DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Service Manintenance for Dornier Genesis Sytem

Directorate of Surgical Services Urology Department, Naval Medical Center San Diego

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide service and maintain the equipment within the original equipment manufacturer's (OEM) specifications, in accordance with the US, State, and Local laws and regulations, US Navy regulations, and Joint Commission requirements..

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Dornier Genesis System full service and maintenance contract as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: Dornier Genesis System service package to include preventive maintenance to all system according to equipment usage, plus emergency callouts and repairs as necessary throughout the contract.

1.4 Objectives: The service contract is to enhance the required operational safety of the aforementioned Dornier Genesis System Equipment. The maintenance and other services performed according to this service contract serve to maintain the equipment in a functional condition and operation of same according to ISO standards.

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1.5 Scope: The contractor shall provide all services, labor, parts, materials, and equipment necessary for the service and maintenance for the government-owned Dornier Genesis System Equipment as listed on Appendix A, "LABEL FOR APPENDIX" at Naval Medical Center San Diego (NMCSD).

1.6 Period of Performance (PoP):

Base - From: 20NOV2026To:19NOV2027 Option 1 - From: 20NOV2027 To:19NOV2028 Option 2 - From: 20NOV2028 To:19NOV2029 Option 3 - From: 20NOV2029 To:19NOV2030

1.6.1 Transition: Transition-in/transition-out period

1.6.1.1.1 The contractor shall comply with transition-in requirements of the DHA, as listed in paragraph 1.11.1, for contractors needing to be issued Common Access Card (CAC) identification, including Department of Defense (DoD) and DHA-directed training and forms submission, prior to network access.

1.6.1.2 Transition-out period: The transition-out plan shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming contractor/Government personnel at the expiration of the contract. See Part 7, Technical Exhibit 1.

1.6.1.2.1 The contractor shall comply with transition-out requirements of the DHA for contractors who have been issued a CAC or who generate “records”, as defined by DoD (records manual), including DoD-directed disposition of records, and others displayed on the In/Out (I/O) Processing Portal.

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at

Urology Department Buildning Three (3), Second Floor

Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134-5000

1.7.2 Recognized Federal holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

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1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.8 Contractor travel: Contractor shall be authorized travel expenses consistent with the cost principles and procedures in Federal Acquisition Regulation (FAR) Part 31.2, Travel Costs and the limitations of funds specified in this contract. All travel requires Government approval/authorization and notification to the Contracting Officer Representative (COR).

1.10 Quality

1.10.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 7, Technical Exhibit 1 - CDRL A001.

1.10.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.11 Contractor personnel

1.11.1 CAC requirements: For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government all the required information per the DHA CAC request process current version 2.1, January 2018, or more recent when updated. See process attached at Part 7 Section 7.1.1 of the PWS. A CAC is the standard identification for eligible DoD contractor personnel.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s).

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements:

1.11.2.1 The DHA’s “Onboarding Checklist for Contractor Employees” is located at the DHA Onboarding and Offboarding Portal at https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx

1.11.2.2 The DHA’s contractor training instructions embedded at Part 7 Section 7.1.2.

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD- and DHA-directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at:

https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note: Public Key Infrastructure (PKI)-restricted, printed versions available).

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.11.4 Key control: The contractor shall establish and implement methods of making sure all keys/key cards issued to the contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the contractor by the Government shall be duplicated. The contractor shall develop procedures covering key control that shall be included in the QCP. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas.

The contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the CO.

1.11.4.1 In the event keys, other than master keys, are lost or duplicated, the contractor shall, upon direction of the CO, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the contractor.

In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the contractor.

1.11.4.2 The contractor shall prohibit the use of Government issued keys/key cards by any persons other than the contractor’s employees. The contractor shall prohibit the opening of locked areas by contractor employees to permit entrance of persons other than contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the CO.

1.11.5 Lock combinations: The contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the contractor’s

QCP.

https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx

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1.12 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO.

The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 07:00 a.m. to 1600 p.m., Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below:

1.14.1 Contractor Manpower Reporting (CMR): RESERVED.

1.14.2 Non-Disclosure Agreement (NDA): All contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA contractor NDA (DHA Form 49) prior to beginning work on the subject contract. The contractor shall execute an NDA on behalf of the company and shall ensure that all staff assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the contractor. The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.14.3 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.15 Contractor Identification

1.15.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor

November 16, 2021 support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel.

Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.15.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order.

Contractor personnel shall make their contractor status known during introductions.

1.15.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.16.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system (If applicable, if not delete 1.16.1 and 1.16.2 and replace to 1.16 Reserved). Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and the security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation.

1.16.2 Company's FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF-85/86. The FSO/Security POC, or the COR must notify the DHA Personnel Security Office in writing of a contractor's termination from the contract, including the termination date.

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI) 6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM

5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate

November 16, 2021 background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.17.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.17.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

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PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D- Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R- Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.2 Acronyms:

AIS Automated Information System APL Approved Products List APL AQL Acceptable Quality Level ARRT Acquisition Requirements Roadmap Tool ATO Authority to Operate B2B Business-2-Business CAC Common Access Card CAP Cloud Access Point CCEVS Common Criteria Cybersecurity Evaluation and Validation Scheme CDI Covered Defense Information CE Computer Environment CDRL Contract Data Requirement List CIO Chief Information Officer

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CJCSM Chairman of the Joint Chiefs of Staff Manual CMMC Cybersecurity Maturity Model Certification CMR Contractor Manpower Reporting CNSSI Committee on National Security Systems Instruction CO Contracting Officer(s) CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative CSP Cloud Service Provider CSSP Cyber Security Service Provider CUI Controlled Unclassified Information DAD-A Deputy Assistant Director for Acquisition DC3 DoD Cyber Crime Center DD Form 254 Department of Defense Contract Security Requirement List (if applicable) DB Design-Build DBB Design-Bid-Build DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DISA Defense Information System Agency DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DSAs Data Sharing Agreements DSAA Data Sharing Agreement Application DMZ Demilitarized Zone DoDM Department of Defense Manual DPCLO DHA Privacy and Civil Liberties Office DUA Data Use Agreement eMSM Enhanced Multi-Service Markets EULA End User License Agreement EVM Earned Value Management FAR Federal Acquisition Regulation FCI Federal contract information FE Facilities Enterprise FedRAMP Federal Risk Authorization and Management Program FISMA Federal Information Security Modernization Act FRCS Facility Related Control Systems FSO Facilities Security Officer HA Health Affairs HIPAA Health Insurance Portability and Accountability Act HCA Head of the Contracting Activity HIT Health Information Technology IGCE Independent Government Cost Estimate IA Information Assurance IO Initial Outfitting I/O In/Out Processing Portal

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IPv Internet Protocol Version IS Information System ISO International Organization for Standardization ISP Internet Service Provider IT Information Technology ISCM Information Security Continuous Monitoring IV&V Independent Verification & Validation MedCOI Medical Community of Interest MHS Military Health System MIL-STD Military Standard MTFs Military Treatment Facilities NCR National Capitol Region NDA Non-Disclosure Agreement NIAP National Information Assurance Partnership NIST National Institute of Standards and Technology OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPM Office of Personal Management OSD Office of the Secretary of Defense P-ATO Personal Authorization to Operate P&R Personnel and Readiness PGI Procedures, Guidance and Information PDT Project Delivery Team PHI Protected Health Information PII Personally Identifiable Information PIT Platform Information Technology PK Public Key PKI Public Key Infrastructure POA&M Plan of Action and Milestones POC Point of Contact PMO Program Management Office PoP Period of Performance PP Personal Property PPSM Ports, Protocols, and Services Management PRS Performance Requirements Summary PSP Personnel Security Program PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RFP Request for Proposal RFQ Request for Quotation RMF Risk Management Framework SP Special Publication

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SPRS Supplier Performance Risk System SRM Sustainment, Restoration and Modernization SRG Security Requirements Guides STIG Security Technical Implementation Guides TOS Terms of Service US United States UFC Unified Facilities Criteria VPN Virtual Private Network XML Extensible Markup Language

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

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PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below: provide

3.2 Facilities: The Government:

☒ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below:

3.3 Utilities: The Government:

☐ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below The contractor may use Government utilities (e.g., electrical power, compressed air, water) that are available and required for any service performed under this contract while at Government facilities. The facilities engineer however must approve of any contractor equipment which would connect to these utilities in order to ensure compatibility with NMCSD utilities.

