N62645-13-R-0036_CombinedSynopsisSolicitation_Final.doc

N62645-13-R-0036

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation of Commercial Items, FAR 13.5 Test Program for Certain Commercial Items and FAR 16.503 Requirements Contracts, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. It is the contractor’s responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR and DFARS clauses may be accessed in full text at this address: http://farsite.hill.af.mil/.

The NAICS code is 325413, with a business size standard of 500 employees.

This Request for Proposal (RFP) is on behalf of the Department of Defense (DOD) Drug Demand Reduction Program (DDRP). This requirement is for immunoassay reagent kits for the detection of amphetamines, d-AMPHETAMINE and d-METHAMPHETAMINE, abuse in urine.

The solicitation number is N62645-13-R-0036.

This solicitation will result in one firm fixed price Requirements type contract with a five year period of performance (nine-month base period, four one-year option periods, and a three-month option period). Period of Performance shall be from 01 January 2014 – 31 December 2018. Approximately 30,000,000 tests shall be required over the five year period. The requirement will be fulfilled via an unrestricted, full and open competitive acquisition.

Proposal Submission

Proposals are due by 24 October 2013 by 03:00 PM Local Time. Proposals shall be submitted in accordance with the Instructions to Offeror of this request to Nicholas.Dankanich@med.navy.mil, (SUBJECT: N62645-13 -R-0036 Amphetamine Reagent Kits).

Kit

Amphetamine Reagent Kits

FFP

d-AMPHETAMINE and d-METHAMPHETAMINE

Modular D & P Reagent Kit: Estimated 4,500,000 tests

**Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN and Total Price (including all CLINS).**

FOB: Destination

PURCHASE REQUEST NUMBER: N6264514ADV1010

ESTIMATED

NET AMT

Kit

FFP

d-AMPHETAMINE and d-METHAMPHETAMINE

Modular D & P Reagent Kit: Estimated 6,000,000 tests

**Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN and Total Price (including all CLINS).**

ESTIMATED

Kit

FFP

d-AMPHETAMINE and d-METHAMPHETAMINE

Modular D & P Reagent Kit: Estimated 6,000,000 tests

**Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN and Total Price (including all CLINS).**

ESTIMATED

Kit

FFP

d-AMPHETAMINE and d-METHAMPHETAMINE

Modular D & P Reagent Kit: Estimated 6,000,000 tests

**Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN and Total Price (including all CLINS).**

ESTIMATED

Kit

FFP

d-AMPHETAMINE and d-METHAMPHETAMINE

Modular D & P Reagent Kit: Estimated 6,000,000 tests

**Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN and Total Price (including all CLINS).**

ESTIMATED

Kit

FFP

d-AMPHETAMINE and d-METHAMPHETAMINE

Modular D & P Reagent Kit: Estimated 1,500,000 tests

**Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN and Total Price (including all CLINS).**

ESTIMATED

STATEMENT OF WORK

1. GENERAL REQUIREMENTS FOR IMMUNOASSAY TEST REAGENT FOR d-AMPHETAMINE and d-METHAMPHETAMINE tc \l 1 "C.1 REQUIREMENTS FOR IMMUNOASSAY TEST REAGENT FOR d-METHAMPHETAMINE AND DESIGNER AMPHETAMINES"1.1. The materials shall be for the immunoassay of both d-AMPHETAMINE and d-METHAMPHETAMINE in urine and are to provide immunologic reagent for initial (screen) testing. The reagent shall be compatible with the Roche Modular Clinical Chemistry Analyzer Systems (DDDD, DDD, DDP, DPP, DP/PP and P) and shall be applicable without modification of the equipment. The reagent shall be compatible with the optimal throughput of the Roche Modular Clinical Chemistry Analyzer Systems (DDDD, DDD, DDP, DPP, DP/PP and 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.

