N6264523R0005 P0001 SF-30 Opiates Amd 1 - Issued.pdf

N6264523R0005

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this Amendment is to answ er Offeror Questions submitted to the RFP (Attachment 2), and correct SF-1449 language as noted by change bars. Also adds sample Small Business Sub-Contracting Plan Template (Attachment 3), clarifies Offeror Evaluation, and states SAM Certification document be replaced by copy of SAM Registration for proof. Added Attachment 4 Small Business Professional excerpt.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 8

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 17-Nov-2022

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X N6264523R0005

X 9B. DATED (SEE ITEM 11)

28-Oct-2022

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

10-Nov-2022

CODE

NAVAL MEDICAL LOGISTICS COMMAND

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

N62645 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 14-Nov-2022 11:00 AM to 21-Nov-2022 11:00 AM.

TABLE OF CONTENTS

The Table of Contents has changed from:

Exhibit/Attachment Table of Contents

DOCUMENT TYPE DESCRIPTION PAGES DATE

Attachment 1 to:

Exhibit/Attachment Table of Contents

DOCUMENT TYPE DESCRIPTION PAGES DATE

Attachment 1 Att 1 Price List Attachment 2 Att 2 - N6264523R0005

Opiate RFP Questions & Answers

09-NOV-2022

Attachment 3 Att 3 - N6264523R0005 Sample SB Subcontracting Plan

09-NOV-2022

Attachment 4 Att 4 - Sm Bus Prof (Govt and Indus) Quick Ref

09-NOV-2022

The following have been modified:

ADDENDUM TO 52.212-1

Addendum to 52.212-1 Instructions to Offerors

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

Proposals shall be submitted in accordance with the Solicitation (Addendum to 52.212-1 – Instructions to Offerors – Commercial Items) to philmore.h.crichlow.civ@health.mil by 11:00 AM eastern time on 21st November 2022.

Proposal Content and Instructions for Preparation of Proposals.

Instructions for preparation of proposals. This section specifies the format and content that Offerors shall use in this Request for Proposal (RFP). The intent is not to restrict the Offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Offerors must submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided shall be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified in the Addendum to 52.212-1. Any proposal that does not provide, as a minimum, that which is required in this solicitation may be determined to be substantially incomplete and not warrant any further consideration. The Government shall award a contract to the responsible Offeror whose offer will be most advantageous to the Government, price and other factors considered.

The proposal shall be submitted in four separate volumes:

Volume I* – Technical Approach;

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

Volume IV – Business Proposal.

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

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

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

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

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

1.3. Volume I: Technical Approach Proposal,

1.4. Evaluation Factor A: FDA and ISO Certification

1.4.1. Certification of FDA approval/authorization for the proposed Opiate Immunoassay Reagent.

Documentation of FDA approval/authorization for use of the Opiate Immunoassay Reagent shall be provided with the offeror’s' proposal.

1.4.2. Documentation of current certification compliance with applicable ISO Standards or documentation of compliance with Statement of Work (SOW) Sections 4.1 through 4.5.6 shall be provided with the offeror’s’ proposal.

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 Naval Medical Readiness Logistics Command and

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

1.5.1. The Offeror’s proposal shall include:

1.5.2. Package insert containing complete, accurate and verifiable information regarding:

(1) Explanation and principles of the testing procedure.

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

Beckman Coulter AU5800 Series Analyzer in the processing of samples.

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

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

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

Series Analyzer.

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

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

1.6. Evaluation Factors 3 & 4 Evaluation Factor C: Performance Test – Minimum

Requirements/Enhancing Factor

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

1.6.2. Upon request, the offeror shall ship a SUFFICIENT number of reagent kits to perform at least

5,000 tests, plus enough reagent for instrument start up, calibration, quality control checks, and shut down. These reagents shall be shipped, at no cost to the Government, to one of the five DoD military drug-screening laboratories located within the continental United States (CONUS).

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

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

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

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

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

2.2.3. Dollar value of the contract.

2.2.4. Description of the reagents provided under the contract.

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

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

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

2.2.8 Any other relevant information.

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

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

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

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

3.1. All Offerors are required to submit a Small Business Participation Commitment (SBPC). 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.

Small Businesses should submit only a Small Business Participation Commitment Other Than Small [Large Businesses] should submit both a Small Business Participation Commitment AND a

Small Business Subcontracting Plan.

3.2. The Contracting Officer will review the SBPC 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, 4001, and 5001 in Attachment 1: Pricing Sheet.

4.4. Offerors shall state the total number of tests per kit proposed for CLINs 0001, 1001, 2001, 3001, 4001, and

5001 in Attachment 1: Pricing Sheet. The number of tests shall be based on the reagent volume recommended by the equipment manufacturer.

4.5. Offerors shall provide a price per kit based on the estimated number of tests proposed for CLINs 0001, 1001, 2001, 3001, 4001, and 5001 in Attachment 1: Pricing Sheet.

4.6. Offerors shall provide the number of kits proposed for CLINs 0001, 1001, 2001, 3001, 4001, and 5001 in

Attachment 1: Pricing Sheet.

4.7. Offerors shall provide a total price per CLINs 0001, 1001, 2001, 3001, 4001, and 5001 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:

Unique Identity number:

4.12. The Offeror must be registered in System for Award Management (SAM.gov) in accordance with FAR

52.204-7 and FAR 52.204-13. The Offeror shall verify its SAM.gov 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 include a PDF copy of their current the SAM.gov Entity Registration reflecting the Active Registration Status, Expiration Date and Cage Number..

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 by email to philmore.h.crichlow.civ@health.mil

5.1.1 The Government does not authorize submission of telegraphic, facsimile, paper or CDROM offers via hand carry or mail carrier for this solicitation.

5.1.2 All proposals submitted in response to this solicitation will be submitted electronically directly to the contract specialist at philmore.h.crichlow.civ@health.mil.

5.1.3 Once the Offeror has submitted their proposal, they shall send a confirmation email to philmore.h.crichlow.civ@health.mil and provide their company name and contact information.

5.1.4 Any data previously submitted in response to another solicitation, whether submitted to the Naval Medical Readiness 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.

5.1.5 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.

5.1.6 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.

5.2.1. Files shall be in Microsoft Office for Windows format (2007 or higher), 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.

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

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

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

5.2.2.3. 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 were due no later than 02:00 PM Local Time, 3rd November 2022. Questions will not be addressed after this cutoff date. Questions were submitted via email to philmore.h.crichlow.civ@health.mil (Subject: N6264523R0005). Offerors were encouraged to submit one set of questions only; multiple submissions were discouraged. An amendment to the solicitation was 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.

(End of Clause)

The following have been deleted:

ATTACHMENT 1- PRICING SHEET

(End of Summary of Changes)