Latest revision as of 13:35, 3 October 2007

Volume 1

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHE Patient Care Coordination

Antepartum Summary (APS)
Technical Framework Supplement
Volume I

Revision 3.0
2008-2009

Public Comment

(PCC TF-1/Preface)Preface to Volume I of the PCC Technical Framework

(PCC TF-1/Introduction)Introduction to the PCC Technical Framework

(PCC TF-1/About)About the Patient Care Coordination Integration Profiles

(PCC TF-1/Dependencies)Dependencies of the PCC Integration Profiles

(PCC TF-1/Overview)PCC Integration Profiles Overview

(PCC TF-1/History)History of Annual Changes

(PCC TF-1/Product Implementations)Product Implementations

The Antepartum Summary (APS) Integration Profile

Obstetric patients in labor and admitted to Labor and Delivery must have a complete summary of their antepartum ambulatory care available at the time of admission to evaluate and / or ameliorate risk. This same data is required at any visit to Labor and Delivery for any other problems or special needs a patient may require.

During the 40 weeks of a typical pregnancy duration, the patient will have an initial History and Physical Examination, followed by repetitive office visits with multiple laboratory studies, imaging (usually ultrasound) studies, and serial physical examinations with recordings of vital signs, fundal height, and the fetal heart rate. As the patient is seen over a finite period in the office, aggregation of specific relevant data important to the evaluation of the obstetric patient upon presentation to Labor and Delivery is caputured on paper forms. The antepartum record contains the most critical information needed including the ongoing Medical Diagnoses, the Estimated Due Date, outcomes of any prior pregnancies, serial visit data on the appropriate growth of the uterus and assessments of fetal well being, authorizations, laboratory and imaging studies. This data must all be presented and evaluated upon entry to the Labor and Delivery Suite to ensure optimal care for the patient and the fetus.

Although the patient and her care provider may plan for a vaginal (natural) method of delivery, there is a substantive chance the delivery route may be surgical, requiring anesthesia and post-surgical care.

Current practice is to copy the patient's (paper) chart at various times during the pregnancy (as at 28 weeks and at 36 weeks of completed gestation), and transport the copies of the chart to the hospital the patient intends to use for delivery. Should the patient arrive prior to the chart copy arriving, or if the chart (or information within the chart) is missing on presentation of the patient to Labor and Delivery (a frequent occurrence), the staff or clinicians repeat laboratory or imaging studies. This results in unwarranted and duplicative tests, is wasteful of time and resources, and leads to dissatisfied patients. Further, missing or incomplete information about the patient’s clinical status may create a situation where critical information is unavailable to clinicians, which may ultimately result in an injury, inadequate aftercare or other undesirable outcome.

Significantly, a large portion of patients arrive in L&D without complete documentation. In one recent U.S. study , ~70% of patients (with paper charts) arrived in L&D without their current medical record being available. While only one hospital was involved in this study, one can see the extent of the issue, with pregnant patients possibly going to a different hospital than planned (preterm labor, rapid labor and unable to make it to the planned delivery hospital, or visiting a distant city), moving mid-care, or with a covering physician (rather than the primary obstetrician) on call.

In a Swedish study done in the 1990’s, critical data on paper records were incomplete from 45 to 87.5% of the time. Thus, availability of current medical records remains a significant problem for most hospital Labor and Delivery units; availability of key information electronically will significantly enhance patient safety.

Technical Approach

The Antepartum Summary is is a content profile that is intended to eventually sit within a larger folder structure that contains documents related to Antepartum care which will be defined in future years called the Antepartum Record. In addition to the APS content, related content profiles would include (existing and new):

Intake patient questionnaire
Intake History and Physical (including surgical and relevant social history)
Summary of OB-specific Ambulatory Visit Data (this profile)
Obstetric related Laboratory Reports
Obstetric related Imaging Reports
Obstetric related Consultation Reports
Non Stress Test (NST) Reports
NST Waveforms (may be covered by DICOM)
Patient Consent Forms for Performance of Procedures
Payer Authorization Forms

Although the scope of this content profile is limited to the Antepartum Ambulatory Prenatal Care, this discussion illustrates the need to view the aggregation of documents for Labor and Delivery as the center of multiple related documents and to include in the content profile the mechanisms for specifically referencing these document types.

Stakeholders

The stakeholders who use this document for decision making in the course of patient care include:

Obstetrician
Perinatologist
Certified Nurse Midwives
Anesthesiologist
Labor and Delivery and Peri-operative personnel (L&D staff, surgical coordinator, scheduling, surgical nursing)
Post-op and Post-Partum Nursing
Social Work (discharge planning)
Obstetrician (after discharge)

Use Cases

Use Case: Antepartum Care Delivery

Pre-condition: The patient’s obstetrician sees the patient for her pregnancy in the ambulatory (office) setting. During the pregnancy, the patient is noted to have a medical problem requiring consultation with a Maternal-Fetal Medicine specialist (perinatologist). The office obtains pre-authorization from the insurance payer for the consult, and for the intended or anticipated route of delivery, and transmits that information to both the consultant and to the hospital.

Events: The patient is seen in the obstetrician’s office where a complete medical and relevant social history are taken by the nurse and recorded in the office EHR, incorporating data from the perinatologist’s consultation report as appropriate. Laboratory and imaging reports ordered by the perinatologist as well as the perinatologist’s consultation report are displayed electronically to the obstetrician. The obstetrician reviews the consultation report from the perinatologist’s office and imaging studies ordered by the perinatologist along with data recorded by the nurse. Physical exam reveals some abnormalities. The obstetrician orders additional laboratory studies, and sends the patient to the hospital to Labor and Delivery.

When the laboratory results return, the physician completes the admission H&P, Allergies, Medications, includes the data prepared or ordered by the perinatologist, and makes it available to L&D. This data includes an assessment of the patient’s health status, and the requisite data summarized from the antepartum care given. The charge nurse for L&D documents that the complete collection of documents needed is available. The Post-Partum discharge planning is notified and assures that there is a suitable environment with appropriate support for post-delivery after-care.

Post-condition: The Pre-delivery H&P and Antepartum Summary with appropriate relationships to the Perinatologist Consultation, and all the antepartum laboratory and imaging studies are available to the obstetrician and the birthing center personnel for incorporation into their respective EHRs. The H&P is also available to the patient for viewing and incorporation into the patient’s PHR, and into the newborn baby’s PHR. For the APS profile, summary content is available to the obstetrician, with a plan for full content to be added in future years through other content profiles that share this use case.

Actors/Transaction

There are two actors in the APS 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 Actor. A Document Consumer, a Document Recipient or a Portable Media Importer may embody the Content Consumer Actor. 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.

APS Actor Diagram

Options

APS Options
Actor	Option
Content Consumer	View Option (1)
	Document Import Option (1)
	Section Import Option (1)
	Discrete Data Import Option (1)

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

Content Consumer Options

View Option

This option defines the processing requirements placed on Content Consumers for providing access, rendering and management of the medical document. See the View Option in PCC TF-2 for more details on this option.

A Content Creator Actor should provide access to a style sheet that ensures consistent rendering of the medical document content as was displayed by the Content Consumer Actor.

The Content Consumer Actor shall be able to present a view of the document using this style sheet if present.

Document Import Option

This option defines the processing requirements placed on Content Consumers for providing access, and importing the entire medical document and managing it as part of the patient record. See the Document Import Option in PCC TF-2 for more details on this option.

Section Import Option

This option defines the processing requirements placed on Content Consumers for providing access to, and importing the selected section of the medical document and managing them as part of the patient record. See the Section Import Option in PCC TF-2 for more details on this option.

Discrete Data Import Option

This option defines the processing requirements placed on Content Consumers for providing access, and importing discrete data from selected sections of the medical document and managing them as part of the patient record. See the Discrete Data Import Option in PCC TF-2 for more details on this option.

Coded Terminologies

This profile supports the capability to record entries beyond the IHE required coding associated with structured data. Actors from this profile may choose to utilize coded data, but interoperability at this level requires an agreement between the communicating parties that is beyond the scope of this Profile.

To facilitate this level of interoperability, the applications that implement actors within this profile shall provide a link to their HL7 conformance profile within their IHE Integration statement. The conformance profile describes the structure of the information which they are capable of creating or consuming. The conformance profile shall state which templates are supported by the application implementing the profile Actors, and which vocabularies and/or data types are used within those templates. It should also indicate the optional components of the entry that are supported.

An Example HL7 Conformance Profile is available to show how to construct such a statement. See the HL7 Refinement Constraint and Localization for more details on HL7 conformance profiles.

Antepartum Summary Content Module

An Antepartum Summary is a type of medical summary, and also incorporates the constraints defined for medical summaries found in a Medical Summary as described in PCC TF-2. In addition, the Antepartum Summary content profile includes additional information to support recording information specific to the ongoing care of a pregnant patient.

Grouping

Cross Enterprise Document Sharing, Media Interchange and Reliable Messages

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 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.

Content	Binding	Actor	Optionality
Antepartum Summary Form C & F	Medical Document Binding to XDS, XDM and XDR	Content Creator	R
Antepartum Summary Form C & F	Medical Document Binding to XDS, XDM and XDR	Content Consumer	R

Notification of Document Availability (NAV)

A Document Source should provide the capability to issue a Send Notification Transaction per the ITI Notification of Document Availability (NAV) Integration Profile in order to notify one or more Document Consumer(s) of the availability of one or more documents for retrieval. One of the Acknowledgement Request options may be used to request from a Document Consumer that an acknowledgement should be returned when it has received and processed the notification. A Document Consumer should provide the capability to receive a Receive Notification Transaction per the NAV Integration Profile in order to be notified by Document Sources of the availability of one or more documents for retrieval. The Send Acknowledgement option may be used to issue a Send Acknowledgement to a Document Source that the notification was received and processed.

Document Digital Signature (DSG)

When a Content Creator Actor needs to digitally sign a document in a submission set, it may support the Digital Signature (DSG) Content Profile as a Document Source. When a Content Consumer Actor needs to verify a Digital Signature, it may retrieve the digital signature document and may perform the verification against the signed document content.

Requirements of APS Actors

This section describes the specific requirements for each Actor defined within this profile. Specific details can be found in Volume 1 and Volume 2 of the technical framework.

Content Creator

A Content Creator shall be able to create an Antepartum Summary according to the specification for that content profile found in PCC TF-2.
A Content Creator shall be grouped with the Time Client Actor, and shall synchronize its clock with a Time Server.
A Content Creator shall be grouped with the Secure Node or Secure Application Actor of the ATNA profile.
All activity initiated by the application implementing the Content Creator shall generate the appropriate audit trail messages as specified by the ATNA Profile. The bare minimum requirements of a Content Creator are that it be able to log creation and export of clinical content.
A Content Creator shall use secure communications for any document exchanges, according to the specifications of the ATNA profile.

