Amendment_1.docx

N6264518R0014

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

To:

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period

CLIN 1001

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

To:

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period

CLIN 2001

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

To:

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period

CLIN 3001

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

To:

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period

CLIN 4001

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

To:

*** Complete Attachment 1: Pricing Sheet to include Catalog Number, Product Description, Price per Test, Number of Tests per Kit, Price per Kit, Number of Kits Proposed, Total Price per CLIN, and Total Price (including all CLINs).Base Period

TABLE OF CONTENTS

The below Table of Contents has been added

Exhibit/Attachment Table of Contents

The following have been added by full text:

PRICING SHEET

CLIN 0001: Estimated Quantity 335,000 tests

Price per Test __________ * Number of Tests per Kit __________ = Price per Kit __________ Number of Kits Proposed __________

CLIN 0001Total Price: __________ CLIN 0001 Catalog Number: __________ CLIN 0001 Product Description: __________

CLIN 1001: Estimated Quantity 335,000 tests

Price per Test __________ * Number of Tests per Kit __________ = Price per Kit __________ Number of Kits Proposed __________

CLIN 1001 Total Price: __________ CLIN 1001 Catalog Number: __________ CLIN 1001 Product Description: __________

CLIN 2001: Estimated Quantity 335,000 tests

Number of Kits Proposed __________

CLIN 2001 Total Price: __________ CLIN 2001 Catalog Number: __________ CLIN 200 Product Description: __________

CLIN 3001: Estimated Quantity 335,000 tests

Number of Kits Proposed __________

CLIN 3001 Total Price: __________ CLIN 3001 Catalog Number: __________ CLIN 3001 Product Description: __________

CLIN 4001: Estimated Quantity 335,000 tests

Number of Kits Proposed __________

CLIN 4001 Total Price: __________ CLIN 4001 Catalog Number: __________ CLIN 4001 Product Description: __________

Total Price (including all CLINs) ________________

The following have been modified:

ADDENDUM 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.

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 should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified in 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, Volume I: Technical Approach Proposal, Evaluation Factor A: FDA and ISO Certification and Evaluation Factor B: Reagent Preparation and Calibration Information. If required, all reagents for the Government evaluation test shall be provided at no cost to the Government. See 52.212-2 Evaluation – Commercial Items, Volume I: Technical Approach Proposal, Evaluation Factor C: Performance Test – Minimum Requirements for instructions regarding submittal of reagents. Reagents shall NOT be sent to Naval Medical Logistics Command.

Page limit for Volume I – Technical Approach Proposal: not to exceed 100 pages (excluding a Cover Sheet and Table of Contents). Any information submitted that is in excess of the page limit shall not be considered as part of the proposal.

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

2.1. The offeror shall describe its past performance on up to three contracts it has held within the last five years that are for the same or similar immunoassay reagents to that which is detailed in this solicitation, or affirmatively state the offeror possesses no relevant past performance directly related to or similar past performance. Descriptions of contracts in excess of the stated limited of three will not be evaluated. Offerors who present similar contracts shall provide a detailed explanation demonstrating the relevance of the contracts to the requirements of the solicitation. 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 six pages (two pages per past performance reference) (excluding a Cover Sheet and Table of Contents). Any information submitted that is in excess of the page limit shall not be considered as part of the proposal.

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

3.1. All offerors are required to submit a small business participation plan (SBPP). If applicable (for other than small business concern offerors under the assigned NAICS code herein), the offeror shall submit a subcontracting plan in accordance with 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. Master subcontracting plans can be included as an appendix to the subcontracting plan.

3.2. The Contracting officer will review the SBPP and subcontracting plan for acceptability. If an offeror fails to negotiate a subcontracting plan acceptable to the Contracting Officer within the time limit prescribed by the Contracting Officer, the offeror will be ineligible for award. If the offeror believes there are no subcontracting possibilities, the offeror shall submit documentation sufficient to support its position.

