S02-BNJ- Gastrocheck Gastrolyzer Breath Monitors.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Request for Brand Name Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH IAW FAR 13.106-1

For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C256-23-AP-0831

1. Contracting Activity: Department of Veterans Affairs Network Contracting Office (NCO) 16 Galleria Financial Center, Ste 750 5075 Westheimer Rd Houston, TX 77030

PR#: 520-23-1-031-0008

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Network Contracting Office (NCO) 16 intends to award a new, firm fixed price, brand name, purchase order for two Bedfont Scientific LTD (BSL) gastrocheck gastrolyzer monitors. This request is for BSL Gastrolyzer Monitors.

Estimated Dollar Value:

Required Delivery Date: 30 days ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Per FAR11.105, Items peculiar to one manufacturer and 12.4 Unique Requirements Regarding Terms and Conditions for Commercial Items. BSL, is uniquely qualified to provide the two BSL gastrocheck gastrolyzer monitors based on the following:

BSL gastrocheck gastrolyzer is world renowned for delivering accurate hydrogen and methane breath testing. The BSL gastrocheck gastrolyzer, is the only equipment in the industry that provides breath analysis for intolerances in lactose, fructose, fructan, sucrose, sorbitol, and xylitol. BSL gastrocheck gastrolyzer, is the only equipment in the industry that has a color touch screen and an on board patient coaching that is dynamic for Veterans.

Breath monitors is a non-invasive medical device that assist doctors in the diagnosis and management of a number of conditions and disorders.

The gastrocheck gastrolyzer breath monitor provide breath analysis for intolerances and malabsorption issues such as fructose, sorbitol, sucrose, fructan, xylitol, and testing for small intestinal bacterial overgrowth.

Last Updated: 02/01/22 Page 2 of 5

The gastrocheck gastrolyzer breath monitor provide instant, non-invasive measurement of methane and hydrogen in lungs. This feature permits doctors to arrive at a diagnosis quickly and accurately and allows patient to have better quality of life and gut health.

The gastrocheck gastrolyzer breath monitor allow for sampling with mouthpiece or breath bag.

The gastrocheck gastrolyzer breath monitor provide instant on and little to no warmup time for operation. The BSL gastrocheck gastrolyzer monitors possess the shortest warmup in the industry thereby spending more time testing less time waiting.

The gastrocheck gastrolyzer breath monitor possess a large color touch screen that works with gloves.

The gastrocheck gastrolyzer breath monitor includes an exhalation guide that coaches patients through entire exhalation process to ensure proper technique and accurate results.

The gastrocheck gastrolyzer breath monitor requires only monthly calibration with instruction and automatic reminder.

The gastrocheck gastrolyzer breath monitor Automatic sample correction using oxygen as a correction factor.

4. Description of market research conducted and results or statement why it was not conducted:

Veteran Small Business Certification (VetCert), Sources Sought Notice, Supply Chain Master Catalog (SCMC), General Services Administration (GSA), Federal Procurement Data System (FPDS) and the Internet were reviewed with the following results:

Veteran Small Business Certification (VetCert) was searched with North American Industry Classification System (NAICS) 334519 to identify verified capable Service Disabled Veteran Owned Small Businesses (SDVOSBs) and Veteran Owned Small Business (VOSBs). NAICS search identified 142 various SDVOSBs and VOSBs.

a. Market research was conducted by the service line identifying the coVita gastrocheck gastrolyzer, that’s manufactured in the UK as the only product in the industry with the following capabilities:

Provide breath analysis for the following:

i. Lactose Intolerance

ii. Fructose Intolerance

iii. Fructan Intolerance

iv. Sucrose Intolerance

Last Updated: 02/01/22 Page 3 of 5

v. Sorbitol Intolerance

vi. Xylitol Intolerance

b. Provide breath analysis for small intestinal bacterial overgrowth.

c. Provide instant, non-invasive measurement of methane and hydrogen in lungs.

d. Allow sampling with mouthpiece or breath bag.

e. Provide instant on/ little to no warmup time.

f. Large color touch screen.

g. Exhalation guide with patient coaching for proper patient technique.

h. Monthly calibration with instruction and automatic reminder.

i. Automatic sample correction using oxygen as a correction factor.

j. Built in protocols.

