Attachment 2 - Statement of Work.docx

Attachment 2 - Statement of Work (SOW) Blanket Purchase Agreement (BPA) Agilent 4150 TapeStation System, Consumables, Accessories, and Maintenance Services Office of Applied Microbiology and Technology (OAMT) Total Period of Performance: Five (5) Years

1. Background and Purpose The Office of Applied Microbiology and Technology (OAMT), Food and Drug Administration (FDA), requires establishment of a five (5) year Blanket Purchase Agreement (BPA) to support the procurement of one (1) Agilent 4150 TapeStation System Bundle (Model G2992A), with the ability to purchase additional units, proprietary ScreenTape consumables, accessories, replacement parts, and associated maintenance and support services throughout the full five-year period of performance.

OAMT currently operates Agilent TapeStation instrumentation integrated into validated standard operating procedures (SOPs), quality control workflows, and ongoing genomic microbiology research protocols. The laboratory relies on the Agilent TapeStation platform for DNA and RNA quality control analysis, including determination of nucleic acid concentration, fragment size distribution, and integrity prior to downstream applications including next-generation sequencing (NGS), whole genome microarray, and quantitative polymerase chain reaction (qPCR) workflows.

Establishment of this BPA will allow OAMT to:

Procure one (1) Agilent 4150 TapeStation System as the initial requirement under the BPA.

Place additional orders for instrumentation, consumables, accessories, and maintenance services throughout the five-year period of performance as laboratory needs evolve.

Reduce administrative burden associated with repetitive procurements.

Ensure continuity of laboratory operations and validated workflows over the full five-year period.

2. Scope of Work The contractor shall provide, via individual BPA calls placed by the Government throughout the five-year period of performance, the following categories of products and services:

Category 1: Agilent TapeStation Instrumentation – Initial requirement of one (1) unit with the ability to order additional units as needed throughout the five-year period.

Category 2: Proprietary Agilent ScreenTape Consumables and Reagents Category 3: Accessories, Replacement Parts, and Ancillary Supplies Category 4: Maintenance and Support Services (Agilent CrossLab Silver Service Plan) Category 5: Software, Firmware, and Software Support Services The Government's initial requirement is one (1) Agilent 4150 TapeStation System Bundle (Model G2992A). The Government reserves the right to purchase additional units of instrumentation, consumables, accessories, and services at any time during the five-year period of performance via individual BPA calls. The Government does not guarantee any minimum purchase quantity beyond the initial instrument order.

3. Period of Performance The period of performance for this BPA is five (5) continuous years from the effective date of BPA award. There are no option years. The BPA shall remain active and available for use by the Government for the full five-year period.

4. Categories of Products and Services

4.1 Category 1 – Agilent TapeStation Instrumentation

The contractor shall provide one (1) Agilent 4150 TapeStation System Bundle (Model G2992A) as the initial BPA call under this agreement. The initial system shall be delivered no later than May 15, 2026, to the location specified in Section 7.

The Government reserves the right to purchase additional Agilent TapeStation instrumentation units at any time during the five-year period of performance via individual BPA calls. Additional units may include:

Additional Agilent 4150 TapeStation System Bundles (Model G2992A).

Successor or compatible Agilent TapeStation models released during the period of performance.

Each unit of instrumentation provided under this BPA shall include:

All necessary hardware, manufacturer-provided software, vortexer, required cables, accessories, and starter consumables required for full system operation.

Delivery, installation, and initial operational verification at the Government-specified location.

Each system shall:

Perform automated electrophoretic analysis of DNA and RNA samples.

Generate quantitative concentration measurements and nucleic acid integrity assessments.

Produce electropherograms and digital data outputs compatible with NGS, whole genome microarray, and qPCR workflows.

Each system shall:

Process up to sixteen (16) samples per run.

Deliver complete analysis results for a 16-sample run within twenty (20) minutes or less.

Require no more than 2 µL of sample input per analysis.

Provide reproducible sizing and quantification results consistent with manufacturer specifications.

Each system shall:

Be fully compatible with existing Government-owned Agilent TapeStation instrumentation.

