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.
Options
| Actor | Option |
|---|---|
| Content Consumer | View Option (1) |
| Document Import Option (1) | |
| Section Import Option (1) | |
| Discrete Data Import Option (1) |
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.
| 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
Volume II
Referenced Standards
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?