CO posted Sources Sought Notice (SSN) 36C25623Q0224 to contracting opportunities on December 13, 2022 with a close date for December 19, 2022, specifically searching for gastrocheck gastrolyzer monitors and other authorized distributors. There was only one response received from Aviate Enterprises Inc., a service disabled veteran owned small business (SDVOSB), communicating their interest to provide gastrocheck gastrolyzer breath monitors. Aviate Enterprises Inc., is not a manufacturer of the product, as well did not provide any documentation to being an OEM authorized distributor or reseller. Aviate Enterprises Inc., can still provide the OEM authorization during the solicitation phase and will be technically evaluated with the factors established in the solicitation.

No alternate product proposals were received from this SSN posting. Also, no questions were posed by interested vendors or submitted from the market regarding said notification, specific equipment or any identified salient characteristics as identified within SSN.

Additional market research by the CO, illustrated Bedfont Scientific LTD as the original equipment manufacturer (OEM) in the United Kingdom (UK) for the Gastrocheck gastrolyzer breath monitor. CLLC, is the authorized distributor and reseller for the OEM. The coVita gastrocheck gastrolyzer breath monitor is the reseller product name.

CO searched the Supply Chain Master Catalog (SCMC) under Gastrolyzer, resulting in no findings. CO also searched the SCMC under gastroenterology testing, resulting in findings as a service requirement for gastroenterology testing. CO further searched the SCMC under breath monitor as a keyword, resulting in ventilator monitoring for intubated patients versus gastrolyzer. CO searched SCMC under breath tracker, resulting in no findings.

CO posted notice RFQ1601303 on General Services Administration (GSA) December 27, 2022 to December 29, 2022 seeking sources for coVita gastrocheck breath monitors to 74 vendors. Zero responses were received from the industry on GSA. No alternate products were communicate from industry for any types of gastrolyzers to support the government need.

CO searched FPDS under keyword coVita, resulting in seven past awards to the Veteran Affairs (VA) from September 28, 2010 to September 21, 2015 for carbon monoxide (CO)

Last Updated: 02/01/22 Page 4 of 5 monitors and Smokerlyzer. In addition, to one award to the Health and Human Services on April 01, 2014 with no detail description. CO further searched Federal Procurement Data System (FPDS) using keyword gastrolyzer, resulting in zero awards identified. CO also search under keyword breath monitor resulting in 12 diverse results. Nine awards were by National Aeronautics and Space Administration (NASA) for research and development, one award by the Department of Army for carbon monoxide monitoring and two awards by the Veteran Affairs that included one for carbon monoxide monitoring and one for sleuth hydrogen breath testing (HBT) monitors.

After finding the previous award to Breathe E Z System Inc (BEZSI) for sleuth hydrogen breath testing (HBT) monitors, CO conducted an FPDS search for BEZSI. Results showed the Veteran Affairs awarded four purchase orders to BEZSI for HBT sleuth monitors from 2007 to 2009. CO than conducted a search on system award management (SAM) to validate if BEZSI is still active. SAM illustrated BEZSI under its unique entity identification number XEVRXFV1CP46, which showed it has been placed as “inactive”, as of December 26, 2019.

CO also conducted a google search for HBT sleuth monitor by BEZSI, which did result in finding the Gastrogenius breath monitor. A nondomestic product by a large business Laborie Medical Technology Corp (LMTC) and another authorized reseller/distributor for Bedfont Scientific (OEM). CO searched FPDS under keyword Gastrogenius, attempting to identify if any awards were made, resulting in zero returns. CO also reviewed BEZSI website for products, of which it clearly identified that the Gastrogenius breath monitor is not available for sale in the United States.

CO searched Veteran Small Business Certification (VetCert) on 01/19/2023 using NAICS 334519 to identify verified and capable SDVOSBs and VOSBs. The search resulted in identifying 142 various SDVOSBs and VOSBs with NAICS. Only one SDVOSB responded to the SSN (Aviate Enterprises Inc). Market research determined the VA Rule of Two cannot be met within this specific requirement.

A significant amount of time was devoted to locating any possible domestic manufacturers of gastrolyzers. No other sources communicated domestic product availability, none communicated an alternate product or questioned the salient characteristics from the SSN 36C25623Q0224 posted on contracting opportunities. CO only identified Bedfont Scientific LTD as a manufacturer in the UK.

The NMR does not apply to this procurement and SBA has not provided a class waiver for the NAICS. This procurement will be competed as 100% Small Business Set Aside.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-

1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the S19 Open Market (FAR13) Award Documentation Form with Abstract to document price reasonableness.

Last Updated: 02/01/22 Page 5 of 5

Anthony Marion Date Contracting Officer

ANTHONY

MARION

Digitally signed by ANTHONY

MARION

Date: 2023.04.14 14:44:32 -05'00'