Signed BNJ Pulmonay Function System.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Brand Name Justification Template >SAT $7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 4

REVISION: 01

Acquisition ID#: 36C259 25 AP 2225

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C259-25-AP-2225 JOFOC Tracker Number: FY25 - NCO 19 - 1343

1. Contracting Activity: Organizational Activity:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 19 (NCO 19) Rocky Mountain Regional VA Medical Center 6162 South Willow Drive, Suite 300 1700 N Wheeling Street Greenwood Village, CO 80111 Aurora, CO 80045

2237# 554-25-2-081-0153

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

This procurement is for replacement of end of life pulmonary function testing equipment at the Rocky Mountain Regional VA Medical Center (RMR VAMC) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items..

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

The Rocky Mountain Regional VAMC (RMR VAMC) would like to procure Vyntus One PFTs and Vyntus One Complete systems as well as upgrades and support for the systems.

They require pulmonary function testing equipment that includes spirometry with flow volume loop graphics, maximum pressure measurements (MIP/MEP), Bronchial Challenge, Cardiopulmonary stress testing, Nitrogen washout, Plethysmography and diffusion capacity in one unit and is compatible with Somnoware. The Equipment should be capable of communicating with VA electronic medical record.

The estimated value of the proposed action is

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. Competition is restricted on this procurement for the reason below:

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute

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Acquisition ID#: 36C259 25 AP 2225

( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Vyntus ONE is the only brand that offers complete pulmonary function testing such as spirometry, Diffusing Capacity of the Lungs for carbon monoxide (DLCO), Bronchial Challenge, nitrogen washout lung volumes, Lung Clearance Index (LCI) and MIP/MEP. The Vyntus One can also run the body box as well as be expanded to do cardiopulmonary stress testing.

The Vyntus BODY is the only body box with digital pressure compensation to reduce environmental influences and improve measurement accuracy. It is the only body box with 1110 liters capacity. The bench is rated for 550 lbs. The Vyntus BODY box is also the only system that can provide Resistance-Volume charts. Jaeger Medical is the only manufacturer that offers an isothermal lung for monthly body box Functional Residual Capacity (FRC) check. Vyntus multigas analyzer for diffusion measurements is the only one with a response time of less than 150 milliseconds and ultrasonic flow sensor factory calibrated that has 1000hz sampling rate that meets 2017 American Thoracic Society/European Respiratory Society (ATS/ERS) DLCO guidelines for flow sensor accuracy of +/- 2%. Jaeger Medical is the only vendor who can provide a validated bacterial/viral applicable filter which works with Jaeger Medical Pulmonary Function Test (PFT) system (per Nelson laboratories and Senetics third-party validation). The Vyntus ONE is the only system that provides the trusted General Electric (GE) cardiosoft Electrocardiogram (ECG) system. Jaeger Vyntus utilizes SentrySuite software includes textual, visual and audible guidance when the 6 seconds of exhalation has been achieved. The Jaeger Vyntus system is the only system that will integrate with the current equipment, data base and uses Sentry Suite software.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Sources Sought (36C25925Q0317) was posted on Contract Opportunities on 3/20/24.

Two (2) SDVOSB responded: Walker and Marshall Management Services L.L.C and BHPE. Additional information was requested from the vendors on if their items were on an existing contract, but as of today, 4/16/2025, no response was received. Contacted Jaeger Medical America Inc on 3/24/24. Mark Williams RRT, Sales Consultant of Jaeger Medical, responded that Jaeger Medical America Inc (SB) is the Manufacturer of all Vyntus products and will provide quote. He also stated TrillaMed LLC (SDVOSB) was their authorized distributor. Further searches were conducted on DSBS resulted in zero

(0) vendors, FPDS resulted in four (4) vendors (Trillamed, Jaeger Medical America Inc, Vynaire Medical 211 Inc now Jaeger, and Carefusion 211 Inc under Vynaire now Jaeger), and GSA Advantage resulted in one (1) vendor, TrillaMed LLC found to have most of the items.

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

The price will be analyzed in accordance with FAR 13.106-3(a)(2) to ensure it is fair and

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Acquisition ID#: 36C259 25 AP 2225 reasonable. The price will be compared to previous prices paid by the Government for comparable requirement. The price will also be compared to the Independent Government Cost Estimate (IGCE).

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

Reasons Market Research Was Not Conducted:

Other vendors (NDD, Cosmed, PulmOne and MedGraphics) contacted by the station’s end user were not able to utilize SentrySuite, cannot communicate with our Electronic Medical Record (EMR) and were not able to integrate with remaining pulmonary function testing equipment. Other vendors did not integrate all required testing functions in one unit or were not able to perform all required testing functions.

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

Use of alternate vendor requires replacement of three (3) additonal testing units, new database build and replacement of software used in the HL7 link which would increase the cost in manpower hours. IT/BioMed would have to build a second database server and maintain two database servers since not all of the equipment would be able to use the same database.

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

TrillaMed LLC, Jaeger Medical America Inc, Walker and Marshall Management

Services L.L.C and BHPE

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:

No further actions are contemplated as this requirement is proprietary to the manufacturer.

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.

Date

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.

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Acquisition ID#: 36C259 25 AP 2225

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.

5/16/25