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

TBD

36C25526Q0653 09-15-2026

Espinosa, Maria/maria.espinosa@va.gov maria.espinosa@va.gov 09-22-2026 10:00am CDT

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

X 100

X

334516

1,000 employees

NET 30 Days

N/A

Department of Veterans Affairs John J. Cochran Veterans Hospital 915 N. Grand Boulevard

St. Louis MO 63106

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15

36C255

Financial Services Center http://www.fsc.va.gov/einvoice.asp

Austin TX

877-353-9791 512-460-5429

See CONTINUATION Page

This solicitation is for ID/AST Instrumentation for rapid analysis of positive blood cultures. FDA approved in accordance to the SOW.

This will be a BPA for a 5 year period of performance.

The issue date is 9/15/2026 and closes 9/22/2026 at 02:00pm Central Standard Time (CST).

1. This solicitation is a small business set-aside .

2. There is a class waiver for NAICS 334516.

3. Contractor must provide FDA approval for equipment.

4. Contractor must provide an authorized distributor letter from the Original Equipment Manufacturer (OEM).

5. The deadline for questions is 9/17/2026 at 2:00pm CST.

6. Evaluation Criteria: Technical Capability, Past performance and Price.

Point of contact for this request for quotes is:

Maria Espinosa at (913)946-1967 or maria.espinosa@va.gov

See CONTINUATION Page

X x

X 1

Maria Espinosa Contracting Officer

36C25526Q0653

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 FAR DEVIATION FEB 2025 Instructions

ITEM INFORMATION

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 STATEMENT OF WORK

1. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1. SCOPE OF PROCUREMENT:

B.4 DELIVERY SCHEDULE

B.5 TERMS AND CONDITIONS

B.6 ADMINISTRATIVE DATA

B.7 PRICING

B.8 GENERAL SUPPLY ORDERS

B.9 AUTHORIZED LIMITS

B.10 OBLIGATION OF FUNDS

B.11 PERIOD OF PERFORMANCE

B.12 AUTHORIZED INDIVIDUALS

B.13 ORDER FORMAT

B.14 AUTHORIZED REPRESENTATIVES

B.15 FEDERAL HOLIDAYS

B.16 MANAGEMENT CONTROL

B.17 INVOICES

B.18 PRECEDENCE

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

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

C.3 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.4 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

(DEVIATION APR 2026)

C.5 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.219-1 SMALL BUSINESS PROGRAM REPRESENTATIONS (NOV 2025)

(DEVIATION)

E.2 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED

BY REFERENCE (JAN 2008)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (OCT 2025) (DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 FAR DEVIATION FEB 2025 Instructions

ITEM INFORMATION

When issuing new solicitations, include the following notice:

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

https://department.va.gov/acquisition-and-logistics/wp-content/uploads/sites/58/2026/03/deviationFar20200320.pdf https://department.va.gov/acquisition-and-logistics/wp-content/uploads/sites/58/2026/03/deviationFar20200320.pdf https://department.va.gov/acquisition-and-logistics/wp-content/uploads/sites/58/2026/03/deviationFar20200320.pdf

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Ordering Period 1: 09/28/2026 – 09/27/2027

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 EA __________________ __________________

Instrument: Includes instrument, instrument control software, firmware, application software, installation and 12-month warranty.

15.00 KT __________________ __________________

Consumable kit (20 units): Contains sample preparation Cartridge and AST

Disc.

Frozen insert (20 units):Contains frozen reagents for sample preparation (to be inserted in sample preparation cartridge before use).

1.00 YR __________________ __________________

Instrument Service (Annual):Extended service available after the initial 12-month warranty expires.

