Position Summary
The Laboratory Director provides overall clinical, scientific, technical, and regulatory oversight of a CLIA-certified high-complexity clinical laboratory performing molecular diagnostic and immunoassay testing. The Laboratory Director is responsible for ensuring that laboratory services are accurate, reliable, timely, clinically appropriate, and performed in compliance with applicable federal and state regulations and accreditation requirements.
The Laboratory Director will fulfill all responsibilities assigned to the Laboratory Director under the Clinical Laboratory Improvement Amendments (CLIA), including 42 CFR §493.1445, and will ensure appropriate oversight of personnel, test systems, quality management, proficiency testing, method validation/verification, and laboratory operations.
The ideal candidate has demonstrated expertise in high-complexity clinical laboratory testing, particularly molecular diagnostics and/or clinical immunology/immunoassay methodologies, and experience operating within a regulated clinical laboratory environment.
Essential Duties and Responsibilities
Regulatory and Clinical Oversight
- Serve as the designated Laboratory Director for the high-complexity CLIA laboratory.
- Provide overall direction and administration of laboratory services in accordance with CLIA and applicable federal, state, and local requirements.
- Ensure laboratory testing provides quality laboratory services appropriate for the patient population served.
- Ensure the laboratory maintains appropriate CLIA certification and, when applicable, accreditation and state laboratory licensure.
- Maintain familiarity with applicable CLIA regulations, accreditation standards, FDA requirements, manufacturer instructions, and recognized laboratory standards and guidelines.
- Ensure that responsibilities delegated to qualified laboratory personnel are clearly defined and appropriately performed.
- Remain accessible to laboratory personnel for consultation regarding technical, clinical, quality, and regulatory matters.
- Ensure sufficient qualified personnel and appropriate resources are available for the volume and complexity of testing performed.
Test Systems and Method Validation/Verification
- Review and approve the selection and implementation of laboratory test systems.
- Ensure appropriate validation or verification of test performance specifications before patient testing is initiated, as applicable to the test system.
- Review and approve validation/verification studies, including applicable assessment of:
- Accuracy
- Precision
- Analytical sensitivity
- Analytical specificity
- Reportable range
- Reference intervals or clinical decision points
- Carryover and interference, when applicable
- Specimen stability and acceptability
- Reagent and instrument performance
- Provide appropriate oversight for laboratory-developed tests (LDTs), modified FDA-cleared/approved assays, and other nonwaived test systems, when applicable.
- Ensure test methods and procedures are scientifically valid and appropriate for their intended clinical use.
- Approve new and substantially revised laboratory procedures before implementation.
Molecular Diagnostics Oversight
Provide scientific and technical oversight of molecular testing, which may include PCR, real-time PCR, multiplex PCR, nucleic acid amplification testing, genotyping, infectious disease testing, pharmacogenomics, or other molecular methodologies offered by the laboratory.
Responsibilities include:
- Review assay design, performance characteristics, controls, calibrators, and acceptance criteria.
- Ensure appropriate contamination-control practices and workflow separation are established.
- Review amplification controls, internal controls, positive and negative controls, and other assay-specific quality measures.
- Evaluate significant shifts or trends in assay performance.
- Provide oversight of molecular result interpretation and reporting.
- Review discordant, unusual, or clinically significant results when appropriate.
- Ensure appropriate policies exist for repeat testing, inhibition, invalid results, contamination events, and troubleshooting.
- Ensure molecular testing is performed according to validated procedures and applicable manufacturer instructions.
Immunoassay Oversight
Provide scientific and technical oversight of immunoassay testing performed by the laboratory, including automated and/or manual immunoassay platforms as applicable.
Responsibilities include:
- Ensure appropriate calibration, quality control, maintenance, and performance monitoring.
- Establish or approve QC procedures and acceptance criteria.
- Review calibration and QC failures and ensure appropriate corrective action.
- Evaluate analytical interference, cross-reactivity, analytical measurement range, and other method-specific limitations as appropriate.
- Ensure appropriate reference intervals and/or clinical decision limits are established or verified.
- Provide oversight of result interpretation, confirmatory testing, and reflex testing algorithms when applicable.
Quality Management
- Establish and maintain an effective laboratory Quality Management System.
- Ensure quality control and quality assessment programs adequately monitor the entire testing process.
- Review laboratory quality indicators, trends, errors, complaints, amended reports, specimen rejection rates, turnaround times, and other relevant performance measures.
- Ensure identified problems are investigated and appropriate corrective and preventive actions are implemented and documented.
- Review the effectiveness of corrective actions.
- Ensure appropriate policies exist for pre-analytic, analytic, and post-analytic phases of testing.
- Participate in management reviews and continuous quality improvement activities.
- Ensure laboratory records and documentation meet applicable retention and regulatory requirements.
Proficiency Testing
- Ensure enrollment in appropriate CMS-approved proficiency testing programs for regulated analytes when applicable.
- Ensure proficiency testing specimens are handled and tested in accordance with CLIA requirements.
- Review and evaluate proficiency testing results.
- Ensure unsuccessful or unacceptable proficiency testing results are investigated promptly and corrective actions are documented.
- Ensure proficiency testing is integrated into the laboratory's overall quality management program.
- Ensure alternative performance assessment is performed at required intervals for tests for which formal proficiency testing is not available or required.
Personnel Oversight
- Ensure laboratory personnel meet applicable CLIA education, training, experience, and competency requirements for the duties they perform.
