N62645-23-R-0005 SF-1449v Issued dtd 10-28-2022.pdf

m

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

1. REQUISITION NUMBER

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE N6264523R0005 28-Oct-2022

7. FOR SOLICITATION a. NAME b. TELEPHONE NUMBER (No Collect Calls) 8. OFFER DUE DATE/LOCAL TIME

INFORMATION CALL: PHILMORE H. CRICHLOW 301-619-8895 11:00 AM 14 Nov 2022

9. ISSUED BY CODE N62645 10. THIS ACQUISITION IS X UNRESTRICTED OR SET ASIDE: % FOR:

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

SMALL BUSINESS

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ELIGIBLE UNDER THE WOMEN-OWNED

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NAICS:

TEL:

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BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

EDWOSB

8(A)

13b. RATING

325413

SIZE STANDARD:

1,250

TION UNLESS BLOCK IS

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SEE SCHEDULE

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SUCH ADDRESS IN OFFER BELOW IS CHECKED SEE ADDENDUM

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QUANTITY

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AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

X

X

X

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(CONTINUED)

19.

ITEM NO.

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SCHEDULE OF SUPPLIES/ SERVICES

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QUANTITY

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PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

N6264523R0005

Section SF 1449 - CONTINUATION SHEET

S TATEMENT OF WORK

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF

OPIATES (HYDROCODONE, HYDROMORPHONE, CODEINE, MORPHINE) IN URINE

1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of hydrocodone, hydromorphone, codeine, and morphine (opiates) in urine. When using the vendor’s recommended calibrator at a concentration of 300 ng/mL, the testing reagent shall be used to detect in urine the select opiates (hydrocodone, hydromorphone, codeine, and morphine) when present individually or in combination at a urine concentration equal to or greater than 300 ng/mL. Since 75% of the morphine excreted in urine is in the form of morphine-3-glucuronide, the reagent offered shall demonstrate cross-reactivity to the presence of morphine-3-glucuronide; or, the reagent may be a two component glucuronide hydrolysis reagent. However, in a glucuronidase assay, the glucuronidase shall be a component of the two reagent assay. A vendor immunoassay reagent proposal that requires a separate manual or automated addition of the beta-glucuronidase to each testing sample prior to testing on the analyzers will not be considered acceptable in this solicitation. Likewise, a vendor’s proposal which requires a separate pretreatment of each testing specimen prior to testing on the analyzers will not be considered acceptable. 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. 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 hydrocodone, hydromorphone, codeine, and morphine in physiological urine specimens when present individually or in combination at concentrations equal to or greater than 300 ng/mL. The reagent shall minimize cross-reactivity with 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 300 ng/mL (initial screen) shall be used for calibration of the analyzer. The testing reagent shall be evaluated for its ability to detect specimens containing hydrocodone, hydromorphone, codeine, and morphine, individually or in combination, at concentrations equal to or greater than the DoD immunoassay screening cutoff concentration of 300 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 one of the select opiates (hydrocodone, hydromorphone, codeine, or morphine). The following drug cutoffs (in ng/mL) are currently used by DoD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively.

The following drug cutoffs are currently used by DOD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively:

Drug Class Drugs/Metabolites (IA target in bold) Initial Screen

(ng/mL) Confirmation

(ng/mL) Marijuana 11-nor-delta-9-THC-carboxylic acid 50 15 Cocaine Benzoylecgonine 150 100 Opioids Morphine 4000

Codeine Hydrocodone

Hydromorphone 100 Heroin 6-Acetylmorphine 10 10 Opioids Oxycodone & Oxymorphone 100 100

Amphetamines d-Amphetamine & d-Methamphetamine 500 100 Designer Amphetamines

Methylenedioxymethamphetamine & Methylenedioxyamphetamine

500 500

Benzodiazepines Nordiazepam, Oxazepam, Temazepam, Lorazepam, Alpha-hydroxyalprazolam

200 100

Synthetic Cannabinoids

JWH-018, JWH-073, UR-144, MAM-2201, AB-

CHIMINACA, AB-PINACA

10 1

Fentanyl Fentanyl & Norfentanyl 1 1 Lysergic Acid Diethylamide

Lysergic Acid Diethylamide & 2-oxo-3-hydroxy-LSD

0.5

0.2

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 the calibration 300 ng/mL shall be accomplished with a drug free control and open controls at target concentrations of 50-75% and 150-200% of the calibrator/cutoff. An acceptable verification will have analytical readings for the drug free < 50-75% control < cutoff (calibrator) < 150-200% control. Open and blind quality control urine shall be distributed throughout a test batch and shall make up a minimum of 5% of the number of total specimens.

