36C24721Q0698_2.docx

36C24721Q0684 Contract Opportunity Modification to a Previous Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

BASE NOTICE TYPE

RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Modification to a Previous Notice ENT Sinus Navigation 36109-3798 36C24721Q0698 P 05-18-2021 13:00

EASTERN TIME, NEW YORK, USA

N

SDVOSBC

339112 Department of Veterans Affairs Central Alabama Veterans Health Care 2400 Hospital Road Bldg 68, Rm 221 Tuskegee, AL 36083 Same as above Benford C Brundage Benford.Brundage@va.gov 334-727-0550 x5033 Charlie Norwood VAMC 1 Freedom Way Augusta, GA 30904

30904

USA

Benford.Brundage@va.gov Benford Brundage Charlie Norwood VAMC – ENT Sinus Navigation System This is a solicitation for commercial items prepared in accordance with the format in Subpart 12.6 and/or 8.4, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will also be attached.

The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. All proposals must be received prior to 1:00pm EST on May 18, 2021. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. NAICS code is 339112, Surgical & Medical Instrument Manufacturing, business size 1,000 employees.

The procurement is 100% Service-Disabled Veteran Owned Small Business Set-Aside. The Government intends to award a firm fixed price contract in accordance with all terms, conditions and provisions. Any resultant contract will be effective at the Government's discretion. Equipment/Supplies will be at such times and in such quantities as required, FOB destination.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-72 effective January 30, 2014. Please see RFQ document 36C24721Q0698 for requirements.

Potential vendors are to complete the attached RFQ document and submit an itemized quote as well as submit sufficient supporting documentation which details product specifications. This supporting documentation will be used to determine whether or not the quoted items meet the requirements of the solicitation.

Information about current or previous vendors providing this/these or similar services such as; Contract Information, Vendor Name, Contract Number, Pricing, etc. WILL NOT be provided to potential bidders.

RFQ Response Requirements and Information

1) This is a brand name or equal procurement.

2) Vendors must complete the VA issued RFQ in order to be considered for award. A vendor provided quote, proposal or attachment is not acceptable as a bid offer.

3) Only one award will be made to one vendor that can provide all items/services at the MOST ADVANTAGEOUS COST TO THE GOVERNMENT.

4) Please provide pictures and specifications if you are not offering EXACTLY what the government is requesting.

5) All RFQ responses must include all associated fees such as; Shipping, Delivery, Administration and delivery if required. See Statement of Work and other attachments for more detail if included.

6) All questions must be addressed by email no later than 4:00pm EST on May 14, 2021.

Quotes are due no later than 1:00pm EST, May 18, 2021. Telephone calls will not be accepted. All quotes are to be sent electronically to Benford.Brundage@va.gov

BID INSTRUCTIONS FOR COMPLETING RFQ / SF 1449

1) Please acknowledge if your firm is a SERVICE DISABLED VETERAN OWNED SMALL BUSINESS, VETERAN OWNED SMALL BUSINESS or NON-VETERAN OWNED SMALL BUSINESS in block 17a on the first page of the SF1449/Solicitation.

2) Please provide pictures and specifications if you are not offering EXACTLY what the government is requesting. If you are offering the EXACT ITEMS/SERVICE/SUPPLIES being requested by the government, please verify and/or state that fact in the on page one (1), block 19 of the SF1449/Solicitation.

3) Information about current or previous vendors providing this/these or similar services such as; Contract Information, Vendor Name, Contract Number, Pricing, etc. WILL NOT be provided to potential bidding vendors.

4) Review Statement of Work and Other Attachments, (if applicable), for DETAILED INFORMATION.

5) Per the solicitation, your firm MUST COMPLETE THE ATTACHED RFQ and email completed document back to this office by the close of award CST in order to be considered for award. A standard quote will not suffice.

