36C26225Q1086 0001.docx

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Contract Specialist Hestia Sim Hestia.Sim@va.gov

PLACE OF PERFORMANCE

VA San Diego Healthcare System

Sterile Processing Service

3350 La Jolla Village Drive

San Diego CA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

The Amendment 0001 against RFQ/Solicitation# 36C26225Q1086 is issued to

i. Update the requesting line items (CLINs) – refer to section A.1 Price/Cost Schedule on page 4 – 5. Changes are highlighted.

ii. Update the Statement of Work – refer to section A.3 Statement of Work on page 6 – 11. Changes are highlighted.

iii. Extend the offer due date through 7/11/2025 10am pacific local time.

All other terms and conditions remain unchanged.

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Getinge Triton 72 Floor Model Ultrasonic Cleaning System or equivalent Ultrasonic Cleaner with large capacity to reprocess complex surgical instruments trays IF EQUAL TO, PLEASE PROVIDE BRAND NAME _____________ & MODEL NUMBER _____________

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

Getinge 1100 Ultrasonic Cleaning or equivalent Compact Tabletop Ultrasonic Cleaner IF EQUAL TO, PLEASE PROVIDE BRAND NAME _____________ & MODEL NUMBER _____________

Getinge Ultrasonic Cleaner 2460C or equivalent Single-Tank Ultrasonic Cleaner IF EQUAL TO, PLEASE PROVIDE BRAND NAME _____________ & MODEL NUMBER _____________

Seismic Anchoring

Installation and Training

De-installation and dispose of total five old equipment PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

A.2 DELIVERY SCHEDULE

2.00

1.00

1.00

4.00

1.00

1.00

A.3 STATEMENT OF WORK

1. GENERAL

The Department of Veterans Affairs (VA), Network Contracting Office 22, requires Sterile Processing Equipment for the Sterile Processing Services (SPS) at the Jennifer Moreno VA Medical Center located in San Diego, California.

2. BACKGROUND

The VA San Diego Healthcare System (VASDHCS) requires the procurement and installation of (2) large-capacity floor-model ultrasonic cleaners.

VASDHCS requires a Contractor to provide the SPS equipment specified in this statement of work and coordinate efforts with SPS staff and contracting personnel to ensure equipment is installed and functional.

The Contractor shall provide all labor, materials, equipment, transportation, installation, and supervision necessary to satisfy the requirement.

3. GENERAL REQUIREMENTS

PLACE OF PERFORMANCE:

VA San Diego Healthcare System 3350 La Jolla Village Drive, San Diego, CA 92161 Bldg 1, Sterile Processing Service Decon, Rm B191K

DELIVERABLES:

The Contractor shall provide the following:

NOTE: Potential offers must be aware that the items being acquired are procured as Brand Name or Equal. For those items that are “or equal”, a description of the salient characteristics is outlined below. The FAR Clause 52.211-6 Brand Name or Equal applies to this acquisition. Offeror quotations must demonstrate meeting the salient physical, and functional characteristics included in this solicitation, otherwise, they will be considered non-responsive and not considered for award.

No remanufactures or gray market items will be acceptable. Vendor shall be an Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor or authorized reseller verified by an authorization letter or other documents from the OEM signed. The letter must either state specific product(s) quoted or that the quoter is an authorized distributor for all the manufacturer’s products. This letter must be on the manufacturer’s letterhead and contain the signature of an authorized official for the manufacturer.

SALIENT CHARACTERISTICS – Large Capacity Ultrasonic Cleaner equivalent to Getinge Triton 72

· Must have a minimum of 30-gallon capacity per basin.

· Must have a minimum of 2 basins per unit to ensure uninterrupted operations. In the event of on basin requires maintenance or repair, this shall allow SPS continue to use the other basin to avoid operational downtime.

· Must have a minimum of 8 to 13 minutes ultrasonic cleaning cycles for laparoscopic and non-lumen instruments.

· Must have Ultrasonic cavitation cycle designed for removal of blood and debris from lumened instruments.

· Must be able to clean robotic instruments such as da Vinci SP and DV5 in accordance with Intuitive Surgical’ s Instructions for Use (IFU). This cleaning function must be a minimum of 15-minutes.

· Must be able to clean a minimum of 40 da Vinci Robotic Instruments in one cycle.

· Must have a minimum of 72 dedicated irrigation ports due to high-volume operational demands.

· Must have a minimum of 12 ports/tray.

· Must be able to process a minimum of 10 robotic or lumen instruments.

· Must be able to cleanse up to a minimum of 4 lumen/standard instrument trays simultaneously, split equally independently per operable basins.

· Must have a minimum of 30” pull-down sprayer faucet for external rinsing of instruments.

· Must have an automatic powered lid opening and load tray elevator.