Ordering Period 1 Total:___________________

Ordering Period 2: 09/28/2027 – 09/27/2028

Ordering Period 2 Total:___________________

Ordering Period 3: 09/28/2028 – 09/27/2029

Ordering Period 3 Total:___________________

Ordering Period 4: 09/28/2029 – 09/27/2030

Ordering Period 4 Total:__________________

Ordering Period 4: 09/28/2030 – 09/27/2031

Ordering Period 5 Total:__________________

GRAND TOTAL: __________________

B.3 STATEMENT OF WORK

STATEMENT OF REQUIREMENTS

ST LOUIS VAMC

CPRR BPA OF RAPID ID/AST SYSTEM

1. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

1.1. INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the VA St. Louis Medical Center, 915 N. Grand Boulevard, St. Louis, Missouri, 63106, to establish a Firm Fixed-price estimated requirements contract for supplies needed for microbiology bacteriology testing. The Blanket Purchase Agreement (BPA) shall be under the FSS Contract, Federal Supply Class (FSC) Group 65 Part VII, In Vitro Diagnostic Substances, Reagents, Test Kits, and Test Sets. The Government will award a Firm-Fixed-Price estimated requirement contract to a single Contractor for Instrumentation that can perform rapid organism identification (ID) and susceptibility (AST) directly from an aliquot from a positive blood culture without additional hands-on preparation besides the transfer of sample into a single sample vial.

The Government will award a CPRR to a single Contractor for ID/AST Instrumentation for rapid analysis of positive blood cultures. Contractor agrees to the following terms of the BPA with the VA ST. LOUIS facilities listed by Attachment A herein and awarded in the final BPA.

However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market.

1.2. ORDERS: This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.

1.3. PRICES AND TERMS: VA Medical Center will provide an estimated volume by test (see 2.4.2.6). Pricing is based on the AVERAGE test volume per instrument/analyzer. The Government estimates the volumes per facility but does not guarantee volumes as listed; they are estimates ONLY.

1.4. TERM OF AGREEMENT: This will be a single award, firm-fixed price five (5)-years BPA. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN intends to establish the base year of the agreement for the period of 8/1/2026 through 7/31/2027.

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

BPA identification numbers are assigned through the VHA Procurement Activity.

1.6. ORDERING METHOD: The participating facilities 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/STATEMENT OF WORK

2.1. SCOPE OF PROCUREMENT:

2.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously 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 by each laboratory.

2.1.3. If Contractor offers a family of analyzers, the technical evaluation panel will determine if the instrumentation proposed meets the needs of the facility.

2.1.4. Equipment shall be acquired for each of the clinical laboratories listed in Attachment A.

2.1.5. The Contractor is required to provide a continuously stocked inventory of 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. 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.

2.1.6. Special handling for emergency orders of supplies: In the event that 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 are 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.

2.2. DEFINITIONS:

2.2.1. Cost per Patient Reportable Result (CPRR)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5 year equipment use, (2) all reagents, standards, quality controls, 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 of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (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 shall provide delivery, installation and removal of equipment at no additional charge.

2.2.2. 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 are required of VHA under the Privacy Rule.

2.2.3. MOU - The VA utilizes a Memorandum of Understanding (MOU) to document the terms and conditions for sharing data and information resources in a secure manner. The following supporting information within the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations, and define the terms of the agreement. Additionally, the MOU provides details pertaining to apportionment of cost and timeline for terminating or reauthorizing the interconnection.

2.2.4. ISA -Technical details on how the interconnection is established or maintained are included within the Interconnection Security Agreement (ISA). A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems; to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections.

2.3. TEST MENU: Refer to 2.4.2.6 for desired products and estimated annual volumes.

2.4. GENERAL REQUIREMENTS:

2.4.1. Operational Features- The instrumentation offered shall have the following:

2.4.1.1. The capability of performing rapid antimicrobial susceptibility analysis as listed in section 2.4 Technical Features.

2.4.1.2. Sufficient capacity and throughput to meet the volume and service demands as defined in 2.4.2.6

2.4.1.3. 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.

2.4.1.4. Minimal daily, monthly, and periodic maintenance.

2.4.1.5. Primary analyzer with an operational continuity plan to avoid significant processing delays in case of downtime.

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

2.4.2.1 The capability of accurately and reliably providing susceptibility results directly from an aliquot of a positive blood culture sample with no offline sample processing that is performed by a technologist or additional instrumentation.

2.4.2.2 The capability to provide antimicrobial susceptibility results in under eight (8) hours after positivity of blood culture has been determined.

2.4.2.3 The ability to use a single kit for each blood culture sample for AST analysis.

2.4.2.4 The ability to perform antimicrobial susceptibility results and obtain minimal inhibitory concentration levels (MIC) results with breakpoint interpretive criteria.

2.4.2.5 The capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. At a minimum, the equipment must provide Minimum Inhibitory Concentrations (MIC) values for at least one antibiotic in each major class of antibiotics for the following antibiotic-bolded organism combinations as suggested for primary testing of Non-fastidious organisms by CLSI in Table 1A of M100-ED36.

