MODIFICATION
66 -- Vitek 2 Compact 30 System
- Notice Date
- 5/21/2009
- Notice Type
- Modification/Amendment
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1055350
- Point of Contact
- Vida - Niles, Phone: 301-827-2476, Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
vida.niles@fda.hhs.gov, doreen.williams@fda.hhs.gov
(vida.niles@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Solicitation # 1055350 The Food and Drug Administration (FDA) is seeking Full and Open Competition for vendors that can provide quotes/proposals. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-24. This announcement constitutes the only solicitation and a written solicitation will not be issued. The synopsis, NAICS code 325413, is to notify contractors that the government intends to issue a Firm Fixed Price Purchase Order in accordance with FAR Part 13, for the following statement of work, under the simplified acquisition procedures. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing Best Value and discussions are not necessary. Project Title: Vitek 2 Compact 30 System Background: The Office of Regulatory Science, Divisions of Microbiology, intends to purchase a Vitek 2 Compact 30. This is an automated biochemical identification instrument which can identify/confirm bacterial isolates in 3 – 8 h. It is the next generation and successor to the Vitek 1 system, which is currently used by the FDA’s ORA laboratories for the biochemical identification and confirmation of pathogenic organisms found in regulatory samples. It has recently been validation through AOAC International’s Research Institute (certification number 020802), as part of a harmonized pre-collaborative study. It should gain official methods status within the next year, which will enable its use with regulatory isolates. The purchase of the Vitek 2 Compact biochemical identification system is essential, since our Vitek 1 system will no longer be supported by bioMerieux in the next few years and the Vitek 2 is its replacement. This system has been validated through AOAC's Research Institute and is in the process of obtaining Official Methods (OMA) validation status. Once it obtains OMA status, it can be used for the analysis of regulatory isolates and will be adopted for use by ORA labs. We are required to only use validated methods with the BAM Salmonella method, since we develop and validate methods for the field labs and because we can be called upon to perform regulatory analysis. The Vitek 2 biochemical identification system is the only AOAC validated system that is currently available. Technical Requirements: QTY 1 A Vitek 2, automated biochemical identification system. The VITEK 2 Compact with 30 card capacity includes sealer/filler/reader module, Compaq PC, laser printer, start up kit and installation. Deliverables: The contractor shall deliver 30 days after receipt of order. Warranty: 1 year Instrument comes with a one year manufacturer’s warranty which will be considered apart of the “base year”: (Base year shall be during the one year manufactuer’s warranty) Option Year 1, service and maintenance agreement Option Year 2, service and maintenance agreement Option Year 3, service and maintenance agreement Option Year 4, service and maintenance agreement CCR: Vendor must be registered in the Central Contractor Register (CCR) prior to the award of the contract. You may register by going to www.ccr.gov. You will need to your Tax ID, Duns Number, Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Vida.Niles@fda.hhs.gov, no later May 28, 2009, 4:30 pm EST. QUOTATIONS DUE: All quotations are due to: Vida.Niles@fda.hhs.gov, no later than 4:30 pm, EST on June 16, 2009. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.232-33, FAR 52.246-9 and FAR 52.246-18. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice shall be sent via email to Vida.Niles@fda.hhs.gov, Telephone calls will not be accepted. Technical Evaluation Criteria Vitek 2 Offeror shall describe how their instrument meets or exceeds each detailed specification, and include supportive data and descriptions wherever possible. Validation Requirements 1. Shall have AOAC Research Institute Validation and Official Methods (OMA) Validation in the future. 2. Technical Requirements a. Shall include 30-card capacity b. Shall include sealer/filler/reader module c. Shall include PC and Printer for data acquisition d. Shall include start-up kit e. Shall include equipment installation 3.Warranty – the Vitek 2 system shall have a one year warranty and for option years for the service and maintenance agreement. Evaluation for Award: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor "Meeting or Exceeding the Requirement," and 2) Price shall include base and four (4) option years. Technical Capability is significantly more important than price. The FDA intends to make an award immediately after the response date of this notice. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1055350/listing.html)
- Place of Performance
- Address: 5100 Paint Branch Pkwy, College Park, Maryland, 20740, United States
- Zip Code: 20740
- Zip Code: 20740
- Record
- SN01824281-W 20090523/090521234727-a63404659e1b266b813e3bfd923c360e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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