36C26127Q0077.docx
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- 6640--Perfusion Cell Saver Lease and Service
- Solicitation number
- 36C26127Q0077
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This is a Solicitation/Contract/Order (Standard Form 1449) for Commercial Products and Commercial Services issued by the Department of Veterans Affairs Network Contracting Office (NCO) 21. The solicitation number is 36C26127Q0077, with an offer due date of October 20, 2026, at 15:00 EDT. This is an unrestricted Request for Quote (RFQ) for a firm fixed price contract using NAICS code 339112 (Medical Device and Supplies Manufacturing). The contracting officer is Mathew B. Czeshinski, and questions must be submitted by October 15, 2026, at 15:00 EDT to Mathew.Czeshinski@va.gov.
The contract is for Pathology and Laboratory Medicine Cell Saver Service at VA Sierra Nevada Healthcare System in Reno, Nevada. The contractor must provide a leased cell saver machine (LivaNova Xtra ATS System or equivalent), intra-operative autotransfusion professional services, and all associated disposable supplies on an as-needed basis for approximately four to six cases annually. The contractor is responsible for all equipment maintenance and must provide a credentialed auto-transfusionist for each procedure. The performance period begins November 1, 2026, through October 31, 2027, with four one-year option periods extending through October 31, 2031. The contractor must submit quarterly quality assurance reports and maintain a VA-approved quality assurance plan compliant with College of American Pathologists standards. All invoices must be submitted electronically through the VA Financial Services Center via Tungsten's e-invoicing system. The solicitation requires submission of FAR 52.225-4 and an authorized distributor letter, and incorporates various VA clauses including those addressing security prohibitions, rejected goods, and service-disabled veteran-owned small business evaluation factors.
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36C26127Q0077
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
654-27-1-113-0014 36C26127Q0077 10-13-2026 Mat Czeshinski 559-231-1067 10-20-2026 15:00
EDT
Department of Veterans Affairs Network Contracting Office (NCO) 21
X 339112 1000 Employees N/A X Department of Veterans Affairs VA Integrated Services Network 5 VA Sierra Nevada Healthcare System 975 Kirman Ave Reno NV 89052 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Central California Health Care System 855 M Street, Suite 1020 Fresno CA 93721
Department of Veterans Affairs FMS-VA-2(101) Financial Services Center
PO BOX 149971
Austin TX 78714-9971 See CONTINUATION Page *Please see below schedule* This solicitation is a brand name or equal unrestricted RFQ for Simunition Police Training Gear for the VA Sierra Nevada Healthcare System for a firm fixed price contract. Respondents shall complete the Price/Cost schedule in section B. Respondents shall review the Salient Characteristics, and the RFQ instructions in Section E.
Responses are due no later than the date and time indicated in box 8. Questions regarding the solicitation may be submitted no later than 15:00 EDT 10/15/2026.
Contracting POC: Mathew.Czeshinski@va.gov Offerors must complete 52.225-4 and provide an authorized distributor letter.
See CONTINUATION Page X Mathew B. Czeshinski Contracting Officer Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 3 |
| B.1 CONTRACT ADMINISTRATION DATA | 3 |
| ?.## Statement of Work | 4 |
| B.2 Salient Characteristics | 16 |
| B.3 PRICE/COST SCHEDULE | 17 |
| ITEM INFORMATION | 17 |
| B.4 DELIVERY SCHEDULE | 21 |
| SECTION C - CONTRACT CLAUSES | 22 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION) | 22 |
| C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 27 |
| C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 27 |
| C.4 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS (DEVIATION APR 2026) | 28 |
| C.5 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025) (DEVIATION) | 28 |
| C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018) | 38 |
| C.7 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION) | 38 |
| C.8 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019) | 39 |
| C.9 VAAR 852.246-71 REJECTED GOODS (OCT 2018) | 39 |
| C.10 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018) | 39 |
| C.11 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018) | 40 |
| C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 40 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 42 |
| SECTION E - SOLICITATION PROVISIONS | 43 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION) | 43 |
| E.2 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION) | 45 |
| E.3 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021) | 45 |
| E.4 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS AND CERTIFICATIONS (NOV 2025) (DEVIATION) | 46 |
| E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 50 |
| E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION) | 50 |
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 36C261 Department of Veterans Affairs Network Contracting Office (NCO) 21
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [] |
| 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 | [] |
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.
