Manage the day-to-day operations of all testing. (clinical, forensic, and HHS/SAMHSA-certified drug testing)
24/7 responsibility and accountability for all testing and staffing.
Ensures all aspects of certification with the National Laboratory Certification Program are maintained.
Oversees lab accreditation activities for other regulatory agencies, including any required reporting, surveys, and inspections.
Ensure that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the HHS-certified laboratory. The RP must ensure the continued competency of laboratory staff by documenting their in-service training, reviewing their work performance, and verifying their skills.
Maintain a complete and current SOP manual that is available to all personnel of the HHS-certified laboratory and ensure that it is followed. The SOP manual must be reviewed, signed, and dated by the RP(s) when procedures are first placed into use and when changed or when a new individual assumes responsibility for the management of the HHS-certified laboratory. The SOP must be reviewed and documented by the RP annually.
Maintain a quality assurance program that ensures the proper performance and reporting of all test results; verify and monitor acceptable analytical performance for all controls and calibrators; monitor quality control testing; and document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
Initiate and implement all remedial actions necessary to maintain satisfactory operation and performance of the HHS-certified laboratory in response to the following: Quality control systems not within performance specifications; errors in result reporting or in analysis of performance testing samples; and inspection deficiencies. The RP must ensure that specimen results are not reported until all corrective actions have been taken and that the results provided are accurate and reliable. Implement all remedial actions necessary to maintain satisfactory operation and performance of the laboratory in response to quality control systems not being within performance specifications, errors in result reporting or in analysis of performance testing samples, and deficiencies identified during NLCP and or SAMHSA inspections.
Oversee the scientific and technical functioning of the department while working collaboratively with disciplinary leads from across the organization. Manage compliance, collection, preparation, and analysis of departmental reports and metrics. Ensure appropriate methodology and equipment is in place and assisting in developing new methods or changes in existing methods.
Operates/supervises operation and maintenance of all equipment and instrumentation in assigned areas of operation.
Sets the example & ensures department personnel adhere to all appropriate safety, technical, and personnel P&P.
Adjusts work schedule to fit the needs of the section. Schedules section personnel to adequately cover workload, to include managing time-off requests.
Manages proficiency testing processes. Reviews results and takes appropriate corrective action.
Complies with HIPAA regulations to safeguard confidentiality of patient information. Ensures patient information is shared only with a need to know
Maintains confidentiality of company information.
Accepts and performs additional duties and responsibilities as assigned. Identifies areas of need and seeks ways to meet them.
Coordinates with other leaders to ensure specimens are received, processed, tested, and reported correctly and within TAT standards.
Proficiently uses the LIS and other business and technical software.hose with a need to know.
Qualifications for an RP designation as outlined by the US Department of Health and Human Services (HHS) for SAMHSA certified laboratories
PhD in Biochemistry, Chemistry, Biology or similar field; or training and experience comparable to a PhD
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.
Prefer at least five years of supervisory experience in a laboratory that performs forensic studies.
Previous HHS/SAMSHA experience in maintaining certification.
Previous work experience in a HHS/SAMHSA certified laboratory and experience in forensic applications of analytical toxicology.
Previous CAP and CLIA experience in maintaining accreditation
Ability to quickly learn and retain new skills and knowledge.
Working knowledge in use of a PC and Microsoft Office software (Word and Excel).
Adequate typing speed – able to do basic typing without looking at keyboard.
Must be able to sit or stand for up to one hour without a break or change in position. Some walking or equivalent mobility required.
Should be able to lift up to 20 pounds of weight.
Possess adequate visual acuity to read requisitions, printed reports and other documents, printed labels, and a computer screen.
Ability to take and give directions and work as a team towards a common goal.
Ability to organize and prioritize workload.
Ability to work well under pressure and maintain emotional composure.
Excellent communication and interactive skills.
Ability to identify and appropriately resolve problems. Use good judgment.
Must be dependable and conduct oneself in a mature, responsible manner. Possess a strong work ethic.