Attachment 0004a - SOW - Perform Site Prep - Rev 3 - 12 Pages.pdf

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SCOPE OF WORK

VA PROJECT TITLE: 437-CSI-241 Perform Site Prep for SPS Equipment

LOCATION: FARGO VA HEALTH CARE SYSTEM, 2101 ELM STREET, FARGO, ND 58102

COR – Contracting Officer Representative: Rooney Villegas

In preparation for and working with Fargo VAHCS, Fargo ND VA Project 437-CSI-241 Perform Site Prep for SPS Equipment, 2101 Elm Street North Fargo, ND 58102 01 00 00 -GENERAL REQUIREMENTS, General Contractor (GC) for installation of sterile processing equipment, including Mechanical, Electrical, Plumbing, Piping, and Technology infrastructure. Removal or connecting, disconnection of MEPT & fire protection services, and construction of site and building elements (enclosure), when Mobile Sterile Processing Trailer is removed. Most of this work will be done in the basement level.

The Equipment Supplier/Contractor must follow design for the installation of RO Water system and Mechanical room for RO water equipment. Site preparation for delivery of a Mobile Sterile Processing trailer provided by the General Contractor (GC). Site preparation includes, but not limited to: Demolition of exterior site elements such as, portions of; retaining walls, sidewalks, concrete ramps, windows, and chain link fence. Preparation of site for concrete pad for trailer and other MEP work. Construction of a wood framed weatherproof enclosure from the Mobile Sterile Processing trailer to the facility. Extension of Mechanical, plumbing, piping, electrical, fire protection, and technology systems to the Mobile Trailer.

Includes but not limited to; Demolishing and renovation of the SPS Decontamination/ Receiving and Prep/ Pack Assembly area, Mechanical space adjacent to the Prep/Pack Assembly area.

Tentative Schedule/Period of Performance (PoP):

Award D

Pre-Construction Conference

• Contractor will initiate trailer procurement

D+7

NTP D+10

Badging/Background check D+10

Submittal/RFI due D+10

Badging/Background check completion D+10

Mobilization D+95

Construction start D+101

Construction Completion D+532

Project Closeout and end D+547

Table 1 Period of Performance (PoP)

A. Schedule Objectives - The anticipated substantial completion of this project is 547 days after “Notice to Proceed” (NTP).

B. This schedule was adjusted accordingly to holidays and no weekends. Weekend, after hour and holiday is allowed if necessary and will be coordinated with the COR.

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General Contractor requirement for Fargo VA

The General Contractor (GC) must have their subcontractors notify the designated Supervisor for any questions or inquiry and not go directly to the Contracting Officer Representative (COR). The General Contractor shall issue RFIs as necessary to the COR.

Contractor shall use an electronic file sharing system for RFI, submittals, meeting minutes, and photos.

Review Specifications 01 33 23 for standard VA review period.

Meeting/Conference Minutes Document meeting minutes with attendance and all discussion items noted, ensure comments from services or staff attending the meetings are recorded in the minutes and provided input.

Contractor must have PIV badges to walk around on-site. If your subcontractors do not have a PIV badge, they shall be escorted by their superintendent that has one. The superintendent shall always be on-site with their subcontractors. The subcontractor shall always have their badge on or they will be removed from site until they do.

Access to Warehouse loading dock is available for unloading of material only Period of Performance shall not exceed 547 days after award.

The installation day/date shall be coordinated with the Contracting Officer Representative of Fargo.

Installation shall be performed during Normal Business Hours 8:00 A.M. – 4:30 P.M Monday - Friday excluding Federally Recognized Holidays. Any installation work performed outside of these hours shall be coordinated with the COR (Contracting Officer Representative) to ensure that VA staff are aware and available if needed for utility outages or overseeing installation activities in sensitive/restricted areas.

Contractor will give provide the COR at least a 21-day notice of all proposed shutdowns of electrical, steam, water, air handlers and any other equipment. Work shall be done on premium time (at no additional cost to the Government) where necessary to minimize impact to critical care and patient operations.

GC is responsible for notifying COR in advance of arrival and departure, providing review of all product and site conditions before signing off.

Trucks cannot be left unattended and must be removed from unloading area after unloading. All contractor vehicles are to be parked only in the designated “Contractor Parking” areas.

GC to coordinate staging location for VA approval.

