Atch No. 1 - SOW NHP Water Purification System 16 July 2026.pdf

Department of Defense Defense Health Agency

Statement of Work (SOW)

Water Purification Equipment

Sterile Processing Department (SPD) Naval Hospital Pensacola (NHP)

Date: 16 July 2026

PART 1: GENERAL INFORMATION

1.1 Scope of Work: The Contractor shall furnish all management, tools, supplies, equipment, transportation and labor necessary to provide, deliver and install a fully functional water purification system, comprehensive preventive maintenance and routine water testing to ensure the continuous water quality meets the "Water for the Processing of Medical Devices" ANSI/AAMI ST108:2023 standard for “Critical Water”. Installation shall include installation qualification and operational qualification per ANSI/AAMI ST108:2023. All equipment and work under this contract shall be performed in accordance with this statement of work and all applicable federal, state and local regulations.

1.2 Location: Naval Hospital Pensacola (NHP) is located at 6000 West HWY-98, Pensacola, FL 32512. The installation, main maintenance, and system testing will be performed in Building No. 2268, Room 2028, which is located on the 2nd floor and serves as the main mechanical space for NHP. Water quality testing samples shall be extracted from both Room 2028 (system supply) and Room 2012E (SPD dirty side point-of-use)

1.3 Background: NHP requires high quality of water for sterile processing services within the Department of Surgery to support patient care. NHP's fixed facility SPD currently only receives standard municipal utility water and is unable to consistently provide the necessary critical water for the final rinse phase of instrument reprocessing. The installation of a dedicated, high-capacity water purification system will support the SPD in effectively processing sterile surgical instruments.

1.4 Recognized Federal Holidays: The contractor is not required to perform routine maintenance or water testing on observed Federal holidays. Holiday shifts falling on weekends will be observed on the preceding Friday or following Monday in accordance with Federal regulations.

1.5 Hours of Operation: Monday through Friday, 0800 to 1630, except Federal holidays or when the Government facility is closed due to local/national emergencies, administrative closings, or similar Government-directed closings.

1.6 Site Maintenance and Clean-up: The Contractor shall keep all work areas clean and clear of safety hazards. Upon completion of the installation and any subsequent maintenance services, the Contractor shall remove all tools, equipment, surplus materials, and debris from the facility. The Contractor shall restore all affected workspaces, walls, floors, and utility connections to a condition equal to or better than that which existed prior to the start of work. Any damage to Government property caused by the Contractor's personnel or operations shall be repaired or replaced with Government standards at the Contractor's sole expense.

1.7 Safety: The Contractor shall follow all federal, state and local regulations for all safety requirements during the performance of this contract.

1.8 Warranty: The Contractor shall provide any original equipment manufacturer (OEM) pass through warranty and standard commercial warranties applicable to the products being purchased at no cost. At a minimum, the Contractor shall provide a one-year warranty, including parts and labor.

PART 2: DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS

2.1 Definitions:

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

Government Point of Contact (POC): An individual authorized to perform technical and administrative contract monitoring functions.

Contract Specialist (CS): An individual responsible for the administrative and procedural management of the contract, serving as the primary point of contact for the Government but lacking the legal authority to bind the Government or sign contract documents.

Critical Water: Water that is extensively treated to ensure that microorganisms and inorganic/organic components are at levels that do not interfere with the cleaning or sterilization process. Performance qualification levels of water quality for medical device processing as defined under “Critical Water” per AAMI ST108:2023, Table 2.

Utility Water: Water as it comes from the tap that might require further treatment to be suitable for the initial stages of instrument processing.

Installation Qualification (IO): Process of establishing by objective evidence that all key aspects of the process equipment and ancillary system installation comply with the approved specification.

Operational Qualification (OQ): Process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures.

2.2 Acronyms:

AAMI: Association for the Advancement of Medical Instrumentation ANSI: American National Standards Institute AQL: Acceptable Quality Level CO: Contracting Officer CPVC: Chlorinated Polyvinyl Chloride CS: Contract Specialist DI: Deionized NHP: Naval Hospital Pensacola OEM: Original Equipment Manufacturer SPD: Sterile Processing Department

2.3 Applicable Publications:

All work provided under this contract must be performed in conformance with the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) ST108:2023 “Water for the processing of medical devices”, National Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA), and Original Equipment Manufacturer (OEM) standards and specifications.

