36C24621Q1044.docx

36C24621Q1044

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

659-21-3-098-0320 36C24621Q1044 08-23-2021 Isaac.Hernandez@va.gov

(910) 488-2120 X: 5862 08-30-2021

8AM

EDT

Department of Veterans Affairs Network Contracting Office 6 201 Hay Street, Suite 304 Fayetteville NC 28301 X X 334510 1250 Employees

NET 30

N/A X See Delivery Schedule

Department of Veterans Affairs Network Contracting Office 6 201 Hay Street, Suite 304 Fayetteville NC 28301

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page This is a brand name solicitation for Philips Physiological Monitoring System Upgrades. Philips products may not be sold by other distributors without written authorization direcrly from Philips.

New Equipment Only; No remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty.

All VA campuses are smoke free.

See CONTINUATION Page 659-3610160-098-820100-3131 010040175 X X X Keeshia Newman Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C246 Keeshia Newman

Department of Veterans Affairs Network Contracting Office 6 201 Hay Street, Suite 304 Fayetteville NC 28301

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

· Scope – Philips Connected Care solutions which includes Patient Monitoring, IntelliSpace Portfolio, Software Evolution Services, IntelliBridge Enterprise Integration systems and software, Professional Services Alarm Management, CareEvent Alarm Notification, all Philips brand name and associated third party hardware, software, services, and maintenance. This includes but is not limited to patient monitors (low and high acuity), software (patient monitor & other necessary server software programs such as SQL etc.), servers, cabling, networking, installation services, training, maintenance & services agreements.

· Scope will include:

· Patient Monitoring, Vital Sign Monitoring

· Vital Sign Data EMR Integration

· Professional Services

· Digital Pathology Products and Services

· ISP Products and Services

· Cath Lab Monitors and Associated Equipment

· Software Evolution and Upgrade Products

· Invivo Patient Monitoring

· Lung and Uronav MR/US Screening Systems

· Dynacad Products and Services

Scope Summary:

This Statement of Work (SOW) describes Salisbury VA Medical Center: requirement to upgrade their existing Philips Patient Monitoring devices and systems to the most current release of Philips software and/or hardware, including upgrade and/or replace any vital sign monitors, patient monitoring bedside monitors, central monitoring stations, Invivo products, Software Evolution and upgrades services (SES’s), and monitoring system infrastructure components that have reached or are nearing end of life support.

Scope Continued:

The Offeror shall provide a quote for all equipment, labor, material and supplies necessary to complete the project.

Offeror will ensure that all monitoring system and network components meet VAMC requirements. Offeror will ensure the system is compatible and functional prior to the completion of the purchase order. Offeror will include all necessary service and support to maintain the Salisbury VAMC functional patient monitoring and applicable system connections and interfaces at the time of installation.

The VA is entitled to all software commercially available within the life of this order. If a newer version of the software becomes available, the Offeror shall install/upgrade the latest release of applicable software at the corresponding VA Medical Center.

Offers should be based on volume of products and services estimated in the parts table. Offeror assumes the responsibility for upgrading all Patient Monitoring, Invivo and Network components that are part of the Philips IntelliVue Monitoring Network, including those that may not be listed on the parts table.

Parts List See Parts List.

Cabling/Network Offeror shall provide the following:

· Cables shall be bundled neatly and in a professional manner especially when cables converge at network hardware.

· Cables shall be marked at each end indicating the termination point of the other end.

· Cabling color shall match or closely match the currently installed monitoring network color.

· Network cabling, terminations, and patch panels used shall be certified CAT5E or greater.

· All cables shall be terminated TIA568A.

· Any cable run through plenum space shall be plenum rated according to NEC and applicable fire codes.

· All cable runs shall be tested and certified in accordance with TSB-67 and TIA/EIA 568-A or latest TIA/EIA Revisions.

· Wireless Medical Telemetry System network shall be an Offeror network.

· The Offeror shall provide a copy of all cabling test results to the COR in electronic format that can be displayed and/or viewed. Offeror installed Cable length shall be included in this report. Non-Offeror cable pulls, and testing validation is to be provided by VA to Offeror.

