Introducing Comprehensive Educational Guides on Updated CLIA Proficiency Testing Regulations

Home - Educational Guides

Introducing Comprehensive Educational Guides on Updated CLIA Proficiency Testing Regulations

We are thrilled to present two educational guides that delve into the newly updated minimum performance specifications for Proficiency Testing by CLIA (Clinical Laboratory Improvement Amendments). These regulations, set to be implemented by 2024, aim to enhance the accuracy and reliability of test results in clinical laboratories. Here, we introduce these invaluable resources designed to assist laboratories in navigating the evolving landscape of proficiency testing.

1. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Microbiology):

Our first guide focuses on the specific regulations and requirements pertaining to microbiology proficiency testing. With a comprehensive exploration of these guidelines, this guide is a useful resource for microbiology labs striving to ensure precision and integrity in their testing procedures. From the required categories of testing to maintaining optimal testing conditions, the guide details the updates that promote adherence to the highest standards of quality and safety.

2. Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Non-Microbiology):

For non-microbiology laboratories, our second guide delves into the updated proficiency testing regulations concerning various analytes. From chemistry to haematology, molecular diagnostics to immunology, this guide offers a comprehensive overview of the new requirements and minimum performance specifications. By embracing these regulations, medical laboratories can uphold the utmost accuracy and reliability in their test results, ensuring optimal patient care and clinical decision-making.

Elevating Laboratory Practices:

These educational guides are indispensable tools that empower laboratories to navigate the changing landscape of proficiency testing regulations. By staying informed and adopting the updated minimum performance specifications, laboratories can maintain compliance, demonstrate excellence, and ultimately deliver the highest quality of care to their patients.

Accessing the Guides:

We invite you to access these comprehensive educational guides by following the link provided below. They offer a wealth of knowledge and practical insights, serving as essential references for laboratory professionals, quality managers, and anyone involved in clinical diagnostics.

Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Microbiology)

Proficiency Testing Regulations Related to Analytes and Acceptable Performance – A Final Rule (Non-Microbiology):

With the implementation of updated CLIA proficiency testing regulations on the horizon, these educational guides come at a crucial time. By embracing the knowledge and guidance they provide, laboratories can navigate the changing landscape with confidence and ensure their adherence to the highest standards of proficiency testing. Together, let’s strive for excellence, precision, and patient-centric care in clinical laboratory practices.

#CLIARegulations #ProficiencyTesting #ClinicalLaboratories #QualityAssurance #PatientCare

Microbiology

Non-Microbiology


Randox Biosciences Resource Hub

Resource Hub | Biosciences

  • Brochures
  • Flyers
  • Videos

Biosciences overview

Immunology

Molecular Testing

CDx & Biopharma Services

Cardiovascular & Metabolic

Biosciences Bioreagents

Biosciences Overview Video

Drug Induced Kidney Injury panel

STI Campaign Video

Biochip Overview

Randox Multiplex Stroke Biochip

Acute Kidney Injury

Randox Coronavirus Biochip Video


Vivalytic Resource Hub

Vivalytic | Resource Hub

Making a Point to Care

 

  • Brochures
  • Flyers
  • Videos
  • Scientific Papers

Vivalytic

VIVALYTIC MG, MH UP/UU Educational Guide

VIVALYTIC MRSA/SA Educational Guide

Vivalytic Overview

Discover more about the Vivalytic

 

 

SARS-CoV-2 Dual Target, Flu A/B and RSV

SARS-CoV-2 Dual Target

Viral Respiratory Infection Array

Sexually Transmitted Infection Array

SARS-CoV-2 Pooling Test

MG, MH, UP/UU Rapid Test

SARS-CoV-2 Rapid Test

MRSA & MSSA Rapid Test

Randox Vivalytic

Vivalytic Installation & Operator User Guide

Vivalytic: Instructional Promo Video

Vivalytic: COVID-19 Testing Process

Coronavirus Testing on the Vivalytic POC Analyser

EVALUATION OF A MULTIPLEX REAL-TIME PCR ASSAY FOR THE DIAGNOSIS OF SEXUALLY-TRANSMITTED INFECTIONS

RAPID AND ACCURATE DETECTION OF MYCOPLASMATACEAE IN CLINICAL SAMPLES


Randox QC Resource Hub

  • Brochures
  • Support Tools
  • Educational Items
  • Posters
  • Industry Articles
  • Webinars
  • Videos
  • Blog
  • Testimonials
The importance of third party controls brochure on the Randox Resource hub

