Clinical Laboratory Improvement Advisory Committee Meeting Transcript April 10-11, 2019 Baltimore, Maryland U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES 1 April 10, 2019 Call to Order and Committee Member Introductions CLIAC CHAIR: Well everybody, I'll ask committee members to take your seats as we prepare to begin the meeting. Do we have quorum? I think we have quorum. CLIAC DFO: Good morning, and welcome to CLIAC. I'd like to take this opportunity to thank our hosts at CMS. This is a great opportunity. It's the first time in CLIAC's history that we have held this meeting at CMS. So it's a great opportunity for us. We begin with introductions and conflicts of interest. And we'd like for each CLIAC member, beginning with Campbell, to introduce themselves, provide just their affiliation, as well as their indication of any conflicts of interest. And we'll go around the table. So we'll take care of introductions and conflicts of interest at the same time. CLIAC MEMBER: I'm Sheldon Campbell from Yale School of Medicine and VA Connecticut Healthcare. I'm on College of American Pathologists Checklists Committee, the Lab Practices Committee of the American Society for Microbiology, and no other conflicts of interest. CLIAC MEMBER: I'm Marc Couturier from University of Utah, ARUP Laboratories. I am also on the Clinical Laboratory Practices Committee through the American Society for Microbiology. I have a financial conflict of interest with BioFire Diagnostics, for which my spouse draws a household income. And I have a conflict of interest for research reagents with Apacor Limited, Meridian Biosciences, and DSORG. CLIAC MEMBER: Good Morning. I'm Lee Hilborne. I am a Medical Director at Quest Diagnostics. That's probably my major conflict of interest. I'm also a professor and Medical Director at UCLA Healthcare. I am on the CAP Accreditation Education Committee, and am on the Commission on Public Policy for ASCP, and then past president of ASCP. I also work for Rand, but they're nonprofit. CLIAC MEMBER Morning. Steve Hinrichs. I'm Chair and Professor of the Department of Pathology at University of Nebraska Medical Center. We are heavily engaged in both research and education, but I have no other financial conflicts. CLIAC MEMBER: I'm Brad Karon. I'm at the Mayo Clinic in Rochester, Minnesota. Clinical pathologist. I am a member of the College of American Pathologists Council on Accreditation. And I have financial conflicts of interest-- I serve on advisory boards for Roche Diagnostics and Radiometer America. CLIAC MEMBER: Good morning. Tom Lorey. I'm the Regional Medical Director of Northern California region of Kaiser Permanente. I have no conflicts, financial or otherwise. CLIAC MEMBER: Good morning. My name is Sharon Massingale and I'm the Laboratory Director for the State of Alabama Bureau of Clinical Laboratories. I'm a member of ABB, where I serve as a representative to the public health interest group. And I'm also part of APHL where I'm a member of the workforce development group. And my laboratory received funds for two cooperative agreements from the CDC. 2 CLIAC MEMBER: Good morning. I'm Lavinia Middleton. I'm a surgical pathologist by training at MD Anderson Cancer Center. I am the Vice Chair for Quality Operations in the Division of Path and Lab Medicine. And I'm also the Deputy CMO for Medical Affairs. I sit on the AAMC Diagnostic Accuracy Committee. And I have no financial conflicts. CLIAC MEMBER: Hello. I'm Helen Mills from Victor 12 in the VA of Orlando, Florida. I have no conflicts at this time. CLIAC MEMBER: Good morning. I'm Valerie Ng. I'm Professor Emeritus of the Department of Laboratory Medicine at the University of California, San Francisco. And I'm currently Chair of the Department of Lab Medicine and Pathology at Alameda Health System in Alameda County, Oakland, California. I'm a member of the Health Laboratory Workforce Initiative Advisory Group for the California Hospital Association. I am a reviewer for the College of American Pathologists Point of Care Checklist. I am a reviewer for the Gordon and Betty Moore Inventors Fellows submissions this year. And I'm the Editorial Lead for Lab Medicine for Doody's Books Reviews. Thank you. CLIAC MEMBER: Good morning. My name is Katherine Perez. I'm the Infectious Diseases Pharmacist in Houston Methodist Hospital System. I direct the antimicrobial [INAUDIBLE]. CLIAC MEMBER: Good morning. I'm Bonnie Rubin, and I'm currently an Adjunct Professor at University of Iowa [INAUDIBLE] college. And my only conflict of interest is that I'm on the Board [INAUDIBLE]. CLIAC MEMBER: Good morning. Greg Sossaman. I'm a clinical biologist at Oshner Health System in New Orleans. I have no financial conflicts. I