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FBO DAILY ISSUE OF MAY 20, 2009 FBO #2732
SOLICITATION NOTICE

66 -- HCV Genotyping

Notice Date

5/18/2009
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs, Minneapolis VAMC, Department of Veterans Affairs Medical Center, Department of Veterans Affairs;VA Midwest Health Care System;Attention: Network Contract Manager;708 S. THIRD ST., SUITE 200E;Minneapolis MN 55415
 

ZIP Code

55415
 

Solicitation Number

VA-263-09-RQ-0268
 

Response Due

5/28/2009
 

Archive Date

6/27/2009
 

Point of Contact

Corinne NygrenContract Specialist<br />
 

E-Mail Address

corinne.nygren@va.gov
(corinne.nygren@va.gov)
 

Small Business Set-Aside

N/A
 

Description

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, in conjunction with FAR 13.5, as applicable, and as supplemented with additional information included in this notice. This acquisition is being conducted in accordance with FAR Subpart 13.5 test program procedures for commercial items. Simplified acquisition procedures will be followed. (ii) This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. (iii) This combined synopsis/solicitation will result in a firm fixed price indefinite delivery indefinite quantity commercial supply reagent rental contract. (iv) This combined synopsis/solicitation Request for Quote is being issued as a full and open competition. (v) This requirement is for The United States Department of Veteran Affairs (VA) Medical Center Microbiology/Molecular laboratory which requires a Hepatitis C virus (HCV) Genotyping system using Analyte Specific Reagents (ASR) to conduct HCV genotype testing. Hepatitis C virus infection is relatively prevalent amongst the US veteran population and is an important cause of morbidity and mortality. Determination of viral load and viral genotype (there are 6 main HCV genotypes) are routinely used laboratory guides to clinical management. Our laboratory performs viral load determination and genotyping assays in-house and serves as a reference lab to the VA system. Existing genotyping methodologies require prior PCR amplification of viral nucleic acid, which is most commonly and most efficiently, accomplished using the very same PCR reaction that is also used for viral load determination in the performing laboratory. We have performed HCV genotyping for many years, however, the current procedure uses components that are classified as RUO (Research Only Use) by the US FDA. We have to change the methodology because we cannot continue the RUO methodology without greatly increased cost and complexity. (vi) REQUIREMENT AND QUANTITIES: Contractor to provide a Hepatitis C Virus genotyping system. This requirement consists of five line items, one for each period of performance: The contractor shall provide a Reagent Rental price for each period of performance. The genotyping estimated annual volume is 360 tests. If contractor charges a cost per kit price, in lieu of cost per test, the contract shall provide the number of tests per kit. The pricing for this line item shall include ALL COSTS FOR PROVIDING THE SYSTEM INCLUDING THE REAGENTS, CONTROLS, AND COMPONENTS described below. (vii) Shipping will be FOB destination, therefore, shipping of all items must be included in the price for the line item. (viii) The selected contractor must be able to deliver all requested equipment by June 30, 2009. Deliverables and acceptance of the deliverables for the system and all components, reagents, controls, etc. will be FOB destination Veterans Affairs Medical Center, Attention: Microbiology/Molecular Laboratory, One Veterans Drive, Minneapolis, MN 55417.(ix) The effective period of the contract shall be date of award through twelve months, with options to extend the contract for four (4) additional years. The contract, including all options years will not exceed five years or 60 months. (x) SPECIFICATIONS: Key system components of the HCV genotyping instrumentation will be provided by the contractor to the laboratory. Requirements for equipment and assay kits include the following: Assay manufacturer's compliance with in-Vitro Diagnostic Device or Analyte Specific Reagent rules of the US Food and Drug Administration; CONTRACTOR SHALL PROVIDE all key components, reagents and controls including: The instrument, analyte specific reagents, controls, filters, cables, hookups, software, and software upgrades required for performing HCV genotyping. The assay should be able to detect HCV genotypes 1 through 6 with reasonable accuracy (Subtype determination is not a requirement.); As a part of the reagent rental pricing technical service shall be available for initial set-up and routine troubleshooting assistance, equipment maintenance and on site repairs. The contractor shall also have included technical support personnel available to provide immediate response during normal working hours Monday - Friday 8:00 a.m. - 5:00 p.m. The contractor shall respond by phone or email to service calls within 24 hours and provide the repairs within 3 working days. The contractor shall provide contact numbers for technical support, maintenance, and service calls; Contractor shall provide an uninterrupted supply chain for reagents. Contractor shall provide and include in the cost, on-site training to 1 or 2 key operators. (xi) MSDS, HAZARDOUS MATERIALS and WASTE STREAM ANALYSIS: The contractor shall provide VA medical facilities in Minneapolis, with a listing of the vendor's products used with this analyzer(s) that are considered hazardous. The listing should also include a determination as to what can be considered harmless to be disposed of by normal methods, such as disposing down the sink or disposing in the trash and what has to be specially handled for disposal and how it is handled. The contractor is required to provide a list identifying any "hazardous materials" that may be provided as a part of this contract that are defined as hazardous under the latest version of Federal Standard No. 313. Material Safety Data Sheets (MSDS) shall be submitted for all products. Contractor shall provide a complete chemical analysis of waste, to include mercury Naazides, carcinogens, reproductive toxins, acute toxins and all other waste that may be considered ignitable, corrosive, reactive or toxic. Contractor will also be required to provide additional subsequent waste analysis studies in the case of any new test or new test formation introductions. Documentation of all analysis will be provided to the VA Contracting Officer for review by the VISN-23 Green Environmental Management Systems (GEMS) Coordinator prior to contract award or introduction of new product after award. (xii) The provisions and clauses incorporated into this solicitation document are incorporated by reference and are those in effect at the time of publication. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulation (FAR) and VAAR provisions and clauses can be accessed on the Internet at http://www.acquisition.gov/far/index.html; http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm (xiii) The provision at 52.212-1 Instructions to Offerors - Commercial applies to this solicitation. (xiv) The provision at 52.212-2 Evaluation - Commercial Items applies to this solicitation. Award will be made to the responsible offeror whose offer conforming to this combined synopsis/solicitation will be most advantageous to the Government, price and other factors considered. A trade off process will be used to evaluate quotes. Technical capability is more important than price. The Government will select the offer that is most advantageous to the Government and the following will be considered when evaluating the offers for Technical Capability: The turnaround time of the testing process; Hands on time required for personnel to operate the analyzer; The number of manual steps versus automated steps required to operate the analyzer; Ease of use and training of laboratory personnel required to operate the analyzer; The assay should be able to detect HCV genotypes 1 through 6 with reasonable accuracy (Subtype determination is not a requirement.); Minimum level of viral load that can produce a genotype result; The rate of un-interpretable test results. (xv) The provision 52.212-3 Offeror Representations and Certifications - Commercial Items applies to this solicitation. The contractor shall either complete the on-line Offeror Representations and Certifications or return a completed copy of the Offeror Representations and Certifications with their quotation. The Online Reps and Certs Application Representations and Certifications Application (ORCA) can be found at http://www.bpn.gov., or a hard copy of the provision may be attained from http://www.arnet.gov/far. (xvi) The clause at 52.212-4 Contract Terms and Conditions - Commercial Items applies to this acquisition. (xvii) The clause at 52.212-5 Contract Terms and Conditions Required To Implement Statutes Or Executive Orders Commercial Items, applies to this acquisition. The following FAR clauses identified in FAR 52.212-5 are considered checked and are applicable to this acquisition: 52.203-6-Restrictionson Subcontractor Sales to the Government, Alt I; 52.219-8 Utilization of Small Business Concerns; 52.219-28-Small Business Program Representation; 52.222-3-Convict Labor; 52.222-19-Child Labor-Cooperation with Authorities and Remedies; 52.222-21-Prohibition of Segregated Facilities; 52.222-26-Equal Opportunity; 52.222-35-Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans; 52.222-36-Affirmative Action for Workers with Disabilities; 52.222-37-Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans; 52.222-39-Notification of Employee Rights Concerning Payment of Union Dues or Fees; 52.222-5-Combating Trafficking of Persons; 52.225-1 Buy American Act-Supplies; 52.225-13-Restrictions on Certain Foreign Purchases; 52.232-34-Payment by Electronic Funds Transfer - Other Than Central Contractor Registration. To be awarded this contract, the offeror must be registered in the CCR. CCR information may be found at http://www.ccr.gov; (xviii) The clause 52.216-18 Ordering applies to this acquisition. (a) Such orders may be issued from date of award through the end of the last option period exercised. (xix) The clause 52.216-19 Order Limitations applies to this acquisition. (a) Minimum order $1,000.00 (b) (1) Any order for a single item in excess of $10,000.00 (2) Any order for a combination of items in excess of $20,000.00 (3) A series of orders from the same ordering office within 10 business days (d) unless that order is returned to the ordering office within 5 business days. (xx) The clause 52.216-22 Indefinite Quantity applies to this acquisition. (d) provided that the contractor shall not be required to make any deliveries under this contract after date of last option period exercised. (xxi) The clause Option to Extend the Term of the Contract applies to this acquisition. (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to 60 days prior to contract expiration. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years. (xxii) Minimum and Maximum Contract Amounts for this contract. During the period specified in FAR clause 52.216-18, ORDERING, the Government shall place orders totaling a minimum of $10,000.00 for the base contract period. (xxiii) The following VAAR clauses apply to this contract: 852.203-70 Commercial Advertising; 852.216-70-Estimated Quantities; 852.246-70-Guarantee; 852.273-76- Electronic Invoice Submission; 852.246-71-Inspection. (xxiv) Quotations are due to the Department of Veterans Affairs, Contracting Office at 708 South 3rd Street, Suite 200E, Minneapolis, MN 55415-1116. by 1:00 PM Central Time, May 28, 2009. Please reference the quote number VA-263-09-RQ-0268 on your documents. Quotes may be submitted via postal mail, by facsimile or email. (xxv) The assigned contact person is Ms. Corinne Nygren. Ms. Nygren may be reached at Corinne.nygren@va.gov (612) 344-2146 or by fax at (612) 333-3792. (xxvi) A COMPLETE QUOTE WILL CONSIST OF THE FOLLOWING: 1) Price for each line item which includes all costs for providing the required equipment and components. All overhead and ancillary costs associated with the equipment and components will be assumed by the Contractor, and should be factored into the quote. This quote shall include all shipping costs to the FOB destination. 2) Signature of the offeror on the page which lists the price. 3) Literature of your products and a detailed narrative addressing how your company's products meet the technical specification requirements in (x), and the technical evaluation criteria described in 52-212-2 (xiv) above. 4) A completed copy of the provisions at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items OR confirmation that this has been completed on-line. (xxvi) Quotes should be of sufficient detail to determine their adequacy. If an offeror's quote does not contain all of the items listed above, the quote may be considered incomplete for evaluation purposes and no further consideration will be given to the offerors quote, thereby making an offeror ineligible for award.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/MiVAMC618/MiVAMC618/VA-263-09-RQ-0268/listing.html)
 

Place of Performance

Address: Veterans Affairs Medical Center;One Veterans Drive;Minneapolis, MN<br />

Zip Code: 55417<br />
 

Record

SN01821639-W 20090520/090518235553-e65d42879db6be236340c5b8f8228e4f (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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