RIQAS Standard Report
There are a variety of RIQAS reports designed to enable quick and easy identification of any trends or test system issues. The standard quantitative report is provided in a user-friendly, one page per parameter format allowing a visual, at-a-glance assessment of performance. The standard quantitative report is split into several easy to interpret subsections each designed to save valuable laboratory time.
You can explore each of the report sections using the table below. Don’t forget, to enlarge the image, simply click on it.
RIQAS EQA Reports
RIQAS Reports Features
Performance data is presented in a simple one page format for each analyte. Each one page report comprises seven sub-reports providing a statistical and graphical representation of laboratory performance.
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The text section provides a statistical breakdown of results by all methods, your method and instrument group. The Mean, CV% and Uncertainty or Measurement is presented for each comparison group.
Your laboratory’s result is compared to the Mean for Comparison (usually the instrument group Mean). Also included are the RIQAS performance indicators; SDI, Target Score and %Deviation.
Acceptable performance criteria:
- SDI <2
- Target Score >50
- %Deviation
The defined acceptable limits default to the RIQAS TDPA values but may be based on CLIA, biological variation or country specific limits.
Performance goals based on Biological Variation are also stated within the text section for information purposes.
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The histogram chart provides an overview of how your laboratory’s result compares to the all method group, your method group and your instrument group. Your result is represented by a black triangle; the closer to the centre the better.
The chart is intended to provide a quick visualisation of performance compared to other method groups and can be used to identify any potential bias.
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The Levey-Jennings chart plots the last 20 SDI’s and is extremely useful for monitoring EQA performance over time, allowing quick and easy identification of any trends or bias. The chart is colour coded making interpretation simple and easy; results that fall in the white area are excellent and those in the red area unacceptable.
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The Target Score (TS) chart is a unique chart which displays your laboratory’s last 20 target scores delivering an instant, visual indication of performance. The TS chart is conveniently colour coded for even easier performance assessment, a TS >50 is acceptable. The TS is a numerical index relating your %Deviation from the mean to a Target Deviation for Performance Assessment (TDPA).
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The %Deviation by sample chart displays the %Deviation for the last 20 EQA samples enabling identification of trends and shifts in performance. Similar to the other charts on the RIQAS report, the %Deviation by sample chart is shaded to indicate the limit of acceptable performance. A black dot within the white section of the chart will represent results with a %Deviation within your acceptable limits of performance; a black dot within the red section of the chart will represent results with a %Deviation outside your acceptable limits of performance. %Deviations are not influenced by the performance of your peers, as seen with the standard deviation index (SDI) and therefore is a better indicator of individual performance.
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The %Deviation by concentration chart enables easy detection of possible concentration related biases. Unlike the other charts provided on the report, the %Deviation by concentration chart displays the concentration range of the previous 20 samples along the bottom of the chart.
Using this scale along with the percentage deviation, you are provided with a rapid assessment of your %Deviation in relation to the concentration of the:
• Current sample (represented by a square)
• Your 19 previous results (represented by circles)
This chart provides an easy interpretation of potential positive or negative biases at high or low concentrations, or whether a particular sample is a random outlier.
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The Multi Method Stat Section provides you with an easy way of assessing the performance of the other methods used to analyse the parameter. This is useful when your laboratory plans to change the analytical method used for the parameter.
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Located at the back of the standard quantitative report, our quick reference summary page details the performance for each registered parameter in the programme.
Within the performance column, RIQAS provides an effortless method of assessing the performance of each parameter within the sample distribution. When a red triangle appears next to the parameter, this indicates that all performance indicators (SDI, TS and %DEV) have exceeded the performance criteria.
The performance indicator limits for each parameter are exceeded when your result produces:
• An SDI greater than +/- 2 standard deviations.
• A Target Score less than 50 (only when Target Scoring is available)
• A %Deviation greater than your set acceptable limits of performance.
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A summary CSV file is available on request to all participating laboratories. The report provides a summary of all statistics, acceptable limits and performance indicators as a .csv file for each sample in the cycle.
A retrospective statistics summary is also available, four weeks after the final submission date for parameters where a result was not submitted on time.