· Documentation of the network shall also be provided and include a marked up drawing (as built) indicating room locations and wireless network area coverage in Visio and PDF formats.

· Drawings that indicate the location of the installed monitoring devices will be provided for the Medical Center.

· Any connections to the VA OI&T network shall be compliant with VA Directive 6500 and 6550.

· Any offsite server or network maintenance or support provided by the Offeror can only be done via VPN access after the Offeror has obtained the VPN access from the VA. A Business Associates Agreement (BAA) and Memorandum of Understanding/Interconnection Security Agreement (MOU/ISA) will be required.

· All networking hardware shall be rack mounted in rooms designated by Facility Project Manager or COR

Clinical Support - Staff Education and Go Live Support The Offeror shall provide clinical education and go live support for all shifts in care environments where Philips systems are installed. Clinical Support would include onsite end user education and go-live support, and follow-up clinical support post go live. Online training and CD training materials shall be provided at no additional charge.

Maintenance Support and Requirements

A. Warranty

The Offeror shall provide a minimum warranty of 12 months after completion of installation or availability for first patient use, whichever occurs first. The Patient Monitoring Systems will perform in compliance with its performance specifications, in the documentation accompanying the System.

B. User and Service Manuals The Offeror shall provide, two (2) complete and unabridged printed copies and one

(1) electronic version (CD) of applicable operator manuals and service manuals. All applicable document needs shall be accessible via the Philips InCenter.

C. Delivery Timeframe Delivery will be 12 months after receipt of order.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Software Evolution Services, Advanced Technology Services with MS Onsite Patching and Clinical Implementation Services PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, Utensils, and Supplies

MANUFACTURER PART NUMBER (MPN): 890224

Software Evolution Services, Advanced Technology Services with MS Onsite Patching and Clinical Implementation Services new sectors

MANUFACTURER PART NUMBER (MPN): 890224

ESMAS_GUARD Guardian SMA (Beds)

MANUFACTURER PART NUMBER (MPN): ESMAS_GUARD

MXU0058 24 Month Clinical Performance Agreement A01 Basic CPA 24 months - 5000 credits

MANUFACTURER PART NUMBER (MPN): MXU0058

IBE: New Implementation Package

MANUFACTURER PART NUMBER (MPN): 98983208111

Project Management: Advanced

MANUFACTURER PART NUMBER (MPN): 989803208691

Cable: HW, Mats, Labor, Tent, Test

MANUFACTURER PART NUMBER (MPN): 989803208601

Installation Site Services A04 Facilities Implem Solutions

MANUFACTURER PART NUMBER (MPN): 890500

IBE System Integration Services A21 FSE Onsite Labor & Travel G04 Guardian SW Install /Conf G09 Guardian ADT Results Bndle G12 Guardian Device User Auth

MANUFACTURER PART NUMBER (MPN): MXU0130

IBE System Integration Services A02 ADT License/Configuration A21 FSE Onsite Labor & Travel P02 PIICix Pat.Identity Match P08 PIICix Bed Lbl Config P12 PIIC/PIIC iX 128 Bed Config

MANUFACTURER PART NUMBER (MPN): MXU0130

Integration Engineer: Standard Hours

MANUFACTURER PART NUMBER (MPN): 989803208151

Integration Engineer: Premium Hours

MANUFACTURER PART NUMBER (MPN): 989803208161

Labor: Travel

MANUFACTURER PART NUMBER (MPN): 989805710145

Labor: Over Time

MANUFACTURER PART NUMBER (MPN): 989805710140

Labor: Install/De-Install Equipment

MANUFACTURER PART NUMBER (MPN): 989805710138

Rack: 6U, Vertical Wall Mount

MANUFACTURER PART NUMBER (MPN): 989805710129

Hardware Sourcing Services

MANUFACTURER PART NUMBER (MPN): 890515

Patient Information Center iX Expand BTC B to C entitlement upgrade RVC PIC iX Software Release C SMC Upgrade SMA to C