3. PERFORMANCE CHARACTERISTICS.

3.1. When calibrated at 300 ng/mL, the reagent shall be capable of identifying specimens as positive for hydrocodone, hydromorphone, codeine, and morphine when present individually or in combination in human urine at concentrations equal to or greater than 300 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 hydrocodone, hydromorphone, codeine and morphine when present individually or in combination in human urine at concentrations below 300 ng/mL as determined by the current immunoassay and GC/MS or LC/MS/MS procedures utilized in the military laboratories.

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

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

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

3.6. Enhancing factors include linearity from 0% to 200% of the calibrator concentration, improved predictive rates, increased specificity, and ease of preparation.

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, LC-MS/MS Nuclear Magnetic Resonance (NMR), and spectrophotometric measurements.

4.1.2. Stability. The kit and each kit component shall be shown to be stable and at the correct concentration over the period of use of the kit. Components that are homogeneous solutions shall not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration).

4.2. Manufacturer’s Equipment.

4.2.1. Preventive maintenance. Routine preventive maintenance procedures, periodic calibration, and any unscheduled maintenance shall be fully documented and in accordance with recommendations of the manufacturer of the equipment.

4.2.2. Calibration and operational checks. All instruments that are used to check a physical parameter of a solution or material shall be calibrated and have documentation available to demonstrate that all required operational checks have been completed. This includes pH meters, spectrometers, micropipettes, etc.

4.2.3. Temperature checks. Water baths, refrigerators, freezers, and other equipment that is intended to maintain a given temperature shall be periodically validated for accuracy and routinely verified for correct settings.

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

4.3. Antibody Drug Molecule.

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

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

4.4. Antibody specificity.

4.4.1 Characteristics. Antibody specificity shall be verified for each lot and the specificity re-evaluated at routine intervals to ensure uniformity and quality of preparations. The reagent shall provide performance characteristics in terms of sensitivity and specificity for detection of hydrocodone, hydromorphone, codeine, and morphine in urine.

Chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use shall be tested to characterize antibody specificity. Specificity testing shall include biochemical materials produced normally in the human body.

4.5. Immunoassays.

4.5.1. Technical performance. Performance of each lot of kits shall be verified. The verification shall establish, as a minimum, the appropriate response to the target molecules and that all other parameters as specified in the contract are met.

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

4.5.3. Manufacturer's production manual. Procedures and criteria required to validate all components (and materials) employed during the manufacture of the reagents in the test kits and the operation of the completed kit over the entire period of shelf-life of the kit shall be described in detail. All steps of each quality control procedure shall be described thoroughly.

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

4.5.5. Corrective action. When a specified quality control parameter is found to be out of limits, the action taken to ensure correction for existing kits (i.e., notification) shall be documented and action taken to ensure that the deficiency does not reoccur and all records shall be retained. The Contracting Officer shall be notified within 2 working days of any deficiencies in existing kits and of all corrective actions for consideration, i.e., delivery of replacement kits at no cost to the Government. The FDA shall be notified according to its regulations.

4.5.6. Lot numbers. Lot numbers shall be used to identify reagent and other preparations to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent shall be described. A single lot number for a kit shall suffice if all materials used in that lot number can be tracked to identify the materials and procedures used in the preparation of that kit.

5. P ACKAGING AND MARKING

5.1. THERMAL PROTECTION FOR BIOLOGIC REAGENTS

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

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 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.

EVALUATION CRITERIA OPIATE

IMMUNOASSAY REAGENT KITS

The proposals will be evaluated for the Best Value to the Government under the following factors:

Volume I: Technical Approach Proposal

Evaluation Factor A: FDA and ISO Certification Evaluation Factor B: Reagent Preparation and Calibration Information Evaluation Factor C: Performance Test – Minimum Requirements Evaluation Factor D: Performance Test – Enhancing Factors

Volume II: Past Performance Proposal Evaluation Factor E: Past Performance

Volume III: Small Business Participation Plan And Subcontracting Plan Proposal Evaluation Factor F: Small Business Participation Plan And Subcontracting Plan

Volume IV: Business Proposal Evaluation Factor G: Price

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

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

Volume I: Technical Approach Proposal

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

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

(1) Explanation and principles of the testing procedure.

