2. Symposium for Clinical Laboratories
October 24 - 26, 2013
Learner Bill of Rights
COLA Resources, Inc. (CRI) recognizes that you are a life-long learner who has chosen to
engage in continuing medical education to identify or fill a gap in knowledge, skill, or
performance. As part of our duty to you as a learner, you have the right to expect that your
continuing medical education experience with CRI includes:
Content that:
promotes improvements or quality in healthcare
is valid, reliable, and accurate
offers balanced presentations that are free of commercial bias for or against a
product/service
is vetted through a process that resolves any conflicts of interests of planners and
faculty
is driven and based on learning needs, not commercial interests
addresses the stated objectives or purpose
is evaluated for its effectiveness in meeting the identified educational need
A learning environment that:
supports learners’ ability to meet their individual needs
respects and attends to any special needs of the learners
respects the diversity of groups of learners
is free of promotional, commercial, and/or sales activities
Disclosure of:
relevant financial relationships planners, speakers, and authors have with
commercial interests related to the content of the activity
commercial support (funding or in-kind resources) of the activity
CRI does not endorse, directly or indirectly, the presentations given at this conference or the
products or services provided by the exhibiting vendors. The use of any particular product is for
demonstration purposes only, and does not imply an endorsement of the product by the
presenter or the sponsors of the symposium.
4. October 24, 2013
COLA Resources Inc. (CRI) would like to welcome you to the Symposium for Clinical
Laboratories. An outstanding activity has been planned for you and we hope you enjoy this
educational experience.
Intended Audience and Scope of Practice
This educational activity has been designed to meet the needs of:
Physicians operating an office laboratory
Healthcare professionals working as laboratory staff in diagnostic medical laboratories, including
testing personnel, technical consultants, supervisors, and laboratory directors
Physician assistants, nurse practitioners, and nurses involved in laboratory testing
Office managers in medical offices with a laboratory
Learning Objectives
The sessions at this Symposium are designed so that participants will be able to:
Recognize and apply the responsibilities and duties of the laboratory director
Comply with the CLIA regulations and applicable laboratory accrediting agencies
Develop processes to assess quality and improve laboratory practices and patient care
Continuing Education Credit Certificates
In order to receive credit for attending this activity, sign-in for the General sessions and Breakout
sessions is required. You must also complete the online CE Credit and Evaluation forms to
receive credit. Access instructions will be emailed to you. Credit Certificates documenting your
attendance will be emailed to you approximately four weeks after the conference. To
demonstrate the content of this educational activity for Laboratory Director Qualification, please
attach the Activity Schedule to your certificate to document the topics covered.
Evaluation and Feedback
Please complete the online Evaluation form to tell us about your overall experience and provide
feedback on each session you attend. Your feedback on this continuing education activity
guides us in planning and improving future activities.
Once again, we hope you find this continuing education activity beneficial. If there is anything we
can do to assist you while you are here, please ask the faculty or staff at the registration desk.
Thank you for coming, enjoy the learning, and have a safe trip home!
Cynthia Cardelino Rose Mary Casados Tricia Hudson
CRI Symposium Education
Curriculum Specialist
CRI President CRI Symposium
Operations Director
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5. Continuing Education Credits
COLA Resources, Inc. is a wholly owned subsidiary of COLA, Inc.
Continuing Education Credits will be issued in the name of the approved provider, COLA.
Continuing Medical Education (CME) Credits for Physicians
AAFP: This Live activity, CRI Symposium for Clinical Laboratories, with a beginning date of October 24,
2013, has been reviewed and is acceptable for up to 20 Prescribed credits by the American Academy of
Family Physicians. Physicians should claim only the credit commensurate with the extent of their
participation in the activity.
AMA/AAFP Equivalency: AAFP Prescribed credit is accepted by the American Medical Association
as equivalent to AMA PRA Category 1 Credit™ toward the AMA Physician’s Recognition Award.
When applying for the AMA PRA, Prescribed credit earned must be reported as Prescribed, not as
Category 1.
As noted in the Activity Schedule on page 3, only designated sessions offer CME credit.
P.A.C.E.® Continuing Education Credits for Laboratorians
All sessions at the symposium offer P.A.C.E.® credit.
COLA is an approved provider of continuing education programs in the clinical laboratory sciences by the
ASCLS P.A.C.E.®
Program. This program (529-102-13) has been approved for up to 20 contact hours.
Florida Agency for Health Care Administration: COLA is an approved provider of continuing
education programs in clinical laboratory sciences by the Board of Clinical Laboratory Personnel,
Division of Medical Quality Assurance at the Florida Agency for Health Care Administration. COLA’s CE
Broker Provider number for this program is 10-1448137. This program is approved for up to 20
continuing education credits.
California Division of Laboratory Science: COLA is an approved provider of continuing education
programs in the clinical laboratory sciences by California Division of Laboratory Science, Department of
Field Services for all California clinical laboratory personnel license types. COLA’s Provider number is
0199. This program (529-102-13) is approved for up to 20 continuing education credits.
Continuing Education Credits for Each Session
Thursday 10/24 AM Lab Director Session: 1.25 credits AM General Session: 1.25 credits
Friday 10/25 AM Lab Director Session: 1.5 credits
AM General Session: 1.25 credits
PM General Sessions: 2.0 credits
Breakouts
Thursday, 10/24- Sessions A, B & C: 1.5 credits for each breakout session
(max. total for A,B,C,D, E is 7.5 credits)Friday, 10/25- Sessions D & E:
Saturday 10/26 General Sessions: 5.25 credits
Special Assistance
CRI adheres to the Americans with Disabilities Act. Please contact the Symposium Registration Desk
with any special needs you may have for participation in and/or access to this educational activity.
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6. Activity Schedule
Indicates the Laboratory Director Curriculum. These sessions offer CME credit.
Thursday October 24, 2013
7:00a – 8:15a Lab Director Session: (Breakfast served in classroom)
Basics of Laboratory Medicine for Physicians
Verlin Janzen, MD
8:00a – 8:45a Breakfast and Exhibits in Exhibit Ballroom
8:45a – 10:00a AM General Session
8:45a – 9:00a Welcome, Overview, and Logistics Tricia Hudson
9:00a – 10:00a Keynote: CLIA Update 2013 Diana Fairbanks
10:00a – 10:30a Break and Exhibits in Exhibit Ballroom
10:30a – 12:00p Breakout Session A (select one)
A01 Competency Assessment Kathy Nucifora
A02 Lab Director Session:
Personnel and Procedures for CLIA Compliance
Ann Bachman
A03 Hematology Basics Kimberly Whiter
A04 Open Forum on QC Practices Terri Wolek
A05 Quality Assurance Program for the POL Jeanne Mumford
12:00p – 1:00p Lunch
12:30p – 1:30p Exhibits and Dessert in Exhibit Ballroom
1:30p – 3:00p Breakout Session B (select one)
B11 Value of the Lab in the New Healthcare Model Kim Futrell
B12 Lab Director Session:
Good Laboratory Practices for Physician Office Testing
Nancy Anderson
B13 Advanced Hematology: Cases in Peripheral Smear Analysis Kimberly Whiter
B14 Issues Facing Laboratory Professionals Lisa Anderson
B15 Introduction to IQCP Kathy Nucifora
3:00p – 3:30p Coffee/Beverage Break in Exhibit Ballroom
3:30p – 5:00p Breakout Session C (select one)
C21 Technology Workshop: Chemistry Instruments Participating Exhibitors
C22 Lab Director Session:
Introduction to Quality Control for Physicians
Verlin Janzen, MD
John T. Daly, MD
C23 Prothrombin Time and the INR Kimberly Whiter
C24 Time Management and Organizational Skills Lisa Anderson
C25 Internal Lab Inspections to Stay “CLIA Ready” Jeanne Mumford
6:00p – 8:00p Reception for participants, faculty and exhibitors
Symposium for Clinical Laboratories
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7. Activity Schedule
Friday October 25, 2013
7:00a – 8:30a Lab Director Session: (Breakfast served in classroom)
Introduction to Proficiency Testing for Physicians
Verlin Janzen, MD
John T. Daly, MD
8:00a – 8:45a Breakfast and Exhibits in Exhibit Ballroom
8:45a – 10:00a AM General Session
8:50a – 10:00a Keynote: HIV Diagnosis and Treatment Donna Sweet, MD
10:00a – 10:30a Break and Exhibits in Exhibit Ballroom
10:30a – 12:00p Breakout Session D (select one)
D31 Technology Workshop: Laboratory Information Systems Participating Exhibitors
D32 Lab Director Session:
Quality Assessment of Proficiency Testing
Verlin Janzen, MD
John T. Daly, MD
D33 Financial Perspectives of Running a Lab Tim Dumas
D34 In Compliance and Ready for Inspection Ann Bachman
D35 Developing and Implementing a Quality Assessment Plan Susan Densford
12:00p – 1:00p Lunch
1:00p – 2:30p Breakout Session E (select one)
E41 OSHA Training Ann Bachman
E42 Lab Director Session:
Lab Director Responsibilities, Part 1: Regulatory
Verlin Janzen, MD
E43 How to Effectively Communicate Crucial Conversations Edward J. Peterson, Jr.
