Attach_1_AB7500_PM PCR PWS.pdf

PERFORMANCE WORK STATEMENT (PWS)

Preventive Maintenance and Remedial Repair Services Applied Biosystems 7500 Fast Real-Time PCR Systems

Food and Drug Administration, Atlanta Human and Animal Food Laboratory

HFP-2026-134289

August 6, 2026 Firm-Fixed-Price Recurring Services

PART 1 — GENERAL INFORMATION

1. General. This is a non-personal services contract to provide preventive maintenance and remedial repair services for Government-owned Applied Biosystems 7500 Fast Real-Time PCR Systems. The Government will not exercise supervision or control over the contractor personnel performing the services. Such personnel are accountable solely to the contractor, who in turn is responsible to the Government.

1.1 Description of Services / Introduction. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform preventive maintenance and remedial repair of the Applied Biosystems 7500 Fast Real-Time PCR Systems identified in Part 3 as defined in this Performance Work Statement, except for items identified as Government-furnished. The contractor shall meet the standards stated in this contract.

1.2 Background. The Food and Drug Administration (FDA) Atlanta Human and Animal Food Laboratory (ATLHAFL) is the largest Office of Regulatory Testing and Surveillance (ORTS) field laboratory. The mission of the ATLHAFL is to provide essential analytical services to ensure public safety in the areas of food and animal feed. The ATLHAFL has maintained accreditation under ISO/IEC 17025 for chemical and biological testing since 2006. A key component of the Office of Laboratory Operations and Applied Science (OLOAS) Strategic Plan is the implementation of efficient and standardized sample analysis across all ORTS laboratories.

FDA methods for the detection of pathogens in food and water require the use of the 7500 Fast Real-Time PCR platform for analysis, and the systems are used for method development and high-throughput analysis. Preventive maintenance of these systems is essential to ensure reliable performance and to maintain laboratory accreditation in compliance with ISO/IEC 17025.

1.3 Objectives. The Government requires the following outcomes:

• Each system covered remains available and operating within manufacturer performance specifications throughout each contract period.

• Each covered system is calibrated so that signal strength and data accuracy support analytical results of known quality.

• System downtime attributable to unscheduled failure is minimized through timely remedial repair at no additional cost to the Government.

• Service records are complete, traceable, and sufficient to support the laboratory's ISO/IEC 17025 accreditation.

1.4 Scope. The contractor shall provide full-service preventive maintenance and remedial repair for the six (6) Applied Biosystems 7500 Fast Real-Time PCR Systems identified in Part 3.

Services include scheduled on-site preventive maintenance, replacement of parts subject to wear, pure dye calibration, remedial repair with all parts, labor, and travel included, technical and application support, and delivery of service documentation. The contractor shall accomplish the objectives in paragraph 1.3 and the tasks in Part 5.

1.5 Period of Performance. The period of performance consists of one (1) 12-month base period and three (3) 12-month option period(s). The Government may exercise options in accordance with the contract terms. See contract for specific dates of each contract period.

1.6 General Information

1.6.1 Quality Control. The Contractor shall maintain and implement an effective quality control program to ensure services are performed in accordance with this PWS. The quality control program may consist of the Contractor's existing corporate quality management system or a contract-specific Quality Control Plan (QCP). Upon request, the Contractor shall provide documentation demonstrating how quality will be managed, including procedures for identifying, correcting, and preventing recurring deficiencies in service performance. The Government reserves the right to review the Contractor's quality control documentation and require corrective action if service performance does not meet contract requirements.

1.6.2 Quality Assurance. The Government will evaluate the contractor's performance under this contract using the Quality Assurance Surveillance Plan (QASP). The QASP defines how the performance standards in Technical Exhibit 1 will be applied, the frequency of surveillance, and the maximum acceptable defect rates. The QASP is a Government document and is not part of the contractor's deliverables.

1.6.3 Recognized Holidays. The contractor is not required to perform on Federal holidays.

Services scheduled for a Federal holiday shall be performed on the next business day. The Federal holidays are: New Year's Day, Birthday of Martin Luther King Jr., Washington's Birthday, Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

1.6.4 Hours of Operation. The contractor shall conduct business between the hours of 8:00 a.m.

and 4:00 p.m. Eastern Time, Monday through Friday, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government-directed facility closings. Performance outside these hours requires prior approval of the Contracting Officer's Representative (COR) obtained at least five (5) business days in advance. When the Government facility is closed for the reasons stated above, the firm-fixed-price for the period is not reduced and no additional reimbursement is due.

