Attachment 1 - SOW.pdf

CDRH-2025-126236

Attachment 1, Statement of Work Annual Maintenance for Agilent G6495BA Triple Quadrupole LC/MS System

STATEMENT OF WORK

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

ANNUAL MAINTENANCE FOR

AGILENT G6495BA TRIPLE QUADRUPOLE LC/MS SYSTEM

1 BACKGROUND

The U.S. Food and Drug Administration (FDA) is committed to protecting public health by ensuring the safety, effectiveness, and quality of drugs, medical devices, food, cosmetics, and radiation-emitting products. In addition to regulatory oversight, the FDA promotes innovation and provides science-based guidance to support the safe and effective use of regulated products.

The Center for Devices and Radiological Health (CDRH), a key component of the FDA, ensures that medical devices and radiation-emitting products are safe, effective, and available to patients and providers in a timely manner. CDRH advances regulatory science, fosters transparent and predictable review pathways, and provides stakeholders with clear, evidence-based information.

As part of its regulatory science initiatives, CDRH employs advanced analytical tools to support the chemical characterization of medical device materials. Since January 2020, the Office of Science and Engineering Laboratories has operated an Agilent 1290 liquid chromatography system coupled with an Agilent 6495C triple quadrupole mass spectrometer (LC-Q3). This system plays a critical role in identifying extractable and leachable compounds from device materials—data that directly inform toxicological risk assessments and support regulatory decision-making.

The LC-Q3 is used routinely and underpins key research projects aimed at improving analytical methodologies, reducing reliance on animal testing, and generating high-quality, quantitative data. Expanding FDA’s capabilities in analytical chemistry helps advance consensus standards, streamline premarket review, and reduce data burdens for industry. Maintaining uninterrupted performance of this system is essential to supporting FDA’s regulatory science mission and enhancing stakeholder confidence in the U.S. device market.

2 OBJECTIVE

The CDRH seeks to procure Contractor Support to establish preventative maintenance routines on an Agilent 1290 liquid chromatography coupled to Agilent 6495C triple quadrupole mass spectrometry system (LC-Q3), located and operated in Office of Science and Engineering Laboratories (OSEL), Division of Biology, Chemistry and Materials Science (DBCMS).

A preventative maintenance contract for the Agilent 1290 liquid chromatography coupled to Agilent 6495C triple quadrupole mass spectrometry system will help ensure the instrument system remains in favorable condition and reduce the financial and labor cost for instrument maintenance.

3 SCOPE

The system on which preventative maintenance shall be performed is made up of the following components with the associated serial numbers:

• Agilent 6595C triple quadrupole mass spectrometer (S/N:

SG1935D204)

• Agilent 1290 High speed pump-G7120A (S/N: DEBA203652)

• Agilent 1290 Multisampler-G7167B (S/N: DEBAQ04045)

• Agilent 1290 Multi Column Thermostat (MCT-G7116B)-(S/N:

DEBA405111)

The Contractor will maintain the entire system and shall include/provide the following in the acceptable completion of that duty:

• The Contractor shall be capable of installing instrument control and data analysis software packages on new computer systems in case of computer system failures.

• The Contractor shall have the capability to troubleshoot issues based on a complete knowledge of the entire instrument system, immediate access to Agilent certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

• The Contractor shall demonstrate the ability to service the instrument system with a high degree of quality control as evidenced by the testimony of other customers, who have utilized the Contractor’s services for instrument systems with similar technical demands, within last three (3) years.

• One (1) preventative maintenance inspection shall be performed during the 12-month period with all travel, labor, and parts included. Vendor should cover the cost for travel, labor and parts associated with the PM services. This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing, and any other preventative maintenance measures deemed necessary by the vendor.

• On-Site Preventive Maintenance (PM) shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• PM shall be provided by service engineers who are trained to maintain the instrument.

Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. All labor, travel costs, and consumable parts required for PM must be covered by the vendor.

• During the on-site visit, the Contractor shall assess the scientific equipment and determine if the necessary repairs shall be covered under the current preventative maintenance agreement. If the repairs are not covered under the service maintenance agreement, the Contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs.

• Repair work that is not covered by the Maintenance Agreement is not to be initiated by the vendor unless the Government has given the vendor proper authorization.

• The Contractor shall, commensurate with the completion of each PM service, provide the end user of the equipment with a copy of the field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, 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, on-site hours expended and parts/components replaced.