SF 1449 sections for Vendor Completion – Section 17a – Vendor Information Section 26 - Total Amount of Bid/Offer Section 30a-c – Vendor name, signature and date

Section B. (Cost/Price Schedule) section for Vendor Completion – Unit Price – Unit Price for each separate line item Amount – Quantity multiplied by Unit price by each separate line item Grand Total – Total aggregate amount of all line items

I have provided a SAMPLE of how to complete Section B.3 – The Price/Cost Schedule below:

B.3 PRICE/COST SCHEDULE

Item Information

Item No. Description Quantity Unit Unit Price Amount

GRAND TOTAL $2,500.00

The B.3 Price/Cost Schedule above is a SAMPLE ONLY

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 ATTA

CHED

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. SIGNAT

URE 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

36C24721Q0698 05-11-2021 Bryant Murray 706-733-0188 x3144 05-18-2021 13:00

EDT

90C Department of Veterans Affairs Central Alabama Veterans Health Care 2400 Hospital Road Tuskegee, AL 36083 36109-3798 X X 339112 1000 Employees N/A X 90C Charlie Norwood VA Medical Center Freedom Way Augusta, GA 30904

Department of Veterans Affairs Central Alabama Health Care System East Campus 2400 Hospital Road Tuskegee AL 36083-5001

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Provide ENT Sinus Navigation - Augusta, GA VAMC This is a Service-Disabled Veteran Owned Business Set-aside.

Your firm must be verified in the VIP database using the appropriate NAICS code at the time of RFQ submission and at the time of award.

This is a BRAND or EQUAL Procurement.

Only one award will be made to on e vendor that can offer all equipment/services at the most advantageous cost to the gov.

All questions must be submitted by 4:00pm EST on 5/14/2021 See CONTINUATION Page X X X Benford C. Brundage Contracting Officer Table of Contents

Page 1 of

Page 1 of

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 36C247 B. Cortez Brundage Department of Veterans Affairs Central Alabama Veterans Health Care 2400 Hospital Road Tuskegee, AL 36083 36109-3798

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

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

Salient Characteristics Image Guided Surgical Stereotactic System for ENT

1. Contractor shall provide one (1) Image Guided Surgical Stereotactic System that meets the specifications outlined in the salient characteristics document and the below listed system requirements:

a) Power: 110 / 120V, 60 Hz Operating Device

· System shall be tested against and comply with IEC 60601-1 (General Requirements for Basic Safety and Essential Performance).

· System shall be tested successfully in accordance with IEC 61000-4-3 (Radiated, Radio-Frequency, Electromagnetic Field Immunity Test) and IEC 61000-4-6 (Immunity to Conducted Disturbances, Induced by Radio Frequency Fields).

b) System Area Footprint: Main system (on rolling cart) shall not exceed 30” in width, shall not exceed 30” in depth (not including monitor/ display protrusion due to articulating arm positioning).

c) Main system shall have a rolling cart (no exceptions).

d) System shall support electromagnetic localization/ navigation (tracking of instruments). System shall be able to localize/ track instruments and patient anatomy simultaneously.

· System shall have low-energy magnetic field emitters that work with instruments containing electromagnetic sensors that allows the navigation software to track instrument location. The emitter shall have an interface box with connection ports to directly interface with specialized instruments. Emitter interface box shall be directly attached and or built into the main system cart.

e) System software shall allow surgeons/ clinical staff to map points between the patient and images. Software shall be able to identify specific points on displayed anatomical images when surgeons touch patient anatomy with tracked instruments.

f) System software shall be compatible with specialized instruments that allow for electromagnetic localization that are already owned by CNVAMC.

g) System shall be compatible with disposable accessories that are already stocked by CNVAMC.

h) System software shall be capable of dynamic referencing in order to ensure accurate instrument navigation when anatomy shifts/ changes position. System shall contain a localizer and emitter capable of supporting dynamic referencing.

i) Electromagnetic (EM) Emitter(s):

· System shall support a side mounted EM Emitter. The EM field suitable for navigation should exceed the following minimum specifications (and meet any other specs below):

· Length: 12” (Along Coronal Plane, Axis from Patient Shoulder to Shoulder).

· 16” for Sagittal Plane Axis.

· Frequency Transmission Range: 3 – 30 kHz.

· Power: Not to exceed 30 W

· Emitter Field Offset: Range 5 – 10 cm.

· System shall support an EM Emitter that may be placed underneath a patient on a surgical table. The EM field suitable for navigation should exceed the following minimum specifications (and meet any other specs below):

· 14” for all three dimensions.

· Frequency Transmission Range: 3 – 30 kHz.

· Power: Not to exceed 30 W.