MANUFACTURER PART NUMBER (MPN): 866390

PIC iX Hardware H3U Server UPS H41 Server Hardware NEW Hardware or OS RVC PIC iX C

MANUFACTURER PART NUMBER (MPN): 866424

PIC iX Hardware HS1 PC Hardware with SSD NEW Hardware or OS RVC PIC iX C

Patient Information Center iX Expand 0VC Overview Rev C 12C 12-Lead ECG Rev C 1XC PIC iX Base NEW New Add On or Expand NTP Network PHY Physio Server PRC Pro Rev C RVC PIC iX Software Release C V1C Visibility Rev C

MANUFACTURER PART NUMBER (MPN): 866390

PIC iX Hardware H1U UPS Hardware HS1 PC Hardware with SSD NEW Hardware or OS RVC PIC iX C

IntelliVue MX450 US AL1 MX450 Advanced Monitor J13 RS232/MIB Interface

MANUFACTURER PART NUMBER (MPN): 866062_NAM

IntelliVue MX550 US AL2 MX550 8 Wave Adv. Monitor J13 RS232/MIB Interface

MANUFACTURER PART NUMBER (MPN): 866066_NAM

IntelliVue MMX 4 PCE B06 Dual Press and Temp SP5 Masimo rainbow SET SpO2

MANUFACTURER PART NUMBER (MPN): 867036

IntelliVue X3 7 PCE A04 4-waves capability B06 Dual Press and Temp C12 Conventional 12 Lead ECG E20 Fix Clamp Mount E31 Carrying Handle H72 Critical Care Transport SW J45 Smart Hopping IF 1.4 GHz SC1 System Cable - 0.75 m SP5 Masimo rainbow SET SpO2

MANUFACTURER PART NUMBER (MPN): 867030

IntelliVue Microstream Extension B06 Add dual IBP, Temp

MANUFACTURER PART NUMBER (MPN): 867041

Clinical Config. & Impl. Services (CMS) A08 3 Consecutive Overtime Shifts

MANUFACTURER PART NUMBER (MPN): 890539

CBL 10 Lead ECG Trunk AAMI/IEC 2m

MANUFACTURER PART NUMBER (MPN): 989803144791

CBL 5 Lead ECG Trunk, AAMI/IEC 2.7m

MANUFACTURER PART NUMBER (MPN): 989803145061

CBL 5 Leadset, Grabber, AAMI, ICU

MANUFACTURER PART NUMBER (MPN): 989803125841

CBL 5 Leadset, Grabber, Chest, AAMI, ICU

MANUFACTURER PART NUMBER (MPN): 989803125881

Dual IBP Adapter

MANUFACTURER PART NUMBER (MPN): 989803199741

Adult NIBP Air Hose 3.0m

MANUFACTURER PART NUMBER (MPN): 989803104341

rainbowSET 10' Cable for LNCS

MANUFACTURER PART NUMBER (MPN): 989803186501

Project Management Services 48 PCE A02 Advanced

MANUFACTURER PART NUMBER (MPN): MXU0575

Rack vertical wall mount WVB-6U

MANUFACTURER PART NUMBER (MPN): 989805710129

Labor Installation & Implementation

MANUFACTURER PART NUMBER (MPN): 989805710139

Labor OT Install/De-Install Equipment

MANUFACTURER PART NUMBER (MPN): 989805710140

Travel Hours

Wall Channel Seismic 19"

MANUFACTURER PART NUMBER (MPN): MXU0175

VHM-PL Arm slide-below, 3"DP, lock, 4 hk

MANUFACTURER PART NUMBER (MPN): 989805710349

Upgrade DBS, Hardware Box Swap Only

MANUFACTURER PART NUMBER (MPN): 989805710169

Upgrade PIIC/Client, box swap per unit

MANUFACTURER PART NUMBER (MPN): 989805710173

IntelliVue MX40 865350 1.4GHz SW Upgrade M02 Impedance Respiration

MANUFACTURER PART NUMBER (MPN): 865348

Labor: Upgrade MX40 per unit, 6+ Units

MANUFACTURER PART NUMBER (MPN): 989805710172

Smart Hop: Coverage, 50,000+ SF

MANUFACTURER PART NUMBER (MPN): MXU0482

Network: Smart Hop Wired (per SF)