E44 Negotiating With Insurance Companies Tim Dumas
E45 Clinical Molecular Diagnostics Siby Sebastian
2:30p – 3:30p Ice Cream Social & Exhibits in Exhibit Ballroom
3:30p – 5:30p PM General Sessions
3:30p – 4:30p Healthcare Reform: Will It (We) Survive? Edward J. Peterson, Jr
4:30p – 5:30p Jumping the Generation Gap (PACE credit only, Lab
Directors attend the session below instead)
Tim Dumas
OR
4:30p – 5:30p Concurrent Lab Director Session: Lab Director
Responsibilities, Part 2: Practical Application
Verlin Janzen, MD
Symposium for Clinical Laboratories
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8. Activity Schedule
Saturday October 26, 2013
7:00a Breakfast in General Session Room
7:00a – 12:45p General Sessions
7:15a – 8:15a Management of Laboratory Operations: Basic Management
Concepts
Edward J. Peterson, Jr.
8:15a – 9:30a Competency Assessment: Does the New CLIA Guidance
Mean Big Changes?
Edward J. Peterson, Jr.
9:45a – 11:00a COLA Accreditation Update Susan Densford
11:00a – 12:30p In Compliance and Ready for Inspection Ann Bachman
12:00p Working Lunch Served in General Session Room
12:30p – 12:45p Conclusion, Wrap-up and Adjourn Susan Densford
All sessions offer P.A.C.E.® credit. Sessions indicated with also offer CME credit for physicians.
Note: ALL General Sessions on Thursday and Friday, specified breakout sessions on Thursday and
Friday, and ALL sessions on Saturday are Lab Director Sessions for the Laboratory Director Qualification
Curriculum. For physicians to demonstrate the content of this educational activity for Laboratory
Director Qualification, please attach a copy of this Activity Schedule to your certificate to
document the topics covered.
Symposium for Clinical Laboratories
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9. Faculty Information, Sessions, and Qualifications
Faculty/Speaker Session(s) Qualifications on the Topic(s)
Lisa Anderson, MMDS, MLS(ASCP) SH
MB
cm
ASCLS Region III Director
LabCorp Molecular Genetics Supervisor
1912 TW Alexander Dr.
Research Triangle Park, NC 27713
919-224-5359
Lisa.anderson.cls@gmail.com
Issues facing Clinical Laboratory
Professionals
Time Management and Organizational
Skills
Master of Molecular Diagnostic
Science
ASCP certified Medical
Laboratory Scientist
ASCLS Region III Director
Nancy L. Anderson, MMSc, MT(ASCP)
Chief of CDC Laboratory Practice
Standards Branch
Atlanta, GA
404-498-2741
Nla0@cdc.gov
Good Laboratory Practices for
Physician Office Testing
Master of Medical Science
ASCP certified Medical
Technologist
Ann Bachman, CLC(AMT), MT(ASCP)
DoctorsManagement, LLC
10401 Kingston Pike
Knoxville, TN 37922
865-470-9605
abachman@drsmgmt.com
Personnel and Procedures for
Implementation of CLIA ’88
In Compliance and Ready for
Inspection
OSHA Training
AMT Certified Laboratory
Consultant
ASCP certified Medical
Technologist
Executive Director, American
Association of Physician Offices
and Laboratories
Director, Compliance
Department,
DoctorsManagement
John T. Daly, MD, FCAP, FASCP
COLA, Chief Medical Officer
800-981-9883 x3740
jdaly@cola.org
Introduction to Proficiency Testing for
Physicians
Introduction to Quality Control for
Physicians
Quality Assessment of PT: Proficiency
Testing Problem Resolution
MD, FCAP, FASCP
Pathologist
COLA Chief Medical Officer
Former COLA Accreditation
Surveyor
Susan Densford, BS, MT(ASCP)
COLA Survey Team Leader
800-981-9883 x3786
sdensford@cola.org
Developing and Implementing a Quality
Assessment Plan
COLA Accreditation Update
ASCP certified Medical
Technologist
COLA Survey Team Leader
Tim Dumas, CLS
Laboratory Consultant
316 Trotters Ridge Dr.
Raleigh, NC 27614
919-325-2888
tdumas@nc.rr.com
Financial Perspectives of Running a
Lab
Negotiating with Insurance Companies
Jumping the Generation Gap
Clinical Laboratory Scientist
Laboratory Consultant
NSA professional speaker
Diana Fairbanks, MT(ASCP)
CMS Region VII Surveyor
Kansas City, MO
816 426-6493
Diana.fairbanks@cms.hhs.gov
CLIA Update 2013 ASCP certified Medical
Technologist
CMS Surveyor
Kim Futrell, MT(ASCP)
Products Marketing Manager
Orchard Software Corporation
Phone: 800-856-1948
Direct: 910-338-9546
kfutrell@orchardsoft.com
The Value of the Laboratory in the New
Healthcare Model
ASCP certified Medical
Technologist
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10. Faculty Information, Sessions, and Qualifications
Faculty/Speaker Session(s) Qualifications on the Topic(s)
Verlin K. Janzen, MD, FAAFP
Hutchinson Clinic, PA
2101 North Waldron
Hutchinson, KS 67502
620-669-2685
janzenv@hutchclinic.com
Basics of Laboratory Medicine for
Physicians
Introduction to Quality Control for
Physicians
Introduction to Proficiency Testing for
Physicians
Quality Assessment of PT: Proficiency
Testing Problem Resolution
Lab Director Responsibilities:
Regulatory
Lab Director Responsibilities: Practical
Application
MD, FAAFP
Family Physician & Laboratory
Director
Clinical Assistant Professor,
Univ. of Kansas School of
Medicine-Wichita
BS in Medical Technology
Master’s in Laboratory
Management and
Administration
Jeanne Mumford, MT(ASCP)
Laboratory Quality Assurance Specialist
Johns Hopkins Community Physicians
Quality, Safety and Services
410-338-3631
Jmumfor3@jhmi.edu
Quality Assurance Program For
Physician Office Labs
Internal Lab Inspections: How we Stay
‘CLIA Ready’ at our Physician Office
Laboratories
ASCP certified Medical
Technologist
Quality Assurance Specialist
Kathy Nucifora, MPH, MT(ASCP)
COLA Accreditation Division Manager
Columbia, MD
800-981-9883 x 3745
knucifora@cola.org
Introduction to IQCP
Competency Assessment
Master’s in Public Health
ASCP Certified Medical
Technologist
Edward J. Peterson, Jr., MBA,
MT(ASCP)
Director of Laboratories
Barnes-Jewish Hospital
One Barnes-Jewish Hospital Plaza
St. Louis, MO 63110
314-362-1786
Ejp9315@bjc.org
How to Effectively Communicate and
Have That Crucial Conversation
Healthcare Reform: Will it (We)
Survive?
Management of Laboratory Operations:
Basic Management Concepts
Competency Assessment: Does the
New CLIA Guidance Mean Big
Changes?
ASCP certified Medical
Technologist
Director of Laboratories
Assistant Professor
Siby Sebastian, PhD, DABMG, DABCC
Associate Professor of Pathology and
Associate Director of Clinical Molecular
Diagnostic Laboratory
Duke University Health System Clinical
Laboratories
Durham, NC
919-613-8432
Siby.s@duke.edu
Clinical Molecular Diagnostics-The
Past, Present and Future
Associate Professor of
Pathology
Board certified by ABMG &
ABCC
Donna Sweet, MD, MACP
Professor of Medicine
The University of Kansas School of
Medicine - Wichita
1010 N. Kansas
Wichita, Kansas 67214
Phone: 316-268-5984
dsweet@kumc.edu
HIV Diagnosis & Treatment MD
Director of Internal Medicine
Education
HIV/AIDS Researcher
Master of the ACP
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11. Faculty Information, Sessions, and Qualifications
Faculty/Speaker Session(s) Qualifications on the Topic(s)
Kimberly Whiter, MS, MLS(ASCP)
CM
Assistant Professor, Medical Laboratory
Science Program
Jefferson College of Health Sciences
Roanoke, VA
540-985-8106
kawhiter@jchs.edu
Hematology Basics and Beyond
Advanced Hematology: Cases in
Peripheral Smear Analysis
Prothrombin Time and the INR
ASCP Certified Medical
Laboratory Scientist
Assistant Professor, Medical
Laboratory Science Program
Terese Wolek, MT(ASCP)
Sr. Sales Product Manager
Bio-Rad Laboratories, Inc.
