Statement of Work 4 THIS IS A SOURCES SOUGHT NOTICE. This is not a request for proposals. The Central Texas VA Health Care System (CTVAHCS) is seeking firms capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 13. The North American Industry Classification System (NAICS) is 325413 In-Vitro Diagnostic Substance Manufacturing (size standard is 1250 Employees). Any firms who wish to identify their interests and capability to provide this service must notify the Contracting Officer no later than 9am Central Time, Sept 18, 2018. Notification shall be e-mailed to Grace Barr, at
[email protected]. Provide Cage Code and or DUNS number. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. DISCLAIMER This Source Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. NO ADDITIONAL INFORMATION IS AVAILABLE OTHER THAN WHAT IS NOTED HEREIN. STATEMENT OF WORK GENERAL INFORMATION 1. Title of Project: Blood Bank Reagents 2. Scope of Work: The contractor shall provide Reagent Red Blood Cells for transfusion compatibility testing. Cells shall include the following: 16 cell panel for antibody identification, check cells, tech check cells for educational purposes, homozygous 3 panel screen cells, A1 & B reference cells, and complement control cells 3. Performance Period: Period of performance is October 1,2018 - September 30, 2019 4. Type of Contract: This is a firm-fixed price contract. GENERAL REQUIREMENTS All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms. TASKS, DELIVERABLES/SUPPLIES Panocell 16 16 cell panel that contains a minimum of 3 cells that may be used as Rh (D) negative screening cells. Checkcell single vial pool of group O red blood cells that are sensitized with an IgG antibody to rule out false negative results with the Coombs test. Panoscreen III 3 cell antibody screen with R1R1, R2R2, and rr red cell donor phenotypes and homozygous expression of Fy, Jk, M, N, S, s Tech Chek serum and red cell kit used to demonstrate competency in forward and reverse ABO/Rh, antibody screen, and antibody identification for competency assessment, student training and continuing education. Reference Cells A1 & B for the determination of the reverse blood group. Complement Control Cells to confirm anti-C3 activity. Schedule of Deliverables Item Quantity Delivery Dates 1 2999 Tech Chek (education use only) 13 10/8/18 11/5/18 12/3/18 12/31/18 1/21/19 2/18/19 3/18/19 4/15/19 5/13/19 6/10/19 7/8/19 8/5/19 9/2/19 9/30/19 2 2332 Panocell16 16X3 26 10/8/18 10/22/18 11/5/18 11/19/18 12/3/18 12/17/18 12/31/18 1/14/19 1/28/19 2/11/19 2/25/19 3/11/19 3/25/19 4/8/19 4/22/19 5/6/19 5/20/19 6/3/19 6/17/19 7/1/19 7/15/19 7/29/19 8/12/19 8/26/19 9/9/19 9/23/19 3 7930 Complement Control Cells 1X3 26 4 2224 Checkcell 1X10 52 5 2381 Panoscreen III 3X10 52 6 2345 Referencells A1B 2X10 52 D. PERFORMANCE REQUIREMENTS Safety: Contractor shall immediately notify the service of any changes in reagents, kit composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulation. Test Performance: All tests, procedures, and equipment must perform at manufacturer specifications. Deviations from the performance specifications shall be corrected by the contractor. a. All test performance will be evaluated by and not limited for performance thru peer comparison, quality control, and CAP peer evaluation. E. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. 3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. F. CONTRACTOR SECURITY REQUIREMENTS This contractor requires no access to CTVHCS or any VA information system. The C&A requirements do not apply. A security accreditation package is not required. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. G. RECORDS MANAGEMENT All records (administrative and program specific) created during the period of the contract belong to Central Texas Veterans Healthcare System (CTVHCS) and must be returned to CTVHCS at the end of the contract. H. QUALITY ASSURANCE SURVELLIANCE PLAN (QASP) The QASP and its performance are as follows: Task Indicator Standard Acceptable Quality Level Method of Surveillance Incentive Safety Recall Notification Timely recall notification of reagent and supplies 100% Monthly Monitoring Exercise of Option Period & Past Performance Quality Assurance Successful peer group comparison CAP survey performance 95% Direct Observation & CAP survey reports Exercise of Option Period & Past Performance Successful reporting of results Repeat runs are minimal 95% Direct Observation & QC reports Customer Satisfaction Timely and accurate shipment of reagents Reagents shipped completely according to shipping schedule 100% Reports of contact or other documentation. Exercise of Option Period & Past Performance