IHE ITI Technical Framework
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20 Cross-Enterprise Sharing of Scanned Documents (XDS-SD)

A variety of legacy paper, film, electronic and scanner outputted formats are used to store and exchange clinical documents. These formats are not designed for healthcare documentation, and furthermore, do not have a uniform mechanism to store healthcare metadata associated with the documents, including patient identifiers, demographics, encounter, order or service information. The association of structured, healthcare metadata with this kind of document is important to maintain the integrity of the patient health record as managed by the source system. It is necessary to provide a mechanism that allows such source metadata to be stored with the document.

This profile defines how to couple such information, represented within a structured HL7 CDA R2 header, with a PDF or plaintext formatted document containing clinical information. Furthermore, this profile defines elements of the CDA R2 header necessary to minimally annotate these documents. Such header elements include information regarding patient identity, patient demographics, scanner operator identity, scanning technology, scan time as well as best available authoring information. Portions of CDA R2 header, along with supplemental document registration information, are then used to populate XDS Document Entry metadata.

This content profile is intended for use in XDS, XDR and XDM environments. Content is created by a Content Creator and is to be consumed by a Content Consumer. The Content Creator can be embodied by a Document Source or a Portable Media Creator, and the Content Consumer by a Document Consumer, a Document Recipient or a Portable Media Importer. Obligations imposed on the Content Creator and the Content Consumer by this profile are understood to be fulfilled by the software that creates the final document for submission and/or consumes profile conformant documents rather than any particular scanning technology.

20.1 Use Cases

20.1.1 Content Use Cases

Text Chart Notes

Examples of this content include handwritten, typed or word processed clinical documents and/or chart notes. These documents are typically multi-page, narrative text. They include preprinted forms with handwritten responses, printed documents, and typed and/or word processed documents, and documents saved in various word processing formats. Appropriate formats are PDF, derived from the word processing format, or plaintext, if the text structure is all that needs to be conveyed. PDF is desirable because it most faithfully renders word processed document content and it preserves meaning embodied in non-textual annotations.

Graphs, Charts and/or Line Drawings

Examples of this content include Growth Charts, Fetal Monitoring Graphs. Line drawings such as those described above are best rendered using PDF versus an image based compression, such as JPEG. However, when computer generated PDFs include lines or lossy compression is not acceptable for diagnostic purposes, PDF should be used.

Object Character Recognition (OCR) Scanned Documents

Clinical documents can contain text and annotations that cannot be fully processed by optical character recognition (OCR). We call attention to the fact that the OCR text content may only partially represent the document content. These are best supported by converting to PDF format, which can mix the use of OCR’d text, compressed scanned text, and scanned image areas.

Electronic Documents

Existing clinical documents that are electronically transmitted or software created (e.g., PDF, or plaintext) can be considered as actually scanned, previously scanned or virtually scanned before they are shared. In this context, “actually scanned” refers to electronic documents, newly created via some scanning technology from legacy paper or film for the purposes of sharing. “Previously scanned” refers to electronic documents that were previously produced via some scanning technology from legacy paper or film, but have existed in their own right for a period of time. “Virtually Scanned” electronic documents are existing electronic documents not derived from legacy paper or film that either are PDF/A or plaintext format or have been converted to one of these formats for the purposes of sharing. This content is covered by this profile.

20.1.2 Content Creator Use Cases

Content is created by a Content Creator. Impact on application function and workflow is implementation specific and out of scope of this content profile, though we note that they will be compliant with this content profile if they can produce CDA wrapped PDF, CDA wrapped plaintext or both. The following example use case is included to aid in the scoping of this content profile:

Legacy Clinic is a small two-physician clinic. They presently store their patient's medical records on paper. The Clinic is trying to figure out what to do with its paper and word processing documents as it converts over to an electronic system. They would like to be able to view the files over their local intranet.

Presently, most records are handwritten on preprinted paper forms that are inserted into specific sections of the patient's chart. More detailed encounter reports are dictated and sent to a transcription company that returns them in a word processing format. The medical records clerk at Legacy Clinic receives these files via e-mail, decrypts them, prints them out, and adds them to the patient's chart in the correct section.

Over the years, Legacy Clinic has used a number of different transcription companies, and the documents are stored in a variety of word processing formats. Several years ago, they began to require that returned documents be in RTF format in an attempt to reduce frustrations induced by dealing with discrepant word processing formats. Only in some cases was patient and encounter metadata stored within the word processing document in a regular format, depending upon the transcription company used at the time. A third party presently handles labs for the clinic. These are usually returned to the Clinic as printed documents. The clerk inserts these into the labs section in the patient's chart.

