ATTACHMENT A - Statement of Work-Rental_Expandable Sterile Processing Unit_REV 07.01.26.pdf

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STATEMENT OF WORK

Rental – Expandable Mobile Sterile Processing Unit

Northern Navajo Medical Center

Indian Health Services – Shiprock Service Unit Shiprock, New Mexico 87420

1.0 BACKGROUND:

The Northern Navajo Medical Center (NNMC), located in Shiprock, New Mexico, is a critical regional healthcare facility serving a high-acuity patient population. NNMC operates a 55-bed inpatient hospital and provides approximately 150,000 outpatient visits and 2,900 inpatient admissions annually. Its multidisciplinary clinical services include Emergency/Urgent Care, Medical-Surgical and ICU, Surgical Services and Anesthesia, Labor & Delivery, Pediatrics, Ambulatory Care, and extensive Ancillary Services, including Radiology, Laboratory, Pharmacy, Dental, Physical Therapy, and

ENT.

To ensure uninterrupted sterile processing operations during internal facility needs, NNMC requires the rental, delivery, installation, commissioning, and maintenance of an Expandable Mobile Sterile Processing Unit (EMSPU). Building on previous deployments, this procurement requires a Contractor-provided temporary EMSPU capable of full sterile processing operations meeting all healthcare, infection control, and utility infrastructure requirements.

The Contractor shall provide all labor, materials, logistics, engineering support, training, and maintenance services necessary to ensure seamless EMSPU installation and operations throughout the rental period.

2.0 PURPOSE OF CONTRACT:

The purpose of this contract is to obtain a fully operational, code-compliant Expandable Mobile Sterile Processing Unit that integrates with NNMC’s existing utility infrastructure and supports full sterile processing operations.

The Contractor shall:

Provide architectural, engineering, and technical design services.

Deliver all required design drawings detailing utility needs, site logistics, infrastructure tie-ins, layout, and operational connectivity.

Ensure safe delivery, installation, commissioning, training, and operational readiness.

Maintain continuous operational functionality throughout the rental term.

The goal is the uninterrupted delivery of sterile processing services and full alignment with all applicable regulatory, safety, and infection control standards.

3.0 LOCATION OF MOBILE UNIT:

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The EMSPU shall be delivered and installed at:

Northern Navajo Medical Center US Highway 491 North Shiprock, NM 87420

A site map identifying installation location, required clearances, access pathways, and utility tie-in locations will be provided as Exhibit A and B.

The EMSPU shall be a temporary, wheeled mobile unit custom-built for healthcare sterile processing. The Contractor must guarantee the structural integrity and mobility of the unit for immediate removal at the end of the rental term. Furthermore, the Contractor shall provide all labor, materials, and specialty equipment required for the safe delivery, precise positioning, structural stabilization, tie-down anchoring, and utility-ready operational readiness of the unit.

4.0 PERIOD OF PERFORMANCE:

The contract shall consist of:

One (1) Base Period of one year, and Four (4) Option Periods of one year each, if exercised by the Government.

The total contract period shall not exceed five (5) years.

All Contractor responsibilities—including delivery, installation, commissioning, training, maintenance, repairs, and removal—shall occur within the approved Period of Performance.

5.0 TECHNICAL REQUIREMENTS:

A. The Contractor shall provide a dedicated Project Manager for the rental unit to oversee product information, ordering, delivery, start-up, commissioning, and staff training. Prior to formal unit acceptance, the maintenance and equipment work order process must be mutually finalized. NNMC will supply the required backup power for the EMSPU.

B. The Contractor shall provide comprehensive Sterile Processing Department (SPD) design, infrastructure assessment, and staff training services. All deliverables must align with current CDC Guidelines and ANSI/AAMI standards to safeguard patient safety. The Contractor shall specifically deliver and complete, compliant floor and piping design layouts, equipment flow specification, utility parameters, and water quality standards. The Contractor shall provide a detailed documentation of existing utility and infrastructure capacities, including specific measurements of available process water quality. The Contractor shall develop and deliver a comprehensive Workflow Map and Project Schedule detailing all operational phases, task dependencies, and major milestones. The Contractor shall provide comprehensive staff training on all newly installed or upgraded EMSPU equipment. The Contractor shall verify that all daily operational workflows meet established infection prevention, quality assurance, and EMSPU best practices.

