SOLICITATION NOTICE
66 -- Automated Pipetting Instrument System
- Notice Date
- 5/6/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, MD, 21702-9203
- ZIP Code
- 21702-9203
- Solicitation Number
- N62645-03-R-0008
- Response Due
- 5/16/2003
- Archive Date
- 5/31/2003
- Point of Contact
- Ralph Payne, Contracting Officer, Phone 301-619-3026, Fax 301-619-2925,
- E-Mail Address
-
repayne@nmlc.med.navy.mil
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. The Request for Proposal number is N62645-03-R-0008. Provisions and clauses in effect through Federal Acquisition Circular 2001-13 are incorporated. NAISC 423490/SIC: 5045. The Navy intends to negotiate (IAW FAR 6.302) with Andwin Scientific, Canoga Park, CA as the only source that can provide an Automated Pipetting Instrument. SOW. 1. REQUIREMENTS FOR AUTOMATED PIPETTING INSTRUMENT (API) FOR USE IN THE MILITARY DRUG TESTING LABORATORIES UNDER THE DOD DRUG DETERRENCE PROGRAM. 1.1. Basic Concept. 1.1.1. The contractor shall provide an automated sample pipetting instrument (API) system which consists of: a) automated sample pipetting instrument(s) (API), and b) all components (i.e. sample racks, carriages, holders, or inserts, and bar-code readers) necessary to perform the forensic transfer of urine aliquots from sample containers (SC) to recipient test tubes pursuant to drug testing. To ensure no cross contamination of specimen, the robotic arms of the dispensing station should not cross other specimen containers or recipient tubes in the course of sample delivery or disposal of used pipette tips. The API should be adaptable to use the Hitachi 30-rack transfer tray for off loading the recipient sample test tubes for direct transfer to the Roche-Hitachi Modular (P and D modules) analyzer. The API shall be used in the urinalysis specimen pour-off and accessioning areas in the military drug testing laboratories in the course of forensic drug analysis. The test tube rack holder that receives the sample aliquot on the API must be compatible for use on the Roche-Hitachi modular (D and P modules) analyzer. The API must be adaptable to urine specimen containers (SC) for the forensic transfer of urine aliquots for use in the course of drug testing within the military drug testing laboratories. Procurement of the API is contingent upon successful adaptation to, and performance of the SC as described herein. 1.1.2. The contractor shall provide an automated pipetting instrument (API) that must be able to extract, in a forensically acceptable manner using disposable plastic pipette tips, approximately a 1.0 mL aliquot of urine from the SC via a self-sealing penetration port without the requirement to open the lid of the SC. The API must transfer urine aliquots from the SCs to 16x100 mm glass receiver specimen tubes that are in 5-well test-tube holders without leakage or splattering of sample during the transfer process. The 5-well tube holders are provided by Roche Diagnostics as part of the high speed Roche-Hitachi modular analyzers used within the military drug testing laboratories. The API should be adaptable to use the Hitachi 30-rack transfer tray for off loading the recipient sample test tubes for direct transfer to the Roche Hitachi analyzer. No modification of either the Hitachi modular system or the Roche 5-well test tube holders shall be required to conform to the operation of the API system. The API must be capable of correctly reading 3 of 9 or code 128 bar-coded specimen identification information on a label located on the SC body or other location (while positioned in the contractor provided SC rack), read and compare the bar code identifier information to a similar bar code label located on the receiver specimen tube (while in the Hitachi test-tube rack compatible for use on the Roche Hitachi modular analyzer). The bar code comparison process will be conducted in real time as part of automated specimen transfer process. 1.1.3. The barcode reader should be capable of reading 3 of 9 and code 128 formats. The API modular design should permit barcode reader upgrades in the future to read double density PDF417 formats. 1.1.4. The API should be able to communicate in real time with a PC to record information regarding the run (error reads, etc are sent to a PC in real time with an audible alarm). Information regarding specimens processed in the batch (Batch number, LAN, rack Identifier numbers) is stored on a PC for possible transfer to the Laboratory Information Management System (LIMS) after completion of a batch run. Errors would be indicated in terms of failure to read barcode on bottle, failure to read barcode on specimen tube, error in barcode comparison between bottle and tube. The PC connected to the API must be able to print on demand a batch report indicating agreement between LANs on the SC and specimen receiving tube. Error codes shall be indicated on any report to explain discrepancies. 