SOLICITATION NOTICE
65 -- CV-1000 Automated Aliquot System
- Notice Date
- 7/29/2002
- 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
- N62645-02-R-0013
- Response Due
- 7/31/2002
- Archive Date
- 8/15/2002
- Point of Contact
- Ralph Payne, Contracting Officer, Phone 301-619-3026, Fax 301-619-2925,
- E-Mail Address
-
repayne@us.med.navy.mil
- 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 N62645-02-R-0013. Provisions and clauses in effect through Federal Acquisition Circular 2001-07 are incorporated. NAICS 326199/SIC 3089. Naval Medical Logistics Command intends to negotiate with Capital Vial Incorporated, Fultonville, NY as the only source that can provide a CV-1000 Automated Aliquot System for use in the DoD Military Drug Testing Laboratories. The resulting contract will be an Indefinite Quantity Indefinite Delivery type contract for a minimum of 2 systems and a maximum of up to 12 systems. SOW. 1. REQUIREMENTS FOR AUTOMATED PIPETTING INSTRUMENT (API). 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. racks, carriages, holders, inserts, and bar-code readers) necessary to hold and perform sample aliquoting of urine samples from sample containers (SC) to recipient test tubes for use in the urinalysis specimen pour-off and accessioning areas in the military drug testing laboratories. The test tube rack holder that receives the sample aliquot must be compatible for use on the Roche-Hitachi modular (D and P modules) analyzer. 1.1.2. The contractor shall provide an automated pipetting instrument (API) that must be able to extract in a forensically acceptable manner, approximately 0.5 - 2.0 mL aliquot of urine from the SC. The API must be compatible with the transfer of aliquots from the SC to receiver specimen tubes compatible without modification to the high speed Roche-Hitachi modular analyzers used within the military drug testing laboratories. The API must be capable of correctly reading bar-coded specimen identification information on a label located on the SC lid and SC body. 2.1. Description. 2.1.1. The API shall: (1) require no more than 1 technician per 8 hour shift to process a minimum throughput of 600 specimens an hour for 14 hours per day to achieve a minimum daily throughput of 8400 samples, up to six days per week; (2) require no more than 1 hour setup and maintenance at the beginning and end of a 16 hour (2 shift) work day; (3) have a minimum of 95% uptime of reliable operation; (4) be capable of unassisted operation except for the loading and unloading of SC racks and test tube racks and refilling disposable pipette tips as necessary; (5) have a secure software for batch and sample tracking and operator identification; (6) have a secure software to track agreement in sample identity between the SC and recipient test tube, and an alarm/documentation of any specimen processing errors; (7) have a fluid depth sensing probe to minimize external surface contamination; (8) have a variable capacity to aliquot between 0.5 -2.0 mL of sample from the SC; (9) eliminate cross-contamination during dispensing of the aliquot into the recipient test tube; (10) have a mechanism for the safe cleansing of the interior and exterior of the transfer probe to remove particle, protein adhesion, or drug absorption on the probe surface between specimen aliquots, or use disposable pipette tips between each sample aliquot process; (11) be equipped with a barcode reader which can read 3 of 9 or code 128 barcodes and must read at a minimum a 10-character numeric barcode string placed on the SC lid and recipient test tube; (12) be able to read positioned barcodes on the SC lid with an error rate of less than 5 barcode read errors per 1,000 reads (13) process the specimen aliquots into transfer tubes or cups compatible with the Roche-Hitachi D-P modular analyzer used for the initial drug screening; (14) have a loading and unloading capacity each of approximately 200 specimens on the API; and (15) have commercial availability of disposable pipette tips for routine use. 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 600 samples per hour for a minimum daily throughput of 8400 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 contractor must provide consumable and disposable supplies 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. 3.1.3. 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 this SOW, 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, storage containers) or during the first year of operation as needed for optimal operation of the system, shall be provided to the government at no additional cost. 3.1.4. 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 that are compatible with the Roche-Hitachi analyzers specified in paragraph C.1.1.1 on the instrument. This includes, but is not limited to racks, carriages, holders, inserts, and bar-code readers. 3.1.5. The contractor must provide documentation of FDA approval. 3.1.6. The API system must be a commercial product that can be sold and serviced in the United States to non-governmental organizations. 3.1.7. 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. 3.1.8. 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. 3.1.9. 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. 3.1.10 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. 3.1.11. 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. 3.1.12. 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. 3.1.13. The security features of the API 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. 3.1.14. The system must include an interface compliant with EIA RS-232C, ASTM E1381 and ASTM E1394 network accessible or provide sufficient data and a technical point of contact to allow the development of the code to interface the API with other host computer systems. The computer interface must have bi-directional capability with real time and batch processing. Interface requirements are: Method of Data Transmission shall be one of the following: RS232, USB, Network (TCP/IP (Ethernet), Direct Database Access (ODBC). Data to transmit to the LIMS using the computer interface: API scanned barcodes, tube and cup position, rack id, error codes. API control commands. At a minimum, ?Start? and ?Stop? commands transmitted to the LIMS. Full data review if data is stored in vendor supplied computer PC database. Ability to process the sample in case of a barcode misread. The contractor must provide the technical support (such as instrument and interface parameters) necessary to set-up and configure the API system to operate optimally to meet the stated throughput requirements. 3.1.15. The API must be equipped with a barcode reader, which can read 3 of 9 or code 128 barcodes. The API must read at a minimum a 10-character numeric barcode string placed on the SC lid and recipient test tube. The API must be able to read positioned barcodes on the SC lid with an error rate of less than 5 barcode read errors per 1,000 reads. In the event of a sample barcode read error, the system must alarm to alert the operator and continue to process all samples including the sample with the barcode read error. The data printout shall identify the sample barcode read error, position location and rack identity of the sample cup and companion test tube. The system should send an error message to the LIMS if there is a barcode read error. The system should have an option to halt operations, notify the operator of the problem and allow the operator to intervene to correct the error. 3.1.16. The API system must be safely operable without the operator contact with contaminated or hazardous materials. 3.1.17. The API system must have automated start-up and maintenance procedures without an operator having to return to the API to input individual instructions/commands. 3.1.18. 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. 3.1.19. 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. 3.1.20. The contractor must meet ISO 9000 certification and quality standards for the manufacture and distribution of the API equipment. 3.1.21. 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. TECHNICAL AND PRICE FACTORS. Capital Vial must provide the following the following for technical compliance and acceptability: (1) Documentation stating compliance or non-compliance with all sections of the SOW. Any non-compliance must be supported as to why. (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 CV-1000 systems sold commercially (minimum of 3 different locations) within the past 5 year period as follows: Name, address, POC and telephone number of the organization; contract or purchase order number and dollar value; date of contract and purchase order. Pricing. Capital Vial must submit unit pricing for each system. To support the offered system price, Capital Vial needs to provide copies 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. 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. Capital Vial 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 to this announcement: 52.212-1, Instructions to Offerors-Commercial Items apply with the exception of (d), (e), (f), (h) and (i), which are "Reserved"; 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. 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, 52.225-16, 52.232.33, and 52.233-3. Capital Vial's offer is due at Naval Medical Logistics Command by 1:00 PM on or before July 31, 2002. Point of contact is Ralph Payne, 301-619-3026 or email repayne@nmlc.med.navy.mil.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/USN/BUMED/N62645/N62645-02-R-0013/listing.html)
- Record
- SN00127957-F 20020731/020729221211 (fbodaily.com)
- Source
-
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