Multi-Species Hematology Analyzer Lease PWS FINAL.pdf

Performance Work Statement Multi-Species Hematology Analyzer Lease

Uniformed Services University of the Health Sciences

Period of Performance: See contract schedule Base plus four (4) option years

Description of Service:

The contractor shall furnish one (1) new Multi-Species Hematology Analyzer, and an IPU CPU Computer. The setup also features a monitor, keyboard, mouse, printer, pneumatic unit, bar-code reader, and all required reagents, controls, and calibration materials. Service during business hours and on-site calibration are also part of the package.

This multi-species hematology system will perform 35 whole blood parameters and includes a specialized body fluid mode, ensuring accurate cell counts and a comprehensive two-part white blood cell differential. Offers parameters like NRBC, Fluorescent PLT, and body fluid counts, delivering precise results even in challenging conditions. Additionally, the analyzer automates Reticulocyte counts and Reticulocyte Hemoglobin measurements.

This multi-species hematology system will perform 35 whole blood parameters and includes a specialized body fluid mode, ensuring accurate cell counts and a comprehensive two-part white blood cell differential. Offers parameters like NRBC, Fluorescent PLT, and body fluid counts, delivering precise results even in challenging conditions. Additionally, the analyzer automates Reticulocyte counts and Reticulocyte Hemoglobin measurements.

Operators will manually load samples for real-time monitoring, tracking sample indices, and ensuring thorough traceability. This system suits-controlled laboratory environments where scientific research and measurements occur. On average, the laboratory processes 150 reticulocyte counts and 165 complete blood counts (CBC) with monthly differential tests. The monthly amount will remain unchanged for 60 months; Monthly tests are not reported. The Clinical Comparative Pathology laboratory will incur no costs aside from the specified cost-per-reportable, and the analyzer will operate on Windows 10 or higher, fully complying with DoD Cyber Security Measures and possessing an authority-to-operate (ATO).

Instrument Specifications:

The current allocated space for a Multi-Species Hematology Analyzer atop a table unit boasts dimensions of 25.4 inches in width, 29.7 inches in depth, and stands 33.7 inches tall, making it a compact yet powerful addition to any workspace; 172 LBS.

The floor-standing wagon will be equipped with a wide range of components. It measures 25.4 inches in width, 36.8 inches in depth, and has an impressive height of 61.5 inches. It is designed to support a maximum weight capacity of 350 pounds.

The contractor will provide the Uninterrupted Power Source (UPS).

Technologies:

Fluorescent flow cytometry is a sophisticated technique that utilizes a high-precision semiconductor laser to illuminate cells as they pass through specialized channels with hydrodynamic focusing. This method ensures that the cell samples are aligned and propelled in a streamlined manner, enhancing the accuracy of the measurements. The flow cytometry process employs direct current sheath flow, ensuring a stable and well-defined path for the cells.

Furthermore, it incorporates a cyanide-free SLS (side scatter light) methodology, which is safer and environmentally friendly. An advanced adaptive cluster analysis system (ACAS) is utilized to categorize and analyze the data, enabling researchers to identify distinct cell populations.

Additionally, specialized three-dimensional shape recognition techniques provide in-depth analysis of each white blood cell (WBC) subpopulation, allowing for a greater understanding of their morphology and functions.

Preventive Maintenance Services:

The contractor will provide both scheduled preventive maintenance and emergent repair services.

Maintenance inspections will include inspection, disassembly, adjustment, replacement of worn or defective parts, reassembly, and system calibration when necessary. Any worn or defective components will be replaced at no cost to the customer. The contractor is required to document the average annual maintenance visits for the equipment and submit this information to the USUHS Comparative Pathology NCOIC and Technical Service Branch.

Additionally, the contractor shall ensure that preventive maintenance (including travel costs, labor, and parts) and any emergent maintenance are performed to meet the testing requirements for the analyzer and UPS unit throughout the duration of this contract.

