36C25724Q0024 CTX Electrophoresis Analyzer.docx

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

36C25724Q0024 10-09-2023 Akisha Woods 214-857-4589 10-20-2023 15:00

CDT

36C257 Department of Veterans Affairs Network Contracting Office (NCO 17) Regional Procurement Office West (RPO-W) 124 E. Hwy 67, Suite 100 Duncanville TX 75137

X

334516 1000 Employees

N/A

36C257 Department of Veterans Affairs Central Texas VA Healthcare System CTVHCS Chemistry Laboratory 1901 Veterans Memorial Drive Temple TX 76504 36C257

NCO 17

Department of Veterans Affairs North Texas Veterans Health Care Center 124 E. Hwy 67, Suite 100 Duncanville TX 75137

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791

(512) 460-5540

See CONTINUATION Page

This solicitation is for an electrophoresis analyzer and reagents for the Central Texas VA Health Care System.

See CONTINUATION Page

Delphia Schoenfeld Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C257 Department of Veterans Affairs Network Contracting Office (NCO 17) Regional Procurement Office West (RPO-W) 124 E. Hwy 67, Suite 100 Duncanville TX 75137

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

http:www.fsc.va.gov/einvoice.asp This is mandatory and the sole source method for submitting invoices.

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

Page 1 of Page 1 of

Statement of Work

The contractor shall provide a FDA approved, semi-automated, gel electrophoresis instruments capable of performing both serum and urine electrophoresis (SPEP/UPEP), and immunofixation (SIFE/UIFE) to identify monoclonal and polyclonal gammopathies. The instruments shall meet all technical specifications stated in the statement of work. Contractor shall provide all necessary maintenance to keep the equipment in good operating condition (including both preventative maintenance and emergency repairs) and training for Government personnel. Contractor is also required to provide delivery, installation, bi-directional interfacing, method validation, and removal of equipment upon completion of agreement.

1. Analyzer Requirements:

Capillary electrophoresis

· 8 Capillary electrophoresis Bench top analyzer

· Test menu: Protein 6, immunotyping

· Continuous sample loading

· Direct sampling from primary tube

· Positive sample identification, full traceability from primary tube to final result

· Barcoded reagents and controls A. Gel electrophoresis

· Semi-automated Gel electrophoresis bench top analyzer

· Test menu: Immunofixation, Bence Jones

· Sample types: Serum, urine

· Must have options of 1, 2, or 4 tests/gel

· Onboard densitometer scanner B. Software

· Networking connection of instruments

· Multi-client configuration for different operators

· Automatic flagging of abnormal values

· Curve recall, review and editing

· Pre-programmed comments or manual entry

· Reference pattern overlay

· Unlimited storage of patient database

· Automatic patient history search

· Color coded profiles

· Bidirectional LIS connection

2. General Requirements:

Electrophoresis instruments shall produce accurate and reproducible assay results on serum or urine specimens for SPEP/UPEP and SIFE/UIFE electrophoresis by established in vitro diagnostic methods. Offered equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

A. Upgrades to the equipment hardware and operating system software shall be provided at no additional cost to the Government. These enhancements shall be delivered and installed within 60 days of issuance to the commercial market.

B. An operator’s manual shall be furnished with each instrument supplied and updates to manual shall be provided in a timely manner. Editable electronic copy in CLSI format of operating procedures shall be furnished with each instrument supplied to the VA.

C. Laboratory assays currently performed shall include, but may not be limited to, the following automated assays.

· Serum Protein Electrophoresis

· Serum Immunofixation.

· Urine Immunofixation.

D. Start-up Reagents and Supplies: The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other items required to establish instrument for operation, validation and acceptance testing for serum and urine electrophoresis testing. The Contractor shall provide and perform validation and method comparison studies for the government. All materials and reagents needed for such correlation are at no cost to the Government. The Contractor shall perform all statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

E. All consumables, reagents, calibrators, controls, supplies, disposable items, parts, accessories and any other items required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a patient test result shall be included if CPRR or RR.

F. Service Requirements: The Contractor shall be able to provide onsite emergency equipment repair and preventative maintenance on the equipment by a qualified service technician.

· A technical assistance center shall be available by telephone 8 hours per day, 5 days per week with a maximum call back response time of 4 hours.

· Equipment repair service shall be provided during core business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

· Equipment repair response time shall be no more than 24 hours.

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

· 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:

· date and time notified

· date and time of arrival

· serial number, type and model number of equipment

· time spent for repair,

· proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

G. Flexibility in test volumes shall be considered.

H. Robotics/automation system is preferred to include preanalytical processing system (sample preparation) as well as auto verification.

