H -- LIMS Validation and Consultation

This is a combined synopsis/request for quote for Commercial Items prepared in accordance with the format in FAR Subpart 12.6, as supplemented Federal Acquisition Circular 2005-05(6) and with additional information included in this notice. This announcement constitutes the only RFQ; quotes are being requested and a written RFQ will not be issued. This procurement is 100% the set aside for small business. The identifying RFQ number is FSIS-25-B-05. The NAICS code is 541512 and the size standard for small business is $21 million per year. The Service Contract Act of 1965 Wage Determinations for Clarke County, Georgia apply to this solicitation. Title: LIMS Validation Consulting Support Scope. The contractor shall furnish all travel and labor to prepare validation test scripts based on FSIS-provided Functional Requirements Specification and Design Specification/Unit Testing Documents for the LabWare LIMS application located at USDA, FSIS, OPHS, EL, 950 College Station Road, Athens, GA 30605. The contractor shall also provide advice concerning FSIS validation of the LIMS implementation as related to ISO 17025, Good Automated Laboratory Practices (GALP), and Good Automated Manufacturing Practices (GAMP4) standards, as needed. Period of Performance. One year from date of award. General. On site work shall be provided during normal working hours, 8:00am to 5:00pm, Monday through Friday (except for Federal Holidays) during each of six work weeks throughout the year. The specific work weeks will be determined and scheduled by the LIMS Project Manager and the contractor. LIMS Project Manager (LPM) - The LPM will act, on-site, as the technical point of contact for the Government, coordinate specific work weeks, and perform acceptance of test scripts. The LPM's authority is limited to technical issues and he/she is not authorized to make contractual decisions. The authority to resolve monetary issues and contractual interpretation is the responsibility of the Contracting Officer. Requirements. Test Scripts. The contractor shall provide on-site test script development. The test scripts will be prepared according to the accepted FSIS laboratory standard format and will serve to test the functionalities documented in the Design Specification/Unit Testing Documents provided by the LPM. Regulatory Advice. The contractor shall serve as a subject matter expert on the GAMP4 standard and will provide his/her expert interpretation of that standard as it relates to questions presented by the LPM. The contractor should become familiar with the FSIS LIMS validation documentation and validation history by reviewing the existing system documentation. IT Systems. The FSIS Laboratory will provide desktop and/or notebook PC workstations in an office environment for the contractor to use while on site. The LPM will provide the contractor working copies of SOPs, Work Instructions, and the existing validation documentation, as well as LabWare LIMS user guides for system administration and programming. The LPM will provide to the contractor access to the LIMS Test Environment and/or development environment, as needed to prepare and test the test scripts. The contractor shall not be responsible for repairs caused by accident misuse, abuse, neglect, theft, riot, vandalism, electrical power failure, fire, water, or other casualty. Test Script Verification: The contractor shall perform a verification that each delivered test script is usable without critical exceptions (as defined in the FSIS Laboratory Software Validation SOP) in the form of an annotated copy of each test script that has passed a test run on the LIMS Test environment. Security Requirements. The contractor shall provide to the LPM information on the names of all employees who will require access to the facility in order to test script development and testing. This should be provided 24 hours in advance of work being performed. All employees provided by contractor must have valid picture identification before being allowed onto the premises. The Government will evaluate and make the award based on - best overall value. Best overall value will be a combination of technical, past performance and price. Address the following: 1. Technical: demonstrated understanding of requirement and demonstrated qualifications (education, experience, expertise and availability of proposed staff) 2. Past performance: demonstrated performance on contracts/subcontracts/orders for LIMS validation services performed during the last three years. Give names, addresses, and contacts of three identifying clients for whom the services were performed. 3. Price: Include a price proposal. Technical will be more important than price. The provisions at 52.212-1, Instructions to Offeror-Commercial, applies to this acquisition. The provision at 52.212-2, Evluation-Commercial Items is applicable and the specific evaluation criteria are as follows: (1) Technical (2) Past performance (3) Price. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Item with its offer. FAR 52.212-4 52.212-1 Instructions to Offerors'Commercial Items. Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items applies to this order. Clauses and Certifications and Representations are attached. Clauses can be found on http://www.arnet.gov/far/. Offerors shall submit 2 copies of their quotes no later than September 23, 2005, 4:00 EDT, to Lorna Craig at: Regular mail: USDA/FSIS/ASD, Mail Stop 5230, Room 2-L188A, 5601 Sunnyside Ave., Beltsville, MD 20705. email: lorna.craig@fsis.usda.gov or FAX 301-504-4276. Faxed and emailed quotations are acceptable.