PAGE 1 OF1. REQUISITION NO.2. CONTRACT NO.3. AWARD ...



PAGE 1 OF1. REQUISITION NO.2. CONTRACT NO.3. AWARD/EFFECTIVE DATE4. ORDER NO.5. SOLICITATION NUMBER6. SOLICITATION ISSUE DATEa. NAMEb. TELEPHONE NO. (No Collect Calls)8. OFFER DUE DATE/LOCALTIME9. ISSUED BYCODE10. THIS ACQUISITION IS UNRESTRICTED ORSET ASIDE:% FOR:SMALL BUSINESSHUBZONE SMALLBUSINESSSERVICE-DISABLEDVETERAN-OWNEDSMALL BUSINESSWOMEN-OWNED SMALL BUSINESS(WOSB) ELIGIBLE UNDER THE WOMEN-OWNEDSMALL BUSINESS PROGRAMEDWOSB8(A)NAICS:SIZE STANDARD:11. DELIVERY FOR FOB DESTINA-TION UNLESS BLOCK ISMARKEDSEE SCHEDULE12. DISCOUNT TERMS 13a. THIS CONTRACT IS ARATED ORDER UNDERDPAS (15 CFR 700)13b. RATING14. METHOD OF SOLICITATIONRFQIFBRFP15. DELIVER TOCODE16. ADMINISTERED BYCODE17a. CONTRACTOR/OFFERORCODEFACILITY CODE18a. PAYMENT WILL BE MADE BYCODETELEPHONE NO.DUNS:DUNS+4:PHONE:FAX:17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKEDSEE ADDENDUM19.20.21.22.23.24.ITEM NO.SCHEDULE OF SUPPLIES/SERVICESQUANTITYUNITUNIT PRICEAMOUNT(Use Reverse and/or Attach Additional Sheets as Necessary)25. ACCOUNTING AND APPROPRIATION DATA26. 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. ADDENDAAREARE NOT ATTACHED.27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDAAREARE NOT ATTACHED28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________29. AWARD OF CONTRACT: REF. ___________________________________ OFFERCOPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH ANDDATED ________________________________. YOUR OFFER ON SOLICITATIONDELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH AREADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIEDSET FORTH HEREIN IS ACCEPTED AS TO ITEMS:30a. SIGNATURE OF OFFEROR/CONTRACTOR31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT)30c. DATE SIGNED31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT)31c. DATE SIGNEDAUTHORIZED FOR LOCAL REPRODUCTION(REV. 2/2012)PREVIOUS EDITION IS NOT USABLEPrescribed by GSA - FAR (48 CFR) 53.2127. FOR SOLICITATIONINFORMATION CALL:STANDARD FORM 1449OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 45VA246-14-Q-098408-13-2014Amy Pitts757-728-314408-15-201412:00 pmDepartment of Veterans AffairsNetwork Contracting Office 6100 Emancipation DriveHampton VA 23667339113500 Employees N/AXSEE ATTACHED DELIVERY SCHEDULEDepartment of Veterans AffairsNetwork Contracting Office 6100 Emancipation DriveHampton VA 23667Department of Veterans AffairsFinancial Services CenterPO BOX 149971Austin TX 78714-9971See CONTINUATION PageThis procurement is for endoscope imaging hardwareSee CONTINUATION PageXXSECTION AA.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMSTable of Contents TOC \o "1-4" \f \h \z \u \x SECTION A PAGEREF _Toc395684184 \h 1A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS PAGEREF _Toc395684185 \h 1SECTION B - CONTINUATION OF SF 1449 BLOCKS PAGEREF _Toc395684186 \h 4B.1 CONTRACT ADMINISTRATION DATA PAGEREF _Toc395684187 \h 4B.2 Salient Characteristics PAGEREF _Toc395684188 \h 5B.3 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE PAGEREF _Toc395684189 \h 6B.4 Price/Cost Schedule PAGEREF _Toc395684190 \h 7Item Information PAGEREF _Toc395684191 \h 7B.5 Delivery Schedule PAGEREF _Toc395684192 \h 9SECTION C - CONTRACT CLAUSES PAGEREF _Toc395684193 \h 11C.1 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) PAGEREF _Toc395684194 \h 11C.2 52.227-19 COMMERCIAL COMPUTER SOFTWARE LICENSE (DEC 2007) PAGEREF _Toc395684195 \h 11C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008) PAGEREF _Toc395684196 \h 12C.4 VAAR 852.211-70 SERVICE DATA MANUALS, MECHANICAL EQUIPMENT (JAN 2008) PAGEREF _Toc395684197 \h 12C.5 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009) PAGEREF _Toc395684198 \h 12C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) PAGEREF _Toc395684199 \h 12C.7 VAAR 852.246-70 GUARANTEE (JAN 2008) PAGEREF _Toc395684200 \h 13C.8 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) PAGEREF _Toc395684201 \h 14C.9 VAAR 852.246-71 INSPECTION (JAN 2008) PAGEREF _Toc395684202 \h 14C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2014) PAGEREF _Toc395684203 \h 14SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS PAGEREF _Toc395684204 \h 20D.1 Manufacturer Disclosure Statement for Medical Device Security (MDS2) and Pre-Procurement Risk Assessment (PPA) PAGEREF _Toc395684205 \h 21D.2 Instructions for the Manufacturer Disclosure Statement for Medical Device Security – MDS2 Version 1.0 PAGEREF _Toc395684206 \h 25Introduction PAGEREF _Toc395684207 \h 25Disclaimer PAGEREF _Toc395684208 \h 28Glossary PAGEREF _Toc395684209 \h 29SECTION E - SOLICITATION PROVISIONS PAGEREF _Toc395684210 \h 37E.1 SUBMISSION INSTRUCTIONS PAGEREF _Toc395684211 \h 37E.2 EVALUATION CRITERIA AND SELECTION PROCESS PAGEREF _Toc395684212 \h 37E.3 EVALUATION FACTORS PAGEREF _Toc395684213 \h 38E.4 SELECTION AND DELIVERY ORDER ESTABLISHMENT PAGEREF _Toc395684214 \h 38E.5 52.209-5 REPRESENTATION BY CORPORATIONS REGARDING AN UNPAID TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (DEVIATION)(MAR 2012) PAGEREF _Toc395684215 \h 38E.6 52.211-6 BRAND NAME OR EQUAL (AUG 1999) PAGEREF _Toc395684216 \h 38E.7 52.217-5 EVALUATION OF OPTIONS (JUL 1990) PAGEREF _Toc395684217 \h 39E.8 52.225-18 PLACE OF MANUFACTURE (SEPT 2006) PAGEREF _Toc395684218 \h 39E.9 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE (JAN 2008) PAGEREF _Toc395684219 \h 40E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (MAY 2014) PAGEREF _Toc395684220 \h 40SECTION B - CONTINUATION OF SF 1449 BLOCKSB.1 CONTRACT ADMINISTRATION DATA(continuation from Standard Form 1449, block 18A.) 1. Contract Administration: All contract administration matters will be handled by the following individuals: a. CONTRACTOR: b. GOVERNMENT: Contracting Officer 00246 Amy PittsDepartment of Veterans AffairsNetwork Contracting Office 6100 Emancipation DriveHampton VA 23667 2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:[X]52.232-34, Payment by Electronic Funds Transfer—Other Than System For Award Management, or[]52.232-36, Payment by Third Party 3. INVOICES: Invoices shall be submitted in arrears: a. Quarterly[] b. Semi-Annually[] c. Other[X] After receipt of order 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 AffairsFinancial Services CenterPO BOX 149971Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:AMENDMENT NODATEB.2 Salient CharacteristicsAutomatic recognition and recording, via station owned Olympus video processor, of the Olympus endoscope serial number being used on each procedure in the patient's electronic record. Automatic adjustment of image mask size to optimize image presentation in patient's record Full HD video and HD still image quality of captured videos and images for patient record. The vendor must have the ability to have on-site support within 3 hours of phone contact.The software shall allow users to customize workflows and menus, and the users shall be able to customize report templates ?Ability interface to VAMC EMR via HL7 and or to PACS via DICOM Images moved from existing GI Endoworks database shall be available on new database for seamless patient data retrieval and continuity.? The solution shall communicate with all existing VA surgical modalities.The system shall be HL7 (Health Level 7) Compliant.This system shall be compatible with Olympus 180 and 190 endoscopy workstations. The system shall be DICOM (Digital Imaging and Communications in Medicine) compliant.The system shall meet all GIQulc registry benchmarking processes.The system shall contribute to local system redesign efforts by including a software tracking system that allows physicians to measure the amount of time required to complete tasks or groups of tasks.The system shall have the capability to authenticate users with user information stored in an internal or external repository.The system shall be on the most recent VISTA Imaging Approved DICOM Modality Interfaces.? The system shall provide full system integration with current VA systems.? The system shall be able to store, print, process, retrieve, and query CINE videos or images, as well as 3D videos or images.The system shall be HIPAA Compliant for patient information.The system shall have the capability to label images.? The system shall also have the capability to place labeled images into an electronic report detailing the procedure, ie physician reports and letters.The system shall be capable of patient registration, scheduling, and reporting. The system must be compatible with Windows 7.? The minimum server capacity is Windows Server 2003, 600GB.? The server must use hot swap storage utilizing RAID level 5, and be expandable to at least 1800 GB. Offer must include upgrade to Windows Server 2008.The image capture workstation hardware shall utilize a Windows operating system, include an LCD monitor, and HD video capture card, and a DVD-RW.? The workstation shall also include a three year next business day warranty on hardware.The registration, scheduling, and reporting workstation hardware shall utilize a Windows operating system, include an LCD monitor, and a DVD-RW.? The workstation shall also include a three year next business day warranty on hardware.The printer provided shall be a color laserjet that prints up to 42ppm in color and 42 ppm when printing black and white documents.? A three year warranty shall be included to cover the printer.B.3 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGEGENERALContractors and contractor 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.VA INFORMATION CUSTODIAL LanguageInformation made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor’s rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).SECURITY INCIDENT INVESTIGATIONThe 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 shall immediately notify the COR 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 has access.LIQUIDATED DAMAGES FOR DATA BREACHConsistent 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 processes or maintains under this contract. 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:Notification;One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;Data breach analysis;Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;One year of identity theft insurance with $20,000.00 coverage at $0 deductible; andNecessary legal expenses incurred by the subjects of an SPI data breach, to repair falsified or damaged credit, are not included in the liquidated damages amount and will be handled as actual damages, which the contractor should anticipate as among the costs of doing business, and should consider in developing its cost estimates. TRAININGAll contractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;Successfully complete the appropriate VA privacy training and annually complete required privacy training; andSuccessfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within one (1) week of the initiation of the contract and annually thereafter, as required. These online courses are located at the following web site: Detailed instructions on account setup will be provided to the successful offeror.