Lab Public Health Reporting Content

Introduction

This is a draft of the Cross Enterprise Sharing of Laboratory Documents for Public Health (XDS-PHLab) to the Patient Care Coordination Technical Framework. This draft is a work in progress, not the official supplement or profile.

Volume 1

PHLab Integration Profile

The motivation for developing this profile is as follows:

• Show that the same standards that support the current IHE profiles for clinical care interoperability can be leveraged by population health.

• Encourage the public health community to come forward to IHE with use cases to further enhance data sharing.

Our goal with this profile is to adapt XDS-LAB integration content profile to accommodate data for a public health laboratory report. Modifications to XDS-LAB will be needed to accommodate non-human subjects, document participants in the laboratory testing process, and to group tests for a reportable condition in a consistent manner. Leveraging the CDA R2 standard and the XDS-LAB profile make the resultant document not only consumable by public health, but able to be sent back to the clinical care provider and even possible to include into an effected patient’s medical record thereby completing a communication loop between individual and population care.

Actors/Transaction

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

PHLab Actor Diagram

Options

PHLab Options

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

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

Content Consumer Options

View Option

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

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

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

Document Import Option

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

Section Import Option

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

Discrete Data Import Option

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

Cross Enterprise Document Sharing, Media Interchange and Reliable Messaging

Actors from the ITI XDS, XDM and XDR profiles embody the Content Creator and Content Consumer sharing function of this profile. A Content Creator or Content Consumer may be grouped with appropriate actors from the XDS, XDM or XDR profiles to exchange the content described therein. The metadata sent in the document sharing or interchange messages has specific relationships or dependencies (which we call bindings) to the content of the clinical document described in the content profile.

The Patient Care Coordination Technical Framework defines the bindings to use when grouping the Content Creator of this Profile with actors from the IHE ITI XDS, XDM or XDR Integration Profiles.

Publc Health Laboratory Report Bindings

Content	Binding	Actor	Optionality
Publc Health Laboratory Report	Medical Document Binding to XD*	Content Creator	R
		Content Consumer	R

PHLab Document Content Module

An Public Health Laboratory Report content document is a type of laboratory report, and incorporates the constraints defined for laboratory reports found in section the XDS-Lab specification. In addition, the PHLab profile adds or constrains XDS-Lab to accommodate non-human subjects, document participants in the laboratory testing process, and to group tests for a reportable condition in a consistent manner. Leveraging the CDA R2 standard and the PHLab profile make the resultant document not only consumable by public health, but able to be sent back to the clinical care provider and even possible to include into an effected patient’s medical record there upon effectively closing the communication loop between individual and population care.

PHLab Process Flow

NOTE: we are working with HITSP/PHDSC to refine this use case

Use Case 1: Case Report for a Public Health Reportable Condition with Laboratory Component

John Doe, MD sees a patient and suspects that this patient has an enteric pathogen. The patient follows through on the doctor’s orders and submits a specimen to the clinic laboratory. Upon completion of laboratory analysis, the laboratory confirms the presence of Salmonella. When a microbiologist has time in the week, they gather all their reportable results and complete the forms for submission to the state public health agency. Additionally, the clinic laboratory needs to submit the Salmonella specimen to the public health laboratory for serotyping. This specimen is mailed along with a hand written requisition to the state laboratory for epidemiological serotyping.

The state laboratory enters the partial information written on the requisition and identifies the Salmonella serotype. A nightly batch process reports the serotype to the clinician. A monthly batch process generates a file for the CDC. Nearby states have small clusters of cases with this same Salmonella serotype. No outbreak investigation is initiated.

The CDC detects this anomaly as monthly reports are received when observed across state borders and an outbreak protocol is started to investigate the potential outbreak. The CDC requests PFGE on the known samples and the outbreak is quickly confirmed two months later. Calls, faxes, and emails are used to transmit information to relevant state, county, local programs, and submitters of outbreak samples. Significant efforts on resolution focus on getting the desired data to the necessary participants. The outbreak is investigated and linked to a restaurant supplier in a popular but off-season resort area.

After this profile is adopted:

Preconditions: The clinical laboratory creates a laboratory report identifying the organism as a Salmonella isolate and that further serotyping will be done at the State Lab. The laboratory report is sent to the clinician, stored within the patient’s electronic medical record, and registered in a clinical interoperability registry. The isolate is mailed to the public health lab.

Events: Upon arrival, the public health laboratory receiving department queries the clinical interoperability registry with the submitter’s patient ID and views the initial laboratory report. The public health laboratory information system pulls forward the patient’s demographic and specimen data from the initial laboratory report. The public health laboratory creates a new laboratory report identifying the Salmonella serotype. The laboratory report is sent to the clinician, stored within the patient’s electronic medical record, registered in the clinical interoperability registry, registered in the state public health interoperability registry, and registered in the national public health interoperability registry.

The CDC program monitors the national public health registry for new cases of Salmonella. An anomaly is immediately detected in the number of new cases for this particular Salmonella serotype when observed across state borders and an outbreak protocol is started immediately to investigate the potential outbreak. The CDC requests PFGE on the current samples and alerts all state laboratories to perform PFGE on new samples of this serotype. The outbreak is confirmed quickly and new cases are identified and tracked seamlessly.

Post conditions: Local, state, and federal epidemiologists and case workers have access to all laboratory reports within their respective interoperability registries and may potentially gain further access to the clinical interoperability registry for additional information, such as the ordering provider and care location, for initiating further investigation.

Key improvements include:

• avoid handwritten forms and data re-entry
• ease transition of data to and from clinical care and public health agencies
• ease transition of data from one public health agency to another
• monitor registries for anomalies in a real-time basis
• response protocols focus on response, not the access to data

Grouping with Other Actors

Cross Enterprise Document Sharing, Media Interchange and Reliable Messaging

The Content Creator and Content Consumer Actors shall be grouped with appropriate actors from the XDS, XDM or XDR integration profiles to support sharing of PHLab documents.

Document Digital Signature (DSG)

Content Creator actors should digitally sign all documents using the Digital Signature (DSG) Content Profile.

Content Consumer actors should verify the Digital Signature of the submission set before use of the information it contains.

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 II

Referenced Standards

• HL7 Clinical Document Architecture Release 2 (CDA R2)

Document Specifications

Please see the following PDF: ContentProfileForPublicHealthReport.pdf

Open Issues

• Still need to discuss the best way to accomodate a non-human living subject in a CDA.
• What of the proposed here should be fed back to XDS-Lab in the form of CPs?
• How to include attachments (such as images)?
• Do we support the concept of "global specimen id" in the XDS metadata (folders? See Keith's CP in ITI Tech)? Can it be queried? For Example: "Find me all documents related to this specimen".
• Should we require XDSDocumentEntry.serviceStartTime, since in this context it correlates to either the original clinical encounter or the date of specimen collection (reception) which is particulary important in public health? If we really desire this to be in metadata, what do we do to the CDA to enforce that this information be there as well?