C. The Contractor shall develop and submit a comprehensive Commissioning Schedule for review and approval by the CO at least 45 days prior to the planned deployment of the EMSPU. The schedule must clearly identify the logical sequence of events and encompass

3 | P a g e the following Government expectations:

Pre-Functional Checklists: Dates for the completion and verification of all pre-functional checks before integrated systems testing begins.

Functional Performance Testing: Specific testing windows for all mechanical, electrical, and control systems to ensure they perform according to EMSPU’s design intent and operational needs.

Government Witnessing: Notification periods of at least 14 days advance notice allowing NNMC personnel or designated representatives to witness critical tests.

Deficiency Resolution: Timeframes allocated for identifying, documenting, and correcting any discrepancies discovered during testing prior to final acceptance.

Operator Training & Handover: A designated timeframe for operator training, final calibration, and the formal submission of Operation and Maintenance (O&M) manuals prior to field deployment.

The schedule will govern the following four phases:

1. Pre-Planning Phase Conduct concept site visits and PDM capacity studies.

Submit comprehensive proposals and execute the contract.

Conduct post-agreement planning, including MEP (Mechanical, Electrical, and Plumbing) page-flips.

2. Pre-Commissioning Phase

Prepare and verify site utility readiness (electrical, drain lines, and water lines).

Outline exact placement of the EMSPU and install road plates.

Conduct a final site walkdown and secure official confirmation of site readiness.

3. Commissioning Phase

Dispatch the mobile solutions install team and deliver the unit to the site.

Expand and level the EMSPU.

Connect electricity, plumbing, and fire suppression systems (Government to provide a forklift and driver).

Unload ancillary equipment from the transport POD and configure the interior layout.

Construct transitional corridors, install tie-downs, and connect IT infrastructure.

Conduct facility and bio-med staff in-services.

Finalize equipment start-up by contractor service technicians.

4. Clinical Activities and Turnover Deliver in-service training for SPD staff.

Confirm successful completion of two (2) IPD (Immediate Use/Indicator

Process Device) cycles.

Perform EVS terminal cleaning and receive final sign-off.

Formally turn over the EMSPU for operational use and go-live.

D. The Contractor shall provide a temporary, wheeled, EMSPU. The unit must meet the spatial requirements of the currently rented mobile unit, measuring approximately 75 feet in length x 30 feet in width x 15 feet in height. The Contractor shall produce a detailed design blueprint for the EMSPU. The design shall be submitted to NNMC for review and approval, ensuring the final mobile unit configuration strictly aligns with facility-specific requirements and

4 | P a g e dimensional constraints. Furthermore, it must be specifically manufactured and certified for healthcare sterile processing operations, designed for temporary deployment on hospital grounds, and compliant with all utility infrastructure connection standards outlined in Section 5.2.

E. The Contractor shall develop and submit detailed utility connection drawings and installation plans for approval prior to the commencement of any site work.

These plans must explicitly demonstrate how the proposed EMSPU will connect to the existing hospital infrastructure. Drawings shall clearly indicate all routing, sizing, tie-in points, and the physical footprint of the connections.

F. The Contractor shall provide and install all related utility connections and associated infrastructure necessary for the full operation of the EMSPU. The Contractor shall also prepare and submit comprehensive installation and utility layout drawings, including [e.g., electrical, plumbing, HVAC] specifications, for NNMC approval prior to commencement of work. This includes, but is not limited to, all connections to:

Electrical power Sewage/wastewater Domestic water Process water HVAC condensate drains Telecommunications and data systems Fire alarm systems Fire sprinkler systems

G. The Contractor shall furnish all necessary hardware and materials to complete the connections between the EMSPU and the existing hospital infrastructure.

This includes, but is not limited to, all hoses, piping, cabling, connectors, adapters, fittings, grounding systems, anchoring systems, and related accessories. To prevent project delays, the Contractor shall conduct a joint inventory assessment with the Facility Manager. The Contractor must finalize and verify the accuracy of all required materials prior to the commencement of on-site work.