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
?.## Statement of Work
Statement of Work Pathology & Laboratory Medicine for Cell Saver Service VA Sierra Nevada Health Care System
1. Section 1: General Information:
1.1 General: The purpose of utilizing a Cell Saver is to suction blood from the patient using a heparinized suction tubing device, collected in a sterile bowl and gently wash and centrifuge red blood cells, then pump it into a blood administration bag for the anesthesiologist to infuse back to the patient. Cell Saver cannot be used on patients with cancer or infections because of the possibility of creating a systemic seeding. Infusing the patient’s blood reduces the amount of banked blood the patient will need to receive. The Cell Saver blood has a lower volume of red blood cells and some of the red cells may sustain damage during the washing process. In cases of massive blood loss, patients will be receiving both cell saver blood as well as banked blood as means of stabilizing the patient.
1.2 Place of Performance: VA Sierra Nevada Health Care System 975 Kirman Ave.
Reno, NV 89502
1.3 Hours of Operation: All repairs shall be performed during business hours of 8:00 am to 4:30 PM Monday through Friday, except Federal Holidays. Contractors may work outside normal business hours by arrangement with the VA POC if such services are provided without additional charge to the government.
1.4 Type of Contract: The government will award a Firm Fixed Price contract.
1.5 Invoicing: All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.
More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.
Vendor e-Invoice Set-Up Information:
Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:
· Tungsten e-Invoice Setup Information: 1-877-489-6135
· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com
· FSC e-Invoice Contact Information: 1-877-353-9791
· FSC e-invoice email: vafsccshd@va.gov
1.6 Period of Performance:
Base Year: November 01, 2026 to October 31, 2027 Option Year #1: November 01, 2027 to October 31, 2028 Option Year #2: November 01, 2028 to October 31, 2029 Option Year #3: November 01, 2029 to October 31, 2030 Option Year #4: November 01, 2030 to October 31, 2031
2. Specific Tasks and Equipment:
The contractor shall provide cell saver perfusion service during certain surgical cases when a large blood loss from the procedure is anticipated. The contractor shall provide the Surgical Service, Patient Care Service and the P&LMS Blood Bank section with their quality assurance reports including function validation test results, under an approved Quality Assurance policy and plan by the medical director of blood bank at VASNHCS. The contractor shall provide a leased cell saver machine, and the services of a credentialed auto-transfusionist for each cell saver procedure.
a. Contractor shall provide a leased Cell Saver Machine (LivaNova Xtra ATS System or EQUAL) which will be located the Operating Room with the sterile disposable supplies that are stocked by the Cell Saver Technician in suitable locked storage. The contractor is responsible for all maintenance as required to ensure the equipment is in proper working order.
b. The contractor shall provide Intra-Operative Non-Cardiac Autotransfusion Professional services (ATS) on an as-needed basis of the VASNHCS. The ATS services will be inclusive of ATS disposable supplies, including but not limited to: bowl set, reservoir, aspiration line.
2.1 Schedule for Service Performance:
a. This is to be initiated by Department of Surgery at VASNHCS on an as needed basis. The operating room procedure schedule will define the cases for the cell saver use. The cell saver may also be utilized for emergency procedures. The annual volume of use will be approximately four to six cases. The service is to be expected to commence in a timely manner, in accordance to the needs of the surgical procedure.
2.2 Reports
2.2.1 Procedural documentation:
2.2.1 The perfusionist operating the autotransfusion machine will be recorded in the patient record.
2.2.3 The perfusionist will document on the specified record the following information:
a. Case number on label.
b. Identification number of the piece of equipment used.
c. Lot numbers and expiration dates of all soft goods and fluids used.
d. Amount of volume processed and re-infused.
e. Reinfusion starts and stop times.
f. Type and amount of anticoagulant.
g. Amount of wash solution.
h. Hematocrit and potassium checked by clinical laboratory and signed off by Blood Bank Supervisor and/or Medical Director of clinical laboratory.
2.2.4 Collected and processed units will be labeled as follows:
a. The case number, operator initials, date, time, and physician.
b. The unit must be labeled as an “Autologous unit”.
c. The label must also denote the volume of the unit.
2.2.5 A report of procedure quality assurance tests will be provided to the Chief of Pathology and Laboratory Medicine one work week after each procedure and summarized into quarterly reports submitted within two work weeks of each quarter, the first two weeks of January for the previous calendar quarter, etc.
