Considerations for OpenSpecimen project(s)

Initial Considerations

All systems implementations require some change in current processes and the adoption of new methods in order to reap the benefits of the new application

Implementing OpenSpecimen requires the process of mutual transformation of both the organization and the technology to achieve success. We need your participation in understanding, describing and documenting your biospecimen processes. If you modify only the technology in order to keep current processes with the mindset of “it’s the way we’ve always done it”, the result will be a painful exercise with an outcome which will fall far short of expectations.  It may even result in an environment that is even more convoluted and work intensive than the current state.

However, if you invest the time to understand how the system application is designed and which system design choices will maximize effective use of the modules, then desired outcomes & reporting can be obtained.  This requires a willingness to implement change and address organizational issues.

The Process

Below is a list of non-system tasks required to streamline the design and implementation of OpenSpecimen in your department:

1. Organize your currently stored specimens in your containers (freezers, refrigerators, room temperature containers)

2. For existing sample management spreadsheets, document associated metadata

3. If these are clinical human specimens, ensure that consent statements are signed and filed in order to ensure permission to store specimens

   1. Define protocol

   2. Participant registration

   3. Logging

4. Take time to document your current state processes from start to finish:

   1. How / who collects specimens? (Users)

   2. Where are specimens collected? (Sites)

   3. What data is captured and why? (Data entry fields)

   4. When is data captured? (During patient registration, different visits over time, following specimen collection)

   5. What happens if something is mislabeled?

   6. What is the timing of each event?

   7. Who touches what? (User access)

   8. Who has access to what? (User privileges)

   9. What steps could be streamlined or made more efficient?

   10. What unique situations have happened in the past?

5. Building on Step 4, identify who will need access to OpenSpecimen and in what capacity.  This will be of immense help when identifying User Roles, Rights and Access Privileges

6. Please visit ProTracks to register your lab project and indicate the desire to use OpenSpecimen.  You will need to complete forms which provide information about the requester, the project and specifics about the Lab operations.

7. Upon completion of the ProTrackS registration you will be contacted by BMIC’s BioSpecimen Navigator who will gather more detailed information and specs in order to get the process started.

 Unique Considerations

BMIC Implementation Support Services include:

1. Assist with the concept design of OS to meet the needs of your lab

   1. Standardize your data, transform it into standard vocabulary, and upload it into OS

   2. Perform the initial Quality Assurance checks

   3. Provide training to your lab staff at all stages of the project

   4. Provide continuing support for the software (version updates and user issues)

 Responsibility of Lab during an OpenSpecimen Implementation

1. Identify Super Users who will be champions of the project, address internal issues,  promote change management & spearhead system design and testing

   1. Purchase identified equipment such as printers

   2. Ensure lab staff meet requested deadlines for assigned tasks

   3. Develop / modify Standards of Practice specific to the lab

   4. Develop / modify Training Materials specific to the lab

Faculty Oversight for Lab Migration

1. Every lab implementation MUST have faculty oversight. This is similar to the PI of a research project who is ultimately responsible for the welfare of the project and will make key design decisions.