Updated V.1 20 Apr 2020_Coagulation SOW.pdf

STATEMENT OF WORK

21 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 shall consist of one (1) primary analyzer with lab automation capable of handling a large volume of samples and one (1) backup analyzer for redundant capability.

The backup analyzer shall provide the same testing and results while using identical reagents and similar supplies and should have an overall smaller physical footprint (width x depth x height) than the primary analyzer.

1.3 The instruments shall interface with our existing hospital computer system, the Composite Health Care System (CHCS) and the new Military Health System (MHS Genesis) after it is deployed to our facility. The analyzer must be capable of producing reliable pro-thrombin, activated partial thromboplastin times, and D-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.

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.

1.6 The contractor shall provide sequestered lots of reagents to minimize lot to lot correlations and provide a mechanism for reagents, calibrators, controls and consumables to be delivered on a scheduled “drop shipment” basis.

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 provide continuous specimen access.

2.3 The analyzers shall have a small enough platform to fit into our laboratory and use our existing (power) facility capabilities. The width of the primary analyzer shall not exceed 40 inches.

2.4 The analyzers shall have sample load and go ("walk away" capability).

2.5 The primary analyzer shall have cap piercing capability and the backup analyzer should have the same capability as well.

2.6 The primary analyzer shall have the ability to program automated QC at desired intervals.

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 field 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 on-site.

4. Training Support

4.1 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.

5. Initial Installation Support

5.1 The contractor shall provide on-site support via a qualified representative to perform all necessary initial method verifications, validations, and correlations. This will be done in accordance with all CAP regulations.

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