Statement of Work - Rental_Expandable Sterile Processing Unit_REV 9.17.25.pdf

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Indian Health Services – Shiprock Service Unit

Northern Navajo Medical Center Shiprock, New Mexico 87420

STATEMENT OF WORK

Rental – Expandable Mobile Sterile Processing Unit

1.0 BACKGROUND:

The Northern Navajo Medical Center (NNMC) is a 55-bed hospital in Shiprock, New Mexico.

Clinical services at NNMC include Emergency Department, Ambulatory Care Clinic, Pediatric Clinic, OB/GYN Women's Health Clinic, Orthopedics Clinic, Physical Therapy, ENT, Operating General Surgery, Anesthesia, Intensive Care Unit, Pediatric Unit, L&D/OB Unit, Med-Surgical Unit, Radiology, Laboratory, Dental and Administrative Division. The workload at NNMC is approximately 150,000 outpatient encounters and 2,900 inpatient admissions annually.

The healthcare facility previously rented a Mobile Sterile Processing Department (SPD) to ensure continuation of critical patient care services to patients in the community. There is a need to obtain a new request for a mobile SPD including contractor delivery, training, collaboration, installation, preventative maintenance and meeting technical requirements outlined in this SOW to fulfill this requirement.

2.0 PURPOSE OF CONTRACT:

NNMC has a requirement for a rental for a design installation of an expandable mobile SPD unit here at our healthcare facility. This will ensure continuation of surgical procedures for patients in our community. We will need design layout and flow specifications, utility requirements, and water quality requirements. NNMC will also describe utility infrastructure available including process water quality available and requirements. NNMC will also need training on the SPD equipment to ensure competencies where all staff are established, and ensure the workflow is adequate and up to infection prevention quality standards.

3.0 LOCATION OF MOBILE UNIT:

Deliver to: Northern Navajo Medical Center, US Hwy 491 North, Shiprock, NM 87420

The expandable mobile sterile processing unit will be placed on NAIHS – SRSU – NNMC property within the State of New Mexico. The physical location of the rental mobile sterile processing unit will be located adjacent to North Utility Plant on Highway 491 North in Shiprock, New Mexico 87420. The expandable mobile sterile processing unit must be parked and position next to an existing fire-resistant wooden decking with corridor leading to main hospital to transport medical devices on carts from Operating Room to mobile expandable sterile processing unit.

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4.0 PERIOD OF PERFORMANCE:

The estimated rental performance period will be for a one year base period, plus four year option period.

5.0 TECHNICAL REQUIREMENTS:

A. The contractor shall provide a project manager for the rental unit to assist in providing information on product description, product ordering and coordinating delivery arrangements from start-up, and commissioning and training. The maintenance or equipment work order process must also be covered prior to acceptance of rental. Backup power requirement for a sterile processing unit is provided by NNMC.

B. The contractor shall provide a commission schedule prior to deployment of unit.

C. The rental mobile unit shall meet the required measurements, 75 ft length x 30 ft width x 15 ft height. The mobile unit must meet the NNMC utility infrastructure connection requirements listed in section 5.2.

D. The contractor must provide the required infrastructure hook-up to the existing sterile processing unit connection. The sterile processing unit will require the following:

electrical power service, cold water supply, hot water supply, process water meeting contractor’s utility water specifications, water quality testing, waste water connection, telephone and data connection, wet system only fire sprinkler water, fire alarm connection, heating and cooling connections/HVAC condensate drain termination, unit anchoring/tie downs, and 4’x8’x1” road plates.

E. The rental mobile unit must meet OSHA and other health/safety requirements.

F. The rental mobile unit must provide two (2) ante rooms one for clean side and one for dirty side.

G. The contractor shall provide a cold weather insulation package.

H. The contractor shall provide an ancillary cooling package.

I. NNMC will provide additional facility assistance for the following, service clearance, road plates and manpower (labor) to set up the expandable mobile SPD unit.

J. The contractor shall provide an initial on-site training including competencies for SPD staff who will be using the equipment, and as needed online trainings.

K. The contractor shall provide training for NNMC’s sterile process unit technicians who will assist with maintaining equipment and troubleshooting when necessary.

L. The contractor shall perform quarterly preventive maintenance and emergency service, including replacement of parts for the rental mobile unit. The preventive maintenance cost shall be included in the cost of this contract and not separately. The contractor shall perform preventive maintenance to ensure that the rental mobile unit is maintained in fully operational condition. Work performed shall include, but not limited to cleaning, adjusting and aligning of each electronic and mechanical component, replace parts when needed to maintain the rental unit in excellent operating condition.

M. The preventative maintenance shall be all inclusive of repairs, labor, and replacement parts.

N. The contractor shall respond within less than four (4) hours after notification of a repair call. Rental unit is to be serviced within 24 hours of initial request. This

3 | P a g e timeframe is appropriate which will provide the hospital staff to re-schedule surgery patients. It’s crucial to inform patients about cancellation as soon as possible to minimize disruption to their lives and allow them to start the rescheduling process promptly.