RIQAS Parameters List
RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 76,000 participants in 139 countries. World renowned for reducing the number of individual programmes required by even the most demanding laboratories, RIQAS covers 360 parameters across 36 flexible multi-parameter programmes. Effective consolidation in this way will not only deliver real cost savings but free up storage space and ultimately reduce the time spent preparing multiple samples at each survey.
RIQAS Parameter List
1-25-(OH)2-Vitamin D
17-OH-Progesterone
25-OH-Vitamin D
5-HIAA
α-1-Acid Glycoprotein
α-1-Antitrypsin
α-2-Macroglobulin
ABO Group
ACE
Acid Phosphatase (Prostatic)
Acid Phosphatase (Total)
ACR
ACTH
AFP
Albumin
Albumin/Microalbumin
Aldosterone
Alkaline Phosphatase
ALP
ALT
ALT (ALAT)
AMH
Amikacin
Ammonia
Amylase
Amylase (Pancreatic)
Amylase (Total)
Androstenedione
Anti Streptolysin O
Antibody Identification
Antibody Screen
Anti-CMV (Total)
Anti-CMV IgG
Anti-CMV IgM
Anti-EBNA IgG
Anti-EBV VCA IgG
Anti-EBV VCA IgM
Antigen Typing
Anti-HAV (Total)
Anti-HAV IgM
Anti-HBc
Anti-HBc IgM
Anti-HBe (Total)
Anti-HBs (Total)
Anti-HCV
Anti-HIV combined
Anti-HIV-1
Anti-HIV-2
Anti-HSV1 IgG
Anti-HSV1 IgM
Anti-HSV1/2 IgG
Anti-HSV1/2 IgM
Anti-HSV2 IgG
Anti-HSV2 IgM
Anti-HTLV combined
Anti-HTLV I
Anti-HTLV II
Anti-Measles IgG
Antimicrobial Susceptibility Testing
Anti-Mumps IgG
Anti-Rubella IgG
Anti-Rubella IgM
Anti-Tg
Antithrombin III
Anti-Toxoplasma IgG
Anti-Toxoplasma IgM
Anti-TPO
Anti-TSH Receptor (TRAb)
Anti-VZV IgG
Apolipoprotein A1
Apolipoprotein B
aPTT
AST
AST (ASAT)
β-2-Microglobulin
Benzoylegonine
Bicarbonate
Bile Acids
Bilirubin
Bilirubin (Direct)
Bilirubin (Total)
Blood
BNP
Buprenorphine
Ca++
CA125
CA15-3
CA19-9
Caffeine
Calcitonin
Calcium
Calcium (Ionised)
Calcium, Adjusted
Cannabinoids (THC)
Carbamazepine
Carboxyhaemoglobin (COHb / HbCO)
CEA
Ceruloplasmin
Chloride
Cholesterol
Cholesterol (Total)
Cholinesterase
Ciclosporin
CK NAC
CK, Total
CK, total (CPK)
CK-MB (Activity)
CK-MB (Mass)
Cl-
CO2(Total)
Compatability (Cross-Match)
Complement C3
Complement C4
Conductivity
Copper
Cortisol
Cotinine
C-Peptide
C-Reactive Protein
Creatinine
CYFRA 21-1 (Cytokeratin 19 fragment)
D-3-Hydroxybutyrate
d-Amphetamine
D-dimer
Deoxyhaemoglobin (RHb / HHb)
DHEA (Unconjugated)
DHEA-S
Digoxin
Direct Bilirubin
d-Methamphetamine
Dopamine
EDDP
eGFR (estimated glomerular filtration rate)
Epidermal Growth Factor (EGF)
Epinephrine
ESR
Estriol
Ethanol
Ethosuximide
Everolimus
Factor II
Factor IX
Factor V
Factor VII
Factor VIII
Factor X
Factor XI
Factor XII
Ferritin
Fibrinogen
Folate
Free Morphine
free β-hCG
Fructosamine
FSH
Galactose
Gastrin
Gentamicin
GGT
GH
GLDH
Glucose
γGT
Haematocrit (HCT)
Haemoglobin (Hb)
Haemolysis
Haptoglobin
HbA1c
HBDH
HBsAg
hCG
HDL
HDL-Cholesterol
Homocysteine
hsCRP