USSD Marketing
510-741-6893
Terese_Wolek@bio-rad.com
Open Forum on QC Practices ASCP Certified Medical
Technologist
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12. Faculty Disclosures
It is the policy of CRI that the faculty, authors, planners, and other persons who may influence
content of this CME activity disclose all relevant financial relationships with commercial
interests* in order to allow CME staff to identify and resolve any potential conflicts of interest.
Faculty must also disclose any planned discussions of unlabeled or unapproved uses of drugs
or devices during their presentation(s).
For this educational activity all conflicts of interests have been resolved, and detailed
disclosures are listed below.
Faculty/Planners Commercial Interest What Was Received? What Was the Role?
Anderson, Lisa
M.
LabCorp Salary Employment
Bachman, Ann DoctorsManagement,
LLC
Salary Employment
Dumas, Tim J &S Medical Consulting fee Trainer
CDS Commission Representative
Medica Commission Representative
Jant Pharmacal Commission Representative
Futrell, Kim Orchard Software Salary Employment
Janzen, Verlin AAFP-PT Consulting fee Consultant
Sweet, Donna E. Pfizer Honoraria Consultant
Gilead Honoraria Speaker
Bristol Myers Squibb Honoraria Speaker
Wolek, Terese Bio-Rad Laboratories Salary Employment
The following Faculty/Planners have no relevant financial relationships with any
commercial interests.
Anderson, Nancy L. Cardelino, Cynthia Casados, Rose Mary
Daly, John T. Densford, Susan Fairbanks, Diana
Hudson, Tricia Mumford, Jeanne Nucifora, Kathy
Peterson, Jr., Edward J. Sebastian, Siby Whiter, Kimberly
* The ACCME defines a commercial interest as any entity producing, marketing, re-selling, or
distributing health care goods or services consumed by, or used on, patients. The ACCME does
not consider providers of clinical service directly to patients to be commercial interests.
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13. Faculty Biographies
Lisa M. Anderson, MMDS,MLS(ASCP)SH MBcm
Lisa Anderson graduated from UNC Chapel
Hill in 2003 with her Bachelor’s degree in Clinical Laboratory Science. She worked at UNC
Hospitals for 6 years in the Core Laboratory as a generalist and then in Special
Hematology/Hematopathology as a Senior Medical Technologist. She left the hospital in 2009 to
pursue her Master’s of Molecular Diagnostic Science at UNC Chapel Hill. Currently she is
employed by LabCorp as the evening shift supervisor for their North Carolina Molecular
Genetics laboratory. She spends much of her free time working to further the profession through
her commitment to the American Society for Clinical Laboratory Science and currently serves as
on the national board as Region III Director.
Nancy Anderson, MMSc, MT(ASCP) Ms. Anderson received her BS Degree at Houghton
College and her Master of Medical Science (MMSc) Degree in Clinical Microbiology from Emory
University. She is an American Society for Clinical Pathology certified Medical Technologist.
She worked in several clinical laboratories and served as the Program Coordinator for Emory
University's MMSc programs in the clinical laboratory sciences before coming to CDC.
After working for 14 years in CDC's Laboratory Practice Standards Branch (LPSB), Division of
Laboratory Science and Standards, Nancy is now Chief of LPSB. As part of this Division that
provides scientific and technical support for the CLIA program, Nancy's responsibilities include
providing oversight of activities to develop regulatory and voluntary standards for laboratory
quality; managing the Clinical Laboratory Improvement Advisory Committee; supporting CMS
responsibilities for proficiency testing program and accrediting organization approvals;
collaborating with CMS and FDA regarding CLIA; and providing information to laboratories,
healthcare professionals, and the public to promote the importance of regulatory compliance
and following good laboratory practices. Nancy is a member of and collaborates with several
professional laboratory organizations and has published and presented information pertaining to
CLIA and laboratory quality at a number of professional meetings.
M. Ann Bachman, CLC(AMT), MT(ASCP) Ms. Bachman is the Director of the Compliance
Department and a partner at DoctorsManagement, LLC, headquartered in Knoxville,
Tennessee. DoctorsManagement is a broad-based medical management firm serving practices
throughout the nation for over 50 years.
Ms. Bachman earned a BS degree from the University of Tennessee, Knoxville, in Microbiology
and Medical Technology. She has worked in the medical field for thirty years, primarily in the
clinical laboratory. She also serves as the Executive Director of the American Academy of
Provider Offices and Laboratories, an educational organization established to meet regulatory
and continuing education needs for individuals in medical and dental practices.
She presents workshops nationwide on OSHA, CLIA, and HIPAA, and contributes to numerous
professional journals such as Tennessee Medicine: Journal of the Tennessee Medical
Association and Advance for Medical Laboratory Professionals. She serves on The Council of
Healthcare Advisors.
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14. Faculty Biographies
Rose Mary Casados, BSMT(ASCP) Rose Mary received her Bachelor’s Degree in Medical
Technology with a minor in Chemistry from St. John’s University and is pursuing her Master’s
Degree in Business Administration from the Nova Southeastern University. She is a member of
the ATHENA CHAPTER National Honor Society and participated in the Kellogg Northeastern
University Marketing Excellence Program. Among her achievements and recognitions are
recipient of the NY Laboratory Excellence Award presented by the St. John’s University College
of Pharmacy and Allied Health, the Becton Dickinson President’s Club Award, Sales Eagles
Club Award, Teamwork Excellence Award, and three time recipient of the Southeast Regional
Sales Award.
Rose Mary has held positions as Medical Technologist in the Infectious Disease segment of the
North Shore/LIJ Health Systems in NY, Microbiology Supervisor at Jupiter Medical Center in FL.
Within Becton Dickinson, Rose Mary has held positions as North America Product Manager,
Worldwide Marketing Manager, Assistant Regional Sales Manager, Application Specialist and
she was appointed US Director of Business Development for Copan Diagnostics.
Rose Mary has been instrumental in the development of various Consultative Selling Programs,
Marketing Plans and Strategic Business Plans, and has been a member of the CLSI Collection
& Transport Committee. She has been with COLA since 2012, as Education Division Manager,
and is now the President of COLA’s new subsidiary, COLA Resources, Inc. She is fluent in four
languages, English, Italian, Spanish and French.
John Daly, MD, FCAP, FASCP Dr. Daly is a pathologist who currently resides on Marco
Island, Florida. Prior to joining COLA, Dr. Daly practiced pathology in Durham, North Carolina,
specializing in clinical pathology.
Dr. Daly is a New York City native and a graduate of Weill Cornell Medical College in New York.
After a residency at Duke University and a tour in the US Navy, Dr. Daly returned to Durham,
NC where he practiced both community and academic pathology, retiring in 2009 as Director of
Laboratories for the Duke University Health System.
Dr. Daly has had extensive experience managing and advising laboratories of all sizes, from
physician office and health clinic laboratories to high volume high complexity laboratories. He
served as a COLA accreditation surveyor for the past two years prior to his appointment as
COLA’s Chief Medical Officer in September, 2011.
Susan Densford, BS MT(ASCP) Susan received her Bachelor’s degree in Medical Technology
from the University of St. Francis in Joliet, IL. She has a wide range of medical technology
experience. She has worked in various levels of management at large reference labs, large and
small hospital laboratories as well as a community-based hospital in Kotzebue, Alaska. Susan
also enjoyed 7 years as a medical sales representative.
Susan has been with COLA for two years, serving currently as the Surveys Team Leader. She
provides leadership and guidance to the COLA surveyor team.
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15. Faculty Biographies
Tim Dumas, CLS For almost 30 years Tim Dumas, AKA "The Lab Guy," has worked as a
clinical laboratory scientist, manager, and consultant. In 1980, Tim attended laboratory training
at MidWestern State University and earned his laboratory degree through the United States Air
Force working in many military as well as civilian hospitals. In 1992 he started his first physician
office laboratory (POL) and since has established and consulted for many more. Tim is also a
consultant to equipment distributors and laboratory information system manufacturers.
