PCC TF-1/FSA

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHE Patient Care Coordination

Technical Framework
Cross-Enterprise Sharing of Medical Summaries (XDS-MS) Integration Profile

Revision 2.0
2006-2007

Draft

Volume 1

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHE Patient Care Coordination

Technical Framework
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

Functional Status Assessment (FSA) Integration Profile

The Functional Status Assessment Profile (FSA) supports the handoff of assessment information between practictioners during transfers of care by defining the Functional Status Assessment option on the XDS-MS and XPHR profiles.

The Institute of Medicine has determined that the highest risk for medical errors occurs during the handoffs of patient care between practitioners, cross-enterprise or intra-enterprise. Continuity of care requires provision of assessments to be available to the receiving practitioner for critical decision making. The transfer of physician documentation provides much of the medical/physiologic condition information. Transfer of nursing documentation provides human response (psychological, social, emotional, physiological and spiritual) of patient/family to changing conditions. Both types of documentation support continuity of patient care as each patient moves through the continuum. This profile demonstrates the collection and exchange of standardized assessment information as it is exchanged across a variety of residential and care provision settings.

Glossary

Term

Definition

IHE Functional Status Assessments Profile Glossary of Terms

IHE Integration Profiles describe the solution to a specific integration problem, and document the system roles, standards and design details for implementors to develop systems that cooperate to address that problem. IHE Profiles are a convenient way for implementors and users to be sure they're talking about the same solution without having to restate the many technical details that ensure actual interoperability.

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 [1].

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 [2].

Clinical Document Architecture (CDA): A document markup standard that specifies the structure and semantics of clinical documents for the purpose of exchange. From the perspective of CDA the CCR is a standardized data set that can be used to constrain CDS specifically for summary documents. More information is available from [3].

Logical Observation Identifiers Names and Codes( LOINC®) A database protocol developed by the Regenstrief Institute for Health Care aimed at standardizing laboratory and clinical code for use in clinical care, outcomes management, and research. LOINC® codes (sometimes in combination with SNOMED-CT codes are used to encode functional status assessments to facilitated health information exchange. Additional information found at [4].

Systematized Nomenclature of Medicine Clinical Terms (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 [5] or the United States National Library of Medicine at [6]

Volume I

Add the following bullet to the list of profiles

• Functional Status Assessment Profile (FSA) - supports the handoff of assessment information between practictioners during transfers of care by defining the Functional Status Assessment option on the XDS-MS and XPHR profiles.

Dependencies

Add the following row(s) to the list of dependencies

Integration Profile	Dependency	Dependency Type	Purpose
Functional Status Assessment	XDS-MS or XPHR	Content Consumers implementing the Functional Status Assessments profile shall be grouped with either the XDS-MS or XPHR Content Consumer. Content Creators implementing the Functional Status Assessments profile shall be grouped with either the XDS-MS or XPHR Content Creator.	Functional Status Assessments are communicated in medical summaries, thus a Content Creator that is capable of producing a medical summary is needed.

Functional Status Assessment

The Functional Status Assessment Profile (FSA) supports the handoff of assessment information between practictioners during transfers of care.

In the context of the Continuity of Care Document, the functional status describes the patient’s status of normal functioning at the time the document was created.

Functional status includes information concerning:

• Ambulatory ability
• Mental status or competency
• Activities of Daily Living (ADL’s) including bathing, dressing, feeding, grooming
• Home/living situation having an effect on the health status of the patient
• Ability to care for self
• Social activity, including issues with social cognition, participation with friends and acquaintances other than family members
• Occupation activity, including activities partly or directly related to working, housework or volunteering, family and home responsibilities or activities related to home and family
• Communication ability, including issues with speech, writing or cognition required for communication
• Perception, including sight, hearing, taste, skin sensation, kinesthetic sense, proprioception, or balance

The Institute of Medicine has determined that the highest risk for medical errors occurs during the handoffs of patient care between practitioners, cross-enterprise or intra-enterprise. Continuity of care requires provision of assessments to be available to the receiving practitioner for critical decision making. The transfer of physician documentation provides much of the medical/physiologic condition information. Transfer of nursing documentation provides human response (psychological, social, emotional, physiological and spiritual) of patient/family to changing conditions. Both types of documentation support continuity of patient care as each patient moves through the continuum.

This profile does not convey the entire functional status, but is an initial interoperabe entry to manage continuity of care with the use of four scales which support assessment comparison related to time/date,informing caregivers for critical decision making. The profile demonstrates the collection and exchange of standardized assessment information as it is exchanged across a variety of residential and care provision settings.