Content Consumer

A Content Consumer shall implement the View Option or Discrete Data import option, or both.
A Content Consumer that implements the Document Import or Section Import Option shall implement the View Option as well.
A Content Consumer that implements the View option shall be able to:
1. Demonstrate rendering of the document for display.
2. Print the document.
3. Display the document with its original stylesheet.
4. Support traversal of any links contained within the document.
A Content Consumer that implements the Document Import Option shall:
1. Store the document.
2. Demonstrate the ability to access the document again from local storage.
A Content Consumer that implements the Section Import Option shall offer a means to import one or more document sections into the patient record as free text.
A Content Consumer that implements the Discrete Data Import Option shall offer a means to import structured data from one or more sections of the document.
A Content Consumer Actor shall be grouped with the Time Client Actor, and shall synchronize its clock with a Time Server.
All activity initiated by the application implementing the Content Consumer shall generate the appropriate audit trail messages as specified by the ATNA Profile. The bare minimum requirements of a Content Consumer are that it be able to log views or imports of clinical content.
A Content Consumer shall log events for any views of stored clinical content.
A Content Consumer shall use secure communications for any document exchanges, according to the specifications of the ATNA profile.

Appendix A - Actor Descriptions

Actors are information systems or components of information systems that produce, manage, or act on information associated with operational activities in the enterprise.

Content Creator: The Content Creator Actor is responsible for the creation of content and transmission to a Content Consumer.

Content Consumer: A Content Consumer Actor is responsible for viewing, import, or other processing of content created by a Content Creator Actor.

Clinical Data Consumer: A clinical data consumer makes use of clinical patient data.
Clinical Data Source: A Clinical Data Sources maintains patient information about vital signs, problem and allergies, results from diagnostic tests (e.g., Lab, Imaging, or other test results), medications, immunizations or historical or planned visits and procedures.

Appendix B - Transaction Descriptions

Transactions are interactions between actors that transfer the required information through standards-based messages. The PCC Technical Framework does not define any specific transactions, as these are assumed to be carried out through the use of transactions defined in other IHE Profiles.

Query Existing Data: Request information about recent patient information, used to obtain vital signs measurements, problems and allergies, diagnostic results, medications, immunizations, or procedures or visits relevant for a patient. The query may request information about some or all of the above topics, or may request information on a specific topic, or one entered for a specific encounter or date range.

Appendix C - How to Prepare an IHE Integration Statement

IHE Integration Statements are documents prepared and published by vendors to describe the conformance of their products with the IHE Technical Framework. They identify the specific IHE capabilities a given product supports in terms of IHE actors and integration profiles described in the technical frameworks of each domain.

Users familiar with these concepts can use Integration Statements to determine what level of integration a vendor asserts a product supports with complementary systems and what clinical and operational benefits such integration might provide. Integration Statements are intended to be used in conjunction with statements of conformance to specific standards (e.g., HL7, IETF, DICOM, W3C, etc.).

IHE provides a process for vendors to test their implementations of IHE actors and integration profiles. The IHE testing process, culminating in a multi-party interactive testing event called the Connectathon, provides vendors with valuable feedback and provides a baseline indication of the conformance of their implementations. The process is not intended to independently evaluate, or ensure, product compliance. In publishing the results of the Connectathon and facilitating access to vendors' IHE Integration Statements, IHE and its sponsoring organizations are in no way attesting to the accuracy or validity of any vendor's IHE Integration Statements or any other claims by vendors regarding their products.

IMPORTANT -- PLEASE NOTE: Vendors have sole responsibility for the accuracy and validity of their IHE Integration Statements. Vendors' Integration Statements are made available through IHE simply for consideration by parties seeking information about the integration capabilities of particular products. IHE and its sponsoring organizations have not evaluated or approved any IHE Integration Statement or any related product, and IHE and its sponsoring organizations shall have no liability or responsibility to any party for any claims or damages, whether direct, indirect, incidental or consequential, including but not limited to business interruption and loss of revenue, arising from any use of, or reliance upon, any IHE Integration Statement.

Structure and Content of an IHE Integration Statement

An IHE Integration Statement for a product shall include:

The Vendor Name
The Product Name (as used in the commercial context) to which the IHE Integration Statement applies.
The Product Version to which the IHE Integration Statement applies.
A publication date and optionally a revision designation for the IHE Integration Statement.
The following statement: "This product implements all transactions required in the IHE Technical Framework to support the IHE Integration Profiles, Actors and Options listed below:"
A list of IHE Integration Profiles supported by the product and, for each Integration Profile, a list of IHE Actors supported. For each integration profile/actor combination, one or more of the options defined in the IHE Technical Framework may also be stated. Profiles, Actors and Options shall use the names defined by the IHE Technical Framework Volume I. (Note: The vendor may also elect to indicate the version number of the Technical Framework referenced for each Integration Profile.)

Note that implementation of the integration profile implies implementation of all required transactions for an actor as well as selected options.

The statement shall also include references and/or internet links to the following information:

Specific internet address (or universal resource locator [URL]) where the vendor's Integration Statements are posted
URL where the vendor's standards conformance statements (e.g., HL7, DICOM, etc.) relevant to the IHE transactions implemented by the product are posted.
URL of the IHE Initiative's web page for general IHE information www.himss.org/ihe.

An IHE Integration Statement is not intended to promote or advertise aspects of a product not directly related to its implementation of IHE capabilities.

Format of an IHE Integration Statement

Each Integration Statement shall follow the format shown below. Vendors may add a cover page and any necessary additional information in accordance with their product documentation policies.

IHE Integration Statement	Date	12 Oct 2005
Vendor	Product Name	Version
Any Medical Systems Co.	IntegrateRecord	V2.3
This product implements all transactions required in the IHE Technical Framework to support the IHE Integration Profiles, Actors and Options listed below:
Integration Profiles Implemented	Actors Implemented	Options Implemented
Cross-Enterprise Sharing of Medical Summaries	Document Consumer	View Option
Audit Trail and Node Authentication	Secure Node	none
Patient Identity Cross-referencing	Patient Identifier Cross-reference Consumer	PIX Update Notification
Internet address for vendor's IHE information:www.anymedicalsystemsco.com/ihe
Links to Standards Conformance Statements for the Implementation
HL7	www.anymedicalsystemsco.com/hl7
Links to general information on IHE
In North America: www.ihe.het	In Europe: www.ihe-europe.org	In Japan: www.jira-net.or.jp/ihe-j

IHE Integration Statement template

An IHE Integration Statement template (MS Word version) is available here.

The IHE Product Registry

The assumption of an integration statement is that all actors listed are functionally grouped and conform to any profile specifications for such groupings. In case of exceptions the vendor must explicitly describe the functional groupings.

IHE has developed a new Web-based database of Integration Statements. The IHE Product Registry enables developers to create, manage and publish Integration Statements for their commercial and open source healthcare IT systems. It allows users to browse for these systems based on their conformance with specific IHE Actors and Profiles. The system is open for use by developers and users now!

Appendix D - Braden Scale for Predicting Pressure Sore Risk

See File:Braden.pdf

Glossary

The following terms are used in various places within this technical framework, and are defined below. The complete IHE Glossary is available on the IHE Wiki at http://wiki.ihe.net/index.php/IHE_Glossary .

Actor: An entity within a use case diagram that can perform an action within a use case diagram. Possible actions are creation or consumption of a message
Acuity Assessment

Also known as triage category, this is the acuity of the patient assigned during the process of ED triage. A number of evidenced based triage scales exist, including the Emergency Severity Index (ESI), Canadian Triage and Acuity Scale (CTAS), the Australasian Triage Scale (ATS), and the Manchester Triage System. In many emergency departments, patients may simply be classified as emergent, urgent or non-urgent.

ADT: Admit, Discharge & Transfer.
Affinity Domain Policy: Affinity Domain Policy that clearly defines the appropriate uses of the XDS Affinity Domain. Within this policy is a defined set of acceptable use Privacy Consent Policies that are published and understood.
ASTM: Formerly the American Society of Testing and Materials, now ASTM International. An SDO that develops a number of standards across a wide variety of industries, including healthcare.
ATNA: Audit Trail and Node Authentication. An IHE ITI profile.
Care Context: The participations surrounding the care provision act, and the attributes of that act. Everything in the document header. Data history, links to clinical reasoning.
Continuity of Care Document(CCD): An HL7 Clinical Document Architecture (CDA) implementation alternative to ASTM ADJE2369 for institutions or organizations committed to HL7 standards. This specification was developed as a collaborative effort between ASTM and HL7. More information is available from http://www.hl7.org.
Continuity of Care Record (CCR): A core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more encounters. The CCR is Designation E2369-05 of the ASTM (American Society for Testing and Materials, International). More information is available from http://www.astm.org.
Clinical Document Architecture (CDA): An HL7 standard for the exchange for clinical documents. It specifies the structure and semantics of clinical documents. More information is available from http://www.hl7.org.
Content Binding: A content binding describes how the payload used in an IHE transaction is related to and/or constrained by the data elements contained within the content sent or received in those transactions.
CRS: Care Record Summary. An implementation guide that constrains CDA Release 2 for Care Record Summary documents.
CT: Consistent Time Integration Profile.
DICOM: Digital Imaging and Communication in Medicine
DSG: Digital Signatures. An IHE ITI Profile.
EDIS: An Emergency Department Information System (EDIS) is an extended EHR system used to manage data in support of Emergency Department patient care and operations. The functions of an EDIS may be provided by a single application or multiple applications.
eMPI: Enterprise Master Patient Index.
EMR: Electronic Medical Record, an Electronic Health Record system used within an enterprise to deliver care (also called EHR-CR by IHE-XDS).
Estimated Time of Arrival: the time the patient being referred can be expected to arrive in the emergency department.
EUA: Enterprise User Authentication Integration Profile.
Expected Actions: Actions which should occur as the result of a trigger event.
HIMSS: Healthcare Information and Management Systems Society.
HL7: Health Level Seven
HIS: Hospital Information System.
IHE: Integrating the Healthcare Enterprise.
Interaction Diagram: A diagram that depicts data flow and sequencing of events.
IT: Information Technology.
Logical Observation Identifiers Names and Codes (LOINC®): A vocabulary developed by the Regenstrief Institute aimed at standardizing laboratory and clinical codes for use in clinical care, outcomes management, and research. Additional information found at http://www.regenstrief.org/medinformatics/loinc/.
Mode of Arrival: The method of transportation used to transport the patient to the Emergency Department.
MPI: Master Patient Index.
MRN: Medical Record Number.
NAV: Notification of Document Availability
OID: Object Identifier. (See also 'Globally Unique Identifier').
Patient Identifier Cross-reference Domain: Consists of a set of Patient Identifier Domains known and managed by a Patient Identifier Cross-reference Manager Actor. The Patient Identifier Cross-reference Manager Actor is responsible for providing lists of "alias" identifiers from different Patient Identifier Domains.
Patient Identifier Domain: A single system or a set of interconnected systems that all share a common identification scheme for patients. Such a scheme includes: (1) a single identifier-issuing authority, (2) an assignment process of an identifier to a patient, (3) a permanent record of issued patient identifiers with associated traits, and (4) a maintenance process over time. The goal of Patient Identification is to reduce errors.
PDF: Portable Document Format.
PIX: Patient Identifier Cross Referencing. An IHE ITI Profile.
PDQ: Patient Demographics Query. An IHE ITI Profile.
PHR: Personal Health Record
Procedure: In the context of a "Pre-procedure History and Physical," the "procedure" is a surgery or an invasive examination of a patient that is required by quality review organizations to be preceded by a pre-procedure assessment of procedure risk and anesthesia risk. This assessment is typically referred to as a "Pre-operative" or "Pre-procedure History and Physical."
Process Flow Diagram: A graphical illustration of the flow of processes and interactions among the actors involved in a particular example.
Proposed disposition: the intended disposition (i.e. admission to ICU, discharge to home, transfer to psychiatric hospital), if known, that the referring provider expects the patient will end up after the emergency department intervention.
Referral Source: An individual, group, or agency that determined the patient should seek care at the ED. Referral source may be used to determine appropriate discharge referrals and services, or to provide surveillance data for program and service planning, or to examine referral patterns.
Role: The actions of an actor in a use case.
RSNA: Radiological Society of North America.
sig.: A Latin abbreviation for signetur used to represent the instruction following the medication name.
Scope: A brief description of the transaction.