2.3 Credentialing:
2.3.1 The auto-transfusionist must be credentialed and able to meet:
a. Identify composition of whole blood
b. Describe function of the red blood cell
c. Explain coagulation components and process
d. Identify replacement needs of coagulation components
e. Describe blood replacement options
f. Discuss benefits, risks, and cost for each option
g. Demonstrate documentation of procedure
h. Demonstrate set up and operation of autotransfusion unit
2.3.2 Autotransfusionist must demonstrate competency by:
Perform 5 procedures to include collection and processing. All 5 cases will be supervised by a credentialed person.
2.3.3 To maintain credentialing the autotransfusionist must yearly:
| Perform a minimum of 3 autotransfusion cases a year. |
| Demonstrate competency by performing supervised procedures. |
2.3.4 Credentialing and competencies shall be completed and maintained by the vendor, and copies of the documentation will be provided to the designated VA POC.
2.4 Maintenance:
2.4.1 Equipment shall be fully maintained by contractor and will be responsible for any and all costs associated with maintenance and repairs. If vendor is unable to repair machine, a replacement will be provided at no additional cost to the facility.
2.5 Security:
2.5.1 A prohibition on unauthorized disclosure: “Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA.” See VA Handbook 6500.6, Appendix C, paragraph 3.a.
2.5.2 A requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access, the contractor/subcontractor shall immediately and simultaneously notify the COIR, the designated ISO, and Privacy Officer for the contract. The term ‘security incident’ means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a.
2.5.3. A requirement to pay liquidated damages in the event of a data breach: “In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals.” See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d, Section 3: Security
3.1. General
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.
3.2. Access to VA Information and VA Information Systems
a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.
b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.
c. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.
Section 4: Quality Assurance Plan:
4.1 A quality assurance plan and the required data must be submitted to Chief of Pathology and Laboratory Medicine at VASNHCS for approval and reviewed annually. This plan must meet the requirements of the College of American Pathologists, or approved accreditation agency of VASNHCS. Changes to the quality assurance plan require the approval of Chief of Pathology and Laboratory Medicine at VASNHCS, who serves to monitor the contractor for compliance with the quality assurance plan and accreditation agencies. The contractor remains ultimately responsible for the operation and outcome of the procedure. The Departments of Surgery, Patient Care and Pathology of Laboratory Medicine are jointly responsible for monitoring the satisfactory performance of the contract by the contractor.
4.2 Sample of Quality Assurance Plan:
4.2.1. A physician’s request is required for procedure and entered in surgery schedule through CPRS.
4.2.2 Procedure is performed by credentialed auto-transfusionist. This individual will be responsible for the operation of the Cell Saver and will accurately collect processes and provide blood to be re-infused when using the Cell Saver according to the procedure outlined.
4.2.3 The patient will receive his/her own blood that has been salvaged and processed during the intra-operative phase in a safe and timely manner.
4.2.4 Quality Assurance monitoring will be done by performing the following:
a. Ensuring clear color of the liquid in the waste line
b. Hematocrit - washed salvaged blood has a hematocrit in the average range of 45- 60%; however, can be case and patient dependent
c. Albumin <1.5 g/dL
d. Potassium < 4.0 mmol/L
e. Volume reinfused will be verified and documented.
f. Visual inspection of equipment, its functional properties, and blood being processed, including clotting/debris will be observed.
4.2.5 Blood containing alcohol, iodofor, sterile water, peroxide, topical coagulation products, Avitene, nonparenteral irrigants, or topical antibiotics should not be aspirated into the reservoir. If these products are aspirated, then the reservoir must be discarded and not processed for patient administration.
4.2.6 Intraoperative blood salvage is contraindicated in the presence of bacterial contamination or malignancy.
4.2.7 The blood temperature in the reservoir is not to exceed 37 degrees Celsius.
4.2.8 A regulated vacuum device must be used. The American Association of Blood Bank guideline recommends suction at levels of 150 mmHg or less to preserve RBC recovery. Discrepancy in any of the events described during machine start-up or if action taken to correct an alarm situation is unsuccessful, follow equipment failure in Safety Manual. See operating instructions attached to the machine.
4.2.9 Blood must be collected in a sterile grade 6 plastic reservoir or cell saver cardiotomy.
4.2.10 Washed red cells will be accurately labeled with patient identification sticker on reinfusion bag.
Section 5: VA Information Custodial Language
a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).
b. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.
c. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.
5.1. Security Incident Investigation
a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the VA POC and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.
b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.
c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.
d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.
