OpenSpecimen

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website:	Go to site
Description:	OpenSpecimen is an open source, web-based biospecimen inventory and tracking technology that can collect high-quality, standards-based data specific to a disease or set of study requirements. OpenSpecimen tracks collection, storage, quality assurance, and distribution of biospecimens labeled through barcoding systems. OpenSpecimen was previously known as caTissue, which was initially developed with the National Cancer Institute (NCI). This technology stores data an Oracle Database, but has the potential to connect to other databases and electronic health records (EHRs), where it can store and manipulate data.
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:	This technology has not been assessed by the Section 508 Office. The Implementer of this technology has the responsibility to ensure the version deployed is 508-compliant. Section 508 compliance may be reviewed by the Section 508 Office and appropriate remedial action required if necessary. For additional information or assistance regarding Section 508, please contact the Section 508 Office at Section508@va.gov.
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v23.2
Decision Date:	02/09/2023 at 03:34:26 UTC
Aliases:	caTissue Core, caTissue
Introduced By:	TRM Request
Vendor Name:	Krishagni Solutions

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Technology, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
caTissue 1.0	12/20/2006
caTissue 1.1	02/02/2007
caTissue 1.2	05/21/2007
caTissue 1.2.1	02/26/2008
caTissue 1.2.2	08/15/2012
OpenSpecimen 1.0	09/30/2014
OpenSpecimen 1.1 RC1	12/08/2014
OpenSpecimen 1.1 RC2	01/23/2015
OpenSpecimen 1.1 RC3	02/24/2015
OpenSpecimen 1.2	03/11/2015
OpenSpecimen 2.5.x	01/06/2016
OpenSpecimen 4.x.x	04/27/2017
OpenSpecimen 5.x.x	01/04/2018
OpenSpecimen 6.x.x	03/05/2019
OpenSpecimen 7.x.x	04/28/2020
OpenSpecimen 10.x.x

Current Decision Matrix (02/02/2023)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

<Past

CY2017

CY2018

CY2019

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

caTissue 1.2.1

Divest
[2, 3, 4, 5]

Divest
[2, 3, 4, 5, 6]

Divest
[2, 3, 6, 7, 8]

Unapproved

caTissue 1.2.2

Divest
[2, 3, 4, 5]

Divest
[2, 3, 4, 5, 6]

Divest
[2, 3, 6, 7, 8]

Unapproved

OpenSpecimen 1.2

Divest
[2, 3, 4, 5]

Divest
[2, 3, 4, 5, 6]

Divest
[2, 3, 6, 7, 8]

Unapproved

OpenSpecimen 2.5.x

Approved w/Constraints
[2, 3, 4, 5]

Approved w/Constraints
[2, 3, 4, 5, 6]

Approved w/Constraints
[2, 3, 6, 7, 8]

Approved w/Constraints
[2, 3, 7, 8, 9]

Divest
[2, 3, 7, 8, 9]

Divest
[2, 3, 8, 10]

Unapproved

OpenSpecimen 4.x.x

Unapproved

Approved w/Constraints
[2, 3, 4, 5, 6]

Approved w/Constraints
[2, 3, 6, 7, 8]

Approved w/Constraints
[2, 3, 7, 8, 9]

Divest
[2, 3, 8, 10]

OpenSpecimen 5.x.x

Unapproved

Approved w/Constraints
[2, 3, 7, 8, 9]

Approved w/Constraints
[2, 3, 8, 10]

OpenSpecimen 6.x.x

Unapproved

OpenSpecimen 7.x.x

Unapproved

OpenSpecimen 10.x.x

Unapproved

Decision Constraints


[1]	Projects using this technology must meet Veterans Affairs (VA) Directive 6500 and implement Federal Information Processing Standards (FIPS 199) for all laptop devices and National Institute of Standards and Technology Special Publication 800-53 for all desktop devices when VA sensitive information is involved, or additional mitigating controls must be documented in an approved System Security Plan (SSP) to prevent potential disclosure of PII/PHI data. Additionally, projects which interface with external VA partner must have a Memorandum of Understanding and Interconnection Security Agreements (MOU/ISA) which detail the security requirements for users and systems that share information and resources outside of the VA production network.

[2]	Users should check with their supervisor, Information Security Office (ISO) or local OIT representative for permission to download and use this software. Downloaded software must always be scanned for viruses prior to installation to prevent adware or malware. Freeware may only be downloaded directly from the primary site that the creator of the software has advertised for public download and user or development community engagement. Users should note, any attempt by the installation process to install any additional, unrelated software is not approved and the user should take the proper steps to decline those installations.

[3]	Technology must remain patched and operated in accordance with Federal and Department security policies and guidelines in order to mitigate known and future security vulnerabilities.

[4]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[5]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[6]	MySQL Database must not be configured for use with this product. (Refer to MySQL Database TRM entry for more details)

[7]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[8]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[9]	This product can be configured with a MySQL Database which currently has TRM constraints for intranet use only due to its many known security issues. If MySQL is selected for use with this product, these factors must be considered especially when an instance of this product will be considered a Moderate or High Risk system. See the MySQL Database TRM entry for more details.

[10]	This technology must use the latest version of JRE (Java Runtime Environment) - Oracle.

Note:

At the time of writing, version 10.0.0 is the most current version released.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
Other	GItHub Openspecimen		This is the GitHub page for this technology.

Technology Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Name	Description
No components have been identified for this entry.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Information Management Technologies Business Intelligence and Data Warehouse Platforms	Clinical Environment and Tools

Open Source

This entry is available as an open source technology.

Operating Systems Supported by the Technology

macOS - Approved w/Constraints
Red Hat Enterprise Linux (RHEL) - Approved w/Constraints
Windows Client - Approved w/Constraints
Windows Server - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This technology is available at no cost through open source licensing and supports VA`s open source initiative.
At the time of writing, no National Institute of Standards and Technology (NIST) vulnerabilities had been reported and no VA Cyber Security Operations Center (CSOC) bulletins had been issued for the latest versions of this technology.
This is a well-documented technology.
This technology may improve productivity for specific staff whose responsibilities include biospecimen analysis.

Adoption Risks

System scans indicate that this technology is no longer in use within the VA network.
As open-source software, this product may be left without clearly defined support options which may result in suboptimal enterprise level support.
This technology can integrate with and alter database technologies.
Due to the rapid release schedule of this technology, the VA may be unable to update to the most recent patch and may require a deployment model requiring the use of specific versions.
The potential exists to store Personally Identifiable Information (PII), Protected Health Information (PHI) and/or VA Sensitive data and proper security standards must be followed in these cases.
This technology relies on Java Runtime Environment (JRE) - Oracle, which has a rapid release and update schedule.

Architectural Benefits

This technology is portable as it runs on multiple TRM-approved operating systems.
This technology can use a VA-preferred database.

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Comparable Technologies:

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VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (02/02/2023)

Decision Constraints

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Technology Components

VA Categories View the VA Categorization Framework

Open Source

Operating Systems Supported by the Technology

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

Adoption Risks

Architectural Benefits

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