01. PWS Bridge Contract for Abbott Architect Jul_Dec 26.pdf

PERFORMANCE WORK STATEMENT (PWS)

Bridge Contract for Immunoassay Reagents, Supplies, and Analyzer Support Services

1. GENERAL INFORMATION

Contract Type: Firm-Fixed-Price (FFP), Non-Personal Services, Commercial Item Delivery/Task Order

Orders may be issued on an individual task or delivery order basis under the bridge contract vehicle.

Bridge To: Contract No. 36F79721D0233/75H70625F80003 NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing PSC/FSC Code: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets Estimated Contract Value: To Be Determined (TBD) by the Government during acquisition planning Requiring Activity: Standing Rock Service Unit, Indian Health Service (IHS) Location of Performance: Ft. Yates IHS, Ft. Yates, North Dakota Period of Performance (POP): 1 July 2026 – 31 December 2026

2. BACKGROUND

The Standing Rock Service Unit requires uninterrupted laboratory diagnostic capability to support patient care services. The Architect i1000SR immunoassay analyzer is currently in use and requires continuous availability of reagents, consumable supplies, maintenance, and technical support services to ensure operational readiness and accuracy of laboratory testing.

This bridge contract is necessary to prevent any lapse in services while follow-on contractual actions are completed. The follow-on acquisition was not completed prior to expiration of the current contract due to acquisition lead-time constraints, including requirements development, market research, internal review processes, and contract coordination activities.

The Government is actively pursuing the follow-on acquisition and has implemented mitigation measures intended to reduce the likelihood of recurring bridge actions. These measures include earlier acquisition planning milestones, enhanced procurement tracking, coordination between program and contracting personnel, and periodic acquisition status reviews to support timely contract award.

3. OBJECTIVE

The objective of this Performance Work Statement is to obtain contractor support for the provision of immunoassay reagents, consumable supplies, preventive and corrective maintenance, and technical support services necessary to maintain uninterrupted operation of the Abbott Architect i1000SR Immunoassay Analyzer.

The Contractor shall support continuous laboratory operations and assist the Government in maintaining operational readiness and timely diagnostic testing capability. This requirement is critical to maintaining uninterrupted patient diagnostic services during the interim period pending award of the follow-on contract. Performance outcomes include maintaining analyzer uptime consistent with manufacturer standards, minimizing service disruptions, supporting uninterrupted patient care operations, and ensuring laboratory testing turnaround times are not adversely impacted by equipment downtime, reagent shortages, or delayed technical support.

4. SCOPE OF SERVICES

The Contractor shall provide all labor, supervision, materials, equipment, reagents, consumables, transportation, and technical support necessary to maintain full operational capability of the Architect i1000SR Immunoassay Analyzer.

Mandatory Services

The following services are required under this contract:

• Provision of manufacturer-approved immunoassay reagents compatible with the Architect i1000SR

• Supply of all required consumables and ancillary materials

• Preventive maintenance services in accordance with manufacturer specifications

• Corrective maintenance and repair services

• Remote and/or on-site technical support and troubleshooting as required to restore operational capability

• Documentation of maintenance activities and service events

Optional or Conditional Services

The following services may be required when applicable to system operation or directed by the Government:

• Software updates and system optimization, if applicable and authorized by the Government

• Provision of quality control materials, if required for system operation

• Additional technical consultation or specialized troubleshooting support beyond standard maintenance requirements

The Contractor shall ensure all products and services comply with OEM specifications, FDA requirements, manufacturer specifications, and all applicable laboratory regulatory standards.

5. EQUIPMENT COVERED

Primary Equipment

• Abbott Architect i1000SR Immunoassay Analyzer

Ancillary Equipment

• Abbott Link Firewall (currently installed and operational)

The Contractor shall maintain all covered equipment in optimal operating condition to support continuous laboratory operations. Maintenance responsibilities include covered ancillary connectivity components necessary for analyzer operation.

6. PERFORMANCE REQUIREMENTS

The Contractor shall meet the following performance standards:

Performance Standard Acceptable

Quality Level

(AQL)

Surveillance Method

Reviewing Official

Remedy for Noncompliance

Deliver reagents and consumables without interruption to operations

100% on-time delivery

Review of delivery records and packing slips

COR or Laboratory

POC

Require corrective action plan and replacement deliveries at no additional cost

Deliver reagents within manufacturer shelf-life requirements

100% compliant Inspection of delivered materials

COR or Laboratory

POC

Rejection and replacement of noncompliant supplies

Performance Standard Acceptable

Quality Level

(AQL)

