36C24719Q0706-001.docx

36C24719Q0659 FedBizOpps Modification to a Previous Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

BASE NOTICE TYPE

RESPONSE DATE (MM-DD-YYYY)

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 FedBizOpps Modification to a Previous Notice Rev. March 2010

619-19-3-490-0157 COMBINED VASCULAR SYSTEM {PERIFLUX}

36C247-619 36109-3798 36C24719Q0706 07-05-2019 N 339112 Department of Veterans Affairs Central Alabama Veterans Health Care 215 Perry Hill Road Montgomery AL 36109-3798 Same as Above Same as above Benford.Brundage@va.gov Benford Brundage Central Alabama Veterans Health Care System (CAVHCS) Combined Vascular 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 3:00pm EST on July 5, 2019. 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; size standard is 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 attached RFQ document 36C247-19-Q-0706 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 LOWEST PRICE TECHNICALLY ACCEPTABLE.

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 36 hours prior to the closing date.

Quotes are due no later than 3:00pm EST, July 5, 2019. Telephone calls will not be accepted. All quotes are to be sent electronically to Benford.Brundage@va.gov

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

619-19-3-490-0157 36C24719Q0659 06-18-2019 Benford Brundage 06-21-2019 0pm EST Department of Veterans Affairs Central Alabama Veterans Health Care 215 Perry Hill Road Montgomery AL 36109-3798 X X 339112 1000 Employees N/A X Dept of VA CAVHCS VA Medical Center ATTN: Warehouse 215 Perry Hill Rd Montgomery, AL 36804 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 Combined Vascular Pressure System for the Central Alabama Veterans Health Care System in Tuskegee/Montgomery, AL.

This is a Service Disabled Veteran Owned Small Business set-aside.

Only one award will be made to one vendor that can provide all supplies/services at the Lowest Price Technically Acceptable. Action may be sole-sourced to on vendor.

Vendor's quote/bid must include all associated fees; Admin, Shipping, Delivery, Install, etc. in Final price/cost.

This RFQ must be completed by the vendor in order to be considered for award. A vendor bid/quote will not suffice.

See Bid Instructions included in this RFQ.

The most current Wage Determination as of 6/18/2019 is hereby incorporated into this solicitation.

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 Benford C. Brundage Department of Veterans Affairs Central Alabama Veterans Health Care

215 Perry Hill Road Montgomery AL 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:

Page 1 of Page 1 of

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.

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

SALIENT CHARACTERICS / STATEMENT OF WORK

FOR

Periflux 6000 Combined System

PURPOSE:

CAVHCS Podiatry service needs equipment with the capability to assess peripheral circulation. If segmental procedures are needed, Veterans are currently being referred out through non-VA care. The Periflux 6000 (or system meeting no less than the specifications/requirements of the combined Periflux 6000 system) combined system will allow the Podiatry clinic to make precise micro- and macrovascular assessments of patients.

The Periflux 6000 is an instrument for transcutaneous oximetry and blood pressure measurements. The tcpO2 system measures the amount of oxygen released locally from the capillaries through the skin, to reflect the metabolic state of the limb. This is particularly used for wound healing prediction, amputation level determination. The pressure system performs noninvasive vascular tests for an objective diagnosis of peripheral arterial disease (PAD) and critical limb ischemia (CLI).

SALIENT CHARACTERISTICS:

The required system must meet or exceed the Periflux 6000 Combined System with the following salient characteristics:

· Combined system: (Wound Healing Assessments and PAD/CLI Diagnosis), tests include toe/ankle pressure, TBI/ABI, PVR and 4ch tcpO2

· Capacity to support up to eight (8) transcutaneous electrodes in one unit (both O2 and O2+CO2 electrodes)

· Heated laser Doppler probes for enhanced blood pressure measurements

· Built-in patient and examination databases

· HIPAA compliant security features

· Ability to assign unique ID numbers (accession numbers) instead of using patient identifying information

· Compliant with VA privacy and security regulations

· Can be configured to perform any combination of tcpO2, tcpCO2, ABI/TBI, SPP, PVR and segmental pressure measurements

· Capability to connect to electronic medical record via DICOM and / or HL7 interface

· Built in programmable examination protocols

· Step-by-step onscreen instructions during examinations

· Instrument specific cart

· Software for instrument setup and back up

· USB connectivity to peripheral, such as, mouse, keyboard, camera and printer

· Automatic report generation/ reporting features and capabilities

· Color coding visual assistance

· Warranty – Perimed manufactured parts are warranted against defects in material and workmanship for a period of 2 years (1 year on probes/electrodes and computers) from date of delivery. Perimed will repair or replace products that prove defective.

The system consists of:

· Main Unit

· LDPM/Temp Unit

· tcpO2 Unit

· Pressure Unit

· Pressure Accessory Kit

· LD Probe

· tcpO2 Electrode

· Panel PC

· PSW Examination Manger Software

· Standard Cart

· Isolation Transformer

· Foot Switch

· Camera

· Color Printer

· Consumables (membrane kits, fixation rings, adhesive strips)

System Network Connectivity requirements:

· PeriSoft for Windows Examination Manager (PSW ExM) (or software no less than the specifications/requirements of the PSW ExM) is a data acquisition software that collects and analyses multi-channel data from Perimed’s laser Doppler and transcutaneous oxygen and carbon dioxide monitoring systems PeriFlux 6000. PSW ExM also controls the operation of the systems. The application supports querying remote systems for a worklist from which patient information is retrieved to the examination. It also supports sending reports from the examinations across the network to other systems.