Icteric
IgA
IgE
IGF-1
IgG
IgM
Inhibin A
Insulin
Interferon gamma (IFN-y)
Interleukin-1 alpha (IL-1α)
Interleukin-1 beta (IL-1β)
Interleukin-10 (IL-10)
Interleukin-2 (IL-2)
Interleukin-4 (IL-4)
Interleukin-6 (IL-6)
Interleukin-8 (IL-8)
Iron
K+
Kappa Light Chain (Free)
Kappa Light Chain (Total)
Ketones
Lactate
Lambda Light Chain (Free)
Lambda Light Chain (Total)
LD (LDH)
LDH
LDL-Cholesterol
Leukocytes
LH
Lipaemic
Lipase
Lipoprotein (a)
Lithium
Lorazepam
LSD
Magnesium
MDMA
Mean Cell Haemoglobin (MCH)
Mean Cell Haemoglobin Concentration (MCHC)
Mean Cell Volume (MCV)
Mean Platelet Volume (MPV)
Metanephrine
Methadone
Methaemoglobin (MetHb)
Methotrexate
Monocyte Chemottractant Protein-1 (MCP-1)
Myoglobin
Na+
NEFA
Nitrite
Non-HDL Cholesterol
Norepinephrine
Normetanephrine
Norpropoxyphene
Nortryptyline
NT proBNP
Oestradiol
Osmolality
Osteocalcin
Oxalate
Oxazepam
Oxygen Content (O2CT)
Oxygen Saturation (sO2 / Vol O2)
Oxyhaemoglobin (O2Hb / HbO2)
P24
PAPP-A
Paracetamol
pCO2
pH
Phencyclidine
Phenobarbital
Phenytoin
Phosphate
Phosphate (Inorganic)
Plasma Renin Activity
Plasminogen
Plateletcrit (PCT)
Platelets (PLT)
PlGF
pO2
Potassium
Prealbumin (Transthyretin)
Primidone
Procalcitonin
Progesterone
Prolactin
Protein
Protein (Total)
Protein C
Protein S
PSA
PSA (Free)
PSA (Total)
PT (including INR)
PTH
Red Blood Cell Count (RBC)
Red Cell Distribution Width (RDW)
Renin (Direct Concentration)
Retinol Binding Protein
Rh(D)
Rheumatoid Factor
Salicylate
Salicylic Acid
Secobarbital
sFlt-1
sFlt-1/PlGF ratio
SHBG
Sirolimus
Sodium
Specific Gravity
Strain Identification
Syphilis
T3 (Free)
T3 (Total)
T4 (Free)
T4 (Total)
Tacrolimus
Testosterone (Free)
Testosterone (Total)
Theophylline
Thyroglobulin
TIBC
Tobramycin
Total Bilirubin
Total Haemoglobin
Total Haemoglobin (tHb)
Total hCG
Total White Blood Cell Count (WBC)
Transferrin
Triglycerides
Troponin I
Troponin T
Trypanosoma Cruzi Antibodies
TSH
TT
Tumour Necrosis Factor alpha (TNF-α)
UIBC
Unconjugated Oestriol
Urea
Uric Acid
Urobilinogen
Valproic Acid
Vancomycin
Vascular Endothelial Growth Factor (VEGF)
Vitamin B12
VMA
Acusera Internal Quality Control Analyte List
Quality Control is our passion; we believe in producing high quality material that can help streamline procedures, whilst saving time and money for laboratories of all sizes and budgets. With an extensive product offering comprising third party controls and calibrators, interlaboratory data management, external quality assessment, and calibration verification, you can count on Randox to deliver trustworthy results time and time again. Just ask one of our 60,000 users worldwide.
Our Acusera Internal Quality Control A – Z analyte list highlights how comprehensive our Acusera product portfolio is. Search through the list to see if we have the analyte you require.
