This Implementation Guide uses FHIR defined resources – Composition Resource, Questionnaire Resource, QuestionnaireResponse Resource, Patient Resource, PractitionerRole Resource, Practitioner Resource, Organization Resource, ServiceRequest Resource and Bundle Resource from FHIR R4. For details on HL7 FHIR R4 see http://hl7.org/fhir/r4.

The Order & Referral by Form (ORF) Implementation Guide describes how forms for eReferrals, requests for information (such as diagnostic imaging results, lab results, discharge reports etc.) can be defined, deployed and used in order to achieve a syntactical and semantically consistent cross enterprise information exchange.

The Implementation Guide supports creation and domain wide deployment of forms for structured and coded information exchange as well as exchange of such forms for referral, orders etc. The Implementation Guide relies on FHIR e.g. the questionnaire resource. Because the Implementation Guide relies heavily on the FHIR Resources Questionnaire and QuestionnaireResponse, forms are addressed here as Questionnaires.

This Implementation Guide is derived from the HL7 Structured Data Capture Implementation Guide, see SDC IG (v2.7.0) and uses the Swiss Core Profiles, see CH Core (v2.0.0).

Download: You can download this Implementation Guide in NPM format from here.

Volume 1 – Order & Referral by Form (CH ORF) Implementation Guide

This Implementation Guide concerns directional information exchange between institutions such as requests for referral, requests for previous imaging results, requests for second opinions etc. as well as corresponding responses. Such request are often done – or could be done – by means of structured forms. The same may apply for responses or documents coming along in case the response consists of a particular payload (e.g. exam results). However, forms for these purposes are in general proprietary constructs and seldom suitable for further machine processing. Furthermore, such forms are more or less hard coded and concerned systems may not easily be updated for new use cases.

The ORF Implementation Guide addresses two issues:

1. It supports a scenario where an authority (e.g. health authority, expert panel etc.) defines a set of forms (here called Questionnaires) for well-defined use cases which then are deployed in a specific enterprise, domain etc. or even nationwide.
2. New use cases or changes in use cases can easily be handled either by modification of existing Questionnaires or new ones. The Implementation Guide itself is agnostic to the nature of a particular Questionnaire and the ORF Implementation Guide puts only little limits on its definition.

Vendors implementing the ORF Implementation Guide benefit of a high re-use potential. Applications which support the ORF Implementation Guide may be used for various settings of directional information exchange. The specific needs of a particular use case will be covered by a adequate design of the Questionnaire and the value sets being used.

When writing the ORF Implementation Guide, the authors had the following use case in mind: A human fills in a Questionnaire for a particular request and sends this Questionnaire to a receiver. There, a human reads the Questionnaire with its content. A corresponding response will work in the same way. There is possibly some payload coming with the Questionnaire: A request may be accompanied by results of preceding exams (e.g. images, reports); the response may be a diagnostic result.

The primary aim of the ORF Implementation Guide is to assure a consistent representation of Questionnaires at both – filler- and receiver – site. But there is the need for further machine processing: at filler site in terms of prepopulating attributes with content from other applications (e.g. demographic data of a patient) whereas the receiver may want to have the content of the form ready for further processing in his applications. Obviously the two aims – semantic interoperability and flexibility in the definition of Questionnaires – are contradictory. The ORF Implementation Guide addresses this problem by a mandatory set of generic elements and codes with defined meaning which are part of every Questionnaire in the ORF Implementation Guide. It is up to a SDC Form Designer to create Questionnaires with additional use case specific elements.

There has been a discussion whether population of the resources such as Patient Resource, ServiceRequest Resource etc. with the content of the QuestionnaireResponse Resource should be done by the order placer application or rather by the order filler application. The argument for assigning the task to the order placer is a result of the following consideration: the authors of a particular implementation guide may decide to define a questionnaire and its rendering but to leave it open if in a particular implementation the questionnaire is implemented or if the representation towards the user is made (in accordance to the questionnaire definition) by other technical means. In such a case, there would be no QuestionnaireResponse Resource in the bundle because all content is already in concerning resources. In order to handle all FHIR exchange formats equal (as far as sensible), the authors decided to mandate the order placer application with the task.

