Attachment 1 - Performance Work Statement.docx

Attachment 1 - Performance Work Statement (PWS) Maxwell RSC 48 DNA Extraction Systems

1. INTRODUCTION

1.1 Purpose

This Performance Work Statement (PWS) establishes the performance objectives, standards, and requirements for the acquisition and installation of Maxwell RSC 48 DNA Extraction Systems to support the Food and Drug Administration's Office of Laboratory Operations and Applied Science, Office of Regulatory Testing and Surveillance, Human and Animal Food Laboratories (OLOAS/ORTS/HAFL).

1.2 Background

The mission of OLOAS/ORTS/HAFL is to protect public health by providing analytical approaches encompassing the use of rapid methodology and expert scientific evaluations in support of investigations involving the safety of foods and other FDA regulated products. The Microbiology Branches use validated rapid, highly sensitive molecular methods and instrumentation for recovery, detection, and quantification of enteric bacterial pathogens and their related toxins isolated from foods and cosmetics as well as related food processing and farm production environments.

1.3 Scope of Work

The Contractor shall provide Maxwell RSC 48 DNA Extraction Systems, including delivery, installation, training, and warranty services over a five-year contract period.

2. APPLICABLE DOCUMENTS

Federal Acquisition Regulation (FAR) HHS Acquisition Regulation (HHSAR) FDA Information Technology Security and Privacy Requirements

3. PERFORMANCE OBJECTIVES

3.1 Overall Objective

The Contractor shall deliver fully operational Maxwell RSC 48 DNA Extraction Systems that meet FDA's functional genomic sequencing needs for DNA extraction and high throughput requirements for high-quality DNA used for FDA validated molecular rapid methods.

3.2 Specific Performance Objectives

Objective 1: Equipment Delivery

- Deliver brand-new, manufacturer-certified Maxwell RSC 48 systems to designated FDA laboratories

- Ensure all systems meet manufacturer specifications and are free from defects Objective 2: Installation Services

- Provide professional installation services by qualified field system engineers

- Ensure systems are fully operational and integrated into laboratory environments Objective 3: Training Services

- Deliver comprehensive on-site training to enable independent operation by laboratory personnel

- Provide training materials and consumables for hands-on instruction Objective 4: Warranty and Support

- Provide minimum one-year warranty coverage from date of installation

- Ensure responsive technical support throughout warranty period

4. PERFORMANCE REQUIREMENTS

4.1 Equipment Specifications

Each Maxwell RSC 48 system shall include the following components:

Maxwell RSC 48 Instrument Tablet PC preloaded with Maxwell RSC Application Software USB Cable for connection of the Maxwell RSC Instrument to the Tablet PC Power Cable for Maxwell RSC Instrument Power Cord for Tablet PC Pair of Maxwell RSC/CSC Deck Trays UV bulb (installed) Tablet PC Holder Quantus Fluorometer and accessories Quick Start Guide Set-up Guide 2 Additional front deck and back deck trays The Maxwell RSC 48 system shall:

Process up to 48 samples in a single run Complete processing in as little as 30 minutes Operate without requiring spin columns or high-speed centrifugation Minimize shearing, clogged tips, or contaminating drips Produce high-quality nucleic acid suitable for FDA validated molecular rapid methods Systems shall be newly manufactured units, not used, refurbished, or previously used for demonstration purposes All systems shall be delivered with necessary supplies and accessories required for installation and start-up

4.2 Delivery Requirements

First Task order:

- Seven (7) Maxwell RSC 48 systems delivered within 90 days of award to the following locations:

- Arkansas Human and Animal Food Laboratory (ARLHAFL), Jefferson, AR

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

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

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

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

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

- New York Human and Animal Food Laboratory (NYHAFL), Jamaica, NY Anticipated Task Orders

- Estimated One (1) to Two (2) systems per year delivered within 90 days of option exercise

- Destinations to be determined at time of order FOB Point: Destination Delivery Hours: Monday - Friday, 8:00 AM - 4:00 PM (excluding Federal holidays) Inside Delivery: Items shall be brought from delivery vehicle into facility's loading dock U.S. Food & Drug Administration Irvine Human and Animal Food Laboratory (IRVHAFL) 19701 Fairchild, Irvine, CA 92612 U.S. Food & Drug Administration Atlanta Human and Animal Food Laboratory (ATLHAFL) 1777 Hardee Ave, Atlanta, GA 30310 U.S. Food & Drug Administration Arkansas Human and Animal Food Laboratory (ARLHAFL) 3900 NCTR Road, Bldg. 26, Jefferson, AR 72079 U.S. Food & Drug Administration Denver Human and Animal Food Laboratory (DENHAFL) 1 Denver Federal Center, 6th Ave and Kipling St., Bldg. 20, Entrance W10, Denver, CO 80225 U.S. Food & Drug Administration San Francisco Human and Animal Food Laboratory (SANHAFL) 1201 Harbor Bay Pkwy, Alameda, CA 94502 U.S. Food & Drug Administration Seattle Human and Animal Food Laboratory (SEAHAFL) 22201 23rd Dr. SE, Bothell, WA 98021 U.S. Food & Drug Administration New York Human and Animal Food Laboratory (NYHAFL) 158-15 Liberty Ave., Jamaica, NY 11433

4.3 Installation Requirements

The Contractor shall:

Coordinate installation schedule with each individual laboratory Technical Point of Contact (TPOC) Move items from loading dock to final point of use Install the unit in the designated room Ensure proper electrical connection and operational functionality Verify instrument is operational through testing procedures Installation shall be performed by qualified field system engineers Engineers must possess appropriate manufacturer certifications and training Installation shall occur within 14 days of delivery Final acceptance documented by TPOC signature on Field Service Report

4.4 Training Requirements

The Contractor shall provide on-site training by qualified field application specialists for up to three (3) users per laboratory.

Training shall enable operators to independently operate the instrument and shall include:

System operation and functionality Sample processing procedures Software operation and data management Routine maintenance procedures Troubleshooting common issues Safety protocols The Contractor shall provide:

Training manuals (electronic and/or hard copy) Consumables for use during training exercises Quick reference guides Access to online resources and support materials Training shall be completed within 14 days of delivery Training schedule coordinated with laboratory TPOC

4.5 Warranty Requirements

The Contractor shall provide a minimum one (1) year warranty from the date of installation that includes:

Coverage on all non-consumable items and parts supplied, including the base instrument and accessories Parts and labor for repairs Unlimited telephone/email support for operational questions On-site service as needed for warranty repairs Warranty period starts on the date of formal government acceptance Continues for a minimum of one (1) year from installation acceptance date The Contractor shall respond to warranty service requests within two (2) business days On-site service shall be provided within five (5) business days when remote support cannot resolve the issue

4.6 Documentation and Reporting Requirements

Upon completion of each installation, the Contractor shall provide the end-user with a report containing:

Equipment name, manufacturer, model number, and serial number of each system Detailed description of installation performed Detailed description of on-site training performed Name(s) and contact information of engineer/specialist who performed installation and training All applicable warranty information Installation acceptance signature page The Contractor shall provide comprehensive warranty documentation including:

Terms and conditions of warranty coverage Procedures for requesting warranty service Contact information for technical support Warranty claim procedures

5. PERFORMANCE STANDARDS

5.1 Delivery Performance Standards

5.2 Installation Performance Standards

5.3 Training Performance Standards

5.4 Warranty Performance Standards

6. SECURITY REQUIREMENTS

6.1 Information Technology Security

The Contractor shall ensure:

IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges Compliance with secure coding best practice requirements as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP) Protection of information deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information

6.2 Physical Security

The Contractor shall:

Take safety precautions prior to and during preventative maintenance and installation Be cleared by security as visitor(s) upon arrival to each facility Provide valid U.S. Real-ID with photo identification to check-in with Security Guards Coordinate with inside contractor regarding security clearance process before arrival

6.3 Data Protection

The Contractor shall protect information that is deemed sensitive or proprietary by HHS/FDA in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data.

7. INSPECTION AND ACCEPTANCE

7.1 Inspection Procedures

Inspection and acceptance will be performed at the delivery location (destination) The Technical Point of Contact (TPOC) will perform inspection upon delivery If damage is observed that does not penetrate through the shipping container, the receiver may open the container prior to acceptance Installation is overseen by the on-site Technical Point of Contact (TPOC) Final acceptance documented by TPOC signature on Field Service Report after installation

7.2 Acceptance Criteria

Systems will be accepted if:

All required components are present and undamaged Equipment matches specifications in contract Packaging and shipping documentation are complete Systems will be accepted if:

Equipment is properly installed in designated location All operational tests are successfully completed System demonstrates required performance characteristics Training has been completed satisfactorily

7.3 Acceptance Timeline

Acceptance is communicated in writing within 30 days of receipt of deliverable(s) If rejection is issued, Contractor shall correct deficiencies within 15 calendar days If Contractor cannot correct deficiencies within timeframe, Contractor shall immediately notify TPOC and provide corrective action plan within 3 business days

8. PERIOD OF PERFORMANCE

8.1 Blanket purchase Agreement (BPA)Period

The Blanket purchase agreement order period of performance begins on the date of contract award execution and extends for five years.

9. GOVERNMENT RESPONSIBILITIES

9.1 Technical Point of Contact (TPOC)

The Government will designate a TPOC at each laboratory location who will:

Coordinate delivery and installation schedules Perform inspection and acceptance Participate in training Serve as primary contact for warranty issues

9.2 Facility Access

The Government will:

Provide access to facilities during normal business hours (8:00 AM - 4:00 PM, Monday-Friday) Ensure security clearance procedures are followed Provide designated installation locations with appropriate utilities and space

9.3 Payment

The Government will make payment in accordance with the Prompt Payment Act upon satisfactory completion and acceptance of deliverables.

10. CONTRACTOR RESPONSIBILITIES

10.1 General Responsibilities

The Contractor shall:

Provide all resources necessary to accomplish tasks and deliverables described in this PWS Maintain communication with Government TPOCs Comply with all security requirements Maintain records of all deliveries, installations, training, and warranty services

10.2 Quality Assurance

The Contractor shall maintain quality assurance procedures to ensure:

Equipment meets manufacturer specifications Installation is performed to professional standards Training is effective and comprehensive Warranty services are responsive and effective

10.3 Subcontractor Management

If subcontractors are used, the Contractor shall:

Ensure subcontractors meet all requirements of this PWS Maintain oversight of subcontractor performance Ensure subcontractors comply with security requirements Remain responsible for all subcontractor performance

11. DELIVERABLES SUMMARY

Option Years 1-4: 1-2 systems per year with corresponding installation, training, reports, and warranty services following same standards.

12. POINTS OF CONTACT

12.1 Government Contacts

Primary Point of Contact: “To be determined” Contracting Officer Representative: “To be determined” Contracting Officer: Michele Jackson Michele.Jackon@fda.hhs.gov Laboratory TPOCs: To be identified at time of award

12.2 Contractor Contacts

The Contractor shall designate and provide contact information for:

Program Manager Installation Coordinator Training Coordinator Warranty/Technical Support Contact Page | 2