36C24226Q0949.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24226Q0949 09-29-2026

Jonathan Kilgore 10-13-2026

12:00PM EDT

36C242 Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904

X

334516

1000 Employees

N/A

X

Albany VA Medical Center Buffalo VA Medical Center Syracuse VA Medical Center

Albany, Buffalo, Syracuse NY

36C242

Department of Veterans Affairs James J. Peters VA Medical Center Network Contracting Office 2 130 West Kingsbridge Road Bronx NY 10468-3904

Tungsten Network https://www.tungsten-network.com/ customer-campaigns/veteransaffairs/

See CONTINUATION Page

This is a Request for Quote (RFQ) for Electrophoresis Testing for the Albany, Buffalo, and Syracuse VA Medical Centers. See Statement of Work for further details.

This RFQ is expected to result in a five year Indefinite Delivery/Indefinite Quantity (IDIQ) contract.

Quotes shall be submitted no later than 12:00PM EST on 10/13/2026 to jonathan.kilgore@va.gov.

See CONTINUATION Page

X

36C24226Q0949

Table of Contents

SECTION A ...................................................................................... Error! Bookmark not defined.

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES ...................................... Error! Bookmark not defined.

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (NOV 2025) (DEVIATION)

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.6 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE

ITEM (MAR 1989)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 54

C.8 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

(DEVIATION APR 2026)

C.9 52.223-23 SUSTAINABLE PRODUCTS (NOV 2025) (DEVIATION)

C.10 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.11 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (NOV 2020)

C.12 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.13 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.14 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

E.2 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.3 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

E.4 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.5 52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (NOV 2020)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (OCT 2025) (DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C242 Jonathan Kilgore

Department of Veterans Affairs

Network Contracting Office 2

James J. Peters VA Medical Center

130 West Kingsbridge Road

Bronx NY 10468-3904

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

Statement of Work

Electrophoresis Cost Per Test

1. LANGUAGE

1.1. INTENT: It is the intent of the Department of Veterans Affairs, specifically the following

Upstate New York Medical Center Laboratories: Albany, Buffalo, and Syracuse to establish an Indefinite Delivery, Indefinite Quantity (IDIQ) contract for Electrophoresis testing to perform a cost per test. This requirement is for Electrophoresis testing of

Serum Protein Electrophoresis (SPEP), Urine Protein Electrophoresis (UPEP), Immuno-

Fixation Electrophoresis (IFE) by Gel Electrophoresis, and Cerebal Spinal Fluid (CSF)/

Oligoclonal Bands. This testing is used for diagnosis and treatment of Multiple

Myeloma, Nephrotic Syndrome, Multiple Sclerosis, and Liver Cirrhosis. The

Government shall award one (1) IDIQ to a single Contractor for cost per test

Electrophoresis testing and subcontracting is not authorized. The Contractor agrees to the following terms of the awarded IDIQ exclusively with all three of the Upstate New

York VA Medical Centers Laboratories and is responsible for executing 100% of the awarded IDIQ. Additional tests, reagents, and instrumentation may be added to the awarded IDIQ, by mutual agreement of the Government and the Contractor, as new technology becomes available on the market to include continuing education to each of the three sites regarding new and upcoming tests as they become available.

1.2. ORDERS: The awarded IDIQ contract does not obligate any funds. The Government is obligated only to the extent of authorized orders issued under the Delivery Order and

Purchase Orders by authorized individuals of the Laboratory Medical Centers.

1.3. PRICES AND TERMS: The three Upstate New York VA Medical Centers Laboratories will provide an estimated monthly testing volume for each of the four required tests.

The following are the estimated monthly testing volumes for each Laboratory. Albany:

SPEP 64 tests a month, UPEP 35 tests a month, and IFE 10 tests a month. Buffalo:

SPEP 50 tests a month, UPEP 40 tests a month, and IFE 50 tests a month. Syracuse:

SPEP 125 tests a month, UPEP 30 tests a month, IFE 20 tests a month, and

CSF/Oligoclonal 1 test a month. Pricing is based on cartridge price plus add-on. Add-on is figured by equipment at the facility divided by the average monthly test volume and includes service. This also includes calibrators and controls (where applicable) to be included in the cost per test pricing. Each of the three Laboratories will be responsible for submitting their test counts each month to the awarded Contractor. The Government estimates the volumes listed above but does not guarantee volumes as listed. These monthly testing numbers are best estimates only derived from past patient care.