Applications claiming for conformance with the ORF Implementation Guide shall:

• Render (and in case of the Questionnaire filler allow for data entry) all elements of a questionnaire in the user interface (e.g. on screen, in print). Grouping of items and the order of items within shall be adequately reproduced according to the Questionnaire.
• In case of an implementation without Questionnaire and QuestionnaireResponse, the content of otherwise implemented UIs shall be in accordance to the questionnaire definition.
• Be able to process all codes related to the generic elements in a Questionnaire.

Vendors of applications with Questionnaire Filler/Questionnaire Receiver Actors are strongly recommended to implement interfaces to other applications (such as HIS and PACS) for all data in the generics elements of Questionnaires.

Applications designed like this will provide out-of-the-box interconnectivity for generic elements as well as out-of-the-box interoperability for all questionnaires as far it concerns user interfaces at filler and receiver site.

Nothing speaks against interfaces for data in the use case specific part of a particular Questionnaire. One has however to keep in mind, that such interfaces are tied to a specific questionnaire. Ownership or other means, which prevent changes of the questionnaire by third parties, are therefore advisable.

The ORF Implementation Guide deals with Transport, Workflow and Content. It is based on FHIR resources and in particular the FHIR Questionnaire resource. FHIR specifies RESTful Web services as a mean for transport.  An implementation based on RESTful Web services is strongly recommended however not mandatory to comply with the ORF Implementation Guide. Workflow is addressed by the scope of ORF Implementation Guide which addresses directional information exchange with request and response. Content is defined by a set of generic given elements and codes and the possibility to extend both as required by the use cases addressed.

ORF Actors, Transactions, and Content Modules

This Implementation Guide depends on the SDC Implementation Guide:

Questionnaires and forms permeate healthcare. They are used to capture administrative data, claims data, clinical information, research information, for public health reporting - every type of data that is manipulated by healthcare systems. They provide a user-friendly mechanism for capturing data in a consistent way. In FHIR, forms are represented using the Questionnaire resource and completed forms are represented using the QuestionnaireResponse resource. The base FHIR specification defines these resources but doesn't provide much guidance around how they should be used, nor does it set minimal expectations for interoperation. The SDC Implementation Guide provides a set of guidance around the use of Questionnaire and QuestionnaireResponse.

SDC Specification relevant to CH ORF

These sections define the different use-cases supported by SDC, specify the profile(s) needed to meet the use-cases.

1. Finding a Questionnaire describes expectations for systems serving as form repositories as well as clients who will need to search for forms.
2. Advanced Rendering describes how to use various questions and the base capabilities of Questionnaire to render different types of form elements
3. Form Behavior describes how to design 'active' forms that adjust what information is displayed and/or that perform calculations based on user input
4. Adaptive Forms describes an architecture to support completing forms where the questionnaire is not pre-defined and instead is dynamically developed based on the user's answers
5. Questionnaire Population describes how to design questionnaires to support pre-population of answers and how to use services that support pre-populating forms
6. Data Extraction describes how to design questionnaires to support converting completed forms into a FHIR resource or Bundle of FHIR resources for subsequent analysis

SDC Actors and workflow relevant to CH ORF

To be considered SDC-conformant, a system must adhere to the requirements defined by at least one of these statements. Some systems might choose to comply with more than one.

• SDC Form Designer - System responsible for creating and editing form designs
• SDC Form Filler - System responsible for capturing user form input to produce partially or fully completed forms
• SDC Form Manager - Repository for form definitions. May also perform pre-population
• SDC Form Response Manager - Searchable repository for storage and retrieval of completed and partially completed forms.
• SDC Form Receiver - Write-only destination to which forms are sent for processing

The relationship between these roles and a summary of how they can interact is shown in ^{[Figure 1]}.

