Biosense Webster - SOW Template with Security Info Carto3 SPU (003).docx

STATEMENT OF WORK TEMPLATE

A. GENERAL INFORMATION

1. Title of Project: Biosense Webster Carto3 Upgrade

2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in the statement of work (SOW), except as may otherwise be specified. This supply will be purchased for direct patient care for Electrophysiology procedures in the EP lab at the West Roxbury Campus.

3. Background: The current Carto3 system is at end of life and needs to be upgraded.

4. Performance Period: The period of performance is 9/30/23-9/29/24.

Work at the government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

5. Type of Contract: Firm-Fixed-Price.

6. Place of Performance: VA Boston Healthcare System in West Roxbury, MA

7. Performance Based Contract: This contract requires the application of an Earned Value Management System that is compliant with the American National Standards Institute /Electronics Industries Alliance (ANSI/EIA) Standard-748, Earned Value Management Systems. [See paragraph Q.]

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting or has advised the contractor that a kick off meeting is waived.

C. GENERAL REQUIREMENTS

1. For every task, the contractor shall identify in writing all necessary subtasks (if any), associated costs by task, together with associated submilestone dates. The contractor's subtask structure shall be reflected in the technical proposal and detailed project management plan (PMP).

2. All written deliverables will be phrased in layperson language. Statistical and other technical terminology will not be used without providing a glossary of terms.

3. Where a written milestone deliverable is required in draft form, the VHA will complete their review of the draft deliverable within 30 calendar days from date of receipt. The contractor shall have 365 calendar days to deliver the final deliverable from date of receipt of the government’s comments.

D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW.

Task One: The contractor shall provide a detailed PMP and briefing for the VHA project team, which presents the contractor's plan for completing the task order. The contractor's plan shall be responsive to this SOW and describe, in further detail, the approach to be used for each aspect of the task order as defined in the technical proposal. At a minimum, the PMP shall include the risk, quality and technical management approach, work breakdown structure (WBS), detailed schedule, cost requirements, and proposed personnel. The contractor shall keep the PMP up to date throughout the period of performance.

Deliverable One: Delivery and Installation of am upgraded Biosense Webster Carto3 System to include a new signal processing unit and software upgrade kit to version 7.2 and Windows 10.

E. EVALUATED OPTIONAL TASKS AND ASSOCIATED DELIVERABLES [If applicable]

Optional Task One: None

Optional Deliverable One: None

F. SCHEDULE FOR DELIVERABLES

1. The contractor shall complete the Delivery Date column in Attachment A for each deliverable specified.

2. Unless otherwise specified, the number of draft copies and the number of final copies shall be the same.

3. If for any reason the scheduled time for a deliverable cannot be met, the contractor is required to explain why (include the original deliverable due date) in writing to the CO, including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response in accordance with applicable regulations.

G. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

H. REPORTING REQUIREMENTS

1. The contractor shall provide the Task Order Project Manager (TOPM) with monthly written progress reports (original plus ___ copies). These are due to the TOPM by the second workday following the end of each calendar month throughout the project's duration.

2. The progress report will cover all work completed during the preceding month and will present the work to be accomplished during the subsequent month. This report will also identify any problems that arose and a statement explaining how the problem was resolved. This report will also identify any problems that have arisen but have not been completely resolved with an explanation.

I. TRAVEL [Not applicable]

J. GOVERNMENT RESPONSIBILITIES [If applicable]

Customer shall provide free access to the installation site and, if necessary, safe and secure space thereon for storage of Products and equipment prior to installation by Biosense Webster.

K. CONTRACTOR EXPERIENCE REQUIREMENTS – KEY PERSONNEL

These skilled experienced professional and/or technical personnel are essential for successful contractor accomplishment of the work to be performed under this contract and subsequent task orders and option. These are defined as key personnel and are those persons whose resumes were submitted. The contractor agrees that the key personnel shall not be removed, diverted, or replaced from work without approval of the CO and TOPM.

