RFQ HT940625R0002.pdf

HT940625R0002

ADMINISTRATIVE INFORMATION

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR Subpart 12.6 and FAR Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a separate written solicitation will not be issued.

Solicitation number HT9406-25-R-0002 is issued as a request for quotation (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-07.

This requirement is Full and Open Competition. The associated NAICS code is 532490 and small business size standard is $40,000,000.00.

A list of line-item numbers and items, quantities, and units of measure to include options are in the Items section.

This requirement is for Urology Laser, Extra-Corporeal Shockwave Lithotripter and MRI-Ultrasound Fusion Services in support of Naval Hospital Jacksonville, FL.

The Period of Performance is:

Base Year: 01 October 2025 – 30 September 2026 Option I: 01 October 2026 – 30 September 2027 Option II: 01 October 2027 – 30 September 2028 Option III: 01 October 2028 – 30 September 2029 Option IV: 01 October 2029 – 30 September 2030 Extension: 01 October 2030 – 31 March 2031

Place of Performance: The work shall be performed at Naval Hospital Jacksonville on the installation Naval Air Station Jacksonville, Florida 32214.

FAR provision 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services and Addendum, applies to this acquisition.

FAR provision 52.212-2, Evaluation-Commercial Products and Commercial Services is applicable to this solicitation and the following factors shall be used to evaluate offers: Factor 1: Capability, Factor 2: Price, and Factor 3: Part Performance.

Offerors shall include a completed copy of the FAR provision 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services, with its offer.

FAR clause 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition.

FAR clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders- Commercial Products and Commercial Services, applies to this acquisition. Additional FAR clauses cited in the clause applicable to this acquisition are marked in the Clauses incorporated By Full Text section.

This requirement is not rated under the Defense Priorities and Allocations System (DPAS).

Offer due date is 10:00 AM Eastern Time 05 May 2025.

Submission of quotes shall be submitted electronically by email ONLY attention to Ryan Poe at ryan.t.poe.civ@health.mil and Carrie Gaither at carrie.e.gaither.civ@health.mil. No phone calls will be accepted.

Questions regarding this solicitation should be submitted to Ryan Poe at ryan.t.poe.civ@health.mil at least 15 calendar days prior to the closing date.

Amendments: The Offeror shall submit to the Contracting Officer signed copies of all amendments issued to this solicitation. Failure to comply may cause your quote to be rejected.

The Government intends to award without discussions, offerors should submit their best prices in their initial offer.

Offerors must submit all information requested in FAR Provision 52.212-2, Evaluation-Commercial Items, and addendum in order for the Government to determine technical acceptability.

The Offeror agrees to hold the prices in its offer firm for 90 calendar days from the date specified for receipt of offers.

A Contracting Officer's Representative (COR) will be appointed at the time of award. The successful Offeror will be furnished the COR name and contact information at the time of contract award.

The Contracting Officer reserves the right to negotiate an earlier Period of Performance start date.

Attachments: Attachment 1 – Pricing Sheet

PERFORMANCE WORK STATEMENT

Department of Defense Defense Health Agency

Performance Work Statement

Urology Laser, Extra-Corporeal Shockwave Lithotripter and MRI-Ultrasound Fusion Services

Directorate of Surgical Services/ Urology

Naval Hospital Jacksonville, FL

Solicitation Number: HT940625R0002 Version: 0

Date: 1 October 2025

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Urology services utilizing a Holmium or Thulium and Greenlight XPS laser; Extracorporeal Shockwave Lithotripter (ESWL), ESWL operator, C-arm fluoroscope, and patient bed; MRI-Ultrasound Fusion with an operator to include procuring imaging from compatible 3T MRI centers with targets identified by radiologists certified to identity target lesions as well as the necessary equipment and software to enable targeted prostate biopsy capability.