Acusera Parameter List
#
5-HIAA
17-OH-progesterone
17β Clostebol
1-25-(OH₂)-Vitamin D
25-OH-Vitamin D
A
α-1-Acid Glycoprotein
α-1-Antitrypsin
α-1-Globulin (Electrophoresis)
α-2-Globulin (Electrophoresis)
α-2-Macroglobulin
α-Fetoprotein (AFP)
α-HBDH
ACE (Angiotensin Converting Enzyme)
Acetaminophen Acid Phosphatase (Non-Prostatic)
Acid Phosphatase (Prostatic)
Acid Phosphatase (Total)
ACTH
Active Vitamin B12 (Holotranscobalamin/HoloTC)
Activated Partical Thromboplastin Time(APTT)
AHD Albumin
Albumin (Electrophoresis)
Aldolase x Aldosterone
Alkaline Phosphatase (ALP)
ALT (GPT)
AMH
Amikacin
Ammonia
AMOZ Amylase
Amylase (Pancreatic)
Androstenedione
Anti-HAV
Anti-HBc
Anti-HBe
Anti-HBs
Anti-HCV
Anti-HIV 1 / 2
Anti-HTLV 1 / 2
Anti-Streptolysin (ASO)
Anti-Thyroglobulin (Anti-TG)
Anti-Thyroperoxidase (Anti-TPO)
Anti-Thrombin III (AT III)
AOZ Apolipoprotein A-I
Apolipoprotein A-II
Apolipoprotein B
Apolipoprotein C-II
Apolipoprotein C-III
Apolipoprotein E
AST (GOT)
β-Globulin (Electrophoresis)
β-2-Microglobulin
BASO-X
BASO-Y
Basophils (BASO)
Basophils % (% BASO)
Bicarbonate
Bile Acids
Bilirubin (Direct)
Bilirubin (Total)
Blood Bone Alkaline Phosphatase (B-ALP)
Borrelia burgdorferi IgG
Borrelia burgdorferi IgM
Brain Natriuretic Peptide (BNP)
C-Peptide
C-Telopeptide
CA 15-3
CA 19-9
CA 72-4
CA 125
Caffeine
Calcitonin
Calcium
Carbamazepine
CEA
Ceftiofur
Ceruloplasmin
Chloramphenicol
Chloride
Cholesterol (HDL)
Cholesterol (LDL)
Cholesterol (Total)
Cholinesterase
CK-MB
CK (Total)
Complement C3
Complement C4
Copper
Cortisol
CRP
Creatinine
Cyclosporine
Cytomegalovirus (CMV) IgG
Cytomegalovirus (CMV) IgM
CYFRA 21
Cystatin C
D-3-Hydroxybutyrate
D-dimer
Deoxypyridinoline
DHEA-Sulphate
DIFF-X
DIFF-Y
Digoxin
Dopamine
E-Selectin (E-SEL)
Eosinophils (EOS)
% Eosinophils (% EOS)
Epidermal Growth Factor (EGF)
Epinephrine
Epstein Barr Virus (EBV) EBNA IgG
Epstein Barr Virus (EBV) IgM
Epstein Barr Virus (EBV) VCA IgG
Estriol
Ethanol
Ethinylestradiol
Ethosuximide
Factor II
Factor V
Factor VII
Factor VIII
Factor IX
Factor X
Factor XI
Factor XII
Ferritin
Fibrinogen
Folate
Fructosamine
FSC-X
FSH
G-6-PDH
γ-Globulin (Electrophoresis)
γGT
Gastrin
Gentamicin
Gestagens (Generic)
GLDH
Glucose
Glutamate
Glutathione Peroxidase (Ransel)
Glutathione Reductase
Glycerol
GM-CSF
Growth Hormone (GH)
Haematocrit (HCT)
Haemoglobin (HGB)
Haemoglobin (Total)
Haemolysis (H)
Haemopioetic Progenitor Cell (HPC)
Haptoglobin
HAV IgM
HbA1c
HBc IgM
HBeAg
HBsAg
hCG
Free β-hCG
Total β-hCG
HDL-3
Helicobacter pylori IgG
Herpes Simplex Virus 1 (HSV-1) IgG
Herpes Simplex Virus 1 (HSV-1) IgM
Herpes Simplex Virus 2 (HSV-2) IgG
Herpes Simplex Virus 2 (HSV-2) IgM
HIV-1 P24Ag
Homocysteine
hsCRP
Icterus (I)
IMIDC
IMIRF
Immature Granulocytes (IG)
% Immature Granulocytes (% IG)
Immature Myeloid Information (IMI)
Immature Platelet Fraction (IPF)
Immunoglobulin A (IgA)
High Sensitivity Immunoglobulin A (hsIgA)
Immunoglobulin E (IgE)
Immunoglobulin G (IgG)
High Sensitivity Immunoglobulin G (hsIgG)
Immunoglobulin M (IgM)
High Sensitivity Immunoglobulin M (hsIgM)
Inhibin A
Insulin
Insulin Like Growth Factor (IGF 1) x
Intercellular Adhesion Molecule-I (ICAM-I)
Interferon-γ (IFN-γ)
Interleukin-Ia (IL-la)
Interleukin-1β (IL-1β)
Interleukin-2 (IL-2)
Interleukin-4 (IL-4)
Interleukin-5 (IL-5)
Interleukin-6 (IL-6)
Interleukin-8 (IL-8)
Interleukin-10 (IL-10)
Interleukin-15 (IL-15)
Iron
Iron (TIBC)
Iron (UIBC)
Kappa Light Chain
Ketones
L-Selectin (L-SEL)