Options

This integration profile supplement adds the following two options to the Cross Enterprise Sharing of Medical Summaries (XDS-MS) Integration Profile, and to the Exchange of Personal Health Record Content (XPHR) Integration Profile.

Functional Status Assessment Options

Actor	Option
Content Consumer	Functional Status Option
Content Creator	Functional Status Option

Functional Status Option

A Content Consumer Actor implementing the Functional Status Option of this profile supplement shall be able to view and consume coded functional status information sent in the functional status section of a Medical Summary or XPHR Extract. If the Content Consumer implements any of the import options of those profiles, it shall be able to import the coded functional status information.

A Content Creator Actor implementing the Functional Status Option of this profile supplement shall be able to create a coded functional status section that contains at least one of the optional functional status assessments in a Medical Summary or XPHR Extract.

This option has the effect of adding the Functional Assessments data element as a required data element in the XPHR Extract, Referral or Discharge Summary content modules.

For Public Comment

How should we handle this profile? Should the coded functional status section be added to XDS-MS and XPHR as conditionally required (when the Functional Status Option is declared on the actor), or should this profile be published on its own.

Content Modules

Content modules describe the content of a payload found in an IHE transaction. Content profiles are transaction neutral. They do not have dependencies upon the transaction that they appear in.

Coded Functional Status Assessment

The coded functional status assessment section contains one or more subsections that include coded functional status assessment information. This is a section content profile that is intended to be used in Medical Summaries of various type, including those described in the XDS Medical Summaries profile, and the XPHR profile. The subsections that are defined by this content profile are further described below.

Numeric Pain Scale

Using the Numeric Pain Scale (NRS 11), a Patient rates his/her pain from 0 to 10, with 0 representing no pain and 10 representing the worst possible pain. This scale is used for age 5 years and older and is the preferred pain scale for many older healthy adults. Reliable and valid per Herr & Garland, 2001; Ho et al, 1996; Price et al, 1994.

This content profile describes how a Pain Scale assessment is reported in a CDA Document.

Braden Scale For Predicting Pressure Sore Risk

The Braden Scale For Predicting Pressure Sore Risk is a summated rating scale made up of six subscales scored from 1-3 or 4, for total scores that range from 6-23. The subscales measure functional capabilities of the patient that contribute to either higher intensity and duration of pressure or lower tissue tolerance for pressure. A lower Braden Scale Score indicates lower levels of functioning and, therefore, higher levers of risk for pressure ulcer development. Reliability and validity research found at [7] Media:braden.pdf

This content profile illustrates how to record the Braden Score within a CDA document.

Geriatric Depression Scale

While there are many instruments available to measure depression, the Geriatric Depression Scale (GDS), first created by Yesavage et al.,(Stanford University) has been tested and used extensively with the older population. It is a brief questionnaire in which participants are asked to respond to the 30 questions by answering yes or no in reference to how they felt on the day of administration. Scores of 0 - 9 are considered normal, 10 - 19 indicate mild depression and 20 - 30 indicate severe depression. The GDS may be used with healthy, medically ill and mild to moderately cognitively impaired older adults. It has been extensively used in community, acute and long-term care settings. As for evidence-based research the GDS was found to have 92% sensitivity and 89% specificity when evaluated against diagnostic criteria per the Hartford Institute for Geriatric Nursing. The validity and reliability of the tool have been supported through both clinical practice and research. More information is available from [8].

This content profile illustrates how to record the Geriatric Depression Scale within a CDA document.

Minimum Data Set

The Minimum Data Set for Long Term Care Version 2.0 (MDS 2.0) is a federally mandated (in the United States) standard assessment form. This instrument is specified by the Centers for Medicare and Medicaid Services, and requires nursing facilities to conduct a comprehensive, accurate, standardized, reproducible assessment of each resident’s functional capacity. Section G Physical Functioning and Structural Problems are included in this demonstration project. More information is found at[9]. Media:SectionG_MDS20.pdf

Process Flow

Three use cases are described in futher detail below.

• Long-Term Care to Acute Care - describes a use case for assessment information during transfers of care from long term to acute care.
• [[#Home/Assisted Living into Acute Care, transfer to Rehab and then Home/Ambulatory care] - describes a use case for assessment information during multiple care transfers.
• Behavioral - describes a use case for assessment information during transfers of care where information about depression in an older patient is used.