Tim specializes in working with POLs and helping them establish and perform COLA/CLIA
accredited POC laboratory testing, enhance the quality of patient care, and maximize practice
revenue. Tim also specializes in choosing, installing, and training for equipment analyzers and
laboratory information systems.
In 2004, Tim earned his accreditation as a professional speaker through the National Speakers
Association (NSA). He has served on NSA Carolinas Board of Directors since 2006. In addition
to his day job, Tim practices and studies his true love: making people laugh. Professional
magician, humorist, and a graduate of Artistic New Directions in New York City, Tim combines
his business background and performing talent to present educational AND entertaining
interactive workshops across the US. Tim helps clients enhance employee morale, improve
their quality of care, and find unique ways to use humor to develop fun and productive work
environments and attitudes. At the core of everything is Tim’s dedication to helping people
“Imagine the Impossible . . . Find a Way to Do It!”
Diana Fairbanks, MT(ASCP) Diana has the lead responsibility for the CLIA program in the
Kansas City, MO CMS Regional Office. She is responsible for conducting surveys, oversight of
the State agency, training, budget issues, and enforcement activities. She obtained her
Bachelor of Art in Microbiology from the University of Kansas and her Bachelor of Science in
Medical Technology from the University of Kansas Medical Center.
In her previous position as Chemistry Section Supervisor at Providence Medical Center in
Kansas City, KS she was responsible for the day to day running of the Chemistry Section of a
medium sized hospital laboratory. This included review of proficiency testing, quality control,
quality assurance activities, verification and validation of new instrumentation and test methods,
training, and evaluation of testing personnel.
Kim Futrell, MT(ASCP) Kim is the Products Marketing Manager at Orchard Software, and in
her role she is an advocate for laboratory, lab informatics, and all of Orchard's products. Kim
works with the product development, marketing, and sales teams to research and publish
relevant material to arm our employees, clients, and the industry with information through
knowledge, communication, and education.
Kim has a Bachelor's Degree in Biology and is a certified Medical Technologist (ASCP) with
over 20 years of laboratory management experience. Prior to joining Orchard in 2012, Kim's role
was as Operations Manager of a multi-specialty physician's office in North Carolina.
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16. Faculty Biographies
Verlin Janzen, MD, FAAFP Dr. Janzen is a family physician practicing at the Hutchinson Clinic
in Hutchinson, Kansas. He also serves as director of the clinic’s laboratory, serving 50+
physicians, outreach clinics and local nursing homes. Before joining the Hutchinson Clinic, Dr.
Janzen practiced seven years in Nebraska City, Nebraska in a two physician practice.
Dr. Janzen’s undergraduate training and Bachelor’s degree were in medical technology. He
worked as a Medical Technologist for 3½ years while studying for a Master’s degree in
laboratory management and administration. He attended medical school at the University of
Nebraska and completed his residency in Family Medicine at St. Joseph’s Hospital, Wichita, KS.
POL issues have been a natural for Dr. Janzen with his training covering both laboratory and
clinical medicine. He has served on a variety of committees dealing with POL issues including
the CAP Primary Care Lab Practice Committee, the AAFP Proficiency Testing Committee, the
AAFP Health Care Services Subcommittee on Laboratory Issues, the NCCLS Subcommittee on
User Demonstration of Performance, and the Clinical Laboratory Improvement Advisory
Committee (CLIAC) at the CDC. He is the Chair of the Accreditation Committee of the COLA
Board of Directors, and the Past-President of the Kansas Academy of Family Physicians. Dr.
Janzen has given talks around the country to various organizations and groups on POL issues.
Jeanne Mumford, MT(ASCP) Jeanne graduated from Salisbury University in 2000 with a
Medical Technology degree. Her first job after graduation was a position as a hospital courier
and outpatient phlebotomist. In this role, she earned a respect for the relationship that our
medical personnel have with the patients that we serve. After three months in this role, she
applied for a position at the University of Maryland Medical Center Blood Bank to make more of
a difference in the lives of those very same patients. Again, she earned a whole new respect for
laboratory medicine and the role that it plays in the health and safety of patients everywhere.
After working for three years as a blood banker, Jeanne moved over into the Immunology lab at
Sinai Hospital of Baltimore. Over those seven years she developed a passion for quality
assurance projects and laboratory management. Three short years ago, she moved into her
current role as Quality Assurance Specialist for Johns Hopkins Community Physicians. In this
role, Jeanne oversees 35+ outpatient physician office laboratories across the state of Maryland.
Kathy Nucifora, MPH, MT(ASCP) Kathy received her Bachelor’s degree in Medical Technology
from Ball State University, and her Master of Public Health (MPH) Degree from Wichita State
University.
Kathy has a wide range of experience managing clinical laboratories, including large and small
POLs, and large and small hospital laboratories. She has also taught Clinical Chemistry and
Urinalysis in the MLT program at the Community College of Baltimore County, and has lectured
on many relevant laboratory topics to a variety of audiences.
Recently, Kathy served on the CLSI workgroup that developed companion products for
Evaluation Protocol 23 (EP23). Kathy has been the Accreditation Division Manager at COLA
since 2009.
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17. Faculty Biographies
Edward J. Peterson, Jr., MBA, MT(ASCP) Ed received his bachelor’s degree in Medical
Technology and Biology from the State University of New York at Fredonia in 1983, completed
his Medical Technology internship at Lenox Hill Hospital, New York City in 1984 and his MBA
from St. Joseph’s University, Philadelphia in 1999.
Ed is currently the Director of Laboratories for Barnes-Jewish Hospital in St. Louis, MO – part of
the Barnes Jewish Corporation with 13 hospitals in Missouri and Illinois. Barnes-Jewish Hospital
is a 1,315 bed academic center affiliated with Washington University School of Medicine. Ed is
responsible for directing, planning, financial and human resource operations that include an
$85M budget, $750M in revenues and over 450 employees in the areas of Chemistry,
Hematology, Microbiology, Blood Bank, Immunology, Surgical and Anatomic Pathology, Point of
Care Testing, Pheresis Center, Cryopreservation Lab, Molecular Diagnostics Lab, HLA Lab,
Clinical Research Labs, Phlebotomy, Laboratory Information Systems and Customer Service.
Ed is also an Assistant Professor for the University of Medicine and Dentistry of New Jersey
where he teaches a 15 week on-line course in Healthcare Regulations and Laboratory
Management that explores the unique applications of management concepts and policies and
regulatory issues in clinical laboratory services through interactive exercises. Ed has given
presentations locally, regionally and nationally on various topics in healthcare and lab
management including human resource and financial management, delegation, corporate
compliance, point of care testing and blood conservation.
Siby Sebastian, PhD, DABMG, DABCC Dr. Sebastian is currently an Associate Professor of
Pathology at the Department of Pathology, Duke University Medical Center, Durham, North
Carolina where he serves as Associate Director of Clinical Molecular Diagnostic Laboratory of
Duke University Health System Clinical Laboratories. He is board certified by American Board of
Medical Genetics (ABMG) and American Board of Clinical Chemistry (ABCC) in Clinical
Molecular Genetics and in Molecular Diagnostics. He has over 15 years of comprehensive
clinical molecular biology/genetics research, diagnostic testing and administrative experience,
including the last 11 years of direct hands-on and/or supervisory experience in reviewing and
verifying clinical test results; development, optimization, validation, implementation, and quality
assurance (QA and cQI) of nucleic acid based clinical molecular assays in the areas of
molecular pathology, molecular genetics and infectious disease testing for a CLIA certified and
CAP accredited high complexity clinical molecular diagnostic laboratory.
Donna Sweet, MD, MACP Dr. Sweet graduated from the University of Kansas School of
Medicine and completed residency training at University of Kansas-Wichita and affiliated
hospitals. She is board-certified in internal medicine and is a Professor of Internal Medicine at
the University of Kansas School of Medicine-Wichita. She is also the Director of Internal
Medicine Education at Via Christi Regional Medical Center-St. Francis in Wichita.
Dr. Sweet is best known for medical treatment and research on AIDS and has been recognized
locally and internationally for her work. She works extensively with the Health Resource Service
Administration on Ryan White issues and a past national Co-Chair of the CDC HRSA AIDS
Advisory Council (CHAC). She is certified as an HIV specialist by the American Academy of
14
18. Faculty Biographies
HIV Medicine of which she is the current board Chair. She has administered Ryan White Part B
funds at her clinic since these funds first became available for patients in Kansas. She has
been the Principal Investigator and Medical Director of the Ryan White Part C Early Intervention
Program since 1993 and in 2009 was granted funds to begin a Ryan White Part D Family
Services program to care for women, infants, children and youth who are infected and affected
by HIV in 2009. In addition, she is also the Principal Investigator and Director of the Kansas
AIDS Education and Training Center.