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1.0 PROJECT REQUIREMENTS

The General Contractor must coordinate all phasing and sequencing with all trades and the owner. The GC must provide a written narrative to outline construction phasing and sequence plans, validating and elaborating on this phasing description. The GC shall also cooperate and work with the equipment and trailer vendor with commissioning, decommissioning and removing and installing equipment/trailer items to create an efficient phasing plan. The equipment and trailer shall integrate with the VA software Censitrac. And all testing listed in the Specification shall be performed and reports sent to the COR/AE via submittals.

Requirements

AAMI ST 108 (2023) – Water for the processing of medical devices (Attachment 1) As of last year, OHE (Office of Healthcare Engineering) has released supporting documents and released presentation (After ASHE) on how the Veteran Healthcare Administration (VHA) should approach the AAMI ST 108 standards. In general, the AAMI ST 108 supersedes AAMI TIR 34. If testing parameters are all out of range the GC will notify the VA as soon as possible, so the VA can notify the reusable medical equipment committee (RME), OHE, and Office of Sterile Processing (OSP) to assist with risk analysis, technical consultation to determine further action. This time (a minimum of 4 weeks) is accounted for between specific phases for testing. VA cannot occupy the new space unless these tests pass. GC shall use this standard in accordance with the drawings and specifications.

The only parameter excluded to meet this ST108 standard is alkalinity for steam tested as condensate.

According to VHA findings the standard for boiler water reaches from 400 – 800 ppm as CaCO2. These numbers shall be mitigated as much as possible but not required to meet the standard (additional detail in 1.c below).

Below are the OHE/HEFP recommended sections for the qualification process. These sections do not dictate the construction project; the GC must review the AAMI ST 108 standards against the procured trailer and the equipment being installed.

1. Referenced Sections and recommendation:

a. 8.4 – Installation and Operational qualifications: the contract drawings have the list of Steris equipment being installed, use this section for the required water quality and treatment needed.

b. 6 and 9 Performance qualifications: reference Tables in these sections. This Table 2 is ideal for the installation of the new equipment and the modification of the new RO system.

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c. 10 and 11 Testing: reference Tables 4, 5, and 6 as a minimum for improvement of water quality and steady state quality. Below is an example up to day 3 for consistent review of parameters.

i.

ii. Steam testing/monitoring – condensate should be sampled at the nearest safe location upstream of the point of use in SPS. (steam trap or filter). For example, the test could be at the sterilizer to demonstrate consistency with measurement at the Boiler plant.

iii. Guidance from HEFP/OHE (Healthcare Engineering Facility Programs) and OSP acknowledges that most VHA locations are unable to meet the extremely low alkalinity and conductivity parameter presented by ST108. Until ST 108 is revised with limits defined by plant steam guidance will follow:

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1.

2. The Fargo VA adjusts their chemical feed accordingly and have met the parameters during design except for alkalinity and conductivity.

Phase 1: RO Water System, HAC, Ante room, and Corridor Construction

Contractor shall start preparing the new mechanical room that will hold the new RO system.

This RO shall meet all the requirements needed to supply the new future equipment and trailer during the construction of the project.

The Contractor must comply with the VA requirements set forth in the Pre-Construction Risk Assessment (PCRA) and the Infection Control Risk Assessment (ICRA). The ICRA/PCRA assessment sheets must be displayed in each construction area. These

• Use of a Mobile ICRA Containment cart when doing work outside of ICRA/construction barrier locations

• Ceiling and Hot Work permits must be filled out as needed and posted on construction sites

• The RO Water System must meet the minimum compliance following AAMI ST108 standards o Tests shall be performed before the trailer and RO system is commissioned and sent to the COR for review. These test may come as a submittal If the test do not pass then the system will not be commissioned until it does.

▪ Qualification Testing Frequency minimum of 3 days. See VHA table below o See Attachment 2: AAMI ST108-2023 Water for the reprocessing of medical

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• The old RO Water system decommissioned, and removed at the end of Project completion

Phase 2: Site Preparation, SPD Trailer, SPD Enclosure Before the SPD mobile trailer arrives on-site the site preparation must be completed. Contractor shall coordinate and supply the SPD trailer and provide on-site VA Staff Training for the Fargo VA Health Care System (FVAHCS). The road must be closed off and safety measures must be taken before the trailer arrivals. A timeline shall be presented to the COR for the VA to take measures and coordinate any deliveries to the East Loading dock. The GC must provide a traffic/safety plan.

The Contractor shall abide to the design drawings and refer to the trailer specifications included in this contract. The attachments listed below is an example of an SPD Trailer that may be procured if the specifications fit.

The Contractor shall be responsible for commissioning, renting, decommissioning, and winterization of the SPD Trailer.

