2_-_Combined_Synopsis_Solicitation_(6-AM).docx

N6264519Q0003

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

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

This Request for Quote (RFQ) is on behalf of the Department of Defense (DOD) Drug Demand Reduction Program (DDRP). This requirement is for immunoassay reagent kits for the detection of designer amphetamines, 6-Acetylmorphine (6-AM) abuse in urine.

The solicitation number is N62645-19-Q-0003.

This solicitation will result in one firm fixed price Requirements type contract with a five year ordering period from 05 October 2019 – 04 October 2024. Approximately 6,000,000 tests shall be required each year. The requirement will be fulfilled via an unrestricted, full and open competitive acquisition.

Proposals are due by 24 May 2019 by 2:00 PM Local Time. Proposals shall be submitted in accordance with the instructions in FAR 52.212-1 Instructions to Offerors--Commercial Items and the Addendum to 52.212-1 via email to Lindsay.k.burdette.civ@mail.mil and usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil (SUBJECT: N62645-19-Q-0003 6AM Reagent Kits).

Kit

6-AM Reagent Kit

FFP

Catalog Number: _______________________ Product Description: ____________________ Estimated 500,000 tests per month.

Estimated Price per Test: $TBD Estimated Number of Tests per Kit: ________ Estimated Quantity of Kits per Year: _______ ** Complete Attachment 1: Pricing Sheet. **

FOB: Destination

PSC CD: 6550

ESTIMATED

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

04-OCT-2024

SEE TASK ORDER(S)

SEE TASK ORDER(S) MD

FOB: Destination N62645

STATEMENT OF WORK

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF 6-ACETYLMORPHINE IN URINE

1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of 6-acetylmorphine (6AM) in urine when present at a concentration equal to or greater than 10 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), 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 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 analyzer shall be calibrated at 10 ng/mL using DOD FTDTL certified solutions containing 6-AM. The controls will utilize the same compound as the calibrator. The reagent shall minimize cross-reactivity with structurally similar drugs/metabolites in addition to the drugs/metabolites on the current DOD drug testing panel, listed below (excluding the compound of interest). 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 following drug cutoffs are currently used by DOD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively.

(ng/mL)

Codeine

Hydrocodone

Hydromorphone

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

1.3.1 Immunoassay kits are considered medical devices and shall have clearance from the 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 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 reagents provided shall be in volumes and packaging that are convenient and applicable to the sample throughput at the FTDTLs 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/controls. The reagents 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 FTDTL 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. The minimum shelf life of any unopened component of the assay shall be at least 180 days from the date of delivery to the FTDTL. Once kit container seals are broken and the components are opened, the shelf-life shall be at least 14 days.

1.6. The FTDTLs intend to use the immunoassay kits in a manner consistent with the FDA approval. The package insert and information for the analyzer settings must contain the information necessary for the FTDTLs to use the immunoassay kits consistent with the device’s FDA approval. This ensures that the FTDTLs can use the immunoassay kits properly and derive the full benefit of the FDA approval.

2. TESTING and QUALITY CONTROL PROTOCOL.

2.1. The reagents supplied shall be compatible with the calibration requirements and characteristics of the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. Verification of each calibration, at 10 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 as follows: drug free control < 50-75% control < cutoff (calibrator) < 150-200% control. The batch may also contain blind negative and positive controls distributed throughout the batch.

3. PERFORMANCE CHARACTERISTICS.

3.1. The reagent shall be capable of identifying specimens as positive for 6AM when present in human urine at concentrations equal to or greater than 10 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 FTDTLs.

3.2. The reagent shall be capable of identifying specimens as negative for 6AM when present in human urine at concentrations below 10 ng/mL as determined by the current immunoassay and GC-MS or LC-MS/MS procedures utilized in the FTDTLs.

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.

3.6. The reagent shall have minimal cross reactivity with analytes other than 6-AM.

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, 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. 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. Preventative 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 supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials shall be established and compliance documented.

4.3. Antibody

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

4.3.2. Stability. The antibody shall be documented to be stable to the expiration date and the immunoassay shall meet all contract specifications to the end of expiration date (a minimum of 180 days from date of delivery to the drug testing laboratory).