Lactate
Lactate Dehydrogenase (LDH)
Lambda Light Chain
Lambda Light Chain (Free)
LAP
Leptin
Leukocytes
Lipase
Lipemia (L)
Lipoprotein (a)
Lithium
Luteinising Hormone (LH)
Lymphocytes (LYMPH)
% Lymphocytes (% LYMPH)
Magnesium
Matrix Metalloproteinase-9 (MMP-9)
Measles IgG
Mean Corpuscular Haemoglobin (MCH)
Mean Corpuscular Haemoglobin Concentration (MCHC)
Mean Corpuscular Volume (MCV)
Mean Platelet Volume (MPV)
Metanephrine
Methandriol
Methotrexate
Methyltestosterone
Microalbumin
Macrophage Inflammatory Protein-1a(MIP-1a)
Monocytes (MONO)
Monocytes % (% MONO)
Monocyte Chemoattractant Protein-1 (MCP-1)
Mumps IgG
Myoglobin
N-MID Osteocalcin (OC)
N-Telopeptide
NEFA
Neuron-Specific Enolase (NSE)
Neutrophils (NEUT)
Neutrophils % (% NEUT)
Neutrophil Gelatinase-associated Lipocalin (NGAL)
Nitrite
Norepinephrine
Normetanephrine
NT-proBNP
Nucleated Red Blood Cells (NRBC)
Nucleated Red Blood Cells % (% NRBC)
Nucleated Red Blood Cells X (NRBC-X)
Nucleated Red Blood Cells Y (NRBC-Y)
Oestradiol
Osmolality
Osteocalcin
Oxalate
Oxyhaemoglobin
P-Selectin (P-SEL)
Paracetamol
PAPP-A
pCO2
pH
Phenobarbital
Phenobarbitone
Phenytoin
Phosphate (Inorganic)
PIGF
Plasminogen
Plasminogen Activator Inhibitor
Platelet Distribution Width (PDW)
Platelet Large Cell Ratio (P-LCR)
Plateletcrit (PCT)
Platelet (PLT)
Platelet Optical Count (PLT-O)
pO2
Potassium
Prealbumin
Primidone
Procalcitonin
Procollagen Type 1 N-Terminal Propeptide (P1NP)
Progesterone
Prolactin
Protein C
Protein S
Protein (Total)
Prothrombin Time (PT)
Pyridinium Crosslinks
Pyridinoline
PSA (Free)
PSA (Total)
PTH (Parathyroid Hormone)
PTH (Intact)
Quinolones (Generic)
Red Blood Cell Y (RBC-Y) x
Red Blood Cell Distribution Width CV (RDW-CV) x
Red Blood Cell Distribution Width SD (RDW-SD) x
Renin
Resistin
Retinol Binding Protein (RBP)
Rheumatoid Factor (RF)
Rubella IgG
Rubella IgM
Salicylate
Semicarbazine (SEM)
Sex Hormone Binding Globulin (SHBG)
sFlt-1
sLDL
Sodium
Soluble IL-2 Receptor a (sIL-2Ra)
Soluble IL-6 Receptor (sIL-6R)
Soluble Transferrin Receptor (sTfR)
Soluble Tumour Necrosis Factor Receptor 1 (sTNFR I)
Soluble Tumour Necrosis Factor Receptor 11 (sTNFR I1)
Specific Gravity
Streptomycin
Superoxide Dismutase (Ransod)
T Uptake
T3 (Free)
T4 (Free)
T3 (Total)
T4 (Total)
Testosterone
Testosterone (Free)
Tetracyclines (Generic)
Theophylline
Thiamphenicol
Thrombin Time (TT)
Thyroglobulin
Tobramycin
Total Antioxidant Status (TAS)
Toxoplasma gondii IgG
Toxoplasma gondii IgM
Transferrin
Treponema pallidum (Syphilis) IgG
Triglycerides
Trimethoprim
Troponin I
Troponin T
TSH
Tumour Necrosis Factor a (TNFa)
Tylosin
Unconjugated Oestriol
Urea
Uric Acid (Urate)
Urine Osmolality
Urobilinogen
Valproic Acid
Vancomycin
Vanillylmandelic Acid (VMA)
Varicella Zoster Virus (VZV) IgG
Vascular Cell Adhesion Molecule-1 (VCAM-1)
Vascular Endothelial Growth Factor (VEGF)
Vitamin B12
White Blood Cells (WBC)
White Blood Cells Differential (WBC-D)
Zinc
The Benefits of Peer Group Data to your Troubleshooting Process
Drive for more accurate results in your laboratory
We’ve all been there, you’re in the middle of a run of patient tests when you are alerted to an out of control event, such as your analyser is reporting QC results 25% low to target. What do you do? In reality, we all know that the problem is unlikely to correct itself, especially if it’s a calibration or analyser issue. Human error is a potential factor, however all possible causes must be eliminated to proceed with patient testing.
