S02 Single Source Justification Getinge Washer 8666_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For SPS Getinge Washer-Disinfectors & Accessories Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C244-24-AP-2326

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Network Contracting Office (NCO) 4 in support of VA Pittsburgh Healthcare System, University Drive C., Pittsburgh, PA 15240, supported

by. Purchase Request # 646-24-1-233-0168.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: VA Pittsburgh Healthcare System has a brand name requirement for the purchase of two (2) Getinge Washer-Disinfectors Model S-8666 & Accessories. The intent of this contract is to procure and fulfill necessary washer-disinfectors for the Sterile Processing Services (SPS) department which will conform to standardization of equipment based on the condition of the current equipment. Current equipment is end-of-life and requires immediate attention to ensure the absolute and seamless operability of the SPS department. Any non-functioning sterile processing equipment will result in an adverse impact to operations and patient care. Total Price of this procurement is .

The procurement package must include the following:

Item # Description/Part Number* Qty

S-86662003 WASHER DISINFECTOR (Description: Washer disinfector S-8666 double)

XZWA000528 STEAM HEATING 2

XZWA000538 DRAIN COOLING 2

XZWA000530 BOOSTER TANK 2

XZWA000531 DEIONIZED WATER 2

XZWA000703 AIR BARRIER 86 2

XZWA000554 ADJUSTIBLE AUDIBLE ALARM 2

XZWA000571 DETERGENT CONTAINER SET 2

XZWA000535 DETERGENT PUMP 3 FC 2

XZWA000540 PRINTER 2

XZWA000541 USB STORAGE 2

ZSUSONLINEINST10 Getinge Online Installation 1-30 units 2

CONNKIT0001 UTILITY CONNECTION PKG, .50 6

6002123402 Description: KIT CONDENSATE COOLING 86BPLC Description: 86 SERIES

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503300700

WASH CART 4-LEVELS 8666 Description: 4-Level Wash Cart, 8666, with removable shelves and spray arms, integrated spray arm blocking plates and prepared for up to six connections for cannula instruments

Equipment Requirements:

a. VA Pittsburgh washer procurement for SPS must have the capabilities to achieve intermediate level thermal disinfection as defined by the FDA Guidance Document for Washer Disinfectors (CDRH Feb 7TH 2002) using 194 degrees Fahrenheit for a minute.

b. Washer-disinfector that our Sterile processing Service is attempting to procure must offer a wash program of 30 min that was validated to meet ISO 15883-5 Annex N Cleaning Requirements.

c. SPS would like the washer disinfector to offer a wash rack size equal to 25.5” X 31.5” and have a control system to use exclusive BPLC software system.

d. Unique characteristics of the washer should offer traps, filters, spray arms and spray arm tips within the washer which can be removable by hand.

e. The washer must also be equipped with shelves for all wash racks, which are adjustable without tools.; and instrument trays must rest fully on the wash rack without any protrusion over the wash rack measurements.

f. The spray arms for the wash rack must be able to be removable by hand, no tools necessary for easy cleaning.

g. The model selected must also allow for monitoring and recording of all cycle performance data and can be viewed remotely utilizing Getinge Online. The washer-disinfector must have the ability to communicate and export information to previously procured third party instrument tracking systems.

h. Features such as a heat exchanger that pre-heats the drying air and serves as a condenser for the outgoing air are also unique requirements for our facility. With this option included, it will allow for energy-savings which means shorter drying times and reduced energy consumption. Integral process monitoring system that monitors key cycle parameters and integral machine functions alerting the operator to any deviations or issues with any of the parameters. Visual error code should also be present with the model procured.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

SPS is requesting to replace the current end of life washer-disinfectors with the same Getinge Washer-Disinfectors Model S-8666 & Accessories. This will ensure a more seamless transition with this process. The current cart washer that we have is compatible with Getinge Washer-Disinfectors

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Model S-8666 as well as consumables, printer paper, detergent and lubricants already approved and purchased for use at VA Pittsburgh Healthcare System.

The equipment must fit the existing space without modifications to the facility. This is due to negative cost changes related to form, fit and function of the equipment, which would also include design and installation changes to utility, power, and physical barriers of the existing space.

In addition, staff is already familiar with the menus and features for the current products in use. The Getinge Washer-Disinfectors Model S-8666 has cycles for specialized instrumentation. Staff have already been trained on these cycles. Introducing a different washer/different product would mean that staff would have to learn different machine cycles and functions, and several new SOPs (Standard Operating Procedures) would be needed. Having 2 different methodologies resulting from different brand machines in this area can lead to confusion and mistakes made by the staff.

4. Description of market research conducted and results or statement why it was not conducted:

The Original Equipment Manufacturer (OEM), Getinge USA Sales, LLC, confirmed that it sells directly to the Government as well as through its sole authorized distributor, TrillaMed LLC. Getinge USA Sales, LLC offers some but not all the required equipment on its VA Federal Supply Schedule 36F79721D0237. Getinge USA Sales, LLC is a large business and TrillaMed LLC is a Service-Disabled Veteran-Owned Small Business.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

ANDREA

BUCKLEY

Digitally signed by

ANDREA BUCKLEY

Date: 2024.04.03 13:53:12 -04'00'