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The largest global EQA scheme in the worldRIQAS explained
Overall objective of EQA:To develop inter-laboratory comparability which allows standardisation of diagnostic testing. EQA measures a laboratory's accuracy using 'blind' samples that are analysed as if they were patient samples. Results are returned to the scheme organiser for statistical analysis. Laboratories receive a report comparing their individual performance against other participants in the programme. EQA has a number of functions:
• Maintaining and improving the analytical quality of laboratory tests
• Improving inter-laboratory agreement and raising standards
• Detecting equipment failures, identifying reagent problems, reviewing staff training
• Initiating and evaluating corrective actions• Comparing different analytical methods
Participation in an EQA scheme will help produce reliable and accurate reporting of patient results. Quality results will reduce time and labour costs, and most importantly provide accurate patient diagnosis and treatment.
Independent Advisory PanelRIQAS participants have access to an independent advisory panel consisting of scientific and clinical experts. This ensures professional and ethical conduct of the scheme and participant confidentiality.
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External Quality Assessment External Quality Assessment (EQA) is an essential aspect of any laboratory operation. EQA provides a means of assessing the analytical performance of a laboratory compared to other laboratories utilising the same methods and instruments.
RIQAS Facts:
A Good EQA scheme should have:• Sufficient number of participants• Effective consolidation of programmes• International recognition through accreditation• Quality material• Regular reports with rapid turnaround times• Independent advisory panel• Flexible programme choices
• Blood Gas• Cardiac• Clinical Chemistry• Coagulation• Glycated Haemoglobin (HbA1c)• Haematology• Human Urine• Immunoassay
• Lipid• Liquid Cardiac• Maternal Screening• Specific Proteins• Therapeutic Drugs• Urinalysis• Urine Toxicology
RIQAS dRandox International Quality Assessment Scheme (RIQAS)RIQAS is the largest international EQA scheme in the world. It is used by more than 16,000 laboratories in 86 countries worldwide. 15 programmes are currently available.
RIQAS Facts:RIQAS SupportRIQAS support staff are on hand to offer advice and troubleshoot technical queries
RIQAS Programmes
Laboratory accreditationRIQAS provides Certificates of Participation as proof of EQA participation for laboratory accreditation. Randox and RIQAS systems and procedures are accredited to a number of internationally recognised standards:• ISO 13485:2003 for the design and
manufacture of medical devices• United Kingdom Accreditation Service
(UKAS) accreditation to ISO/IEC Guide 43-1:1997 “Development and operation of proficiency testing schemes” through assessment against ILAC-G13:2007 “Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes”
• Recognised by the UK National Quality Assurance Advisory Panel (NQAAP)
• Recognised by the Joint Working Group on Quality Assurance (JWG QA)
These certifications highlight the superior quality and excellence of RIQAS
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RIQAS Features and Benefits
1. Text Section
• A high level of participation ensures a large database of results and analytical methods, therefore increasing statistical validity
• Programmes accepted by National and International accreditation bodies worldwide
• Human samples free from interfering preservatives increase confidence that EQA performance mirrors performance on patient samples
• Samples received at start of each cycle
• Wider range of parameters covering a wide spectrum of laboratory testing
• Regular reports with rapid turnaround, ensuring corrective action can be taken prior to analysis of subsequent samples
• User friendly reports, easy to read at a glance, saving valuable laboratory time
• Reduced parameter options for selected programmes offer greater flexibilty, ensuring suitability for laboratories of all sizes and budgets
• Participant certificates provide evidence of participation in a reputable EQA scheme
• Multi-instrument reports allow assessment of performance of all systems in the laboratory
• Inter-laboratory group reports allow comparison of multiple connected laboratories
• Reference method values are provided in the Clinical Chemistry programme
RIQAS samples are custom-manufactured to be both stable and similar to human samples.
RIQAS Reports
RIQAS Reports• Statistical breakdown by all methods, your
method and your instrument including running means for the last 10 samples
• Compare your instrument group, method group and all methods using the histogram
• Identify trends, biases and precision problems using the Levey-Jennings chart
• The Target Score chart grades your performance in a moving window over the last 20 samples, including the previous cycle
• At-a-glance summary page for all parameters in the programme
RIQAS E-transfer SoftwareE-transfer software enables fast data transfer at no extra cost and allows participants to view and store reports electronically. RIQAS E-transfer reduces turnaround time for receiving reports to 3 days. RIQAS E-transfer is available in a number of languages.