SNOMED-CT® A comprehensive clinical terminology, originally created by the College of American Pathologists (CAP) and, as of April 2007, owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a non-for-profit association in Denmark. The CAP continues to support SNOMED CT operations under contract to the IHTSDO and provides SNOMED-related products and services as a licensee of the terminology. More information available from http://www.ihtsdo.org/ or the United States National Library of Medicine at http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html

Transport Mode: the method the patient employs, or is provided to get to the emergency department.
Trigger Event: An event such as the reception of a message or completion of a process, which causes another action to occur.
UID: Unique Identifier (See also Globally Unique Identifier).
Universal ID: Unique identifier over time within the UID type. Each UID must belong to one of specifically enumerated species. Universal ID must follow syntactic rules of its scheme.
Use Case: A graphical depiction of the actors and operation of a system.
XUA: Cross Enterprise User Authentication
XDS: Cross Enterprise Document Sharing

Volume 2

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHE Patient Care Coordination

Antepartum Summary (APS)
Technical Framework Supplement
Volume II

Revision 3.0
2008-2009

Public Comment

(PCC TF-2/Preface)Preface

(PCC TF-2/Introduction)Introduction

IHE Transactions

This section defines each IHE transaction in detail, specifying the standards used, and the information transferred.

Cross Enterprise Document Content Transactions

At present, all transactions used by the PCC Content Profiles appear in ITI TF-2. General Options defined in content profiles for a Content Consumer are described below.

View Option

A Content Consumer that supports the View Option shall be able to:

Use the appropriate XD* transactions to obtain the document along with associated necessary metadata.
Render the document for viewing. This rendering shall meet the requirements defined for CDA Release 2 content presentation semantics (See Section 1.2.4 of the CDA Specification: Human readability and rendering CDA Documents). CDA Header information providing context critical information shall also be rendered in a human readable manner. This includes at a minimum the ability to render the document with the stylesheet specifications provided by the document source, if the document source provides a stylesheet. Content Consumers may optionally view the document with their own stylesheet, but must provide a mechanism to view using the source stylesheet.
Support traversal of links for documents that contain links to other documents managed within the sharing framework.
Print the document to paper.

Document Import Option

This Option requires that the View Option be supported. In addition, the Content Consumer that supports the Document Import Option shall be able to support the storage of the entire document (as provided by the sharing framework, along with sufficient metadata to ensure its later viewing) both for discharge summary or referral documents. This Option requires the proper tracking of the document origin. Once a document has been imported, the Content Consumer shall offer a means to view the document without the need to retrieve it again from the sharing framework. When viewed after it was imported, a Content Consumer may chose to access the sharing framework to find out if the related Document viewed has been deprecated, replaced or addended.

Note:

For example, when using XDS, a Content Consumer may choose to query the Document Registry about a document previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.

Section Import Option

This Option requires that the View Option be supported. In addition, the Content Consumer that supports the Section Import Option shall be able to support the import of one or more sections of the document (along with sufficient metadata to link the data to its source) both for discharge summary or referral. This Option requires the proper tracking of the document section origin. Once sections have been selected, a Content Consumer shall offer a means to copy the imported section(s) into local data structures as free text. This is to support the display of section level information for comparison or editing in workflows such as medication reconciliation while discrete data import is not possible. When viewed again after it is imported, a Content Consumer may chose to access the sharing framework to find out if the related information has been updated.

Note:

For example, when using XDS, a Content Consumer may choose to query the Document Registry about a document whose sections were previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.

This Option does not require, but does not exclude the Content Consumer from offering a means to select and import specific subsets of the narrative text of a section.

Discrete Data Import Option

This Option does not require that the View, Import Document or Section Import Options be supported. The Content Consumer that supports the Discrete Data Import Option shall be able to support the storage of the structured content of one or more sections of the document. This Option requires that the user be offered the possibility to select among the specific sections that include structured content a set of clinically relevant record entries (e.g. a problem or an allergy in a list) for import as part of the local patient record with the proper tracking of its origin.

Note:

The Discrete Data Import Option does not require the support of the View, Import Document or Import Sections Options so that it could be used alone to support implementations of Content Consumers such as Public Health Data or Clinical Research systems that might aggregate and anonymize specific population healthcare information data as Document Consumer Actors, but one where no care provider actually views the medical summaries.

When discrete data is accessed after it was imported, a Content Consumer may choose to check if the document related to the discrete data viewed has been deprecated, replaced or addended.

A Content Consumer Actor grouped with the XDS Document Source Actor may query the Document Registry about a document from which discrete data was previously imported in order to find out if this previously imported document may have been replaced or has received an addendum. This capability is offered to Content Consumers by this Integration Profile, but not required, as the events that may justify such a query are extremely implementation specific.

IHE Patient Care Coordination Bindings

This section describes how the payload used in a transaction of an IHE profile is related to and/or constrains the data elements sent or received in those transactions. This section is where any specific dependencies between the content and transaction are defined.

A content integration profile can define multiple bindings. Each binding should identify the transactions and content to which it applies.

The source for all required and optional attributes have been defined in the bindings below. Three tables describe the three main XDS object types: XDSDocumentEntry, XDSSubmissionSet, and XDSFolder. XDSSubmissionSet and XDSDocumentEntry are required. Use of XDSFolder is optional. These concepts are universal to XDS, XDR and XDM.

The columns of the following tables are:

<XXX> attribute – name of an XDS attribute, followed by any discussion of the binding detail.
Optional? - Indicates the required status of the XDS attribute, and is one of R, R2, or O (optional). This column is filled with the values specified in the XDS Profile as a convenience.
Source Type – Will contain one of the following values:

Source Type	Description
SA	Source document Attribute – value is copied directly from source document. The Source/Value column identifies where in the source document this attribute comes from. Specify the location in XPath when possible.
SAT	Source document Attribute with Transformation – value is copied from source document and transformed. The Source/Value column identifies where in the source document this attribute comes from. Specify the location in XPath when possible. Extended Discussion column must not be empty and the transform must be defined in the extended discussion
FM	Fixed (constant) by Mapping - for all source documents. Source/Value column contains the value to be used in all documents.
FAD	Fixed by Affinity Domain – value configured into Affinity Domain, all documents will use this value.
CAD	Coded in Affinity Domain – a list of acceptable codes are to be configured into Affinity Domain. The value for this attribute shall be taken from this list.
CADT	Coded in Affinity Domain with Transform - a list of acceptable codes are to be configured into Affinity Domain. The value for this attribute shall be taken from this list.
n/a	Not Applicable – may be used with an optionality R2 or O attribute to indicate it is not to be used.
DS	Document Source – value comes from the Document Source actor. Use Source/Value column or Extended Discussion to give details.
O	Other – Extended Discussion must be 'yes' and details given in an Extended Discussion.

Source/Value – This column indicates the source or the value used.

The following tables are intended to be summaries of the mapping and transforms. The accompanying sections labeled 'Extended Discussion' are to contain the details as necessary.

Medical Document Binding to XDS, XDM and XDR

This binding defines a transformation that generates metadata for the XDSDocumentEntry element of appropriate transactions from the XDS, XDM and XDR profiles given a medical document and information from other sources. The medical document refers to the document being stored in a repository that will be referenced in the registry. The other sources of information include the configuration of the Document Source actor, the Affinity Domain, the site or facility, local agreements, other documents in the registry/repository, and this Content Profile.

In many cases, the CDA document is created for the purposes of sharing within an affinity domain. In these cases the context of the CDA and the context of the affinity domain are the same, in which case the following mappings shall apply.

In other cases, the CDA document may have been created for internal use, and are subsequentyly being shared. In these cases the context of the CDA document would not neccessarily coincide with that of the affinity domain, and the mappings below would not necessarily apply.

Please note the specifics given in the table below.

