36C24220Q1032_1.docx

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J065--l SERVICES Abbot Cardiac Mapping Federal contract opportunity
Solicitation number
36C24220Q1032
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 2

About this file

This notice announces the Department of Veterans Affairs' intent to award a sole source contract to Abbott Laboratories for maintenance services of a cardiac mapping system. The contractor will provide all necessary labor, equipment, tools, materials, repair services, software updates, and parts to maintain the Ensite Velocity Mapping System located at the VA New York Harbor Healthcare System in Manhattan. The contract will have a one-year base period of performance from November 1, 2020 to October 31, 2021. Interested parties must submit supporting documentation by August 13, 2020 to be considered for competitive award; otherwise, the VA intends to proceed with a sole source award to the incumbent, Abbott Laboratories. The NAICS code is 339112 for medical equipment repair with a size standard of 1,000 employees.

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36C24220Q1032

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

630-20-4-4456-0109 36C24220Q1032 10-08-2020 Marshand Boone marshand.boone@va.gov 718-836-6600 x 3145 10-20-2020

2PM

36C242 Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx

NY

10468-3904 X 339112 1000 Employees N/A X See Delivery Schedule

36C242 Department of Veterans Affairs James J. Peters VA Medical Center Network Contracting Office 2 130 West Kingsbridge Road Bronx

NY

10468-3904

Tungsten Network http://www.tungsten-network.com/us/en /veterans-affairs

RFQ for Ensite Velocity Mapping System Service for VA New York Harbor (Manhattan Campus) Statement of work begins on page 15, solicitation instructions on p. 66 and evaluation factors on p. 70 X Marshand Boone Contracting Officer Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 CONTRACT ADMINISTRATION DATA4
B.2 IT CONTRACT SECURITY5
REQUIREMENTS:16
II.DEFINITIONS/ACRONYMS:16
III.CONFORMANCE STANDARDS:17
IV.HOURS OF COVERAGE:17
IV.LABOR:18
V.REPAIRS:18
VI.SCHEDULED MAINTENANCE:18
VII.PARTS:20
VIII.SERVICE/REPAIR:20
IX.SERVICE MANUALS:20
X.DOCUMENTATION/REPORTS:20
XI.REPORTING REQUIREMENTS:21
XII.PAYMENT:21
XIII.ADDITIONAL CHARGES:22
XIV.REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:22
XV.QUALIFICATIONS:22
XVI.CONDITION OF EQUIPMENT24
XVII.COMPETENCY OF PERSONNEL SERVICES EQUIPMENT:24
XVIII.TEST EQUIPMENT:25
XIX.IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:25
XX.INSURANCE25
B.3 PRICE/COST SCHEDULE26
ITEM INFORMATION26
SECTION C - CONTRACT CLAUSES28
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)28
C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)34
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)34
C.4 52.237-3 CONTINUITY OF SERVICES (JAN 1991)34
C.5 52.249-1 TERMINATION FOR CONVENIENCE OF THE GOVERNMENT (FIXED-PRICE) (SHORT FORM) (APR 1984) ALTERNATE I (APR 1984)35
C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)35
C.7 VAAR 852.211-70 SERVICE DATA MANUALS, MECHANICAL EQUIPMENT (JAN 2008)35
C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)36
C.9 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (OCT 2019)37
C.10 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)38
C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)40
C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2020)40
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS48
SECTION E - SOLICITATION PROVISIONS62
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)62
E.2 52.203-98 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS—REPRESENTATION (DEVIATION) (FEB 2015)68
E.3 52.204-20 PREDECESSOR OF OFFEROR (JUL 2016)69
E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)70
E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (JUN 2020)71

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 36C242 Marshand Boone Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904

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

[X]
52.232-33, Payment by Electronic Funds Transfer—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] monthly

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.

Tungsten Network http://www.tungsten-network.com/us/en /veterans-affairs

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

AMENDMENT NO
DATE

B.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. 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 COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR 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.

c. 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.

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

e. 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.

f. 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.

g. The contractor/subcontractor agrees to:

(1) 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:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) 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

(2) 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.

h. 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.

(1) "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.

(2) "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.

(3) "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.

i. 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.

j. 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.

k. 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.

l. 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.

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

a. 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 vulnerablity 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 COR 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.

b. 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.

c. 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.

d. 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.

e. 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 COR. 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.

f. 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.

g. 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.

h. 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:

(1) Vendor must accept the system without the drive;

(2) 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

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

(4) 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;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the 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/ subcontractor has access.