Surveillance Method

Reviewing Official

Remedy for Noncompliance

Perform preventive maintenance according to manufacturer schedule

100% compliant

Review of maintenance reports and service logs

COR or Laboratory

POC

Require corrective maintenance and documentation updates

Acknowledge service calls within 24 hours or the next business day, initiate technician dispatch or remote troubleshooting within the same timeframe, and complete corrective actions as soon as practicable based on the severity of the issue and parts availability

95% compliance

Review of service call logs and response documentation

COR or Laboratory

POC

Require corrective action plan and escalation to Contracting Officer for repeated deficiencies

Restore analyzer functionality following service events

95% successful resolution

Verification of equipment operational status

COR or Laboratory

POC

Re-performance of services at no additional cost

Maintain analyzer operational uptime consistent with OEM standards

95% uptime excluding scheduled maintenance

Review of downtime logs and service records

COR or Laboratory

POC

Require corrective action plan and service escalation for repeated downtime events

Provide technical support as needed

Continuous availability during normal operating hours

End-user feedback and review of support records

COR or Laboratory

POC

Document performance deficiency and require corrective measures

The Contractor shall meet the following performance standards:

Acceptable Quality

Level (AQL)

Deliver reagents and consumables without interruption to operations 100% on-time delivery

Deliver reagents within manufacturer shelf-life requirements 100% compliant

Perform preventive maintenance according to manufacturer schedule 100% compliant

Acceptable Quality

Level (AQL)

Acknowledge service calls within 24 hours or the next business day, initiate technician dispatch or remote troubleshooting within the same timeframe, and complete corrective actions as soon as practicable based on the severity of the issue and parts availability

95% compliance

Restore analyzer functionality following service events 95% successful resolution

Provide technical support as needed Continuous availability during normal operating hours

7. NON-PERSONAL SERVICES

This is a non-personal services contract. Contractor personnel shall not be supervised by Government personnel. Nothing in this contract shall be construed to create an employer-employee relationship between the Government and Contractor personnel.

Contractor personnel shall not perform inherently governmental functions as defined in FAR

7.503. All decisions involving Government policy, contract administration authority, inherently governmental determinations, or official Government representation shall remain the sole responsibility of Government personnel.

8. PLACE OF PERFORMANCE

All services shall be performed at:

Standing Rock Service Unit 10 Standing Rock Ave, Fort Yates, ND 58538

(701) 854-3831

9. DELIVERABLES

The Contractor shall provide the following deliverables:

Deliverable Submission Format Delivery Timeline Receiving Official

Immunoassay reagents and consumables

Packing slip and delivery documentation

As ordered and coordinated with the Government

Designated COR or Laboratory POC

Preventive maintenance documentation

Electronic PDF service report

Within 5 business days after each maintenance event

Designated COR or Laboratory POC

Corrective maintenance/service reports

Electronic PDF service report

Within 3 business days after each service call

Designated COR or Laboratory POC

Technical support documentation

Electronic correspondence or service summary

As required following support activity

Designated COR or Laboratory POC

Resolution summaries for service interruptions

Electronic incident summary report

Within 3 business days following incident resolution

Designated COR or Laboratory POC

10. QUALITY ASSURANCE SURVEILLANCE

The Government will monitor Contractor performance in accordance with the Quality Assurance Surveillance Plan (QASP), when applicable, to ensure compliance with contract requirements. The QASP may identify surveillance methods, performance metrics, monitoring frequency, and responsible Government officials associated with oversight of Contractor performance.

Performance may be evaluated through:

• Review of maintenance and service reports

• Verification of delivery timeliness

• Monitoring of analyzer operational status

• Review of corrective action responses

• End-user feedback regarding technical support and service quality

All products provided under this contract shall be FDA-approved or FDA-cleared, as applicable.

Contractor performance and supplied materials shall also comply with applicable Clinical Laboratory Improvement Amendments (CLIA) requirements, College of American Pathologists (CAP) accreditation standards, and other applicable laboratory regulatory or accreditation requirements governing the facility.

11. PERIOD OF PERFORMANCE

Base Period

1 July 2026 through 31 December 2026

No formal transition-in period is anticipated due to the incumbent system and existing operational environment. However, the Contractor shall ensure continuity of services, supplies, and maintenance support without interruption at the start of performance.

At the conclusion of the bridge period, the Contractor shall cooperate with the Government and any successor contractor, as applicable, to support an orderly transition of services and minimize disruption to laboratory operations.

12. GOVERNMENT-FURNISHED PROPERTY (GFP)

The Contractor shall exercise reasonable care and accountability for all Government-furnished property and equipment provided under this contract. The Contractor shall immediately report any damage, loss, theft, misuse, or malfunction involving Government-furnished equipment to the designated COR or Government POC.

