SOLICITATION NOTICE
65 -- Phencyclidine (PCP) Reagent
- Notice Date
- 11/22/2002
- 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
- N62645-03-R-0002
- Response Due
- 12/20/2002
- Archive Date
- 1/4/2003
- 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 N62645-03-R-0002. Provisions and clauses in effect through Federal Acquisition Circular 2001-09 are incorporated. NAICS 325413/SIC 2835. Naval Medical Logistics Command has the following requirement for immunoassay reagent for Phencyclidine (PCP) for use in the DoD Military Drug Testing Laboratories. The resulting contract will be a requirements type contract with a base year (CLIN 0001) and four option years (CLINS 0002-0005). The estimated number of tests per year is 1.6 million. SOW. 1. GENERAL REQUIREMENTS FOR IMMUNOASSAY TEST REAGENT FOR PHENCYCLIDINE. 1.1. The materials shall be for the immunoassay of phencyclidine (PCP) in urine and are to provide immunological reagent for initial (screen) testing. The reagent must be compatible for use with the Roche (Modular "D" and "P") and Olympus AU800 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 testing reagent must detect 95% of all specimens containing the screening metabolites at concentrations equal to or greater than 125% of the cutoff concentration of the initial test. The testing reagent must be specific for the initial test cutoff metabolite such that no less than 85% of the specimens identified as positive will confirm positive for the metabolite by GC/MS at the GC/MS confirmation cutoff. The following drug cutoffs in urine specimens are currently used by the DoD for the initial immunoassay and GC/MS confirmation tests. The reagent provided shall meet sensitivity and specificity requirements at the following cutoffs (in ng/mL). 11?Nor?delta?9?THC?carboxylic acid (THCCOOH) 50, 15; Cocaine (Benzoylecgonine) 150, 100; Opiates (Morphine) 2000, Morphine 4000; Codeine 2000; Phencyclidine (PCP) 25, 25; Amphetamine/Methamphetamine (amphetamines) 500, 500; Barbiturates (secobarbital) 200, 200; Lysergic acid diethylamide (LSD) 0.5, 0.2. 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) 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 that 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 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 shelf life must be at least 14 days. Once diluted the material must have a shelf life of 24 hours. 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 Roche (Modular "D" and "P") and Olympus AU800 high-speed automated analyzer. Verification of each calibration will be accomplished with a drug free control, a control at 75% of cutoff concentration, a control at 125% of cutoff concentration and a control at 200% of cutoff concentration. An acceptable verification will have analytical readings for the drug free < 75% < cutoff < 125% < 200% controls. Open and blind quality control urine will be distributed throughout a test batch and will make up about 10% of the number of total specimens. The reagent must meet the performance criteria outlined in C.3 using this testing protocol. 3. CHARACTERISTICS OF REAGENTS. 3.1. PCP. The reagent shall identify specimens containing PCP. The assay shall identify as positive by the initial test 95% of the specimens that contain 31 ng/mL or more of PCP. No less than 85% of the presumptive positives shall be confirmed positive by GC/MS at the 25-ng/mL-confirmation cutoff for PCP. The initial test cutoff concentration is 25 ng/mL of PCP. 3.2. An assay of 20 sequential aliquots of each of the following samples using the reagent must have a coefficient of variation of the mean concentration value of less than 7.5%: cutoff calibrator, control urine with concentration at 75% of cutoff and control urine with concentration at 125% of cutoff. The coefficient of variation for calibrators and controls at these concentrations distributed throughout a testing batch must also be less than 10%. A batch will consist of the samples tested between verifications of calibration. Throughout the batch there must not be significant drift in control values. 3.3. The contractor must provide 250 ml of drug free (for amphetamines, LSD, THCCOOH, Benzoylecgonine, Cocaine, Barbiturates, PCP, and Opiates, and must also contain less than 20 ng/mL of benzodiazepines) urine with each reagent kit order (equivalent to 2,000 tests/reagent kit). The drug free urine provided with the reagent must have a GC/MS drug concentration less than the limit of quantitation for the analyte methodologies. In addition, immunoassay of the drug free urine should have semi-quantitative concentration readings equivalent to or less than those recorded for drug controls at 20% of the DoD immunoassay cutoff concentrations. The negative urine should not be sent automatically. If a laboratory request negative urine, it may be shipped with the monthly reagent delivery and supplied in 1-liter volume containers. The military laboratories cannot redeem or exchange unused allocations of negative urine accrued by reagent purchase for additional reagents or other supplies from the vendor. 