· Must have slide and lock mechanism for loading of trays.

· Must have a minimum of 6-tray capacity to meet high-volume operational demands.

· Must be able to support a minimum of total 80-lb instrument weight capacity, a minimum of 40lbs each basin per cycle. The SPS handles a high volume of reusable medical devices (UMDs) that require reprocessing on a daily basis. This will accommodate the large quantity of instruments processed each cycle and allow SPS to load as many UMDs as possible, thereby reducing the total number of processing cycle required.

· Electrical voltage must be 208-volt wall receptacle.

· Unit dimension must not exceed 33-3/8″W x 49-11/16″D x 67-1/2″H at rest, open position due to limited staging/operating space. Equipment exceeding this dimension cannot be accommodate at the facility due to space constraints.

· Must include a rotating and adjustable screen display to allow users of varying height to easily view pertinent operating information during use.

· Must have fully automatic wash, flush, internal wash, external wash, air purge cycles, and drain.

· Must have Tap water compatible.

· Must have an automatic lifts and slide-lock trays.

· Must not have degassing for optimal cleaning process as degassing may interrupt or delay the cavitation process critical to effective ultrasonic cleaning.

· Must come with seismic anchoring.

SALIENT CHARACTERISTICS – Compact Countertop Ultrasonic Cleaner 1100

· Must offer adjustable cycle time up to 10-minutes; allowing users to comply with different instrument manufacturer’s IFU.

· Must be able to process both lumen and non-lumen instruments in the same cycle simultaneously.

· Must have a minimum of 12.5-lb total instrument weight capacity

· Must be equipped with 8 piezoelectric bonded transducers to ensure sensing heat level meets the minimum temperature to break bioburden in the RMD instruments.

· Must have adjustable irrigation allowing users to control water flow for multiple instrument types

· Must have a minimum of 12 dedicated irrigation ports for lumen instrument cleaning.

· Must works with or without irrigation.

· Must have graphical touchscreen display with programmable timer.

· Must have a Bi-fold lid allowing placement beneath overhead cabinets.

· Must have a minimum of 2 shelves for supplies

· Must have automatic fill, wash, and drain functions.

· Must have automatic degas

· Must be tap, reverse osmosis, and deionized water compatible.

· Must have a minimum of 5.75-gallon basin capacity.

· Must have 120-volt wall receptacle.

· Must not exceed overall dimension of 32-1/2”W x 18-3/4”D x 17-9/16”H (lid open) due to limited space.

· Must accept hospital trays without irrigation.

· Must come with seismic anchoring.

SALIENT CHARACTERISTICS – Single-Tank Floor-Mounted UC 2460

· Must have hands-free starting and stopping of cycle.

· Must have powered load tray elevator with safe lifting capacity of up to 35 lbs.

· Must have free moving lid that automatically closes and opens with tray elevator action; lid must not be fixed but moves freely and is automatically operated in conjunction with the tray elevator.

· Must be stainless steel construction of exterior panels and sonic cleaning chamber for durability, ease of cleaning, and resistance to corrosion.

· Must include a common operating control for start/stop functions, drain and system alarm accessible via the external back display panel due to the separation of clean and dirty sides of Sterile Processing. The start/stop function is needed on the back panel, which is on the dirty side. Any draining need to happen on the decontamination area and the employees need to be able to control those functions.

· Programming buttons, controls for process time, detergent dispensing must be located within the unit to help safeguard unauthorized changes to the program parameters.

· Must have a minimum of 5” external back panel as a splash guard to prevent process water from getting onto the wall.

· Must have marine edges to keep process water from spilling onto the floor as trays are removed from the unit.

· Must include a hinged cover designed to minimize the overhead clearance required for chamber access.

· The cover must fold or lay flat against the machine’s surface to prevent processing water from splashing outside the unit.

· Lid must be double pan construction with insulation between pans. Due to the strength/hazard of the detergents used to break down and clean any bioburden on the instrument trays, the equipment must have a safety mechanism to help contain the detergent and not easily breakdown the glass plan that separates the clean and dirty sides.

· Must have automatic detergent fill; allowing users to press ‘start’ to press cycle so the system detects how much detergent is needed for the process.

· Must have a low liquid level sensor to assure the heaters are covered with water.

· Must have a high liquid level sensor provided to assure proper liquid level depth for ultrasonic cleaning.

· Must have built-in overflow protection to drain basin.

· Must have automatic cycle start and stop.

· Must have an audible cycle alarm to signal the start/end of a cycle

· Must have automatic cycle timers to allow specific instrument trays to complete a cycle.

· Must have a thermostat that automatically controls heater and maintains tank solution at pre-set temperature.

· Must have a controller that automatically dispenses pre-set amount of sonic detergent into the water as the tank fills.