(2) Description of each reagent composition of the reagents for use on the 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 one of the select opiates (hydrocodone, hydromorphone, codeine, or morphine).

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

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

Shelf-Life: In accordance with the Statement of Work paragraph 1.5, the Offeror shall state the reagent kit proposed has a minimum shelf life of any unopened component of the assay shall be at least 180 days from date of delivery at the drug testing laboratory. Once kit container seals are broken and the component opened, the shelf-life shall be at least 14 days.

Evaluation Factor C: Performance Test – Minimum Requirements. If the Offeror passes Factors A and B, the Government shall conduct an evaluation of the vendor’s reagent at one of the five DoD military drug screening laboratories located within the continental United States (CONUS). The test shall be conducted in accordance with the established protocol cited below in the Performance Test Section. 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 one of the five DoD military drug-screening laboratories located within the continental United States (CONUS).

Performance Test – Minimum Requirements

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

The Calibrator (CAL) shall be at a target concentration of 300 ng/mL for the initial screen. Quality Control (QC) specimens 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 opiate test reagent’s ability to meet minimum requirements. All performance tests shall be performed using the calibrator concentration of 300 ng/mL.

1. Previously confirmed and archived opiate positive specimens that are authorized for disposal shall be re- confirmed as positive (opiates at or above the 300 ng/mL confirmation cut-off) and analyzed by immunoassay. If previously confirmed specimens are not readily available, verified negative urine samples spiked with known concentrations of opiate can be used to as substitute or supplement the numbers, in order to meet the requirement. At least 20, but no more than 100, positive specimens shall be analyzed with water blanks between each specimen.

1.1. The minimum requirement for the initial screen is met if at least 95% of the specimens are correctly identified as positive by the Offeror’s immunoassay reagent for the presence of opiates, utilizing the DoD initial screen cutoff concentration of 300 ng/mL.

2. Approximately 2,000 specimens, submitted to the laboratory for routine testing, shall be analyzed by immunoassay using the 300 ng/mL calibrator.

2.1. Over 95% of the 0% QC specimens screen negative and provide values less than the mean of the 50-75% QC specimens both within runs and between runs.

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

2.3. The minimum requirement is met if 95% of the 150-200% QC specimens screen positive and provide values greater than the mean of the 100% QC specimens both within runs and between runs.

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

3.1. There shall be a positive correlation (correlation coefficient (R2) ≥80%) 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. Enhancing factor is the ability to produce a positive correlation, R2≥95.

3.2. Individual replicates at 0%, 50%, 100%, and 150% shall demonstrate a distinctive range of values with no overlap of 2 standard deviations (SD) from the mean of 0% and 100%.

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 shall be less than 15%.

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

(1) Linearity. A correlation coefficient which is closer to +1, as determined by linear regression analysis of data from 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 2,000 actual military specimens will be analyzed to evaluate the reagent’s ability to distinguish between specimens containing opiates at or above the 300 ng/mL screening cutoff and specimens that contain less than 300 ng/mL opiates. Confirmation results will be compared to immunoassay results. Samples that yield a positive opiate initial screen result and samples that give an opiate 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 opiates with concentrations below 300 ng/mL and positive samples with opiates with concentrations above 300 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 fentanyl, norfentanyl, methadone, tramadol, meperidine, naloxone, and naltrexone. 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 the calibrator containing 300 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. The kit shall also be evaluated for cross reactivity with individual specimens containing morphine-6-glucuronide, morphine-3- glucuronide, and codeine-6-glucuronide when present at 125% of the cutoff concentration (300 ng/mL). The ability of the kit to positively identify these samples 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 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 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 base year contract with options up to 5 years. The Government may award multiple CLINs if 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.

ESSENTIAL CHARACTERISTICS

OPIATE IMMUNOASSAY REAGENT KITS

The Department of Defense (DOD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality management Documented Opiate immunoassay reagent kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting of hydrocodone, hydromorphone, codeine, and morphine in human urine samples. Proposals shall comply with the Statement of Work (SOW).

