Ross Owen Email & Phone Number

Lincolnshire, Illinois, United States

Chicago, Illinois, United States

Supported the Clinical Laboratory to ensure CAP/CLIA/NYS/FDA regulatory compliance for all five of the accredited laboratories across the United States that are in the Tempus Labs system.Maintained CLIA certification, CAP accreditation and State licensure for all five of the clinical laboratories in the Tempus Labs system as required. Coordinated and supported various QA activities such as: • Maintenance of training plans and training records, including job descriptions and CVs. • Record Retention for Lab Documents including onsite and offsite storage management. • Act as Administrator of document control (MediaLab and ETQ Reliance Modules) supporting CAP compliance such as Personnel Documentation, Compliance/CE, Inspection Proof and others as applicable.Authored and reviewed SOPs/Policies, verification/validation Protocols and Reports.Conducted laboratory walkthroughs and CAP self-inspections for the Tempus clinical laboratories. Lead inspection readiness efforts and host inspections as needed.

Chicago, Illinois

Cement, operationalize & execute Tempus partnerships with customer success as my goal. While I largely focus on Research partnerships, the scope of my partnerships include:- Retrospective sequencing for researchers- Managing investigator-initiated trials or association-sponsored programs for prospective patients - Owning overall relationship and communications with high-touch, high-volume prospective orderersPartner Operations also ensures smooth coordination of all customer-touch points. This includes:- EMR Integrations - Biological Modeling projects- Radiomics projects

Northfield, Il

• Staff liaison of the Point of Care Testing committee and the Immunohistochemistry (IHC) committee.• Validate technical accuracy of Surveys and Quality Improvement products through: - critical oversight of creation of documents - integration of information from all contributing sources - coordination of production schedules• Manage and ensure accuracy of databases/specifications result forms.• Review grading criteria and interpret data.• Provide comprehensive consultative services to all internal groups directly involved in, or otherwiseimpacted by, the Surveys Programs.• Serve as a training resource to mentor staff liaisons for resource committees, further departmentalknowledge, or assist in developmental projects as identified, or as collaborated with, by technicalanalysts, project managers, technical managers, or directors.• Provide direction and consultative services externally on an ongoing basis.Major interfaces include: o CMS, o CDC, o FDA, o NIST, o CLSI, o State Departments of Health, o Medical associations.• Maintain awareness of activities in the field of laboratory medicine in assigned disciplines and forregulatory and legislative processes in general.

Responsibilities include:- Managing, researching, developing, interpreting and delivering Surveys and Quality Management program and resource committee projects content to meet customers’ needs and support College objectives.- Being the primary resource for communication and consultation services for a broad constituency, internally and externally.- Identifying and leading process improvements and managing department projects.- Working independently, using comprehensive decision making skills and diverse procedures/policies requiring analytical and interpretive thinking to manage and develop Surveys products.Primary duties and responsibilities:- Staff the Point of Care Testing committee- Staff the Hematology committee- Validate technical accuracy of Surveys and Quality Improvement products through: - critical oversight of creation of documents - integration of information from all contributing sources - coordination of production schedules- Manage and ensure accuracy of databases/specifications result forms.- Review grading criteria and interpret data.- Provide comprehensive consultative services to all internal groups directlyinvolved in, or otherwise impacted by, the Surveys Programs.- Serve as a training resource to mentor staff liaisons for resource committees,further departmental knowledge, or assist in developmental projects asidentified, or as collaborated with, by technical analysts, project managers,technical managers, or directors.- Identify, propose, develop, or improve projects, products, or processeswithin the Surveys Department.- Provide direction and consultative services externally on an ongoing basis.- Major interfaces include:o CMS,o CDC,o FDA,o NIST,o CLSI,o State Departments of Health,o vendors,o commercial manufacturers, ando medical associations.- Maintain awareness of activities in the field of laboratory medicine inassigned disciplines and for regulatory and legislative processes in general.

Responsibilities include:- Analyze, organize, and process pre-inspection materials for all accreditation programs and initiate follow up where necessary.- Perform/review checklist usage audit, on applications, reapplications and completed staff assignments, to ensure proper checklist assignment for the inspection process.- Maintain and update inspection/accreditation database.- Provide phone assistance to program participants, inspectors, and commissioners regarding accreditation cycle, application process or materials, requirements for accreditation and inspection process.- Provide consultation to laboratories throughout the inspection and accreditation process on LAP Products and services and LAP/Regulatory requirements as they pertain to accreditation.Specific responsibilities related to supervising operations staff includes:- Assisting with the hiring, coaching, and goal setting of new and existing Operations staff.- Providing leadership, assistance, and direction to Operations staff in the absence of the department Director.- Ensuring Operations staff is adequately trained in new and existing procedures.- Ensuring adequate staffing, improving department performance, and ensuring accurate and timely follow up on all documents and communications for accreditation application/reapplications.- Working independently in diverse situations, applying in-depth knowledge of CAP/LAP procedures and policies.

My duties within the laboratory include, but are not limited to:-Overseeing the receiving and processing area of the Core Laboratory and also the Beckman Coulter Automated Power Processor.-Performing preventative and routine maintenance on the Power Processor.-Troubleshooting and resolving mechanical issues.-Serving as the lead representative for the on-line laboratory procedure manual, SoftTech-Writing procedures and submiting them for approval.-Assigning procedures via SoftTech to be reviewed by staff-Training staff-Re-evaluating protocol for general improvement-Instituting and delegating new procedures to improve Turn-Around-Time.-Administering the ordering of supplies and reagents-Working directly with engineers that service the automated Power Processor-Holding daily meetings with staff to update on issues that may be present.-Serving as a Lab Leader and meeting monthly with the Director of the Laboratory, Managers, Supervisors, etc.-Serving as the lead role in the recent laboratory resulting software update (Sunquest).-Performing correlation testing-Attending meetings at off-site locations to educate staff on the storage and transport requirements of samples.I also spend much time outside of my office where I am able to maintain bench work duties:Operate blood and urine analyzers; perform quality control, routine maintenance, and performance checks for many specialized instruments; verify and report critical results; perform correlation studies between various methods of analysis; maintain various records

Biochemistry

Generalist