4. Volume IV: Business Proposal. In accordance with file submission requirements given in this section, the offeror shall submit the following:

4.1. Offerors shall propose a Catalog Number in Attachment 1: Pricing Sheet.

4.2 Offerors shall propose a Product Description in Attachment 1: Pricing Sheet.

4.3. Offerors shall propose a price per test based on the estimated number of tests for CLINs 0001, 1001, 2001, 3001, and 4001in Attachment 1: Pricing Sheet.

4.4. Offerors shall state the total number of tests per kit proposed for CLINs 0001, 1001, 2001, 3001, and 4001 in Attachment 1: Pricing Sheet. The number of tests shall be based on the reagent volume recommended by the reagent manufacturer.

4.5. Offerors shall provide a price per kit based on the estimated number of tests proposed for CLINs 0001, 1001, 2001, 3001, and 4001in Attachment 1: Pricing Sheet.

4.6. Offerors shall provide the number of kits proposed for CLINs 0001, 1001, 2001, 3001, and 4001 in Attachment 1: Pricing Sheet.

4.7. Offerors shall provide a total price per CLINs 0001, 1001, 2001, 3001, and 4001in Attachment 1: Pricing Sheet.

4.8. Offerors shall provide a total price including all CLINs in Attachment 1: Pricing Sheet.

4.9. Offerors shall provide an order and delivery schedule. The proposed schedule shall include Order Dates (latest date order can be placed) and Order Delivery Dates (date orders will be delivered).

4.10. Offerors shall provide the Federal Supply Schedule (FSS) number, if the items are on FSS, or make note if the reagent kits are Open Market.

4.11. Offeror shall provide:

Complete company name and address:

Company Point of Contact:

Email Address:

Phone number:

Tax Identification Number (TIN):

CAGE Code:

DUNS number:

4.12. The offeror must be registered in System for Award Management (SAM) in accordance with FAR 52.204-7 and FAR 52.204-13. The offeror shall verify its SAM record is current, accurate, complete and applicable to this solicitation as of the date of this offer and is incorporated in this offer by reference. The offeror shall complete the SAM Certification Sheet (Refer to Attachment 2).

4.13. The offeror shall complete and submit FAR Clause 52.209-11 [Representation By Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016)].

4.14. The offeror shall include a statement with the offerors Volume IV: Business Proposal acknowledging the combined synopsis/solicitation and all amendments issued under this combined synopsis/solicitation.

4.15. ***The offeror shall include a statement in their Volume IV: Business Proposal acknowledging their understanding that the price per test is requested for evaluation purposes only and that the contract will reference prices per kit only.***

Page limit for Volume IV – Business Proposal: There is NO page limit for Volume IV – Business Proposal.

5. File Submission.

5.1 Offerors are invited to submit a proposal in accordance with Instructions to Offerors, to arrive electronically through the AMRDEC SAFE website no later than the proposal due date for this solicitation. The Government does not authorize submission of telegraphic, facsimile, paper or CDROM offers via hand carry or mail carrier for this solicitation.

All proposals submitted in response to this solicitation will be submitted electronically via the AMRDEC SAFE website. No paper copies or electronic copies submitted outside of the SAFE website (i.e., emailed directly to the contract specialist or other NMLC email inbox) will be accepted.

Submitting your proposal:

The AMRDEC SAFE application is used to send large files to individuals which would normally be too large to send via email. There are no user accounts for SAFE - authentication is handled via email and Civilian Access Card (CAC). The application is available for use by offerors.

The AMRDEC SAFE application can be accessed via https://safe.amrdec.army.mil/safe.

Offerors shall proceed as “Non- CAC Users” under all circumstances.

After selecting the “Non- CAC Users” option above, the page will be redirected to the package upload form. Fill in all the required input fields (field names are in italics):

Personal Information:

Your Name - Your name, Your Company Name.

Your Email address - Your email address.

Confirm Your Email Address - Re-enter your email address.

File Information:

Description of File(s) - Enter a description for the package;

File(s) - Click the "Browse" button to select your file(s). You may add up to 25 files per package, so long as the total file size does not exceed 2GB. The total file size is the combined file size of all submitted files.