have held several volunteer positions through ASCE. CLIAC MEMBER: Hello. My name is Cindy Wilkerson. I'm the Director of the Laboratory Medicine Department at the Sloan Kettering Cancer Center in New York City, and I have no conflicts. CLIAC MEMBER: Good morning. I'm Donna Wolk. I'm the Division Director and Laboratory Medicine at Geisinger Health, and an adjunct professor at Wilkes University. I have grant-funded financial conflicts with Roche, GenMark, Upjohn, CEPHIA, DiaSorin, BioFire, and I hold advisory positions with Streck and Safeguard. I also have a CBC-funded pandemic flu grant through ABT, and I'm the editor for "The Clinical Microbiology" newsletter from Elsevier. ADVAMED LIAISON: Good morning. I'm Andy Quintenz, and I am a liaison to the CLIAC, and from Biroad Laboratories. I'm also the chair of the ISO technical committee for the US executive committee for TC-212, which is clinical lab testing. And members of the AACC corporate advisory board and CLSI consensus council. CLIAC EXECUTIVE SECRETARY: Good morning. I'm Nancy Anderson from the Division of Laboratory Systems at CDC. I'm the Executive Secretary for CLIAC and I have no conflicts. CDC EX OFFICIO: Good morning, everyone. I'm CDC EX OFFICIO Fitzgerald. I'm in the Division of Laboratory Systems at CDC. I'm the CDC Ex Officio for CLIAC. I have no conflicts of interest. CLIAC DFO: Good morning. I'm Ren Salerno from CDC's Division of Laboratory Systems, and I'm the designated Federal Official for CLIAC. No conflicts. CMS EX OFFICIO: And I'm CMS EX OFFICIO Dyer. I'm the Director of Division of Clinical Laboratory Improvement here at CMS, and I have no conflicts. 3 FDA EX OFFICIO: Good morning. I'm Peter Tobin from the Office of In Vitro Diagnostics and Radiological Health at FDA, and I have no conflicts of interest. CLIAC CHAIR: And we have-- I believe we have Dr. Williams on the phone. Thomas Williams, are you on the phone? Susan Gross, are you on the phone? Is anybody on the phone? Do we have anybody on the phone? CLIAC MEMBER: I'm Susan Gross. I am the Medical Director of the Reproductive Genetic Laboratory at Sema4. And I'm also a professor at the Genomics Department at Icahn School of Medicine, Mount Sinai. My other conflicts to say today, I am a consultant at [INAUDIBLE], which is an artificial intelligence software company for genomic medicine for interpretation and complication variance. And I'm also the President of the OBG project, which is a peer to peer educational online site. CLIAC CHAIR: Thank you, Dr. Gross. Do we have Dr. Laser on the phone? Well, that brings us to me. I'm Ramy Arnaout. I'm the Medical Director of Clinical Microbiology at Beth Israel Deaconess Medical Center and Harvard Medical School up in Boston. I consult for Lexent Bio, a cell-free DNA diagnostics company, and Embold Health, a health care analytics company. I also sit on the informatics and personalized medicine committees for CAP, for the College for American Pathologists. And with that, I think we will get started So about public comments. So during the period for committee discussion, participation is limited to CLIAC members. However, public comment periods are scheduled for both meeting days. Public comments will be limited to a total time of five minutes per individual or group. And we've got a pretty dense couple of days, so we do appreciate it for public commenters keeping to that. If anyone in the audience wishes to address the committee, the public comment portion of the meeting is the proper forum to do so. Those who are planning to provide a public comment must fill out a speaker information form located at the registration desk. And again, please do restrict your oral comments to five minutes. Can I get a show of hands for any public comments today? OK. Somebody help me count. I count three. OK, fantastic. Thank you very much. And could you, three of you, please indicate which topics your comments will relate to. Just yell it out. AUDIENCE: Proficiency testing. CLIAC CHAIR: Moving across the room, who's the second hand? AUDIENCE: [INAUDIBLE]. CLIAC CHAIR: Which one? AUDIENCE: Sorry. CLIAC CHAIR: No worries. Take your time. AUDIENCE: [INAUDIBLE]. CLIAC CHAIR: Personnel? Personnel. OK. Thanks. And the third one? AUDIENCE: Personnel qualifications. 4 CLIAC CHAIR: Thanks all three of you. All right. Copies of all our PowerPoint presentations and other meeting materials are posted on the CLIAC website. It's www.cdc.com/cliac. Everybody should be able to get into our guest wireless here. If you have any trouble, turn to your neighbors who can help you out. At the start of each presentation, I will do my best to remember to announce a presentation number to assist you in locating the correct electronic file.