Combined_Synopsis_Solicitation_-_MDMA_-_N62645-18-Q-0048.docx

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, METHYLENEDIOXYMETHAMPHETAMINE (MDMA) and METHYLENEDIOXYAMPHETAMINE (MDA) abuse in urine.

The solicitation number is N62645-18-Q-0048.

This solicitation will result in one firm fixed price Requirements type contract with a five year period of performance (no options). Period of Performance shall be from 01 February 2019 – 31 January 2024. Approximately 6,600,000 tests shall be required each year. The requirement will be fulfilled via an unrestricted, full and open competitive acquisition.

Proposals are due by 29 October 2018 by 12:00 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: N62645-18-Q-0048 MDMA/MDA Reagent Kits).

Kit

MDMA/MDA Reagent Kit

FFP

Estimated 550,000 tests per month.

Estimated Number of Tests per Kit: ________ Estimated Quantity of Kits per Year: _______ Catalog Number: _______________________ Product Description: ____________________ ** Complete Attachment 1: Pricing Sheet to include Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, and Total Price per Year. ** FOB: Destination

PURCHASE REQUEST NUMBER: N6264518RC3D002

PSC CD: 6550

ESTIMATED

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

31-JAN-2024

SEE TASK ORDER(S)

SEE TASK ORDER(S) MD

FOB: Destination N00000

STATEMENT OF WORK (SOW)

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF METHYLENEDIOXYMETHAMPHETAMINE (MDMA) AND METHYLENEDIOXYAMPHETAMINE (MDA) IN URINE

1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of both of the designer amphetamines, methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine (MDA), in urine. When using the vendor’s recommended calibrator at a 500 ng/mL concentration, the testing reagent shall be used to detect MDMA and MDA in urine when present individually or in combination at a urine concentration equal to or greater than 500 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 MDMA and MDA in physiological urine specimens when present individually or in combination at concentrations equal to or greater than 500 ng/mL. The reagent shall be calibrated with either MDMA or MDA and the cross-reactivity of the reagent to MDMA and MDA must be 80 percent or greater. The reagent shall minimize cross-reactivity with other pharmacological drugs or metabolites commonly associated with cold medications containing over-the-counter (OTC) medications such as, but not limited to, l-amphetamine/l-methamphetamine, ephedrine, pseudoephedrine, phenylpropanolamine and other sympathomimetic amines in addition to 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 500 ng/mL shall be used for calibration of the analyzer. The testing reagent shall be evaluated for its ability to detect specimens containing MDMA and MDA, individually or in combination, at concentrations equal to or greater than the DoD immunoassay screening cutoff concentration of 500 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 MDMA or MDA. 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) –

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 500 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. Open and blind QC samples 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 MDMA and MDA when present individually or in combination in human urine at concentrations equal to or greater than 500 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 MDMA and MDA when present individually or in combination in human urine at concentrations below 500 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 QC samples, 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 at least 80 percent cross reactivity to MDMA and MDA.

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

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 (which is 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 MDMA and MDA 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.

4.4. Immunoassays.

4.4.1. 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.

4.4.2. Stability. The performance parameters involved in the testing procedures shall be verified and documented to be consistent throughout the shelf life of the kit.

4.4.3. 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.

4.4.4. 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.

4.4.5. 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.

4.4.6. 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.

5. PACKAGING AND MARKING

5.1. THERMAL PROTECTION FOR BIOLOGIC REAGENTS

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

5.2. MARKING OF SHIPMENTS (COMMERCIALLY PACKAGED ITEMS)

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

(a) Additional markings are stated below:

Contract Number:

Government Delivery Order Number:

5.3. DETERIORATIVE MATERIAL MARKING

5.3.1. The contractor shall 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.

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.212-1 (Dev) INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (DEVIATION 2018-O0013) (AUG 2018)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF 1449). However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers. Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC 20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision. Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers exceeding the micro-purchase threshold and offers at any dollar value if the solicitation requires the Contractor to be registered in the System for Award Management (SAM) database. The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation ``Unique Entity Identifier'' followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) System for Award Management. Unless exempted by an addendum to this solicitation, by submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance and through final payment of any contract resulting from this solicitation. If the Offeror does not become registered in the SAM database in the time prescribed by the Contracting Officer, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror. Offerors may obtain information on registration and annual confirmation requirements via the SAM database accessed through https://www.acquisition.gov.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

(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:

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:

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, (Performance Test of reagent) to determine compliance. If an offeror’s technical proposal is judged to have failed under Evaluation Factor C, the offeror’s proposal 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 offeror’s proposal will be further evaluated on a tradeoff basis. Thus, Evaluation Factors D-G will be taken into consideration. In doing so, Evaluation Factor D (Performance Test – Enhancing Factors) is more important than Evaluation Factor E (Past Performance). The combination of Evaluation Factors D and E will be more important than Evaluation Factor F (Small Business Participation Plan and Subcontracting Plan). The combination of Evaluation Factors D, E and F will be more important than Evaluation Factor G (Price).

Tradeoff Evaluation Factor Ratings:

Evaluation Factor D: Performance Test – Enhancing Factors

Evaluation Factor E: Past Performance

Volume I: Technical Approach Proposal

Evaluation Factor A: FDA and ISO Certification. Certification of Food and Drug Administration (FDA) approval/authorization for the proposed MDMA/MDA Immunoassay reagent. Documentation of FDA approval/authorization for use of the MDMA/MDA Immunoassay reagent shall be provided with the offeror’s' proposal. Documentation of current certification compliance with applicable International Standards Organization (ISO) Standards (in the form of a copy of the applicable certificate(s)) or documentation of compliance with Statement of Work (SOW) Sections 4.1 through 4.4.6 shall be provided with the offeror’s’ proposal.