2.4.2.6 The capability to provide FDA cleared Minimum Inhibitory Concentrations (MIC) values for antibiotics for non- bolded organisms as suggested for primary testing of Non-fastidious organisms by CLSI in Table 1A of M100-ED36 is a value added feature of the instrument.

Drug Class Antibiotic Enterobacteriales P.

aeruginosa

Acinetobacter spp. S. maltophilia

Other non- Enterobacte rales

Aminoglycosides

Amikacin X X

Gentamicin X X X

Tobramycin X X X X β-lactams

Amoxicillin-clavulanate X

Ampicillin-sulbactam X X

Piperacillin-tazobactam X X X X

Carbapenems

Ertapenem X

Imipenem X X X X

Meropenem X X X X

Cephalosporins

Cefazolin X

Cefepime X X X X

Cefotetan X

Cefoxitin X

Ceftazidime X X X

Ceftriaxone X

Cefuroxime X

Fluoroquinolones

Ciprofloxacin X X X X

Levofloxacin X X X X

Moxifloxacin X

Folate Pathway Inhibitors

Trimethoprim-sulfamethoxazole X X X X

Monobactams Aztreonam

Pencillins Ampicillin X

Tetracyclines Minocycline X X X

Tetracycline X

Drug Class Antibiotic Staph.

spp.

Enterococcus spp.

S.

pneumoniae

Strep spp.

(β gp)

Strep spp.

(Viridans gp)

Carbapenems Meropenem X

Cephalosporins

Cefotaxime X X

Cefoxitin X

Ceftriaxone X X

Fluoroquinolones Levofloxacin X

Moxifloxacin

Folate Pathway Inhibitors

Trimethoprim-sulfamethoxazole X X

Glycopeptides Vancomycin X X X X

Lincosamides Clindamycin X X X

Lipopeptides Daptomycin X X

Macrolides Erythromycin X X X

Oxazolidinones Linezolid X X

Pencillins

Ampicillin X X X

Penicillin X X X X X

Oxacillin X

Tetracyclines

Doxycycline X X

Minocycline X

Tetracycline X X X

2.4.2.7 Contractor shall provide, when commercially available, software or equipment modifications as needed to comply with changes in standards for identification or susceptibility testing established by CLSI, FDA and/or Center for Disease Control (CDC). Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades.

2.4.2.8 The system shall have a built-in quality control program to regularly monitor system performance.

2.4.2.9 The capability of accurately and reliably identifying organisms, Gram-negative and Gram-positive, is a value-added feature to providing susceptibility results.

2.5 Hardware Features- The instrumentation shall have the following:

2.5.1 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory and should be capable of being placed on a benchtop.

2.5.2 An uninterruptible power supply for each instrument provided, as necessary, including replacement of batteries.

2.5.3 An adjustable monitor/screen that is easily readable.

2.5.4 A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

2.6 Method performance/comparison: Shall be at the expense of the Contractor, shall include control material and reference organisms and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) Standards and federal regulations, for the following:

2.6.1 Correlation studies for each analyte. A minimum of 20 samples, containing organisms which span the MIC reportable range(s) for each antibiotic as available, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

2.6.2 Precision study using normal (susceptible) and abnormal (resistant) control/reference organisms. This shall consist of a “within” run precision study of at least 1 sample run in duplicate and a day-to-day precision study using the same sample(s) processed in duplicate by another technologist.

2.6.3 Sensitivity and Specificity. Sensitivity and specificity may be validated concurrently using data from the correlation and precision studies.

2.6.4 Testing will not be implemented at the individual facilities for the selected system if the validation fails statistical studies as determined by the facility Pathology & Laboratory Service Chief.

2.7 Reference Range - The reference range for the susceptibility interpretation of each antibiotic must follow CLSI and/or FDA published guidelines. Any antibiotics that do not have established ranges or interpretations must be validated by each laboratory prior to routine use and reporting.

2.8 Reports - The Contractor shall provide to the Contracting Officer’s and the Contracting Officer Representative (COR) at the Medical Centers a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales, amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective Laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge shall not be accepted. There will be no additional charges for any reports required as part of the BPA.

2.9 Support Features

2.9.1. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment.

Discontinued models that are only being made available as remanufactured equipment are not acceptable.