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

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

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

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

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

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

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

(1) Notification;

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

(3) Data breach analysis;

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

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

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

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

9. TRAINING

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

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

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

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

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

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

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

(End of Clause) New York Manhattan VA Medical Center New York, New York

Statement of Work (SOW) –

Background: The Manhattan VA Medical Center in New York, New York is currently seeking a full-Service contract to include a Base + 4 Option Years starting on 11/01/2020 through 10/31/2021 for the government owned equipment listed below.

Equipment to be serviced/maintained includes:

ENSITE VELOCITY MAPPING SYSTEM

S#14041442 (EE#26430)

Assurance Premium Service Plan

• Extended Product Warranty: Parts replacement coverage

• Software Revisions/Upgrades and Expansion Modules

• Annual Preventive Maintenance

• On-site service, Priority Response Level 2 (within two business days)

• Shipping Level 2: Priority Next Business-Day morning

• 24hrs x 7 days x 365 days telephone technical support

• Remote System Diagnostics and Maintenance (requires network connection and client set-up)

• Loaner Equipment/Components/Modules (as needed during service/repair of Covered Product)

• Technical User Training Course (as applicable)

• Advanced Training (as applicable)

• Discount on Parts & Labor related to services not covered by Service Plan

• Hardware Upgrades / Revision released during the term of service coverage

• Software Expansion Modules released during the term of service coverage

Location at Manhattan VAMC:

CARDIAC CATHLAB SERVICE

REQUIREMENTS:

A.Furnish all necessary labor, equipment, tools materials, repair service, software updates, parts, etc., for complete On-Site Maintenance Service as specified below in accordance with the terms, conditions and schedule of this agreement.
B.Contract Extension: The Government will have the Option to extend the Term of the contract for Four (4) additional years. This is in accordance with the provision of FAR 52.217-9 in Section - I “Contract Clauses” of this Solicitation.
II.DEFINITIONS/ACRONYMS:

A. Biomedical Engineering - Chief or designee, at:

Manhattan VAMC, 212-686-7500 ext. 7309

B.CO - Contracting Officer.
C.COR - Contracting Officer Representative.
D.PM - Preventive Maintenance

Inspection. Services, which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with incidence of malfunction or inoperative conditions.

E.FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.
F.ESR - Vendor Engineering Service

Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

G.Acceptance Signature - VA employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR.
H.Authorization Signature - COR’s signature; indicates COR accepts work status as stated in ESR.
I.NFPA - National Fire Protection Association.
J.CDRH - Center for Devices and Radiological Health.
K.VAMC - Department of Veterans Affairs Medical Center.
L.OSHA - Occupational Safety and Health Agency.
M.OEM - Original Equipment Manufacturer.
III.CONFORMANCE STANDARDS:

Contract service shall ensure that the equipment functions in conformance with the latest published editions of NFPA-99, OSHA, CDRH, and [include performance standards and specifications used when the Ensite Cardiac Mapping System were procured by VA National, Acquisition Center and any upgrades/updates].

IV. HOURS OF COVERAGE:

A. Normal business hours of coverage are [Monday through Friday], [8:00am

- 4:30pm], excluding federal holidays. All service/repairs will be performed during the normal business hours of coverage unless requested and approved by the COR.

B.Preventive maintenance will be performed [annually]. Preventive maintenance is to be performed inside normal business hours.
C.Work performed inside the normal hours of coverage will include service time, and exclude parts and travel time.

Note: Hardware/software scheduled and performed inside normal hours of coverage at no additional charge to the Government (unless it performed outside normal hours of coverage would be detrimental to equipment up-time; to be determined by COR).

D. Federal Holidays observed by the VAMC are:

New Years Day Labor Day Martin Luther King Day Columbus Day President’s Day Veterans Day Memorial Day Christmas Day Thanksgiving Day Independence Day And any other day specifically declared by the President of the United States to be a national holiday.

IV. LABOR:

A. Unlimited labor is included within the hours of coverage noted above.

V. REPAIRS:

A. The contractor shall maintain the equipment in accordance with the Conformance Standards Section, by furnishing all necessary labor, unlimited technical phone support, equipment, tools, materials, repair service, shipping charges and all peripherals.

Equipment repairs/service as specified in Section C, in Section C, I, Equipment, software updates and parts for service in accordance with the terms, conditions and schedule of this agreement. The contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts and maintaining the equipment, including all intervening calls necessary between regular services calibrations.