Deletion Date – Leave this date at the default setting of two weeks (14 days) from the submission date.

Recipient Information:

Manually Enter Email Address: Input usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil and hit the add button. (To remove a recipient, highlight their name and click the "Remove" button.)

Email Settings:

Check all four of the boxes:

To the right of “Email Settings” is a nondescript box with two options (None or FOUO). Select the FOUO option and select “sensitive” from the dropdown menu below.

Review all fields for accuracy and hit the ‘submit” button. Clicking the "Submit" button will upload the files and submit the package. Guest users will need to check their email to verify their email address before the recipients will be notified. After the package has been uploaded, the Government will receive a link to the package download page as well as a password. These passwords are unique for each recipient (not the package), and will be disabled once SAFE detects that the user successfully downloaded each file within the package.

Once the offeror has submitted their proposal, they shall send a confirmation email to usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil and provide their company name and contact information as well stating that they have submitted a complete proposal to SAFE in response to solicitation N6264518R0014. Submission of proposals is a onetime affair (unless in unusual circumstances multiple SAFE submissions are required because an offeror exceeded the 25 file limit per SAFE submission.).

Any data previously submitted in response to another solicitation, whether submitted to the Naval Medical Logistics Command or another agency, should be assumed to be unavailable during this proposal evaluation and source selection process. Proposal data shall not be incorporated into the proposal by referring to another proposal or other source.

The Government reserves the right to request additional information after receipt of Offeror’s response to the RFP. The proposal shall be valid for not less than 180 calendar days from the proposal due date. The Offeror shall make a clear statement that the proposal is valid until such date in Volume I.

Offerors are cautioned that in order for their proposal to be eligible for award, the proposal shall be in compliance with all of the terms and conditions set forth in the RFP.

5.1.1. Files shall be in Microsoft Office for Windows format (2007 or 1997-2003), either .doc or .docx file and/or Adobe Acrobat (.pdf file), with one (1) inch margins all around, Times New Roman font of not less than ten (10) point font size.

5.1.2. Each volume shall contain the following items in addition to the technical/descriptive data required by this Request for Proposal (RFP):

5.1.2.1. Cover sheet which indicates RFP Number, Name and Address of Offeror.

5.1.2.2. Table of contents which provides sufficient detail as to allow the important elements to be easily located.

5.1.2.3. Each page of each document shall have a footer indicating the name of the offeror, “page X of Y,” and the following legend “Source Selection Information: See FAR Part 3.104.”

6. Solicitation Questions. Questions concerning the solicitation are due no later than 02:00 PM Local Time, seven days after the solicitation is issued. Questions will not be addressed after this cutoff date. Questions shall be submitted via email to usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil (Subject: N6264518R0014). Offerors shall submit one set of questions only; multiple submissions shall not be accepted. An amendment to the solicitation will be issued providing responses to the questions.

7. Discussions. The Government intends to evaluate proposals and award a single contract without discussions with offerors. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary.

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:

The proposals will be evaluated 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 (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. 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 HYDROCODONE/HYDROMORPHONE Immunoassay Reagent. Documentation of FDA approval/authorization for use of the HYDROCODONE/HYDROMORPHONE 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 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 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 hydrocodone or hydromorphone.

(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: In accordance with the SOW 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. The offeror shall specifically address shelf-life capabilities.

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. 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 HYDROCODONE/HYDROMORPHONE test reagent’s ability to meet the solicitation requirements, as described below.

The Calibrator (CAL) shall be a target concentration of 300 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 HYDROCODONE/HYDROMORPHONE 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 Hydrocodone and Hydromorphone positive specimens that are authorized for disposal will be re-confirmed as positive (Hydrocodone and Hydromorphone above 300 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 Hydrocodone and Hydromorphone, utilizing the DoD initial screen cutoff concentration of 300 ng/mL.

