Sole Source Justification_Redacted.pdf
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- Attached to
- Pharmacy Inspection and Certification
- Solicitation number
- 36C24727P0019
About this file
This is a Justification and Approval (J&A) document for a sole source contract award to a Service-Disabled Veteran-Owned Small Business (SDVOSB) under the Department of Veterans Affairs.
The contracting activity is the Atlanta VA Medical Center (NCO 07), seeking to award a fixed-price service contract for USP 797 pharmaceutical compounding compliance monitoring. The requirement includes environmental sampling of viable and non-viable particle testing, with certification testing performed semiannually and monthly surface sampling by a certified CETA (Controlled Environment Testing Association) contractor. The contract has a base period from November 9, 2026 to November 8, 2027, followed by four one-year option periods extending through November 8, 2031. The total estimated cost is redacted. The statutory authority for the sole source award is 41 USC §3304(a)(5) and 38 U.S.C. § 8127(c), implemented through VAAR 819.7008 (DEVIATION) for SDVOSB awards up to $5,000,000. The selected contractor is Health Systems Sciences LLC (HSS), determined to be a responsible source based on satisfactory performance under previous contract 36C24724P0090 and verified certification in the SBA's Small Business Search tool. The justification documents that market research confirmed HSS's SDVOSB eligibility, that the estimated requirement cost is under $5 million, and that the contractor's performance is satisfactory. Fair and reasonable pricing will be established through comparison with historical data from sam.gov and past acquisition history. The acquisition plan action ID is 36C247-27-AP-0735.
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Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format IAW VAAR 819.7008/9
VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 3 Revision: 05 Effective Date: 12/15/2025
DEPARTMENT OF VETERANS AFFAIRS
Justification and Approval (J&A) For
Other Than Full and Open Competition
Acquisition Plan Action ID: 36C247-27-AP-0735
1. Contracting Activity: Department of Veterans Affairs, NCO 07, Atlanta VA Medical Center, VA2237:
508-27-1-539-0003
2. Nature and/or Description of the Action Being Approved: The government intends to award a new fixed-price service contract. This requirement will have a 1-year base period and four 1-year option periods.
3. Description of Supplies/Services Required to Meet the Agency’s Needs: The purpose of this contract is to monitor compliance with USP 797 (Pharmaceutical Compounding-Sterile Preparations) to ensure the sterilization of drugs that are used in compounding sterile preparations.
Environmental sampling of viable and non-viable particle testing is included in the compliance testing. Per USP 797 standard, certification testing must be performed semiannually (i.e., every six months and monthly for surface sampling) by a certified CETA (Controlled Environment Testing Association) contractor.
Period of Performance and estimated cost:
Base Year: 11/09/2026 – 11/08/2027, Option 1: 11/09/2027 – 11/08/2028, Option 2: 11/09/2028 – 11/08/2029, Option 3: 11/09/2029 – 11/08/2030, Option 4: 11/09/2030 – 11/08/2031, Total Estimated Cost:
4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.
Code § 8127(c), as implemented by RFO 6.103-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7008 (DEVIATION) or VAAR
819.7009 (DEVIATION)- up to $5,000,000. Check the specific VAAR clause used below:
(X) 819.7008 Sole source awards to a certified service-disabled veteran-owned small business; or ( ) 819.7009 Sole source awards to a certified veteran-owned small business
5. Demonstration that the Contractor’s Unique Qualifications and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The authority under 38 U.S.C. 8127(c) allows sole source awards to SDVOSB/VOSB concerns. Health Systems Sciences LLC (HSS) has been determined to be a responsible source based on the performance from the previous contract, 36C24724P0090. Further, HSS meets all eligibility requirements as outlined in VAAR 819.7003.
6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by RFO 6.301 and, if not, which exemption under RFO 5.101(b)(1) applies:
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