· Emitter Field Offset: 5 cm (± 1 cm)

j) System shall have a High Definition touchscreen display.

k) System shall have a keyboard and mouse.

l) The proposed Stereotactic Surgical System shall allow CNVAMC Surgeons to achieve the navigation/ localization necessary in order to successfully complete the following procedures (not limited to the list below, but inclusive):

i. Sinus Surgery

ii. Airway Procedures

iii. Otology, Neurotology, Lateral, and Trans-nasal Skull Base Surgery.

iv. Otology and Neurotology Procedures

v. Inferior Turbinoplasty

STATEMENT OF WORK

Image Guided Surgical Stereotactic System for ENT

A. GENERAL INFORMATION

1. Purpose: Procurement of Surgical Stereotactic System for Otolaryngology (ENT).

2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. Contractor shall procure, deliver and install a Surgical Stereotactic System as identified in this document.

3. Background: ENT currently uses a Medtronic Stealth Station S7 Image Guided Stereotactic System for surgical procedures that requires navigation (localization) of instruments in relation to anatomical structures. The existing system is getting closer to end-of-life and will soon exceed life expectancy. CNVAMC ENT is seeking to replace the system with a newer, upgraded model.

4. Performance Period: This is a onetime purchase; delivery should be completed within sixty (60) days from date of award.

5. Type of Contract: Firm-Fixed-Price.

6. Place of Performance: Delivery will be made to Charlie Norwood VA Medical Center, 1 Freedom Way, Augusta GA 30904. Installation will be performed in Building 801, Operating Room located on 3rd Floor, Wing A.

7. Hours of Operation: Warehouse deliveries are accepted between 8am and 3:30pm, Monday through Friday, excluding holidays.

Hospital normal hours of operation are between 8am and 4:30pm, Monday through Friday, excluding holidays.

B. GENERAL REQUIREMENTS

2. Contractor shall provide one (1) Image Guided Surgical Stereotactic System that meets the specifications outlined in the salient characteristics document and the below listed system requirements:

m) Power: 110 / 120V, 60 Hz Operating Device

· System shall be tested against and comply with IEC 60601-1 (General Requirements for Basic Safety and Essential Performance).

· System shall be tested successfully in accordance with IEC 61000-4-3 (Radiated, Radio-Frequency, Electromagnetic Field Immunity Test) and IEC 61000-4-6 (Immunity to Conducted Disturbances, Induced by Radio Frequency Fields).

n) System Area Footprint: Main system (on rolling cart) shall not exceed 30” in width, shall not exceed 30” in depth (not including monitor/ display protrusion due to articulating arm positioning).

o) Main system shall have a rolling cart (no exceptions).

p) System shall support electromagnetic localization/ navigation (tracking of instruments). System shall be able to localize/ track instruments and patient anatomy simultaneously.

· System shall have low-energy magnetic field emitters that work with instruments containing electromagnetic sensors that allows the navigation software to track instrument location. The emitter shall have an interface box with connection ports to directly interface with specialized instruments. Emitter interface box shall be directly attached and or built into the main system cart.

q) System software shall allow surgeons/ clinical staff to map points between the patient and images. Software shall be able to identify specific points on displayed anatomical images when surgeons touch patient anatomy with tracked instruments.

r) System software shall be compatible with specialized instruments that allow for electromagnetic localization that are already owned by CNVAMC.

s) System shall be compatible with disposable accessories that are already stocked by CNVAMC.

t) System software shall be capable of dynamic referencing in order to ensure accurate instrument navigation when anatomy shifts/ changes position. System shall contain a localizer and emitter capable of supporting dynamic referencing.

u) Electromagnetic (EM) Emitter(s):

· System shall support a side mounted EM Emitter. The EM field suitable for navigation should exceed the following minimum specifications (and meet any other specs below):

· Length: 12” (Along Coronal Plane, Axis from Patient Shoulder to Shoulder).

· 16” for Sagittal Plane Axis.

· Frequency Transmission Range: 3 – 30 kHz.

· Power: Not to exceed 30 W

· Emitter Field Offset: Range 5 – 10 cm.

· System shall support an EM Emitter that may be placed underneath a patient on a surgical table. The EM field suitable for navigation should exceed the following minimum specifications (and meet any other specs below):

· 14” for all three dimensions.

· Frequency Transmission Range: 3 – 30 kHz.

· Power: Not to exceed 30 W.

· Emitter Field Offset: 5 cm (± 1 cm)

v) System shall have a High Definition touchscreen display.

w) System shall have a keyboard and mouse.

x) The proposed Stereotactic Surgical System shall allow CNVAMC Surgeons to achieve the navigation/ localization necessary in order to successfully complete the following procedures (not limited to the list below, but inclusive):

vi. Sinus Surgery

vii. Airway Procedures

viii. Otology, Neurotology, Lateral, and Trans-nasal Skull Base Surgery.

ix. Otology and Neurotology Procedures

x. Inferior Turbinoplasty

3. Contractor shall complete installation and configuration for the Stereotactic Surgical System and all associated equipment.