1.2. Sensitivity and Specificity. The reagent shall be used for the identification of both d-AMPHETAMINE and d-METHAMPHETAMINE associated with drug abuse in physiological urine specimens when present at concentrations equal to or greater than 500 ng/mL. The reagent shall detect both d-AMPHETAMINE and d-METHAMPHETAMINE relative to the sensitivity and specificity of the current immunoassay procedure(s) used in the military laboratories. The immunoassay reagent shall minimize the cross-reactivity with other pharmacological drugs or metabolites commonly associated with cold medications containing over-the-counter (OTC) medications such as, but not limited to, l amphetamine/l methaphetamine, ephedrine, pseudoephedrine, phenylpropanolamine and other sympathomemetic amines. The immunoassay reagent shall minimize cross-reactivity with the drugs or drug metabolites listed above. DoD laboratory certified solutions of d-METHAMPHETAMINE at a concentration of 500 ng/mL shall be used for calibration of the Roche Modular Clinical Chemistry Analyzer Systems (DDDD, DDD, DDP, DPP, DP/PP and P). The testing reagent shall be evaluated for its ability to detect specimens containing both d-AMPHETAMINE and d-METHAMPHETAMINE at concentrations equal to or greater than the DoD cutoff concentration of 500 ng/mL. The reagent shall demonstrate calibration stability, as reflected by repeated control failures, to no more than one calibration per shift. The immunoassay reagent shall maintain reproducibility in quality control (QC) and quality assurance (QA) measurements. 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; Opiates (Morphine) 2000, 4000 and codeine 2,000, 2,000; 6-acetylmorphine (6-AM) 10, 10; oxycodone/oxymorphone 100, 100; Phencyclidine (PCP) 25, 25; d-Amphetamine / d-Methamphetamine 500, 100; MDMA / MDEA / MDA 500, 500.

1.3. Compliance with Food & Drug Administration (FDA) Requirements.

1.3.1. 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.

1.4. 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 10,000 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 Roche Modular Clinical Chemistry Analyzer Systems 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.

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 shall be at least 30 days. Once diluted, the material shall have a shelf life of at least 30 days.

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 Modular Clinical Chemistry Analyzer Systems (DDDD, DDD, DDP, DPP, DP/PP and P). Verification of each calibration shall be accomplished with a drug free control, a d-METHAMPHETAMINE control at 375 ng/mL, a d-METHAMPHETAMINE control at 675 ng/mL, and a d-METHAMPHETAMINE at 1,000 ng/mL. An acceptable verification shall have analytical readings for the drug free control < 375 ng/mL control < 500 ng/mL calibrator <675 ng/mL control <1,000 ng/mL control. Open and blind quality control urine shall be distributed throughout a test batch and shall make up about 5% of the number of total specimens. The reagent shall meet the performance criteria outlined in 1.3 and 1.4. using this testing protocol.

3. CHARACTERISTICS OF d-AMPHETAMINE/d-METHAMPHETAMINE REAGENT.

3.1. The reagent shall identify specimens containing the d-AMPHETAMINE and d-METHAMPHETAMINE when present in human urine at concentrations equal to or greater than 500 ng/mL. The assay reagent shall correctly identify quality control specimens that contain d-METHAMPHETAMINE concentrations greater than or equal to 675 ng/mL. The assay reagent shall correctly identify positive and negative human test specimens as compared to the same samples identified as positive by the current immunoassay and confirmed by GC/MS procedures employed in the military laboratories. The reagent shall also minimize the number of "false positive" screens requiring GC/MS confirmatory analysis due to the presence of cold medications containing OTC pharmaceuticals such as, but not limited to, l amphetamine, l methamphetamine, ephedrine, pseudoephedrine, phenylpropanolamine and other sympathomemetic amines. A specimen is considered to be a "false positive" screen if GC/MS fails to detect the presence of the either d-methamphetamine or d-amphetamine.

3.2. An assay of 4 replicates of 10 sequential aliquots shall correctly identify 97.5% or greater of the 375 ng/mL d-METHAMPHETAMINE controls as negative and 675 ng/mL d-METHAMPHETAMINE controls as positive. The coefficient of variation for 4 replicates of 10 sequential 500 ng/mL d-METHAMPHETAMINE calibrators and d-METHAMPHETAMINE controls at concentrations of 375 ng/mL and 675 ng/mL shall be 10 or less%.

3.3. 97.5% or greater of the open 375 ng/mL d-METHAMPHETAMINE Low quality control samples and open 675 ng/mL d-METHAMPHETAMINE High quality control samples shall produce negative and positive results, respectively, in the summary of actual batch analyses as calculated during the performance evaluation.