· PSW ExM is a computer software used in combination with the medical devices PeriFlux 6000. PSW ExM consists of one main application for data recording, and one configuration tool, the (Examination) Plan Editor. The Plan Editor allows users to build Examination Plans (custom-made, standardized measurement scripts), which can be launched from the main application.

STATEMENT OF WORK:

The contractor will deliver the equipment and provide all necessary labor, management, skills, materials, etc. required to install and train VA staff. Training to VA staff will be given in person and on-site. Installation activities inclusive of the need for Network Access, working in conjunction with IT department and BioMed as needed.

Maintenance activities will require a VA escort for onsite maintenance and include contact with and presence of ISO, IT representative, BioMed and Privacy Officer if removal of hard drives for sanitization processes is required. Any necessary files created during maintenance will not be saved via vendor. Retention of data will be on internal VA server only. All backup data will be completed, performed and maintained by Pharmacy service.

PLACE OF PERFORMANCE:

Products shall be delivered to the CAVHCS- East Campus Warehouse which is physically located at 2400 Hospital Road Tuskegee, AL 36083.

SCHEDULE OF DELIVERABLES:

All requested products on this transaction shall be completely manufactured as specified and delivered to the jobsite delivery no later than the earliest time feasible once contract is awarded. This should not take longer than 30 days. Equipment installation is to occur between time of delivery of equipment and timeframe indicated by CAVHCS Facility COR. The Vendor shall perform all work during normal business hours (Monday thru Friday, 8:00am to 4:30pm), unless otherwise stipulated by the COR/Designee.

CONTRACTOR QUALIFICATIONS:

The contractor will provide trained client support engineers to perform the technical support. The contractor will provide trained field service technicians for on-site training.

DELIVERY:

The equipment will be received via CAVHCS policy at the CAVHCS warehouse with inspection and acceptance occurring at the time of receipt. Final acceptance will occur with the completion of installation and setup.

PROGRAM POINT OF CONTACT (POC) and/or CONTRACTING OFFICER TECHNICAL REPRESENTATIVE (COTR): The COTR for the acquisition is Chi K Lemley, Administrative Officer of Acute Care and Specialties/Surgery and may be reached at (334) 272-4670 ext.: 4967 or chi.lemley@va.gov .

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

MARCH 12, 2010 VA HANDBOOK 6500.6

APPENDIX C

C-1

VA INFORMATION AND INFORMATION SYSTEMS SECURITY/PRIVACY LANGUAGE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

VA HANDBOOK 6500.6 MARCH 12, 2010

APPENDIX C

C-2

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

MARCH 12, 2010 VA HANDBOOK 6500.6

APPENDIX C

C-3

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold

VA HANDBOOK 6500.6 MARCH 12, 2010

APPENDIX C

C-4 payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

6. SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other

VA HANDBOOK 6500.6 MARCH 12, 2010

APPENDIX C

C-10 compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SP/ the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

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

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

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

MARCH 12, 2010 VA HANDBOOK 6500.6

APPENDIX C

C-11

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

VA HANDBOOK 6500.6 MARCH 12, 2010

APPENDIX C

C-12

9. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix D relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

COMBINED VASCULAR/PRESSURE SYSTEM

LOCAL STOCK NUMBER: 93-00202-US:ME

HL7/DICOM UPGRADE

LOCAL STOCK NUMBER: 95-00042

ON-SITE TRAINING

LOCAL STOCK NUMBER: TRAINING 1

SERVICE MANUAL

SECTION C - CONTRACT CLAUSES

C.1 FSS RFQ INTRODUCTORY LANGUAGE

The terms and conditions of the contractor's FSS contract (including any contract modifications) apply to all Blanket Purchase Agreements (BPA) and task or delivery orders issued under the contract as a result of this RFQ. When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the BPA or task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the FSS contract. Any unique terms and conditions of a BPA or order issued under the contract that are not a part of the applicable FSS contract will govern. In the event of an inconsistency between the terms and conditions of a BPA or task/delivery order and the Contractor's FSS terms, other than those identified above, the terms of the FSS contract will take precedence.

C.2 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION)

(a) Definition. For the Department of Veterans Affairs, “Service-disabled veteran-owned small business concern or SDVSOB”:

(1) Means a small business concern:

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans or eligible surviving spouses (see VAAR 802.201 Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans (or eligible surviving spouses) or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been verified for ownership and control pursuant to 38 CFR 74 and is so listed in the Vendor Information Pages database, (https://www.vip.vetbiz.gov); and

(v) The business will comply with subcontracting limitations in 13 CFR 125.6, as applicable

(2) “Service-disabled veteran” means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(b) General.

(1) Offers are solicited only from verified service-disabled veteran-owned small business concerns. Offers received from concerns that are not verified service-disabled veteran-owned small business concerns shall not be considered.

(2) Any award resulting from this solicitation shall be made to a verified service-disabled veteran-owned small business concern.

(c) Agreement. A service-disabled veteran-owned small business concern agrees that in the performance of the contract, the concern will comply with the limitation on subcontracting requirements in 13 CFR §125.6.

(d) A joint venture may be considered a service-disabled veteran owned small business concern if the joint venture complies with the requirements in 13 CFR 125.15, provided that any reference therein to SDVO SBC is to be construed to apply to a VA verified SDVOSB as appropriate.

(e) Any service-disabled veteran-owned small business concern (non-manufacturer) must meet the requirements in FAR 19.102(f) of the Federal Acquisition Regulation to receive a benefit under this program.

(End of Clause)

C.3 52.211-6 BRAND NAME OR EQUAL (AUG 1999)

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

(End of Provision)

C.4 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

(End of Clause)

Page 1 of

Page 1 of

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

Page 1 of

SECTION E - SOLICITATION PROVISIONS

Page 1 of