Denise Lynn Abbott

250 Crossbow Drive #M22

Columbia, SC 29212
Home phone: 803-661-7143
Work phone: 803-545-4291
Cell phone: 803-201-0979
email:
Objective
To find a position where I can use my regulatory and quality assurance experienc
e.
Summary of Qualifications
Currently the CLIA Program Manager for the State of South Carolina.
Hold Florida Supervisor License - Chemistry and licensed in all areas.
Three years of experience with regulatory compliance
B.S. Degree in Chemistry and Biology with 17 years of experience running highly
technical equipment including 4 years of supervisory experience.
Professional Accomplishments
Personnel Management:
Responsible for the South Carolina Clinical Laboratory Improvement Amendment Pro
gram(CLIA).
In a year process hundreds of applications for laboratories and dialysis facilit
ies and reviewed inspection reports from the field.
In one year inspected clinical laboratories for the Florida Agency for Health Ca
re Administration in the panhandle and the Orlando area.
Led team of 3 technicians and 2 temporaries in a routine chemistry lab turning o
ut over 90,000 analyses annually and more than 40 methods with turn-around times
that average 2 days.
Significantly improved laboratory sample turn-around-time, sample log-in procedu
res, staff relations, and data accuracy improvements as measured in a customer s
urvey.
Implemented a comprehensive cross-training program that guaranteed coverage on a
ll tests at all times.
Reduced cost per analysis to less than $6 per reported result.
Quality Assurance Skills
Perform clinical laboratory audits according to the standards that govern the sp
ecific type of laboratory such as CLIA or ISO.
Responsible for methods development, validation, and method writing for laborato
ries which included the writing of over 20 methods and revisions for about anoth
er 20.
ISO coordinator for routine chemistry lab responsible for equipment calibrations
, records, and implementing control charting.
Trained ISO auditor.
Technical Skills:
Developed a variety of Access databases for maintaining document control and equ
ipment inventory for a state bureau.
Assisted in the implementation and trained employees on the use of a Laboratory
Information Management System
Trained on most laboratory equipment including HPLC, GC/MS and AA
Responsible for methods development and validation of 20 methods in areas includ
ing AA, rheometry, and physical testing.
Integral part of teams responsible for over $250,000 in annual savings as part o
f a corporate cost reduction program.
WORK HISTORY
South Carolina Department of Health and Environmental Control
September 22, 2008 - present
Manage the CLIA program by ensuring Centers for Medicare and Medicaid(CMS) State
Agency Performance Criteria are met annually. Review inspection reports to ensu
re write ups have followed CMS's Principles of Documentation and evaluate Plan o
f Corrections. Analyze proficiency testing from various proficiency companies
for unsuccessful participations. Examine workload schedules to determine if meet
ing CMS guidelines for the number of inspections to be performed monthly and tha
t the inspections are also geographically located near each other. Perform labo
ratory inspections by CMS standards. Answer questions regarding CLIA regulation
s. Am responsible for submitting monthly and annual reports to Centers for Medic
are and Medicaid. Supervise surveyor and administration specialist and perform
annual evaluations. Attend CLIA trainings to keep abreast of changes in regulat
ions, interpretive guidelines, standards of practice, CMS's transmittals. Perfo
rm a few on-site inspections per month.
Florida Agency for Health Care Administration
July 14, 2006 - September 15, 2008
Health Facilities and Service Consultant
Consulted with medical laboratory inspectors in the field regarding inspection i
ssues. Review inspection reports to make sure the documentation is thorough and
accurate. Provided technical guidance for laboratories. Explained federal and
state laboratory regulations to inspectors and dialysis and laboratory facilitie
s. Reviewed end - stage renal dialysis unit applications and coordinate activiti
es between Centers for Medicaid and Medicare, Network 7 and dialysis units.
Oversee support staff. Liaison for the various databases such as FRAES which is
an oracle based program and SET which the department and agency currently is up
dating and implementing. Gave guidance to new State regulations at a medical te
chnologist conference.
Florida Agency for Health Care Administration
Oct. 3, 2005- July 14, 2006
Biological Scientist III - Laboratory Surveyor
Job Duties:
Performed inspections on medical laboratories to determine compliance to federal
and state regulations. During inspections evaluated Levy Jennings reports, det
ermined if quality assurance was being achieved, and reviewed proficiency testin
g. Developed personal schedule of high work load for the month. Composed labora
tory compliance reports. Provided counseling laboratories on good laboratory pr
actices. Assisted with other state area's laboratory audits around the state.
