Christian L E, Peddecord K M, Francis D P, Krolak J M
Graduate School of Public Health, San Diego State University, CA, USA.
Clin Lab Manage Rev. 1997 Nov-Dec;11(6):374-81.
CLIA '88 regulations require that laboratories evaluate and assure the competency of all personnel who perform laboratory tests. The study objective was to determine the interpretation of, compliance with, and implementation of these regulations by laboratories. Interviews were conducted with a stratified nonrandom sample of 20 laboratories including hospital, blood bank, commercial reference, physician office, group practice, and independent laboratories from 12 selected states. Information was collected about the history and development of their competency assessment programs and activities, their definition of competent staff, the interrelationship of competency assessment with performance appraisals, cost, benefits, and the assessment methods and tools used. Competence of laboratory personnel is a complex issue reflecting the dynamics and environment of each unique laboratory setting. This research found no consistent method of competency assessment implementation. This report provides a summary of methods and approaches. Learning what other laboratories are doing will assist managers in developing meaningful and cost-effective competency assessment programs. Documenting all competency assessment activities is important; it serves as a personnel performance management tool and satisfies inspectors. Used in the spirit of continuous quality improvement, the competency assessment program may point to ways of improving processes, personnel, and performance.
《1988年临床实验室改进修正案》规定，实验室要对所有从事实验室检测的人员的能力进行评估并确保其具备相应能力。本研究的目的是确定各实验室对这些规定的理解、遵守及执行情况。我们对来自12个选定州的20家实验室进行了分层非随机抽样访谈，这些实验室包括医院实验室、血库、商业参考实验室、医生办公室实验室、集团诊所实验室和独立实验室。收集了有关其能力评估计划和活动的历史与发展、对合格员工的定义、能力评估与绩效评估的相互关系、成本、效益以及所使用的评估方法和工具等方面的信息。实验室人员的能力是一个复杂的问题，反映了每个独特实验室环境的动态情况。本研究发现，能力评估的实施没有一致的方法。本报告总结了相关方法和途径。了解其他实验室的做法将有助于管理人员制定有意义且具有成本效益的能力评估计划。记录所有能力评估活动很重要；它可作为人员绩效管理工具并满足检查人员的要求。本着持续质量改进的精神使用能力评估计划，可能会指出改进流程、人员和绩效的方法。