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 Urology services utilizing a Holmium or Thulium and Greenlight XPS laser; Extracorporeal Shockwave Lithotripter (ESWL), ESWL operator, C-arm fluoroscope, and patient bed; MRI-Ultrasound Fusion with an operator to include procuring imaging from compatible 3T MRI centers with targets identified by radiologists certified to identity target lesions as well as the necessary equipment and software to enable targeted prostate biopsy capability 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: Naval Air Station Jacksonville Florida via Naval Hospital Jacksonville Florida Main Operating Room provides health services to military members (active duty, reservists, family and retirees), many of whom require Urology services utilizing a Holmium, Thulium, or Greenlight XPS laser. The Main Operating Room has a requirement for the contractor to provide in house Holmium or Thulium and as-needed Greenlight lasers, laser operator and consumables required for the laser surgery. There is also a requirement for the contractor to provide as-needed extracorporeal shock wave lithotripter (ESWL), ESWL operator, C-arm fluoroscope, and patient bed. There is also requirement to provide as-needed MRI- Ultrasound Fusion with an operator. This will include procuring imaging from compatible 3T MRI centers with targets identified by radiologists certified to identity target lesions as well as the necessary equipment and software to enable targeted prostate biopsy capability.

1.4 Objectives: Contractor shall provide onsite, holmium or thulium laser services with consumables. Additionally, the contractor shall provide Greenlight XPS laser services with consumables, onsite ESWL capability, and onsite MRI-Ultrasound Fusion capability with consumables on a case-by-case basis. Equipment and consumables may be required for delivery after hours and/or weekends. All scheduled cases will be booked at least 48 hours in advance and all after hours urgent/emergent cases will be scheduled as soon as the need is identified with as much advanced notice as possible to facilitate the on-call technician’s arrival.

1.5 Scope: The scope of this requirement necessitates the contractor to provide lasers, lithotripters, imaging hardware and/or software, consumables, and operators/technicians.

Services include comprehensive, on-site, as needed service for the use of an in-house maintained holmium or thulium laser. The contractor shall provide Greenlight XPS laser services on a case-by-case basis. Corrective system maintenance coverage shall include response times, as specified. The contractor shall accomplish on an as-needed basis ESWL and MRI-US Fusion Prostate Biopsy services.

1.6 Period of Performance (PoP): The Period of Performance will consist of one 12-month base period, and four 12-month option periods.

Base Year: 01 October 2025 – 30 September 2026 Option I: 01 October 2026 – 30 September 2027 Option II: 01 October 2027 – 30 September 2028 Option III: 01 October 2028 – 30 September 2029 Option IV: 01 October 2029 – 30 September 2030 Extension: 01 October 2030 – 31 March 2031

1.7 Administrative Specifications

1.7.1 Place of Performance: The work shall be performed at Naval Hospital Jacksonville on the installation Naval Air Station Jacksonville in the state of Florida.

1.7.2 Recognized Federal holidays: The contractor shall provide services on federal holidays in the case of urgent/emergent cases.

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

1.7.3 Hours of Operation: The contractor is responsible for conducting scheduled services during normal business hours Monday thru Friday 0700 to 1700 Eastern Time (ET) 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 always 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. On occasion, holmium or thulium laser services may be required on weekends or holidays outside of normal duty hours.

1.8 Contractor Travel: Not government funded.

1.9 Other Direct Costs (ODC): N/A

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. Quality Control Plan will be submitted electronically via email to the Contracting Officer’s Representative (COR) and Contracting Officer (CO) within 30 days of award. The government will have 5 business days to approve the report. If report is returned to contractor for rework, the contractor will have 3 business days to make changes. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing within 5 business days 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 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.

1.12 Reporting

1.12.1 Contractor Manpower Reporting (CMR): RESERVED.

1.12.2 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.

1.13 Contractor Identification

1.13.1 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.

1.13.2 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.

1.13.3 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.

