N0018924RZ162.pdf

SEE ADDENDUM

(No Collect Calls)

N0018924RZ162 15-Oct-2024

b. TELEPHONE NUMBER

215-697-2000

8. OFFER DUE DATE/LOCAL TIME

05:00 PM 22 Nov 2024

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

N001899. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

JAMES W. BERGHAIER

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

NAVSUP FLC NORFOLK PHILADELPHIA OFFICE

ATTN: JAMES BERGHAIER

700 ROBBINS AVE., BLDG 2B

PHILADELPHIA PA 19111-5083

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE N68850 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

NAVY DRUG SCREENING LABORATORY, JAX

KALA BENSON

NAVAL AIR STATION

BUILDING H-2033 ADAMS AVENUE

JACKSONVILLE FL 32212-5000

TEL: (904) 542-7755 X 100 FAX: (904) 542-7761

FAX:

TEL: 215-697-2022 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,250

NAICS:

325413

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF64

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

N0018924RZ162

Section SF 1449 - CONTINUATION SHEET

NOTE TO QUOTERS

Questions:

Questions must be received in writing via email to James Berghaier at james.w.berghaier.civ@us.navy.mil no later than 1500 ET on 18 October 2024.

SUBMISSION OF QUOTES

The Navy is soliciting interested sources in accordance with FAR 13.106-1(a) using the procedures and evaluation factors described in this provision. It is emphasized that this is intended to streamline the source selection and be minimally burdensome for both the Navy and vendors interested in competing for this requirement. The procedures of FAR 15.3 do not apply to the source selection. The contracting officer will make the source selection using the following two-step process.

Step One To be submitted no later than 25 October 2024 at 1500 EST via email to james.w.berghaier.civ@us.navy.mil, interested sources shall provide sufficient technical documentation (including but not limited to: product literature, specifications) demonstrating their ability to meet the Statement of Work and containing the information required below:

FDA, ISO Certification or Quality Assurance Documentation, Statement of Work (SOW) Compliance Attestation, and OEM requirements.

-Documentation of FDA approval/authorization for use of the 6am Immunoassay Reagent.

-Documentation of current certification compliance with applicable ISO Standards OR documentation of compliance with SOW Sections 4.1 through 4.4.5.

-SOW Compliance Attestation in accordance with SOW Section 6.1.

-Interested source is AND has provided evidence of being Original Equipment Manufacturer (OEM) of reagents, or an authorized dealer, authorized distributor, or authorized reseller for the proposed reagents such that OEM parameters, quality controls, and services are provided and maintained by the OEM.

If the interested source’s Step One submission does not include ALL of the items above, the Step One submission will not be considered and the interested source will be excluded from further evaluation.

Reagent Preparation and Calibration Information. Package inserts shall contain complete, accurate, and verifiable information including:

-Explanation and principles of the testing procedure.

-Description of each reagent’s composition for use on the Beckman Coulter AU5800 Series Analyzer in the processing of specimens. The immunoassay procedure is limited to a two (2) reagent assay procedure.

-Instructions for reagent handling, mixing, and storage.

-Reagent stability and storage requirement for both un-opened and opened reagent kits.

-Minimum shelf life for un-opened and opened reagent kits. In accordance with the SOW Section 1.5, the un-opened reagent kits shall have a 180-day minimum shelf life from the date of product delivery and opened reagent kits shall be stable for at least 14 days.

-Calibration and Instrument parameters for use on the Beckman Coulter AU5800 Series Analyzer. The calibrators and controls shall be DoD-prepared and -certified solutions containing 6am.

-Performance characteristics anticipated in terms of accuracy, precision, and sensitivity to the target analyte, 6am.

-Table of cross-reactivity and specificity of the assay to commonly encountered scheduled compounds, common over-the-counter medications, and other principal drugs of abuse.

Submissions in response to Step One shall not exceed 40 pages, excluding a Cover Sheet and Table of Contents, in length. The page limitations are inclusive of any charts, diagrams, and/or other graphics. Each “page” is defined as one sheet, 8 ½ “ x 11”, with at least one inch margins on all sides, using a font with a point size of 12 or greater (e.g., "Times New Roman" style with 12 point font) and “Normal” character spacing. Lines shall, at a minimum, be single-spaced. The only exceptions to the font size requirement include the following: (1) the text contained in graphics, charts, headers and footers may be point size of 8 or greater. Pages shall be consecutively numbered.