Salient Requirements:

The SPD Trailer must have these specifications for a complete and functional installation (Contractor to verify trailer meets design and specifications):

1. Trailer Dimensions

Trailer dimensions shall integrate to the provided drawings – the concrete pad and enclosure.

The dimensions should be roughly (Contractor to verify):

For Operational Envelop: ~75’ L x 30’ W x 15’ H

Trailer Overall: ~61’ L x 23’ W x 14’ H

Trailer: ~53’ L x 9’ W x 14’ H

2. Electrical Plan Requirements

500 kW Diesel Mobile Generator (Contractor – Rental)

500 KVA Pad-Mounted Transformer 23.9 KV Primary/480V Secondary (Contractor– Rental)

Trailer output: 480VAC, 3-phase, (2) 250 AMP

Configuration: 4 wire (L1, L2, L3, G)

Frequency: 60hz

Shoreline Cable

Provides earth grounding (NEC Article 250)

Power Requirements (Normal Power)

Contractor must read these requirements if the cold and cooling packages are required to accommodate these services

3. Cold Water Supply Requirements

4. Hot Water Supply Requirements

5. Wastewater

6. Fire Sprinkler –Wet System

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7. Heating and Cooling Connections / HVAC Condensate Drain Terminations

These connections need to comply to the trailer provided requirements and specifications

8. Water Quality:

Water requirements must meet the minimum AAMI ST108 water requirements. The hot, cold and RO water supplied by the VA must be tested if it meets these requirements. The Contractor must read the water requirements of the trailer.

9. Telephone and Data Connections

Network CAT6 interface

Must utilize VA IT approved software to be compatible with VA software Censitrac

The trailer must have at most 2 unmanaged IT switches dedicated to the vendor and VA equipment

Customer must extend their IT network to the Mobile SPD for their IT provided equipment.

Coordinate with the VA if computers, phones or printers are not provided

10. Fire Alarm Connection

Trailer is provided with pre-installed conventional analogy fire alarm system

11. Unit Anchoring / Tie Downs

Must be able to anchor and tie down.

12. Service Clearance & Road Plates:

The trailer will need a minimum of 70’x30’ area for landing and service clearance when deployed.

Road plates if necessarily needed for weight distribution

13. COLD WEATHER INSULATION PACKAGE

Some trailers require a cold weather insulation package for their trailer. This must be purchased with the trailer unless optional and the Contractor will provide additional information to protect the trailer’s utility under these conditions

14. ANCILARY COOLING PACKAGE FACILITY REQUIREMENT

See comments for Cold Weather

15. TRAILER SPS EQUIPMENT

Should include the minimum below. Coordinate with vendor and SPS department for needs.

a. 3 bay sink

b. Sonic irrigator

c. 2 washers

d. 4 work stations

e. 1 low temp starilization system

f. 2 medium sterilizers

g. 4 loading carts

h. Hand wash with eye wash

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Phase 3: INSTALLATION All work and tests should be completed and verified for the SPD trailer before working in the SPS space.

1. Demolition/removal of existing equipment to include off-site disposal.

2. GC must coordinate with the equipment vendor to have the equipment disconnected before construction starts.

3. Remove old hookups and install new ones. General Contractor shall provide final connections for the equipment vendor to install the new equipment. The new equipment will be VA procured and stored on-site the facility until needed for installation.

a. (2) 3 bay sinks

b. (2) medium steam sterilizers

c. (2) small steam sterilizers

d. Rack return

e. (2) Washer/disinfectors

• (2) Load/unload conveyors

• (2) Chemical holders

f. (1) air management system

g. (2) pass-through window

h. (2) pass-thru endoscope reprocessing

i. (2) Sonic irrigators

j. (1) Ultrasonic cleaners

k. (1) Astra Tee Probe

• Installation Requirements and additional general contractor requirements. Completion of the installation requirement will require the following minimal tasks:

1. The Fargo VAHCS will not provide equipment, tools or labor to assist in deliveries. All necessary equipment and manpower must be included in quote.

2. The Fargo VAHCS will not provide on-site storage for equipment requirements for the Fargo project unless negotiated in the best interest of the VA. Necessary storage must be included in proposal.

3. Deliveries must be scheduled through the COR before installation.

4. The contractor shall provide an installation schedule to the COR for review and approval prior to starting any work on-site at the facility. Once the COR has reviewed and approved the install schedule, the contractor must arrange equipment delivery to the installation site location in accordance with the Installation Schedule.