1.6.5 Place of Performance. The work will be performed at the FDA Atlanta Human and Animal Food Laboratory, 1777 Hardee Avenue SW, Atlanta, GA 30310, at the location within the facility where each system resides.

1.6.6 Type of Contract. The Government will award a firm-fixed-price contract for the recurring services described in this PWS.

1.6.7 Security and Personnel Suitability. Contractor personnel performing under this contract shall meet the personnel security and suitability requirements applicable to the level of access required. Contractor personnel shall hold a valid driver's license and shall present it to security personnel upon arrival at the facility. The contractor shall ensure personnel obtain and maintain the required determinations for the life of the contract and shall comply with HHS and FDA personnel security, physical access, and badging procedures.

1.6.7.1 Physical Security. The contractor shall safeguard all Government equipment, information, and property provided for contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

1.6.8 Special Qualifications. The contractor shall meet and maintain the following qualifications for the life of the contract and shall furnish documentation of each upon request:

• Service personnel shall be factory trained by the equipment manufacturer on the 7500 Fast Real-Time PCR platform or shall hold documented training on that platform that is equivalent in scope and currency to manufacturer factory training, covering both hardware and software.

• Service personnel shall have continuous access during the period of performance to manufacturer or manufacturer-equivalent technical support resources for the hardware and software of the covered systems.

• The contractor shall have access to a supply of new parts for the covered systems sufficient to complete preventive maintenance and remedial repair without avoidable delay, excluding build-to-order parts.

• The Contractor shall perform all maintenance, calibration, and repair services in accordance with the manufacturer's published procedures or equivalent documented procedures that achieve the same performance outcome. The Contractor shall furnish documentation sufficient to support the Government's ISO/IEC 17025 laboratory accreditation, including calibration traceability documentation and service records required by this PWS.

• The contractor shall maintain the ability to service the systems covered for the entire potential contract period, including all option periods. This requirement does not oblige the Government to exercise any option period.

1.6.9 Contracting Officer's Representative (COR). The COR will be identified in the contract.

The COR monitors the technical aspects of the contract and assists in contract administration within the limits of the designation. The COR is authorized to: confirm that the contractor performs the technical requirements; perform inspections necessary in connection with performance; maintain communication with the contractor on technical matters; issue written interpretations of technical requirements; monitor performance and notify the Contracting Officer and the contractor of deficiencies; and coordinate the availability of Government-furnished property and site access. The COR is not authorized to change any term or condition of the contract, including cost, price, scope, or delivery dates. Only the Contracting Officer may modify the contract.

1.6.10 Identification of Contractor Employees. Documents and reports produced by the contractor shall be marked as contractor products or otherwise disclose contractor participation.

1.6.11 Contractor Travel. All travel required in performance of this contract, including travel for scheduled preventive maintenance and for remedial repair visits, is included in the firm-fixed price. No travel is separately reimbursed and no not-to-exceed travel amount is established.

1.6.12 Other Direct Costs (ODC). No other direct costs are authorized under this contract. All parts, components, consumables, calibration materials, and shipping required for performance are included in the firm-fixed price.

1.6.13 Data Rights. The Government has unlimited rights to all documents and materials produced under this contract. All such documents and materials are Government property. The contractor shall not use or release them for any other purpose without the written permission of the Contracting Officer. This right does not abrogate any other Government right.

PART 2 — DEFINITIONS AND ACRONYMS

2.1 Definitions.

2.1.1 Contractor. A supplier or vendor awarded a contract to provide supplies or services to the Government. As used in this contract, the term refers to the prime contractor.

2.1.2 Contracting Officer (CO). A person with authority to enter into, administer, and terminate contracts and make related determinations and findings on behalf of the Government. The only individual who can legally bind the Government.

2.1.3 Contracting Officer's Representative (COR). An individual designated in writing by the Contracting Officer to monitor technical performance within the scope and limits of the designation. The COR may provide technical direction within scope that does not constitute a change and has no cost or funding impact. The COR may not change any term or condition of the contract.

2.1.4 Defective Service. A service output that does not meet the performance standard associated with this PWS.

2.1.5 Deliverable. Anything that can be delivered under the contract, including non-physical items such as meeting minutes or reports.

2.1.6 Field Service Report (FSR). The written record of a service event furnished by the contractor after each preventive maintenance or remedial repair visit, containing the content required by paragraph 5.6.1.

2.1.7 Key Personnel. Contractor personnel whose qualifications are material to performance and, where evaluated in source selection, may be required to perform under the contract.