2.9.2. Start-Up Reagents. The Contractor shall provide all reagents, organisms, calibrators, controls, consumable/disposable items, parts, accessories and other items required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with all validation studies including: precision, method comparison with current analyzer, verification of reference interval, and determination of sensitivity and specificity. All materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

2.9.3. 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 contractor shall provide training that includes: operation of the system, data manipulation, and basic troubleshooting and repair. Thereafter, the Contractor shall provide training each year as needed for additional operators or updates to the equipment, at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

2.9.4. Equipment Preventive Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:

2.9.4.1. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum callback response time of 2 hours.

2.9.4.2. Equipment repair service shall be provided during core business hours, Monday through Friday, 8am to 5pm. 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.

2.9.4.3. Equipment response time shall be no more than 24 hours.

2.9.4.4. A minimum of 1 scheduled preventative maintenance call per year.

2.9.4.5. 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:

2.9.4.5.1. Date and time notified

2.9.4.5.2. Date and time of arrival

2.9.4.5.3. Serial number, type and model number of equipment

2.9.4.5.4. Time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

2.9.5. 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. 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.

2.9.6. Ancillary support equipment - The Contractor shall provide, install and maintain, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary) and universal 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.

2.9.6.1. The Contractor shall be responsible for providing all hardware required for the connection, implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below).

2.9.6.2. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in the chart below.

2.9.6.3. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

2.9.7. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g. computer disk containing their procedure manual or an on-line procedure manual in the instrument software.

2.9.8. 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.

2.9.9. The determination and description shall address the following:

2.9.9.1. Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

2.9.9.2. Waste ignitability (Reference 40CFR261.21)

2.9.9.3. Waste corrosivity (Reference 40CFR261.22)

2.9.9.4. Waste reactivity (Reference 40CFR261.23)

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

40CFR261.31)

2.9.9.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33)

2.9.9.7. Solid Waste (Reference 40 CFR261.2)

2.9.9.8. Exclusions (Reference 40 CFR261.4)

2.9.10. The Contractor will provide written instructions and training material to ensure VHA Laboratory staff 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.

2.9.11. 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, corrosivity, 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 Contractor response:

2.9.11.1. Barium (Total)

2.9.11.2. Cadmium (Total)

2.9.11.3. Chromium (Total)

2.9.11.4. Copper (Total)

2.9.11.5. Cyanide (Total)

2.9.11.6. Lead (Total)

2.9.11.7. Mercury (Total)

2.9.11.8. Nickel (Total)

2.9.11.9. Silver (Total)

2.9.11.10. Zinc (Total)

2.9.11.11. Arsenic (Total)

2.9.11.12. Selenium (Total)

2.9.11.13. Tin (Total)

2.9.11.14. pH (Total)

2.9.11.15. Flash Point (to higher than 200°F)

2.9.11.16. BOD; biochemical oxygen demand

2.9.12. The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

2.9.13. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe.

Contractors shall not be penalized for implementation timelines that extend beyond the 60 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.9.13.1. Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

2.9.13.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 60 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to confirm to the transition period shall be considered as sufficient to terminate BPA for cause under the Termination for Cause clause of the BPA.

2.9.13.3. At the end of 60 days from award of the BPA, the awarded contractor shall have full and sole responsibility for services under the awarded BPA.

2.10. Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the government. This also includes replacement, 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 30 consecutive calendar days by operating in conformance with the contractor’s technical specification or as quoted in any BPA at an effectiveness level of 90% or more.

2.10.1. In the event that equipment does not meet the standard of performance during the initial 30 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 30 consecutive days.

2.10.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled “Termination for cause.” (The contractor shall receive revenue for tests reported during the 90-day acceptance period.)

2.10.3. 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 of time 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.

2.10.4. 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.

2.10.5. The government will maintain daily records to satisfy the requirements of this paragraph 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.

2.10.6. During the term of the BPA, 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 COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with 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 equipment.

2.11. Government’s Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

2.12. 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 returned to the contractor. The contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

2.13. The vendor/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/system. Any vendor/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 the facility.

2.14. Prior to termination or completion of this BPA, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this BPA 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 or completion of the BPA.

2.15. 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 BPA 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/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the BPA or disposal or return of the IT equipment, whichever is earlier.

