36C25023Q0524.docx

36C25023Q0524

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.

UEI:

EFT:

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. SIGNAT

URE OF OFFEROR/CONTRACTOR

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

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

36C25023Q0524 04-24-2023 Chad Kemper 937-268-6511 x4541 05-05-2023

2 PM

EDT

36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 3140 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337 X 517810 $35 Million N/A X 36C655 Department of Veterans Affairs Aleda E. Lutz VA Medical Center 1500 Wiess Street Saginaw MI 48602 36C250 Department of Veterans Affairs Network Contracting Office (NCO) 10 3140 Governors Place Blvd. Suite 210 Kettering OH 45409-1337

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 X See CONTINUATION Page The vendor shall provide all supplies, equipment, and personnel necessary to install, update and troubleshoot Platform Six Software upgrade for Vocera equipment located at the Aleda E. Lutz VA Medical Center.

The Government intends to award a Firm Fixed Price (FFP) contract/order for this effort. There will be no options assigned to this contract. All invoices must submitted via the Tungsten Network https://authentication.tungsten-network.com/login All questions and requests for information must be submitted via email only to chad.kemper@va.gov.

Question deadline shall be May 3, at 2PM EST.

This procurement is being conducted under FAR 13.

See CONTINUATION Page X X John McCallum

VA-VHA-SAOC-2018-95B7

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: Company Name: _______________________________________________

CAGE: ________________________________________________________

Tax ID #: ______________________________________________________

b. GOVERNMENT: Contract Specialist 36C250 Chad Kemper / chad.kemper@va.gov / 937-268-6511 x4541 or any NCO 10 Contract Specialist as assigned Department of Veterans Affairs Network Contracting Office (NCO) 10 3140 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337

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.

B.2 STATEMENT OF WORK

SCOPE OF WORK:

The contractor shall supply all necessary labor, supervision, supplies, and equipment necessary to furnish the following services: project management, deployment planning, system migration, configuration, integration, testing, validation, training, knowledge transfer, and Go-Live support. The contract shall include on-site contractors for training and Go-Live support.

The contractor shall make remote diagnostic and corrective repairs using a web-based connection (that is monitored by VA personnel) to the Vocera system at the Aleda E. Lutz Medical Center if repairing over the phone does not fix problem. The contractor shall also participate in remote system migration, training, testing, and configuration using a web-based connection (that is monitored by VA personnel) to the Vocera system if unable to do so over the phone. Telephone migration and project management support may include remedial instruction on basic system usage, assistance with the performance of routine system procedures as described in the user documentation; consultation of proposed workflow and system configuration changes, system and application performance tuning, system and application configuration, and changes to group configuration files.

REQUIREMENTS:

1. PROJECT DETAILS:

The Contractor is responsible for providing the following services and parts pursuant to the manufacturer’s specifications.

Services:

1. Project Management and Deployment Planning Services:

A Vocera Project Manager will be assigned to this project at order acceptance. Project scheduling requests for project kick-off and other engagement activities, including but not limited to, Vocera workshop; Vocera call flow design; installation and implementation; end user training and go-live services; as well as the required Vocera resources for these project activities, can only be committed by the assigned Vocera Project Manager. The Vocera Project Manager will schedule a project kick-off call with the Customer to officially initiate the project, review the scope of services to be provided, introduce team members, set expectations and develop a communications plan.

1. System Migration, Configuration and Testing Services Deliverable: Implementation Report

1. Install and configure the 6.x version of Vocera for Voice and Messaging and Telephony services.

1. Work with internal groups as identified by Customer to ensure external access while maintaining internal security practices.

1. Vocera will synchronize the Messaging service with the Vocera Voice service and Customer’s Active Directory, prior to provisioning the Vocera Vina application.

1. Validate that your system environment will support this release. The System must adhere to Vocera requirements specified in the Vocera Sizing Matrix and the Infrastructure Guide.

1. Conduct end-to-end testing of the Vocera solution, working with your team to troubleshoot issues which may arise during the end-to-end testing.

1. Vocera will provide an Implementation Report documenting the initial configuration of the system at the completion of the installation

1. Vocera Enterprise Platform 6 Basic Knowledge Transfer Services Deliverable: Course Completion Certificate

Provide a maximum of two (2) sessions of training over three (3) hours each. Both classes will be held over two (2) consecutive days for up to three (3) participants and delivered remotely by a Vocera Implementation Engineer. Participants will receive an overview of the Vocera Platform, including navigating the Web Console, using specific platform features such as Staff Assignment and Vina Web, managing users and devices, and understanding end-to-end communication workflow.

1. Vocera Training and Go-Live Support Services Deliverable: Training and Go-Live Support Report

Vocera’s Clinical Informaticist will develop and deliver tailored training as the Vocera Collaboration Suite (VCS) Application is changed to Vina Application.