In the case of Legacy Clinic, the link between the word processing documents and the patient has been maintained for many of its documents, since the existing manual process maintains that association, and some of the files also contain the encounter metadata. However, the link to the specific encounter will need to be reestablished by interpreting the document content, which will require a great deal of manual effort for some of their documents which do not have it, and will still require custom handling depending upon the format used to store this metadata.

Legacy Clinic uses a transcription provider that can generate PDF documents, wrapped in a CDA Release 2.0 header. These are sent to Legacy Clinic via e-mail. While the same manual process is used, these documents are now in a format that is ready to be used by their new EHR system.

20.1.3 Content Consumer Use Cases

Content is consumed by a Content Consumer. Impact on application function and workflow is implementation specific and out of scope of this content profile. However, we note that adoption of this profile will necessitate the Content Consumer, upon document receipt, support the processing of both CDA wrapped PDF and CDA wrapped plaintext.

20.2 XDS-SD Actors/Transactions

There are two actors in the XDS-SD Profile, the Content Creator and the Content Consumer. Content is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile. A Document Source or a Portable Media Creator may embody the Content Creator. A Document Consumer, a Document Recipient or a Portable Media Importer may embody the Content Consumer. The sharing or transmission of content or updates from one actor to the other is addressed by the use of appropriate IHE profiles described in the section on Content Bindings with XDS, XDM and XDR.

Figure 20.2-1 shows the actors directly involved in the Scanned Documents Content Integration Profile and the relevant transactions between them. Other actors that may be indirectly involved due to their participation in other profiles are not necessarily shown.

XDS-SD Actor Diagram

Figure 20.2-1: Scanned Documents Actor Diagram

20.2.1 XDS-SD Required Actor Groupings

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

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

Table 20.2.1-1: XDS-SD - Required Actor Groupings

XDS-SD Actor Actor(s) to be grouped with Reference Content Bindings Reference
Content Creator XDS.b / Document Source (Note 1) ITI TF-1: 10.1 ITI TF-3: 5.2
XDR / Document Source (Note 1) ITI TF-1: 15.1
XDM / Portable Media Creator (Note 1) ITI TF-1: 16.1
Content Consumer XDS.b / Document Consumer (Note 1) ITI TF-1: 10.1 --
XDR / Document Consumer (Note 1) ITI TF-1: 15.1
XDM / Portable Media Importer (Note 1) ITI TF-1: 16.1

Note 1: One or more of the Document Sharing infrastructure groupings shall be supported.

20.3 XDS-SD Actor Options

Options for Scanned Documents leverage those in the IHE Patient Care Coordination Technical Framework (PCC TF). Options that may be selected for this Integration Profile are listed in the Table 20.3-1 along with the actors to which they apply. Dependencies between options when applicable are specified in notes.

Table 20.3-1: XDS-SD - Actors and Options

Actor Options Vol. & Section
Content Creator No options defined --
Content Consumer (Note 1) View Option PCC TF-2: 3.1.1
Document Import Option PCC TF-2: 3.1.2

Note 1: The actor shall support at least one of these options.

20.4 Scanned Documents Bindings to XDS, XDR, XDM

Actors from the ITI XDS, XDM and XDR Profiles embody the Content Creator and Content Consumer sharing function of this profile. A Content Creator or Content Consumer may be grouped with appropriate actors from the XDS, XDM or XDR Profiles to exchange the content described therein. The metadata sent in the document sharing or interchange messages has specific relationships or dependencies (which we call bindings) to the content of the clinical document described in the content profile. The Patient Care Coordination Technical Framework (PCC TF) defines the bindings to use when grouping the Content Creator of this profile with actors from the IHE ITI XDS, XDM or XDR Integration Profiles. See PCC TF-2: 4.

20.5 Scanned Documents Content Process Flow

This profile assumes the following sequence of events in creation of an XDS-SD document.

  1. A legacy paper document is scanned and a PDF/A is rendered. Alternatively, an electronic document is converted, if necessary, to PDF/A or plaintext format (see ITI TF-3: 5.2.1 and
  2. Software, conformant to this profile and most likely with the aid of user input (e.g., to provide document title, confidentiality code, original author), renders the CDA R2 header pertaining to the PDF or plaintext produced. The document is wrapped and the XDS-SD document is completed (see ITI TF-3: 5.2.3 ).
  3. XDS metadata is produced from data contained in the CDA header and supplemental information (see ITI TF-3: 5.2.2 ).
  4. The completed XDS-SD document and corresponding metadata is sent via the Provide a Register Document Set-b [ITI-41] transaction of XDS/XDR, or the Distribute Document Set on Media [ITI-32] transaction of XDM.