P03_Justification and Approvals_OVER 250K_770-21-1-801-0168_Redacted.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 5 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-21-AP-0104 (770-21-1-801-0168)

1. Contracting Activity:

National CMOP Contracting Office 3450 S. 4th St. Trafficway Leavenworth, KS 66048-5581

Requesting Activity:

VA CMOP National Office 23501 W 84th Street Shawnee, KS 66227

PR-IFCAP (2237): 770-21-1-801-0168

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

This procurement is for BRAND NAME supplies as requested by the VA Medical Centers from the VA CMOP NATIONAL OFFICE 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.

PR-IFCAP: 770-21-1-801-0168

ACTION REQUESTED: 1 (New Requirement) Action will be awarded as a new contract, firm-fixed-price This Justification & Approval (J&A) is a class J&A authorizing Other Than Full and Open Competition

CLASSIFICATION CODE: 65(MEDICAL EQUIPMENT)

Purchase of: MedSurg Supplies.

Drug Name: "Multiple" PROCUREMENT VEHICLE: Open Market SOCIOECONOMIC CATEGORY: Service Disabled Veteran Owned SB PURCHASING SCOPE: 3 (Multi-VISN-Wide) Est. Award Date: 12-03-2020 Est. Comp. Date: 12-17-2020

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

BRAND NAME supplies as requested by the VA Medical Centers from the VA CMOP NATIONAL OFFICE Drug Name: "Multiple"

· MedSurg supplies have been prescribed for patients by VA Physician to meet the specific needs of the Veteran.

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 5

Revision 02 Date: 08/04/2020

770-21-1-801-0168 -Glucose test strips- National CMOP PRINCIPAL NAICS CODE: 325413(In-Vitro Diagnostic Substance Manufacturing) PRODUCT CODE: 6515(Medical and Surgical Instruments, Equipment, and Supplies) Delivery Timeframe: 10 Days ARO

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:

(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):

Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Brand Specific” products are the same thing as “dispense as written” on a physician prescription. No NDC substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify “brand specific” products in the VA PRINT NAME. This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code. The site is not requesting purchase from any certain vendor. Multiple vendors offer these items.

DESCRIPTION PKG QTY UNIT NDC/SKU#

1 ITEM ID NO. 6243 (XZ173) ONE TOUCH ULTRA

(GLUCOSE) TEST STRIP 50CT (53885-0244-50)

PKG: 50 per BT

50 360 BT 53885-0244-50

2 ITEM ID NO. 6247 ONE TOUCH ULTRA

(GLUCOSE) TEST STRIP 100CT (XZ173) PKG: 100

per BT

100 1440 BT 53885-0245-10

3 ITEM ID NO. 6243 (XZ173) ONE TOUCH ULTRA

(GLUCOSE) TEST STRIP 50CT (53885-0244-50)

PKG: 50 per BT

50 240 BT 53885-0244-50

4 ITEM ID NO. 6243 (XZ173) ONE TOUCH ULTRA

(GLUCOSE) TEST STRIP 50CT (53885-0244-50)

PKG: 50 per BT

50 420 BT 53885-0244-50

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 5

Revision 02 Date: 08/04/2020

Accordingly, only the supplies described in Section III above will be suitable, and are essential to the Government’s requirements, thereby precluding consideration of a product manufactured by another company.

Nature of Urgency: ***EMERGENCY*** Date Needed: 11-04-20

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

This will be posted on FCO (Open Market & Service Disabled Veteran Owned SB) with limited competition per Name Brand Only and Gray Market requirements.

SOLICITATION RFQ NUMBER: 36C77021Q0121

ISSUE DATE: 11-20-20

NEED DATE: 11-04-20

RESPONSE DUE DATE: 11-30-20

PROCUREMENT VEHICLE: Open Market SOCIOECONOMIC CATEGORY: Service Disabled Veteran Owned SB

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

· The CO will determine the anticipated cost to be considered fair and reasonable based on the following:

· Comparison with the IGCE.

· Historical purchases of these MedSurg supplies.

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

• Because the Government is not allowed to do business using Wholesale Trade or Retail Trade NAICS codes, searches must be conducted using manufacturer NAICS codes.

• Market research was conducted through Vet Biz under NAICS 325413(In-Vitro Diagnostic Substance Manufacturing).

• This search resulted in 2 or more SDVOSB companies doing business using this NAICS code.

• Effective August 17, 2020, the U.S. Small Business Administration (SBA) granted a class waiver of the Nonmanufacturer Rule (NMR) for diabetic test strips under North American Industry Classification System (NAICS) code 325413 and Product Service Code (PSC) 6515. This U.S. industry comprises establishments primarily engaged in manufacturing diabetic test strips. (see Federal Register, “Class Waiver of the Nonmanufacturer Rule” [Docket No. SBA–2020–0014] [85 FR 43634])

• Due to the Class Waiver, the identified SDVOSB/VOSBs comply eligibility requirements in 13 CFR part 121.406 and 13 CFR 125.6.

• VA Rule of Two requirements can be met based on the Class Waiver to the NMR and market research.

• Therefore, due to the SBA regulations and the Nonmanufacturers Rule, as defined in FAR Part 19 and 13 Code of Federal Regulations (CFR) 121.406, in accordance with VAAR Part 13 and 19, an SDVOSB/VOSB set aside is feasible.

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 5

Revision 02 Date: 08/04/2020

• Contact Officer recommends a(n) SDVOSB/Service Disabled Veteran Owned SB procurement, to a(n) Open Market Vendor.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, and will advise industry of the pending acquisition and soliciting inquiries from interested parties.

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

· None

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

· None

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:

· Future acquisitions for these MedSurg supplies will continue to be solicited as quantities in available stock stabilize and become available in the open market.

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.

HANSON, CYNTHIA

Supply Systems Analyst VA CMOP National Office - 770

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.

Prepared by:

McAlhaney, Michael W.

Contract Specialist

Nichols Fellows, Lori J.

Contracting Officer

Digitally signed by Cynthia Hanson 248482 Date: 2020.10.28 10:21:26 -05'00'

Cynthia Hanson 248482

DigDigDiDigigDigigDiggDigDigigiggDigDigDiDiDigigiggiggggDDiigggggitally signed by Cynthia HanHanHanHaHanaHanaHanHaHaHaanHanaaananHHHHHanaHanHaanaHananHH nnson 248482 DDate: 20220000 0.10.28 10:21:26 -05'00'

Cynthia Hanson 248482

MICHAEL W MCALHANEY 592393 Digitally signed by MICHAEL W MCALHANEY 592393 Date: 2020.11.17 10:35:24 -06'00'

Lori J. Nichols Fellows 1029477

Digitally signed by Lori J. Nichols Fellows 1029477 Date: 2020.11.17 13:16:26 -06'00'

PM Part 813.5 SAP for Certain Commercial Items Page 5 of 5

Revision 02 Date: 08/04/2020

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

Crum, Ralph R.

Supervisory Contract Specialist, CMOP Team 2

Ralph R. Crum 547284 Digitally signed by Ralph R. Crum 547284 Date: 2020.11.17 13:42:05 -06'00'