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 BIOMED Biomedical Department CAC Common Access Card CAL Calibration CAP Cloud Access Point CAP College of American Pathologists CCEVS Common Criteria Cybersecurity Evaluation and Validation Scheme

CDI Covered Defense Information CE Computer Environment CDRL Contract Data Requirement List CIO Chief Information Officer 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 EHR Electronic Health Record eMSM Enhanced Multi-Service Markets ESWL Extracorporeal Shock Wave Lithotripter 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 FSE Field Service Engineer FSO Facilities Security Officer HA Health Affairs

HIPAA Health Insurance Portability and Accountability Act HCA Head of the Contracting Activity HDD Hard Disk Drive HIT Health Information Technology IGCE Independent Government Cost Estimate IA Information Assurance IO Initial Outfitting I/O In/Out Processing Portal IPv Internet Protocol Version IS Information System 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 MMD Materials Management Department MRI Magnetic Resonance Imaging 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 OEM Original Equipment Manufacturer 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 PM Preventive Maintenance 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 SPRS Supplier Performance Risk System SRM Sustainment, Restoration and Modernization SRG Security Requirements Guides ST Safety Testing STIG Security Technical Implementation Guides TJC The Joint Commission TOS Terms of Service US United States UFC Unified Facilities Criteria VPN Virtual Private Network XML Extensible Markup Language

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:

a. The Government will be responsible for maintaining the proper environment, including utilities and site requirements, necessary for the system to function properly as specified by the

OEM.

b. The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of vendor supplies, materials, or for the personal belongings brought onto Government property by vendor personnel.

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:

Operating room at Naval Hospital Jacksonville.

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:

Power/electricity

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:

3.5 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:

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:

a. Maintenance Services

b. Training

c. Operator/Technician Services

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

4.4 Materials: The contractor shall furnish materials, supplies, personnel, and equipment necessary to meet the requirements under this PWS.

Equipment/services/consumables/supplies/laser fibers must be Food & Drug Administration (FDA) approved and comply with FDA standards and cannot be wireless due to the Defense Health Agency (DHA) Medical Community of interest (MEDCOI) network restrictions.

4.5 Equipment: The contractor shall furnish the following to meet the requirements under this

PWS:

a. Provide a Holmium or Thulium and Greenlight XPS laser with operator.

b. Provide extracorporeal shock wave lithotripter, compatible bed, and C-arm with operator.

c. Provide MRI-Ultrasound fusion hardware, software, and imaging support with operator.

4.6 Facilities: N/A

PART 5

5.0 SPECIFIC TASKS

5.1 Laser:

5.1.1 Contractor shall supply a 100-watt holmium laser or equivalent thulium laser to be maintained in house at Naval Hospital Jacksonville. Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.

5.1.2 Contractor shall supply a Greenlight XPS laser with 20-180W in 10A increment power settings, solid state, frequency doubled, 532nm wavelength and 5mW aiming beam and consumables on an as needed basis.

5.1.3 Contractor shall provide certified English speaking laser operator/technician who is able to gain unescorted access to Naval Air Station Jacksonville in order to reach the hospital to provide services.

5.1.4 All operation, software, hardware, and consumables need to be compatible.

5.1.5 The contractor shall supply any additional laser rental equipment requested for scheduled cases and be brought in 1 hour prior to the case for BIOMED equipment check prior to use.

5.1.6 The contractor shall supply all necessary laser fibers to support the surgical cases scheduled within this rental contract.

5.1.7 Lasers must meet the performance characteristics for accuracy and precision.

5.1.8 All equipment must meet and maintain sufficient safety features to avoid unnecessary exposure.

5.1.9 All provided equipment shall be fully operational by the scheduled time of procedure.

5.2 Extra-corporeal Shockwave Lithotripter:

5.2.1 Provide extracorporeal shock wave lithotripter, compatible bed, ESWL operator/technician and C-arm fluoroscope on an as needed basis.

5.2.2 Contractor shall provide certified English-speaking operator/technician who is able to gain unescorted access to Naval Air Station Jacksonville in order to reach the hospital to provide services.