2.16. 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 vendor at the end of lease, for trade-in, or other purposes. The options are:

2.16.1. Vendor must accept the system without the drive;

2.16.2. VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

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

2.17.1. The equipment vendor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2.17.2. 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/metfhods/tools.

2.17.3. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or BPA.

2.17.4. A statement needs to be 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 ISO needs to maintain the documentation.

Attachment A – PARTICIPATING MEDICAL CENTERS

Participating Medical Centers: The following medical centers shall be authorized to place delivery orders against the BPA.

1. St. Louis VA Health Care System:

a. Hours of Operation for Microbiology: 24X7

b. Contact Name: Cari Orth (cari.orth@va.gov)

c. Phone Number: 314-652-4100 ext. 53140

d. Address:

VA Medical Center, 915 North Grand Blvd, St. Louis, Missouri 63106

Note:

Vendors are advised that VA reorganization may necessitate adding additional locations to this contract in the future. Any such additions will be completed by bilateral modification.

B.4 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001-

St. Louis VAMC 915 N. Grand Boulevard St. Louis, MO 63106

ALL See Line Items

1001-

St. Louis, MO 63106

ALL See Line Items

2001-

St. Louis, MO 63106

ALL See Line Items

3001-

St. Louis, MO 63106

ALL See Line Items

4001-

St. Louis, MO 63106

ALL See Line Items

B.5 TERMS AND CONDITIONS

The Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs:

B.6 ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Primary Point of Contact: Maria Espinosa

Contracting Officer: Maria Espinosa maria.espiosa@va.gov

913-946-1967

Cognizant Office (Include complete address):

Network Contracting Office (NCO) 15

B.7 PRICING

Contract Supplies as listed below, with associated pricing, can be ordered under this BPA.

The Contractor shall be allowed to vary within the categories for successful and efficient task completion not to exceed funded values of each order awarded under this agreement. As proposed, the Contractor will apply applicable extended/tier pricing to all categories used in the performance of orders issued under this Agreement. Orders may be awarded on a basis only.

All Calls/Orders placed against this BPA are subject to the terms and conditions of the referenced BPA, the Contractor's proposal and this Agreement, except where noted below.

Contractor's proposal dated TBD is hereby referenced.

B.8 GENERAL SUPPLY ORDERS

A properly appointed Department of Veterans Affairs Contracting Officer will request a quote from the Contractor based upon the requirements of the individual calls/orders, usually in the form of a Statement of Work (SOW). The information provided to the Contractor will include the place of performance, required period of performance, and other particular task requirements.

Travel may be required (reimbursement of travel expenses will be IAW applicable Federal travel regulations). The vendor will reply within 7 business days with a quote depending on the details required by the SOW. The Contractor may offer additional spot discounts on any order, as they deem appropriate. All subcontractor activity must be clearly identified in each new order proposal as applicable.

B.9 AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $350.00/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at $340,000.00 over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary.

Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

B.10 OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.

B.11 PERIOD OF PERFORMANCE

This BPA expires on 09-27-2031 or such later ending date as determined by the exercise of any option.

B.12 AUTHORIZED INDIVIDUALS

Individuals Authorized to Place Orders:

DVA authorizes the following entities to place orders:

B.13 ORDER FORMAT

Orders will be placed against this BPA via e-mail, Electronic Data Interchange (EDI), FAX, or in hardcopy format. Each individual BPA Order will describe the tasks, services and deliverables required.

B.14 AUTHORIZED REPRESENTATIVES

The primary Contracting Officer (CO) for this Agreement is:

Maria Espinosa Contracting Officer Department of Veterans Affairs Network Contracting Office (NCO) 15

Leavenworth, KS 66048 maria.espinosa@va.gov The Primary Contracting Officer's Representative (COR) for projects under this Agreement is:

The Secondary Contracting Officer's Representative (COR) for projects under this Agreement is:

The Primary and/or Secondary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions:

(1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;

(2) Waive or agree to modification of the delivery schedule;

(3) Make any final decision on any contract matter subject to the Disputes Clause;

(4) Terminate, for any reason, the contractor's right to proceed;

(5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action.

The contractor shall immediately notify the Contracting Officer in writing if the COR has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations.

The contractor shall provide the Contracting Officer information copies of all correspondence to the COR.

B.15 FEDERAL HOLIDAYS

Unless specifically authorized in writing by the Contracting…