3.4. 97.5% or greater of the 675 ng/mL d-METHAMPHETAMINE quality control samples shall be identified as positive in the summary of actual batch analyses as calculated during the performance evaluation.

3.5. An assay of 4 replicates of 10 sequential controls containing drug at 1,000 ng/mL shall all screen positive and have a coefficient of variation for the mean concentration reading 10% or less.

3.6. Each immunological reagent shall be checked for cross reactivity to other illicit or pharmacological abused drugs, chemicals, or metabolites that might produce a false positive response.

3.7. The contractor shall provide upon request 250 ml of drug-free urine (free of amphetamines, LSD, THCCOOH, benzoylecgonine, cocaine, PCP, and opiates, oxycodone/oxymorphone, hydrocodone/hydromorphone, 6-AM and shall also contain less than 20 ng/mL of benzodiazepines) with each reagent kit order (equivalent to 2,000 tests/reagent kit). The drug-free urine provided with the reagent shall have a GC/MS drug concentration less than the limit of detection for the analyte methodologies. In addition, immunoassay of the drug-free urine shall have a semi-quantitative concentration readings equivalent to or less than those recorded for drug controls at 20% of the DoD immunoassay cutoff concentrations. If a laboratory requests negative urine, it may be shipped with the monthly reagent delivery and supplied in 1 liter volume containers. The military laboratories shall not redeem or exchange unused allocations of negative urine accrued by reagent purchase for additional reagents or other supplies from the vendor.

4. QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL POSSESS CURRENT ISO-9000 SERIES CERTIFICATION OR INCLUDE DOCUMENTATION OF THE FOLLOWING ELEMENTS:

4.1. Chemicals and Reagents.

4.1.1. 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.

4.1.2. 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).

4.2. Manufacturer’s Equipment.

4.2.1. 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.

4.2.2. 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.

4.2.3. 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.

4.2.4. Glassware and other reusable laboratory supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials shall be established and compliance documented.

4.3. Antibody Drug Molecule.

4.3.1. Authenticity. The prepared antibody drug molecule shall be verified to be authentic and its purity established.

4.3.2. 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).

4.4. 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 both d-AMPHETAMINE and d-METHAMPHETAMINE in urine as the current immunoassay procedure(s) used in the military laboratories. The number of "false positive" screens requiring GC/MS confirmatory analysis due to the presence of OTC cold medications containing pharmaceuticals such as, but not limited to ephedrine, pseudoephedrine, or phenylpropanolamine and other sympathomemetic amines, shall be minimized. Cross reactivity with l-amphetamine and l-methamphetamine shall also be minimized. 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 d-AMPHETAMINE and d-METHAMPHETAMINE equal to or above 500 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. The Vendor will inform the contracting officers when the antibody pool for this assay is changed. Specificity testing shall include biochemical materials produced normally in the human body (this may be evaluated by testing actual military member’s urine specimens).

4.5. Immunoassays.

4.5.1. 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.

4.5.2. Stability. The performance parameters involved in the testing procedures shall 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 shall 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 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.

4.5.5. 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.

4.5.6. 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.

PACKAGING & MARKING

1. THERMAL PROTECTION FOR BIOLOGIC REAGENTS

1.1. The contractor will ship biologic reagent items used in drug assays in insulated thermal containers to ensure protection of the reagents against thermal (Heat/Cold) damage which would affect reagent performance contained in the Statement of Work of this contract.

2. MARKING OF SHIPMENTS (COMMERCIALLY PACKAGED ITEMS)

2.1. Marking shall be in accordance with ASTM D 3951 88, "Standard Practice for Commercial Packaging."

(a) Additional markings are stated below:

Contract Number:

Government Delivery Order Number:

3. DETERIORATIVE MATERIAL MARKING

3.1. The contractor will include as part of the marking, the following information:

(a) Expiration date.

(b) Required storage conditions for each kit component.

(c) Type I or Type II shelf life date as specified in MIL-STD-129 for each unit of material, issue, package, intermediate container and exterior shipping container.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERIES OR PERFORMANCE

PERIOD OF PERFORMANCE

The period of performance is from 01 January 2014 – 31 December 2018, to include a nine-month base period, four one-year option periods and a three-month option period, if exercised. The total period of performance for this contract shall not exceed five years.

