SOLICITATION NOTICE
65 -- AMPLIFICATION ASSAY INSTRUMENT
- Notice Date
- 3/10/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 624190
— Other Individual and Family Services
- Contracting Office
- Department of the Army, U.S. Army Medical Command, MEDCOM, North Atlantic Regional Contracting Office, Medcom Contracting Center North Atlantic, ATTN: MCAA NA Bldg T20, 6900 Georgia Avenue NW, Washington, DC 20307-5000
- ZIP Code
- 20307-5000
- Solicitation Number
- W91YTZ-09-T-0078
- Response Due
- 3/17/2009
- Archive Date
- 5/16/2009
- Point of Contact
- donna.blossom, (910) 907-6851<br />
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This solicitation uses Simplified Acquisition Procedures (SAP) authorized in FAR Subpart 13.5 and is expected to result in the award of one firm-fixed price contract for a six month period from 1 April 09 through 30 September 2009 with one tweve month option from 1 October 2009 to 30 September 2010. The resulting award will be made on SF 1449, for commercial items. This announcement constitutes the only solicitation. A written solicitation will not be issued. The North Atlantic Regional Contracting office, Womack Army Medical Center, Fort Bragg, NC intends to solicit, negotiate, and award a sole source requirements contract where quantities and amounts are estimated. We will be using other than full and open competition procedures to Gen Probe, San Diego, CA for Amplification Assay Instruments. This is solicitation number W91YTZ-09-T-0078 and is a request for quotation (RFQ). This is an unrestricted procurement. The Standard Industrial Classification Code is 3826 and the NAICS code of 624190. The contract performance shall be in strict compliance with all terms, conditions, and provisions contained herein. Contractor shall provide the following line items see Statement of Work additional information: Line item One: Contractor to deliver reagents, testing equipment, material, supplies, consumables, training for government personnel, and all equipment maintenance and any other items necessary for testing for Chlamydia trachomatis (ct), neisseria gonorrhea (ng) and mycobacterium species. The contractor shall provide at no additional charge to the government the Tigris dts system (cat # 105580); eppendorf reagent pipettors; and one (1) each leader 50 product #3100, pn/cn: 3100; one each eppendorf pipettor, product #2113, pn/cn: 2113. Line item two: Urine Transport (50 Test kit) Catalog # 301040, PN / CN 301040 Quantity (50), Price per Kit totals: Line item three: Swab Transport (50 Test box), Catalog # 301041, PN / CN 301041 Quantity (240), Price per Kit totals: Line item four: Aptima Multi-Pack Kit (1000 tests / Kit), Catalog #301130B Quantity (14), Price per Kit totals: Line item five: 1791 Detection Reagent (1200 tests / Kit), PN / CN 1791 Quantity (2), Price per Kit totals: Line item six: 1847 Leader Printer Paper, (One roll / Pack), PN / CN 1847 Quantity (1), Price per Pack totals: Line item seven: 2860 MTD Accuprobe, (20 tests / Kit), PN / CN 2860 Quantity (3), Price per Kit totals: Line item eight: 2845 Myco Avium Complex, (20 Tests/Kit), Quantity (3), Price per Kit totals: Line item nine: 2800 Accuprobe, Identification Reagent, PN / CN 2800 Quantity (5), Price per BX totals: Line item ten: ASR CT (100 Tests), PN / CN 105302, Quantity (2), Price per Kit totals: Line item eleven: ASR GC (100 Tests / Kit), PN / CN 105301, Quantity (2), Price per Kit totals; Twelve Month Option: Line item 1001: From 01 October 2009 to 30 September 2010. Contractor to deliver reagents, testing equipment, material, supplies, consumables, training for government personnel, and all equipment maintenance and any other items necessary for testing for chlamydia trachomatis (ct), neisseria gonorrhea (ng) and mycobacterium species. The contractor shall provide at no additional charge to the government the tigris dts system (cat # 105580); Eppendorf reagent pipettors; one (1) each leader 50 product #3100, pn/cn: 3100; one each eppendorf pipettor, product #2113, pn/cn: 2113. Line item 1002: Urine Transport (50 Test kit) Catalog # 301040, PN / CN 301040 Quantity (100), Price per Kit totals: Line item 1003: Swab Transport (50 Test box), Catalog # 301041, PN / CN 301041 Quantity (435), Price per Kit totals: Line item 1004: Aptima Multi-Pack Kit (1000 tests / Kit), Catalog #301130B Quantity (28), Price per Kit totals: Line item 1005: 1791 Detection Reagent (1200 tests / Kit), PN / CN 1791 Quantity (3), Price per Kit totals: Line item 1006: 1847 Leader Printer Paper, (One roll / Pack), PN / CN 1847 Quantity (1), Price per Pack totals: Line item 1007: 2860 MTD Accuprobe, (20 tests / Kit), PN / CN 2860 Quantity (6), Price per Kit totals: Line item 1008: 2845 Myco Avium Complex, (20 Tests/Kit), Quantity (6), Price per Kit totals: Line item 1009: 2800 Accuprobe, Identification Reagent, PN / CN 2800 Quantity (9), Price per BX totals: Line item 1010: ASR CT (100 Tests), PN / CN 105302, Quantity (3), Price per Kit totals: Line item 1011: ASR GC (100 Tests / Kit), PN / CN 105301, Quantity (3), Price per Kit totals; STATEMENT OF WORK 1. The contractor shall provide one instrument that has the ability to perform testing for Chlamydia trachomatis/Neisseria gonorrhoeae using Nucleic Acid Amplification technology that is a fully automated walk-a-way enclosed system. 