36C25221Q0676.docx

36C25221Q0676

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

578-21-3-105-0281 36C25221Q0676 Amy Burger 414 844-4800 05-17-2021

3PM

CDT

36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 X X 339112 1000 Employees N/A X 36C252 Great Lakes Acquisition Center (GLAC) Department of Veterans Affairs 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 See CONTINUATION Page This is a brand-name only solicitation. Only authorized vendors of Medtronic equipment can participate.

Please submit proof of authorization with bid.

See full description of order in Section B.

See CONTINUATION Page X X X Teresa Beers-Wesolowski

SECTION B - CONTINUATION OF SF 1449 BLOCKS

CONTRACT ADMINISTRATION DATA

B.1 CONTRACT ADMINISTRATION

All contract administration matters will be handled by the following individuals:

A. CONTRACTOR: ____________ ___________ (Contractor’s Name) _________________ ___ (Address) ____ __(City-State-Zip) (Point of Contact/Title)

PHONE NUMBER: _________________________

FAX NUMBER: ______ ______________ _

E-MAIL ADDRESS: _________________________

DUNS NUMBER: ____________________ ____

B. GOVERNMENT: AMY BURGER, CONTRACT SPECIALIST

DEPARTMENT OF VETERANS AFFAIRS

GREAT LAKES ACQUISITION CENTER

115 S. 84TH ST., SUITE 100

MILWAUKEE WI 53214-1476

PHONE NUMBER: 414-844-4800 EXT. 43272

EMAIL: AMY.BURGER@VA.GOV

B.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

B.3 INVOICES

Invoices shall be submitted in arrears in accordance with:

a. 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

b. UPON ACCEPTANCE OF ITEMS

B.4 GOVERNMENT INVOICE ADDRESS

All invoices from the contractor shall be submitted electronically in accordance with 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

FACSIMILE, E-MAIL, AND SCANNED DOCUMENTS ARE NOT ACCEPTABLE FORMS OF SUBMISSION FOR PAYMENT REQUESTS.

For assistance setting up e-Invoice, the below information is provided:

* Vendors must register online at http://www.tungsten-network.com/veteransaffairs/

* Tungsten Network Setup Information: 1-866-340-4980

* Tungsten Network email: VA.Registration@tungsten-network.com

* FSC Vendor Support Section Contact: 1-877-353-9791

* FSC Vendor Support Section email: vafsccshd@va.gov

Vendors can inquire on the status of payments by accessing VIS at: https://www.vis.fsc.va.gov/login.aspx?ReturnUrl=%2fDefault.aspx

INVOICES: Invoices shall be submitted in arrears:

Vendor inquires: Toll Free Number 1-877-353-9791

Statement of Work Study Title: Defining novel pharyngeal pressure metrics to predict dysphagia treatment outcomes and clinical prognosis using high-resolution manometry

Equipment Title: High Resolution Manometry (pHRM) ManoScan® system (ManoScan® ESO High Resolution Manometry System)

Background Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. In 2016, speech-language pathologists working in the VA completed more than 102,905 evaluation and 77,786 treatment procedures for oropharyngeal dysphagia. This highlights not only the incidence of suspected dysphagia in the Veteran population but also the substantial need for dysphagia management with appropriate outcomes tracking. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function.

We propose that adding pHRM to standard assessments will help address three current issues: 1) lack of objective measures to accurately monitor treatment effects; 2) uncertainty of how physiological measures relate to patient-reported outcome measures; and 3) absence of prognostic algorithms that predict treatment effects. This proposed project will address our central hypotheses that objective swallowing measures (including pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment.

This work begins to address a significant deficit in knowledge and thus clinical care: How does swallowing function change following treatment? Dysphagia is a significant healthcare burden for Veterans; the clinical framework used to justify treatment is weakly supported by research; and dysphagia sequelae represent a major component of U.S. health care spending annually (a half billion dollars). With advances in clinical tools to measure swallowing, we can evaluate function with greater precision. This work leverages several novel recent innovations in instrumentation and mathematical modelling/computer programming to create a more robust clinical environment that will empower clinicians, patients, caregivers, and healthcare networks to provide guided and justified care of dysphagia. Combining objective pHRM data with other measures of swallowing physiology and patient-centered factors will support the creation of algorithms to track and predict rehabilitative success. When these aims are completed, we will set the path for a precision medicine approach that can be used to investigate the role of any new, novel, or even poorly supported dysphagia treatment that has clinical promise but needs an evidence-base. The support and success of this research vision will lead to a paradigm shift in the care of Veterans with dysphagia.