The Contractor shall not remove, modify, relocate, or use Government-furnished equipment for any purpose other than performance under this contract without prior written Government approval. Any damage caused by Contractor negligence or unauthorized use may result in Contractor liability in accordance with applicable contract terms and Federal regulations. (GFP)

The Government will provide access to the Abbott Architect i1000SR analyzer currently installed at the facility. No additional Government-furnished property is anticipated.

13. CONTRACTOR RESPONSIBILITIES

The Contractor shall ensure that maintenance, repair, and technical support services are performed by OEM-certified technicians or manufacturer-authorized support personnel qualified to service the Abbott Architect i1000SR Immunoassay Analyzer and associated components.

The Contractor shall:

• Provide trained and qualified personnel for equipment maintenance and support

• Ensure compliance with all applicable safety and infection control standards

• Coordinate deliveries and service visits with designated Government personnel

• Maintain confidentiality of patient, facility, and operational information

• Ensure all personnel comply with applicable facility access procedures

• Maintain adequate staffing and resources to fulfill contract requirements

14. GOVERNMENT RESPONSIBILITIES

The Government shall:

• Provide access to the equipment and facility as required

• Designate a Contracting Officer’s Representative (COR) or Point of Contact (POC)

• Review and accept deliverables

• Coordinate facility access for Contractor personnel

15. SECURITY AND PRIVACY REQUIREMENTS

Contractor personnel may be required to complete facility access requirements prior to performing work under this contract. Such requirements may include acknowledgment of Rules of Behavior, cybersecurity or information security awareness training, background investigations or suitability determinations, and compliance with applicable facility security procedures, as determined by the Government.

The Contractor shall comply with all applicable Federal privacy and security requirements, including HIPAA requirements where applicable. No patient-identifiable information shall be disclosed without proper authorization.

16. ACCEPTANCE CRITERIA

The designated Contracting Officer’s Representative (COR) or authorized Government Point of Contact (POC) shall be responsible for inspection and acceptance of supplies and services provided under this contract.

Supplies and services shall be considered acceptable when:

• Delivered items meet manufacturer specifications and are free from damage

• Maintenance and repair tasks are completed successfully

• Equipment is fully operational following service activities

• Required documentation is submitted accurately and timely

The Government shall inspect deliverables and services within a reasonable period following receipt or completion. The Government reserves the right to reject supplies or services that fail to meet contract requirements, manufacturer specifications, or applicable regulatory standards.

The Contractor shall correct deficiencies identified by the Government at no additional cost to the Government within a timeframe determined appropriate by the COR or Contracting Officer.

17. INVOICING

Invoices shall be submitted in accordance with FAR 52.212-4, Contract Terms and Conditions— Commercial Products and Commercial Services, and any applicable Indian Health Service (IHS) invoicing procedures.

Invoices shall be submitted electronically through the Invoice Processing Platform (IPP), unless otherwise directed by the Contracting Officer and shall include, at a minimum:

• Contract number and applicable task or delivery order number

• Invoice number and invoice date

• Contractor name, address, and point of contact information

• Description of supplies or services provided

• Quantities delivered or services performed

• Unit prices and total invoiced amount

• Period of performance covered by the invoice

• Shipping or delivery documentation, if applicable

• Name of the designated COR or receiving official

Invoices shall be submitted to the payment office and designated Government officials identified in the award document or task order.

Payment for supplies and services under this contract shall be issued by the Standing Rock Service Unit through individual task orders and processed in accordance with Prompt Payment Act requirements and applicable agency procedures.

18. POINT OF CONTACT

The Contracting Officer will designate the Government Point of Contact and/or Contracting Officer’s Representative upon contract award.

APPENDIX A – ESTIMATED TEST VOLUMES

Note: Reagent catalog and list numbers shall be verified by the Government and Contractor for accuracy prior to solicitation release and award. Any discrepancies identified in manufacturer list numbers, product descriptions, or reagent specifications shall be corrected through amendment or clarification, as applicable.

The following represents estimated reagent test volumes for the six-month bridge period for the Architect i1000SR analyzer. These estimates are based on historical usage and are provided for planning and cost-estimation purposes only. Quantities listed do not guarantee minimum purchases.

Reagent Description Estimated Volume

Architect IA BNP Reagent (List Number 08K28)

Architect IA Digoxin Reagent 43

Architect IA Free T4 Reagent 72

Architect IA hCG (Total Beta-hCG) Reagent 79

Architect IA Troponin-I Reagent 326

Architect IA TSH Reagent 454

Architect IA Vancomycin Reagent 38