Instrument Manager (IM)

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:	The Instrument Manager (IM) software acts as a middleware utilized to regulate laboratory environments. This technology allows users to support various hardware instruments (e.g., chemistry/hematology/immunology lab instruments or microbiology instruments) and manage them from Laboratory Information Systems (LIS). This technology stores data in an Intuitive Reliable Inoperable Scalable (IRIS) for Health database.
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 v24.6
Decision Date:	06/21/2024 at 22:00:33 UTC
Introduced By:	TRM Request
Vendor Name:	Data Innovations, LLC

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
8.13	12/02/2013	01/01/2026
8.14.x	11/30/2015	01/01/2026
8.15.x	05/31/2017	01/01/2026
8.16.x	06/14/2018	01/01/2026
8.17.x	04/01/2020
9.0.x	07/23/2023

Current Decision Matrix (06/20/2024)

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

CY2023

CY2024

CY2025

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

8.13

Unapproved

8.14.x

Unapproved

8.15.x

Unapproved

8.16.x

Divest
[5, 14, 15, 16]

Unapproved

8.17.x

Approved w/Constraints
[5, 14, 15, 16]

Divest
[5, 15, 17, 18]

Divest
[5, 17, 18, 19]

Divest
[5, 18, 19, 20, 21]

Unapproved

9.0.x

Approved w/Constraints
[1, 5, 14, 15, 16]

Approved w/Constraints
[5, 15, 17, 18]

Approved w/Constraints
[5, 17, 18, 19]

Approved w/Constraints
[5, 18, 19, 20, 21]

Decision Constraints


[1]	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.

[2]	Veterans Affairs (VA) users must ensure VA sensitive data is protected properly in accordance with VA Handbook 6500 and the Federal Information Security Management Act (FISMA). Per VA Handbook 6500, FIPS 140-2 certified encryption must be used to protect and encrypt data in transit and at rest if Personally Identifiable Information/Protected Health Information/VA (PII/PHI/VA) sensitive information is involved. If FIPS 140-2 certified encryption is not used, additional mitigating controls must be documented in an approved System Security Plan (SSP). In addition, the technology must be implemented within the VA production network (not in a Demilitarized Zone (DMZ)), unless the specific uses and instances of the technology are approved by the Enterprise Security Change Control Board (ESCCB). All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500. In cases where the technology is used for external connections, a full ESCCB review is required in accordance VA Directive 6004, VA Directive 6517 and VA Directive 6513.

[3]	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.

[4]	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).

[5]	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.

[6]	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).

[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]	Users must ensure that Microsoft Internet Explorer (IE) is implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’)

[9]	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.

[10]	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).

[11]	Users must ensure that Microsoft Internet Explorer (IE) is implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must divest the use of Internet Explorer with this technology. Other approved internet browsers are available. See Category Tab for details. Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM.

[12]	Users must ensure that Microsoft Internet Explorer (IE), Intuitive Reliable Inoperable Scalable (IRIS) for Health and Google Chrome are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must divest the use of Internet Explorer with this technology. Other approved internet browsers are available. See Category Tab for details. Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM.

[13]	Users must ensure that Microsoft .NET Framework, Mozilla Firefox, Intuitive Reliable Inoperable Scalable (IRIS) for Health and Google Chrome are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must not use Internet Explorer with this technology as it is in end of life status at this time. Other approved internet browsers are available. See Category Tab for details. Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM.

[14]	Microsoft Internet Explorer, a dependency of this technology, is in End of Life status and must no longer be used. Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM.

[15]	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 System Security Officer (ISSO) 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).

[16]	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 ISSO (Information System Security Officer) to ensure compliance with VA Handbook 6500.

[17]	Users must utilize approved internet browsers, as Microsoft Internet Explorer has reached End of Life status. See Category Tab for details. Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM.

[18]	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 ISSO (Information System Security Officer) to ensure compliance with both VA Handbook 6500 and VA Directive 6500.