^{[Figure 1]} SDC Role operations

CH ORF

This section defines the actors, transactions, and/or content modules specific to this Implementation Guide.

Actor	Definition
Questionnaire Filler	A system that renders Questionnaires and allows for filling in. The Questionnaire Filler is also responsible for filling in the corresponding resources in the Bundle, corresponds to the SDC Form Filler.
Questionnaire Receiver	A system that receives a Bundle (according to the Questionnaire) from a Questionnaire filler and renders it, corresponds to the SDC Form Receiver.

^{[Table 1]} Actors in the ORF Implementation Guide

^{[Figure 2]} Questionnaire Handling Actor Diagram

^{[Figure 2]} shows the actors directly involved in the ORF Implementation Guide and the relevant transactions between them. Actors which have a mandatory grouping are shown in conjoined boxes.

Actors	Transactions	Optionality	Reference
Questionnaire Filler	Submit Bundle [CH ORF-1]	O	3.1
Questionnaire Receiver	Submit Bundle[CH ORF-1]	O	3.1

^{[Table 2]} Actors in the ORF Implementation Guide

^{[Table 2]} lists the transactions for each actor directly involved in the Order & Referral by Form (ORF) Implementation Guide. To claim compliance with this Implementation Guide, an actor shall support all required transactions (labeled “R”) and may support the optional transactions (labeled “O”).

The Submit Bundle transaction is marked as optional to allow solutions which choose a different communication transaction method like IHE XDS, XDR, XMD to be conform with this Implementation Guide.

A product implementation using this Implementation Guide groups actors from this guide with actors from a workflow or transport Implementation Guide to be functional. The grouping of the content module described in this Implementation Guide to specific actors is described in more detail in the “Required Actor Groupings” section below.

^{[Table 3]} lists the content module defined in the Order & Referral by Form (ORF)) Implementation Guide. To claim support with this Implementation Guide, an actor shall support all required content modules (labeled “R”) and may support optional content modules (labeled “O”). The content module is based on the [Swiss core] profiles.

Actors	Content Modules	Optionality	Reference
Questionnaire Filler	ORF Content Module [Note 1]	R	Vol 3
Questionnaire Receiver	ORF Content Module [Note 1]	R [Note 1]	Vol 3

^{[Table 3]} Order & Referral by Form (ORF) Implementation Guide - Actors and Content Modules

^{[Note 1]} The content of the form depends on the form which itself is defined by the FHIR Questionnaire The FHIR Questionnaire defines elements and structure of the form. Codes for coded attributes are provided with a corresponding value set (details see ORF Content Module)

ORF Actor Descriptions and Actor Requirements

Most requirements are documented in Transactions (Volume 2) and Content Modules (Volume 3). This section documents any additional requirements on Implementation Guide's actors.

Questionnaire Filler and Questionnaire Receiver Actors may be implemented on a mobile device, although this is not the primary setting in mind. All other Actors will rather be implemented in a stationary setting because the use case addressed involve mostly stationary applications.

ORF Actor Options

Options that may be selected for each actor in this profile, if any, are listed in ^{[Table 4]}. Dependencies between options when applicable are specified in notes.

Actor	Option Name	Reference
Questionnaire Filler	No options defined	--
Questionnaire Receiver	No options defined	--

^{[Table 4]}ORF - Actors and Options

ORF Required Actor Groupings

An Actor from this Implementation Guide (Column 1) shall implement all of the required transactions and/or content modules in this profile in addition to all of the transactions required for the grouped actor (Column 2).

If this is a content module, and actors from this Implementation Guide are grouped with actors from a workflow or transport profile, the Content Bindings reference column references any specifications for mapping data from the content module into data elements from the workflow or transport transactions.

In some cases, required groupings are defined as at least one of an enumerated set of possible actors; this is designated by merging column one into a single cell spanning multiple potential grouped actors. Notes are used to highlight this situation.

