Seabrook Jacqueline M, Hubbard Roger A
Molecular Pathology Laboratory Network, Maryville, Tenn, USA.
Arch Pathol Lab Med. 2003 Aug;127(8):978-83. doi: 10.5858/2003-127-978-AQRRAM.
Laboratories contemplating either the addition of new molecular tests or modifying methods approved by the Food and Drug Administration for human papillomavirus testing should be aware of a variety of procedural, performance, and regulatory issues surrounding such activity. Diagnostic medical laboratory testing in the United States is regulated by the Centers for Medicare and Medicaid Services, an agency formerly known as the Health Care Finance Administration. The regulatory vehicle of the Centers for Medicare and Medicaid Services is manifested in the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program has put into place specific regulations for laboratory quality control, which includes specific recommendations for method validation. Regulations that must be followed regarding personnel, quality control, quality assurance, method validation, and proficiency testing depend on the complexity category of the individual test. All molecular diagnostic tests, including those for human papillomavirus, are considered high complexity. The Centers for Medicare and Medicaid Services retains the authority to allow private, national accreditation organizations to "deem" that a laboratory is compliant with CLIA '88 requirements. Accreditation organizations, such as the Joint Commission for Accreditation of Hospitals, the Commission on Office Laboratory Accreditation, and the College of American Pathologists (CAP), as well as several state medical laboratory-accrediting agencies, possess the authority to deem laboratories as "CLIA-approved." The CAP, through its Laboratory Accreditation Program, has promoted standards for laboratory performance and method validation. In general, guidelines set forth in the CAP Laboratory Accreditation Program checklists specify that all clinical laboratory testing must essentially meet those requirements defined for high-complexity testing under CLIA '88, including test validation standards, reportable/reference ranges, performance criteria, and proficiency testing.
考虑增加新的分子检测项目或修改经美国食品药品监督管理局批准的人乳头瘤病毒检测方法的实验室，应了解围绕此类活动的各种程序、性能和监管问题。美国的诊断医学实验室检测由医疗保险和医疗补助服务中心监管，该机构前身为医疗保健财务管理局。医疗保险和医疗补助服务中心的监管手段体现在《临床实验室改进修正案》（CLIA）中。CLIA计划已制定了实验室质量控制的具体规定，其中包括方法验证的具体建议。关于人员、质量控制、质量保证、方法验证和能力验证必须遵循的规定取决于单个检测的复杂程度类别。所有分子诊断检测，包括人乳头瘤病毒检测，都被视为高复杂性检测。医疗保险和医疗补助服务中心保留允许私营的全国认可组织“认定”实验室符合CLIA '88要求的权力。认可组织，如医院联合评审委员会、办公室实验室评审委员会和美国病理学家协会（CAP），以及几个州的医学实验室认可机构，都有权将实验室认定为“CLIA认可”。CAP通过其实验室认可计划，推动了实验室性能和方法验证的标准。一般来说，CAP实验室认可计划清单中规定的指南明确指出，所有临床实验室检测必须基本符合CLIA '88规定的高复杂性检测要求，包括检测验证标准、报告/参考范围、性能标准和能力验证。