1.1.5. The system should be a modular configuration to facilitate repair and to permit reconfiguration of the APT to accept system upgrades to improve automation efficiencies within the DoD Laboratories. 1.1.6. The API system must have automated start-up and self check maintenance procedures without an operator having to return to the API to ?step? the API through individual instructions/ commands/inputs. 1.1.7. The contractor must provide on-site training to personnel at each laboratory site upon installation of the equipment. The extent and number of personnel for the on-site training must be in accordance with each military drug testing laboratory?s requirements. The contractor shall provide an option to train laboratory personnel to maintain the system at a field engineer level. 1.1.8. The API system must currently be in manufacture production and must be supportable (i.e. repair parts, maintenance, etc) for a minimum of 5 years from the date of delivery. 1.1.9. The contractor must meet ISO 9000 certification or demonstrate adherence to good laboratory standards for the manufacture and distribution of the API equipment. 1.1.10. The warrantee repair time must not exceed 24 hours from notification of a system component failure; with the exception of the facility in Hawaii, for which 36 hours will be permitted when parts must be shipped. Routine spare parts shall be available onsite at each laboratory to minimize potential downtime, and is especially required for the Hawaii facility. 1.1.11. The contractor must provide consumable (cleaning reagents, wash solutions, etc) and disposable supplies (tubing lines, o-rings, gaskets, plungers, etc) used for the API, either periodically or based upon the volume of testing. All consumable and disposable supplies will be provided for one year from the date of system delivery. 1.1.12. The contractor must complete a site survey of each laboratory site prior to API delivery to verify all requirements are available to operate the API system(s) and meet the contractor?s specifications prior to installation. The contractor shall deliver the API system to a location inside the laboratory, uncrate, setup, install the API system and demonstrate performance of the system in accordance with Section C, prior to government acceptance of the system. The contractor will provide all cables needed to interface the system to a PC and/or host Laboratory Information Management System (LIMS). All extra equipment identified during installation (i.e. uninterrupted power supply (UPS), sump pump, water pump, vacuum pump, waste storage containers, rinse water containers, etc) or during the first year of operation as needed for optimal operation of the system, shall be provided to the government as part of the original cost submission. 2.1. Description. 2.1.1. The API shall be an automated sample processing system that eliminates manual sample pouring while maintaining the forensic integrity of the specimen in a closed container system. The API must be capable of using the Hitachi 5-well test-tube racks and the Hitachi 30-rack carrier tray as part of the API system for direct loading and removal of sample batches from the API to facilitate direct transfer onto the Hitachi Modular Analyzer. The API must require no more than 1 hour setup and maintenance at the beginning and end of a 16 hour (2 shift) work day; have a fluid depth sensing probe to minimize external surface tip contamination and ensure aliquot aspiration; have no evidence of cross-contamination during transfer and dispensing of the aliquot into the recipient test tube that might compromise the reliability of sample processing; use commercially available disposable pipette tips that are automatically changed between each sample aliquot process; and, be able to process batches of approximately 100- 150 SC specimens and 100-150 test tubes in a run. 3.1. Essential Characteristics. 3.1.1. The API system shall require no more than 1 technician per eight-hour shift to achieve a minimum throughput of 400 samples per hour for a minimum daily throughput of 5,600 member samples within 14 hours for up to six days per week. The system shall include enough API processing accessory units (i.e. SC racks, SC holders) for 8,000 samples at any given time. The cost of all required components, sub-components, and accessories of the API system shall be included in the total price of the system. 3.1.2. The API system must be able to transfer approximately 1.0 ml of sample, without opening the actual urine container. Specimen transfer will use commercially available disposable plastic pipette tips. The specimen transfer will occur by having the disposable pipette tip enter the SC via a self-sealing port. The self-sealing port must be able to withstand a minimum of three potential sampling entries through the self-sealing port without the port leaking fluid if tipped on its side or inverted for extended periods of time. The API pipette system must be constructed so the disposable pipette tip is able to penetrate both a thin tamper evident tape placed across the self-sealing port and the self-sealing port during the specimen transfer process. The API system must be adaptive to the use of Hitachi 30 rack carrier trays for the efficient off-loading of specimen aliquots for transfer to the Hitachi modular system. The API must be adaptive to the use of a vendor supplied carrier tray for the efficient on loading and off-loading of specimens containers after completing the batch aliquot transfer process. 