SOLICITATION NOTICE
65 -- 6-Acetylmorphine Assay
- Notice Date
- 3/15/2004
- Notice Type
- Solicitation Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- 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
- N6264504R0010
- Response Due
- 3/26/2004
- Archive Date
- 4/10/2004
- Point of Contact
- Ralph Payne, Contracting Officer, Phone 301-619-3026, Fax 301-619-2925,
- E-Mail Address
-
repayne@nmlc.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 N62645-04-R-0010. Provisions and clauses in effect through Federal Acquisition Circular 2001-20 are incorporated. NAICS 325413/SIC 2835. The Navy intends to negotiate with Microgenics Corporation, Freman, CA as the only source that can provide the immunoassay reagent for 6-Acetylmorphine for use in the DoD Military Drug Testing Laboratories. The resulting contract will be a requirements type contract with a base year and five option years. The estimated number of tests per year is 1.0 million. SOW. 1. GENERAL REQUIREMENTS FOR IMMUNOASSAY TEST REAGENT FOR 6-ACETYLMORPHINE. 1.1. The materials shall be for the specific immunoassay detection of 6-acetylmorphine (6-AM) in urine. The reagent must be compatible for use with the Hitachi Modular (D and P modules) automated drug screening equipment, and must be applicable without modification of the equipment. The reagent must be compatible with the optimal throughput of the instrument being used to perform the assay in the military laboratory. 1.2. Sensitivity and Specificity. The sensitivity of the reagent must be such that it will accurately detect the presence of 6-AM when present at a concentration of 10 ng/mL in no less than 85% of cases, yet have a specificity such that the number of samples identified as presumptive positive do not adversely impact the GC/MS confirmation section in the number of samples requiring confirmation (GC/MS) analysis as determined by the DoD Drug Testing Laboratories. The DoD for the initial immunoassay and GC/MS confirmation tests currently uses the following drug cutoffs in urine specimens. The reagent must not interfere with the other drugs of abuse testing listed below: Drug/Metabolite; Cutoff in ng/mL, Initial test, GC/MS. 11 Nor delta 9 THC carboxylic acid (THCCOOH), 50, 15; Cocaine (Benzoylecgonine), 150, 100; Opiates (Morphine), 2000, morphine 4000, codeine 2000, 6-AM 10; Phencyclidine (PCP), 25, 25; Amphetamine/Methamphetamine (amphetamines), 500, 500; Designer Amphetamines MDA/MDMA/MDEA, 500, 500; Barbiturates (secobarbital), 200, 200; Lysergic acid diethylamide (LSD), 0.5, 0.2; 2-oxo, 3-hyroxy-LSD, 0.5, 1.0. 1.3. Compliance with Food & Drug Administration (FDA) Requirements. 1.3.1. Immunoassay kits are medical devices and must have clearance from the Food and Drug Administration (FDA) to be marketed. The registration and listing process specified by the FDA must be followed and the manufacturer must adhere to good manufacturing processes (GMP), such as ISO 9000, in the manufacture of the devices. Any mandatory recalls of the kits provided under this contract and any other problems that require notification to the FDA must be resolved as required by the FDA regulations current at the time. The contractor shall notify the contracting officer of any recall or FDA notification within two working days of the event. 1.3.2. Except as provided herein, the reagents supplied throughout the term of this contract shall be identical to the reagents offered by the contractor and accepted by the Government at the time of the contract award. If, during the course of this contract, the manufacturer wishes to change or improve its kit, that product modification must be proposed in writing to the Contracting Officer for approval prior to its incorporation into the kits to be delivered. The contractor's proposal must include documentation that demonstrates the manufacturer has complied with all applicable FDA regulations, including those concerning the filing of a new 510k notice if such action and subsequent FDA clearance are warranted by the nature of the modification. 1.4. The materials provided must be in volumes and packaging that are convenient and applicable to the throughput of the military laboratories and should not result in the loss or unnecessary disposal of significant volumes of reagent. The contractor will not be required to provide calibrators and control materials for the drug reagents. The military laboratories will separately obtain or provide calibrators and control materials to be used with the reagents. The materials must be provided with an instruction sheet that complies with all requirements of the FDA and includes data demonstrating specific performance characteristics, such as, accuracy, precision, sensitivity, specificity, cross reactivity, and safety precautions. The instruction sheet(s) shall include procedures optimized for military drug testing laboratory operations as represented in these specifications and cutoffs as utilized by the DoD. The Government will not develop procedures or optimize the performance of a kit for the contractor. 1.5. Shelf life. Minimum refrigerated shelf life of any unopened component of the assay shall be at least 180 days from date of delivery at the drug-testing laboratory. Once kit container seals are broken and the component opened, the refrigerated shelf life must be at least 14 days. Once diluted the material must have an operation stability of 24 hours on the instrument. 