S02_JnA_Q0362_.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Brand Name

Acquisition Plan Action ID: 36C770-24-AP-0427

1. Contracting Activity: Department of Veterans Affairs, NCO 15, National Contracting Office. 2237 # 760-24-2-050-0675, Leavenworth CMOP, Leavenworth, KS.

2. Nature and/or Description of the Action Being Processed: This procurement is for a medical surgical (med/surg) diabetic supplies for the messurement of glucose in the human body 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:

Item Number IMFN Description NDC Quantity

Unit of Measure

Packaging Multiple

OEM Name

Country of Origin Useage

1 6243 One Touch

Ultra (Glucose) Test Strip

53885-0244-50 240 BX 50 LifeScan Europe GmbH

United Kingdom

Glucose Measurements

2 6247 One Touch

Ultra (Glucose) Test Strip

53885-0245-10 2880 BX 100 LifeScan Europe GmbH

United Kingdom

Glucose Measurements

This is an individual brand name justification to support the procurement of the two (2) Brand Name Specific, Med/Surg items (One Touch Ultra (GLUCOSE) Test Strip 50CT & 100CT) listed in the above table. The proposed procurement action will be a firm-fixed-priced contract.

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

Effective Date: 02/01/2022 Page 2 of 4

( ) 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. “Name Brand Only/Gray Market Requirements” products are the samething as “dispense as written” on a physician prescription. Absolutely no Generic glucose test strip quotes that will be accepted – Name Brand Only. 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 (DNF) will most always identify “Name Brand Only/Gray Market Requirements” products in the VA PRINT NAME. Vendors must provide proof of supply from an authorized MFG distributor. This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A synopsis of this requirement and the RFQ will be posted to SAM.gov as a Brand Name procurement. Only qualified vendors will be able to submit quotes due to Gray Market/Name Brand only requirements for the two line itmes .

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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: The Consolidated Mail Outpatient Pharmacy (CMOP) has identified that this Med/Surg item not available from mandatory sources (e.g., prime vendor) and, therefore, has submitted the acquisition to Network Contracting Office (NCO 15) which provides acquisition support to CMOP. This acquisition is for a medical surgical supplies that has been specifically identified using the manufacture part number (MPN) and name. Since the (MPN) identifies the medical surgical item prescribed for the individual patient, market research must utilize (MPN) as the primary search criteria to ensure the correct product (i.e., Med/Surg) is purchased.

A search of Daily Med and the National Acquisition Center (Pharmaceutical Catalog) with no results.

However, a seach of the VA Vista system using the Item Master File Number (IMFN) showed two or more SDVOSB that has provide the brand name One Touch Ultra Glucose Test Strips in the past. Vet Cert shows 134 SDVOSB/VOSB using NAICS 325412 and there is an SDVOSB/VOSB NMR Class Waiver in place for glucose test strips posted to the Federal Register in 85 Fed. Reg. 43634 on July 17, 2020.

Based on the market research conducted, the CO determined there is a reasonable expectation that quotes would be received from two (2) or more SDVOSBs that can comply with the NMR.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be an SDVOSB set-aside RFQ for the One Touch Ultra Glucose Test Strip 50CT & 100CT due to Gray Market / Brand Name only requirements.

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

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

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

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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.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.