Importance of Third Party Controls

Infectious Disease Controls (Serology)

Acusera Linearity Sets

IQC - Liquid 30 Day Controls

RIQAS External Quality Assessment

RIQAS Point of Care (RIQAS POC)

Qnostics - Molecular Infectious Disease Controls

QCMD - EQA for Molecular Infectious Disease Testing

International Brochures

Download our brochures in other languages

Serum Indices

The Role of Six Sigma in a Modern QC Strategy

The Cost of Poor Quality in the Clinical Laboratory

How to Establish QC Reference Ranges

Basic QC Statistics

ISO 15189 Requirements for Measurement Uncertainty

Commutability

The Role of EQA in QC

Troubleshooting QC Errors

What Format Is Best For Your Laboratory - Download

What Format Is Best For Your Laboratory

Quality Control for POCT - Download

Quality Control for POCT

Importance of Third Party Controls in Molecular Infectious Disease Testing

Designing An Appropriate QC Design Procedure

Which QC is The Right QC - Downloads

Which QC is The Right QC

How Often Is Right For QC - Download

How Often Is Right For QC

QC Statistics Infographic - Download

QC Statistics Infographic

The Difference Between IQC & EQA - Download

The Difference Between IQC & EQA

Linearity Verification Clinical Chemistry - Download

Linearity Verification Clinical Chemistry

Linearity Verification Cardiac - Download

Linearity Verification Cardiac

Using QC Multi-rules - Download

Using QC Multi-Rules

Preparing QC - Step-by-Step Guide - Download

Preparing QC - Step-by-Step Guide

Monitoring EQA Performance - Download

Monitoring EQA Performance

Guide to Running QC - Download

Guide to Running QC

RIQAS Frequency - Lipase

RIQAS Past Panels Flyer

Measurement Uncertainty in the Clinical Laboratory – Medical Buyer

Measurement Uncertainty in the Clinical Laboratory – Medical Buyer

Using Sigma metrics and Measurement Uncertainty in QC – MLO

Using Sigma metrics and Measurement Uncertainty in QC – MLO

RIQAS Report Interpretation

Importance of Third Party Controls in Molecular Diagnostics

Fully syndromic approach to molecular testing

Performance & Statistics - How EQA Can Help You Excel

The Role of EQA in QC Management

Importance of EQA

Why is the third party QC important for COVID-19 detection in Molecular testing

The Need for Robust Molecular Quality Assurance in the Wake of the Pandemic

RIQAS Reporting

Utilisation of QC Software for Identification of Performance Issues

Medlab- 24.7 Webinar with Patrick Else

SARS-CoV-2 Proficiency Testing

Acusera 24•7 Webinar: Utilisation of QC software and metrics to help identify performance issues

Acusera Third Party Controls

True Third Party Controls

Randox Acusera Quality Controls

Consolidation

QC Serology Video

Acusera 24.7 Live Online

Guide to Running Quality Control

Medical Lab Professionals Week 2016

Acusera 24•7 Interlaboratory Data Management

Acusera 247 Video

Customer Testimonial | Adrian Cudmore NHS

Customer Testimonial | DR Caje Moniz NHS

Customer Testimonial | Dr Rosa Sierra Amor

Customer Testimonial | Dr Bianca Thakkar

Customer Testimonial | Dr. Anil Shah

Customer Testimonial | Dr Pragati Desai

Customer Testimonial | Dr Pramod Ingale

Customer Testimonial | Dr Rajeev Mehta

Customer Testimonial | Dr Simple Bhuptani

Customer Testimonial | Dr SM Patel

Customer Testimonial | Dr Trupti Patel

Customer Testimonial | Dr A Vahed Mulla


Evidence Series Resource Hub

Evidence Series | Resource Hub

  • Brochures
  • Flyers
  • Videos
  • Blogs
  • Scientific Posters
  • Whitepapers