2. TESTING AND QUALITY CONTROL PROTOCOL. The following testing and quality control protocol will be used for all military testing. The reagents supplied must be adaptable to the calibration requirements and characteristics of the Hitachi Modular (D and P modules) high speed automated analyzer. Verification of each calibration will be accomplished with a drug free control, a control at 7.5 ng/ml, a control at 12.5 ng/ml, and a control at 20.0 ng/ml. An acceptable verification will have analytical readings for the drug free <7.5ng/ml <10.0 ng/ml cutoff calibrator <12.5 ng/ml <20.0 ng/ml controls. Open and blind quality control urine will be distributed throughout a test batch and will make up about 5% of the number of total specimens. The reagent must meet the performance criteria outlined in 3. below using this testing protocol. 3. CHARACTERISTICS OF 6-ACETYL MORPHINE REAGENT. 3.1. The reagent shall identify specimens containing 6-AM at concentrations equal to or greater than the 10 ng/ml screen cutoff for 6-AM. The reagent used in the initial assay screen shall correctly identify 95% of the positive and negative control specimens when present at 12.5 ng/mL and 7.5 ng/ml respectively of 6-AM. The sensitivity of the reagent must be such that it will accurately detect the presence of 6-AM when present at a concentration of 10 ng/mL in no less than 85% of cases, yet have a specificity such that the number of samples identified as presumptive positive do not adversely impact the confirmation (GC/MS) section in the number of samples requiring GC/MS analysis as determined by the DoD Drug Testing Laboratories. 3.2. The reagent used in the assay of 4 specimen batches containing 20 sequential aliquots at each of the following concentrations per batch (7.5 ng/ml, 10 ng/ml, 12.5ng/ml, and 20.0 ng/ml) must have a percent coefficient of variation of the mean concentration value (%CV) of less than 10%. 3.3. The coefficient of variation for calibrators and respective controls at the concentrations listed in paragraph 3.2, when distributed throughout a normal laboratory-testing batch, must be less than 10%. A laboratory batch consists of approximately 100 specimens and controls. Throughout the batch there must not be significant drift in control values. 3.4. A minimum of 95 percent of the open 7.5-ng/ml quality control samples must produce negative results in each analytical run and as calculated on a weekly basis. 3.5. A minimum of 95 percent of the open 12.5 ng/ml quality control samples must be identified as positive in each analytical run and as calculated on a weekly basis. 3.6. The 6-AM assay reagent shall be checked for cross reactivity to commonly encountered pharmaceuticals or metabolites that may be found in normal urine specimens that might be expected to produce a positive response. 3.7. The 6-AM assay reagent shall be checked for cross-reactivity to each drug/metabolite listed in 1.2. The vendor must provide information regarding the extent or concentration of drug at which their reagent will cause a positive screening result. 4. MANUFACTURER’S QUALITY ASSURANCE PRODUCTION PROCESSES. 4.1. Adherence to Good Laboratory and Manufacturing Practices, such as ISO-9000 certification, must be documented. 4.1.1. Quality and authenticity. All materials used in the preparation of reagents should be verified as to authenticity and purity. 4.1.2. Stability. The kit and each kit component must be shown to be stable and at the correct concentration over the period of use of the kit. Components, which are homogeneous solutions, must not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration). 4.1.3. Antibody specificity/cross reactivity. Antibody specificity must be verified for each lot of reagent and provide equivalent sensitivity and specificity to the detection of 6-AM. 4.1.4. Lot numbers. Lot numbers must be used to identify reagents and other preparations to allow tracking of all immunoassay components. Lot numbers should be bar-coded and/or should be compatible for use with the Hitachi Modular (D and P modules) Analyzer System. The procedures used to assign unique lot numbers for each solution or reagent must be clearly recognizable. A single lot number for a kit will suffice if all materials used in that lot number can be tracked to identify the materials and procedures used in the preparation of that kit. 4.1.5. Corrective action. When a specified production lot that has been shipped for distribution or is in use is found to be out of control limits as stated above, the action taken to ensure correction for existing kits (i.e., notification) must be documented and action taken to ensure that the deficiency does not reoccur and all records must be retained. The Contracting Officer must be notified within 2 working days of any deficiencies in existing kits and of all corrective actions. The FDA must be notified according to its regulations. 5. FIRST ARTICLE TEST REQUIREMENTS. 5.1. Reagent for testing up to 5,000 specimens shall be required for the first article testing and approval. Testing of reagent will be performed on a pass/fail basis. To obtain approval, the first article test shall meet the specifications, inclusive of acceptable performance levels, set forth in 1. through 3. above and the manufacturers must meet requirements described in 4. above. 