S02 - 36C26124Q0027_1.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

36C261-23-AP-4170

36C26124Q0027 09-12-2023

Shelley Self 702-791-9000 09-15-2023

12:00 PDT

00261 Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

X

325413

1250 Employees

Net 30 Days

N/A

Department of Veterans Affairs VA Southern Nevada Healthcare System

6900 N Pecos Rd North Las Vegas NV 89086

00261

Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6

Financial Services Center P.O. Box 149971

Austin TX 78714-9971

See CONTINUATION Page

This RFQ is a Sole Source to Biomerieux Inc for the Brand Name Vitek Microbiology cost per test analysis and supplies in support of VA Southern Nevada Healthcare System.

Please fill in the unit price and complete required information in Section B.2 "Price/Cost Schedule".

Please provide delivery timeframe in terms of number of days after receipt of order in Section B.3 "Delivery Schedule".

Please send information to: Shelley.Self2@va.gov no later than the date and time indicated in Block 8 above.

Please complete block 17 above and identify UEI number.

See CONTINUATION Page

Maxwell W. Derck Contracting Officer

36C26124Q0027

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

e. Support Features –

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (DEC 2022)

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

C.3 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.5 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 24

C.8 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.9 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.10 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (MAR 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

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

SERVICES (NOV 2021)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

None

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 36C261 Maxwell W. Derck

Network Contracting Office 21

VA Southern Nevada Healthcare System

6900 N. Pecos Road, Building 6

North Las Vegas NV 89086

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] Upon delivery and Government acceptance.

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.

VA - FSC - Tungsten http://www.fsc.va.gov/einvoice.asp

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

AMENDMENT NO DATE

STATEMENT OF WORK

1. REQUIREMENTS/SCOPE: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in this SOW, perform all the required tests described within this solicitation, 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. SPECIFIC TASKS:

2.1 Equipment shall maintain, or preferably reduce the number of workstations and/or overall labor required to accomplish the required testing by each laboratory.

2.2 The Contractor shall 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 dates shall be clearly marked on reagents, 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.

2.2.1 Primary analyzer(s) – Base equipment offered shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all the technical specifications of this solicitation. If a backup analyzer is required, the backup analyzer shall meet the technical functionality and the capabilities of the primary analyzer, to include additional analyzer(s) that meet the definition of a primary analyzer.

a. Operational Features - The instrumentation offered shall have the following, at a minimum:

i. The capability of performing analysis on 100% of the test panels listed.

ii. Sufficient capacity and throughput to meet the volume and service demands as defined in list.

iii. Safety features to avoid exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal through the use of sealed consumables.

iv. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be included and immediately available for implementation to the VA computerized hospital information system.

(1) The accuracy of the barcode reading shall have less than a 1% failure rate.

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

v. Equipment shall accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric, depending on the facility.

vi. Minimal daily, monthly, and periodic maintenance.

vii. Ability to store and retransmit records twenty-four (24) hours of maximal instrument throughput) in case of interface outage.

b. Technical Features - The instrumentation shall be approved by the FDA and shall have the following, at a minimum:

i. The capability of accurately and reliably identifying gram-negative and gram-positive bacteria, yeast, and anaerobes 90 – 99% of the time.

ii. The capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. At a minimum, the equipment shall provide Minimum Inhibitory Concentrations (MIC) values for the following antibiotic-organism combinations in B.3.4.d.iii.

iii. A list of current needs include:

iv. The information below shall be updated as new versions of standards are released:

0.45% NACL SALINE BAG/CASE

0.45% SALINE 1000ml Bottle/CASE

2mm x 75mm POLYSTYRENE TUBES

ACCESSORY KIT VITK2 PIP/DIL

KIT DENSICHEK PLUS STANDARDS

GN TEST KIT VTK2

GP TEST KIT VTK2

YST TEST KIT VTK2

NH TEST KIT VTK2

ANC TEST KIT VTK2

AST-GP TEST KIT

AST-ST02 TEST KIT

AST-GN TEST KIT

AST-XN TEST KIT

ii. The capability of detecting emerging antimicrobial resistance.