Beyond her work with HIV/AIDS, Dr. Sweet is the Past Chair of the American College of
Physicians Foundation Board and is Chair Emeritus of the American College of Physicians
Board of Regents. Dr. Sweet was Chair of the Board of Regents for 2005-2006, and at the
conclusion of her term was named a Master of the ACP (MACP) for her service to medicine and
to the American College of Physicians. She has been an ACP representative to the COLA
Board of Directors and is a member and past Chair of the COLA Board. She is an AMA
delegate for the ACP and is a member of the Council on Medical Service of the AMA.
In March 2000, the AMA identified Dr. Sweet as one of four “Heroes in Medicine” by awarding
her with one of the first Pride in the Profession awards for her leadership in confronting AIDS
issues and her care for patients with the disease. She lectures in her home state of Kansas,
nationally, and internationally to educate health care providers about HIV and AIDS. She works
closely with the Eurasian Medical Education Program of the American College of Physicians
and has been educating physicians about HIV/AIDS internationally for over 11 years.
Kimberly A. Whiter, MS, MLS(ASCP)CM
Kim is originally from Louisiana and has 8 years of
experience in the Medical Laboratory profession. Her experience includes working in a small
OB-GYN hospital laboratory, blood banking in a busy oncology hospital with a high population of
sickle cell anemia patients, and performing specialty laboratory testing in an 800+ bed hospital-
based /reference lab.
She is currently working full-time as a Medical Laboratory Science Assistant Professor at
Jefferson College of Health Sciences in Roanoke, VA. She is an active member of ASCP and
contributes to a professional online blog for ADVANCE for Medical Laboratory Scientists. She
LOVES the Lab profession and has a passion for sharing that laboratory professionals play key
roles in the healthcare team!
Terese Wolek, MT(ASCP) Terri is the US Marketing Product Manager for Bio-Rad
Laboratories’ QC product line. Bio-Rad is one of the top 10 diagnostic companies in the world
and the world leader in third party quality control products and services. Terri was an account
manager and a Quality System Specialist prior to becoming the Marketing Product Manager.
Her long career with Bio-Rad has allowed her meet with clinical laboratories from a variety of
sizes and test menus. She has helped laboratories create optimal operational solutions to meet
their regulatory requirements and assist in establishing valid QC ranges for the laboratory. Terri
also helped laboratories find the best QC data management solution for their unique operation.
Prior to her current position, she worked as a QC/QA Specialist and then a Toxicology
Supervisor at a large university health system in Maryland.
15
19. Exhibitors at the Symposium
A vital segment of the Symposium for Clinical Laboratories is the manufacturers and
distributors of laboratory instrumentation, information systems, and support services and
supplies. In the Exhibit Hall, the following company representatives are exhibiting
laboratory equipment specific to laboratory operations, offering you the opportunity to get
up close and personal with the newest and best equipment in the laboratory industry. To
allow you a comfortable pace to view all of the exhibits, we have scheduled periods
specifically for interaction with the representatives in the Exhibit Hall.
AAFP- PT
Alfa Wassermann Diagnostic
Technologies
AMS Diagnostics, LLC
Apex Healthware
AUDIT MicroControls, Inc.
Baytree National Bank & Trust
Bio-Rad Laboratories
Carolina Liquid Chemistries
Centers for Disease Control and
Prevention (CDC)
COLA
CompuGroup Medical
CRI (COLA Resources Inc.)
Erba Diagnostics Mannheim GmbH
Genial Genetics/Rainbow Scientific,
Inc.
GFMD Ltd. The Centrifuge
Henry Schein Medical
Hitachi Chemical Diagnostics
HORIBA Medical
Immunodiagnostic Systems, Inc.
J & S Medical Associates
Jant Pharmacal Corporation
Laboratory Supply Company
Maine Standards Company
McKesson
Medica Corporation
Medicus Middleware
MedTest
Merge Healthcare
Orchard Software Corp.
Randox Laboratories-US, Ltd.
Roche Diagnostics
Sarstedt, Inc.
Schuyler House
Siemens
Tosoh Bioscience, Inc.
Trinity Biotech
WSLH-PT
16
20. CRI would like to thank the
following companies for
their financial support:
AUDIT MicroControls
Symposium Flash Drive
CompuGroup Medical
Reception Bar
Medica Corporation
Pads and Pens
Orchard Software
Symposium Tote Bags
17
21. Exhibitor Listing by Company
Company & Contact Information Exhibitor Statement of Products & Services
AAFP-Laboratory Proficiency Testing
Booth # 309
www.aafp.org/pt
Cheryl Murray, MPA, MT(ASCP)SM
Manager, AAFP-PT Education &
Technical Assistance
11200 Tomahawk Creek Parkway
Leawood, KS 66211
Phone: 800-274-7911
Email: pt@aafp.org
AAFP Proficiency Testing is a full-service program that helps
POLs, clinics, and small hospitals maintain laboratory excellence
and regulatory compliance. AAFP-PT offers a variety of flexible,
customizable modules and other educational products, including
the POL Microscopy Atlas. Superior technical assistance and
customer service provided. Participants can earn 12 CME
credits.
Alfa Wassermann Diagnostic
Technologies
Booth # 204
www.AlfaWassermannUS.com
Scott Lavine, Director of Sales &
Marketing, LIS
4 Henderson Drive
West Caldwell, NJ 07006
Phone: 800-220-4488
Email: info@alfawassermannus.com
Alfa Wassermann Diagnostic Technologies (AWDT) is the market
leader in clinical chemistry analyzers for the physician office
laboratory. The next generation ACE Axcel is designed to meet
the needs of the POL and is cleared by the FDA specifically for
use in physician office labs. The system offers touch screen
functionality, an intuitive user interface, and internet connectivity
for faster, more cost-effective in-office laboratory testing. With
eleven consecutive years of award winning customer
satisfaction, AWDT systems provide reliable, accurate results
with a high level of service and support. Recently, AWDT
entered into a marketing promotion to offer the mini VIDAS
, a
benchtop immunoassay system designed for the POL.
AMS Diagnostics, LLC
Booth # 110
www.amsdiagnostics.com
Bruno Borganti, General Manager
1790 N Commerce Parkway
Weston, FL 33326
Phone: 843-277-1642
Email: bb@amsdiagnostics.com
AMS Diagnostics, based in Weston FL, manufactures a
comprehensive line of reagents, assay, controls and calibrators
for the most popular floor model analyzers in the market.
Introducing the Liasys 450 Clinical Chemistry Systems, the
bench-top of choice for general chemistry, specialty assay and
drugs of abuse qualitative and semi-quantitative testing.
Manufactured by AMS Diagnostics, this small foot print but
powerful system is capable of processing up to 450 tests/h and
comes with a comprehensive test menu; it is LIS bidirectional-
ready and includes a QC monitored on-board cuvette-washing
system that delivers unsurpassed value to your laboratory with
the precision and accuracy normally expected from much larger
analyzers. On-site installation, training and post-sales service
contracts are available with all installations. Call us today for a
ROI analysis and benefit from the quality and savings of AMS
Diagnostics.
Apex Healthware
Booth # 206
www.apexhealthware.com
Scott Lavine, Director of Sales &
Marketing, LIS
4 Henderson Drive
West Caldwell, NJ 07006
Phone: 800-220-4488 x249
Email: sales@apexhealthware.com
Apex Healthware provides the POL with a customized, cost
effective LIS designed to integrate laboratory results into any
certified EHR. One Apex workstation can connect up to 8
diagnostic instruments without the need for dedicated servers or
other expensive hardware. The Apex LIS supports multi-location
facilities, offers remote access to patient results, and interfaces
to reference labs. Automatic management of analyzer Quality
Control and preparation of CLIA compliance reports assists the
POL in meeting regulatory requirements.
18
22. Exhibitor Listing by Company
Company & Contact Information Exhibitor Statement of Products & Services
AUDIT MicroControls, Inc
Booth # 108
www.auditmicro.com
Betsy Lohse
5670 El Camino Real, Suite C
Phone: 866.252.8348
Email: blohse@auditmicro.com
AUDIT is the only total solution in daily quality controls and
calibration verification materials for clinical laboratories. AUDIT
provides value to customers through high-quality products, easy
to use data management tools and unrivaled personalized
service. Our partnership with Aalto Scientific, a leader in
manufacture and supply for more than thirty years, enables us to
offer significant cost savings to our customers. This synergistic
partnership means our customers benefit from a broad line of
superior solutions that address the challenges faced by today's
labs. By better understanding our customers' needs, AUDIT can
find ways to make life in the lab a little easier.