Any personnel the contractor offers as substitutes shall have the ability and qualifications equal to or better than the key personnel being replaced. Requests to substitute personnel shall be approved by the TOPM and the CO. All requests for approval of substitutions in personnel shall be submitted to the TOPM and the CO within 30 calendar days prior to making any change in key personnel. The request shall be written and provide a detailed explanation of the circumstances necessitating the proposed substitution. The contractor shall submit a complete resume for the proposed substitute, any changes to the rate specified in the order (as applicable) and any other information requested by the CO needed to approve or disapprove the proposed substitution. The CO will evaluate such requests and promptly notify the contractor of approval or disapproval thereof in writing.

L. CAPABILITY MATURITY MODEL FOR SOFTWARE INTEGRATION [If applicable]

The organizational entity, within the contractor organization, that will be performing the work required by the SOW shall have been assessed at CMMI Level 2 or higher by an external assessment team led by a Software Engineering Institute (SEI) certified Lead Assessor. The Level 2 Key Process Areas of the S-CMMI are:

*Requirements Management, *Software Project Planning, *Software Project Tracking and Oversight, *Software Subcontract Management, *Software Quality Assurance, and *Software Configuration Management.

M. ARCHITECTURAL GUIDELINES [If applicable]

All developer tools and associated version numbers, if not included in the “VHA Installed Base of Hardware and Software” document, shall be documented by the contractor as part of their proposal. The CO will provide the “VHA Installed Base of Hardware and Software” document to the contractor.

The contractor shall adhere to all VHA policies, standards and tools for managing systems development artifacts. Specifically, these tools will include utilization of the Configuration Management tool, PVCS Dimensions by Serena, as well as the Requirements Traceability Management (RTM) tool by Integrated Chipware. The contractor may not replace these tools.

The contractor shall develop all desktop and NT Server software deliverables to be functional on both the current VHA client/server environment and a Windows 2000 client/server environment. Specifically, NT Server based software shall be developed to be operational on both the Windows NT 4 Server and the Windows 2003 Enterprise Server.

N. SECURITY

Information System Security

The contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The contractor’s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA project manager and the VBA Headquarters Information Security Officer as soon as possible. The contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation.

Security Training

All contractor employees and subcontractors under this contract or order are required to complete the VA's on-line Security Awareness Training Course and the Privacy Awareness Training Course annually. Contractors must provide signed certifications of completion to the CO during each year of the contract. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s).

Government Furnished Equipment

Contractor supplied equipment, PCs of all types, equipment with hard drives, etc. for contract services must meet all security requirements that apply to Government Furnished Equipment (GFE) and Government Owned Equipment (GOE) as identified in VA Policy. If non-VA owned equipment must be utilized, a waiver must be in place. See VA Handbook 6500 for waiver content and format. Security Requirements include: a) VA Approved Encryption Software must be installed on all laptops or mobile devices before placed into operation, b) Bluetooth equipped devices are prohibited within the VA; Bluetooth must be permanently disabled or removed from the device, c) Equipment must meet all sanitization requirements and procedures before disposed of, d) All remote systems (VAGFE and OE) must be equipped with, and use, VA Approved Antivirus Software and a personal (host-based or enclave based) firewall that is configured with a VA Approved Configuration. The COTR, CO, the Project Manager, and the ISO must be notified and verify all security requirements have been adhered to.

Contractor Personnel Security

All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award, and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident.

The investigative history for contractor personnel working under this contract must be maintained in the databases of either the Office of Personnel Management (OPM) or the Defense Industrial Security Clearance Organization (DISCO). Should the contractor use a vendor other than OPM or Defense Security Service (DSS) to conduct investigations, the investigative company must be certified by OPM/DSS to conduct contractor investigations.

1. Background Investigation

The position sensitivity impact for this effort has been designated as [LOW, MODERATE, or HIGH] Risk and the level of background investigation is [NACI, MBI, or BI].

2. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the contractor shall reimburse the VA within 30 days.

b. Background investigations from investigating agencies other than OPM are permitted if the agencies possess an OPM and Defense Security Service certification. The Vendor Cage Code number must be provided to the Security and Investigations Center (07C), which will verify the information and advise the contracting officer whether access to the computer systems can be authorized.

c. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak and understand the English language.

d. After contract award and prior to contract performance, the contractor shall provide the following information, using Attachment B, to the CO:

(1) List of names of contractor personnel.

(2) Social Security Number of contractor personnel.

(3) Home address of contractor personnel or the contractor's address.

e. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

1. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

g. Further, the contractor will be responsible for the actions of all individuals provided to work for the VA under this contract. In the event that damages arise from work performed by contractor provided personnel, under the auspices of this contract, the contractor will be responsible for all resources necessary to remedy the incident.”

3. Government Responsibilities 1.

1. a. The VA Security and Investigations Center (07C) will provide the necessary forms to the contractor or to the contractor's employees after receiving a list of names and addresses.

b. Upon receipt, the VA Security and Investigations Center (07C) will review the completed forms for accuracy and forward the forms to OPM to conduct the background investigation.

c. The VA facility will pay for investigations conducted by the OPM in advance. In these instances, the contractor will reimburse the VA facility within 30 days.

d. The VA Security and Investigations Center (07C) will notify the contracting officer and contractor after adjudicating the results of the background investigations received from OPM.

e. The contracting officer will ensure that the contractor provides evidence that investigations have been completed or are in the process of being requested.

O. ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS

INTERNET/INTRANET

The contractor shall comply with Department of Veterans Affairs (VA) Directive 6102 and VA Handbook 6102 (Internet/Intranet Services).

VA Directive 6102 sets forth policies and responsibilities for the planning, design, maintenance support, and any other functions related to the administration of a VA Internet/Intranet Service Site or related service (hereinafter referred to as Internet). This directive applies to all organizational elements in the Department. This policy applies to all individuals designing and/or maintaining VA Internet Service Sites; including but not limited to full time and part time employees, contractors, interns, and volunteers. This policy applies to all VA Internet/Intranet domains and servers that utilize VA resources. This includes but is not limited to va.gov and other extensions such as, “.com, .edu, .mil, .net, .org,” and personal Internet service pages managed from individual workstations.

VA Handbook 6102 establishes Department-wide procedures for managing, maintaining, establishing, and presenting VA Internet/Intranet Service Sites or related services (hereafter referred to as “Internet”). The handbook implements the policies contained in VA Directive 6102, Internet/Intranet Services. This includes, but is not limited to, File Transfer Protocol (FTP), Hypertext Markup Language (HTML), Simple Mail Transfer Protocol (SMTP), Web pages, Active Server Pages (ASP), e-mail forums, and list servers.

VA Directive 6102 and VA Handbook 6102 are available at:

Internet/Intranet Services Directive 6102 http://www.va.gov/pubs/directives/Information-Resources-Management-(IRM)/6102d.doc Internet/Intranet Services Handbook 6102 http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/6102h.doc

Internet/Intranet Services Handbook 6102 Change 1 – updates VA's cookie use policy, Section 508 guidelines, guidance on posting of Hot Topics, approved warning notices, and minor editorial errors.

http://www.va.gov/pubs/handbooks/Information-Resources-Management-(IRM)/61021h.doc

In addition, any technologies that enable a Network Delivered Application (NDA) to access or modify resources of the local machine that are outside of the browser's "sand box" are strictly prohibited. Specifically, this prohibition includes signed-applets or any ActiveX controls delivered through a browser's session. ActiveX is expressly forbidden within the VA while .NET is allowed only when granted a waiver by the VA CIO *PRIOR* to use.

JavaScript is the preferred language standard for developing relatively simple interactions (i.e., forms validation, interactive menus, etc.) and Applets (J2SE APIs and Java Language) for complex network delivered applications.

SECTION 508

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

In December 2000, the Architectural and Transportation Barriers Compliance Board (Access Board), pursuant to Section 508(2)(A) of the Rehabilitation Act Amendments of 1998, established Information Technology accessibility standards for the Federal Government. Section 508(a)(1) requires that when Federal departments or agencies develop, procure, maintain, or use Electronic and Information Technology (EIT), they shall ensure that the EIT allows Federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. The Section 508 requirement also applies to members of the public seeking information or services from a Federal department or agency.