What’s the solution?
ISO 15189:2012 recommends that a laboratory should “have a procedure to prevent patient results in the event of a quality control failure”. Implementing an interlaboratory data management program which features peer group reporting can help you meet this requirement and monitor the results you are producing. Such programs can help detect errors in the analytical phase of patient testing, through the automatic application of pre-programmed QC rules, thus alerting staff to failed results.
Why must Peer Groups be a feature?
A peer group is defined as a “Community in which most or all members have roughly the same characteristics…” (Businessdictionary.com, accessed 2017). In this instance the characteristics could refer to the; instrument, test method or QC material in use. As such peer group programmes could help you detect errors in your laboratory by comparing your results to those who are employing a similar method, instrument and QC to what you are using, i.e. comparing apples for apples. Therefore it is essential that the peer group data you require is available in real-time, to ensure you are accessing the most up-to-date data when reviewing your patient test results.
Scenario
Take the example from the introduction. You’re in the middle of a run of patient tests when you are alerted to an out of control event, such as your analyser is reporting QC results 25% low to target. As part of your troubleshooting procedures, you are able to compare your results to the results of your peer group and note that this is an isolated incident. Consequently, you have eliminated a widespread problem with the QC, reagent or calibrator and narrowed down the root cause to one of the components in your test system. Thus saving you time in the troubleshooting process.
Benefits of Peer Group Comparison
There are a number of benefits to employing peer group comparison in your laboratory. Peer group data comparisons facilitate faster troubleshooting, helping you identify whether the problem you are seeing is unique to your laboratory, or if other laboratories are reporting the same issue. If other laboratories are reporting the same issue it is possible to conclude that there is a widespread problem with either the QC, reagent or calibrator. On the other hand, if it is not occurring within your peer group you will have to investigate further, reviewing your QC processes. As a result, you could resolve issues much quicker by eliminating either a supplier or laboratory issue. Furthermore, you can also eliminate the need for unnecessary repeat tests or instrument maintenance, saving both valuable time and money.
Other characteristics you should look out for
Whilst peer group comparison is a useful feature there are a number of other features you should consider when selecting the right interlaboratory data management program for you. These include;
- Automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics
- Multiple laboratory management on a single platform
- Accessing data anytime, anywhere via PC, laptop or tablet via a web-based platform
- All data charts you may require to assess whether any bias or imprecision issues are present
- Ability to combine data for multiple QC lots, analytes and instruments on a single Levey-Jennings or Histogram chart
- Automated data import via a direct connection to your LIMS
What can Randox offer?
