A04 Requirements Document WOSU Clinical Chemistry Analyzer Lease and Support 2026.docx

INDIAN HEALTH SERVICE

Portland Area Requirements Document

1. Title Clinical Chemistry Analyzer Lease and Support

2. Background The Western Oregon Service Unit (WOSU) outpatient clinic provides primary care and pharmacy services and maintains an on-site Laboratory Department. Clinical chemistry and immunoassay testing is required to support direct patient care and to meet Clinical Laboratory Improvement Amendments (CLIA) requirements. WOSU currently has an in-place Vitros 5600 clinical chemistry analyzer platform that is integrated to the Government's Laboratory Information System (LIS) environment. This requirement is to ensure continuity of operations through lease/rental and full support of the in-place analyzer, including all required reagents, calibrators, controls, and other consumables necessary to perform the minimum required test menu identified in Appendix A, and to include a planned end-of-life replacement in 2028 with parallel testing and removal of the legacy analyzer.

3. Scope The Contractor shall provide continuous lease/rental and full-service support for the currently installed integrated clinical chemistry analyzer system at WOSU, including preventive maintenance, corrective maintenance, remote and on-site technical support, and all consumables required to perform the minimum required test menu identified in Appendix A (e.g., reagents, controls, calibrators, and disposables). This requirement shall be performed in a manner consistent with the applicable terms and conditions of the awarded parent contract for the clinical analyzer program. The currently installed analyzer shall remain in place and supported until a single planned analyzer replacement (swap) in approximately June 2028. That replacement shall include installation of the replacement analyzer, a parallel testing period (up to 30 calendar days) with both analyzers installed simultaneously to validate results, removal of the legacy analyzer, and transition services to avoid interruption of patient testing.

4. Specific Tasks or Specifications The Contractor shall, at a minimum, provide the following, in a manner consistent with the applicable terms and conditions of the awarded parent contract (including the included items and service features customarily provided under the parent contract's cost-per-test or equivalent clinical analyzer program):

• Parent contract alignment: Order-level requirements are intended to be read in harmony with, and not to supersede, the terms and conditions of the awarded parent contract. Included items shall encompass, as applicable under the parent contract, equipment usage/lease, service, accessories, reagents, controls, calibrators, consumables, shipping, and routine manufacturer-required modifications and software/hardware updates. Title to leased equipment shall remain with the Contractor.

• Required minimum test menu: The analyzer system and all furnished reagents, controls, calibrators, consumables, and accessories shall support the minimum required assay menu listed in Appendix A. Equivalent assay nomenclature may be used only if the assay functionality is the same and accepted by the Government. The planned June 2028 replacement shall maintain the full Appendix A menu without loss of capability.

• Current system continuity: The currently installed analyzer shall remain in place and supported until the single planned June 2028 replacement. Immediate platform replacement at the start of the period of performance is not contemplated under this requirement.

• Regulatory compliance: All assays and materials provided shall be appropriate for clinical diagnostic use and support CLIA compliance. The Contractor shall furnish documentation (e.g., package inserts, IFUs, calibration/quality-control information, and service records) needed to support laboratory quality management for the Appendix A menu.

• Training: No separately priced routine training is required beyond what is included under the parent contract. The Contractor shall provide only the training reasonably necessary to support installation/verification activities and the June 2028 replacement/cutover (e.g., orientation to any user-interface differences and updated maintenance procedures).

• Removal and disposition: Remove the legacy analyzer after successful validation and Government acceptance. The Contractor shall be responsible for removal from the site and lawful disposition in accordance with applicable law and manufacturer procedures.

• Parallel testing/validation: Maintain both analyzers on-site and operational during a Government-directed validation period of up to 30 calendar days to allow side-by-side testing and confirmation of acceptable results before the legacy analyzer is removed.

• 2028 replacement (one swap): Provide and install one replacement clinical chemistry analyzer (new or equivalent) at end-of-life, targeted for June 2028, at no additional cost. The replacement shall meet all performance, dry-chemistry, and interface requirements, maintain the Appendix A test menu, and be implemented consistent with the parent contract delivery/installation terms.

• Interface compatibility: The analyzer must support bi-directional result transmission via the Government's third-party instrument manager (Data Innovations) to the Government's proprietary Electronic Health Record / Resource and Patient Management System (RPMS). The Contractor shall coordinate analyzer-side interface/communication settings with the Government as needed. The instrument manager software is Government-procured and is not part of this acquisition.

• Continuity of testing: The Contractor shall ensure the Government's ability to perform required testing during business hours with no interruption to patient testing capability. If an outage is expected to exceed the duration reasonably supportable by routine troubleshooting, the Contractor shall provide a no-cost contingency solution (e.g., loaner, swap, or other comparable continuity measure) consistent with the parent contract and the awarded order.

• Service support: Provide technical assistance and on-site service consistent with the parent contract service plan. At a minimum, telephone technical assistance shall be available 24 hours per day, 7 days per week. When the issue cannot be resolved remotely, on-site service shall be provided during contract coverage hours and scheduled no later than the next covered business day, unless more favorable response is included under the parent contract.

• Remote technical support, when approved by the Government, using a secure method that does not involve direct connectivity to the Government network. The Contractor shall not directly connect to the Government's network or access Government information systems. Remote support shall be limited to the analyzer as configured and approved by the Government, such as analyzer-only remote diagnostics or secure dial-in features integral to the system.

• Corrective maintenance and repair services consistent with the parent contract service plan, including covered labor, travel, non-consumable parts, and manufacturer-required modifications/software upgrades, to maintain operational availability during clinic business hours (7:30 a.m. - 5:00 p.m., local time), Monday through Friday excluding Federal holidays. Government staff will perform routine operator maintenance specified in the operator manual.