XDSDocumentEntry Metadata

XDSDocumentEntry Attribute	Optional?	Source Type	Source/ Value
availabilityStatus	R	DS
authorInstitution	R2	SAT	$inst <= /ClinicalDocument/author /assignedAuthor /representedOrganization The authorInstitution can be formated using the following XPath expression, where $inst in the expression below represents the representedOrganization. concat($inst/name)
authorPerson	R2	SAT	$person <= /ClinicalDocument/author The author can be formatted using the following XPath expression, where $person in the expression below represents the author. concat( $person/id/@extension,"^", $person/assignedPerson/name/family,"^", $person/assignedPerson/name/given[1],"^", $person/assignedPerson/name/given[2],"^", $person/assignedPerson/name/suffix,"^", $person/assignedPerson/name/prefix,"^", "^^^&", $person/id/@root,"&ISO")
authorRole	R2	SAT	This metadata element should be based on a mapping of the participation function defined in the CDA document to the set of author roles configured for the affinity domain. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate: /ClincicalDocument/author/ participationFunction
authorSpecialty	R2	SAT	This metadata element should be based on a mapping of the code associated with the assignedAuthor to detailed defined classification system for healthcare providers such configured in the affinitity domain. Possible classifications include those found in SNOMED-CT, or the HIPAA Healthcare Provider Taxonomy. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate: /ClinicalDocument/author/ assignedAuthor/code
classCode	R	CADT	Derived from a mapping of /ClinicalDocument/code/@code to an Affinity Domain specified coded value to use and coding system. Affinity Domains are encouraged to use the appropriate value for Type of Service, based on the LOINC Type of Service (see Page 53 of the LOINC User's Manual). Must be consistent with /ClinicalDocument/code/@code
classCodeDisplayName	R	CADT	DisplayName of the classCode derived. Derived from a mapping of /ClinicalDocument/code/@code to the appropriate Display Name based on the Type of Service. Must be Consitent with /ClinicalDocument/code/@code
confidentialityCode	R	CADT	Derived from a mapping of /ClinicalDocument/confidentialityCode/@code to an Affinity Domain specified coded value and coding system. When using the BPPC profile, the confidentialyCode may also be obtained from the <authorization> element. /ClinicalDocument/ confidentialityCode/@code -AND/OR- /ClinicalDocument/authorization/ consent[ templateId/@root= '1.3.6.1.4.1.19376.1.5.3.1.2.5' ] /code/@code
comments	O	DS
creationTime	R	SAT	/ClinicalDocument/effectiveTime Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.
entryUUID	R	DS
eventCodeList	O	CADT	These values express a collection of keywords that may be relevant to the consumer of the documents in the registry. They may come from anywhere in the CDA document, according to its purpose.
eventCodeDisplayNameList	R (if event Code is valued)	CADT	These are the display names for the collection of keywords described above.
formatCode	R	FM	The format code for each PCC Document content profile is provided within the document specifications.
healthcareFacilityTypeCode	R	CAD	A fixed value assigned to the Document Source and configured form a set of Affinity Domain defined values. Must be concistent with /clinicalDocument/code
healthcareFacility TypeCodeDisplay Name	R	CAD	Must be concistent with /clinicalDocument/code
intendedRecipient (for XDR, XDM)	O	SAT	$person <= /ClinicalDocument/intendedRecipient and/or $inst <= /ClinicalDocument/intendedRecipient/receivedOrganization The intendedRecipient can be formated using the following XPath expression, where $inst in the expression below represents the receivedOrganization and where $person in the expression below represents the intendedRecipient. concat( $person/id/@extension,"^", $person/informationRecipient/name/family,"^", $person/informationRecipient/name/given[1],"^", $person/informationRecipient/name/given[2],"^", $person/informationRecipient/name/suffix,"^", $person/informationRecipient/name/prefix,"^", "^^^&", $person/id/@root,"&ISO", "\|" $inst/name) "^^^^^&", $inst/id/@root, "&ISO", "^^^^", $inst/id/@extension) -->
languageCode	R	SA	/ClinicalDocument/languageCode
legalAuthenticator	O	SAT	$person <= /ClinicalDocument/ legalAuthenticator The legalAuthenticator can be formatted using the following XPath expression, where $person in the expression below represents the legalAuthenticator. concat( $person/id/@extension,"^", $person/assignedPerson/name/family,"^", $person/assignedPerson/name/given[1],"^", $person/assignedPerson/name/given[2],"^", $person/assignedPerson/name/suffix,"^", $person/assignedPerson/name/prefix,"^", "^^^&", $person/id/@root,"&ISO")
mimeType	R	FM	text/xml
parentDocumentRelationship	R (when applicable)	DS	Local document versions need not always be published, and so no exact mapping can be determined from the content of the CDA document. The parentDocumentRelationship may be determined in some configurations from the relatedDocument element present in the CDA dsocument. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate: /ClinicalDocument/relatedDocument/@typeCode
parentDocumentId	R (when parent Document Relationship is present)	DS	Local document versions need not always be published, and so no exact mapping can be determined from the content of the CDA document. The parentDocumentId may be determined in some configurations from the relatedDocument element present in the CDA dsocument. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate: $docID <= /ClinicalDocument/ relatedDocument/parentDocument/id The parentDocumentId can be formatted using the following XPath expression, where $docID in the expression below represents the identifier. concat($docID/@root,"^", $docID/@extension)
patientId	R	DS	The XDS Affinity Domain patient ID can be mapped from the patientRole/id element using transactions from the ITI PIX or PDQ profiles. See sourcePatientId below. If the context of the CDA coincides with that of the affinity domain, then the following x-path may be appropriate: $patID <= /ClinicalDocument/recordTarget/ patientRole/id
practiceSettingCode	R	CAD	This elements should be based on a coarse classification system for the class of specialty practice. Recommend the use of the classification system for Practice Setting, such as that described by the Subject Matter Domain in LOINC.
practiceSettingCodeDisplayName	R	CAD	This element shall contain the display names associated with the codes described above.
serviceStartTime	R2	SAT	/ClinicalDocument/documentationOf/ serviceEvent/effectiveTime/low/ @value Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.
serviceStopTime	R2	SAT	/ClinicalDocument/documentationOf/ serviceEvent/effectiveTime/high/ @value Times specified in clinical documents may be specified with a precision in fractional sections, and may contain a time zone offset. In the XDS Metadata, it can be precise to the second, and is always given in UTC, so the timezone offset if present must be added to the current time to obtain the UTC time.
sourcePatientId	R	SAT	$patID <= /ClinicalDocument/recordTarget/ patientRole/id The patientId can be formatted using the following XPath expression, where $patID in the expression below represents the appropriate identifier. concat($patID/@extension,"^^^&", $patID/@root, "&ISO")
sourcePatientInfo	R	SAT	/ClinicalDocument/recordTarget/ patientRole The sourcePatientInfo metadata element can be assembled from various components of the patientRole element in the clinical document.
title	O	SA	/ClinicalDocument/title
typeCode	R	CADT	/ClinicalDocument/code/@code The typeCode should be mapped from the ClinicalDocument/code element to a set of document type codes configured in the affinity domain. One suggested coding system to use for typeCode is LOINC, in which case the mapping step can be omitted.
typeCodeDisplay Name	R	CADT	/ClinicalDocument/code/@displayName
uniqueId	R	SAT	$docID <= /ClinicalDocument/id The uniqueId can be formatted using the following XPath expression, where $docID in the expression below represents the identifier. concat($docID/@root,"^", $docID/@extension)

XDSSubmissionSet Metadata

The submission set metadata is as defined for XDS, and is not necessarily affected by the content of the clinical document. Metadata values in an XDSSubmissionSet with names identical to those in the XDSDocumentEntry may be inherited from XDSDocumentEntry metadata, but this is left to affinity domain policy and/or application configuration.

Use of XDS Submission Set

This content format uses the XDS Submission Set to create a package of information to send from one provider to another. All documents referenced by the Medical Summary in this Package must be in the submission set.

Use of XDS Folders

No specific requirements identified.

Configuration

IHE Content Profiles using this binding require that Content Creators and Content Consumers be configurable with institution and other specific attributes or parameters. Implementers should be aware of these requirements to make such attributes easily configurable. There shall be a mechanism for the publishing and distribution of style sheets used to view clinical documents.

Extensions from other Domains

Scanned Documents (XDS-SD)

XDS-SD is a CDA R2 document and thus conforms to the XDS Metadata requirements in the PCC-TF, volume 2, Section 5 unless otherwise specified below.

XDSDocumentEntry

XDS-SD leverages the XDS DocumentEntry Metadata requirements in the PCC-TF, volume 2, Section 5.1.1.1.1 and in PCC_TF-2/Bindings unless otherwise specified below

XDSDocumentEntry.formatCode

The XDSDocumentEntry.formatCode shall be urn:ihe:iti:xds-sd:pdf:2008 when the document is scanned pdf and urn:ihe:iti:xds-sd:text:2008 when the document is scanned text. The formatCode codeSystem shall be 1.3.6.1.4.1.19376.1.2.3.

XDSDocumentEntry.uniqueId

This value shall be the ClinicalDocument/id in the HL7 CDA R2 header. The root attribute is required, and the extension attribute is optional. In accordance with the XDS.a profile, total length is limited to 128 characters; for XDS.b the limit is 256 characters. Additionally see PCC-TF, volume 2, Section 5.1.1.1.1 or PCC_TF-2/Bindings for further content specification.

Relating instances of XDS-SD documents

In general, most instances of XDS-SD will not have parent documents. It is possible, however, in some specific use cases that instances of XDS-SD documents are related. For example, for a particular document it may be the case that both the PDF scanned content and somewhat equivalent plaintext need to be wrapped and submitted. Each document would correspond to separate XDSDocumentEntries linked via an XFRM Association that indicates one document is a transform of the other. These can be submitted in a single submission set, or in separate ones. Other specific examples may exist and this profile does not preclude the notion of a parent document for these cases.

XDSSubmissionSet

No additional constraints. Particular to this profile, a legitimate use of submission sets would be to maintain a logical grouping of multiple XDS-SD documents. We encourage such usage. For more information, see PCC-TF-2 Section 5.1.1.1.2 or PCC_TF-2/Bindings.

XDSFolder

No additional requirements. For more information, see PCC-TF-2 Section 5.1.1.1.3 or PCC_TF-2/Bindings.

Basic Patient Privacy Consents (BPPC)

Laboratory Reports (XD-LAB)

XD-Lab is a CDA R2 document and thus conforms to the XDS Metadata requirements in the PCC-TF, volume 2, Section 5 unless otherwise specified below.

XDSDocumentEntry

XD-Lab leverages the XDS DocumentEntry Metadata requirements in the PCC-TF, volume 2, Section 5.1.1.1.1 and in PCC_TF-2/Bindings unless otherwise specified below

XDSDocumentEntry.eventCodeList

XD-Lab documents further constrain the the XDSDocumentEntry.eventCodeList to the following.

XDSDocumentEntry
Attribute	Optional?	Source Type	Source/ Value
eventCodeList	R2	SAT	ClinicalDocument / component / structuredBody / component / section / entry / act / entryRelationship / organizer (templateId="1.3.6.1.4.1.19376.1.3.1.1")/ component / observation(templateId="1.3.6.1.4.1.19376.1.3.1.1.1")/code AND ClinicalDocument / component / structuredBody / component / section / entry / act / subject / code If the document has Reportable Condition, then this code shall be among those listed in the eventCodeList. Additionally, if the document contains information about a Non-Human Subject, then the code that indicates what this subject is shall be among those listed in the eventCodeList. Thus, this attribute has been enhanced from the XDS profile from O to R2.

XDSDocumentEntry.formatCode

The XDSDocumentEntry.formatCode shall be urn:ihe:lab:xd-lab:2008 The formatCode codeSystem shall be 1.3.6.1.4.1.19376.1.2.3.

XDSSubmissionSet

No additional constraints. For more information, see PCC-TF-2 Section 5.1.1.1.2 or PCC_TF-2/Bindings.

XDSFolder

No additional requirements. For more information, see PCC-TF-2 Section 5.1.1.1.3 or PCC_TF-2/Bindings.

Namespaces and Vocabularies

This section lists the namespaces and identifiers defined or referenced by the IHE PCC Technical Framework, and the vocabularies defined or referenced herein.

The following vocabularies are referenced in this document. An extensive list of registered vocabularies can be found at http://www.hl7.org/oid/.

