P03 Brand Name Part813.5_Atch1_FAR13.5_JA_OVER_SAT_766-21-1-400-0068_BrChfSigned_P_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 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-0072________________

1. Contracting Activity: Department of Veterans Affairs, NCO15 Contracting Office, Charleston CMOP (766); 2237# 766-21-1-400-0068

2. Nature and/or Description of the Action Being Processed: This procurement is for medical surgical (med/surg) 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 med/surg supplies listed below in the following table. The estimated value for the required med/surg supplies is . Items are to be delivered 10 days after receipt of order.

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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3

Revision 02 Date: 08/04/2020

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 SDVOSB set aside 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 of competition and/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; due to an SBA waiver to the non-manufacturer rule for glucose testing strips, the VA “Rule of Two” can be met and a SDVOSB set-aside solicitation is feasible.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be a

SDVOSB set aside RFQ and Gray Market/Name-Brand only requirements apply.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Qualified SDVOSB vendors such as PCCS Medical and ASE Direct have expressed interest in past similar procurements.

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.

Glenda Dame Date Inventory Specialist

Glenda Dame 541700

Digitally signed by Glenda Dame 541700 Date: 2020.12.10 11:43:01 -05'00'

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

Revision 02 Date: 08/04/2020

Charleston CMOP

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.

Lori Nichols-Fellows Date Title Facility

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.

Ralph Crum Date NCO15/CMOP Branch Chief Team 2

Ralph R.

Crum 547284

Digitally signed by Ralph R.

Crum 547284 Date: 2020.12.11 13:46:45 -06'00'