The reagent kits are required for a period of performance of up to five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month.

The vendor shall comply with the FDA and Quality Management Documentation as specified in the SOW. The vendor shall comply with the Reagent Preparation and Calibration Information as specified in the SOW.

C ONTRACT ADMINISTRATION

1. CONTRACT ADMINISTRATION

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

Naval Medical Readiness Logistics Command Detachment Fort Detrick (NMRLC-DFD) Attn: Philmore Crichlow, Jr.

693 Neiman Street Fort Detrick, Maryland 21702 Office Phone: (301) 619-8895 Email: philmore.h.crichlow.civ@health.mil

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

2. INVOICING INSTRUCTIONS.

See 252.232-7006 Wide Area Workflow Payment Instructions.

3. DESIGNATION OF ORDERING ACTIVITIES

The following Requiring Activities and their designated Ordering Office are hereby authorized to place delivery orders:

Requiring Activity Ordering Office/Activity

Navy Drug Screening Laboratory Great Lakes 2500 Rodgers Street, Bldg 5501 Great Lakes, IL 60088-2952

Same as Requiring Activity

Navy Drug Screening Laboratory Jacksonville 68850 Adams Avenue, Building H-2033 Naval Air Station Jacksonville, FL 32212-5000

HQ Air Force Drug Testing Laboratory 2480 Ladd Street, Building 3750 Lackland Air Force Base, TX 78236-5130

Army Forensic Toxicology Drug Testing Laboratory 2490 Wilson Street Fort Meade, MD 20755-5235

Army Forensic Toxicology Drug Testing Laboratory 1 Jarrett White Road, Building 40 Tripler Army Medical Center (AMC), HI 96859-

Pacific Contracting Center

ATTN: MCAA-PC

Tripler AMC, HI 96859

Armed Forces Medical Examiner System (AFMES) 115 Purple Heart Drive Dover Air Force Base, DE 19902-5051

DOD Drug Demand Reduction Program (DDRP)

Naval Medical Readiness Logistics Command Detachment Fort Detrick (NMRLC-DFD) / Previously Naval Medical Logistics Command (NMLC) 693 Neiman Street Ft. Detrick, MD 21702

All delivery orders must be signed by a warranted Contracting Officer or Purchasing Officer. The activities’ ordering office is responsible for issuing and administering any orders placed hereunder. Ordering officers have no authority to modify any provision of the basic contract. Any deviations from the terms of the basic contract must be submitted and approved by a NMRLC-DFD warranted Contracting Officer.

4. ORDERING /DELIVERY ORDERS

The contract hereby authorizes requiring/ordering activities to place delivery orders via SF 1449, DD Form 1155, or other locally approved form signed/executed in writing by the Contracting/Purchasing Officer using the government purchase card or Wide Area Workflow for payment methods. Deliveries will never be sent to NMRLC-DFD at Fort Detrick. Ordering Lab site will match Delivery Lab location.

5. MAXIMUM QUANTITIES.

All available quantities for this requirement are given in Contract Line Item Numbers (CLINs).

6. CONTENT OF DELIVERY ORDERS

Delivery orders shall contain the following "minimum" information:

1. Date of order.

2. Contract Number and Order Number.

3. Item Number and Description, Quantity, and Unit Price.

4. Unit of Issue.

5. Delivery Date and Place of Delivery.

6. Accounting and Appropriation data

7. Payment Office Address.

8. Invoicing Instructions with Point of Contact Information.

Ordering activities are required to provide a copy of each delivery order via email to the DDRP Laboratory Services Mailbox at: u sn.hampton-roads.navmcpubhlthcenpors.list.nmcphc-labservices@health.mil . (SUBJECT: Contract Number & Delivery Order Number).

7. REPORTS

The contractor shall provide an electronic monthly report of sales within ten (10) calendar days after the close of each month’s orders.

Reports, in Microsoft Excel, shall be emailed to DDRP Laboratory Services Mailbox at:

u sn.hampton-roads.navmcpubhlthcenpors.list.nmcphc-labservices@health.mil. (SUBJECT: Contract Number).

Reports shall contain the following information:

a. Date of order.

b. Contract number and delivery order number.

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

d. Total Amount.

e. Delivery date and place of delivery.

f. Payment method.