5. The contractor is responsible to visit the site, complete an on-site “walk-through” of the facility and review the logistics of equipment delivery and installation to ensure sufficient clearance for movement and installation of all equipment and materials.

6. For the entire duration of the project, the functional operation of SPS services must not be interrupted. The staff must be fully integrated and established into the SPD trailer before work starts.

7. During both removal of machines and installation and the Contractor shall follow the requirements of the (PCRA) Pre-construction Risk Assessment and (ICRA) Infection Control Risk Assessment as directed by the Government – see attached sample of ICRA/PCRA requirements.

The Contractor shall provide required containment walls to enclose the worksite. This will require hard walls, no plastic sheeting. Equipment such as negative air machines and HEPA filtration will be required to limit contamination and prevent dust/debris from migrating out of the work-site containment area into clean areas.

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8. Complete installation of SPS equipment in accordance with Government approved manufacturer specific drawings and specifications. Any missing or damaged products must be replaced IMMEDIATELY.

9. The installation shall be reviewed and approved by the sterilizer manufacturer representative to ensure that proper access is provided to all required maintenance/service areas of the equipment as per manufacturers requirements. Any variations from manufacturers documented requirements shall be noted and discussed with VA Contracting Officer Representative prior to proceeding with installation.

10. Contractor is responsible for ensuring that the equipment are mated to building utilities and are fully functional and all SPS equipment load data is flowing into Censitrac for VA final acceptance. Manufacturers complete start-up and testing reports for all functions shall be completed and provided to the VA for final acceptance. Testing results shall be submitted to SPS Chief, COR and Biomed.

11. The contractor will be responsible for any damage to the building which occurs during delivery and installation. It is incumbent upon the successful contractor to identify any existing damage to the building by means of a pre-installation and delivery walk thru.

12. The contractor shall clean up and dispose of waste materials or rubbish in accordance with this paragraph and all applicable federal, state, and local regulations, standards, codes and laws. The contractor shall keep the job site, including staging and storage areas used by the contractor, free from accumulations of waste material or rubbish. Prior to completion of the work, the contractor shall remove from the vicinity of the work all shipping containers, packing, rubbish, unused materials, and other like material, belonging to the contractor or used under the contractor’s direction.

13. The Contractor will be responsible for obtaining all necessary permits.

14. Provide on-site management, coordination and technical assistance by a project manager working with the Government representative throughout the installation phase. All on-site installation personnel shall meet the following VA Mandatory Safety Training Requirements:

a. Prior to commencing work, general contractor shall provide proof that an OSHA certified “Competent Person” (CP) (29 CFR 1926.20(b)(2) will maintain a presence at the work site whenever the general or subcontractors are present. The OSHA certified CP shall have the 30-hour OSHA certified Construction Safety course and/or other relevant competency training, as determined by VA COR with input from the Construction Safety Committee. A copy of 30-hour OSHA card for CP to shall be provided to the VA COR if requested.

b. All employees of general contractor or subcontractors shall have the 10-hour OSHA certified Construction Safety course and/or other relevant competency training, as determined by VA COR with input from the Construction Safety Committee. Provide copy of 10-hour OSHA card for CP to VA COR if requested.

15. Additional VA requirements for Construction Safety and protection of the VA facility require that all contractors obtain the proper permits from the VA Engineering Office PRIOR to undertaking the following construction/work activities:

a. All welding, brazing, metal cutting (by torch or grinding), and any activity that will use an open flame or produce sparks etc. requires the contractor to be issued a Hot Work Permit for the day that the work will be taking place.

b. Any work that will take place above the lay-in-tile (L.I.T.) ceiling requires the contractor to be issued an Above Ceiling Work Permit for the day that the work will be taking place.

16. The contractor will be responsible for confining its crew and work to the designated project areas.

The contractor will also be responsible for ensuring that the installation personnel are identifiable. Temporary VA badges will be provided by VA Engineering Office and are required

P a g e 10 | 10 to be worn by all Contractors and Sub-contractors while on VA Campus. Contractor Badges are available at VA Engineering Office Room BD-50 phone extension 3361.

17. Contractor staff will be entering both Sterile processing and non-sterilizing areas. Staff will be required to know and adhere to gowning and removal of gowns per VA requirements.

