Preventive Maintenance and Repair Service Agreement for multiple types of Waters instrument systems

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Office of the Chief Scientist (OCS), requirement for Preventive Maintenance and Repair Service Agreement for multiple types of Waters instrument systems identified herein.   

The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is- 811210 - Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million.

Statement of Work

Purpose:

The purpose of this requirement is to obtain preventive maintenance, repair services, and related service agreement coverage for three (3) Waters Acquity H-Class systems, three (3) Waters Acquity Classic systems, seven (7) Waters Arc systems, one (1) Waters Alliance system used for the certification of color additives, and twenty (20) Waters Empower software licenses.

Background:

The U.S. Food and Drug Administration (FDA) enforces the Federal Food, Drug, and Cosmetic Act and other applicable laws and regulations intended to protect consumers’ health and safety. FDA’s Color Certification Program assures the safe use of certified color additives (synthetic dyes and pigments) in foods, drugs, cosmetics, and certain medical devices. Certified color additives are listed in 21 CFR Parts 74 and 82 together with specifications for their impurities. High-performance liquid chromatography (HPLC) is the primary technique used by certification chemists to determine levels of subsidiary colors, intermediates, and related impurities, which range from a few percentage points to nanograms per gram.

Reliable and timely maintenance and repair of the HPLC instrument systems is critical to the successful performance of FDA’s Color Certification Program. It is therefore important that these instruments be placed under a service contract. See attachment 1 for list of instruments to be covered.

A service contract (Order No. 75F40121F80010) was previously in place for the preventive maintenance and repair of Waters instruments used for the certification of color additives. That contract ended on December 7, 2024 and the instruments have been without active service contract since that time. This service contract was discontinued due to lack of funds. This requirement is to reestablish service for the Division of Color Certification and Technology’s HPLC instruments.

For purposes of this requirement, line item references herein are notional. If a future solicitation is issued, it is anticipated that Line Item 1 would be the base service agreement and Line Item 2 would be for separately quoted and approved pre-inspection repairs necessary to bring instruments to acceptable performance standards for service agreement coverage.

Because the instruments have been without active service coverage, the Contractor may determine that a pre-inspection is necessary to assess whether an instrument meets the performance standards required for service agreement coverage. If the Contractor determines that a pre-inspection is necessary, it shall be conducted during the initial scheduled preventive maintenance visit.

The pre-inspection shall be included in the service agreement price and shall not be separately billed. Any repairs, replacement parts, or additional labor or travel identified during the pre-inspection that are necessary to bring an instrument to acceptable performance standards for coverage shall be quoted separately and, if approved, billed under repair Line Item 2.

Instrument components in need of attention or repair that are known at this time:

Alliance G21SM4653A – power supply has died

Acquity H-Class F11UPL092A – suspected blockage in or just outside of flow cell

Acquity H-Class G15UPL501A – suspected dirty flow cell

Objectives

The objective of this effort is to ensure continued operational readiness and service coverage for Waters instrument systems and Empower software used in the certification of color additives.

Scope 

Independently, and not as an agent of the Government, the Contractor shall provide on-site preventive maintenance and repair, original equipment manufacturer (OEM) parts, software upgrades, and technical support for these analytical instruments and their software:

1. Three (3) Waters Acquity H-Class systems, each including a quaternary pump, a sample manager, a column compartment, and a PDA detector.
2. Three (3) Waters Acquity Classic systems, each including a quaternary pump, a sample manager, and a column compartment.
3. Seven (7) Waters Arc systems, each including a quaternary pump, a sample manager, a column compartment, and a PDA detector.
4. One (1) Waters Alliance system, including a separations module and a column compartment, and a PDA detector.
5. Twenty (20) Waters Empower software licenses used for the certification of color additives.

