SPECIAL NOTICE
66 -- Automated Pipetting Instrument and Specimen Collection Containers
- Notice Date
- 12/2/2003
- Notice Type
- Special 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
- N62645-04-T-0003
- Response Due
- 2/6/2004
- Archive Date
- 2/21/2004
- Point of Contact
- Susan Wellen, Contracting Officer, Phone 301-619-3022, Fax 301-619-2925,
- E-Mail Address
-
sdwellen@nmlc.med.navy.mil
- Description
- THIS SPECIAL NOTICE IS BEING PRESENTED AS AN "INFORMATION SOUGHT". NO PROPOSAL IS BEING SOUGHT AT THIS TIME. FOLLOWING ARE THE BASIC REQUIREMENTS FOR THE INSTRUMENT AND CONTAINERS. 1. REQUIREMENTS FOR AUTOMATED PIPETTING INSTRUMENT (API) AND SPECIMEN COLLECTION CONTAINER (SCC) FOR USE IN THE MILITARY DRUG TESTING LABORATORIES UNDER THE DOD DRUG DETERRENCE PROGRAM. 1.1. Basic Concept. The military drug testing laboratories have an interest in procuring an automated pipetting instrument (API) and compatible urine specimen collection container (SCC) to automate the manual urine specimen pouring procedure currently in use within the six military drug testing laboratories. SCC's received in the laboratory shall be opened, organized, labeled if needed, placed into the API for aliquoting to receiver test tubes that are located in Hitachi racks, finally the Hitachi racks are loaded into Hitachi trays for testing on the Hitachi analyzer. This system affects both the field collection processes and the laboratories sample handling and testing processes with the goal of enhancing the forensic quality and process efficiency of the drug testing program. To accomplish this goal the API shall offer a rugged instrument design that provides a high degree of forensic accuracy and assurance in operations to meet the stringent legal challenges of a military court martial. The API shall improve efficiency in the laboratory by replacing repetitive manual sample pouring operations and by interfacing the API and the Hitachi high-speed analyzer system. The SCC shall also offer ease of urine collection of both male and female military members and minimize the impact on environmental disposal and bulk storage on shipboard and field operations. The SCC shall also offer a high degree of forensic integrity in the collection, transportation, and aliquot process to meet the stringent legal challenges of a military court martial. 1.1.1. The API shall be used in the urinalysis specimen pouring and accessioning areas in the military drug laboratories. The API shall include all components (i.e. sample racks, carriages, holders, or inserts, and bar-code readers) necessary to perform the forensic transfer of urine aliquots from SCC's to receiver test tubes pursuant to drug testing. The SCC's shall be used in the field for sample collection, storage, and transport to the drug testing laboratories. The SCC kit shall include 12 specimen collection cups, a 12 well shipping container, and accompanying tamper evident tapes (as needed) to optimize sample handling in the field as well as provide optimal forensic integrity. 2. Description of the API. 2.1. The API shall be an automated sample processing system that eliminates manual specimen pouring while maintaining forensic integrity of the specimen. The API shall 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 the direct loading and unloading of sample batches from the API onto the Hitachi Modular Analyzer. The requirement for adapting the Hitachi 30 rack carrier tray and 5-well test tube rack is to minimize technician intervention in operation of the API associated with manual on-loading and off loading of each Hitachi test-tube rack on the API. The API shall 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 contamination of the pipette tip and ensure aliquot aspiration; have no evidence of cross-contamination during transfer and dispensing of the aliquot into the receiver test tube; and, be able to process batches of approximately 100-150 SCC specimens and 100-150 test tubes in a run. 3. Essential Characteristics of the API. 3.1. The API system shall require no more than 2 technicians 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. 3.2. The system shall include enough API processing accessory units (i.e. SCC racks, SCC 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. 3.3. DoD Instruction 1010.16 indicates that nothing shall enter the specimen container. While an API that maintains this characteristic is desirable, the cost and complexity involved in achieving the desired degree of automation may necessitate consideration of alternative procedures with forensic safeguards acceptable to the Military Legal Community. The Legal Community has favorably considered the use of disposable pipette tips between sample aliquots and other enhancements to ensure that no foreign material or cross contamination can occur during operation of the API. If a disposable pipette tip is used it must conform to these guidelines. The use of disposable pipette tips shall be of sufficient volume to transfer the desired volume in a single step. The pipette tip shall be automatically disposed of and changed with a new pipette tip in a safe and forensically acceptable manner between each sample. The pipette tip and fitting to the API shall be secure to ensure there is no splatter or leakage of sample during the operation of the API. Other processes will be considered if they adhere to DOD Instruction 1010.16. 