PART 3: QUALITY CONTROL, ASSURANCE & SECURITY

3.1 Quality Control (QC): The Contractor shall develop, implement, and maintain effective Quality Control to ensure all work is performed in accordance with this SOW.

3.2 Quality Assurance (QA): The Government shall inspect all work performed by the Contractor. Work performance shall be deemed satisfactory and acceptable to the Government when the Government point of contact declares the work satisfactory.

3.3 Acceptable Quality Level (AQL): After installation, 100% operational uptime of the water purification system during standard operating hours, ensuring uninterrupted “Critical Water” supply to the SPD. Water sample laboratory results showing zero deviations from ANSI/AAMI ST108:2023 “Critical Water” thresholds.

3.4 Base Access Control: The Contractor is solely responsible for complying with all local installation base entry procedures and security protocols at NAS Pensacola and Naval Hospital Pensacola. All contractor personnel must successfully obtain and maintain required base and facility access passes. The contractor shall coordinate with the Government POC to initiate the sponsor process for base visitor passes or local badges in advance of scheduled work.

3.5 System Isolation and Cybersecurity: The water purification system, including all digital displays, sensors, and monitoring equipment, shall be completely air-gapped. The Contractor shall not connect any equipment to the Naval Hospital Pensacola or DHA local area networks (LAN), wireless networks (Wi-Fi), or cellular networks. No remote monitoring or telemetry data transmission is authorized under this contract.

3.6 Physical Security and Key Control: The Contractor shall be responsible for safeguarding all Government facilities, equipment, and materials provided for contractor use. The Contractor shall ensure that Room 2028 (mechanical space) remains secured at all times and is never left unattended while unlocked. The Contractor shall immediately report any lost keys, badges, or suspicious activity to the NHP Security Office and the Government POC.

3.7 Personnel Qualifications: The Contractor shall provide properly trained technicians to provide preventive maintenance for the water purification equipment and water quality testing/reports.

PART 4: GOVERNMENT FURNISHED EQUIPMENT

4.1 Services: The Government will not provide Government-furnished services in support of this contract.

4.2 Facilities: The Government will provide physical space within Room 2028 (main mechanical space) and Room 2012E (SPD dirty side) for the installation, testing, and maintenance of the water purification system.

4.3 Utilities: The Government will provide standard facility utilities (electrical power, municipal utility feedwater, and drainage access) within Room 2028 and Room 2012E as required to operate and test the water purification system.

4.4 Equipment and Materials: The Government will not provide any tools, specialized installation equipment, testing gear, installation materials, piping, fittings, filters, chemicals, or consumables. The Contractor is fully responsible for providing all items required to execute this contract.

PART 5: SPECIFIC TASKS

5.1 Water Purification System: The Contractor shall design, supply, and install a clinical-grade water purification system meeting all ANSI/AAMI ST108: 2023 requirements.

5.1.1 The system shall provide sufficient flow rates, volume, pressure, and chemical purity to continuously support the following equipment:

5.1.1.1 Two (2) Steris Washer-Disinfectors (Reliance Synergy) requiring 9.5 gallons per cycle with an estimated workload of six (6) cycles per day per unit.

5.1.1.2 One (1) Steris 3-Basin Reprocessing Sink configured with one (1) DI (deionized) faucet with an estimated 2 GPM and an estimated total of 50 gallons per day.

5.1.1.3 One (1) DI Faucet located on the clean side of the SPD with an estimated 2 GPM and an estimated total of 20 gallons per day.

5.1.1.4 One (1) Caviwave Ultrasonic Cleaning System (CR12) with 20 gallon capacity.

5.1.2 The water purification system shall support an estimate of 25 gallons per minute, and 300-gallon consumption per day.

5.1.3 Water purification system must be capable of continuously and simultaneously monitoring critical functions to include but are not limited to product water conductivity, water pressure and ultraviolet (UV) output.

5.1.4 Water purification system must include a critical alarm function. The critical alarm must be configured to be audible and/or visual both in the water treatment area.

5.1.5 Site Layout Footprint: The Government shall provide space within Room 2028 for the install of equipment. The area provided will be 5 feet x 16 feet.