Specific Tasks

Task  - Preventive Maintenance, Pre-Inspection, and Repair

1. The Contractor shall provide one (1) scheduled on-site preventive maintenance visit per year for each covered instrument system.
2. During the initial scheduled preventive maintenance visit, the Contractor shall assess each instrument to determine whether a pre-inspection is necessary to evaluate whether the instrument meets the performance standards required for service agreement coverage. If the Contractor determines that a pre-inspection is necessary, the Contractor shall perform the pre-inspection during that initial scheduled preventive maintenance visit and shall conduct all necessary tests to qualify the instrument for the service agreement. Any such pre-inspection and associated testing performed during the initial scheduled preventive maintenance visit shall be included in the service agreement price and shall not be separately billed.
3. Any repairs, replacement parts, or additional labor and travel identified as necessary during the Contractor’s assessment or any pre-inspection performed during the initial scheduled preventive maintenance visit, and required to bring an instrument to acceptable performance standards for service agreement coverage, shall be quoted separately and billed under Line Item 2, Pre-Inspection Repairs, which shall have a not-to-exceed ceiling of $TBD. The Contractor shall submit a detailed written repair quote identifying the failed component or deficiency, labor hours by labor category, parts, travel, and any other applicable charges.
4. The Contractor must receive written approval from the Contracting Officer before performing any work under Line Item 2. No work under Line Item 2 shall commence without such approval, and the Contractor shall not exceed the obligated amount without prior contract modification.
5. Travel associated with the initial scheduled preventive maintenance visit, including any assessment, pre-inspection, and associated testing performed during that visit, shall be included in the service agreement price and shall not be separately billed. If separately approved repair work under Line Item 2 requires an additional return visit beyond the initial preventive maintenance visit, the associated labor, parts, and travel may be billed under Line Item 2, as approved by the Contracting Officer.
6. Once the Contractor determines that an instrument meets the performance standards required for service agreement coverage, whether through the initial scheduled preventive maintenance visit alone or through completion of any separately approved repairs under Line Item 2, the instrument shall be considered accepted into service agreement coverage. Thereafter, covered corrective maintenance and repairs during the period of performance shall be included in the service agreement price.   
7. Pricing under Line Item 1 shall include labor, travel, replacement parts, components, subassemblies, and other costs required to perform covered maintenance and repair for instruments accepted into service agreement coverage.
8. The Contractor shall coordinate mutually agreed times for each scheduled service visit and any additional repair visits as necessary. 
9. The Contractor shall perform preventive maintenance per the Waters maintenance plan and industry standards.
10. The Contractor shall provide unlimited technical support (via phone and email) for software and hardware, including equipment troubleshooting, Monday through Friday (excluding Federal Holidays).
11. The Contractor shall provide an OEM certified technician within 3-5 business days of an instrument repair request.
12. The Contractor shall provide instrument repairs, including replacement parts and, if deemed necessary, replacement of instrument components or subassemblies.  
13. Repair parts shall be installed within two (2) business days after the initial service visit. If that timeframe cannot be met, the Contracting Officer’s Representative (COR) may approve alternate arrangements in writing by email.
14. The Contractor shall supply the most up to date instrument software updates when they become available from Waters to include server software and software for standalone workstations.
15. The Contractor shall provide preventive maintenance to include at a minimum plunger replacement, plunger seal replacement, check valve replacement or rebuilding,  solvent filter replacement, draw off and reference valve rebuilding, seal pack and needle rebuilding or replacement, fluid pack rebuilding or assembly replacement, manual injector rebuilding, detector source lamp replacement, detector lens or window replacement, and mass spectrometry vacuum pump maintenance, system cleaning, fan filters, valve rebuilding, and O-rings.
16. The Contractor shall use OEM parts and materials for preventive maintenance and repairs.

Deliverables

1. If the Contractor determines that a pre-inspection is necessary, the Contractor shall provide written documentation of the pre-inspection findings, including any deficiencies identified and whether the instrument qualifies for service agreement coverage or requires repair prior to acceptance.
2. The Contractor shall provide a written repair quote for any repairs identified during the Contractor’s assessment or any pre-inspection that are necessary to bring an instrument to acceptable performance standards for service agreement coverage. The quote shall identify the failed component or deficiency, labor hours by labor category, parts, travel, and any other applicable charges.
3. The Contractor shall provide a preventive maintenance report or repair report for each component of the instrument systems upon completion of a preventive maintenance visit. Detailed performance maintenance documentation shall be provided by printed document or electronic correspondence for each component of each instrument system.
4. The Contractor shall provide a summary of their work in writing in the instrument’s designated laboratory notebook upon completion of preventive maintenance, repairs, part replacements, or other changes to an instrument system. The summary shall include the date(s) the work was done, a description of the work done, and a signature with the responsible technician’s initials.
5. The Contractor shall demonstrate the ability to provide Waters certified technicians for both on site and phone support of the Waters HPLC, UPLC, and prep-LC equipment and software. The certification must be specific to the equipment being serviced if applicable. No other technicians, engineers or personnel may service Waters HPLC, UPLC, and prep-LC equipment and software without this certification.

Security

The Contractor shall use a temporary account provided by FDA IT staff when accessing FDA workstations. The account shall be active only during scheduled site visits at the COR’s request. The Contractor shall use the credentials provided by FDA to access the account. The Contractor shall install, update, or otherwise make changes to Waters software on FDA workstations only with the approval and assistance of FDA IT staff. The Contractor shall arrange software installation, updates, and other changes with the COR and IT staff.

Period of Performance:

June 1, 2026 through May 31, 2027.

Preventive maintenance and repair visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV.

Place of Performance:

Food and Drug Administration

Office of the Chief Scientist (OCS)

4300 River Road

College Park, MD 20740

Work shall be conducted Monday through Friday, excluding federal holidays. Scheduling is to be coordinated through the COR on the Contract.

Holidays and Government Closures

The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

New Year’s Day

Martin Luther King Day

President’s Day

Memorial Day

Juneteenth Day

Independence Day

Labor Day

Columbus Day

Veteran’s Day

Thanksgiving Day

Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service.  The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

Anticipated Contract Type:

 Line Item 1 (Base Year Service Agreement) is anticipated Firm Fixed Price.

Line Item 2 (Pre-Inspection Repairs) is anticipated to be a time-and-materials, not-to-exceed line item, with funding, if applicable, to be established at time of award. The Government anticipates use of FAR RFO 12.210-1(e)(2), Unpriced Purchase Order. An unpriced purchase order is an order for supplies or services, the price of which is not established at the time of issuance of the order.

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond.  At a minimum, responses shall include the following:

• Business name, SAM Unique Entity ID 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 if responding to provide a product manufactured by another firm);
• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.
  • Technical specification shall be included for each listed item in the minimum required characteristics section in attachment 1.
• Three (3) years of past performance information, where the respondent has provided same or substantially similar product/service solutions on the same or near-same requirements. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 SAM Unique Entity ID number and size status) if not the respondent.
• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.
• 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.
• Identification of AbilityOne Contracts available that can meet the requirement.
• Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0  (MS Word) provided by the Industry Technology Industry Council (ITIC).
• Provide information if any of these specifications are too restrictive. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.
• If a large business, identify the subcontracting opportunities that would 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; and
• Though this is not a request for quote, informational pricing is required

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

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 4, 2026 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference OC-2026-133636.

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

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 sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

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).