N6264517Q0028.pdf

N6264517Q0028

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, 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. The solicitation number is N6264517Q0028. The solicitation is issued as a request for proposals (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2005-95 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses:

https://www.acquisition.gov/ and http://farsite.hill.af.mil/. The NAICS code is 325413, with a small business size of 1,250. The requirement will be fulfilled via an unrestricted, full and open competitive acquisition.

This RFP is on behalf of the Department of Defense (DoD) Drug Demand Reduction Program (DDRP). This requirement is for an immunoassay test reagent for the detection of Oxycodone and Oxymorphone in urine.

Proposal Submission Proposals are due no later than 27 October 2017 by 02:00 PM Local Time. Proposals shall be submitted in accordance with the Addendum to 52.212-1 Instructions to Offerors.

ITEM NO SUPPLIES/SERVICES ESTIMATED

QUANTITY

UNIT UNIT PRICE ESTIMATED AMOUNT

0001 6,600,000 Each Oxycodone & Oxymorphone Reagent Kits

FFP

**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 ADDITIONAL MARKINGS: See Individual Delivery Orders

ESTIMATED

NET AMT

https://www.acquisition.gov/ http://farsite.hill.af.mil/

UNIT UNIT PRICE ESTIMATED AMOUNT

1001 6,600,000 Each OPTION Oxycodone & Oxymorphone Reagent Kits

FFP

**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).**

UNIT UNIT PRICE ESTIMATED AMOUNT

2001 6,600,000 Each OPTION Oxycodone & Oxymorphone Reagent Kits

FFP

**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).**

UNIT UNIT PRICE ESTIMATED AMOUNT

3001 6,600,000 Each OPTION Oxycodone & Oxymorphone Reagent Kits

FFP

**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).**

UNIT UNIT PRICE ESTIMATED AMOUNT

4001 6,600,000 Each OPTION Oxycodone & Oxymorphone Reagent Kits

FFP

**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).**

STATEMENT OF REQUIREMENTS

1. General requirements for an immunoassay test reagent for the detection of Oxycodone and Oxymorphone in urine.

1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of oxycodone and oxymorphone in urine. When using the vendor’s recommended calibrator at a 100 ng/mL concentration, the testing reagent shall be used to detect oxycodone and oxymorphone in urine when present individually or in combination at a urine concentration equal to or greater than 100 ng/mL. The reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers, in use at the Department of Defense (DoD) Forensic Toxicology Drug Testing Laboratories (FTDTLs), and shall be compatible without modification of the equipment. The immunoassay procedure is limited to a two reagent assay procedure. A vendor’s reagent proposal which requires a separate pretreatment of each testing specimen prior to testing on the Beckman analyzer will not be considered acceptable. The reagent shall be compatible with the optimal throughput of the analyzer systems 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 oxycodone and oxymorphone in physiological urine specimens when present individually or in combination at concentrations equal to or greater than 100 ng/mL. The reagent shall minimize cross-reactivity with natural and synthetic opioids and the drugs or drug metabolites listed below (excluding the compound(s) of interest). DoD laboratory certified solutions of the vendor’s recommended calibrator at a concentration of 100 ng/mL shall be used for calibration of the analyzer. The testing reagent shall be evaluated for its ability to detect specimens containing oxycodone and oxymorphone, individually or in combination, at concentrations equal to or greater than the DoD immunoassay screening cutoff concentration of 100 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 vendor recommended calibrator and QC analyte shall be oxycodone or oxymorphone. The following drug cutoffs (in ng/mL) are currently used by DoD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively.

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

Benzoylecgonine (BZE) 150, 100;

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-hydroxyalprazolam (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;

MAM-2201 (MAM22) 10, 1;

AB-CHIMINACA (ABCHM) 10, 1;

AB-PINACA (ABPIN) 10,1.

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

1.3.1 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.

1.3.2. Except as provided herein, the reagents supplied throughout the term of this contract shall be identical to the reagents offered by the contractor and accepted by the Government at the time of the contract award. If, during the course of this contract, the manufacturer wishes to change or improve its kit, that product modification shall be proposed in writing to the Contracting Officer for approval prior to its incorporation into the kits to be delivered.

The contractor's proposal shall include documentation that demonstrates that the manufacturer has complied with all applicable FDA regulations, including those concerning the filing of a new 510k notice if such action and subsequent FDA clearance are warranted by the nature of the modification.

1.4. 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. 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.

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 Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. Verification of each calibration (at 100 ng/mL) shall be accomplished with a drug free control and open controls at target concentrations of 50-75% and 150-200% of the calibrator/cutoff. An acceptable verification will have analytical readings for the drug free < 50-75% control < cutoff (calibrator) < 150-200% control. 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 oxycodone and oxymorphone when present individually or in combination in human urine at concentrations equal to or greater than 100 ng/mL as determined by the current immunoassay and gas chromatography/ mass spectrometry (GC/MS) or liquid chromatography/ tandem mass spectrometry (LC/MS/MS) procedures utilized in the military laboratories.

3.2. The reagent shall be capable of identifying specimens as negative for oxycodone and oxymorphone when present individually or in combination in human urine at concentrations below 100 ng/mL as determined by the current immunoassay and GC/MS or LC/MS/MS procedures utilized in the military laboratories.

3.3. The reagent performance, as evaluated through the performance of controls, shall be stable over the course of the day and shall not require re-calibration within an eight hour period.

3.4. The reagent shall display precision and accuracy both within and between batches for concentrations ranging between 50-200% of the calibrator concentration.

3.5. The reagent shall produce non-overlapping ranges for samples analyzed at 0%, 50%, 100%, 150%, and 200% of the calibrator concentration.

