The Clinical Laboratory Improvement Advisory Committee (CLIAC) met in Atlanta, March 12-13, 2003. The meeting included routine updates from the Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC). After the updates, members learned and discussed Direct Access Testing (DAT). Although much time was spent on DAT, the meat of the meeting was the CLIA regulation update from CMS.
CMS update: Judy Yost, Director, Division Laboratory Services, Center for Medicaid and State Operations, CMS, presented information on the Federal Register publication Jan. 24, 2003,
(), which included CLIAs final regulations for board-certified directors of high complexity laboratories and quality control (QC). Although the final rule has been published, Appendix C (Survey Procedures and Interpretative Guidelines for Laboratories and Laboratory Services) of the State Operations Manual (CMS Pub. 7, referred to as the guidelines) is in the process of being finalized. A draft form will be issued to CLIAC members, professional associations, manufacturers and experts in the field to provide comments prior to its final publication, which is due out this fall. The final guidelines will be posted on CLIAs website (www.cms.gov/CLIA). The guidelines will define compliance-acceptable laboratory QC processes.
Scott Young, MD, Senior Clinical Advisor, Office of Clinical Standards and Quality, CMS presented an update of the Ambulatory Safety and Quality Task Force. This group convened the Agency for Healthcare Resource and Quality, CMS, and The Leapfrog Group (a coalition of more than 130 public and private organizations) to develop initiatives to improve the safety and quality of healthcare services in ambulatory care settings.
One of the focus areas is e-laboratory test results management, recognized as having the potential to improve safety and quality by making a practitioner aware of test results that have been received but not reviewed. The systems can also reduce unnecessary test ordering by giving practitioners easier access to previous test results. David N. Sundwall, MD, president of the American Clinical Laboratory Association and CLIAC member, suggested the references to laboratory errors be revised to recognize that most errors associated with laboratory test results are management errors that occur outside the laboratory. Dr. Young acknowledged this and promised to revise his handouts and statements to reflect that point.
The CDC is sponsoring a Quality Institute April 13-15, 2003, in Atlanta that will focus on what can be done in the future to improve laboratory services. To obtain information on the QI, go to www.phppo.cdc.gov/mlp/qiconference.
CDC update: Elliot P. Cowan, PhD, and Thomas Hearn, PhD, gave an overview of FDA-approved OraQuick rapid HIV CLIA-waived test. The difference with this waived test from others is the restrictions that are placed on it. The waived procedure has the same restrictions as the moderate complexity procedure, which includes a declaration that the intended user is a certified laboratory (this restriction is meant to prohibit self-testing). The CDC is developing a Quality Assurance document for supervisors and test performers. The document will address: organization of testing, personnel, process control, documents and records, and troubleshooting.
DAT education and discussions: Toby Merlin, MD, Chair, put the committee on the same page by defining DAT as a test that a consumer chooses, for which he pays and for which he is responsible for interpreting and following up the results. Merlin charged the committee to think about what advice CLIAC would have for the Secretary of Health and Human Services about DAT. The big question is whether the role of government should be a bystander, observer and monitor and/or regulator.
Rhonda Whalen, Branch Chief, Laboratory Practice Standards, CDC, provided an overview of where the CLIA regulations currently address DAT. Three perspectives followed: physicians point of view, by Verlin Janzen, MD; laboratory offering DAT, by Hughes Bakewell, Jr., Vice President, Consumer Health, Quest Diagnostics, Inc.; and consumer advocacy, by Charles B. Inlander, President, Peoples Medical Society. Public comments were made by representatives for ASCLS, ASCP, CAP and Healthcheckusa.com. The committee was convinced that the topic warrants further discussion.
Changing of the guard
The March 12-13 gathering marked the last meeting for current chair, Dr. Merlin. Taking over the helm will be Dr. Sundwall. Also leaving will be Executive Secretary Edward L. Baker, MD, Director, Health Practice Program Office, CDC. Robert Martin, MDPH Director, Division of Laboratory Systems, Public Health Practice Program Office, CDC, will step in as acting director. Six other current members concluded their terms with this meeting. The entire meeting minutes are scheduled to be posted on the CDC CLIAC website at
Anne Pontius, a longtime MLO contributor and member of its Editorial Advisory Board, also serves as a member of the Board of Directors of the CLMA and is president of Laboratory Compliance Consultants Inc. in Raleigh, NC.
April 2003: Vol. 35, No. 4
© 2003 Nelson Publishing, Inc. All rights reserved.