Multiple pages, double pages, or two-sided pages, will count as an equivalent number of 8 ½" x 11" pages. The cover sheet and table of contents (not to exceed one page each) will not count toward the page limit. Pages submitted in excess of the page limitations described above, and as broken out below, will not be evaluated. The Government may exercise discretion in determining which specific pages are considered to be in excess of the page limitations.

The contracting officer will evaluate each submission and determine which sources are viable competitors for award. Sources that fail to meet the requirements above will be deemed nonviable. The contracting officer may communicate with an interested source if such communications will enhance the contracting officer’s determination of whether the source is a viable competitor for award. The contracting officer will notify those sources determined nonviable that they are eliminated from further consideration and invite interested sources determined viable to submit a quote in response to Step Two.

Step Two Upon the completion of Step One, the Contracting Officer will request the information detailed in FAR 52.212-1 and its addendum, and FAR 52.212-2 of the Request for Quotations from quoters (i.e., all sources determined to be viable competitors under Step One). Refer to FAR 52.212-1 and its addendum for entirety of instructions and FAR 52.212-2 and its addendum for evaluation criteria.

The non-price evaluation factors in Step Two are: Performance Test, Past Performance, and Socio-Economic Plan.

Performance Test is more important than Past Performance. Performance Test and Past Performance are each significantly more important than Socio-Economic Plan.

In addition to the information submitted by quoters, the contracting officer may consider other information reasonably related to the evaluation factors, to include the personal knowledge of the quoter’s commercial and Government customers, and past performance databases. The contracting officer is not obligated to evaluate all information submitted from each quoter. For example, the contracting officer may curtail evaluation of a quote if at any point the contracting officer determines the quoter is unlikely to provide best value.

Any quotations received from sources that were determined not viable during Step One and not invited to submit a quotation based on the review conducted during Step One will not be evaluated and will be immediately disqualified for consideration in this requirement. Sources determined to be viable will be requested to submit a non-price and price quote via email to james.w.berghaier.civ@us.navy.mil. Sources determined to be viable will also be required to ship a SUFFICIENT number of reagent kits to perform at least 5,000 tests, plus enough reagents for instrument start up, calibration, quality control checks, and shut down. These reagents shall be shipped, via express delivery at no cost to the Government, to one of the DoD forensic toxicology drug testing laboratories (FTDTL) in the Continental United States (CONUS). The location for shipment of reagent kits will be provided by the contracting agency upon notification of viability as a result of Step One. The non-price quote, price quote, and reagent kits shall be received no later than 22 November 2024 at 1700 PM Eastern Time.

STATEMENT OF WORK (SOW)

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF 6-

ACETYLMORPHINE IN URINE

The Department of Defense (DoD) Drug Demand Reduction Program (DDRP) has a requirement for FDA and Quality Management Documented 6-acetylmorphine Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems. The reagents shall be capable of detecting 6-acetylmorphine in human urine samples. Proposals shall comply with the Statement of Work (SOW).

The reagent kits are required for a period of performance (PoP) of five (5) years. The estimated number of tests shall accommodate up to 500,000 tests per month.

Only Original Equipment Manufacturer (OEM) of reagents, authorized dealer, authorized distributor or authorized reseller for the proposed reagents, such that OEM parameters, quality controls and services are provided and maintained by the OEM, will be considered. All storage, shelf-life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions, as specified in the SOW.

The OEM’s reagent product shall not be repackaged by the Offeror unless authorized, as specified in the SOW.

The vendor shall comply with the FDA and Quality Management Documentation, as specified in the SOW.

The vendor shall comply with the Reagent Preparation and Calibration Information, as specified in the SOW.

1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of 6-acetylmorphine (6AM) in urine when present at a concentration equal to or greater than 10 ng/mL The reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers (hereafter referred to as “analyzer”) in use at the Department of Defense (DOD) Forensic Toxicology Drug Testing Laboratories (FTDTLs), to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology Division, without modification of the equipment.

The immunoassay procedure is limited to a two reagent assay procedure. A vendor’s reagent proposal which requires a separate pretreatment of each testing specimen prior to testing on the analyzer will not be considered acceptable. The reagent shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments. The reagent shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the contractor’s reagent on the analyzer. Immunoassay kits shall have clearance from the FDA in order to meet the requirements of DoDI 1010.16 Rev. (June 15, 2020). Immunoassay kits will be evaluated based on their ability to accurately detect 6AM based on the testing and performance characteristics in conjuncture with all evaluation factors.