PDF ReportingRIQAS reports can now be presented in pdf (portable document format), offering easy review and storage of your laboratory’s EQA data. There are many advantages associated with pdf reporting, increasing the usability and efficiency of data analysis.
Multi-Instrument Reports Laboratories can register up to five instruments at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report allows the comparative performance of each instrument.
RIQAS reports are presented in a user friendly, one page per parameter format. This allows easy interpretation of your analytical performance.
RIQAS Facts:Inter-Laboratory Group reportsThe Group Reporting facility enables laboratory groups to monitor satellite sites. Laboratories can receive individual reports with the group supervisor receiving a report comparing the laboratories within the group. This allows easy assessment of performance of all laboratories within a group.
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Web-Based Data TransferThe RIQAS web system offers easy direct access for the submission of results and retrieval of reports straight from the RIQAS host server.
• Confidentiality and security is maintained through the use of password protected access
• Submit current, corrected, late and future results (normal policies apply), directly into RIQAS database. No confirmations are required.
• Reports are emailed in pdf format as soon as they are prepared
• If your PC fails, don’t worry - up to two cycles of reports are available to be downloaded from website
• View, print, store or distribute reports as you wish
• All that is required is web access, Adobe Reader (for viewing reports) and a valid password to access system. No additional software required.
Data on each parameter is presented in a one page format with seven sub-reports
Standard Report
N
N
C
C
L
L
N C L
HistogramMethod and instrument comparison
Multi Method Stat SectionEnabling assessment of the performance of each method
Levey-Jennings ChartDetailing features of your laboratory’s performance
Target ScoreThis unique chart provides a numerical index of performance allowing at a glance assessment
% Deviation by Sample Helps to identify trends and shifts in performance
% Deviation by Concentration Rapid assessment of concentration related biases
Text SectionFor all methods, your method and instrument group
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Text SectionNumber of laboratories who returned results in time for processing
Report is presented in your chosen unit Standard Deviation Index =
Your result - Mean for comparisonSD of Mean for comparison group
Standard Deviation Coefficient of Variation
% Deviation from the mean for comparison
Biological variation stated for information purposes only
Performance statement appears here if performance indicators exceed limits:SDI > 2SDTarget Score < 50% Deviation > defined acceptable limits
Performance limit set for this parameter
Ideally this will be your instrument group mean. If N<5 for your instrument group, your method group mean is selected.
Running Mean SDI is the average of the last 10 SDIs for this parameter
Target ScoreThe closer the value is to 120, the better the result
Average value of all laboratories’ results
After statistical reduction, some results are excluded
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N C L
HistogramThe Bar Graph is intended as a quick visualisation of how your lab’s result falls into the overall picture of:
All methods
Your method group
Your instrument group
A total of 314 laboratories reported values between 107.67 and 109.19
25 laboratories reported values between 101.60 and 103.12 in your method group
RIQAS reports show your unit of measurement Your result
19 laboratories reported values between 113.75 and 115.27 in your instrument group
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N
N
C
C
L
L
C = Corrected results will be accepted in exceptional cases where, for example, you have made a transcription error. Corrected results will be accepted up to 4 weeks after the final date deadline
N = No result returned from your laboratory
Sample number
Your SDI (Standard Deviation Index)
L = Late result received after “final date” deadline. Late results will be accepted up until the “final date” of the next sample
Levey Jennings ChartThe mean for comparison for each sample is indicated at the top of the chart, allowing easy assessment of concentration related bias
This line indicates a change to the registration details for this parameter
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N
N
C
C
L
L
Target Score Chart
High score in the lighter shaded area represents good performance
Heavy shading for values 10 to 50 signifies poor performance
The Target Score (TS) allows laboratories to assess their performance at a glance. The TS relates the % deviation of your result from the mean to a Target % deviation. The aim is to achieve a deviation smaller than the Target % deviation. The lower the deviation in relation to the target deviation, the higher the TS.
