N62645-19-Q-0002__0002.docx

N6264519Q0002

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

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

If an offeror’s technical proposal passes both Factors A and B, then the offeror will subsequently be notified with instructions concerning the performance test of its reagent to determine compliance. Reagent kit performance will be evaluated on a pass/fail basis under Factor C. If an offeror’s Factor C evaluation fails, then the firm’s offer will receive no further consideration for award unless there are no other technically compliant proposals.

If an offeror’s proposal receives a passing rating on Factors A, B, and C, then the firm’s remaining factors will be evaluated to achieve a best-value award. Factor D will be evaluated using the five tiered scale noted below:

Rating Scale for Evaluation Factor D: Performance Test – Enhancing Factors

The rating of Factor D, Performance Test – Enhancing Factors is more important than Factor E, Past Performance. Factor E will be evaluated using the following scale:

Rating Scale for Evaluation Factor E: Past Performance

Past Performance, is 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 Factor G, Price.

Volume I: Technical Approach Proposal

Evaluation Factor A: FDA and ISO Certification. Proposals shall include the following:

(1) Documentation of FDA approval/authorization for use of the Amphetamine (AMP) and Methamphetamine (METH) Immunoassay Reagent shall be provided with the offeror’s' proposal.

(2) Documentation of current certification compliance with applicable ISO Standards or documentation of compliance with Statement of Work Sections 4.1 through 4.4.5 shall be provided with the offeror’s’ proposal.

Evaluation Factor B: Reagent Preparation and Calibration Information. Proposals shall address the following:

(1) Include a Package Insert containing complete, accurate, and verifiable information.

(2) Explanation and principles of the testing procedure.

(3) Description of each reagent composition of the reagents for use on the Beckman Coulter AU5800 Series Analyzer in the processing of samples. The immunoassay procedure is limited to a two reagent assay procedure.

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

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

(6) Minimum shelf life for unopened and opened reagents. In accordance with SOW paragraph 1.5:

a. the unopened kits shall have a 180 day minimum shelf life from the date of delivery at the FTDTL, and

b. opened reagents shall be shelf stable for at least 14 days.

(7) Calibration AND Instrument parameters for use on the Beckman Coulter AU5800 Series Analyzer. The drug contained in the calibrator and positive controls shall be recommended by the reagent kit manufacturer, but must be either d-amphetamine or d-methamphetamine.

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

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

Evaluation Factor C: Performance Test – Minimum Requirements. Offerors that pass Factors A and B, will receive instructions from the Government so it can conduct a performance test of the vendor’s reagent. The test will be conducted as follows. 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 four DOD FTDTLs located within the continental United States.

Data obtained will be analyzed as to the DAMP/DMETH test reagent’s ability to meet the solicitation requirements, as described below. The Calibrator (CAL) shall be either DAMP or DMETH with 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 each reagents’ ability to meet minimum requirements. The absorbance is normalized so that 100 indicates a positive result (results less than 100 are negative).

1. Previously confirmed and archived DAMP and DMETH positive specimens that are authorized for disposal shall be re-confirmed as positive (DAMP and DMETH above 100 ng/mL, individually or in combination) and analyzed by immunoassay. At least 20, but no more than 100, positive specimens shall be analyzed with water blanks between each specimen.

1.1. The minimum requirement is met if at least 95% of the specimens are correctly identified as positive by the offeror’s immunoassay reagent for the presence of DAMP and DMETH, utilizing the DOD initial screen cutoff concentration of 500 ng/mL.

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

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

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

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

3. Precision/Accuracy, Linearity, and Calibration Stability of the DAMP/DMETH 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 100%, 125%, 150%, and 200% of the CAL are less than 10% within each run and less than 15% within the three timed runs. The CVs of the 20 replicate values at 75% of the CAL shall be less than 20% within each run and within the three times 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% and 125% of the cutoff concentration. The analyte used to calibrate the kit is the target analyte. Other analyte to be detected by the kit is the non-target analytes (i.e. DAMP is the non-target analyte when the calibrator contains DMETH).

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 as demonstrated through the following criteria:

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

4.1.2. For the 125% non-analyte QC sample replicates, 90% of the normalized responses must be greater than or equal to 100.

Evaluation Factor D: Performance Test – Enhancing Factors. Reagents meeting the minimum requirements of the Performance Test will then be evaluated by the government on the following enhancing 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: the ability to correctly identify positive and negative specimens. Specimens that yield a positive DAMP/DMETH initial screen result (current kit and kit(s) being evaluated) will be confirmed by GC-MS or LC-MS/MS. Greater ability to correctly identify confirmed negative samples and positive specimens (fewer false positives and fewer false negatives) will increase the value of the kit.

(3) 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 by spiking drug-free urine with high concentrations of potentially interfering analytes in the table below. Cross reactivity will be evaluated according to the response values.

Better specificity (lower/negative response values for non-analyte of interest specimens) will increase the rating of the enhancing factor.

(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 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.

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