Summary

ClinSpark supports direct bi-directional integration with safety labs via an HL7 interface.

Here is an architecture overview:

Note that while Hospitals sometimes have a barcode shared by all tubes for a patient visit, with ClinSpark each tube will have a unique barcode. Test results coming from the lab must reference the specific barcode for the tube the test was performed on.

Safety Lab Integration Onboarding Process

Onboarding a safety lab integration involves collaboration between the customer lab operations team, Foundry Health support and typically support from the technical lab team or LIMS vendor. The following depicts the overall process at a high level:

Kickoff Meeting Discussion Topics

1. Who are the key contacts at the customer site?

2. What current LIMS system is used?

3. Lab Contacts? Foundry will work closely and directly with the labs.

4. Is there a Lab Test environment, separate from production?

5. Target Label Workflow (See below)

Data Flow

The lab integration is a bi-directional interface where messages in the form of HL7 files pass back and forth via a set of shared SFTP directories.

Orders

This is the order data flow. It is initiated when the user creates an order within ClinSpark prior to shipping the samples.

Order Confirmations

An optional interaction allows the lab to confirm the receipt of an order. In this confirmation the accession number for the sample is sent along with potentially other information which could be used to create labels.

Results

Results are passed into ClinSpark as follows. Note that these can be sent in realtime as they become available from the analyzers.

Polling interval for both results and confirmation is configuratble within ClinSpark and by default is 30 seconds.

Workflow

Option #1: New labels required for the lab

In the relabeling workflow, tubes are labeled first by ClinSpark, then later relabeled with barcodes suitable for use within the lab analyzers.

The typical workflow for processing samples is as follows:

1. ClinSpark produces specimen tube labels

2. Tubes are labeled with the above prior to sample collection

3. During sample collection, both the subject and the tube are scanned, and ClinSpark verifies the tubes are correct and also records an audit of the collection time

4. The lab user creates an Order within ClinSpark.

5. ClinSpark produces a PDF manifest for printing and including in the shipment. In addition the HL7 order is immediately sent out to the safety lab via SFTP

6. The specimen is registered with the LIMS and a confirmation containing the accession number is sent back to ClinSpark via SFTP

7. To prepare the samples for shipment, the tube is scanned again. ClinSpark produces a new label containing the accession #, which is suitable for consumption by the lab analyzers.

8. The tube is relabeled with this new lab-specific label

9. The shipment of samples is sent to the labs

10. Results are sent from the LIMS to ClinSpark via HL7 over SFTP. These can be sent as they become available, without waiting for the full set of results

11. Results can be viewed within ClinSpark

Option #2: Lab accepts ClinSpark labels

Some LIMS systems have flexibility to accept ClinSpark labels for use by their analyzers. In this workflow, since the order from ClinSpark informs the lab of the tubes and their ClinSpark barcodes, the LIMS system pre-registers these new barcodes with the lab-internal accession number.

This workflow is the same as the default except that it does not require a confirmation message and no relabeling is required.

Note that not all labs are able to support this workflow.

Option #3: Results-only interface

Customers with an established workflow for ordering safety labs and labeling tubes with lab-specific external labels may wish to continue using this workflow while still integrating results with ClinSpark. Support for this workflow is being added after the 1.5 release. This option does not use any ordering capabilities in ClinSpark, and it requires that an external system is used to place orders and print tube labels.

1. User creates safety lab orders using an external system

2. User prints tube labels using an external (i.e. not ClinSpark) system. These should be directly consumable by the safety lab

3. User applies these external labels to the collection tubes

4. During data collection, the user scans the subject wristband

5. During data collection, the user scans the external barcode on the tube. ClinSpark now associates this barcode with the collection tube and is ready to receive results from a lab using this identifier

6. User sends the samples to the lab

7. The lab sends results to ClinSpark. These results use the scanned barcode identifier to identify the tube

8. User reviews results within ClinSpark