2. Routinely submitted military specimens will be analyzed by immunoassay. The military specimens are screened with an initial immunoassay kit (not the kit being solicited) to identify specimens that are presumptively positive for opioids which are subject to adjunct testing (using the kit identified in this solicitation). Approximately fifteen to twenty (15-20) adjunct batches containing opioid presumptive positive specimens will be analyzed.

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 HYDROCODONE/HYDROMORPHONE reagent will be evaluated based on analysis of 20 replicates of QC samples at target concentrations of 0%, 50%, 75%, 100%, 125%, 150%, and 200% of the CAL analyzed at 0 hours, 4 hours, and 8 hours after calibration.

3.1. The minimum requirement is met if there is a positive correlation for the slopes (i.e., increasing concentrations result in increasing values) of the lines drawn between the mean replicate values of the 0% through 150% concentrations.

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

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

3.4. The minimum requirement is met if the CVs of the 60 replicate values at 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% and 125% 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. Hydromorphone is the non-target analyte when the calibrator contains Hydrocodone).

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 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 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: The specimens analyzed in the Minimum Requirements section 2 will be analyzed to evaluate the reagent’s ability to distinguish between specimens containing Hydrocodone and Hydromorphone at or above the 300 ng/mL screening cutoff and specimens that contain less than 300 ng/mL of Hydrocodone and Hydromorphone. Confirmation results will be compared to immunoassay results. Samples that yield a positive HYDROCODONE/HYDROMORPHONE initial screen result and samples that give a HYDROCODONE/HYDROMORPHONE 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 Hydrocodone and/or Hydromorphone with concentrations below 300 ng/mL and positive samples with Hydrocodone and/or Hydromorphone 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 calibrators 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.

(4) Ease of preparation will be evaluated as an enhancing factor. Ready-to-use reagents with no additional mixing will be evaluated as 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.

(End of provision)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/

(End of clause)

252.211-7003 ITEM UNIQUE IDENTIFICATION AND VALUATION (MAR 2016)

(a) Definitions. As used in this clause-

Automatic identification device means a device, such as a reader or interrogator, used to retrieve data encoded on machine-readable media.

Concatenated unique item identifier means--

(1) For items that are serialized within the enterprise identifier, the linking together of the unique identifier data elements in order of the issuing agency code, enterprise identifier, and unique serial number within the enterprise identifier; or

(2) For items that are serialized within the original part, lot, or batch number, the linking together of the unique identifier data elements in order of the issuing agency code; enterprise identifier; original part, lot, or batch number; and serial number within the original part, lot, or batch number.

Data Matrix means a two-dimensional matrix symbology, which is made up of square or, in some cases, round modules arranged within a perimeter finder pattern and uses the Error Checking and Correction 200 (ECC200) specification found within International Standards Organization (ISO)/International Electrotechnical Commission (IEC) 16022.

Data qualifier means a specified character (or string of characters) that immediately precedes a data field that defines the general category or intended use of the data that follows.

DoD recognized unique identification equivalent means a unique identification method that is in commercial use and has been recognized by DoD. All DoD recognized unique identification equivalents are listed at http://www.acq.osd.mil/dpap/pdi/uid/iuid_equivalents.html.

DoD item unique identification means a system of marking items delivered to DoD with unique item identifiers that have machine-readable data elements to distinguish an item from all other like and unlike items. For items that are serialized within the enterprise identifier, the unique item identifier shall include the data elements of the enterprise identifier and a unique serial number. For items that are serialized within the part, lot, or batch number within the enterprise identifier, the unique item identifier shall include the data elements of the enterprise identifier; the original part, lot, or batch number; and the serial number.

Enterprise means the entity (e.g., a manufacturer or vendor) responsible for assigning unique item identifiers to items.

Enterprise identifier means a code that is uniquely assigned to an enterprise by an issuing agency.

Government's unit acquisition cost means--

(1) For fixed-price type line, subline, or exhibit line items, the unit price identified in the contract at the time of delivery;

(2) For cost-type or undefinitized line, subline, or exhibit line items, the Contractor's estimated fully burdened unit cost to the Government at the time of delivery; and

(3) For items produced under a time-and-materials contract, the Contractor's estimated fully burdened unit cost to the Government at the time of delivery.

