FDA-SSN-1242412 MRI Pre-inspection and Svc Contract.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the National Center for Toxicological Research (NCTR)’s Division of Neurotoxicology in order to determine if there are existing small business sources capable of providing a number of services which are/may be required on a Bruker cryocooler which consists of two major components:

1. Cryopump: Model – CRYOMECH CP2870, serial number – CP28H7W2DQCE-160707A

2. Cold head: Model – CRYOMECH, serial number – WM332762E-160725A

First, the instrument, serial number 10216453 (consisting of the units listed above), has not been covered under a service agreement since installation and it will require a pre-inspection to determine what servicing and/or repairs it may require to put a preventative maintenance agreement in place. Note the customer indicates that to the best of their knowledge the unit is fully functional and may or may not require repairs.

Second, once the pre-inspection has been completed, if the instrument does require repairs prior to service contract initiation, a company will be required to perform the required repairs.

Third, once pre-inspection and any necessary repairs have been completed, a service agreement will be required to maintain the instrument for one year, as noted below in the Minimum Performance Requirements Section.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 811219 – Other Electronic and Precision Equipment Repair and Maintenance; with a Small Business Size Standard of $22 Million, and you believe that your firm would be able to provide the FDA with the system described below, please submit an email as instructed below. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Minimum Performance Requirements

1. Pre-Inspection

a. The Contractor shall provide pre-inspection for the Cryo-coolers

2. Necessary repairs revealed during pre-inspection:

a. Contractor shall be able to perform any repairs necessary to bring the instrument into specs so that the service contract can be put in place

3. Service Contract Requirement:

a. Cryo-cooler service requirement on a Bruker Biospec 47/40 (SN 10216453): Ensure display readings are maintained as per the below:

helium pressure (BMU): within 950 ≤ p ≤ 1200mbar helium level: ≥ 80% relative heating voltage (%): within 0 ≤ U ≤ 60%

b. Monitor the cryogen levels

c. Refill the cryostat with liquid helium at intervals defined by manufacturer’s recommendations

d. Supply the necessary refill cryogens

e. Maintain the transfer lines, cold head, Cryo-cooler, and heat exchanger

f. Generate regular reports of the magnet boil off rates and service activity.

g. In the event of catastrophic loss of magnet field (quench) during a cryogen refill by provider personnel, personnel will restore the magnet to an operating condition in accordance with magnet’s specifications.

h. In the event of catastrophic loss of magnet field (quench) during a cryogen refill by provider personnel where the magnet cannot be restored, a comparable replacement magnet will be delivered and installed on site

i. If a Cyro-cooler is not operational, the service provider will use overnight carrier services to ship repair parts to NCTR. After repairs are completed, provider will pay for the return of defective components to their facility.

j. Provide labor for one planned maintenance visits for the Cyro-cooler

k. Review the results of each planned maintenance visit with the primary user of the equipment

l. Technical phone support shall be available 9am-5:30pm Monday-Friday, excluding holidays.

m. After provider notified of equipment error, user receives required assistance via phone within 48hrs; if error not fixed, on site visit scheduled within 48hrs of initial notification.

n. Provide replacement parts as required; all parts warranted for 90 days after installation.

o. Inclusive of parts, labor, and travel.

p. Includes quality assurance-image quality inspections to achieve consistent, high-quality images within quality specifications as issued by factory

q. All parts must be OEM and all repairs/service calls must be completed by an engineer certified by the original equipment manufacturer, which is Bruker.

r. Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

s. The Maintenance and Repair activities shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

t. The Contractor shall include unlimited software and firmware updates during the coverage period(s).

u. The Contractor shall guarantee technical support Monday through Friday (excluding Federal Holidays) 8:00AM - 5:00PM Eastern Time.

v. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Service Records and Reports: The Contractor shall, commensurate with the completion of each preventive maintenance service visit, provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA COR or Technical Point of Contact (TPOC) and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Period(s) of Performance: One year, estimated as 07/15/2021 through 07/14/2022

Place of Performance

US FDA/NCTR

3900 NCTR Rd, BLDG 62, room M05 Jefferson AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service for a Cryocooler to include date of sale, description of service provided, equipment serviced, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. showing the products can meet the above requirements. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide if subcontracting opportunities exist for small business concerns.

• Though this is not a request for quote, informational pricing is encouraged.

The Government is not responsible for locating or securing any information not identified in the response.

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 12:00 pm (Central Time in Jefferson AR) on June 1, 2021 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference: FDA-SSN- 1242412.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in beta.SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

mailto:suzanne.martella@fda.hhs.gov