O. The contractor shall perform quality control test semi-annually.

a. Review of daily quality control testing records

b. Measurement of water quality

c. Review and monitor heating and cooling connection

d. The contractor shall provide a record copy of tests to the sterile processing unit supervisor, facility staff, and bio-medical staff.

e. The contractor will provide the initial operator training for the hospital based on the rental mobile unit for new technology and equipment upon installation, annual training if required thereafter. The training cost shall be included in the cost of this contract and not separately.

P. The contractor shall comply with the current maintenance, IT, telecommunication, quality control, infection control, and security requirements. If required, NNMC IT will provide the IT equipment and WIFI connection.

Q. The contractor shall ensure that all equipment is working properly before turning over to the facility. The contractor shall provide startup commissioning documents to NNMC.

R. The contractor shall be in accordance with all Federal, State, Local, Tribal and IHS regulations.

S. The sterile processing unit will be deployed with minimal divergence from the schedule established, also with minimum disturbance and maximum protection of government personnel, property, and general public.

5.1 Mobile Sterile Processing Unit Equipment:

At a minimum the equipment inside the mobile expandable sterile processing unit must meet or exceed our Sterile Processing Department (SPD) equipment or current mobile expandable sterile processing unit.

Section Quantity Equipment

A 1 Clean Up Sink - three (3) Well Sink 10' long or equivalent

B 1 Ultrasonic Irrigator or equivalent

C 1 Wall Mounted detergent dispenser - two (2) Container or equivalent

D 2 Single-Chamber Washer/Disinfector with Double Door Electric Heat or equivalent

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

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F 1

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

G 4 Single Prep and Pack Workstation (2.5' x 5') or equivalent

H 1

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

I 2

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 4 Loading Car and Transfer Carriage (3') or equivalent

K 2 Power Electric Steam Generator 76kW with 1 Blow Down Tank or equivalent

L 1 Healthcare Water Treatment System or equivalent

M 1 Blow-Down Separator Kit with Chromalox Tank or equivalent

N 1 Emergency Exit with Staircase and Platform or equivalent

O 2 Hand Wash Sink with Eye Wash or equivalent

P 1 Decontamination Room HVAC System or equivalent

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 process flow must go from dirty (e.g., decontamination) to clean (e.g., sterile) side with ante rooms on both sides.

5.2 NNMC UTILITY INFRASTRUCTURE CONNECTION:

Below are the current utility infrastructure connections provided by NNMC Facilities.

Section Quantity Description Specification

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A 1 Contractor

Electrical Input 277/480V, 3-phase, 60Hz, (2)

250Amp

B 2

Contractor Electrical

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

C 2

Contractor 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 Facility Electrical

Connection

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

Mounted on Disconnect Panel

F 1 Facility Electrical

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 Contractor

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 Facility Cold

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

L 1 Facility Cold

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 Facility Hot Water

Supply Dynamic pressure 50-60 psi at

MSPD

O 1 Facility Hot Water

Supply Temperature: 120°F Min, 140°F

Max

P 1 Facility Hot Water

Supply 300 GPH average (20 GPM peak)

Q 1 Facility

Wastewater 4-inches wastewater connection

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R 1 Facility

Wastewater In-line Sump Pump

S 1

Contractor Telephone and

Data Connection Patch Panel made available for IT

Connections

T 1

Facility 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

X 1 Contractor Fire

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 Contractor Fire

Alarm Connection

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

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

Contractor 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)

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Contractor 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 h 1

Facility Provided Electrical Input Service for Hot

Weather Cooling Package

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

Contractor Provided HVAC for Hot Weather Cooling Package

Provide Pre-Cooling Unit including All Ancillary Components

5.3 NNMC PROCESS WATER QUALITY REQUIREMENTS:

The water quality must meet ANSI/AAMI Standard 108: Water for the processing of medical devices. The process water quality criteria found on Table 21 must be adhered to and maintained.

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

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Conductivity µS/cm <500 <10 <10

Copper mg/L <0.1 <0.1 <0.1

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.

Any data from a water sample collected by the contractor shall be provided to the NNMC facility supervisor. NNMC will send any water samples collected to a qualified water testing facility to test and provide a report. The report will be shared with the contractor. Any corrective action will be shared with the hospital Water Quality Committee and corrections will be made.

6.0 RESPONSIBILITY:

The Contractor Shall collaborate with the Facility Manager, Bio-Med Supervisor, SPD Supervisor, and/or Maintenance Supervisors and is expected to perform assignments independently.

All contract activities must be overseen and managed by Contracting Officer Representative (COR). This ensures that contract obligations are met effectively and efficiently, particularly regarding timeliness and quality. The COR serves as a liaison between the contractor and contracting officer, monitoring performance, and reporting any issues.

No government personnel, other than a Contracting Officer (CO), is authorized to make commitments or enter agreements on behalf of the government.

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