Laboratory Sanctions for Proficiency Testing Sample Referral and Result Communication: A Review of Actions From 1993–2006

Abstract

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for proficiency testing (PT) include prohibitions against intentional PT sample referral or result communication, and specify sanctions against laboratories that violate these regulations. There has been little published analysis of sanctions against clinical laboratories because of PT violations. To examine the application of principal sanctions as reported by the Centers for Medicare and Medicaid Services annually in the Laboratory Registry and to examine relevant aspects of judicial hearings and appeals in these cases. The Laboratory Registry was examined for all available years (1993-2006) to determine the incidence of application of principal sanctions for PT violations. In addition, the decisions from the US Department of Health and Human Services hearings and appeals were reviewed to better understand the judicial disposition of these cases. During the 14-year period examined, 78 laboratories received a principal sanction for a PT violation involving sample referral or result communication. During the same period, the number of laboratories in nonexempt states that would be expected to have participated in PT averaged 45 983. The interpretive meaning of the key terms intentional and referral, and the implications for sanctioned laboratories and their owners and operators are discussed. Applications of a principal sanction for a PT violation were rare during the period of this study. However, the consequences of the imposition of such a sanction are severe. Suggestions are offered on policies and practices to minimize the risk of a PT sample referral or result communication.