B-7_N62645-15-R-0002_Combined_Syn_Sol.doc

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6 and FAR 13.5, Streamlined Procedures for Evaluation and Solicitation of Commercial Items, 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. There are no set-aside restrictions for this requirement.

This Request for Proposal (RFP) is on behalf of the Department of Defense (DOD) Drug Demand Reduction Program (DDRP). This requirement is for immunoassay test reagent for the detection of Benzoylecgonine (BZE) and cross-reactive Cocaine Metabolites in urine.

The solicitation number is N62645-15-R-0002.

This solicitation will result in one firm fixed price requirements contract with a five year period of performance (a one-year base period and four one-year option periods). Period of Performance shall be from 01 October 2015 – 30 September 2020. The requirement will be fulfilled via an unrestricted, full and open competitive acquisition.

Proposal Submission

Proposals are due by 30 January 2015 by 02:00 PM Local Time. Proposals shall be submitted in accordance with the Instructions to Offeror of this request and a proposal submission confirmation emailed to Nicholas.Dankanich@med.navy.mil, (SUBJECT: N62645-15-R-0002 BZE Reagent Kits).

Kit

BENZOYLECGONINE IMMUNOASSAY REAGENT KITS

FFP

BZE Reagent Kit: Estimated 550,000 tests per month

Immunoassay reagent kit for the detection of Benzoylecgonine (BZE) and cross-reactive Cocaine Metabolites in urine.

**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

MILSTRIP: N6264515RC3D000

PURCHASE REQUEST NUMBER: N6264515RC3D000

ESTIMATED

NET AMT

Kit

FFP

BZE Reagent Kit: Estimated 550,000 tests per month

Immunoassay reagent kit for the detection of Benzoylecgonine (BZE) and cross-reactive Cocaine Metabolites in urine.

**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

ESTIMATED

Kit

FFP

BZE Reagent Kit: Estimated 550,000 tests per month

Immunoassay reagent kit for the detection of Benzoylecgonine (BZE) and cross-reactive Cocaine Metabolites in urine.

**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

ESTIMATED

Kit

FFP

BZE Reagent Kit: Estimated 550,000 tests per month

Immunoassay reagent kit for the detection of Benzoylecgonine (BZE) and cross-reactive Cocaine Metabolites in urine.

**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

ESTIMATED

Kit

FFP

BZE Reagent Kit: Estimated 550,000 tests per month

Immunoassay reagent kit for the detection of Benzoylecgonine (BZE) and cross-reactive Cocaine Metabolites in urine.

**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

ESTIMATED

STATEMENT OF WORK

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF BENZOYLECGONINE (BZE) AND CROSS-REACTIVE COCAINE METABOLITES IN URINE

1.1. The materials shall be for the detection of benzoylecgonine (BZE) in urine and are to provide immunologic reagent for the initial (screening) test. The reagent shall be compatible with a high throughput, liquid reagent, immunochemistry screening analyzer such as the Roche Hitachi Chemical Analyzer Modular (D/P) or Beckman Coulter AU58300 Clinical Chemistry Analyzer (analyzer), in use at the Department of Defense (DoD) Forensic Toxicology Drug Testing Laboratories (FTDTLs), and shall be compatible without modification of the equipment. The reagent shall be compatible with the optimal throughput of the analyzers 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 contractor’s reagent on the analyzer.

1.2. Sensitivity and Specificity. The reagent shall be used for the identification of BZE in physiological urine specimens when present at concentrations equal to or greater than 150 ng/mL. The reagent shall minimize cross-reactivity with the drugs or drug metabolites listed below (excluding BZE). DoD laboratory certified solutions of BZE at a concentration of 150 ng/mL shall be used for calibration of the analyzer. The testing reagent shall be evaluated for its ability to detect specimens containing BZE at concentrations equal to or greater than the DoD immunoassay screening cutoff concentration of 150 ng/mL. The reagent shall demonstrate calibration stability, as evaluated by frequency of control failures, and shall require calibration no more than one time during an 8 hour period. The reagent shall maintain reproducibility in quality control (QC) and quality assurance (QA) measurements. The following drug cutoffs (in ng/mL) are currently used by DoD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively.

benzoylecgonine (BZE) 150, 100;

