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OpenSpecimen-Overview

OpenSpecimen-Overview

Owned by Mary Irion
Last updated: Jan 18, 2021
3 min read

OpenSpecimen - Overview

Initial Considerations

OpenSpecimen is a Laboratory Management software program designed specifically for labs to track specimen storage and processing based upon clinical study design.

 The OpenSpecimen General Design

 The standard workflow of collecting specimens:

  1. There are two types of protocols that are supported by OpenSpecimen:

    1. Specimen-centric: for studies in which no patient data is collected or tracked with the sample (biobanking) 

    2. Participant-centric: for studies in which participant demographic and disease-specific data is collected, stored, and linked to specimen data.

      1. Planned: Longitudinal studies can be designed to specify details regarding specimen collection for predefined time points.

      2. Unplanned: No defined visits or specimen requirements are set allowing the user to record the collection of any specimen type at any time.

  2. Listed below are key features associated with each Collection Protocol type:

Feature

Specimen-centric

Participant-centric

 

 

Planned

Unplanned

Customized storage container design and organization

X

X

X

Automatically assign next available storage location

X

X

X

Restrict storage location by sample type or study protocols

X

X

X

View of storage container contents by specimen ID

X

X

X

Maintain traceability of derivatives and aliquots

X

X

X

Track specimen processing events

X

X

X

Track distributed samples

X

X

X

Record samples received back from customers or processing labs

X

X

X

Customized Queries, Reports, Invoices

X

X

X

Bulk operations

X

X

X

Store samples without patient data (Biobanking)

X

 

 

Track storage of legacy samples without participant data

X

 

 

Patient data is collected with specimen

 

X

X

Consent statements are tracked and stored

 

X

X

Collect multiple specimens over time from the same participant

 

X

X

Set predefined visits with expected timing

 

X

 

Collect visit-specific patient information

 

X

 

Set specimen requirements for each expected visit

 

X

 

 General Laboratory Management capabilities of OpenSpecimen

  1. Opportunity for labs to comply with FDA and CLIA regulations for securing specimens

  2. Access restrictions to PHI based on user roles

  3. Consent statement tracking for each participant

  4. Upload of Pathology Reports

  5. Collection instructions to study coordinators

  6. Query interface to search for specimens or participants based on your own criteria

  7. Customized dashboard with metrics of interest

  8. Custom forms to record study-specific information

  9. Label creation according to a predefined schema

  10. Automatic assignment of storage locations

  11. Restricting sample storage by type and/or Collection Protocol

  12. Recording of specimen processing events

  13. Reservation of specimens for specific projects or collaborators

  14. Reporting functionality for distribution and receiving

Features not supported in OpenSpecimen

  1. Managing large scale laboratory processes. OS is not a general LIMS.

  2. Direct interface with Epic (this option is supported by OS, but the University of Utah does not yet support this option).

    • If you are interested in an interface for your lab, the laboratory director should complete a Help Desk ticket HelpDesk Ticket Link

  3. Utilization of your legacy sample numbering system as the primary participant ID or specimen IDs.

  4. Automatic translation and upload of legacy data

    1. Supports manual upload of bulk data in .csv format

    2. User must map legacy data fields to fields in OpenSpecimen

Unique Considerations

  1. If projects are assigned different IRB numbers, use one Collection Protocol per IRB.

  2. Be open to change regarding modifications to your current sample process flow and specimen labeling schema used by your laboratory.

    • Import of legacy data can be performed maintaining the current sample labeling, but implementing new specimen labeling will likely be necessary.

  3. If custom data fields are required by the Collection Protocol, custom forms can be designed, but this process involves a learning curve to use the advanced features. The BMIC can offer support.

  4. A networked label printer is required for label printing.

CTSI BMIC Help Center https://ctsi.utah.edu/cores-and-services/bmic