Cepheid Reagents and Consumables

Department of Health and Human Services Indian Health Service 1 Statement of Work (SOW) Cepheid Reagent Test Cartridges and Consumables 1. PURPOSE OF THE PROJECT The Indian Health Service (IHS), a federal agency within the Department of Health and Human Services, is responsible for providing federal health services to American Indians and Alaska Natives. The mission of IHS is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level and assure that comprehensive, culturally acceptable personal and public health services are available and accessible to members of the 574 federally recognized Tribes across the United States. The Lawton Service Unit is a Joint Commission accredited federal facility in Oklahoma. To meet our mission, Cepheid Reagent Test Cartridges and Consumables are medical modalities that have been deemed necessary to augment the services as such are necessary to support and supplement health care within the hospital. The mission of the Lawton Service Unit is to deliver quality care to attain positive health outcomes for all our valued patients with emphasis on cultural sensitivity and human dignity. The Lawton Service Unit (LSU) Laboratory, Indian Health Service (IHS) has a requirement to establish a Blanket Purchase Agreement for molecular diagnostic reagent test kits and consumables for Cepheid Genexpert Analyzer. 2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS 2.1. The contractor shall enter into an IDIQ BPA with Lawton Service Unit for replenishment of reagent test kits and other consumables. 3. PERIOD OF PERFORMANCE The base year Period of Performance will be 12 months from date of award with four (4) twelve (12) month option years. 4. LEVEL OF EFFORT 4.1. The contractor shall furnish Lawton Indian Hospital will furnish all necessary to manufacture and ship molecular diagnostic test reagent in accordance to CLIA ’88 and FDA regulations for clinical environment to the Lawton Indian Hospital. • Estimated annual reagent test kits are based on Patient Test Volumes and include a 40% increase for Quality Control testing, Proficiency Testing and Validation Studies. • Lawton Indian Hospital Reagent Kit Annual Volume XPRS4PLEX 1627 GXCT/NG-10 1306 GXTV-10 1624 XPRSTREPA-10 1725 GXCDIFF/EPI-10 84 -- 1 of 3 -- Department of Health and Human Services Indian Health Service 2 5. SPECIAL REQUIREMENTS 5.1. In accordance with HHSAR 304.1300(b) non-routine contractor employees shall comply with OPDIV DHHS/SE Region – Human Resources, Security Clearance Guidance – Visitors (3/29/12) policy for contract performance period. Contractor employees will be required to obtain a visitor’s pass upon arrival for services from Facilities Management. - (Security Clearance for on-site human services) 5.2. The USPHS Lawton Service Unit is a tobacco/smoke free environment (buildings and grounds). No tobacco/smoking use will be tolerated during service. 5.3. Security Requirements: Contractor personnel will be required to contact the government designated point of contact upon arrival when reporting for service calls or delivery supplies. The contractor shall be responsible for the security of all organizational information. Current rules and regulations applicable to the premises where the work shall be performed, shall apply to the contractor and its employees while working on the premises. These regulations include but are not limited to, escort by Lawton Service Unit official, presenting valid identification, smoking restrictions and any safety procedures. 5.4. The contractor shall not disclose or cause you to disseminate any information concerning operations of Lawton Service Unit. Such action(s) could result in violation of the contract and possible legal actions. 5.4.1. All inquiries, comments, or complaints arising from any matter observed, experienced or learned of because of or in connection with the performance of the contract, the resolution of which may require the dissemination of official information, shall be directed to the government’s designated representative. 6. DELIVERABLES AND REPORTING REQUIREMENTS 6.1. Delivery: The contractor will coordinate the delivery, installation and training date with the designated government employee. The contractor shall deliver to Lawton Indian Hospital at 1515 Lawrie Tatum Rd, Lawton OK 73507 with all installation instructions, warranty documents, and specifications. No deliveries can be made after 4:15pm. Driver needs a valid ID. 6.2. Contractor Point of Contact: The contractor shall furnish one designated point of contact (POC) to the government’s designated representative for coordination of supplies, delivery, and/or maintenance. The POC will be empowered to make daily decisions to ensure that the contract implementation and day-to-day maintenance meets the terms and conditions of this contract. 6.3. Contractor’s Phone Numbers: The contractor shall provide a toll-free telephone number for service calls, which must be answered during at least eight working hours, between 8:00 am and 4:30 pm, Monday through Friday. -- 2 of 3 -- Department of Health and Human Services Indian Health Service 3 7. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES 7.1. IAW FAR Part 52.245-1, The Government shall supply the 7.2. 8. CHANGES TO THE STATEMENT OF WORK (SOW) 8.1. Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor. 9. DELIVERABLES/PERFORMANCE MATRIX Item No. GXSACOMP-10 XPRS4PLEX XPRSFLU/RSV-10 XPRS-COV2-10 GXCT/NG-10 GXTV-10 GXCDIFF/EPI-10 XPRSTREPA-10 Services delivered and completed within time frame as set forth in contract Yes or No Contractor was professional Yes or No Item delivered meets specifications of this SOW Yes or No Contractor provided a POC …