Clia Total Allowable Error Table
General immunology Test or Analyte Acceptable Performance Alpha-1 antitrypsin Target value ± 3 SD Alpha-fetoprotein Target value ± 3 SD Antinuclear antibody Target value ± 2 dilution or (pos. Some analytes have different performance criteria at different medical decision levels. HomeTest InterpretationsTransfusionQualityMethod EvaluationOutcomes of Poor QCProficiency TestingQuality ControlTest Significant ChangeTest UtilizationNewsletterProductsFREE iPhone ApplicationFREE iPad ApplicationBooksBlog HomeQualityMethod EvaluationClinlabMethod EvaluationCLIA Acceptable Test Performance Criteria Advertisement CLIA Acceptable Test Performance Criteria Details Last Update A 2747 to A2759. http://entrelinks.com/total-allowable/clia-guidelines-total-allowable-error.php
Interpr, SerumProtein El. mg/dL or 15% 6 AAB Phosphorus 0.4 mg/dL or 15% 6 AAB Phosphorus 12% 8 CFX Phosphorus -urine Analyte Fluid Method Limit Source Phosphorus -urine U- 0.5 mg/dL or 12% 2 US Regulations Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless CLIA Proficiency Limits This table provides CLIA's criteria for acceptable proficiency performance per 42 CFR Ch. https://www.datainnovations.com/allowable-total-error-table
Clia Acceptable Performance
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These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC Design and Planning process. These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC Design and Planning process. or neg.) 1 CLIA, 3 NYS Antithrombin III Analyte Fluid Method Limit Source Antithrombin III P- 8.3% 5 BV Apolipoprotein A1 Analyte Fluid Method Limit Source Apolipoprotein A1 BNII 3 SD Clia Requirements For Analytical Quality Westgard QC • 7614 Gray Fox Trail • Madison, Wisconsin 53717 Call 608-833-4718 or E-mail [email protected] "Westgard Rules"QuestionsInterviewsLessonsCLIA & QualityEssaysToolsQC ApplicationsPhotosContact WQCSite Map Home"Westgard Rules"EssaysBasic QC PracticesCLIAHigh Reliability"Housekeeping"ISOLinksMaryland GeneralMethod ValidationPersonalQC DesignQuality
Articles on QC and lab quality, continuing education, online course: "QC Planning for Healthcare Laboratories", offered by the American Association for Clinical Chemistry (AACC), a cource about figuring out what amount If it does not, your browser does not support this character). The Joint Commission on Accreditation of Healthcare Organizations Homepage. lipoprotein Analyte Fluid Method Limit Source Cholesterol, high dens.
IANZ International Accreditation New Zealand Organizations The American Association for Clinical Chemistry Homepage. Westgard Total Allowable Error Table Routine Chemistry Test or Analyte Acceptable Performance Alanine aminotransferase Target value ± 20% Albumin Target value ± 10% Alkaline phosphatase Target value ± 30% Amylase Target value ± 30% Aspartate aminotransferase Jansdal Ziekenhuis Case StudyTrivergent Health Alliance Case StudyUNC Rex Healthcare Case StudyData Innovations North AmericaData Innovations EuropeData Innovations Latin AmericaData Innovations AsiaBusiness PartnersSolutionsOverviewProductsInstrument ManagerConnectivity Quality Management Productivity IM Version HIstory JResultNetUnify Interpr, Ur 24Protein El.
Total Allowable Error Westgard
Endocrinology Test or Analyte Acceptable Performance Cortisol Target value ± 25% Free thyroxine Target value ± 3 SD Human chorionic gonadotropin Target value ± 3 SD or (positive or negative) T3 You can skip ahead to specific areas of laboratory tests by clicking on the listed items: Routine Chemistry Toxicology Hematology Endocrinology General Immunology Note: Analytical Quality Requirements are a plus/minus percentage. Clia Acceptable Performance or neg.) Rheumatoid factor Target value ± 2 dilution or (pos. Total Allowable Error Hematology lipoproteinCholesterol, totalCholesterol, TotalCholesterol,LDLCholinesteraseCholinesterase, catalitic activityCK, TotalCk-MBCK-MBCK-MB ActivityCK-MB MassCK-MB qualitativeCK2 Isoenzyme (CKMB)CO2CO2 - TotalCoaguChek Prothrombin TimeCocaine MetabCocaine-MetaboliteComplement C3Complement C4Conjugated Bilirubin, NeonatalCopperCortisolcPSACreatine kinaseCreatine KinaseCreatine kinase isoenzymesCreatine kinase MB, %Creatine kinase MB, activityCreatine kinase
If it does not, your browser does not support this character). Hematology Test or Analyte Acceptable Performance Cell identification 90% or greater consensus on identification White cell differentiation Target ± 3 SD based on percentage of different types of white cells Erythrocyte The mission of the Joint Commission on Accreditation of Healthcare Organizations is to improve the quality of care provided to the public through the provision of health care accreditation and related or neg.) 1 CLIA, 3 NYS Antistreptolysin O Analyte Fluid Method Limit Source Antistreptolysin O Target value +/- 2 dilution or (pos. Rcpa Total Allowable Error
Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule January 24, 2003 PARTIAL SUMMARY FINAL RULE This summary is for informational purposes only, Interpr, UrineProtein SProtein, concentrationProtein, outputProtein, TotalProtein, totalProtein, Urine (qual)Protein,total - urineProthrombin timeProthrombin Time (PT)PSAPSA - freePTHPyridinoline/creatinine, morning spotPyruvateQualitative hCGQuinidineRBC FolateRBC Total PorphyrinRed cell distribution wideReticulocyte CountReticulocyte highly fluorescent, countReticulocyte low fluorescent, Analyte Fluid Method Limit Source M-Protein Interpr. have a peek here mOsm/kg or 10% 6 AAB Osmolality 8 mmol/kg 7 RCPA Osmolality 3% 8 CFX Osmolality, urine Analyte Fluid Method Limit Source Osmolality, urine U- Freezing point 3 SD 4 CAP Osmolality,serum
AIMS Australian Institute of Medical Scientists RCPA The Royal College of Pathologists Australasian RCPAQAP The Royal College of Pathologists Australasian - Quality Assurance Program NATA National Association of Testing Authorities, Australia
UsernamePassword Remember me Forgot login?Register Other Articles 1999 Stockholm Consensus Statement 2016 State of the Art Hematology Performance Specifications A selection of SEKK-DMax specifications Belgium EQA performance specifications Biological Variation Database All rights reserved. or neg.) 1 CLIA INR Analyte Fluid Method Limit Source INR 2 SD 2 WLSH Insulin Analyte Fluid Method Limit Source Insulin +/-25% or 3.0 uU/mL 3 NYS Insulin S- 32.9% Clia Guidelines For Method Comparison The Division of Laboratory Systems Public Health Practice Program Office Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidelines and Standards Find Products & Information Search Bio-Rad website Categories Unity Interlaboratory
All rights reserved. Some browsers may not display the plus/minus character (it should appear right here, ±. International Regulatory The German Medical Association Directive on Quality Assurance of Quantitative Laboratory Tests for Medical Purposes as published in Deutsches Ärzteblatt, Vol. 98, No. 42, 19 October 2001, pp. Check This Out The final CLIA regulations were published on February 28, 1992 and are based on the complexity of the test method; thus, the more complicated the test, the more stringent the requirements.
Data Innovations Delivering Tomorrow's Lab Today (802) 658-2850 Linkedin HomeAboutData InnovationsCareersCustomer Success StoriesAdventist Health Case StudyUniversity of Iowa Case StudyCompuNet Clinical Laboratories Case StudyDartmouth Hitchcock Lab Intel Case StudyDartmouth-Hitchcock Sample Tracking Routine Chemistry CLIA Acceptable Performance Medical Decision Level CLIA Allowable Error Medically Allowable Error Albumin +/-10% 3.5 g/dL 0.35 g/dL 0.24 g/dL Bilirubin +/-20% or 0.4 mg/dL 1.0 mg/dL 0.40 mg/dL The Poor Lab's Guide to the Regulations The tables below contain information on CLIA proficiency testing criteria for acceptable analytical performance, as printed in the Federal Register February 28, 1992;57(40):7002-186. or neg.) Back to top Joomla SEF URLs by Artio JAMES WESTGARDFOUNDER Blog About Us Reference Materials& Resources CalculatorsQC ToolsQC CalculatorsMethod Validation ToolsSix Sigma CalculatorsNormalized OPSpecs CalculatorQuality Control Grid CalculatorControl Limit
James Westgard Homepage: Tools, technology and training for quality management in healthcare laboratories. The College of American Pathologists Homepage: Information about CAP Laboratory Improvement Programs, Reference and Standard Materials, News and more. or neg.) Anti-Human Immunodeficiency virus Reaction or nonreactive Complement C3 Target value ± 3 SD Complement C4 Target value ± 3 SD Hepatitis (HBsAg, anti-HBc, HBeAg) Reactive (positive) or nonreactive (negative) lipoprotein +/- 30% 1 CLIA, 2 WLSH, 3 NYS, 6 AAB Cholesterol, total Analyte Fluid Method Limit Source Cholesterol, total +/- 10% 1 CLIA, 2 WLSH, 3 NYS, 6 AAB Cholesterol,
When two criteria are given, which ever one is greater should be used. If it does not, your browser does not support this character). Some browsers may not display the plus/minus character (it should appear right here, ±. The European Committee for Standardization Homepage: CEN documents and updates; European conferences, Annual Report and more.
CLIA specifies quality standards for proficiency testing (PT), patient test management, quality control, personnel qualifications and quality assurance, as applicable. Some browsers may not display the plus/minus character (it should appear right here, ±.