Amendment 0003.pdf

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:

1. Clarify that contractors must adhere to the Government’s established drug test cutoff levels.

2. Revise the delivery time frame from 10 days After Receipt of Order (ARO) to reflect that delivery shall be no later than (NLT) 60 days ARO.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 8

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

16C. DATE SIGNED

BY 11-Jul-2025

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 M0026325Q1010

X 9B. DATED (SEE ITEM 11)

04-Apr-2025

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

11-Jul-2025

CODE

REGIONAL CONTRACTING OFFICE

ATTN: DEDRIENE GREEN

P.O. BOX 5069 MCRD

(843)228-1955

PARRIS ISLAND SC 29905

M00263 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

M0026325Q1010

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION A - SOLICITATION/CONTRACT FORM

The required response date/time has changed from 27-May-2025 10:00 AM to 18-Jul-2025 10:00 AM.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

DESCRIPTION OF REQUIREMENTS

Description of Requirement Marine Corps Recruiting Command

Drug Test Kits

Updated 07/10/2025

Background The Marine Corps Recruiting Command (MCRC) has a requirement for non-instrumental, single-use instant drug test kits. These kits are used at the Military Entrance Processing Station (MEPS) to screen poolees/applicants as they go through the enlistment process. This is a commercial item that may require modifications of a type customarily available in the commercial marketplace, or minor modifications of a type not customarily available in the commercial marketplace made to meet Federal Government requirements.

Scope The scope of this requirement is to provide drug test kits, as needed, to each of the six (6) Marine Corps Districts (MCDs), by issuance of a Delivery Order. Delivery of drug test kits will be to eight (8) Recruiting Stations (RS) within each MCD. The Delivery Orders are typically issued on a quarterly basis. The Contractor shall provide all materials, equipment, personnel, and facilities necessary to manufacture, produce and deliver the drug test kits. The delivery address for the location will be identified on each order issued.

Requirements Point of Contacts Government Point of Contact for Marine Corps Recruiting Command (MCRC):

Aria Plewa Contract Specialist Marine Corps Recruiting Command (G-4) 3280 Russell Rd, 2nd Floor Quantico, VA 22134 Email: aria.plewa@marines.usmc.mil

The Contractor shall establish a single management point of contact to accomplish the administrative, managerial, and financial aspects of this Indefinite Delivery Requirements contract, and to serve as the primary interface with the Government POC and the Contracting Office.

Place of Performance The place of performance will be at the contractor’s facility.

Requirement The required drug test kits shall test urine for the following drugs at the specified cutoff levels. Contractors must follow the government’s established drug test cutoff levels, and all test kits provided must match the government-mandated cutoff levels. Compliance with these standards is mandatory and non-negotiable.

Drug Class Cutoff nanograms/milliliter (ng/mL)* Amphetamines 100 Designer Amphetamines 500 Benzodiazepines 100 Cannabinoids (Marijuana) 15 Synthetic Cannabinoids 1.0 Cocaine Metabolites 100 Opioids (Morphine / Codeine) 2,000 Opioids (Heroin metabolite 6-monoacetylmorphine) 10

Opioids (Oxycodone / Oxymorphone) 100 Opioids (Hydrocodone / Hydromorphone) 100 Opioids (Fentanyl / Norfentanyl) 1.0

The drug test kits shall test, at a minimum, for the drugs listed above at the specified cutoff levels. The drug test kits may include testing of additional drugs with cutoff levels at or above current industry standards. All drug assays shall be contained in a single test cup. The cup shall also include a built-in validity/adulteration test and a built-in temperature strip and screw on lid.

Estimated Quantities Provided below are the estimated quantities for each MCD:

DISTRICT BASE

YEAR

OY1 OY2 OY3 OY4 TOTAL

1MCD 16,700 16,700 16,700 16,700 16,700 83,500

4MCD 14,640 14,640 14,640 14,640 14,640 73,200

6MCD 17,100 17,100 17,100 17,100 17,100 85,500

8MCD 12,800 12,800 12,800 12,800 12,800 51,200

9MCD 17,700 17,700 17,700 17,700 17,700 88,500

12MCD 16,500 16,500 16,500 16,500 16,500 66,000

TOTAL 95,440 95,440 95,440 95,440 95,440 477,200

Specifications

TEST FEATURES:

1. The drug test kits shall be designed to allow test results to be easily photocopied.

2. The product shall be a one-step, all-inclusive test kit for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine and also have built-in validity/adulteration testing.

3. The test shall not require any pre-treatment of the urine sample prior to testing and must be non-instrument based, free of plumbing and electrical systems, with an ease of use based on practical portable field application and use. No pipettes, droppers, patches, or other devices/materials shall be required for operation and use.

