PERFORMANCE WORK STATEMENT ABBOTT.docx

Department of Defense Defense Health Agency Performance Work Statement

ASSURE ELITE SERVICE PLAN

ELECTROPHYSIOLOGY EQUIPMENT

NMRTC SAN DIEGO

DIRECTORATE FOR MEDICAL SERVICES

CARDIAC CATHETERIZATION LABORATORY

Solicitation Number:

Version:

Date:

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide services/upgrade to the existing electrophysiology equipment located in the Cardiac Catheterization Laboratory.

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 maintenance/upgrade of the OCT equipment located in the Cardiac Cath Lab 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: The Electrophysiology (EP) equipment located in the Cardiac Catheterization Laboratory is a major role player when EP interventions are performed in the lab. The system will provide assistance with cardiac mapping, electric cardiac impulses, and intracardiac imagery.

1.4 Objectives:

-Service maintenance.

1.5 Scope: The contractor is required to provide all services and materials necessary for the repair/replace, and preventative maintenance of the EP equipment. The equipment is located in the Cardiac Cath Lab at Naval Medical Readiness and Training Command (NMRTC) to ensure dependable and reliable equipment operation. Services include a one-time system upgrade to include software and hardware, and proper preventive maintenance for a year. The contractor shall accomplish this service/upgrade during the time allotted while providing the services.

1.6 Period of Performance (PoP): 01 MAY 2026 thru 30 APRIL 2030

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at Cardiac Cath Lab, Building 1, 2nd Floor, NMRTC San Diego, 34800 Bob Wilson Drive, San Diego CA 92134. # 619.532.7843

1.7.2 Recognized Federal holidays: Contractor is not required to perform services during holidays.

Independence Day

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:. If an emergency happens, our cardiovascular technicians will reach out to representative who will provide with everything needed. On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.8 Contractor travel: N/A. 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).

1.9 Other Direct Costs (ODC): No other Direct Costs.

1.10 Quality

1.10.1 Quality Control (QC): N/A

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

N/A

1.13 Data rights: N/A

1.14 Reporting

1.14.1 Contractor Manpower Reporting (CMR): RESERVED.

Contractor will be required to contact the Cardiology Department Inventory Manager to request a Base Access form and submit it for processing 2-weeks prior. In the case of emergent repairs/service, the contractor will wait at the main gate for an escort from Cardiology Department personnel.

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 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):

Vendor will not require access to network.

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

Contractor is required to report to the Material Management Department, Biomed Repair Division, Bldg 1, Ground Floor, Room GD-18H1, NMRTC San Diego, for visitor badges during the hours of 0800-1600, M-F, prior to and upon completion of any service/repair performed.

OR

Contractor is required to report to the Cardiology Department, Bldg 3, 3rd Floor, Room 3M 21R5, NMRTC San Diego.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

No additional definitions, acronyms, and applicable publications/instructions are required.

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: N/A

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: N/A

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, and water) that are available and required for any service performed under this contract. The building engineer, to ensure compatibility with the Naval Medical Center's electrical wiring and equipment, must approve contractor electrical equipment.

3.4 Equipment: The Government:

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

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

3.4.1 Procurement Integrated Enterprise (PIEE), GFP Module Application N/A

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: N/A

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: N/A

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: N/A 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: N/A

4.5 Equipment: Contractor shall be provided reasonable access to all equipment to be serviced and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on -duty personnel responsible for such equipment.

4.6 Facilities: N/A

PART 5

5.0 SPECIFIC TASKS

5.1 Specific Tasks:

The contractor is required to provide all services and materials necessary for the repair/replace, and preventative maintenance of the EP Equipment. The equipment is located in the Cardiac Cath Lab at Naval Medical Readiness and Training Command (NMRTC) to ensure dependable and reliable equipment operation.

Contractor will provide the Assurance Elite Service Plan to provide service, upgrades, and repairs to the existing EP equipment.

Contractor will provide maintenance/repair to the equipment located in the Cardiac Cath Lab.

Contractor shall not assume possession or control of any part of the equipment. The government retains ownership to title thereof.

Contractor shall be provided reasonable access to all equipment to be serviced and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on -duty personnel responsible for such equipment.

NMRTC employees will not perform maintenance or attempt repairs to the equipment without proper instruction from contractor and/or approval from Biomed in writing.

Contractor shall furnish a written or electronic vendor supplied Field Service Report to the duty staff at:

Naval Medical Readiness & Training Command San Diego BioMedical Repair Building 1, Ground Floor, Room GD-18H1 Phone: 619-532-8010 Fax: 619-532-8013 Email: Melinda.o.canales.civ@health.mil or alexis.rios.civ@health.mil

The report will include the following:

Contractor Name Technician’s Printed Name, Phone Number and Signature Date and Time of Arrival Equipment ECN and Serial Number Time Spent Repairing/Service; Labor Hours, Rate, and Materials Summary of Work Performed and Accepted by End-User All FSR shall be submitted within 72 hours of completion of service.

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.)

6.2.1 TIER II: Non-critical sensitive position. The OCT is considered a non-critical sensitive equipment and it is not connected to the network.

6.3 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal information requirements: No PII/PHI will be involved.

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: N/A

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 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: Reserved

6.5.15. The contractor shall mitigate supply chain risk to the government by complying with DFARS 252.239-7018 and only utilizing unified capability equipment identified on the DODIN Unified Capabilities Approved Products List (https://aplits.disa.mil/processAPList), unless granted a waiver in accordance with DODI 8100.04, DOD Unified Capabilities (UC).

6.6 Risk Management Framework (RMF) for DoD IT: Reserved.

6.6.12 The contractor shall mitigate supply chain risk to the government by complying with DFARS 252.239-7018 and only utilizing unified capability equipment identified on the DODIN Unified Capabilities Approved Products List (https://aplits.disa.mil/processAPList), unless granted a waiver in accordance with DODI 8100.04, DOD Unified Capabilities (UC).

6.7. Facility Related Control Systems: Reserved

6.8. System Communications - RESERVED

6.9 MHS Demilitarized Zone (DMZ) Medical Community of Interest (MedCOI) Business-to-Business (B2B) Gateway

N/A

6.10 Contractor Provided IT Infrastructure

N/A

6.11 System Authorization Acess Request (SAAR), Defense Department (DD) Form 2875

N/A

6.12 MHS Systems Telecommunications

N/A

6.14 Contractors Located On Military Installations

N/A

PART 7

7.0 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

N/A

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