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.4 Price/Cost ScheduleItem InformationITEM NUMBERDESCRIPTION OF SUPPLIES/SERVICESQUANTITYUNITUNIT PRICEAMOUNT0001HW74-255: New - Image Capture Workstation hardware. Includes Windows, LCD monitor, HD video capture card, and DVD-RW. 3-year IBM next business day warranty on hardware. 7.00EA____________________________________0002HW74-601: New - Registration, scheduling, and reporting workstation hardware. Includes Windows, LCD monitor, and DVD-RW. 3-year IBM next business day warranty on hardware. 1.00EA____________________________________0003HW74-800: New - HL7 interface workstation hardware. Includes Windows, LCD monitor, and DVD-RW. 3-year IBM next business day warranty on hardware. 1.00EA____________________________________0004IT-HW-00061: New - SERVER OLYMPUS SUPPLIED 600GB 1.00EA____________________________________0005CV-MTXR-10-1: New - 10FT CV-160 DIGITAL FILE CABLE1.00EA____________________________________0006HW-HP4525DN: New - HP COLOR LASERJET CP4525N PRINTER, INCL. 3 YEAR WARRANTY 1.00EA____________________________________0007CV-SDI-10: New - HD Video cable for CV-190 10' MATROX VIO video card HD only7.00EA____________________________________000855645L25-1: New - 25'CV-160/180/190 DIGITAL FILE 7.00EA____________________________________000956688L25: New - CAT5e patch cable 25 ft.8.00EA____________________________________0010EW74-ENG: New - EndoWorks Customization 9.00EA____________________________________1001Contract Period: Option 1POP Begin: 09/01/2015POP End: 8/31/2016Annual Maintenance/Service for System12.00MO____________________________________2001Contract Period: Option 2POP Begin: 09/01/2016POP End: 08/31/2017Annual Maintenance/Service for System12.00MO____________________________________3001Contract Period: Option 2POP Begin: 09/01/2017POP End: 08/31/2018Annual Maintenance/Service for System12.00MO____________________________________GRAND TOTAL__________________B.5 Delivery ScheduleITEM NUMBERQUANTITYDELIVERY DATE0001SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38757.009/30/20140002SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38751.009/30/20140003SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38751.009/30/20140004SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38751.009/30/20140005SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38751.009/30/20140006SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38751.009/30/20140007SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38757.009/30/20140008SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38757.009/30/20140009SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38758.009/30/20140010SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 38759.009/30/20141001SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 387512.00SEE CLIN2001SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 387512.00SEE CLIN3001SHIP TO:DURHAM VAMC508 FULTON STDURHAM ,NC 27705 387512.00SEE CLINSECTION C - CONTRACT CLAUSESADDENDUM 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.1 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days prior to end of the contract period; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed four (4) years.(End of Clause)C.2 52.227-19 COMMERCIAL COMPUTER SOFTWARE LICENSE (DEC 2007) (a) Notwithstanding any contrary provisions contained in the Contractor's standard commercial license or lease agreement, the Contractor agrees that the Government will have the rights that are set forth in paragraph (b) of this clause to use, duplicate or disclose any commercial computer software delivered under this contract. The terms and provisions of this contract shall comply with Federal laws and the Federal Acquisition Regulation. (b)(1) The commercial computer software delivered under this contract may not be used, reproduced, or disclosed by the Government except as provided in paragraph (b)(2) of this clause or as expressly stated otherwise in this contract. (2) The commercial computer software may be— (i) Used or copied for use with the computer(s) for which it was acquired, including use at any Government installation to which the computer(s) may be transferred; (ii) Used or copied for use with a backup computer if any computer for which it was acquired is inoperative; (iii) Reproduced for safekeeping (archives) or backup purposes; (iv) Modified, adapted, or combined with other computer software, provided that the modified, adapted, or combined portions of the derivative software incorporating any of the delivered, commercial computer software shall be subject to same restrictions set forth in this contract; (v) Disclosed to and reproduced for use by support service Contractors or their subcontractors, subject to the same restrictions set forth in this contract; and (vi) Used or copied for use with a replacement computer. (3) If the commercial computer software is otherwise available without disclosure restrictions, the Contractor licenses it to the Government without disclosure restrictions. (c) The Contractor shall affix a notice substantially as follows to any commercial computer software delivered under this contract: Notice—Notwithstanding any other lease or license agreement that may pertain to, or accompany the delivery of, this computer software, the rights of the Government regarding its use, reproduction and disclosure are as set forth in Government Contract No. __________________.(End of Clause)C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008) The bidder or offeror agrees that if a contract is awarded to him/her, as a result of this solicitation, he/she will not advertise the award of the contract in his/her commercial advertising in such a manner as to state or imply that the Department of Veterans Affairs endorses a product, project or commercial line of endeavor.(End of Clause)C.4 VAAR 852.211-70 SERVICE DATA MANUALS, MECHANICAL EQUIPMENT (JAN 2008) The contractor agrees to furnish two hard copies of a manual, handbook or brochure containing operating, installation, and maintenance instructions (including pictures or illustrations, schematics, and complete repair/test guides as necessary). Where applicable, it will include electrical data and connection diagrams for all utilities. The instructions shall also contain a complete list of all replaceable parts showing part number, name, and quantity required.(End of Clause)C.5 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009) The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses or veteran-owned small businesses proposed as subcontractors in accordance with 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, or to substitute one or more service-disabled veteran-owned small businesses or veteran-owned small businesses for subcontract work of the same or similar value.(End of Clause)C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) (a) Definitions. As used in this clause— (1) Contract financing payment has the meaning given in FAR 32.001. (2) Designated agency office has the meaning given in 5 CFR 1315.2(m). (3) Electronic form means an automated system transmitting information electronically according to the Accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests. (4) Invoice payment has the meaning given in FAR 32.001. (5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract. (b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required. (c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following: (1) VA’s Electronic Invoice Presentment and Payment System. (See Web site at .) (2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI). The X12 EDI Web site () includes additional information on EDI 810 and 811 formats. (d) Invoice requirements. Invoices shall comply with FAR 32.905. (e) Exceptions. If, based on one of the circumstances below, the contracting officer directs that payment requests be made by mail, the contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for: (1) Awards made to foreign vendors for work performed outside the United States; (2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information; (3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies; (4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or (5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.(End of Clause)C.7 VAAR 852.246-70 GUARANTEE (JAN 2008) The contractor guarantees the equipment against defective material, workmanship and performance for a period of 3 year hardware/1 year equipment, said guarantee to run from date of acceptance of the equipment by the Government. The contractor agrees to furnish, without cost to the Government, replacement of all parts and material that are found to be defective during the guarantee period. Replacement of material and parts will be furnished to the Government at the point of installation, if installation is within the continental United States, or f.o.b. the continental U.S. port to be designated by the contracting officer if installation is outside of the continental United States. Cost of installation of replacement material and parts shall be borne by the contractor.(End of Clause)C.8 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) (a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. (b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act. (c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.(End of Clause)C.9 VAAR 852.246-71 INSPECTION (JAN 2008) Rejected goods will be held subject to contractors order for not more than 15 days, after which the rejected merchandise will be returned to the contractor's address at his/her risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the contractor's account.(End of Clause)(End of Addendum to 52.212-4)C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2014) (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) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)). Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104 (g)). (2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). [] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (APR 2010)(41 U.S.C. 3509). [] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) [X] (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). [] (5) [Reserved] [] (6) 52.204-14, Service Contract Reporting Requirements (JAN 2014) (Pub. L. 111-117, section 743 of Div. C). [] (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (JAN 2014) (Pub. L. 111-117, section 743 of Div. C). [X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (31 U.S.C. 6101 note). [] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). [] (10) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (MAY 2012) (section 738 of Division C of Pub. L. 