| 65 -- Phencyclidine (PCP) Immunoassay Reagent |
| Program Summary |
 |
| Title: |
65 -- Phencyclidine (PCP) Immunoassay Reagent |
| GovCB Opps ID : |
ADP12066377490001109 |
| Document Type: |
Combine Solicitation |
| FSC Code: |
65 - Medical, Dental, and Veterinary Equipment and Supplies
|
| NAICS Code: |
325413 - In-Vitro Diagnostic Substance Manufacturing |
| SIC Code: |
2835 - Diagnostic substances |
| Solicitation No.: |
N62645-08-R-0011 |
| Source: |
http://www1.fbo.gov/spg/DON/BUMED/N62645/N62645%2D08%2DR%2D0011/Combine%20Synopsis%5FSol... |
Place of
Performance: |
Address: 1681 Nelson St Frederick, MD 21701 Postal Code: 21701 Country: UNITED STATES
|
Posted Date:
|
Mar 26, 2008 |
| Last Update: |
Mar 26, 2008 |
| Due Date: |
Apr 30, 2008 |
|
| Description |
|
General Information
| Document Type: |
Combine Solicitation |
| Solicitation Number: |
N62645-08-R-0011 |
| Posted Date: |
Mar 26, 2008 |
| Original Response Date: |
Apr 30, 2008 |
| Current Response Date: |
Apr 30, 2008 |
| Original Archive Date: |
May 15, 2008 |
| Current Archive Date: |
May 15, 2008 |
| Classification Code: |
65 -- Medical, dental & veterinary equipment & supplies |
| Naics Code: |
325413 -- In-Vitro Diagnostic Substance Manufacturing |
Contracting Office Address
Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, MD, 21702-9203, UNITED STATES
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 N62645-08-R-0011. Provisions and clauses in effect through Federal Acquisition Circular 2005-24 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 location of the Drug Testing Laboratories are as follows: Great Lakes, IL; Jacksonville, FL; San Diego, CA;Brooks City-Base, TX; Fort Meade, MD 20755, Tripler AMC, HI; and Washington, DC.
The resulting contract will be a requirements type contract with a base year (CLIN 0001) and five option periods (CLINS 1001-5001) for a total of five years. The estimated number of tests per year is 1.5 million. The following is a partial Scope of Work. The full scope of work can be accessed at http://www.nmlc.med.navy.mil and then selecting Public Access/Acquisitions/ Services/RFP/N62645-08-R-0011.
GENERAL REQUIREMENTS FOR IMMUNOASSAY TEST REAGENT FOR PHENCYCLIDINE
The materials shall be for the immunoassay of phencyclidine in urine and are to provide immunologic reagent for initial (screen) testing. The reagent shall be compatible with the Roche Chemical Analyzer Modular Systems (DDD, DDP, DPP, DP/PP, P) and shall be applicable without modification of the equipment. The reagent shall be compatible with the optimal throughput of the Roche Chemical Analyzer Systems (DDD, DDP, DPP, DP/PP, P) and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments. The reagent shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the offeror's reagent on the analyzer.
Sensitivity and Specificity. The reagent shall be used for the identification of phencyclidine associated with drug abuse in physiological urine specimens when present at concentrations equal to or greater than 25 ng/mL. The reagent shall detect phencyclidine relative to the sensitivity and specificity of the current immunoassay procedure(s) used in the military laboratories. DoD laboratory certified solutions of phencyclidine at a concentration of 25 ng/mL shall be used for calibration of the Roche Chemical Analyzer Systems (DDD, DDP, DPP, DP/PP, P). The testing reagent shall be evaluated for its ability to detect specimens containing phencyclidine at concentrations equal to or greater than the DoD cutoff concentration of 25 ng/mL. The reagent shall demonstrate calibration stability, as reflected by a low frequency of control failures, to no more than one calibration per 8 hour period. The immunoassay reagent shall maintain reproducibility in quality control (QC) and quality assurance (QA) measurements. The immunoassay reagent shall minimize cross-reactivity with the drugs or drug metabolites in the DoD Drug Testing Program testing panel. The following drug cutoffs (in ng/mL) are currently used by the Department of Defense (DoD) for the initial immunoassay and GC/MS confirmation test respectively. 11-Nor-delta-9-THC-carboxylic acid (THCCOOH) 50, 15; Cocaine (Benzoylecgonine) 150, 100; morphine 2000, 4000; codeine 2,000, 2,000; 6-acetylmorphine (6-AM) 10, 10; oxycodone/oxymorphone 100, 100; Phencyclidine (PCP) 25, 25; amphetamine/ methamphetamine 500, 100; MDMA / MDEA / MDA 500, 500.
