RFI 36C26027Q0058.docx

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

The Puget Sound VA Medical Center is comprised of:

Seattle VA Medical Center.

American Lake VA Medical Center.

Auburn VA Clinic.

Everett VA Clinic.

Mount Vernon VA Clinic North Olympic Peninsula VA Clinic Oak Harbor VA Clinic Olympia VA Clinic Puyallup VA Clinic Renton VA Clinic Silverdale VA Clinic South Lucile Street 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 November 13th, 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.

Statement of Work (SOW)

A. SCOPE OF PROCUREMENT:

The VA Puget Sound Health Care System Pathology and Laboratory Medicine Service requires a histology staining workflow system which includes: Two (2) immunohistochemistry (IHC) and two (2) in-situ hybridization (ISH) immunostainers, and two (2) special stainers, and a specimen tracking system which promotes proper identification of specimens and slides and will audit workflow to identify areas that need improvement and reduce errors.

The tracking system will improve patient safety, provide a chain of custody, and will monitor productivity. All the components of the workflow system must communicate with each other in order to track the workflow. The stainers attached to this system must be automated and allow the system to track and label slides for special staining and immunostaining. The workflow system must be compatible with the IT systems VISTA and/or Cerner, as well as any other new electronic health record system the VA acquires and also be compatible with Data Innovations middleware.

2. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials, to include replacement parts, required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers.

Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

3. The Contractor will provide a detailed list of all parts and supplies that are to be purchased by the facility and are not included in the CPRR contract.

4. The Contractor will provide a service maintenance agreement for the special stainers, Immunohistochemistry and in-situ hybridization stainer, and specimen tracking system.

5. Special handling for emergency orders of supplies: In the event, the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery is required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

B. DEFINITIONS:

1. Cost Per Test (CPT) and Cost Per Reportable Result (CPRR) - as defined in the Federal Supply Schedule FSC Group 66, Part III, CPT / CPRR Clinical Laboratory Analyzers – Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5-year equipment use, (2) all reagents, standards, quality controls, linearity material, calibration verification material, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

2. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA.

These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.

3. Throughput – The speed that the equipment processes and/or operates reported in units per hour.

4. Test Menu: Refer to Attachment A for desired test menu and estimated annual volumes by laboratory.

C. GENERAL REQUIREMENTS FOR THE IHC AND IN SITU HYBRIDIZATION (ISH) IMMUNOSTAINER

1. Due to limited space, the stainers must be free standing and have the physical dimensions of approximately 44x33x62 inches (width x depth x height).

2. Vendor must provide the most current version of the stainers.

3. Primary Immunostainer: Base equipment offered that shall fully support the scope of operations (minimal requirements).

4. Back-up Immunostainers: Base equipment shall also fully support the scope of operations. Must be a mirror image of the primary immunostainer.

5. Installation (applies only if selected): Contractor will provide an alternate site for validation of the instrumentation if space is not available for side-by-side validation with existing instrumentation. Contractor will perform a mini validation when instrumentation is installed in the final workspace per customer’s recommendations.

Equipment installation shall not require construction or alteration of space.

6. The vendor must provide/install any routine and special items required to operate/maintain the immunostainer in optimal conditions.

7. The Customer and vendor will conduct ongoing reviews no less than every 6 months to monitor contract performance.

8. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and Information system security as delineated in this contract.839.201 Contract Clause for Information and Information Technology Security.

9. Must have at least 30 slide positions and 35 reagent positions.

10. Individual slide drawers with continuous access to slides always. Continuous loading capacity.

11. Throughput: Processes up to 60 slides in 8 hours and/ or 120 slides with an overnight run.

12. Continuous access to bulk reagents and waste, and level sense capabilities.

13. At a minimum, must have the capability of performing all (100%) of the tests listed in Attachment A. Capacity for additional tests (immunohistochemical stains) is necessary as per requirements of the clinical service (Pathology and Laboratory Medicine Services).

14. Must have minimal daily maintenance.

15. Full automation of drying, baking, deparaffinization and staining with histochemistry reagents of special stains in a single unit that achieves uniform and consistent results.

16. Must have a biotin-free technique that prevents background staining related to improper binding of the endogenous biotin to avidin.

17. Must have a management system that provides continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records.

18. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

19. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and/or numeric depending on site that may be enabled concurrently.

20. Bar coding of reagents and the ability to track reagent containers throughout the testing process using bar code technology.

21. Contractor Middleware Management: The middleware shall be able to communicate via HL7 messages version 2 or latest version.

22. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

23. An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated archive storage, etc.,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

D. GENERAL REQUIREMENTS FOR THE SPECIAL STAINER

1. Due to limited space, and workflow constraints due to location, the stainers must be free standing, have the physical dimensions of approximately 20x24x51 (width, depth, height) and be independent of an H&E stainer.

2. Primary Special Stainer: Base equipment offered shall fully support the scope of operations (minimal requirements).

3. Back-up Special Stainer: Base equipment shall also fully support the scope of operations. Must be a mirror image of the primary Special Stainer.

4. Vendor must provide the most current version of the special stainer.

5. Installation (applies only if selected): Contractor will provide an alternate site for validation of the instrumentation if space is not available for side-by-side validation with existing instrumentation. Contractor will perform a mini validation when instrumentation is installed in the final workspace per customer’s recommendations.

Equipment installation shall not require construction or alteration of space.

6. The vendor must provide/install any routine and special items required to operate/maintain the special stainer in optimal conditions.