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). [] (11) 52.219-3, Notice of HUBZone Set-Aside or Sole Source Award (NOV 2011) (15 U.S.C. 657a). [X] (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JAN 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). [] (13) [Reserved] [] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644). [] (ii) Alternate I (NOV 2011). [] (iii) Alternate II (NOV 2011). [] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). [] (ii) Alternate I (Oct 1995) of 52.219-7. [] (iii) Alternate II (Mar 2004) of 52.219-7. [] (16) 52.219-8, Utilization of Small Business Concerns (MAY 2014) (15 U.S.C. 637(d)(2) and (3). [] (17)(i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637(d)(4)). [] (ii) Alternate I (Oct 2001) of 52.219-9. [] (iii) Alternate II (Oct 2001) of 52.219-9. [] (iv) Alternate III (JUL 2010) of 52.219-9. [] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)). [] (19) 52.219-14, Limitations on Subcontracting (NOV 2011) (15 U.S.C. 637(a)(14)). [] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). [] (21)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (OCT 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer.) [] (ii) Alternate I (June 2003) of 52.219-23. [] (22) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). [] (23) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). [] (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f). [X] (25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C 632(a)(2)). [] (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). [] (27) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). [X] (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755). [X] (29) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (JAN 2014) (E.O. 13126). [X] (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). [X] (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). [X] (32) 52.222-35, Equal Opportunity for Veterans (SEP 2010) (38 U.S.C. 4212). [X] (33) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). [X] (34) 52.222-37, Employment Reports on Veterans (SEP 2010) (38 U.S.C. 4212). [] (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). [] (36) 52.222-54, Employment Eligibility Verification (AUG 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) [] (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) [] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) [] (38)(i) 52.223-13, Acquisition of EPEAT?-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514). [] (ii) Alternate I (JUN 2014) of 52.223-13. [] (39)(i) 52.223-14, Acquisition of EPEAT?-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514). [] (ii) Alternate I (JUN 2014) of 52.223-14. [] (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007)(42 U.S.C. 8259b). [] (41)(i) 52.223-16, Acquisition of EPEAT?-Registered Personal Computer Products (JUN 2014) (E.O.s 13423 and 13514). [] (ii) Alternate I (JUN 2014) of 52.223-16. [X] (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) [] (43) 52.225-1, Buy American—Supplies (MAY 2014) (41 U.S.C. chapter 83). [] (44)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43. [] (ii) Alternate I (MAY 2014) of 52.225-3. [] (iii) Alternate II (MAY 2014) of 52.225-3. [] (iv) Alternate III (MAY 2014) of 52.225-3. [] (45) 52.225-5, Trade Agreements (NOV 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). [X] (46) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). [] (47) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). [] (48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). [] (49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). [] (50) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). [] (51) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). [] (52) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332). [X] (53) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). [] (54) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332). [] (55) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). [] (56)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). [] (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [] (1) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67). [] (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). [] (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). [] (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67). [] (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67). [] (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67). [] (7) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). [] (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). [] (9) 52.237-11, Accepting and Dispensing of $1 Coin (SEP 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause— (i) 52.203-13, Contractor Code of Business Ethics and Conduct (APR 2010) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (MAY 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17. (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Veterans (SEP 2010) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). (vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. (viii) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67). (ix) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)). Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67). (xi) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67). (xii) 52.222-54, Employment Eligibility Verification (AUG 2013). (xiii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.(End of Clause)SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTD.1 Manufacturer Disclosure Statement for Medical Device Security (MDS2) and Pre-Procurement Risk Assessment (PPA)Contractor must provide a completed Manufacturer Disclosure Statement for Medical Device Security (MDS2) and Pre-Procurement Risk Assessment (PPA) in accordance with VHA Directive 6550. Manufacturer Disclosure Statement for Medical Device Security--MDS2Device Category * FORMTEXT ?????Manufacturer * FORMTEXT ?????Document ID FORMTEXT ?????Document Release Date FORMTEXT ?????Device Model FORMTEXT ?????Software Revision FORMTEXT ?????Software Release Date FORMTEXT ?????Other FORMTEXT ????? FORMTEXT ?????Manufacturer or Representative Contact InformationName FORMTEXT ?????Title FORMTEXT ?????Department FORMTEXT ?????Company Name FORMTEXT ?????Telephone Number FORMTEXT ?????E-mail FORMTEXT ?????MANAGEMENT OF ELECTRONIC PROTECTED HEALTH INFORMATION (PHI) As defined by HIPAA Security Rule, 45 CFR Part 164Yes No N/ANote #Can this device transmit or maintain electronic Protected Health Information (ePHI)? FORMTEXT ????? FORMTEXT ?????Types of ePHI data elements that can be maintained by the device:Demographic (e.g., name, address, location, unique identification number)? FORMTEXT ????? FORMTEXT ?????Medical record (e.g., medical record #, account #, test or treatment date, device identification number)? FORMTEXT ????? FORMTEXT ?????Diagnostic/therapeutic (e.g., photo/radiograph, test results, or physiological data with identifying characteristics)? FORMTEXT ????? FORMTEXT ?????Open, unstructured text entered by device user/operator? FORMTEXT ????? FORMTEXT ?????Maintaining ePHI: Can the deviceMaintain ePHI temporarily in volatile memory (i.e., until cleared on by power-off or reset)? FORMTEXT ????? FORMTEXT ?????Store ePHI persistently on local media? FORMTEXT ????? FORMTEXT ?????Import/export ePHI with other systems? FORMTEXT ????? FORMTEXT ?????Mechanisms used for the transmitting, importing/exporting of ePHI: Can the deviceDisplay ePHI (e.g., video display)? FORMTEXT ????? FORMTEXT ?????Generate hardcopy reports or images containing ePHI? FORMTEXT ????? FORMTEXT ?????Retrieve ePHI from or record EPHI to removable media (e.g., disk, DVD, CD_ROM, tape, CF/SD card, memory stick)? FORMTEXT ????? FORMTEXT ?????Transmit/receive or import/export ePHI via dedicated cable connection (e.g., IEEE 1073, serial port, USB, FireWire)? FORMTEXT ????? FORMTEXT ?????Transmit/receive ePHI via a network connection (e.g., LAN, WAN, VPN, intranet, Internet)? FORMTEXT ????? FORMTEXT ?????Transmit/receive ePHI via an integrated wireless connection (e.g., WiFi, Bluetooth, infrared)? FORMTEXT ????? FORMTEXT ?????Other FORMTEXT ????? FORMTEXT ?????ADMINISTRATIVE SAFEGUARDSYes No N/ANote #Does manufacturer offer operator and technical support training or documentation on device security features? FORMTEXT ????? FORMTEXT ?????What underlying operating system(s) (including version number) are used by the device? FORMTEXT ????? FORMTEXT ?????PHYSICAL SAFEGUARDSYes No N/ANote #Are all device components maintaining ePHI (other than removable media) physically secure (i.e., cannot remove without tools)? FORMTEXT ????? FORMTEXT ?????Does the device have an integral data backup capability (i.e., backup onto removable media such as tape, disk)? FORMTEXT ????? FORMTEXT ?????Can the device boot from uncontrolled or removable media (i.e., a source other than an internal drive or memory component)? FORMTEXT ????? FORMTEXT ?????TECHNICAL SAFEGUARDSYes No N/ANote #Can software or hardware not authorized by the device manufacturer be installed on the device? FORMTEXT ????? FORMTEXT ?????Can the device be serviced remotely (i.e., maintenance activities performed by service person via network or remote connection)? FORMTEXT ????? FORMTEXT ?????Can the device restrict remote access to specific devices or network locations (e.g., specific IP addresses)? FORMTEXT ????? FORMTEXT ?????Can the device log provide an audit trail of remote-service activity? FORMTEXT ????? FORMTEXT ?????Can security patches or other software be installed remotely? FORMTEXT ????? FORMTEXT ?????Level of owner/operator service access to device operating system: Can the device owner/operator?Apply device manufacturer-validated security patches? FORMTEXT ????? FORMTEXT ?????Install or update antivirus software? FORMTEXT ????? FORMTEXT ?????Update virus definitions on manufacturer-installed antivirus software? FORMTEXT ????? FORMTEXT ?????Obtain administrative privileges (e.g., access operating system or application via local root or admin account)? FORMTEXT ????? FORMTEXT ?????Does the device support user/operator specific ID and password? FORMTEXT ????? FORMTEXT ?????Are access sessions terminated after a predetermined length of inactivity (e.g., auto logoff)? FORMTEXT ????? FORMTEXT ?????Events recorded in device audit log (e.g., user, date/time, action taken): Can the audit log recordLogin and logout by users/operators? FORMTEXT ????? FORMTEXT ?????Viewing of ePHI? FORMTEXT ????? FORMTEXT ?????Creation, modification or deletion of ePHI? FORMTEXT ????? FORMTEXT ?????Import/export or transmittal/receipt of ePHI? FORMTEXT ????? FORMTEXT ?????Does the device incorporate an emergency access (“break-glass”) feature that logs each instance of use? FORMTEXT ????? FORMTEXT ?????Can the device maintain ePHI (e.g., by internal battery) during power service interruptions? FORMTEXT ????? FORMTEXT ?????Controls when exchanging ePHI with other devices:Transmitted only via a physically secure connection (e.g., dedicated cable)? FORMTEXT ????? FORMTEXT ?????Encrypted prior to transmission via a network or removable media? FORMTEXT ????? FORMTEXT ?????Restricted to a fixed list of network addresses (i.e., host-based access control list)? FORMTEXT ????? FORMTEXT ?????Does the device ensure the integrity of the ePHI data with implicit or explicit error detection/correction technology? FORMTEXT ????? FORMTEXT ?????