MMWR Recomm Rep. 1997 Dec 19;46(RR-17):1-19.
The Papanicolaou test--or Pap smear test--is one of the most effective cancer screening tests available, and its ability to detect premalignant conditions has contributed to the decline in cervical cancer morbidity and mortality in the United States since its development in 1941. The success of this screening test has created confidence among women, health-care providers, and public health officials. However, this screening tool is not perfect: false-negative findings are a special concern because they can delay necessary follow-up of and treatment for women who have cervical cancer precursor lesions or invasive cervical cancer. Recent media attention has focused on cytology laboratories that have been closed as a result of deficiencies (including a high proportion of false-negative reports), and in some states legal action has been taken against individual laboratories. With the advent of revised federal regulations implementing the Clinical Laboratory Improvement Amendments (CLIA) of 1988, scrutiny of the quality of cytology laboratory practice has increased. Between 1992 and 1994, a total of 10 cytology laboratories were closed by regulatory action of the Health Care Financing Administration because they were considered a threat to the public's health. Although such closures represent <1% of CLIA-certified cytology laboratories, the attendant publicity may trigger anxiety among women. Public health officials must respond to those concerns with appropriate clinical and community actions to ensure the health and safety of women whose Pap smears were evaluated by the closed laboratories. There are no published recommendations to help develop a public health response to the regulatory closure of a cervical cytology laboratory. In April 1994, the Association of State and Territorial Public Health Laboratory Directors, through a cooperative agreement with CDC, convened a working group to provide background on the current practice of clinical cervical cytology in the United States, summarize the CLIA regulations that established specific quality assurance standards for this specialty, and recommend actions that a public health agency may initiate to deliver a measured response to laboratory closings and other regulatory sanctions. This report includes this background and summary of the workshop. The working group made three recommendations: (a) public health officials should plan for a cervical cytology laboratory closure, then, when a laboratory is closed by regulatory action, they should (b) assess the severity of the situation and determine an appropriate response and (c) provide accurate, timely information to the public.
巴氏试验（即宫颈涂片检查）是现有的最有效的癌症筛查测试之一。自1941年发明以来，其检测癌前病变的能力促使美国宫颈癌的发病率和死亡率有所下降。这项筛查测试的成功让女性、医疗服务提供者及公共卫生官员都信心十足。然而，这个筛查工具并非完美无缺：假阴性结果尤其令人担忧，因为这可能会延误对患有宫颈癌前病变或浸润性宫颈癌的女性进行必要的后续检查和治疗。最近，媒体关注的焦点是那些因存在缺陷（包括假阴性报告比例过高）而被关闭的细胞学实验室，在一些州，已对个别实验室采取了法律行动。随着1988年《临床实验室改进修正案》（CLIA）修订后的联邦法规的出台，对细胞学实验室操作质量的审查力度加大。1992年至1994年间，共有10家细胞学实验室因医疗保健财务管理局的监管行动而被关闭，因为它们被认为对公众健康构成威胁。尽管此类关闭的实验室占获得CLIA认证的细胞学实验室的比例不到1%，但其引发的宣传报道可能会引发女性的焦虑情绪。公共卫生官员必须通过适当的临床和社区行动来回应这些担忧，以确保那些巴氏涂片由被关闭实验室评估的女性的健康和安全。目前尚无已发表的建议来帮助制定针对宫颈细胞学实验室监管关闭的公共卫生应对措施。1994年4月，州和地区公共卫生实验室主任协会通过与疾病控制和预防中心的合作协议，召集了一个工作组，以提供美国临床宫颈细胞学当前实践的背景信息，总结为该专业制定特定质量保证标准的CLIA法规，并建议公共卫生机构可能采取的行动，以便对实验室关闭及其他监管制裁做出适度回应。本报告包含了此次研讨会的背景信息和总结内容。该工作组提出了三项建议：（a）公共卫生官员应针对宫颈细胞学实验室关闭制定预案，然后，当一家实验室因监管行动被关闭时，他们应（b）评估形势的严重性并确定适当的应对措施，以及（c）向公众提供准确、及时的信息。