5.2.3 All operation, software, hardware, and consumables need to be compatible.

5.2.4 The contractor shall supply rental equipment requested for scheduled cases and be brought in 1 hour prior to the case for BIOMED equipment check prior to use.

5.2.5 The contractor shall supply all necessary equipment and consumables to support the surgical cases scheduled within this rental contract.

5.2.6 Equipment must meet the performance characteristics for accuracy and precision.

5.2.7 All equipment must meet and maintain sufficient safety features to avoid unnecessary exposure.

5.2.8 All provided equipment shall be fully operational by the scheduled time of procedure.

5.3 MRI-Ultrasound Fusion:

5.3.1 The contractor shall supply the ultrasound, ultrasound probe and consumables with MR- Ultrasound fusion hardware, software, and imaging support with prostate lesions properly targeted and an operator/technician on an as needed basis to enable targeted prostate biopsy capability.

5.3.2 The MRI imaging support must include procuring imaging from compatible 3T MRI centers with targets identified by radiologists certified to identity target lesions and include at least three separate radiology (MRI) locations to preserve patient options of MRI imaging locations.

5.3.3 The Contractor must arrange to have the images targeted by a qualified radiologist.

5.3.4 The Contractor must arrange to have the targeted images uploaded to their imaging platform. The imaging platform with targeted images must be brought to the patient location on the day of biopsy for the Urologist to perform the biopsy.

5.3.5 Contractor shall provide certified English-speaking operator/technician who is able to gain unescorted access to Naval Air Station Jacksonville in order to reach the hospital to provide services.

5.3.6 All operation, software, hardware and consumables shall be compatible. The software and hardware shall not connect directly to any NH Jacksonville equipment. The resultant imaging captured or recorded shall be captured on a compact disc that can be uploaded to the patient’s medical record in MHS Genesis on a delayed basis. This shall be completed within one week from the date the service is rendered.

5.3.7 The contractor shall supply rental equipment requested for scheduled cases and be brought in 1 hour prior to the case for BIOMED equipment check prior to use.

5.3.8 The contractor shall supply all necessary equipment and consumables to support the surgical cases scheduled within this rental contract.

5.3.9 Equipment must meet the performance characteristics for accuracy and precision.

5.3.10 All equipment must meet and maintain sufficient safety features to avoid unnecessary exposure.

5.3.11 All provided equipment shall be fully operational by the scheduled time of procedure.

5.4 Maintenance:

5.4.1 The vendor shall provide Original Equipment Manufacturer (OEM)-trained, experienced, English-speaking personnel.

5.4.2 The vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance.

5.4.3 The vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract.

5.4.4 A systems operator shall be made available to answer technical questions regarding system operations and applications.

5.4.5 Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturers (OEM’s) specifications/equipment certification.

5.4.6 The vendor shall provide maintenance services Monday through Friday from 0730-1700 Eastern time, excluding Federal Government holidays. This includes annually required performance maintenance.

5.4.7 Customer and Technical support shall be available by phone 24 hours, 7 days a week.

5.5 Preventive Maintenance:

5.5.1 Normal Business Hour Maintenance Coverage will be Monday through Friday, from 0730- 1700 Eastern time, excluding Federal Government holidays.

5.5.2 Vendor shall provide full-service preventive maintenance.

5.5.3 Preventive maintenance shall be performed in accordance with OEM recommendations.

5.5.4 The vendor shall perform PM service checks during the base contract period at the OEM’s recommended intervals.

5.5.5 Vendor will also perform PM service checks during each option year at a date and time mutually agreed upon by the vendor and the Government.

5.5.6 All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with TJC, OEM, the College of American Pathologist’s (CAP), FDA, and National Institute of Standards and Technology (NIST) standards.

5.6 Corrective Maintenance:

5.6.1 Vendor shall provide on-site corrective maintenance from 0730-1700 Eastern Time, Monday-Friday, to include unlimited service calls.

5.6.2 Telephonic technical support shall be available 24 hours per day, 7 days per week.

5.6.3 A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty-four (24) hours after receipt of trouble call. Equipment shall be repaired and deemed operational within 48 hours.