3.1.3. The API system is defined as all components necessary to hold and perform sample aliquoting of urine samples from sample containers to recipient test tubes. As specified in paragraph C.1.1.1, this includes, but is not limited to SC racks, SC carriages, SC holders, inserts, and bar-code readers. 3.1.4. The API system must be a core commercial product that can be sold and serviced in the United States to non-governmental organizations. Modular configurations permitting system upgrades are desirable if constructed around a core commercially available design. 3.1.5. The contractor must support the maintenance and service of the API system under an initial one-year full service warranty with response times within 4 hours telephonically and onsite service within 24 hours. The API system must have a 95% or better uptime, based upon the percentage of time available during the operating hours at the full volume capacity specified in this solicitation. 3.1.6. The API system shall operate from utilities listed below. 115 VAC+/- 10%, 60Hertz+/- 2 Hertz or 208 VAC+/- 10% Phase, 60-Hertz +/- 2 Hertz and 20-amp power service. 3.1.7. The contractor must ensure that the component parts of the API are commercially available at competitive prices, and the parts must be interchangeable from one instrument to another. 3.1.8. The contractor must provide API operating instructional manuals, maintenance manuals, routine repair instructions, and all associated charts, graphs, diagrams, alarm warnings necessary for the safe operation of the API equipment. 3.1.9. The API system must include all hardware, software, and firmware capable of unambiguously identifying the sample throughout the sample aliquot process and maintain the identity of each sample without confusion with other samples. The API shall provide a method of reading and storing in memory the identity of the sample as part of a defined batch of samples being prepared for testing. The API shall provide a method of ensuring agreement in specimen identity of the SC and recipient test tubes in real time. 3.1.10. The API Security requirements must have computer software and hardware security levels of access to instrument operation, data files, and instrument operating parameters, including security for any component of the system. Software and access to various files must have password and security level protection. 3.1.11. The security features of the API-PC system will include an audit trail capable of recording operator identity; date and time of operator access; date and time and operator ID of any edits made to the instrument configurations or to batch ID, specimen ID. The audit trail information must be capable of being transmitted across an interface to the host LIMS. 3.1.12. The API system must be safely operable without the operator in direct contact with contaminated or hazardous materials. Andwin must provide, (1) a document addressing each paragraph of the SOW stating either "concur" or "nonconcur". In the event of a "nonconcur" an explanation must be provided to support. (2) Any brochures, technical or product literature to support the system offered. (3) For past performance, provide dates of contracts or purchase orders, both Government and commercial, for the systems sold commercially (minimum of 3 different locations) within the past 3 year period as follows: Name, address, POC and telephone number of the organization; contract or purchase order number and dollar value; date of contract or purchase order. The government anticipates award of an Indefinite Quantity Indefinite Delivery type contract for a minimum of 1 system (for First Article Testing IAW FAR 52.209-4 (provided in full test below)) and a maximum of up to 14 systems, over a two-year period. Andwin must submit firm-fixed pricing for all units for the period specified. To support the offered price, documentation needs to be provided of published commercial price list, or other documentation setting forth prices changed to the general public. Any applicable discounts to the Government need to be stated, and if applicable, any GSA schedule numbers. Contract award will be based on 1). Determination of technical acceptability of system offered, and 2). Determination that the proposed price is fair and reasonable. Andwin must be registered in CCR; provide DUNS number; Cage Code and TIN. Additionally, the provisions at FAR 52.212-3 must be completed and submitted. The following FAR Clauses and Provisions are also applicable. 