Brand Name JA - Med.Surg Glucose Testing - HCA Signed_Redacted - Copy.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 3 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-0153

1. Contracting Activity: Department of Veterans Affairs, NCO15 Contracting, CMOP Dallas.

2237 # 763 21 1 021 0225

2. Nature and/or Description of the Action Being Processed: This procurement is for medical surgical supplies 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 sill require a justification using the format of FAR 6.303 2. The proposed procurement action will be a new firm fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand name justification to support the procurement of the medical surgical items listed below in the following table. The estimated value for the required MedSurg supplies is Items are to be delivered 10 days after receipt of order.

Item Number

File Number

Description NDC Quantity Unit of Measure

Packaging Multiple

0001 13642 GLUCOSE

SENSOR (3)

GUARDIAN

MMT 7020A

GUARDIAN

MMT-7020A

(XJ430)

1700 BX 4 PER BOX

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

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

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’s prescription. No National Drug Code (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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A synopsis of this requirement was posted to Beta.SAM.gov and the RFQ will be posted as an Other than Full and Open solicitation. Only qualified vendors will be able to submit quotes due to Gray Market/Name Brand only requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be fair and reasonable based off competition or the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 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; however, non manufacturer requirements apply and the VIP database search concluded there are no known SDVOSB or VOSB manufacturers of the above referenced MedSurg items for NAICS code 325413.

Therefore, the “Rule of Two” cannot be met and no set aside solicitation is feasible.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be an Other than Full and Open RFQ due to Gray Market/Name Brand only requirements.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Qualified small business vendors tend to vary from procurement to procurement.

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:

No action is being taken at this time due to the fact that no NDC substitutions are permitted based on physician’s specific orders.

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.

CMOP Lancaster Date

21/December/20

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

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:

George Johnson Date Contract Specialist National CMOP Contracting Office (NCO 15)

Approved by:

Ralph Crum Date Contracting Officer National CMOP Contracting Office (NCO 15)

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.

James Justus Date Director, CMOP Acquisition, NCO 15 CMOP Division

Scott R Fiscus Date Director, NCO 15 Contracting

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($700K to $7million (or $13.0 million for acquisitions described in FAR 13.500(c)) for the other than full and competition.

Date

Terry L. Spitzmiller Executive Director Regional Procurement Office Central (VHA)

GEORGE A

JOHNSON 1048817

Digitally signed by GEORGE A

JOHNSON 1048817

Date: 2020.12.23 14:38:36 -06'00'

Ralph R. Crum 547284 Digitally signed by Ralph R. Crum 547284 Date: 2020.12.31 09:32:54 -06'00'

James D. Justus 1030208 Digitally signed by James D. Justus 1030208 Date: 2021.01.04 12:52:23 -06'00'

SCOTT R FISCUS 381888 Digitally signed by SCOTT R FISCUS 381888 Date: 2021.01.05 07:39:54 -06'00'

01/06/2021

TERRY L.

SPITZMILLER

394683

Digitally signed by TERRY L.

SPITZMILLER 394683

Date: 2021.01.06 13:18:06 -06'00'