Section 1.5 describes some optional groupings that may be of interest for security considerations and section 1.6 describes some optional groupings in other related profiles.

ORF Actor	Actor to be grouped with	Reference	Content Bindings Reference
Questionnaire Filler	Questionnaire Receiver	1.1	Volume 3
Questionnaire Receiver	Questionnaire Filler	1.1	Volume 3
Questionnaire Filler	CT Time Client	ITI TF-1: 7.1	na
Questionnaire Receiver	CT Time Client	ITI TF-1: 7.1	na

^{[Table 5]}ORF - Required Actor Groupings

ORF Overview

Use Cases

Questionnaire Usage Process Flow

Dr. Miller has a new Patient John Doe who has had an MRI at the radiology service “S-U-P-E-R-XR”. Dr. Miller retrieves a special order questionnaire from the SDC Form Manager at S-U-P-E-R-XR which allows ordering of images and reports of previous exams. Dr. Miller fills in this questionnaire and sends it back. At S-U-P-E-R-XR, a staff member will fill in another Questionnaire with a reply, attaches images and reports an sends all to Dr. Miller.

ORF Security Considerations

A resource server should not return any patient information unless proper authentication and communications security have been proven.

There are many reasonable methods of securing interoperability transactions. These security models can be layered in without modifying the characteristics of the ORF Profile transactions. The use of TLS is mandatory.

User authentication on mobile devices is encouraged using Internet User Authorization (IUA) Profile. The network communication security and user authentication are layered in at the HTTP transport layer and do not modify the interoperability characteristics defined in the ORF Profile.

The Security Audit logging (e.g. ATNA) is recommended. Support for ATNA-based audit logging on the mobile health device may be beyond the ability of this constrained environment.

In case vendors decide to include the Patient ID (patient.identifier) as a query parameter on the Resource URL (what would be out of the scope of ORF Implementation Guide), this URL pattern would present a risk when using typical web server audit logging of URL requests, and browser history. In both of these cases the URL with the patient identity would be clearly visible. These risks should be mitigated in system or operational design.

Volume 2 – Transactions

Submit Bundle [CH ORF-1]

This section corresponds to Transaction CH ORF-1. Transaction CH ORF-1 is used by the Questionnaire Filler and Questionnaire Receiver. This is a combination of extracting resources outlined in the SDC Workflow 10.1 Optional EHR extracts information from Questionnaire Response and sending a Bundle including the extracted information according to Volume 3 and Questionnaire Response to the Questionnaire Receiver.

Scope

This transaction is used to submit a filled in questionnaire together with required additional resources and attachments in a Bundle from a Questionnaire Filler to a Questionnaire Receiver.

Actor Roles

^{[Figure 3]} Use Case Diagram

Actor	Role
Questionnaire Filler	A system that allows querying a SDC Form Manager in order to fill in the elements for a Questionnaire Response. Upon completion, a corresponding bundle will be submitted to the Questionnaire Receiver.
Questionnaire Receiver	A system that receives bundles and processes them compliant to the ORF Profile.

^{[Table 6]}Actor Roles

Referenced Standard

• HL7 FHIR - Fast Healthcare Interoperability Resources
• HL7 SDC IG - Structured Data Capture Implementation Guide
• IETF RFC 2616 - Hypertext Transfer Protocol – HTTP/1.1
• IETF RFC 7540 - Hypertext Transfer Protocol – HTTP/2
• IETF RFC 3986 - Uniform Resource Identifier (URI): Generic Syntax
• IETF RFC 4627 - The application/json Media Type for JavaScript Object Notation (JSON)
• IETF RFC 6585 - Additional HTTP Status Codes
• IHE Appendix on HL7 FHIR - Appendix Z – FHIR Implementation Material (Trial Implementation)

Interaction Diagram

^{[Figure 4]} Interaction Diagram

Submit Bundle

The transaction uses the HTTP POST method on the target Questionnaire Receiver endpoint to convey the questionnaire bundle as a FHIR transaction.

