A Review of Regulations, Terminology, and Practical Approaches to Reportable Range Verification

被引：1
|
作者：
Xiao, Yi [1 ]
Chambliss, Allison B. [2 ]
机构：
[1] Childrens Hosp Los Angeles, Dept Pathol, Lab Med, Los Angeles, CA USA
[2] UCLA, Dept Pathol, Lab Med, David Geffen Sch Med, Los Angeles, CA 90095 USA
来源：
JOURNAL OF APPLIED LABORATORY MEDICINE | 2023年 / 8卷 / 04期
关键词：
LINEARITY;
D O I：
10.1093/jalm/jfad001
中图分类号：
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号：
1001 ;
摘要：
Background In the United States, federal regulations under CLIA '88 require reportable range verification of quantitative assays used for clinical purposes. Some accreditation agencies and other standards development organizations have their own additional requirements, recommendations, and/or terminologies relating to reportable range verification, leading to varying practices among clinical laboratories. Content Requirements and recommendations related to reportable range or analytical measurement range verification from different organizations are reviewed and compared. Optimal approaches to materials selection, data analysis, and troubleshooting are collated. This review clarifies key concepts and outlines various practical approaches to reportable range verification.
引用
收藏
页码：773 / 788
页数：16
相关论文
共 50 条
  • [21] Thresholds for domino effects and safety distances in the process industry: A review of approaches and regulations
    Alileche, Nassim
    Cozzani, Valerio
    Reniers, Genserik
    Estel, Lionel
    RELIABILITY ENGINEERING & SYSTEM SAFETY, 2015, 143 : 74 - 84
  • [22] A Practical Review on Linear and Nonlinear Global Approaches to Flow Instabilities
    Fabre, D.
    Citro, V.
    Sabino, D. Ferreira
    Bonnefis, P.
    Sierra, J.
    Giannetti, F.
    Pigou, M.
    APPLIED MECHANICS REVIEWS, 2018, 70 (06)
  • [23] Practical physical activity measurement in youth: a review of contemporary approaches
    Jerome N. Rachele
    Steven M. McPhail
    Tracy L. Washington
    Thomas F. Cuddihy
    World Journal of Pediatrics, 2012, 8 : 207 - 216
  • [24] Practical physical activity measurement in youth: a review of contemporary approaches
    Rachele, Jerome N.
    McPhail, Steven M.
    Washington, Tracy L.
    Cuddihy, Thomas F.
    WORLD JOURNAL OF PEDIATRICS, 2012, 8 (03) : 207 - 216
  • [25] Synthesising the shifting terminology of community health: A critiquing review of agent-based approaches
    Peters, Laura E. R.
    Kelman, Ilan
    Shannon, Geordan
    Tan, Des
    GLOBAL PUBLIC HEALTH, 2022, 17 (08) : 1492 - 1506
  • [26] Formal verification approaches and standards in the cloud computing: A comprehensive and systematic review
    Souri, Alireza
    Navimipour, Nima Jafari
    Rahmani, Amir Masoud
    COMPUTER STANDARDS & INTERFACES, 2018, 58 : 1 - 22
  • [27] Numerical Study of a Francis Turbine over Wide Operating Range: Some Practical Aspects of Verification
    Trivedi, Chirag
    Iliev, Igor
    Dahlhaug, Ole Gunnar
    SUSTAINABILITY, 2020, 12 (10)
  • [28] Performance based approaches in standards and regulations for smart ventilation in residential buildings: a summary review
    Guyot, Gaelle
    Walker, Iain S.
    Sherman, Max H.
    INTERNATIONAL JOURNAL OF VENTILATION, 2019, 18 (02) : 96 - 112
  • [29] Formulating a terminology for source document profiling through a literature review: from functionalist to documentational approaches
    Miyata, Rei
    PERSPECTIVES-STUDIES IN TRANSLATION THEORY AND PRACTICE, 2023, 31 (05): : 864 - 881
  • [30] Review of the Terminology, Approaches, and Formulations Used in the Guidelines on Quantitative Risk Assessment of Chemical Hazards in Food
    Domenech, Eva
    Martorell, Sebastian
    FOODS, 2024, 13 (05)
12345