18. Upon completion of sterilizer installation, the Contractor shall provide a complete set of As-Built Documentation to meet the following requirements:

a. Drawings: The Offeror shall submit a set of as-built drawings in electronic format (that is compatible with AutoCAD) and in hard copy format with any changes noted on the plans that were made during the construction activities. This shall include new sterilizer and equipment installation, differing site conditions, piping modifications for water and steam, ductwork modifications, piping or ductwork size issues, rerouted utilities, etc.

b. Sterilizer Manufacturer Final Start-Up and Inspection Report – the contractor shall provide both hard copy and electronic copies (in PDF format) of the Manufacturers completed Final Start-up and Inspection Report to the VA COR.

c. Digital Photographs – photographs, both hardcopy and electronic (jpeg or other VA approved electronic/digital picture format) of the before and after conditions shall be provided and clearly labeled.

d. Electronic documents shall be submitted on DVD-ROM or CD-ROM disks as approved by the VA COR.

e. All helpdesk or (technical support) contact information shall be provided to Bio-Med.

At the competition of the project the Vendor shall provide the Bio-Med Chief with:

i. All service-related documentation (etc. Manuals, CD’s)

ii. URL’s for service ticket review.

iii. Contact Phone Numbers for service requests.

iv. Information on Submitting Service tickets.

• Installation must be performed by licensed and bonded installers and all installation personnel shall have completed OSHA 30-hour or 10-hour training as required and have documentation of training.

• Upon the completion of each step in the installation process the VA’s corresponding trade professional shall inspect and give approval to continue.

No person, including the COR or any other VA personnel are authorized to request additional work be performed by the contractor. Any additional services performed that are not authorized by the contracting officer will be considered inclusive.

Training - SPS Equipment users

The equipment vendor and trailer vendor shall provide a minimum of one day (8 hours) hands-on sterilizer equipment user training on-site at the Fargo VA for VA SPS staff. Provide two (2) printed copies of user training manuals and one copy in electronic format. Training date to be scheduled with the VA COR. The warranty period shall not start until on-site training is to be completed.

Training – VA Bio-med Equipment service

The equipment vendor shall provide off-site training equivalent to manufacturer training for 2 (two) Bio-Med staff. Provide a minimum of 2 (two) service/maintenance training manuals. One printed copy and 1 in electronic format.

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SAFETY REQUIREMENTS

1. The contractor shall be responsible for providing barricades and barrier tape, as required, to control unauthorized entry to the work areas, as well as maintaining a safe working area adjacent to the actual work area.

2. The contractor shall comply with VA and U.S. Occupational Safety & Health Administration (OSHA) safety and security measures, the lock- out-tag-out program, and special work permits. The contractor is also required to coordinate with the COR to gain access to the specific work areas.

3. All Contractors and Subcontractors performing services for the Government shall comply with all OSHA, State, County and Municipal Safety and Occupational Health Standards and any other applicable rules and regulations. All Contractors and Subcontractors shall be held responsible for the safety of their employees and any unsafe acts or conditions that may cause injury or damage to any persons or property within and around the work site area under this contract.

4. Any person entering the FARGO VA Health Care System shall adhere to the facility COVID compliance requirements. These requirements may change as necessary. Any person not adhering to the requirements will not be allowed to remain on the VA campus.

5. Contractor shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract.

6. General Security/Privacy Clause - 839.201 Contract clause for Information and Information Technology Security: Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

RISK CONTROL

Contractor shall take all measures for safety & infection control and provide all material necessary for protecting existing equipment and property in affected areas of construction against dust and debris, so that equipment and affected areas to be used in the Medical Centers operations will not be hindered.

2.0 DELIVERY

DELIVERY

1. Delivery [FOB Destination], (all shipping and handling charges shall be paid by the contractor) installation/configuration of all solutions must by managed (completed/coordinated) during normal facility operating hours (between 8:00am and 4:00pm) to ensure timely government occupancy and smooth facility operations. If these times differ, then the Contractor will notify the COR for any alternative timelines. Responsibility and liability for loss or damage shall remain with the contractor until final inspection and acceptance by the customer agency. Contractor shall verify that the new equipment will fit in the existing sterilizer space. Contractor shall verify that route (to move new equipment inside the VA facility) will provide adequate clearance in corridors and through doorways.

If the contractor requires any extra work to make route accessible or provide additional clearance for equipment, this shall be provided at no additional cost to the VA.

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a. Delivery Address:

Department of Veterans Affairs, Fargo VAHCS 2101 N. Elm St Fargo, ND 58102

VA Project Manager. The contractor will coordinate all deliveries and installation with the Contracting Officer Representative Rooney Villegas 701-232-3241 x3518 rooney.villegas@va.gov

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