3.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

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☐ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below:

3.4.1 Procurement Integrated Enterprise (PIEE), GFP Module Application The contractor shall be responsible for obtaining and maintaining access, training and successful operation of the PIEE/GFP Module application for the entirety of the contract/task order PoP.

The PIEE GFP Module application is located at the following website: https://wawf.eb.mil/piee-landing/. Access to PIEE/GFP Module application training materials and in-depth information applicable to the contractor’s responsibilities regarding GFP can be found at the following website: https://dodprocurementtoolbox.com/.

Contracting Office Responsibilities:

The Contracting Office shall ensure close coordination and validation of the GFP items with the COR and DHA Accountable Property Officer prior to uploading the GFP Attachment into the PIEE/GFP Module. At the time GFP is anticipated and identified, the Government will upload the GFP Attachment into the PIEE/GFP Module. It is the Contracting Office’s responsibility to prepare, upload and maintain the GFP Attachment in the PIEE/GFP Module in accordance with the GFP Attachment instructions provided at the DoD Procurement Toolbox. The CO and COR shall manage and keep an inventory of any GFP associated with contract/task orders awarded through DHA, in accordance with applicable FAR Part 45, DoD FAR Supplement (DFARS) 245 with respective clauses, DHA AI 095 and PD 45-01 following the change in disposition of items listed on that PIEE/GFP Module Attachment.

The contracting office will also review, acknowledge, reject and/or approve shipment orders provided by the contractor as appropriate. Functional roles can be determined within the Contracting Office, and requested within the PIEE/GFP Module system.

Contractor Responsibilities:

A key contractor responsibility is to work with the CO and COR to ensure the PIEE/GFP Module data, to include the PIEE/GFP Attachment, provides a timely, complete and accurate accounting of the GFP applicable to the contract/task order. Contractors are required to report the receipt of any GFP shipped to them, regardless of whether it is listed on the GFP Attachment for their contract. Similarly, contractors are required to utilize the GFP Module application in conjunction with the shipment of GFP to the Government, or in reporting Property Loss of GFP issued (such as destruction or loss). Discrepancies or disputes regarding property shipped to or shipped from the contractor must be reported via the GFP Module application, with the CO having authority over final designation of status.

The contractor shall report semi-annually 100% inventories, reconciliations, and final disposition of GFP provided by the government. Final invoices will not be paid pending GFP reconciliation.

Contractors shall be aware of and ensure compliance with applicable FAR Part 45, DFARS 245 and 252.245, Defense Pricing and Contracting Policies, Procurement Integrated Enterprise Environment Standards, DHA Administrative Instruction 094 and DHA Guidance. (If this https://wawf.eb.mil/piee-landing/ https://wawf.eb.mil/piee-landing/ https://dodprocurementtoolbox.com/

November 16, 2021 option is used, a semi-annual GFP inventory CDRL will need to be added to the PWS Technical Exhibit 1.)

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below

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PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☒ WILL provide Contractor Furnished Services required in support of this contract/task orders.

These Services are described below:

4.2 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

4.3 Secret Facility Clearance: The contractor shall possess and maintain a SECRET facility clearance from the Defense Security Service. The contractor’s employees, performing work in support of this contract shall have been granted a SECRET security clearance from the Defense Industrial Security Clearance Office.

4.4 Materials: The contractor shall be responsible for all materials.

4.5 Equipment: The contractor shall be responsible for all equipment.

4.6 Facilities: The contractor places of performance shall be:

Urology Department Buildning Three (3), Second Floor Naval Medical Center San Diego

PART 5

5.0 SPECIFIC TASKS

5.1 Scope: The contractor shall provide all services, labor, parts, materials, and equipment necessary for the service and maintenance for the government-owned Dornier Genesis System equipment as listed on Appendiz A, "LABEL FOR APPENDIX" at Naval Medical Center San Diego (NMCSD).

