NOTIFICATION OF INTENT TO SOLE SOURCE The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to Regents of the University of California, San Francisco (UCSF), Clinical Toxicology and Environmental Biomonitoring Lab. To analyze urine samples for cocaine, fentanyl, heroin, and methamphetamine and their metabolites (benzoylecgonine, norfentanyl, 6-acetylmorphine, morphine, and hydromorphone). This lab is responsible for the Drug Enforcement Administration’s Toxicology Testing Program. Results will be provided of analyses within one month. By utilizing UCSF for this analysis, the lowest achievable detection is possible and the extent of exposure to illicit drugs can be determined which is critical for this research. Forensic science division workers conduct investigations and handle evidence related to illicit drugs including fentanyl and its analogues, with 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. Additionally, these scientists are potentially unaware of contamination through routine sample processing and of the need to report accidental exposures and symptoms. NIOSH has completed several Health Hazard Evaluations (HHEs) at the request of public safety employers and forensic scientists concerned about occupational exposures to opioids and illicit drugs. In forensic drug laboratories, detectable levels of cocaine, fentanyl (and their metabolites), and methamphetamine were found in the employees’ urine. Additionally, using air, hand, and surface wipe sampling, NIOSH HHEs found that employees are possibly exposed via inhalation, contact with mucous membranes, or through accidental ingestion. These data, paired with the questionnaire data, showed that exposure controls were not preventing drug exposure as well as they could (NIOSH 2022a, b). This study will address important gaps in knowledge about the illicit drug-exposed workforce. There is an insufficient body of literature characterizing current exposure and potential health risks associated with occupational exposures to illicit drugs. Additionally, more research is needed to understand the controls needed to reduce illicit drug exposures as more toxic and dangerous opioids are developed. The high potency of the newly developed synthetic analogues of fentanyl, large volume of distribution, and potential active metabolites have raised concerns about the management of people exposed as well as the safety of those accidentally exposed. The rising trends of illicit drug use with higher potency raise concerns about the increased potential for work-related exposure to these hazardous chemical substances among crime scene technicians and forensic chemists. Biomonitoring accounts for all routes of exposure: inhalation, ingestion, percutaneous exposure and dermal or mucous membrane absorption. Urine was selected as the biomonitoring medium of choice as it is less invasive than blood collection and most drugs have a longer analytical detection time in urine compared to blood. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) will be utilized for urine analysis to provide the lowest levels of quantification achievable. Previous HHEs determined the laboratory with the lowest achievable detection limit of illicit drugs in urine to be the University of California, San Francisco (UCSF). Urine samples will be analyzed for cocaine, fentanyl, heroin, and methamphetamine and their metabolites (benzoylecgonine, norfentanyl, 6-acetylmorphine, morphine, and hydromorphone) under contract by Dr. Roy Gerona and his staff at the University of California, San Francisco (UCSF), Clinical Toxicology and Environmental Biomonitoring Lab. This lab is responsible for the Drug Enforcement Administration’s Toxicology Testing Program. These services are currently being performed under contract 75D30123P17756 by UCSF. 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). UCSF utilizes a proprietary LC-MS/MS technology for illicit drugs and their metabolites detection. Additionally, the turnaround time is less than one month which is critical for the time sensitive nature of the studies being conducted. Modification 0002 to contract 75D30123P17756 is to increase quantities due to an unforeseen increase in the number of urine samples received for analysis. UCSF has the required knowledge and is capable of providing these services with seamless continuity and without disruption and delays. The period of performance for these services is 3/01/2024 – 2/28/2027. This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) (SAP) and 41 U.S.C. 3304(a)(1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive quotations; however, all responses received within five (5) days of the issuance of this notice will be considered by the government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any response should be emailed to contract specialist at
[email protected] by 1:00pm Eastern Time, November 15, 2024. See attached SSJ.