MANUFACTURER PART NUMBER (MPN): MXU0524

Cable: SF, Mats, Labor, Tent, Test

MANUFACTURER PART NUMBER (MPN): 989803208551

Project Management: Advanced

MANUFACTURER PART NUMBER (MPN): 989803208691

Biomedical Training Courses A13 CMS2460 MX400/MX800 A21 CMS2032 MX40 ITS/ PIIC iX A27 CMS2180 PICiX Rev C Biomed

MANUFACTURER PART NUMBER (MPN): MXU0011

PIC iX Hardware HS1 PC Hardware with SSD NEW Hardware or OS RVC PIC iX C

M3176C Information Center USB Recorder A01 One Recorder

MANUFACTURER PART NUMBER (MPN): 862120

24" Widescreen LCD Display - touch

MANUFACTURER PART NUMBER (MPN): 866126

Labor: Install/De-Install Equipment

MANUFACTURER PART NUMBER (MPN): 989805710138

Labor: Travel

Project Management: Foundation

MANUFACTURER PART NUMBER (MPN): 989803208681

Wall Channel: 19" Seismic

MANUFACTURER PART NUMBER (MPN): MXU0175

Mount: Display, Tilt Only, 75/100mm VESA

MANUFACTURER PART NUMBER (MPN): MXU0545

Cable: HW, Mats, Labor, Tent, Test

MANUFACTURER PART NUMBER (MPN): 989803208601

UPS: Rack, PC 6 Outlets, 500VA, 1U

MANUFACTURER PART NUMBER (MPN): 989805700057

Mount: CPU, Underdesk, 360 Degree Swivel

MANUFACTURER PART NUMBER (MPN): 989805710251

Mount: CPU, 4.5" to 7", Wall Channel

MANUFACTURER PART NUMBER (MPN): 989805710247

Salisbury VA - Microstream Extensions

IntelliVue Microstream Extension for the Charlotte HCC

IntelliVue Microstream Extension for Kernersville HCC

B.4 DELIVERY SCHEDULE

1601 Brenner Avenue Salisbury, NC 28144

USA

704-762-6140 david.sledge2@va.gov

3506 W Tyvola Rd.

Charlotte, NC 28208

USA

1695 Kernersville Medical Pkwy Kernerville, NC 27284

USA

B.5 SPECIAL CONTRACTING REQUIREMENTS

A. WORK HOURS

The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required, except in case of emergency, to furnish such services on Federal Holidays or during off duty hours as described below.

The following terms have the following meanings:

Normal working hours: Monday through Friday, 8:00 a.m. – 4:30 p.m., excluding federal holidays.

New Year’s Day Martin Luther King’s Day Memorial Day President’s Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas Juneteenth

Any other day specifically declared by the President of the United States to be a federal holiday.

When one of the holidays falls on Sunday, the following Monday shall be observed as a Federal Holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

B. BILLING AND PAYMENT

Invoices shall be submitted monthly, in arrears to the VA’S Electronic Invoice Presentment and Payment System (see website at http://www.fsc.va.gov/einvoice.asp), and shall include at a minimum:

Date of invoice Contract Number Purchase Order Number Vendor Name Invoice Number CLIN & Date of service

C. CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

(a) FAR 42.1502 direct all Federal agencies to collect past performance information on contracts. The Department of Veterans Affairs has implemented use of the Contractor Performance Assessment Reporting System (CPARS) to comply with this regulation. One or more past performance evaluations will be conducted in order to record your contract performance as required by FAR 42.15

(b) The past performance evaluation process is a totally paperless process using CPARS. CPARS is a web-based system that allows for electronic processing of the performance evaluation report. Once the report is processed, it is available in the Past Performance Information Retrieval System (PPIRS) for Government use in evaluating past performance as part of a source selection action.

