Compliance Analyst, Laboratory Compliance
CurrentSupport clinical diagnostic laboratories compliance with federal and state regulations applicable to laboratories. Agencies include CMS/CLIA, CDC, DOT accreditation agencies (CAP, COLA, and The Joint Commission) and state agencies (MN, WI and NYS departments of health). In addition, the FDA regulations as apply to clinical laboratories. Responsibilities include surveillance and interpretation of regulations, review of new standards, interpreting applicability to discrete lab issues and participating in inspections by the various agencies. Interact with the agencies for further guidance on interpretations of the regulations. Serve as primary contact for NYS submission of laboratory tests. Build and deliver educational sessions on regulations of laboratories Review lab records for compliance. Evaluate lab test systems to classify reagents, instruments and software to define billing and guide the labs on extent of validation required for tests.Support the laboratory reference business with similar activities and assist with client questions as relates to regulatory and compliance.Analyze laboratory information in conjunction with the regulations and write interpretations and opinions to assist with development of laboratory and Mayo Clinic policy.Built quality systems for two research labs for compliance for inspections by CMS and CAP, the inspections yielded no deficiencies.Was primary regulatory support for the laboratory clinical trials unit from 2006 until unit closed in2009. Helped management, staff and clients with understanding of Good Clinical Practices as applied to testing in diagnostic labs. Conducted regulatory review of study proposals and setup for regulatory risk. Supported inspections of lab practices and lab data by clients and the FDA.