Excellent
Good
Acceptable
Need for improvement
Unacceptable
This is the upper deviation limit for this parameter. TDs are calculated from ‘State of the Art’ historical performance and are reviewed annually
10
N C L
% Deviation by Sample Chart
% Deviation from mean of comparison
Acceptable limits of performance
Plot of running mean % deviations, average of the last 10 % deviations for the sample indicated
This chart helps to identify trends and shifts in performance and unlike plotting of SDIs, % deviations are not influenced by performance of peers.
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% Deviation by Concentration Chart
% Deviation at specific concentration
This chart enables rapid assessment of concentration related biases. Biases at low or high concentrations may be easily determined, also whether a particular sample is a random outlier or if a bias is always present at that concentration.
N C L
Current sample indicated by square
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% Deviation by Concentration Chart Multi Method Stat SectionThis section provides an easy way of assessing the performance of the other methods used to analyse the parameter.
N C L
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Summary PageYour unique and confidential laboratory identification
Red triangle appears when all performance indicators (SDI, %DEV, and TS) exceed set limits:SDI > 2SDTS < 50%DEV > acceptable limits set
RMSDI - is the Running Mean of the 10 previous SDIs (if fewer than 10 results on file, “too few” is printed)
Average from the last 10 %DEV for this parameter
Overall RMTS = average RMTS for this sample distribution
Overall RMSDI = average RMSDI for this sample distribution
Overall RM%DEV = Average RM%DEV for this sample distribution
Average from the last 10 Target Scores for this parameter
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Screening Section�����������
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Abbreviations TN True Negative
TP True Positive
FN False Negative
FP False Positive
RC Referred for Confirmation
NT Not Tested
Your Result
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��Performance history of your
method over all cut-offs, based on the previous 10 samples
Your performance history for this parameter, based on the
previous 10 samples.
Performance of your method over all cut-offs
for this sample
Performance history of all methods over all cut-offs, based
on the previous 10 samples
Performance of all methods over all cut-offs
for this sample
SCREENING SUMMARY:Your screening result shown in the appropriate response category and your cut off for this sample.
Screening results for all cut-offs returned for this sample within your method group.
Total screening results over all your cut-offs for your laboratory’s method.
Screening results for other methods using the same cut-off as your laboratory.
Screening results for all cut-offs returned for this sample over all methods
Total screening results over all cut-offs for all methods.
Comment section for RIQAS to provide your laboratory with additional relevant information regarding this sample.
Screening result response categories. All abbreviations indicated at the bottom of the report page.
KEYTN - true negativeTP - true positiveFN - false negativeFP - false positiveRC - sent for confirmationNT - not tested
SCREENING RESULTS: This chart is a quick visualisation of your performance over the last 20 samples. A result in the white section indicates a correct response. A result in the upper red section indicates a False Positive re-sponse, and a result in the lower red sec-tion indicates a False Negative response.
SCREENING TEXT SECTION
16
Quantitative Section�����������
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Abbreviations TN True Negative
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Your Result
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QUANTITATIVE TEXT SECTION:Comparison statistics. Caution is needed when the N value is too small to support statistical significance
Your MFC
Your Result
All available method statistics
QUANTITATIVE RESULTS HISTOGRAM:This graph provides a quick visualisation of how your quantitative result falls into the overall picture for all methods and your method group
Standard Deviation Index = (Your Result – Mean for Comparison) / SD of Mean for comparison group
17
Standard Deviation Index =Your result - Mean for comparison
SD of Mean for comparison group
Urinalysis Report
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Your Result
Categories stated in your unit
Your method group and categories
Results from all methods (dipsticks) able to return results in the same categories as your lab
Results from all methods for all available categories
Your Result
Performance Statement
YOUR CATEGORIES HISTOGRAM:A quick visualisation of how your lab’s result falls into the overall picture for your categories
Possible reporting categories for your method
All available methods for this parameter
SCREENING RESULTSAll categories (result options) available for this parameter for any method (dipstick)
Your categories (available result options for your chosen dipstick and unit)
ALL CATEGORIES HISTOGRAMa quick visualisation of how your lab’s result falls into the overall picture for all categories
DETAILED SUMMARY OF RESULTSThis table enables you to see how you compare to all other results
Your categories
Comments Box
Results submitted from a category not applicable to your method
18
Participation in RIQAS
Participant receives a certificate for participating at the end of the cycle
General Clinical Chemistry ProgrammeSeptember 2008 - March 2009
Randox Laboratories
After completion of enrolment documents, participant registers methods used in their lab
Participant analyses the sample on the recommended date
Participant recieves a set of numbered samples for the cycle
Participant receives report by e-mail or post Participant uploads the results to RIQAS, or sends the return sheet by fax or post,
before the “final date” deadline
Participant enters the results on the web,e-transfer software or on the return sheet
Participant reviews the report to assess performance
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RIQAS Programmes
RED = Parameters with Reference Method Values PURPLE = The only parameters available on RQ9135/a + = Programmes awaiting accreditation To ILAC G13: 2007 * = Pilot study ongoing
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, Reference Method Values Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription, Weighed-in values
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription
Samples every month, 1 x 12 month cycle, 12 month subscription
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription
HbA1c
GLYCATED HAEMOGLOBIN PROGRAMME
CK, TotalCK-MB Activity
CK-MB MassHomocysteine
MyoglobinTroponin I
Troponin T
CARDIAC PROGRAMMEWith target scoring
Apolipoprotein A1Apolipoprotein B
Cholesterol, totalHDL-cholesterol
LDL-cholesterolLipoprotein (a)*
Triglycerides
AFPfree Beta hCG
total hCG Inhibin A
PAPP-AUnconjugated Oestriol
BNPCK-MB MassDigoxin
HomocysteinehsCRPMyoglobin
NT proBNPTroponin ITroponin T
LIPID PROGRAMME
MATERNAL SCREENING PROGRAMME+
LIQUID CARDIAC PROGRAMME+
With target scoring
With target scoring
With target scoring
AFPAlbuminAlpha-1-acid glycoproteinAlpha-1-antitrypsinAlpha-2-macroglobulinAnti Streptolysin OAntithrombin IIIBeta-2-microglobulinCaeruloplasmin
Complement, C3Complement, C4C-Reactive ProteinFerritinHaptoglobinImmunoglobulin AImmunoglobulin EImmunoglobulin GImmunoglobulin M
Free Kappa Light ChainTotal Kappa Light ChainFree Lambda Light ChainTotal Lambda Light Chain Prealbumin (Transthyretin)Retinol Binding ProteinRheumatoid FactorTransferrin
AmikacinCaffeineCarbamazepineCyclosporineDigoxin
EthosuximideGentamicinLithiumMethotrexateParacetamol
PhenobarbitonePhenytoinPrimidoneSalicylic acidTheophylline
TobramycinValproic acid Vancomycin
SPECIFIC PROTEINS PROGRAMME
THERAPEUTIC DRUGS PROGRAMME
Acid phosphatase, prostaticAcid phosphatase, totalAlbuminAlkaline phosphataseALT (ALAT)Amylase, pancreaticAmylase, totalAST (ASAT)BicarbonateBile acidsBilirubin, direct
Bilirubin, totalCalciumCalcium, ionisedChloride CholesterolCK, total (CPK) CopperCreatinine D-3-hydroxybutyrateGamma GTGLDHGlucoseHBDH
