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**IMPORTANT: Please read this email notice in full BEFORE responding!**

The Veterans Health Administration (VHA), Program Contracting Activity Central (PCAC) is in the process of planning a requirement in which a contractor will be required to provide a Vyaire Medical Vyntus One PC System and Body Diffusion System pulmonary function analyzer (brand name or equal) for use in the new VA Pacific Islands Health Care System, Akaka VA Clinic (see P02 - SOW - Honolulu Pkg 6 - Pulmonary Analyzer - v1.1 1.5.23 DRAFT)

The VA is conducting market research and is seeking written responses with information to assist with identifying potential sources that are interested in, and capable of, providing the products described (in whole or in part). The VA is seeking responses from both NON-MANUFACTURER AUTHORIZED DEALERS/DISTRIBUTORS AND SMALL BUSINESS MANUFACTURERS of the identified brand name or potential equivalent equipment.

Please review the information contained herein and identify whether your company has the capability and interest to provide the brand name items listed or equivalent items that possess the salient characteristics as described. Please see section titled SUBMITTAL OF RFI RESPONSE below for what information to include in your company s response.

GOVERNMENT QUESTIONS
The VA is requesting vendors answer the following questions in response to this notice.

Are there any specifications for individual items that you believe may be too restrictive when taking into consideration industry standards (see draft Statement of Work)? What specifications and why?
Are there any accessories for any equipment item that are normally separately priced? What accessories?
Are there any items that you would recommend be purchased with the items in this requirement? What items and why?
Does your company manufacture the items in accordance with the Limitations on Subcontracting (see FAR 52.219-14, 52.219-27, and 13 C.F.R. § 125.6) or supply the product of a small business manufactured in the United States?
If you answered yes to question 6 and are the original equipment manufacturer, does your company have authorized distributors?
If you answered yes to question 7, please provide the business information, point of contact information, and identify the socio-economic category of your authorized distributors.
SDVOSB Service-Disabled Veteran-Owned Small Business
VOSB Veteran-Owned Small Business
SB Small Business
Please indicate the lead time for all equipment on this requirement.
Please indicate if there is additional delivery times for shipments from mainland U.S. to Hawaii (OCONUS).
CLIN
DESCRIPTION
QTY
LEAD TIME
0001
VYNTUS ONE PC System (Brand Name or Equal)
1

0002
VYNTUS BODY DIFF ADD Diffusion system (Brand Name or Equal)
1

0003
GAS .3%CO .3%CH4 21%02 BAL N2 (ED) (Brand Name or Equal)
2

0004
GAS- 99.00% OXYGEN(USP) (Brand Name or Equal)
1

0005
GAS 16%O2 5%CO2 0.3%CO/CH4/BAL N2 E CYL (Brand Name or Equal)
1

0006
ITGV SIMULATOR (Brand Name or Equal)
1

0007
Power Cord Hospital Grace (Brand Name or Equal)
1

0008
SES STANDALONE Device to be configured as a standalone (Brand Name or Equal)
1

0009
Additional Breathing Circuit for Vyntus ONE (Brand Name or Equal)
1

0010
Additional Breathing Circuit for Vyntus BODY (Brand Name or Equal)
1

0011
VYN-PFT Fundamentals Training, 3-day Customer Hosted for four (4) staff (Brand Name or Equal)
1

0012
SERVICE-VYN ONE PFT/DL+BODY-PROTECT BASIC (Brand Name or Equal)
1

0013
SERVICE-SES-CLIENT/DEVICE SW MGMT (Brand Name or Equal)
1
Is there any reason you would not be interested in responding to a solicitation? What are the reason(s) and why?
Do you have any questions or comments that may otherwise assist us?

SET-ASIDE
Complete responses to this notice will assist the VA in determining any potential set-aside for the requirement. Not providing all information requested in response to this notice may result in the VA being unable to determine a vendor potentially capable of satisfying the requirement and, subsequently, if the rule of two criteria is not met, a specific set-aside category may not be decided by the Contracting Officer.

USE OF CONRACTOR SUPPORT SERVICES
Prospective contractors are hereby notified that the Department of Veterans Affairs utilized the following contractors as official advisors:

Strategic Medical Equipment Solutions, LLC

Contractor personnel signed a non-disclosure agreement. Advisors are bound contractually by organizational conflict of interest and disclosure clauses with respect to proprietary information. For this acquisition, an OCI does exist. Therefore, Strategic Medical Equipment Solutions, LLC will be barred from submitting a quote as a prime, teaming partner, or subcontractor.

SOLICITING PRIOR TO THE AVAILABILITY OF FUNDS
Funds are not presently available for this acquisition. No contract award will be made until appropriated funds are made available. It is anticipated funds will become available in early Fiscal Year 2023. The Government reserves the right to cancel this solicitation, either before or after the closing date, and not award a contract. In the event the Government cancels this solicitation, the Government has no obligation to reimburse any Offeror for any costs incurred.

