Brand Name Justification - Washer Disinfector Signed.pdf

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

Revision: 01 Effective Date: 11/15/2024 Page 1 of 3 Acquisition ID#: 36C344 25 AP 0959

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106 1 For

Over Micro Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C244 25 AP 0959

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Network Contracting Office (NCO) 4 in support of VA Wilkes Barre Medical Center, 1111 East End Blvd, Wilkes Barre PA 18711, supported

by. Purchase Request # 693 25 1 179 0002.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: VA Wilkes Barre Medical Center has a brand name requirement for the purchase of one (1) additional Getinge Washer Disinfectors Model S 86682003 & 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. The current washer/disinfector in place is being replaced with a Getinge Brand same model. This additional washer must be identical to the replacement for conformity of systems. Any non functioning sterile processing equipment will result in an adverse impact to operations and patient care.

Total estimated Price of this procurement is $102,857.86.

The procurement package must include the following:

Product # Description Qty

8DHSEBFNNBSUNNN WASHER DISINFECTOR S-8668 1

CONNKIT0001 UTILITY CONNECTION PCK, .50 3

6036000012 POWERCON TRIPLE ENZYME, 3X5L 1

6036000011 POWERCON NEUTRAL, 3X5L 1

6036000013 INSTRUMENT LUBRICANT PLUS, 3X5L 1

6002123402 KIT CONDENSATE COOLING 86BPLC 1

6001000501 WASH CART 3-LEVELS ASSY 3

6020720171 LOADING TROLLEY 4

ZSUS-CTRIM-1-20 CUSTOM TRIM 1 MAX 5IN TRIM 20 FEET MAX 7

MP224 KIT FOR ALARM FOR 9100 & 9027 1

ZSUS6613-IR-8666 INSTALL/REMOVE 86-SERIES WASHER 1

ZSUSDISPOSAL-1PC DISPOSAL PER PIECE 1 1

ZSUSFINAL-CONN-LV1 FINAL CONENCTIONS LEVEL 1 1

ZSUSINSTAL-WKD-

XHR WEEKEND/AFTERHOURS (PER PIECE)

Revision: 01 Effective Date: 11/15/2024 Page 2 of 3 Acquisition ID#: 36C344 25 AP 0959

J60016 T-DOC PLUS SLA DL 1

TDCY26 DATA LOG GETINGE G1 WASHER 1

TDCY32 PROCESS DATA EXPORT MODULE 1

ZSUSLUA-I-NETCOM NETCOM INSTALLATION, 3 HOURS 1

ZSUSTDOCINSTALL T-DOC INSTALLATION PER HOUR 1

ZSUSONLINEINST10 GETINGE ONLINE INSTALLATION 1-30 UNITS 1

ZSUSONLINEPREM10 GETINE ONLINE SUBSCRIPTION 1

Equipment Requirements:

a. Wilkes Barre VA Medical Center 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:

Revision: 01 Effective Date: 11/15/2024 Page 3 of 3 Acquisition ID#: 36C344 25 AP 0959

VISN 4 has a contract (#36F79721D0237; 36C24422AO042) period 9 20 2022 through 9 19 2027; in support of Preventive Maintenance and repair for Getinge Washer/Disinfector.

SPS is requesting this additional washer disinfectors with the Getinge Washer Disinfectors Model S 86682003 & Accessories. This will ensure a more seamless transition with this process and conformity of system. The equipment must conform with the existing Getinge model in place without major 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.

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.

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.

Benjamin Villasenor Date Contracting Officer