7. Must have minimal daily maintenance.

8. Must have random batch accessioning

9. Must have bulk and waste fluid sensing.

10. Must meet the middleware and barcode requirements listed under the general requirements of the immunostainer.

11. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

12. Full automation of drying, deparaffinization and staining of special stains in a single unit that achieves uniform and consistent staining.

13. At a minimum, the stainer must have the capability of performing all (100%) of the tests listed in Attachment A. Capacity for additional tests (special stains) is necessary as per requirements of the clinical service (Pathology and Laboratory Medicine Services), including Acid Fast Bacteria (AFB), Alcian Blue, Congo Red (Amyloid), Elastin, Grocott Methenamine Silver (GMS), Gram, Prussian Blue Iron, Mucicarmine, Periodic Acid-Schiff (PAS) with and without diastase and/or light green for fungus, Rectiulin, Steiner, and Trichrome (blue).

14. The stainer must have a separate staining platform for each slide as a prevention of cross contamination by stains.

E. VALUE ADDED ITEMS:

1. The Contractor/Vendor has an immunostainer with the following general requirements:

a.) Must have the capability to perform Immuno-Histo-Chemistry (IHC) staining simultaneously with In Situ Hybridization (ISH) and Direct Immunofluorescence (DIF) b.) Must have continuous access to slide drawers to load and unload slides independently throughout the day.

c.) Must have the ability to add/remove reagents without interruption of staining process.

d.) Must have the ability to run unexpected test requests without interrupting cases already in staining process.

e.) Must have bulk and waste fluid sensing.

f.) Must have safe hazardous waste removal system.

2. The Contractor/Vendor has a specimen tracking system with the following general requirements:

a.) Must be able to identify the location of a given specimen block, slide, stain status, and the expected completion time.

b.) Streamlines workflow and visibility of the specimen at all times.

c.) Has the flexibility to add comments on quality issues and special instructions at both the block and slide level.

d.) Contains a quality assurance monitoring program and workload analysis.

e.) Must be able to communicate via HL7 messages version 2 or latest version.

f.) Must be able to support multiple barcode formats (Code 39, Code 128) g.) Must be compatible with the IT systems VISTA and/or Cerner, as well as any other new electronic health record system the VA acquires and be compatible with Data Innovations middleware.

h.) Capability to have instructions, special stains, and immunohistochemistry order entry by the Pathologists.

F. METHOD VALIDATION & PERFORMANCE REQUIREMENTS

1. Method performance/comparison shall be at the expense of and performed by the Contractor, shall include reagents and consumables, accessories and any other items included on the list of supplies defined in the Federal Supply Schedule contract and required to validate instruments for operation for performance of acceptance testing. Validation must be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and regulations. All studies performed will be appropriate for the test menu of the respective laboratory. All studies must be approved by the local Laboratory Medicine Medical Director and made electronically available. These requirements shall be in effect during installation and any future changes to the test menu and/or method updates.

2. Correlation studies:

a. For a non-predictive assay, the validation should test a minimum of 10 positives and 10 negative tissues. A minimum of 20 samples including both abnormal and normal shall be run by the present and the proposed method.

b. For a predictive assay, the validation should test a minimum of 20 positives and 20 negative tissues. A minimum of 40 samples including both abnormal and normal shall be run by the present and the proposed method.

c. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall meet current standards defined by CLSI and CAP guidelines.

3. Throughout the life of the agreement, the vendor shall provide assistance to the user in setting up and maintenance/troubleshooting user-defined assay if additional tests are brought in house.

4. Training: The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. The key operator training shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. In addition, basic operator training shall be provided by Contractor on-site for all operators on all shifts, as applicable. Also, the Contractor will provide enhanced training including all costs for staff.

G. SERVICE AND MAINTENANCE REQUIREMENTS

1. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum callback response time of 1 hour.

2. Equipment repair service shall be provided Monday through Friday 8am to 4:30 pm on site. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be no more than 24 hours.

3. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

4. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

a. Date and time notified

b. Date and time of arrival

c. Serial number, type, and model number of equipment

d. Time spent for repair

e. Proof of repair that includes documentation of findings and corrective actions

5. Each notification for an emergency repair service call shall be treated as a separate and new service call.

6. Uptime Guarantee/Performance Penalty: The vendor agrees that all equipment provided shall be operable no less than 98% of operational time.

7. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. All software upgrades will be accompanied by a summary of changed features and functionality. Changes to maintenance procedures or operations will be outlined in a written document. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability.

8. Ancillary support equipment - The Contractor shall provide, install, and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance, and repair, etc.), printers, uninterruptible power supply (UPS), and interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

H. RECORDS MANAGEMENT

1. The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

2. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a);

36 CFR Part 1222 and Part 1228.

3. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

4. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

5. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

6. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

7. The Government Agency owns the rights to all data/records produced as part of this contract.

8. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

9. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [email, fax, etc.] or state of completion [draft, final, etc.].

10. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

11. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

I. PRIVACY OFFICER LANGUAGE

1. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1).

2. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

3. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records, and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

4. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations, and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

5. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

J. PERFORMANCE REQUIREMENTS SUMMARY

1. The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

K. PERIOD OF PEFORMANCE

Base Year: 2/1/2027 to 1/31/2028 Option Period 1: 2/1/2028 to 1/31/2029 Option Period 2: 2/1/2029 to 1/31/2030 Option Period 3: 2/1/2030 to 1/31/2031 Option Period 4: 2/1/2031 to 1/31/2032