5.2. The reagent kits provided for First Article Testing shall contain a complete set of manufacturer's procedural instructions for use and calibration of the reagent on the Hitachi Modular (D and P modules) Analyzer System. 5.3. The testing and evaluation of the kits will be performed by Government personnel at one of the Drug Screening Laboratories specified by the Government. 5.4. The contractor will be authorized two observers present at the initiation of first article laboratory testing. Following laboratory testing, the observers will depart the laboratory and technical evaluation personnel will analyze and summarize data. Within 30 calendar days of completion of first article testing, the company will be notified of the results of the testing. The technical evaluation panel will be established by the Government and will be present during first article testing. 5.5. The objective of the First Article Testing is to provide assurance of the qualitative and quantitative performance of the reagent offered in meeting the specification for the detection of 6-AM. The provisions at far 52.212-1, Instructions to Offerors-Commercial Items apply with the exception of (d), (f), (h) and (i), which are reserved. FAR 52.212-2, Evaluation-Commercial Items is not applicable. The offeror Representations and Certifications-Commercial Items at FAR 52.212-3 and the provision at DFARS 252.212-7000, Offerors Representations and Certifications-Commercial Items apply and must be submitted with the offeror’s business proposal. The Contract Terms and Conditions-Commercial Items at FAR 52.212-4 apply. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Order-Commercial Item (xxx2001)(deviation) applies. With respect to FAR 52.212-5, the following clauses 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. The following clauses cited in DFARS 252.212-7001 apply: 252.205-7000, 252.225-7012, 252.243-7002, 252.247-7023 and 7024. DFARS 252.204-7000, required Central Contractor Registration applies. Addendum clauses that apply are 52.216-18, Ordering; 52.216-19, Order Limitations; 52.216-21, Requirements; and 52.209-4, First Article Approval -- Government Testing. The following proposal instructions and evaluation factors will be used. The technical acceptance is more important than price. 1. The business proposal must be submitted in an original and one (1) copy and must include the following: 1a. Proposed price must be provided on a per test basis. 1b. State the total number of tests per kit. The number of tests shall be based on the reagent volume recommended by the equipment manufacturer. 1c. Order and delivery schedule. 1d. Published commercial price list, or other documentation setting forth the prices charged to the general public. 2. Evaluation. The above requested information will be evaluated for completeness and a determination that the proposed price is fair and reasonable. Also, an evaluation of all submitted FAR and DFARS requirements will be conducted for completeness and adherence. 3. The technical proposal must be submitted in an original and two (2) copies and must include the following: 3a. Documentation of FDA clearance to market the 6-AM reagent. 3b. ISO-9000 certification or equivalent. 3c. Package insert containing complete, accurate and verifiable information regarding: (1) Explanation and principles of the testing procedure. (2) Description of each reagent composition. (3) Instructions for reagent handling, mixing, and storage. (4) Reagent stability and storage requirement unopened and as an open working reagent. (5) Calibration setting for use on the Hitachi Modules (D & P) Analyzers. (6) Performance characteristics anticipated in terms of accuracy, precision, and sensitivity to the principal analyte(s). (7) Table of cross reactivity and specificity to 6-AM and codeine and morphine metabolites as well as other over-the-counter medications, or similar isomeric analogue compounds (hydrocodone, hydromorphone, oxycodone, oxymorphone) and other principal drugs of abuse namely THC, Barbiturates, Amphetamine, Methamphetamine, PCP, LSD, etcetera. (8) Health precautions and safety warning or environmental handling procedures associated with use of the reagent kit components. 4. Technical Evaluation. The above requested information will be reviewed for technical acceptability. 5. Past Performance. The contractor is not required to submit any past performance information. The contractor's past performance will be based on the contracting officer's knowledge of their performance on past and present like reagent contracts. Offeror's proposal is due at Naval Medical Logistics Command, 1681 Nelson Street, Code 02/Ralph Payne, Fort Detrick, MD 21702 by 1:00 pm on or before March 26, 2004. Point of contact is Ralph Payne, 301-619-3026 or email repayne@nmlc.med.navy.mil.
- Web Link
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Link to FedBizOpps document.
(http://www.eps.gov/spg/DON/BUMED/N62645/N6264504R0010/listing.html)
- Record
- SN00545204-F 20040317/040315223423 (fbodaily.com)
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