E1 - Amendment 0001.docx-.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 Amendment 0001 is to provide the Government's responses to questions received from industry regarding Section L of the solicitation and to extend the proposal submission deadline to 16 May 2025.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 5

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

16C. DATE SIGNED

BY 30-Apr-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

30-Apr-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 02-May-2025 10:00 AM to 16-May-2025 10:00 AM.

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been added by full text:

QUESTIONS AND ANSWERS

M0026325Q1010 Amendment 0001 Drug Testing Kits

Industry Question and Government Reponses

1. Section C: In the quote, we do not see Fentanyl listed. We have Fentanyl available with several different cutoffs, but it does not appear in the drug class list. Should there be a line item for Fentanyl? If not, we will assume it should be excluded — please confirm.

Government Response:

Yes-The requirement for Fentanyl was under “Opioids (Fentanyl / Norfentanyl)” and is for 1.0ng/ml.

2. Section A: Our other clients haven’t had issues making copies (photos or photocopies) of our products with the results. If that’s the intended use, it should not be a problem. However, please note that the cups are round and do not have a flat side. For a 10-panel test, this shouldn’t be an issue.

Government Response:

Understood.

3. Section B: Regarding the government’s comment on initial screening levels — how does this relate to the quote we are currently preparing, which includes different cutoffs? We interpreted it as additional information that isn’t directly relevant to the quote. Should we proceed on that basis?

Government Response:

Yes, this was additional information and isn’t relevant to the quote you are preparing.

4. Section C: We reviewed this link: CAP Proficiency Testing Info. We can provide an instruction sheet with cutoff levels and product information. All of our products come with this documentation. Will this satisfy what the client is asking for?

Government Response:

Possibly, we would like to see a copy instruction sheet/product information before confirming.

5. Section A: No adulterants were requested in the quote, so we were unsure why this was mentioned. The government’s response referencing AMP, BZO, THC, synthetic cannabinoids, and cocaine seems unrelated. We are inclined to ignore the adulterant question unless advised otherwise.

Government Response:

We would like an adulterant that ensures that the test was valid, e.g., checks for specific gravity, pH, temperature, creatinine levels, and the presence of certain chemicals to detect potential adulteration.

6. The cutoff levels listed in Section C — particularly for Amphetamines, Benzodiazepines, THC, Cocaine metabolites, and 6-MAM — are a little lower than the standard FDA-approved levels for commercial test kits. A few of these are closer to forensic-use thresholds and would likely require custom configurations that aren’t FDA-cleared for routine use.

I just wanted to check if those levels were intentionally set that way, and whether the government would be open to kits that follow FDA-approved standards, or if custom manufacturing is preferred in this case. Here are the cutoff levels that are low and FDA-approved levels:

• Amphetamines(AMP): 100 ng/mL FDA approved cutoff level is 500ng/ml and 1000ng/ml

• Benzodiazepines(BZO): 100 ng/ml FDA approved cutoff level is 300ng/ml

• Cannabinoids (THC): 15 ng/mL (weed) FDA approved cutoff level is 50ng/ml

• Synthetic Cannabinoids: 1.0 ng/mL (man-made weed-like drugs) FUO FOR FORENSIC USE cutoff level is 50ng/ml

• Cocaine Metabolites: 100 ng/mL (cocaine breakdown products) FDA approved cutoff level is 150ng/ml and 300ng/ml

• Opioids (Heroin metabolite 6-monoacetylmorphine): 10 ng/mL (specific heroin marker) FDA approved for OPI low cutoff is 300 ng/ml Government Response:

Yes, our current drug tests have the below cutoffs.

Amphetamines(AMP): 500ng/ml Benzodiazepines(BZO): 200 ng/ml Cannabinoids (THC): 15 ng/mL Synthetic Cannabinoids: 10 ng/mL Cocaine Metabolites: 150ng/ml Opioids (Heroin metabolite 6-monoacetylmorphine): 10 ng/mL

7. Were these low cutoff levels set on purpose?

Government Response:

Yes, to align with DOD drug testing requirements.

8. Would the government consider using kits that meet the standard FDA-approved levels?

Government Response:

No.

9. Is the government specifically requesting custom, forensic-level kits?

Government Response:

No.

10. Are FREE sample units of the test kits permitted or recommended to be submitted along with our proposal, even though not explicitly requested in the solicitation documents? If so, to which address should we send them to?

Government Response:

No sample units are required or recommended.

11. Could you kindly confirm whether any special packaging or labeling requirements (such as barcoding, MIL-STD labeling, or UID compliance) are expected beyond standard commercial packaging and clear identification of drug panels, expiration dates, and tamper-evident seals?

Government Response:

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 along with tracking information. Also reference MIL-STD-129. This standard provides the minimum requirements for uniform military marking for shipment and storage.

12. Is shipping from the manufacturer directly to the government address allowed if the shipping is made under our Company's name (KLIMB Solution LLC) and with all the required documentation?

Government Response:

Yes.

The following have been modified:

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% HUBZone 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

(End of Summary of Changes)