2. Contractor shall provide training two slots initially for the analyzer. This training will occur at the contractors headquarters for two technologists per instrument provided for a minimum of three days in regards to assay performance, troubleshooting, preventive maintenance, and quality control. Contractor will also provide subsequent on-site technical training to pertinent testing personnel in regards to assay performance troubleshooting, preventative maintenance, and quality control for one day per quarter per year. 3. Contractor shall provide service maintenance for the period of 1 April 2009 through 30 September 09, with one twelve month renewable option. Service will be 7 days a week, 24 hours a day for all equipment. 4. Workload numbers for test performed are estimated. Payment will be made for actual items received. Estimated annual workload for Chlamydia trachomatis/Neisseria gonorrhoeae testing is 32,000 samples annually. 5. Assay must utilize nucleic acid amplification technology for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical swabs, male urethral specimens, female and male urine specimens, ThinPrep liquid pap specimen plus vaginal swabs, either patient collected and physician collected. 6.Assay must be approved by the Bureau of Biologics of the Food and Drug Administration (FDA) for in vitro diagnostic use with either symptomatic or non-symptomatic patients using either endocervical swabs, male urethral specimens, female and male urine specimens, ThinPrep liquid pap specimens and vaginal specimens. 7. All reagents and equipment must be provided on a reagent rental basis, i.e. reagent purchase/equipment provided basis. 8. Equipment design requirements should not exceed the area established for the current testing laboratory. 9. Assays must be automated such that at least five hundred samples (patient specimens plus controls) can be tested by one technologist in an 8.5 hour period with no more than two hours hands on time. 10. Assay procedures must be such that determinations are made and recorded electronically with output hardware capable of interface with the Laboratorys data processing system. 11. Reagents must be supplied in a form requiring minimal preparation, and in a configuration and package size compatible with the projected user volume so as to minimize product wastage. 12. Delivery of reagent must be guaranteed within five (5) working days after receipt of an order. 13. Test kits must have at least two months of the expiration date remaining at the time they are received in the laboratory. 14. Back-up equipment must be provided initially, or onsite technical backup must be guaranteed within twenty-four hours of any reported failure for essential equipment and seventy-two hours of determination that in-house trouble-shooting was unsuccessful. 15. Vendor technical assistance via telephone must be available within four hours of a reported assay or equipment problem. On-site technical backup must be guaranteed within twenty four hours of any reported assay failure for equipment for which in-house troubleshooting was unsuccessful. 16. The vendor will supply at no additional cost all specimens, specimen collection kits and assay kits required to verify the system to satisfy the current CLIA-88 requirements for verification. Anticipated volume for method verification study is 100 tests. 17. During the course of the contract, if volume increases by 30% or more, the vendor must provide, at no cost to the consumer, additional or updated instrumentation and upgraded data management systems to accommodate the workload increase. 18. Specimen collection kits must be offered by the vendor for use with their NAAT assay. If the specimen collection kits differ from those currently used, the vendor will work with the laboratory and field personnel to ensure that an acceptable plan is in place to replace existing specimen collection kits with new specimen collection kits. 19. Specimen collection kits should not require refrigeration for storage. Collected specimen transport kit must be acceptable shipped under ambient conditions. 20. All collected specimens must be acceptable for testing at least 30 days post-collection with storage at ambient conditions. 21. All FDA approved specimen types must be able to be tested without further manipulations such as swab expression, swab removal, or centrifugation. 22. Specimen collection kits must have penetrable caps for use on automated instrumentation for pipetting to eliminate the need for swab removal from the collection tube. 23. Assays must have FDA acknowledged sensitivity versus patient infected status of at least 94% (Chlamydia trachomatis)/91% (Neisseria gonorrhoeae) and specificity versus patient infected status of at least 97% (Chlamydia trachomatis)/97% (Neisseria gonorrhoeae) for all specimen types. 24. The instrument must have the following capability: a. The instruments should be controlled by a high performance microprocessor. b. The instruments should have a safe memory for programs with a file protection scheme. c. The user should be able to protect programs against unauthorized modifications. d.Software should be menu-driven with a full numeric keypad. e. All output hardware should be designed to interface with the Laboratory network drive. 