3.4. The contractor shall provide an API that will be able to extract, in a forensically acceptable manner, approximately 1.0 ml aliquot of urine from the SCC. The minimum acceptable volume for transfer is 0.75 ml. 3.5. The API shall transfer approximate 1.0 ml urine aliquots from the SCC's to 16x100 mm glass receiver tubes that are in 5-well Hitachi 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 shall be adaptable to use the Hitachi 30-rack transfer tray for off loading the receiver 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. 3.6. If pipette tips are used they shall be commercially available disposable plastic pipette tips. 3.7. If a penetration port is used for entering the container, the port shall be able to withstand a minimum of two potential sampling entries through the port without the port leaking fluid if the SCC is tipped on its side or inverted for up to one week, or repeatedly frozen and thawed for up to 3 freeze/thaw cycles. If a penetration port is used, the API pipette system shall be constructed so the disposable pipette tip is able to penetrate any tamper evident/resistant seal placed across the penetration port (if required) and the port itself. 3.8. The API system is defined as all components necessary to hold and perform sample aliquoting of urine samples from sample containers to receiver test tubes. As specified in section 1.1.1, this includes, but is not limited to SCC racks, SCC carriages, SCC holders, inserts, and bar-code readers. 3.9. The contractor shall support the maintenance and service of the API system under an initial one-year full service warranty with response times within 1 hour telephonically and onsite service within 24 hours, except for the Hawaii drug laboratory which would require on-site service within 36 hours. The API system shall 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. Routine spare parts shall be available onsite at each laboratory to minimize potential downtime, and is especially required for the Hawaii facility. 3.10. 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. 3.11. The contractor shall 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. 3.12. The API system shall 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 specimen container and receiver test tubes in real time. 3.13. The API Security requirements shall include a minimum of 3 groups of access based on user types (USER, SUPERVISOR, SYSTEM ADMIN). The USER group will allow the operator access to all normal maintenance functions used to prepare the system for operation, access to normal processing operations, and access to maintenance functions needed for system shutdown. The SUPERVISORY group will include user level access as well as any non-routine functions such as instrument operating parameters. The SYSTEM ADMIN group will allow the operator access to user and supervisor functions as well as administrative procedures such as software updates and menu access level controls. The SYSTEM ADMIN group will allow the modification of menu access for each of the user types. For instance, a monthly maintenance function might be added to the user type allowing users access to that screen. Software and access to key data files shall have password and security level protection. Data files should be protected only allowing access through the API application. The software shall allow the operator to log out of the system without stopping operations. This permits accurate tracking of audit events as the API may have multiple individuals responsible for API operations during the operations. 3.14. The API-PC system must use current government approved operating system to run on the network (MS Windows 2000, MS Windows XP Professional). The API-PC system and software must allow appropriate security patches and operating system service packs to be applied without adversely affecting API operations. 3.15. The security features of the API-PC system shall include an audit trail capable of recording operator identity; date and time of operator access; date, time, operator ID, and any edits made to the instrument configurations or to batch ID, specimen ID. The audit trail information shall be capable of being printed in a report format from the PC. The contractor shall 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. 