A.09.03_Statment_of_Objectives-Winn.pdf

Performance Work Statement

Winn Army Community Hospital

Department of Pathology

Fort Stewart, Georgia 31314

1.1 Objectives: The contractor shall supply and install four (4) automated analyzers. The contractor shall provide reagents, supplies, necessary associated equipment for full functionality, and service maintenance capable of performing Food and Drug Administration (FDA) cleared assays.

1.2 Place of Performance:

One (1)-Hawks Troop Medical Clinic Bldg. 412, 192 Lindquist Rd Fort Stewart, GA 31314

One (1)-Tuttle Army Health Clinic 230 Duncan Dr., Hunter Army Airfield Savanah, GA 31409

Two (2)-Winn Army Community Hospital Bldg. 302 1061 Harmon Ave, Fort Stewart, GA 31314

1.3 Hours of Operation: The contractor shall ensure equipment operational 0800-1800 Monday thru Friday except when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.4 In the event that consumables are found to be defective, back order or recalls, items shall ship overnight. The Contactor shall provide notification within 24 hours of orders placed, when items are backordered.

1.5 Maintenance: The awardee Maintenance plan will be added at the time of award. The Contractor shall accept request for service only from the Chief, Medical Maintenance or Government Representative from the Dept. of Pathology. Specific Point of Contact information will be provided at the time of award to include Email and Phone.

1.5.1 Equipment: Discontinued models are not acceptable. New automated analyzers shall be made available at the exercise of each option period and provided at no additional cost. Software updates shall be coordinated with WINN – DPALS personnel. Hardware upgrades that are related to safety concerns or needed to maintain instrument performance specifications will be mandatory and shall be performed by the

Field Service personnel at no cost to the Government.

1.5.2 The analyzer must also be able to interface with the Laboratory Information System (LIS), the

Department of Defense Composite Health Care System (CHCS) and Cerner MHS Genesis to allow for the transfer of results.

1.5.3 The contractor shall provide all necessary supplemental equipment for full functionality to include, but not limited to a device, such as an Uninterrupted Power Supply (UPS), to serve as a back-up in case of power instability or power failure.

1.5.4 Installation. The contractor shall deliver and setup each analyzer in accordance with their installation plan.

1.5.4.1 The Contractor shall provide all labor, reagents, supplies, parts, tools, travel, and diagnostic equipment necessary to perform equipment implementation and validation studies for the clinical chemistry and immunology analyzer platforms located in the Main Lab, Winn Army Community Hospital and Hawks

TMC, on Fort Stewart, and Tuttle Army Health Clinic at Hunter Army Airfield, GA.

1.5.4.2 The Contractor will perform complete correlation, precision, carry-over, and validation studies at the time of installation and for all new tests added throughout the contract period on contractor supplied assays. Contractor shall complete all correlation/validation studies between contract award date and performance start date. Contractor shall coordinate with the core lab staff to determine the required reagents needed to perform all studies, to include correlation studies, reference range studies, and carry-over studies needed to begin clinical testing. Population Studies will consist of at least 50-100 samples tests. Within three business days of correlation study completion, the contractor shall provide all statistical instrument set-up study documents for review and approval by the Laboratory Director. All validation studies will meet recommended Clinical and Laboratory Standards Institute (CLSI) guidelines.

1.5.4.3 Validation, Correlation, Linearity shall follow Clinical Laboratory Improvement Amendment

493.1253b (CLIA) guidelines and be completed between contract award date and performance start date.

Method Validation shall include but not be limited to, normal range verification, demonstration of linearity with establishment of limits of quantitation (reportable range), correlation with current methods

(comparison of methods study), validation of analytical measurement range (AMR), validation of precision

(replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials designated by the Laboratory Director. The Contractor will provide a qualified Technical Service

Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. All reagents, calibrators and linearity materials used in the Method Validation Study shall be provided by the Contractor at no additional cost to the

Government. These materials will not be used in the analysis of specimens for patient care. Both the

Contractor and personnel at each location will abide by all Health Insurance Portability & Accountability

Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study.

1.5.5 All costs associated with the removal of contractor’s equipment shall be at the contractor’s expense.

Within 30 days after the expiration or termination of the contract the contractor shall remove the equipment from the Government premises, to include disconnection, packaging, and shipping. In the event the contractor fails to remove the equipment within the time specified herein, the Government may return the equipment to the contractor at the contractor’s expense

1.5.7 The Contractor will provide all upgrades to the equipment hardware and operating system software without additional charge to the Government. These enhancements to the equipment shall be delivered to the Government site and be installed by the Contractor within 50 calendar days of their issuance date of first commercial availability. The Contractor shall provide new or updates for user manuals when changes are made.

1.6 Training

1.6.1 The Contractor shall provide operational and technical training for all shifts during initial instrument set up and during the first 14 working “go live” days. Provide basic and advanced training for operating personnel per analyzer. During initial set up and installation of the analyzers the contractor will provide on-site training, at no cost, to all personnel who will operate the equipment. The Contractor shall provide supplemental training to the Government personnel, without charge to the Government, upon installation of upgrade(s) in equipment hardware or operating system software. Additional training slot(s) provided by the contractor off-site during the option year(s). Travel will be in accordance with the Joint Travel

Regulation.