4 TASKS

In fulfillment of this order, the Contractor will perform or supply the following:

4.1 PROJECT MANAGEMENT

The Contractor shall work with the CDRH to provide transparent communication throughout the process of providing both preventative maintenance and nonroutine maintenance, which may be necessary under extenuating circumstances.

4.1.1 Kick-Off Meeting

Within five (5) business days after the effective date of the Order, the Contractor shall participate in a Kick-Off Meeting with the Technical POC, the COR, the CO, and other CDRH Staff. The Contractor shall provide meeting materials and agenda two (2) days prior to the Kickoff meeting.

The Contractor shall prepare summary meeting minutes, detailing the discussion held, and provide a copy of the minutes to the COR and the Technical POC within ten (10) business days after the meeting.

4.1.2 Project Work Plan

Prior to beginning maintenance work, the Contractor shall provide CDRH staff with a work plan detailing the steps that they expect to take during the preventative maintenance inspection, the date(s) on which the inspection shall take place, and the disclose the staff who shall be inspecting and repairing the system.

4.1.3 Meetings and Briefings

In addition to providing service records and reports at the conclusion of each inspection, the Contractor shall meet with CDRH staff (Instrument owner) to give an overview of the maintenance provided, express any concerns regarding the systems, and recommend any changes that might benefit the longevity of the system.

4.2 PREVENTATIVE MAINTENANCE

The Contractor shall perform preventative maintenance on the system, which is made up of the following components with the associated serial numbers:

• Agilent 6595C triple quadrupole mass spectrometer (S/N:

SG1935D204)

• Agilent 1290 High speed pump-G7120A (S/N: DEBA203652)

• Agilent 1290 Multisampler-G7167B (S/N: DEBAQ04045)

• Agilent 1290 Multi Column Thermostat (MCT-G7116B)-(S/N:

DEBA405111)

4.2.1 Preventative Maintenance Inspection

The Contractor shall perform one (1) preventative maintenance inspection during each 12-month period. This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing, and any other preventative maintenance measures deemed necessary by the vendor.

On-Site Preventive Maintenance (PM) shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

The Contractor shall assess the scientific equipment and determine if the necessary repairs shall be covered under the current preventative maintenance agreement. If the repairs are not covered under the PM service agreement, the Contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs for the government.

4.2.2 Service Records and Reports

The Contractor shall, commensurate with the completion of each PM service, provide the end user of the equipment with a copy of the field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, 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, on-site hours expended and parts/components replaced.

4.3 NONROUTINE MAINTENANCE

Should the Contract determine that the system repairs are not covered under the service maintenance agreement, the Contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs for the government.

Repair work that is not covered by the Preventative Maintenance Agreement is not to be initiated by the Contractor unless the Government has given the vendor proper authorization.

Upon approval of the Contractor’s quote, the Contractor shall service the system as necessary, following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

4.3.1 Service Records and Reports

The Contractor shall, commensurate with the completion of each PM service, provide the end user of the equipment with a copy of the field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, 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, on-site hours expended and parts/components replaced.

5 DELIVERABLES, PROGRESS REPORTS AND DATES

Electronic copies submitted by the Contractor shall be in a format compatible with Office 365 and Adobe Acrobat (version 10 or later). Documents submitted by the Contractor shall be Section 508 compliant.

5.1 DELIVERABLES ACCEPTANCE

Be advised that the FDA does not accept documents which contain the use of macros.

Document submissions required throughout the period of performance of this Task Order must not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

All deliverables generated under this requirement remain the property of the Government.

5.2 SUMMARY OF DELIVERABLES

Table 1: Deliverables

Deliverables Quantity/Frequency Due Date

4.1.1 Kickoff Meeting Minutes Once Within 10 days of Kickoff Meeting

4.1.2 Project Work Plan

Prior to beginning maintenance work

Prior to performing work

4.1.3 Meetings and Briefings

At the conclusion of each inspection

Within 10 days of completing inspection

4.2.1 Preventative Maintenance

Inspection Once yearly As scheduled

4.2.2, 4.3.3

Service Records and Reports

Once per Inspection As scheduled

Deliverables Quantity/Frequency Due Date

4.3.1 Emergency Nonroutine

Maintenance As Necessary

As necessary

4.3.2 Nonemergency Nonroutine

Maintenance As Necessary

As necessary

6 GOVERNMENT FURNISHED PROPERTY, MATERIAL, EQUIPMENT, OR INFORMATION

(GFP, GFM, GFE, OR GFI)

Government furnished property (materials, equipment, and/or information) is to be provided in conjunction with required performance under this contract as determined by mutual agreement between FDA and the Contractor.