4.1 Train-the-Trainer class size not to exceed eight (8) seats and will be scheduled for up to two (2) hours.

4.2 Instructor Led Training (ILT) class size not to exceed twelve (12) seats and will be scheduled for up to 60 minutes.

4.3 Staff Assignment and Web Console class size not to exceed ten (10) seats and should be scheduled for up to 30 minutes.

4.4 Maximum number of classes per day not to exceed five (5).

4.5 A minimum of 15 minutes will be scheduled between each class for prep time.

4.6 Class attendees to the Vina ILT must come to class with the Vina application installed on their smartphone and smartphone battery fully charged and configured.

4.7 It is recommended that class attendees come to class after reviewing any applicable Computer Based Training (CBT) modules via Health Stream or the Customer’s Learning Management System

4.7.1 Customer is responsible for CBT management of completion rate.

4.8 Provide consultation on training strategies and best practices to meet the needs of Customer as well as on unit support during training days to support staff to effectively utilize Vocera.

4.9 Customer Trainer(s) will train all remaining staff.

4.10 Vocera will work with the customer to establish the training schedule.

4.11 Customer is responsible for ensuring full attendance to all training sessions scheduled.

1. Vocera Go-Live Support Services Deliverable: Training and Go-Live Support Report

5.1 The Vocera Implementation Team will work with Customer Project Manager to coordinate the delivery of go-live support. Go-Live Support services include:

5.1.1 Incident reporting

5.1.2 Incident tracking

5.1.3 Incident diagnosing and resolution

5.1.4 System Administration

5.1.5 Tiered System Administration Support (if applicable)

5.1.6 Database issue tracking and modifications

5.2 Vocera recommends the following Go Live Support shifts, however Vocera Professional Services resources will provide an Implementation Engineer for 2 Go-Live Support Dayshifts, no After-Hour shifts and no onsite trips. Customer must provide all remaining Go-Live Support.

· Vocera Implementation Engineer: 3 Day Shifts

· Vocera Clinical Informaticist: 3 Day Shifts and 3 After-Hour Shifts

1. Vocera Analytics Installation, Configuration and Testing Services Deliverable: Implementation Report

The Vocera Implementation Engineer will complete the following tasks:

5. Install and configure the most current GA release of Vocera software on the Vocera Analytics server.

5. Install and configure Vocera Analytics “monitoring agents” on the Vocera Analytics server for data collection.

5. Verify connectivity and data collection for all configured data sources.

5. If applicable, the Vocera Implementation Engineer will configure a maximum of five (5) existing scheduled reports into the Vocera Analytics Server. Your Systems Administrator will configure additional scheduled reports if needed.

5. Conduct end-to-end testing of the Vocera Analytics solution, including:

5. Review of Vocera Analytics data and User Interface presentation.

5. Dashboard review of facilities, units, and users.

5. Vocera will provide an Implementation Report documenting the initial configuration of the system at the completion of the installation.

1. Vocera Analytics Administrator Training Services Deliverable: Implementation Report

6. Provide a comprehensive overview of the Vocera Analytics server functionality including basic system troubleshooting and monitoring services.

7.1.1 Administration training services will be provided over two (2) hours for up to three (3) participants

1. Vocera Analytics Training Services Deliverable: Implementation Report

Vocera’s Clinical Informaticist will develop and deliver tailored training remotely for Vocera Analytics. End users.

8.1 Provide remote Vocera Analytics end user training.

8.1.1 One (1) Vocera Analytics class will be provided.

8.1.2 Vocera Analytics User class size not to exceed twelve (12) seats.

8.2 Training will be delivered via webinar.

8.3 Customer Trainer(s) will train all remaining staff.

8.4 Vocera will work with the customer to establish the training schedule.

8.5 Customer is responsible for ensuring full attendance to each training session scheduled.

Parts:

Vocera Software:

Software License, Vocera Platform

· Qty: 1

· Part No.: 900-04165

· SIN: OM

Vocera Analytics License

· Qty: 1

· Part No.: 900-01862

· SIN: OM

· Qty: 1

· Part No.: 920-01965

· SIN: OM

Vocera Platform, Premier Support, Virtual Appliance

· Qty: 2

· Part No.: 920-04137

· SIN: OM

· Qty: 229

· Part No.: 240-01361

· SIN: OM

Service, Reimbursable Expenses

· Qty: 2730

· Part No.: 240-01239

· SIN: OM

1. CUSTOMER RESPONSIBILITIES

· Provide a single point of contact to manage the Vocera implementation, obtain resources, schedule client personnel, and review and approve engagement deliverables.

· Acquire and configure all related server and network hardware and resources as identified by Vocera in the Deployment Sizing Matrix (and/or specifications provided by Vocera at time of project initiation). Ensure hardware required for Vocera System is ready at the time services are provided. This includes rack mounting servers, procuring IP address for servers, and configuring servers to network.