H. The EMSPU and all associated systems, equipment, utility connections, and operational components shall comply with all applicable hospital regulations, healthcare standards, OSHA requirements, fire and life safety codes, infection prevention requirements, environmental safety requirements, and all applicable Federal, State, Tribal, local and Indian Health Service (IHS) regulations and codes, including NFPA, NEC, CMS, CDC, ANSI/AAMI, and Joint Commission (JC) standards.

I. The Contractor shall provide a rental EMSPU with two (2) distinct anterooms.

The unit must feature:

One (1) designated clean-side anteroom for hygienic personnel entry, garbing, and supply transfer.

One (1) designated dirty-side anteroom to support containment, donning/doffing of personal protective equipment (PPE), and waste handing.

Both anterooms must maintain proper pressure differentials, seamless surfaces

5 | P a g e for daily sanitization, and physical lines of demarcation to prevent cross-contamination.

J. The Contractor shall provide a cold weather insulation package that includes both a fully operational, thermostatically controlled heating system and thermal insulation. The EMSPU’s interior must be actively heated to maintain a safe and operable environment.

K. The Contractor shall provide, install, and operationalize a complete ancillary cooling package to regulate the ambient temperature and humidity inside the EMSPU, including all necessary equipment, materials, and labor required for proper operation.

L. The Contractor shall delivery initial on-site, instructor-led training for all SPD staff operating the equipment. This includes verifying staff competencies. Additionally, the Contractor shall provide supplementary online training modules on an as-needed basis.

M. The Contractor shall develop and deliver a comprehensive training program for NNMC’s SPD unit technicians. The training curriculum must equip technicians with the necessary competencies to safely perform routine equipment maintenance and execute frontline troubleshooting procedures.

N. The Contractor shall provide quarterly preventive maintenance and on-call emergency repair services, including all necessary parts, for the rental mobile unit. All preventive maintenance costs must be all-inclusive and bundled into the total contract value, with no separate billing permitted. The Contractor's preventive maintenance program shall include, but is not limited to, cleaning, adjusting, aligning, inspecting, testing, and replacing components as necessary to sustain the rental unit in a fully operational and safe condition. The Contractor shall develop and submit an annual PM schedule to the Facility Manager, Contracting Officer (CO), and Contracting Officer's Representative (COR) for approval. Any proposed revisions to the schedule or requests for routine system downtime must be communicated via email to all three parties no later than 7 days prior to the scheduled service date.

O. The Contractor shall provide all-inclusive preventative maintenance. This includes all necessary diagnostic services, scheduled maintenance, unscheduled repairs, labor, and replacement parts required to maintain the equipment in optimal operational condition at no additional cost.

P. The contractor shall acknowledge repair service calls with four (4) hours of notification and initiate service on the EMSPU within twenty-four (24) hours of the initial request. These strict response times are essential to prevent interruptions in patient care and surgical scheduling. Furthermore, the Contractor must maintain regular communication with NNMC staff regarding equipment downtime and repair status updates.

Q. The Contractor shall execute semi-annual quality control evaluations to ensure optimal system performance, safety, and operational readiness. The semi-annual scope of work shall encompass the following deliverables:

Record Auditing: Conduct a comprehensive review of daily quality control records and logs to verify adherence to established operational standards.

Water Quality Assurance: Perform detailed measurements and verification of water quality parameters to maintain system integrity and compliance.

System Monitoring: Evaluate and monitor the connectivity and operational efficiency of heating and cooling systems.

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Reporting: Compile and deliver comprehensive testing records and analytical reports to the SPD Supervisor, Facilities Management, and Biomedical staff.

Operator Training: Deliver initial operator training upon system installation, supplemented by annual refresher courses. All training and associated instructional costs must be fully inclusive of the total contract price and shall not be invoiced as separate line items.

R. The Contractor shall strictly adhere to all current NNMC operational and facility standards, including life safety systems (such as fire alarms), IT, telecommunications, quality control, infection control, and security requirements.

Should specific IT hardware or Wi-Fi connectivity be required for performance, NNMC IT will supply these resources.

S. The Contractor shall prepare and submit a comprehensive list of required startup and commissioning documentation for NNMC approval. Prior to facility handover, the Contractor shall execute all necessary inspections and testing to ensure that all equipment and systems are completely operational and compliant with prevailing healthcare codes and regulations. Upon successful testing, the Contractor shall deliver all related compliance, testing, and operational records to NNMC.