1.2. Sensitivity and Specificity. The analyzer shall be calibrated at 10 ng/mL using DOD FTDTL prepared and certified solutions containing 6-AM. The controls will utilize the same compound as the calibrator. The reagent shall minimize cross-reactivity with structurally similar drugs/metabolites in addition to the drugs/metabolites on the current DOD drug testing panel, listed below (excluding the compound of interest). The reagent shall demonstrate calibration stability, as evaluated by frequency of control failures, and shall require calibration no more than one time during an 8 hour period. The following drug cutoffs are currently used by DOD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively.

Drug Class Drugs/Metabolites (IA target in bold) Initial Screen

(ng/mL) Confirmation

(ng/mL) Marijuana 11-nor-delta-9-THC-carboxylic acid & 11-nor-delta-8-THC-carboxylic acid 50 15

Cocaine Benzoylecgonine 150 100 Opioids Morphine 300

Codeine 2000 Hydrocodone 100 Hydromorphone 100 Heroin 6-Acetylmorphine 10 10 Opioids Oxycodone & Oxymorphone 100 100 Amphetamines d-Amphetamine & d-Methamphetamine 500 100 Designer Amphetamines

Methylenedioxymethamphetamine & Methylenedioxyamphetamine

500 500

Benzo-diazepines

Nordiazepam, Oxazepam, Temazepam, Lorazepam, Alpha-hydroxyalprazolam

200 100

Synthetic Cannabinoids

4MBUT, 4MBTN, 5FADB, 5MPCA, ADBTN,

ABFUB, M4PIN, MFUBN

10 1

Fentanyl Fentanyl & Norfentanyl 1 1

Lysergic Acid Diethylamide

Lysergic Acid Diethylamide & 2-oxo-3-hydroxy-LSD

0.5 0.2

1.3. Compliance with Food & Drug Administration (FDA) Requirements.

1.3.1 Immunoassay kits are considered medical devices and shall have clearance from the FDA to be marketed. The registration and listing process specified by the FDA shall be followed and the manufacturer shall adhere to good manufacturing processes in the manufacture of the devices. Any mandatory recalls of the kits provided under the resulting contract and any other problems that require notification to the FDA shall be resolved as required by the FDA regulations current at the time. The contractor shall notify the Contracting Officer of any recall or FDA notification within two working days of the event.

1.3.2. Except as provided herein, the reagents supplied throughout the term of this contract shall be identical to the reagents offered by the contractor and accepted by the Government at the time of the contract award. If, during the course of this contract, the manufacturer wishes to change or improve its kit, that product modification shall be proposed in writing to the Contracting Officer for approval prior to its incorporation into the kits to be delivered.

The contractor's proposal shall include documentation that demonstrates that the manufacturer has complied with all applicable FDA regulations, including those concerning the filing of a new 510k notice if such action and subsequent FDA clearance are warranted by the nature of the modification.

1.4. Packaging. The reagents provided shall be in volumes and packaging that are convenient and applicable to the sample throughput at the FTDTLs and shall not result in the loss or unnecessary disposal of more than 3% of the working volume of reagent. The contractor shall not be required to provide calibrators/controls. The reagents shall be provided with an instruction sheet that complies with all requirements of the FDA and includes data demonstrating specific performance characteristics, such as accuracy, precision, sensitivity, specificity, cross-reactivity, and safety precautions. The instruction sheet(s) shall include procedures and instrument parameters optimized for FTDTL operations as represented in these specifications and cutoffs as utilized by the DOD. The Government shall not develop procedures or optimize the performance of a kit for the contractor. Offeror shall not repackage or relabel an OEM product unless authorized.

1.5. Shelf Life. The minimum shelf life of any unopened component of the assay shall be at least 180 days from the date of delivery to the FTDTL. All storage, shelf life, and expiration dates associated with the reagents shall be in accordance with the OEM terms and conditions. Once kit container seals are broken and the components are opened, the shelf-life shall be at least 14 days.

1.6. The FTDTLs intend to use the immunoassay kits in a manner consistent with the FDA approval. The package insert and information for the analyzer settings must contain the information necessary for the FTDTLs to use the immunoassay kits consistent with the device’s FDA approval. This ensures that the FTDTLs can use the immunoassay kits properly and derive the full benefit of the FDA approval.

2. TESTING and QUALITY CONTROL PROTOCOL.

2.1. The reagents supplied shall be compatible with the calibration requirements and characteristics of the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. Verification of each calibration, at 10 ng/mL, shall be accomplished with a drug free control and open controls at target concentrations of 50-75% and 150-200% of the calibrator/cutoff. An acceptable verification will have analytical readings as follows: drug free control < 50-75% control < cutoff (calibrator) < 150-200% control. The batch may also contain blind negative and positive controls distributed throughout the batch.

