11 71 01.pdf

FY19 Hospital Modernization, Misawa AB, Japan December 23, 2019 Legacy Project #QKKA188003, Opportunity 1090686

SECTION 11 71 01

MOBILE STERILE PROCESSING DEPARTMENT (SPD)

PART 1 GENERAL

1.1 REFERENCES

The publications listed herein form a part of this specification to the extent referenced. The publications are referred to within the text by the basic designation only.

Refer to Specification Section 01 42 00.00 33 JIS ACCEPTABLE ALTERNATIVES for a listing of Japanese standards which are considered acceptable alternatives to the listed US standards. Japanese standards not included in this list or not referenced elsewhere in these specifications as being acceptable alternatives to US standards may be submitted to the Contracting Officer's Representative for approval as acceptable alternatives. Prior to the use of such Japanese standards, written approval by the Contracting Officer's Representative is required. See part 2.2 Mandatory U.S. Products in Specification Section 01 42 00.00 33 JIS ACCEPTABLE ALTERNATIVES for a list of products and materials that must meet US standards and be procured from the U.S.

AMERICAN SOCIETY OF HEATING, REFRIGERATING AND AIR-CONDITIONING

ENGINEERS (ASHRAE)

ASHRAE 170 Ventilation of Healthcare Facilities

1.2 SUBMITTALS

Government approval is required for submittals with a "G" designation;

submittals not having a "G" designation are for IO&T Contractor Quality Control approval. When used, a designation following the "G" designation identifies the office that will review the submittal for the Government.

Submit the following in accordance with Section 01 33 00 SUBMITTAL

PROCEDURES:

SD-02 Shop Drawings

Approved Detail Drawings; G

SD-03 Product Data

ASME Form U1 Materials and Equipment Spare Parts

SD-10 Operation and Maintenance Data

Operating Manual Maintenance Manual Training

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PART 2 PRODUCTS

2.1 SYSTEM DESCRIPTION - MATERIALS AND EQUIPMENT

Mobile Sterile Processing unit shall be easily transported and setup for temporary purposes. Unit shall be fully compliant with all FGI, ASHRAE 170, TIR34, ANZI, VA and DOD design standards and requirements when in operation for design, HVAC, safety, surfaces and finishes. Unit shall have all utilities fully engineered with single point connections for all utilities required for operation. Unit shall come with all significant equipment required to have a fully functional SPS department.

2.1.1 Mobile SPD Chassis

Mobile SPD Chassis shall be:

Mobile SPD that is a 1 to 3 expandable Approximately 53 feet long by 22 feet wide when deployed 3 axles Single point connections with manifolds and pressure regulators for hot and cold water Single point connection for drain Single point connection for fire sprinkler system 8 anchor points (2 per corner) that meets 10,000 lb tensile strength for wind / seismic ratings

2.1.2 SPD Equipment

SPD Equipment provided within mobile SPD unit shall be:

1 - 120 inch 3 Well Sink with compressed air and pure water guns 2 - Passthrough Washers Electric with a 35 min cycle or less and 4 transfer carts and manifolds 1 - Pass Thru Window with power open and close 1 - Sonic Cleaner with Da Vinci capability and baskets 1 - Sonic Cleaner as second unit if required by client 1 - Rack return 4 - Prep and Pack tables with bins, computer holder and light 2 - 36 inch Passthrough sterilizers with 4 loading carts/carriages 1 - Low Temperature VHP Sterilizer 2 - Steam Generators 1 - Hot blow down tank for the steam generators 1 - Critical pure water system that meets TIR34 1 - System for monitoring equipment and environmental conditions remotely by cellular service

Safety:

2 - Hand wash and eye wash sinks that meet ANZI and FGI standards (1 - Decontamination, 1 - Prep and Pack) 2 - Fire extinguishers 1 - Emergency exit door 1 - Fully engineered wet fire sprinkler system 1 - Stand alone fire panel with capability to communicate with main facility fire system

2.2 CONSTRUCTION AND DESIGN

Mobile SPD General Construction and Design shall contain the following:

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Design shall be: Mobile unit shall be a 3-stage design in a single unit utilizing passthrough sterilizers and shall have the following dedicated space for:

o Decontamination Vestibule o Decontamination o Prep and pack o Sterilizer Load o Sterilizer unload and cooling o Sterile vestibule o Mechanical space

Shall have a wind rating for 110 MPH sustained

2.2.1 Floors

Floors shall be:

o Homogenous sheet vinyl with pattern from top layer to bottom.

o All floor seams shall be welded o Tightly sealed transitions over hinges of expandable panels.

o Cove molding shall be tight to the floor and wall.