4.3.3. 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 6AM 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 may include biochemical materials produced normally in the human body.

4.4. Immunoassays

4.4.1. Technical Performance. Performance of each lot of reagent 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. The performance parameters involved in the testing procedures shall be verified and documented to be consistent throughout the shelf life of the kit.

4.4.2. 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.

4.4.3. Records. The production and quality control records generated by each procedure performed above shall be maintained in a systematic fashion to permit the verification of the completion of all production parameters and shall be available for inspection during the term of the contract.

4.4.4. 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. 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.

4.4.5. Lot numbers. Lot numbers shall be used to identify reagents 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.

5. PACKAGING AND MARKING

5. 1. THERMAL PROTECTION FOR BIOLOGIC REAGENTS

5. 1.1. The contractor will ship biologic reagent items used in the reagent kits 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.

5. 2. MARKING OF SHIPMENTS (COMMERCIALLY PACKAGED ITEMS)

5. 2.1. Marking shall be in accordance with ASTM D 3951 15, "Standard Practice for Commercial Packaging."

(a) Additional markings are stated below:

Contract Number:

Government Delivery Order Number:

5. 3. DETERIORATIVE MATERIAL MARKING

5. 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.

(End)

CLAUSES INCORPORATED BY REFERENCE

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 Quote (RFQ). 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 this Addendum. 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 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 and Enhancing Factors 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.

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 DFARS Clause 252.219-7003, Small Business Subcontracting Plan (DoD Contracts)--Basic (DEVIATION 2018-O0007). 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 per year in Attachment 1: Pricing Sheet.

4.4. Offerors shall state the total number of tests per kit proposed per year in Attachment 1: Pricing Sheet. The number of tests shall be based on the reagent volume recommended by the reagent manufacturer.

4.5. Offerors shall propose a price per kit based on the estimated number of tests proposed per year in Attachment 1: Pricing Sheet.

4.6. Based on the estimated tests per month identified in CLIN 0001 of the solicitation, Offerors shall propose the estimated number of kits per year in Attachment 1: Pricing Sheet.

4.7. Offerors shall propose a total price per year in Attachment 1: Pricing Sheet.

4.8. Offerors shall propose a total 5-year price in Attachment 1: Pricing Sheet.

4.9. Offerors shall propose 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 The 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 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 the 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 usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@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:

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 usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@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 N6264519Q0003. 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 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 RFQ. 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 RFQ.

5.1.1. Files shall be readable in Microsoft Office 2013 for Windows format, 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 Quote (RFQ):

5.1.2.1. Cover sheet which indicates RFQ 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 this solicitation are due no later than 02:00 PM Local Time, NLT seven days after the solicitation is issued. Questions will not be addressed after this cutoff date. Questions shall be submitted via email to usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil (Subject: N62645-19-Q-0003). Offerors may also include a cc to the Contract Specialist noted in the CONTRACT ADMIN DATA section. 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 determines them to be necessary.

(End)

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. A process known as a tradeoff between non-cost factors and cost/price will allow the Government to accept other than the lowest priced proposal or other than the highest technically rated proposal to achieve a best-value contract award. Proposals will be evaluated based on the evaluation criteria below:

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 and Enhancing Factors Volume II: Past Performance Proposal Evaluation Factor D: Past Performance Volume III: Small Business Participation Plan and Subcontracting Plan Proposal Evaluation Factor E: Small Business Participation Plan and Subcontracting Plan Volume IV: Business Proposal Evaluation Factor F: Price

Evaluation Factors A and B will be evaluated individually on a pass/fail basis. If an offeror's technical proposal fails under Evaluation Factors A or B, either initially or following discussions if they are conducted, the offer will receive no further consideration for award unless there are no other technically compliant proposals.

