Immuno-Biological Laboratories, Inc. (IBL-America)

Compensation

Full Description

KMI Diagnostics is seeking a part-time CLIA Lab Director. The high-complexity laboratory director will work very limited hours (2 hours per month on average (working remotely), plus 2 onsite visits). While the majority of the work can be done from a remote location, the director is required to be onsite biannually, with at least 4 months between visits. Salary: $8000 annually to compensate for approximately 5 days of coverage per year. KMI will also assume the cost of any travel, hotel, and meal expenses related to the two required onsite visits. RESPONSIBILITIES The CLIA laboratory director is responsible for the overall operation and administration of the clinical laboratory per 42 CFR 493.1445 (lab director responsibilities) and 42 CFR 493.1457 (clinical consultant responsibilities), and when delegating any responsibilities to other qualified personnel (such as the Director of Laboratory Operations) remains accountable for ensuring that all duties are properly performed. Specific responsibilities are summarized below. 1. The Director must be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed. 2. The Director must ensure that the established quality assurance program is maintained to identify failures in quality as they occur. To facilitate this process, the Director of Laboratory Operations, in their role as Quality Manager provides the Director with a semi-annual quality assurance report. The topics in the report (including but not limited to the following) are reviewed and discussed during semi-annual consultation meetings. - Laboratory occurrences/non-conforming events (NCEs) - Quality Control failure tracking - Equipment calibration/verification status - Proficiency testing summary/status - New method validation/verification, if applicable - Training and competency assessment status - Procedure update status and review, if applicable - Certification/licensure status (CLIA, CA, MDH) - CAPA (corrective action/preventive action) investigations, if applicable 3. The Director must review and approve/sign records documenting the performance of their responsibilities and/or the oversight of delegated tasks during semi-annual consultation visits. Applicable records typically include the following. - Quality assurance reports - Quality control logs/charts - Proficiency testing reports - Procedure review The CLIA laboratory director is expected to fill the role of Clinical Consultant if/when needed. 1. The Clinical Consultant provides consultation regarding the appropriateness of the testing ordered and interpretation of test results. 2. The Clinical Consultant provides consultation related to the quality of reported results and their interpretation concerning specific patient conditions. EDUCATION AND CERTIFICATION REQUIREMENTS (per 42 CFR 493.1445) For MDs: Must be certified by the American Board of Pathology For PhDs: Note: There have been recent (2024) changes to the qualification requirements for PhDs. However, an individual is considered qualified as a laboratory director of high complexity testing under this section if they were already qualified and serving as a laboratory director of high complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. If they were not already qualified and serving as a director, all of the current qualifications as described in 42 CFR 493.1445 (and summarized below) must be met. - Must hold from an accredited institution an earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology (or other doctoral degree meeting specific requirements per 42 CFR 493.1445). - Be certified and continue to be certified by an HHS approved board. • ABB – American Board of Bioanalysis • ABB public health microbiology certification • ABCC – American Board of Clinical Chemistry • ABFT – American Board of Forensic Toxicology (limited to individuals with a doctoral degree with Fellow status) • ABMGG – American Board of Medical Genetics and Genomics (formerly known as American Board of Medical Genetics (ABMG)) • ABMLI – American Board of Medical Laboratory Immunology (no longer accepting new exam applicants) • ABMM – American Board of Medical Microbiology • ACHI -American College of Histocompatibility and Immunogenetics (formerly known as American Board of Histocompatibility and Immunogenetics (ABHI)) • NRCC – National Registry of Certified Chemists (limited to individuals with a doctoral degree) • DMLI – Diplomate in Medical Laboratory Immunology (ASCP Board of Certification) - Have at least 2 years of laboratory training or experience (or both) and laboratory experience directing or supervising high complexity testing. - Have at least 20 CE credit hours in laboratory practice that cover the Director responsibilities defined in 42 CFR 493.1445.