Evidence

Evidence Investigator

Evidence MultiSTAT

Evidence+

Evidence Evolution

Biochip Technology Explained

Evidence series Overview

Discover more about the Evidence series

 

Cytokines Flyer

DIKI Renal Flyer

A4 Renal Flyer

AKI Covid-19 Flyer

Evidence Investigator - Molecular Diagnostic Testing

Evidence MultiSTAT Demonstration

Evidence Evolution - World's Most Advanced Immunoanalyser

Evidence Investigator - Myco 9 Array, Step By Step

DEVELOPMENT OF A BIOCHIP ARRAY FOR THE SIMULTANEOUS DETECTION OF CANCER BIOMARKERS ON THE RANDOM ACCESS, FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER

DEVELOPMENT OF A DUPLEX BIOCHIP ASSAY FOR THE SIMULTANEOUS DETECTION OF ANTI-THYROGLOBULIN AND ANTI-THYROID PEROXIDASE ANTIBODIES ON THE FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER

DEVELOPMENT OF NEW BIOCHIP ARRAYS FOR THE DETERMINATION OF BIOMARKERS RELATED TO ACUTE KIDNEY INJURY APPLIED TO THE EVIDENCE INVESTIGATOR ANALYSER

DEVELOPMENT OF A NEW BIOCHIP BASED IMMUNOASSAY FOR THE DETECTION OF PARATHYROID HORMONE APPLIED TO THE EVIDENCE EVOLUTION ANALYSER

DEVELOPMENT OF A HIGHLY MULTIPLEXED MOLECULAR ASSAY FOR DETECTION OF INFECTION IN CF AIRWAYS

Repeatability and within-laboratory precision were assessed (n=80): Assay Repeatability Within-laboratory precision CV (%) CV (%) VCAM-1 4.5 6.8 ICAM-1 5.6 8.8 ESEL 12.8 16.6 PSEL 3.5 4.7 LSEL 5.7 8.2 17.096, 097.105RDRT DEVELOPMENT OF A BIOCHIP ARRAY FOR THE DETECTION OF ADHESION MOLECULES ON THE NEW RANDOM ACCESS FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER

DEVELOPMENT OF A NEW BIOCHIP BASED IMMUNOASSAY UNAFFECTED BY DHEA-S INTERFERENCE FOR THE ACCURATE MEASUREMENT OF SERUM PROGESTERONE

DEVELOPMENT OF A BIOCHIP ARRAY FOR THE RAPID, SIMULTANEOUS DETECTION OF PEPSINOGEN I, PEPSINOGEN II AND GASTRIN 17, ON THE NEW RANDOM ACCESS, FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER

CLINICAL EVALUATION OF A RAPID FULLY-AUTOMATED MULTIPLEX BIOCHIP ARRAY FOR STROKE DIAGNOSIS

DEVELOPMENT OF A NEW BIOCHIP ARRAY APPLIED TO THE NEW RANDOM ACCESS FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER FOR THE SIMULTANEOUS MEASUREMENT OF TSH, FREE T4 AND FREE T3

DEVELOPMENT OF A NEW BIOCHIP BASED IMMUNOASSAY FOR THE MEASUREMENT OF TOTAL 25-HYDROXYVITAMIN D IN SERUM AND THE ACCURATE CLASSIFICATION OF VITAMIN D STATUS

DEVELOPMENT OF A BIOCHIP ASSAY FOR THE DETECTION OF THYROXINE-BINDING GLOBULIN (TBG) ON THE NEW RANDOM ACCESS FULLY AUTOMATED EVIDENCE EVOLUTION ANALYSER

GENETIC DIAGNOSIS OF MONOGENIC OR POLYGENIC FAMILIAL HYPERCHOLESTEROLEMIA IN NORTHERN IRELAND: EVALUATION OF THE RANDOX FH ARRAYS IN COMBINATION WITH THE RANDOX 6SNP POLYGENIC HYPERCHOLESTEROLEMIA ARRAY