5.6.4 The Government’s request for corrective maintenance will be placed by Biomedical Engineering Department (BIOMED) personnel, directly to the vendor or its representatives.

Corrective maintenance shall be completed during the hours specified in the contract.

5.6.5 The vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a vendor Field Service Engineer (FSE). Telephone consultation shall:

1) provide instruction in determining operator error.

2) determine the most likely cause of the problem.

3) determine if resolution of the problem requires the dispatch of a FSE; and

4) identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

5.6.6 The vendor’s quoted annual pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping.

5.6.7 The Vendor shall have and provide to its representatives its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and/or repair of all equipment included in this contract.

5.7 Training:

5.7.1 The vendor shall provide on-site laser safety training to all Main Operating Room Staff at Naval Hospital Jacksonville bi-annually.

5.7.2 The vendor shall provide on-site training for Urology department and / or Main Operating Room staff on an as-needed basis for familiarization, orientation, and provision of MRI-US Fusion biopsy services.

5.8 Additional Contractor Requirements:

5.8.1 Technicians must clear required background checks to enable unescorted access to Naval Air Station Jacksonville base for the purpose of providing services to the hospital operating room.

5.8.2 The Contractor must ensure adequate case coverage with desired equipment to support surgical cases and all urgent/emergent cases within a 2-hour call window.

5.8.3 All service and maintenance must be provided as needed by the contractor to maintain surgical availability.

5.8.4 All hardware and software upgrades must be completed when available.

5.8.5 All hardware, software and necessary documentation and imaging must be compatible with current (MHS Genesis) and future Electronic Health Record (EHR) systems for transfer to patient records.

5.8.6 Contractor shall provide on-site scheduled and corrective service of their medical equipment as needed with a replacement available for any equipment found not repairable onsite to include the 100-watt holmium (or thulium) laser maintained onsite at NAS Naval Hospital Jacksonville.

5.8.7 Contractor shall have size and scale to support all manufacturer surgical services requirements.

5.8.8 Contractor completed work documentation shall pass audit requirements from The Joint Commission (TJC) or other governing agencies and will supply upon request a full-service history.

5.8.9 Contractor shall provide supply management of single inventory database for all clinical equipment, provide Preventative Maintenance tracking, and user error and failure trending as requested by Naval Hospital Jacksonville’s BIOMED repair department.

5.8.10 All equipment maintenance and management processes shall be completed in accordance with the standards of The Joint Commission (TJC).

5.8.11 Contractor shall maintain Quality Department regulatory patrols to stay informed and up to date on any regulatory changes that may affect our operations or customer environments.

5.8.12 The vendor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the Vendor service technicians and as required for the completion of the services in accordance with this contract.

5.8.13 During normal duty hours, vendor FSE personnel shall check-in with the Biomedical Engineering Division (BIOMED) upon arrival at the Government site and again prior to departure. The vendor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, vendor FSEs shall notify the Officer of the Day Desk and the systems’ operator designated by BIOMED personnel.

5.8.14 The vendor shall provide to BIOMED personnel a full-service report within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

- Name of Vendor

- Contract Number

- Name of field service technician performing service

- Vendor log/control number

- Date, time (beginning and ending), and hours on-site for service call.

- Description of problem reported by user.

- Equipment identification factors to include manufacturer, make, model, serial number and Facility Equipment Control Number (ECN)

- Itemized description of service performed to include labor and travel costs, parts used, parts cost, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended.

- Problem resolution or pending action.

- Total billing cost

- Signatures:

1. Field Service Technician performing services

2. BMET verifying service rendered.

- In the event that agents/sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name, point of contact, and contact information (i.e., telephone number and email)

5.8.15 The vendor shall be responsible for the repair and/or replacement of damaged Government-owned equipment and property, resulting from the negligence of the vendor or its representatives. All such replacement or repair shall be completed at the vendor's expense and shall be inspected to the satisfaction of the Contracting Officer (KO) or his/her appointed representative.

