SSN.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 Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable providing a Preventative Maintenance (PM) and unlimited repair service contract on a Werfen ACL TOP 550 coagulation analyzer (Ser #: 21091977). The instrument was purchased in 2021 and is currently covered under a service contract with the manufacturer which will expire as of 03/31/2024.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 811210 – Electronic and Precision Equipment Repair and Maintenance; with a Small Business Size Standard of $34 Million, and you believe that your firm would be able to provide the FDA with the service described below, please submit an email to suzanne.martella@fda.hhs.gov.

Other than small business concerns are also encouraged to submit capability statements. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements.

The PM and unlimited repair service contract shall consist of a Base year plus four (4) possible one-year options. Each year shall be funded at the time the option year is exercised; options will be exercised based on funds availability and the needs of the Federal Government. The initial Service period shall be for one year and the subsequent periods of performance may be renewed at the government’s option for the period between 12-24 months, 24-36 months, 36-48 months and 48-60 months beyond the initial contract service period. Contractor quotes shall include details of the items covered under the service contract, any differing levels of the plan that are available, and the levels of service response that are available.

Minimum Performance Requirements for the Preventative Maintenance & Unlimited Repair Service Contract

1. The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year which shall include all labor, travel, and OEM factory-certified replacement parts, components, subassemblies, etc., as well as consumables.

mailto:suzanne.martella@fda.hhs.gov

2. The 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.

3. The offeror shall provide certified Original Equipment Manufacturer (OEM) parts for all repairs and maintenance.

4. All maintenance and repair activities shall be performed by service technicians/engineers who are formally trained and certified by the original manufacturer. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. All repairs and PM services shall be performed following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.

5. Service contract shall include unlimited free OEM system software, firmware and hardware support and updates.

6. The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 6:00AM - 5:00PM Eastern Time.

7. The contract shall enable the FDA Technical Point of Contact (TPOC) and system operator personnel to have access to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

8. All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. for the ACL TOP 550 coagulation analyzer.

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/TPOC and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Period(s) of Performance: Anticipated to be a Base plus four (4) Option Years with projected period of performance dates estimated as:

Base Year: 04/01/2024 – 03/31/2025 Option Year 1: 04/01/2025 – 03/31/2026 Option Year 2: 04/01/2026 – 03/31/2027 Option Year 3: 04/01/2027 – 03/31/2028 Option Year 4: 04/01/2028 – 03/31/2029

Place of Performance

The equipment is located and shall be maintained at the Center for Biologics Evaluation and Research (CBER) at the following address:

US FDA/CBER

10903 New Hampshire Avenue Building 52/72, Room 4234A Silver Spring, MD 20993-0002

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, Unique Entity ID (SAM) 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 to include date of sale, description, 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 Unique Entity ID (SAM) number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing or selling.

• 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.

• The offeror’s capability to initiate service within 3 days of original notification.

• 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 applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.

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

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes.

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 11:00am (Central Time in Jefferson AR) on January 25, 2024 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40124SSN121766.

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 or combined synopsis/ solicitation may be published in 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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.

mailto:suzanne.martella@fda.hhs.gov