5.1.1 Contractor shall service and maintain the equipment within the original equipment manufacturer's (OEM) specifications, in accordance with the US, State, and Local laws and regulations, US Navy regulations, and Joint Commission requirements

5.2 Definitions: As used throughout this work statement, the following terms shall have the meaning set forth below:

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5.2.1. Service and maintenance: (a) any modification, adjustment, or replacement of the equipment that corrects a malfunction and effectively brings the equipment into material conformity with the technical specification for that equipment as designated by the original equipment manufacturer (OEM), (b) a procedure or routine that, when observed in the regular, proper operation of the equipment, avoids the material adverse effect of the applicable nonconformity, (c) any measures performed that assure the continued operation of the equipment or returns the equipment to its designed efficiency and capacity, (d) replacement of a piece of equipment on a one-for-one basis in order to provide a substitute of equal or greater value in lieu of a damaged or defective device for compensation, return, or refund of equipment.

5.2.2. Contracting Officer (KO): A warranted representative of the federal government who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

5.2.3. Technical Representative (TR): A Government employee appointed by the KO and responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract.

5.3. Location:

Places of performance shall be:

Urology Department

Building Three, Second Floor Naval Medical Center San Diego

5.4. Requirements:

5.4.1. General Performance Requirements:

5.4.1.1. The Contractor shall provide equipment maintenance services to include all periodic planned maintenance and unscheduled repairs in accordance with OEM specifications and in compliance with Dornier Genesis standards, to include repairs necessitated by operator error.

5.4.1.2. The Contractor may use third party service vendors not limited to the Original Equipment Manufacturer (OEM), however, these vendors must be approved in advance by the KO and TR. The Contractor must submit a list of any sub-contractors they intend to use as third party service vendors to the KO and TR for approval. Third party service vendors shall not perform any work under this contract prior to such approval.

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5.4.1.3. Ensure that only fully-qualified field engineers and/or technicians who have gone through OEM or equivalent third-party service schools for the equipment shall be employed in the performance of any and all work performed under this contract. Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product. Upon request, Contractor shall provide written assurance of the competency their personnel as well as a list of credentials for approved field service personnel. The KO and/or TR may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

5.4.1.4. Test equipment: Test equipment calibration shall be traceable to National Institutes of Standards and Technology (NIST traceable). Any efforts conducted without equipment within the calibration intervals is not performance in accordance with this contract. Upon request by TR, the Contractor and/or service vendors shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on NMCSD equipment.

5.4.1.5. Field Service Reports: Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR) to the Duty Staff at NMCSD Biomed. All FSR’s shall be submitted within 72 hours of completion of service and shall be sent to the following email address:

usn.nmcsd-contractadministrator@mail.mil

The contractor or their representative shall complete the FSR to include, at a minimum, the following information:

1. Contractor Name

2. Technician’s printed name, telephone number, and signature

3. Date and Time of Arrival

4. ECN (to be provided by Navy) and Serial Number of Equipment

5. Time Expended Repairing/Service: Labor Hours, Rate, Materials

6. Summary of Work Performed and Accepted by End-User, with Government Representative’s Printed name and Signature)

Completed Field Service Reports are required prior to acceptance of any invoice. Failure to submit a Field Service Report to NMCSD Biomed can result in delay of payment or rejection of invoice from Government. It is highly recommended that the contractor attach a copy of the Field Service Report to their Wide Area Workflow Invoice in addition to the required submission to NMCSD Biomed in order to expedite invoicing process.

5.4.2. NMCSD Preventive Maintenance Requirements:

5.4.2.1. Preventive maintenance shall be performed in a manner which will minimize corrective maintenance and will include but is not limited to: calibration, adjustment, lubrication, updating software for security, safety, or system functionality issues, testing required to maintain a safe environment of care, electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

mailto:usn.nmcsd-contractadministrator@mail.mil

5.4.2.2. Make repairs to the extent necessary, as determined by inspection tests or disassembly, to ensure a functional system that will efficiently serve its intended purpose and the technical specification for that equipment as designated by the original equipment manufacturer.

5.4.2.3. Installation of system update changes to resolve specific product reliability problems.

Hardware and software upgrades, defined as those changes that enhance or add product features, are not included.

5.4.2.4. Preventive Maintenance shall be performed at a minimum of 4 times per year, with these scheduled preventive maintenance actions to be coordinated with NMCSD BIOMED after contract award.

5.4.2.5. Preventive Maintenance Completion: Contractor must insure that 95% or more of all periodic maintenance is performed within 30 days of due date, and that 100% of periodic maintenance is performed within 60 days of the due date.