11-nor-delta-9-THC-carboxylic acid (THC) 50, 15;

morphine (MOR) 300, 4000;

codeine (COD) 300, 2000;

hydrocodone (HYDC) 300, 100;

hydromorphone (HYDM) 300, 100;

6-acetylmorphine (6AM) 10, 10;

oxycodone (OXYC) 100, 100;

oxymorphone (OXYM) 100, 100;

d-amphetamine (AMP) 500, 100;

d-methamphetamine (MET) 500, 100;

methylenedioxymethamphetamine (MDMA) 500, 500;

methylenedioxyamphetamine (MDA) 500, 500;

benzodiazepines (BZD) -nordiazepam (NORD) 200, 100;

oxazepam (OXAZ) 200, 100;

alpha hydroxy-alprazolam (AHAL) 200, 100;

lorazepam (LORA) 200, 100;

temazepam (TEMA) 200, 100;

synthetic cannabinoids (SYCAN) –

JWH-018 (J018) 10, 1;

JWH-073 (J073) 10, 1;

UR-144 (U144) 10, 1.

1.3. Compliance with Food & Drug Administration (FDA) Requirements. Immunoassay kits are considered 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 sample throughput at 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 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 to the drug testing laboratory. Once kit container seals are broken and the components are 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.

2.1. The following testing and quality control protocol shall be used for testing. The reagents supplied shall be adaptable to the calibration requirements and characteristics of the Roche Hitachi Modular Chemical Analyzer Systems or Beckman Coulter AU5830 Clinical Chemistry Analyzer . Verification of each calibration (at 150 ng/mL) shall be accomplished with a drug free control and BZE controls at target concentrations of 50-75%, 125-150%, and 200% of the calibrator/cutoff. Open and blind quality control urine shall be distributed throughout a test batch and shall make up a minimum of 5% of the number of total specimens.

3. PERFORMANCE CHARACTERISTICS.

3.1. The reagent shall be capable of identifying specimens as positive for BZE when BZE is present in human urine at concentrations equal to or greater than 150 ng/mL (as determined by the current immunoassay utilized in the military laboratories).

3.2. The reagent shall be capable of identifying specimens as negative for BZE when BZE is present in human urine at concentrations below 150 ng/mL (as determined by the current immunoassay utilized in the military laboratories).

3.3. The reagent shall be capable of identifying specimens as positive for BZE when BZE is present in human urine at concentrations at or above 100 ng/mL (as determined by the current GC/MS procedures utilized in the military laboratories).

3.4. The reagent shall be capable of identifying specimens as negative for BZE when BZE is present in human urine at concentrations below 100 ng/mL (as determined by the current GC/MS procedures utilized in the military laboratories).

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 pH meters, spectrometers, micropipettes, etc.

4.2.3. Temperature checks. Water baths, refrigerators, freezers, and other equipment that is intended to maintain 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 BZE in urine equal to or better than the current immunoassay procedure used in the military laboratories. The assay reagent shall be evaluated in terms of confirmation rate relative to screen positive rate (# of specimens confirmed positive/# of specimens 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 contractor’s screening reagent shall be evaluated for the presence of BZE equal to or above 100 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).

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 AND 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:

DELIVERY INFORMATION

30-SEP-2016

FOR SHIP TO/ PAYMENT INSTRUCTIONS

NAVAL MEDICAL LOGISTICS COMMAND

SEE ORDER

FOB: Destination N62645

30-SEP-2017

N62645

30-SEP-2018

N62645

30-SEP-2019

N62645

30-SEP-2020

N62645

CONTRACT ADMINISTRATION

CONTRACT ADMINISTRATION

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, Maryland 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.

3. DESIGNATION OF ORDERING ACTIVITIES

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

Navy Drug Screening Laboratory Great Lakes

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 Jacksonville

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 Contracting Resources Group, Inc. from Baltimore, MD, 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 de-obligation 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 its proposal that was accepted by the Government, 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 closeout 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 four separate volumes:

Volume I* – Technical Approach;

Volume II* – Past Performance; and

Volume III*-- Small Business Participation Plan And Subcontracting Plan.

Volume IV – Business Proposal.

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

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: Small Business Participation Plan And Subcontracting Plan.

3.1. 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.

3.2. 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.

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

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

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

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

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

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

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

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

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

4.9. 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).