PLACE OF PERFORMANCE

The specific locations of delivery are:

Navy Drug Screening Laboratory Great Lakes

320B B Street Building 38H

Great Lakes, IL 60088-2808

Navy Drug Screening Laboratory

Building H-2033 Adams Avenue

Naval Air Station

Jacksonville, FL 32212-5000

Navy Drug Screening Laboratory San Diego

34425 Farenholt Avenue, Suite 40, Building 26, Floor 2B

San Diego, CA 92134-7040

Headquarters Air Force Drug Testing Laboratory

Wilford Hall Medical Center

Building 3750, Ladd Street

Lackland Air Force Base, TX 78236

Army Forensic Toxicology Drug Testing Laboratory

2490 Wilson Street

Fort Meade, MD 20755-5235

Army Forensic Toxicology Drug Testing Laboratory

ATTN: MCHK-FT

1 Jarrett White Road, Building 40

Tripler Army Medical Center, HI 96859-5000

Armed Forces Medical Examiner System (AFMES)

115 Purple Heart Drive

Dover Air Force Base, DE 19902

DELIVERY INFORMATION

30-SEP-2014

SEE DO/TO

SEE DO/TO MD

N00000

30-SEP-2015

N00000

30-SEP-2016

N00000

30-SEP-2017

N00000

30-SEP-2018

N00000

31-DEC-2018

N00000

CONTRACT ADMIN DATA

1. CONTRACT ADMINISTRATION

(a) The name, address and telephone number of the Contract Specialist responsible for administering this contract is:

Naval Medical Logistics Command

Nicholas Dankanich

693 Neiman Street

Fort Detrick, MD 21702

(301) 619-8419

Email: Nicholas.Dankanich@med.navy.mil

(b) Unless otherwise stated herein, any correspondence or discussion regarding this contract will be directed to the Contract Specialist in (a) above.

2. INVOICING INSTRUCTIONS

See 252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (May 2013).

3. DESIGNATION OF ORDERING ACTIVITIES

The following requiring activities and their ordering office are hereby named to place delivery orders.

Navy Drug Screening Laboratory

320B B Street Building 38H

Great Lakes, IL 60088-2815 Navy and Marine Corps Public Health Center

620 John Paul Jones Circle, Suite 1100

Portsmouth, VA 23708-2103

Navy Drug Screening Laboratory

Building H-2033 Adams Avenue

Naval Air Station

Jacksonville, FL 32212-5000 Same as Requiring Activity

Navy Drug Screening Laboratory San Diego

34425 Farenholt Avenue, Suite 40, Building 26, Floor 2B

San Diego, CA 92134-7040 Same as Requiring Activity

Headquarters Air Force Drug Testing Laboratory

Wilford Hall Medical Center

Building 3750, Ladd Street

Lackland Air Force Base, TX 78236 59 Medical Logistics & Readiness Squadron

2200 Bergquist Dr. Bldg 4550 Suite 1

Lackland Air Force Base, TX 78236

Army Forensic Toxicology Drug Testing Laboratory

2490 Wilson Street

Fort Meade, MD 20755-5235 Same as Requiring Activity

Army Forensic Toxicology Drug Testing Laboratory

ATTN: MCHK-FT

1 Jarrett White Road, Building 40

Tripler Army Medical Center, HI 96859-5000 Pacific Contracting Center

ATTN: MCAA-PC

Tripler AMC, HI 96859

Armed Forces Medical Examiner System (AFMES)

115 Purple Heart Drive

Dover Air Force Base, DE 19902 Same as Requiring Activity

The activities’ ordering office is responsible for issuing and administering any orders placed hereunder. Ordering officers have no authority to modify any provision of the basic contract. Any deviations from the terms of the basic contract must be submitted and approved by the Contracting Officer for contractual action.

4. ORDERING

The contract hereby authorizes requiring/ordering activities to place delivery orders. The contract hereby authorizes requiring/ordering activities to place delivery orders via SF 1449, DD Form 1155, or other locally approved form signed by a contracting officer or an ordering officer using the government purchase card or Wide Area Workflow for payment methods.