Issuing agency means an organization responsible for assigning a globally unique identifier to an enterprise, as indicated in the Register of Issuing Agency Codes for ISO/IEC 15459, located at http://www.aimglobal.org/?Reg_Authority15459.

Issuing agency code means a code that designates the registration (or controlling) authority for the enterprise identifier.

Item means a single hardware article or a single unit formed by a grouping of subassemblies, components, or constituent parts.

Lot or batch number means an identifying number assigned by the enterprise to a designated group of items, usually referred to as either a lot or a batch, all of which were manufactured under identical conditions.

Machine-readable means an automatic identification technology media, such as bar codes, contact memory buttons, radio frequency identification, or optical memory cards.

Original part number means a combination of numbers or letters assigned by the enterprise at item creation to a class of items with the same form, fit, function, and interface.

Parent item means the item assembly, intermediate component, or subassembly that has an embedded item with a unique item identifier or DoD recognized unique identification equivalent.

Serial number within the enterprise identifier means a combination of numbers, letters, or symbols assigned by the enterprise to an item that provides for the differentiation of that item from any other like and unlike item and is never used again within the enterprise.

Serial number within the part, lot, or batch number means a combination of numbers or letters assigned by the enterprise to an item that provides for the differentiation of that item from any other like item within a part, lot, or batch number assignment.

Serialization within the enterprise identifier means each item produced is assigned a serial number that is unique among all the tangible items produced by the enterprise and is never used again. The enterprise is responsible for ensuring unique serialization within the enterprise identifier.

Serialization within the part, lot, or batch number means each item of a particular part, lot, or batch number is assigned a unique serial number within that part, lot, or batch number assignment. The enterprise is responsible for ensuring unique serialization within the part, lot, or batch number within the enterprise identifier.

Type designation means a combination of letters and numerals assigned by the Government to a major end item, assembly or subassembly, as appropriate, to provide a convenient means of differentiating between items having the same basic name and to indicate modifications and changes thereto.

Unique item identifier means a set of data elements marked on items that is globally unique and unambiguous. The term includes a concatenated unique item identifier or a DoD recognized unique identification equivalent.

Unique item identifier type means a designator to indicate which method of uniquely identifying a part has been used. The current list of accepted unique item identifier types is maintained at http://www.acq.osd.mil/dpap/pdi/uid/uii_types.html.

(b) The Contractor shall deliver all items under a contract line, subline, or exhibit line item.

(c) Unique item identifier. (1) The Contractor shall provide a unique item identifier for the following:

(i) Delivered items for which the Government's unit acquisition cost is $5,000 or more, except for the following line items:

Contract line, subline, or exhibit line item No. Item description

(ii) Items for which the Government's unit acquisition cost is less than $5,000 that are identified in the Schedule or the following table:

NONE APPLICABLE

Contract line, subline, or exhibit line item No. Item description

(If items are identified in the Schedule, insert ``See Schedule'' in this table.)

(iii) Subassemblies, components, and parts embedded within delivered items, items with warranty requirements, DoD serially managed reparables and DoD serially managed nonreparables as specified in Attachment Number ----.

(iv) Any item of special tooling or special test equipment as defined in FAR 2.101 that have been designated for preservation and storage for a Major Defense Acquisition Program as specified in Attachment Number ----.

(v) Any item not included in paragraphs (c)(1)(i), (ii), (iii), or

(iv) of this clause for which the contractor creates and marks a unique item identifier for traceability.

(2) The unique item identifier assignment and its component data element combination shall not be duplicated on any other item marked or registered in the DoD Item Unique Identification Registry by the contractor.

(3) The unique item identifier component data elements shall be marked on an item using two dimensional data matrix symbology that complies with ISO/IEC International Standard 16022, Information technology--International symbology specification--Data matrix; ECC200 data matrix specification.