1.4. TERM OF CONTRACT: This will be a single award, firm-fixed price IDIQ contract for five years. If the Contractor fails to perform in a manner satisfactory to the Contracting

Officer, the awarded contract may be terminated with thirty days written notice to the

Contractor by the Contracting Officer. The contract awarded shall be reviewed annually.

The three Upstate New York VA Medical Centers Laboratories shall establish the first year of the agreement for the period from November 1, 2026 through October 31, 2027

[Tentative].

1.5. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable

Contract Number and the corresponding Purchase Order Numbers for the three VA

Medical Center Laboratories.

1.6. ORDERING METHOD: The three Laboratories may order products via Electronic Data

Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2. DESCRIPTION/SPECIFICATIONS

2.1. SCOPE OF PROCUREMENT:

2.1.1. The desired instrumentation shall have the capability of performing and reporting the clinical parameters as defined in this statement of work. The instrument shall be able to perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the

Clinical and Laboratory Standards Institute (CLSI).

2.1.2. Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing.

2.1.3. The Contractor is required to provide reagents, standards, controls, supplies, disposables, and any other materials 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. The expiration date must be clearly marked on all reagents, standards, and control containers. Unexpected changes in methodology and technology shall be at the expense of the

Contractor. Any delays in shipment as well as any technical advisory recalls and alerts, prior to or simultaneously with field alerts, shall be forwarded to the VA Medical Center Laboratory POCs identified at contract award.

2.1.4. Special Handling for Emergency Orders of Supplies: In the event that 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 twenty-four hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government Laboratory in the most expeditious manner possible at no 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 are required by the Government, they shall be honored by the Contractor until the arrival at the Laboratory of the monthly standing order or routine supplies delivery.

2.1.5. Data Management and Middleware Capabilities: The ability to provide

Middleware that are able to provide services such as but not limited to: interface with laboratory computer system, advanced quality control that can be used to determine method precision and accuracy including Levy Jennings graphs, and storage of patient results with the ability to retransmit and print results in the event of an LIS problem or barcode read error. Each of the three Laboratories requires its own Middleware Server.

2.2. DEFINITIONS:

2.2.1. Cost per Test (CPT) - The Contractor is required to provide a price for each test that can be performed on their equipment. The per test price shall include costs covering the following: (1) Five-year equipment use. (2) All reagents, standards, quality controls, supplies, consumable and disposable items, parts, accessories, and any other items required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result. All products to be shipped FBO Destination. (3) All necessary maintenance to keep the equipment fully operational including emergency repairs. Daily/weekly/monthly Preventive

Maintenance is the responsibility of the Laboratory Technicians. (4) Training for Government personnel. (5) Contractor is required to provide delivery, installation, and removal of their equipment upon contract completion at no additional charge.

2.2.2. Parameter definitions-

2.2.2.1. A fully automated analysis system that is FDA approved and has been on the market for at least one year that can perform electrophoresis testing for SPEP, UPEP, IFE, and CSF/Oligoclonal.

2.2.2.2. Contractor shall supply all instrumentation, reagents, supplies, and consumables to perform approximately 5,100 patient test results per year. Please note that this patient testing amount is the estimated total yearly number for all three Laboratories combined for all four tests.

2.2.2.3. Calibrators traceable to International Federation of Clinical

Chemistry (IFCC). Ability to prioritize STAT testing without compromising existing programmed testing.

2.2.2.4. Minimum sample size shall be no more than 2ml.

2.3. TEST MENU: Refer to the Ordering Information section below for desired test menu and estimated annual volumes.

2.4. GENERAL REQUIREMENTS:

2.4.1 One Analyzer for Each Site – Base equipment offered that shall fully support the scope of operations while meeting all minimal requirements of operation.

2.4.2 Operational Features- The instrumentation offered shall have the following:

2.4.2.1 The capability of performing analysis on 100% of the tests listed in the

Ordering Information section below.

