RFI 36C26026Q0932.docx

The Department of Veterans Affairs (VA), Network Contracting Office 20 (NCO 20), is conducting market research on behalf of the Walla Walla VA Medical Center to identify potential contractors capable of providing reagents and consumables for laboratory tests for the VA medical facilities and clinics.

The Jonathan M. Wainwright Memorial (Walla Walla) VA Medical Center is comprised of:

Jonathan M. Wainwright Memorial VA Medical Center.

La Grande VA Clinic.

Lewiston VA Clinic.

Morrow County VA Clinic.

Richland VA Clinic.

Yakima Valley VA Clinic.

To be considered a responsive and potential source, interested parties shall provide a capabilities statement containing the following information:

1. Business name, address, point of contact, phone number and email address.

2. Business size, type, and SAM Unique Identifier Number

3. Affirmation that the vendor is capable of performing in accordance with the attached Statement of Work.

4. The vendor shall provide copies of government licenses appropriate to do the work described in the Statement of Work.

Additionally, contractors can provide feedback on the attached Requirements Description, which may be considered if a solicitation is posted.

Provide the requested information to Hector Baltazar at hector.baltazar@va.gov before 10:00 am PST on September 7th 2026. All questions must be submitted in writing; no telephonic inquiries will be accepted.

This is a sources-sought notice only. The purpose of this notice is to obtain information regarding the availability and capability of verified sources to include qualified SDVOSB/VOSB to perform this potential requirement. Responses received will assist the Government in determining the appropriate acquisition strategy. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time, and this is not a request for quotes.

1. CONTRACT TITLE: SUBSCRIPTION FOR EP EVALUATOR SOFTWARE

This procurement is for commercial subscription services supporting the continued use of a software platform by the Pathology and Laboratory Medicine Service (PLMS) at the Jonathan M. Wainwright Memorial VA Medical Center (VAWW). The subscription shall provide uninterrupted access to the software application and associated manufacturer-supported services necessary to perform analytical verification, method validation, instrument comparison, reportable range verification, reference interval verification, precision studies, linearity studies, interference studies, and other statistical analyses required to support clinical laboratory operations. Subscription services shall include software licensing, manufacturer-provided maintenance, software updates, version upgrades, technical support, and access to product documentation and training resources throughout the period of performance. The requested subscription services support compliance with applicable Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), Veterans Health Administration (VHA), and Clinical and Laboratory Standards Institute (CLSI) requirements governing the verification and validation of clinical laboratory testing systems.

2. BACKGROUND.

VAWW PLMS performs moderate- and high-complexity clinical laboratory testing in support of outpatient, Community-Based Outpatient Clinic (CBOC), and specialty healthcare services provided to Veterans throughout the facility’s service area. Laboratory testing is performed across multiple disciplines, including clinical chemistry, hematology, coagulation, immunology, urinalysis, toxicology, microbiology, and molecular testing. The laboratory routinely implements new instrumentation, introduces new testing methodologies, modifies existing assays, and performs verification studies necessary to ensure the accuracy, precision, and clinical reliability of patient testing.

Federal regulations, accreditation standards, and VHA policy require laboratories to perform analytical verification and validation studies before implementing new instrumentation, new methodologies, or significant modifications to existing testing systems. These studies routinely include, but are not limited to, precision, method comparison, analytical measurement range (AMR), reportable range, linearity, calibration verification, reference interval verification, interference, carryover, and other analytical performance evaluations necessary to demonstrate that laboratory testing systems perform as intended. Documentation supporting these activities must be maintained and be suitable for review during inspections conducted under CLIA, CAP, and other applicable regulatory or accrediting organizations.

Manual statistical analysis and documentation of analytical verification studies are labor-intensive, increase the potential for transcription and calculation errors, and may result in inconsistent documentation between laboratory sections or individual users. The Government requires a commercial software platform specifically designed for clinical laboratory analytical performance verification that standardizes statistical analyses, automates implementation of recognized CLSI evaluation protocols, and generates professional, inspection-ready reports suitable for regulatory review and laboratory director approval. Standardization of these activities improves consistency, reduces administrative burden, supports regulatory compliance, and promotes efficient implementation of new laboratory instrumentation and testing methodologies while maintaining the high-quality standards required for clinical laboratory operations.

3. SCOPE

This contract is for the provision of commercial subscription services for the platform in support of clinical laboratory analytical verification, validation, and quality assurance activities performed by the PLMS at VAWW. The contractor shall provide all software subscription services necessary to ensure uninterrupted access to a software application and associated manufacturer-supported resources throughout the period of performance.

Subscription services shall include software licensing, manufacturer-provided software maintenance, software updates, version upgrades, technical support, access to product documentation, and access to manufacturer-provided training resources necessary to maintain full subscription functionality. The contractor shall provide all subscription services required to support continued use of the software for analytical verification and validation studies performed in accordance with applicable CLIA, CAP, VHA, and CLSI requirements.