5. CONTENT OF DELIVERY ORDERS

Delivery orders shall contain the following "minimum" information:

1. Date of order.

2. Contract number and order number.

3. Item number and description, quantity, and unit price.

4. Delivery date and place of delivery.

5. Accounting and appropriation data.

7. Payment office address.

8. Invoicing instructions with Point of Contact Information.

Ordering activities are required to provide a copy of each delivery order via email to the Naval Medical Logistics Command (NMLC) via NMLC DOD Drug Testing Program Mailbox at NMLC.DODDrugTestingProgram@med.navy.mil (SUBJECT: Contract Number & Delivery Order Number).

6. REPORTS

The contractor shall provide an electronic monthly report of sales within seven calendar days after the close of each month’s sales. Reports, in Microsoft Excel, shall be emailed to NMLC DOD Drug Testing Program Mailbox at NMLC.DODDrugTestingProgram@med.navy.mil (SUBJECT: Contract Number).

Reports shall contain the following information:

1. Date of order.

2. Contract number and delivery order number.

3. Item number, description, quantity, and unit price.

4. Total Amount.

5. Delivery date and place of delivery.

6. Payment method.

7. COMMUNICATIONS

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor's facility or in any other manner communicate with contractor personnel during the performance of this contract shall constitute a change under the "Changes" clause of this contract.

(b) The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and, notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer's. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

SPECIAL CONTRACT REQUIREMENTS

CONTRACTOR SUPPORT

NOTICE: NAVY USE OF SUPPORT CONTRACTOR FOR CONTRACT CLOSEOUT FUNCTIONS

Naval Medical Logistics Command uses two private contractors in support of the contract closeout process. Those companies are Universal Consulting Services (UCS) of Fairfax, Virginia, doing business under the authority of the Small Business Administration’s 8(a) program, and the Ability One Program, doing business under the authority of the Javits-Wagner O’Day Act (41 U.S.C. § 47).

The contract closeout process includes activities such as processing deobligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information you provide to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical proposals and performance information.

Naval Medical Logistics Command has signed Non-Disclosure Agreements with each support contractor employee and has required both contractors to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity.

By submission of the proposal that resulted in the award of this contract, the contractor and its subcontractors consent to access of their business sensitive/confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services.

CLAUSES INCORPORATED BY REFERENCE

ADDENDUM TO 52.212-1

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS

In addition to the guidance included in FAR Provision 52.212-1 entitled “Instructions to Offerors – Commercial Items,” the following are applicable for the preparation and submission of proposals.

Proposal Content and Instructions for Preparation of Proposals.

Instructions for preparation of proposals. This section specifies the format and content that offerors shall use in this Request for Proposal (RFP). The intent is not to restrict the offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Offerors must submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified in the Addendum to 52.212-1. Any proposal that does not provide, as a minimum, that which is required in this solicitation 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.

The proposal shall be submitted in three separate volumes:

Volume I* – Technical Approach;

Volume II* – Past Performance; and

Volume III – Business Proposal.

*No pricing information shall be included in Volumes I or II.

A complete Volume I – Technical Approach, Volume II – Past Performance, and Volume III – Business Proposal shall be submitted by the closing date specified in this solicitation. If any one proposal volume is received past the stated closing date specified in this solicitation, the entire proposal will be considered late. No further consideration will be given to any offeror who submits any of these volumes late in accordance with FAR 52.212-1(f).

1. Volume I: Technical Approach. Technical Approach Proposals shall not include any pricing information. In accordance with file submission requirements given in this section, the offeror shall submit the following:

1.1. The offeror shall provide sufficient technical documentation (including but not limited to: product literature, specifications) demonstrating the offeror’s ability to meet the Statement of Work and to allow for thorough evaluation of proposal.

1.2. The offeror shall provide the information specified in 52.212-2 Evaluation – Commercial Items, Volume I: Technical Approach Proposal, Evaluation Factor A: FDA and ISO Certification and Evaluation Factor B: Reagent Preparation and Calibration Information. If required, all reagents for the Government evaluation test shall be provided at no cost to the Government. See 52.212-2 Evaluation – Commercial Items, Volume I: Technical Approach Proposal, Evaluation Factor C: Performance Test – Minimum Requirements for instructions regarding submittal of reagents. Reagents shall NOT be sent to Naval Medical Logistics Command.

Page limit for Volume I – Technical Approach Proposal: not to exceed 100 pages (excluding a Cover Sheet and Table of Contents). Any information submitted that is in excess of the page limit shall not be considered as part of the proposal.