Note:

Italicized text in the use cases below denote information in the use case that provides details regarding patient condition and workflow, but will not be included as part of the content integration profile.

Long-Term Care to Acute Care

Media:Visio-UseCase1-Diagram-v2.pdf

Primary Actor(s): Discharge nurse in LTC facility, Admitting nurse in acute care facility

Stakeholder(s): Primary Care Physician, Hospitalist

Use Case Overview: A diabetic nursing home patient is transferring from the LTC environment to an in-patient acute care hospital based on deteriorating functional status assessments.

Use Case Scenario

1. A 76 year old resident/patient of a LTC facility has become increasingly weak, lethargic and has a low-grade fever. Resident refuses to get out of bed and is complaining of chills and the nurse noted reddened area on coccyx during assessment. Resident's glucose level is elevated and the maximum sliding-scale dose indicated in medication order is not controlling blood sugar.
   1. Nurse documents vital signs.
   2. Nurse documents finger-stick glucose measurement.
   3. Nurse documents current functional assessment.
   4. Nurse documents braden score.
   5. Nurse initiates phone collaboration with Primary Care Provider (PCP).
   6. Primary care provider(PCP)and nurse review patient status information on the electronic health record (EHR). Note: Interdisciplinary collaboration supports evaluation of physiologic changes and critical thinking leading to early intervention.
   7. PCP enters transfer order to acute care facililty via computerized physician order entry (CPOE).
2. The patient's baseline and serial functional assessment data is sent to the acute care hospital via a document exchange server.
   1. Nurse admission coordinator reviews transfer documents via the EHR. Note: Early comprehensive patient information availability allows the admission coordinator to assign appropriate unit and adjust staffing based on potential acuity. Appropriate nurse to patient acuity staffing ratios support both staff and patient safety, reducing risk of errors.
   2. Bed is assigned on medical floor at acute care facility, pending admission is sent to charge nurse on the medical floor.
3. Charge nurse reviews the patient's functional status assessment data, VS, glucose values and braden score from LTC facility. Note: The charge nurse is provided additional time to reassign other patients and/or allowing the admitting nurse more time to prepare for the patient admission.
   1. Based on the information reviewed, Charge nurse adjusts shift assignment based on patients level of care.
4. Patient arrival to medical floor at acute care facility.
   1. Admitting nurse takes patient VS and completes admission assessment in EHR. Note: Nurse compares serial EHR preadmission assessments to new admission assessment data. Serial EHR assessments allow nurse to compare baseline assessement to last assessment at LTC and first hospital assessment supporting critical thinking related to discharge goals.
   2. Nurse records admission assessment data in EHR and EHR identifies pressure sore risk due to Braden Score total and fall risk.
   3. Electronic health record flags need for skin care protocol to clinician. Note: Electronic notifications are an adjunct to support the critical thinking skills of the nurse taking care of the patient and reinforce the proactive monitoring and management of patient's safety needs.
   4. An individualized patient plan of care (POC) initiated by nurse in EHR.
   5. Skin care protocol and fall risk protocol implemented according to facility protocols.
   6. Acute care physician assesses patient and reviews serial preadmission and current nurse assessment data in EHR. Physician adds to plan of care. Note: Having one location (EHR) for documentation from all disciplines saves time by reducing time needed to find various documentation paper tools. One EHR also supports communication and collaboration between clinicians, minimizing potential for errors.
5. Patient's medical issues are addressed during course of hospitalization (5 days).
   1. • Patient's individualized POC is reviewed and updated daily by each clinician. Note: Clinician is able to review data on-line and quickly update based on availability of previous data. Plan of care and prior knowledge of baseline allow relevent and reachable goals for discharge.
   2. Progress and level of care requirement is continuously monitored by nurse and hospitalist assigned to patient
6. After several days of care, patient ready for discharge as evidenced by blood sugar levels WNL and increased functional status (including ambulation with assistance).
   1. Series of functional assessments and overal progress reviewed by care providers.
   2. Patient POC goals met, except level of functional status and unresolved skin risk as noted in EHR.
   3. Acute care physician enters discharge order via CPOE.
   4. PCP notified of transfer back to LTC facility and review of patient statusincluding unresolved issues.
7. Long Term Care/Hospital collaborate on discharge plan/transfer. Note: Multiple series of assessment and POC data can be quickly reviewed and compared to maximize safety in transfer and supports interdisciplinary decision making to reach patient goals.
   1. Patient readied for discharge, EHR documents completed.
   2. EHR discharge documents sent to document exchange server; message sent to LTC to download documents.
   3. Patient returns to LTC.