Compliance with Food & Drug Administration (FDA) Requirements.
Immunoassay kits are medical devices and shall have clearance from the Food and Drug Administration (FDA) to be marketed. The registration and listing process specified by the FDA shall be followed and the manufacturer shall adhere to good manufacturing processes (GMP) in the manufacture of the devices. Any mandatory recalls of the kits provided under the resulting contract and any other problems that require notification to the FDA shall 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.
Packaging. The materials provided shall be in volumes and packaging that are convenient and applicable to the throughput of the military laboratories and shall not result in the loss or unnecessary disposal of more than 3% of the working volume of reagent. Any individual bottle of reagent which would be prepared for use at one time shall not include materials for more than 3,000 tests. The contractor shall not be required to provide calibrators and control materials for the drug reagent. (The military laboratories shall separately obtain or provide calibrators and control materials to be used with the reagent.) The materials shall 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 and instrument parameters optimized for military drug testing laboratory operations as represented in these specifications and cutoffs as utilized by the DoD. The Government shall not develop procedures or optimize the performance of a kit for the contractor.
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 shall be at least 14 days. Once diluted, the material shall have a shelf life of at least 24 hours.
2. TESTING and QUALITY CONTROL PROTOCOL. The following testing and quality control protocol shall be used for all military testing. The reagents supplied shall be adaptable to the calibration requirements and characteristics of the Roche Chemical Analyzer Systems (DDD, DDP, DPP, DP/PP, P). Verification of each calibration shall be accomplished with a drug free control, a phencyclidine control at 18.75 ng/mL, 31.25, and 50 ng/mL. An acceptable verification shall have analytical readings for the drug free control less than 18.75 ng/mL control less than 25 ng/mL calibrator less than 31.25 ng/mL control less than 50 ng/mL control. Open and blind quality control urine shall be distributed throughout a test batch and shall make up about 10% of the number of total specimens. The reagent shall meet the performance criteria outlined in 2a(1)-2a(3) using this testing protocol.
CHARACTERISTICS OF PHENCYCLIDINE REAGENT.
Please refer to the complete scope of work available at http://www.nmlc.med.navy.mil
QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL POSSESS CURRENT ISO SERIES CERTIFICATION OR INCLUDE DOCUMENTATION OF THE FOLLOWING ELEMENTS: Chemicals and Reagents
Quality and authenticity. All materials used in the preparation of reagents shall be verified as to authenticity and purity. Methods may include, but are not limited to, the determination of melting points, GC/MS, Nuclear Magnetic Resonance (NMR), and spectrophotometric measurements. Stability. The kit and each kit component shall be shown to be stable and at the correct concentration over the period of use of the kit. Components that are homogeneous solutions shall not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration).
Manufacturer's Equipment. Preventive maintenance. Routine preventive maintenance procedures, periodic calibration, and any unscheduled maintenance shall be fully documented and in accord with recommendations of the manufacturer of the equipment.
Calibration and operational checks. All instruments that are used to check a physical parameter of a solution or material shall 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.
Temperature checks. Water baths, refrigerators, freezers, and other equipment that maintains a given temperature shall be periodically validated for accuracy and routinely verified for correct settings.
Glassware and other reusable laboratory supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials shall be established and compliance documented.
Antibody Drug Molecule.
Authenticity. The prepared antibody drug molecule shall be verified to be authentic and its purity established.
Stability. The antibody drug shall be documented to be stable to the expiration date and the immunoassay shall meet all contract specifications to the end of expiration date (which is 180 days minimum).
Antibody specificity. Antibody specificity shall be verified for each lot and the specificity re-evaluated at routine intervals to ensure uniformity and quality of preparations. The reagent shall provide performance characteristics in terms of sensitivity and specificity for detection of the phencyclidine in urine as the current immunoassay procedure(s) used in the military laboratories. The assay reagent shall be evaluated in terms of confirmation rate relative to screen positive rate (# of samples confirmed positive/# of samples screened positive x 100). A higher percent confirmation rate shall be considered better than a lower percent confirmation rate. Specimens identified as presumptive positive by the offeror?s screening reagent shall be evaluated for the presence of phencyclidine equal to or above 25 ng/mL by the GC/MS procedure in the military laboratories. Chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use shall be tested to characterize antibody specificity. Specificity testing shall include biochemical materials produced normally in the human body (this may be evaluated by testing actual military member's urine specimens).
Immunoassays.
Technical performance. Performance of each lot of kits shall be verified. The verification shall establish, as a minimum, the appropriate response to the target molecule and that all other parameters as specified in the contract are met.
Stability. The performance parameters involved in the testing procedures shall be verified and documented to be consistent throughout the shelf life of the kit.
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 shall be described in detail. All steps of each quality control procedure shall be described thoroughly.
Records. The production and quality assurance records generated by each procedure performed above shall 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.
Corrective action. When a specified quality control parameter is found to be out of limits, the action taken to ensure correction for existing kits (i.e., notification) shall be documented and action taken to ensure that the deficiency does not reoccur and all records shall be retained. The Contracting Officer shall be notified within 2 working days of any deficiencies in existing kits and of all corrective actions for consideration, i.e., delivery of replacement kits at no cost to the Government. The FDA shall be notified according to its regulations.
Lot numbers. Lot numbers shall be used to identify reagent and other preparations to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent shall be described. A single lot number for a kit shall 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.
INSTRUCTIONS AND CONDITIONS
The following Proposal Instructions and Evaluation Factors shall be used:
INSTRUCTIONS FOR PREPARATION OF PROPOSALS. Offerors shall submit a comprehensive proposal. Information provided shall be precise, factual and complete. Any proposal that does not offer as a minimum, that which is requested, may be determined to be substantially incomplete and not warrant any further consideration. The Government shall award a contract to the responsible offeror whose offer will be most advantageous to the Government, price and other factors considered.
Business Proposals shall be submitted in an original and one (1) copy and MUST INCLUDE THE FOLLOWING:
Offeror shall propose a price per test based on the estimated number of tests for CLINs 0001 through 5001. The estimated number of tests per year is 1.5 million.
Offerors 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.
Offerors shall provide an order and delivery schedule. The proposed schedule shall include Order Dates (latest date order can be placed), and Order Delivery Dates (date orders will be delivered).
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.
Acknowledgement of all solicitation amendments.
Technical Proposals shall be submitted in an original and three (3) copies. Offerors shall provide the information specified in paragraph 2(a) of the complete scope of work, Technical Evaluation Factors. All reagents for the Government evaluation test shall be provided at no cost to the Government. See the complete scope of work for instructions regarding submittal of reagents. Reagents shall NOT be sent to Naval Medical Logistics Command. Offers shall be mailed or hand- delivered to Naval Medical Logistics Command, ATTN: Code 02, Specialist 024D, 1681 Nelson Street, Fort Detrick, MD 21702, or emailed to Acquisitions@med.navy.mil (subject: Code 024D).
Questions shall be referred to:
Naval Medical Logistics Command
ATTN: Code 02, 024D
1681 Nelson Street
Fort Detrick, MD 21702-9203
FAX (301) 619-2925
Email: Acquisitions@ med.navy.mil Subject: Code 024D
If an offeror submits a question and does not receive a response to the question from Naval Medical Logistics Command within 72 hours of the time of submission, the question shall be resubmitted.
EVALUATION FACTORS FOR AWARD
EVALUATION FACTORS. Listed below are the technical and price evaluation factors that shall be used. Factors A and B will be evaluated individually on a pass/fail basis. If an offeror's technical proposal is judged to have failed under Factors A or B, the firm's offer will receive no further consideration for award. If an offeror?s technical proposal is judged to have passed both Factors A and B, then the offeror will subsequently be notified of Factor C, the Evaluation Test of their reagent to determine compliance. If 2 or more offerors? reagents pass the Evaluation Test, test results will be evaluated in the following descending order of importance: 2a(3.5) False Negative Rate, then 2a(3.6) False Positive Rate of the complete scope of work. If an offeror is judged to have passed under all Factors A, B and C, then the firm's offer will be further evaluated on a best value basis taking into consideration Factors A-D and Price. In doing so, the combination of Technical Factors A-D will be significantly more important than Price.
Technical Evaluation Factors.