I. Extended expiration date of supplies shall be provided.

J. Training for all testing personnel, and Key Operator training for a minimum of two operators is required.

K. Systems shall provide ease of use menus, with minimal maintenance required and simple troubleshooting processes.

L. Environmental and hazardous materials handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into the facility’s drain system, the contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

3. Technical Requirements:

A. The analyzer system must be capable of interfacing with the VA hospital’s electronic health record and shall provide a fully bi-directional, ASTM, HL7 Information System (LIS) interfacing. If the government moves to a new information system, the vendor will ensure interfacing and autoverification requirements are operational and validated. All downloads/software necessary to transfer orders and data into patient files via LIS interface will be at no additional cost to VA.

B. The contractor must have an established driver compatible for interfacing the analyzer with the VAs electronic health record and data innovations instrument manager.

C. Contractor shall provide at least one (1) each automated, auto-sampler instrument and (1) each automated electrophoresis/scanner instrument and peripherals.

D. Electrophoresis separation system shall have barcode reading capabilities to assure Positive Patient ID.

E. Electrophoresis instrument shall be a bench top model to fit into the current laboratory configuration.

F. Data backup shall be provided.

G. Peripherals (e.g. Uninterruptible power supply, surge protection, battery backup, instrument specific terminals and CPUs) shall be provided and serviced by the vendor for all associated electrical instruments and ancillary components excluding the printer.

H. Imaging system must provide permanent file retention of non-modified pattern image.

Schedule of Deliverables Item No.

Item

Semi-Automated Gel electrophoresis instrument Semi-Automated Immunofixation instrument

Quantity

Delivery Date

Within 60 calendar days after award

Reagents, Controls and consumables for SPEP testing Reagents, Controls and consumables for SIFE testing Reagents, Controls and consumables for UIFE testing

IDIQ

IDIQ

IDIQ

PERFORMANCE REQUIREMENTS

A. Maintenance: The contractor shall perform preventative maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

· Inventory and recording of systems components.

· Monthly deliverables shall be received in full.

· Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer’s specifications.

· After Preventative Maintenance (PM), the contractor shall submit a detailed work report within 24 hours of the repair at no additional cost to the government.

· Delivery of PM parts or materials: the contractor shall provide all preventative service materials at no additional cost to the government.

· Repairs and support

· Technical support: Support Personnel will be available by telephone from 0800 to 1700 each business day.

· On site repairs: Contractor will dispatch on-site support personnel within 24 business hours of determining that phone support is insufficient to correct problem. After repair, the contractor shall submit a detailed work report to include all required materials at no charge to the facility.

B. For the delivery of repair parts or materials, the contractor shall provide all parts and materials at no additional cost to the government.

C. Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to, but not limited to, repairs, replacements, recall, and upgrades without any cost to the government. The government may add reagents through the life of this contract as a result of advances in technology or changes in clinical practice standards. Any such change will be mutually agreed upon by the contractor and the government.

D. Training: The contractor will provide initial onsite training to all technicians assigned to the chemistry section prior to the initiation of use of the analyzer for patient testing.

· This training will be provided at no cost to the government and by a qualified contractor training personnel that encompasses basic operation, basic maintenance, troubleshooting, operator level periodic maintenance, the use of the data management/quality control software and interpretation of results.

· All training manuals/guides, instructional literature and any other related written/electronic materials shall be in the English language.

E. Safety: Contractor shall immediately notify the service of any changes in reagents, kit composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulation.

F. Test Performance: All tests, procedures, and equipment must perform at manufacturer specifications. Deviations from the performance specifications shall be corrected by the contractor.

· All test performance will be evaluated by, and not limited to, performance thru peer comparison, quality control, and CAP peer evaluation.

G. Should consumables be 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 shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity.

CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

CONTRACTOR SECURITY REQUIREMENTS

This contractor requires no access to CTVHCS or any VA information system. The analyzers will be interfaced to the CTVHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

The C&A requirement do not apply. A security accreditation package is not required.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

RECORDS MANAGEMENT

All records (administrative and program specific) created during the period of the contract belong to Central Texas Veterans Healthcare System (CTVHCS) and must be returned to CTVHCS at the end of the contract.

NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Central Texas Veterans Health Care System (CTVHCS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to CTVHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to CTVHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

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

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with CTVHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public CTVHCS information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The CTVHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which CTVHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take CTVHCS -provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

HYDRAGEL 2 IF DYNAMIC MASK "or Equal" Ordering Period 1 POP Begin: 12-01-2023 POP End: 11-30-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

HYDRAGEL 4 IF DYNAMIC MASK "or Equal"

POP Begin: 12-01-2023 POP End: 11-30-2024

HYDRAGEL 1 BENCE JONES DYNAMIC MASK "or Equal"

POP Begin: 12-01-2023 POP End: 11-30-2024

CLEAN PROTECT

POP Begin: 12-01-2023 POP End: 11-30-2024

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 12-01-2023 POP End: 11-30-2024

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 12-01-2023 POP End: 11-30-2024

HYDRASYS DESTAIN SOLUTION

POP Begin: 12-01-2023 POP End: 11-30-2024

HYDRASYS WASH SOLUTION

POP Begin: 12-01-2023 POP End: 11-30-2024

CAPILLARYS PROTEIN 1400 ML

POP Begin: 12-01-2023 POP End: 11-30-2024

CAPILLARYS IT

POP Begin: 12-01-2023 POP End: 11-30-2024

CAPILLARYS BUFFER

POP Begin: 12-01-2023 POP End: 11-30-2024

CAPILLARYS WASH SOLUTION

POP Begin: 12-01-2023 POP End: 11-30-2024

CAPICLEAN

POP Begin: 12-01-2023 POP End: 11-30-2024

CLEAN PROTECT

POP Begin: 12-01-2023 POP End: 11-30-2024

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 12-01-2023 POP End: 11-30-2024

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 12-01-2023 POP End: 11-30-2024

IT/IF CONTROL

POP Begin: 12-01-2023 POP End: 11-30-2024

CAPY FLEX WEDGE ADAPTORS

POP Begin: 12-01-2023 POP End: 11-30-2024

HYDRASYS 2 WITH SCAN REAGENT RENTAL

POP Begin: 12-01-2023 POP End: 11-30-2024

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 12-01-2023 POP End: 11-30-2024

HYDRAGEL 2 IF DYNAMIC MASK "or Equal" Ordering Period 2 POP Begin: 12-01-2024 POP End: 11-30-2025

HYDRAGEL 4 IF DYNAMIC MASK "or Equal"

POP Begin: 12-01-2024 POP End: 11-30-2025

HYDRAGEL 1 BENCE JONES DYNAMIC MASK "or Equal"

POP Begin: 12-01-2024 POP End: 11-30-2025

CLEAN PROTECT

POP Begin: 12-01-2024 POP End: 11-30-2025

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 12-01-2024 POP End: 11-30-2025

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 12-01-2024 POP End: 11-30-2025

HYDRASYS DESTAIN SOLUTION

POP Begin: 12-01-2024 POP End: 11-30-2025

HYDRASYS WASH SOLUTION

POP Begin: 12-01-2024 POP End: 11-30-2025

CAPILLARYS PROTEIN 1400 ML

POP Begin: 12-01-2024 POP End: 11-30-2025

CAPILLARYS IT

POP Begin: 12-01-2024 POP End: 11-30-2025

CAPILLARYS BUFFER

POP Begin: 12-01-2024 POP End: 11-30-2025

CAPILLARYS WASH SOLUTION

POP Begin: 12-01-2024 POP End: 11-30-2025

CAPICLEAN

POP Begin: 12-01-2024 POP End: 11-30-2025

CLEAN PROTECT

POP Begin: 12-01-2024 POP End: 11-30-2025

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 12-01-2024 POP End: 11-30-2025

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 12-01-2024 POP End: 11-30-2025

IT/IF CONTROL

POP Begin: 12-01-2024 POP End: 11-30-2025

CAPY FLEX WEDGE ADAPTORS

POP Begin: 12-01-2024 POP End: 11-30-2025

HYDRASYS 2 WITH SCAN REAGENT RENTAL

POP Begin: 12-01-2024 POP End: 11-30-2025

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 12-01-2024 POP End: 11-30-2025

HYDRAGEL 2 IF DYNAMIC MASK "or Equal" Ordering Period 3 POP Begin: 12-01-2025 POP End: 11-30-2026

HYDRAGEL 4 IF DYNAMIC MASK "or Equal"

POP Begin: 12-01-2025 POP End: 11-30-2026

HYDRAGEL 1 BENCE JONES DYNAMIC MASK "or Equal"

POP Begin: 12-01-2025 POP End: 11-30-2026

CLEAN PROTECT

POP Begin: 12-01-2025 POP End: 11-30-2026

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 12-01-2025 POP End: 11-30-2026

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 12-01-2025 POP End: 11-30-2026