Oropharyngeal dysphagia is a devastating condition that affects 1 in 25 adults, leading to debilitating psychosocial sequelae and life-threatening complications, such as aspiration pneumonia, as well as 500 million dollars of annual healthcare spending. In 2016, speech-language pathologists working in the VA completed more than 102,905 evaluation and 77,786 treatment procedures for oropharyngeal dysphagia. This highlights not only the incidence of suspected dysphagia in the Veteran population but also the substantial need for dysphagia management with appropriate outcomes tracking. Clinical tools available for monitoring dysphagia therapy outcomes are limited, preventing the development of prognostic clinical algorithms, limiting accuracy in interventions, and undermining confidence in patient care. Pharyngeal high-resolution manometry (pHRM) provides direct and objective measurement of swallow-related pressure and timing events in the pharynx. Research by our team has resulted in a normative pHRM database and ensured that pHRM quantifies the complex physiology of normal and intentionally perturbed human swallowing with detail, consistency, and reliability. A critical step forward in dysphagia management is evidencing the clinical utility of pHRM

This study is designed to advance dysphagia management by capturing objective data following treatment, with the long-term goal of improving precision and predictive capabilities of dysphagia diagnostic tools. We propose that adding pHRM to standard assessments, biological data, and patient reported outcome measures will address three issues: 1) lack of objective measures to adequately monitor treatment effects; 2) uncertainty of how physiological measures relate to patient-reported outcome measures; and 3) absence of prognostic algorithms that predict treatment effects. This application is innovative and will influence the management of millions of patients, potentially reduce dysphagia-related mortality, provide realistic treatment expectations, and improve utilization of resources. This multi-site trial will follow a cohort of Veterans with dysphagia (n=150) for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. During treatment, patients will undergo pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome (PRO) questionnaires at 3 standardized time points: baseline, 4 weeks after treatment initiation, and after treatment completion (8 weeks). Non-dysphagic controls (n=50) will also undergo data collection at parallel time points.

We propose to achieve our objectives by using the data collected to complete the following three specific aims:

1. To quantify change in pHRM and other measures of swallowing function resulting from dysphagia treatment. This aim will a) identify pHRM metrics that characterize the diagnoses of pharyngeal dysphagia due to muscle weakness at baseline; b) document physiological progress, or lack thereof, over the course of dysphagia therapy, and c) determine the normal variability of pHRM and other metrics in non-dysphagic adults over time. Logistic regression will discern which pressure metrics, calculated from baseline pHRM data, best define the patient group compared to normative values. All metrics will be compared across time points to identify which metrics change with therapy, and how they change relative to non-dysphagic controls. Hypotheses: Clusters of metrics will distinguish the patients from controls at baseline. Metrics will remain stable in controls over time. Clusters of metrics will change in patients with successful treatment in a direction towards normative values. Significance: Identification of clinically-relevant pressure metrics, as well as documentation of natural pressure variability, will improve the validity of pHRM as a clinically useful tool.

2. To determine which combination of standard of care and/or pHRM-based metrics best track with outcome measures of treatment effect. Magnitude of change between time points will be calculated for each metric extracted from videofluoroscopy, diet, and pHRM data and analyzed using regression models, with treatment effect (change in total Sydney Swallow Questionnaire (SSQ) score and Modified Barium Swallow Impairment Profile(MBSImPTM ) pharyngeal impairment score between time points) as the dependent variable. Hypothesis: pHRM metrics will account for significant variance in regression models predicting treatment effect. Significance: Identifying a combination of metrics that change in response to treatment will provide clinicians with salient variables to monitor and will provide data for prognostic algorithms.

3. To develop multimodal prognostic algorithms that predict treatment success from baseline diagnostic measures. We will use mathematical models (artificial neural network programming and regression models) populated with physiological and patient-specific data to identify metrics most predictive of treatment success (change toward control values on SSQ and MBSImPTM). Hypothesis: pHRM data and factors such as age and adherence will nest with treatment success. Significance: Currently, no prognostic algorithms exist for dysphagia rehabilitation. This aim will provide a tool to help guide patients and clinicians towards realistic expectations for treatment outcomes.

Swallowing Disorders Impact Personal Health, Quality of Life, and Healthcare Cost to Society: Swallowing is a fundamental, yet biomechanically complex, function of the human body. Standard of care diagnostic and outcome tools used in the evaluation of the oropharyngeal swallowing are largely qualitative in nature and do not allow for the quantification of the pressure abnormalities that occur with swallowing dysfunction (dysphagia). As such, the proposed research is highly significant in its applying a novel and objective tool, pharyngeal high-resolution manometry (pHRM), as an adjunct for diagnosis, prognosis, and outcome tracking in personalized clinical care of oropharyngeal dysphagia. Once diagnosed with dysphagia, the ability to restore swallowing function to an optimal state significantly impacts overall health status. Dysphagia is a tremendous financial burden, has disabling psychosocial consequences, and increases risk of hospitalization and life-threatening medical complications including malnutrition, dehydration, and aspiration pneumonia. Therefore, improvement in precision of dysphagia rehabilitation is imperative.