5.4.2.6. Equipment in Use: If, for reasons beyond the Contractor’s control, equipment is not made available for maintenance for the entire 30 days before the maintenance due date, and 60 days following due date, the Contractor shall immediately notify the COR.

5.4.2.7. Equipment Unable to Locate (UTL): If the Contractor is unable to locate an item within the maintenance window specified, the Contractor shall immediately notify the TR. The TR may determine that the property has been disposed of or otherwise inactive or unavailable for use and may adjust the equipment covered under this Statement of Work accordingly.

4.2.8. 100% Preventive Maintenance: Under the circumstances of 4.2.6. and/or 4.2.7., the TR and Contractor shall arrange a means of complying with the requirements for preventive maintenance at no additional cost to the government. Equipment determined missing, lost, or stolen shall be exempt from maintenance.

5.4.2.9. Uptime Rate: The Contractor shall maintain an overall uptime rate of 95% or better for all equipment covered by this effort. Individual uptime rate for specific equipment, if required, will be as specified on Appendix A.

5.4.9B Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance history with NMCSD, the uptime shall be calculated cumulatively for the entire duration of the contract

5.4.3. NMCSD Corrective Maintenance Requirements:

5.4.3.1. Correct inoperable condition in a timely manner. Contractor shall respond no later than two (2) hours after telephone notification from BIOMED, Monday-Friday, between the hours of 0800-1600.

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5.4.3.2. Provide only the work necessary to restore the equipment to a properly serviceable/operating condition by adjustments, replacement parts, or minor repairs when it is determined that extensive repairs and parts are not necessary.

5.4.3.3. Equipment improvements/modifications shall be made only upon BIOMED written approval and direction. This includes software updates to the device. All updates/improvements/modifications performed shall be notated on the field service report or equivalent.

5.4.3.4. Notify BIOMED immediately upon receipt of OEM safety recall notices or upon receipt of recall notices pertaining to any parts or materials utilized by contractor on the equipment.

5.4.3.5. Ensure that the original design and functional capabilities shall not be changed, modified, or altered without express written authorization from BIOMED.

5.4.3.6. Provide suitable OEM recommended repair equipment/tools required for the satisfactory execution of all repairs made.

5.4.3.7. Furnish OEM approved lubricants and lubricate wear points within the equipment in accordance with OEM guidelines.

5.4.3.8. Replacement parts shall be covered by the contractor for the duration of the contract.

Extend to the Government all commercial warranties on replacement parts. All replacement parts or supplies utilized shall be new parts or OEM refurbished parts. OEM refurbished parts shall only be accepted upon written request from the contractor to NMCSD Biomed and shall only be utilized/installed upon written approval from NMCSD Biomed to the contractor.

5.4.4. End-User Requirements:

5.4.4.1. Service shall be performed on all devices included under contract, regardless of the nature of the cause warranting service/maintenance. Contractor shall not refuse any device under this contract submitted for services. Contractor will perform an official inspection of the device, make an estimate for the services/parts required and the time required for the repairs and an official determination of the cause of the issue, and will provide the required parts and labor in order to restore the equipment to function within the OEM specifications.

5.4.4.2. Services shall be unlimited for the devices under the contract for the term of the agreement. There shall be no cap or limit placed upon the number of repairs/replacements on any individual unit, or on the facility.

5.4.4.3. Contractor shall perform preventive maintenance on the (3) Dornier Genesis units at least 4 times per year. Contractor shall perform preventive maintenance as per the schedule on Appendix B.

November 16, 2021

5.4.4.4. Contractor shall keep department personnel informed as to the status/condition of equipment during PM and the repair status/condition when equipment is down or out for repair.

Points of contact for the department are: Biomedical Repair Contracts team at 619-532-8017 or usn.nmcsd-contractadministrator@mail.mil.

CATASTROPHIC DAMAGE CLAUSE

5.4.4.5. If equipment is received and is irreparably damaged, the department requires a written report as to the extensiveness of the damage and the suspected cause or type of maltreatment necessary to cause such damage (e.g., dropped, crushed , mechanically, overloaded, etc.). The field service report may serve in this regard if comprehensive.