Home/Ambulatory Care into Acute Care

Media:Visio-UseCase-2_Diagram.pdf

Primary Actor(s)

ED Nurse, ED Doctor, Surgeon, Orthopedic nurse in acute care facility, Nurse in rehab facility, Clinical staff in assisted living facility

Secondary Actor(s)

Paramedics, Physical Therapist

Stakeholder(s)

Primary Care Physician, Hospitalist

Use Case Overview

A normally active, older adult in an assisted living community has an accidental fall requiring admission to an acute care facility. Alteration in functional status requires the patient discharge to a nursing home for rehabilitation with the long term goal of returning to assisted living.

Use Case Scenario

1. A 69 year old single male, living in an assisted community, is normally very active and self sufficient and requires only minimal assistance from staff for medication management. While walking outside, the patient falls, right lower extremity alignment changes noted. The patient has a large 10 cm hematoma on his side with bruising that extends down his right hip and leg. A laceration on his forehead noted, possibly from his glasses breaking during the fall. The patient is pale, and complaining of severe pain in his right hip. The patient is unable to move and an ambulance is called. Patient is transferred from the assisted living community to the emergency department at an acute care facility. There is no baseline functional assessment data available from the assisted living community. Medical information is maintained on EHR in assisted living.
   1. Nurse charts vital signs
   2. Nurse documents information regarding hematoma, area of bruising on right side and notes alignment changes.
   3. Nurse documents information regarding head laceration and covers wound with 2x2 gauze/tape.
   4. Primary care physician is notified of ambulance transfer to acute care facililty
2. The patient's history from the assisted living community is reviewed with the paramedics before the patient is moved to the ambulance prior to transfer to the acute care facility emergency department.
   1. Paramedics are provided with a brief summary of patient including age, date of birth, medical history, medications and allergies.
3. Patient is brought to emergency department of acute care facility and is assessed by clinical staff. Nurse and physician assigned to patient review accident information and patient history via the electronic health record. The nurse performs a thorough assessment of the patient's current condition, x-rays and labs are ordered. Patient is medicated for pain prior to the x-ray.
   1. ED nurse charts vital signs and accident information in electronic health record.
   2. ED nurse assesses patient's level of pain using numeric rating scale in the electronic health record.
   3. ED nurse notifies doctor of pain score.
   4. ED doctor assesses patient and reviews history.
   5. ED doctor orders hip x-ray and pain medication in electronic health record. ED doctor determines patient has hip fracture and recommends patient be transferred to the orthopedic floor with a surgical consult.
   6. ED doctor writes up admission to ortho floor and orders surgical consult in the electronic health record.
4. Patient transferred to orthopedic floor at acute care facility and has surgical consult.
   1. Admitting nurse takes patient VS and completes admission assessment including numeric rating scale for pain and Braden scale for pressure risk in the electronic health record.
   2. The electronic health record evaluates admission assessment data entered by the clinician and flags patient for skin integrity problem and fall risk.
   3. Skin care and fall risk protocol implemented in the electronic health record according to facility protocols.
   4. Nurse documents numeric response to pain medication.
   5. Surgeon assesses patient condition and recommends total hip replacement surgery.
5. Patient has surgery and returns to orthopedic floor. Nurses continue to monitor patient, provide interventions and assess pain level and medicate as needed. Patient begins physical therapy 1st day post-op.
   1. Individualized patient plan of care initiated in electronic health record.
      • Patient's individualized POC is reviewed and updated daily by each clinician. Note: Clinician is able to review data on-line and quickly update based on availability of previous data. Plan of care and prior knowledge of baseline allow relevent and reachable goals for discharge.
   2. Patient's pain level is assessed pre and post medication using numeric rating scale and documented in electronic health record.
   3. Progress and level of care requirement is continuously monitored by nurse, surgeon and physical therapist assigned to patient.
   4. Physical therapist establishes rehabilitation plan and goals post total hip surgery and documents progress in electronic health record, adding rehabilitation goals to POC. Note: Interdisciplinary care planning and documentation on single EHR minimizes time spent documenting by eliminating repetition and redundancy while focusing on patient goals. Patient focus by interdisciplinary team reduces length of stay.
6. Patient regains strength and is able to transfer and toilet with assistance. Staples have been removed from hip incision and bruising is resolving. Patients level of pain has dropped significantly since admission and is requiring less pain medication.
   1. Skin care protocol is suspended.
   2. Patient plan of care updated to reflect level of care patient requires.
7. After several days of care post total hip surgery, the patient is progressing, but still not able to function independently (at previous baseline). The surgeon recommends the patient be transferred to a rehabilitation facility for more intense therapy.
   1. Series of functional assessments and overal progress reviewed by interdisciplinary team.
   2. Plan of care is updated in the electronic health record.
   3. Primary care physician is notified of plan to transfer.
   4. Patient is prepared for discharge to rehabilitation facility with final assessment completed.
8. The patient's baseline and recent functional status assessments are sent to the rehabilitation facility via a document exchange server.
   1. Rehabilitation facility nurse admission coordinator reviews transfer documents.
   2. Bed is assigned on orthopedic floor at rehabilitation facility.
   3. Notification of pending admission is sent to charge nurse on the floor at the rehabilitation facility.
9. Charge nurse reviews patient accident history, functional assessment data, and patient progress from acute care facility. Based on the information reviewed, nurse determines that patient will require assistance transferring, toileting and ambulation and will be at risk for falls.
   1. Rehab facility charge nurse adjusts shift assignment based on patients level of care. # Patient regains strength and is able to transfer, toilet and ambulate with minimal assistance after one week and has not required pain medicine the last 3 days. Surgeon recommends patient for transfer back to assisted living facility.
   2. Series of functional assessments and overal progress reviewed by care providers.
   3. Plan of care is updated in EMR system.
   4. Primary care physician is notified of plan to transfer patient back to assisted living facility.
   5. Patient is prepared for discharge to assisted living facility with final assessment completed.
10. The patient's baseline and recent functional status assessments are sent to the assisted living facility via a document exchange server. Note: Early transfer of health information and plan of care facilitates maximum planning for safety and patient's arrival.
    1. Series of functional assessments and overal progress from rehabilitation center is reviewed by assisted living care providers.
11. Assisted living clinical staff review patients hospitalization and rehab history, functional assessment data, and patient progress. Based on the information reviewed, nurse determines that patient will require assistance transferring, toileting and ambulation and will be at risk for falls.
    1. Series of functional assessments and overal progress reviewed by interdisciplinary care team.
    2. Patient's assisted living needs have been updated to reflect fall risk and assistance with ambulation, toileting and transfer in the electronic health record.