4. Contractor shall test and certify that the Stereotactic Surgical System and associated equipment meets manufacture and any other healthcare safety standards. Contractor shall certify that the system is ready and safe for patient use after testing. A testing/ compliance certificate or report shall be provided to CNVAMC Biomedical Engineering.

5. Contractor shall accept trade-in of the existing Stereotactic System owned by CNVAMC:

· EE # 79692

· Serial Number: N06232679

· Model #: STEALTHSTATION S7

6. Contractor shall provide a listing of all recalls, Safety Alerts, and Field Engineering Change Notices pertaining to the proposed Stereotactic Surgical System for the past 12 months.

7. Contractor shall provide a copy of all service literature, including any necessary service and maintenance software, keys, and or passwords.

8. Contractor shall provide at minimum below listed training:

a) End-User Training (Clinical In-Service), on-site training required.

9. Contractor shall provide a one-year manufacturer’s warranty at no cost to the government.

10. Contractor shall provide on dock delivery.

11. Contractor shall confirm that the performance of the proposed system shall not be affected by EMI radiated or conducted through the power lines from another device.

C. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

The Contractor shall only invoice for the total amount agreed to on this procurement contract. The Contractor shall not conduct any work not included within this SOW / provided by the original pricing of this contract, including but not limited to labor, travel, parts provision, and shipping. If any additional services or equipment is necessary, the Contractor shall contact the Contracting Officer (CO) and Contracting Officer Representative (COR) immediately. The Contractor shall be liable for any work conducted (or equipment provided) outside the scope of this SOW (original order) without approval from the CO.

D. INVOICES

1. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer’s Representative (COR), and submitted electronically through OB-10 (https://portal.tungsten-network.com/).

2. A properly prepared invoice will contain:

a) Invoice Number and Date

b) Contractor’s Name and Address

E. SECURITY

PER REVIEW OF VA HANDBOOK 6500.6, CONTRACT SECURITY, APPENDIX A- INFORMATION SECURITY AND PRIVACY CHECKLIST:

1. “The C&A requirements do not apply and a Security Accreditation Package is not required.”

2. Acquisition of this service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information to the vendor.

3. There may exist exposure to VA sensitive information, in particular to sensitive personal information (SPI) while implementing contractual services.

Minimum Statutory Requirements

1. 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/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). See VA Handbook 6500.6, Appendix C, paragraph 3.a.

2. 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 COR, 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

3. Requirement to pay liquidated damages in the event of a data breach: 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.

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.

Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

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;

Information System Security

The contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The contractor’s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA project manager and the VBA Headquarters Information Security Officer as soon as possible. The contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation.

Security Training

All contractor employees and subcontractors under this contract or order are required to complete the VA's on-line Security Awareness Training Course and the Privacy Awareness Training Course annually. Contractors must provide signed certifications of completion to the CO during each year of the contract. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s).

Contractor Personnel Security

All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident.

The investigative history for contractor personnel working under this contract must be maintained in the databases of either the Office of Personnel Management (OPM) or the Defense Industrial Security Clearance Organization (DISCO). Should the contractor use a vendor other than OPM or Defense Security Service (DSS) to conduct investigations, the investigative company must be certified by OPM/DSS to conduct contractor investigations.

1. Background Investigation

The position sensitivity impact for this effort has been designated as [LIMITED, MODERATE, SUBSTANTIAL, or MAJOR] Risk and the level of background investigation is [NACI, MBI, or BI].

2. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the contractor shall reimburse the VA within 30 days.

b. Background investigations from investigating agencies other than OPM are permitted if the agencies possess an OPM and Defense Security Service certification. The Vendor Cage Code number must be provided to the Security and Investigations Center (07C), which will verify the information and advise the contracting officer whether access to the computer systems can be authorized.

c. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language.

d. After contract award and prior to contract performance, the contractor shall provide the following information, using Attachment B, to the CO:

(1) List of names of contractor personnel.

(2) Social Security Number of contractor personnel.

(3) Home address of contractor personnel or the contractor's address.

e. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

f. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

g. Further, the contractor will be responsible for the actions of all individuals provided to work for the VA under this contract. In the event that damages arise from work performed by contractor provided personnel, under the auspices of this contract, the contractor will be responsible for all resources necessary to remedy the incident.”