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 accordance 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 a minimum of 180 days from date of delivery to the drug testing laboratory).

4.4. Antibody specificity.

4.4.1 Characteristics. 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 oxycodone and oxymorphone in urine. 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.

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 molecules 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 Requirements of this contract.

2. Marking of Shipments (Commercially Packed 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: To Be Determined At Contract Award Government Delivery Order Number: See Individual Delivery Orders

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.

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 Shannon Lertora 693 Neiman Street

Fort Detrick, Maryland 21702

(301) 619-0287 Email: Shannon.P.Lertora.civ@mail.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.

Requiring Activity Ordering Activity 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

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 160 Takata Road Fort Shafter Flats, HI 96858

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.

mailto:Shannon.P.Lertora.civ@mail.mil

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 usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.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 usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.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.

CONTRACTOR SUPPORT

Notice: Navy Use of Support Contractor For Contract Closeout Functions

Naval Medical Logistics Command (NMLC) uses two private contractors in support of the contract closeout process. Those companies are Contracting Resources Group (CRG) of Federal Hill, 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 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 mailto:usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil mailto:usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil 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.

NMLC 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 a proposal in response to the solicitation, the awardee 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.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 1001 Destination Government Destination Government 2001 Destination Government Destination Government 3001 Destination Government Destination Government 4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 01-OCT-2018 TO

30-SEP-2019

N/A NAVAL MEDICAL LOGISTICS COMMAND

SEE DO/TO

SEE DELIVERY/TASK ORDERS

FOR SHIP TO/ PAYMENT INSTRUCTIONS

SEE DO/TO MD

SEE ORDER

N62645

1001 POP 01-OCT-2019 TO

30-SEP-2020

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 01-OCT-2020 TO

30-SEP-2021

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 01-OCT-2021 TO

30-SEP-2022

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 01-OCT-2022 TO

30-SEP-2023

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-18 Prohibition on Contracting With Entities That Require Certain

Internal Confidentiality Agreements or Statements-- Representation

JAN 2017

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

JAN 2017

52.204-7 System for Award Management OCT 2016 52.204-13 System for Award Management Maintenance OCT 2016 52.209-7 Information Regarding Responsibility Matters JUL 2013 52.212-1 Instructions to Offerors--Commercial Items JAN 2017 52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017 52.219-9 Alt II (Dev)

Small Business Subcontracting Plan (Deviation 2016-O0009)

- Alternate II

JAN 2017

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

DEC 2013

52.247-34 F.O.B. Destination NOV 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7005 Representation Relating to Compensation of Former DoD Officials

NOV 2011

252.204-7008 Compliance With Safeguarding Covered Defense Information Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

OCT 2016

252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991 252.213-7000 Notice to Prospective Suppliers on Use of Past Performance

Information Retrieval System--Statistical Reporting in Past Performance Evaluations

JUN 2015

252.215-7008 Only One Offer OCT 2013 252.219-7003 (Dev) Small Business Subcontracting Plan (DOD Contracts)--Basic

(Deviation 2016-O0009)

AUG 2016

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013 252.225-7012 Preference For Certain Domestic Commodities DEC 2016 252.225-7021 Trade Agreements--Basic DEC 2016 252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business Concerns

SEP 2004

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7002 Requests for Equitable Adjustment DEC 2012 252.244-7000 Subcontracts for Commercial Items JUN 2013 252.246-7000 Material Inspection And Receiving Report MAR 2008 252.247-7023 Transportation of Supplies by Sea APR 2014

ADDENDUM 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.

Four separate and complete volumes (listed above) 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 Requirements 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. Descriptions of contracts in excess of the stated limited of three will not be evaluated. 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. All offerors are required to submit a small business participation plan (SBPP). 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 SBPP and 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 IV: 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 reagent manufacturer. The Government may deviate from the reagent manufacturer’s recommended parameters when conducting testing.

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 must be registered in System for Award Management (SAM) in accordance with FAR 52.204-7 and FAR 52.204-13. The offeror shall verify its SAM record is current, accurate, complete and applicable to this solicitation as of the date of this offer and is incorporated in this offer by reference. The offeror shall complete the SAM Certification Sheet (Refer to Attachment 2).

4.13. The offeror shall complete and submit FAR Clause 52.209-11 [Representation By Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016)].

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

4.15. ***The offeror shall include a statement in their Volume IV: Business Proposal acknowledging their understanding that the price per test is requested for evaluation purposes only and that the contract will reference prices per kit only.***

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 Shannon.P.Lertora.civ@mail.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 https://safe.amrdec.army.mil/SAFE/Welcome.aspx 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 Shannon.P.Lertora.civ@mail.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 N6264517Q0028. 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 Shannon.P.Lertora.civ@mail.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 solicitation are due no later than 02:00 PM Local Time, seven days after the solicitation is issued. Questions will not be addressed after this cutoff date. Questions shall be submitted via email to Shannon.P.Lertora.civ@mail.mil (Subject: N6264517Q0028). 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

52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A

FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that--

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that--

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

(End of provision)

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:

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: Small Business Participation Plan and Subcontracting Plan 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 Oxycodone Immunoassay Reagent. Documentation of FDA approval/authorization for use of the Oxycodone 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 Requirements 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 Beckman Coulter AU5800 Series Analyzer in the processing of samples.

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

(4) Reagent stability and storage requirement for both unopened and opened working reagent.

(5) Calibration AND Parameter settings for use on the Beckman Coulter AU5800 Series Analyzer. The reagent calibrator and positive controls shall be oxycodone or oxymorphone.

(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, and 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.

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.