2. Volume II: Past Performance. Past Performance Proposals shall not include any pricing information. In accordance with file submission requirements given in this section, the offeror shall submit the following:

2.1. The offeror shall describe its past performance on up to three contracts it has held within the last five years that are for the same or similar immunoassay reagents to that which is detailed in this solicitation, or affirmatively state the offeror possesses no relevant past performance directly related to or similar past performance. Offerors who present similar contracts shall provide a detailed explanation demonstrating the relevance of the contracts to the requirements of the solicitation. The Government reserves the right to contact any references.

2.2. The offeror shall provide the following information regarding its past performance:

2.2.1. Contract number(s), award date, dates of performance and location(s) of performance.

2.2.2. Name, phone number, and email address of a validated point of contact at the federal, state, local government or commercial entity for which the contract was performed. Offeror shall verify the validity of the contact information provided.

2.2.3. Dollar value of the contract.

2.2.4. Description of the reagents provided under the contract.

2.2.5. The number, type, and severity of any quality or delivery problems in performing the contract, the corrective action taken and the effectiveness of the corrective action (if applicable).

2.2.6. The total number of rejected or returned reagents, with reasons for rejection or return, and total number of kits replaced (if applicable).

2.2.7. Provide information regarding compliance with established delivery schedules and ability to provide timely replacement reagents due to recall or return.

2.2.8 Any other relevant information.

2.2.9 Answer “Has the POC agreed to be to be contacted as a reference?”

2.3. The government reserves the right to consider other past performance information at its disposal, in addition to any information obtained from the references provided above. The government is likely to randomly select references provided for contact and does not commit to contact every reference.

Page limit for Volume II – Past Performance Proposal: not to exceed six pages (two pages per past performance reference) (excluding a Cover Sheet and Table of Contents). Any information submitted that is in excess of the page limit shall not be considered as part of the proposal.

3. Volume III: Business Proposal. In accordance with file submission requirements given in this section, the offeror shall submit the following:

3.1. Offerors shall propose a Catalog Number in Attachment 1: Pricing Sheet.

3.2 Offerors shall propose a Product Description in Attachment 1: Pricing Sheet.

3.3. Offerors shall propose a price per test based on the estimated number of tests for CLINs 0001, 1001, 2001, 3001, 4001, and 5001 in Attachment 1: Pricing Sheet.

3.4. Offerors shall state the total number of tests per kit proposed for CLINs 0001, 1001, 2001, 3001, 4001, and 5001 in Attachment 1: Pricing Sheet. The number of tests shall be based on the reagent volume recommended by the equipment manufacturer.

3.5. Offerors shall provide a price per kit based on the estimated number of tests proposed for CLIN 0001, 1001, 2001, 3001, 4001, and 5001 in Attachment 1: Pricing Sheet.

3.6. Offerors shall provide the number of kits proposed for CLINs 0001, 1001, 2001, 3001, 4001, and 5001 in Attachment 1: Pricing Sheet.

3.7. Offerors shall provide a total price per CLIN 0001, 1001, 2001, 3001, 4001, and 5001 in Attachment 1: Pricing Sheet.

3.8. Offerors shall provide a total price including all CLINs in Attachment 1: Pricing Sheet.

3.9. 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).

3.10. Offerors shall provide the Federal Supply Schedule (FSS) number, if the items are on FSS, or make note if the reagent kits are Open Market.

3.11. Offeror shall provide:

Complete company name and address:

Company Point of Contact:

Phone number:

Tax Identification Number (TIN):

CAGE Code:

DUNS number:

3.12. The Offeror Representations and Certifications-Commercial Items at FAR 52.212-3 Alternate I shall be submitted with the offeror’s Price Proposal.

3.13. The offeror shall complete and submit DFARS Provision 252.209-7995 [Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction Under any Federal Law – Fiscal Year 2013 Appropriations (Deviation 2013-O0010) (APR 2013)].

3.14. The offeror shall complete and submit DFARS Provision 252.209-7997 [Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction Under any Federal Law – DOD Appropriations (Deviation 2013-O0006) (JAN 2013)].

3.15. The offeror shall include a statement with the offerors Volume III: Business Proposal acknowledging the combined synopsis/solicitation and all amendments issued under this combined synopsis/solicitation.