* Recommend use of ECRI’s Universal Medical Device Nomenclature System (UMDNS).Adapted from Information Security for Biomedical Technology: a HIPAA Compliance Guide, ACCE/ECRI, 2004.ACCE—the American College of Clinical Engineering; ECRI—formerly the Emergency Care Research Institute.Manufacturer Disclosure Statement for Medical Device Security--MDS2RECOMMENDED SECURITY PRACTICES FORMTEXT ?????EXPLANATORY NOTES (from questions 1 – 19)IMPORTANT: Refer to Instructions for the Manufacturers Disclosure Statement for medical Device Security for the proper interpretation of information provided in this form. FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Adapted from Information Security for Biomedical Technology: a HIPAA Compliance Guide, ACCE/ECRI, 2004.ACCE—the American College of Clinical Engineering; ECRI—formerly the Emergency Care Research Institute.D.2 Instructions for the Manufacturer Disclosure Statement for Medical Device Security – MDS2 Version 1.0IntroductionIn light of increased focus on medical device security and the upcoming April 21, 2005 deadline for compliance with the HIPAA Security Rule, the HIMSS Medical Device Security Workgroup has created a standard Manufacturer Disclosure Statement for Medical Device Security (MDS2). The intent of the MDS2 is to supply healthcare providers with important information that can assist them in assessing the vulnerability and risks associated with electronic Protected Health Information (ePHI) transmitted or maintained by medical devices. Because security risk assessment is a broad, organization-wide effort, this document focuses on only those elements of the risk assessment process associated with medical devices and systems that maintain or transmit ePHI. A standardized form allows manufacturers to quickly respond to a potentially large volume of requests from providers for information regarding the security-related features of the medical devices they manufacture. The standardized form also facilitates the providers’ review of the large volume of security-related information supplied by the manufacturers. This form was adapted from portions of the ACCE/ECRI Biomedical Equipment Survey Form, a key tool found in Information Security for Biomedical Technology: A HIPAA Compliance Guide (ACCE/ECRI, 2004). HIMSS recommends that the information in the MDS2 be used to help complete the ACCE/ECRI form and associated processes as part of each organization’s HIPAA Security compliance efforts.The manufacturer-completed MDS2 should: Be useful to healthcare provider organizations worldwide. While the form does supply information important to providers who must comply with the HIPAA Security Rule, the information presented is intended to be useful for any healthcare provider who aspires to have an effective information security and risk management program. Outside the US, providers would therefore find the MDS2 an effective tool in addressing such regional regulations as EC 95/46, HPB 517, and PIPEDA.Include device-specific information addressing the technical security-related attributes of the individual device model.This completed MDS2 form provides a simple, flexible way of collecting the technical, device-specific elements of the total information needed by provider organizations (device users/operators) in preparing for their first round of medical device risk assessments. Providers around the world should find a completed MDS2 form useful in controlling information security (i.e., confidentiality, integrity, and availability) risks. Note, however, that the MDS2 is not intended and should not be used as a basis for medical device procurement. Writing procurement specifications requires a deeper and more extensive knowledge of security and the provider’s mission.Using the information provided by the manufacturer in the MDS2 combined with information collected about the care delivery environment (e.g., through tools like ACCE / ECRI’s guide for Information Security for Biomedical Technology), the provider’s multidisciplinary risk assessment team can review assembled information and make informed decisions on implementing a local security management plan.The Role of Healthcare Providers and Medical Device Manufacturers in the Security Management ProcessResponsibility for effective security management must ultimately lie with the provider organization. Generally the device manufacturers can assist providers in their security management programs by offering information associated with the type of data maintained / transmitted by the manufacturer’s device or systemhow data is maintained / transmitted by the manufacturer’s device or systemany security–related features incorporated in the manufacturer’s device or systemIn order to effectively manage medical information security and comply with relevant regulations, healthcare providers must employ administrative, physical and technical safeguards, most of which (other than some technical safeguards) must be adopted and employed on-site extrinsic to the actual device. Other than some general recommendations with regard to medical devices:there are few ADMINISTRATIVE safeguards manufacturers can address beyond providing assistance in security trainingthere are few PHYSICAL safeguards manufacturers can address beyond incorporating physical security features (e.g., component lock & key, theft/intrusion alarms) in their devicesThe greatest impact manufacturers can have on medical device security is to incorporate TECHNICAL Safeguards (i.e., security features) in their devices to facilitate the providers efforts in maintaining an effective security program and meeting any relevant regulations. The medical device manufacturing industry is increasingly aware of the importance of having effective security features in their devices and systems. Manufacturers are generally including such features in the production of new devices and systems based provider needs and requirements.Instructions for Obtaining and Using the MDS2Information provided on the MDS2 is intended to assist professionals knowledgeable in security and risk assessment processes in their management of medical device security issues. The information on the MDS2 is not intended and may be inappropriate for any other pleted MDS2 forms for many devices and systems may be available directly from the device manufacturer. Check the manufacturer’s web site first for relevant forms and, when not available there, contact a manufacturer’s representative to request a MDS2 for the appropriate device(s)/system(s). If a manufacturer does not have a completed MDS2 for the appropriate device(s)/system(s), enter the device category, manufacturer and model information in the appropriate boxes on the top of a blank form and submit the form(s) and these instructions to the manufacturer’s compliance office for their completion. Note that HIMSS suggests that a standard naming convention be used for the device category terms and manufacturer names listed on the form. This assists providers in matching information from the form to their equipment inventories.? ECRI’s Universal Medical Device Nomenclature System (UMDNS) is the most widely used.? Adopted by thousands of healthcare providers worldwide, UMDNS has been adopted by the National Library of Medicine into its Universal Medical Language System, and has been recommended by the Institute of Medicine for inclusion in the US Department of Health and Human Services (HHS) National Committee on Vital and Health Statistics (NCVHS) core terminology group. For more information about UMDNS contact ECRI at .Side 1 of the MDS2 contains descriptive information on the type of data maintained/transmitted by device, how the data is maintained/transmitted, and any security–related features incorporated in the device. Side 2 contains manufacturer-optional recommended security practices and space for numbered explanatory notes that may expand on answers to questions 1 through 19. Manufacturers may elect to attach supplementary material if additional space for recommended practices or explanatory notes is necessary.Question-specific notes.Maintaining ePHI includes storage on an internal disk, removable media, short-term computer memory, etc.Transmitting ePHI includes receiving/sending external to the device via network, telephone, direct connect cable, removable media, etc.The four sections of this question relate directly to the 18 data elements referred to in HIPAA, any of which, if present, render the entire electronically transmitted/maintained data set as ePHI. The 18 data elements included in the Rule are: NameGeographic data (e.g., address)Dates (e.g., date of birth, admission, discharge, death, treatment)Telephone No.Fax No.E-mail addressSocial Security No.Medical record No.Health plan beneficiary No.Account No.Certificate/license numbersVehicle identifiersDevice identifiersUniversal Resource Locators (URLs)IP address numbersBiometric identifiersFull face (or comparable) photographic images Any unique identifying number, characteristic, or codeThe open, unstructured text question (2d) is intended to indicate an additional element where a provider might put further identifying information.Here the manufacturer provides more detail on how ePHI is maintained. Note that a fully networked device is likely to have all three items with a ‘Yes’ response.Persistently on local media refers to media created or directly attached to the device under consideration (e.g., MR Scanner, 3-D workstation), not a remote archive. Import/export ePHI refers to data that is sourced or destined to remote storage devices (e.g., an MR scanner that relies on an image server in a PACS system).Import and export refer to movement of information via published open protocols to devices outside of the medical device under consideration (e.g., medical information bus (IEEE 1073), serial port, and published protocol that allows general access to ePHI). Dedicated cable here refers to communication via a point to point cable to a device or system outside of the device under consideration.This question includes either explicit security training or explicit sections of administrator or user manuals that detail the device security features and their use.This question identifies the underlying 3rd party system software platform (operating system) name or indicates if there is no 3rd party platform (i.e., proprietary system created for this manufacturer alone).Refers to the typical installation of the manufacturer's device.Refers to an integrated feature that supports information backup onto removable media (e.g., optical disk, magnetic disk, tape).Identifies whether it is possible to start the device with software from any source other than the manufacturer's normal startup device (e.g., an integral hard disk or ROM).Does the device allow, through root access, administrative privilege, or other non-intrusive method, a local user and/or IT staff to install software not provided and not explicitly authorized by the manufacturer (e.g., email client, office applications, virus scanner, browsers, games)?Remote service refers to device maintenance activities performed by a service person via network or other remote connection.Level of owner/operator access to device operating system. Here the manufacturer details what is technically possible if the device owner (generally the healthcare provider) has the technical ability to install security controls on the medical device under consideration. A MANUFACTURER ANSWERING ‘YES’ TO ANY OF THESE QUESTIONS DOES NOT MEAN THAT THE MANUFACTURER AUTHORIZES THE OWNER TO PERFORM THESE FUNCTIONS. THE OWNER ASSUMES