Specific times: "1/2 an hour before breakfast for 10 days from 23-Dec 2011"
• Date range: "15 Oct 2013, 17 Oct 2013 and 1 Nov 2013”
• “As needed”

When the request transitioned to being actionable.

The individual or entity who initiated the device request and has responsibility for its activation.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Carries DeviceRequest.requester when the requester is a CareTeam, Group, Patient, or RelatedPerson, which are allowed in FHIR R6 but not in FHIR R4.

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

Aa resource (or, for logical models, the URI of the logical model).

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

Plain text narrative that identifies the resource in addition to the resource reference.

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Desired type of performer for doing the diagnostic testing.

DO NOT USE THIS DATA ELEMENT. It will be removed from version R6 of the FHIR Device Request Profile. To capture the device performer role, use DeviceRequest.extension:device-user extension

Indicates specific responsibility of an individual within the care team, such as "Primary physician", "Team coordinator", "Caregiver", etc.

The desired performer for doing the diagnostic testing.

System SHALL use the device-user extension to record the person(s) who will be using the device

Codes indicating the reason or justification for requesting the device. This can be a code for a diagnosis, problem, or condition that necessitates use of the requested device. Complements the DeviceRequest.extension:clinical-justification.extension:note and DeviceRequest.reasonReference data elements.

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: ICD-10-CM J96.11 “Chronic respiratory failure with hypoxia”
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: ICD-10-CM I61.1 “Nontraumatic intracerebral hemorrhage in hemisphere, cortical”; ICD-10-CM I69.320 “Aphasia following cerebral infarction”; ICD-10-PCS F06Z1KZ “Speech-Language Pathology and Related Disorders Counseling Treatment using Audiovisual Equipment”
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: ICD-10-CM S83.261 “Peripheral tear of lateral meniscus, current injury, right knee”; ICD-10-PCS 0SQC4ZZ “Repair Right Knee Joint, Percutaneous Endoscopic Approach”; SNOMED 8510008 “Reduced mobility (finding)”; SNOMED 301572006 “Does mobilize using aids (finding)”; ICD-10-CM Z73 “Problems related to life management difficulty”
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: ICD-10-CM C50.811 “Malignant neoplasm of overlapping sites of right female breast”; ICD-10-CM C50.812 “Malignant neoplasm of overlapping sites of left female breast”; SNOMED 367336001 “Chemotherapy (procedure)”; ICD-10-CM R11.0 “Nausea”; SNOMED 18846006 “Chemotherapy-induced nausea and vomiting (disorder)”; ICD-10-CM R63 “Symptoms and signs concerning food and fluid intake”; ICD-10-CM R63.6 “Underweight”; SNOMED 404923009 “Weight gain advised (situation)”; SNOMED 229912004 “Enteral feeding (regime/therapy)”

Reason or justification for the request or use of this device. Complements the DeviceRequest.extension:clinical-justification.extension:note and DeviceRequest.reasonCode data elements.

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: Documentation of a plan to support the patient’s participation in the community event via the US Core CarePlan
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: Documentation of an order for therapy sessions via the US Core ServiceRequest profile
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: Documentation of the use of the brace and grabber to support mobility and independent living via the US Core CarePlan profile
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: Documentation of an enteral nutrition order via the PFE NutritionOrder profile

Insurance plans, coverage extensions, pre-authorizations and/or pre-determinations that may be required for delivering the requested service.

Additional clinical information about the patient that may influence the request fulfilment. For example, this may include where on the subject's body the device will be used (i.e. the target site).

Examples:

• For a patient receiving home health services with chronically low oxygen saturation levels due to a chronic lung disease, and needs a portable oxygen pack in order to participate in a community event: Documentation of their chronic lung disease and hypoxia in an HL7 Condition profile
• For a patient at a long-term care facility who had a stroke, now has aphasia because of the stroke and needs a communication device to use during speech-language therapy sessions: Documentation of stroke via the HL7 DiagnosticReport profile; and aphasia via the PFE ConditionEncounterDiagnosis profile
• For a patient who had right knee surgery for a meniscus tear, has limited mobility due to the surgery, is being discharged from an inpatient rehab facility to their home, and needs a knee brace and grabbing tool in order have adequate mobility to live independently: Documentation of the surgery via the HL7 Procedure profile; and limited ability to live independently captured during activities of daily living (ADL), instrumental activities of daily living (iADL), and pain assessments conducted with and without the devices via the PFE Collection profile
• For a patient with breast cancer admitted to a skilled nursing facility who lost weight due to treatment-induced nausea, and needs an enteral nutrition device to gain weight and maintain it: Documentation of cancer via the HL7 DiagnosticReport profile; chemotherapy via the HL7 Procedure profile; nausea via the via the ConditionEncounterDiagnosis profile; and weight loss via US Core BodyWeight profile

Knowing where the device is targeted is important for tracking if multiple sites are possible.

Details about this request that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.

Key events in the history of the request.

This might not include provenances for all versions of the request - only those deemed "relevant" or important. This SHALL NOT include the Provenance associated with this current version of the resource. (If that provenance is deemed to be a "relevant" change, it will need to be added as part of a later update. Until then, it can be queried directly as the Provenance that points to this version using _revinclude All Provenances should have some historical version of this Request as their subject.