P03 Limiting Sources Justification_OVER_SAT Getinge Sterilizers Final.pdf

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Attached to
6515--SPS Getinge Sterilizers Federal contract opportunity
Solicitation number
36C24123Q0395
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 1

About this file

This limited sources justification document requests approval to award a sole source contract to Getinge USA Sales, LLC for the acquisition of two Getinge 67N sterilizers for $300,336.36. The sterilizers will be installed at the VA Connecticut Healthcare System's Leeds campus to replace older units in a temporary sterile processing facility. Market research found the Getinge sterilizers are optimized for space-constrained facilities and standardized trays, improving maintenance contracting across the VA network. Price reasonableness was determined through GSA schedules. Approval was granted by the contracting officer and division chief to award the sole source contract to Getinge due to the specialized nature and compatibility needs of the sterilizers.

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36C24123P0402_2.docx DOCX document

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LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-23-AP-1572

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 01, located at 200 Springs Rd, Bedford MA, in support of VISN 01 VA Health Care System at , VA CWM Medical Center 421 N MAIN STREET, LEEDS, MA 01053. 2237 # 631-23-2-3014-0017.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The contractor shall provide all resources necessary to accomplish the deliverables described in the statement of work (SOW), except as may otherwise be specified. The objective of this project is to obtain two new Getinge 67N Sterilizers, including the installation and removal of older units. This is a new requirement to an FSS contract vie delivery order.

Order against: FSS Contract Number: 36F79721D0237

Name of Proposed Contractor: Getinge USA Sales, LLC

Street Address: 45 Barbour Pond Dr

City, State, Zip: Wayne, NJ 07470-2094

Phone: 888-9GETUSA

(3) Description of Supplies or Services:

The estimated value of the proposed action is $300,336.36

Part Number Description

6028457780 STEAM STERILIZER 67N131E

CONNKIT0002 UTILITY CONNECTION PKG, .75

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

P0010302 VALVE,DRAIN,.25 NPT,.25 AMP

6020724074 LOADING TROLLEY

564668970 PAIR OF BRACKETS

6020727503 BATTERY LOADING TROLLEY SMART

6023375074 AUT.LOAD SHELFRACK 67X13 GL64

6028457672 STEAM STERILIZER 67N101E

CONNKIT0002 UTILITY CONNECTION PKG, .75

6020724072 LOADING TROLLEY

FAR PART 8.405-6

564668970 PAIR OF BRACKETS

6020727503 BATTERY LOADING TROLLEY SMART

6023375072 AUT.LOAD SHELFRACK 67X10 GL64

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

P0010302 VALVE,DRAIN,.25 NPT,.25 AMP

ZSUS15626-IR-GSS67 INSTALL/REMOVE GSS67 STERILIZER

ZSUSDISPOSAL-1PC Disposal per piece 1 ZSUSFINAL-CONN-LV1 Final Connections Level 1 ZSUSINSTAL-WKD-XHR Weekend/Afterhours (per piece) ZSUSSW1STYEARPOSPM POS First Year PM SWIC Equipment

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

The CWM Medical Center’s Sterile Processing Department is currently operating from a temporary location withing a trailer. The Getinge GSS67N Steam Sterilizer is optimized and ideal for placement where space is at a premium. The unit is also optimized for ambulatory surgical centers and the larger instrument sets required for orthopedic surgeries. The sterilizer can

ORDER >SAT

FAR PART 8.405-6

process 12 trays in the given footprint and is validated for 25 pounds sterilizer tray loads to help with productivity in the limited space provided.

The purchase of this brand name will satisfy the standardization of the SPS department. They will have one vendor for each part of the sterilization process. This will improve the maintenance contracting process to allow for one contract across all devices as opposed to having multiple service contracts.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

Price reasonableness has been determined by GSA. Discount will be request because the requirement is expected to be over SAT.

(6) Describe the Market Research Conducted:

(7) Any Other Facts Supporting the Justification: N/A

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

SIGNATURE

Lynn Malouin, SPD Supervisor, CWM VA Medical Center

LYNN MALOUIN

Digitally signed by LYNN

MALOUIN

Date: 2023.02.02 12:12:02 -05'00'

This is a Brand-name only requirement for Getinge Model 67N Sterilizer. Getinge USA LLC is the US sales unit of Getinge. This fact is supported by a sole source letter. Getinge identified SDVOSB Trillamed as their only small business distributor. The requirement is expected to be over SAT. Therefore, the limitations on subcontracting and the NMR apply. There is an SBA NMR Waiver for NAICS 339113, but it does not apply to sterilizers. There are no small business manufacturers of any class. Therefore, a set aside cannot be made. The solicitation may be made on an unrestricted basis, however, there is no reasonable expectation that competition will be obtained. As a second option, an order may be placed against Getinge's FSS 36F79721D0237.

FAR PART 8.405-6

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Deborah Reardon Contracting Officer

NCO1

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

Pedro Lara Branch/Division Chief

Deborah L. Reardon 350203

Digitally signed by Deborah L.

Reardon 350203 Date: 2023.02.02 15:26:42 -05'00'

Pedro R. Lara 3603990

Digitally signed by Pedro R. Lara 3603990 Date: 2023.02.02 15:33:18 -05'00'

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