3. PERFORMANCE CHARACTERISTICS.

3.1. The reagent shall be capable of identifying specimens as positive for 6AM when present in human urine at concentrations equal to or greater than 10 ng/mL as determined by the current immunoassay and gas chromatography-mass spectrometry (GC-MS) or liquid chromatography- tandem mass spectrometry (LC-MS/MS) procedures utilized in the FTDTLs (and AFMES).

3.2. The reagent shall be capable of identifying specimens as negative for 6AM when present in human urine at concentrations below 10 ng/mL as determined by the current immunoassay and GC-MS or LC-MS/MS procedures utilized in the FTDTLs (and AFMES).

3.3. The reagent performance, as evaluated through the performance of controls, shall be stable over the course of the day and shall not require re-calibration within an eight hour period.

3.4. The reagent shall display precision and accuracy both within and between batches for concentrations ranging between 50-200% of the calibrator concentration.

3.5. The reagent shall produce non-overlapping ranges for samples analyzed at 0%, 50%, 100%, 150%, and 200% of the calibrator concentration.

3.6. The reagent shall have minimal cross reactivity with analytes other than 6-AM.

4. QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL POSSESS

CURRENT ISO-9000 SERIES CERTIFICATION, CURRENT ISO 13485 SERIES OR INCLUDE

DOCUMENTATION OF THE FOLLOWING ELEMENTS:

4.1. Chemicals and Reagents

4.1.1. Quality and Authenticity. All materials used in the preparation of reagents shall be verified as to authenticity and purity. Methods may include, but are not limited to, the determination of melting points, GC-MS, Nuclear Magnetic Resonance, and spectrophotometric measurements.

4.1.2. Stability. The kit and each kit component shall be shown to be stable and at the correct concentration over the period of use. Components that are homogeneous solutions shall not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration).

4.2. Manufacturer’s Equipment

4.2.1. Preventative maintenance. Routine preventive maintenance procedures, periodic calibration, and any unscheduled maintenance shall be fully documented and in accordance with recommendations of the manufacturer of the equipment.

4.2.2. Calibration and operational checks. All instruments that are used to check a physical parameter of a solution or material shall be calibrated and have documentation available to demonstrate that all required operational checks have been completed. This includes pH meters, spectrometers, micropipettes, etc.

4.2.3. Temperature Checks. Water baths, refrigerators, freezers, and other equipment that is intended to maintain a given temperature shall be periodically validated for accuracy and routinely verified for correct settings.

4.2.4. Glassware and other reusable supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials shall be established and compliance documented.

4.3. Antibody

4.3.1. Authenticity. The prepared antibody shall be verified to be authentic and its purity established.

4.3.2. Stability. The antibody shall be documented to be stable to the expiration date and the immunoassay shall meet all contract specifications to the end of expiration date (a minimum of 180 days from date of delivery to

FTDTL/AFMES).

4.3.3. Specificity. Antibody specificity shall be verified for each lot and the specificity re-evaluated at routine intervals to ensure uniformity and quality of preparations. The reagent shall provide performance characteristics in terms of sensitivity and specificity for detection of 6AM in urine. Chemical compounds that may reasonably be found in urine resulting from prescription or non-prescription drug use shall be tested to characterize antibody specificity. Specificity testing may include biochemical materials produced normally in the human body.

4.4. Immunoassays

4.4.1. Technical Performance. Performance of each lot of reagent shall be verified. The verification shall establish, as a minimum, the appropriate response to the target molecules and that all other parameters as specified in the contract are met. The performance parameters involved in the testing procedures shall be verified and documented to be consistent throughout the shelf life of the kit.

4.4.2. Manufacturer’s production manual. Procedures and criteria required to validate all components (and materials) employed during the manufacture of the reagents in the test kits and the operation of the completed kit over the entire period of shelf-life of the kit shall be described in detail. All steps of each quality control procedure shall be described thoroughly.

4.4.3. Records. The production and quality control records generated by each procedure performed above shall be maintained in a systematic fashion to permit the verification of the completion of all production parameters and shall be available for inspection during the term of the contract.

4.4.4. Corrective action. When a specified quality control parameter is found to be out of limits, the action taken to ensure correction for existing kits (i.e., notification) shall be documented and action taken to ensure that the deficiency does not reoccur. All records shall be retained. The Contracting Officer shall be notified within 2 working days of any deficiencies in existing kits and of all corrective actions for consideration, i.e., delivery of replacement kits at no cost to the Government. The FDA shall be notified according to its regulations.