(4) Data syntax and semantics of unique item identifiers. The Contractor shall ensure that--

(i) The data elements (except issuing agency code) of the unique item identifier are encoded within the data matrix symbol that is marked on the item using one of the following three types of data qualifiers, as determined by the Contractor:

(A) Application Identifiers (AIs) (Format Indicator 05 of ISO/IEC International Standard 15434), in accordance with ISO/IEC International Standard 15418, Information Technology--EAN/UCC Application Identifiers and Fact Data Identifiers and Maintenance and ANSI MH 10.8.2 Data Identifier and Application Identifier Standard.

(B) Data Identifiers (DIs) (Format Indicator 06 of ISO/IEC International Standard 15434), in accordance with ISO/IEC International Standard 15418, Information Technology--EAN/UCC Application Identifiers and Fact Data Identifiers and Maintenance and ANSI MH 10.8.2 Data Identifier and Application Identifier Standard.

(C) Text Element Identifiers (TEIs) (Format Indicator 12 of ISO/IEC International Standard 15434), in accordance with the Air Transport Association Common Support Data Dictionary; and

(ii) The encoded data elements of the unique item identifier conform to the transfer structure, syntax, and coding of messages and data formats specified for Format Indicators 05, 06, and 12 in ISO/IEC International Standard 15434, Information Technology-Transfer Syntax for High Capacity Automatic Data Capture Media.

(5) Unique item identifier.

(i) The Contractor shall--

(A) Determine whether to--

(1) Serialize within the enterprise identifier;

(2) Serialize within the part, lot, or batch number; or

(3) Use a DoD recognized unique identification equivalent (e.g. Vehicle Identification Number); and

(B) Place the data elements of the unique item identifier (enterprise identifier; serial number; DoD recognized unique identification equivalent; and for serialization within the part, lot, or batch number only: Original part, lot, or batch number) on items requiring marking by paragraph (c)(1) of this clause, based on the criteria provided in MIL-STD-130, Identification Marking of U.S. Military Property, latest version;

(C) Label shipments, storage containers and packages that contain uniquely identified items in accordance with the requirements of MIL-STD-129, Military Marking for Shipment and Storage, latest version; and

(D) Verify that the marks on items and labels on shipments, storage containers, and packages are machine readable and conform to the applicable standards. The contractor shall use an automatic identification technology device for this verification that has been programmed to the requirements of Appendix A, MIL-STD-130, latest version.

(ii) The issuing agency code--

(A) Shall not be placed on the item; and

(B) Shall be derived from the data qualifier for the enterprise identifier.

(d) For each item that requires item unique identification under paragraph (c)(1)(i), (ii), or (iv) of this clause or when item unique identification is provided under paragraph (c)(1)(v), in addition to the information provided as part of the Material Inspection and Receiving Report specified elsewhere in this contract, the Contractor shall report at the time of delivery, as part of the Material Inspection and Receiving Report, the following information:

(1) Unique item identifier.

(2) Unique item identifier type.

(3) Issuing agency code (if concatenated unique item identifier is used).

(4) Enterprise identifier (if concatenated unique item identifier is used).

(5) Original part number (if there is serialization within the original part number).

(6) Lot or batch number (if there is serialization within the lot or batch number).

(7) Current part number (optional and only if not the same as the original part number).

(8) Current part number effective date (optional and only if current part number is used).

(9) Serial number (if concatenated unique item identifier is used).

(10) Government's unit acquisition cost.

(11) Unit of measure.

(12) Type designation of the item as specified in the contract schedule, if any.

(13) Whether the item is an item of Special Tooling or Special Test Equipment.

(14) Whether the item is covered by a warranty.

(e) For embedded subassemblies, components, and parts that require DoD unique item identification under paragraph (c)(1)(iii) of this clause, the Contractor shall report as part of, or associated with, the Material Inspection and Receiving Report specified elsewhere in this contract, the following information:

(1) Unique item identifier of the parent item under paragraph (c)(1) of this clause that contains the embedded subassembly, component, or…