36C26226Q0748.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Contract Specialist Jasmine Pressley-Barnard jasmine.pressley-barnard@va.gov 602-860-7808

PLACE OF PERFORMANCE

New Mexico VA Health Care System

1501 San Pedro SE

Albuquerque NM

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION.

SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e).

DISCLAIMER

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

SOURCES SOUGHT/RFI DESCRIPTION

This is NOT a solicitation announcement. This is a RFI only. The purpose of this RFI is to gain information about potential qualified sources and their size classification relative to NAICS 339112 (size standard of 1,000 Employees). Responses to this RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this RFI, further RFIs and/or a solicitation or other announcements may be published.

The Department of Veterans Affairs (VA) is seeking sources capable of providing replacement of stability chambers for New Mexico VA Health Care System.

The list of DRAFT characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required.

If your company is interested and capable of providing the required supplies and services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:

(1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SALIENT CHARACTERISTICS requirements. For instances where your company cannot meet the SALIENT CHARACTERISTICS, please explain. For instances where your company can meet the SALIENT CHARACTERISTICS requirement(s), please show how your company meets/exceeds each requirement.

(2) Please review the list of SALIENT CHARACTERISTICS requirements and provide any additional feedback or suggestions. If none, please reply as N/A.

(3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.

(4) Is your company considered small under the NAICS code identified in this RFI?

(5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SALIENT CHARACTERISTICS?

(6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available).

(7) If you’re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified.

(8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6?

(9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items?

(10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice?

(11) Please indicate whether your product conforms to the requirements of the Buy American Act?

(12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate.

(13) What is estimated life span of your solution? What support/services does that entail?

(14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained.

(15) Does your organization offer a leasing solution? Please elaborate.

(16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s).

(17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract.

(18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

(19) Please provide your SAM.gov Unique Entity ID/Cage Code number.

Responses to this notice shall be submitted via email to jasmine.pressley-barnard@va.gov. Telephone responses will not be accepted. Responses must be received no later than Tuesday, May 5, 2025 by 10:00 AM PT Local.

All responses to this Sources Sought/RFI will be used for planning purposes only. Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.

STATEMENT OF WORK

1. BACKGROUND

The VA Cooperative Studies Program in Albuquerque, needs a replacement of stability chambers. The stability chambers that are currently being used are over 10 years old and have been in default several times with major parts having to be replaced. New stability chambers that will be installed and validated will help ensure the quality, safety, and efficacy of drug products over their intended shelf life.

2. SCOPE

The contractor shall provide all equipment, parts, installation, and training.

3. SPECIFIC TASKS

DELIVERABLES

1. One year of Sensolv Monitoring Service

2. Compressed air connection (includes solenoid valve and flow meter for customer's facility supplied dry air hookup. Exact dewpoint and cfm necessary will be unique to each application and cannot be specified. Generally, it is recommended to have an air supply rated at 40 degrees C lower dewpoint than chamber setpoint. Tanks of compressed air are not acceptable.

3. Kason 171 Series Edgemount Magnetic Latch, straight, chrome, with lock and two keys.

4. Open wire stainless steel shelf for -034 model chambers, priced per each. Includes shelf clips.

5. Total standard freight for chamber(s) above (does not include inside delivery, or other additional services--please call for quote if a forklift or receiving dock are not available). Please note--If other carrier is selected, additional packaging charges will apply, and incoterms will default to EXW. Liftgate service is included.

6. White Glove Installation Service. This option includes delivery with ground level access, uncrating and removal of debris, installation of casters, final placement of chambers (to accessible, unobstructed site), basic initial start-up, and owner training by technicians. Does not include transport of chamber up or down steps, or other additional services not specifically stated herein. This option minimizes warranty issues and startup issues.

7. Provide the labor, equipment and travel to perform the Commissioning, Calibration and Qualification Services located at your Albuquerque, NM Pharmaceutical Coordinating Center facility for the controlled environmental chambers.

8. Calibrations of the controls and instrumentation of each chamber, traceable to the National Institute of Standards and Technology (NIST). The Commissioning, Calibration and Qualification of: (2) PH034 reach-in temperature and relative humidity controlled environmental chambers (using 12 thermocouples and 4 RH sensors) with Kaye RF Valprobes.

9. Each chamber's instruments will receive three-point calibration verification or in accordance with the manufacturer’s recommendations. The “as-found” readings will be documented and the device returned to service. In the event that the “as-found” readings are not within the stated accuracy, the device will be calibrated using the manufacturer’s calibration procedure. After calibrating the instrument, the “as-left” readings will be documented using the same points from the calibration verification to verify the instrument is reading with-in the manufacturer’s stated accuracy.

10. THE COMMISSIONING: For each chamber being commissioned, a commissioning document will include a checklist to verify the chamber is functioning per manufacturer’s specifications, label plate information and manufacture Operation and Maintenance Manuals.

11. THE QUALIFICATION: Darwin Chambers’s standard Qualification Protocols will be submitted for your review and approval. Each Protocol will include (1) IQ section, (1) unloaded OQ mapping tests, and (1) loaded PQ mapping tests, (load provided by client) including (1) Open Door Demonstrations and (1) Power Down/Failure Demonstration. All RF Valprobes are calibrated yearly to NIST. Data for each test will be collected at 5-minute intervals and presented using standard Kaye Qualification and Qualification Summary Reports. The maximum and minimum data reported during the 24-hour interval will be presented using the Kaye Qualification Summary Reports and will be summarized in table and graphical form in the final report. All deviations noted during the execution of the protocol will be discussed in the executor's final report.

Stability Chambers must have following salient characteristics:

1. 25C/60%RH

2. 30C/65%RH

3. 40C/75%RH

4. Accelerated stability testing is a critical step in pharmaceutical development used to evaluate a drug product’s stability under controlled environmental conditions, such as elevated temperature and humidity. The is to predict the product’s shelf life and identify potential degradation pathways in a short time frame compared to real-time stability testing.

4. PERFORMANCE MONITORING

Installation will be performed by a certified manufacturer-trained service engineer. Installation Qualification (IQ) and Operational Qualification (OQ) will be performed by the manufacturer-trained service engineer to ensure proper working specifications.

5. SECURITY REQUIREMENTS

This procurement is primarily for goods (equipment and software), but there is an installation component as well. Contractor’s personnel shall be required to come to the CSPCRPCC facility to install the equipment. Contractor’s personnel shall have no access to VA IT systems, PHI, or any equipment connected to the VA network.

Additionally, contractor personnel shall be escorted and monitored at all times by a CSPCRPCC staff member as mandated and strictly enforced according to CSPCRPCC security policy.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

6. PLACE OF PERFORMANCE

VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106

7. PERIOD OF PERFORMANCE

Contractor must deliver equipment no later than (NLT) 3-months after receipt of contract and complete all services NLT 6-months after receipt of contract.

Sources Sought Notice