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Quality Control Assurance

Location:
San Antonio, TX, 78209
Posted:
February 19, 2013

Contact this candidate

Resume:

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)



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