S02 Brand Name Justification - GETINGE Steam Sterilizer_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C244-24-AP-2075

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Officer 4 (NCO 4), supporting Butler Health Care System, Abie Abraham VA Health Care Clinic (HCC), 353 N. Duffy Rd, Butler, PA 16001. Purchase Request #: 529-24-2-107-000.

2. Nature and/or Description of the Action Being Processed: This procurement is for Getinge Steam Sterilizers and Accessories in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The action will be awarded as a new firm fixed price contract.

The Butler Health Care System has a requirement to purchase two (2) GSS67N Getinge Steam Sterilizers (51” deep) as a Name Brand procurement. This acquisition will include the Sterilizers, Racks and Trollies, Air Compressors, Installation, Removal and Disposal, along with Stainless Steel Trim. This request also includes the deinstallation of two current Getinge Sterilizers that are beyond end-of-life and the installation of all new sterilization equipment. The end-of-life sterilizerswere installed in approximately 2016 with the building construction of the Health Care Center.

This equipment is needed to sterilize Reusable Medical Equipment (RME) while meeting AAMI (Accredited Standards Development Organization by the National Standards Institute) guidelines with a capacity of 12 trays and is fully programmable cycles to comply with instrument manufacturer processing requirements.

The Vendor will work in collaboration with the Sterile Processing Service (SPS) Department, as noted in the Statement of Need.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Quantity Part Number Description 1 6028457770 Steam Sterilizer 67N131A 1 6028457772 Steam Sterilizer 67N131A 2 CONNKIT0002 Utility Connection Pkg, .75 2 TDCY24 Data Log Getinge G1 Sterilizer 2 TDCY32 Process Data Export Module 4 ZSUSTDOCINSTALL T-DOC Installation per hour 2 ZSUSLUA-I- NETCOM NetCOM Installation, 3 hours 2 J60016 T-DOC Plus SLA DL 4 564603470 Shelf Rack 8 564604470 Pair of Shelves 4 6020720674 Loading Trolley

Effective Date: 02/01/2022 Page 2 of 4

2 564600470 Rails for Shelf Rack 66/67x13

2 P0010301 CPRSR, AIR, 2.0HP, 5.0CFM, AT 100P

2 ZSUS15626-IR- GSS67 Install/Remove GSS67 Sterilizer 2 ZSUSINSTAL-WKD- XHR Weekend/Afterhours (per piece) 2 ZSUSDISPOSAL- 1PC Disposal per piece 1 2 ZSUSFINAL-CONN- LV1 Final Connections Level 1 3 ZSUS-CTRIM-1-20 Custom Trim Max 5in Trim 20 Feet Max

The total estimated value of the acquisition is .

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The SPS department at VA Butler Health Care System currently has 2 Getinge high-capacity steam sterilizers that are beyond economical repair due to the age of the equipment. Based on the dimension and size of the area that the current Getinge sterilizers sit, the exact size and diminsion sterilizer must be procured to replace the current sterilizers to avoid any delays and hardship to patient care. With the space that the two (2) new GSS67N Getinge Steam Sterilizers (51” deep) will be installed in; will require no structure changes. Market research was conducted for Sterile Processing Services Steam Sterilizers.

Five companies were found. Three of the companies researched Consolidated Sterilizer Systems, BMT USA and Heidolph Tuttnauer all specialized in Laboratory sterilization, not Reusable Medical Devices utilized on Veterans. An informal quote was received from Steris, but their Sterilizers will not fit into the current space. Major structural changes would be needed to the two rooms that support Sterile Processing Servcies and the Prep-Assembly room if Steris Steam Sterilizers were purchased.

In the interest of Economy and Efficiency it would not be in the Government’s best interest to award to a different contractor, which would require structural changes to the location of the current sterlizers. For a new contractor to be able to provide the required equipment, they would need to furnish different vendor equipment and major construction would be required to have the equipment fit into the area needed. The process would be both timely and costly to the Government.

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Accordingly, Getinge GSS67N Steam Sterilizers is the only brand capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The Contracting Officer posted a synopsis of the proposed contract action, advising industry of the pending acquisition and soliciting inquiries from interested parties.

Additionally, the CO intends to post the to SAM.gov for public response from vendors that at are able to provide this brand of equipment as well as post a copy of the Brand Name Justification.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The anticipated cost will be considered fair and reasonable based on the fact that the solicitation will be competed by posting on SAM.gov for public response from vendors that at are able to provide this brand of equipment. Additionally, the Contracting Officer has identified 3 recent VA purchases for the same/similar equipment that can be used to compare prices. Finally, the main sterilizer unit, which makes up approximately 73% of the acquisition’s price, can be compared to Getinge’s VA FSS contract price, which has been determined to be fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

The Contracting Officer used the following sources to conduct Market Research:

• Synopsis of Proposed Action on SAM.gov Supply Chain Master Catalog (SCMC)

• Federal Procurement Data System

• ADDS UP

• GSA Advantage!

• Vendor Information Pages (VIP) Search/SBA VetCert

• Informal Quote from Original Equipment Manufacturer (OEM)

The Buy American statute applies and clause FAR 52.225-1 Buy American – Supplies and provision 52.225-2 Buy American Certificate will be included in the solicitation and resulting award. Reviewing Getinge’s VA FSS catalog and recent acquisitions for this same/similar equipment indicates that the equipment in manufactured in the USA.

As described in Paragraph 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. No responses were received.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Only known sources are the Original Equipment Manufacturer (OEM), Getinge USA Sales, LLC and their sole authorizerd distributor, TrillaMed LLC.

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11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: If the Government requires this equipment in the future, market research will be conducted at that time to determine if there are other brands that can meet the Government requirements.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

(This signature is the requestor’s supervisor, fund control point official, chief of service, someone with responsibility and accountability)

Melissa Achtziger, MSN, RN Date Associate Director, Patient Care Services Butler VA Health Care System

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer, NCO 4 Commodities 1

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Branch Chief, NCO 4 Commodities 1

MELISSA

ACHTZIGER

Digitally signed by

MELISSA ACHTZIGER

Date: 2024.03.11 08:02:18 -04'00'

ANDREA

BUCKLEY

Digitally signed by ANDREA

BUCKLEY

Date: 2024.03.18 09:39:59 -04'00'

HOLLY WATSON

Digitally signed by HOLLY

WATSON

Date: 2024.03.18 12:05:56 -04'00'