Clinical Laboratory Improvement Advisory Committee Summary Report February 14 - 15, 2012 Atlanta, Georgia U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Page 1 of 30 Clinical Laboratory Improvement Advisory Committee February 14 - 15, 2012 Summary Report Table of Contents I. Record of Attendance II. Clinical Laboratory Improvement Advisory Committee (CLIAC) - Background III. Call to Order and Committee Introductions IV. Agency Updates and Committee Discussion Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) Board of Scientific Counselors Update V. Presentations and Committee Discussion Coordinating Council on the Clinical Laboratory Workforce (CCCLW) Update CLIA Individualized Quality Control Plan (IQCP) CLSI EP23-A Laboratory Quality Control Based on Risk Management; Approved Guideline Semi-Automated Cytology Workload • Introduction and Background • Workload Issues for Computer-Aided Cytology Devices • A Career that has Eternal Significance • American Society of Cytopathology Task Force Recommendations Emerging Issues in Digital Pathology • Introduction and Background • Digital Pathology: The Pathologist’s Perspective • FDA Regulation of Whole Slide Imaging (WSI) Devices: Current Thoughts • FDA Research and Scientific Issues in Digital Pathology • CLIA Guidance for Digital Pathology Communication and Electronic Health Records Integrating Laboratory Services into Evolving Healthcare Models • Introduction and Background • Medicare Shared Savings Program • Accountable Care Organizations and the Laboratory • ACOs & Medical Homes: What’s the Lab Got to Do with It? VI. Public Comments VIII. Adjourn Page 2 of 30 RECORD OF ATTENDANCE Designated Federal Official Dr. May Chu Committee Members Present Dr. Paula Santrach, Chair Dr. Paul Kimsey Rev. Eugene R. Augustine, Jr. Ms. Karen Lacy Dr. Robert A. Baldor Dr. Anthony Okorodudu Dr. Christine Bean Dr. Linda Sandhaus Dr. Edward L. Chan Dr. Robert Sautter Dr. Martha Crenshaw Dr. Linda D. Ward Dr. Judy Daly Dr. David S. Wilkinson Dr. Anand Dighe Dr. Rosemary Zuna Dr. John Fontanesi Ms. Julie Gayken Liaison Representative Mr. Robert Di Tullio, AdvaMed Committee Members Absent Dr. Jeffrey A. Kant Dr. Gail Vance E x Officio Members Dr. Alberto Gutierrez, FDA Dr. Devery Howerton, CDC Ms. Judith Yost, CMS Executive Secretary Ms. Nancy Anderson Page 3 of 30 Record of Attendance – cont’d Centers for Disease Control and Prevention (CDC) Dr. Simon M. Adebova Ms. Leslie McDonald Mr. Todd Alspach Mr. Kevin Malone Dr. J. Rex Astles Dr. Joanne Mei Ms. Diane Bosse Dr. Ninad Mishra Ms. Cathryn Cambria Mr. James Nowicki Dr. Roberta Carey Ms. Anne Pollock Dr. Nancy Cornish Mr. John Ready Dr. Maryam Daneshvar Dr. John Ridderhof Mr. Swapnil Deshpande Ms. Megan Sawchuk Ms. Sheila Dooley-Edwards Ms. Andrea Scott-Murphy Dr. W. David Dotson Dr. Shahram Shahangian Ms. Joanne Eissler Mr. Darshan Singh Dr. Seth Foldy Ms. Theresia Snelling Ms. Maribeth Gagnon Ms. Heather Stang Dr. Amy Gargis Dr. Julie Taylor Ms. Patricia Haskell Mr. H. Eric Thompson Mr. Matthew Hough Ms. Pamela Thompson Mr. Richard Jones Mr. Ron Van Duyne Dr. Lisa Kalman Ms. Betsy Weirich Dr. John Krolak Ms. Glennis Westbrook Dr. Elizabeth Leibach Ms. Irene Williams Ms. Millie Linville Dr. Laurina Williams Mr. Ken Long Dr. Yang Xia Dr. Ira Lubin Ms. Yasmine Zavahir Ms. Isabel McAuliffe Dr. Barbara Zehnbauer Ms. Alana McCoy Mr. Jonathan Zhong Department of Health and Human Services (Agencies other than CDC) Dr. Aldo Badano (FDA) Ms. Tremel Faison (FDA) Mr. Daniel Cajigas (CMS) Ms. Elizabeth November (CMS) Mr. Ramil Codina (DoD) Ms. Debra Sydnor (CMS) Dr. Elliot Cowan (FDA) Ms. Harriet Walsh (CMS) Ms. Karen Dyer (CMS) Ms. Cheryl Wiseman (CMS) In accordance with the provisions of Public Law 92-463, the meeting was open to the public. Approximately 30 public citizens attended one or both days of the meeting. Page 4 of 30 Clinical Laboratory Improvement Advisory Committee The Secretary of Health and Human Services is authorized under Section 353 of the Public Health Service Act, as amended, to establish standards to assure consistent, accurate, and reliable test results by all clinical laboratories in the United States. The Secretary is authorized under Section 222 to establish advisory Committees. The Clinical Laboratory Improvement Advisory Committee (CLIAC) was chartered in February 1992 to provide scientific and technical advice and guidance to the Secretary and the Assistant Secretary for Health regarding the need for, and the nature of, revisions to the standards under which clinical laboratories are regulated; the impact on medical and laboratory practice of proposed revisions to the standards; and the modification of the standards to accommodate technological advances. The Committee consists of 20 