5.8.16 No equipment shall be removed without the approval of the Contracting Officer’s Representative and Materials Management Department (MMD) of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the vendor via the MMD of the MTF. Any failure to obtain such passes, which results in detainment or prosecution of service vendor personnel, is the sole responsibility of the service vendor and their personnel.

5.8.17 The vendor shall provide a detailed description of removed items on the vendor’s company letterhead. For associated items/accessories, the vendor shall provide a detailed written description and quantities of items to be removed. Descriptions shall include, at a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment/items removed. In the event that items/sub-assemblies/accessories are “repaired by replacement”, a detailed description of replaced items is to be included upon return of repaired components.

5.8.18 No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a vendor determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the vendor. The vendor shall provide insurance coverage for damage to or loss of equipment while in vendor or service vendor’s custody.

5.8.19 In regard to patient information confidentiality and privacy, all vendors and/or service vendors shall not remove equipment containing personally identifiable information or patient health information from the Government site. The equipment hard disk drive (HDD) shall be removed by MTF personnel prior to equipment removal from the site. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees.

If HDD are to be replaced, the HDD in disrepair shall be left at the MTF for disposal.

5.8.20 The vendor shall immediately, but not later than 24 consecutive hours after discovery, notify BIOMED in writing of the existence of or the development of any defects in the scheduled equipment, for which the Vendor considers they are not responsible for repairing under the terms of this contract.

5.8.21 At the same time of the notification required by 5.8.21, the vendor shall furnish BIOMED with a written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract but would be ordered under a separate purchase order.

5.8.22 Equipment and consumables may be required for delivery after hours and/or weekends.

All scheduled cases shall be booked at least 48 hours in advance and all after hours urgent/emergent cases shall be scheduled as soon as the need is identified with as much notice in advance as possible to facilitate the on-call operator/technician’s arrival.

5.8.23 The Government shall approve schedule changes in advance. In the event visits are to be rescheduled due to emergent reasons; the vendor shall notify the Government as soon as possible.

5.8.24 Work under this contract is unclassified. The contractor shall comply with all applicable DOD security regulations and procedures during the performance of this contract. Contractor shall not disclose and must safeguard procurement sensitive information, computer systems and data, privacy act data, Personally Identifiable Information (PII)/Protected Health Information (PHI), Federal information requirements and government personnel work products, which are obtained or generated in the performance of this contract.

PART 6

ATTACHMENTS/EXHIBITS

EXHIBIT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

PWS Reference Acceptable Quality Level

(AQL)

Method of Surveillance

Performance Requirements Summary (PRS) # 1.

Equipment Function

The contractor shall ensure all equipment functions as intended.

PWS Part 5. Section 5.1, 5.2, 5.3

95% of the time

Periodic Surveillance by the

COR

PRS # 2

Contractor Response Time

The contractor shall provide telephonic technical support 24 hours per day, 7 days per week and a service technician shall respond by telephone within 2 hours after receipt of the trouble call.

PWS Part 5. Section 5.6.2, 5.6.3

100% of the time

PRS # 3

Corrective Action Response

The contractor shall provide onsite corrective maintenance as necessary to ensure equipment is repaired and deemed operational within 48 hours or provide equivalent replacement equipment to maintain 95% uptime.

PWS Part 5. Section 5.6.1, 5.6.3, 5.8.6

PRS # 4

Service Reports

The contractor shall provide service reports detailing performed services within 2 days after completion of all services performed. Reports will be received complete, on time, and comprehensive.

PWS Part 5. Section 5.8.14

PRS # 5

Preventative Maintenance

Preventative Maintenance visits will be scheduled and completed to maintain equipment uptime of 95%.