3. Government Responsibilities 1.

1. a. The VA Security and Investigations Center (07C) will provide the necessary forms to the contractor or to the contractor's employees after receiving a list of names and addresses.

b. Upon receipt, the VA Security and Investigations Center (07C) will review the completed forms for accuracy and forward the forms to OPM to conduct the background investigation.

c. The VA facility will pay for investigations conducted by the OPM in advance. In these instances, the contractor will reimburse the VA facility within 30 days.

d. The VA Security and Investigations Center (07C) will notify the contracting officer and contractor after adjudicating the results of the background investigations received from OPM.

e. The contracting officer will ensure that the contractor provides evidence that investigations have been completed or are in the process of being requested.

F. ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS

INTERNET/INTRANET

The contractor shall comply with Department of Veterans Affairs (VA) Directive 6102 and VA Handbook 6102 (Internet/Intranet Services).

VA Directive 6102 sets forth policies and responsibilities for the planning, design, maintenance support, and any other functions related to the administration of a VA Internet/Intranet Service Site or related service (hereinafter referred to as Internet). This directive applies to all organizational elements in the Department. This policy applies to all individuals designing and/or maintaining VA Internet Service Sites; including but not limited to full time and part time employees, contractors, interns, and volunteers. This policy applies to all VA Internet/Intranet domains and servers that utilize VA resources. This includes but is not limited to va.gov and other extensions such as, “.com, .edu, .mil, .net, .org,” and personal Internet service pages managed from individual workstations.

VA Handbook 6102 establishes Department-wide procedures for managing, maintaining, establishing, and presenting VA Internet/Intranet Service Sites or related services (hereafter referred to as “Internet”). The handbook implements the policies contained in VA Directive 6102, Internet/Intranet Services. This includes, but is not limited to, File Transfer Protocol (FTP), Hypertext Markup Language (HTML), Simple Mail Transfer Protocol (SMTP), Web pages, Active Server Pages (ASP), e-mail forums, and list servers.

VA Directive 6102 and VA Handbook 6102 are available at:

Internet/Intranet Services Directive 6102 http://www.va.gov/pubs/directives/Information-Resources-Management-(IRM)/6102d.doc Internet/Intranet Services Handbook 6102 http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/6102h.doc

Internet/Intranet Services Handbook 6102 Change 1 – updates VA's cookie use policy, Section 508 guidelines, guidance on posting of Hot Topics, approved warning notices, and minor editorial errors.

http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/61021h.doc

In addition, any technologies that enable a Network Delivered Application (NDA) to access or modify resources of the local machine that are outside of the browser’s ”sand box" are strictly prohibited. Specifically, this prohibition includes signed-applets, or any ActiveX controls delivered through a browser's session. ActiveX is expressly forbidden within the VA while .NET is allowed only when granted a waiver by the VA CIO *PRIOR* to use.

JavaScript is the preferred language standard for developing relatively simple interactions (i.e., forms validation, interactive menus, etc.) and Applets (J2SE APIs and Java Language) for complex network delivered applications.

SECTION 508

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

In December 2000, the Architectural and Transportation Barriers Compliance Board (Access Board), pursuant to Section 508(2)(A) of the Rehabilitation Act Amendments of 1998, established Information Technology accessibility standards for the Federal Government. Section 508(a)(1) requires that when Federal departments or agencies develop, procure, maintain, or use Electronic and Information Technology (EIT), they shall ensure that the EIT allows Federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. The Section 508 requirement also applies to members of the public seeking information or services from a Federal department or agency.

Section 508 text is available at:

http://www.opm.gov/HTML/508-textOfLaw.htm http://www.section508.gov/index.cfm?FuseAction=Content&ID=14

G. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

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

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

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Stereotactic Surgical System for use by ENT. The estimated price includes a trade-in allowance for a Medtronic Stealth Station 7.

LOCAL STOCK NUMBER: 9735669TIKIT1

Sterotactic Surgical System ENT SOFTWARE

LOCAL STOCK NUMBER: 9735736

Sterotactic Surgical System Kit ENT SIDE EMITTER

LOCAL STOCK NUMBER: 9735960

Installation & 6 In-Service Support Visits

Training for staff and surgeons

B.3 DELIVERY SCHEDULE

1.00

1.00

1.00

1.00

1.00

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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,…