PERFORMANCE WORK STATEMENT_NANOCARE_NOI.docx

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Notice of Intent to Sole Source – Nanosonics, Inc – Maintenance of NanoCare Pro Trophon2 Devices
Solicitation number
HT941026N0070
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This is a Performance Work Statement (PWS) for full-service maintenance and repair of four NanoCare Pro Trophon2 sterilization devices located at Naval Hospital Guam. The contractor shall provide all personnel, equipment, supplies, tools, and materials necessary to perform preventive maintenance and out-of-warranty repair services in accordance with original equipment manufacturer (OEM) specifications. Services include a 5000-cycle major service, out-of-warranty break-fix repair for 12 months, original manufacturer parts, two loaner devices, and shipping costs to transport devices to the Nanosonics Service Center in Indianapolis, Indiana and return them to the facility. The contract requires that only fully qualified service engineers and technicians who have completed OEM service training schools perform all work. The four Trophon2 devices are located in the OB/GYN Clinic (Serial No. 142282-018), Radiology (Serial No. 142282-080), Emergency Department (Serial No. 142282-081), and Apra Harbor Branch Clinic (Serial No. 313148-001).

The contract period of performance is one base year (August 26, 2026 through July 31, 2027) with four one-year option periods extending through July 31, 2031. Work is performed at the contractor's service center in Indianapolis, Monday through Friday excluding federal holidays, with no travel authorization required. The contractor must maintain an effective quality control program and comply with all applicable DoD personnel security requirements, including background investigations for personnel requiring access to DHA networks. Monthly invoicing is authorized upon commencement of services, with all shipping costs included in the price. A Contracting Officer's Representative will monitor technical performance, and the contractor must attend post-award conferences and periodic progress meetings at no additional cost to the government.

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Performance Work Statement

NANOCARE PRO TROPHON PREVENTIVE MAINTENANCE SERVICE

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide full service maintenance and repair service for four (4) government owned NanoCare Pro Trophon equipment.

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 full service maintenance and repair of 4 Trophon devices as defined in this Performance Work Statement (PWS). The contractor shall perform to the standards in this PWS.

1.3 Background: Perform full service maintenance and repair service in accordance with original equipment manufacturer (OEM) specifications. Ensure that only fully qualified service engineers and technicians who has gone through the OEM service schools for the above mentioned equipment, shall be employed in the performance of all work performed under this contract, Upon request, the contractor shall provide training certificates to the contracting Officer or Biomedical Equipment Repair Division.

1.4 Objectives: Conduct full service maintenance and repair service in accordance with OEM standards, and all local, state, and federal policies.

1.5 Scope: All services, materials, and equipment will be provided by the contractor to conduct full service maintenance and repair services. Services includes out-of-warranty break/fix repair service for 12 months, original manufacturer parts, 5000 Cycle Major Service, two loaner devices and shipping cost to send the devices to the service center and back to USNMRTC Guam.

Trophon 2 Serial No. and Locations:

142282-018 OB/GYN Clinic 142282-080 Radiology 142282-081 Emergency Department 313148-001 Apra Harbor Branch Clinic

1.6 Period of Performance (PoP):

Base Year: 1 August 26 - 31 July 27 Option Year 1:1 August 27 - 31-July 28 Option Year 2: 1 August 28 - 31 July 29 Option Year 3: 1 August 29 - 31 July 30 Option Year 4: 1 August 30 - 31 July 31

1.6.1 Transition: N/A

1.6.1.1 Transition-in period: N/A

1.6.1.1.1 N/A

1.6.1.2 Transition-out period: N/A

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at Nanosonics Service Center:

Nanosonics Inc 7205 E 87th Street Indianapolis, IN 46256

1.7.2 Recognized Federal holidays:

New Year’s DayLabor Day
Martin Luther King Jr.’s BirthdayColumbus Day
President’s DayVeteran’s Day
Memorial DayThanksgiving Day
Juneteenth DayChristmas Day

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:. N/A

1.8 Contractor travel: Contractor travel is not authorized.

1.9 Other Direct Costs (ODC): All shipping cost is included.

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.

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: N/A

1.12 Key personnel (Contractor): N/A

1.13 Data rights: N/A

1.14 Reporting

1.14.1 Contractor Manpower Reporting (CMR): RESERVED.

1.14.2 Non-Disclosure Agreement (NDA): N/A

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. NOTE: COR Appointment – N/A

1.14.4 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

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)

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 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.

1.17.1.4. Invoicing: The contractor shall only bill for services performed. Invoicing is authorized monthly after beginning of performance in accordance with Part 6 of the Contract PWS.

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:

AISAutomated Information System
CACCommon Access Card
CAPCloud Access Point
CMRContractor Manpower Reporting
COContracting Officer(s)
CONUSContinental United States (excludes Alaska and Hawaii)
CORContracting Officer Representative
COTRContracting Officer's Technical Representative
CUIControlled Unclassified Information
DAD-ADeputy Assistant Director for Acquisition
DFARSDefense Federal Acquisition Regulation Supplement
DHADefense Health Agency
DoDDepartment of Defense
DoDIDepartment of Defense Instruction
DoDMDepartment of Defense Manual
FARFederal Acquisition Regulation
FSOFacilities Security Officer
HAHealth Affairs
HIPAAHealth Insurance Portability and Accountability Act
HCAHead of the Contracting Activity
IAInformation Assurance
ISInformation System
ITInformation Technology
NDANon-Disclosure Agreement
ODCOther Direct Costs
POCPoint of Contact
PoPPeriod of Performance
PSPPersonnel Security Program
PWSPerformance Work Statement
QAQuality Assurance
QASPQuality Assurance Surveillance Plan
QCQuality Control

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

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:

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:

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.

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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