D2d. SSJ_23P17756_MOD 00002_COSigned_Redacted.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER

$250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

NIOSH/DFSE/FRB

1090 Tusculum Avenue, Mailstop R14 Cincinnati, OH 45226

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 2920 Brandywine Road Atlanta, GA 30341

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Urine analysis for low-level detection of cocaine, benzoylecgonine, methamphetamine, heroin, 6-monoacetylmorphine, hydromorphone, morphine, fentanyl, and norfentanyl using liquid chromatography-tandem mass spectrometry (LC-MS/MS) from University of California San Francisco

(UCSF).

Modification 00002 is to increase the number of urine analysis samples by a quantity of 35 for the current option year one through option year three (a total quantity increase of 105). This is an increase for work that is currently being provided under purchase order 75D30123P17756.

b. Procurement Request (PR) Number (if available): HCCKC-2025-90488

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor:

Rev. 5/14/19

UCSF Clinical Toxicology and Environmental Biomonitoring Lab, University of California, San Francisco Mt. Zion Cancer Research Building 2 Attention: Dr. Roy Gerona, 340 Sutter Street, S-271 San Francisco, CA 94115, DUNS Number 094878337 Federal Tax ID Number 94-6036493,

b. Estimated Procurement Modification 00002 Amount:

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number: N/A

Justification:

1. The justification for this non-competitive action is:

In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

Urgency Exclusive licensing agreements/Proprietary data Brand name required Industrial mobilization Other (only vendor that specializes in testing chemicals from cocaine, benzoylecgonine, methamphetamine, heroin, 6-monoacetylmorphine, hydromorphone, morphine, fentanyl, and norfentanyl)

In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

Urgency Only One Source Logical Follow Up Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

University of California San Francisco (UCSF) specializes in continuously improving and achieving the lowest achievable detection limit in urine for these analytes of interest (cocaine, benzoylecgonine, methamphetamine, heroin, 6-monoacetylmorphine, hydromorphone, morphine, fentanyl, and norfentanyl) using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Additionally, the turnaround time is less than one month which is critical for the time sensitive nature of the studies being conducted. The vendor utilizes a proprietary LC-MS/MS technology for illicit drugs and their metabolites detection.

Forensic science division workers who conduct investigations and handle evidence related to illicit drugs, including fentanyl and its analogues, perform activities such as collecting, transporting, processing, and analyzing evidence. Possible exposure routes to illicit drugs can vary based on the source and form of the drug, which includes powder, tablet, and liquid form. Evidence collection and processing activities have the potential for dermal exposure, ingestion, percutaneous exposure (e.g., needlestick), as well as activities that could aerosolize powders, potentially leading to inhalation or mucus membrane exposure. When handling illicit drugs with known adverse health effects, it is possible that accumulating, negative health effects could be the result of low-level chronic exposures. Additionally, when symptoms do arise, they may not be accurately linked to these chronic low-level exposures.

There are very little data on the exposures and health risks to workers who may be chronically exposed to low levels of illicit drugs while performing their jobs. Basic research is needed to better understand the unintentional occupational exposures to illicit drugs. Illicit drugs and their metabolite analyses in urine will help to determine if these analytes are being inhaled or absorbed through the mucus membranes or dermal contact. Currently, this technology is not available within NIOSH.

b. What other products/services were considered and why did they not meet the need?

No other vendors were considered since UCSF has the proprietary liquid chromatography-tandem mass spectrometry (LC-MSMS/MS) technology (see https://geronalab.ucsf.edu/chemical-repository) that is required. This vendor was awarded as no other vendors could provide this type of service for the specific type of sample at the detection level needed in the desired timeframe. Modification 00002 is for an increase in quantities for work that is currently being provided under purchase order 75D30123P17756.

3. Program Office efforts to seek potential offerors:

The program reviewed web sites such as LabCorp and Quest for the requested analysis and found only UCSF was able to provide the necessary services.

D. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

CIO Project Officer Name:

Center/Institute/Office COR/Program Official Signature:

Certification Date: October 23, 2024

E. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name:

Contracting Officer Signature:

Certification Date: Novenber 4, 2024