AUTHORIZED DEALER/DISTRIBUTOR VERIFICATION
Per VHA specific requirements set forth in VHAPM Part 813.106 (paragraph 2.3) and VAAR Clause 852.212-71 Gray Market (medical supplies/equipment), 852.212-72 Gray Market and Counterfeit Items, or 852.212-73 Gray Market and Counterfeit Items Information Technology (IT) Maintenance Allowing Other-than-New-Parts, the VHA aims to prevent the sale of gray market goods, defined as goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

This requirement is for new equipment ONLY; remanufactured or gray market items will not be accepted. Gray market, also known as parallel market is the trade of a commodity through distribution channels which, while legal, are unofficial, unauthorized, or unintended by the original manufacturer.
Any vendor interested in this requirement shall be an Original Equipment Manufacturer (OEM) authorized dealer or distributor for the proposed equipment/system such that OEM warranty and services are provided and maintained by the OEM or that the OEM gives authorization to the vendor to fulfill all warranty, service, and/or preventative maintenance obligations for the equipment on their behalf. All software licensing, warranties, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

To assist the VA in determining any potential set-aside, we are requesting vendors provide the authorized dealer/distributor letter in response to this Request for Information (RFI). Any future solicitation will include the requirement for vendors to provide authorized dealer verification for all items of equipment. To satisfy this requirement, the vendor shall provide the original documentation from the manufacturer stating they are an authorized dealer/distributor for the items being procured. This letter shall be on the manufacturers official letter head or from an official manufacturer email and guarantees the products are safe, are not counterfeit or adulterated devices, have maintained adequate storage conditions, and that:

All product warranties and service and/or preventative maintenance agreements transfer to the VA and will be honored by the OEM or Guarantees that the OEM gives authorization to the vendor to fulfill all warranty, service, and/or preventative maintenance obligations for the equipment.

LIMITATIONS ON SUBCONTRACTING AND THE NON-MANUFACTURER RULE (NMR)
The requirement that a non-manufacturer supply the product of a small business concern is referred as the Non-Manufacturer Rule (NMR) [13 C.F.R. § 121.406]. In order to qualify as a small business concern for a small business set-aside, an offeror must either manufacture the item in accordance with the Limitations on Subcontracting (see FAR section 52.219-14, 52.219-27 and 13 C.F.R. § 125.6) or supply the product of a small business made in the United States.

BUY AMERICAN ACT
In accordance with FAR 25.101, the Buy American Statute restricts the purchase of supplies that are not domestic end products. The exception at FAR 25.103(b) Nonavailability states the Buy American statute does not apply with respect to articles, materials, or supplies if articles, materials, or supplies of the class or kind to be acquired, either as end items or components, are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Any solicitation will include FAR 52.225-1, Buy American-Supplies (JAN 2021).

Please provide the country of manufacture for each line item.

Line Item No.
Country of Origin
0001

0002

0003

0004

0005

0006

0007

0008

0009

0010

0011

0012

0013
AMERICAN MADE SOUGHT
The Government is seeking potential alternatives manufactured in the United States if the brand name basis of design brand is not manufactured in the United States. If you have or are offering an American made alternative, please provide the manufacturer, make, model, and part number for each item and the location of manufacture. Please also include item specifications so the facility can determine whether the alternative meets the required salient characteristics.

SALIENT CHARACTERISTICS/DELIVERY SPECIFICATIONS/WARRANTY SPECIFICATIONS
See attached Updated Statement of Work (SOW) as of 1/5/2023 including salient characteristics (ATTACHMENT 1).

SUBMITTAL OF RFI RESPONSE
If you believe you are capable of meeting this requirement (in whole or in part), please provide a complete response no later than Friday January 13, 2023 at 1:00 PM (Eastern). A complete response satisfies the information requested below.

The Government requests responders provide the following information:
Company information including name, address, point of contact, and DUNS Number
The make and model information for each item,
If an equivalent item will be proposed, cut sheets containing specifications,
Authorized dealer verification (see below),
The contract number of any applicable GSA schedule if one exists from which these items can be procured, and
Answers to government questions

STATEMENT OF WORK COMMENTS
The Government welcomes any comments or questions on the DRAFT Statement of Work associated with this requirement. Please provide clear comments or questions and provide the page and section reference for each comment or question.

NAICS AND PSC CODES
Further, if you believe a different NAICS code or Product Service Code (PSC) is a better fit for the subject requirement, please provide that information to us as well.

NAICS: 339112 Surgical and Medical Instrument Manufacturing [Size Standard: 1000 Employees]
PSC: 6515 Medical and Surgical Instruments, Equipment, and Supplies

NOTE: This email is being sent solely for information and planning purposes and does not constitute a solicitation or obligation on the part of the Government. Per FAR 15.201(e), responses to this notice are not considered offers, shall not be used as a proposal, and cannot be accepted by the Government to form a binding contract. Neither unsolicited proposals nor any other kinds of offers will be considered in response to this notice. No evaluation letters and/or results will be issued to the respondents; however, the Government does reserve the right to contact any respondent and/or respondent reference to obtain additional information. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. Any resulting procurement action will be the subject of a separate, future announcement. The information is provided for discussion purposes and any potential strategy for this acquisition may change prior to any solicitation release. The acquisition strategy, evaluation methodology, contract type, and any other acquisition decisions are to be determined.

ATTACHMENTS:
P02 - SOW - Honolulu Pkg 6 - Pulmonary Analyzer - v1.1 1.5.23 DRAFT
/END OF NOTICE/

Attachments/Links