Laboratory Director

Statement of Work

Background: This statement of work is for medical services to support two program offices within CBP’s Office of Human Resources Management (HRM): National Programs Division’s (NPD) Medical and Fitness Branch (MFB) and CBP Hiring Center (CBP HC). CBP National Programs Division is located in Washington, D.C, and for the purposes of this SOW, is responsible for the Drug Free Workplace Program, Independent Medical Examinations, reviews of medical documentation, and general examinations. CBP Hiring Center (CBP HC) is located in Bloomington, MN, and for the purposes of this SOW, is responsible for the coordination of the pre-employment candidate medical examinations and fitness tests for positions with medical standards and physical requirements, and for the scheduling of specimen collection services for the drug testing of candidates selected to occupy safety-sensitive positions.  

Place of performance: Services will be performed primarily at an HHS-certified laboratory facility, with oversight responsibilities supporting a nationwide network of laboratories and testing locations. Limited travel may be required for site visits, audits, or program coordination.

Schedule Hours: Services shall be provided on a continuous, as-needed basis to support CBP operations. The Contractor shall support standard business hours, as well as extended hours, evenings, weekends, and holidays, as required.

Requirements:

• Certified as a laboratory director in forensic or clinic laboratory toxicology in the continental U.S., where the Contractor’s designated laboratory is located.  The Contractor shall provide evidence of certification or licensure as a laboratory director with the proposal and at six (6) month intervals thereafter At a minimum, hold a Ph.D. in one of the natural sciences as defined in HHS Guidelines

• Evidence of a minimum of five (5) years of experience providing day-to-day management of a clinical laboratory; and

• Evidence of minimum of three (3) years providing day-to-day management of an HHS-certified laboratory within the last three (3) years of this requirement.

• Experience in forensic toxicology with emphasis on the collection and analysis of biological specimens for drugs of abuse; and

• Experience in forensic applications of analytical toxicology (e.g. publications, court testimony, conducting research on the toxicology of drugs of abuse) or qualify as an expert witness in forensic toxicology. 

Duties and Responsibilities will include, but are not limited to the following:

• Provide overall leadership, management, and oversight of laboratory operations supporting the CBP Drug-Free Workplace Program (DFWP)

• Ensure the laboratory operates in full compliance with HHS Mandatory Guidelines, applicable federal regulations, and CBP requirements

• Oversee the processing, analysis, and reporting of all drug testing specimens, ensuring accuracy, reliability, and timeliness

• Ensure the laboratory maintains required HHS certification and meets all regulatory standards for forensic drug testing

• Manage laboratory capacity to ensure the ability to process a minimum required volume of specimens annually while maintaining quality standards

• Ensure proper chain of custody procedures are followed for all specimens, maintaining integrity and legal defensibility of results

• Oversee quality assurance and quality control programs to ensure accurate testing, validation, and reporting of results

• Ensure all laboratory results are transmitted through secure electronic systems in accordance with federal data security and privacy requirements

• Coordinate with the Medical Review Officer (MRO) to ensure timely review, verification, and reporting of test results

• Maintain and oversee laboratory staff qualifications, certifications, and training requirements

• Ensure all laboratory personnel comply with applicable licensing, credentialing, and professional standards

• Monitor laboratory performance metrics, identify issues, and implement corrective actions to maintain compliance and performance standards

• Ensure compliance with all security, confidentiality, and data protection requirements, including safeguarding sensitive medical and testing information

• Coordinate with subcontracted laboratories, if applicable, to ensure consistent compliance and performance across all testing locations

• Support audits, inspections, and Government reviews by maintaining complete and accurate documentation of laboratory operations and certifications

• Ensure readiness to support nationwide and 24/7 testing requirements, including surge or contingency operations as required