P03 - Redacted JOFOC (AP-2127) Pharmacy Trailer Lease_Redacted.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 5 Revision: 02 Effective Date: 04/15/2023

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C259-23-AP-2127 JOFOC Tracking: FY24 - NCO 19 - 345

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 19 (NCO 19), 6162

South Willow Drive, Suite 300, Greenwood Village, Colorado, 80111

Organizational Activity: Department of Veterans Affairs, Veterans Integrated Services Network 19 (VISN 19), Eastern Oklahoma Veterans Affairs Medical Center System (EOVAHCS), 1011 Honor Heights, Muskogee, OK. 74401

2237: 623-24-1-1247-0002

2. Nature and/or Description of the Action Being Approved:

EOVAHCS requires the continuation of a lease for a Pharmacy Compounding Trailer. The VAMC once had an IV and Chemo Room, but that space was given to Logistics. The process of planning and obtaining funding for the construction of the new IV and Chemo Room was years in the making. An RFQ for the renovation was published in the recent past, however the requirement needed to be further clarified by the service in order to allow industry to properly quote. This clarification led to a necessary Cost Limit Increase (CLI) that will be funded through the VISN. Engineering is approximately from obtaining funds and submitting the procurement package to Contracting, and the NCO 19 Construction Team believes that an award can be expected after the package is submitted by the VAMC. Construction will take approximately to complete barring any setbacks. There will also be new requirements in FY 26 for new pharmacy systems to outfit the IV and Chemo Room, and the lead time for those procurements delivery and installations are unknown.

This action requiring review and approval is a Service-Disabled Veteran Owned Business (SDVOSB) Sole Source Direct Award to Stripes Global Inc, for the lease of a Pharmacy Compounding Trailer in support of EOVAHCS. Stripes Global Inc. is a Small Business Administration Verified SDVOSB. The requirement was previously awarded to Stripes Global Inc (36C25919P0965, 36C25922P0487 and 36C25923P0469) to provide a trailer which meets all required certifications and validations for USP <797> and <800>, National Institute of Occupational Safety and Health (NIOSH), and FDA Anteroom and Cleanroom regulations.

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

The purpose of this procurement is to provide the EOVAHCS with a firm fixed-price base, plus three option years lease of a Mobile Pharmacy Cleanroom Trailer. The mobile pharmacy cleanroom will allow the Pharmacy Service to continue preparing pharmaceutical compounded sterile preparations that meet the standards of the United States Pharmacopoeia (USP) Chapter797 (USP <797>), Chapter (USP <800>) and complies with the (NIOSH). There is no local pharmacy capable of providing the pharmaceutical compounded sterile preparations necessary to treat patients.

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Effective Date: 04/15/2023 seamlessly transition without a lapse in coverage would require support from a local pharmacy, and there is not a local pharmacy available 24 hours a day seven days a week.

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 FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies:

A sources Sought Notice was posted on Sam.gov Two (2) SDVOSB’s responded with the results captured in paragraph eight (8) below.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Stripes Global stated they will not increase the cost more than for the base year after researching US Bureau of Labor’s Consumer Price Index (CPI). The following years will be increased by no more than per year, which has been found fair and reasonable on previous contracts. Given the average published inflation rate of fiscal year 23 being 5.6%, accepting a base year cost increase of is fair and reasonable. At a minimum, the government stands to save 0.6% through the base year considering Stipes Global can easily quote a 5.6% increase to keep their operating costs even with inflation.

The increase for the base year would equate to per month. An option for contract 36C24920P0587 which was awarded to Modular Devices for a Laboratory Trailer that requires similar initial and reoccurring operating costs due to following USP 800 standards, has a contracted monthly cost of . Contract 36C25923P0839 awarded to Stripes Global for the same requirement at Oklahoma City VAMC has a monthly cost of per month.

Under these two comparisons the price can be determined to be fair and reasonable.

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

FPDS was searched for Pharmacy Trailers. The search resulted in three vendors having been awarded a contract by the VA in the past four years: Stripes Global (SDVOSB), Germfree Laboratories (Large Business), and Modular Devices. Modular Devices was called, and an email sent via their website, but no response was received. Stripes Global, who holds the current contract at the facility was called, the owner Tyson Shultz stated that the trailer is available for a new contract, is currently certified and there would be no lapse in coverage between the current contract and a new one.

GSA Advantage was searched for Pharmacy trailers and yielded two results; Nomad Global Communication Solution (GS-30F-027-BA) whose Sales Representative specified that they do not lease their Pharmacy Trailers, and Global Enterprises (GS-30F-040BA) whose delivery is expected to be 280 days after receipt of order (ARO) per their GSA Advantage estimated delivery schedule.

Global Enterprise was contacted but a response was not received.

GSA eLibrary was searched for Pharmacy Trailers resulting in two vendors found; Lifeline Mobile (47QMCA19D000H), and Nomad Global Communication Solutions (GS-30F-027-BA). Lifeline’s price list spoke to other medical type trailers, but not Pharmacy. Nomad’s spoke to the purchase of a Pharmacy Trailer but not a lease, which is a required facility budgetary characteristic.

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Effective Date: 04/15/2023

NAC Medsurge Catalogue, SAC and DSBS were searched for Pharmacy Trailers to no avail.

A Sources Sought Notice was posted to Sam.gov which resulted in two responses.

of JMG Veteran Contracting responded to the Sources Sought Notice stating that they can meet the VAMC’s need with small business manufacturer Modular’s trailer. Mitchell stated that they can purchase a Modular trailer specifically to meet the limitations on subcontracting for this requirement. JMG could have the trailer on site two weeks ARO and would require the trailer on site one week prior to the period of performance start date. Mitchell stated that the trailer would be connected, and cleaned four days after the trailer is onsite, a third-party sterility certification would begin on day five, and the return of viable samples would be returned 10 days later. This means the VAMC would be without a Pharmacy Compounding Trailer for at least 14 days, and that is if the trailer is certified after the first attempt. There was no information provided to show conformance with FDA compounding and clean room regulations.

of United Trinity Investment Group responded to the Sources Sought Notice stating that they can offer a Cleanroom Solutions trailer, which they would be leasing from Cleanroom Solutions. Due to this finding, United Trinity Investment Group would not meet the limitations on subcontracting, as the lease of the trailer by the SDVOSB from the manufacturer would be considered a subcontract to a small business which is not a like situated business concern.

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

None, this sole source is at the discretion of the Contracting Officer IAW 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute).

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

Stripes Global Inc. (SDVOSB) 245 4th Street Bremerton, WA. 98337

JMG Veteran Contracting, LLC (SDVOSB)

SDVOSB

7235 E. Hampton Avenue, Suite 111 Mesa, AZ. 85209

United Trinity Investment Group, LLC 21502 Abbey LN.

Crest Hill, IL. 60403

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:

Additional market research will be conducted by the government to ensure the circumstances justifying a sole source award today are still valid during option periods and for future like requirements. Considering technology is advancing exponentially, it is of the utmost importance to

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Effective Date: 04/15/2023 conduct market research on a continual basis to stay current on the sectors of industry we as contracting professionals contribute our expertise and business acumen in support of VA medical Centers.

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:

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 the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.