8. COMMUNICATIONS

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

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

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

(End of clause)

A DDENDUM TO 52.212-1

Addendum to 52.212-1 Instructions to Offerors

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

Proposals shall be submitted in accordance with the Solicitation (Addendum to 52.212-1 – Instructions to Offerors – Commercial Items) to philmore.h.crichlow.civ@health.mil by 11:00 AM eastern time on 14 November 2022.

Proposal Content and Instructions for Preparation of Proposals.

Instructions for preparation of proposals. This section specifies the format and content that Offerors shall use in this Request for Proposal (RFP). The intent is not to restrict the Offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes.

Offerors must submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided shall be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified in the Addendum to 52.212-1. Any proposal that does not provide, as a minimum, that which is required in this solicitation may be determined to be substantially incomplete and not warrant any further consideration. The Government shall award a contract to the responsible Offeror whose offer will be most advantageous to the Government, price and other factors considered.

The proposal shall be submitted in four separate volumes:

Volume I* – Technical Approach;

Volume II* – Past Performance; and Volume III*-- Small Business Participation Plan and Subcontracting Plan.

Volume IV – Business Proposal.

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

Four separate and complete volumes (listed above) shall be submitted by the closing date specified in this solicitation. If any one proposal volume is received past the stated closing date specified in this solicitation, the entire proposal will be considered late. No further consideration will be given to any Offeror who submits any of these volumes late in accordance with FAR 52.212-1(f).

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

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

1.2. The Offeror shall provide the information specified in 52.212-2 Evaluation – Commercial Items,

1.3. Volume I: Technical Approach Proposal,

1.4. Evaluation Factor A: FDA and ISO Certification

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

1.5. and Evaluation Factor B: Reagent Preparation and Calibration Information.

If required, all reagents for the Government evaluation test shall be provided at no cost to the Government. See 52.212-2 Evaluation – Commercial Items, Volume I: Technical Approach Proposal, Evaluation Factor C:

Performance Test – Minimum Requirements for instructions regarding submittal of reagents. Reagents shall N OT be sent to Naval Medical Readiness Logistics Command Detachment Fort Detrick.

The Offeror’s proposal shall include:

Package insert containing complete, accurate and verifiable information regarding:

(1) Explanation and principles of the testing procedure.

(2) Description of each reagent composition of the reagents for use on the Beckman Coulter AU5800

Series Analyzer in the processing of samples.

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

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

(5) Calibration AND Parameter settings for use on the Beckman Coulter AU5800 Series Analyzer.

The reagent calibrator and positive controls shall be one of the select opiates (hydrocodone, hydromorphone, codeine, or morphine).

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

Evaluation Factors 3 & 4 Evaluation Factor C: Performance Test – Minimum Requirements/Enhancing Factor

If the Offeror passes Factors A and B, the Government shall conduct an evaluation of the vendor’s reagent at one of the five DoD military drug screening laboratories located within the continental United States (CONUS). The test shall be conducted in accordance with the established protocol cited below in the Performance Test Section.

Upon request, the Offeror shall ship a SUFFICIENT number of reagent kits to perform at least 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 five DoD military drug-screening laboratories located within the continental United States (CONUS).

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

2.1. The Offeror shall describe its past performance on up to three contracts it has held within the last five years that are for the same or similar immunoassay reagents to that which is detailed in this solicitation, or affirmatively state the Offeror possesses no relevant past performance directly related to or similar past performance. Descriptions of contracts in excess of the stated limited of three will not be evaluated. Offerors who present similar contracts shall provide a detailed explanation demonstrating the relevance of the contracts to the requirements of the solicitation. The Government reserves the right to contact any references.

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

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

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

2.2.3. Dollar value of the contract.

2.2.4. Description of the reagents provided under the contract.

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

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

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

2.2.8 Any other relevant information.

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

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

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

3. Volume III: Small Business Participation Plan and Subcontracting Plan.

3.1. All Offerors are required to submit a small business participation plan (SBPP). If applicable (for other than small business concern Offerors under the assigned NAICS code herein), the Offeror shall submit a subcontracting plan in accordance with FAR Clause 52.219-9 and DFARS Clause 252.219-7003 (for reference see FAR 19.704 and DFARS 219.704). The subcontracting plan requirement is not applicable to small business concerns qualified as such under the NAICS code assigned to this solicitation.