Vocabularies Used
codeSystem	codeSystemName	Description
1.3.6.1.4.1.19376.1.5.3.1	IHE PCC Template Identifiers	This is the root OID for all IHE PCC Templates. A list of PCC templates can be found below in CDA Release 2.0 Content Modules.
1.3.6.1.4.1.19376.1.5.3.2	IHEActCode	See IHEActCode Vocabulary below
1.3.6.1.4.1.19376.1.5.3.3	IHE PCC RoleCode	See IHERoleCode Vocabulary below
1.3.6.1.4.1.19376.1.5.3.4		Namespace OID used for IHE Extensions to CDA Release 2.0
2.16.840.1.113883.10.20.1	CCD Root OID	Root OID used for by ASTM/HL7 Continuity of Care Document
2.16.840.1.113883.5.112	RouteOfAdministration	See the HL7 RouteOfAdministration Vocabulary
2.16.840.1.113883.5.1063	SeverityObservation	See the HL7 SeverityObservation Vocabulary
2.16.840.1.113883.5.7	ActPriority	See the HL7 ActPriority Vocabulary
2.16.840.1.113883.6.1	LOINC	Logical Observation Identifier Names and Codes
2.16.840.1.113883.6.96	SNOMED-CT	SNOMED Controlled Terminology
2.16.840.1.113883.6.103	ICD-9CM (diagnosis codes)	International Classification of Diseases, Clinical Modifiers, Version 9
2.16.840.1.113883.6.104	ICD-9CM (procedure codes)	International Classification of Diseases, Clinical Modifiers, Version 9
2.16.840.1.113883.6.26	MEDCIN	A classification system from MEDICOMP Systems.
2.16.840.1.113883.6.88	RxNorm	RxNorm
2.16.840.1.113883.6.63	FDDC	First DataBank Drug Codes
2.16.840.1.113883.6.12	C4	Current Procedure Terminology 4 (CPT-4) codes.
2.16.840.1.113883.6.257	Minimum Data Set for Long Term Care	The root OID for Minimum Data Set Answer Lists
1.2.840.10008.2.16.4	DCM	DICOM Controlled Terminology; PS 3.16 Content Mapping Resource, Annex D
2.16.840.1.113883.6.24	MDC	ISO/IEEE 11073 Medical Device Nomenclature
2.16.840.1.113883.3.26.1.5	NDF-RT	National Drug File Reference Terminology (NCI version)
2.16.840.1.113883.11.19465	nuccProviderCodes	National Uniform Codes Council Healthcare Provider Terminology
2.16.840.1.113883.6.255.1336	X12DE1336	Insurance Type Code (ASC X12 Data Element 1336)
2.16.840.1.113883.6.256	RadLex	RadLex (Radiological Society of North America)

The IHE FormatCode vocabulary is now managed in an Implementation Guide published using FHIR.

formal canonical URI https://profiles.ihe.net/fhir/ihe.formatcode.fhir/ValueSet-formatcode.html
formal publication URL https://profiles.ihe.net/fhir/ihe.formatcode.fhir/
FormatCode gitHub repository for source of the Implementation Guide can be used to register issues, or create pull requests for modifications. Formal governance is managed by ITI Technical Committee.

This FormatCode vocabulary represents:

Code System 1.3.6.1.4.1.19376.1.2.3
Value Set 1.3.6.1.4.1.19376.1.2.7.1

IHEActCode Vocabulary

CCD		ASTM/HL7 Continuity of Care Document
CCR		ASTM CCR Implementation Guide

The IHEActCode vocabulary is a small vocabulary of clinical acts that are not presently supported by the HL7 ActCode vocabulary. The root namespace (OID) for this vocabulary is 1.3.6.1.4.1.19376.1.5.3.2. These vocabulary terms are based on the vocabulary and concepts used in the CCR and CCD standards listed above.

Code	Description
COMMENT	This is the act of commenting on another act.
PINSTRUCT	This is the act of providing instructions to a patient regarding the use of medication.
FINSTRUCT	This is the act of providing instructions to the supplier regarding the fulfillment of the medication order.
IMMUNIZ	The act of immunization of a patient using a particular substance or class of substances identified using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
DRUG	The act of treating a patient with a particular substance or class of substances identified using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
INTOL	An observation that a patient is somehow intollerant of (e.g., allergic to) a particular substance or class of substances using a specified vocabulary. Use of this vocabulary term requires the use of either the SUBSTANCE or SUBSTCLASS qualifier described below, along with an identified substance or class of substances.
SUBSTANCE	A qualifier that identifies the substance used to treat a patient in an immunization or drug treatment act. The substance is expected to be identified using a vocabulary such as RxNORM, SNOMED CT or other similar vocabulary and should be specific enough to identify the ingredients of the substance used.
SUBSTCLASS	A qualifier that identifies the class of substance used to treat a patient in an immunization or drug treatment act. The class of substances is expected to be identified using a vocabulary such as NDF-RT, SNOMED CT or other similar vocabulary, and should be broad enough to classify substances by mechanism of action (e.g., Beta Blocker), intended effect (Dieuretic, antibiotic) or ...

For Public Comment

What else needs to appear above for SUBSTCLASS?

IHERoleCode Vocabulary

The IHERoleCode vocabulary is a small vocabulary of role codes that are not presently supported by the HL7 Role Code vocabulary. The root namespace (OID) for this vocabulary is 1.3.6.1.4.1.19376.1.5.3.3.

IHERoleCode Vocabulary
Code	Description
EMPLOYER	The employer of a person.
SCHOOL	The school in which a person is enrolled.
AFFILIATED	An organization with which a person is affiliated (e.g., a volunteer organization).
PHARMACY	The pharmacy a person uses.

HL7 Version 3.0 Content Modules

This section contains content modules based upon the HL7 CDA Release 2.0 Standard, and related standards and/or implementation guides.

CDA Document Content Modules

(1.3.6.1.4.1.19376.1.5.3.1.1.1)Medical Documents Specification

(1.3.6.1.4.1.19376.1.5.3.1.1.2)Medical Summary Specification

(1.3.6.1.4.1.19376.1.5.3.1.1.11.2)Antepartum Summary

CDA Header Content Modules

(1.3.6.1.4.1.19376.1.5.3.1.2.4)PCC TF 2:6.3.2.4 Patient Contacts

(1.3.6.1.4.1.19376.1.5.3.1.2.4.1)PCC CDA Supplement 2:6.3.2.5 Spouse

(1.3.6.1.4.1.19376.1.5.3.1.2.4.2)PCC CDA Supplement 2:6.3.2.6 Natural Father of Fetus

(1.3.6.1.4.1.19376.1.5.3.1.2.5)PCC CDA Supplement 2:6.3.2.7 Authorization

CDA Section Content Modules

This list defines the sections that may appear in a medical document. It is intended to be a comprehensive list of all document sections that are used by any content profile defined in the Patient Care Coordination Technical Framework. All sections shall have a narrative component that may be freely formatted into normal text, lists, tables, or other appropriate human-readable presentations. Additional subsections or entry content modules may be required.

Other Condition Histories

The sections defined below provide historical information about the patient's conditions.

(1.3.6.1.4.1.19376.1.5.3.1.3.6)PCC TF 2:6.3.3.2.3 Active Problems

(1.3.6.1.4.1.19376.1.5.3.1.3.13)PCC TF 2:6.3.3.2.11 Allergies and Other Adverse Reactions

(1.3.6.1.4.1.19376.1.5.3.1.3.14)PCC TF 2:6.3.3.2.12 Family Medical History

(1.3.6.1.4.1.19376.1.5.3.1.3.15)PCC TF 2:6.3.3.2.13 Coded Family Medical History

(1.3.6.1.4.1.19376.1.5.3.1.3.16)PCC TF 2:6.3.3.2.14 Social History

(1.3.6.1.4.1.19376.1.5.3.1.1.5.3.4)PCC TF 2:6.3.3.2.18 Pregnancy History

(1.3.6.1.4.1.19376.1.5.3.1.1.11.2.2.1)PCC CDA Supplement 2:6.3.3.2.28 Estimated Delivery Dates

Medications

This section contains section content modules that describe activities surrounding the use of medication.

(1.3.6.1.4.1.19376.1.5.3.1.3.19)PCC TF 2:6.3.3.3.1 Medications

(1.3.6.1.4.1.19376.1.5.3.1.3.23)PCC TF 2:6.3.3.3.5 Immunizations

Physical Exams

(1.3.6.1.4.1.19376.1.5.3.1.3.25)PCC TF 2:6.3.3.4.4 Vital Signs

(1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2)PCC TF 2:6.3.3.4.5 Coded Vital Signs

Plans of Care

This section provides content modules for sections that describe the plan of care intended for the patient.

(1.3.6.1.4.1.19376.1.5.3.1.3.31)PCC TF 2:6.3.3.6.1 Care Plan

(1.3.6.1.4.1.19376.1.5.3.1.3.34)PCC TF 2:6.3.3.6.5 Advance Directives

(1.3.6.1.4.1.19376.1.5.3.1.3.35)PCC TF 2:6.3.3.6.6 Coded Advance Directives

Impressions

(1.3.6.1.4.1.19376.1.5.3.1.1.11.2.2.2)PCC CDA Supplement 2:6.3.3.9.3 Visit Summary

(1.3.6.1.4.1.19376.1.5.3.1.1.13.2.4)PCC CDA Supplement 2:6.3.3.9.7 Assessments

CDA and HL7 Version 3 Entry Content Modules

PCC TF 2:6.3.4.1 Authors and Informants

PCC TF 2:6.3.4.2 Linking Narrative and Coded Entries

(1.3.6.1.4.1.19376.1.5.3.1.4.1)PCC TF 2:6.3.4.3 Severity

(1.3.6.1.4.1.19376.1.5.3.1.4.1.1)PCC TF 2:6.3.4.4 Problem Status Observation

(1.3.6.1.4.1.19376.1.5.3.1.4.1.2)PCC TF 2:6.3.4.5 Health Status

(1.3.6.1.4.1.19376.1.5.3.1.4.2)PCC TF 2:6.3.4.6 Comments

(1.3.6.1.4.1.19376.1.5.3.1.4.3)PCC TF 2:6.3.4.7 Patient Medication Instructions

(1.3.6.1.4.1.19376.1.5.3.1.4.3.1)PCC TF 2:6.3.4.8 Medication Fulfillment Instructions

(1.3.6.1.4.1.19376.1.5.3.1.4.4)PCC TF 2:6.3.4.9 External References

(1.3.6.1.4.1.19376.1.5.3.1.4.4.1)PCC TF 2:6.3.4.10 Internal References

(1.3.6.1.4.1.19376.1.5.3.1.4.5.1)PCC TF 2:6.3.4.11 Concern Entry

(1.3.6.1.4.1.19376.1.5.3.1.4.5.2)PCC TF 2:6.3.4.12 Problem Concern Entry

(1.3.6.1.4.1.19376.1.5.3.1.4.5.3)PCC TF 2:6.3.4.13 Allergy and Intolerance Concern

