薮から棒に・・と思われるでしょうが、結構大事な話です。
肺炎を疑われる患者さんの喀痰が検査会社で培養に供された時に・・
もし、その患者の喀痰のみが1つの血液寒天培地で培養されるならば良いですが、
もし、その患者の喀痰と他の患者達の喀痰8人分全部が8等分された、ひとつの血液寒天培地にうえられたら・・
でも日本では、このようなとんでもないPracticeを制御するRuleが無いらしい・・（本当に）
クリア(CLIA-Clinical Laboratory Improvement Amendments)
クリアとは、「臨床検査改善修正法案」とよばれ、国家基準に基づくすべての小・中規模の臨床検査室の質を保証するために、1988年にアメリカで施行された法律です。現在ではアメリカのみならず、欧州でも施行されている優位な検査室認定プログラムの一つとして認知されています。
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm
Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
FDA
Categorizes tests based on complexity
Reviews requests for Waiver by Application
Develops rules/guidance for CLIA complexity categorization
CMS
Issues laboratory certificates
Collects user fees
Conducts inspections and enforces regulatory compliance
Approves private accreditation organizations for performing inspections, and approves state exemptions
Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
Publishes CLIA rules and regulations
CDC
Provides analysis, research, and technical assistance
Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
Conducts laboratory quality improvement studies
Monitors proficiency testing practices
Develops and distributes professional information and educational resources
Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)
肺炎を疑われる患者さんの喀痰が検査会社で培養に供された時に・・
もし、その患者の喀痰のみが1つの血液寒天培地で培養されるならば良いですが、
もし、その患者の喀痰と他の患者達の喀痰8人分全部が8等分された、ひとつの血液寒天培地にうえられたら・・
でも日本では、このようなとんでもないPracticeを制御するRuleが無いらしい・・（本当に）
クリア(CLIA-Clinical Laboratory Improvement Amendments)
クリアとは、「臨床検査改善修正法案」とよばれ、国家基準に基づくすべての小・中規模の臨床検査室の質を保証するために、1988年にアメリカで施行された法律です。現在ではアメリカのみならず、欧州でも施行されている優位な検査室認定プログラムの一つとして認知されています。
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm
Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
FDA
Categorizes tests based on complexity
Reviews requests for Waiver by Application
Develops rules/guidance for CLIA complexity categorization
CMS
Issues laboratory certificates
Collects user fees
Conducts inspections and enforces regulatory compliance
Approves private accreditation organizations for performing inspections, and approves state exemptions
Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
Publishes CLIA rules and regulations
CDC
Provides analysis, research, and technical assistance
Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
Conducts laboratory quality improvement studies
Monitors proficiency testing practices
Develops and distributes professional information and educational resources
Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)