5.1.6 Floor Drain: A floor drain is located within the site layout footprint.

5.1.7 Water Supply/Plumbing: The Contractor shall coordinate the water supply and plumbing requirements with the Government and provide detailed water supply and plumbing specifications for the water purification system. The Government will provide the necessary water supply and plumbing connections. The Government will construct and install a distribution loop utilizing approximately 1.25” CPVC SCH 80 piping, with an estimated length of 200 linear feet, running from Room 2028 to Room 2012E. The contractor shall complete all final connections of the water purification equipment.

5.1.8 Electrical: The Contractor shall coordinate the electrical requirements with the Government and provide detailed electrical specifications for the water purification system. The Government will provide the necessary electric connections. The contractor shall accomplish all final connections of the water purification equipment.

5.1.9 Site Conditions: Equipment may have to be transported across the 1st floor roof due to stairwell and door limitations to Room 2028. There is an elevator for transporting equipment from the ground to the 2nd floor. The door leading to the roof is 46 inches wide.

5.2 Water Purification Preventive Maintenance: The Contractor shall establish and execute a routine preventive maintenance for the newly installed water purification system in strict accordance with the OEM's technical recommendations and operational manuals. The Contractor shall provide a preventive maintenance schedule for installed equipment and a preventive maintenance report for each scheduled service to include scheduled services completed, issues found, and corrective actions taken.

5.2.1 Minimum Preventive Maintenance Activities: The Contractor’s proposed preventive maintenance plan shall include, at a minimum, the following actions and frequencies to ensure the system continuously meets the performance requirements:

5.2.1.1 Monthly:

5.2.1.1.1 Replacement of all system pre-filters (sediment and carbon).

5.2.1.1.2 Replacement of the final distribution loop post-filter.

5.2.1.1.3 Topping off of the anti-scalant chemical reservoir

5.2.1.2 Every 6 Months:

5.2.1.2.1 Exchange of all deionization (DI) tanks.

5.2.1.3 Annually:

5.2.1.3.1 Exchange of the primary carbon filtration media tank(s).

5.2.1.3.2 Replacement of the Ultraviolet (UV) disinfection lamp.

5.2.1.3.3 Replacement of the storage tank's vent filter.

5.2.2 All replacement filters, membranes, tanks, and electronic components must be

Original Equipment Manufacturer (OEM) certified. Any proposed substitution or use of non-OEM "equivalent" components must be explicitly evaluated and approved by the Sterile Processing Department (SPD) Subject Matter Experts (SMEs) prior to installation to prevent the introduction of counterfeit or substandard components into the critical water supply.

5.3 Routine Water Quality Testing: The Contractor shall perform routine water quality testing in accordance with ANSI/AAMI ST108 (2023 or as amended). Water samples must be extracted from the main system output (Room 2028) and points of use (Room 2012E). The Contractor shall provide a detailed report for all water sample locations.

5.3.1 Remediation of Failed Water Quality Tests: In the event that any water sample fails to meet the required ANSI/AAMI ST108:2023 parameters, the Contractor shall execute the following remediation steps:

5.3.1.1 Immediate Notification: The Contractor shall notify the Government POC and the SPD Subject Matter Experts (SMEs) immediately (within 4 hours of receiving the failed laboratory results).

5.3.1.2 Corrective Action: The Contractor shall respond on-site within 24 hours to conduct a root-cause analysis and implement immediate corrective actions (e.g., emergency system sanitization, membrane replacement, or loop disinfection).

5.3.1.3 Re-Testing: Following corrective action, the Contractor shall immediately draw new samples for expedited laboratory testing to verify the system has returned to compliance.

5.3.1.4 Financial Responsibility: The Contractor shall bear all costs associated with the emergency service call, corrective maintenance to the water purification system, and expedited re-testing required to bring the system back into compliance.

PART 6: DELIVERABLES

Deliverable Frequency Medium / Format

Submit To

Warranty Information Within 30 days of system installation Electronic CO / Government

POC

Preventive Maintenance Schedule

Within 30 days of system installation Electronic CO / Government

POC

Preventive Maintenance Reports

Within 5 working days following each PM service

Electronic CO / Government

POC

Water Quality Laboratory Reports

Within 5 working days of each testing per AAMI ST108 Schedule

Electronic CO / Government

POC