5.2. Liquidated Damages for Data Breach
a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/ subcontractor processes or maintains under this contract. However, it is the policy of the VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in the amount determined to be adequate by the agency.
b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
c. Each risk analysis shall address all relevant information concerning the data breach, including the following:
(1) Nature of the event (loss, theft, unauthorized access);
(2) Description of the event, including:
(a) date of occurrence;
(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
(3) Number of individuals affected or potentially affected;
(4) Names of individuals or groups affected or potentially affected;
(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
(6) Amount of time the data has been out of VA control;
(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
(8) Known misuses of data containing sensitive personal information, if any;
(9) Assessment of the potential harm to the affected individuals;
(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $_37.50_ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
(1) Notification;
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
(3) Data breach analysis;
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
(6) Necessary legal expenses may incur to repair falsified or damaged credit records, histories, or financial affairs.
5.3. Training
a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide the contracting officer and/or the VA POC a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
5.4. Security Requirements for Unclassified Information Technology Resources
The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.
5.5. Security Accreditation Package (C&A) –
The C&A requirements do not apply and a Security Accreditation Package is not required.
Section 6: Attachments and Links
VA Handbook 6500.6; https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=471&FType=2 36C26127Q0077
Page 1 of Page 1 of B.2 Salient Characteristics
Brand Name Item: Autoprofusionist Services / Cell Saver Lease
1) Essential/significant physical, functional, or performance characteristics.
· The purpose of utilizing a Cell Saver is to suction blood from the patient using a heparinized suction tubing device, collected in a sterile bowl and gently wash and centrifuge red blood cells, then pump it into a blood administration bag for the anesthesiologist to infuse back to the patient.
· This system is indicated for use for intraoperative recovery of blood, washing of blood collected in the postoperative period and preoperative sequestration (with indirect patient connection).
· Unit Dimensions Height = 660 mm (1055 mm*) - pole lowered Height = 1585 mm (1980 mm*) - pole completely lifted Height = 835 mm (1230 mm*) - display lifted Width = 375 mm - including the eccentric rings Width = 800 mm - with poles completely open Depth = 500 mm - 680 mm including the front and rear handles* = with cart
· Cart Dimensions Height = 500 mm Width = 480 mm Depth = 595 mm
· Mains voltage (power supply) 230 V ~ or 100-120 V~
· Power absorption: Maximum: 320VA (550VA w/ vacuum on Intra mode)
· Plug on cords: Type VII (CEE(7) VII), Type NEMA 5-15, Type BS89/10 (BS 1363/A), Type I/3) CEI 23-16)
· Unit Electrical safety: Class I, Type B (EN 60601-1)
2) Applicable model/make/catalog number - NA
3) Manufacturer name – Perfusion Inc.
B.3 PRICE/COST SCHEDULE
ITEM INFORMATION
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 4.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service inclusive of ATS disposable supplies(bowl set, reservoir, aspiration line) Contract Period: Base POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies
MANUFACTURER PART NUMBER (MPN): N/A
| 12.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service. Inclusive of ATS Disposable supplies - on call
POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Perfusion Equipment lease (LivaNova Xtra ATS System (New) OR Medtronic Autolog IQ ATS. Service included.
POP Begin: 11-01-2026 POP End: 10-31-2027 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 4.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service inclusive of ATS disposable supplies(bowl set, reservoir, aspiration line)
POP Begin: 11-01-2027 POP End: 10-31-2028 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service. Inclusive of ATS Disposable supplies - on call
POP Begin: 11-01-2027 POP End: 10-31-2028 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Perfusion Equipment lease (LivaNova Xtra ATS System (New) OR Medtronic Autolog IQ ATS. Service included.
POP Begin: 11-01-2027 POP End: 10-31-2028 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 4.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service inclusive of ATS disposable supplies(bowl set, reservoir, aspiration line)
POP Begin: 11-01-2028 POP End: 10-31-2029 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service. Inclusive of ATS Disposable supplies - on call
POP Begin: 11-01-2028 POP End: 10-31-2029 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Perfusion Equipment lease (LivaNova Xtra ATS System (New) OR Medtronic Autolog IQ ATS. Service included.
POP Begin: 11-01-2028 POP End: 10-31-2029 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 4.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service inclusive of ATS disposable supplies(bowl set, reservoir, aspiration line)
POP Begin: 11-01-2029 POP End: 10-31-2030 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service. Inclusive of ATS Disposable supplies - on call
POP Begin: 11-01-2029 POP End: 10-31-2030 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Perfusion Equipment lease (LivaNova Xtra ATS System (New) OR Medtronic Autolog IQ ATS. Service included.