- Ensure appropriate individuals are designated to fulfill required CLIA positions and responsibilities, including Technical Supervisor, Clinical Consultant, General Supervisor, and Testing Personnel, as applicable.
- Ensure responsibilities are appropriately delegated only to qualified personnel.
- Ensure personnel receive adequate orientation and training before independently performing patient testing.
- Ensure competency assessments are performed and documented at required intervals and include the applicable elements required by CLIA.
- Review personnel performance issues that may affect the quality of laboratory testing.
- Promote a laboratory culture emphasizing patient safety, quality, compliance, scientific integrity, and continuous improvement.
Standard Operating Procedures
- Ensure that a complete and current laboratory procedure manual is available to personnel.
- Review and approve new procedures and significant procedural changes prior to implementation.
- Ensure procedures adequately address specimen requirements, test methodology, calibration, quality control, result interpretation, limitations, reporting, troubleshooting, corrective action, and safety as applicable.
- Ensure discontinued procedures are retained according to regulatory requirements.
Result Review and Clinical Consultation
- Ensure laboratory reports are accurate, complete, clinically appropriate, and issued in a timely manner.
- Establish policies for result review, release, correction, and amendment.
- Establish criteria for critical or significantly abnormal results when applicable.
- Provide consultation to healthcare providers regarding test selection, methodology, analytical limitations, interpretation, and clinical significance when appropriate.
- Review complex, unusual, discordant, or questionable laboratory results as necessary.
- Ensure mechanisms are established for promptly identifying and correcting laboratory errors that could affect patient care.
Laboratory Operations and Safety
- Work collaboratively with laboratory management to ensure adequate staffing, instrumentation, reagents, supplies, facilities, and information systems.
- Ensure the physical and environmental conditions of the laboratory are appropriate for the testing performed.
- Ensure appropriate biosafety, chemical safety, exposure-control, waste-management, and infection-control procedures are maintained.
- Support laboratory preparedness for regulatory inspections and accreditation surveys.
- Participate in responses to deficiencies, corrective action plans, and regulatory inquiries as appropriate.
Minimum Qualifications
Candidates must meet the applicable CLIA qualifications for Director of a laboratory performing high-complexity testing under 42 CFR §493.1443.
Depending upon the candidate's professional pathway, qualifications may include an appropriately qualified:
- Physician (MD or DO);
- Doctoral scientist (PhD or equivalent doctoral degree) in a chemical, physical, biological, or clinical laboratory science with applicable certification and qualifications required by CLIA; or
- Other individual meeting an applicable CLIA high-complexity Laboratory Director qualification pathway.
The successful candidate must:
- Meet all current federal requirements to serve as Laboratory Director of a high-complexity CLIA laboratory.
- Meet applicable state laboratory director licensure requirements for states in which the laboratory operates or holds permits, if required.
- Possess appropriate board certification where required by the candidate's CLIA qualification pathway.
- Have demonstrated knowledge of high-complexity clinical laboratory testing and regulatory compliance.
Preferred Qualifications
- Doctoral degree (PhD, MD, DO, or equivalent) with qualifications appropriate for high-complexity laboratory directorship.
- Board certification appropriate to the individual's discipline and CLIA qualification pathway.
- Experience directing or providing technical oversight for a high-complexity CLIA laboratory.
- Experience with molecular diagnostic testing, including real-time PCR and multiplex nucleic acid amplification assays.
- Experience with clinical immunoassay testing and automated immunoassay platforms.
- Experience with assay validation/verification and implementation of new test systems.
- Experience with laboratory-developed tests and/or modified FDA-cleared or FDA-approved assays.
- Experience with proficiency testing, quality management, competency assessment, and regulatory inspections.
- Familiarity with CLIA and, when applicable, CAP or other CMS-approved accreditation requirements.
- Experience reviewing clinical laboratory reports and providing consultation to healthcare providers.
Knowledge, Skills, and Abilities
The successful candidate should demonstrate:
- Strong knowledge of CLIA high-complexity laboratory requirements.
- Expertise in clinical laboratory quality systems.
- Knowledge of molecular diagnostic principles, assay performance, and troubleshooting.
- Knowledge of immunoassay principles, quality control, calibration, interference, and result interpretation.
- Ability to critically evaluate analytical performance data.
- Ability to review and approve laboratory validation and verification studies.
- Strong scientific judgment and problem-solving skills.
- Effective written and verbal communication skills.
- Ability to work collaboratively with laboratory leadership, technical personnel, clinicians, compliance personnel, and executive management.
- Strong commitment to patient safety, regulatory compliance, and laboratory quality.
Time Commitment and Availability
The Laboratory Director must devote sufficient time to the laboratory to fulfill all CLIA Laboratory Director responsibilities effectively, considering the laboratory's test complexity, testing volume, personnel, number of locations, and scope of services.
The Laboratory Director must be reasonably accessible to laboratory management and testing personnel for consultation and must participate in laboratory oversight activities at a frequency appropriate to laboratory operations.
Compliance Statement
Employment and designation as Laboratory Director are contingent upon verification that the candidate satisfies all applicable CLIA high-complexity Laboratory Director qualification requirements, as well as any applicable state licensure, certification, accreditation, and organizational requirements.
The Laboratory Director is expected to perform all duties required under applicable CLIA regulations, including the responsibilities specified in 42 CFR §493.1445, and any additional requirements applicable to the laboratory's testing menu and regulatory status.
Pay: $1,500.00 - $3,500.00 per month
Benefits:
Work Location: In person