3.4. A minimum of 95 percent of the open low concentration quality control samples (75 percent of the 25 ng/mL PCP cutoff) 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 positive quality control samples (125 percent of the 25 ng/mL PCP cutoff) must be identified as positive in each analytical run and as calculated on a weekly basis. 3.6. An assay of 20 sequential controls containing drug at 200% of the cutoff concentration must have a coefficient of variation of the mean concentration reading less than 7.5%. 3.7. PCP. Each immunological reagent shall be checked for cross?reactivity to drugs, chemicals, or metabolites that might be expected to produce a positive response. Drugs required to be tested for cross-reactivity include but are not limited to dextromethorphan. 3.8. The immunological reagent shall be checked for cross-reactivity to each drug/metabolite listed in C.1.2. With the exception of the cross reactivity between amphetamine and methamphetamine, the reagent must not give a positive assay result for any of the drug/metabolites listed from any of the other six drug classes when they are in concentrations greater than 1 mg/mL or the solubility limit of the drug in urine, whichever is less. 4. The Quality Assurance Program of the Manufacturing Process Must Include the Following Elements. 4.1. Chemicals and Reagents. 4.1.1. Quality and authenticity. All materials used in the preparation of reagents should be verified as to authenticity and purity. Methods may include, but are not limited to, the determination of melting points, and GC/MS, Nuclear Magnetic Resonance (NMR), and spectrophotometric measurements. 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). 4.2. Manufacturers Equipment. 4.2.1. Preventative maintenance. Routine preventative maintenance procedures, periodic calibration, and any unscheduled maintenance must be fully documented and in accord with recommendations of the manufacturer of the equipment. 4.2.2. Calibration and operational checks. All instruments that are used to check a physical parameter of a solution or material must be calibrated and have documentation available to demonstrate that all required operational checks have been completed. This includes gamma counters, pH meters, spectrometers, micropipettes, etc. 4.2.3. Temperature checks. Water baths, refrigerators, freezers, and other equipment, which maintain a given temperature, must be periodically validated for accuracy and routinely verified for correct settings. 4.2.4. Glassware and other reusable laboratory supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials must be established and compliance documented. 4.3. Labeled Drug Molecule. 4.3.1. Authenticity. The prepared (labeled) drug molecule must be verified to be authentic and its purity established. 4.3.2. Stability. The labeled drug must be documented to be stable to the expiration date and the immunoassay must meet all contract specifications to the end of expiration date (which is 180 days minimum). 4.4. Antibody specificity/cross reactivity. Antibody specificity must be verified for each lot and the specificity reevaluated at routine intervals to ensure uniformity and quality of preparations. The testing reagent must detect 95% of all specimens containing the screening metabolites at concentrations equal to or greater than 125% of the cutoff concentration of the initial test. The testing reagent must be specific for the initial test cutoff metabolite such that no less than 85% of the specimens identified as positive will confirm positive for the metabolite by GC/MS at the GC/MS confirmation cutoff cited in C.1.2. Chemical compounds that may reasonably cross react with the antibody must be tested to characterize antibody specificity. These will include biochemical materials produced normally in the human body (this may be evaluated by testing numbers of specimens of normal human urine). 4.5. Immunoassays. 4.5.1. Technical performance. Performance of each lot of kits must be verified. The verification must establish, as a minimum, the appropriate response to the target molecule and that all other parameters as specified in the contract are met. 4.5.2. Stability. The performance parameters involved in the testing procedures must be verified and documented to be consistent throughout the shelf life of the kit. 4.5.3. Manufacturer's production manual. Procedures and criteria required to validate all components (and materials) employed during the manufacture of the reagents in the test kits and the operation of the completed kit over the entire period of shelf-life of the kit must be described in detail. All steps of each quality control procedure shall be described thoroughly. 