2.1.8 Physical Security. Actions that prevent the loss of or damage to Government property.

2.1.9 Preventive Maintenance (PM). Scheduled service performed on a covered system to keep it operating within manufacturer performance specifications, including replacement of parts subject to wear, as distinguished from repair performed in response to a failure.

2.1.10 Pure Dye Calibration. The calibration procedure performed on a covered system to verify signal strength and data accuracy in accordance with manufacturer specifications.

2.1.11 Quality Assurance (QA). Government actions to verify that services are performed to acceptable standards.

2.1.12 Quality Assurance Surveillance Plan (QASP). A Government document specifying the methodology used to survey contractor performance.

2.1.13 Quality Control (QC). All measures taken by the contractor to ensure that the quality of an end product or service meets contract requirements.

2.1.14 Remedial Repair. Service performed in response to a reported failure or degraded performance of a covered system, to restore the system to operational condition.

2.1.15 Subcontractor. An entity that contracts with a prime contractor. The Government has no privity of contract with the subcontractor.

2.1.16 Work Day. The number of hours per day the contractor provides services in accordance with the contract.

2.1.17 Work Week. Monday through Friday, unless specified otherwise.

2.2 Acronyms.

ACOR Alternate Contracting Officer's Representative AQL Acceptable Quality Level ATLHAFL Atlanta Human and Animal Food Laboratory CFR Code of Federal Regulations CO Contracting Officer COR Contracting Officer's Representative COTS Commercial Off-the-Shelf FAR Federal Acquisition Regulation FDA Food and Drug Administration FSR Field Service Report FTR Federal Travel Regulation

GFP Government-Furnished Property HHS Department of Health and Human Services HHSAR HHS Acquisition Regulation IEC International Electrotechnical Commission ISO International Organization for Standardization NIST National Institute of Standards and Technology NTE Not-to-Exceed OCI Organizational Conflict of Interest ODC Other Direct Costs OLOAS Office of Laboratory Operations and Applied Science ORTS Office of Regulatory Testing and Surveillance PCR Polymerase Chain Reaction PIPO Phase-In / Phase-Out PM Preventive Maintenance POC Point of Contact PPE Personal Protective Equipment PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan SCLS Service Contract Labor Standards SOP Standard Operating Procedure TE Technical Exhibit

PART 3 — GOVERNMENT-FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. Government-Furnished Items and Services. The Government will provide the following at no cost to the contractor for use in performance.

3.1 Services. None.

3.2 Facilities. Access to the laboratory space at the place of performance where each covered system resides, during the hours stated in 1.6.4.

3.3 Utilities. Electrical power and standard laboratory utilities at the place of performance. If utilities are furnished, the contractor shall operate so as to preclude waste of utilities.

3.4 Equipment. The Government-owned systems to be serviced under this contract are the following six (6) Applied Biosystems 7500 Fast Real-Time PCR Systems:

Item System Serial Number

1 Applied Biosystems 7500 Fast Real-Time PCR System SN275014615

2 Applied Biosystems 7500 Fast Real-Time PCR System SN275015014

3 Applied Biosystems 7500 Fast Real-Time PCR System SN2750107890

4 Applied Biosystems 7500 Fast Real-Time PCR System SN275011896

5 Applied Biosystems 7500 Fast Real-Time PCR System SN275014842

6 Applied Biosystems 7500 Fast Real-Time PCR System SN2750108424

3.5 Materials. Government facility safety, security, and access procedures applicable to the place of performance.

PART 4 — CONTRACTOR-FURNISHED ITEMS AND SERVICES

4. Contractor-Furnished Items and Responsibilities.

4.1 General. The contractor shall furnish all labor, supplies, equipment, facilities, and services required to perform the work under this contract that are not identified as Government-furnished in Part 3.

4.2 Materials.

4.2.1 The contractor shall furnish all parts, components, and consumables required for preventive maintenance and remedial repair. All parts shall be new, guaranteed, factory tested, and of a quality meeting or exceeding the manufacturer's specification for the covered systems. The contractor shall not use parts salvaged from other instruments. Used, refurbished, and demonstration parts and equipment are not acceptable.

