Statement of Work - Osmometer Revsied.docx

VA HANDBOOK 6500.6 APPENDIX C

MARCH 12, 2010

STATEMENT OF WORK (SOW) - Revised Advanced Instruments Osmo1 Single-Sample Micro-Osmometer Clinical Chemistry Laboratory Central Arkansas Veterans Healthcare System (CAVHS) Little Rock, AR 72205

1. PURPOSE

1.1. The overall purpose is to establish a purchase contract to provide one Advanced Instruments Osmo1 Single-Sample Micro-Osmometer in the Clinical Chemistry Laboratory at Central Arkansas Veterans Healthcare System (CAVHS), 4300 W. 7th St, Little Rock, AR 72205.

1.2. This instrument will be in the Clinical Chemistry section of Pathology & Laboratory Medicine Service (P&LMS) and used for measurement of osmolality in serum, plasma, urine, and other body fluids to support patient care and meet CLIA and College of American Pathologists (CAP) requirements.

1.3. Osmolality testing is required for evaluation of electrolyte and water balance, toxic alcohol ingestion, and other critical clinical conditions. A dedicated micro‑osmometer is necessary to support current and projected testing volumes, reduce turnaround time, and improve accuracy and reliability of results.

2. SCOPE

2.1. The Contractor shall provide all listed equipment. All products must meet all salient characteristics defined in this section.

2.2. All equipment must meet manufacturer and VA specifications.

2.3. The Contractor shall furnish all materials, parts, tools, supplies, equipment, facilities, and services required for delivery of the equipment.

2.4. The Contractor is responsible for supplying all required parts, components, tools, and accessories necessary for the VA to complete the installation in accordance with manufacturer specifications.

2.4.1. VA personnel will perform the physical installation, but the Contractor remains responsible for ensuring that all required items are supplied.

2.5. The equipment will be a bench‑top, single‑sample micro‑osmometer intended for clinical laboratory use to perform quantitative osmolality measurements using the freezing point depression method.

3. Specifications / Salient Characteristics

3.1. Advanced Instruments Osmo1 Single-Sample Micro-Osmometer

3.2. Bench‑top/tabletop instrument.

3.3. Uses freezing point depression principle for osmolality measurement.

3.4. Accepts serum, plasma, urine, and other body fluid samples as validated by the laboratory.

3.5. Sample volume requirement: 20 microliters or less per test.

3.6. Measuring range: at least 0–2000 mOsm/kg H₂O.

3.7. Resolution: 1 mOsm/kg H₂O.

3.8. Accuracy and precision must meet or exceed manufacturer’s stated performance claims across the analytical range.

3.9. Throughput sufficient to support routine clinical workload (minimum 20 patient samples per hour).

3.10. Integrated or attached touchscreen user interface.

3.11. Integrated barcode scanner for sample identification.

3.12. Integrated thermal printer for result printouts.

3.13. Capability to store results and operator information internally.

3.14. Connectivity ports (e.g., Ethernet and/or USB) for potential interface to a laboratory information system (LIS) or middleware, if requested by the facility.

3.15. Operation on standard electrical power (100–240 V, 50/60 Hz) with appropriate power cord.

3.16. Compact footprint suitable for placement on existing chemistry laboratory bench space.

3.17. Instrument must support 2‑ or 3‑point calibration and calibration verification to meet CLIA requirements.

3.18. Instrument must include on‑screen or documented step‑by‑step guidance for calibration, quality control, and routine operation.

4. Documentation

4.1. The Contractor shall provide complete sets of operator’s manuals (hard copy or digital, if available).

4.2. The Contractor shall provide technical/service manuals, if available (hard copy or digital).

5. DELIVERY AND INSTALLATION

5.1. DELIVERY

5.1.1. The Contractor shall deliver all equipment to:

Central Arkansas Veterans Healthcare System (CAVHS) 2200 Fort Roots Drive (Building 182) North Little Rock, Ar. 72114

5.1.2. Final location of instrument:

Central Arkansas Veterans Healthcare System (CAVHS) Pathology & Laboratory Medicine Service – Clinical Chemistry Laboratory 4300 W. 7th St. Little Rock, AR 72205

5.2. Deliver materials in the manufacturer’s original sealed containers with brand name marked thereon.

5.3. Package to prevent damage or deterioration during shipment, handling, and storage. Maintain protective covering in place and in good repair until removal is necessary.

5.4. Any Government‑requested delayed delivery up to 90 days after the initial delivery date shall be at no additional cost to the Government.

5.5. A pre‑delivery meeting may be conducted prior to initial negotiated delivery date for verification of delivery dates.

5.6. Delivery will be coordinated through the Contracting Officer’s Representative (COR).

5.7. Installation will be completed by VA staff.

6. INSPECTION AND ACCEPTANCE

6.1. The Contractor shall conduct a joint inspection with the COR upon delivery of equipment.

6.2. Final acceptance will be contingent upon:

6.2.1. Successful completion of the laboratory’s verification/validation studies demonstrating that performance meets manufacturer and laboratory requirements.

7. DELIVERABLES

7.1. Equipment

7.1.1. One Advanced Instruments Osmo1 Single-Sample Micro-Osmometer, fully assembled and operational.

7.1.2. All standard accessories required for operation as described under Salient Characteristics.

7.2. Documentation

7.2.1. Operation and Maintenance Manuals

7.2.1.1. Complete sets of operator’s manuals (hard copy and digital, if available).

7.2.1.2. Technical/service manuals, if available (hard copy and/or digital).

7.2.2. Maintenance Schedule

7.2.2.1. Compilation of all manufacturer‑recommended maintenance and operation materials packaged in binder(s) or electronic format to the COR upon delivery.

8. WARRANTY

8.1. The Contractor shall provide a minimum one‑year manufacturer’s warranty on all parts and labor for the osmometer and associated components, starting upon completion of installation and Government acceptance, unless otherwise specified in the contract.

8.2. The warranty shall include all travel and shipping costs associated with any warranty repair.

8.3. The Contractor shall provide telephone and/or remote technical support for troubleshooting during normal business hours.

8.4. Documentation of all maintenance and repairs will be provided to the COR and the Clinical Engineering/Biomedical Engineering department, as applicable.

9. PROTECTION OF PROPERTY

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