HYDRASYS DESTAIN SOLUTION

POP Begin: 12-01-2025 POP End: 11-30-2026

HYDRASYS WASH SOLUTION

POP Begin: 12-01-2025 POP End: 11-30-2026

CAPILLARYS PROTEIN 1400 ML

POP Begin: 12-01-2025 POP End: 11-30-2026

CAPILLARYS IT

POP Begin: 12-01-2025 POP End: 11-30-2026

CAPILLARYS BUFFER

POP Begin: 12-01-2025 POP End: 11-30-2026

CAPILLARYS WASH SOLUTION

POP Begin: 12-01-2025 POP End: 11-30-2026

CAPICLEAN

POP Begin: 12-01-2025 POP End: 11-30-2026

CLEAN PROTECT

POP Begin: 12-01-2025 POP End: 11-30-2026

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 12-01-2025 POP End: 11-30-2026

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 12-01-2025 POP End: 11-30-2026

IT/IF CONTROL

POP Begin: 12-01-2025 POP End: 11-30-2026

CAPY FLEX WEDGE ADAPTORS

POP Begin: 12-01-2025 POP End: 11-30-2026

HYDRASYS 2 WITH SCAN REAGENT RENTAL

POP Begin: 12-01-2025 POP End: 11-30-2026

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 12-01-2025 POP End: 11-30-2026

HYDRAGEL 2 IF DYNAMIC MASK "or Equal" Ordering Period 4 POP Begin: 12-01-2026 POP End: 11-30-2027

HYDRAGEL 4 IF DYNAMIC MASK "or Equal"

POP Begin: 12-01-2026 POP End: 11-30-2027

HYDRAGEL 1 BENCE JONES DYNAMIC MASK "or Equal"

POP Begin: 12-01-2026 POP End: 11-30-2027

CLEAN PROTECT

POP Begin: 12-01-2026 POP End: 11-30-2027

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 12-01-2026 POP End: 11-30-2027

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 12-01-2026 POP End: 11-30-2027

HYDRASYS DESTAIN SOLUTION

POP Begin: 12-01-2026 POP End: 11-30-2027

HYDRASYS WASH SOLUTION

POP Begin: 12-01-2026 POP End: 11-30-2027

CAPILLARYS PROTEIN 1400 ML

POP Begin: 12-01-2026 POP End: 11-30-2027

CAPILLARYS IT

POP Begin: 12-01-2026 POP End: 11-30-2027

CAPILLARYS BUFFER

POP Begin: 12-01-2026 POP End: 11-30-2027

CAPILLARYS WASH SOLUTION

POP Begin: 12-01-2026 POP End: 11-30-2027

CAPICLEAN

POP Begin: 12-01-2026 POP End: 11-30-2027

CLEAN PROTECT

POP Begin: 12-01-2026 POP End: 11-30-2027

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 12-01-2026 POP End: 11-30-2027

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 12-01-2026 POP End: 11-30-2027

IT/IF CONTROL

POP Begin: 12-01-2026 POP End: 11-30-2027

CAPY FLEX WEDGE ADAPTORS

POP Begin: 12-01-2026 POP End: 11-30-2027

HYDRASYS 2 WITH SCAN REAGENT RENTAL

POP Begin: 12-01-2026 POP End: 11-30-2027

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 12-01-2026 POP End: 11-30-2027

HYDRAGEL 2 IF DYNAMIC MASK "or Equal" Ordering Period 5 POP Begin: 12-01-2027 POP End: 11-30-2028

HYDRAGEL 4 IF DYNAMIC MASK "or Equal"

POP Begin: 12-01-2027 POP End: 11-30-2028

HYDRAGEL 1 BENCE JONES DYNAMIC MASK "or Equal"

POP Begin: 12-01-2027 POP End: 11-30-2028

CLEAN PROTECT

POP Begin: 12-01-2027 POP End: 11-30-2028

IF ANTISERA SET DYNAMIC MASK (FIX G-A-M-K-L)

POP Begin: 12-01-2027 POP End: 11-30-2028

BJ ANTISERA SET DYNAMIC MASK (GAM-K-L-fK-fL)

