Kareo.webinar.06.18.14

© CRI 2013

Hyatt Regency St. Louis at the Arch St. Louis, MO

October 24 - 26, 2013

Presented by

COLA Resources, Inc. (CRI)

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.


Program Information and Table of Contents Pages

Participant Information 1

Accreditation, Credits, Special Assistance 2

Activity Schedule 3

Faculty Information and Biographies 6

Faculty Disclosures 9

Exhibitor Listing 16

Financial Support Acknowledgement 17

Flash Drive and Laboratory Resources 27

Future Symposium Information 29

In This Binder

All General Session handout materials are here in this binder. Instructions were provided to registered participants by email for accessing and printing the handout materials for your selected breakout sessions.

For your convenience, the contents of this binder, the handout materials for ALL sessions, and extensive Laboratory Resources can be found on the October 2013 Symposium Flash Drive.

General Session Handouts

Pages Thursday AM, October 24, 2013

CLIA Update 2013 (Fairbanks) 30

Friday AM, October 25, 2013

HIV Diagnosis and Treatment (Sweet) 42

Friday PM, October 25, 2013

Healthcare Reform (Peterson) 86

Jumping the Generation Gap (Dumas) 94

Saturday, October 26, 2013

Management of Laboratory Operations (Peterson) 98

Competency Assessment (Peterson) 108

COLA Update (Densford) 116

In Compliance and Ready for Inspection (Bachman) 126

© CRI 2013

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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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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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


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Activity Schedule

Friday

October 25, 2013

7:00a – 8:30a Lab Director Session: (Breakfast served in classroom) Introduction to Proficiency Testing for Physicians


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


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


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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.


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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 [email protected]

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 [email protected]

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 [email protected]

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 [email protected]

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 [email protected]

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 [email protected]

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 [email protected]

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 [email protected]

The Value of the Laboratory in the New Healthcare Model

ASCP certified Medical Technologist

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Verlin K. Janzen, MD, FAAFP Hutchinson Clinic, PA 2101 North Waldron Hutchinson, KS 67502 620-669-2685 [email protected]

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 [email protected]

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 [email protected]

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 [email protected]

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 [email protected]

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 [email protected]

HIV Diagnosis & Treatment MD

Director of Internal Medicine Education HIV/AIDS Researcher Master of the ACP

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Kimberly Whiter, MS, MLS(ASCP)CM

Assistant Professor, Medical Laboratory Science Program Jefferson College of Health Sciences Roanoke, VA 540-985-8106 [email protected]

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 [email protected]

Open Forum on QC Practices ASCP Certified Medical Technologist

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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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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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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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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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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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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

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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.

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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

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

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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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.

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mailto:[email protected]



AUDIT MicroControls, Inc Booth # 108 www.auditmicro.com Betsy Lohse 5670 El Camino Real, Suite C Phone: 866.252.8348 Email: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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.

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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: [email protected]

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: [email protected]

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: [email protected]

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.

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Erba Diagnostics Mannheim GmbH Booth # 304 Frank Matuszak 14100 NW 57

th Court

Miami Lakes, FL 33014 Phone: 800-327-4565 Email: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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.

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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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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


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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected] [email protected] Sales: [email protected]

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: [email protected]

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


MedTest Booth # 300 www.medtestdx.com Debbie Whitehair, VP, Marketing 5449 Research Drive Canton, MI 48188 Phone: 800-445-9853 Email: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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.

24


Roche Diagnostics Booth # 111 www.mylabonline.com Ellen Byrum, CTSM Meeting Management Consultant 9115 Hague Rd. Indianapolis, IN 46256 Phone: 317-521-2000 Email: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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


Email: [email protected]

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: [email protected]

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: [email protected]

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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About The Flash Drive For easy access and storage, all the materials in the syllabus binder, handouts for all educational sessions, and additional laboratory resources are provided to you in separate folders on the Symposium Flash Drive: Syllabus Front Pages: This folder contains all the information from the front section of the syllabus binder, including CE credit information, the schedule, speaker contact information and biographies, and exhibitor information. General Sessions and Lab Director Sessions: This folder contains the handouts for the General sessions and the Laboratory Director sessions offered at this symposium. A, B, C, D, E Breakout Sessions: This folder contains the handouts for all the breakout sessions presented at this symposium, including the breakouts in the Lab Director track. Laboratory Resources: This folder contains numerous resources for the laboratory, as described on the next page.

27© CRI 2013

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


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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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Health & Medicine

Kareo.webinar.06.18.14