Trigger Events

After the Questionnaire is completed by the Questionnaire filler user, the Questionnaire Filler submits the corresponding bundle to the Questionnaire receiver.

Message Semantics

The Questionnaire Filler shall initiate a FHIR “transaction” using a “create” action by sending an HTTP POST request method composed of a FHIR Bundle Resource containing the Composition resource and all resources referenced in, in particular one Questionnaire Resource, one QuestionnaireResponse Resource and additional resources according to the Questionnaire Profile.

The media type of the HTTP body shall be either “application/json+fhir” or “application/xml+fhir”.

See http://hl7.org/fhir/http.html#transaction for complete requirements of a transaction. See http://hl7.org/fhir/bundle-transaction.html for example of a transaction bundle.

Submit Bundle is sent to the base URI as defined in FHIR. See http://hl7.org/fhir/r4/http.html for the definition of “http” access methods and “base”.

Bundle Resources

For complete information on constructing a FHIR Bundle Resource, see: http://hl7.org/fhir/r4/bundle.html

The FHIR Bundle.meta.profile shall include the value http://fhir.ch/ig/ch-orf/StructureDefinition/ch-orf-document.

Expected Actions

The Questionnaire Receiver shall accept both media types application/json+fhir and application/xml+fhir.

On receipt of the submission, the Questionnaire Receiver shall validate the resources and respond with one of the HTTP codes defined in Section 3.4.4.2.2 Message Semantics.

Status Message

The Questionnaire receiver returns a HTTP Status code appropriate to the processing, conforming to the transaction specification requirements as specified in http://hl7.org/fhir/r4/http.html#transaction

Trigger Events

This message shall be sent once the questionnaire bundle is received and completely processed.

Message Semantics

When the Questionnaire Receiver has successfully processed the POST transaction, then the Questionnaire Receiver shall return an HTTP response with an overall status code.

In order to allow the Questionnaire Filler to know the outcomes of processing the transaction, and the identities assigned to the resources by the Questionnaire Receiver, the Questionnaire Receiver shall return a Bundle, with type set to transaction-response, that contains one entry for each entry in the request, in the same order, with the outcome of processing the entry. See FHIR http://hl7.org/fhir/r4/bundle.html#transaction-response

Each entry element shall contain a response element which details the outcome of processing the entry - the HTTP status code. All other elements are not required.

On success, the Questionnaire Receiver shall return the HTTP status code 200 – OK.

Guidance on handling Access Denied related to use of 403 and 404 can be found in IHE Appendix on HL7 FHIR Z.7.

On failure, the Questionnaire Receiver shall return the HTTP status codes as follows:

• 400 Bad Request - resource could not be parsed or failed basic FHIR validation rules like reference inconsistencies, schema violations, etc.
• 404 Not Found - resource type not supported.
• 422 Unprocessable Entity - one or more proposed resources violated applicable FHIR profiles or server business rules.

In addition, the Questionnaire Receiver may also send 5xx HTTP status codes to indicate non-transaction related failures. Note that the Questionnaire Filler may also encounter non-FHIR endpoints which will not return a Bundle in the response.

The Questionnaire Receiver may return HTTP redirect responses (responses with HTTP status codes 301, 302, 303 or 307) in response to a request.

Expected Actions

If the Questionnaire Receiver returns an HTTP redirect response (HTTP status codes 301, 302, 303, or 307), the Questionnaire Filler shall follow that redirection, although it may stop processing if it detects a loop.

The Questionnaire Receiver processes the results according to application-defined rules.

If a Questionnaire Receiver cannot automatically recover from an error condition, at a minimum, it should display the error to the user.

Conformance Resource

Questionnaire Receiver implementing this transaction should provide a Conformance Resource as described in IHE Appendix on HL7 FHIR Z.3 indicating the operation has been implemented.