5.4.5. Response Time and Labor:

5.4.5.1. Contractor shall use commercially reasonable efforts to respond by telephone to any report of a malfunction requiring repair within two (2) hours of notification from NMCSD Biomed, Monday through Friday, 0800-1700, Pacific Standard Time. The Contractor shall also provide telephone consulting services, twenty-four (24) hours per day, seven (7) days a week.

This consulting service shall be provided to avoid delays in contract service coverage during after-hours and weekend/holiday periods as applicable. Under no circumstances shall the Contractor assume an inquiry, via telephone or any other means, is authorization to provide services not specifically covered by the terms of the contract.

5.4.5.2. Contractor shall use commercially reasonable efforts to provide on-site support within two (2) business days from notification by NMCSD Biomed, unless otherwise noted in Section 4.4.

5.4.5.3. Work required in the performance of this contract shall be performed between the hours of 0800 and 1700, Pacific Standard Time. All compensation for labor from the hours of 0800 to 1700 Pacific Standard Time is provided for in this contract and included in the contract price.

Contractor may be permitted to arrange for the performance outside of these hours via coordination with NMCSD Biomed at no additional-cost-to-the-government.

5.4.5.4. Any work that would require overtime must be approved, in writing, in advance by the

KO.

5.5. Travel and Related Expenses: Contractor shall be responsible for its service related trip expenses, including round trip travel, mileage, and overnight living expenses.

5.6. Shipment: The contractor shall not exceed two (2) business days for shipment of all equipment coming from and/or going to NMCSD Biomed minus exceptions or conditions as mailto:usn.nmcsd-contractadministrator@mail.mil

November 16, 2021 previously noted in this Statement of Work. All shipping expenses/costs are provided for in this contract and included in the contract price.

5.7. Liability:

5.7.1. The contractor shall not be liable for any loss, damage, or delay due to any cause beyond their reasonable control, including but not limited to fire, explosion, theft, flood, riot, civil commotion, war, malicious acts of mischief, or other circumstances outside of human control.

5.7.2. NMCSD Employees will not perform maintenance or attempt repairs to equipment covered under this contract while such equipment is under the purview of this contract without express, written concurrence from contractor.

5.7.3. Insurance: Contractor shall be required to have liability insurance to cover any actions on the part of the Contractor or their sub-contractors which result in injury or death to patients, staff, visitors, or other Contractors. Coverage shall be of at least $500,000 per occurrence.

Additionally, Contractor is required to have property damage liability insurance of at least $500,000. Liability insurance shall meet the requirements set forth in FAR 28.307-2.

137708 DORNIER MED TECH INC 0053 1034310

136660 DORNIER MED TECH INC 0050 GENESIS

136890 DORNIER MED TECH INC 0057 1034310

November 16, 2021

PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified

6.2 The TIER 1 or TIER 2 levels and position sensitivity designation for positions under this contract is: (Requirement must be checked in order to be a requirement for this PWS)

OR 6.2.1 TIER II: Non-critical sensitive

6.3 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal information requirements:

6.3.1. Data Sharing Agreements (DSAs): Contractors requiring access to PII, which includes PHI, or access to de-identified data, are subject to the DHA Privacy and Civil Liberties Office (DPCLO) (Privacy Office) Data Sharing Program. This program requires DHA to enter into DSAs with parties outside the MHS who use or create MHS data. A DHA contract may use the term Data Use Agreement (DUA) rather than DSA. DSAs assure that outside parties protect MHS data in accordance with the Privacy Act and the HIPAA Rules. To apply for a DSA, the contractor submits a Data Sharing Agreement Application (DSAA) to the DHA DPCLO. The contractor submits the DSAA even if a subcontractor will be the party accessing MHS data.

After review and approval of the DSAA, the Privacy Office provides a DSA to the contractor for execution.

6.3.2. Processing Procurement Sensitive Information: All individuals shall seek guidance from the CO regarding the coordination of documents, dissemination, and transmission of procurement sensitive information. Procurement sensitive information shall not be transmitted electronically unless encryption is utilized. Depending on a particular procurement, other restrictions may apply.