PWS Part 5. Section 5.4, 5.5, 5.6

EXHIBIT 2

DELIVERABLE SCHEDULE TABLE

Deliverable Frequency Medium/Format Submit To PWS Reference

Quality Control Plan

NLT 30 days after award

Electronic copy (MS Word) via email

COR 1.10.1

Service Report NLT 2 days after completion of all services

Electronic copy (MS Word) via email

BIOMED and

5.8.14

EXHIBIT 3

ESTIMATED WORKLOAD DATA

This technical exhibit lists the estimated annual workload data based on historical data.

ITEM NAME ESTIMATED QUANTITY

1 Greenlight XPS 12 procedures/sessions

2 Holmium/Thulium 175 procedures/sessions

3 ESWL 24 procedures/sessions

4 MRI/Fusion 60 procedures/sessions

GENERAL INFORMATION

Contractor Compliance: The contractor shall not comply with any order, direction, or request of Government personnel unless it is issued in writing and signed by the Contracting Officer or is pursuant to specific authority otherwise included as a part of this contract. Doing so places the contractor at risk of nonpayment.

Payment: Payment for the resultant contract will be made by Electronic Funds Transfer (EFT) through the Defense Finance and Accounting Services (DFAS) utilizing Wide Area Workflow (WAWF). See DFARS 252.232-7006 Wide Area Workflow Payment Instructions for more information.

Contact Points of Contact (POC) Information:

Contracting Officer’s Representative (COR) - Name: COR POC will be provided at time of award.

Email:

Contracting Officer – DHACA-HCD Southeast Name: Carrie E. Gaither Email: carrie.e.gaither.civ@health.mil

Contract Specialist – DHACA-HCD Southeast Name: Ryan Poe Email: ryan.t.poe.civ@health.mil

Contractor/Vendor - TBD

POC:

Phone:

Email:

Cage:

UEI:

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12 Sessions

GREENLIGHT XPS LASER SERVICE

FFP

To include lease of equipment, greenlight fiber(s) & technician support in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2025 - 9/30/2026 FOB: Destination

PURCHASE REQUEST NUMBER: 0011943416

J065

NET AMT

0002 175 Session

HOLMIUM OR THULIUM LASER SERVICE

FFP

To include lease of equipment, Holmium fiber(s) & technician support in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2025 - 9/30/2026 FOB: Destination

0003 24 Sessions

EXTRACORPOREAL SHOCKWAVE LITHOTRIPTER

FFP

To include lease of Extracorporeal Shockwave Lithotripter (ESWL), ESWL operator, C-arm fluoroscope, and patient bed in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2025 - 9/30/2026 FOB: Destination

0004 60 Sessions

MRI-ULTRASOUND FUSION

FFP

To include lease of equipment with an operator to include procuring imaging from compatible 3T MRI centers with targets identified by radiologists certified to identity target lesions as well as the necessary equipment and software to enable targeted prostate biopsy capability in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2025 - 9/30/2026 FOB: Destination

0005 20 Each

STANDBY FEE

FFP

In the event that the start time of a session under CLIN 0001 or CLIN 0002 is delayed in excess of 20 minutes or cancelled, vendor is allowed to bill a standby fee. Stand-by fees are to be billed in units equivalent to 15 minutes.

Period of Performance: 10/1/2025 - 9/30/2026 FOB: Destination

0006 6 Each Greenlight Moxy Fiber

FFP

Greenlight Moxy Fiber Period of Performance: 10/1/2025 - 9/30/2026 FOB: Destination

0007 12 Each Greenlight Cystoscope Continuous Flow

FFP

Per Greenlight Laser treatment session Period of Performance: 10/1/2025 - 9/30/2026

0008 50 Each Fiber

FFP

One time use Fiber. Consumables required for the laser surgery in accordance with Performance Work Statement. 200 um, 272 um, 365 um, 550 um, 1000 um.

Period of Performance: 10/1/2025 - 9/30/2026

1001 12 Sessions

OPTION GREENLIGHT XPS LASER SERVICE

FFP

To include lease of equipment, greenlight fiber(s) & technician support in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2026 - 9/30/2027

1002 175 Session

OPTION HOLMIUM OR THULIUM LASER SERVICE

FFP

To include lease of equipment, Holmium fiber(s) & technician support in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2026 - 9/30/2027

1003 24 Sessions

OPTION EXTRACORPOREAL SHOCKWAVE LITHOTRIPTER

FFP

To include lease of Extracorporeal Shockwave Lithotripter (ESWL), ESWL operator, C-arm fluoroscope, and patient bed in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2026 - 9/30/2027

1004 60 Sessions

OPTION MRI-ULTRASOUND FUSION

FFP

To include lease of equipment with an operator to include procuring imaging from compatible 3T MRI centers with targets identified by radiologists certified to identity target lesions as well as the necessary equipment and software to enable targeted prostate biopsy capability in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2026 - 9/30/2027

1005 20 Each

OPTION STANDBY FEE

FFP

In the event that the start time of a session under CLIN 1001 or CLIN 1002 is delayed in excess of 20 minutes or cancelled, vendor is allowed to bill a standby fee. Stand-by fees are to be billed in units equivalent to 15 minutes.

Period of Performance: 10/1/2026 - 9/30/2027

1006 6 Each OPTION Greenlight Moxy Fiber

FFP

Greenlight Moxy Fiber Period of Performance: 10/1/2026 - 9/30/2027

1007 12 Each OPTION Greenlight Cystoscope Continuous Flow

FFP

Per Greenlight Laser treatment session Period of Performance: 10/1/2026 - 9/30/2027

1008 50 Each OPTION Fiber

FFP

One time use Fiber. Consumables required for the laser surgery in accordance with Performance Work Statement. 200 um, 272 um, 365 um, 550 um, 1000 um.

Period of Performance: 10/1/2026 - 9/30/2027

2001 12 Sessions

OPTION GREENLIGHT XPS LASER SERVICE

FFP

To include lease of equipment, greenlight fiber(s) & technician support in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2027 - 9/30/2028

2002 175 Session

OPTION HOLMIUM OR THULIUM LASER SERVICE

FFP

To include lease of equipment, Holmium fiber(s) & technician support in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2027 - 9/30/2028

2003 24 Sessions

OPTION EXTRACORPOREAL SHOCKWAVE LITHOTRIPTER

FFP

To include lease of Extracorporeal Shockwave Lithotripter (ESWL), ESWL operator, C-arm fluoroscope, and patient bed in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2027 - 9/30/2028

2004 60 Sessions

OPTION MRI-ULTRASOUND FUSION

FFP

To include lease of equipment with an operator to include procuring imaging from compatible 3T MRI centers with targets identified by radiologists certified to identity target lesions as well as the necessary equipment and software to enable targeted prostate biopsy capability in accordance with Performance Work Statement. A session is defined as the length of time it takes to complete the procedure being performed.

Period of Performance: 10/1/2027 - 9/30/2028

2005 20 Each

OPTION STANDBY FEE

FFP

In the event that the start time of a session under CLIN 2001 or CLIN 2002 is delayed in excess of 20 minutes or cancelled, vendor is allowed to bill a standby fee. Stand-by fees are to be billed in units equivalent to 15 minutes.

Period of Performance: 10/1/2027 - 9/30/2028

2006 6 Each OPTION Greenlight Moxy Fiber

FFP

Greenlight Moxy Fiber Period of Performance: 10/1/2027 - 9/30/2028

2007 12 Each OPTION Greenlight Cystoscope Continuous Flow

FFP

Per Greenlight Laser treatment session Period of Performance: 10/1/2027 - 9/30/2028

2008 50 Each OPTION Fiber

FFP

One time use Fiber. Consumables required for the laser surgery in accordance with Performance Work Statement. 200 um, 272 um, 365 um, 550 um, 1000 um.

Period of Performance: 10/1/2027 - 9/30/2028

3001 12 Sessions

OPTION GREENLIGHT XPS LASER SERVICE

FFP

To include lease of equipment, greenlight fiber(s) & technician support in accordance with Performance Work Statement.