4.2.2 Spectral Calibration Kits. The contractor shall furnish spectral calibration kits sufficient to perform Pure Dye Calibration on each covered system serviced. The contractor shall provide Applied Biosystems 7500 Fast Spectral Calibration Kit I (Part No. 4360788) and Applied Biosystems 7500 Fast Spectral Calibration Kit II (Part No. 4362201) for each scheduled preventive maintenance service. Each kit shall be new and shall be accompanied by the manufacturer's Certificate of Analysis for the applicable lot. Calibration kits shall be delivered to the place of performance at least forty-eight (48) hours before the scheduled arrival of the service technician. The cost of the calibration kits is included in the firm-fixed-price contract and shall not be separately priced or reimbursed.

4.3 Equipment. The contractor shall furnish all tools, test equipment, and personal protective equipment (PPE) required to perform the work safely and in compliance with FDA facility safety requirements. Inspection, measuring, and test equipment used in performance shall be traceable to the National Institute of Standards and Technology (NIST) or to an equivalent national or international standard.

PART 5 — SPECIFIC TASKS

5. Specific Tasks.

5.1 General. The contractor shall perform the tasks in 5.2 through the final task in this Part.

Each task states the required outcome and the conditions of acceptance and corresponds to one or more measurable rows in Technical Exhibit 1. Methods of performance are the contractor's responsibility except where this Part states that a specific method is a mandatory requirement.

5.2 Preventive Maintenance. Each covered system is maintained in operating condition meeting the manufacturer's performance specifications through scheduled on-site preventive maintenance.

5.2.1 The Contractor shall perform one preventive maintenance service on each covered system during each 12-month contract period at the location where the system resides. The Contractor shall coordinate the date and time of each preventive maintenance visit in advance with the COR.

5.2.2 Each preventive maintenance visit includes replacement of all parts subject to wear identified by the manufacturer's maintenance checklist for the covered platform, or by an equivalent documented checklist maintained by the contractor and furnished to the COR upon request.

5.2.3 Following each preventive maintenance visit, the covered system is returned to service operating within the manufacturer's performance specifications, and the system's condition as found and as left is documented in the Field Service Report required by 5.6.1.

5.2.4 Scheduled preventive maintenance visits are provided at no charge beyond the firm-fixed price for the contract period.

5.3 Calibration and Measurement Traceability. Each covered system is calibrated so that signal strength and data accuracy support analytical results of known quality, and calibration is traceable to recognized standards.

5.3.1 Pure dye calibration is performed on each covered system during each preventive maintenance visit in accordance with the manufacturer's specification, and passing results are documented in the Field Service Report.

5.3.2 Standards used for inspection, measuring, and test equipment are traceable to NIST or to an equivalent national or international standard. The contractor furnishes documentation of traceability to the COR upon request.

5.4 Remedial Repair, Warranty, and Performance Guarantee. Covered systems that fail or perform outside specifications are restored to operating condition at no additional cost to the Government.

5.4.1 Remedial repair includes all parts, labor, and travel at no additional charge beyond the firm-fixed price for the contract period. The number of remedial service calls during the contract period is not limited.

5.4.2 Following notification by the COR of a system failure or degraded performance, the contractor responds on site within two (2) business day(s) of notification.

5.4.3 Performance of a covered system following preventive maintenance is guaranteed for a minimum of ninety (90) days. If a covered system fails within that period due to the preventive maintenance performed, the contractor returns to the site at no additional cost and troubleshoots and repairs the system within two (2) business days of notification.

5.4.4 The Contractor warrants all parts and labor furnished under this contract for twelve (12) months from the date of Government acceptance of the applicable service event.

5.5 Technical and Application Support. Laboratory staff receive timely technical and application support for the systems covered throughout the contract period.

5.5.1 The contractor provides telephone and electronic mail access to technical instrument support and application support throughout the period of performance and responds within two (2) business days of initial contact.

5.6 Service Documentation and Records. Service records are complete, traceable, and sufficient to support the laboratory's ISO/IEC 17025 accreditation.

5.6.1 A Field Service Report and the associated traceability certificates are furnished to the

COR, in electronic or hard copy, within twenty-four (24) hours of service completion. Each Field Service Report contains:

ο the name and address of the laboratory where the service was performed;

ο unique identification of the unit, such as the serial number, appearing on each page of the report or certificate;

ο reference to the method used to maintain the instrument;

ο a description of the condition of, and an unambiguous identification of, the item serviced;

ο the date the service was performed;

ο test results, including the unit of measure;

ο the name, function or title, and signature of the person preparing the report or certificate;

ο evidence that any standards and measuring and test equipment used during the service are traceable to a national or international standard;

ο results as found and as left after the instrument is serviced; and ο a page number on each page.

