P03 JA Attach1 FAR 13.5 Sole Source Justification - LANSOPRAZOLE (23P0129)_rk_BC_redacted.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

Pharmaceutical – Urgent and Compelling Award

Acquisition Plan Action ID: 36C77023AP0245

1. Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, Tucson CMOP, 2237:

762-23-1-040-0594, Tucson CMOP, Tucson, AZ

2. Nature and/or Description of the Action Being Processed: The CMOP facility in Tucson, AZ requires pharmaceutical Lansoprazole (NDC 00378-6981-88) to be procured as an urgent and compelling justification to fulfill Veteran patient prescriptions as inventory is very low and without this product, Veteran presecriptions cannot be filled. The proposed procurement action will be a new firm fixed-price contract award.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is a justification to support the emergency procurement of the following item:

a. Pharmaceutical: Lansoprazole 30mg, SA Disintegrating Tab

b. NDC #00378-6981-88

c. Quantity: 684 boxes

d. One-time delivery for Tucson CMOP, needed immediately

e. Estimated value: $588,240.00

f. Options: 3 quarterly options for same quantity, for a one year supply (options allow Tucson

CMOP to supply this product uninterrupted for one year)

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. The purpose of this justification is for the reason below:

( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( X ) 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

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

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

Unusual and compelling Urgency. IAW FAR 6.302(b)(2), a delay in award of this contract could result in serious injury to our Veterans. This pharmaceutical, Lansoprazole, is prescribed by VA physcians for the short-term treatment (four weeks) for healing and symptom relief of active duodenal ulcers (open sores that develop on the inside of the upper portion of the small intestine, the duodenum).

Tucson CMOP has indicated that due to backorders, their supply of this product is very low and soon they may not be able to fulfil Veteran prescriptions for this pharmaceutical. If Tucson CMOP is unable to fill an order for Lansoprazole, Veteran’s well-being could be adversely affected.

This procurement was competed as unrestricted resulting in 13 quotes, all were non-domestic. A Buy American Waiver package was prepared and submitted. However, due to the time line for the BA Waiver approval, and the immediate need from Tucson CMOP, this order has become an urgent & compelling need. Without this immediate award, Veterans will suffer as their prescriptions will not be filled.

Pharmaceuticals are 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.” The VA PRINT NAME is the official identifier of what the drug name should be.

This along with the Product Code is how the facility identifies what drug they should dispense. 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: This order was posted on SAM.gov as unrestricted so that all types of businesses could submit a quote. The solicitation resulted in 13 quotes, of which, all were non-domestic.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The awarded price is considered reasonable . Historically, per VISTA purchases, from November 2022 to January 2023, price ranged from box . The awarded amount of per box is lower than the historical range and below the IGCE value of per box.

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

a. Checked VISTA & eCMS, results: VISTA reports 7 purchases from 11-30-2022 to 1-23-2023 with price range of per bottle. In eCMS: 05/18/22 awarded 36C77022P0346 emergency order for

b. Checked VA Federal Supply Schedule Service (FSS) Contract Pharmaceutical Catalog via Acquisition Knowledge Portal (AKP). Searched GSA eLibrary. Searched Master Item Number in IFCAP VISTA for historical data. Searched eCMS briefcase for documents related to prior award of same product (36C77022P0346), results: FSS V797D50492, Takeda Pharmaceuticals

Effective Date: 02/01/2022 Page 3 of 4

America Inc, price per bottle, GSA eLibrary no record found, VISTA prior purchases price per unit range from 11/2022 to 01/2023, eCMS documents verify emergency order with 2 quotes (SB & SDVOSB).

c. Checked VetCert @ veterans.certify.sba.gov, results: as of 1/26/23, listed are 115 SDVOSB/VOSBs providing NAICS 325412 products.

d. Posted solicitation as unrestricted on SAM.gov so all types of businesses had opportunity to submit a quote, results: 13 quotes were received, with 6 different NDC numbers that were approved by Tucson CMOP and all were made in India.

Since this product is made in India, a Buy American Act VA Nonavailability Determination must be approved by the SAO. However, since this procurement has become an urgent and compelling need and requires immediate award, the Buy American Act VA nonavailability Determination will be processed after the award of this emergency order.

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

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

a. PBA Health, rick.mingori@pbahealth.com

b. Parkpine Inc, a@parkpine.com

c. Disabled Veterans Hawaii, rob@vetshi.com

d. HyGen Pharmaceuticals, Inc., mdiego@hygenpharma.com

e. Ds Ventures dba Logmet Solutions, rscott@logmetsolutions.com

f. Woods International, woodscan@gmail.com

g. Dr. Reddy’s Laboratories Inc., jcalvarez@drreddys.com

h. Global medical Services LLC, kudogu@gmail.com

i. 3T Business Group LLC, pharma@3Tfederal.com

j. ASE Direct Inc., jradestock@asedirect.com

k. GBS Med-Pharm, gbs@gbsmedpharminc.com

l. Viti Pharmaceuticals, LLC, christy@vitipharma.com

m. Melling LLC dba Melling Medical, thearn@mellingmedical.com

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: N/A

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.

Juan Silva, Inventory Management Specialist or Michael Sutherland, Director, SW CMOP Tucson CMOP

JUAN SILVA

Digitally signed by

JUAN SILVA

Date: 2023.03.09 12:27:32 -07'00'

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

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.

Renee Kreutzer Contracting Officer National CMOP Contracting Office

(NCO 15)

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.

Contracting Officer National CMOP Contracting Office

(NCO 15)

RENEE KREUTZER

Digitally signed by RENEE

KREUTZER

Date: 2023.03.09 15:13:13 -06'00'

CHRISTY

PENDLAY

Digitally signed by

CHRISTY PENDLAY

Date: 2023.03.13 17:08:31 -05'00'