The requested subscription services shall support the laboratory’s ongoing performance of analytical verification and validation studies, including implementation of new instrumentation, new analytical methods, assay modifications, method comparison studies, precision studies, analytical measurement range and reportable range verification, linearity studies, reference interval verification, interference studies, carryover evaluations, and other analytical performance assessments required to support clinical laboratory operations. The subscription shall provide uninterrupted access to previously created projects, historical validation studies, statistical analyses, and associated reports maintained within the software throughout the period of performance.

The contractor shall furnish all services necessary to maintain the software in fully supported operational status, including access to manufacturer-issued software updates, product enhancements, technical assistance, and other subscription benefits made generally available to commercial subscribers during the contract period. The Government shall retain responsibility for the performance, review, interpretation, and approval of all analytical verification and validation studies conducted using the software.

4. SPECIFIC TASKS

TASK 1 – SUBSCRIPTION SERVICES

The contractor shall provide commercial subscription services for the software platform for the duration of the period of performance. Subscription services shall provide uninterrupted access to all software functionalities necessary to support clinical laboratory analytical verification, validation, and quality assurance activities performed by the Government. The subscription shall include all software licensing required for authorized Government users and activation of subscription services. Subscription services shall remain active throughout the contract period without interruption and shall include all manufacturer-provided benefits generally available to commercial subscribers.

TASK 2 – SOFTWARE MAINTENANCE AND PRODUCT UPDATES

The contractor shall provide all manufacturer-issued software maintenance, updates, revisions, patches, enhancements, and version upgrades released during the period of performance at no additional cost to the Government. Software updates shall maintain compatibility with supported Microsoft Windows operating systems and preserve existing project files, historical study data, user-defined settings, and software functionality whenever technically feasible. The contractor shall notify the Government of major software releases that significantly affect system functionality or introduce new analytical capabilities.

TASK 3 – TECHNICAL SUPPORT SERVICES

The contractor shall provide manufacturer technical support throughout the period of performance to assist Government personnel with software installation, licensing, activation, troubleshooting, software operation, statistical analysis functionality, and other issues associated with routine use of the software. Technical support shall be provided by personnel knowledgeable in both the operation of the software and its application to clinical laboratory performance verification studies. Support services shall be available through standard commercial communication methods, including telephone and electronic mail, during the contractor’s normal business hours. Contractor support shall include reasonable assistance with software errors, licensing issues, software configuration, and questions regarding implementation of supported statistical analyses.

TASK 4 – PRODUCT DOCUMENTATION AND TRAINING RESOURCES

The contractor shall provide access to current electronic product documentation, user guides, release notes, technical reference materials, and other documentation necessary to support effective operation of the software. The contractor shall also provide access to manufacturer-developed training resources made available under the commercial subscription program, including recorded educational materials, webinars, tutorials, and other instructional content intended to assist Government personnel in the effective use of the software’s analytical and reporting capabilities.

5. PERFORMANCE MONITORING.

Contract performance will be monitored by the Laboratory Manager, designated Contracting Officer’s Representative (COR), and designated PLMS personnel through routine oversight of the subscription services provided under this contract. Performance monitoring activities shall verify that the contractor maintains uninterrupted software subscription services, provides timely access to manufacturer-issued software updates and version releases, maintains software licensing throughout the period of performance, and provides technical support in accordance with the terms of the contract.

The Government will monitor contractor performance through routine evaluation of software availability, successful activation and continuation of subscription services, accessibility of software updates and product documentation, responsiveness to technical support requests, and the contractor’s ability to maintain the software in a fully supported operational status. Performance will also be evaluated based upon the contractor’s ability to provide continued access to historical projects, validation studies, statistical analyses, and previously generated reports necessary to support ongoing laboratory operations and regulatory compliance.

Any failure to maintain active subscription services, provide required software updates, restore software functionality following identified issues, or furnish technical support consistent with commercial subscription services may be documented by the Government and addressed with the contractor in accordance with the terms and conditions of the contract. The contractor shall provide documentation necessary to verify subscription status, software version updates, and other support activities performed during the period of performance upon request by the Government.

6. SECURITY REQUIREMENTS.

The contractor shall comply with all applicable VA security, privacy, and information security requirements applicable to the performance of this contract. Contractor personnel shall not have routine access to VA sensitive information, protected health information (PHI), personally identifiable information (PII), or VA information systems in the performance of this contract.

Subscription services and technical support provided under this contract shall be performed utilizing the contractor’s standard commercial support processes. The EP Evaluator software is currently implemented and operational within the VAWW laboratory environment. This procurement provides continuation of software subscription services, maintenance, and manufacturer support for the existing implementation.

7. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI).

No Government-Furnished Equipment (GFE) or Government-Furnished Information (GFI) will be provided to the contractor under this contract. The Government will provide reasonable coordination with designated Pathology and Laboratory Medicine Service (PLMS) personnel, the Contracting Officer’s Representative (COR), and Office of Information and Technology (OI&T) personnel, as necessary, to facilitate contract performance.

8. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS.

A. IDENTIFICATION OF POSSIBLE FOLLOW-ON WORK.

Upon completion of the base period and any exercised option periods, the Government may require continued commercial subscription services, software maintenance, technical support, version upgrades, and software enhancements necessary to support ongoing clinical laboratory analytical verification and validation activities. Any continued subscription services beyond the period of performance established under this contract shall be accomplished under a separate procurement action, if required.

B. IDENTIFICATION OF POTENTIAL CONFLICTS OF INTEREST (COI).

No known organizational conflicts of interest exist at the time of this procurement

C. TECHNICAL AND OPERATIONAL REQUIREMENTS.

The subscription shall provide continued access to a commercial clinical laboratory performance verification software platform specifically designed to support analytical verification, validation, and quality assurance activities performed within a moderate- and high-complexity clinical laboratory. The software shall support implementation of recognized CLSI evaluation protocols and generate standardized documentation suitable for review during inspections conducted under CLIA, CAP, The Joint Commission, and other applicable accrediting organizations.

The software shall support analytical performance evaluations including precision studies, method comparison studies, calibration verification, analytical measurement range verification, reportable range verification, linearity studies, reference interval establishment and verification, carryover evaluation, interference studies, qualitative and quantitative method evaluation, instrument comparison studies, and other statistical analyses routinely required to support implementation and verification of clinical laboratory testing systems.

The software shall provide automated statistical calculations, standardized analytical workflows, project management capabilities, historical project retention, professional reporting, concurrent multi-user operation, comprehensive user documentation, and access to manufacturer-developed educational resources. The software shall preserve existing analytical projects and associated reports throughout the period of performance and maintain compatibility with supported Microsoft Windows operating systems.

D. INSPECTION AND ACCEPTANCE CRITERIA.

The Government will inspect and evaluate the subscription services upon activation and throughout the period of performance to verify that the contractor has provided the software licensing, subscription services, software maintenance, technical support, and manufacturer-issued updates required by this contract. Acceptance shall be based upon successful activation of the subscription, continued access to all licensed software functionality, availability of manufacturer support services, and the contractor’s fulfillment of all contractual requirements. The COR or designated Government representative shall be responsible for acceptance of services provided under this contract.

9. RISK CONTROL.

The continued use of the software is consistent with established laboratory quality management practices and supports the analytical verification and validation activities routinely performed by PLMS. The software is used as a decision-support tool to perform statistical analyses and generate documentation associated with laboratory validation studies. Final review, interpretation, and approval of all validation studies and associated reports shall remain the responsibility of qualified laboratory personnel and the Laboratory Director.

This procurement represents the continuation of an existing software subscription and does not introduce new analytical methods, patient testing procedures, or changes to established laboratory workflows. The continued availability of the software supports standardized validation practices, regulatory compliance, and consistent documentation while minimizing the risk of calculation errors associated with manual statistical analysis.

10. PLACE OF PERFORMANCE.

The services required under this contract shall be provided in support of PLMS at VAWW:

Jonathan M. Wainwright Memorial VA Medical Center Laboratory Service 77 Wainwright Drive Walla Walla, WA 99362

Subscription services, software maintenance, software updates, technical support, and other contract requirements shall be performed remotely unless otherwise coordinated with the Government. Any onsite services determined to be necessary during the period of performance shall be coordinated in advance with the COR or designated Government representative.

11. PERIOD OF PERFORMANCE.

The period of performance for this contract shall consist of one (1) twelve-month base period followed by four (4) optional twelve-month periods, exercisable at the sole discretion of the Government. The total potential period of performance shall not exceed sixty (60) months.

The contractor shall provide uninterrupted commercial subscription services, software maintenance, manufacturer-issued software updates, version upgrades, technical support, and access to all subscription benefits throughout the base period and any option periods exercised by the Government. Exercise of each option period shall be in accordance with applicable Federal Acquisition Regulation (FAR) provisions and shall not obligate the Government to exercise any or all option periods.

The anticipated periods of performance are as follows:

• Base Period: Twelve (12) months from date of contract award.

• Option Period One: Twelve (12) months.

• Option Period Two: Twelve (12) months.

• Option Period Three: Twelve (12) months.

• Option Period Four: Twelve (12) months.

12. DELIVERY SCHEDULE.

The contractor shall provide all subscription services necessary to ensure uninterrupted access to the software throughout the period of performance. Software subscription activation, licensing, and access to applicable subscription benefits shall be provided no later than the first day of the base period and each exercised option period.

The contractor shall provide all applicable subscription documentation, licensing information, software update notifications, and other information necessary to support continued operation of the software throughout the contract period. Manufacturer-issued software updates, version upgrades, and maintenance releases made available during the subscription period shall be provided to the Government in accordance with the contractor’s standard commercial subscription program.

Delivery of technical support, software maintenance, and other subscription services shall be continuous throughout the period of performance. All subscription services shall be coordinated with the COR or designated Government representative, as appropriate.