N6264517Q0028_Amendment0001.pdf

N6264517Q0028

Amendment 0001 03 October 2017

Description of Amendment/Modification:

The purpose of this amendment is to answer questions received regarding the solicitation. In addition, the point of contact for the Naval Medical Logistics Command has been updated in the Contract Administration and Addendum 52.212-1 sections. The hour and date specified for receipt of offer is not extended. There are no other changes.

The following have been added by full text:

AMENDMENT 0001

Question 1: Is there a minimum test requirement for the kit yield on the Beckman Coulter AU5800?

Answer 1: There is no minimum test requirement for the kit yield on the Beckman Coulter AU5800. In accordance with the solicitation, Addendum to 52.212-1 Instructions to Offerors and 52.212-2 Evaluation – Commercial Items, the offeror is required to provide per-test reagent volumes to determine the number of tests per kit.

Question 2: Shelf-Life, page 5, what is your requirement for on-board stability?

Answer 2: In accordance with the solicitation, Addendum to 52.212-1 Instructions to Offerors and 52.212-2 Evaluation – Commercial Items, the offeror is required provide stability of unopened and opened reagents and storage requirements to achieve these. Opened stability may include on-board stability.

Question 3: The solicitation states that the reagent must be compatible with the Beckman Coulter AU5800. Do you require that documentation of this be supported by registration in the FDA database provided here?

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

Answer 3: In accordance with the solicitation, Statement of Requirements, 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. In addition, in accordance with the Statement of Requirements, Addendum 52.212-1, and 52.212-2 Evaluation – Commercial Items, the offeror is required to provide certification of FDA approval/authorization for the proposed Oxycodone Immunoassay Reagent. Documentation of FDA approval/authorization for use of the Oxycodone 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 Requirements Sections 4.1 through 4.5.6 shall be provided with the offeror’s’ proposal. Lastly, in accordance with 52.212-2 Evaluation – Commercial Items, offerors shall submit calibration and parameter settings for use on the Beckman Coulter AU5800 Series Analyzer.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

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 4001 in 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. The Government may deviate from the reagent manufacturer’s recommended parameters when conducting testing.

4.5. Offerors shall provide a price per kit based on the estimated number of tests proposed for CLINs 0001, 1001, 2001, 3001, and 4001 in 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 4001 in 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 Dominica.a.gay.civ@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:

- Encrypt email message when possible.

- Notify me when file(s) downloads are STARTED.

- Notify me when file(s) downloads are COMPLETED.

- Require CAC for Pick-up (all recipients will need to log in with a CAC to download file(s).

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 Dominica.a.gay.civ@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 N6264517Q0028. 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.). Additional documents will not be accepted after receipt of the confirmation email from the offeror to the Dominica.a.gay.civ@mail.mil inbox that confirms successful submission of the proposal.

https://safe.amrdec.army.mil/SAFE/Welcome.aspx mailto:Shannon.P.Lertora.civ@mail.mil

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 Dominica.a.gay.civ@mail.mil (Subject: N6264517Q0028). 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.

CONTRACT ADMINISTRATION

1. Contract Administration

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

Naval Medical Logistics Command Dominica Gay 693 Neiman Street Fort Detrick, Maryland 21702

(301) 619-9333 Email: dominica.a.gay.civ@mail.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.

mailto:dominica.a.gay.civ@mail.mil

3. Designation of Ordering Activities

The following requiring activities and their ordering office are hereby named to place delivery orders.

Requiring Activity Ordering Activity Navy Drug Screening Laboratory Great Lakes 320B B Street Building 38H Great Lakes, IL 60088-2815

Navy and Marine Corps Public Health Center 620 John Paul Jones Circle, Suite 1100 Portsmouth, VA 23708-2103

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

Same as Requiring Activity

Headquarters Air Force Drug Testing Laboratory Wilford Hall Medical Center Building 3750, Ladd Street Lackland Air Force Base, TX 78236

59 Medical Logistics & Readiness Squadron 2200 Bergquist Dr. Bldg 4550 Suite 1 Lackland Air Force Base, TX 78236

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

Same as Requiring Activity

Army Forensic Toxicology Drug Testing Laboratory 160 Takata Road Fort Shafter Flats, HI 96858

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

Same as Requiring Activity

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 the Contracting Officer for contractual action.

4. Ordering

The contract hereby authorizes requiring/ordering activities to place 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 by a contracting officer or an ordering officer using the government purchase card or Wide Area Workflow for payment methods.

5. 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. Delivery date and place of delivery.

5. 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 Naval Medical Logistics Command (NMLC) via NMLC DOD Drug Testing Program Mailbox at usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil (SUBJECT: Contract Number & Delivery Order Number).

6. Reports mailto:usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil

The contractor shall provide an electronic monthly report of sales within seven calendar days after the close of each month’s sales. Reports, in Microsoft Excel, shall be emailed to NMLC DOD Drug Testing Program Mailbox at usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil (SUBJECT: Contract Number).

Reports shall contain the following information:

1. Date of order.

2. Contract number and delivery order number.

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

4. Total Amount.

5. Delivery date and place of delivery.

6. Payment method.

7. 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 Summary of Changes) mailto:usn.detrick.navmedlogcomftdmd.mbx.doddrugtestingprogramnmlc@mail.mil