CONS Draft Marked_Coagulation Analyzers SOW 3 April 2020.docx

STATEMENT OF WORK

3 April 2020

Clinical Laboratory Coagulation Analyzers 11th Medical Group Joint Base Andrews, MD

1. Description of Services

1.1 The contractor shall furnish two (2) coagulation analyzers, two (2) data management systems, two (2) printers, two (2) un-interruptible power supplies, an operators manual, accessory kits, reagents, calibrators, controls, and consumables necessary to operate the analyzers for the contracted tests.

1.2 The two coagulation analyzers should consist of two (2) identical primary analyzers with lab automation capable of handling a large volume of samples. Both instruments should provide similar testing and results while requiring identical reagents and supplies.

1.3 The instruments should interface with our existing Hospital Computer System and be capable of producing reliable pro-thrombin, activated partial thromboplastin times, and 0-Dimer test results.

1.4 The instrument's test menu must meet the needs of Malcolm Grow Medical Center (MGMC) medical staff, with an acceptable throughput of the analyzer (how many tests can it do in an hour), the contractor shall provide analyzers to meet the testing needs of our facility (since we are a medical center with emergency room capabilities).

1.5 The analyzers, instrument methodology and results shall be in accordance with the requirements of professional standards of the College of American Pathologists (CAP) and the Joint Commission (JC) and any applicable Directives from the Department of Defense (DOD), or Office of the Air Force Surgeon General Standards or requirements. The Requirements and standards are incorporated in this Statement of Work (SOW).

The Contractor shall submit reports and documentation as identified throughout the SOW.

2. Analyzer Requirements

2.1 The analyzers shall be capable of producing reliable pro-thrombin, activated partial thromboplastin times, and D-Dimer test results.

2.2 The analyzers shall possess a magnet ball mechanical clot detection that is not affected by hemolysis and lipemia, a vital requirement in support of ER trauma patients where hemolysis is common.

2.3 The contractor shall provide pre-calibrated D-Dimer assay.

2.4 The analyzers shall provide continuous specimen access.

2.5 The analyzers shall have a small enough platform to fit into our laboratory and use our existing (power) facility capabilities.

3. Maintenance and Repair

3.1 The contractor shall provide 24/7 technical phone support.

3.2 The contractor shall perform require preventive maintenance and emergency maintenance necessary to fulfill the customer’s test requirements. Emergency maintenance will be provided within 24 hours of notification of malfunction.

3.3 The contractor shall provide all tools, parts and labor needed for emergency maintenance and incur all associated travel costs.

3.4 The contractor shall provide emergency and routine maintenance service and all reagents, calibrators, controls, and consumables required to perform coagulation testing between the hours of 8:00a.m. – 5:00p.m., Monday – Friday.

3.5 The contractor shall provide all software updates to this equipment, to include filed modification, safety corrections, revisions designed to correct software deficiencies and equipment modifications normally furnished by the manufacturer. Upgrades and modifications will be furnished at no additional cost under the contract and installed during the next PMI after the manufacturer makes them available. These software updates, upgrades and modifications will not include those designed primarily as performance enhancements or performance upgrades.

4. Training Support

4.1 The contractor shall provide Inter-Laboratory Quality Assurance Programs.

4.2 Analyzer training shall be provided for two (2) initial operators for high complexity instrumentation, to include, room, board, and airfare for all off-site training. One additional on-site training, per instrument for each completed year of customer agreement.

4.3 The contractor shall provide on-site technical service specialist that will provide setup, method validation, and correlations.

5. Orientation

5.1 The contractor shall be responsible for providing an orientation program to the clinical laboratory staff.