T. The Contractor shall perform all work in strict compliance with governing Federal, State, Local, and Tribal regulations, including but not limited to environmental, safety, and labor codes. Furthermore, the Contractor must comply with all applicable IHS Policies and Procedures relevant to the project.

U. The Contractor shall execute the end-to-end deployment of the EMSPU encompassing all required delivery, installation, commissioning, and operational readiness. All work must be conducted in strict accordance with the approved schedule. To maintain continuity of care, all on-site activities must occur during designated off-hours or weekends. Any timeline deviations require prior written approval and must be strictly minimized to prevent disruption to hospital operations, government personnel, visitors, property, and the general public.

5.1 Mobile Sterile Processing Unit Equipment:

At a minimum, all equipment provided within the EMSPU must meet the list below or exceed the functionality, capacity, operational performance, and quality standards of NNMC’s existing Sterile Processing Department equipment. All equipment shall be suitable for healthcare sterile processing operations and support industry-standard infection prevention and sterilization practices.

Section

Quantity Equipment

A

Clean Up Sink - three (3) Well Sink 10' long or equivalent

B

1 Ultrasonic Irrigator or equivalent

C

Wall Mounted detergent dispenser - two (2) Container or equivalent

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D

Single-Chamber Washer/Disinfector with Double Door Electric Heat or equivalent

E 4 Transfer Carts with three (3) Level Manifold Rack or equivalent

F

Pass-Thru Window with Set-Down Counter between Decontamination and Sterile sides or

G

Single Prep and Pack Workstation (2.5' x 5') or

H

VPRO or equivalent Low Temperature Sterilization System with Single Door Cabinet with four (4) Locking Casters

I

Medium Steam Sterilizer - 2'-2" x 3'-1.5" x 3') Double Left-Right Hinged Doors Recessed two

(2) Walls Steam Heat or equivalent

J

Loading Car and Transfer Carriage (3') or

K

Power Electric Steam Generator 76kW with 1 Blow Down Tank or equivalent

L

Healthcare Water Treatment System or

M

Blow-Down Separator Kit with Chromalox Tank or equivalent

N

Emergency Exit with Staircase and Platform or

O

2 Hand Wash Sink with Eye Wash or equivalent

P

Decontamination Room HVAC System or

Q

1 Sterilizer Cube HVAC System or equivalent

R

1 Front Sterile Room HVAC System or equivalent

S

1 Rear Sterile Room HVAC System or equivalent

The Contractor shall design, configure, and install the EMSPU to support a strict unidirectional workflow. All physical layouts, equipment, and personnel movements shall progress continuously from soiled/decontamination zones to clean and sterile preparation areas. The Contractor must provide a detailed, to-scale floor plan and workflow diagram for clinical approval prior to manufacturing and deployment, demonstrating exactly how the unit prevents cross-contamination. The EMSPU must fully comply with ANSI/AAMI and all applicable infection prevention industry

8 | P a g e standards. The Contractor’s proposed design must explicitly include airflow separation, dedicated ante rooms, and material transfer operations.

5.2 NNMC UTILITY INFRASTRUCTURE CONNECTION:

The Contractor shall ensure that all utility infrastructure connections, systems, equipment, and associated components supporting the EMSPU strictly comply with all governing Federal, State, Tribal, local, and IHS regulations. Compliance encompasses, but is not limited to, standards set forth by:

Occupational Safety and Health Administration (OSHA) National Fire Protection Association (NFPA) (Life Safety Code) National Electrical Code (NEC) Centers for Medicare & Medicaid Services (CMS) Centers for Disease Control and Prevention (CDC) (Infection Prevention Guidelines) Association for the Advancement of Medical Instrumentation (AAMI / ANSI) The Joint Commission (TJC FGI Guidelines, AAMI ST79, and standard model plumbing and mechanical codes

The Contractor shall submit a comprehensive, to-scale floor plan and workflow diagram for NNMC approval. This documentation must explicitly detail how the unit's utility systems integrate with and operate the EMSPU, demonstrating safe and efficient functionality.

