MODIFICATION
66 -- Mass Spectrometer System
- Notice Date
- 5/26/2009
- Notice Type
- Modification/Amendment
- NAICS
- 334516
— Analytical Laboratory Instrument 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
- 1055942
- 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
- REQ # 1055942 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 of firm fixed price purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-32. NAICS Code 334516 Project Title: Proteomics and metabolomic applications with a high mass accuracy, and high mass range mass spectrometer. Background: The division of hematology within the Office of Blood Research and Review has a need for a quadrupole - time of flight mass spectrometer for the identification of a range of biomolecules from both animal and human tissue samples for the purposes of identifying protein oxidative modification and small molecule biomarkers of oxidative stress. We are developing methods for the analysis of protein cross-links and amino acid oxidations on hemoglobin, and other plasma/tissue proteins. These analyses are critical to understanding mechanisms of hemoglobin and hemoglobin based oxygen carrier induced pre-clinical and clinical toxicity. This instrument shall support two major directives of our department mission. a) Development of methodology for establishing biomarkers particularly for oxidative stress. b) Research for the evaluation, development and application of analytical methods for the assessing safety and efficacy of regulatory products. Technical Specifications 1) New instrument Shall be a newly manufactured unit, not used and refurbished or previously used for demonstration 2) Curtain gas The instrument shall provide some gas flow orthogonal to the spray source for the purpose of prevention of fouling of the interface at higher solvent flow rates and for nebulization. This curtain gas flow rate should be variable to be amenable to a range of solvent flow rates. Electrospray ionization source The instrument shall have a nanospray source which is capable of maintaining a stable spray at 200 nL/min and it must also include a microspray source. Use of a lock mass for accurate mass measurement the instrument shall include a built in capability for introducing a standard compound during analysis for accurate mass data. Sensitivity The instrument shall be able to detect less than or equal to 20 fmol/uL of [Glu]- Fibrinopeptide using an on column injection and nanospray mode with a signal to noise ratio of 50:1 Spectral acquisition rate The instrument shall be able to acquire at least 10 MS/MS spectra per second. Quantitative range The system shall demonstrate linear response over at least three orders of magnitude with better than 3 ppm mass accuracy. The upper and lower limits of dynamic range shall be demonstrated. Quantitative data analysis software The package shall include the ability to quantitate using both internal and external standards. this should also include the ability to do “label free” quantitation from multiple analyses using separate on column injections. This shall also include the ability to perform multivariate analysis on complex metabolomic samples. Qualitative data analysis software The software package shall include batch processing of raw data files for qualitative sample sets and a spectral library search feature. The software shall provide the ability to process and review spectra and chromatograms. Data analysis should be exportable to non-proprietary software such as Excel, or alternatively an option shall be provided to view results of data analysis on systems not equipped with vendor software. Operating system Specific mention shall be made if the operating system is other than Windows XP Professional. Warranty The entire system shall be warranted for parts and labor for two years and should include at least one PM visit during that time. Instrument control, stability and data system The system shall be user friendly, and easy to learn, with most control feature automatable, while retaining the optional manual operation. The instrument must be capable of automatic mass calibration and automatic optimization of tuning, and MS/MS parameters for target compounds. Tuning parameters must remain stable for a time period designated as reasonable by LBVB operators. Vendors shall submit the names of three laboratories that are currently using the instrument that can be contacted for experienced opinions on the use of their instruments. Installation The vendor shall demonstrate upon installation that the instrument shall meet all performance specifications claimed in the bids. The instrument will not be accepted until those performance specifications have been met. Sufficient training shall be provided so that LBVB operators may independently operate the instrument. Training The vendor shall include on-site multiple day training for up to two operators after the instrument has been accepted, and LBVB operators have become familiar with the system. Mechanical The entire system to include mass spectrometer LC, computer and monitor shall be able to fit into an area 88 inches in length 58 inches of the length is 48 inches in width and the remainder is 24 inches in width. Maintenance Standard Manufacturer Warranty (Base year plus 4 option years) Technical Evaluation Factors Evaluation factors for selection of a liquid chromatography QTOF mass spectrometer system are as follows: The evaluation factors used for this solicitation shall be the offeror’s ability to meet the technical specifications, the compatibility of the system with the environment in which it will be housed, the vendor’s ability provide on site service for maintenance and repairs of all system components (eg. HPLC, mass spectrometer, software, and computer), and telephone based technical support the vendors ability to provide adequate training for the use of the system.) 1) Technical Specifications Spectral acquisition rate. The offeror shall demonstrate a spectral acquisition rate of at least 10 Ms/ second in MS mode and 20 scans/sec in MS/MS mode. This data shall be provided with real samples from an on-column injection of specified concentration, and volume. Sensitivity The offeror shall demonstrate the ability to detect a signal for the doubly charged precursor ion at 786 m/z for an injection of 50 pmol/uL of Glu-fibrinopeptide B with an on column injection for no more than 2 uL onto a C18 column packed with 300 angstrom, 5.0 micron particles with a flow rate of 200 – 400 nL measured at the spray tip. Sensitivity may also be demonstrated for the same sample with a column and flow rate of the vendors own choosing in addition to the configuration specified here. Quantitative range The offeror shall demonstrate the ability to do label free quantitation with a tryptic digestion mixture of seven different proteins injected over a concentration range that spans at least three orders of magnitude. The digestion mixture should contain alpha-lactalbumin, beta-galactosidase, hemoglobin, bovine serum albumin, and three other proteins of the vendors choosing. Three different injections should be demonstrated with three different concentration ratios for the individual proteins. One sample should provide the bovine serum albumin at a concentration 30 