(c) Please furnish the Contracting Officer with the name, position title, phone number, and email address for each person designated to have access to your firm’s past performance evaluation(s) for the contract no later than 30 days after award. Each person granted access will have the ability to provide comments in the Contractor portion of the report and state whether or not the Contractor agrees with the evaluation, before returning the report to the Assessing Official. The report information must be protected as source selection sensitive information not releasable to the public.

(d) When your Contractor Representative(s) (Past Performance Points of Contact) are registered in CPARS, they will receive an automatically-generated email with detailed login instructions. Further details, system requirements, and training information for CPARS are available at www.cpars.gov. The CPARS User Manual, registration for online training for Contractor Representatives may be found at this site.

(e) Within 60 days after the end of a performance period, the Contracting Officer will complete an interim or final past performance evaluation and the report will be accessible at www.cpars.gov Contractor Representatives may then provide comments in response to the evaluation, or return the evaluation without comment. Comments are limited to the space provided in Block 22. Your comments should focus on objective facts in the Assessing Official’s narrative and should provide your views on the causes and ramifications of the assessed performance. In addition to the ratings and supporting narratives, blocks 1-17 should be reviewed for accuracy, as these include key fields that will be used by the Government to identify your firm in future source selection evaluations. If you elect not to provide comments, please acknowledge receipt of the evaluation by indicating, “No Comment” in Block 22, and then signing and dating Block 23 of the form. Without a statement in Block 22, you will be unable to sign and submit the evaluation back to the Government. If you do not sign and submit the CPAR within 30 days, it will automatically be returned to the Government and will be annotated: “The report was delivered/received by the contractor on (date). The contractor neither signed nor offered comment in response to this assessment.” Your response is due within 30 calendar days after receipt of the CPAR.

(f) The following guidelines apply concerning your use of the past performance evaluation:

(1) Protect the evaluation as “source selection information.” After review, transit the evaluation by completing and submitting the form through CPARS. If for some reason you are unable to view and/or submit the form through CPARS, contact the Contracting Officer for instructions.

(2) Strictly control access to the evaluation within your organization. Ensure the evaluation is never released to persons or entities outside of your control.

(3) Prohibit the use of or reference to evaluation data for advertising, promotional material, pre-award surveys, responsibility determination, production readiness reviews, or other similar purposes.

(g) If you wish to discuss a past performance evaluation, you should request a meeting in writing to the Contracting Officer no later than seven days following your receipt of the evaluation. The meeting will be held in person or via telephone or other means during your 30-day review period.

(h) A copy of the completed past performance evaluation will be available in CPARS for your viewing and for Government use supporting source selection actions after it has been completed.

D. CONTRACT ADMINISTRATION

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor.

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity or quality of performance of this contract.

In the event the contractor effects any such change at the direction of any person other than the contracting officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

Points of Contact Contracting Officer Salisbury VAMC Keeshia Newman David Sledge 100 Emancipation Drive, Bldg. 27 1601 Brenner Ave, Hampton, VA 23667 Salisbury, NC 28144 Keeshia.Newman@va.gov david.sledge2@va.gov

E. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, FOR MEDICAL EQUIPMENT

1. GENERAL

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

1. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

1. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

2. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

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

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

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

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

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

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

1. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

3. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

3. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

3. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

3. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

3. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

3. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

3. The contractor/subcontractor agrees to:

6. Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

0. The Systems of Records (SOR); and

0. The design, development, or operation work that the contractor/subcontractor is to perform;

3. Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

3. Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

3. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

9. “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

9. “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

9. “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

3. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

3. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days.

3. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ____ days.

3. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

1. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

4. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

4. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

4. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

4. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

4. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

4. VA prohibits the installation and use of personally-owned or contractor/subcontractor-owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

4. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

4. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

7. Vendor must accept the system without the drive;

7. VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

7. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

7. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

3. The equipment vendor must have an…