2.4.2.2 Sufficient capacity and throughput to meet the volume and service demands as defined in the Ordering Information section below.

2.4.2.3 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.

2.4.2.4 System must have a bi-directional bar-coded computer interface compatible with Data Innovations. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system for all three Laboratories simultaneously.

2.4.2.4.1 The accuracy of the barcode reading must have less than a 1% failure rate.

2.4.2.4.2 Software with user defined parameters to assist with auto calibration or auto calibration alert multipoint calibration.

2.4.2.4.3 Computer connections and servers used for transferring data between the instrument and the VA’s data server shall be provided by the Contractor and be compatible with the VA’s data servers’ existing data ports.

2.4.2.4.4 Windows 10 compatibility and hardware and software

functionality for direct network connectivity.

2.4.2.4.5 The ability to interface with the Vista System through

Data Innovations bidirectionally.

2.4.2.4.6 Contractor is responsible for any licensing or hardware used to connect to Data Innovations and the Network.

2.4.2.4.7 Any connections from the analyzer back to the Contractor shall follow the Department of Veterans Affairs guidelines and has to be FIPS 140-2 and CRISP compliant.

2.4.2.5 Daily maintenance shall require no more than ten minutes to complete.

2.4.2.6 Technician intervention not required once samples have been loaded into the analyzer and the results have been printed.

2.4.2.7 Ability to store and retransmit records for twenty-four hours of maximal instrument throughput in case of interface outage.

2.4.2.8 Reagent stability sufficient to accommodate both high and low volume use.

The Contractor shall provide expiration dates of at least one year for reagents. New lots of reagents and controls shall be supplied one month in advance to allow for complete cross-over studies.

2.4.3 Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following Technical Features:

2.4.3.1 Muti-parameter automated agarose gel electrophoresis instrument for

SPEP, UPEP, IFE, and CSF/Oligoclonal testing.

2.4.3. Sequenced sample application, migration, incubation, staining, destaining, and drying.

2.4.3.3 High voltage protein separation and direct protein detection of the following five protein zones: Albumin, Alpha-1, Alpha-2, Beta, and Gamma.

2.4.3.4 Scanner required for the identification of protein fractions.

2.4.3.5 Independent and separate self-contained assay kits.

2.4.3.6 Software compatible with instrumentation to provide complete patient demographic, curve editing, modification of the baseline, fraction identification, and curve overlay.

2.4.3.7 Software to provide a comprehensive patient report with electrophoretic curve, immunofixation pattern, and quantitative specific protein results.

2.4.3.8 Software program to allow for viewing of previous patient results to compare with current testing.

2.4.3.9 A comprehensive quality control program with two levels of quality control to include Levy-Jennings charts.

2.4.4 Hardware Features- The instrumentation shall have the following

Hardware Features:

2.4.4.1 A total equipment footprint that when installed in the laboratories shall not impact the functionality and/or operations of each Laboratory.

2.4.4.2 Contractor shall supply a printer, replacement printers if required, and toner cartridges when required, as part of their cost per test pricing.

2.4.4.3 Equipment must be able to support multiple barcode formats with a minimum of ten characters in the specimen identifier.

2.4.4.4 Ability to store and retransmit records in case of interface outage.

2.4.4.5 The flexibility to set multiple units of measurement.

2.4.6 Method Performance and Validation Requirements

Method performance and comparison will be at the expense of the

Contractor and shall include the following: all reagents, consumables and replacement parts, assayed quality control material, calibration material, and linearity material every six months. Linearity material and reagents, and results shall be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards, and

Federal Regulations.

2.4.6.1 The Contractor shall perform method validation to include correlation study, crossover studies, sensitivity, linearity, reproducibility, and any additional test workup required to demonstrate satisfactory instrument performance consistent with

CLSI Standards.

2.4.6.2 Carryover Studies. Successful carryover studies, demonstrating absence of any clinically significant carryover, shall be completed by the Contractor on the analyzers during installation. These studies shall be performed using either

Contractor developed programs or programs developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

2.4.7 Support Features-

2.4.7.1 Commercial marketing. The equipment models being offered shall be in current production as of the date the Contractor’s offer is submitted. For purposes of this Statement of Work, “current production” shall mean that the chemistry laboratory analyzer model being offered is new equipment.