ALL RESPONSIBILITY FOR UNAUTHORIZED INSTALLATION or REPAIRS. UNAUTHORIZED INSTALLATION or REPAIRS MAY VOID APPLICABLE WARRANTIES AND SERVICE AGREEMENTS. Authorization to perform these security-related services or changes to a medical device should be obtained in writing from the device manufacturer. Unauthorized changes to a medical device may remove it from government regulatory controls (e.g., FDA) and render the device an experimental medical device.Self-explanatory.Self-explanatory.Clarifications:Controlled viewing refers to operations that have to do with the display, printing, or other use of ePHI (e.g., image display, record print-out).Creation, modification, or deletion would mean that all these events are tracked in the log file.Export or transmittal refers to the movement of ePHI outside of the device under consideration.Emergency access features allow operators emergency access to the device in cases where the normal authentication cannot be successfully completed or is not working properly. Self-explanatory.Clarifications:Physically secure connection is a cabling system that is not accessible to the general public. (i.e., it is in a physically controlled space such as examining rooms, communication closets, or building plenum).Fixed list is an explicit mechanism that limits the connections and nature of connections on a per-device basis.Ensure integrity refers to methods that can detect and/or correct differences between the source makeup of an ePHI message and the ePHI message received by an external device. Is such a method available for use as part of the device under consideration (either in transmission or receipt of ePHI)?DisclaimerThis document is intended to assist healthcare providers in meeting their regulatory obligations regarding medical device security. It is the obligation of the users of this document (e.g., the healthcare provider) to employ all necessary and appropriate safeguards to meet their regulatory and organizational requirements. HIMSS does not assume any responsibility for the application or the content of this form.Medical Equipment Pre-Procurement Assessment WorksheetGlossaryTermDefinitionAccess Read, write, modify, or transmit/receive data or otherwise make use of any system resource [45 CFR Part 164]Administrative SafeguardsAdministrative actions, policies, and procedures to manage the selection, development, implementation, and maintenance of security measures to protect electronic Protected Health Information and to manage the conduct of the covered entity’s workforce in relation to the protection of that information [45 CFR Part 164]Anti-Virus SoftwareSee Virus CheckingArchiveStore (data) for extended period of time (e.g., years)Audit TrailData collected and potentially used to facilitate a security audit [45 CFR Part 142]AvailabilityThe property that data or information is accessible and usable on demand by an authorized person [45 CFR Part 164]Biometric IDA biometric identification system identifies a human from a measurement of a physical feature or repeatable action of the individual (e.g., hand geometry, retinal scan, iris scan, fingerprint patterns, facial characteristics, DNA sequence characteristics, voice prints, handwritten signature)[45 CFR Part 142]Compact Disk (CD) Optical storage mediaCompact Flash (CF) Card? Any of a family of solid-state memory cardsConfidentiality The property that data or information is not made available or disclosed to unauthorized persons or processes [45 CFR Part 164]Digital Versatile Disk (DVD)Optical storage mediaElectronic MediaElectronic storage media, including memory devices in computers (hard drives) and any removable/transportable digital memory media, such as magnetic tapes or disks, optical disks, or digital memory cards Transmission media used to exchange information already in electronic storage media, including, for example, the Internet (wide open), extranet (using Internet technology to link a business with information accessible only to collaborating parties), leased lines, dial-up lines, and private networks, and the physical movement of removable/transportable electronic storage media. Certain transmissions, including of paper via facsimile and of voice via telephone, are not considered to be transmissions via electronic media because the information being exchanged did not exist in electronic form before the transmission [45 CFR Part 160]EPHI Individually Identifiable Health Information that is (1) transmitted or (2) maintained by electronic media [45 CFR Part 160]Individually Identifiable Health Information (IIHI)Any information, including demographic data collected from an individual, thatis created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse; andrelates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual, andidentifies the individual, orwith respect to which there is a reasonable basis to believe that the information can be used to identify the individual[45 CFR Part 160]Integrity The property that data or information has not been altered or destroyed in an unauthorized manner [45 CFR Part 164]Local Area Network (LAN)See NetworksMemory Stick?One of a family of solid-state memory cardsNetworks A communication capability that allows one user or system to connect to another user or system and can be part of a system or a separate system; examples of networks include local area or wide area networks, including public networks such as the Internet [NIST SP 800-26]Operating SystemA collection of computer programs that manages the hardware for other computer applications; examples include Microsoft Windows, Novell Netware, Unix, Linux, Mac OSPassword Confidential authentication information composed of a string of characters [45 CFR Part 164]PC CardA standard laptop personal computer device that plugs into a personal computer slot approximately the size of a credit card (formerly known as PCMCIAtm card)Personal Identification Number (PIN)A number or code assigned to an individual and used to provide verification of identity[45 CFR Part 142]Physical SafeguardsThe physical measures, policies, and procedures to protect a covered entity’s electronic information systems and related buildings and equipment from natural and environmental hazards and unauthorized intrusion [45 CFR Part 164]Remote ServiceProvide support service (e.g., testing, diagnostics, software upgrades) while not physically or directly connected to the device (e.g., remote access via modem, network, Internet)Removable MediaSee Electronic MediaRisk AnalysisConducting an accurate and thorough assessment of the potential risks and vulnerabilities to the integrity, availability, and confidentiality of electronic Protected Health Information[45 CFR Part 164]Risk ManagementThe ongoing process of assessing risk, taking steps to reduce risk to an acceptable level, and maintaining that level of risk [NIST SP 800-26]Security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level [45 CFR Part 164]Secure Digital (SD) Card?One of a family of solid-state memory cardsTechnical SafeguardsThe technology, policies, and procedures to protect electronic Protected Health Information and control access to it [45 CFR Part 164]TokenA physical authentication device that the user carries (e.g., smartcard, SecureIDtm, etc.). Often combined with a PIN to provide a two-factor authentication method that is generally thought of as superior to simple password authenticationVirtual Private Network (VPN)See NetworksVirusA computer program that is either:A type of programmed threat—a code fragment (not an independent program) that reproduces by attaching to another program. It may damage data directly, or it may degrade system performance by taking over system resources, which are then not available to authorized users Code embedded within a program that causes a copy of itself to be inserted in one or more other programs; in addition to propagation, the virus usually performs some unwanted function[45 CFR Part 142]Virus CheckingA computer program (“anti-virus software”) that identifies and disables another “virus” computer program, typically hidden, that attempts to attach itself to other programs and has the ability to replicate (unchecked virus programs result in undesired side effects generally unanticipated by the user)[45 CFR Part 142]VulnerabilityA flaw or weakness in system procedures, design, implementation, or internal controls that could be exercised (accidentally triggered or intentionally exploited) and result in a security breach or a violation of the system’s security policy [NIST SP 800-30]Wide Area Network (WAN)See NetworksMedical Equipment Pre-Procurement Assessment WorksheetEquipment Description: FORMTEXT ?????Vendor/Model: FORMTEXT ????? Vendor Contact: FORMTEXT ?????Requesting Clinical Service: FORMTEXT ?????Contact Information & Sign-Off Clinical Service POC: FORMTEXT ?????Phone: FORMTEXT ????? Biomedical Engineering POC: FORMTEXT ?????Phone: FORMTEXT ????? ISO: FORMTEXT ?????Phone: FORMTEXT ????? IT POC: FORMTEXT ?????Phone: FORMTEXT ?????Medical Equipment Documentation Review FORMCHECKBOX Manufacturer Disclosure Statement for Medical Device Security (MDS2) FORMCHECKBOX Existing Site-to-Site or 1 VA VPN Agreement FORMCHECKBOX Purchase documents and associated equipment quotations FORMCHECKBOX Business Associate Agreement (as required) FORMCHECKBOX Equipment description, information flow, and network connectivity requirements FORMCHECKBOX Documentation of network configuration and installation requirements FORMCHECKBOX Interface specifications for connection to VA Health Care Information systems FORMCHECKBOX Does the equipment require a Medical Device Supplemental Questionnaire? FORMCHECKBOX YES FORMCHECKBOX NOSecurity Precautions FORMCHECKBOX Does the equipment support Anti-virus protection with updates via ePolicy? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Does the equipment support OS critical patch installation via WSUS? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Will the medical equipment be configured for Device Authentication using Active Directory? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Will the medical equipment be configured for User Authentication using Active Directory? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Will IT provide and manage: Disaster Recovery? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Will vendor require Remote Access via VPN? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Will vendor provide a network device (switch, router)? Needs risk assessment and ISO approval. FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Will vendor provide any wireless devices? Needs risk assessment and ISO approval. FORMCHECKBOX YES FORMCHECKBOX NONetwork Design and Constraints FORMCHECKBOX Notification to network administrator to configure medical VLAN Medical VLAN: FORMTEXT ????? FORMCHECKBOX Network administrator reviews risk assessment and ISO approval for any network or wireless devices. FORMCHECKBOX Network administrator configures the restrictive ACL, verifies connectivity, and documents configuration. FORMCHECKBOX IT prepares network drawing showing documenting equipment configuration and network connectivity. IT Post Installation Support Strategy FORMCHECKBOX IT will provide remediation information, network management and the following security precautions for this equipment: FORMTEXT ????? FORMCHECKBOX IT will provide the following additional technical support to the Clinical Service or Biomedical Engineering: FORMTEXT ????? FORMCHECKBOX Entry created in Networked Medical Device Inventory to document interface and system integration.Additional Comments: FORMTEXT ?????Medical Equipment Configuration FORMCHECKBOX What OS does the system utilize? FORMTEXT ????? FORMCHECKBOX Can the system be patched automatically? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Does the device incorporate a switch or hub into its design? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Is the switch or hub required as part of the system configuration? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Which Anti-virus software is approved by the device manufacturer? FORMTEXT ????? FORMCHECKBOX If server based, does the system require a specific version of Java for proper client operation? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX If server based, does the system utilize ActiveX control for client interaction? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX If yes, specify configuration requirements. FORMTEXT ????? FORMCHECKBOX Where will the device be installed? FORMTEXT ?????Authentication and User Accounts FORMCHECKBOX Is an administrator or power user account required to operate the device? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Is an administrator account required for service? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Does user authentication support Strong Passwords? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Does user authentication support password aging? FORMCHECKBOX YES FORMCHECKBOX NOData Handling FORMCHECKBOX Will the medical device require data backups? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Is ePHI stored on a drive partition to assist with end of service media sanitization? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX What ePHI data elements are stored on the device? FORMTEXT ????? FORMCHECKBOX Who will be responsible for performing the backups? FORMTEXT ????? FORMCHECKBOX Where will the data be stored? FORMTEXT ?????Networking FORMCHECKBOX What are the LAN/WAN requirements for full connectivity/performance? FORMTEXT ????? FORMCHECKBOX What Ports are utilized for network communication? FORMTEXT ????? FORMCHECKBOX Can unutilized ports be closed without negatively impacting device operation? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Can the device support DHCP for network address configuration? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX How many IP addresses does the device require? FORMTEXT ????? FORMCHECKBOX Can the device operate properly without connection to the Internet? FORMCHECKBOX YES FORMCHECKBOX NOWireless FORMCHECKBOX Does the device utilize wireless communication? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX What protocols are used? FORMTEXT ????? FORMCHECKBOX Is any ePHI transmitted via the wireless link FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Does the device support installation of FIPS certified wireless security clients? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX If so, which ones? FORMTEXT ?????Integration with VA Health Care Information Systems FORMCHECKBOX Is the device on the Clinical Procedures validation list? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Is the device on the VistA Imaging validation list? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Does the device have a validated bi-directional HL7 interface? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX Has a DICOM conformance statement been provided? FORMCHECKBOX YES FORMCHECKBOX NO FORMCHECKBOX List the target VA systems the device will communicate with. FORMTEXT ????? FORMCHECKBOX Can the target system be addressed via FQDN? FORMCHECKBOX YES FORMCHECKBOX NOItems in Italics are to be answered by VA; while all other items should be addressed by the manufacturer/vendorSECTION E - SOLICITATION PROVISIONSADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS Provisions 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 provisions are incorporated into 52.212-1 as an addendum to this solicitation:E.1 SUBMISSION INSTRUCTIONSVendors shall submit pricing and any supporting information if proposing “equal” products through the vendor portal. Vendor shall also provide documentation stating the vendor is an authorized reseller from the manufacturer if offering “equal” products. Only new products will be accepted; grey market or refurbished equipment quotes will not be considered.Vendor shall submit up to four references using the offered system, preferably references who have been using the system for at least one year, and preferably two VA references (not within VISN6) and two references from the private sector. References to include the contract number, address, telephone number, and contact person’s name which can validate past experience within the last three (3) years regarding:Quality of Service (to include timeliness of service, documentation and communication of work/repairs at time of service, does service repair/fix the problem on the first site visit or does service have to return to repair/fix the problem again, are parts/tools available when service is performed or is service delayed due to ordering replacement parts), and technical support, including method validation.Customer satisfactionThe Government will consider the relevance of past performance information obtained in relation to the scope of this procurement. Note that Government evaluators may avail themselves of various federal, state, and local past performance databases including, but not limited to, Past Performance Information Retrieval System (PPIRS). Government evaluators reserve the right to contact any of the provided references to solicit additional information or clarification regarding the Offeror’s past performance. The Contracting Officer and/or technical evaluators may research Offeror performance on any federal, state, local, and commercial contract performance of the Offeror that is known to the Contracting Officer, but not included as a reference on a submitted quotation. Additionally, personal experience and evaluator knowledge of your particular past performance may be utilized by the technical evaluation team members as long as there’s sufficient documentation which can support their position. Pricing shall be submitted using the pricing schedule in section B IAW FAR 52.211-6.Contractor shall also provide a completed Manufacturer Disclosure Statement for Medical Device Security (MDS2) and Pre-Procurement Risk Assessment (PPA) in accordance with VHA Directive 6550 (see Section D).Vendors shall submit quotes electronically to Amy Pitts at Amy.Pitts@.E.2 EVALUATION CRITERIA AND SELECTION PROCESSEvaluations will be conducted in accordance with FAR Part 13.106-2. The Purchase Order will be issued to the Vendor(s) whose quote represents the best value to the Government. E.3 EVALUATION FACTORSVISN-6 will evaluate quotes using the following evaluation factors:Technical capability: Ability of vendor’s product to meet the salient characteristics.Past performancePriceVISN-6 will evaluate the reasonableness of the quoted price to determine overall best value. E.4 SELECTION AND DELIVERY ORDER ESTABLISHMENTQuotes must demonstrate a clear understanding of the nature and scope of the products and services required. Failure to provide a realistic, reasonable, and complete quote may reflect a lack of understanding of the requirements and may result in a determination that you are technically unacceptable. A purchase order will be established with the responsible Vendor whose quote conforms or exceeds the requirements outlined in this RFQ and is the most advantageous to the Government based on the best value determination. From Technical Capability, Past Performance, and Price data a best value determination will be made. E.5 52.209-5 REPRESENTATION BY CORPORATIONS REGARDING AN UNPAID TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (DEVIATION)(MAR 2012) (a) In accordance with Division H, sections 8124 and 8125 of P.L. 112-74 and sections 738 and 739 of P.L. 112-55 none of the funds made available by either Act may be used to enter into a contract with any corporation that— (1) Has an unpaid federal tax liability, unless the agency has considered suspension or debarment of the corporation and the Suspension and Debarment Official has made a determination that this action is not necessary to protect the interests of the Government. (2) Has a felony criminal violation under any Federal or State law within the preceding 24 months, unless the agency has considered suspension or debarment of the corporation and Suspension and Debarment Official has made a determination that this action is not necessary to protect the interests of the Government. (b) The Offeror represents that— (1) The offeror does [ ] does not [ ] have any unpaid Federal tax liability that has been assessed and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability. (2) The offeror, its officers or agents acting on its behalf have [ ] have not [ ] been convicted of a felony criminal violation under a Federal or State law within the preceding 24 months.(End of Provision)E.6 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)E.7 52.217-5 EVALUATION OF OPTIONS (JUL 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).(End of Provision)E.8 52.225-18 PLACE OF MANUFACTURE (SEPT 2006) (a) Definitions. As used in this clause— "Manufactured end product" means any end product in Federal Supply Classes (FSC) 1000-9999, except— (1) FSC 5510, Lumber and Related Basic Wood Materials; (2) Federal Supply Group (FSG) 87, Agricultural Supplies; (3) FSG 88, Live Animals; (4) FSG 89, Food and Related Consumables; (5) FSC 9410, Crude Grades of Plant Materials; (6) FSC 9430, Miscellaneous Crude Animal Products, Inedible; (7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products; (8) FSC 9610, Ores; (9) FSC 9620, Minerals, Natural and Synthetic; and (10) FSC 9630, Additive Metal Materials. "Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture. (b) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly— (1) In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or (2) Outside the United States.(End of Provision)E.9 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE (JAN 2008) The following provisions or clauses incorporated by reference in this solicitation must be completed by the offeror or prospective contractor and submitted with the quotation or offer. Copies of these provisions or clauses are available on the Internet at the Web sites provided in the provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference, or the clause at FAR 52.252-2, Clauses Incorporated by Reference. Copies may also be obtained from the contracting officer.