PRESOL | B | Quantiferon Gold-In-Tube Testing

FBO DAILY ISSUE OF JANUARY 31, 2009 FBO #2623
SOLICITATION NOTICE

B -- Quantiferon Gold-In-Tube Testing

Notice Date: 1/29/2009
Notice Type: Combined Synopsis/Solicitation
NAICS: 541990 — All Other Professional, Scientific, and Technical Services
Contracting Office: Other Defense Agencies, Uniformed Services University of the Health Sciences, Directorate of Contracting, 4301 Jones Bridge Road, Bethesda, Maryland, 20814-4799
ZIP Code: 20814-4799
Solicitation Number: PMB9B002
Archive Date: 2/24/2009
Point of Contact: Timothy R Bunting, Phone: 301-295-1375, Tosin Abari,, Phone: 301-295-3962
E-Mail Address: timothy.bunting@usuhs.mil, tosin.abari@usuhs.mil
Small Business Set-Aside: N/A
Description: The Uniformed Services University of the Health Sciences (USU), located on the National Naval Medical Campus in Bethesda, MD, has a requirement for the purchase of personnel and equipment needed to perform Quantiferon-TB Gold-In-Tube (QFT-GIT) testing on 2,750 specimens to aid in the diagnosis of Mycobacterium Tuberculosis infection and disease. This is a combined synopsis/solicitation for commercial items prepared under the authority of FAR Part 13 and Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. This is a request for quotations (RFQ) in accordance with FAR Part 13 - Simplified Acquisition Procedures. It is the responsibility of the contractor to monitor FedBizOpps for any amendments to the solicitation. This RFQ incorporates all provisions and clauses in effect through Federal Acquisition Circular 2005-29. All responsible sources may submit a quote, which will be considered by USUHS. For this procurement, the North American Industry Classification System (NAICS) code is 541990 (All Other Professional, Scientific and Technical Services) and the Small Business Size Standard is $7.0 M. The contractor shall provide pricing for the following Contract Line Item Number (CLIN): CLIN Quantity Description 0001 1 See Statement of Work Below STATEMENT OF WORK-QUANTIFERON GOLD-IN-TUBE TESTING Scope of Work: The proposed study, entitled "Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits" aims to assess the feasibility and potential impact of using a targeted testing approach and two interferon-gamma release assays (IGRA), the Quantiferon Gold In-Tube (QFT-GIT) and T-SPOT.TB, as an alternative to the universal application of the Mantoux tuberculin skin test (TST) to identify latent TB infection (LTBI) among military recruits. The Quantiferon-Gold-in-tube test is intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection and disease. The QFT-GIT Interferon Gamma Release Assay (IGRA) measures interferon-gamma released from lymphocytes in whole blood samples incubated with antigens to MTB (Mycobacterium tuberculosis). Earlier generations of the test have been used in the United States for several years, and this generation product was approved by the FDA for use in the US in October 2007. Three additional milliliters (3 ml) of blood will be collected for QFT-GIT testing from each subject during the entry level medical examination. The set of three QFT-GIT tubes containing 1 ml of fresh blood will be incubated at 37o C at Fort Jackson by study personnel for 16 to 24 hours. Incubation will begin within 12 hours of collecting the blood. After incubation the tubes will be centrifuged for 5 minutes and stored at 2 to 8 o C until shipped cold via Federal Express or other contract carrier to the laboratory where the test will be completed. Only study ID number will be affixed to the sample, and will not include any identifying or other information. To measure the inter-assay reproducibility of the QFT-GIT, 10% of the participants will have two samples collected at enrollment but tested in separate batches, and the results compared. QFT-GIT results will not be used in clinical care of subjects. Tasks and Responsibilities: o Provide fully qualified and proficient personnel and equipment o Have the capacity to perform QFT-GIT testing for up to 2,750 specimens o Meet the processing window listed in the package insert o Prepare and maintain diagnostic reagents provided by USUHS. o Provide proper preventive maintenance, calibration, operation and quality control of laboratory instruments and equipment necessary to obtain an accurate determination of laboratory procedure. o Recognize any abnormal results obtained and promptly bring this information to the attention of the supervisor. o Coordinate with study personnel at USAMEDDAC Ft. Jackson to addresses supply problems and issues related to sample labeling and receipt. o Use software provided for analysis of QFT-GIT raw data and calculation of results. o Submit final results to the Clinical Data Manager at the Data Coordinating and Analysis Center (DCAC). o Coordinate with the Clinical Data Manager to resolve any data queries. o Perform all Quality Control and Quality Assurance functions related to QFT-GIT testing o Adhere to Good Clinical Laboratory practice USUHS/IDCRP is responsible for: o Obtain IRB approval o Obtain and hold IND for Battey antigen o Perform consent, questionnaires, blood draws, and skin test administration, reading and documentation on 2500 recruits (2750 specimens) o Obtain QFT-GIT Tube Packs for obtaining specimens o Obtain and provide QFT-GIT ELISA kits o Provide software for analysis of QFT-GIT raw data and calculation of results o Collect and handle specimens according to the QFT-GIT package insert. o