Utilize proprietary Agilent ScreenTape consumables currently in use within the laboratory.

Integrate with validated laboratory SOPs, quality control thresholds, and established data workflows.

Each system shall include manufacturer-provided software capable of:

Automated data acquisition and analysis.

Electropherogram visualization.

Concentration and fragment size calculation.

Data export in formats compatible with existing laboratory data systems.

4.2 Category 2 – ScreenTape Consumables and Reagents

The contractor shall provide proprietary Agilent ScreenTape consumables and associated reagents throughout the five-year period of performance as ordered by the Government via individual BPA calls. Products shall include but are not limited to:

DNA ScreenTape assay kits (various types as required) RNA ScreenTape assay kits (various types as required) Sample buffers and loading reagents Instrument Quality Control (IQC) ScreenTapes Any new or updated consumable products released by Agilent during the period of performance that are compatible with Government-owned instrumentation All consumables shall be:

Genuine Agilent OEM products.

Delivered with a minimum of 6 months remaining shelf life at the time of delivery unless otherwise agreed upon in writing by the Government POC.

Packaged and shipped in accordance with manufacturer specifications to maintain product integrity.

4.3 Category 3 – Accessories, Replacement Parts, and Ancillary Supplies The contractor shall provide accessories, replacement parts, and ancillary supplies throughout the five-year period of performance as ordered by the Government via individual BPA calls. Products shall include but are not limited to:

Vortexers and vortex adapters compatible with Agilent TapeStation instrumentation.

Sample tubes, tips, and loading accessories.

Replacement hardware components compatible with Government-owned Agilent TapeStation instrumentation.

Any additional accessories or ancillary supplies required to support laboratory operations.

All parts and accessories shall be genuine Agilent OEM products unless otherwise approved in writing by the Government POC.

4.4 Category 4 – Maintenance and Support Services

The contractor shall provide Agilent CrossLab Silver Service Plan coverage for each Government-owned Agilent TapeStation system throughout the five-year period of performance as ordered via individual BPA calls. As additional instrument units are procured under Category 1, the Government reserves the right to add CrossLab Silver Service Plan coverage for each additional unit via subsequent BPA calls.

The contractor shall provide:

One (1) preventive maintenance visit per 12-month service period per covered instrument.

Inspection, calibration, performance verification, and adjustment necessary to maintain covered systems in accordance with Agilent manufacturer specifications.

Scheduling of each PM visit coordinated with the Government POC no fewer than 10 business days prior to the planned visit date.

The contractor shall provide:

Repair services including replacement of defective parts, labor, and travel necessary to restore covered systems to full operational status.

All replacement parts shall be genuine Agilent OEM parts.

Non-OEM parts shall not be used without prior written approval from the Government POC.

If system restoration cannot be completed within 5 business days, the contractor shall provide written notification to the Government POC with a revised timeline and written justification.

All covered systems shall maintain a minimum operational uptime of 95% during scheduled Government business hours (Monday–Friday, 8:00 AM – 4:00 PM, excluding Federal holidays) across each 12-month service period. Downtime attributable to scheduled preventive maintenance coordinated in advance with the Government POC shall be excluded from uptime calculations.

A field service report shall be submitted to the Government POC within 5 business days following each preventive or corrective maintenance event. Each report shall include, at a minimum:

Date(s) of service Name and qualification of service personnel Description of services performed Parts replaced, including part numbers Software or firmware updates applied System status at conclusion of service Any outstanding issues or recommended follow-up actions All maintenance and repair services shall be performed by OEM-trained and Agilent-authorized service personnel. The contractor shall provide documentation of personnel qualifications upon request by the Government POC.

4.5 Category 5 – Software, Firmware, and Software Support Services The contractor shall provide software and firmware products and support services throughout the five-year period of performance as ordered by the Government via individual BPA calls. Services shall include:

Manufacturer-released software updates and upgrades applicable to all Government-owned Agilent TapeStation instrumentation.

Firmware updates applicable to covered systems.

Software installation and configuration support as needed.