· Schedule all client personnel as necessary for implementation activities, and review and approve engagement deliverables.

· Ensure that all necessary client IT and clinical personnel as identified by Vocera are available at mutually agreed times and dates to support key meetings, including but not limited to call flow design meeting, installation, assessment, and training.

· Ensure that all necessary client IT and clinical personnel as identified by Vocera review and completion of deliverables. Any changes to deliverables will be handled through a change order process. Change Order request can be initiated by either the Client or by Vocera.

· Assign technical resources that have access and adequate permissions on the Vocera servers and configuration computers.

· Customer must ensure VMWare ESX is available for virtual environment configuration.

· Schedule all onsite Vocera Standard services in local time between the hours of 12pm - 7pm Monday; 7am - 7pm Tuesday through Thursday; and 7am - 12pm Friday. There is a 20% upcharge for Premium services which are delivered outside of these hours. Vocera services are performed in 8-hour days.

· Provide a desk, telephone, and internet access for the Vocera Implementation Team.

· Schedule all remote Vocera Standard services in local time between the hours of 9am and 5pm Monday thru Friday. There is a 20% upcharge for Premium services which are delivered outside of these hours. Vocera services are performed in 8-hour days.

· Customer will need to have existing third-party distributor install and configure any necessary components (HW/SW/Licensing)

· Customer will coordinate and make available all 3rd party implementation resources necessary to deliver the project.

· Customer must provide access to all locations required for system installation, configuration, and training.

· Customer must provide remote access via VPN (site-to-site or client-based) for remote configuration, testing and support. Vocera requires the Vocera Implementation Engineer to be granted full security access to the Engage service as necessary to complete this statement of work.

· Vocera will require cooperation of the EHR vendor and/or customer interface analysts to provide Vocera with a complete HL7 ADT feed for each managed facility.

· Customer will need to have existing nurse call distributor and the Customer team and/or partner work with Vocera to enable nurse call system caregiver call back functionality, if applicable

· Identify all staff to be trained by Vocera.

· Vocera Staff Assignment Training should be scheduled as a classroom training session, if applicable. Each participant should be provided with a workstation that has intranet/internet access to connect to the Vocera Staff Assignment application.

· Vocera Web Console Training should be scheduled as a classroom training session, if applicable. Each participant should be provided with a workstation that has intranet/internet access to connect to the Web Console.

· Ensure the Vocera Systems Administrator is always available to support the Vocera trainer during the training classes and make changes as necessary to the database to support modifications and changes uncovered during training.

· Identify help desk staff who can support any issues uncovered during training.

· Designate training rooms of adequate size with wireless coverage and a speaker phone for demonstration purposes.

1. ASSUMPTIONS:

Vocera is not responsible for the following:

· Troubleshooting or maintaining hardware infrastructure, including servers, network, SQL Server Database and the PBX.

· Third party system interfaces (licensing, configuration, interoperability).

· Configuration of telephone switch/PBX.

· Wireless remediation, including but not limited to configuration and/or adjustment to network controllers/settings

· Deployment of MDM solution.

· Allocation of names and locations of access points.

· Any services not included in this Statement of Work are considered out of scope.

1. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who shall serve as the backup.

"Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in the Section B schedule. For field experience, the FSE(s) has a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance, on the Vocera Data Server Units.

All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the SVAMC. The COR may authenticate the training requirements, request training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any SVAMC equipment. The CO and/or COR specifically reserves the right to reject any of the Contractor's personnel and refuse them permission to work on the Aleda E. Lutz Medical Center equipment.

Test Equipment: Not Applicable

1. SERVICE MANUALS:

The VAMC shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to all 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 COR upon request.

1. SECURITY:

All equipment, hardware, software and other computer and network related equipment must meet all VA Standards, adhere to VA Physical and Information Systems Security and Privacy Requirements. This is to include but not limited to sub-components, background processes and services. All software included in the installation must meet the most recently approved version in the VA TRM.

1. SOFTWARE SUPPORT:

After the project is completed, the vendor will supply IT personnel at the Aleda E. Lutz VAMC with appropriate updates and patches to be applied to the system within the limitations of the current service contract. Updates shall include all modifications, corrections, and enhancements to software applications that the manufacturer makes available to its customers. All software updates and patches shall meet VA Information Security standards and shall comply with the most recently approved version found in the VA Technical Reference Model (TRM). Updates shall include mandatory updates, mandated by the manufacturer or to comply with changes in federal or state laws and regulations.

1. VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors (Amended October 25, 2021)

Contractor employees who work in or travel to VHA locations must comply with the following:

1. Documentation requirements:

0. If fully vaccinated, shall show proof of vaccination.

0. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

0. If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date.

0. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

0. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

1. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

0. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

1. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

B.3 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.