x greater than hemoglobin and alpha-lactalbumin in the presence of the other proteins at varying ratios. The reverse condition should also be demonstrated, and a sample in which all proteins are present at equimolar concentration should be given. Metabolite Identification and Quantitation The offeror shall provide data that demonstrates the utility of using their software package for the identification of metabolite markers from urine or plasma. This information should include qualitative and quantitative information. It should also demonstrate reproducibility of quantitative values for an n of 5 individual on column injections. Mass Range The offeror shall demonstrate the upper limit of the mass range for intact proteins using a TOF only mode, and quadrupole mass range in resolving and non-resolving mode. HPLC The offeror shall provide data showing the combined ability of their HPLC and QTOF system to achieve complete coverage for a tryptic digest of BSA at a concentration of no more than 100 fmol/uL using the C18 column provided in their installation package. The offeror shall demonstrate the ability to provide speed of separation of individual peptides and separation efficiency. New instrument The offeror shall demonstrate the ability to provide a newly manufactured unit, not used and refurbished or previously used for demonstration. Curtain gas The offeror shall demonstrate the ability to provide an instrument which provide some gas flow orthogonal to the spray source for the purpose of prevention of fouling of the interface at higher solvent flow rates and for nebulization. This curtain gas flow rate shall be variable to be amenable to a range of solvent flow rates. Electrospray ionization source The instrument shall have a nanospray source which is capable of maintaining a stable spray at 200 nL/min and it must also include a microspray source. Spectral acquisition rate The instrument shall be able to acquire at least 10 MS/MS spectra per second. Quantitative range The system shall demonstrate linear response over at least three orders of magnitude with better than 3 ppm mass accuracy. The upper and lower limits of dynamic range shall be demonstrated. Quantitative data analysis software The package shall include the ability to quantitate using both internal and external standards. this should also include the ability to do “label free” quantitation from multiple analyses using separate on column injections. This should also include the ability to perform multivariate analysis on complex metabolomic samples. Qualitative data analysis software The software package shall include batch processing of raw data files for qualitative sample sets and a spectral library search feature. The software shall provide the ability to process and review spectra and chromatograms. Data analysis shall be exportable to non-proprietary software such as Excel, or alternatively an option must be provided to view results of data analysis on systems not equipped with vendor software. Operating system Specific mention shall be made if the operating system is other than Windows XP Professional. Warranty The entire system shall be warranted for parts and labor for two years and should include at least one PM visit during that time. Support Instrument control, stability and data system The system shall be user friendly, and easy to learn, with most control feature automatable, while retaining the optional manual operation. The instrument shall be capable of automatic mass calibration and automatic optimization of tuning, and MS/MS parameters for target compounds. Tuning parameters must remain stable for a time period designated as reasonable by LBVB operators. Installation The offeror shall demonstrate upon installation that the instrument will meet all performance specifications claimed in the bids. The instrument will not be accepted until those performance specifications have been met. Sufficient training will be provided so that LBVB operators may independently operate the instrument. Training The offeror shall include on-site multiple day training for up to two operators after the instrument has been accepted, and LBVB operators have become familiar with the system. Mechanical The entire system shall includes mass spectrometer LC, computer and monitor shall be able to fit into an area 88 inches in length 58 inches of the length is 48 inches in width and the remainder is 24 inches in width Deliverables: The contractor shall deliver 60 days after receipt of order. Warranty: Extended warranties for the Xevo QTOF System shall be provided for year 1 and year 2. Warranties shall be for the product explicitly stated. 2) Relevant Experience The contractor shall describe their relevant experience in fulfilling this requirement. Identify other organizations with which you have acted as a contractor while participating in the same or similar efforts. Include the degree of your involvement, the size and complexity of the organization and other information describing your experience. Vendors shall submit the names of three laboratories that are currently using the instrument that can be contacted for experienced opinions on the use of their instruments. Past Performance Factor: Contractors shall submit a list of three (3) reference contracts. Contracts listed may include those entered into by the Federal Government, agencies of State and local governments and commercial customers. Contractors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. The reference list of the three (3) references shall include the following information for each contract and subcontract: 1.Name of contracting activity 2.Contract number 3.Contract type 4.Total contract value 5.Contract work 6.Contracting officer and telephone 7.Program manager and telephone 8.Administrative contracting officer, if different from #6, and telephone Each vendor will be evaluated on performance under existing and prior contracts for similar products or services. Performance information will be used as an evaluation factor against which contractor’s relative rankings will be compared to assure best value to the government. The government will focus on information that demonstrates quality of performance relative to the size and complexity of the contract under consideration. Price: The vendor shall provide a price in accordance with the requirements of the technical specifications. The proposed price shall include the standard manufacturer’s warranty for two years. Evaluation for Award: Award will be made to the party whose quote offers the best value to the Government, technical, past performance, 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," Past Performance and 2) Price. Technical Capability and Past Performance significantly is 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. 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 June 1, 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 July 01, 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1055942/listing.html)
- Place of Performance
- Address: 8800 Rockville Pike, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01827458-W 20090528/090526235514-1d0869233c2bdd106498a77bfafdc42c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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