Section 508 text is available at:

http://www.opm.gov/HTML/508-textOfLaw.htm http://www.section508.gov/index.cfm?FuseAction=Content&ID=14

P. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response.

3. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

Q. Earned Value Management System

1. An Earned Value Management System (EVMS) is required for major acquisitions for development, in accordance with OMB Circular A-11. The Government may also require an EVMS for other acquisitions, in accordance with agency policy contained in VA Directive 6061. Contractors that are required to have their own EVMS shall follow procedures contained in the VA EVMS Application Guide.

2. The following paragraphs reflect EVMS requirements and may be modified as necessary for selected use.

a. Contractor Independent Deliverables. This contract requires the contractor to operate as a distinct entity to produce a deliverable(s). The contractor is required to have its own compliant EVMS, per VA Directive 6061, Table B-1, and provide EVM reports to the VA.

(1). Non-Compliant EVMS. If the offeror proposes to use a system that has not been determined to be in compliance with the American National Standards Institute /Electronics Industries Alliance (ANSI/EIA) Standard-748, Earned Value Management Systems, the offeror shall submit a comprehensive plan for compliance with these EVMS standards. Offerors shall not be eliminated from consideration for contract award because they do not have an EVMS that complies with these standards.

(2). EVMS Reports. As a minimum, contracting officers shall require contractors to submit EVMS monthly reports for those contracts for which an EVMS applies.

(3). Subcontractors. EVMS requirements will be applied to subcontractors using the same rules as applied to the prime contractor. VA will decide the flow down of the EVM requirement to subcontractors. In all cases, the prime contractor is responsible for reporting EVM data.

(4). EVMS Plan. When an offeror is required to provide an EVMS plan as part of its proposal, the contracting officer will determine the adequacy of the proposed EVMS plan prior to contract award.

(5). Performance Measurement Baseline. Contractors are required to resource load schedules in order to set a performance measurement baseline. Resources do not have to be specifically named.

(6). Program Management Reviews. The Contractor shall conduct Program Management Review (PMR) meetings at mutually agreed upon dates and locations. During these reviews, the contractor shall present integrated cost, schedule, and technical performance status. Government Integrated Product Team (IPT) leads or functional managers shall include cost information in discussions of schedule status, technical performance, and risk using earned value as an integrating tool. The following shall be addressed: Cost/schedule trends, significant cost/schedule/technical variances, projected impacts, quantified risk assessments, and corrective action plans.

(7). Contractor Earned Value Management. The Cost Performance Report Description (VA-DI-MGMT-81466A), and Integrated Master Schedule Description (VA-DI-MGMT-81650) shall be developed, maintained, updated/statused and reported on a monthly basis per deliverable requirements, respectively. The contractor shall establish, maintain, and use in the performance of this contract, an integrated management system compliant with the Industry Guidelines for Earned Value Management Systems (EVMS) ANSI/EIA-748 as determined by the Government.

An EVMS that has been formally validated and accepted by the cognizant contracting officer is required for all (fixed price, cost, or incentive) contracts, subcontracts, and other agreements valued at or greater than $50 million in then-year dollars. The application of these concepts shall provide for early indicators of contract cost and schedule problems.

For contracts valued at or greater than $20 million but less than $50 million then-year dollars, the following statement applies: The contractor is required to have an Earned Value Management System that complies with ANSI/EIA-748; however, the government will not formally validate/accept the contractor's management system (no formal review). The contractor will submit an EVMS description and proof of prior certification with its bid.