When the Government provides equipment, then the Contractor shall maintain a detailed inventory accounting system for Government Furnished Property (GFP) following contract award. The inventory accounting system must specify, at a minimum:

• Product description (make, model)

• Government tag number

• Date of receipt

• Name of receipt

• Location of receipt

• Current location

• Contract/order number under which the equipment is being used

The Contractor shall attach an update inventory report to each MPR unless otherwise specified by the COR. In either case, the Contractor’s inventory listing must be available for Government review within one (1) business day of COR request. The Contractor shall remain responsible and accountable for all GFP for the duration of the contract and ensure the return of the property upon completion of all work required under this contract.

All property, data and information provided by the Government in the performance of this order remains the property of the Government and shall be surrendered to the Government upon completion or termination of this requirement.

7 CONTRACT TYPE

This will be a Firm Fixed Price order.

8 PLACE OF PERFORMANCE

The vendor will need to do the work on-site. The work cannot be done remotely; work will be done at the Government site where the equipment is currently located within the Washington DC area. The contractor shall work on-site using FDA furnished property on the FDA network.

Space will be provided at FDA's White Oak Headquarters:

10903 New Hampshire Ave

Building 64, Room 3015

Silver Spring, MD 20993

9 PERIOD OF PERFORMANCE

The Period of Performance (POP) will be for twelve (12) months from date of award, with four

(4) twelve (12) month option periods.

10 GOVERNMENT CONTACTS

Contracting Officer (CO):

Maria Finan Maria.Finan@fda.hhs.gov

Contract Specialist (CS):

Erika Crawford Erika.Crawford@fda.hhs.gov

Contracting Officer's Representative (COR):

TBD at time of award mailto:Maria.Finan@fda.hhs.gov mailto:Erika.Crawford@fda.hhs.gov

11 HOLIDAYS AND GOVERNMENT CLOSURES

The Government hereby provides notification that Government personnel observe the listed days as holidays:

Date Holiday

Wednesday, January 1, 2025 New Years Day

Monday, January 20, 2025 Birthday of Martin Luther King, Jr.

Monday, January 20, 2025 * Inauguration Day

Monday, February 17, 2025 ** Washington’s Birthday

Monday, May 26, 2025 Memorial Day

Thursday, June 19, 2025 Juneteenth National Independence Day

Friday, July 04, 2025 Independence Day

Monday, September 1, 2025 Labor Day

Monday, October 13, 2025 Columbus Day

Tuesday, November 11, 2025 Veterans Day

Thursday, November 27, 2025 Thanksgiving Day

Thursday, December 25, 2025 Christmas Day

*This holiday is designated as "Inauguration Day" in section 6103(c) of title 5 of the United States Code, which is the law that specifies holidays for Federal employees. Federal employees in the Washington, DC, area are entitled to a holiday on the day a President is inaugurated on January 20th for each fourth year after 1965.

**This holiday is designated as "Washington's Birthday" in section 6103(a) of title 5 of the United States Code, which is the law that specifies holidays for Federal employees. Though other institutions such as state and local governments and private businesses may use other names, it is our policy to always refer to holidays by the names designated in the law.

In addition to the days designated as holidays, the Government observes the following days:

Any other day designated by Federal Statute Any other day designated by Executive Order

Any other day designated by the President’s Proclamation

a. When any such day falls on a Saturday, the following Monday is observed.

Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

b. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

c. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this award.

12. Contracting Officers Authority

The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFP; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this award. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the award. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the award.

The Contracting Officer’s Representative (COR) is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the contract and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

13. Order of Precedence

The Contractor shall follow the terms and conditions of this contract. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4.

The Contractor shall not auto-renew any subscriptions, licenses, maintenances and services not authorized under this contract. Any auto-renewals are at the risk of the Contractor, and the Government will not reimburse the Contractor.

In the event of any inconsistencies between any licensing agreement incorporated into this order as an attachment and the FAR and HHSAR Clauses incorporated into this order, the FAR or HHSAR Clauses shall take precedence.