Lela Henkel CLS ASCP CRA
Corpus Christi,TX
Summary
Clinical Laboratory Scientist with 9 years bench experience and 5 years as a CLIA Federal Regulatory and Compliance Specialist.
Overview
18
18
years of professional experience
Work History
Technical Supervisor/Clinical Laboratory Scientist
Corpus Christi Medical Center
Corpus Christi
08.2014 - Current
Perform high complexity laboratory procedures using established and approved protocols in areas such as blood banking, immunology, serology,hematology, chemistry,and microbiology. Analyze quality control and corrects problems using scientific principles while maintaining accuracy and precision. Participates in the evaluation of new techniques in the laboratory including method comparison, cost analysis, and establishment of reference intervals; writing and revising technical procedures. Serve as Clinical Laboratory Science student educator for local universities and colleges.
CLIA Compliance Specialist IV
Texas Department of State Health Services
San Antonio
06.2008 - 11.2013
Survey Experience:
Compiles, reviews and analyzes information from preanalytic, analytic and post analytic processes derived from
clinical record reviews of quality control data, quality analysis data, patient charts, consumer and facility staff
interviews and on site observations
Evaluates management , supervision and quality of care delivery. Determines the validity of allegations in the
complaint and compliance with state and federal regulations
Plans of Corrections:
Evaluates and approves or requests additional information for plans of corrections for deficient practices identified during the survey. Uses state and federal guidelines concerning the necessary elements that constitute an
acceptable plan of correction
Report Writing:
Documents survey findings in written reports. Recommends adverse state enforcement action and federal
termination action if applicable
Public Relations:
Represents the department by making presentations, providing information and testimony , collaborating with
customers, other state agencies and federal partners. Provided consultation and pre survey conferences to
regulated healthcare facility provides and potential providers to assist them in maintaining compliance with state
and federal regulations..
Education
Certification - Clinical Research Associate
Kriger International Research Center
2013
Bachelor of Science - Advanced Clinical Laboratory Science
University of Texas Health Science Center San Antonio
Skills
Clinical laboratory testing, auditing, consultation, report writing,presentations, Problem resolution, public relations, quality control, quality assurance, regulatory affairs, staffing, supervision
Skills
- Blood Banking
- Immunology
- Hematology
- Coagulation
- Microbiology
- Urinanalysis
- Laboratory quality control
- Scientific recruitment and educator
- 42 CDFR 493 Regulatory Affairs and Compliance Pre analytic, analytic and post analytic laboratory system
- SOPs
- ICH
- GCP
Accomplishments
- Generalist Clinical Laboratory Scientist for 9 years with a main focus in blood banking for the last four years .
- Regulatory Specialist IV for Texas Department of State Health Services Conducted complex CLIA (Clinical Laboratory Improvement Amendment) audit surveys in accordance with 42 CFR 493 regulations.
- Hematopathology Laboratory Manager
- Biopharmaceutical Recruiter. Recruited Regulatory and Clinical staff for positions across the country for the pharmaceutical and biopharmaceutical industry.
Affiliations
American Society of Clinical Pathologist Board Certified (ASCP)
National Certified Investigator (NCI) from the Council on Licensure, Enforcement and Regulation
Affiliations
American Society of Clinical Pathology (ASCP)
Timeline
Technical Supervisor/Clinical Laboratory Scientist
Corpus Christi Medical Center
08.2014 - Current
CLIA Compliance Specialist IV
Texas Department of State Health Services
06.2008 - 11.2013
Certification - Clinical Research Associate
Kriger International Research Center
Bachelor of Science - Advanced Clinical Laboratory Science
University of Texas Health Science Center San Antonio