2.2.2 Walls

Walls shall be:

o Fire rated o High impact o Antimicrobial o No gaps or holes

2.2.3 Ceiling

Ceiling shall be:

o Surgical grade ceiling tiles that are washable and cleanable o Clipped in or provide enough pounds per square inch to meet FGI guidelines

2.2.4 Sinks/Eyewash

Sinks/Eyewash shall be o Solid surface countertops o Sink made of stainless steel or other nonporous material.

o Eyewash single movement that meets ANZI requirements for time and temperature

2.2.5 HVAC

HVAC shall meet ASHRAE 170 and shall:

Be Dedicated HVAC unit for Decontamination o Maintain negative pressure relating to prep and pack and sterilization o Use 2 stage filtration that meets or exceeds ASHRAE 170

6 air exchanges per hour

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2 external air exchanges per hour 60 to 73 degrees 10 to 55 percent humidity.

Be Dedicated HVAC for Sterilizer room o Maintain negative relationship to clean and sterile rooms

In duct humidifier system

2.3 MOBILE SPD PAST PERFORMANCE AND OTHER CONSIDERATIONS

Shall have completed 40 plus dedicated sterile processing mobile deployments in North America.

Shall have successfully completed VA / DOD mobile sterile processing deployments.

Shall provide as part of its Mobile SPD / SPS solution o Clinical consulting to aid with the operational workflow while using the Mobile unit

Onsite visit to be prior to deploying the unit Follow up go live onsite support o Inservice on all Mobile equipment as part of startup o Equipment service to include preventive and corrective maintenance on all equipment and the Mobile unit itself.

o Biweekly (at a minimum) status calls during deployment

PART 3 EXECUTION

3.1 INSTALLATION

Install equipment at locations indicated in Drawings and in accordance with manufacturer's printed installation instructions, Section 11 70 00 GENERAL REQUIREMENTS FOR MEDICAL AND DENTAL EQUIPMENT, and approved detail drawings.

Submit detail drawings containing complete wiring and schematic diagrams and any other details required to demonstrate that Mobile SPD has been coordinated and will function as a unit. Drawings shall show proposed layouts and anchorage, and relationship to current facility. Drawings shall include installation details and settings, drain piping connections, and complete electrical wiring and control diagrams. Necessary items shall be furnished and installed as required for the type of equipment furnished.

3.2 ADJUSTING

Following installation, flows, timers, levelers, and similar components and operation devices shall be adjusted as appropriate. After testing, and before acceptance, equipment shall be examined to ensure that adjustments are correct and that any additional adjustments deemed necessary during product testing or because of timing, have been incorporated.

3.3 UTILITIES

3.3.1 Service Runs

Connect service runs from equipment to building services as indicated.

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3.4 MANUFACTURER'S FIELD SERVICE

Provide the services of a manufacturer's representative who is experienced in the installation, adjustment, and operation of the equipment specified.

The representative shall supervise the installation, adjustment, and testing of the equipment.

3.5 TRAINING

3.5.1 Training Course

Conduct training course for operation staff as designated by the Contracting Officer. The training period, for a total of two hours of normal working time, shall start after systems are functionally complete but prior to final acceptance. The field instructions shall cover all of the items contained in the operations and maintenance instructions, as well as demonstrations of routing maintenance operations. Notify Contracting Officer at least 14 days prior to date of proposed conduction of training course. The manuals shall be approved prior to the training course.

3.5.2 Operating Manual

Submit six complete copies of operation manual outlining the step-by-step procedures required for system startup, operation, and shutdown. The manuals shall include the manufacturer's name, model number, service manual, parts list, and brief description of all equipment and their basic operating features.

3.5.3 Maintenance Manual

Submit six complete copies of maintenance manual listing routine maintenance procedures, possible breakdowns and repairs, and trouble shooting guide. The manuals shall include simplified schematic diagrams for the equipment as installed. Submit operation and maintenance data in accordance with Section 01 78 23 OPERATION AND MAINTENANCE DATA.

3.6 FIELD QUALITY CONTROL

3.6.1 Tests

Test each item to ensure equipment is operational and conforms to specification requirements.

3.6.2 Inspection

Examine each item for visual defects and conformance to specifications.

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