4. The test shall be able to be stored at room temperature, with a minimum shelf life of 12 months from date of delivery.

5. The test and test results shall be clear and easy to read visually.

6. The test cup shall be able to run standing upright and shall not require tilting or inverting the cup upside down to run the test.

7. The test time to completion for read, once operator begins the test, shall not exceed five (5) minutes, but test results shall remain stable for up to one (1) hour.

8. The test cup shall have a screw on lid, and be a one-step, all-inclusive cup requiring no additional keys or devices for the specimen to interact with test material.

ACCURACY AND RELIABILITY:

1. The drug assays at the specified cutoff levels shall be approved by the US Food and Drug Administration (FDA) for commercial distribution as a medical device with an active 510(K) notification document.

2. The test product shall be manufactured to be “negative specific.”

3. The assays shall have been proficiency tested by the College of American Pathologists and subsequently published on their product/method Master List indicating that products meet the proficiency testing requirements.

QUALITY CONTROL:

1. The Contractor shall have a specialized internal quality control test which provides guaranteed quality product for each lot produced.

2. The device shall provide an easily read internal control test which indicates that the device is functioning properly.

3. Device test results shall not be openly visible to the donor (i.e. the area of the test results should remain covered until the test administrator is ready to read the results and the donor cannot remove the cover without clear evidence of tampering).

4. The assay test strips within the device shall be encapsulated and protected from donor tampering.

5. Tamper-evident security seals shall be provided for each device to ensure that the cup has not been reopened once the specimen has been submitted, and to allow the specimen to be sent to a laboratory for further GC/MS confirmation if desired or needed. The seals shall provide surface and space for written data related to the specimen collection and donor and operator information, if needed.

6. The Contractor shall supply a legally defensible drug test results from incorporating a photocopy template to allow actual test results to be copied and kept on record along with related donor information, if needed.

TRAINING AND SUPPORT:

1 Contractor shall have current training systems in place via:

a. Online web-based training; or

b. Product-specific user manual supported by DVD/CD training materials, delivered to each delivery location on the first Delivery Order.

This training shall be provided, if needed, at the written request of the Contracting Officer.

2. Customer Service Support

a. The Contractor shall provide Customer Service support available via telephone during the standard operating hours of 8:00 AM to 8:00 PM, Eastern Standard Time (EST). This Customer Service support will include answering questions about the product’s features and functionality.

3. Technical Support

a. The Contractor shall provide access to technical and toxicology specialists for any specialized questions, as needed.

b. The Contractor shall offer expert witness testimony and support for any unforeseen legal issues, should they ever arise.

Delivery The Contractor shall deliver the drug testing kits in accordance with each Delivery Order.

Shipping addresses and a Point of Contact will be listed for each delivery location on the Delivery Order. Delivery shall be no later than (NLT) 60 days After Receipt of Order (ARO).

Deliverables The Contractor shall deliver drug test kits in the quantities specified in each individual Delivery Order.

The Contractor shall provide in every box a separate packing list which reflects the Delivery Order number and the quantity of drug test kits included.

The Contractor shall provide to the Government POC via email prior to invoice submission in Wide Area Work Flow (WAWF); a document, that shows the Government receipt of drug test kits delivered to each location. The Government POC Will Be Provided at Award.

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

FAR 52.212-1 ADDENDUM

The instructions contained in FAR 52.212-1 Instructions to Offerors-Commercial Items are applicable to this solicitation, but are tailored as follows:

Paragraph (c) is modified to require the offeror to agree to hold the prices in its offer firm for 60 days calendar days from the date specified for receipt of offers.

Paragraphs (e) “Multiple offers” and (h) “Multiple awards” are not applicable.

This addendum contains additional instructions below applicable to this specific solicitation:

GENERAL INSTRUCTIONS

1. The Regional Contracting Office, Parris Island (RCO-PI) intends to award a firm fixed price purchase order as a result of this solicitation. The objective of this requirement is to provide drug test kits, as needed, to each of the six

(6) Marine Corps Districts (MCDs), by issuance of a Delivery Order.

2. Solicitation number M00263-25-Q-1010 is issued as a Request for Quote (RFQ) using the commercial procedures in accordance with FAR Part 12 and Simplified Acquisition Procedures FAR Part 13.5 This solicitation is an 100% Small Business Set-aside, and the North American Industrial Classification System (NAICS) code for this requirement is 334516 with a size standard 1,000 employees.

3. Questions: Any/all questions regarding this RFQ shall be received by this office no later than 24 April 2025 at 10:00AM Eastern Standard Time (EST). All questions must be submitted to the email addresses listed below. No phone call please for questions.