POP Begin: 12-01-2027 POP End: 11-30-2028

HYDRASYS DESTAIN SOLUTION

POP Begin: 12-01-2027 POP End: 11-30-2028

HYDRASYS WASH SOLUTION

POP Begin: 12-01-2027 POP End: 11-30-2028

CAPILLARYS PROTEIN 1400 ML

POP Begin: 12-01-2027 POP End: 11-30-2028

CAPILLARYS IT

POP Begin: 12-01-2027 POP End: 11-30-2028

CAPILLARYS BUFFER

POP Begin: 12-01-2027 POP End: 11-30-2028

CAPILLARYS WASH SOLUTION

POP Begin: 12-01-2027 POP End: 11-30-2028

CAPICLEAN

POP Begin: 12-01-2027 POP End: 11-30-2028

CLEAN PROTECT

POP Begin: 12-01-2027 POP End: 11-30-2028

NORMAL CONTROL - AGAROSE/CAPILLARY

POP Begin: 12-01-2027 POP End: 11-30-2028

HYPERGAMMA CONTROL SERUM - AGAROSE/CAPILLARY

POP Begin: 12-01-2027 POP End: 11-30-2028

IT/IF CONTROL

POP Begin: 12-01-2027 POP End: 11-30-2028

CAPY FLEX WEDGE ADAPTORS

POP Begin: 12-01-2027 POP End: 11-30-2028

HYDRASYS 2 WITH SCAN REAGENT RENTAL

POP Begin: 12-01-2027 POP End: 11-30-2028

CAPILLARYS 2 FLEX PIERCING REAGENT RENTAL

POP Begin: 12-01-2027 POP End: 11-30-2028

B.3 DELIVERY SCHEDULE

All items will be delivered to:

Central Texas Veterans Healthcare System (CTVHCS) Pathology and Laboratory Medicine Service 1901 Veterans Memorial Drive Temple, Texas 76504

SECTION C - CONTRACT CLAUSES

C.1 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)

(End of Addendum to 52.212-4)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JUN 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232–40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[X] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C. 3509).

[] (3) 52.203–15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117–328).

[X] (9) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

[] (10) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41 U.S.C. 2313).

[] (11) [Reserved] [] (12) 52.219–3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) (15 U.S.C. 657a).

[X] (13) 52.219–4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (14) [Reserved] [] (15)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-6.

[] (16)(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-7.

[X] (17) 52.219-8, Utilization of Small Business Concerns (OCT 2022) (15 U.S.C. 637(d)(2) and (3)).

[] (18)(i) 52.219–9, Small Business Subcontracting Plan (OCT 2022) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JUN 2020) of 52.219–9.

[] (v) Alternate IV (SEP 2021) of 52.219–9.

[] (19)(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

[] (ii) Alternate I (MAR 2020) of 52.219-13.

[] (20) 52.219–14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 657s).

[] (21) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) (15 U.S.C. 637(d)(4)(F)(i)).

[] (22) 52.219–27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) (15 U.S.C. 657f).

[X] (23) (i) 52.219–28, Post-Award Small Business Program Rerepresentation (MAR 2023) (15 U.S.C. 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219–28.

[] (24) 52.219–29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (OCT 2022) (15 U.S.C. 637(m)).

[] (25) 52.219–30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (OCT 2022) (15 U.S.C. 637(m)).

[] (26) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

[] (27) l(26) 52.219–33, Nonmanufacturer Rule (SEP 2021) (15 U.S.C. 657s).

[X] (28) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[X] (29) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (DEC 2022) (E.O. 13126).

[X] (30) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (31)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (32)(i) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

[] (ii) Alternate I (JUL 2014) of 52.222-35.

[X] (33)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

[] (ii) Alternate I (JUL 2014) of 52.222-36.

[X] (34) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[X] (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (36)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[] (37) 52.222-54, Employment Eligibility Verification (MAY 2022). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

[] (38)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (MAY 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (39) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (40) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (41)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (42)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (43) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

[] (44)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-16.

[X] (45) 52.223–18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

[] (46) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (47) 52.223-21, Foams (JUN 2016) (E.O. 13693).

[] (48)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (ii) Alternate I (JAN 2017) of 52.224-3.

[] (49)(i) 52.225-1, Buy American—Supplies (OCT 2022) (41 U.S.C. chapter 83).

[] (ii) Alternate I (OCT 2022) of 52.225–1.

[] (50)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (DEC 2022) (19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[] (ii) Alternate I [Reserved].

[] (iii) Alternate II (DEC 2022) of 52.225-3.

[] (iv) Alternate III (JAN 2021) of 52.225-3.

[] (v) Alternate IV (OCT 2022) of 52.225-3.

[X] (51) 52.225–5, Trade Agreements (DEC 2022) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (52) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[] (53) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

[] (54) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150).

[] (55) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C. 5150).

[X] (56) 52.229–12, Tax on Certain Foreign Procurements (FEB 2021).

[] (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (NOV 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

[] (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (NOV 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

[X] (59) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018) (31 U.S.C. 3332).

[] (60) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (JUL 2013) (31 U.S.C. 3332).

[] (61) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (62) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[] (63) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

[] (64)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631).

[] (ii) Alternate I (APR 2003) of 52.247-64.

[] (iii) Alternate II (NOV 2021) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[] (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[] (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[] (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

[] (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

[] (9) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement.