Integrated Path Workflow

Also available as a Word document at File:IntegratedLabWorkflow 02.docx

IHE Anatomic Pathology Profile Proposal

• Proposed Profile Name: Integrated Path Lab Workflow
• Proposal Date: September 23, 2012
• Status: Proposed
• Version History: r02
• Editors:

{|- |Name |Affilliation |e-mail |- |Harry Solomon |GE Healthcare |harry.solomonm@ge.com |- |}

1. Brief Description of the Problem:

There is a need for a comprehensive approach to pathology lab workflow that takes into account the needs of both imaging lab equipment and clinical (chemistry) lab equipment (which is also used in pathology). This workflow must be aligned with the needs of clinicians, lab directors, and device and system manufacturers, including Laboratory Information System manufacturers, for a unified approach to workflow management.

IHE AP has specified a departmental workflow (APW Profile) that leverages DICOM services for worklist management. Results (images) are managed as DICOM objects by an Image Manager/Archive, with references to that data handled in the LIS.

In contrast, IHE Lab has specified a departmental workflow (LAW Profile) that leverages HL7v2 messages for workflow management and results. Results (including images) are presumed to be managed directly by the LIS. IHE AP has recognized the problem with proposals variously called "Device automation integration profile", or "Enhanced Imaging Workflow", but those have not yet gained consensus.

2. Key Use Cases

Use Case 1: Solid tumor with whole slide imaging

(adapted from DICOM Part 17 Annex NN)

Preliminary activities (not part of this storyboard) – specimen and pathology order is received in lab; specimen is accessioned into the LIS. Based on the order, LIS either retrieves, or establishes local hyperlinks to, the patient medical history summary, the interventional radiology or surgery report for the specimen collection procedure, the radiology or peri-operative imaging, and other relevant clinical input. Retrieving such documentation may require traversal of a health information exchange, but is out of scope of this use case.

The pathologist reviews the incoming clinical documentation and performs a gross evaluation of the specimen, notes any findings into the LIS, and takes photographic images, which are sent to the LabPACS. The pathologist determines that specimen tissue should be analyzed further through histology, and directs a work order (through the LIS) to prep and image the tissue in accordance with an appropriate histology protocol known by the LIS.

The lab technician processes the tissue with a fixative, places it into a labeled container (cassette), and embeds the tissue in the cassette in a paraffin block; these manual steps, including the fixation materials and process parameters, are logged into the LIS with the cassette (block) identifier. From the block, a lab tech slices very thin sections (~5 μm, in accordance with the protocol) on a microtome, and places the sections on slides and the slides in a rack; these manual steps, including the slice thickness and spatial relationships of the sections to each other and to the block, are logged into the LIS with the slide and rack identifiers.

The lab tech may place slides from other cases that are following the same histology protocol into the same rack. The lab tech places the rack of slides into the slide stainer. The stainer reads the rack label, and queries the LIS for the stain protocol to be used. The LIS responds with the protocol (e.g., H&E), and the stainer executes the protocol. When done, the stainer reports the status to the LIS with the specific parameters of the staining (including lot numbers).

The lab tech removes the rack of slides from the slide stainer and places it into the whole slide scanner. The scanner takes each slide, reads the label, and queries the LIS for the scanning protocol to be used. The LIS responds with the protocol (e.g., 40X RGB) and other slide preparation attributes (specimen type, thickness, stain), and the scanner executes the protocol. The whole slide images are stored in the LabPACS. When done, the scanner reports the status to the LIS with the specific parameters of the imaging and references to each slide’s image(s).

When the last step in the histology protocol is done, the LIS creates a technical summary report for the pathologist, and makes the case data available for interpretation.

Post activities (not part of this storyboard) – Pathologist reviews all study information, creates a clinical report (e.g., IHE APSR Profile). Report is returned to referring physician, either directly or via HIE (XDR, XDS).

Use Case 2: Immunohistochemistry

Similar to solid tumor

3. Standards that might Apply

<list standards that you think might be relevant. Eg, HL7 CDA, HL7 CCD, SNOMED-CT, ...>

4. Further Discussion

<further describe evidence of need for the profile. (ie medical evidence that supports need, reference ONC use case, etc)>

5. Resources/People that could help.

<list people that could help the technical committee define, clarify and write the proposal. Also list skills of that person(ie Technical experience vs clinical experience). Bringing resources to the table increases the probability that the profile can be done.>