If an offeror’s technical proposal passes both Evaluation Factors A and B, then the offeror will subsequently be notified of Evaluation Factor C, the performance test of the reagent. The offeror will be further evaluated on a tradeoff basis to determine compliance. Reagent kit performance will be rated on a five tiered scale. The rating from Factor C is more important than Factor D, Past Performance. Factor D, is more important than Factor E, Small Business Participation Plan and Subcontracting Plan. The combination of Evaluation Factors C, D and E will be more important than Factor F, Price

Rating Scale for Evaluation Factor C: Performance Test – Minimum Requirements and Enhancing Factors

Rating Scale for Evaluation Factor D: Past Performance

Volume I: Technical Approach Proposal

Evaluation Factor A: FDA and ISO Certification. Documentation of FDA approval/authorization for use of the 6AM 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 Sections 4.1 through 4.4.5 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. The immunoassay procedure is limited to a two reagent assay procedure.

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

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

(5) Minimum shelf life for unopened and opened reagents. In accordance with the Statement of Work paragraph 1.5, the unopened kits shall have a 180 day minimum shelf life from the date of delivery at the FTDTL, and opened reagents shall be shelf stable for at least 14 days.

(6) Calibration AND Instrument parameters for use on the Beckman Coulter AU5800 Series Analyzer. The drug contained in the calibrator and positive controls shall be 6AM.

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

(8) 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.

Evaluation Factor C: Performance Test. If the offeror’s proposal passes Factors A and B, the Government will conduct an evaluation of the vendor’s reagent at one of the four DOD FTDTLs located within the continental United States. The test will 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 5,000 tests, plus enough reagent for instrument start up, calibration, quality control checks, and shut down. These reagents shall be shipped, at no cost to the Government, to the designated FTDTL.

Data obtained will be analyzed as to the 6AM test reagent’s ability to meet the solicitation requirements, as described below. The Calibrator (CAL) shall be 6AM with a target concentration of 10 ng/mL. Quality Control (QC) samples containing the calibrator analyte at target concentrations of 0%, 50-75%, and 150-200% of the CAL concentration shall be analyzed with each batch of specimens. Data obtained will be evaluated to determine each reagents’ ability to meet minimum requirements. The absorbance is normalized so that 100 indicates a positive result (results less than 100 are negative).

1. Previously confirmed and archived 6AM positive specimens that are authorized for disposal shall be re-confirmed as positive (6AM above 10 ng/mL) 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 6AM, utilizing the DOD initial screen cutoff concentration of 10 ng/mL.

2. Approximately 2,000 specimens, submitted to the FTDTL for routine testing, shall be analyzed by immunoassay.

2.1. The minimum requirement is met if 100% of the 0% QC samples screen negative and provide values less than the mean of the 50-75% QC samples both within runs and between runs.

2.2. The minimum requirement is met if at least 95% of the 50-75% QC samples screen negative.

2.3. The minimum requirement is met if 97.5% of the 150-200% QC samples screen positive.

2.4. An enhancing factor is the ability to correctly identify positive and negative specimens. Specimens that yield a positive 6AM initial screen result (current kit and kit(s) being evaluated) will be confirmed by GC-MS or LC-MS/MS. Greater ability to correctly identify confirmed negative samples and positive specimens (fewer false positives and fewer false negatives) will increase the value of the kit.

3. Precision/Accuracy, Linearity, and Calibration Stability of the 6AM reagent will be evaluated based on analysis of 20 replicates of QC samples 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 of the 0% through 150% concentrations.

3.2. The minimum requirement is met if individual replicates at 0%, 50%, 100%, and 150% demonstrate a distinctive range of values with no overlap with adjacent concentrations.

3.3. The minimum requirement is met if the coefficients of variation (CVs) of the 20 replicate values at 75%, 100%, 125%, 150%, and 200% of the CAL are less than 10% within each run and less than 15% within the three timed runs.

4. The effect/interference of endogenous matrix components, commonly encountered compounds, and compounds that are structurally similar to the analytes of interest on the immunoassay response will be evaluated by spiking drug-free urine with high concentrations of potentially interfering analytes in the table below. Cross reactivity will be evaluated according to the response values.

4.1. An enhancing factor is a low cross reactivity with the interference study analytes. Better specificity (lower/negative response values for non-analyte of interest specimens) will increase the rating of the enhancing factor.