(1.3.6.1.4.1.19376.1.5.3.1.4.5)PCC TF 2:6.3.4.14 Problem Entry

(1.3.6.1.4.1.19376.1.5.3.1.4.6)PCC TF 2:6.3.4.15 Allergies and Intolerances

(1.3.6.1.4.1.19376.1.5.3.1.4.7)PCC TF 2:6.3.4.16 Medications

(1.3.6.1.4.1.19376.1.5.3.1.4.12)PCC TF 2:6.3.4.17 Immunizations

(1.3.6.1.4.1.19376.1.5.3.1.4.7.3)PCC TF 2:6.3.4.18 Supply Entry

(1.3.6.1.4.1.19376.1.5.3.1.4.7.2)PCC TF 2:6.3.4.19 Product Entry

(1.3.6.1.4.1.19376.1.5.3.1.4.13)PCC TF 2:6.3.4.20 Simple Observations

(1.3.6.1.4.1.19376.1.5.3.1.4.13.1)PCC TF 2:6.3.4.21 Vital Signs Organizer

(1.3.6.1.4.1.19376.1.5.3.1.4.13.2)PCC TF 2:6.3.4.22 Vital Signs Observation

(1.3.6.1.4.1.19376.1.5.3.1.4.15)PCC TF 2:6.3.4.23 Family History Organizer

(1.3.6.1.4.1.19376.1.5.3.1.4.13.4)PCC TF 2:6.3.4.24 Social History Observation

(1.3.6.1.4.1.19376.1.5.3.1.4.13.3)PCC CDA Supplement 2:6.3.4.25 Family History Observation

(1.3.6.1.4.1.19376.1.5.3.1.4.13.5)PCC CDA Supplement 2:6.3.4.26 Pregnancy Observation

(1.3.6.1.4.1.19376.1.5.3.1.1.11.2.3.1)PCC CDA Supplement 2:6.3.4.27 EDD Observation

(1.3.6.1.4.1.19376.1.5.3.1.1.11.2.3.2)PCC CDA Supplement 2:6.3.4.28 Antepartum Visit Summary Battery

(1.3.6.1.4.1.19376.1.5.3.1.4.13.7)PCC CDA Supplement 2:6.3.4.29 Advance Directive Observation

(1.3.6.1.4.1.19376.1.5.3.1.4.14)PCC CDA Supplement 2:6.3.4.31 Encounters

(1.3.6.1.4.1.19376.1.5.3.1.4.19)PCC CDA Supplement 2:6.3.4.33 Procedure Entry

(1.3.6.1.4.1.19376.1.5.3.1.1.12.3.1)PCC CDA Supplement 2:6.3.4.38 Pain Score Observation

Appendix A - Examples Using PCC Content Profiles

Example documents conforming to each profile can be found on the IHE wiki at the following URLs.

Profile and Content	URL
XDS-MS
Referral Summary	XDSMS Example1
Discharge Summary	XDSMS Example1
XPHR
XPHR Content	XPHR Example1
XPHR Update	XPHR Example2
(EDR) ED Referral	EDR Example
(APS) Antepartum Summary	APS Example
(EDES)
Triage Note	EDES Example1
ED Nursing Note	EDES Example2
Composite Triage and Nursing Note	EDES Example3
ED Physician Note	EDES Example4
(FSA) Functional Status Section	FSA Example

Appendix B - Validating CDA Documents using the Framework

Many of the constraints specified by the content modules defined in the PCC Technical Framework can be validated automatically by software. Automated validation is a very desirable capability, as it makes it easier for implementers to test the correctness of their implementations. With regard to validation of the content module, the PCC Technical Framework narrative is the authoritative specification, not any automated software tool. Having said that, it is still very easy to create a validation framework for the IHE PCC Technical Framework using a XML validation tool such as Schematron. Since each content module has a name (the template identifier), any XML instance that reports itself to be of that "class" can be validated by creating assertions that must be true for each constraint indicated for the content module. In the XML representation, the <templateId> element is a child of the element that is claiming conformance to the template named. Thus the general pattern of a Schematron that validates a specific template is shown below:

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReferralSummary'>
    <rule context='*[cda:templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.3]"'>
      <!-- one or more assertions made by the content module -->
    </rule>
  </pattern>
</schema>

Validating Documents

For document content modules, the pattern can be extended to support common document content module constraints as shown below:

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReferralSummary'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.1.3]"'>
      <!-- Verify that the template id is used on the appropriate type of object -->
      <assert test='../ClinicalDocument'>
        Error: The referral content module can only be used on Clinical Documents.
      </assert>
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.1.2"]'>
        Error: The parent template identifier for medical summary is not present.
      </assert>
      <!-- Verify the document type code -->
      <assert test='code[@code = "34133-9"]'>
        Error: The document type code of a referral summary must be
        34133-9 SUMMARIZATION OF EPISODE NOTE.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The document type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
      <!-- Verify that all required data elements are present -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: A referral summary must contain a reason for referral.
      </assert>
      <!-- Alert on any missing required if known elements -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.8"]'>
        Warning: A referral summary should contain a list of history of past illnesses.
      </assert>
      <!-- Note any missing optional elements -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.3.18"]'>
        Note: This referral summary does not contain the pertinent review of systems.
      </assert>
    </rule>
  </pattern>
</schema>

Validating Sections

The same pattern can be also applied to sections with just a few minor alterations.

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <pattern name='ReasonForReferralUncoded'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <!-- Verify that the template id is used on the appropriate type of object -->
      <assert test='section'>
        Error: The coded reason for referral module can only be used on a section.
      </assert>
      <assert test='false'>
        Manual: Manually verify that this section contains narrative providing the
        reason for referral.
      </assert>
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral 
        module is not present.
      </assert>
      <!-- Verify the section type code -->
      <assert test='code[@code = "42349-1"]'>
        Error: The section type code of the reason for referral section must be 42349-1
        REASON FOR REFERRAL.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The section type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
  </pattern>
  <pattern name='ReasonForReferralCoded'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.2"]'>
      <!-- The parent template will have already verified the type of object -->
      <!-- Verify that the parent templateId is also present. -->
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral 
        module is not present.
      </assert>
      <!-- Don't bother with the section type code, as the parent template caught it -->
      <!-- Verify that all required data elements are present -->
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.13"]'>
        Error: A coded reason for referral section must contain an simple observation.
      </assert>
      <!-- Alert on any missing required if known elements -->
      <!-- Note any missing optional elements -->
    </rule>
  </pattern>
</schema>

A similar pattern can also be followed for Entry and Header content modules, and these are left as an exercise for the reader.

Phases of Validation and Types of Errors

Note that each message in the Schematrons shown above start with a simple text string that indicates whether the message indicates one of the following conditions:

An error, e.g., the failure to transmit a required element,
A warning, e.g., the failure to transmit a required if known element,
A note, e.g., the failure to transmit an optional element.
A manual test, e.g., a reminder to manually verify some piece of content.

Schematron supports the capability to group sets of rules into phases by the pattern name, and to specify which phases of validation should be run during processing. To take advantage of this capability, one simply breaks each <pattern> element above up into separate patterns depending upon whether the assertion indicates an error, warning, note or manual test, and then associate each pattern with a different phase. This is shown in the figure below.

<schema xmlns="http://www.ascc.net/xml/schematron" xmlns:cda="urn:hl7-org:v3">
  <ns prefix="cda" uri="urn:hl7-org:v3" />
  <phase id="errors">
    <active pattern="ReasonForReferralUncoded_Errors"/>
    <active pattern="ReasonForReferralCoded_Errors"/>
  </phase>
  <phase id="manual">
    <active pattern="ReasonForReferralUncoded_Manual"/>
  </phase>
  <pattern name='ReasonForReferralUncoded_Errors'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <assert test='section'>
        Error: The coded reason for referral module can only be used on a section.
      </assert>
      <assert test='code[@code = "42349-1"]'>
        Error: The section type code of the reason for referral section must be 42349-1
        REASON FOR REFERRAL.
      </assert>
      <assert test='code[@codeSystem = "2.16.840.1.113883.6.1"]'>
        Error: The section type code must come from the LOINC code 
        system (2.16.840.1.113883.6.1).
      </assert>
    </rule>
  </pattern>
  <pattern name='ReasonForReferralUncoded_Manual'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
      <assert test='false'>
        Manual: Manually verify that this section contains narrative providing the
        reason for referral.
      </assert>
  </pattern>
  <pattern name='ReasonForReferralCoded_Errors'>
    <rule context='*[templateId/@root="1.3.6.1.4.1.19376.1.5.3.1.3.2"]'>
      <assert test='templateId[@root="1.3.6.1.4.1.19376.1.5.3.1.3.1"]'>
        Error: The parent template identifier for the reason for referral not present.
      </assert>
      <assert test='.//templateId[@root = "1.3.6.1.4.1.19376.1.5.3.1.4.13"]'>
        Error: A coded reason for referral section must contain an simple observation.
      </assert>
    </rule>
  </pattern>
</schema>

Using these simple "templates" for template validation one can simply create a collection of Schematron patterns that can be used to validate the content modules in the PCC Technical Framework. Such Schematrons are expected to be made available as part of the MESA test tools that are provided to IHE Connectathon participants, and which will also be made available to the general public after connectathon.

Appendix C - Extensions to CDA Release 2.0

This section describes extensions to CDA Release 2.0 that are used by the IHE Patient Care Coordination Technical Framework.

IHE PCC Extensions

All Extensions to CDA Release 2.0 created by the IHE PCC Technical Committee are in the namespace urn:ihe:pcc:hl7v3.

The approach used to create extension elements created for the PCC Technical Framework is the same as was used for the HL7 Care Record Summary (see Appendix E) and the ASTM/HL7 Continuity of Care Document (see secion 7.2).

replacementOf

The <replacementOf> extension element is applied to a section appearing in a PHR Update Document to indicate that that section's content should replace that of a previously existing section. The identifier of the previously existing section is given so that the PHR Manager receiving the Update content will know which section to replace. The model for this extension is shown below.

Model for replacementOf

Use of this extension is shown below. The <replacementOf> element appears after all other elements within the <section> element. The <id> element appearing in the <externalDocumentSection> element shall provide the identifier of the section being replaced in the parent document.