25. Instrumentation must include at least the following: a. Must have the capability of positive specimen identification. b.Must have automated reagent and specimen pipetting capabilities. c.Must have liquid level detection for reagents and patient samples. d. Must have reagent lot number and expiration date tracking. e. Automated pipetting instrumentation must have throughput of 490 patient specimens/8 hour shift. 26..Naturally occurring components in patient samples (such as blood, mucous, or bilirubin) and other man-made components (such as vitamins or gynecological products) should not show interference with the performance of the assay in the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae. 27. There should be no cross-reactions with organisms other than Chlamydia trachomatis and Neisseria gonorrhoeae noted in performance of the assays. 28. Quotes are to be emailed to Donna Blossom at donna.blossom@us.army.mil no later than 1:00 on 17 March 2009. For questions not answered in solicitation, please email them to donna.blossom@us.army.mil. The following provisions in their latest editions apply to this solicitation. FAR Clauses and provisions apply and can be viewed at http://www.arnet.gov/far. (1)FAR 52.212-1, Instructions to Offeror-Commercial Items with the addendum that: The offer submitted shall include: (1) proposed prices (including Option Years); (2) Technical capability to include product literature, catalog price lists if available; (3) completed copy of FAR 52.212-3. Offer Representations and Certifications-Commercial items, and (4) Past Performance, minimum of three references for similar scope of work, with whom past performance can be verified, to include contact name, telephone number, e-mail address and contract number and dollar value. Offers may submit any other information regarding specific contracts that they deem relevant to the evaluation of their past performance. (2) FAR 52.222-50 Combating Trafficking in Persons (3)FAR 52.212-2, The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitations will be most advantageous to the Government, price and other factors considered. Evaluation Criteria: The following are the evaluation criteria for each factor and any sub-factors under that factor. A. Technical and past performance when combined are more important than price. B. Technical Factor is more important than Past Performance. The following factors shall be used to evaluate Offers: Technical Capability, Price and Past Performance. Technical will be evaluated as either Acceptable or Unacceptable. Definitions are as follows: Technical will be evaluated as either Acceptable or Unacceptable. Definitions are as follows: ACCEPTABLE: To be rated acceptable, the offerors technical proposal must demonstrate it can meet all requirements in the Statement of Work. UNACCEPTABLE: A technical proposal that fails to demonstrate it can meet one or more requirements of the Statement of work will be determined unacceptable. Past Performance will be evaluated as high risk, medium risk and low risk with definitions as follows: Unsatisfactory / High Risk - Significant doubt exists that the offeror will satisfactorily perform the services on solicitation, based on preponderance of unsatisfactory performance records under the various factor evaluations, or offerors record of unsuccessful past and current contracts performance in fulfilling requirements similar to the size and complexity of the services under solicitation. Verification of past performance shows that offerors have consistently not met work schedules and other obligations, have defaulted on at least one contract within the past three years, or have chronically failed to meet contract terms. -Satisfactory / Moderate Risk - Some doubt exists based on instances of record of poor performance, especially in contracts similar to the size and complexity of the services under solicitation. Verification of past performance shows that offeror meets work schedules and specified services most of the time, meets contract terms without failure or resolves issues immediately, and has not been defaulted on any contract within the past three years. Good / Low Risk - Little doubt exists, based on the offeror's preponderance of good, if not excellent past and current records of contract performance, especially in large contracts similar to the size and complexity of the services under solicitation. Verification of past performance shows that offeror consistently meets work schedules, provides specified services, meets contract terms without failure, and has not been defaulted on any contract within the past three years. Offeror without technical or insufficient technical information to show that their offer meets the performance work statement shall not be evaluated for award. Neutral Risk No relevant past performance Information. PRICE: Price will be evaluated separately from past performance and will be evaluated for fairness and reasonability. Offeror shall provide their published price list with their