Volume 3 – Content Modules

Questionnaire Content

This section describes the content of a form. The following definitions apply:

Request and responses consist of filled in questionnaires. Some elements of the questionnaire are generic given elements (such as author, data entry person, receiver etc.) and are always present in a questionnaire compliant to the ORF Implementation Guide. In addition, a questionnaire will contain elements which are use case specific. The ORF Implementation Guide makes no assumptions about the nature of such elements: structure and content (including coding of codes elements) are in the responsibility of those creating a form for a particular use case.

As this Implementation Guide is based on FHIR, the following rules apply:

Items, grouping of items, order of groups and order of elements within groups of a questionnaire shall be defined in a Questionnaire Resource. The Questionnaire Resource is defined by means of the SDC From Designer and made available by the SDC Form Manager.

Based on the Questionnaire, a Questionnaire Filler defines a QuestionnaireResponse and appropriate additional resources aimed at transmitting the information provided by the Questionnaire filler in a standardized structured form. Upon completion of the questionnaire, the Questionnaire Filler shall create a bundle with all resources mentioned above.

Questionnaires may be accompanied by additional material which can be attached or sent by postal mail (e.g. xray-films or paper documents). The use case may require some references between attached objects (e.g. which pdf-reports belongs to which imaging study).

Generic elements of a questionnaire

A questionnaire shall have a set of generic elements (e.g. author, data entry person, receiver etc.). ^{[Table 7]} lists the generic given elements.

Name	Role taker		HL7 V3 Equivalent	FHIR Representation	Comment
	Human	Organization
Author	X	X	Author	PractitionerRole	The person/organization responsible for the form content.
Data Entry Person	X	X	DataEnterer	PractitionerRole	The person/organization who has typed/filled in the form content.
Urgent Notification Contact for this document	X	X	PrimaryInformationRecipient	PractitionerRole	An information recipient to notify for urgent matters (e.g. in a radiology service, the radiologist has to be called by phone right away at the time the document is received.)
Urgent Notification Contact for the Response to this document	X	X	PrimaryInformationRecipient	PractitionerRole	An information recipient to notify for urgent matters about the response (e.g. in a clinical setting, the referring doctor has to be called by phone right away at the time the images and reports arrive). The Urgent Notification Contact for the Response can be specified already in the request. At the time the response is written, this element shall be populated to the Urgent Notification Contact element in the response.
Receiver	X	X		PractitionerRole	Person/organization who receives the document.
Copy Receiver	X	X		Patient/Organization	Person/organization who receives the copy of this order (shall receive also all results therefrom).
Patient	X			Patient	The principle target of a particular form content is one patient (for obstetrical and neonatal use cases see...).
Precedent Document Identifier	na	na			This element provides a link to the preceding document (Bundle.identifier) in a thread (e.g. from a response to the request).
Date	na	na			Date, the document was created.
Priority	na	na			Order priority.

^{[Table 7]} Generic elements in Questionnaires compliant to the ORF Implementation Guide

^{[Table 7]} shows that the FHIR representation of elements representing a person and/or an organisation is defined by the PractitionerRole resource. The Practitioner and/or the Organisation resource can then be referenced from the PractitionerRole resource.

Healthcare domain specific elements of a questionnaire

ServiceRequest resource

The CH ORF context specific requirements for this resource are shown in the profile CH ORF ServiceRequest.

DocumentReference resource

There may be the need to provide a linkage between particular files or between a particular file and an imaging study (e.g. a link between a PDF-File containing a report and a DICOM study). Such links shall be expressed with a DocumentReference resource.

The CH ORF context specific requirements for this resource are shown in the profile CH ORF DocumentReference.

FHIR Representation

FHIR depicts forms (questionnaires) in a Questionnaire Resource. A Questionnaire Resource can be conceived as an empty questionnaire where as the filled in questionnaire refers to the QuestionnaireResponse Resource. QuestionnaireResponse Resources are certainly structured but due to their flexibility in design not in a standardized manner. FHIR addresses this issue by means of its standardized resources.