4.10. 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.

4.11. Offeror shall provide:

Complete company name and address:

Company Point of Contact:

Email Address:

Phone number:

Tax Identification Number (TIN):

CAGE Code:

DUNS number:

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

4.13. The offeror shall complete and submit DFARS Provision 252.209-7994 [Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction Under any Federal Law – Fiscal Year 2014 Appropriations (Deviation 2014-O0010) (October 2013)].

4.14. 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.

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

5. File Submission.

5.1 Offerors are invited to submit a proposal in accordance with Instructions to Offerors, to arrive electronically through the AMRDEC SAFE website no later than the proposal due date for this solicitation. The Government does not authorize submission of telegraphic, facsimile, paper or CDROM offers via hand carry or mail carrier for this solicitation.

All proposals submitted in response to this solicitation will be submitted electronically via the AMRDEC SAFE website. No paper copies or electronic copies submitted outside of the SAFE website (i.e., emailed directly to the contract specialist or other NMLC email inbox) will be accepted.

Submitting your proposal:

The AMRDEC SAFE application is used to send large files to individuals which would normally be too large to send via email. There are no user accounts for SAFE - authentication is handled via email and Civilian Access Card (CAC). The application is available for use by offerors.

The AMRDEC SAFE application can be accessed via https://safe.amrdec.army.mil/safe.

Offerors shall proceed as “Non- CAC Users” under all circumstances.

After selecting the “Non- CAC Users” option above, the page will be redirected to the package upload form. Fill in all the required input fields (field names are in italics):

Personal Information:

Your Name - Your name, Your Company Name.

Your Email address - Your email address.

Confirm Your Email Address - Re-enter your email address.

File Information:

Description of File(s) - Enter a description for the package;

File(s) - Click the "Browse" button to select your file(s). You may add up to 25 files per package, so long as the total file size does not exceed 2GB. The total file size is the combined file size of all submitted files.

Deletion Date – Leave this date at the default setting of two weeks (14 days) from the submission date.

Recipient Information:

Manually Enter Email Address: Input nicholas.dankanich@med.navy.mil and hit the add button. (To remove a recipient, highlight their name and click the "Remove" button.)

Email Settings:

Check all four of the boxes:

- Encrypt email message when possible.

- Notify me when file(s) downloads are STARTED.

- Notify me when file(s) downloads are COMPLETED.

- Require CAC for Pick-up (all recipients will need to log in with a CAC to download file(s).

To the right of “Email Settings” is a nondescript box with two options (None or FOUO). Select the FOUO option and select “sensitive” from the dropdown menu below.

Review all fields for accuracy and hit the ‘submit” button. Clicking the "Submit" button will upload the files and submit the package. Guest users will need to check their email to verify their email address before the recipients will be notified. After the package has been uploaded, the Government will receive a link to the package download page as well as a password. These passwords are unique for each recipient (not the package), and will be disabled once SAFE detects that the user successfully downloaded each file within the package.

Once the offeror has submitted their proposal, they shall send a confirmation email to Nicholas.dankanich@med.navy.mil and provide their company name and contact information as well stating that they have submitted a complete proposal to SAFE in response to solicitation N62645-15-R-0002. Submission of proposals is a onetime affair (unless in unusual circumstances multiple SAFE submissions are required because an offeror exceeded the 25 file limit per SAFE submission.). Additional documents will not be accepted after receipt of the confirmation email from the offeror to the Nicholas.dankanich@med.navy.mil inbox that confirms successful submission of the proposal.

Any data previously submitted in response to another solicitation, whether submitted to the Naval Medical Logistics Command or another agency, should be assumed to be unavailable during this proposal evaluation and source selection process. Proposal data shall not be incorporated into the proposal by referring to another proposal or other source.

The Government reserves the right to request additional information after receipt of Offeror’s response to the RFP. The proposal shall be valid for not less than 180 calendar days from the proposal due date. The Offeror shall make a clear statement that the proposal is valid until such date in Volume I.

Offerors are cautioned that in order for their proposal to be eligible for award, the proposal shall be in compliance with all of the terms and conditions set forth in the RFP.

5.1.1. 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.

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

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

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

5.1.2.3. 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.”