3.16. The API shall be equipped with barcode readers, which can read 3 of 9 andcode 128 barcodes. The API shall read at a minimum a 10-character numeric barcode string placed on the SCC and receiver test tube. The API shall be able to read positioned barcodes on the SCC 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 shall 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 shall send an error message to the PC or if interfaced, to the LIMS when there is a barcode read error. 3.17. The API shall 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 (LAN, SCC rack identifier numbers, aliquot rack identifier number, sample position number in aliquot rack) is stored on a PC for possible transfer to the Laboratory Information Management System (LIMS) after completion of a batch run. Errors will 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 shall be able to print on demand a batch report indicating agreement between LANs on the SCC and specimen receiving tube. Error codes shall be indicated on any report to explain discrepancies. 3.18. The API system shall be safely operable without the operator in direct contact with contaminated or hazardous materials. 3.19. To ensure no cross contamination during operation of the API, any robotic arms or dispensing station movement shall not cross other SCC or receiver tubes in the course of sample delivery or disposal of used pipette tips. 3.20. The API system shall be configured to facilitate on-site repair by a laboratory technician to as great extent as practicable and permit reconfiguration of the API to accept system upgrades to improve automation efficiencies within the DoD Laboratories. 3.21. The API system shall 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. 3.22. The contractor shall 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 shall 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. 3.23. The contractor shall 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 shall be provided for one year from the date of system delivery. 3.24. The contractor shall 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, and install the API system and demonstrate performance of the system in accordance with Section C (Statement of Work), prior to government acceptance of the system. The contractor shall provide all cables needed to interface the system to a PC and/or host 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. 3.25. The API system shall be supportable (i.e. repair parts, maintenance, etc) for a minimum of 5 years from the date of delivery. 3.26. The contractor shall have and maintain a Quality Assurance Process. The Government considers ISO 9000 certification to be an enhancement factor. 4. Description of the Specimen Collection Container (SCC) and Collection Kit 4.1. To facilitate collection, the SCC should have a wide mouth with a maximum diameter of approximately 2 inches with a volume of a minimum of 40.0 ml and a maximum of 110.0 mls. The SCC that offers ease of urine collection forboth male and female military members while maintaining the forensic integrity of the system will be consider preferable to the Government. The volume is dictated in part by the diameter of the container, having sufficient depth to prevent splatter during collection, while not of such large volume as to be cumbersome to laboratory processing and storage. The wide mouth container shall be of sufficient volume: (1) to minimize or eliminate, the need for a separate collection vessel from which urine is manually poured into the SCC for shipment to a military drug testing laboratory and (2) to provide user convenience in urine collection before the need for possible urine flow diversion to a urinal or toilet is required. The desire for laboratory automation shall not impose inconvenience upon the collection unit. The specimen container shall be secured by a tamper evident or tamper resistant tape or some other mechanism to identify possible tampering. The SCC shall be adaptive to the operation of the API and shall consider the requirements of DoD Instruction 1010.16 and Section 1.1 above. 4.2. The collection kit shall consist of 12 SCC, 12 well shipping container, and accompanying tamper evident tapes (as needed). The 12 well cardboard shipping container must meet U.S. Postal and International Air Transport Association (IATA) standards for transport of biological fluids. 4.3. As noted in section 1.1. above, the government requires that only one SCC be opened at a time or a suitable alternative to the opening of the SCC be devised. One alternative method may be the use of a penetration port without the requirement to open the lid of the SCC and does not leave a permanent hole from which the specimen may leak or through which foreign material may enter the SCC. Other processes will be considered if they adhere to DOD Instruction 1010.16. 4.4. If a penetration port is used for entering the container, the port shall be able to withstand a minimum of two sampling entries through the port without the port leaking fluid if the SCC is tipped on its side or inverted for up to one week, or repeatedly frozen and thawed for up to 3 freeze/thaw cycles. 