Determine if plan of corrections submitted by laboratories are acceptable. Thes
e duties were accomplished with little guidance from management. Handled allega
tions against health clinic laboratories regarding unacceptable practices.
Florida Department of Agriculture and Consumer Services
Division of Food Safety - Bureau of Food Laboratories
December 2004 - October 2005
Chemist II - Career Service
Job Duties:
Assisted the quality manager in obtaining ISO 17025 accreditation.
Performed gap analysis of Bureau against the ISO 17025 requirements to find wher
e Bureau is deficient and what documents were needed. Designed and managed Acces
s databases. Created 3 new databases which include cross reference for document
s, equipment inventory including service due dates, and laboratory notebooks. I
mproved functionality of existing databases to better serve the QA unit. Respons
ible for distribution of documents and managing Access database for document con
trol. Maintain the webpage for the bureau. Converted word documents to Adobe pd
f.
Perform audits on the sample receiving process including sample reports, visitor
log, and incident log for the microbiology laboratory. Designed audit plan for
laboratory equipment and the corresponding records. Reviewed and monitored Corre
ctive Actions.
Additional Training:
Certified Public Manager - Florida Department of Agriculture and Consumer Servic
es
Beginning, Intermediate, and Advanced Access - Software Solutions - Tallahassee,
Fl
Beginning Front Page - Software Solutions - Tallahassee, Fl
Florida Department of Agriculture and Consumer Services
Division of Dairy - Bureau of Compliance Monitoring
May 2004 - December -2004
Lab Supervisor - Chemist II SES
Job Duties:
I was unable to perform my described duties due to the fact that the Dairy Labor
atory was closed two days after I started. I was trained on various dairy testi
ng but it was decided that the laboratory would not be recertified.
Tropicana Products, Inc. (a division of Pepsico), Bradenton, Fl.
1998-2004
Lab Assistant/Assistant Scientist/Lab Supervisor
Job Duties:
Coordinated the every day high pace workload making sure all areas were
appropriately covered.
Trained new employees and maintained their training records.
Set early goals for direct reports, coached them and performed their
reviews at the end of the year.
Performed routine and non Routine analysis
Participated on project teams to improve testing procedures, set up new
specifications and trained plant personnel on new procedures.
ISO coordinator.
Responsible for equipment calibrations and records,
implementing control charting, validating new methods and new
instruments using statistical data, and writing and reviewing methods
or procedures.
Assisted in setting up a Laboratory Information Management System by
providing parameters for tests. Trained employees on LIMS system.
Lab Skills:
Highly skilled with Atomic Absorption, Orbisphere dissolved oxygen
analyzer, Instron, Horiba analyzer, ThermoHaake Rotoviscometer, Optomax
Particle Imager, Mocon Headspace analyzer, pH and titrations. Mettler
Autotitrator, Masseli Refractometer, Gretag - Macbeth
Spectrophotometer, Brookfield viscometers, CEM Moisture Analyzer, and,
Hach Turbidimeter.
Working knowledge of HPLC (Agilent 1100's with chemstation), GC/MS
(Agilent 5973), Spectrophotometer, Brookfield viscometers, CEM Moisture
Analyzer, and, Hach Turbidimeter.
Additional Training
Basic Statistics, Corrective Action, Personal Empowerment - Tropicana
Coaching to Higher Performance, Giving and Receiving Feedback -Tropicana
Foundations in Leadership, Inclusion Training -Tropicana
Quality Control and Assurance in the Laboratory - Pittcon
Perkin-Elmer Atomic Absorption Training - Atlanta,Ga
7 Habits of Highly Effective People - Cassettes
Wishard Memorial Hospital, Indianapolis, Ind.
1990-1998
Performed tests on several instruments, such as: EKTA 750, ACA 3, ACA
Star, Dimension AR Stratus, high performance liquid chromatography, DU
50 spectrophotometer and gas chromatography.
Calibrated and performed routine preventive maintenance on instruments.
Trained new employees
EDUCATION
Indiana University - Purdue University, Indianapolis, Indiana 1984-1987
Upper Class Honors - With a double major in Chemistry &
Biology
B.S. Allied Health Sciences - Medical Technology -
A.S.C.P. certified in 1987
References
Available upon Request