Baytree National Bank & Trust
Booth # 405 (E)
Dan Melamedorf
190 Broadhead Road, Suite 302
Bethlehem, PA 18017
Phone: 866-606-0400
Email: dmelamedorf@baytreebank.com
Baytree isn't just your leasing company; we're your long-term
partner, committed to your company's success. Our programs
are backed by the expansive resources of a nationally chartered
bank, which means we have significant flexibility in creating and
underwriting a wide variety of financing solutions. As a direct
lender we do not have to wait for others to respond to your
inquiries or to make decisions.
Bio-Rad Laboratories
Booth # 105
www.Bio-Rad.com
Terri Wolek, Sr. Sales Product Manager
5500 East 2
nd
Street
Benicia, CA 94510
Phone: 717-701-0061
Email: Terese_Wolek@Bio-Rad.com
Bio-Rad Laboratories is a leading global clinical diagnostics and
life science company. We are focused on meeting the diagnostic
testing needs of our customers in all areas of hospital and
reference laboratories. Bio-Rad provides products for diagnostic
testing performed in core labs, microbiology, serology, molecular
and blood bank laboratories.
Carolina Liquid Chemistries, Corp.
Booth # 310
www.carolinachemistries.com
Patricia Anne Shugart, COO
Wake Forest Biotech Place
Innovation Quarter
575 N. Patterson Ave
Winston-Salem, NC 27101
Phone: 336-722-8910
Email: pattigaull@aol.com
Carolina Liquid Chemistries (CLC) makes starting your lab easy!
We specialize in setting up physician office labs, providing
chemistry, hematology and immunoassay instruments along with
an LIS system. We provide bar-coded reagents and service
contracts for use on Synchron and Olympus instruments.
Centers for Disease Control and
Prevention (CDC)
Division of Laboratory Science and Standards
(DLSS)
Booth 408 (H)
www.cdc.gov/osels/lspppo/index.html
Theresia Snelling, Health Scientist
1600 Clifton Road N. E.
Mail Stop F-11
Atlanta, GA 30329-4018
Phone: 404-281-9017
Email: TSnelling@cdc.gov
The Division of Laboratory Science and Standards (DLSS) has a
portfolio of clinical laboratory related standard-setting and
research initiatives that is unique within CDC. The vision that
guides the work of DLSS is "healthy people through quality
laboratory testing and services." While DLSS is not dedicated to
the control and prevention of a specific pathogen, disease, or
chronic condition, our cross-cutting efforts are aimed at ensuring
and improving the framework for laboratory quality through both
regulatory and non-regulatory approaches. In order to achieve its
objectives, DLSS members collaborate with other centers within
the Agency, other federal and state agencies, laboratory and
medical professional organizations, domestic and international
healthcare standard-setting organizations, the medical device
industry, and other members of the healthcare community.
19
23. Exhibitor Listing by Company
Company & Contact Information Exhibitor Statement of Products & Services
COLA
Booth #211
www.cola.org
Client portal: www.colacentral.com
James Liggins, CMO
9881 Broken Land Parkway, Ste. 200
Columbia, MD 21046-1195
Phone: 800-981-9883 x3736
Email: jliggins@cola.org
COLA is the premier clinical laboratory education, consultation,
and accreditation organization. We are an independent
accreditor whose practical, educational standards have a positive
and immediate impact. Our services enable clinical laboratories
and staff to meet CLIA and other regulatory requirements, act in
accordance with Quality Systems, and provide the best possible
patient care. We provide year round technical assistance, and
our online portal COLAcentral helps you better manage your
laboratory and remain in compliance 365 days per year. We help
to ensure through prevention and hands-on services that your
laboratory will operate more efficiently and meet regulatory
requirements with total confidence. COLA is your partner in
prevention, performance and profitability.
CompuGroup Medical
Booth # 210 & 212
www.CGMus.com
Paul Taylor, Sales
228 Business Center Drive
Reisterstown, MD 21136
Phone: 410-517-0330
Email: CGMUSA.Lab.Sales@cgm.com
CompuGroup Medical provides the U.S. medical community with
laboratory information systems, laboratory outreach solutions,
comprising ONC-ATCB certified electronic health records (EHR),
practice management, and revenue cycle management (RCM).
CGM LABDAQ® Laboratory Information System is the essential
element of a successful laboratory. CompuGroup Medical’s
Laboratory Division has been providing connectivity for
laboratories across the U.S. for over 20 years with the market
leading CGM LabDAQ LIS.
With over 2,800 installations nationwide, CGM LabDAQ
continues to be the #1 placed LIS in the US.
CGM LABNEXUS® Laboratory Outreach Solution simplifies
processes and provides limitless growth opportunities for
reference laboratories with a variety of methods of staying
connected to providers, all within a cloud-based system.
CRI (COLA Resources Inc.)
Booth # 213
www.CRIedu.org
Rose Mary Casados, President
9881 Broken Land Parkway, Ste. 200
Columbia, MD 21046-1195
Phone: 800-981-9883 x3736
Email: rcasados@cola.org
CRI (COLA Resources Inc.), a newly formed COLA subsidiary, is
a leading provider in education and consultative services for
health care professionals, promoting excellence in the
performance and delivery of healthcare services.
Through LabUniversity Center, an on-line educational platform,
symposia and LIVE webinars, CRI’s educational offerings include
subject content drawn from current laboratory practices,
providing tangible knowledge information, affording participants
the ability to satisfy local, state, and federal government
requirements for continuing education and/or to meet other
federal government regulatory requirements.
CRI’s consultative services, through tailored educational
products and uniquely designed programs, provides quality
based assistance in adopting and maintaining higher quality
safeguards and standards to improve the accuracy of clinical test
results, thereby improving patient care and laboratory medicine
procedures.
Through education and consultation, CRI’s goal is to eliminate or
reduce inaccurate test results, redundant or otherwise
unnecessary laboratory testing, thereby increasing the safety,
quality, reliability, efficiency and performance of the participating
laboratories.
20
24. Exhibitor Listing by Company
Erba Diagnostics Mannheim GmbH
Booth # 304
Frank Matuszak
14100 NW 57
th
Court
Miami Lakes, FL 33014
Phone: 800-327-4565
Email:
Frank_matuszak@erbadiagnostics.com
ERBA Diagnostics, Inc. (NYSE MKT: ERB), a fully integrated in
vitro diagnostics company, is pleased to announce ERBA
Diagnostics will be exhibiting the full range of products from
ERBA Diagnostics, including not only the Autoimmune and
Infectious Elisa product lines, but also the New product lines from
its Drew/Jas subsidiary of hematology and Hb1AC equipment
and reagents. Erba will also be displaying its full line of
biochemistry, clinical chemistry and urine analysis products of
the parent company, ERBA Mannheim.
Genial Genetics/ Rainbow Scientific,
Inc.
Booth # 306
www.genialgenetics.com
Jonathan Douglas, Account Manager
83 Maple Ave.
Windsor, CT 06095
Phone: 860-298-8382
Email: jdouglas@genialgenetics.com
Genial Genetics through their distributor Rainbow Scientific, Inc.
offers iPassport, iGene and mWare Integration Engine and
Interface Software.
iPassport provides a comprehensive solution for managing and
controlling all healthcare based documents as part of a complete
Quality Management System. iPassport runs over the Internet,
with user access via a standard web browser such as Internet
Explorer or Firefox. The system allows our clients to organize,
review and approve all laboratory documents in accordance with
national regulations. iPassport provides a solution for both single
and multiple site laboratories in the standardization of policies
and procedures while ensuring that technical staff have access to
the most up-to-date authorized document version at their points
of use. Every approved change throughout the document control
process is faithfully and automatically recorded within iPassport.
A full document history is associated with each individual record.
GFMD Ltd. The Centrifuge
Booth # 406 (F)
www.gfmd.com
Charles Hildreth, Western Regional
Manager
63345 Pine Knoll Circle
Bend, OR 97701
Phone: 541-350-0669
Email: charles.hildreth@gfmd.com
US Manufacturer of the Silent Solution Centrifuge - Silencer.
World Leaders in autoimmune diagnostic technology and
automation - Immuno Concepts.
Henry Schein Medical Inc.