Volume II: Past Performance Proposal

Evaluation Factor D - Past Performance. The Past Performance evaluation will result in an assessment of the offeror’s probability of meeting the solicitation requirements. The Government is likely to randomly select references provided for contact and does not commit to contact every reference.

The Government will evaluate past performance for (a) Relevancy: how pertinent a recent effort accomplished by the offeror is to the effort to be acquired through the source selection; (b) Quality: total number of rejected or returned reagents, with reasons for rejection or return, and total number of kits replaced; and (c) Responsiveness: vendor's compliance with established delivery schedules and ability to provide timely replacement reagents due to recall or return.

The Government reserves the right to utilize other information not provided by the vendor and will evaluate information readily available. It is the responsibility of the offeror to ensure names and phone numbers of points of contact are verified and accurate. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror will not be evaluated favorably or unfavorably on past performance (FAR 15.305(a)(2)(iv)). The offeror will receive a neutral rating.

Volume III: Small Business Participation Plan and Subcontracting Plan Proposal

Evaluation Factor E: Small Business Participation Plan and Subcontracting Plan. All offerors (both large and small businesses) will be evaluated on the level of small business commitment that they are demonstrating for the proposed acquisition, and their level of commitment to utilizing small businesses in performance of prior contracts.

The small business participation plan factor will be evaluated against the requirements in “ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS”, on an “Acceptable (Pass)” or “Unacceptable (Fail)” basis and one of these ratings will be assigned accordingly.

The following shall evidence small business participation:

a. The extent to which such firms, as defined in FAR Part 19, are specifically identified in proposals;

b. The extent of commitment to use such firms (enforceable commitments will be weighted more heavily than non-enforceable ones);

c. The complexity and variety of the work small firms are to perform;

d. The realism of the proposal;

e. Past performance of the offeror in complying with requirements of the clauses at DFAR 252.219-7003, Small Business Subcontracting Plan (DoD Contracts)--Basic (DEVIATION 2018-O0007);

f. The extent of participation of such firms in terms of the value of the total acquisition;

g. The extent to which the offeror provides detailed explanations/documentation supporting the proposed participation percentages, or lack thereof.

The Department of Defense (DOD) has established small business goals as an assistance to assure small business receives a fair proportion of DOD awards. The goals for this procurement are as follows:

Small Business: {30%} of the total *contract value;

Small Disadvantaged Business: {5.0%} of the total contract value;

Woman-Owned Small Business: {5.0%} of the total contract value;

Historically Underutilized Business Zone (HUBZone) Small Business: {3.0%} of the total contract value;

Veteran Owned Small Business: {3.0%} of the total contract value;

Service Disabled Veteran Owned Small Business: {3.0 %} of the total contract value.

(Note, for example, that a participation plan that reflects {5.0%} of the contract value for Woman-Owned Small Business would also count towards the overall Small Business Goal).

*The Government recognizes that these goals are stated as a percentage of the total contract value for the small business participation plan; whereas, the goals included in the subcontracting plan (FAR Clause 52.219-9) are stated in terms of a percentage of total subcontract dollars.

Volume IV: Business Proposal

Evaluation Factor F – Price. Price will not be scored or rated. Evaluation of price will be performed using one or more of the price analysis techniques in FAR 13.106-2(b). Through these techniques the Government will determine whether prices are reasonable. Inasmuch as the best value offer will be determined through tradeoff analysis, the Government is not bound to award to the lowest evaluated price. On the other hand, if the Government determines that a higher rated proposal offers value-added features but at an unreasonable/unjustifiable incremental amount, it is not bound to award to a higher technically rated proposal. The Government intends to award a 5-year contract without options. The Government may award multiple CLINs as necessary to allow for different price per year estimates.

The proposal will also be evaluated for completeness. Completeness is the offeror’s proposal being submitted in accordance with the Volume IV: Business Proposal instructions in the solicitation, specifically the Addendum to 52.212-1 paragraph 4 in its entirety.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (OCT 2018)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u)) of this provision.

(a) Definitions. As used in this provision --

“Economically disadvantaged women-owned small business (EDWOSB) Concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or service-

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

“Inverted domestic corporation” means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except--

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440,…