JA_sole_source.doc

19-10049

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD on behalf of the Department of Defense (DoD) Drug Demand Reduction Program (DDRP) to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for award of a contract on a sole source basis for a four month supply of immunoassay screening reagents for the detection of Fentanyl / Norfentanyl in human urine. DDRP has an immediate need for the fentanyl reagent. On 29 March 2019, the Office of the Under Secretary of Defense for Personnel and Readiness indicated that fentanyl and norfentanyl will be added to the DDRP drug testing panel within 90 days. In recent years, the emergence of fentanyl, a synthetic opioid which requires much lower doses to produce narcotic effects and which dramatically increases the likelihood of abuse and overdose, has been recognized as a serious public health issue. This is done to protect the interest and concerns of military and civilian members and our nation by providing identification and preventative action of drug abuse and potential drug overdose. The Government intends on awarding a Firm Fixed Price (FFP) contract. The proposed source is Immunalysis Corporation, 9975 Summers Ridge Rd, San Diego, CA 92121.

3. Description of the supplies/services required.

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION OF FENTANYL IN URINE.

1.1. Scope. The materials shall be for the initial (screen) immunoassay for the detection of fentanyl in urine when present at a concentration equal to or greater than 1 ng/mL. Without modification of the instrumentation, the reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers in use at the Department of Defense (DoD) Forensic Toxicology Drug Testing Laboratories (FTDTLs) to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology Division. The immunoassay is limited to a two (2) reagent assay procedure. A vendor’s reagent proposal which requires a separate pre-treatment of each 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 Food & Drug Administration (FDA) in order to meet the requirements of DoDI 1010.16.

1.2. Sensitivity and Specificity. The analyzer shall be calibrated at 1 ng/mL using DoD FTDTL-prepared and DoD FTDTL-certified solutions containing fentanyl. All controls, DoD FTDTL-prepared and DoD FTDTL–certified, will utilize the same compound as the calibrator. The reagent shall minimize cross-reactivity with structurally similar drugs/metabolites in addition to all drugs and metabolites on the current DoD drug testing panel as 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 once per 8 hour testing period. The following drug cutoffs are currently used by DoD for the initial immunoassay screen and chromatographic/spectrometric confirmation tests, respectively:

(ng/mL)

Codeine

Hydrocodone

Hydromorphone

*Fentanyl/Norfentanyl are being added to the DoD drug testing panel within 90 days per Office of the Under Secretary of Defense (Personnel and Readiness) memo of 29 May 2019. Initially, a smaller subset of specimens will be tested through pulse testing or adjunct testing paradigms

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 to the Government sites. 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 510(k) 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 specimen 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 and 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 for or optimize the performance of a kit for the contractor.

1.5. Shelf Life. The minimum shelf life of any unopened component of the assay shall be a minimum of 180 days from the date of delivery to the FTDTL. Once kit container seals are broken and the components are opened, the shelf-life shall be a minimum of 14 days.

1.6. The FTDTLs intend to use the immunoassay kits in a manner consistent with the FDA approval except as otherwise stated in this statement of work. 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 1 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 demonstrate 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 fentanyl when present in human urine at concentrations equal to or greater than 1 ng/mL as determined by gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-tandem mass spectrometry (LC-MS/MS) procedures utilized by the FTDTLs (and AFMES).

3.2. The reagent shall be capable of identifying specimens as negative for fentanyl when present in human urine at concentrations below 1 ng/mL as determined by GC-MS or LC-MS/MS procedures utilized by 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 testing period.

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

3.5. The reagent shall produce non-overlapping ranges for quality control (QC) samples analyzed at 0%, 50%, 100%, 150%, and 200% of the calibrator/cutoff concentration.

3.6. The reagent shall have minimal cross reactivity with analytes other than fentanyl, fentanyl metabolites, and fentanyl structural analogues.

4. QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL POSSESS CURRENT ISO-9000 SERIES CERTIFICATION 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 (NMR), 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 shall be 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 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 shall be 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 fentanyl 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 molecule(s) 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 QC procedure shall be described thoroughly.

4.4.3. Records. The production and QC 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 QC parameter is found to be out of limits, the action taken to ensure correction for existing kits (i.e., notification) shall be documented and documented action(s) shall be taken to ensure that the deficiency does not reoccur. All records shall be retained for the term of the contract. 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 component of the reagents 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.

Operation and Maintenance funds in the amount of $x will be used to fund the requirement.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1), FAR 13.501(a), Only One Responsible Source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Immunalysis Corporation is the only vendor that can provide Fentanyl / Norfentanyl immunoassay screening reagents to meet the requirements of the Government. As a result of the immediate requirement of this new reagent for DDRP and since only one known source has an existing supply, NMLC will pursue a sole source purchase of a four-month supply of fentanyl from Immunalysis Corporation, the only vendor which has demonstrated it is capable of meeting the minimum requirements of the Government,. NMLC will consider a strategy for a longer term contract.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the NECO and/or FedBizOpps in accordance with FAR 5.202. NMLC is developing the acquisition strategy for a longer term contract.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in March, April, and May 2019. It included a search of the Internet using Google, Bing, GSA Advantage, and Federal Procurement Data System - Next Generation (FPDS-NG) at https://www.contractdirectory.gov/contractdirectory/. Contact was also made with subject matter expert Brittany Wolf, Deputy of Navy Drug Testing Program regarding requirement capabilities. It was determined that Immunalysis Corporation, Ark Diagnostics, and Carolina Liquid Chemistries were sources that could potentially provide reagents to meet the requirements of the Government, and at the time all were small businesses. This requirement was competed as a small business set-aside and multiple offers were received. However, none of the offers received from small businesses could meet the minimum requirements. Immunalysis Corporation was no longer considered a small business at the time of proposal evaluation and thus was ineligible for award, though it was found to meet the minimum requirements. Immunalysis Corporation is thus the only vendor identified which is capable of immediately meeting the requirements of the Government for a four month supply of reagent. NMLC is developing the acquisition strategy for a longer term contract beyond four months.

A notice of Intent to sole source to Immunalysis was posted to Fed Biz Opps on 13 September 2019 with a closing date of 28 September 2019. No responses were received.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FedBizOpps in accordance with FAR 5.202. All known sources have been contacted via a Small Business Set-Aside solicitation N62645-19-Q-0017 by NMLC resulting in no technically sufficient offerors. NMLC is developing the acquisition strategy for a longer term contract beyond four months.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval is Adam Belanger, who may be reached