· Must have low detergent indicator display.

· Must have automatic drain function.

· Safety door interlock to cut power when access door is opened, causing the elevator to lower, lid to close, and unit to drain

· Dimensions must not exceed 33 1/2 “ L x 27 ½” W x 41”H due to limited space.

· Chamber overall dimension must be a minimum of 13” x 15” x 27”.

· Must be able to clean and disinfect with hospital grade disinfectants.

· Must meet electrical supply of 220 1-ph 50-60hz, 6.2 full load amps.

· Must include manual and motorized position locking capabilities.

· Must have a minimum of 62.5-Liter Capacity.

· Must come with Seismic anchoring.

4. IMPLEMENTATION AND INSTALLATION

Installation and validation shall be included in the procurement cost and shall include but not limited to:

· Assembly of devices and validation

· All materials required to assemble the ultrasonic shall be provided by the contractor

· The contractor will deliver ultrasonic cleaning systems and accessories to:

3350 La Jolla Village Dr, San Diego, CA 92161-0002, BLDG 1, Room B191K

· Installation must occur during normal working hours: Monday through Friday 8:00am – 3:00pm.

5. TRAINING

The contractor shall provide onsite training for all MWV VAMC staff that requires training. Training shall be set up between SPS educator and contractor on a mutually agreed upon time and date.

6. DELIVERY

· The contractor shall deliver necessary equipment to the San Diego VA Medical Center facility as required in the quantities specified above.

· The contractor must give VAMC staff 3 weeks’ notice of shipment and delivery of the ultrasonic and accessories.

· The contractor shall coordinate all deliveries, installation, and parking arrangements with the program office manager.

· Delivered materials will arrive in manufacturer’s original sealed containers with the associated purchase order number listed on the outside of the box.

· The contractor shall conduct a joint inspection with the program office manager upon delivery of the equipment and shall provide the program office manager a list of missing or damaged items found upon inspection.

· The contractor shall remove all related shipping debris and packing from the VAMC facilities.

· Delivery Address:

3350 La Jolla Village Dr, San Diego, CA 92161-0002, BLDG 1, West Dock

7. INSPECTION AND ACCEPTANCE

· The contractor shall conduct a joint inspection with the program office manager upon delivery of equipment.

· The contractor shall provide the VA program office manager a list of missing and /or damaged items found upon inspection and have those items replaced at no cost to the Government.

· The program office manager shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the VA Contracting Officer.

8. DELIVERABLES

· Operation and Maintenance Manuals

· Deliver compilation of all manufacturers recommended maintenance schedules and operation materials packaged upon delivery. Manuals shall be made available in an electronic format.

· The contractor shall deliver and install the system with all specified salient characteristics. Only new equipment will be accepted.

· The contractor shall provide shipping, transport, installation, and all equipment necessary to meet the requirements and capabilities.

· The assembly and validation of the system must be performed by the technician who are either Original Equipment Manufacturer (OEM) certified or has been formally trained and approved by OEM.

· The contractor is responsible for identifying any missing parts or components not included in the order for the ultrasonic systems to be successfully installed and validated to their full potential and full function listed under the Statement of Work.

9. OPERATOR TRAINING

· Onsite education and training by a vendor service trained representative will be provided to MWV clinical staff, facilities and engineering staff, and the biomedical engineering staff. The scheduling of operator training shall be coordinated with the MWV clinical staff after delivery and installation.

10. PROTECTION OF PROPERTY

· The contractor shall protect all items from damage. The contractor shall take precaution against damage to the building(s), grounds and furnishings.

· The contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.

11. SECURITY REQUIREMENTS

· The contractor must have a photo ID available when performing work at the VA Medical Center and be willing to present it to VA staff.

· The contractor is responsible for providing any personal protective equipment (PPE) that is deemed necessary to complete tasks stated in this requirement.

12. WARRANTY

· At a minimum the ultrasonic cleaning systems must include a 1-year warranty on all parts and labor at no cost to the Government.

· The warranty shall begin upon completion of validation testing and approved by the program office manager.

· Warranty shall include on-site repairs and over-the-phone support.

· Contractor shall provide routine maintenance service program during warranty period. Routine maintenance includes daily, weekly, and monthly maintenance.

· Warranty and routine maintenance shall include contractor’s responsibility of draining and cleaning of basin, cleaning of the external surfaces, inspecting electrical connections, cleaning water level sensors, cleaning filter screens, checking and replacing drain screen, checking all plumbing connections, and checking peristaltic pump and tubing for cracks or leaks.

· All repairs shall be performed by the OEM or contractors that have been certified and approved by the OEM to perform the repairs.

· The warranty shall include all travel and shipping costs associated with any warranty repair.

Page 1 of

Amendment to a Previous Combined Solicitation