All software and firmware updates shall be:

Delivered within 60 calendar days of manufacturer release.

Coordinated with the Government POC to minimize disruption to laboratory operations.

Documented in a field service report or delivery confirmation as applicable.

5. Deliverables

6. Performance Metrics

7. Place of Performance and Delivery All deliveries and on-site services shall be performed at:

All deliveries and on-site services shall occur during normal Government business hours:

Monday through Friday, 8:00 AM – 4:00 PM, excluding Federal holidays.

The Government reserves the right to specify alternate delivery locations within the FDA enterprise on individual BPA calls.

8. BPA Call Order Procedures

8.1 Issuance of BPA Calls

The Government will issue individual BPA calls against this agreement on an as-needed basis throughout the five-year period of performance. Each BPA call shall specify:

Category of product or service ordered Item description, part number, and quantity Required delivery date or service period Delivery location Applicable unit price from the BPA pricing schedule

8.2 Order Acknowledgment

The contractor shall acknowledge receipt of each BPA call within 2 business days of issuance during normal Government business hours (Monday–Friday, 8:00 AM – 4:00 PM, excluding Federal holidays).

8.3 Order Fulfillment Timeframes

9. Acceptance Criteria

9.1 Instrumentation

Acceptance of each instrumentation unit shall occur upon:

Successful delivery to the specified location during normal Government business hours.

Completion of installation coordinated with the Government POC.

Verification that the system meets all technical requirements specified in Section 4.1.

9.2 Consumables and Accessories

Acceptance of consumables and accessories shall occur upon:

Delivery of correct items in correct quantities as specified in the BPA call.

Government POC verification that products are genuine Agilent OEM products.

Confirmation that consumables meet the minimum shelf life requirement of 6 months at time of delivery.

9.3 Maintenance Services

Maintenance services shall be considered accepted upon:

Government POC confirmation that the covered system has been restored to full operational status or that preventive maintenance has been completed satisfactorily.

Receipt of a complete and accurate field service report within the required timeframe.

9.4 Software and Firmware

Acceptance of software and firmware shall occur upon:

Successful installation and verification of functionality on covered Government systems.

Government POC confirmation of successful update application.

10. Contractor Responsibilities The contractor shall:

Deliver one (1) Agilent 4150 TapeStation System Bundle (Model G2992A) as the initial BPA call no later than 30 days after award Maintain the capability to fulfill orders across all five categories for the full five-year period of performance.

Maintain status as an authorized Agilent reseller and service provider for the duration of the BPA and notify the Government POC immediately and in writing if authorized status is revoked or lapses for any reason.

Provide all equipment, consumables, parts, labor, tools, and travel necessary to fulfill individual BPA calls.

Coordinate all delivery, installation, and maintenance activities with the Government POC in advance.

Maintain records of all orders fulfilled and services performed and provide documentation as specified herein.

Ensure all personnel performing maintenance and repair services are OEM-trained and Agilent-authorized.

Notify the Government POC promptly of any product discontinuations, supply chain disruptions, pricing changes, or other issues that may affect the contractor's ability to fulfill BPA calls.

11. Government Responsibilities The Government shall:

Designate a Contracting Officer's Representative (COR) to serve as the primary point of contact for all technical and administrative matters related to this BPA.

Issue the initial BPA call for one (1) Agilent 4150 TapeStation System Bundle upon BPA award.

Issue subsequent BPA calls for additional instrumentation, consumables, accessories, and services as needed throughout the five-year period of performance.

Provide the contractor with reasonable access to Government facilities during normal business hours for delivery, installation, and maintenance activities.

Review and accept or reject deliverables in a timely manner.

Maintain records of system uptime and contractor performance against the metrics specified in Section 6.

12. Remedies for Non-Performance

13. Reporting Requirements

14. Points of Contact The Government will designate a COR to serve as the primary point of contact for all technical and administrative matters under this BPA. The contractor shall designate a primary point of contact and an escalation point of contact for order coordination, service scheduling, and issue resolution. Contractor points of contact shall be provided to the Government POC within 5 business days of BPA award and updated promptly upon any changes.

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