[Contracting officer shall list all FAR and 48 CFR Chapter 8 (VAAR) provisions and clauses incorporated by reference that must be completed by the offeror or prospective contractor and submitted with the quotation or offer.](End of Provision)FAR NumberTitleDate52.225-25PROHIBITION ON CONTRACTING WITH ENTITIES ENGAGING IN CERTAIN ACTIVITIES OR TRANSACTIONS RELATING TO IRAN—REPRESENTATION AND CERTIFICATIONSDEC 2012(End of Addendum to 52.212-1)E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (MAY 2014) An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically via . If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision. (a) Definitions. As used in this provision— "Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program. "Forced or indentured child labor" means all work or service— (1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or (2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties. "Inverted domestic corporation", as used in this section, means a foreign incorporated entity which is treated as an inverted domestic corporation under 6 U.S.C. 395(b), i.e., a corporation that used to be incorporated in the United States, or used to be a partnership in the United States, but now is incorporated in a foreign country, or is a subsidiary whose parent corporation is incorporated in a foreign country, that meets the criteria specified in 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c). An inverted domestic corporation as herein defined does not meet the definition of an inverted domestic corporation as defined by the Internal Revenue Code at 26 U.S.C. 7874. "Manufactured end product" means any end product in Federal Supply Classes (FSC) 1000-9999, except— (1) FSC 5510, Lumber and Related Basic Wood Materials; (2) Federal Supply Group (FSG) 87, Agricultural Supplies; (3) FSG 88, Live Animals; (4) FSG 89, Food and Related Consumables; (5) FSC 9410, Crude Grades of Plant Materials; (6) FSC 9430, Miscellaneous Crude Animal Products, Inedible; (7) FSC 9440, Miscellaneous Crude Agricultural and Forestry Products; (8) FSC 9610, Ores; (9) FSC 9620, Minerals, Natural and Synthetic; and (10) FSC 9630, Additive Metal Materials. "Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture. "Restricted business operations" means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate— (1) Are conducted under contract directly and exclusively with the regional government of southern Sudan; (2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization; (3) Consist of providing goods or services to marginalized populations of Sudan; (4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization; (5) Consist of providing goods or services that are used only to promote health or education; or (6) Have been voluntarily suspended. "Sensitive technology"— (1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically— (i) To restrict the free flow of unbiased information in Iran; or (ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and (2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)). "Service-disabled veteran-owned small business concern"— (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; and (ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran. (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). "Small business concern" means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation. "Subsidiary" means an entity in which more than 50 percent of the entity is owned— (1) Directly by a parent corporation; or (2) Through another subsidiary of a parent corporation. "Veteran-owned small business concern" means a small business concern— (1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) 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 veterans; and (2) The management and daily business operations of which are controlled by one or more veterans. "Women-owned business concern" means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women. "Women-owned small business concern" means a small business concern— (1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and (2) Whose management and daily business operations are controlled by one or more women. "Women-owned small business (WOSB) concern eligible under the WOSB Program" (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States. (b)(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website. (2) The offeror has completed the annual representations and certifications electronically via the SAM website access through . After reviewing the SAM database information, the offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs . (c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply. (1) Small business concern. The offeror represents as part of its offer that it [ ] is, [ ] is not a small business concern. (2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a veteran-owned small business concern. (3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern. (4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, for general statistical purposes, that it [ ] is, [ ] is not a small disadvantaged business concern as defined in 13 CFR 124.1002. (5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is, [ ] is not a women-owned small business concern. (6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that— (i) It [ ] is, [ ] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and (ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: ___________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation. (7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that— (i) It [ ] is, [ ] is not an EDWOSB concern, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and (ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: ___________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold. (8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is a women-owned business concern. (9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price: ___________________________________________ (10) [Complete only if the solicitation contains the clause at FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, or FAR 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting, and the offeror desires a benefit based on its disadvantaged status.] (i) General. The offeror represents that either— (A) It [ ] is, [ ] is not certified by the Small Business Administration as a small disadvantaged business concern and identified, on the date of this representation, as a certified small disadvantaged business concern in the SAM Dynamic Small Business Search database maintained by the Small Business Administration, and that no material change in disadvantaged ownership and control has occurred since its certification, and, where the concern is owned by one or more individuals claiming disadvantaged status, the net worth of each individual upon whom the certification is based does not exceed $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); or (B) It [ ] has, [ ] has not submitted a completed application to the Small Business Administration or a Private Certifier to be certified as a small disadvantaged business concern in accordance with 13 CFR 124, Subpart B, and a decision on that application is pending, and that no material change in disadvantaged ownership and control has occurred since its application was submitted. (ii) [ ] Joint Ventures under the Price Evaluation Adjustment for Small Disadvantaged Business Concerns. The offeror represents, as part of its offer, that it is a joint venture that complies with the requirements in 13 CFR 124.1002(f) and that the representation in paragraph (c)(10)(i) of this provision is accurate for the small disadvantaged business concern that is participating in the joint venture. [The offeror shall enter the name of the small disadvantaged business concern that is participating in the joint venture: ___________________.] (11) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that— (i) It [ ] is, [ ] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material change in ownership and control, principal office, or HUBZone employee percentage has occurred since it was certified by the Small Business Administration in accordance with 13 CFR Part 126; and (ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR Part 126, and the representation in paragraph (c)(11)(i) of this provision is accurate for the HUBZone small business concern or concerns that are participating in the joint venture. [The offeror shall enter the name or names of the HUBZone small business concern or concerns that are participating in the joint venture:____________.] Each HUBZone small business concern participating in the joint venture shall submit a separate signed copy of the HUBZone representation. (d) Representations required to implement provisions of Executive Order 11246— (1) Previous contracts and compliance. The offeror represents that— (i) It [ ] has, [ ] has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and (ii) It [ ] has, [ ] has not filed all required compliance reports. (2) Affirmative Action Compliance. The offeror represents that— (i) It [ ] has developed and has on file, [ ] has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or (ii) It [ ] has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor. (e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352). (Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made. (f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American—Supplies, is included in this solicitation.) (1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product." The terms "commercially available off-the-shelf (COTS) item," "component," "domestic end product," "end product," "foreign end product," and "United States" are defined in the clause of this solicitation entitled "Buy American—Supplies." (2) Foreign End Products: Line Item No Country of Origin ______________ _________________ ______________ _________________ ______________ _________________[List as necessary] (3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. (g)(1) Buy American—Free Trade Agreements—Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act, is included in this solicitation.) (i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms "Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product," "commercially available off-the-shelf (COTS) item," "component," "domestic end product," "end product," "foreign end product," "Free Trade Agreement country," "Free Trade Agreement country end product," "Israeli end product," and "United States" are defined in the clause of this solicitation entitled "Buy American—Free Trade Agreements—Israeli Trade Act." (ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled "Buy American—Free Trade Agreements—Israeli Trade Act": Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products: Line Item No. Country of Origin ______________ _________________ ______________ _________________ ______________ _________________[List as necessary] (iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) of this provision) as defined in the clause of this solicitation entitled "Buy American—Free Trade Agreements—Israeli Trade Act." The offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of "domestic end product." Other Foreign End Products: Line Item No. Country of Origin ______________ _________________ ______________ _________________ ______________ _________________[List as necessary] (iv) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. (2) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate I. If Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled "Buy American—Free Trade Agreements—Israeli Trade Act": Canadian End Products: Line Item No. __________________________________________ __________________________________________ __________________________________________[List as necessary] (3) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate II. If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled "Buy American—Free Trade Agreements—Israeli Trade Act": Canadian or Israeli End Products: Line Item No. Country of Origin ______________ _________________ ______________ _________________ ______________ _________________[List as necessary] (4) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision: (g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”: Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products: Line Item No. Country of Origin ______________ _________________ ______________ _________________ ______________ _________________[List as necessary] (5) Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade Agreements, is included in this solicitation.) (i) The offeror certifies that each end product, except those listed in paragraph (g)(5)(ii) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled "Trade Agreements". (ii) The offeror shall list as other end products those end products that are not U.S.