(1) MRSA (Methicillin Resistance Staphylococcus aureus, VRE (Vancomycin Resistant Enterococcus, ESBL (Extended Spectrum Beta Lactamase), KPC (Klebsiella pneumonia Carbapenemase), and others as they arise.

iii. Comprehensive and extensive database of bacteria and yeast species that is consistent with FDA/CLSI guidelines.

iv. Software or equipment modifications, to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC), and other governing or authoritative bodies. Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades.

(1) The platform shall be able to increase throughput by connecting the two machines together.

(2) The included middleware shall include, as a standard, the ability for continuous remote notification of critical events, and delayed processing steps.

(3) The included middleware shall be able to manage multiple instruments through a unified interface.

v. Comprehensive array of bacterial antimicrobial susceptibility panels Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions and limitations for their methodology at time of quote.

vi. Built-in quality control program to continuously monitor system performance.

c. Data Management - The System shall have the following, at a minimum:

i. Capability to provide varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles, i.e. using conditional statements (if/then statements), that all search and retrieval of specific information (by patient, by organism, by antimicrobial agent, by specimen type, by MIC, etc.)

(1) Conditional statements shall also allow for modification of reporting/not reporting selected antimicrobial agents by enabling/disabling suppression rules.

(2) Capability to connect to the Veterans Health Information Systems and Technology Architecture (VISTA) interface.

a. The Contractor shall supply IT personnel support to implement VISTA verification from the supplied equipment middleware interface upon installation of the instrumentation.

ii. Capability to record, store, and print the following information:

(1) Manufacturer required quality control and instrument maintenance information.

(2) Patient demographic information and specimen results

(3) Capability of manipulating/sorting the patient demographic information and patient microbiology test results to generate epidemiological reports, i.e. antibiograms (with the option of first-isolate antibiograms), organism trending report, phenotype occurrence report, etc.

(4) Sufficient memory to store patient information and test results with downloading capability to an encrypted/password-protected external hard drive, thumb drive, or equivalent medium for long-term storage of patient records and other information.

d. Hardware Features - The instrumentation shall have the following, at a minimum:

i. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

ii. An on-board monitor/screen that is easily readable.

iii. 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).

iv. An uninterruptible power supply with line conditioner for each instrument provided.

e. Support Features –

i. Commercial marketing. The equipment models being quoted shall be in current production as of the date this quote is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being quoted as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Gray market equipment, supplies, reagents are not acceptable.

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

iii. Training. The Contractor shall provide an off-site instrument training program for up to two operators initially that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and equivalent to a training program that the Contractor provides in the commercial market.

This shall include, but is not limited to, training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility 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 VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.

iv. Service Requirements

(1) A technical assistance center shall be available by telephone twenty-four (24) hours per day, seven (7) days per week with a maximum call back response time of one (1) hour.

(2) Equipment repair service shall be provided on site during core business hours between 8 AM and 5 PM within twenty-four (24) hours. If equipment malfunction is deemed to jeopardize the need for continuation of patient care, then the Contractor will provide an emergent on-site repair service to be conducted outside routine business hours within twenty-four

(24) hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

(3) Equipment repair response time shall be no more than two (2) hours.

(4) Preventative maintenance will be performed on all primary and back-up instrumentation and any incremental support equipment as frequently as published in manufacturer’s operator’s manual and within two (2) weeks of the scheduled due date.

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

a. Date and time notified

b. Date and time of arrival

c. Serial number, type and model number of equipment

d. Time spent for repair, and

e. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance

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

v. Upgrades. The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system, 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 quoted, i.e. new version of software, expanded database, 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 includes replacing the original piece of equipment provided under the BPA if the new equipment is deemed superior by the receiving facility and results in significant changes in the hardware operational capability.

vi. Ancillary support equipment. The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), 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.

vii. The Contractor shall be responsible for moving the quoted instrumentation/equipment in the event of facility renovation, or as needed by the VA, for the term of the BPA and subsequent Delivery Orders.

viii. Commercial offerings. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CSLI format or an on-line procedure manual in the instrument software.

ix. 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.

