36C24218Q0285-004.pdf

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >$150K

VHAPM Part 808.405-6 Limiting Sources Page 1 of 4 Original Date: 08/30/2017

LIMITED SOURCES JUSTIFICATION

ORDER >$150,000

FAR PART 8.405-6

Acquisition Plan Action ID: VA242-18-AP-3595

1. Contracting Activity and Agency:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 2 VA Medical Center 76 Veterans Avenue 800 Irving Avenue Bath, NY 14810 Syracuse, NY 13210

Purchase Request (2237): 528-18-2-7245-0004

2. Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501).

The Department of Veterans Affairs, Veterans Integrated System Network (VISN) 2, and the VA Medical Center in Syracuse, NY anticipate a fixed-price commodity procurement of two

(2) Steris Corporation V-PRO MAX sterilizers for the Sterilization Processing Section (SPS).

Order against: FSS Contract Number: V797D-60613

Name of Proposed Contractor: Steris Corporation Street Address: 5960 Heisley Road

City, State, Zip: Mentor, OH 44060 Phone: 440-354-2600

3. Description of Supplies or Services:

The Syracuse VA Medical center is requesting to purchase two (2) Steris Corporation model V-PRO MAX sterilizers. These low temperature sterilizers will replace existing ethylene oxide (ETO) sterilizers that have reached their “end-of-life” and therefore, not cost effective to continue to service and repair, and will complement two (2) existing V-PRO MAX sterilizers already in use at the facility. The Steris Corporation sterilizers will be used to sterilize compatible reusable medical instruments using proprietary VHP® (Vaporized Hydrogen Peroxide) technology that provides highly effective sterilization at a low temperature. The sterilizer must also have the capability to have remotely located controls.

The new sterilizers will use currently owned load carts and racks that are designed for the older models and are 100% compatible. The V-PRO sterilizer is fully compatible with current Steris Corporation equipment on site.

https://www.gpo.gov/fdsys/pkg/USCODE-2009-title41/pdf/USCODE-2009-title41-chap4-subchapIV-sec251.pdf https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPM Part 808.405-6 Limiting Sources Page 2 of 4 Original Date: 08/30/2017

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and

(C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

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; See below

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.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data.

Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

This requirement is two replace two old ethylene oxide sterilizers with two Steris Corporation manufactured V-PRO MAX sterilizers for reusable medical equipment (RME) sterilizers. The Syracuse facility purchased two (2) V-PRO MAX sterilizers in FY16. The two sterilizers being requested in this procurement action will mean the facility will have four (4) identical sterilizers for their RME sterilization requirement ensuring continuity of equipment, controls, cabinetry, user-training and manufacturer maintenance. The new sterilizers are compatible with current controls already set up and in use. Steris Corporation is the only manufacturer that can provide the identical controls as the current models presently in use. This ensures standardization for safe operation while providing patients with optimal services. Other manufacturers’ sterilizers do not match in controls and they are not compatible with the current carts and racks. A Steris sterilizer cannot use another manufacturer’s rack and or vice versa. Sterilizers are validated as required by the FDA based on each manufacturer using their own cart and rack. The Syracuse SPS already has the necessary carts and racks and another manufacturer would have to include the carts and racks as part of their quote. This would mean they would have to spend additional money to purchase equipment that they do not need and cannot afford. There is also the issue https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891

VHAPM Part 808.405-6 Limiting Sources Page 3 of 4 Original Date: 08/30/2017 of potentially putting the wrong rack into the incorrect sterilizer, thus resulting in the sterilizer not operating per the manufacturer’s specifications. They are required to ensure standardization in both the reprocessing equipment used as well as the instrumentation. This ensures high quality care is being provided to help in eliminating any potential for issues in having two or more different products and devices being used for similar purposes.

Standardization also allows for the elimination and added expense of having to train staff on new equipment and procedures.

(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:

As described in paragraph 4 above, Steris Corporation is the only manufacturer that can provide a completely compatible addition to the sterilizers currently in use at the Syracuse facility. In addition, the equipment required is available via Steris Corporation’s Federal Supply Schedule contract. In accordance with FAR 8.404(d), supplies on the schedule are listed at fixed prices and GSA has already determined the prices of supplies under schedule contracts to be fair and reasonable. Therefore, ordering activities are not required to make a determination of fair and reasonable pricing, and by placing an order against a schedule contract, the ordering activity has concluded that the order represents the best value and results in the lowest overall cost alternative to meet the Government’s needs.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

A comprehensive search was conducted on Veterans Information Pages (VIP) at www.vetbiz.gov to make a determination as to the availability of Veteran Owned Small Businesses and/or Service Disabled Veteran Owned Small Businesses (VOSB/SDVOSB). A search of the key work “Steris” resulted in 6 vendors listed. A comprehensive search on FPDS-NG indicated that there are likely three (3) SDVSOB vendors that can provide a proposal for the required items shown on the RFQ.

(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:

In this particular procurement action, it is the CO’s determination that there is a valid and verifiable justification for limiting the sources for this purchase to Steris Corporation or its authorized distributors (pending determination of fair and reasonable pricing.) CO will post a solicitation to FBO, SDVOSB set-aside, on a Lowest Price Technically Acceptable (LPTA) basis and will determine fair and reasonable pricing. If pricing is determined to not be fair and http://www.vetbiz.gov/

VHAPM Part 808.405-6 Limiting Sources Page 4 of 4 Original Date: 08/30/2017 reasonable, CO will request an unrestricted, limited sources award directly to Steris Corporation.

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

CHIEF, SPS

VAMC - SYRACUSE

(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.

CONTRACTING OFFICER

NETWORK CONTRACTING OFFICE 2

b. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

SUPERVISORY CONTRACT SPECIALIST

NETWORK CONTRACTING OFFICE 2