52.212-1, Instructions to Offerors-Commercial Items apply with the exception of (d), (e), (f), (h), and (i), which are "Reserved". Paragraph (o) of this clause is replaced by the warranty conditions stated in 3.1.5 of the SOW above. 52.212-4, Contract Terms and Conditions-Commercial Items; 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items to include Class Deviation 2001-O0002. With respect to FAR Clauses 52.212-5, the following also apply: 52-222-3, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-13, 52.225-15, 52.232.33, and 52.233-3. 52.209-4--First Article Approval--Government Testing (Sep 1989) with Alternate I (Jan 1997). (a) The Contractor shall deliver one API unit within 15 calendar days from the date of this contract to the Government at Naval Drug Screening Laboratory, Great Lakes, IL for first article tests. The shipping documentation shall contain this contract number and the Item identification. The characteristics that the first article must meet and the testing requirements are specified elsewhere in this contract. (b) Within 7 calendar days after the Government receives the first article, the Contracting Officer shall notify the Contractor, in writing, of the conditional approval, approval, or disapproval of the first article. The notice of conditional approval or approval shall not relieve the Contractor from complying with all requirements of the specifications and all other terms and conditions of this contract. A notice of conditional approval shall state any further action required of the Contractor. A notice of disapproval shall cite reasons for the disapproval. (c) If the first article is disapproved, the Contractor, upon Government request, shall submit an additional first article for testing. After each request, the Contractor shall make any necessary changes, modifications, or repairs to the first article or select another first article for testing. All costs related to these tests are to be borne by the Contractor, including any and all costs for additional tests following a disapproval. The Contractor shall furnish any additional first article to the Government under the terms and conditions and within the time specified by the Government. The Government shall act on this first article within the time limit specified in paragraph (b) of this clause. The Government reserves the right to require an equitable adjustment of the contract price for any extension of the delivery schedule or for any additional costs to the Government related to these tests. (d) If the Contractor fails to deliver any first article on time, or the Contracting Officer disapproves any first article, the Contractor shall be deemed to have failed to make delivery within the meaning of the Default clause of this contract. (e) Unless otherwise provided in the contract, the Contractor -- (1) May deliver the approved first article as a part of the contract quantity, provided it meets all contract requirements for acceptance and was not consumed or destroyed in testing; and (2) Shall remove and dispose of any first article from the Government test facility at the Contractor's expense. (f) If the Government does not act within the time specified in paragraph (b) or (c) of this clause, the Contracting Officer shall, upon timely written request from the Contractor, equitably adjust under the Changes clause of this contract the delivery or performance dates and/or the contract price, and any other contractual term affected by the delay. (g) The Contractor is responsible for providing operating and maintenance instructions, spare parts support, and repair of the first article during any first article test. (h) Before first article approval, the acquisition of materials or components for, or the commencement of production of, the balance of the contract quantity is at the sole risk of the Contractor. Before first article approval, the costs thereof shall not be allocable to this contract for (1) progress payments, or (2) termination settlements if the contract is terminated for the convenience of the Government. (i) The Government may waive the requirement for first article approval test where supplies identical or similar to those called for in the schedule have been previously furnished by the Offeror/Contractor and have been accepted by the Government. The Offeror/Contractor may request a waiver. (j) The Contractor shall produce both the first article and the production quantity at the same facility. Andwin's offer is due at Naval Medical Logistics Command by 1:00 PM on or before 16 May 2003. POC is Ralph Payne, 301-619-3026, email repayne@nmlc.med.navy.mil. See Numbered Note 1.
- Place of Performance
- Address: DoD Military Drug Testing Laboratories
- Record
- SN00318929-W 20030508/030506213508 (fbodaily.com)
- Source
-
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