Perform initial processing of lab specimens, including incubation and centrifugation of specimens at USAMEDDAC Ft. Jackson. o Shipping of up to 100 de-identified specimens per day Place of Performance: Specimen collection and preparation for testing: USAMEDDAC Ft. Jackson, SC 29207 Period of Performance: Study initiation is planned for February 2009. The study will continue until the target enrollment is reached. Testing will commence and continue in parallel to study enrollment. Applicable Standards: Technicians conducting the testing will strictly adhere to the instructions detailed in the QFT-GIT package insert. The assay will be performed using the principles of Good Laboratory Practice (GLP). Deliverables Schedule: QFT-GIT results will be sent to the Clinical Data Manager at the DCAC on a controlled-access, password-protected server two weeks after all testing has been completed. The DCAC will receive a data dictionary for all variables in the lab database. Any queries will be resolved with the technician responsible for testing and data entry. Acceptance Criteria: All tests must be completed according to the standards describe above in the section Applicable Standards. After all data queries have been resolved and QA reports have been received and accepted, the contract will be terminated. EVALUATION FACTORS The government will award a Firm-Fixed-Price (FFP) contract resulting from this solicitation to the responsible offeror whose quote, conforming to this announcement, will be most advantageous to the government. Award will be made on a best value determination considering price and non-price factors in accordance with FAR 52.212-2 - Evaluation - Commercial Items Clause. 1. Price : Firm-Fixed Price for all requirements listed in the SOW. 2. Technical : Quality must demonstrate experience in administering QFT-GIT testing, expertise of technicians, ability to handle large volume specimens (100 per day) with good quality control, and qualifications of supervisory personnel. 3. Past Performance : Contractor's knowledge of previous experience with QFT-GIT testing. Please provide two references from relevant past experiences. To be eligible for contract award, a contractor must be registered with the Central Contractor Registration (CCR) database. For instructions on registering with the CCR, please see the CCR website at www.ccr.gov. All offerors are required to submit a completed copy of the Federal Acquisition Regulation (FAR) Provision 52.212-3 (Offeror Representations and Certifications-Commercial Items), with their offer. USUHS reserves the right to award without discussions. All questions must be directed by email to Timothy.Bunting@usuhs.mil and Tosin.Abari@usuhs.mil (as a secondary contact). Questions must be received by 12:00 PM (EST) on February 3, 2009. Responses to questions will be addressed as an amendment to the RFQ. No questions will be answered over the phone. Quotes shall be accepted by email only. No other method of submission will be accepted. Email all quotes to Timothy.Bunting@usuhs.mil and Tosin.Abari@usuhs.mil (as a secondary contact). Quotes must be received by 11:00 AM on February 9, 2009. All offerors must be aware that this solicitation includes the following provisions: • FAR 52.252-1 - Solicitation Provisions Incorporated by Reference This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address: www.gsa.gov/far (End of provision) • FAR 52.252-2 - Clauses Incorporated by Reference This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. In addition, the full text of a clause may be accessed electronically at this/these address: www.gsa.gov/far • FAR 52.237-2 - Protection of Government Buildings, Equipment and Vegetation • FAR 52.212-1 - Instructions to Offerors-Commercial Items • FAR 52.212-3 - Offeror Representations and Certification-Commercial Items • FAR 52.212-2 - Evaluation - Commercial Items (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: 1. Price 2. Technical Factors 3. Past Performance (End of clause) • FAR 52.212-4 - Contract Terms and Conditions-Commercial Items (Feb 2007) • FAR 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Feb 2008) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (2) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.) ___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (SEP 2006), with Alternate I (OCT 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). ___ (2) 52.219-3, Notice of HUBZone Small Business Set-Aside (Jan 1999) (15 U.S.C. 657a). ___ (3) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JUL 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). ___ (4) [Removed]. ___ (5)(i) 52.219-6, Notice of Total Small Business Set-Aside (JUNE 2003) (15 U.S.C. 644). ___ (ii) Alternate I (OCT 1995) of 52.219-6. ___ (iii) Alternate II (MAR 2004) of 52.219-6. ___ (6)(i) 52.219-7, Notice of Partial Small Business Set-Aside (JUNE 2003) (15 U.S.C. 644). ___ (ii) Alternate I (OCT 1995) of 52.219-7. ___ (iii) Alternate II (MAR 2004) of 52.219-7. ___ (7) 52.219-8, Utilization of Small Business Concerns (MAY 2004) (15 U.S.C. 637 (d)(2) and (3)). ___ (8)(i) 52.219-9, Small Business Subcontracting Plan (Nov 2007) (15 U.S.C. 637(d)(4)). ___ (ii) Alternate I (OCT 2001) of 52.219-9 ___(iii) Alternate II (OCT 2001) of 52.219-9. ___ (9) 52.219-14, Limitations on Subcontracting (DEC 1996) (15 U.S.C. 637(a)(14)). ___ (10) 52.219-16, Liquidated Damages--Subcontracting Plan (JAN 1999) (15 U.S.C. 637(d)(4)(F)(i)). ___ (11)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (SEP 2005) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). ___ (ii) Alternate I (JUNE 2003) of 52.219-23. ___ (12) 52.219-25, Small Disadvantaged Business Participation Program--Disadvantaged Status and Reporting (OCT 1999) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (13) 52.219-26, Small Disadvantaged Business Participation Program--Incentive Subcontracting (OCT 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). ___ (14) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (MAY 2004) (U.S.C. 657 f). _X__ (15) 52.219-28, Post Award Small Business Program Rerepresentation (JUNE 2007) (15 U.S.C. 632(a)(2)). _X__ (16) 52.222-3, Convict Labor (JUNE 2003) (E.O. 11755). _X__ (17) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (FEB 2008) (E.O. 13126). _X__ (18) 52.222-21, Prohibition of Segregated Facilities (FEB 1999). _X__ (19) 52.222-26, Equal Opportunity (MAR 2007) (E.O. 11246). ___ (20) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of theVietnam Era, and Other Eligible Veterans (SEP 2006) (38 U.S.C. 4212). _X__ (21) 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C. 793). ___ (22) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (SEP 2006) (38 U.S.C. 4212). ___ (23) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (DEC 2004) (E.O. 13201). _X__(24)(i) 52.222-50, Combating Trafficking in Persons (AUG 2007) (Applies to all contracts). ___ (ii) Alternate I (AUG 2007) of 52.222-50. ___ (25)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (AUG 2000) (42 U.S.C. 6962(c)(3)(A)(ii)). ___ (ii) Alternate I (AUG 2000) of 52.223-9 (42 U.S.C. 6962(i)(2)(c)). ___ (26) FAR 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). ___ (27)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (DEC 2007) (E.O. 13423). ___ (ii) Alternate I (DEC 2007) of 52.223-16. _X__ (28) 52.225-1, Buy American Act--Supplies (JUNE 2003) (41 U.S.C. 10a-10d). _X__ (29)(i) 52.225-3, Buy American Act--Free Trade Agreements--Israeli Trade Act (AUG 2007) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, Pub. L 108-77, 108-78, 108-286, 109-53 and 109-169). ___ (ii) Alternate I (JAN 2004) of 52.225-3. ___ (iii) Alternate II (JAN 2004) of 52.225-3. ___ (30) 52.225-5, Trade Agreements (Nov 2007) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). ___ (31) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2006) (E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury). ___ (32) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (33) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (34) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). ___ (35) 52.232-30, Installment Payments for Commercial Items (OCT 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). ___ (36) 52.232-33, Payment by Electronic Funds Transfer--Central Contractor Registration (OCT 2003) (31 U.S.C. 3332). ___ (37) 52.232-34, Payment by Electronic Funds Transfer--Other than Central Contractor Registration (MAY 1999) (31 U.S.C. 3332). _X__ (38) 52.232-36, Payment by Third Party (MAY 1999) (31 U.S.C. 3332). ___ (39) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a). ___ (40)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). ____ (ii) Alternate I (APR 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.) ____ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). ____ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). ____ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act--Price Adjustment (Multiple Year and Option Contracts) (NOV 2006) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). ____ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act--Price Adjustment (February 2002) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). ____ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.). ____ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Nov 2007) (41 U.S.C. 351, et seq.). ____ (7) 52.237-11, Accepting and Dispensing of $1 Coin (AUG 2007)(31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records--Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in paragraphs (i) through (vi) of this paragraph in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-- (i) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (ii) 52.222-26, Equal Opportunity (MAR 2007) (E.O. 11246). (iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (SEP 2006) (38 U.S.C. 4212). (iv) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). (v) 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (DEC 2004) (E.O. 13201). (vi) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (vii) 52.222-50, Combating Trafficking in Persons (AUG 2007) (22 U.S.C. 7104(g)). Flow down required in accordance with paragraph (f) of FAR clause 52.222-50. (viii) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (ix) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services--Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (x) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor May include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of clause)
Web Link: FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=004d08d820f8307c7444b5a38f639db2&tab=core&_cview=1)
Place of Performance: Address: USAMEDDAC, Ft. Jackson, South Carolina, 29207, United States; Zip Code: 29207
Record: SN01740434-W 20090131/090129215822-004d08d820f8307c7444b5a38f639db2 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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B -- Quantiferon Gold-In-Tube Testing