members, including the Chair. Members are selected by the Secretary from authorities knowledgeable in the fields of microbiology, immunology, chemistry, hematology, pathology, and representatives of medical technology, public health, clinical practice, and consumers. In addition, CLIAC includes three ex officio members, or designees: the Director, Centers for Disease Control and Prevention; the Commissioner, Food and Drug Administration; the Administrator, Centers for Medicare & Medicaid Services; and such additional officers of the U.S. Government that the Secretary deems are necessary for the Committee to effectively carry out its functions. CLIAC also includes a non-voting liaison representative who is a member of AdvaMed and such other non-voting liaison representatives that the Secretary deems are necessary for the Committee to effectively carry out its functions. Due to the diversity of its membership, CLIAC is at times divided in the guidance and advice it offers to the Secretary. Even when all CLIAC members agree on a specific recommendation, the Secretary may not follow their advice due to other overriding concerns. Thus, while some of the actions recommended by CLIAC may eventually result in changes to the regulations, the reader should not infer that all of the Committee’s recommendations will be automatically accepted and acted upon by the Secretary. Page 5 of 30 CALL TO ORDER – INTRODUCTIONS/FINANCIAL DISCLOSURES Dr. May Chu, Designated Federal Official (DFO), Clinical Laboratory Improvement Advisory Committee (CLIAC), and Director, Laboratory Science, Policy and Practice Program Office (LSPPPO), Office of Surveillance, Epidemiology and Laboratory Services (OSELS), CDC, welcomed the Committee and the members of the public, acknowledging the importance of public participation in the advisory process. She said the meeting would begin with a legal update from Kevin Malone followed by updates from the CDC, FDA, Board of Scientific Counselors, and the Coordinating Council on the Clinical Laboratory Workforce. The Committee would then hear a presentation from CMS on the CLIA individualized quality control plan and a presentation on CLSI EP23- A. The remainder of the day would be spent on the topics of semi-automated cytology workload and emerging issues in digital pathology. She said Wednesday would begin with a presentation and discussion on communication and electronic health records. The remainder of Wednesday would be spent on the topic of integrating laboratory services into evolving healthcare models. Dr. Chu recognized the five CLIAC members who were to receive plaques and letters of appreciation for their service on the Committee. They were Dr. Christine Bean, Ms. Julie Gayken, Dr. Paul Kimsey, Dr. Linda Sandhaus, and Dr. Rosemary Zuna. Dr. Paula Santrach, Chair, CLIAC, welcomed the Committee and called the meeting to order. All members then made self-introductions and financial disclosure statements relevant to the meeting topics. AGENCY UPDATES AND COMMITTEE DISCUSSION Centers for Disease Control and Prevention (CDC) Update Addendum A Addendum B Devery Howerton, Ph.D. Addendum C Division of Laboratory Science and Standards (DLSS) Laboratory Science, Policy and Practice Program Office (LSPPPO) Office of Surveillance, Epidemiology and Laboratory Services (OSELS) Centers for Disease Control and Prevention Dr. Howerton’s presentation highlighted the major activities underway within the DLSS. She began by updating the Committee on the progress being made in the area of standards, guidelines, and reference material development. The Genetic Testing Reference Materials (GeT-RM) program group is involved in the development of reference materials for cytogenetic microarray analysis. The current program goal is to characterize 95 reference materials with common cytogenetic abnormalities for use by laboratories and manufacturers. She described the efforts of the Next-generation Sequencing: Standardization of Clinical Testing (Nex-StoCT) working group that are Page 6 of 30 culminating with the development of a guidance document for next generation sequencing in clinical practice. She reviewed the historical timeline of the Morbidity and Mortality Weekly Reports Recommendations and Reports: Good Laboratory Practices for Biochemical Genetic Testing and Newborn Screening for Inherited Metabolic Disorders, announcing an expected publication date of April 2012. With regard to laboratory proficiency testing (PT) she apprised the Committee of the status of the CLIA PT regulatory revisions and mentioned the CDC-Association of Public Health Laboratories collaborative survey to evaluate how laboratories use PT for quality improvement. Dr. Howerton discussed the Division’s educational outreach activities reminding