DEVELOPMENT OF A BIOCHIP ARRAY FOR THE SIMULTANEOUS MEASUREMENT OF DISTINCT FATTY ACID-BINDING PROTEINS (FABPs)

DEVELOPMENT OF A NEW ENZYME-LINKED IMMUNOSORBENT ASSAY KIT TO DETECT NGAL IN HUMAN SERUM AND ITS APPLICATION TO CHRONIC KIDNEY DISEASE

SCREENING AND SELECTION OF ANTIBODIES FOR THE DETECTION OF MIP-1 ALPHA AND ITS APPLICATION TO THE STUDY OF CHRONIC KIDNEY DISEASE

DEVELOPMENT OF A 4-PLEX BIOCHIP ARRAY FOR THE EARLY DETECTION OF CHRONIC KIDNEY DISEASE

DEVELOPMENT OF A THIRD GENERATION TSH ASSAY ON THE NEW RANDOM ACCESS EVIDENCE EVOLUTION FULLY AUTOMATED BIOCHIP ANALYSER

APPLICATION OF THE NEW RANDOM ACCESS, FULLY AUTOMATED BIOCHIP ANALYSER EVIDENCE EVOLUTION TO SIMULTANEOUSLY MEASURE ANALYTES RELATED TO ENDOCRINE FUNCTION

STRATIFYING RISK OF ACUTE KIDNEY INJURY IN PRE AND POST CARDIAC SURGERY PATIENTS USING A NOVEL BIOMARKER-BASED ALGORITHM AND CLINICAL RISK SCORE

SARS-CoV-2 Vascular & Multi-System Dysfunction

Acute Kidney Injury and Antimicrobial Stewardship


Linearity Verifier Sets

Contact Us

Challenge your Instrument Throughout the Reportable Range with Acusera Linearity Verifier Sets

  • null
    Complimentary data reduction software is provided delivering an immediate indication of performance.
  • null
    Samples are provided in a user-friendly format with both liquid and lyophilised options available.
  • null
    An extended open vial stability keeps waste to a minimum and ensures availability of product for troubleshooting.
  • null
    Supplied in a minimum of 5 levels to accurately challenge the AMR and remove the need for manual dilution.
  • null
    Ensure specific instrument requirements are met with the availability of dedicated solution for both Roche Cobas and Beckman systems.
  • null
    Multi-analyte calibration verifiers will reduce costs, storage space and the number of products required to cover your test menu.
Solutions for Roche Cobas Analysers

 

Solutions for Beckman Analysers

 

Calibration verification or linearity assessment is defined as the testing of materials of known concentration in the same manner as patient specimens to ensue the test system is accurately measuring samples throughout the reportable range.

CLIA recommend calibration verification once every six months and/or in the event of; a reagent lot change, major preventative maintenance, replacement of critical parts, when QC materials are outside acceptable limits or reflect an unusual trend and as part of new instrument validation.

Our Acusera range of instrument dedicated verifiers are designed to challenge the entire analytical measuring range whilst helping to meet the CLIA requirements. Our range covers Clinical Chemistry, Bilirubin, Apolipoproteins, Enzymes, CRP, Esoterics, Lipids, TDM‘s and more.

Quality Control

Resource Hub

Contact Us


Randox Reagents Resource Hub

Resource Hub | Reagents

  • Brochures
  • Featured Reagents
  • Blogs
  • Webinars
  • Educational Items
Reagents Brochure

Reagents Brochure

Superior Performance & Unique Tests

Veterinary Diagnostic Solutions Brochure

Veterinary Diagnostic Solutions

Diabetes Portfolio Brochure

Diabetes Portfolio

Antioxidants Brochure

Antioxidants

Cardiology & Lipid Testing Brochure

Cardiology & Lipid Testing

Total Bile Acids Flyer

Total Bile Acids (5th Generation)

Specific Proteins Brochure

Specific Proteins

sdLDL-C Flyer

sdLDL-C

sdLDL-C Flyer

sdLDL-C (USA ONLY)

Reagents Brochure

Reagents Brochure - Spanish

Reagents Brochure

Reagents Brochure - French

Reagents Brochure

Reagents Brochure - Portuguese

Reagents Brochure