B.Only, the CO, COR or designated alternate has the authority to approve/ request a service call from the contractor.
C.Response Time: Contractor’s FSE must respond with a phone call to the COR and his/her designee within [one (1) hour] after receipt of telephoned notification [24 hours per day]. If the problem can not be corrected by phone, the FSE will commence work (on-site physical response) within [four (4) hours] after receipt of notification or completion of phone support, and will proceed progressively to completion without undue delay. Except when outside hours of coverage is authorized by the COR.
D.Repair Up-Time: From the time when the FSE commences the on-site unscheduled maintenance, the repairs/service must be completed within are 24 hours (24 hours/day).
VI.SCHEDULED MAINTENANCE:

A. The contractor shall perform Preventive Maintenance (PM) service to ensure that equipment listed in the schedule performs in accordance with Section C, III, Conformance Standards. The contractor shall make thorough technical inspections of the equipment covered in the Schedule. Within ten (10) days after the award of the contract, the contractor shall submit a schedule of PMs and a PM checklist describing in detail the scheduled maintenance procedures for inspecting each piece of equipment listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM. All equipment listed under Section C, I, Equipment, will have PM service performed annually.

PM services shall include, but need no be limited to, the following:

1.Cleaning of equipment if applicable.
2.Reviewing operating system software diagnostics to ensure that system is operating to the manufacturer’s specifications.
3.Calibrating and lubricating the equipment if applicable.
4.Performing remedial maintenance of non-emergent nature.
5.Test and replacing faulty and worn parts and/or parts which are likely to become faulty, fail or become worn.
6.Adjusting and calibrating as necessary.
7.Inspecting electrical wiring and cables for wear and fraying.
8.Inspecting all mechanical components including, but not limited to patient restraints and support devices, chains, belts, bearing and tracks, interlocks, clutches, motors, mechanical integrity, safety, and performance.
9.Performing Electrical Safety Inspections, which should include line cord ground wire resistance and leakage as specified in the Conformance Standards.
10.Returning the equipment to the operating condition defined in Section

C, III,

Conformance Standards.

B.PM services shall be performed in accordance with, and during the hours defined in, the Preventive Maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.
C.All parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise.
D.Upon completion of the preventive maintenance and electrical safety inspection, the FSE must tag the equipment with the appropriate labels used by each facility, if required by the facility. The FSE must fill-in label sections for: date inspection, date next due, and initials of FSE. Labels will be provided to the FSE when reporting (signing-in) to Biomedical Engineering.
VII.PARTS:

The contractor shall furnish and replace parts to meet the repair up-time requirements as stated in Section C, V, Unscheduled Maintenance, D, Repair Up-time. If parts cannot be furnished by this time, the COR must be notified. The contractor has ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. New parts shall be furnished by the contractor and guaranteed against defects and/or failure for a period of 1 year from of completion installation of the component.

VIII. SERVICE/REPAIR:

The contractor shall maintain all of the equipment listed in Section C, I, Equipments. In the event that an equipment needs service/repair, the contractor’s FSE must respond with a phone call to the COR and his/her designee within [one(1)hour] after receipt of telephoned notification [24 hours per day]. If the problem can not be corrected by phone, the FSE will commence work (on-site physical response) to identify and help eliminate any problems, within [eight (8) hours] after receipt of notification or completion of phone support, and will proceed progressively to completion without undue delay.
IX.SERVICE MANUALS:

The VAMC shall not provide service manuals or service diagnostic software to the contractor. They shall obtain, have on file, and make available to its FSE’s all operational and technical documentation, (such as; operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

X. DOCUMENTATION/REPORTS:

The documentation will include legible detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour service) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards Section. In addition, each ESR must as a minimum document the following data legibly and in complete detail:

A.Name of Contractor.
B.Name of FSE who performed services.
C.Contractor Service ESR Number/Log Number.
D.Date, Time (starting and ending),

Equipment Downtime and Hours-On-Site for service call.

E.VA PO#(s) covering the call, if outside normal working hours.
F.Description of Problem Reported by COR/User.
G.Identification of Equipment to be serviced:

INV. ID#, Manufacturer’s Name, Device Name, Model #, Serial #, and any other Manufacturers identification numbers.

H. Itemized Description of Service Performed (including Cost associated with after normal working hour services), including:

Labor and Travel, Parts (with parts #) and Materials and Circuit Location of problem/corrective action.

I. Total Cost to be billed.

J.Signatures:
1.FSE performing services described.
2.A Employee who witnessed service described.

K. Equipment downtime Note: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COTR BEFORE SERVICE IS COMPLETED!

XI. REPORTING REQUIREMENTS:

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