Furthermore, the Contractor is responsible for ensuring all utility systems and connections are fully installed, tested, inspected, and maintained in compliance with all relevant healthcare facility regulations and recognized industry best practices prior to final acceptance and operation.

Section Quantity

Description Specification

A 1

Contractor Electrical Input

277/480V, 3-phase, 60Hz, (2) 250Amp

B 2

Electrical

Connection Meltric Input PT#39-24243-K04 and PT#596M6 Angled Box

C 2

Electrical

Shoreline Cable

Minimum of 75', 3/0 Type W Cable With Meltric Connector

PT#39-28243-K04 with PT#2H2 Handle

D 1

Facility Electrical

Input

500 Amp NEMA Disconnect Panel, four (4) wire configuration (L1, L2, L3, G) with (2) 250 Amp Breakers Located within 50' of

Mobile Unit Location

E 2

Connection

Meltric Inlet PT#39-24243-K04 and PT# 596M6 Angled Box

Mounted on Disconnect Panel

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F 1

Ground

Earth Ground Provided per NEC Article 250

G 1 Facility Electrical

Ground

Single Point Ground Stud Located Directly Under the Roadside

Power Connection

H 1

Electrical Ground 20' Ground Cable with (2) clamps

I 1

Contractor Cold Water Supply

1-1/2-inches connection (#5 Roadside Belly Box) reducer to 1-

1/4-inches may required.

J 1

Facility Cold Water Supply

Dynamic pressure 50-60 psi at

MSPD

K 1

Water Supply Temperature: 40°F Min, 70°F Max

L 1

Water Supply 700 GPH average (70 GPM peak)

M 1

Facility Hot Water Supply

1-1/2-inches connection (#5 Roadside Belly Box)

N 1

Supply

Dynamic pressure 50-60 psi at

MSPD

O 1

Supply

Temperature: 120°F Min, 140°F Max

P 1

Supply 300 GPH average (20 GPM peak)

Q 1

Facility Wastewater 4-inches wastewater connection

R 1

Wastewater In-line Sump Pump

S 1

Telephone and

Data Connection Patch Panel made available for IT

Connections

T 1

Telephone and

Data Connection Provide Switch, if required

U 1

Contractor Fire Sprinkler Supply - Wet System Only

2-inch Victaulic coupling (rear of unit)

V 1

Facility Fire Sprinkle Supply - Wet System Only Supply required: 143 GPM at SPD

W 1

Facility Fire Sprinkle Supply - Wet System Only

Residual Pressure 46 psi minimum at SPD

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X 1

Alarm Connection

Conventional analog fire alarm system with local audible-visual, horn-strobe alarm devices for occupant warning

Y 1 Contractor Fire

Alarm Connection

Unit alarm system configured with 2 zones with detection and pull stations

Z 1

Alarm Connection

Unit alarm system configured with 1 zone supervisory tamper switch on sprinkler water control valve a 1

Alarm Connection

Unit alarm system configured with 1 zone for water flow switch on sprinkler system b 1

Contractor/Facility

Fire Alarm Connection

Unit alarm system configured with system exports trouble, supervisory and alarm conditions to three dry contacts available at the rear of the unit.

c 4

Heating and

Cooling Connection/

HVAC

Condensate Drain

Terminations Nominal 3/4-inch pipe(s) at front and rear of units d 8

Contractor Unit Anchors

Mobile Unit two (2) per corner (8 total) e 8

Provided

Anchoring Straps to Secure the Mobile Unit

Anchor point at 9,200 lb. capacity to be located 45° from the ground f 1

Facility Provided Electrical Service for Cold Weather

Insulation Package

70 Amp NEMA Disconnect Panel, 208/240 VAC, 2 pole, Single

Phase, 60Hz g 4

Contractor Supply Cold Weather

Heaters Insulation Package

4000-watt, 240V heaters with NEMA rating

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Facility Provided Electrical Input Service for Hot

Weather Cooling Package

30-Amp NEMA Disconnect Panel, 30 Amp Breakers, 3-phase, 60Hz i 1

Provided HVAC for Hot Weather Cooling Package

Provide Pre-Cooling Unit including All Ancillary Components

5.3 NNMC PROCESS WATER QUALITY REQUIREMENTS:

The Contractor shall ensure the EMSPU water quality strictly complies with ANSI/AAMI Standard 108: Water for the Processing of Medical Devices. Process water parameters outlined in Table 21 must be continuously monitored, maintained, and documented throughout the period of performance.