(1) The determination and description shall address the following:

a. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

b. Waste ignitability (Reference 40 CFR §261.21)

c. Waste corrosivity (Reference 40 CFR §261.22)

d. Waste reactivity (Reference 40 CFR §261.23)

e. Hazardous waste from non-specific sources (F-listed) (Reference 40

CFR §261.31)

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

g. Solid Waste (Reference 40 CFR §261.2)

h. Exclusions (Reference 40 CFR §261.4)

(2) The Contractor shall 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 shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

(3) The Contractor shall provide a description of all wastes that 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 shall be determined and documented. Any mercury containing reagents shall 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, thimerosol and formaldehyde) shall be developed and SDS sheets shall 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 shall be included with Contractor response:

a. Barium (Total)

b. Cadmium (Total)

c. Chromium (Total)

d. Copper (Total)

e. Cyanide (Total)

f. Lead (Total)

g. Mercury (Total)

h. Nickel (Total)

i. Silver (Total)

j. Zinc (Total)

k. Arsenic (Total)

l. Selenium (Total)

m. Tin (Total)

n. pH

o. Flash point (to higher than 200°F)

p. BOD; biochemical oxygen demand

(4) The documentation the Contractor provides will be used to work with the VAHS 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.

x. Implementation/transition timeframe. The implementation of the services/requirements described in this solicitation shall be completed no later than 30 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. Contractor shall not be penalized for implementation timelines that extend beyond the 30-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

(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 [TBD] days.

During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

(2) Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed [TBD] 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 conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA.

(3) At the end of [TBD] days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA.

f. 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 after the installation date, equipment verification, and after the written acceptance by the VA that the equipment can perform the requirements stated within this solicitation. It shall end when the equipment has met the standard of performance for a period of thirty

(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.

g. In the event that equipment does not meet the standard of performance during the initial thirty (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 thirty (30) consecutive days.

i. If the equipment fails to meet the standard of performance after sixty (60) 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 Part 52.212-4 entitled “Termination for Cause.” (The Contractor shall receive revenue for tests reported during the ninety (90)-day acceptance period.)

ii. 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.

iii. During the performance period for a system, a minimum of one-hundred (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 one-hundred (100) hours.

iv. The Government shall 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.

v. 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 POC 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.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

5.00 BX __________________ __________________

0.45% NACL SALINE BAG/CASE

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

LOCAL STOCK NUMBER: 417820

0.45% SALINE 1000ML BOTTLE/CASE

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 423718

12.00 BX __________________ __________________

2MM X 75MM POLYSTYRENE TUBES/2000 BO

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 69285

30.00 BX __________________ __________________

ACCESSORY KIT VITK2 PIP/DIL

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 21219

2.00 BX __________________ __________________

KIT DENSICHEK PLUS STANDARDS/EACH

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 21255

250.00 BX __________________ __________________

GN TEST KIT VTK2 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 21341

100.00 BX __________________ __________________

GP TEST KIT VTK2 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 21342

YST TEST KIT VTK2 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 21343

NH TEST KIT VTK2 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 21346

ANC TEST KIT VTK2 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 21347

125.00 BX __________________ __________________

AST-GP TEST KIT 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: VARIOUS

AST-ST02 TEST KIT 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 420915

275.00 BX __________________ __________________

AST-GN TEST KIT 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

275.00 BX __________________ __________________

AST-XN TEST KIT 20 CARDS

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

AST-YS09

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325413 - In-Vitro Diagnostic Substance Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical

LOCAL STOCK NUMBER: 423331

GRAND TOTAL __________________

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

C.3 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

Funds are not presently available for this contract. The Government's obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

(End of Clause)

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.5 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB

2023)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided.

This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/ parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer.