6515--Medication Return Envelopes and Disposal PO#765-A40009

Active

Contract Opportunity

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP
Attachment 5: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 11
Original Date: 03/22/11 Revision 11 Date: 02/11/2021
Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For
Other Than Full and Open Competition (>SAT)
Acquisition Plan Action ID: 36C77024AP0199_

Contracting Activity:
Department of Veterans Affairs, RPO Central
Consolidated Mail Outpatient Pharmacy Network Contracting Office 15
3450 S. 4th Street Leavenworth, Ks. 66048

2237#: 765-24-1-869-0001

Nature and/or Description of the Action Being Processed:
The Department of Veteran s Affairs implemented consumer Take-Back medication program in 2014 to encourage responsible disposal of medications. This program allows Veteran s to mail in unused medications through the United states Postal Service (USPS) to an approved Drug Enforcement Administration (DEA) Registered Reverse Distributor and Collector. As of 8/31/2023, Veterans have returned over 390 Tons of unneeded/unwanted medication using VA approved medication return envelopes and onsite receptacles.

The proposed limited source action is for a firm-fixed-price (FFP) contract for the procurement of Consumer Medication Mail-back Envelopes that meet the requirements of the Drug Enforcement Administration (DEA) final rule for disposal of controlled substances as published in the Federal Register Volume 79, number 174 on September 9, 2014. The envelopes provide a safe and responsible mechanism for Veterans to dispose of unneeded medication by sending them back to a third party DEA registered mail-back vendor for disposal. The purpose of this procurement is to purchase a five month supply of Mail-back Envelopes from the existing Vendor, Sharps Compliance, Inc. 9220 Kirby Dr., Suite 500, Houston, Texas 77054. Sharps is a Large Business that has supplied Envelopes to VA for the past ten years however, recent Market Research identified a Small Business that may be able to provide a similar service. The five month supply is to ensure there is no break in service and to allow for transition if it is determined the Small Business has the Technical capability to meet PWS Requirements.

FAR13.5 Simplified Procedures for Certain Commercial Items:
This procurement is for the purchase and distribution of Medication Return Envelopes 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.

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

This non-personal services requirement is for the purchase, storage, delivery, postage, processing, destruction, and reporting of Medication Return Envelopes and their contents. Contractor must have a signed service agreement with the United States Postal Service (USPS) prior to submitting a bid and must maintain that agreement throughout the life of the contract. Contractor shall distribute envelopes to VA Medical Centers (VAMC s) or other facilities that will be identified on each individual Purchase Order (PO). The envelope system must meet the Veterans Health Administration (VHA) procedures for shipping and privacy of the Veterans information. The Contractor shall setup a VA approved electronic ordering system that will accept, track and confirm delivery of all orders from VA sites. The Contractor shall receive, process and destroy medication at the address listed on the envelope and must be an approved Drug Enforcement Administration (DEA) Registered Reverse Distributor and Collector. Reporting of destruction will be done on a quarterly basis for each envelope and per VA site. Information shall include, but is not limited to, package weight, poundage per ordering site and total poundage each month.
Estimated Performance Period: Five months with no Option Periods Estimated Delivery Date: 12/15/2023
Estimated Dollar value, Base Year: $320,155.00 Estimated Quantity: 68,750 envelopes
Estimated Dollar value including options: $320,155.00 Estimated Quantity including options: 68,750 envelopes

Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;
( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability
or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;
( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4
( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5; ( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;
( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):
The Contractor will use the United States Postal Service (USPS) as the common carrier for mail-back envelopes and be able to demonstrate the shipping process is approved by USPS as an acceptable method of shipping at the time of contract award. USPS must be used to ensure the Veteran has the fastest and easiest means of getting unused/unwanted medications into the mail stream. Other shipping methods put extra burden on the Veteran to include a need to travel outside of their residence resulting in a drop in participation.The Contractor shall receive, process and destroy medication at the address listed on the envelope and must be an approved Drug Enforcement

Administration (DEA) Registered Reverse Distributor and Collector. Sharps is the only firm capable of providing the supplies and services described in Section 3 above without the Veteran s Health Administration experiencing unacceptable delays in fulfilling its requirements.

Based on market research and a Request for Information that was posted on Sam.gov the TakeAwayTM envelope patient medication return solution, manufactured by Sharps Compliance, Inc. of Texas, is the only Consumer Return Medication Envelope product that meets all of the requirements of the DEA final rule regarding mail based disposal of controlled substances (meeting these requirements is mandatory by law) and VHA regulations. Therefore, TakeAway envelopes are unique because they are the only product in the commercial marketplace that meet the mandatory requirement to have DEA certification. This brand name justification meets the exemption under FAR 11.105(a)(1), Items Peculiar to One Manufacturer because the required mailback envelopes have been determined to be essential to meeting the Government s requirement for a DEA certified mail based means for VHA patients to return unneeded pharmaceuticals, including controlled substances.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:
A Request for Information/Sources Sought announcement #36C77024Q0051 was posted using the North American Classification System (NAICS) code for the acquisition was 339113 (750 employees). This Sources Sought Notice was part of market research and was used to make appropriate acquisition decisions including whether the procurement warrants a set-aside for Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), or Small Business (SB). The announcement closed on 11/13/2023 with four Small Businesses (SB s) and no Service Diabled Veteran Owned Small Business (SDVOSB) responding to the request. It was determined that none of the responses would be able to meet the technical requirements to include, registered with DEA as a collector, currently has no mailback program in place and did not have the capability to conduct one as under the law. Under the law, the company providing the envelopes (The DEA registered collector), must have ability to receive and destroy the envelopes at their registered location. Under authority of 10 USC 2304(c)(1), Only one responsible source, since it is this survey of the market place that confirms our assumptions regarding the capability of industry to meet our needs.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:
The Takeaway Medication Recovery Envelopes are on GSA, item #17040-250 which includes 250 envelopes at a cost of $1,815.00 per case. Sharps lowered the cost to $1,163.00 due to a volume discount of $978.00 applied to each case. The purchase price includes storage, bulk shipment to VAMC s, mail costs through USPS, destruction, tracking of each envelope and record keeping.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:
A Request for Information/Sources Sought announcement #36C77024Q0051 was posted using the North American Classification System (NAICS) code for the acquisition was 339113 (750 employees). This Sources Sought Notice was part of market research and was used to make appropriate acquisition decisions including whether the procurement warrants a set-aside for Service-Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), or Small

Business (SB). The announcement closed on 11/13/2023 with four Small Businesses (SB s) and no Service Diabled Veteran Owned Small Business (SDVOSB) responding to the request

Any Other Facts Supporting the Use of Other than Full and Open Competition:
Sharps Compliance Inc. and the Takeaway Medication Recovery Envelopes are the only system currently in place that meets both the DEA and the VHA requirements for patient medication return and disposal. The government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:
American RX Groug (ARXG) Sales Bump, Inc.
Anchorex
Echo Consulting Solutions

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
A follow-on competitive acquisition is planned. Furthermore, new NIACS Codes will be added to increase awareness of the Governments needs. This one time purchase of Medication Return Envelopes will allow a continuation of service while the acquisition strategy can be finalized.
Projected timeline for a competitive acquisition will be within the next five months.

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.
(This signature is the requestor s supervisor, fund control point official, chief of service, someone with responsibility and accountability)


RICK PURKO
Digitally signed by RICK PURKO Date: 2024.01.05 10:55:09
-06'00'
Name
Rick Purko RPh

01/05/2024
Date

Title
Acting Deputy Chief Consultant PBM/CMOP

Facility
Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

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.

LARRY ZARITZ
Digitally signed by LARRY ZARITZ
Date: 2024.01.05 15:23:41
-06'00'
01/05/2024

Name:
Larry Zaritz
Date

Title: Contracting Officer, NCO 15 CMOP

Facility
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.

CHRISTY PENDLAY
Digitally signed by CHRISTY PENDLAY
Date: 2024.01.08 18:53:10
-06'00'

Name:
Christy Pend ay
Date

Title: NCO 15 Branch Chief, CMOP

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