The contractor shall submit comprehensive, to-scale floor plans and workflow diagrams for NNMC approval. The documentation must clearly detail the integration of water quality systems with the EMSPU to ensure safe, efficient operations. Prior to operation and acceptance by NNMC, the contractor is responsible for the proper installation, testing, and inspection of all utility connections in accordance with healthcare facility regulations and industry best practices. Furthermore, all water, treatment, and utility systems must meet all applicable Federal, State, Tribal, local, and IHS codes. Compliance encompasses, but is not limited to, OSHA standards, NFPA fire and life safety codes, National Electrical Code (NEC), plumbing and mechanical codes, Center for Medicare & Medicaid Services (CMS) requirements, Centers for Disease Control and Prevention (CDC) infection prevention guidelines, ANSI/AAMI standards, and Joint Commission (JC) standards.

Table 2—Categories and performance qualification levels of water quality for medical device processing

Water Quality Measurement

Units Utility Water Critical Water Steam* pH @ 25 °C: pH 6.5 – 9.5 5.0 – 7.5 5.0 – 9.2**

Total Alkalinity mg CaCO3/L <400 <8 <8

Bacteria CFU/mL <500*** <10 N/A

Endotoxin EU/mL N/A*** <10 N/A Total Organic Carbon

(TOC) mg/L (ppm) N/A <1.0 N/A

Color and Turbidity Visual Colorless, clear, without sediment

Colorless, clear, without sediment

Colorless, clear, without sediment

Ionic Contaminants

Aluminum mg/L <0.1 <0.1 <0.1

Chloride mg/L <250 <1 <1

Conductivity µS/cm <500 <10 <10

Copper mg/L <0.1 <0.1 <0.1

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Iron mg/L <0.1 <0.1 <0.1

Manganese mg/L <0.1 <0.1 <0.1

Nitrate mg/L <10 <1 <1

Phosphate mg/L <5 <1 <1

Sulfate mg/L <150 <1 <1

Silicate mg/L <50 <1 <1

Total Hardness mg CaCO3/L <150**** <1 <1

Zinc mg/L <0.1 <0.1 <0.1

* Steam parameters are for monitoring as steam condensate **See 6.3 a) for specifics. For local steam generation, the condensate pH should be 5.0 to 7.5. For boiler-treated steam, most boilers should be treated to maintain a condensate pH of 7.5 to 9.2 *** When Utility Water is used after chemical high-level disinfection as a final rinse, the bacteria should be <10 CFU/mL and endotoxin <10 EU/mL **** If hardness is greater than 150 mg/L a water softener is recommended unless used for washing where the cleaning chemistry is capable of handling higher levels of hardness i i Association of the Advancement of Medical Instrumentation (2023), ANSI/AAMI Standard 108: Water for the Processing of Medical Devices, Arlington, VA: AAMI.

Data and reporting for all water samples collected by the Contractor shall be submitted to the NNMC Facility Supervisor for review and documentation. NNMC reserves the right to submit duplicate or independent water samples to a certified laboratory for parallel analysis. All independent testing reports will be shared with the Contractor for prompt review and response. The Contractor must promptly communicate any identified deficiencies, non-compliance findings, or required corrective actions to the hospital’s Water Quality Committee. Additionally, the Contractor shall collaborate with NNMC to ensure ongoing compliance with ANSI/AAMI standards, hospital infection prevention protocols, and all applicable healthcare regulations and codes.

6.0 RESPONSIBILITY:

The Contractor shall execute all assignments independently while coordinating as necessary with the Facility Manager, Bio-Med Supervisor, SPD Supervisor, and/or Maintenance Supervisors.

All contract activities are subject to the technical oversight and management of the Contracting Officer's Representative (COR). The COR will serve as the primary liaison between the Contractor and the Contracting Officer (CO), monitoring performance to ensure strict adherence to quality standards and schedule requirements.

The Contractor is advised that no government personnel, other than the CO, possess the authority to make commitments, issue changes, or enter into agreements on behalf of the Government.