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Summary
This CLIA and Lab Management Consultant is a HighComplexity Laboratory Director with 12-15 years of cumulative high complexity and moderate complexity management and participated or lead over a dozen laboratory/facility audits and inspections with COLA, CLIA, JC, ISO, FDA-GLP, OSHA, and CAP. She is a Certified Quality Auditor(ASQ), Certified Laboratory Consultant (AMT), Diplomate of Laboratory Management (ASCP), and Qualification inLaboratory Safety (ASCP). 12 years of lab bench experience including performing high complexity and moderate complexity testing, technical supervisor for validations and regulatory management, and research development under both clean and dirty room regulations. 10 years of designing and certifying laboratories to meet regulatory requirements and creating regulatory documents including SOPs, technical manuals, and responsible for the management of all QA records for external and internal audits under various QMS systems. She has been part of multiple depositions, case and document reviews for the courts, participated in mock trials for upcoming cases and has provided consultation services as an expert in multiple fields. She understands the court room etiquette and the professionalism required and is aware of how to answer questions in depositions and on the stand.
Highlights
- Best practice lab management and processes
- Expert inCOLA, CLIA, JC, ISO, FDA-GLP, OSHA and CAP
- Clinical Laboratorycertification
- Toxicological Chemist
- Forensic Consulting
- Laboratory Design
- CLIA submission, audits, and regulatory requirements includingSOPs.
- Laboratory training best practices
- Laboratory policies and procedures and performing test procedures
Relevant Accomplishments
- Acted as Moderate and High Complexity Laboratory Director, Technical Consultant, or TechnicalSupervisor for multiple clients ensuring that policies and procedures are established for technologists and supervisors that conduct pre-analytical, analytical, and post-analytical phases of testing to verify that they maintain all regulations and competencies required.
- Designed laboratories to meet the testing needs of the facility to include space design, workflow design, budget oversight, preparing for CLIA submission and subsequent audits, preparing all regulatory requirements including SOPs, hiring and training of all personnel required, preparing for proficiency testing, working with billing and coding to ensure proper billing methods and paperwork is completed, working with collection facilities to train and provide all necessary paperwork, and managing the system through the first CLIA audit and maintaining compliance as Lab Director or with a chosen Lab Director.
- Responsible for maintaining the billing reports, revenue cycle including budgets for laboratories, preparing companies to use the appropriate billing codes and services to work with CMS and that they stay within all regulatory and quality compliance
- Work with medical directors and clinical directors to make sure all staff were trained appropriately and help them work through audits from regulatory companies such as CLIA or Joint Commission.
- Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre analytic, analytic, and post analytic phases of clinical laboratory testing. Working with CMS to make sure the appropriate billing codes were being submitted based on the type of testing and facility being set up.
- Ensure that policies and procedures are established for monitoring individuals who conduct testing to assure they are competent and maintain their competency to process specimens, perform test procedures, and report test results promptly and proficiently. Designed and implemented all SOPs, training guidelines, and monthly reporting guidelines. Selected test methodology appropriate for clinical use of the test menu.
- Responsible for independent planning, scheduling, and conducting QA inspections, audits, reviews to assure adherence to corporate policies, internal standards/requirements, and compliance with regulatory requirements. Responsible for all audit requirements (internal and external) to be maintained, be present for all audits, and perform any corrective actions needed.
Roles
- Independent Consultant
- Director of Environmental Health and Safety and GLP Quality
- Serologist / Laboratory Technician
- Technologist
Request Expert / Similar Expert
Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs
To apply for this job email your details to haleymmagnani@gmail.com