• Preventive maintenance in accordance with the manufacturer's recommendations and the parent contract/service manual, including documentation of maintenance performed. Preventive maintenance shall be performed not less than annually, or more frequently if required by the manufacturer.

• All reagents, controls, calibrators, and consumables necessary to support the Appendix A required test menu and daily operations, including all testing supplies and consumables needed to perform correlation/parallel studies during the 30-day validation period approx. June 2028, required furnished in quantities sufficient to prevent interruptions in testing.

• A dry chemistry (waterless) methodology analyzer solution that does not require external water lines or drains for operation.

• Lease/rental of the currently installed integrated clinical chemistry analyzer system and associated components necessary to perform routine and STAT testing for outpatient laboratory operations. Relocation of the analyzer is not included under this requirement unless separately authorized by the Government and addressed consistent with the parent contract.

5. Performance Monitoring (if applicable) The Government (COR/Project Manager) will monitor Contractor performance through service ticket tracking, review of preventive maintenance documentation, verification of uptime/availability during business hours, confirmation that the Appendix A test menu remains supported, and inspection/acceptance of delivered consumables. Successful performance includes timely response to service calls, completion of maintenance in accordance with schedule, and maintaining continuity of testing.

6. Security Requirements Facility access: Contractor personnel must present government-issued identification, sign in at the front reception desk, and wear a visitor badge while in the clinic. Contractor personnel shall comply with all WOSU safety and infection control requirements while in clinical areas. Information security: Remote support may be permitted only when approved by the Government and implemented in a manner that does not provide the Contractor direct access to the Government network or Government information systems. Any remote connectivity must be limited to the analyzer and must comply with HHS/IHS security and privacy requirements as directed by the Contracting Officer and COR.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI) The Government will provide: (1) access to the Laboratory Department and reasonable facility space for the analyzer(s), including electrical power and environmental conditions consistent with normal laboratory operations; (2) the Government-procured instrument manager software (Data Innovations) and RPMS LIS environment; (3) Government coordination for receiving, access, and scheduling; and (4) routine operator maintenance and daily laboratory quality control activities in accordance with the operator manual and local laboratory procedures. If remote support requires a modem or secure dial-in feature integral to the analyzer, the Government will provide the associated communications service; the Contractor is not responsible for paying for internet/telephone service.

8. Other Pertinent Information or Special Considerations Deliveries will be made to the Laboratory Department at 3750 Chemawa Road NE, Salem, OR 97305 during business hours, unless otherwise approved by the COR. The Contractor shall coordinate deliveries with the COR and comply with facility receiving and visitor requirements. The analyzer is already in place; this requirement is primarily for lease/support and consumables, with no immediate transition at the start of the period of performance and a single planned replacement in 2028. This requirement contemplates a single ship-to location at WOSU.

a. Identification of Possible Follow-on Work Follow-on work may be required after the end of this period of performance to continue analyzer lease/support or to replace the analyzer at future end-of-life; however, no additional follow-on work is included in this requirement beyond the single planned replacement targeted for June 2028.

b. Inspection and Acceptance Criteria Inspection and acceptance will occur at the delivery point (Laboratory Department). Consumables will be accepted upon visual inspection for damage, verification against packing lists, and confirmation of unexpired shelf-life. Service will be accepted when the analyzer is restored to operational status and meets required performance, including successful quality control per laboratory procedures and continued support of the Appendix A menu. For the 2028 replacement, acceptance will occur after successful parallel testing/validation, confirmation that the replacement supports the Appendix A minimum test menu and interface requirements, and Government approval to cut over to the replacement analyzer.

9. Risk Control (Contracting Officer to delete if not applicable) Key risks include analyzer downtime, delays in replacement installation, and supply chain disruptions for reagents/consumables. The Contractor shall mitigate these risks by maintaining adequate inventory, providing timely service response, having access to required parts, and coordinating the 2028 replacement plan well in advance with the COR and laboratory staff.

10. Place of Performance / Delivery Address / Location Western Oregon Service Unit (WOSU) – Laboratory Department 3750 Chemawa Road NE Salem, OR 97305

11. Period of Performance Base Period: 04/01/2026 – 03/31/2027 Option Period 1: 04/01/2027 – 03/31/2028 Option Period 2: 04/01/2028 – 03/31/2029 (includes planned analyzer replacement around June 2028) Option Period 3: 04/01/2029 – 03/31/2030 Option Period 4: 04/01/2030 – 03/31/2031

12. Delivery Schedule The analyzer is currently installed. Consistent with the parent contract, standard delivery for reagents, controls, calibrators, consumables, and other routine supplies shall be within 5 days after receipt of order (ARO), unless otherwise coordinated; expedited delivery may be requested consistent with parent contract terms. Replacement capital equipment associated with the June 2028 swap shall be coordinated in advance and delivered in accordance with the parent contract delivery terms. Shipments may be established on a standing schedule (e.g., quarterly or biannual) or ordered as needed at the Government's option. This requirement contemplates a single ship-to location. Deliveries will be coordinated with the COR and will occur during normal business hours unless otherwise authorized.

Appendix A. Required Minimum Test Menu The assays below reflect the current WOSU test menu and constitute the minimum required menu for this acquisition. The offered solution shall maintain these capabilities throughout the period of performance, including after the planned June 2028 replacement. Drug-screen cutoff values are shown in parentheses where applicable.

Chemistry / Immunochemistry / Calculated Assays

Drug of Abuse Screen Assays