Evaluation Factor B: Reagent Preparation and Calibration Information. Package-insert with complete, accurate and verifiable information shall contain the following:

(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 recommended by the reagent kit manufacturer, and shall be either MDMA or MDA.

(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, with regards to commonly encountered scheduled compounds, common over-the-counter medications, and other principal drugs of abuse.

Note: DDRP intends to use the immunoassay kits in a manner consistent with their FDA approval. The package insert and information for the analyzer settings must contain the information necessary for DDRP to use the immunoassay kits consistent with the device’s FDA approval. This ensures DDRP can use the immunoassay kits properly and derive the full benefit of the FDA-approval.

Shelf-Life: The offeror shall specifically address shelf-life capabilities. In accordance with the Statement of Work paragraph 1.5, the offeror shall provide reagent kits with a minimum shelf life of at least 180 days from date of delivery at the drug testing laboratory for any unopened component of the assay. 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 Evaluation Factors A and B, the Government shall conduct an evaluation of the vendor’s reagent at one of the five DoD military drug screening laboratories located within the continental United States (CONUS). The test shall be conducted in accordance with the established protocol cited below in the Performance Test Section. Upon request, the offeror shall ship a SUFFICIENT number of reagent kits to perform at least five thousand (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 one of the four DoD military drug-screening laboratories located within the continental United States (CONUS).

Performance Test – Minimum Requirements

Data obtained will be analyzed as to the MDMA/MDA test reagent’s ability to meet the solicitation requirements, as described below.

The Calibrator (CAL) shall be a target concentration of 500 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 the vendor’s MDMA/MDA test reagent’s ability to meet minimum requirements. The absorbance is normalized so that 100 indicates a positive result (results less than 100 are negative, results 100 or above are positive).

1. Previously confirmed and archived MDMA and MDA positive specimens that are authorized for disposal will be re-confirmed as positive (MDMA and MDA above 500 ng/mL, individually or in combination) and analyzed by immunoassay. At least twenty (20), but no more than one hundred (100), positive specimens will 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 MDMA and MDA, utilizing the DoD initial screen cutoff concentration of 500 ng/mL.

2. Approximately two thousand (2,000) specimens, submitted to the laboratory for routine testing, will 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 100% of the 150-200% QC samples screen positive.

3. Precision/accuracy, linearity, and calibration stability of the MDMA/MDA 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 50%, 75%, 100%, 125%, 150%, and 200% of the CAL are less than 10% within each run.

3.4. The minimum requirement is met if the CVs of the 60 replicate values at 50%, 75%, 100%, 125%, 150%, and 200% of the CAL are less than 15% within the three timed runs.

4. Cross reactivity to the non-target analyte will be evaluated based on analysis of 10 replicates of QC samples spiked with the non-target analyte at target concentrations of 100%, 125%, and 150% of the cutoff concentration. The analyte used to calibrate the kit is the target analyte. Other analytes that are to be detected by the kit are the non-target analytes (i.e. MDA is the non-target analyte when the calibrator contains MDMA).

4.1 The minimum requirement is met if the average response of the QC specimens, spiked with the non-target analyte, demonstrate at least 80% cross reactivity.

4.1.1. For the 150% non-analyte QC sample replicates, the average normalized response of the 10 replicates must be greater than or equal to 120.

4.1.2. For the 125% non-analyte QC sample replicates, the average normalized response of the 10 replicates must be greater than or equal to 100.

4.1.3. For the 100% non-analyte QC sample replicates, the average normalized response of the 10 replicates must be greater than or equal to 80.

Evaluation Factor D: Performance Test – Enhancing Factors. Reagents meeting the minimum requirements of the Performance Test will then be evaluated on the following factors:

(1) Linearity: A correlation coefficient which is closer to +1, as determined by linear regression analysis of data from Evaluation Factor C, 3. (0%, 50%, 75%, 100%, 125%, 150% and 200% of the CAL), will increase the value of the reagent.

(2) Sensitivity/Positive and Negative Predictive Rates: Approximately two thousand (2,000) actual military specimens will be analyzed to evaluate the reagent’s ability to distinguish between specimens containing MDMA and MDA at or above the 500 ng/mL screening cutoff and specimens that contain less than 500 ng/mL of MDMA and MDA. Confirmation results will be compared to immunoassay results. Samples that yield a positive MDMA/MDA initial screen result and samples that give a MDMA/MDA screening index value greater than/equal to 75 (current kit and kit(s) being evaluated) will be confirmed by GC/MS or LC/MS/MS. Greater sensitivity (ability to discriminate between negative samples with MDMA and/or MDA with concentrations below 500 ng/mL and positive samples with MDMA and/or MDA with concentrations above 500 ng/mL) and predictive rates (fewer false positives and fewer false negatives) will increase the value of the kit.

(3) Specificity: 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. Assessment will be performed by spiking drug-free urine with high concentrations of potentially interfering analytes. Cross reactivity will be evaluated with individual specimens containing 10 µg/mL of compounds such as l-amphetamine/l-methamphetamine, ephedrine, pseudoephedrine, phenylpropanolamine, other sympathomimetic amines and phentermine. Individual specimens containing 10 µg/mL of the compounds on the current DoD testing panel (refer to SOW 1.2) shall also be evaluated. Cross reactivity will be measured by comparing response values to values for calibrators containing 500 ng/mL of the vendor’s recommended calibrator. Better specificity (lower/negative response values for non-analyte of interest specimens) will increase the value of the kit.

(4) Ease of preparation will be evaluated as an enhancing factor. Ready-to-use reagents with no additional mixing will be an enhancing factor. Any additional required preparation will reduce the value of the kit.

Volume II: Past Performance Proposal

Evaluation Factor E - 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 contacting 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

(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 (POCs) 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 F: 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 G – 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…