5.6.2 Certificates and service documentation furnished under 5.6.1 shall provide sufficient information to demonstrate calibration traceability and support the Government's ISO/IEC 17025 laboratory accreditation, including identification of the standards used, traceability information, and applicable measurement results.

5.6.3 The contractor's standard operating procedure (SOP) for this service is furnished to the COR within five (5) business days of a request.

PART 6 — APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions). The contractor shall comply with all applicable publications, manuals, codes, regulations, and local policies and procedures, including:

• Manufacturer's published maintenance, service, and calibration specifications for the 7500 Fast Real-Time PCR platform.

• ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories.

• FDA and HHS facility safety, security, and access procedures applicable to the place of performance.

PART 7 — ATTACHMENT / TECHNICAL EXHIBIT LISTING

7. Attachment / Technical Exhibit List.

7.1 Technical Exhibit 1 – Performance Requirements Summary.

7.2 Technical Exhibit 2 – Deliverables Schedule.

7.3 Technical Exhibit 3 – Estimated Workload Data

TECHNICAL EXHIBIT 1 — PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives tied to mission-essential outcomes. The performance threshold states the maximum acceptable defect rate for each objective. Each row corresponds to a task in Part 5.

Performance Objective

(PWS ¶)

Standard Performance Threshold (Max Defect Rate / AQL)

Method of Surveillance

PRS #1. Preventive maintenance completed as scheduled (5.2.1, 5.2.2)

Preventive maintenance is performed on each covered system at the required frequency and includes replacement of all wear parts identified by the applicable

0/100% percent

100 Percent Inspection

Performance Objective

(PWS ¶)

Standard Performance Threshold (Max Defect Rate / AQL)

Method of Surveillance checklist. The system is returned to service operating within manufacturer performance specifications.

PRS #2. Pure dye calibration performed and documented (5.3.1)

Pure dye calibration is performed during each preventive maintenance visit in accordance with the manufacturer's specification, with passing results documented in the Field Service Report.

0/100% percent

100 Percent Inspection

PRS #3. Remedial repair response (5.4.1, 5.4.2)

The contractor responds on site within the required number of business days of COR notification and restores the covered system to operating condition at no additional charge.

10/90% percent

Periodic Surveillance

PRS #4. Post-maintenance performance guarantee (5.4.3)

No covered system fails within ninety (90) days of preventive maintenance due to the maintenance performed. If a failure occurs, the contractor returns on site within two (2) business days at no additional cost.

0/100% percent

Validated Customer Complaint

PRS #5. Technical and application support response (5.5.1)

The contractor responds to telephone or electronic mail requests for technical or application support within two (2) business days of initial contact.

10/90% percent

Random Sampling

PRS #6. Service documentation furnished and complete (5.6.1, 5.6.2)

A Field Service Report and service documentation and calibration traceability documentation containing all content required by

5.6.1 are furnished within twenty-four (24) hours of service completion.

5/95% percent

100 Percent Inspection

TECHNICAL EXHIBIT 2 — DELIVERABLES SCHEDULE

This exhibit lists all deliverables required under the PWS, including frequency, number of copies, medium and format, and recipient. Every deliverable referenced in the PWS shall appear here.

Deliverable (PWS ¶) Frequency No. of Copies

Medium / Format

Submit To

Quality Control Documentation (if requested by the CO or

COR) (1.6.1)

Within five (5) business days after Government request

1 Electronic CO and

COR

Proof of ISO/IEC 17025 accreditation and personnel qualification documentation (1.6.8)

Upon request 1 Electronic CO and

COR

Spectral calibration kits (4.2.2)

At least 48 hours before each scheduled service visit

As required per system serviced

Physical delivery

COR, place of performance

Field Service Report and calibration traceability documentation (5.6.1, 5.6.2)

Within 24 hours of each service completion

1 Electronic or hard copy

COR

Measurement traceability documentation (5.3.2)

Upon request 1 Electronic COR

Standard Operating Procedure for this service (5.6.3)

Within 5 business days of request

1 Electronic COR

TECHNICAL EXHIBIT 3 — ESTIMATED WORKLOAD DATA

This exhibit lists historical or estimated workload data used to prepare the Independent Government Cost Estimate (IGCE).

Item Estimated Quantity

Applied Biosystems 7500 Fast Real-Time PCR Systems covered

Six (6)

Preventive maintenance visits per system per contract period

One (1)

Remedial service calls per contract period, historical average

10 average

Spectral calibration kits consumed per contract period 1 of each kit per instrument (6 of each: Calibration Kit I and Kit II)