POP Begin: 11-01-2029 POP End: 10-31-2030 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 4.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service inclusive of ATS disposable supplies(bowl set, reservoir, aspiration line)
POP Begin: 11-01-2030 POP End: 10-31-2031 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Intra-Operative Non-Cardiac Autotransfusion Professional Service. Inclusive of ATS Disposable supplies - on call
POP Begin: 11-01-2030 POP End: 10-31-2031 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| 12.00 |
| EA |
| __________________ |
| __________________ |
Perfusion Equipment lease (LivaNova Xtra ATS System (New) OR Medtronic Autolog IQ ATS. Service included.
POP Begin: 11-01-2030 POP End: 10-31-2031 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing
| GRAND TOTAL |
| __________________ |
B.4 DELIVERY SCHEDULE
| ITEM NUMBER |
| SHIPPING INFORMATION |
| QUANTITY |
| DELIVERY DATE |
| 0001-0003 |
| SHIP TO: |
| VA Sierra Nevada Healthcare System |
975 Kirman Ave.
Reno, NV 89052
USA
| 1 LOT |
| 11/01/2026- 10/31/2027 |
| FOB: |
| DESTINATION |
| 1001-1003 |
| SHIP TO: |
| VA Sierra Nevada Healthcare System |
975 Kirman Ave.
Reno, NV 89052
USA
| 1 LOT |
| 11/01/2027- 10/31/2028 |
| FOB: |
| DESTINATION |
| 2001-2003 |
| SHIP TO: |
| VA Sierra Nevada Healthcare System |
975 Kirman Ave.
Reno, NV 89052
USA
| 1 LOT |
| 11/01/2028- 10/31/2029 |
| FOB: |
| DESTINATION |
| 3001-3003 |
| SHIP TO: |
| VA Sierra Nevada Healthcare System |
975 Kirman Ave.
Reno, NV 89052
USA
| 1 LOT |
| 11/01/2029- 10/31/2030 |
| FOB: |
| DESTINATION |
| 4001-4003 |
| SHIP TO: |
| VA Sierra Nevada Healthcare System |
975 Kirman Ave.
Reno, NV 89052
USA
| 1 LOT |
| 11/01/2030- 10/31/2031 |
| FOB: |
| DESTINATION |
Page 1 of
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)
(a) Definitions. The clause at Federal Acquisition Regulation (FAR) 52.202-1, Definitions, is incorporated by reference.
(b) 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.
(c) 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.
(d) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.
(e) 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 FAR 52.233-1, Disputes, which is incorporated in this contract by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.
(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. Examples of occurrences include 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. When an excusable delay occurs, the Contractor shall—
(1) Notify the Contracting Officer in writing as soon as possible;
(2) Remedy the delay as quickly as possible; and
(3) Notify the Contracting Officer when the occurrence is over.
(g) Invoice. The Government will handle invoices according to the Prompt Payment Act (31 U.S.C. 3903) and 5 CFR part 1315. The Contractor shall submit invoices to the address designated in the contract to receive invoices. An invoice must include the information required by 5 CFR part 1315.9(b).
(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) 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 that appears on the payment check or the specified payment date if an electronic funds transfer payment is made.
(4) 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;
(D) Contractor point of contact; and
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(5) 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 FAR part 33 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 FAR part 32).
(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 termination for cause.
(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 for interest credits prescribed in FAR part 32 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 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. The Government will send a cure notice to the Contractor, unless the reason for the termination is late delivery. 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 under this contract 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) 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; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Government-financed air transportation; and 41 U.S.C. chapter 21 relating to procurement integrity.
(r) 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 Disputes, Payments, Invoice, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;
(3) Other contract clauses incorporated in the solicitation or contract;
(4) Addenda to this solicitation or contract,
(5) Solicitation provisions incorporated in the solicitation.
(6) Other paragraphs of this clause.
(7) Other documents, exhibits, and attachments; and
(8) The specification.
(s) Unauthorized obligations.
(1) Except as stated in paragraph (s)(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 (s)(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.
(t) Comptroller General examination of record. This paragraph applies if this contract was awarded using other than sealed bid procedures and is in excess of the simplified acquisition threshold on the date of award of this contract.
(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…
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