Booth # 305
www.henryschein.com
Donna Gardiner, Sales Manager
54 Cassin Hill Dr.
Garnet Valley, PA 19060
Phone: 717-406-6159
Email: donna.gardiner@henryschein.com
Henry Schein is a unique Fortune 500 Medical distributor that
has a dedicated team of laboratory consultants. Their function is
to evaluate your Medical practice and provide assistance in
maximizing revenues while achieving cost containment. We have
a broad range of Laboratory product offerings to suit any size lab.
21
25. Exhibitor Listing by Company
Hitachi Chemical Diagnostics, Inc.
Booth #409 (I)
www.hcdiagnostics.com
Barry Steinberg, National Sales Manager
630 Clyde Court
Mountain View, CA 94043-2239
Phone: 901-628-6278
Email: bsteinb210@aol.com
Hitachi Chemical Diagnostics - a division of Hitachi Chemical
Company, Tokyo, Japan - is headquartered in the heart of Silicon
Valley in Mountain View, California, and is a global leader of
multiplex in vitro allergy diagnostics. The company works with
industry leaders, laboratories, and distributors in more than 40
countries. The company holds many in vitro allergy testing
technology patents and continues to pioneer advancements in
the field. Visit www.hcdiagnostics.com to learn more.
HORIBA Medical
Booth # 102
www.horiba.com/medical
Jim Knowles, Hematology Product
Manager
34 Bunsen Drive
Irvine, CA 92618
Phone: 888-903-5001
Email: info.medical@us.horiba.com
HORIBA Medical, since 1983, designs, develops, manufactures
and distributes in-vitro diagnostic systems - capturing a
significant portion of the global market. Our U.S. facility, Irvine-
CA, is home base for customer and technical support, training
and distribution, marketing and sales support. We are keenly
focused on hematology and clinical chemistry markets with
instrumentation designed for rapid, economical, and easy
analysis in the Physicians Office Laboratory and small-to-
medium hospitals.
Immunodiagnostic Systems, Inc.
Booth # 215
www.idsplc.com
Bill Supinski
Regional Sales Manager
8425 N. 90th Street, Suite 8
Scottsdale, AZ 85258
Phone: 877-852-6210
Email: info.us@idsplc.com
IDS is dedicated to the development and provision of innovative
immunoassays for use in the clinical and research laboratories.
The company also supplies specialist immunoassay kits and
automated immunoanalyzer technologies worldwide.
J&S Medical Associates
Booth # 107
www.labtrak.com
John Bouchard, President
35 Tripp Street, Bldg. 1
Framingham, MA 01702
Phone: 508-370-9797
Email: john@jsmed.com
LabTrak LIS is designed specifically for the POL market. It is very
affordable and simple to use. LabTrak can interface to most
analyzers on the market today as well as interface with most
EMR companies. We offer both on-line or on-site installation
options. Please stop by our booth to discuss your specific needs.
Jant Pharmacal Corporation
Booth # 307
www.accutest.net
Eyal Golan, Director of Business
Development
16255 Ventura Blvd., Suite 505
Encino, CA 91436
Phone: 818-986-8530
Email: Golan@accutest.net
Jant Pharmacal Corporation provides the physician lab with
consultation and laboratory solutions, including laboratory
information systems, clinical chemistry, hematology,
immunoassay and urinalysis systems and reagents.
The company's product portfolio also includes an extensive menu
of CLIA waived point-of-care rapid tests and instrumentation for
physicians' offices, hospitals and laboratory practice settings.
CLIA-waived tests include urinalysis, coagulation, infectious
disease, drugs of abuse and cancer screens.
Jant Pharmacal's consultation services are available to assist the
laboratory professional in maximizing laboratory efficiency and
operational productivity. These services include financial
feasibility assessment, work flow optimization, as well as
regulatory and proficiency compliance.
22
26. Exhibitor Listing by Company
Laboratory Supply Company
Booth # 200
www.labsco.com
Mike Sandulo, Diagnostic Sales
Consultant
1951 Bishop Lane, Suite 300
Louisville, KY 40218
Phone: 502-363-1891
Email: bsmallwood@labsco.com
LABSCO is the leader in delivering superior diagnostics to the
hospital, physician office laboratories and alternate healthcare
settings. With a specialized focus in the clinical laboratory
setting, LABSCO is a full line distributor of diagnostic and
instrumentation systems and laboratory supplies to the hospital,
physician office laboratory (POL), and other alternate care
settings.
Maine Standards Company
Booth #314
www.mainestandards.com
Russell Stibitz, Direct Sales Specialist
221 US Route 1
Cumberland Center, ME 04110
Phone: 207-892-1300
Email: rstibitz@mainestandards.com
Maine Standards Company's VALIDATE® Makes Calibration
Verification / Linearity Testing Easier. VALIDATE® test kits are
offered for over 80 analytes including General Chemistries, Urine
Chemistries, Enzymes, Lipids, TDMs, Cardiac Markers, Thyroids,
Serum Proteins, Vitamin D and Prostate Specific Antigen.
Multiple product configurations meet the needs of the many
instrument systems available, virtually eliminating dilutions while
maximizing reportable ranges. Visit www.mainestandards.com
or call 1-800-377-9684 for more information.
McKesson Booth # 205 & 207
www.McKesson.com
Lynn Glass,
Senior Director of Clinical Laboratory
Consulting
MedSol Laboratory Consulting by PSS
4345 Southpoint Blvd
Jacksonville, FL 32216
Phone: 904-332-3235
Email: lglass@pssd.com
McKesson Corporation, currently ranked 14th on the FORTUNE
500, is a healthcare services and information technology
company dedicated to making the business of healthcare run
better. We partner with payers, hospitals, physician offices,
pharmacies, pharmaceutical companies and others across the
spectrum of care to build healthier organizations that deliver
better care to patients in every setting. McKesson helps its
customers improve their financial, operational, and clinical
performance with solutions that include pharmaceutical and
medical-surgical supply management, healthcare information
technology, and business and clinical services. For more
information, visit http://www.mckesson.com.
Medica Corporation
Booth # 202
www.medicacorp.com
Gary Thomann, US Sales Manager
Ray Morrill, Product Manager
5 Oak Park Drive
Bedford, MA 01730
Phone: 781-275-4892
Email: gthomann@medicacorp.com
rmorrill@medicacorp.com
Sales: dchalifour@medicacorp.com
Medica Corporation has a long history of bringing easy-to-use
and easy-to-maintain electrolyte and blood gas products to the
worldwide marketplace. With this core philosophy in mind,
Medica introduces the EasyRA®, a fully automated, clinical
chemistry analyzer that is easy to use and maintain, and is also
reliable and affordable. EasyRA offers 150 tests/hour
(>300tests/hr with ISE), a simple user interface accessed through
a convenient touch screen, less than 5 minutes of daily
maintenance, and limited user replaceable components all within
a compact bench-top layout.
Designed specifically to meet the needs of the small laboratory
where space is limited and varying user skill levels exist, EasyRA
is an easy choice for your lab.
Medicus Middleware
Booth # 214
www.medicusmiddleware.com
Karen Bornstein. President
1137 Laguna Drive
Weston, FL 33326
Phone: 888-643-8081
Email:
cmartinez@medicusmiddleware.com
Medicus Middleware offers data solutions for your medical
practice, veterinarian practice, clinics, reference laboratories and
hospitals. We move patient laboratory data seamlessly to your
electronic medical record systems. Our robust, high-powered
system provides applications that streamline and connect
multiple laboratory instruments.
23
27. Exhibitor Listing by Company
MedTest
Booth # 300
www.medtestdx.com
Debbie Whitehair, VP, Marketing
5449 Research Drive
Canton, MI 48188
Phone: 800-445-9853
Email: dwhitehair@medtestdx.com
MedTest, a Michigan based company, offers two of the most
widely known product brands in the industry - Pointe Scientific
and MedTest DX. Together, these comprehensive product lines
offer a range of: Chemistry and hematology instruments,
Chemistry and drugs of abuse reagents, Packaged and
Barcoded Open Channel Reagents, Calibrators, controls, and
standards and Instrument services and training.
MedTest offers all this to both the direct consumer as well as
through distribution channels in the United States and abroad.
Our products can be found all over the world in mid-to-low
volume laboratories such as: Hospitals, Physician Office
Laboratories, Pain Management Clinics, Reference Laboratories
and Research Facilities.
Exclusive in the United States only through MedTest: A
Complete Solution for the Low-to-Mid Volume Laboratory – The
Mindray™ BS-200 Suite. Only through MedTest is your
laboratory able to bring together an analyzer, reagents, support
and service… all provided to you through one company. And that
company is MedTest.