-made or designated country end products. Other End Products: Line Item No. Country of Origin ______________ _________________ ______________ _________________ ______________ _________________[List as necessary] (iii) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for such products are insufficient to fulfill the requirements of the solicitation. (h) Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only if the contract value is expected to exceed the simplified acquisition threshold.) The offeror certifies, to the best of its knowledge and belief, that the offeror and/or any of its principals— (1) [ ] Are, [ ] are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency; (2) [ ] Have, [ ] have not, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a Federal, state or local government contract or subcontract; violation of Federal or state antitrust statutes relating to the submission of offers; or Commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property; (3) [ ] Are, [ ] are not presently indicted for, or otherwise criminally or civilly charged by a Government entity with, commission of any of these offenses enumerated in paragraph (h)(2) of this clause; and (4) [ ] Have, [ ] have not, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,000 for which the liability remains unsatisfied. (i) Taxes are considered delinquent if both of the following criteria apply: (A) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted. (B) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded. (ii) Examples. (A) The taxpayer has received a statutory notice of deficiency, under I.R.C. Sec. 6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights. (B) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. Sec. 6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights. (C) The taxpayer has entered into an installment agreement pursuant to I.R.C. Sec. 6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment. (D) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. 362 (the Bankruptcy Code). (i) Certification Regarding Knowledge of Child Labor for Listed End Products (Executive Order 13126). (1) Listed end products.Listed End ProductListed Countries of Origin (2) Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (i)(1) of this provision, then the offeror must certify to either (i)(2)(i) or (i)(2)(ii) by checking the appropriate block.] [ ] (i) The offeror will not supply any end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. [ ] (ii) The offeror may supply an end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. The offeror certifies that it has made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any such end product furnished under this contract. On the basis of those efforts, the offeror certifies that it is not aware of any such use of child labor. (j) Place of manufacture. (Does not apply unless the solicitation is predominantly for the acquisition of manufactured end products.) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly— (1) __ In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or (2) __ Outside the United States. (k) Certificates regarding exemptions from the application of the Service Contract Labor Standards. (Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services.) [ ] (1) Maintenance, calibration, or repair of certain equipment as described in FAR 22.1003-4(c)(1). The offeror [ ] does [ ] does not certify that— (i) The items of equipment to be serviced under this contract are used regularly for other than Governmental purposes and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontract) in substantial quantities to the general public in the course of normal business operations; (ii) The services will be furnished at prices which are, or are based on, established catalog or market prices (see FAR 22.1003- 4(c)(2)(ii)) for the maintenance, calibration, or repair of such equipment; and (iii) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract will be the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers. [ ] (2) Certain services as described in FAR 22.1003- 4(d)(1). The offeror [ ] does [ ] does not certify that— (i) The services under the contract are offered and sold regularly to non-Governmental customers, and are provided by the offeror (or subcontractor in the case of an exempt subcontract) to the general public in substantial quantities in the course of normal business operations; (ii) The contract services will be furnished at prices that are, or are based on, established catalog or market prices (see FAR 22.1003-4(d)(2)(iii)); (iii) Each service employee who will perform the services under the contract will spend only a small portion of his or her time (a monthly average of less than 20 percent of the available hours on an annualized basis, or less than 20 percent of available hours during the contract period if the contract period is less than a month) servicing the Government contract; and (iv) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract is the same as that used for these employees and equivalent employees servicing commercial customers. (3) If paragraph (k)(1) or (k)(2) of this clause applies— (i) If the offeror does not certify to the conditions in paragraph (k)(1) or (k)(2) and the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation, the offeror shall notify the Contracting Officer as soon as possible; and (ii) The Contracting Officer may not make an award to the offeror if the offeror fails to execute the certification in paragraph (k)(1) or (k)(2) of this clause or to contact the Contracting Officer as required in paragraph (k)(3)(i) of this clause. (l) Taxpayer Identification Number (TIN) (26 U.S.C. 6109, 31 U.S.C. 7701). (Not applicable if the offeror is required to provide this information to the SAM database to be eligible for award.) (1) All offerors must submit the information required in paragraphs (l)(3) through (l)(5) of this provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the Internal Revenue Service (IRS). (2) The TIN may be used by the Government to collect and report on any delinquent amounts arising out of the offeror's relationship with the Government (31 U.S.C. 7701(c)(3)). If the resulting contract is subject to the payment reporting requirements described in FAR 4.904, the TIN provided hereunder may be matched with IRS records to verify the accuracy of the offeror's TIN. (3) Taxpayer Identification Number (TIN). [ ] TIN: _____________________. [ ] TIN has been applied for. [ ] TIN is not required because: [ ] Offeror is a nonresident alien, foreign corporation, or foreign partnership that does not have income effectively connected with the conduct of a trade or business in the United States and does not have an office or place of business or a fiscal paying agent in the United States; [ ] Offeror is an agency or instrumentality of a foreign government; [ ] Offeror is an agency or instrumentality of the Federal Government. (4) Type of organization. [ ] Sole proprietorship; [ ] Partnership; [ ] Corporate entity (not tax-exempt); [ ] Corporate entity (tax-exempt); [ ] Government entity (Federal, State, or local); [ ] Foreign government; [ ] International organization per 26 CFR 1.6049-4; [ ] Other _________________________. (5) Common parent. [ ] Offeror is not owned or controlled by a common parent; [ ] Name and TIN of common parent: Name _____________________. TIN _____________________. (m) Restricted business operations in Sudan. By submission of its offer, the offeror certifies that the offeror does not conduct any restricted business operations in Sudan. (n) Prohibition on Contracting with Inverted Domestic Corporations (1) Relation to Internal Revenue Code. An inverted domestic corporation as herein defined does not meet the definition of an inverted domestic corporation as defined by the Internal Revenue Code 25 U.S.C. 7874. (2) Representation. By submission of its offer, the offeror represents that— (i) It is not an inverted domestic corporation; and (ii) It is not a subsidiary of an inverted domestic corporation. (o) Prohibition on contracting with entities engaging in certain activities or transactions relating to Iran. (1) The offeror shall email questions concerning sensitive technology to the Department of State at CISADA106@. (2) Representation and certifications. Unless a waiver is granted or an exception applies as provided in paragraph (o)(3) of this provision, by submission of its offer, the offeror— (i) Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of Iran or any entities or individuals owned or controlled by, or acting on behalf or at the direction of, the government of Iran; (ii) Certifies that the offeror, or any person owned or controlled by the offeror, does not engage in any activities for which sanctions may be imposed under section 5 of the Iran Sanctions Act; and (iii) Certifies that the offeror, and any person owned or controlled by the offeror, does not knowingly engage in any transaction that exceeds $3,000 with Iran’s Revolutionary Guard Corps or any of its officials, agents, or affiliates, the property and interests in property of which are blocked pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (see OFAC’s Specially Designated Nationals and Blocked Persons List at ). (3) The representation and certification requirements of paragraph (o)(2) of this provision do not apply if— (i) This solicitation includes a trade agreements certification (e.g., 52.212–3(g) or a comparable agency provision); and (ii) The offeror has certified that all the offered products to be supplied are designated country end products.(End of Provision) ................
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