SOW Hematology Analyzer_Renewal 1.docx

STATEMENT OF WORK

FOR

HEMATOLOGY ANALYZER

1. Scope: The Contractor shall maintain one (1) XN-550 fully automated hematology analyzer. Cost will be calculated on a cost per reportable result (CPRR) arrangement based on the estimated number of patient tests listed in Table 1.

2. Hematology Analyzer Features:

2.1. Contractor will maintain for the Government the existing XN-550 multi-parameter automated hematology analyzer that is capable of performing (at a minimum) the following EDTA whole blood tests on a single compact platform:

Complete Blood Count including the following parameters:

White Blood Cell Count Red Blood Cell Count Hemoglobin (HGB) Hematocrit (HCT) Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Platelet Count Red Cell Distribution Width (RDW) Mean Platelet Volume (MPV)

5 Part White Blood Cell Differential analysis including the following parameters:

Neutrophil Absolute (#) Count Neutrophil Percent (%) Count Lymphocyte Absolute (#) Count Lymphocyte Percent (%) Count Monocyte Absolute (#) Count Monocyte Percent (%) Count Eosinophil Absolute (#) Count Eosinophil Percent (%) Count Basophil Absolute (#) Count Basophil Percent (%) Count

Reticulocyte count including the following parameters:

Reticulocyte Absolute (#) Count Reticulocyte Percent (%) Count

2.2. Due to facility space limitations, the instrument shall not exceed 35” Width, 20” Height, 33” Depth.

2.3. The analyzer must be able to bi-directionally interface with DoD’s GENESIS System and be approved to operate on the Air Force network (dial in not required).

2.4. The analyzer system must include a data management system for control of the operation of the analyzer system, management of the quality control results to include participation in a peer-group quality assurance program, management of reagent packs, management of patient results with user-defined decision rules; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system’s data management system.

2.5. The analyzer shall (must) utilize a windows based operating system. The system shall be Windows 10 compliant.

2.6. Routine maintenance activities (e.g. daily startup) performed on the analyzer must take no longer than 30 minutes.

2.7. Analyzer must be compatible with 110 volt power outlet.

2.8. The analyzer systems must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes.

3. Installation Requirements:

3.1. The Government will furnish the facilities for set-up and operation of the analyzer. The Contractor shall not alter the facilities without written approval of the Contracting Officer Representative. The Contractor shall return the facilities to the Government in the same condition as received, fair wear and tear and approved modifications excepted.

3.2. The Contractor shall provide Safety Data Sheets for each reagent delivered under this contract.

3.3. The Contractor shall provide one (1) paper and one (1) electronic copy of the Operator’s and Maintenance manuals if revised since installation.

3.4. The Contractor shall be responsible for the removal of the equipment upon expiration or termination from the contract.

4. Training:

4.1. The Contractor shall provide one (1) training slot per each additional contract year, at the Contractor’s training site, at no additional cost to the Government.

4.2. Training shall include basic operation of the analyzer, trouble-shooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

5. Equipment, maintenance and service:

5.1. The analyzer system shall be serviced at:

2d Medical Group, Clinical Laboratory 243 Curtiss Road Barksdale AFB, LA 71112

5.2. If during the term of this contract analyzer XN-550 is discontinued, the Contractor will give the Government reasonable notice to allow time to set up a new analyzer which includes installation, method validation, and technician training.

5.3. The analyzer system includes the hematology analyzer and peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, printer)

5.4. Title to the equipment will remain with the Contractor.

5.5. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition.

5.6. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level will be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual.

5.7. The Contractor shall provide full unscheduled and preventative maintenance at no additional cost. Service shall include:

5.7.1. Contractor will provide 24-hours day, 7-days a week, 365-days per year technical hotline support.

5.7.2. On-site service 8:00 am-4:00 pm local time Monday-Friday, excluding holidays/clinic down days.

5.7.3. Emergency service scheduled by next business day.

5.7.4. Field service call back within 1 hour, 8am-4pm, Mon-Fri excluding holidays/clinic down days.

5.8. Replacement of worn-out or defective non-consumable parts on all equipment will be installed and provided at no charge.

5.9. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

5.10. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the Government to troubleshoot the instrument failure prior to notification of the Contractor.

5.11. All work shall be performed in a professional manner by an authorized service representative.

5.12. Contractor service personnel must possess the necessary documents to obtain access to a military installation. This includes but is not limited to two forms of government identification, proof of vehicle registration and proof of vehicle insurance.

5.13. Contractor personnel shall present a neat appearance and be easily recognized as contractor employees. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any U.S. Government facility.

5.14. The Contractor shall notify the Customer of the exact date and time for performance of a preventive maintenance service within ten (10) calendar days prior to the scheduled preventive maintenance services.

6. Reagents:

6.1. The Contractor shall provide the reagents and shall establish exact quantities and shipment schedule of reagent/reagent packs, calibrators/standards, quality control materials and consumables required to perform the volume of tests listed in Table 1.

6.2. The Contractor will also estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools or supplies necessary to perform operator level periodic maintenance tasks.

6.3. The Contractor shall ensure that requirements for routine quality control testing, calibration, linearity, and troubleshooting are considered when calculating yearly reagent requirements.

6.4. Reagents will be shipped as a standing order on a quarterly or bi-annual basis. If additional reagents or consumables are needed, the customer may phone in additional orders at no charge.

6.5. Contractor will warrant that all reagents and supply items are free of manufacture defects and will repair or replace any unsatisfactory items at their expense.

6.6. The Contractor shall make best efforts to deliver the reagents in the same lot.

7. Cost Per Reportable Result Pricing:

7.1. Price will be established based on the total estimated annual volume of reportable tests to be reported.

7.2. Price includes:

7.2.1. All reagents necessary to perform the total of all patients tested plus calibration, quality control, linearity and repeat testing for (1) fiscal year, Oct 1 through 30 Sep.

7.2.2. Use of analyzer and all peripherals such as uninterrupted power supply (UPS), work station, printer, etc.

7.2.3. All consumables as calculated for the customer test volume.

7.2.4. Installation and training as described.

7.2.5. Preventative maintenance and service as described.

7.3. Customer workload listed in the table below is an estimate based on projected patient workload. Actual workload may vary and may fluctuate during the year due to changes in the distribution of patient care. The numbers represent patient reportable results and do not include calibration, calibration verification, linearity, quality control, or repeat testing due to confirmation or troubleshooting.

Table 1. – Estimated Annual Patient Testing Volume

8. Billing:

8.1. Prices include equipment, reagents, consumables, service, installation, and training.

8.2. Pricing will be established based on the total estimated annual volume of reportable tests.

8.3. Price will be divided by 12 to determine the fixed monthly amount the customer will be invoiced during the fiscal year.