P03- JA Pulmonary Equipment - DDOC Signed.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 4 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: 36C257-24-AP-0630

JOFO #: 2023-FY24-NCO 17-603

1. Contracting Activity: Department of Veterans Affairs, VISN 17, VA North Texas Health Care System, 4500 South Lancaster Road, Dallas, TX 5216-7167. Purchase request 59-24-1-2055-0022.

2. Nature and/or Description of the Action Being Approved: This procurement is for Vyntus Pulmonary Function Testing Equipment 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. This action will be awarded as a new firm-fixed-price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Vendor shall furnish all necessary labor, equipment, tools, materials, repair service, software, parts, etc., for the installation of three (3) fully operable Vyntus Body Diffusion Systems to include software, services and protection coverage. Vendor shall provide the following resources and deliverables:

Item Number Description Quantity Unit of Measure

VYNTUS BODY DIFFUSION SYSTEM Includes 1110L body plethysmograph with 551-pound patient bench and 25-inch telescoping arm, breathing circuit (including Ultrasonic sensor, Flow Path Valve, and Demand Valve), SentrySuite software, validated WIN 10 PC with sanitizable medical keyboard/mouse, 27-inch flat panel monitor, Office Jet printer, 3-L manual syringe, DLCO pressure regulator, 6-cylinder gas stand, box of 80 MicroGard IIB filters. Tests performed: Spirometry (FVC, SVC, MVV), Lung subdivisions (VTG, FRCpl, RV, TLC, Raw, Conductance and specific resistance and Resistance Volume Loops), Real-time DLCO (both Single Breath and (No Suggestions)), MIP/MEP, and pre/post-bronchodilator. Standard software includes Guidance and Stabilitrac instructional applications, pre-formatted reports, and reference sets with design tools for modification, automated interpretation algorithms, QA checks, and physician interpretation templates. 1st-year warranty included 4 EA

STANDARD CART WITH 2 SHELVES: TOP HALF CART IS

ADJUSTABLE UP/DOWN HEIGHT left/right mousepad, 4 EA

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 2 of 4

Effective Date: 04/15/2023 monitor mount, mounting mechanism for arm, isolation transformer & cable-management spine

0003 SES CLIENT DEVICE to be configured as a network client 4 EA

0004 SERVICE-VYN-PFT FUNDMTLS TRG-3 DAYS - CUST HOSTED 2 EA

PROFESSIONAL SERVICES - CUSTOMIZED REPORTS (PACK

OF 5) PROVIDES A VYAIRE PROFESSIONAL SEVICES

RESOURCE TO CREATE 5 CUSTOM REPORT WITHIN THE

EXISTING ENVIRONMENT. Limited to a single round of customization/revisions. Once the 5 customized reports are signed off by the facility, future revisions to those same reports will be subject to additional charges. 1 EA

SERVICE-SES-CLIENT/DEVICE SW MGMT-4 YEARS:

MAINTAINS SENTRY SUITE/VMAX SOFTWARE APPLICATION

ON WORKSTATION (S); PROVIDES PROACTIVE NO 4 EA

SERVICE-VYN BODY-PROTECT PREMIUM-1 YEAR includes major system components, computer, monitor, includes major system components, computer, monitor, keyboard, mouse, and printer coverage for repairs; minor system omponent coverage for repairs; routine replacement parts allowance; expedited shipping for urgent parts needs;

ground shipping for routine/nonurgent parts needs; phone and web-based support by factory-trained, certified Technical Support specialists for remote troubleshooting and guided solutions; travel and on-site service support for repairs, by factory-trained, certified technicians; 25% list price discount on travel and on-site support by factory-trained, certified technicians to complete a System Quality Certification; priority Field Service scheduling and on-site response when your system is down, with target response time of 1-2 business days; 35% list price discount on biomedical technical training tuition; and detailed Service Report provided following on-site service visits. On-site response times typically fall within the timeframe noted above and are based on normal business hours, which are Monday through Friday, 8 am to 5 pm local time. 4 EA

0008 GAS .3%co .3%ch4 21%02 BAL N2(ED) 4 EA

Oval filter with a nose clip, single patient use, a box of 80Oval filter with a nose clip, single patient use, box of 80 4 EA

SENTRYCONNECT SEAT LICENSE FOR SES Single Seat license to connect to SentryConnect gateway- SentrySuite instrument, SentrySuite reading station, Sentry.NET remote access 4 EA

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 3 of 4

The estimated total value of the acquisition is $265,881.00. The period of performance for this is 60 days ARO with five-year warranty/support.

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (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):

Authorized or Required by Statue (FAR 6.302-5) – Veterans First Contracting Program as required by 38 U.S. Code § 8127(c); as implemented by VA Acquisition Regulation (VAAR) 819.7001(c) with guidance from revised Procurement Policy Memorandum (2016-05) (Revised Aug 2019). Contractors must be verified as a Service-Disabled Veteran-Owned Small Business (SDVOSB) to be eligible for the award. The contractor, TrillaMed LLC is currently an SDVOSB in VetCert and is determined to be a responsible source for the performance required.

The statutory limitation of a sole source acquisition under this authority is $5,000,000.00 and the total procurement value of this acquisition will be under that limit.

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: Contacted Vyaire Medical the Manufacturer for authorized distributors. It was determined that they have one authorized distributor, TrillaMed LLC, a verified SDVOSB who is active in SAM. The manufacturers themselves are capable of fulfilling the requirement as they are active in SAM. Additional market research was conducted in FPDS where awards for the same brand items have been awarded to TrillaMed LLC. No further market research was conducted for equal items as no equal item would be sufficient to fulfill the requirement as described above.

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

Reasonable: Pricing will be evaluated using a comparison to recently awarded contracts and a comparison with the Independent Government Cost Estimate. Pricing will be found fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Limited Market Research was conducted; only one brand will suffice due to the form, fit, and function of currently owned government equipment. The manufacturer is a large business and has one authorized distributor, SDVOSB, Trillamed LLC.

Nonmanufacturer Rule (NMR) findings: There is an SBA class waiver for this requirement, 72 Fed.

Reg. 72433, for NAICS code 334510. This waiver allows for a sole source to an SDVOSB.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None. This acquisition will be procured utilizing the authority under 38 USC 8127(c ).

https://www.va.gov/oal/docs/business/pps/deviationVaar20230216.pdf https://www.va.gov/oal/docs/business/pps/deviationVaar20230216.pdf https://www.va.gov/oal/docs/business/pps/deviationVaar20230216.pdf https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 4 of 4

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

TrillaMed LLC authorized distributor SDVOSB and Vyaire Medical Inc. (manufacturer) large business are the only two sources capable of fulfilling the requirement.

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:

At the time the current government server is required to be replaced, the system’s compatibility and requirements will be re-evaluated to provide for future competition.

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.

Valetta Williams North Texas Health Care System Program Manager

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.

James C. Easley Contracting Officer

NCO 17

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.

Jeff Morris Division Chief

NCO 17

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