Discontinued models that are only being made available as remanufactured equipment are not acceptable. The Contractor shall perform to the satisfaction of the Government, as determined by the Laboratory Medical

Director at each of the three sites, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity

(reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity as part of the cost per test pricing. The Contractor shall perform all statistical analysis as stated in the

Method Performance and Validation section above and report data in an organized and clearly comprehensible format to the satisfaction of the

Laboratory Medical Director at each of the three sites.

2.4.7.2 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable and disposable items, parts, accessories, and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform to the satisfaction of the

Government, as determined by each of the three Laboratory Medical

Directors all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity as part of the cost per test pricing. The Contractor shall perform all of the statistical analysis as stated in the Method Performance and Validation section above and report data in an organized and clearly comprehensible format to the satisfaction of each of the three Laboratory

Medical Directors.

2.4.7.3 Training. The Contractor shall provide an instrument training program, as well as onsite training, that is coordinated with and timely to the equipment installation, sufficient to the size and scope of each of the three Sites services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the

Contractor shall provide training for minimally two operators per Laboratory per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the three Laboratories and the Contractor. A training program that involves off site travel shall include the cost of airfare and room and board for each participant.

2.4.7.4 Equipment Preventative Maintenance and Repair Service. The Contractor shall provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation according to the following terms:

2.4.7.4.1 Service Requirements

2.4.7.4.1.1 Technical support by telephone is available 24 hours a day, 7 days a week. Onsite service Monday through Friday from 8:00 AM to 5:00 PM with emergency service provided within 24 hours.

2.4.7.4.1.2 A current contractor Service Agreement Plan will

replace equipment and or any incremental networking or support equipment within one business day of complaint being received.

2.4.7.5 Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software, excluding analyzers and related accessories, to maintain the integrity of the system and the state-of-the-art technology as part of their cost per test price. These upgrades shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new versions of software, correction of hardware defects, upgrades offered to commercial customers at no additional charge, upgrades to replace a model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the awarded contract; however, it does refer to significant changes in the hardware operational capability.

2.4.7.6 Ancillary Support Equipment - The Contractor shall provide, install, and maintain through the life of the awarded contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, cabinetry to support and house the analyzers, if necessary, water systems (including consumable polishers, filters, etc.), and universal interface equipment. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment they are proposing to include starter kits, tables and stands, etc. If a table(s) is included, it should be of sufficient size so that all Contractor equipment is able to be placed on the table.

2.4.7.7 Commercial Offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, to include a Computer Disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

2.4.7.8 Characterization of Waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the

Environment” Part 261 et seq. and applicable state and local requirements.

Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational

Safety and Health Administration (OSHA) and Environmental Protection

Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results.

Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal

Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

2.4.7.8.1 The determination and description shall address the following:

2.4.7.8.1.1 Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

2.4.7.8.1.2 Waste ignitability (Reference 40 CFR §261.21)

2.4.7.8.1.3 Waste corrosivity (Reference 40 CFR §261.22)

2.4.7.8.1.4 Waste reactivity (Reference 40 CFR §261.23)

2.4.7.8.1.5 Hazardous waste from non-specific sources (F-listed) (Reference

40 CFR §261.31)

2.4.7.8.1.6 Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

2.4.7.8.1.7 Solid Waste (Reference 40 CFR §261.2)

2.4.7.8.1.8 Exclusions (Reference 40 CFR §261.4)

2.4.7.8.2 The Contractor will provide written instructions and training material to ensure all required VHA Laboratory Staffs are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.4.7.8.3 The Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum, the characteristics of ignitability, corrosiveness, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations.