offer. The Government reserves the right to award to other than the low offeror for better technical capability and/or better performance records. The Government intends to evaluate offers and award without discussion. However, the Government reserves the right to conduct discussions if determined to be in its best interest to do so. It is now a requirement that all contractors doing business with the Department of Defense is registered with CCR (the website may be accessed on the internet at: www.ccr.gov to register. Referenced provisions and clauses may be accessed electronically at these addresses: http://www.arnet.gov/far; http://farsite.hill.af.mil; http://www.dtic.mil/dfar (4)FAR 52.204-7, Central Contractor Registration (5)FAR 52.212-3, Offeror Representations and Certifications; a completed copy of which shall be submitted with the offer. (6)FAR 52.212-4, Contract Terms and Conditions and FAR Clauses 52.217-8 (30 days prior to expiration of the contract), 52.217-9 (a) 30 days; Intent letter within 60 days; 52.232-19 (30 September 2008). (7)FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders, specifically, para (b)(15), (16),(17), (18), (19), (31) (8)FAR 52.216-18, Ordering, Any Supplies and Services to be furnished under this contract shall be ordered by issusance of delivery orders or task orders by the individuals or activities desingated in the schedule. Such order may be issued from 1 April 2009 to 30 September 2010. (9)FAR 52.216-19, Order Limitation, (a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $10,00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract. (b) Maximum order. The Contractor is not obligated to honor purchase over $200,000.00 (1) Any order for a single item in excess of $25,000.00; or (2) Any order for a combination of items in excess of $50,000.00; or (3) A series of orders from the same ordering office within one day that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section. (c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section. (d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within five days after issuance, with written notice stating the Contractors intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source. (10) 52.216-21 Requirements. (a) This is a requirements contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the Governments requirements do not result in orders in the quantities described as estimated or maximum in the Schedule, that fact shall not constitute the basis for an equitable price adjustment. (b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. Subject to any limitations in the Order Limitations clause or elsewhere in this contract, the Contractor shall furnish to the Government all supplies or services specified in the Schedule and called for by orders issued in accordance with the Ordering clause. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations. (c) Except as this contract otherwise provides, the Government shall order from the Contractor all the supplies or services specified in the Schedule that are required to be purchased by the Government activity or activities specified in the Schedule. (d) The Government is not required to purchase from the Contractor requirements in excess of any limit on total orders under this contract. (e) If the Government urgently requires delivery of any quantity of an item before the earliest date that delivery may be specified under this contract, and if the Contractor will not accept an order providing for the accelerated delivery, the Government may acquire the urgently required goods or services from another source. (f) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractors and Governments rights and obligations with respect to that order to the same extent as if the order were completed during the contracts effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after 30 September 2010. (10)FAR 52.217-8, Option to Extend Services (11)FAR 52.219-28, Post-Award Small Business Program Representation (12)FAR 52.222-21, Prohibition of Segregated Facilities (13)FAR 52.222-26, Equal Employment (14)FAR 52.222-35, Equal Opportunity for Special Disabled Veterans (15)FAR 52.222-36, Affirmative Action for Workers with Disabilities (16)FAR 52.222.37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and other Eligible Veterans. (17)FAR 52.225-3, Buy American Act North American Free Trade Agreement (18)FAR 52.232-19, Availability of Funds (19)FAR 52.252-1: for all referenced clauses/provisions, see web site http://www.arnet.gov/far or http://web2deskbook.osd.mmil/default.asp (20)FAR 52.228-5, Insurance-Work on a Government Installation (21)DFAR 252.225-7000, Buy American Act Balance of Payments Program Certificate (22)DFAR 252.212-7001, Contract Terms (23)DFAR 252.225-7002, Qualifying Country Sources as Subcontractors (24)DFAR 252.232.7003, Electronic Submission of Payment Request and Receiving Report (25)DFAR 252.204-7004, Required CCR
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- Place of Performance
- Address: Medcom Contracting Center North Atlantic ATTN: MCAA NA Bldg T20, 6900 Georgia Avenue NW Washington DC<br />
- Zip Code: 20307-5000<br />
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