MedTest - your one partner for everything related to the
Mindray™ BS 200 Chemistry Analyzer.
Merge Healthcare
Booth #103
www.merge.com
Grace Hardy, Segment Marketing
Coordinator
350 N Orleans Street, 1st Floor
Chicago, IL 60654
Phone: 312-946-2509
Email: grace.hardy@merge.com
Merge is a leading provider of clinical systems and innovations
that seek to transform healthcare. Merge's enterprise and cloud-
based imaging solutions for image intensive specialties provide
access to any image, anywhere, any time.
Orchard Software Corporation
Booth # 201 & 203
www.orchardsoft.com
Kerry Foster, Director of Marketing
701 Congressional Blvd, Suite 360
Carmel, IN 46032
Phone: 800-856-1948
Email: sales@orchardsoft.com
Orchard Software is known for its award-winning laboratory
information systems. Today, more than 1,200 laboratories
across the country have turned to Orchard Software for their
Laboratory Information System; including all types and sizes of
multi-site and multi-specialty clinics and physician office
laboratories, hospitals, regional reference labs, student health
services, and public health organizations.
Randox Laboratories US Ltd
Booth # 100
www.randox.com
Rajneesh Mathur, National Manager
Randox Laboratories-USA, Ltd.
515 Industrial Blvd.
Kearneysville, WV 25430
Office Phone: 304-728-2890
Cell Phone: 760-208-3879
304-728-1890
Email: Rajneesh.Mathur@randox.com
Randox is an international diagnostic solutions company
dedicated to revolutionizing healthcare worldwide. Randox
provide a range of clinical chemistry analyzers, from low to high
throughput. Our extensive portfolio of high quality reagents
includes over 100 disease markers for comprehensive testing.
The Acusera range of quality control material offers over 350
routine and specialized parameters with many liquid ready to use
controls available.
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28. Exhibitor Listing by Company
Roche Diagnostics
Booth # 111
www.mylabonline.com
Ellen Byrum, CTSM
Meeting Management Consultant
9115 Hague Rd.
Indianapolis, IN 46256
Phone: 317-521-2000
Email: ellen.byrum@roche.com
Roche Diagnostics offers a broad portfolio of flexible solutions
including integrated and scalable chemistry and immunoassay
analyzers with the broadest test menu on one platform.
Sarstedt, Inc.
Booth # 407 (G)
www.sarstedt.com
Peter Rumswinkel, VP/GM
P.O. Box 468
Newton, NC 28658
Phone: 800-257-5101
Email: customerservice@sarstedt.us
Sarstedt's medical and diagnostic product range includes blood
and specimen collection systems; items for sample transport and
storage; automated pre- and post-analytical instrumentation; and
blood banking equipment.
The S-Monovette® venous blood collection system, an
alternative to traditional vacuum-only systems, provides
innovative solutions for reducing hemolysis and waste while
improving venipuncture success and safety.
Schuyler House
Booth # 315
www.schuylab.com
Joe Gosser, Regional Sales Manager
27821 Fremont Court Ste. 8
Valencia, CA 91355
Phone: 800-706-0266 Ext 603
Email: joe@schuylerhouse.com
Schuyler House produces a full-featured suite of (LIS) Software -
Laboratory Information Systems and medical information
systems for the laboratory and clinical practice. Our users include
physician offices and their associated laboratories, large-scale
reference labs with hundreds of clients, and hospitals. All our
products feature powerful, intuitive graphical user interfaces that
combine an easy learning curve with a streamlined workflow.
This graphical interface allows experienced users to perform
tasks quickly and efficiently, and minimizes training time for new
users. SchuyLab can also connect to your EMR/HIS/EHR and
transmits results directly to that system, relieving you of the need
to print and distribute reports to your doctors. All Schuyler House
software is compliant appropriately with: COLA / CLIA / HIPAA /
HITECH / NPI / 5010 / ISO / ANSI 837 / HL7
Siemens Healthcare
Booth # 301 & 303
www.usa.siemens.com/healthcare
Peg Eckenwiler, Distribution Capital
Sales Manager
4755 Delaware Ave
Larkspur, CO 80118
Phone: 303-470-6179
Email:
margaret.eckenwiler@siemens.com
Siemens Healthcare is one of the world’s largest suppliers to the
healthcare industry and the first full-service diagnostics company.
The company is known for bringing together innovative medical
technologies, healthcare information systems, management
consulting, and support services, to help customers achieve
tangible, sustainable, clinical, and financial outcomes. Siemens
offers instrumentation in Chemistry, Immunochemistry,
Coagulation, Hematology, Microbiology and Urinalysis.
Tosoh Bioscience, Inc.
Booth #106
tosohbioscience.us
Paul Pearce, Western Regional Manager
6000 Shoreline Ct. Ste 101
South San Francisco, CA 94080
Phone: 800-248-6764
Tosoh Bioscience manufactures innovative analyzers for
immunoassay and HbA1c testing. For HbA1c, the Tosoh G8
HPLC Analyzer utilizes the Gold Standard Ion-Exchange method
of HbA1c measurement with less than 2% CVs and an analysis
time of only 1.6 minutes.
Tosoh's latest advancement, the AIA-900 Automated
Immunoassay Analyzer, is available in three configurations. The
instrument can be expanded as testing volumes increase. Also
for immunoassay, the AIA-2000 is an extremely powerful and
25
29. Exhibitor Listing by Company
Email: paul.pearce@tosoh.com feature-rich analyzer for high throughput diagnostics. The
compact AIA-360 is a cost-effective solution for lower volumes.
All Tosoh AIA systems utilize the same Unit Dose Test Cup
reagent format, so results are consistent and interchangeable
between systems.
Trinity Biotech
Booth #101
www.trinitybiotech.com
Heidi Maxwell, Regional Account
Manager
2823 Girts Road
Jamestown, NY 14701
Phone: 800-325-3424
Email: Heidi.maxwell@trinityusa.com
Trinity Biotech specializes in the development, manufacture and
marketing of diagnostic test kits used in the clinical laboratory
and point-of-care segments of the world wide diagnostic market.
Our kits are used to detect infectious diseases, sexually
transmitted diseases, autoimmune and hemoglobin disorders, for
the detection, monitoring and control of diabetes.
WSLH-PT
Booth # 311
www.wslhpt.org
Kristine Hansbery, Director
465 Henry Mall
Madison, WI 53706
Phone: 800-562-4261
Email: kristine.hansbery@slh.wisc.edu
The Wisconsin State Laboratory of Hygiene has been
administering a proficiency testing (PT) program since the 1960s.
Our PT program is approved as a PT provider under CLIA ’88 by
the Centers for Medicare and Medicaid Services (CMS).
WSLHPT is accepted by the CAP’s Laboratory Accreditation
Program (LAP) as PT provider for their accredited labs and is
accepted as a PT provider by Joint Commission, COLA and all
States. WSLH PT has over 4000 customers (over 700 CAP
accredited customers), and over 180 different products covering
a wide range of laboratory specialties and subspecialties.
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31. Laboratory Resources
You will find the following Laboratory Resources on the Symposium Flash Drive:
Laboratory Resources
Acronyms and Abbreviations
Glossary
Regulatory Information
Newsletters
Professional Management Organizations
Directory of Organizations
Additional Resources include:
Proficiency Testing Programs
Personnel Qualifications
Waived & PPM FAQs and the MMWR report on waived testing
Educational Products Available from COLA Resources, Inc.
Selected COLA LabGuides
CLIA Brochures from CMS:
Brochure #1 - CLIA Updated Regulations: How do they affect my laboratory?
Brochure #2 - Verification of Performance Specifications
Brochure #3 - Calibration and Calibration Verification
Brochure #4 - Equivalent Quality Control Procedures
Brochure #5 - How to Obtain a CLIA Certificate
Brochure #6 - How to Obtain a CLIA Certificate of Waiver
Brochure #7 - Laboratory Director Responsibilities
Brochure # 8 - Proficiency Testing
Brochure # 9 - Complaints: Do You Have a Concern About a Laboratory’s
Operation?
Brochure #10 – What Do I Need to Do to Assess Personnel Competency?
Brochure #11 – Introduction to Individualized Quality Control Plans
Symposium for Clinical Laboratories
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32. Thank you for coming to the Symposium!
We look forward to seeing you at our next conference.
Mark your calendars for:
October 15 - 18, 2014
Buena Vista Palace Resort & Spa
Lake Buena Vista, FL
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