The Order & Referral by Form Implementation Guide is based on two FHIR Resources profiles. For details on profiling FHIR see HL7 FHIR http://www.hl7.org/fhir/profiling.html. For details on FHIR resources and data-types see HL7 FHIR http://hl7.org/fhir/.

1. The Order & Referral by Form Questionnaire (ORF) Implementation Guide defines the usage of the FHIR Questionnaire Resource within the Order & Referral by Form. The Questionnaire Resource is an organized collection of questions intended to solicit information from patients, providers or other individuals involved in the healthcare domain. They may be simple flat lists of questions or can be hierarchically organized in groups and sub-groups, each containing questions. The Questionnaire defines the questions to be asked, how they are ordered and grouped and what the constraints are on the allowed answers. The results of a Questionnaire can be communicated using the QuestionnaireResponse resource (see http://www.hl7.org/fhir/questionnaire.html).
2. The Order & Referral by Form Document (ORF) Profile defines the usage of the FHIR Bundle within the Order & Referral by Form (ORF) Implementation Guide. The ORFDocumentProfile consist of a FHIR document (bundle) that contains the results of a filled in Questionnaire (QuestionnaireResponse Resource) together with the structured resources which map all information filled in the questionnaire. The Bundle is of type "document" and has a Composition resource as the first resource in the bundle, followed by a series of other resources, referenced from the Composition resource. The bundle gathers all the content of the document into a single document which may be signed and managed as required. The resources include both human readable and computer processable sections. In addition, a bundle as defined in this profile shall include a CSS stylesheets and optionally it may include a signature.
   
   Any resource referenced directly in the Composition Resource shall be included in the bundle. Other resources that these referenced resources refer to shall also be included in the bundle. Including these additional resources will make the document bigger, but will save applications from needing to retrieve the linked resources.

FHIR Resources Constraints

This section lists FHIR resources for which these CH ORF profiles provide additional information. Resources not listed here follow the specifications of FHIR. For details refer to https://www.hl7.org/fhir/resourcelist.html.

Composition resource

The CH ORF context specific requirements for this resource are shown in the profile CH ORF Composition.

In the Composition, general information about the document is defined, such as title, type and category. In the CH ORF exchange format, no fixed values are determined for these elements, only a preferred binding to specific ValueSets is made. These values are context-dependent and have to be specified in the corresponding derived exchange format. They must be defined as fixedValues or limited ValueSet in the Composition profile.

Element	Description	DataType	ValueSet
Composition.title	Meaningful human-readable title of the document	string	-
Composition.type	Precise type of the document	CodeableConcept	DocumentEntry.typeCode
Composition.category	High-level kind of the document at a macro level	CodeableConcept	DocumentEntry.classCode

^{[Table 8]} Generel information about the document defined in Composition

Questionnaire resource

The intention of the ORF Implementation Guide is to provide a standardized representation of forms at sender and receiver site as well. This is achieved with the Questionnaire Resource, which defines representation of all elements for the user (with the help of a CSS) and user interaction as well (e.g. with drop down lists).

This approach requires two things:

1. Precise definition of all questions
2. Mapping between elements of the Questionnaire Resource and the corresponding elements of the other resources in the bundle

Both is achieved by assigning meaningful concepts to all elements concerned. For codes refer to Appendix A.

The CH ORF context specific requirements for this resource are shown in the profile CH ORF Questionnaire.

QuestionnaireResponse resource

The QuestionnaireResponse Resource depends of the definition of the Questionnaire Resource and is therefore use case specific. For deriving QuestionnaireResponse Resources from the Questionnaire Resources refer to https://www.hl7.org/fhir/r4/questionnaireresponse.html.

The CH ORF context specific requirements for this resource are shown in the profile CH ORF QuestionnaireResponse.