Oropharyngeal Dysphagia Treatment Outcome Measurement: Current State & Limitations: Clinical rehabilitation of swallowing function can be directed at one or more physiological goals: 1) improvement in strength of swallowing-related muscle activity; 2) relief of upper esophageal sphincter dysfunction; and/or 3) improvement in the timing and coordination of swallowing events. To address these physiological processes, various therapeutic options are used alone or in combination. While most theories supporting these treatments are physiologically sound, there remains a major gap in the literature confirming the physiological changes following these treatments. Although videofluoroscopy remains custom for dysphagia diagnosis and monitoring of treatment progress, this standard tool alone is ineffective in providing unbiased interpretation, direct and reproducible measurements, or complete understanding of mechanism of the dysphagia nor the functional changes following dysphagia treatment. It is also unclear how patient-reported outcome measures for dysphagia, and biological conditions such as age and disease severity, are related to physiological changes in swallowing function. Our research will fill this critical gap in knowledge and will pave the way for a personalized medicine approach for dysphagia.

Pharyngeal HRM is Poised to Support Dysphagia Treatment Outcome Measurement: Measurement of intraluminal pressure provides quantification of pharyngeal muscle functionality. Pharyngeal high-resolution manometry (pHRM) is a minimally-invasive, non-radiation based tool used to quantify pressure generation and gradients within the alimentary canal at high spatiotemporal resolution (50Hz, sensors every cm, spanning 36cm). Published reports from around the world have illustrated the successful use of pHRM to define normal pressure events and the effects of maneuvers, bolus volumes, and age. pHRM incorporated with impedance allows for bolus tracking, pharyngeal residue identification, and airway invasion risk prediction. Thus far, pHRM has been applied to study pressure characteristics in a variety of swallowing dysfunction pathologies. Preliminary evidence has been published illustrating case examples using pHRM to document progress from pharyngeal muscular strengthening and outlet obstruction relief. However, the heterogeneous nature of dysphagia warrants study of a large number of patients using multivariate analyses and available relevant data.

Scientific Premise, Central Hypotheses, and Clinical Impact of Proposed Study: The premise of this work lies in the overwhelming evidence of the successful, reproducible, and informative application of pHRM, alongside other standard measures, in the evaluation of healthy swallowing physiology and detection of swallowing dysfunction. Preliminary evidence illustrates that pHRM metrics can improve characterization of the neuromuscular failures underlying any form of dysphagia and can document change with treatment over time (specifically in pharyngeal strengthening and UES dysfunction therapy cases). The strength of these data indicates that pHRM has moved from a state of infancy to a point where it now has the potential to be useful in dysphagia clinical care. However, further study is needed to provide confirmation of its clinical usefulness and discern all the salient metrics in this heterogeneous group of patients. Further, there are currently no prognostic algorithms for swallowing rehabilitation.

Small peer-reviewed studies have shown the potential power in pHRM to train neural network systems to classify pathological states of swallowing. We hypothesize that introducing pHRM will add precision to clinical outcome care, allow us to define relationships among physiological changes and patient reported outcomes, and provide prognostic algorithms that predict treatment effects. Studying patient populations with pHRM will also add greatly to the understanding of the mechanisms responsible for unique patient-specific manifestations of dysphagia. By determining objective measures that quantify therapeutic clinical improvement, or lack thereof, this work will result in additional clinical tools that can be used to target treatment plans for patients based on individualized pressurerelated metrics and/or prognostic algorithms.

This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.

Scope The High Resolution Manometry (pHRM) ManoScan® system (ManoScan® ESO High Resolution Manometry System will be used to address three issues: 1) lack of objective measures to adequately monitor treatment effects; 2) uncertainty of how physiological measures relate to patient-reported outcome measures; and 3) absence of prognostic algorithms that predict treatment effects. This application is innovative and will influence the management of millions of patients, potentially reduce dysphagia-related mortality, provide realistic treatment expectations, and improve utilization of resources.

Tasks or Requirements:

ManoScan™ ESO Z module and catheter provide circumferential assessment of bolus movement as well as physiological mapping of esophageal motor function.