Behavioral

Media:Visio-UseCase-3_Diagram.pdf

Primary Actor(s)

Psychiatric nurse, Attending physician/hospitalist, Home health nurse

Stakeholder(s)

Primary Care Physician, Outpatient psychiatrist

Use Case Overview

A recently widowed 75 year old woman is admitted to an adult inpatient floor of a behavior health hospital for depression post suicide attempt

Use Case Overview

1. A 75 year old woman who lives alone and has become increasingly withdrawn since the sudden death of her husband 6 weeks ago took several days worth of medication at one time from her pill pack. A neighbor found the confused elderly woman in the woman's home, and immediately took her to her psychiatrists office. Patient was diagnosed as depressed by her psychiatrist, and was a direct admission from her doctor's office to an adult inpatient floor in a behavioral health facility.
   
2. Psychiatrist notes patient issue regarding depression into electonic health record notes.
3. Patient screened by adult inpatient admission nurse using the geriatric depression scale. Her initial score was 26, indicating severe depression. Patient information was entered into the electronic health record. Patient states that she has a hard time getting going each day and is afraid of how she will survive without her husband. She has lost her appetite and is unhappy with her life without her husband.
   1. Nurse documents geriatric depression scale results in the electronic health record.
   2. Nurse documents patient's feelings and concerns in progress notes in the electronic health record.
   3. Nurse initiates plan of care for management of depression.
4. Psychiatrist reviews the patient's progress and visits patient. Psychiatrist orders anti-depressant and mood stabilizer medications via CPOE.
5. Social work evaluates the patient for her social support and financial status. The patient has no limitations in activity of daily living. She has a housekeeper come in monthly to clean and does her own grocery shopping and laundry weekly. Her nearest relative is over 1,000 miles away and her only support network are friends and neighbors that are also frail and elderly. The social worker also collaborates with the nurse regarding the signs of depression and the geriatric depression scale score. The plan of care is updated by the social worker and discharge planning begins.
6. Daily, nursing gives patient medication and assesses the patient's depression status using the geriatric depression scale. Interventional therapy sessions provided to patient to improve mood and outlook for the future.
   1. Nurse documents administration of medication.
   2. Nurse documents depression assessment.
   3. Nurse documents patient's response to therapies.
   4. Nurse documents udpate to the plan of care.
7. After 5 days, patient is progressing well and responding to therapy. Most recent geriatric depression scale score documented in the electronic health record is 15, indicating mild depression.
   1. Nurse documents administration of medication.
   2. Nurse documents depression assessment.
   3. Nurse documents patient's response to therapies.
   4. Plan of care updated by nurse and social worker.
8. Patient care conference is done with patient, nurse, social worker and physician. Based on progress, patient will be discharged to home with home health visits.
   