4.4.5. Lot numbers. Lot numbers shall be used to identify reagents to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent shall be described. A single lot number for a kit shall suffice if all materials used in that lot number can be tracked to identify the materials and procedures used in the preparation of that kit.

5. PACKAGING AND MARKING.

5.1. Thermal Protection for Biologic Reagents. The contractor shall ship biologic reagent items used in the reagent kits in insulated thermal containers to ensure protection of the reagents against thermal (heat and cold) damage which would affect reagent performance contained in the Statement of Work of this contract.

5.2. Marking of Shipments (Commercially-Packaged Items). Marking shall be in accordance with ASTM D 3951 15, "Standard Practice for Commercial Packaging."

5.2.1. Additional markings include: Contract Number & Government Delivery Order Number.

5.3. Deteriorative Material Marking. The contractor shall include as part of the marking, the following information:

(a) Expiration date; (b) Required storage conditions for each kit component; and (c) Type I or Type II shelf life date as specified in MIL-STD-129 for each unit of material, issue, package, intermediate container and exterior shipping container.

6. SOW COMPLIANCE

6.1. The Offeror shall attest to compliance with the entire SOW and the Offeror shall attest that their proposed reagent kit complies with the entire SOW.

7. REPORTING

7.1 Vendor shall send monthly reports to the government via the laboratory services email: usn.hampton-roads.navmcpubhlthcenpors.list.nmcphc-labservices@health.mil

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 Each 6-AM Reagent Kit

FFP

Reagent kits to test for 6-Acetylmorphine Immunoassay found in urine.

Must be able to produce a minimum of 500,000 tests a month, around 6,000,000 annually.

FOB: Destination

PSC CD: 6550

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 15-JAN-2025 TO

14-JAN-2030

N/A NAVY DRUG SCREENING LABORATORY,

JAX

KALA BENSON

NAVAL AIR STATION

BUILDING H-2033 ADAMS AVENUE

JACKSONVILLE FL 32212-5000

(904) 542-7755 X 100 FOB: Destination

N68850

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.204-7 System for Award Management OCT 2018 52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-22 Alternative Line Item Proposal JAN 2017 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.204-26 Covered Telecommunications Equipment or Services-- Representation.

OCT 2020

52.204-27 Prohibition on a ByteDance Covered Application JUN 2023 52.209-10 Prohibition on Contracting With Inverted Domestic

Corporations

NOV 2015

52.212-1 Instructions to Offerors--Commercial Products and Commercial Services

SEP 2023

52.212-4 Contract Terms and Conditions--Commercial Products and Commercial Services

NOV 2023

52.217-5 Evaluation Of Options JUL 1990 52.219-1 Alt I Small Business Program Representations (FEB 2024)

Alternate I

FEB 2024

52.229-11 Tax on Certain Foreign Procurements--Notice and Representation

JUN 2020

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

MAY 2024

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

JAN 2023

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2023

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.211-7003 Item Unique Identification and Valuation JAN 2023 252.219-7003 Small Business Subcontracting Plan (DOD Contracts) DEC 2019 252.223-7008 Prohibition of Hexavalent Chromium JAN 2023

252.225-7001 Buy American and Balance of Payments Program FEB 2024 252.225-7002 Qualifying Country Sources As Subcontractors MAR 2022 252.225-7035 Buy American--Free Trade Agreements--Balance Of

Payments Program Certificate--Basic

FEB 2024

252.225-7048 Export-Controlled Items JUN 2013 252.225-7972 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned

Aircraft Systems (DEVIATION 2020-O0015)

MAY 2020

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7002 Requests for Equitable Adjustment DEC 2022 252.244-7000 Subcontracts for Commercial Products or Commercial

Services

NOV 2023

252.247-7023 Transportation of Supplies by Sea JAN 2023

CLAUSES INCORPORATED BY FULL TEXT

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (NOV 2021)

(a) Definitions. As used in this clause--

Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial products or commercial services, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of clause)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services--

Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

(a) Definitions. As used in this provision--

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means--

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror ( ) has ( ) does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in--

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management, which can be accessed via https://www.sam.gov (see 52.204-7).

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision --

"Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

"Economically disadvantaged women-owned small business (EDWOSB) concern" means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or service-

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

"Highest-level owner" means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

"Immediate owner" means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

"Inverted domestic corporation" means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

"Manufactured end product" means any end product in product and service codes (PSCs) 1000-9999, except--

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

"Place of manufacture" means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

"Predecessor" means an entity that is replaced by a successor and includes any predecessors of the predecessor.

"Reasonable inquiry" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

"Restricted business operations" means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate--

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets…