Introducing Comprehensive Educational Guides on Updated CLIA Proficiency Testing Regulations

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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


Acusera 24.7 – Interlaboratory Data Management Reporting Software

Acusera 24•7 is a live, cloud based interlaboratory data management and peer group reporting software, intended to assist in the management of daily QC activities.

Designed to complement our range of Acusera true third party controls.

Key Benefits of Acusera 24•7

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Peer Group Statistics

Updated live in real-time, labs can compare statistics to their peers and identify any unique or widespread issues to help reduce time and money spent on troubleshooting.

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Fully Interactive Charts

Ability to compare performance, assess trends and monitor performance with automatically generated Levey-Jennings, Histograms and Performance Summary Charts.

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Highly Flexible

Labs can configure their own performance limits, multi-rules, consensus groups and target values for each instrument or lot of QC.

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Comprehensive Reports

Comprehensive, easy-to-read and customisable reports have been designed to speed up the review process and include Statistical Metrics, Uncertainty of Measurement, Exception & more.

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24/7 Access

Gain access to this cloud-based software at anytime, anywhere. Removing the need installation, software maintenance and frequent back-ups.

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Advanced Statistical Analysis

Automatically calculating advanced statistics including %Bias, Total Error and Sigma Metrics helps enhance performance assessment, improve QC strategy, and meet regulatory requirements.

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Unique Dashboard Interface

Reduce time spent analysing data as instant identification of any QC failures over the past 7 days and alerts of product expiry are highlighted in the unique dashboard design.

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Automated Data Import

Upload QC data directly to Acusera 24•7 via LIMS and middleware. This automated function eliminates the need for manual data entry and helps save money whilst increasing efficiency.

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Technical Support

Expert technical support is available for users. Laboratories can access this service for troubleshooting purposes and therefore eliminates the need for on-site assistance.

Features of Acusera 24•7

  • Home Screen
  • Comprehensive Reports
  • Interactive Charts
  • Daily Data Review
  • Preview Mode
  • Results Entry
Computer screen with Acusera 24.7 the interlaboratory data management system

The fast, intelligent user interface on 24•7 enables rapid review of QC data and QC failures, reducing the time spent analysing and identifying errors.

The new and improved home screen allows users to carry out tasks such as: Creation of new tests/panels | Filtering results by analyte/ instrument/ lot number | Entering single or several QC test(s) without having to navigate away to multiple areas within the application.

Computer screen with a statistical analysis report from Acusera 24.7 the interlaboratory data management system

Specifically designed to speed up the review process, our comprehensive range of easy-to read reports include: Data Review | Exception Report | Statistical Analysis Report | Statistical Metrics Report

Customise reports to show data for a specific date range aswell as a particular test or instrument.

Computer screen with a Levey Jennings Chart from Acusera 24.7 the interlaboratory data management system

Instant access to interactive Levey-Jennings, Histogram and Performance Summary Charts as well as the ability to add events and multiple data sets to a single chart allows for swift performance monitoring and superior identification of trends across multiple instruments.

One location for all of your statistical analysis needs.

 

The enhanced data review screen on 24•7 allows users to review all QC results within a 7-day date range.

Reviewing all QC results and not just violations on a daily basis provides greater control of any potential issues occurring before they become widespread.

Preview mode on 24•7 allows users to recall the assay and instrument configurations used to create each QC test directly from the home screen.

Direct access into: Results Entry | Charts | Data Entry | QC Test Configuration | Assay Configuration for a single test, from any area in the application

Computer screen with a data review from Acusera 24.7 the interlaboratory data management system

New toggle feature allows users to set whether they are entering single or summarised results.

Reducing the number of fields for single result entry and therefore keystroke tabbing, allowing for greater ease-of-use.

Resources

We Are Here To help

To learn more about how 24•7 works as an interlaboratory data management system/ peer group reporting software. Or, to see the software in action, click below or visit our video demonstrations now.

 

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Acusera 24•7 FAQs

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Neonatal Bilirubin External Quality Assessment

The RIQAS Neonatal Bilirubin EQA programme has been designed to assess the performance of total and direct bilirubin assays with levels tailored to neonatal bilirubin testing.

  • Lyophilised for enhanced stability
  • Monthly reporting
  • Human based serum
  • Submit results and view reports online via RIQAS.net
  • Rapid turnaround of reports allows for any necessary corrective actions to be taken with minimal disruption to laboratory output

Not accredited to ISO/IEC 17043

Cat NoKit SizeFrequencyCycle StartParameters
RQ91912 x (6x3ml)MonthlyJuly2

Parameter

  • Direct Bilirubin
  • Total Bilirubin

Please note, product availability may vary country to country.


Randox International Quality Assessment Scheme (RIQAS)

RIQAS is the world’s largest External Quality Assessment scheme with more than 75,000 laboratory participants spanning over 138 countries.

Key Benefits of RIQAS

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Cost Effective

Consolidate EQA analysis, reduce workload and costs with our comprehensive, multi-parameter programmes.

Flexible

Flexible Programme Options

Flexible programme options are available to suit all laboratory budgets. The option to register up to five instruments per programme (volume permitting) at no extra cost for comparative performance assessment

Highly Accredited

Accredited

RIQAS is accredited to ISO/IEC 17043:2010 “Conformity Assessment – General Requirements for Proficiency Testing” which is accepted by national and international accreditation bodies. Please see accreditation schedule for additional information.

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Expansive Peer Group Database

The availability of large peer groups ensures robust data is available for a wide range of instruments and methods.

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Rapid, User-Friendly Reports

Our rapid, user-friendly reports allow at-a-glance performance assessment. Complimentary multi-instrument, inter-laboratory and end-of-cycle reports are also available.

Commutable

Commutable Samples

A commutable sample matrix increases confidence that performance mimics that of patient samples.

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Early Identification of Test System Errors

Frequent reporting allows early identification of test system errors, while our 72 hour report turnaround enables corrective action to be taken with minimum disruption to the lab.

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Convenient Data Upload System

RIQAS.net is a convenient, web-based data entry system which allows participants to return results and view reports online.

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High Quality Samples

EQA samples are manufactured to the highest quality standard and span clinically relevant levels.

RIQAS EQA Programmes

Choice & flexibility are guaranteed with our 36 programme portfolio.

Browse the programmes below

 

RIQAS EQA Reports

User-friendly, one-page per parameter reports allow for at-a-glance performance assessment.

Browse the reports below.

What Does RIQAS Provide?

The benefits of Randox Riqas as an external quality assessment

RIQAS Calendar 2024

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RIQAS Brochure

RIQAS Parameters

RIQAS.net

RIQAS Calendar

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RIQAS Past Panels

RIQAS (Randox International Quality Assessment Scheme) is the largest global EQA scheme with over 50,000 participants in more than 139 countries. Our range currently comprises 36 programmes and the majority of clinical testing.

What are RIQAS Past Panels?

Stemming from RIQAS, the world’s largest External Quality Assessment programme, RIQAS Past Panels* facilitate a series of QC and interlaboratory functions, including:

 

Method Validation

New Instrument Validation

Assay Evaluation

Poor Performance Troubleshooting

Staff Training

Available Panels

Available RIQAS Past Panels* include:

• Ammonia/ Ethanol
• Anti-Müllerian Hormone (AMH)
• Anti-TSH Receptor
Blood Gas
• BNP
• Cardiac
• Cardiac Plus
Cerebrospinal Fluid (CSF)
• Coagulation
• CO-Oximetry
• CYFRA 21-1
Cytokines
• ESR
• General Clinical Chemistry
• Glycated Haemoglobin (HbA1c)
• Haematology
• Human Urine
• Immunoassay
• Immunoassay Speciality 1
• Immunoassay Speciality 2
• Immunosuppressant
• Lipid
• Maternal Screening
• Microbiology (Bacterial Identification)
• Neonatal Bilirubin
Serology (Anti-SARS-CoV-2)
Serology (EBV)
• Serology (HIV/ Hepatitis)
Serology (Syphilis)
Serology (ToRCH)
Serum Indices
Specific Proteins
Sweat Testing
• Therapeutic Drugs
• Urinalysis 
• Urine Toxicology
*Product availability is dependent on RIQAS stock surplus levels.

Benefits of RIQAS Past Panels

Support Data Included

All RIQAS Past Panels are provided with an Excel document containing supporting data for the instrument and method of interest.

Multi Level Samples

RIQAS Past Panel samples span multiple levels, making them ideal for ensuring accurate instrument performance across the measuring range.

Comprehensive Reports

RIQAS Past Panels allow laboratories to receive comprehensive external QC reports even after program close.

For more information on RIQAS Past Panel availability or to take part in this EQA scheme, contact us today and speak to one of our friendly and knowledgeable sales representatives. 


RIQAS Serology Report

The Serology report is available within ten days of the final submission date. The results for each parameter are displayed on a single page report. There are two types of Serology report – one for qualitative reporting and one for quantitative reporting. Each of these report ensure quick and easy performance assessment.

RIQAS EQA Reports

The Qualitative report comprises three subsections including a text section, Histogram and method summary. The text section conveniently displays your laboratory’s result to the correct result for your method. The Histogram visually displays your laboratory’s result in relation to all of the results submitted for your method group and the all method group. Finally, the method summary provides a breakdown of the results for all methods registered with RIQAS.

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The Quantitative report comprises four subsections including a text section, Histogram, Levey-Jennings chart and method summary. The text section conveniently displays your laboratory’s result to the mean for comparison, the histogram visually displays your laboratory’s result to the mean for comparison, the Levey-Jennings chart displays the SD for the last 20 samples ensuring instant identification of performance over time and finally the method summary provides a breakdown of the results submitted for all methods registered with RIQAS.

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RIQAS Urinalysis Report

RIQAS Urinalysis reports have been designed specifically for participants of the RIQAS Urinalysis programme (RQ9138). Report features include;

  • Scoring system
  • Ability to rate performance and visualise historical performance data
  • Visual representation of performance
  • Peer group comparison levels

To find out more on the range of features available with the report, see the table below.

RIQAS EQA Reports

The Urinalysis Report scoring system, scores participants based on a spread of results over each category and how far a participant is away from the consensus, which is referred to as the Target Category.

The score calculated is based on how close to the target category a participant’s result falls. A score of 0 refers to a result which falls within the target category and therefore, the comment “acceptable” will be given. A laboratory’s performance is described as being acceptable or unacceptable based on this calculated score.

A laboratory must achieve a score of between -6 and +6 for their performance to be deemed acceptable. Scores can fall between the values of -10 and +8.

  1. If a participant’s result matches the target category then they will receive the score of 0 and the comment “acceptable” given.
  2. Where a participant returns a negative result and the target category is positive (category 9), the participant score will be -10. The comment “unacceptable” will be given.
  3. Where a participant returns a positive result (category 9) and the target category is negative, the participant score will be +8 and the comment “unacceptable” given.

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Current Sample

The score achieved for the current reported sample together with the associated comment of acceptable, unacceptable or borderline will be listed in the comments box located towards the top of the results page for each registered parameter. The percentage (%) of results from the selected peer group which fall within the target category are also stated.

Potential Historical Information

The number of correct scores (i.e. scores of 0) that have been submitted in the last “n” samples, up to a maximum of 6 previous samples. The number of acceptable assessments that have been submitted in the last “n” samples, up to a maximum of 6 previous samples.

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Charting of Current & Historical Information

Results of scoring for each sample are displayed on a Levey-Jennings style chart with “0” score in the middle and scoring categories positioned on either side for 2, 4, 6, 8 and 10. The chart is shaded into bands depending on the scores.

Acceptable scores (0-6) have no shading, Borderline scores (6-8) have light red shading and unacceptable scores (8-10) are shaded a darker red.

Scores for each of the last 12 samples are plotted against the appropriate sample number and the chart also indicates whether the participant’s reported result category is higher or lower than the target category.

The target categories are stated along the top of the chart and if there are no target categories due to a lack of numbers then an “X” is plotted to show that a result has been submitted but could not be scored.

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Reporting – Summary Page

The summary page at the end of the report lists all of the parameters that a participant has registered for.

For each parameter the following information is stated:

  1. Target Category, which is dependent on the unit registered
  2. The result which has returned by the participant
  3. The score achieved for the current sample
  4. The comment of Acceptable / Unacceptable / Borderline
  5. Where the comment is “Unacceptable” it is highlighted in bold italics and underlined
  6. The number of “Acceptable” assessments that have been achieved over the previous 6 samples

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RIQAS Urine Toxicology Report

A dedicated report is provided for the Urine Toxicology programme. The report is divided into two subsections; the screening (qualitative) and the quantitative section, allowing for visual performance assessment at-a-glance.

RIQAS EQA Reports

Your laboratory’s result is displayed along with the correct response. A visual chart is also provided displaying performance of the last 20 samples. A breakdown of the screening results submitted by other laboratories in your method group and all method groups for the current sample is also provided at a variety of cut-offs. A further breakdown is provided for various methods at your specific cut-off.

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The Quantitative section of the Urine Toxicology report is further broken down into a text section comparing your laboratory’s performance to the mean for comparison, a Histogram chart indicating your laboratory’s performance in relation to the method group and the all method group and a multi-method section highlighting the performance of other methods.

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This Christmas, treat your laboratory to the “gift” of Randox Quality Control

At Christmas time all around the globe, people search for the best gift for their loved ones, something they will really like. At Randox Quality Control, we understand you care for your patients, and your laboratory. This year, show how much you care by treating your lab to a Randox Quality Control.

With over 35 years’ experience in the market, Quality Control is our passion and streamlining QC practice is our forte! Our extensive product offering comprises true third party controls, interlaboratory data management, external quality assessment and calibration verification.

Last year we looked in depth at Acusera – our range of true third party controls. This year, lets add another product to the Christmas wish list in the form of RIQAS, the world’s largest EQA scheme. Don’t wait until Christmas to wake up to a RIQAS programme under your tree – enrol in one of our comprehensive programmes today.

With over 45,000 laboratory participants across 133 countries, our RIQAS portfolio spans 32 comprehensive programmes ranging from Chemistry to Immunoassay, Lipids to Cardiac, Drugs to Serology and much more!

User-friendly, one page per parameter reports are available within 72 hours of the submission deadline.  These reports enable at-a-glance performance assessment, ultimately allowing your laboratory to save valuable time. You will also gain access to complimentary multi-instrument and inter-laboratory reports as well as an end-of-cycle report  summarising laboratory performance for each cycle and helping to identify progress over time.

Consolidation is key – and with an extensive parameter index available (up to 360 parameters) RIQAS will help you to significantly reduce costs, time and the number of individual programmes required to cover your test menu.

All RIQAS samples are free from interfering preservatives ensuring a commutable matrix that reacts to the test system in the same manner as a patient sample.

Additionally, enrolling in RIQAS isn’t just enrolling in an EQA scheme. Our programmes are accepted by National and International accreditation bodies worldwide and at the end of each cycle, participation in the scheme results in a certificate that can be used to decorate your laboratory all year around – not just at Christmas!

So this Christmas don’t give your laboratory second best, choose RIQAS, and reap the rewards.

To find out more on any of our RIQAS programmes visit our website – http://www.randox.com/riqas-external-quality-assessment/ or email us at acusera@randox.com

Randox Quality Control wish you all Season’s Greetings & a Prosperous New Year!


RIQAS Instrument Group Report

All RIQAS participants are entitled to register up to five separate instruments per programme at no extra cost.

Individual reports for each instrument are supplied as normal in addition to a complimentary instrument group report allowing the performance of each instrument to be uniquely compared and assessed easily.

RIQAS EQA Reports

The multi-instrument group report displays the %Deviation for the last 10 samples along with the RM%Dev across all registered laboratory instruments. The %Dev for each instrument is plotted on a user-friendly, colour coded chart for instant identification of poor performing instruments.

As an ISO requirement, the Multi-Instrument Report is an extremely useful and beneficial tool for laboratories – “Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers” – ISO 15189:2012.

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