   1. Patient's plan of care is updated and unresolved issues to be managed by home health services.
   2. Physician enters discharge to home order with home health services into the electronic health record.
9. Patient is discharged home with home health referral.
10. Home health nurse reviews patient status electronically and prepares for visit to patient home.
    1. Home health nurse reviews geriatric depression scale ratings from hospital and history of patient stay and underlying issues. Note: Communication of needs and depression status support early intervention by home health staff, minimizing length of time in care.
11. Home health nurse visits patient at home.
    1. Nurse assesses patient using the geriatric depression scale and enters into the electronic health record.
    2. Nurse assesses patient using oasis and enters into the electronic health record.
12. Outpatient psychiatrist reviews patient's progress from home health and follows up with patient. Note: Availability of EHR documentation to all providers of care to this patient supports continuity of care.
    1. Psychiatrist reviews continuing progress of geriatric depression scale rating since in electronic health record.
    2. Psychiatrist reviews home health Oasis assessment information in electronic health record.
    3. Outpatient psychatric appointment made by home health nurse for continuity of care. Note: Interoperable patient information available to provider at the point of care reduces redundant provision of care, thereby reducing cost, but protects patient safety during the transitions.

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:

1. The Vendor Name
2. The Product Name (as used in the commercial context) to which the IHE Integration Statement applies.
3. The Product Version to which the IHE Integration Statement applies.
4. A publication date and optionally a revision designation for the IHE Integration Statement.
5. 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:"
6. 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:

1. Specific internet address (or universal resource locator [URL]) where the vendor's Integration Statements are posted
2. URL where the vendor's standards conformance statements (e.g., HL7, DICOM, etc.) relevant to the IHE transactions implemented by the product are posted.
3. 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

Technical Framework
Emergency Department Referral
Volume 2

Revision 2.0
2006-2007

Draft

HIMSS and RSNA
Integrating the Healthcare Enterprise

IHE Patient Care Coordination

Technical Framework
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:

1. Use the appropriate XD* transactions to obtain the document along with associated necessary metadata.
2. 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.
3. Support traversal of links for documents that contain links to other documents managed within the sharing framework.
4. 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.

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

• (1.3.6.1.4.1.19376.1.5.3.1.1.3)Referral Summary Specification

• (1.3.6.1.4.1.19376.1.5.3.1.1.4)Discharge Summary Specification

CDA Header Content Modules

• (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.

• (1.3.6.1.4.1.19376.1.5.3.1.3.17)PCC TF 2:6.3.3.2.15 Functional Status

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.2.1)PCC CDA Supplement 2:6.3.3.2.22 Coded Functional Status

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.2.2)PCC CDA Supplement 2:6.3.3.2.23 Pain Scale Assessment

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.2.3)PCC CDA Supplement 2:6.3.3.2.24 Braden Score

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.2.4)PCC CDA Supplement 2:6.3.3.2.25 Geriatric Depression Scale

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.2.5)PCC CDA Supplement 2:6.3.3.2.26 Physical Function

Impressions

• (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

• (1.3.6.1.4.1.19376.1.5.3.1.4.13.7)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

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.3.2)PCC CDA Supplement 2:6.3.4.39 Braden Score Observation

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.3.3)PCC CDA Supplement 2:6.3.4.40 Braden Score Component

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.3.4)PCC CDA Supplement 2:6.3.4.41 Geriatric Depression Score Observation

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.3.5)PCC CDA Supplement 2:6.3.4.42 Geriatric Depression Score Component

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.3.7)PCC CDA Supplement 2:6.3.4.43 Survey Panel

• (1.3.6.1.4.1.19376.1.5.3.1.1.12.3.6)PCC CDA Supplement 2:6.3.4.44 Survey 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.

Example use of the replacementOf extension

<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.

Example use of the Patient Identifier Extension

<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.