6.4 Training

6.4.1 Contractor employees performing cybersecurity/cyberspace functions shall comply with the following requirements:

6.4.1.1 Training: All contractor and associated subcontractor employees working Cybersecurity Information Assurance (IA)/Cyberspace functions must comply with DoD training requirements in Department of Defense Directive (DoDD) 8140.01 and DoD 8570.01-M. Contractors shall identify, document, track, and report qualifications of contract support personnel who perform cyberspace work roles.

6.4.1.2 Certification: The contractor shall ensure that personnel accessing IS have the proper and current IA certification to perform IA functions at contract award in accordance with DoD

November 16, 2021

8570.01–M, IA Workforce Improvement Program. The contractor shall meet the applicable IA certification requirements as outlined in DFARS 252.239-2001, including:

6.4.1.2.1 DoD-approved IA workforce certifications appropriate for each category and level as listed in the current version of DoD 8570.01–M; and

6.4.1.2.2 Appropriate operating system certification for IA technical positions as required by DoD 8570.01–M.

6.4.1.2.2.1 Upon request by the Government, the contractor shall provide documentation supporting the IA certification status of personnel performing IA functions.

6.4.1.2.2.2 Contractor personnel who do not have proper and current certifications shall be denied access to DoD IS for the purpose of performing IA functions.

6.4.2 User requirements: All contractor employees that require access to DHA IT must comply with the requirements of DHA-Procedural Instruction 8140.01, Acceptable Use of DHA IT, to include those contract employees with privileged access.

6.5 Cybersecurity Requirements for Non-DoD IT or Covered Contractor IS:

6.5.1 The contractor shall, at time of award, have implemented the security requirements prescribed in the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations” (available via the internet at http://dx.doi.org/10.6028/NIST.SP.800- 171), in accordance with DFARS clause 252.204-7012.

6.5.2 NIST SP 800-171 DoD Assessment Methodology. The DFARS provision 252.204-7019 introduces the “NIST SP 800-171 DoD Assessment Methodology” requirement. This requirement enables a strategic assessment of a contractor’s implementation of the NIST SP 800- 171 requirements as required in DFARS clause 252.204-7012. The DoD Assessment Methodology requirement flows down to subcontractors.

6.5.2.1 Basic Assessment: The contractor shall obtain and maintain access to the Supplier Performance Risk System (SPRS) via the PIEE, (available via the internet at https://www.sprs.csd.disa.mil/)

6.5.2.1.1 The contractor shall perform a Basic Assessment, using the NIST SP 800-171 DoD Assessment Scoring Template, and enter the results electronically in SPRS for each covered contractor information system that is relevant to an offer, contract, task order, or delivery order.

See Attachment 2, Deliverable Schedule Table.

6.5.2.1.2 The contractor shall ensure that applicable subcontractors also have their results of a current assessment posted in SPRS prior to awarding a subcontract or other contractual instrument in accordance with DFARS clause 252.204-7020.

https://www.sprs.csd.disa.mil/

November 16, 2021

6.5.3 The contractor shall provide the government with access to its facilities, systems, and personnel when necessary to conduct or renew a higher-level (i.e., Medium or High) assessment in accordance with DFARS clause 252.204-7020.

6.5.4 Cybersecurity Maturity Model Certification (CMMC) (When applicable): The CMMC (DFARS clause 252.204-7021) builds upon the NIST SP 800-171 DoD Assessment Methodology by adding a comprehensive and scalable certification element to verify the implementation of processes and practices associated with the achievement of a cybersecurity maturity level. The CMMC is designed to increase assurance to the DoD that federal contract information (FCI) and DoD Controlled Unclassified Information (CUI) is protected at a level commensurate with the risk. The CMMC requirement flows down to subcontractors.

6.5.4.1 The contractor shall have a current (i.e., not more than three years old) CMMC certificate in SPRS issued by an accredited CMMC Third Party Assessment Organization (3PAO) at the required CMMC level. The description of CMMC levels is available at https://www.cmmcab.org/.

6.5.5 The contractor shall submit requests to vary from NIST SP 800-171 in writing to the CO or COR, for consideration by the DoD Chief Information Officer (CIO). The contractor need not implement any security requirement adjudicated by an authorized representative of the DoD CIO to be non-applicable or to have an alternative, but equally effective, security measure that may be implemented in its place.

6.5.6 If the DoD CIO has previously adjudicated the contractor’s requests indicating that a requirement…