Lela Henkel MT (ASCP)
Park
San Antonio,
Texas 78209
Cell: (210) 863-
3951
E-Mail:
aboe3n@r.postjobfree.com
m
Professional
Background
I am an experienced CLIA (Clinical
Laboratory Improvement
Amendment) Compliance
Specialist IV with over 4 years of
experience auditing clinical
laboratories of all specialties and
complexities.
I am an experienced Medical
Technologist with over 4 years of
hands on laboratory testing among
several disciplines.
Skill
Highlights
• Medical Technologist MT (ASCP)
• Hematology
• Regulatory Affairs • Microbiology
• Compliance specialist • Chemistry
• Problem resolution • Molecular
• Management • Immunology
• Quality Control • Virology
• Pre-analytic systems • Mycology
• Analytic Systems • Dermatology
• Post Analytic Systems • Histology
• Report writing • Pathology
• Educator • Blood Banking
Accomplishm
ents
Clinical Services:
• I Performed laboratory
testing on patient
samples that exceeded
requirements
mandated by Federal
Guidelines and the
physicians ordering the
tests.
• I performed over 400
CLIA (Clinical
Laboratory
Improvement
Amendment) audits
across numerous
disciplines. I performed
audits among several
levels of complexities
and volumes spanning
from small test
volumes to volumes in
the millions.
Policy Development:
• I was a contact
person for
consultation to
laboratories
writing policies
and procedures
according to CLIA
federal
guidelines.
• I ensured the
laboratories I
audited were
following their
established policies
and procedures in
accordance with
federal guidelines.
Total Quality Management:
• I was responsible for
reviewing all laboratory
quality control material
as well as all quality
assurance programs
established by the
laboratories to ensuring
the laboratories were
following their QC/QA
policies and procedures
according to federal
guidelines.
• I was responsible for writing citations and enforcement action when laboratories
deviated from federal guidelines established by CLIA (Clinical Laboratory
Improvement Amendment).
Professional Experience
September 2008 to Texas Department of State Health Services
November 2012 San Antonio, Texas
CLIA Program Specialist IV
February 2006 to November 2008
Survey
Plans of Corrections:
Experience:
I Evaluated and approved or requested additional information needed to justify plans of
I compiled,
corrections, for deficient practices identified during the audit process. I referred to state
reviewed and
and federal guidelines concerning the necessary elements that constitute an acceptable
analyzed critical
plan of correction.
information from
pre-analytic,
Report Writing:
analytic and post
analytic
I Documented survey findings included in written reports. I recommend adverse state
processes.
enforcement action and federal termination action if applicable
These analytic
processes were
Public Relations:
derived from
clinical record
I represented my department by making presentations, providing information and
reviews of quality
testimony, collaborating with customers, other state agencies and federal partners. I
control data,
provided consultation and pre survey conferences to educate regulated health care
quality analysis
facilities.
data, patient
charts, and
consumer and
facility staff
interviews and on
site observations.
I evaluated the
management,
Corpus Christi Cancer Specialists
supervision and
quality of care
Corpus Christi, Texas
delivery. I
Laboratory Manager/Medical Technologist
determined the
validity of I oversaw all laboratory operations including:
allegations in the Specimen processing
complaint
Laboratory testing
process and
Equipment validation
determined
Equipment calibration
compliance with
Quality control material
state and federal
Quality Assessments
regulations.
Corrective action assessments
Data analysis
Proficiency test results
Day to day maintenance of equipment
Ordering of supplies
Preparation for audits
University Hospital
San Antonio, Texas
Medical Technologist Virology/Immunology/Molecular/Serology
I performed laboratory testing for a high volume virology/Immunology laboratory to
ensure accuracy and reportability of patient test results in a timely manner.
May 1997 to
July 2008
MAGIC Biopharmaceuticals
June 2006 to
Austin, TX
April 2008
Biopharmaceutical Recruiter
I provided staffing solutions (mainly for research and development positions) for
worldwide regulatory and clinical agencies within the pharmaceutical industry.
Education and Training
1997 University of Texas Health Science Center of San Antonio
San Antonio, Texas, USA
Clinical Laboratory Sciences
Bachelors of Science in Medical Technology
Curriculum included the clinical studies of:
Parasitology and Mycology
Quality Assurance for Clinical laboratories
Medical Microbiology
Clinical Hematology
Clinical Immunology
Clinical Chemistry
Clinical Biochemistry
Molecular Diagnostics
Management
Certifications
American Society of Clinical Pathologist Board Certified (ASCP)
National Certified Investigator (NCI) from the Council on Licenser, Enforcement and
Regulation
Affiliations
American Society of Clinical Pathology (ASCP)