HDL-CholesterolIronLD (LDH)LipaseLithium Magnesium NEFA*OsmolalityPhosphate, inorganicPotassiumProtein, total PSA Sodium
TIBCFree T3Total T3Free T4Total T4Triglycerides TSHUreaUric acid Zinc
GENERAL CLINICAL CHEMISTRY PROGRAMMEWith target scoring
RQ911210 Parameters only
RQ9112/S17 Parameters only
RQ9113Full 46 Parameters
RQ911118 parameters
RQ9127/a2 Parameters only (choose from 7)
RQ9127/bFull 7 Parameters
RQ91369 Parameters
RQ911426 parameters,
RQ9126/a3 Parameters only (choose from 6)
RQ9126/bFull 6 Parameters, samples every 2 weeks
Samples every month, 1 x 12 month cycle, 12 month subscriptionSample every month, 1 x 12 month cycle, 12 month subscription
RQ91376 ParametersRQ9129
1 Parameter
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RED = Parameters with Reference Method Values PURPLE = The only parameters available on RQ9135/a + = Programmes awaiting accreditation To ILAC G13: 2007 * = Pilot study ongoing
RIQAS Programmes
2 x 6 monthly cycles (RQ9125/a, RQ9125/b, RQ9125/c) , 12 month subscription1 x 12 month cycle (RQ9130), 12 month subscription
AlbuminBilirubinBloodCreatinine
GalactoseGlucosehCGKetones
LeukocytesNitritepHProtein
Specific GravityUrobilinogen
URINALYSIS PROGRAMME+
With target scoring
AFPBeta-2-microglobulinCA125CA15-3CA19-9CarbamazepineCEACortisolDHEA-SDHEA Unconjugated
DigoxinFerritinFolateFSHGHhCGIgEInsulinLHOestradiol
17-OH-progesteronePhenytoinProgesteroneProlactinFree PSATotal PSAPTHSHBGFree T3Total T3
Free T4Total T4TestosteroneTheophyllineThyroglobulinTSHValproic acidVitamin B12
IMMUNOASSAY PROGRAMME
RQ9125/a 4 Parameters only (choose from 38)
RQ9125/b13 Parameters only (choose from 38)
RQ9125/cFull 38 Parameters
RQ9130Full 38 Parameters
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription
Samples every month, 1 x 12 monthly cycle, 12 months subscription
Samples every month, 1 x 12 monthly cycle, 12 month subscription
pCO2pHpO2
tCO2Ca++Cl-
K+Na+Glucose
Lactate
BLOOD GAS PROGRAMME+
With target scoring
Haematocrit (HCT)Haemoglobin (Hb)Mean Cell Haemoglobin (MCH)Mean Cell Haemoglobin Concentration (MCHC)
Mean Cell Volume (MCV)Platelets (PLT)Red Blood Cell Count (RBC)Total White Blood Cell Count (WBC)
HAEMATOLOGY PROGRAMME
aPTTPT (including INR)TTFibrinogen
Antithrombin IIIPlasminogenProtein CProtein S
Factor IIFactor VFactor VIIFactor VIII
Factor IXFactor XFactor XIFactor XII
COAGULATION PROGRAMME+
RQ91188 Parameters
RQ913410 Parameters
RQ9135/a5 selected Parameters only (aPTT, PT, TT, Fibrinogen, Antithrombin III)
RQ9135/bFull 16 Parameters
With target scoring
AlbuminAmylaseCalciumChlorideCopperCortisol
CreatinineDopamineEpinephrineGlucoseMetanephrineNorepinephrine
Normetanephrine MagnesiumOsmolalityOxalatePhosphate, inorganicPotassium
Protein, total SodiumUrea Uric acidVMA5-HIAA
HUMAN URINE PROGRAMME
d-Amphetamined-MethamphetaminePhenobarbitalSecobarbitolCreatinine
LorazepamOxazepamCannabinoids (THC)BenzoylecgonineEthanol
LSDEDDPMethadonePhencyclidineNorpropoxyphene
NortriptylineBuprenorphineFree Morphine
URINE TOXICOLOGY PROGRAMME+
Samples every 2 weeks Samples every 2 weeks Samples every 2 weeks Samples every month
Samples every 2 weeks, 2 x 6 monthly cycles, 12 month subscription
Samples every month, 1 x 12 month cycle, 12 month subscription
RQ911524 Parameters
RQ913918 Parameters
Samples every 2 months 1 x 12 month cycle, 12 month subscription
RQ913814 Parameters
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RIQASt: +44 (0) 28 9442 2413, e: [email protected]
e-transfer results and method changes: e: [email protected]: www.riqas.com
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Randox Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, BT29 4QY, United Kingdomt: +44 (0) 28 9442 2413 f: +44 (0) 28 9445 2912 e: [email protected] www.randox.com
Randox Laboratories Limited is a company registered within Northern Ireland with company number N.I. 15738. VAT Registered Number: GB 353 030 400. Product availability may vary from country to country. Please contact your local Randox representative for information.
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