SOLICITATION NOTICE
65 -- AUTOIMMUNE TESTING
- Notice Date
- 5/9/2005
- Notice Type
- Solicitation Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of the Air Force, Air Force Materiel Command, HSW - 311 Human Systems Wing, 311th HSW/PK 8150 Aeromedical Road, Brooks AFB, TX, 78235-5123
- ZIP Code
- 78235-5123
- Solicitation Number
- Reference-Number-F1JEAB5036B001
- Response Due
- 6/9/2005
- Archive Date
- 6/24/2005
- Description
- STATEMENT OF WORK IN SUPPORT OFAFIOH/SDE IMMUNOLOGY AUTOIMMUNE TESTING 06 MAY 2005 1. DESCRIPTION OF SERVICES: The Vendor shall provide AFIOH/SDE (Epidemiological Surveillance Division), Bldg 930, Brooks City Base TX 78235-5132 with FDA approved test equipment, In-Vitro capability, test equipment support service, training and reagents on a 24 hour response per?call basis with Walk Away Capability as necessary to perform autoimmune testing for the Immunology Reference Laboratory. 2. REQUIREMENTS: The Vendor shall provide to the Immunology Reference Laboratory instruments via Reagent-Rental Agreement (also known as Cost per Test Agreement) capable of performing analyses of all of the analytes in the indicated volumes. Instrumentation shall be capable of performing automated walk-away analyses and will include uninterruptible power supplies (UPS) for each instrument. Instrumentation shall be of sufficient reliability in order to circumvent a work stoppage in process flow at any given time. The Contractor shall also include Controls and serum diluents sufficient to do the established volume of testing, at no additional cost. 2.1 The contractor shall provide for an automated system and reagents capable of performing sample dilution and slide preparation, necessary to perform the following: anti-nuclear antibody (ANA) tests by indirect immunofluorescence (preferably utilizing HEp-2 cells as substrate), dsDNA antibody tests by indirect immunofluorescence (preferably utilizing Crithidia luciliae as substrate), and extractable nuclear antigen (ENA) tests by immunodiffusion for the following antibodies: Sm, RNP, SS-A, SS-B, Scl-70, Jo-1 and PCNA. 2.1.2 All reagents must be FDA-approved and should exhibit at least 95% sensitivity and 95% specificity. Upon request, sufficient reagents should be provided by the Vendor for in-house evaluation of each analyte. Following evaluation, each reagent should exhibit at least 90% agreement with reagents currently in use in the Immunology Reference Laboratory. 3. ESTIMATED USAGE: There is no guaranteed annual minimum; however, the Immunology Laboratory performs an estimated 37,800 total tests per year for the autoimmune tests listed below. 3.1 In the event the Immunology Laboratory should surpass the forecasted 37,800 test/year figure, the Contractor shall also propose a cost per test for >45,000 tests/year. Description Tests/Yr. Projected Increase ANA test 25,200 31,600 DNA test 3,000 3,400 ENA test 9,600 10,000 37,800 45,000 4. AGREEMENT PERIOD: A Blanket Purchase Agreement (BPA) shall be established for a period of one basic year and if exercised, one option year. The Government also reserves the right to discontinue services without incurring any additional costs, if there is a change in mission requirements, or if the instrument fails to perform as described by the vendor. Should a change in mission/testing requirements occur, the Government will notify the vendor in writing 30 days prior to the proposed discontinuation of services. 5. POINTS OF CONTACT: Primary Technical Program Manager: Capt Jeannette Watterson, (210) 536-1672, FAX (210) 536 ?2638 Alternate Technical Program Manager: Sylvia Trevino, (210) 536-8727, FAX (210) 536-2638 Contract Program Manager: Ruben T. Sandoval, (210) 536-5790, FAX (210) 536-5877 6. EQUIPMENT: The Vendor shall be responsible for transportation, installation, training, maintenance, and servicing of equipment. The Vendor shall provide all required tools, parts, and labor as necessary and repairs /replacement within 48 hours from service call. 7. OWNERSHIP: The Vendor shall retain title to the instruments during the entire term of the agreement. 8. MONITORING: The Vendor shall monitor equipment to ensure downtime does not exceed 48 hours for a single occurrence and there are not more than three occurrences per month. 9. LIABILITY: The Vendor will indemnify and defend the US Air Force from and against any and all third party claims, demands, actions, debts, liabilities, and attorney?s fees arising out of, claimed on account of, or in any manner predicated upon loss of, or damage to the property of, and injuries to, or death of any and all persons whatsoever, in any manner caused or contributed to by simple negligence or misconduct of the Vendor, use of its product, or negligent or willful wrongdoing by its agents, servants, or employees. EVALUATION CRITERIA FOR PROPOSALS IN SUPPORT OF AFIOH/SDE IMMUNOLOGY AUTOIMMUNE TESTING 06 MAY 2005 The Vendor will provide a written proposal in response to the SOW. The Government anticipates awarding a ?best value? Blanket Purchase Agreement to the Vendor whose proposal is the most technically advantageous to the Government, while price and other factors will be considered as lesser factors than technical. Technical proposals will be evaluated on the factors described below, listed in order of importance. Technical merit is more significant than price. Vendors must describe in detail their instrument, their instrument?s capability and their current FDA approved test equipment, support service, and training, walk away capability and reagents on a 24 hour response per-call basis as necessary in performing autoimmune testing. The vendor shall provide a broad testing menu capability as per paragraphs 2 and 3 of the Statement of Work (SOW) essential in performing autoimmune testing for the Immunology Reference Laboratory. Each Vendor will be evaluated on the basis of equipment that efficiently and effectively responds to and successfully completes tasks defined in the RFP. 1. Vendor?s products must meet the Immunology Laboratory?s needs with respect to evaluation and interpretation, i.e., immunofluorescence slides must be of high enough quality and clarity to facilitate reading/interpretation. Reagents must exhibit at least 90% agreement with reagents currently in use in the Immunology laboratory 2. Exceptional assay precision of 90 % or greater will be on a pass/fail evaluation. 3. Higher ratings will be given for the greater sensitivity, and specificity of all analytes performed as per paragraph 2.1.2 of the SOW 4. Greater consideration will be given to the following: a) Capacity of IFA slides processed per run b) highest specimen capacity c) Single and serial dilution capabilities d) Combination of screens and titrations performed on same slides e) Pipetting imprecision < 2.0 % CV at 100 ?l f) Sample, reagents and controls which require less preparation, i.e. ready to use g) lowest operator interventions 5. Greatest consideration will be given to automated systems that are easiest to use. These systems should have: a) software with user-friendly capabilities and compatibility with current laboratory information system b) processing displays with simple selection of work lists, c) sample or control specific dilutions can be selected d) graphic interface for continuous update on progress of work being performed by the instrument. e) mechanism in place to eliminate pipetting carryover and crossover well contamination 6. Greatest consideration will be given to and exceptional competency record. The contractor shall also describe their ability to respond to instrumentation service calls. No down time greater than 48 hours will be acceptable. 7. The Contractor shall propose cost per test amount to include Serum diluents and Controls for the annual average usage as per paragraph 3 of the SOW. More consideration will be given to the lower cost per test via the annual average usage.
- Place of Performance
- Address: BROOKS CITY BASE
- Record
- SN00803239-W 20050511/050509211833 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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