All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

2.4.7.8.3.1 Barium (Total)

2.4.7.8.3.2 Cadmium (Total)

2.4.7.8.3.3 Chromium (Total)

2.4.7.8.3.4 Copper (Total)

2.4.7.8.3.5 Cyanide (Total)

2.4.7.8.3.6 Lead (Total)

2.4.7.8.3.7 Mercury (Total)

2.4.7.8.3.8 Nickel (Total)

2.4.7.8.3.9 Silver (Total)

2.4.7.8.3.10 Zinc (Total)

2.4.7.8.3.11 Arsenic (Total)

2.4.7.8.3.12 Selenium (Total)

2.4.7.8.3.13 Tin (Total)

2.4.7.8.3.14 pH

2.4.7.8.3.15 Flash point (to higher than 200F)

2.4.7.8.3.16 BOD; biochemical oxygen demand

2.4.7.8.4 The documentation the Contractor provides will be used to work with the VA Medical Centers to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

2.4.7.8.5 The systems shall be totally self-contained excluding waste and shall not require external water, pressure, or vacuum. The Contractor shall provide a waste stream analysis for each proposed instrument and if any waste requires special handling before disposal.

2.4.7.9 Implementation And Transition Timeframe - The implementation of the requirements described in this Statement of Work shall be completed no later than ninety days after the contract award date. This ninety-day timeline is based on a reasonable attempt of the Contractor to complete all necessary implementation requirements within the stated ninety-day timeframe. The Contractor shall not be penalized for implementation timelines that extend beyond the ninety-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.4.7.9.1 Upon award of the contract, the transition period for the Contractor to have all equipment and peripherals installed and operational shall be from the date of award through ninety days. During this ninety-day time all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. Training will include two operators per instrument at the Contractor’s location for all of the Laboratories shifts. Further, training shall include provisions for additional training at the Contractor’s location or at the respective Laboratory Facility as agreed upon by the Contractor and the respective Laboratory facility. During this ninety-day time all initial validations shall be completed to the satisfaction of each of the three Laboratory Directors.

2.4.7.9.2 The Contractor shall provide with their proposal an implementation plan for installation of their new equipment. The Contractor’s submitted plan shall not exceed ninety days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., and performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate the awarded contract.

2.4.7.9.3 At the end of ninety days from the award of the contract, the

Contractor shall have full and sole responsibility for services under the awarded contract.

2.4.8 Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the awarded contract is accepted by the Government. This also includes replacements, substitute machines, and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of thirty consecutive calendar days by operating in conformance with the Contractor’s technical specification or as specified in the awarded contract at an effectiveness level of

90% or more.

2.4.8.1 If the equipment does not meet the standard of performance during the initial thirty consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of thirty consecutive days.

2.4.8.2 If the equipment fails to meet the standard of performance after ninety calendar days from the installation date, the Government at its discretion may request a replacement or decide to terminate the awarded contract. The

Contractor shall receive payment for tests reported during the ninety-day acceptance period.

2.4.8.3 Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the

Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

2.4.8.4 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

2.4.8.5 The Government shall maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the

Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

2.4.8.6 During the term of the awarded contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the facility POC to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with the manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for the equipment.

2.4.9 Government’s Responsibility- The Laboratory Technicians shall perform routine preventive maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The Laboratory Technicians shall maintain written records to satisfy the required maintenance requirements.

2.4.10 Ownership of Equipment- Title to the equipment shall remain with the

Contractor. All accessories (unused consumables, etc.) furnished by the

Contractor shall accompany the equipment when it is returned to the Contractor.

The Contractor upon expiration of the awarded contract shall remove their equipment at no additional charge to the Government. The Contractor shall disconnect the analyzers (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzers from each of the three

Laboratories.

2.4.11 The Contractor will identify if removable media is required to perform their duties.

The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device and system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from each of the three Laboratories.

2.4.12 Prior to termination or completion of the awarded contract, the Contractor must not destroy information received from the VA, or gathered and created by the

Contractor while performing the awarded contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor 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 thirty days of termination or completion of the awarded contract.

2.4.13 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the awarded contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the

Contractors/subcontractors that contain VA information must be returned to the

VA for sanitization or destruction, or the Contractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within thirty (30) days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier.

2.4.14 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

2.4.14.1 Contractor must accept the system without the drive.

2.4.14.2 The VA’s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in.

2.4.14.3 The VA must reimburse the company for media at a reasonable open market replacement cost at the time of purchase.

2.4.15 Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment and systems, if it is not possible for the respective VA Medical Centers to retain the hard drive then;

2.4.15.1 The equipment Contractor must have an existing Business Associate

Agreement (BAA) if the device being traded in has protected health information stored on it and hard drives from the system are being returned physically intact; and

2.4.15.2 Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation.

Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies, methods, and tools.

Applicable media sanitization specifications need to be pre-approved and described in the awarded contract.

2.4.15.3 A statement signed by the Director (System Owner), that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

Baseline Configurations

Microsoft Windows Server

The following versions are approved, with baseline compliance, for enterprise use:

- Windows Server 2019

- Windows Server 2022

Microsoft Windows OS Desktop and Laptop

- Windows 10

Microsoft Windows Medical Device Protection Program (MDPP)

- Windows 10 Pro

- Windows 10 LTSB

- Windows 10 LTSC

Macintosh Mac OS Workstation and Laptop

- Mac OS 12.7.X Monterey

- Mac OS 13.6.X Ventura

- Mac OS 14.6 Sonoma

Linux

- Red Hat Enterprise Linux 8

- Red Hat Enterprise Linux 9

Database Platforms SQL

- SQL Server 2019

- SQL Server 2022

Oracle

- Oracle 12c

- Oracle 19c

- Oracle 21c

Server Virtualization (Virtual Machines)

With full virtualization the hypervisor is installed directly onto server hardware. Full virtualization has no underlying Operating System (OS). In Host-based virtualization the hypervisor is installed on the host OS. Moving forward, host-based virtualization is not authorized in VA.

The Visibility to Servers (V2S) Application Suite is not to be installed on virtual server hosts; however, Visibility to Everything (V2E) requires a Simple Network Management Protocol (SNMP) configuration be in place on server hosts. VA does require guest Virtual Machines (VM’s) have the V2S Application Suite installed:

- MacAfee Virus Scan Enterprise

- McAfee Host Intrusion Prevention (HIPS)

- McAfee ePolicy Agent

- System Center Configuration Manager Client (SCCM)

- BigFix

- SNMP

- ENCASE

The attached 6550 form and the attached Manufacturer Disclosure Statement (MDS) for Medical Device Security form must be completely filled out and submitted with your proposal.

Ordering Information

Individual Orders – Delivery Orders and Purchase Orders will be issued by a Contracting Officer. No other methodology for ordering is acceptable. Only warranted Contracting Officers have the authority to issue Delivery Orders and Purchase Orders.

Delivery – Delivery is required within ten days after receipt of Order for all Delivery Orders and Purchase Orders issued against the awarded IDIQ. All deliveries shall be made to the following addresses:

Albany VA Medical Center

Attention: Pathology & Laboratory Medicine

113 Holland Avenue

Albany, NY 12208

Buffalo VA Medical Center

3495 Bailey Avenue

Buffalo, NY 14215

Syracuse VA Medical Center

800 Irving Avenue

Syracuse, NY 13210

Shipping – All Delivery Orders placed against the awarded IDIQ are to be shipped FOB Destination.

Invoices - The obligation of funds will occur at the Delivery Order level. Each Delivery Order will have a corresponding Purchase Order. To receive payment, the Contractor must invoice against the Purchase Order associated with the corresponding Delivery Order. Invoices must be submitted electronically through the Tungsten Network against the correct Purchase Order Number.

The Guaranteed Minimum amount is $10,000.00 This amount will be obligated at the time the first Delivery Order is issued.

For unit pricing purposes only, the Contractor’s quote shall consider the following annual need estimate of 5,100 tests each year. This annual testing estimate is for all three Laboratories combined.

Note: This is an annual estimate of the three required tests for all three Laboratories combined.

These are not required minimum purchases. The Government is not obligated to purchase any specific quantity of any specific item under the awarded IDIQ.

All interested Offerors shall provide pricing for the individual tests below as well as cumulative total pricing for each year of the contract. Offerors Cost per Test pricing is to be inclusive of all necessary and appropriate labor, materials, equipment, consumables, reagents, and supplies to provide Electrophoresis Cost Per Test pricing in accordance with the terms, conditions, specifications, and requirements listed in the SOW.