4. Interested offerors MUST be registered and active in the System for Award Management (SAM).

5. Quote Deliverables

The Government intends to evaluate offers and award a contract without discussions. Therefore, the offeror’s initial offer should contain the offeror’s best terms from a price and technical standpoint. Offerors are cautioned to examine this solicitation in its entirety and to ensure that their proposal contains all necessary information, provides all required documentation and is complete in all respects.

Use of general or vague statements such as “standard procedures will be used” will not satisfy this requirement.

Unnecessary elaboration or presentations beyond what is sufficient to present a complete and effective solution are not desired and may be construed as a lack of understanding of the requirement.

Late submissions will not be considered for evaluation. Telegraphic and Facsimile offers are not authorized for this solicitation and will not be considered for evaluation.

Quotations must be prepared in accordance with these instructions. Failure to do so may result in the offeror’s submission being determined unacceptable and ineligible for award. Each offeror’s submission shall be screened by the Contract Specialist upon receipt to ensure completeness and compliance with the instructions contained in this solicitation.

A. OFFEROR TO COMPLETE BLOCKS 12, 17 (include Offeror name, Point of Contact, Cage code, Duns code,), 23, 24, AND 30(30a through 30c) on page 1 of the SF 1449

B. The offeror shall provide a specification sheet for item(s) to be delivered that contains sufficient information for the Government to be able to determine whether each item meets the product specifications outlined at section C of the solicitation.

C. The Offeror shall fill in prices for all CLIN in Section B

D. The offeror shall complete provisions provided in Section K of the SF1449 submit with quote, or complete the Reps and Certs in the System for Award Management (SAM) and reference SAM completion in quote.

E. SAM-validated and NAICS Code 334516 compliant.

F. The offeror must acknowledge all solicitation amendments.

G. The offeror must affirmatively state that they take no exceptions to the terms and conditions of the RFQ. Include a cover letter delineating any exceptions taken to the solicitation terms and conditions. However, offerors are cautioned that any noncompliance with the terms and conditions of the solicitation may cause their quote to be determined unacceptable.

H . Quotes must be good for 60 days from the closing date of the solicitation.

6. Offeror Submission

Electronic submission via email is authorized (see email addresses below). Send email to the primary point of contact and also copy (cc) the secondary point of contact. The written submission must arrive by the stated deadline in order for a quote to be considered complete and to be evaluated. Failure of any portion of the quote to arrive by the stated deadline will result in rejection of the entire quote.

Note: Offerors submitting via email must ensure that attachments do not exceed 5 MB; offerors with attachments larger than 5 MB must split their response into multiple emails to meet the 5 MB attachment limitation. In addition, .zip files will be filtered and removed by the MCRDPI firewall. Any attachments must be in .pdf, .jpeg, and or .docx format.

7. Government Points of Contact:

Primary POC Secondary POC Dedriene Green Kacy Mohead Contract Specialist Contracting Office dedriene.l.green.civ@usmc.mil kacy.m.mohead@usmc.mil

SECTION M - EVALUATION FACTORS FOR AWARD

52.212-2 EVALUATION--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(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, past performance, and other factors considered. The following factors shall be used to evaluate quotes:

(i) Price

(ii) Past Performance: The apparent successful, prospective contractor must have satisfactory or neutral past performance. Past Performance shall be evaluated in accordance with FAR 13.106-2. The Supplier Performance Risk System (SPRS) application (https://www.sprs.csd.disa.mil), the Contractor Performance Assessment and Reporting System (CPARS), Federal Awardee Performance and Integrity Information System (FAPIIS), and any other sources available to the Government may be utilized to evaluate Past Performance

(iii) Other Factors: Contractor’s quoted supplies or services shall, at a minimum, meet the specifications, deliverables, or performance requirements outlined in the solicitation.

In accordance with FAR 13.106-2(b)(3), the government will conduct a comparative evaluation of quotations based on price and other non-price factors. If more than one quotation is received, quotations shall be ranked in order of lowest price to highest price. Evaluations will commence with the lowest priced quotation. Evaluations will continue until at least two competing quotations are found to be acceptable and have acceptable past performance.

The Government will conduct a comparative assessment of the two competing quotations that are found to be mailto:dedriene.l.green.civ@usmc.mil mailto:starleana.brown@usmc.mil acceptable and have acceptable past performance. The award will be made to the offeror whose quote is determined to have both a fair & reasonable price and to be the most advantageous to the Government.

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

52.217-5 EVALUATION OF OPTIONS (JUL 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

(End of provision)

(End of Summary of Changes)