Factor A - FDA Certification. Certification of FDA approval for the proposed phencyclidine immunoassay reagent kits. Documentation of FDA license for use shall be provided with the offeror?s proposal.
Factor B - Reagent Preparation and Calibration Information. (a) 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 for unopened reagents and as an open working reagent. (5) Calibration settings for use on the Roche Chemical Analyzer Systems (DDD, DDP, DPP, DP/PP, P). (6) Calibration frequency, for use on the Roche Chemical Analyzer Systems (DDD, DDP, DPP, DP/PP, P), 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 phencyclidine as compared to common over-the-counter medications, or similar isomeric analogue compounds, and other commonly encountered drugs and pharmaceuticals.
Factor C - Performance Test. If the offeror passes Factors A and B, the government shall conduct an evaluation of the vendor's reagent at one of the five DoD military drug-screening laboratories located within the continental United States (CONUS). The test shall be conducted in accordance with the established protocol, Attachment A. If requested, the offeror shall ship enough reagents to test 40,000 samples, at no cost to the government, to the Navy Drug Screening Laboratory, Building H-2033, Naval Air Station, Jacksonville, FL 32212.
PERFORMANCE TEST
1. Pleeas see complete scope of work for a description of the performance test at www.nmlc.med.navy.mil
Factor D Past Performance. (a) Provide dates of contracts, both Government and commercial, for the same or similar immunoassay reagents, performed in the past three year period as follows: Name, address, and telephone number of the contracting organization; contract number and dollar value; date of contract and period of performance; and brief description of contract. For Government contracts, identify the name and telephone number of the procuring and administrative Contracting Officer(s). (b) Quality: State for each contract cited above, the total number of rejected or returned reagents, with reasons for rejection or return, and total number of kits replaced. (c) Responsiveness: For each of the contracts cited above subject to recall or return, provide information regarding the vendor?s ability to provide timely replacement reagents.
Price Evaluation Factors. Price proposals shall be evaluated with consideration given to the following factors: (a) Completeness. 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 of any amendments. (b) Reasonableness. The Government's determination that the proposed price is fair and reasonable based on price analysis. (c) Realism. The offeror's CLIN prices shall be examined to identify unusually low pricing, inconsistent pricing patterns, and potential misunderstanding of the requirements.
FAR 52.212-1 Instructions to Offerors?Commercial Items applies. The offeror Representations and Certifications-Commercial Items at FAR 52.212-3 and the provisions 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 (FEB 2008) applies. With respect to FAR 52.212-5, the following clauses apply: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37,52.222-39, 52.225-1, 52.225-3, 52.225-13, and 52.232-33. The following clauses cited in DFARS 252.212-7001 apply: 52.203-3, 252.225-7012, 252.225-7014, 252.232-7003, 252.243-7002, 252.247-7023 and 252.247-7024. 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. In addition, the following FAR clauses also apply: 52.246-2, 52.246-16, 52.242-15, 52.242-17, 52.247-34, 52.203-6, 52.203-6 Alt I, 52.243-7001, 252.246-700, 52.216-18, 52.216-19, 52.216-21, and 52.217-9.
Offerors' proposals are due at Naval Medical Logistics Command, 1681 Nelson Street, Code 02-24D,Fort Detrick, MD 21702 by 1:00 pm E.S.T on or before April 30, 2008. In accordance with paragraph 2a(3), Evaluation Factors, of the complete Scope of Work, offerors passing technical factors A and B will be notified by email to send their reagents to the Jacksonville laboratory. Point of contact is Tameka Davis, 301-619-1677 or email Acquisitions@med.navy.mil Subject- Code 02- 024D.
THIS IS NOT A COMPLETE SCOPE OF WORK. A COMPLETE SCOPE OF WORK CAN BE ACCESSED AT http://www.nmlc.med.navy.mil and then selecting Public Access/Acquisitions/ Services/RFP/N62645-08-R-0011.
Point of Contact
Tameka Davis, Contract Specialist, Phone 301-619-1677, Fax 301-619-2925, Email tameka.davis@med.navy.mil - Burzie Baker III, Contracting Officer, Phone 301-619-0707, Fax 301-619-2925, Email Burzie.Baker@med.navy.mil
Place of Performance
| Address: |
1681 Nelson St
Frederick, MD 21701 |
| Postal Code: |
21701 |
| Country: |
UNITED STATES |
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