4.5. The contractor shall be capable of providing the required number of SCC's for approximately 120 thousand specimen collections during the first contract year and to provide an appropriate number of SCC's for approximately 4.5 million specimen collections to support the DoD military drug testing program in subsequent years. 4.6. 12 well shipping containers will be available as an option and independent line item in the contract. If special tamper evident tape is required for proper SCC closure it will also be available as an option and an independent line item in the contract. 5. Essential Characteristics of the SCC and shipping box. 5.1. The SCC shall: 5.1.1. Consist of a wide mouth container not to exceed 2 and 1/2 inches in diameter including the container cover. The opening to the SCC should be maximized for ease of sample collection. 5.1.2. Be part of a SCC kit and shall not require or shall minimize the requirement for an ancillary specimen collection container to facilitate specimen collection from male and female military personnel. 5.1.3. Have a total volume capacity between 40 and 110 ml. 5.1.4. Fit within a 12 well shipping box the dimensions of which shall approximate the current shipping box used in the military drug testing program but not exceed 7.5? x 10? x 3.5?. 5.1.5. Have a cap closure that will not leak in refrigerator or freezer storage or during routine air courier transport. 5.1.6. Be compatible for use on the contractor provided automated pipetting device and carrier racks. 5.1.7. Have sufficient space on the body of the SCC for a 2 in X 4 in bar-coded label containing SSN information and specimen ID information, and sufficient space on the lid or body of the SCC for the application of a bar-coded laboratory accessioning number (LAN) label such that the LAN can be read by the API bar-code reader. 5.1.8. Consist of a material that will withstand freezer temperatures down to ?20 C and transport temperatures as high as 120 F as may be encountered in hot weather delivery transit. 5.1.9. Consist of a material that does not bind, or minimizes the adhesion of the tetrahydrocannabinol acid (THC-COOH) molecules to the container. 5.1.10. Consist of a material clear enough to see the liquid volume. 5.1.11. Consist of a material and plasticizer that does not leach into the urine to interfere with gas chromatography/mass spectrometry (GC/MS) or immunoassays (IA) analysis for drugs of abuse. 5.1.12. Meet International Air Transport Association (IATA) standards for shipment of biological specimens. 5.1.13. Withstand cracking or breaking if dropped onto a concrete or tiled floor from a height of approximately three feet. 5.1.14. If a specialized port or cap is used the vendor must provide a system to easily determine if the port has been tampered with. Any new tamper evident system must meet be approved by the government. If tamper evident tape is used it will be provided as part of the SCC kit. 5.2. The shipping box shall: 5.2.1. Meet International Air Transport Association (IATA) standards for shipment of biological specimens. 5.2.2. Use the same closure style as the current shipping box. If an alternative is offered the government shall evaluate for ease of use and forensic quality in the field and at the laboratory and retains the right to require the contractor provide the current shipping closure style. Technical Evaluation Factors. The SCC enhancing factors are significantly more important than the API enhancing factors. The combined technical factors are significantly more important than price. 1. API Enhancing Factors (a) A formal QA process such as ISO 9000 certification. (b) Ability to change the barcode location and format. (c) Ability to interface the API with LIMS. (d) Ability for real time interface between API and LIMS. 2. SCC Enhancing Factors (a) To facilitate gender collection of urine, the larger the diameter of the SCC with the highest volume with the least storage requirement. (b) To Minimize the need for a separate collection vessel from which urine is manually poured into the SCC for shipment to a military drug testing laboratory. A Pre-solicitation conference will be held at Naval Medical Logistics Command at 9:00 AM on 21 January 2004. All interested companies are encouraged to attend. Notification of intent to attend must be emailed to sdwellen@nmlc.med.navy.mil no later than COB 16 January 2004. Company representatives are limited to no more than two. Questions for discussion at the conference must be submitted to the above email address no later than COB 7 January 2004. All correspondence regarding this requirement must be done in writing. No phone calls please.
- Place of Performance
- Address: Department of Defense, Military Drug Testing Laboratories
- Record
- SN00479782-W 20031204/031202212309 (fbodaily.com)
- Source
-
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