For technical trouble calls, the contractor will provide a designated point of contact and an alternate for the USUHS Comparative Pathology NCOIC or representative of Clinical Comparative Pathology. Emergency repair services must be performed within 24-48 hours of notification. The contractor will supply all labor and non-wearable parts to fix malfunctions.

Upon completion of each service call, the contractor must submit a report to the USUHS Laboratory NCOIC or a representative of Clinical Comparative Pathology. This report must detail all actions taken during site visits, whether for preventive maintenance or repairs. At a minimum, the report should include the following information: date and time of notification, date and time of arrival, the serial number and model number of the equipment, time spent on maintenance or repairs, a description of the actions taken, and proof of repair. Proof of repair must include documentation of acceptable quality control results for all assays conducted after the repair and before the departure of the technical representative.

USUHS Clinical Comparative Pathology Laboratory personnel will conduct daily routine maintenance and cleaning as outlined in the manufacturer's operation and maintenance instructions. These personnel are also responsible for maintaining appropriate daily records. The contractor shall deliver and install upgrades to the equipment hardware and operating software at no additional charge to the government within sixty (60) days of their issuance or availability. In summary, the contractor will provide scheduled preventive maintenance, emergent maintenance, and repairs. At the same time, the USUHS will grant the contractor access to the equipment for maintenance purposes.

Reagents, controls, and calibrators:

The reagents, controls, and calibrators attachment present an estimation of the quantities of reagent and quality control (QC) materials necessary for an annual testing volume of 780 tests. This estimate considers not only the standard requirements for control runs but also anticipated repeat tests, ensuring a comprehensive overview of needed resources. The Contractor may propose differing quantities and other reagents, controls, and calibrators that meet USU requirements for the yearly testing volume. The costs for these materials shall be included in the total yearly leasing cost.

The Laboratory will be able to use the analyzer at no cost other than the quoted cost-per-reportable. Supplies will be provided to USUHS in regular, predetermined shipment intervals in amounts required by historical average test volumes.

Quality Control (QC) program:

Quality control in the laboratory environment is essential. We require a comprehensive tri-level quality control product specifically designed to evaluate Complete Blood Count (CBC), Differential (Diff), Platelet (PLT), and Reticulocyte (RET) parameters. This advanced solution not only ensures the reliability of test results but also adheres to stringent industry standards.

Additionally, our laboratory engages in body fluid analysis. It requires a specialized bi-level quality control product to address the unique challenges of this type of testing, thereby promoting accuracy and precision. Furthermore, we need a quality monitoring system that serves as a unified platform for effective quality control. Various quality metrics will enable laboratory professionals to oversee and maintain the highest standards of accuracy and reliability in their testing processes.

The extensive quality control file system includes both current and newly introduced lot information. These files play a critical role in monitoring the stability and performance of laboratory testing over time.

However, our laboratory cannot participate in the Insight web-based Interlaboratory Quality Assessment Program (IQAP) because we focus primarily on research rather than clinical testing.

Although we have a close-knit network of colleagues dedicated to continuous improvement and maintaining established best practices, our limited workload poses challenges to actively engaging with such programs. This smaller scale restricts our ability to contribute meaningfully to broader interlaboratory assessments, making it difficult to fully benefit from what IQAP offers. As a result, our technicians and technologists will primarily be responsible for monitoring the quality control of the analyzer by utilizing comprehensive tri-level quality control and specialized bi-level quality control products for body fluid analysis.

Installation and Training:

The contractor shall make the analyzer available for correlation and validation with the current USUHS analyzer, and the contractor will assist with correlation/validation. Installation and implementation shall include, but is not limited to, contractor performed method validation, calibration, precision, accuracy, mode-to-mode studies and data stream verifications, and correlation with current methods (comparison of methods study), validation of precision to ensure successful implementation

The Contractor is responsible for all associated costs of analyzer install and set-up. All reagents, calibrators and linearity materials used in the method validation studies will be provided by the Contractor at no additional cost to the customer. The contractor will provide virtual instructor lead training for USUHS staff members.