[19]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 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 or its successor 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 or 140-3 compliant full disk encryption (FOE) must be implemented on the storage device 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 System Security Officer (ISSO) 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). By September 22, 2026, all FIPS 140-2 certificate validations will be placed on the Historical List, please refer to FIPS Transition Effort for further guidance and timeline of changes.

[20]	Users must ensure that Intuitive Reliable Interoperative Scalable (IRIS) for Health, Google Chrome and Microsoft Edge are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM.

[21]	The Federal Information Processing standards (FIPS) 140-2 certification status of this technology was not able to be verified. This technology will require a 3rd party FIPS 140-2 or 140-3 certified solution for any data containing PHI/PII or VA sensitive information, where applicable. More information regarding the Cryptographic Module Validation Program (CMVP) can be found on the NIST website.

Note:

At the time of writing, version 9.00.10 is the most current version.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

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
Autoverification Solution	Autoverification Solution reviews patient results based on laboratory criteria and has the ability to review multiple instruments and work areas at one time.
Connectivity Solution	Connectivity Solution can connect to more than one Laboratory Information System or laboratory during testing.
Daily and Peer Quality Control (QC)	Daily and Peer Quality Control (QC) allows seamless integration of third-party QC systems, such as Bio-Rad Unity Real Time, into results production.
Data Mining Solution	Data Mining Solution provides a way to generate ad hoc or standardized reports from an information rich source to improve operational efficiency.
Hematology WorkCell	Hematology WorkCell automates the release of most of the specimens while providing a comprehensive view of the exceptions.
High Availability & Disaster Recovery for Instrument Manager	The High Availability & Disaster Recovery for Instrument Manager component ensures that laboratory tools are configured to avoid data loss in the event of a failure.
Laboratory Intelligence	Laboratory Intelligence is a business solution designed to provide a snapshot of laboratory operations at a glance through customizable dashboards.
Maintenance Manager	Maintenance Manager application supports regulatory compliance by providing an electronic maintenance tracking and reminder process.
Moving Averages and Moving Medians	Moving Averages and Moving Medians provides an application to monitor any test, any work area from anywhere on the network real time.
Notifier	The Notifier module can trigger email, text messages, network notifications, and visual signals via a light pole when Instrument Manager system issues occur.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Application Technology Integration Software	Device Integration
Health Care Health Services	Pathology and Laboratory Medicine Services

Operating Systems Supported by the Technology

Windows Client - Approved w/Constraints
Windows Server - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

Intuitive Reliable Interoperative Scalable (IRIS) for Health
Microsoft .NET Framework
Microsoft Edge. - (required for some configurations)
Microsoft Remote Desktop Client for Windows

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This is a well-documented technology.
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 technology features Laboratory Intelligence which displays Key Performance Indicators (KPIs) through pivot tables in interactive dashboards to monitor processes, which may improve performance.
This technology provides built-in backup capability even when a Laboratory Information Systems (LIS) is unavailable. The solution can automatically print chartable reports and complete audit trails for full traceability. The technology can generate ad hoc reports with any Open Database Connectivity (ODBC) compliant application.

Adoption Risks

There is no indication based on either the vendor documentation or the Cryptographic Module Validation Program (CMVP) that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
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.
There are other approved solutions that provide similar functionality available on the TRM. The use of several similar solutions may increase organization requirements for support and maintenance.
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.
This technology can integrate with and alter database technologies.
This technology can potentially use Secure Sockets Layer (SSL), an unapproved protocol.

Architectural Benefits

The technology can interoperate with Veterans Health Information Systems and Technology Architecture (VistA). The solution supports a wide variety of drivers to connect Laboratory Information Systems (LIS) and instruments. Additionally, the solution can interface instruments to multi-LIS systems concurrently. The solution can interface with instruments from any manufacturer.

Architectural Risks

This technology is not portable as it runs only on Windows platforms.
This technology does not use a VA-preferred database to store data.

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