6. Solicitation Questions. Questions concerning the proposal are due no later than 02:00 PM Local Time, on 14 January 2015. Questions will not be addressed after this cutoff date. Questions shall be submitted via the AMRDEC SAFE website in accordance with the Instructions provided in Section 5 “File Submission” to the Addendum to 52.212-1 “Instructions to Offeror.” Offerors shall submit one set of questions only; multiple submissions shall not be accepted. An amendment to the solicitation will be issued providing responses to the questions.

7. 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 (OCT 2014)

(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:

EVALUATION CRITIERA

BENZOYLECGONINE IMMUNOASSAY REAGENT KITS

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: Small Business Participation Plan And Subcontracting Plan Volume IV: Business Proposal

Evaluation Factor G: 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 Factor A, B, and C minimum requirements, then the firm’s offer will be further evaluated on a tradeoff basis taking into consideration Evaluation Factors D-G. 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 more important than Factor F, Small Business Participation Plan And Subcontracting Plan. The combination of Evaluation Factors D, E and F will be more important than G, Price.

Volume I: Technical Approach Proposal

Evaluation Factor A: FDA and ISO Certification. Certification of FDA approval/authorization for the proposed Benzoylecgonine Immunoassay Reagent. Documentation of FDA approval/authorization for use of the Benzoylecgonine 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 Roche Hitachi Modular Analyzer and the Beckman Coulter AU5830 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) Calibration AND Parameter settings for use on the Roche Hitachi Modular Analyzer and the Beckman Coulter AU5830 Analyzer. The reagent calibrator and positive controls shall be Benzoylecgonine.

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

(7) 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.

Shelf-Life: In accordance with the Statement of Work paragraph 1.5, the offeror shall state the reagent kit proposed has a 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.

Evaluation Factor C: Performance Test – Minimum Requirements. 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. Upon request, the offeror shall ship a SUFFICIENT number of reagent kits to perform at least 2,000 tests, plus enough reagent for instrument start up, priming/purging lines, calibration, quality control checks, and shut down. In total, a SUFFICIENT number of reagent kits shall be shipped to perform the EQUIVALENT of at least 5,000 tests. 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 Benzoylecgonine test reagent’s ability to meet the solicitation requirements, as described below.

The Calibrator (CAL) shall be Benzoylecgonine at a target concentration of 150 ng/mL. Quality Control (QC) specimens containing Benzoylecgonine at target concentrations of 0%, 50%, 75%, 125%, 150% and 200% of the CAL concentration shall be analyzed with each batch of specimens. Data obtained will be evaluated to determine the vendor’s Benzoylecgonine test reagent’s ability to meet minimum requirements.

1. Previously confirmed and archived Benzoylecgonine positive specimens that are authorized for disposal shall be re-confirmed as positive (above 150 ng/mL Benzoylecgonine) and analyzed by immunoassay. At least 20 but, no more than 100 positive specimens shall be analyzed with water blanks between each specimen.

1.1. The minimum requirement is met if at least 95% of the specimens are correctly identified as positive by the offeror’s immunoassay reagent for the presence of Benzoylecgonine, utilizing the DoD initial screen cutoff concentration of 150 ng/mL.

2. Approximately 2,000 specimens (20 batches), submitted to the laboratory for routine testing, shall be analyzed by immunoassay.

2.1. The minimum requirement is met if at least 97.5% of the 125% QC specimens screen positive.

2.2. The minimum requirement is met if at least 97.5% of the 75% QC specimens screen negative.

2.3. The minimum requirement is met if 100% of the 0% QC specimens screen negative and provide values less than the mean of the 50% QC specimens both within runs and between runs.

2.4. The minimum requirement is met if 100% of the 150% QC specimens screen positive and provide values greater than the mean of the 100% QC specimens both within runs and between runs.

3. Precision/Accuracy, Linearity, and Calibration Stability of the Benzoylecgonine reagent will be evaluated based on analysis of 20 replicates of Benzoylecgonine QC specimens at target concentrations of 0%, 50%, 75%, 100%, 125%, 150%, and 200% of the CAL analyzed at 0 hours, 4 hours, and 8 hours after calibration.

3.1. The minimum requirement is met if there is a positive correlation for the slopes (i.e., increasing concentrations result in increasing values) of the lines drawn between the mean replicate values…