3.16. Small Business Subcontracting Plan:

3.16.1. If applicable (for other than small business concern offerors under the assigned NAICS code herein), the offeror shall submit a subcontracting plan in accordance with FAR Clause 52.219-9 and DFARS Clause 252.219-7003 (for reference see FAR 19.704 and DFARS 219.704). The subcontracting plan requirement is not applicable to small business concerns qualified as such under the NAICS code assigned to this solicitation. Master subcontracting plans can be included as an appendix to the subcontracting plan.

3.16.2. The Contracting officer will review the subcontracting plan for acceptability. If an offeror fails to negotiate a subcontracting plan acceptable to the Contracting Officer within the time limit prescribed by the Contracting Officer, the offeror will be ineligible for award. If the offeror believes there are no subcontracting possibilities, the offeror shall submit documentation sufficient to support its position.

Page limit for Volume III – Business Proposal: There is NO page limit for Volume III – Business Proposal.

4. File Submission. Only electronic files will be accepted unless otherwise noted in the subsections of this paragraph.

4.1 The Volume I: Technical Approach, Volume II: Past Performance, and Volume III: Business Proposal, shall be submitted in electronic format via email or as files on CD-ROMs. Offers shall be mailed or hand-delivered (CD-ROMS) to Naval Medical Logistics Command, ATTN: Code 02, Nicholas Dankanich, 693 Neiman Street, Fort Detrick, Maryland 21702, or emailed to Nicholas.Dankanich@med.navy.mil (SUBJECT: N62645-13-R-0036 Amphetamine Reagent Kits). The contract specialist will acknowledge receipt of all proposals via reply email. If the contract specialist does not acknowledge receipt of the proposal within two business days, the offeror shall resubmit the proposal. If the offeror submits their proposal less than two business days prior to the due date/time for receipt of proposals, the offeror is encouraged to contact the contract specialist to confirm receipt of their proposal.

4.1.1. Files shall be in Microsoft Office for Windows format (2007 or 1997-2003), either .doc or .docx file and/or Adobe Acrobat (.pdf file), with one (1) inch margins all around, Times New Roman font of not less than ten (10) point font size.

4.1.2. Each volume shall contain the following items in addition to the technical/descriptive data required by this Request for Proposal (RFP):

4.1.2.1. Cover sheet which indicates RFP Number, Name and Address of Offeror.

4.1.2.2. Table of contents which provides sufficient detail as to allow the important elements to be easily located.

4.1.2.3. Each page of each document shall have a footer indicating the name of the offeror, “page X of Y,” and the following legend “Source Selection Information: See FAR Part 3.104.”

4.2. If submitted via CD-ROM, three identical sets of CD-ROMs shall be submitted. Each CD-ROM shall be labeled as to the name of the offeror and the contents of the CD-ROM. The offeror is responsible for ensuring that submitted CD-ROMs include all complete files and are not physically damaged nor contain corrupted files such that they are not readable by the Government. The offeror shall ensure that the three sets of CD-ROMs are identical.

5. Solicitation Questions. Questions concerning the proposal are due no later than 03:00 PM Local Time, on 01 October 2013. Questions shall be submitted to Nicholas.Dankanich@med.navy.mil by the required time, and no questions shall be addressed after this cutoff date. Offerors shall submit one set of questions only; multiple emails shall not be accepted. An amendment to the solicitation will be issued providing responses to the questions.

6. Discussions. The Government intends to evaluate proposals and award a single contract without discussions with offerors. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary.

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 EVALUATION--COMMERCIAL ITEMS (JAN 1999)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

This is a best value source selection conducted in accordance with Federal Acquisition Regulation (FAR) Part 12, as supplemented by other parts of the FAR and the Defense Federal Acquisition Regulation Supplement (DFARS), and the Navy Marine Corps Acquisition Regulation Supplement (NMCARS). The Government will select the best overall offer, based upon an integrated assessment of Technical Approach, Past Performance, and Price. As part of making the assessment, a best value analysis will be performed determining whether or not exceeding the minimum requirements at an associated price provides the best value to the Government.

