RFI- VITEK MAINTENANCE.pdf

Request for Information (RFI)

VITEK Systems Preventive Maintenance and Service

SOLICITATION INFORMATION

Solicitation Number: FDA-SS-26-132839 Posted Date: 3/5/26 Response Date: 3/11/26 Classification Code: NAICS 811210 - Electronic and Precision Equipment Repair and Maintenance Set Aside: [To be determined]

1. INTRODUCTION

1.1 Purpose

The U.S. Food and Drug Administration (FDA), Office of Regulatory Testing and Surveillance (ORTS) is issuing this Request for Information (RFI) to gather information from qualified contractors capable of providing preventive maintenance, calibration, and repair services for VITEK laboratory systems across multiple FDA laboratory locations.

1.2 Background

The ORTS laboratory network performs scientific testing on FDA-regulated products. To ensure testing results are competent and suitable for regulatory purposes, ORA laboratories are accredited to ISO/IEC 17025:2005 standards, which require annual calibration of scientific equipment with standardized and documented procedures.

VITEK instruments are present throughout ORTS food testing laboratories and require periodic maintenance and calibration services, as well as software and computer updates.

1.3 RFI Objective

This RFI seeks to identify potential contractors with the capability, experience, and resources to provide comprehensive maintenance and support services for ORTS's fleet of VITEK, APS One, MYLA, and PREVI Color Systems. The information gathered will inform the development of a potential Indefinite Delivery/Indefinite Quantity (IDIQ) contract solicitation.

2. SCOPE OF SERVICES

2.1 Equipment Coverage

Services shall cover the following systems:

- VITEK Compact 15

- VITEK Compact 30

- VITEK Compact 60

- VITEK MS PLUS

- APS One

- MYLA

- PREVI Color Systems

2.2 Service Requirements

The anticipated contract would require:

1. Annual Preventive Maintenance (PM) : At least one scheduled PM visit per year per instrument

2. Calibration Services : ISO 17025-compliant calibrations with Service Reports/Certificates of Calibration

3. Repair Services : On-site repair calls when necessary with maximum 72-hour on-site response time

4. Technical Support : Unlimited telephone and email access Monday-Friday, 8:00 AM - 4:00 PM local time (all continental U.S. time zones)

5. Parts and Labor : Factory-certified OEM replacement parts and OEM-trained technician labor

6. Software Upgrades : Capability to provide software upgrades to extend instrument lifetime

3. PERFORMANCE LOCATIONS

Services must be performed on-site at the following FDA laboratories:

7. Arkansas Human and Animal Food Laboratory (ARHAFL) - Jefferson, AR

8. Denver Human and Animal Food Laboratory (DENHAFL) - Denver, CO

9. New York Human and Animal Food Laboratory (NYHAFL) - Jamaica, NY

10. Irvine Human and Animal Food Laboratory (IRVHAFL) - Irvine, CA

11. Seattle Human and Animal Food Laboratory (SEAHAFL) - Bothell, WA

12. San Francisco Human and Animal Food Laboratory (SANHAFL) - Alameda, CA

13. Atlanta Human and Animal Food Laboratory (ATLHAFL) - Atlanta, GA

4. ANTICIPATED CONTRACT INFORMATION

4.1 Contract Type

Indefinite Delivery/Indefinite Quantity (IDIQ)

4.2 Period of Performance

• Base Period: 1 year

• Option Periods: Four (4) one-year option periods

• Total Potential Duration: 5 years

5. INFORMATION REQUESTED

Interested parties are requested to provide the following information:

5.1 Company Information

14. Company name, address, and primary point of contact

15. DUNS number and CAGE code

16. Business size and socioeconomic status (small business, woman-owned, veteran-owned, etc.)

17. Years in business providing similar services

5.2 Technical Capabilities

18. OEM Relationship : Describe your relationship with BioMérieux as it relates to service authorization, training, and parts access

19. Technician Qualifications :

• Number of OEM-trained technicians available

• Geographic distribution of technicians

• Certification and training documentation processes

20. ISO 17025 Compliance : Experience providing calibration services compliant with ISO/IEC 17025:2005 standards

21. Response Time Capabilities : Ability to meet 72-hour on-site response time across all seven laboratory locations

22. Parts Management :

• Access to OEM factory parts (not build-to-order)

• Policy on use of salvaged parts (note: salvaged parts are not acceptable)

• Parts warranty and quality assurance processes

5.3 Experience and Past Performance

23. Contracts of similar scope, size, and complexity (preferably with federal agencies)

24. Experience servicing multi-site laboratory networks

25. Experience with the specific equipment types listed in Section 2.1

26. References from at least three (3) clients with similar requirements

5.4 Service Delivery Approach

27. Proposed approach to scheduling and coordinating PM visits across seven geographically dispersed locations

28. Technical support infrastructure (call center, help desk, remote diagnostic capabilities)

29. Quality assurance and quality control procedures

30. Documentation and reporting processes (field service reports, calibration certificates)

31. Approach to emergency repairs and expedited service

5.5 Additional Information

32. Any challenges or concerns you foresee with the requirements as described

33. Recommendations for improving service delivery or contract structure

34. Any additional services or value-added capabilities you can provide

35. Minimum order quantities or other limitations

SUBMISSION INSTRUCTIONS

Responses to this RFI should be submitted electronically to Nina Montgomery;

nina.montgomery@fda.hhs.gov no later than March 11, 2026 at 10:00AM (EST). Please reference the RFI number in the subject line.

IMPORTANT NOTICES

36. This is NOT a solicitation:This RFI does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. It does not commit the Government to contract for any supply or service.

37. No reimbursement:The Government will not pay for information provided in response to this RFI or reimburse any costs incurred in preparing responses.

38. No evaluation:Responses will not be evaluated or scored. Information provided will be used for market research purposes only.

39. Proprietary information:If your response contains proprietary information, please clearly mark it as such. The Government will protect such information to the extent permitted by law.

40. Follow-on actions:Based on responses received, the Government may issue a formal solicitation. Companies responding to this RFI are not guaranteed consideration in any future solicitation.

POINTS OF CONTACT

Contracting Officer: Nina Montgomery; nina.montgomery@fda.hhs.gov mailto:nina.montgomery@fda.hhs.gov