Tests to be performed: Serum Protein Electrophoresis, Urine protein Electrophoresis, Immunofixation, CSF/Oligoclonal

VA SITE # of SPEP’s/month

# of UPEP’s/month

# of IFE’s/month

# of CSF’s/month

TOTAL #

of

TESTS

ALBANY VA

64 (768/year) 35 (420/year) 10 (120/year)

0 1,308

BUFFALO VA

50 (600/year) 40 (480/year) 50 (600/year)

0 1,680

SYRACUSE

VA

(1,500/year)

30 (360/year) 20 (240/year)

1 (12/year) 2,112

TOTAL

TESTS/YEAR

2,868 1,260 960 12

5,100

Year 1: November 1, 2026 – October 31, 2027 [Tentative dates]

CLIN Item # Item Description Unit Price per Test 0001 SPEP Testing - Albany Job 0002 SPEP Testing - Buffalo Job 0003 SPEP Testing - Syracuse Job 0004 UPEP Testing - Albany Job 0005 UPEP Testing - Buffalo Job 0006 UPEP Testing - Syracuse Job 0007 IFE Testing - Albany Job 0008 IFE Testing - Buffalo Job 0009 IFE Testing - Syracuse Job 0010 CSF/Oligoclonal Testing -

Syracuse Job

Total Cumulative Price for Year 1:

Year 2: November 1, 2027 – October 31, 2028 [Tentative dates]

1001 SPEP Testing - Albany Job 1002 SPEP Testing - Buffalo Job 1003 SPEP Testing - Syracuse Job 1004 UPEP Testing - Albany Job 1005 UPEP Testing - Buffalo Job 1006 UPEP Testing - Syracuse Job 1007 IFE Testing - Albany Job 1008 IFE Testing - Buffalo Job

1009 IFE Testing - Syracuse Job 1010 CSF/Oligoclonal Testing -

Total Cumulative Price for Year 2:

Year 3: November 1, 2028 – October 31, 2029 [Tentative dates]

2001 SPEP Testing - Albany Job 2002 SPEP Testing - Buffalo Job 2003 SPEP Testing - Syracuse Job 2004 UPEP Testing - Albany Job 2005 UPEP Testing - Buffalo Job 2006 UPEP Testing - Syracuse Job 2007 IFE Testing - Albany Job 2008 IFE Testing - Buffalo Job 2009 IFE Testing - Syracuse Job 2010 CSF/Oligoclonal Testing -

Total Cumulative Price for Year 3:

Year 4: November 1, 2029 – October 31, 2030 [Tentative dates]

3001 SPEP Testing - Albany Job 3002 SPEP Testing - Buffalo Job 3003 SPEP Testing - Syracuse Job 3004 UPEP Testing - Albany Job 3005 UPEP Testing - Buffalo Job 3006 UPEP Testing - Syracuse Job 3007 IFE Testing - Albany Job 3008 IFE Testing - Buffalo Job 3009 IFE Testing - Syracuse Job 3010 CSF/Oligoclonal Testing -

Total Cumulative Price for Year 4:

Year 5: November 1, 2030 – October 31, 2031 [Tentative dates]

4001 SPEP Testing - Albany Job 4002 SPEP Testing - Buffalo Job 4003 SPEP Testing - Syracuse Job 4004 UPEP Testing - Albany Job 4005 UPEP Testing - Buffalo Job 4006 UPEP Testing - Syracuse Job 4007 IFE Testing - Albany Job 4008 IFE Testing - Buffalo Job 4009 IFE Testing - Syracuse Job 4010 CSF/Oligoclonal Testing -

Total Cumulative Price for Year 5:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

768.00 EA ________________

SPEP Testing - Albany Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

NATIONAL STOCK NUMBER: N/A

LOCAL STOCK NUMBER: N/A

600.00 EA ________________

SPEP Testing - Buffalo Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory

Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

1,500.00 EA ________________

SPEP Testing - Syracuse Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

420.00 EA ________________

UPEP Testing - Albany Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

480.00 EA ________________

UPEP Testing - Buffalo Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

360.00 EA ________________

UPEP Testing - Syracuse Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

120.00 EA ________________

IFE Testing - Albany Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

IFE Testing - Buffalo Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

240.00 EA ________________

IFE Testing - Syracuse

Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

12.00 EA ________________

CSF/Oligoclonal Testing - Syracuse Cost per test to include equipment, consumables, service and maintenance.

Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

MANUFACTURER PART NUMBER (MPN): N/A

SPEP…