(8). Integrated Baseline Review (IBR). The contractor shall review its performance measurement baseline plan with the Government within six months of contract award or initiation of an Undefinitized Contract Action, and subsequently, when required, following major changes to the baseline. The Government will verify during the IBR, and follow-on IBRs when required that the contractor has established and maintains a reliable performance measurement baseline. The contractor will ensure that the baseline includes the entire contract technical scope of work consistent with contract schedule requirements, and has adequate resources assigned. The contractor will assure the Government that effective earned value methodologies are used to accurately measure work accomplished and determine contract cost, schedule, and technical performance. The IBR will be used to achieve a mutual understanding of the baseline plan, cost and schedule risk, and the underlying management processes used for planning and controlling the project.

(9). Subcontract Cost/Schedule Management and Reporting. Subcontracts exceeding $20M in then-year dollars will apply the requirements of the Integrated Master Schedule Description (VA-DI-MGMT-81650) and the Cost Performance Report Description (VA-DI-MGMT-81466). For contracts valued at or greater than $20 million but less than $50 million, the following statement applies: The contractor is required to have an Earned Value Management System that complies with ANSI/EIA-748; however, the Government will not formally validate/accept the contractor's management system (no formal review). EVMS flow down to contracts of less than $20M in then-year dollars or Firm Fixed Price contracts that exceed 12 months duration is a risk-based decision and will be as mutually agreed between the contractor and the Government.

(10). Contract Work Breakdown Structure (CWBS). The contractor shall develop and maintain the CWBS and CWBS dictionary.

(11). over Target Baseline (OTB)/Restructure. The contractor may conclude the baseline no longer represents a realistic plan in terms of budget/schedule execution. In the event the contractor determines an OTB/Restructuring action is necessary, the contractor must obtain Government approval prior to implementing an OTB/Restructuring action. The request should also include detailed implementation procedures as well as an implementation timeframe. The contractor will not implement the OTB/Restructuring prior to receiving written approval from the Contracting Officer.

(12). Award Fee Criteria. For contracts that include an award fee, the contractor will demonstrate the use of Earned Value Management (EVM) as a tool for cost and schedule control and as a basis for communicating with the Government. The Government will determine the eligibility for of and amount of any award fee granted. In addition to demonstrating the use of EVM award fee criteria for the contractor will include the following:

(a). Maintain timely detail planning as far in advance as practical;

(b). Ensure the system provides accurate cost/schedule performance status, reliable and timely cost/schedule projections, and quantified risk assessments;

(c). Provide clear and comprehensive explanations of performance problems and associated impacts, and establish and carry out effective recovery plans;

(d). Control and minimize changes to the baseline particularly in the near term;

(e). Ensure all subcontractor-authorized effort is detail planned into measurable objective work packages to the extent possible;

(f). Provide program-level Estimate at Completion (EAC) assessments that include consideration of potential risks and cost containment plans; and

(g). Demonstrate responsiveness regarding management system and cost/schedule performance questions and issues/concerns raised by the Government.

Attachment A Schedule of Deliverables

Deliverable No.

One Item

Quantity

Delivery Date

Within 365 calendar days after award

The contractor shall provide a detailed PMP and briefing for the VHA project team, which presents the contractor's plan for completing the task order. The contractor's plan shall be responsive to this SOW and describe, in further detail, the approach to be used for each aspect of the task order as defined in the technical proposal. At a minimum, the PMP shall include the risk, quality and technical management approach, work breakdown structure (WBS), detailed schedule, cost requirements, and proposed personnel. The contractor shall keep the PMP up to date throughout the period of performance.

Deliverable One: Delivery and Installation of an upgraded Biosense Webster Carto3 System to include a new signal processing unit and software upgrade kit to version 7.2 and Windows 10.

Attachment B

SECURITY

BACKGROUND INVESTIGATION INFORMATION

(Submit after award and prior to contract performance)

Complete this form after contract award if contractor employee does not possess a NACI clearance. The completed form must be sent directly to the Contracting Officer within ten days of award.

Vendor Name: Biosense Webster Cage Code No.______________

Address:

City, State, and Zip Code:

1. Was the employee prescreened? _____ yes or _____ no

2. Is the employee a U.S. Citizen? _____ yes or _____ no

3. Can the employee read, write, speak and understand English language?

_____ yes or _____no

Information From Employee Requiring a Clearance

Address

City State Zip Code