<section>
 <id root=' ' extension=' '/>
 
 <title>Name of the Section</title>
 <text>Text of the section</text>
 <entry></entry>
 <component></component>
 <pcc:replacementOf xmlns:pcc='urn:ihe:pcc:hl7v3'>
   <pcc:externalDocumentSection>
     <pcc:id root='58FCBE50-D4F2-4bda-BC1C-2105B284BBE3'/>
   <pcc:externalDocumentSection/>
 </pcc:replacementOf>
</section>

Extensions Defined Elsewhere used by IHE PCC

Entity Identifiers

There is often a need to record an identifer for an entity so that it can be subsequently referenced. This extension provides a mechnism to store that identifier. The element appears after any <realm>, <typeId> or <templateId> elements, but before all others in the entity where it is used:

<playingEntity classCode='ENT' determinerCode='INSTANCE'>
 <sdtc:id root='1.3.6.4.1.4.1.2835.2' extension='EntityID'/>
   :
   .
</playingEntity>

Patient Identifier

There is a need to record the identifer by which a patient is known to another healthcare provider. This extension provides a role link between the assigned, related or associated entity, and the patient role.

Use of this extension to record the identifier under which the patient is known to a provider is shown below.

<assignedEntity>
 <id extension='1' root='1.3.6.4.1.4.1.2835.1'/>
 
 <addr>
   <streetAddressLine>21 North Ave</streetAddressLine>
   <city>Burlington</city>
   <state>MA</state>
   <postalCode>01803</postalCode>
   <country>USA</country>
 </addr>
 <telecom value='tel:(999)555-1212' use='WP'/>
 <assignedPerson>
   <name>
     <prefix>Dr.</prefix><given>Bernard</given><family>Wiseman</family><suffix>Sr.</suffix>
   </name>
 </assignedPerson>
 <sdtc:patient xmlns:sdtc='urn:hl7-org:sdtc' >
   <sdtc:id root='1.3.6.4.1.4.1.2835.2' extension='PatientMRN'/>
 </sdtc:patient>
</assignedEntity>

The <patient> element records the link between the related, assigned or associated entity and the patient. The <id> element provides the identifier for the patient. The root attribute of the <id> should be the namespace used for patient identifiers by the entity. The extension attribute of the <id> element shall be the patient's medical record number or other identifier used by the entity to identify the patient.

@@ Line 3: / Line 3: @@
 </noinclude>
-__TOC__
+==The Antepartum Summary (APS) Integration Profile ==
+Obstetric patients in labor and admitted to Labor and Delivery must have a complete summary of their antepartum ambulatory care available at the time of admission to evaluate and / or ameliorate risk. This same data is required at any visit to Labor and Delivery for any other problems or special needs a patient may require.
-==Profile Abstract==
+During the 40 weeks of a typical pregnancy duration, the patient will have an initial History and Physical Examination, followed by repetitive office visits with multiple laboratory studies, imaging (usually ultrasound) studies, and serial physical examinations with recordings of vital signs, fundal height, and the fetal heart rate. As the patient is seen over a finite period in the office, aggregation of specific relevant data important to the evaluation of the obstetric patient upon presentation to Labor and Delivery is caputured on paper forms.  The antepartum record contains the most critical information needed including  the ongoing Medical Diagnoses, the Estimated Due Date, outcomes of any prior pregnancies, serial visit data on the appropriate growth of the uterus and assessments of fetal well being, authorizations, laboratory and imaging studies.  This data must all be presented and evaluated upon entry to the Labor and Delivery Suite to ensure optimal care for the patient and the fetus.
-The Antepartum Summary (APS) describes the content structures for the ACOG Antepartum Record Forms.
-  It is divided into 4 content profiles:
-# Forms A&B - The initial assessment and physical
-# Form C&F - Update records and progress notes
-# Form D - Laboratory Evaluations
-# Form E - Education Assessment
-# Form G - Progress Notes
-The ACOG form also includes:
+Although the patient and her care provider may plan for a vaginal (natural) method of delivery, there is a substantive chance the delivery route may be surgical, requiring anesthesia and post-surgical care.
-# An Obstetric Medical History
-# A Postpartum Form
-A sample may be found at [http://sales.acog.com/acb-custom/aa128.pdf http://sales.acog.com/]
+Current practice is to copy the patient's (paper) chart at various times during the pregnancy (as at 28 weeks and at 36 weeks of completed gestation), and transport the copies of the chart to the hospital the patient intends to use for delivery. Should the patient arrive prior to the chart copy arriving, or if the chart (or information within the chart) is missing on presentation of the patient to Labor and Delivery (a frequent occurrence), the staff or clinicians repeat laboratory or imaging studies. This results in unwarranted and duplicative tests, is wasteful of time and resources, and leads to dissatisfied patients.
+Further, missing or incomplete information about the patient’s clinical status may create a situation where critical information is unavailable to clinicians, which may ultimately result in an injury, inadequate aftercare or other undesirable outcome.
-This profile defines the implementation of HL7 CDA documents to represent Form C, along with the XDS, XDR, and XDM bindings.  Future profiles will focus on other related forms along with mechanisms to group them into a single logical folder.
+Significantly, a large portion of patients arrive in L&D without complete documentation. In one recent U.S. study , ~70% of patients (with paper charts) arrived in L&D without their current medical record being available. While only one hospital was involved in this study, one can see the extent of the issue, with pregnant patients possibly going to a different hospital than planned (preterm labor, rapid labor and unable to make it to the planned delivery hospital, or visiting a distant city), moving mid-care, or with a covering physician (rather than the primary obstetrician) on call.
-==Glossary==
+In a Swedish study done in the 1990’s, critical data on paper records were incomplete from 45 to 87.5% of the time. Thus, availability of current medical records remains a significant problem for most hospital Labor and Delivery units; availability of key information electronically will significantly enhance patient safety.
-'''The following terms are found in Form C of the Antepartum Record.'''
+===Technical Approach ===
+The Antepartum Summary is is a content profile that is intended to eventually sit within a larger folder structure that contains documents related to Antepartum care which will be defined in future years called the Antepartum Record. In addition to the APS content, related content profiles would include (existing and new):
-; Antepartum : Period of pregnancy between conception and onset of labor, referring to the mother.
+* Intake patient questionnaire
+* Intake History and Physical (including surgical and relevant social history)
-; Cervix Exam (Dil/Eff/Sta) : Examination to determine, '''Dilation''', '''Effacement''', and '''Station''' of the fetus.
+* Summary of OB-specific Ambulatory Visit Data  (this profile)
-*'''Dilation''' refers to the size of the opening in the cervix, usually recorded in centimeters (measured from 0[=closed] to 10 [=fully dialated or open]).
+* Obstetric related Laboratory Reports
-*'''Effacement''' refers to the thickness or thinness of the cervix (measured from 0% (or uneffaced, =thick) to 100% (completely thinned out).
+* Obstetric related Imaging Reports
-*'''Station''' refers to the progress of the head (or presenting part) though the pelvis (measured in negative number, 0, and positive numbers, either in cms above or below the ischial spines or in relative distance to the introitus, (i.e., “thirds.”).
+* Obstetric related Consultation Reports
+* Non Stress Test (NST) Reports
-; EDD : Expected Date of Delivery, a fixed date determined by ultrasound measurements and /or last menstrual period. Also called EDC - Expected Date of Confinement.
+* NST Waveforms (may be covered by DICOM)
+* Patient Consent Forms for Performance of Procedures
-; Initial EDD : Expected Date of Delivery, assuming 40 weeks or 280 days since last menstrual period.
+* Payer Authorization Forms
-; FHR : Fetal Heart Rate. A measurement of the pulse of the fetus.
-; Fetal Movement : Maternal perception of movement by the fetus
-; Fundal Height : Measurement of the size of the uterus from the top of the pubic bone to the top of the uterus in centimeters. This measurement is used to assess fetal growth. This measurement should be done at every prenatal visit.
-; Fundal Height at Umbilicus : The point in the pregnancy when the uterus is at the umbilicus (belly button), which usually corresponds to 20 weeks gestation (the half-way point of the pregnancy).
-; LMP : Last Menstrual Period: as measured from the first day of a woman’s last cycle prior to the pregnancy.
-; Presentation : Refers to the part of the fetus that is presenting first, i.e. breech, vertex, etc.
-; Preterm Labor Signs/Symptoms : Any sign or symptom suggesting possible labor, that occurs before 37 weeks of gestation. For example: regular or irregular contractions, ruptured membranes, abdominal cramps, low, dull backache, pelvic or abdominal pressure, change in type or increase of vaginal discharge.
-; Quickening : A woman’s initial awareness of movement of the fetus within the womb/uterus. Usually reported between 18 – 20 weeks gestation with a first pregnancy, often as early as 16 weeks with subsequent pregnancies.
-; Ultrasound length : Identifying the size and position of the fetus by ultrasound exam to estimate gestational age
-; Weeks Gestation (Best est.) : The best estimate of the length of time since conception.
-'''The following terms are found in Form A of the Antepartum Record.'''
-; AB Induced : Number of induced abortions the mother has had
-; AB Spontaneous : Number of spontaneous abortions the patient has had
-; Ectopics : Number of ectopic pregnancies the patient has had
-; Frequency : Length of duration for patient’s typical monthly period
-; Full Term : Number of babies the mother has delivered between 37 and 42 weeks gestation
-; hCG +  : Specify date of positive Human Chorionic Gonadotropin pregnancy test.
-; Living : Number of living children the mother has
-; LMP (last menstrual period) : measured from the first day of the patient’s cycle
-*Definite - Patient is sure of the date of last menstrual period
-*Approximate – Patient is unsure of exact date but can offer an approximate date
-*Unknown – Patient does not know date of last menstrual period.
-*Final – Finally agreed upon date of LMP after U/S measurements.
-; Menarche (age onset) : Age at onset of initial menstrual period
-; Menses Monthly : Specify that the patient has a monthly period or not.
-; Multiple Births : Number of multiple deliveries the mother has had.
-; Normal Amount/Duration : Specify that the last menstrual period was typical or not in amount and duration for this patient.
-; On BCP Concept : Specify if the patient was on birth control pills at conception
-; Premature : Number of premature babies the mother has delivered
-; Prior Menses : Date of patient’s prior period.
-; Total Pregnancy : Total number of times the patient has been pregnant
-''''Prior Pregnancies' Section:'''
-; Anesthesia : Specify the type of anesthesia used for previous pregnancy, i.e., epidural, etc.
-; Birth Weight : Weight of baby at birth for previous pregnancies
-; Date : (Day)/Month/Year of delivery of previous pregnancies (day may be optionally recorded)
-; GA Weeks : Gestational age in weeks at delivery for previous pregnancies
-; Length of Labor : Number of hours in labor for previous pregnancies
-; Place of Delivery : Specify where the previous babies were delivered.
-; Preterm Labor : Specify if the patient had preterm labor with the previous pregnancies.
-; Sex : Sex of babies for previous pregnancies
-; Type Delivery  : Specify type of delivery for previous pregnancy, i.e. vaginal, cesarean
-; ART Treatment : Assisted Reproductive Technology Treatment
-=Volume I=
-<pre>Add the following bullet to the list of profiles</pre>
-* Antepartum Summary - A folder of content profiles that contains the summarization record or the antepartum care delivery including initial patient history and physical, ambulatory checks of mother and fetus, laboratory studies, and patient education .
-===Dependencies===
-<pre>Add the following row(s) to the list of dependencies</pre>
-{|style='background-color:#7f7f7f;' align='center' border='1' cellspacing='0'
-!Integration Profile
-!Dependency
-!Dependency Type
-!Purpose
-|- style='background-color:#ffffff;' align='center'
-|Antepartum Summary Form A&B
-|IHE History and Physical
-|Child
-|Initial Intake and Assessment for antepartum care
-|-
-|- style='background-color:#ffffff;' align='center'
-|Antepartum Summary Form C&F&G
-|Medical Summary
-|Child
-|Update and Progress Note
-|-
-|- style='background-color:#ffffff;' align='center'
-|Antepartum Summary Form D
-|XD-Lab
-|Child
-|Obstetric Lab Evaluation
-|-
-|- style='background-color:#ffffff;' align='center'
-|Antepartum Summary Form E
-|
-|
-|Obstetric Education Form
-|-
-|}
-Because many document sections are shared with other Medical Summary document types, an Antepartum Ambulatory Prenatal Care Summary document would fit in nicely with the IHE collection of Medical Summary Documents. The ability for the IHE Medical Summary documents to incorporate the sections required for an Antepartum Summary as well as the inclusion or reference of imaging and laboratory reports and other clinical documents is an important consideration.
-Specifically, this proposal is to publish content profiles for additional sections within the new Section Content Profile Framework being developed and then publish a medical summary document content profile for the full Antepartum Ambulatory Prenatal Care Summary document. The section unique to an Antepartum Ambulatory Prenatal Care Summary is the cumulative aggregation of office visits over the defined prenatal period, coupled with the similar requirements of the Pre-Procedure H&P documentation.
+Although the scope of this content profile is limited to the Antepartum Ambulatory Prenatal Care, this discussion illustrates the need to view the aggregation of documents for Labor and Delivery as the center of multiple related documents and to include in the content profile the mechanisms for specifically referencing these document types.
-==Profile Name==
-The Antepartum Summary Profile (APS)
-Obstetric patients in labor and admitted to Labor and Delivery must have a complete summary of their antepartum ambulatory care available at the time of admission to evaluate and / or ameliorate risk.  This same data is required at any visit to Labor and Delivery for any other problems or special needs a patient may require.
-As the patient is seen over a finite period in the office, aggregation of specific relevant data is important to the evaluation of the obstetric patient upon presentation to Labor and Delivery.  During the 40 weeks of a typical pregnancy duration, the patient will have an initial History and Physical Examination, followed by repetitive office visits with multiple laboratory studies, imaging (usually ultrasound) studies, and serial physical examinations with recordings of vital signs, fundal height, and the fetal heart rate.  The original New OB History & Physical, ongoing Medical Diagnoses, the Estimated Due Date, outcomes of any prior pregnancies, serial visit data on the appropriate growth of the uterus and assessments of fetal well being, authorizations, laboratory and imaging studies must all be presented and evaluated upon entry to the Labor and Delivery Suite to ensure optimal care for the patient and the fetus.
-Although the patient and her care provider may plan for a vaginal (natural)  method of delivery, there is a substantive chance the delivery route may be surgical, requiring anesthesia and post-surgical care.
-Current practice is to copy the patient's (paper) chart at various times during the pregnancy (as at 28 weeks and at 36 weeks of completed gestation), and transport the copies of the chart to the hospital the patient intends to use for delivery.  Should the patient arrive prior to the chart copy arriving, or if the chart (or information within the chart) is missing on presentation of the patient to Labor and Delivery (a frequent occurrence), often the staff or clinicians repeat laboratory or imaging studies.  This results in unwarranted and duplicative tests, is wasteful of time and resources, and leads to dissatisfied patients.
-Further, missing or incomplete information about the patient’s clinical status may create a situation where critical information is unavailable to clinicians, which may ultimately result in an injury, inadequate aftercare or other undesirable outcome.
-Significantly, a large portion of patients arrive in L&D without complete documentation.  In one recent U.S. study , ~70% of patients (with paper charts) arrived in L&D without their current medical record being available.  While in this study, only one hospital was involved, one can see the extent of the issue, with pregnant patients possibly going to a different hospital than planned (preterm labor, rapid labor and unable to make it to the planned delivery hospital, or visiting a distant city), moving mid-care, or with a covering physician (rather than the primary obstetrician) on call.
-In a Swedish study done in the 1990’s, critical data on paper records were incomplete from 45 to 87.5% of the time.   Thus, availability of current medical records remains a significant problem for most hospital Labor and Delivery units; availability of key information electronically will significantly enhance patient safety.
-===Technical Approach ===
-The Antepartum Summary is a  folder in XDS that defines a collection of documents.  Several content profiles must be completed for the various kinds of documents that might be found in the Pre-Procedure Folder. These content profiles would include (existing and new):
-* Pre-procedure patient questionnaire
-* Pre-procedure H&P (including surgical and relevant social history)
-* Summary of OB-specific Ambulatory Visit Data
-* Laboratory Reports
-* Imaging Reports
-* Consultation Reports
-* Diagnostic Imaging (Ultrasound) Images
-* Non Stress Test (NST) Reports
-* NST Waveforms (may be covered by DICOM)
-* Patient Consent Forms for Performance of Procedures
-* Payer Authorization Forms
-Although the scope of this content profile is limited to the Antepartum Ambulatory Prenatal Care, this discussion illustrates the need to view the aggregation of documents for L&D as the center of multiple related documents and to include in the content profile the mechanisms for specifically referencing these document types.
 ==Stakeholders==
@@ Line 210: / Line 53: @@
 When the laboratory results return, the physician completes the admission H&P, Allergies, Medications, includes the data prepared or ordered by the perinatologist, and makes it available to L&D.  This data includes an assessment of the patient’s health status, and the requisite data summarized from the antepartum care given. The charge nurse for L&D documents that the complete collection of documents needed is available.  The Post-Partum discharge planning is notified and assures that there is a suitable environment with appropriate support for post-delivery after-care.
-; Post-condition: The Pre-delivery H&P and Antepartum Summary with appropriate relationships to the Perinatologist Consultation, and all the antepartum laboratory and imaging studies are available to the obstetrician and the birthing center personnel for incorporation into their respective EHRs. The H&P is also available to the patient for viewing and incorporation into the patient’s PHR, and into the newborn baby’s PHR.
+; Post-condition: The Pre-delivery H&P and Antepartum Summary with appropriate relationships to the Perinatologist Consultation, and all the antepartum laboratory and imaging studies are available to the obstetrician and the birthing center personnel for incorporation into their respective EHRs. The H&P is also available to the patient for viewing and incorporation into the patient’s PHR, and into the newborn baby’s PHR.  For the APS profile, summary content is available to the obstetrician, with a plan for full content to be added in future years through other content profiles that share this use case.
 {{Content Profile Actors and Transactions|APS}}
@@ Line 217: / Line 60: @@
 {{:PCC TF-1/Coded Terminologies}}
+=== Antepartum Summary Content Module ===
+An Antepartum Summary is a type of medical summary, and also incorporates the constraints defined for medical summaries found in a Medical Summary as described in PCC TF-2. In addition, the Antepartum Summary content profile includes additional information to support recording information specific to the ongoing care of a pregnant patient.
+===Grouping===
 {{:PCC TF-1/Content Bindings with XDS, XDM and XDR|PCC_TF-1/APS|=
 |1.3.6.1.4.1.19376.1.5.3.1.1.11.2|Antepartum Summary Form C & F|Medical Document Binding to XDS, XDM and XDR|R|R}}
-===Grouping===
-==== Cross Enterprise Document Sharing, Media Interchange and Reliable Messages ====
-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]] must be grouped with appropriate actors from the XDS, XDM or XDR profiles, and the metadata sent in the document sharing or interchange messages has specific relationships to the content of the clinical document described in the content profile.
 ==== [[Notification of Document Availability]] (NAV) ====
@@ Line 234: / Line 78: @@
 When a [[Content Creator]] Actor needs to digitally sign a document in a submission set, it may support the Digital Signature (DSG) Content Profile as a [[Document Source]].
 When a [[Content Consumer]] Actor needs to verify a Digital Signature, it may retrieve the digital signature document and may perform the verification against the signed document content.
+{{:PCC Actor Requirements|APS|
+# A Content Creator shall be able to create an Antepartum Summary according to the specification for that content profile found in PCC TF-2.}}
 <noinclude>

