P03 J_A_Redacted.doc

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C252-20-AP-3253

1. Contracting Activity:

Department of Veterans Affairs

Great Lakes Acquisition Center, NCO-12

115 South 84th Street, Suite 101

Milwaukee, WI 53214-1476

Department of Veterans Affairs

Jesse Brown VA Medical Center

2030 West Taylor

Chicago, IL 60612-4223 Identify purchase request number: 537-20-3-969-0843

2. Nature and/or Description of the Action Being Processed:

This justification and approval is for a brand name Olympus America Inc. only Gastroscope - Colonoscopy Tower procurement which will be set-aside for small businesses and awarded as a firm-fixed-priced purchase order.

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for a Gastroscope - Colonoscopy Tower 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.

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

Jesse Brown VA has a requirement that will be used in the Operating Room to treat gastrointestinal (GI) patients by means of diagnosis and conduct invasive procedures for both upper and lower procedures. Furthermore, the facility is requesting installation and training for staff who will be using the equipment in the Operation Room.

Estimated Amount: $X.XX

4. Statutory Authority Permitting Other than Full and Open 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:

( ) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business; or

( ) 819.7008 Sole source awards to a verified veteran-owned small business

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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 requested Olympus 190 Gastroscope ‐ Colonoscopy Tower will standardize equipment among the Operating Room, GI Lab, GU Procedure Clinic and Anesthesia Department. This will ensure both compatibility and continuity of care amongst all departments.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Contract Specialist received email from Original Equipment Manufacturer (OEM) stating that the OEM exclusively works with Contractor A who is Vendor Information Pages (VIP) verified as a Service-Disabled Veteran-Owned Small Business (SDVOSB). Contract Specialist also reviewed Olympus America Inc. website olympusamericaprodictation.com/dealers/ for additional small businesses and located Contractor B who is a small business under NAICS 339113 Surgical Appliance and Supplies Manufacturing.

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

The steps to be taken to find that the price will be determined fair and reasonable will be based on competitive offers and historical data from Federal Procurement Data System - Next Generation (FPDS-NG).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Original Equipment Manufacturer (OEM) for this requirement is Olympus America Inc. who is considered an Other Than Small Business (OTSB) per System for Award Management (SAM) Reps & Certs. Contract Specialist received email from OEM stating that the OEM exclusively work with Contractor A who is Vendor Information Pages (VIP) verified as a Service-Disabled Veteran-Owned Small Business (SDVOSB). Contract Specialist also reviewed Olympus America Inc. website olympusamericaprodictation.com/dealers/ for additional small businesses and located Contractor B who is a small business under 339113 Surgical Appliance and Supplies Manufacturing.

VIP query on August 03, 2020, keyword Gastroscope revealed one Service-Disabled Veteran-Owned Small Businesses (SDVOSB) who services/repairs Gastroscope but does not manufacture Gastroscopes.

GSA Advantage search revealed that Olympus America Inc. has Gastroscope on schedule GIF-XP190N MAS Schedule/SIN: 65IIA/A-9.

Government-wide database revealed that Contractor A has Gastroscope on eCAT schedule; however, per Roger Richardson items being requested exceeds eCAT threshold of $250K. Therefore, acquisition was given to contracting to procure

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

Non-Manufacturer Rule (NMR): Definition – for SD/VOSB set-asides applicability, other than for construction or services, any concern proposing to furnish a product that it did not itself manufacture, must furnish the product of a small business manufacturer unless the SBA has granted a waiver. If the IGCE is less than $10,000.00 the NMR does not apply and a SD/VOSB set-aside shall be sought. If the IGCE is equal to or greater than $10,000.00 the NMR applies.

With regards to the “Rule of Two,” 13 CFR § 121.406(a) General. In order to qualify as a small business concern for a small business set-aside, service-disabled veteran-owned small business set-aside or sole source contract, HUBZone set-aside or sole source contract, WOSB or EDWOSB set-aside or sole source contract, 8(a) set-aside or sole source contract, partial set-aside, or set aside of an order against a multiple award contract to provided manufactured products or other supply items, an offeror must either:

(1) Be the manufacturer or producer of the end item being procured (and the end item must be manufactured or produced in the United States); or

(2) Comply with the requirements of paragraph (b), (c) or (d) of this section as a nonmanufacturer, a kit assembler or a supplier under Simplified Acquisition Procedures.

Market research revealed that the OTSB manufacturer has one small business and one SDVOSB authorized to distribute; therefore, the VA will address the requirements of paragraph (b), (c), or (d).

13 CFR § 121.406(b) Nonmanufacturers

(1) A firm may qualify as a small business concern for a requirement to provide manufactured products or other supply items as a nonmanufacturer if it:

(i) Does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS Code 541519, which is found at § 121.201, footnote 18);

(ii) Is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied;

(iii) Takes ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; and

(iv) Will supply the end item of a small business manufacturer, processor or producer made in the United States, or obtains a waiver of such requirement pursuant to paragraph (b)(5) of this section.

As stated above, OEM is an OTSB; therefore, the VA will address the requirements of paragraph (b)(5).

(5) The Administrator or designee may waive the requirement set forth in paragraph (b)(1)(iv) of this section under the following two circumstances:

(i) The contracting officer has determined that no small business manufacturer or processor reasonably can be expected to offer a product meeting the specifications (including period for performance) required by a particular solicitation and SBA reviews and accepts that determination; or

(ii) SBA determines that no small business manufacturer or processor of the product or class of products is available to participate in the Federal procurement market.

SBA may have waived NMR; therefore, the VA will address the requirements of paragraph (b)(7).

(7) SBA's waiver of the nonmanufacturer rule means that the firm can supply the product of any size business without regard to the place of manufacture. However, SBA's waiver of the nonmanufacturer rule has no effect on requirements external to the Small Business Act which involve domestic sources of supply, such as the Buy American Act or the Trade Agreements Act.

Per U.S. Small Business Administration (SBA), a class waiver is not applicable to a procurement unless the NAICS code, Federal Supply Schedule (FSC), and NAICS code Descriptor currently in effect match the item(s) being procured. As mentioned above, the appropriate NAICS code for this requirement is 334510, the FSC is 6525, and the Descriptor is Electromedical and Electrotherapeutic Apparatus Manufacturing; This U.S. industry comprises establishments primarily engaged in manufacturing Electromedical and electrotherapeutic apparatus, such as magnetic resonance imaging equipment, medical ultrasound equipment, pacemakers, hearing aids, electrocardiographs, and electromedical endoscopic equipment. Therefore, an SBA NMR class waiver does exist for this requirement.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Contractor: Contractor A DUNS: xxxxxxxxx Size Standard: Service-Disabled Veteran-Owned Small Businesses (SDVOSB) Contractor: Contractor B DUNS: xxxxxxxxx Size Standard: Small Business

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:

Brand Name Olympus America Inc. Only Gastroscope - Colonoscopy Tower shall be set-aside for small businesses.

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.

ES_______________________________________________________

Carl R. Weber Contract Specialist

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

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.

ES_______________________________________________________

Thomas H. Chesak Contracting Officer

One Level Above the Contracting Officer (Required over SAT but not exceeding $700K):

I certify the justification meets requirements for brand name only.

ES_______________________________________________________

Parris S. Weidenbach Equipment Branch Chief – Contracting Officer