Impedance measurements to improve the ability to predict the success of failure of bolus movements through the esophagus

Maps from the pharynx to the stomach, with a single placement of the catheter

High resolution esophageal catheter with impedance:

36 channels with 12 measuring points per sensor provide 432 points of measurement 18 impedance channels display bolus transition from pharynx to esophagus

4.2 mm diameter True circumferential sensors

Selection Criteria The ManoScan ESO high resolution manometry system enables full evaluation of the motor functions of the esophagus. The system allows for enhanced sensitivity that provides useful information to support diagnosis of conditions like dysphagia, achalasia, and hiatal hernia. By precisely quantifying the contraction of the esophagus and its sphincters, a more complete pressure profile for patients is provided.

Attributes unique to the ManoScan System include:

Portable cart system LCD flat panel touchscreen with articulating arm Modular data acquisition controller Windows®*-based operating system LAN connection and WiFi-enabled Integrated catheter auto-calibration system Large lockable wheels Patient isolation transformer High-speed quality printer ManoView™ software Procedural tools yield precise measurement and detailed data analysis Anatomical profile display includes graphical pointers to identify landmarks, including LES, UES, and PIP eSleeve function instantly measures and ensures that sphincter barrier pressures are correctly recorded, despite movement of the LES/EGJ during swallowing High-resolution and conventional displays provide versatile and complete motility visualization ManoView™ software can be installed on any Windows®*-based computer

B.5 PRICE/COST SCHEDULE

ITEM INFORMATION

47177 MANOSCAN HRM WORKSTATION WITH CART. DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 47177

FGS-8039 MANOSCAN CART X1. DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: FGS-8039

111489 PS MONITOR 22IN ELO MULTITOUCH X1. DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 111489

111490 PS PRINTER DELL LASER X1. DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 111490

FGS-0651 WS GIFD 3020 WIN 10 W SW.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770.

LOCAL STOCK NUMBER: FGS-0651

3282-CALIBRATION SET UP MODULAR CARTX1.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 3282

3283 MODULAR CART ACCESSORY KIT X1.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 3283

FGS-8043 ESOPHAGEAL HRM PRACTICAL GUIDE.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: FGS-8043

FGS-0571 MANOSCAN V3.0 SOFTWARE KITX1.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: FGS-0571

FGS-0628 SOFTWARE MANOVIEW ESO V3.3.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770.

LOCAL STOCK NUMBER: FGS-0628

FGS-8030 MANOVIEW V3.0 SOFTWARE KIT.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: FGS-8030

FGS-4374 MANOSCAN A120 ACQUISITION MOD.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: FGS-4374

4189 MANOSCAN Z A200 X1.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 4189

4284-GIV ACCESSORY KIT HRMZ X1.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 4284-GIV

3890 MANOSCAN ESO Z CATH X1.DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 3890

80372 HRM CATHETER EXTENDED WARRANTY 1 YEAR. DELIVER TO BUILDING 12, 3RD FLOOR ROOM 309B:EIL IS 770

LOCAL STOCK NUMBER: 80372

2680 PS MICKAEY M-3PONG PC POWER CORDX1. DELIVER TO BUILDING 12, 3RD FLOOR rOOM 309B: EIL IS 770

LOCAL STOCK NUMBER: 2680

ESTIMATED FREIGHT 1375.68.

B.2 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

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

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

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

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

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

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

(i) Payment.—

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

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

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

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

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

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

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

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

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

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

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

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

(A) The date fixed under this contract.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

(1) The schedule of supplies/services.

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

(3) The clause at 52.212-5.

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

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

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

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

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

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

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

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

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

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

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

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

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

C.3 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.] [] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[X] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[X] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.

[X] 852.232–72, Electronic Submission of Payment Requests.

[] 852.233–70, Protest Content/Alternative Dispute Resolution.

[] 852.233–71, Alternate Protest Procedure.

[] 852.237–70, Indemnification and Medical Liability Insurance.

[X] 852.246–71, Rejected Goods.

[] 852.246–72, Frozen Processed Foods.

[] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.

[] 852.270–1, Representatives of Contracting Officers.

[] 852.271–72, Time Spent by Counselee in Counseling Process.

[] 852.271–73, Use and Publication of Counseling Results.

[] 852.271–74, Inspection.

[] 852.271–75, Extension of Contract Period.

[] 852.273–70, Late Offers.

[] 852.273–71, Alternative Negotiation Techniques.

[] 852.273–72, Alternative Evaluation.

[] 852.273–73, Evaluation—Health-Care Resources.

[] 852.273–74, Award without Exchanges.

(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause:

[] 852.237–74, Nondiscrimination in Service Delivery.

(End of Clause) C.4 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes FAR 52.219-6 Notice of Total Small Business Set-Aside.

(b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

(End of Clause) C.5 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting commitments.

(End of Clause)

C.6 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause) (End of Addendum to 52.212-4)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020) (DEVIATION)

(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 items:

(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 (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115–232).

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

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 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…