Solicitation_Amendment_2.docx

N6264518Q0048

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

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

Tradeoff Evaluation Factor Ratings:

Evaluation Factors C and D: Performance Test

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 90% 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 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 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.

(End of provision)

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