Difference between revisions of "PCC TF-1/APS"

Latest revision as of 13:35, 3 October 2007

Volume 1

The Antepartum Summary (APS) Integration Profile

Technical Approach

Stakeholders

Use Cases

Use Case: Antepartum Care Delivery

Actors/Transaction

Options

Content Consumer Options

View Option

Document Import Option

Section Import Option

Discrete Data Import Option

Coded Terminologies

Antepartum Summary Content Module

Grouping

Cross Enterprise Document Sharing, Media Interchange and Reliable Messages

Notification of Document Availability (NAV)

Document Digital Signature (DSG)

Requirements of APS Actors

Content Creator

Content Consumer

Appendix A - Actor Descriptions

Appendix B - Transaction Descriptions

Appendix C - How to Prepare an IHE Integration Statement

Structure and Content of an IHE Integration Statement

Format of an IHE Integration Statement

IHE Integration Statement template

The IHE Product Registry

Appendix D - Braden Scale for Predicting Pressure Sore Risk

Glossary

Volume 2

IHE Transactions

Cross Enterprise Document Content Transactions

View Option

Document Import Option

Section Import Option

Discrete Data Import Option

IHE Patient Care Coordination Bindings

Medical Document Binding to XDS, XDM and XDR

XDSDocumentEntry Metadata

XDSSubmissionSet Metadata

Use of XDS Submission Set

Use of XDS Folders

Configuration

Extensions from other Domains

Scanned Documents (XDS-SD)

XDSDocumentEntry

XDSDocumentEntry.formatCode

XDSDocumentEntry.uniqueId

Relating instances of XDS-SD documents

XDSSubmissionSet

XDSFolder

Basic Patient Privacy Consents (BPPC)

Laboratory Reports (XD-LAB)

XDSDocumentEntry

XDSDocumentEntry.eventCodeList

XDSDocumentEntry.formatCode

XDSSubmissionSet

XDSFolder

Namespaces and Vocabularies

IHEActCode Vocabulary

IHERoleCode Vocabulary

HL7 Version 3.0 Content Modules

CDA Document Content Modules

CDA Header Content Modules

CDA Section Content Modules

Other Condition Histories

Medications

Physical Exams

Plans of Care

Impressions

CDA and HL7 Version 3 Entry Content Modules

Appendix A - Examples Using PCC Content Profiles

Appendix B - Validating CDA Documents using the Framework

Validating Documents

Validating Sections

Phases of Validation and Types of Errors