As a basis for award, trade-offs between price and non-price factors are permitted. Therefore, the Government reserves the right to award a contract to other than the lowest proposed price or other than the highest technically rated proposal. However, the closer the merits of the Technical Approach and Past Performance proposals are to one another, the greater importance of price in making the award determination.

The Technical Approach shall be rated by their content only and the Government will not assume that performance will include areas not addressed. The Government will evaluate proposed prices for reasonableness using price analysis techniques. Proposed prices evaluated as unreasonable may be grounds for eliminating a proposal from competition.

Evaluation Criteria

The proposals will be evaluated under the following factors:

Volume I: Technical Approach Proposal

Evaluation Factor A: FDA and ISO Certification

Evaluation Factor B: Reagent Preparation and Calibration Information

Evaluation Factor C: Performance Test – Minimum Requirements

Evaluation Factor D: Performance Test – Enhancing Factors

Volume II: Past Performance Proposal

Evaluation Factor E: Past Performance

Volume III: Business Proposal

Evaluation Factor F: Price

Relative Importance of Factors. The relative importance of each factor is as follows:

Evaluation Factor A and Evaluation Factor B will be evaluated individually on a pass/fail basis. If an offeror's technical proposal is judged to have failed under Evaluation Factors A or B, either initially or following discussions if they are conducted, the firm's offer will receive no further consideration for award unless there are no other technically compliant proposals. If an offeror’s technical proposal is judged to have passed both Evaluation Factors A and B, then the offeror will subsequently be notified of Evaluation Factor C the performance test of their reagent to determine compliance. If an offeror’s technical proposal is judged to have failed under Evaluation Factor C, the firm’s offer will receive no further consideration for award unless there are no other technically compliant proposals. If an offeror is judged to have passed under all Evaluation Factors A, B and C minimum requirements, then the firm’s offer will be further evaluated on a trade off basis taking into consideration Evaluation Factors D-F. In doing so, Factor D, Performance Test – Enhancing Factors, is more important than Factor E, Past Performance. The combination of Evaluation Factors D and E will be significantly more important than F, Price.

Volume I: Technical Approach Proposal

Evaluation Factor A: FDA and ISO Certification. Certification of FDA approval/authorization for the proposed Amphetamine Immunoassay Reagent. Documentation of FDA approval/authorization for use of the Amphetamine Immunoassay Reagent shall be provided with the offeror’s' proposal. Documentation of current certification compliance with applicable ISO Standards or documentation of compliance with Statement of Work (SOW) Sections 4.1 through 4.5.6 shall be provided with the offeror’s’ proposal.

Evaluation Factor B: Reagent Preparation and Calibration Information. Package insert containing complete, accurate and verifiable information regarding:

(1) Explanation and principles of the testing procedure.

(2) Description of each reagent composition of the reagents for use on the Hitachi modular analyzer in the processing of samples.

(3) Instructions for reagent handling, mixing, and storage.

(4) Reagent stability and storage requirement unopened and as an open working reagent.

(5) Shelf life. Minimum shelf life of any unopened component and once kit container seals are broken and the component opened.

(6) Calibration AND Parameter settings for use on the Roche Modular Clinical Chemistry Analyzer Systems (DDDD, DDD, DDP, DPP, DP/PP and P). The kit calibrator and positive QC controls shall be d-METHAMPHETAMINE.

(7) Performance characteristics anticipated in terms of accuracy, precision, and sensitivity to the principal analyte(s).

(8) Table of cross reactivity and specificity of the assay to commonly encountered scheduled compounds, common over-the-counter medications, or other principal drugs of abuse.

Evaluation Factor C: Performance Test – Minimum Requirements. See Performance Test Criterion below. 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 cited below in the Performance Test Section. If requested, the offeror shall ship a SUFFICIENT number of reagents to test APPROXIMATELY 2,000 specimens, plus enough reagents for instrument start up, priming of lines, calibration, QC check, and shut down purging of lines. In total, a SUFFICIENT number of reagents shall be shipped to test the EQUIVALENT of 5,000 specimens but not less than two large reagent kits. These reagents shall be shipped, at no cost to the government, to one of the five DOD military drug-screening laboratories located within the continental United States (CONUS).

Performance Test – Minimum Requirements

Data obtained will be analyzed as to the Amphetamines test reagent’s ability to meet the solicitation requirements as to:

1. Archived, ready for disposal, previously…