4.5.4. Records. The production and quality assurance records generated by each procedure performed above must be maintained in a systematic fashion to permit the verification of completion of all production parameters and shall be available for inspection during the term of the contract. 4.5.5. Corrective action. When a specified quality control parameter is found to be out of control limits, 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. 4.5.6. Lot numbers. Lot numbers must be used to identify reagents and other preparations to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent must be described. 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. 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 following proposal instructions and evaluation factors will be used. 1. Instructions for preparation of proposals. 1a. Business proposals must be submitted in an original and one (1) copy and must include the following: 1a(1). Proposed prices will be provided on a per test basis. 1a(2). Offeror shall state the total number of tests per kit proposed. The number of tests shall be based on the reagent volume recommended by the equipment manufacturer. 1a(3). Offeror shall provide an order and delivery schedule. 1b. Technical proposal must be submitted in an original and one (1) copy. Offeror will provide the information specified in technical evaluation factors a and b below. 2. Evaluation factors. Listed below are the technical and price evaluation factors that will be used. The overall technical FACTORS (A-D) are substantially more important than price. 2a. Technical evaluation factors. 2a(1). FACTOR A - FDA certification. Certification of FDA approval for the proposed PCP reagent. Documentation of FDA license for use shall be provided with the offerors' proposal. 2a(2). FACTOR B - Quality Assurance program. 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 roche chemical analyzer systems (DDP). (6) Calibration frequency for use on the roche chemical analyzer systems (DDP), to maintain calibration and control performance. (7) Performance characteristics anticipated in terms of accuracy, precision, and sensitivity to the principal analyte(s). (8) Table of cross reactivity and specificity to PCP as compared to common over-the-counter medications, or similar isomeric analogue compounds, and other principal drugs of abuse namely LSD, l-methamphetamine, THC, Barbiturates, Cocaine, Benzoecognine, Opiates, Amphetamine. FACTOR C - Performance Evaluation Test. The government will conduct an evaluation test of offeror's reagent at the Navy Drug Screening Laboratory, Building h2033, Jacksonville, FL 23312. The test will validate that the offeror's reagent meets the statement of work. The test will be conducted in accordance with the established protocol that is posted on the NMLC home page at http://www-nmlc.med.navy.mil, click on acquisition management directorate, contractor information, protocol for PCP testing. The offeror will ship enough reagent to test 30,000 samples, at no cost to the government, to the Jacksonville laboratory no later than the closing date of this announcement. FACTOR D - Past Performance. The contractor's past performance will be based on the contracting officer's knowledge of the contractor's performance on past and present like reagent contracts. Past performance is less important than evaluation FACTORS A-C. 2b. Price Evaluation. Price proposals will be evaluated with consideration to the following: the offeror has submitted the price per test, total number of tests per kit, order and delivery schedule, completed all required representations and certifications, and acknowledgement to any amendments. Additionally, to support the offered price, offerors must include copies of published commercial price list, or other documentation setting forth the prices charged to the general public. Contract award will be based on the best value to the government. 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. Offeror's proposals are due at Naval Medical Logistics Command, 1681 Nelson Street, Code 02/Ralph Payne, Fort Detrick, MD 21702 and their reagent at the Jacksonville laboratory by 1:00 pm on or before December 20, 2002. Point of contact is Ralph Payne, 301-619-3026 or email repayne@us.med.navy.mil.
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