At Randox we are passionate about quality control and believe in producing high-quality material that can streamline procedures for laboratories of all sizes and budgets through our Randox Quality Control brand. Acusera 24.7 Live Online is just one aspect of our extensive laboratory portfolio that has been designed to help you produce results you can trust. With Acusera 24.7 Live Online you can drive for more accurate results by monitoring and interpreting QC data online, anytime, anywhere. With access to an impressive range of features, including the automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics, Acusera 24.7 will ensure analytical quality.
ISO 22870- Are you meeting expectations?
Quality control has recently become crucial in the Point-of-Care (POC) field due to the introduction of ISO 22870 regulations and increased focus in patient safety. Quality control is critical in reducing turnaround time and saving money.
There is now an international standard specifically for POC testing, ISO 22870. This standard is intended to be used in conjunction with the standard for medical laboratories, ISO 15189. This means that aspects relating to Point-of-Care such as training, competence and documentation should be carefully planned, implemented and governed by a quality management system and there is a requirement for QC and EQA to be performed, where available.
POCT is typically carried out by non-laboratory staff, therefore when selecting the appropriate IQC material for POCT there are a number of key characteristics you must consider;
- Format of the material – QC material employed should be liquid stable, requiring no preparation, reducing the likelihood of human error and increasing convenience.
- Value assignment – all values must be accurately assigned. Look out for suppliers who use a large number of independent labs to determine the target value.
- Third party controls – manufactured independently from any specific instrument or method third party controls are designed to deliver unbiased performance assessment.
- Storage – for convenience controls should be liquid stable, as these can be easily stored in a fridge at 2oC – 8oC and won’t need to be shipped on dry ice.
- Stability – a control with a good open vial stability will mean that it can be used for longer with less waste produced, meaning it is more convenient for the medical professional to use.
- Transportation– the liquid stable controls can be conveniently stored at 2oC – 8oC reducing the need to ship on dry ice
- Minimal training– easy to use with little training required, therefore suitable for use by non-laboratory personnel
In addition to IQC, External Quality Assessment (EQA) must also be employed to ensure a comprehensive review of test system performance. It is best to select a programme that offers frequent reporting with a large database of users. This will enable rapid error identification and ultimately accurate and reliable patient testing.
Our Acusera liquid ready-to-use controls include:
- Blood Gas Control– A liquid stable control provided in easy to open ampoules for added convenience and ease-of-use. Assayed, method specific target values are provided for the most common blood gas instruments.
- Liquid Cardiac Control– This is a highly convenient liquid stable cardiac control offering excellent consistency. Assayed, instrument specific target values are provided for 8 cardiac markers, enabling flexibility and consolidation.
- Liquid Urinalysis Control– Liquid control that is compatible for use with both manual and automated methods of dipstick analysis. Available in convenient 12ml vials or 25ml dropper bottles with assayed ranges provided for 13 parameters covering the chemical examination of urine specimens.
- Liquid HbA1c Control– This is another highly convenient liquid ready-to-use control. With an open vial stability of 30 days, keeping waste and costs to a minimum.
Complementary EQA programmes are also available to meet the needs of ISO 22870.
IQCP: Where Are We Now?
What is IQCP?
IQCP stands for Individualized Quality Control Plan, and it is an all-inclusive approach to creating a customized quality control plan for a laboratory.
IQCP focuses on assuring quality in the lab using more in-depth means than simply carrying out a certain number of QC tests at a specific frequency. Many different aspects of laboratory operations will be evaluated, such as the test system, reagents, environment, testing personnel etc.
Where are we now?
As of January 2016, many labs in and outside the USA have implemented their IQCP’s, but what impact has this had on day-to-day operations?
In order to gauge the overall effectiveness and user-experience of implementing IQCP, Westgard QC1 conducted a survey for all IQCP participants both in the USA and globally.
Opinions were mixed regarding the effectiveness of IQCP:
Positive Opinions of IQCP
- Some users found that IQCP decreased the number of QC materials required
- There is a greater emphasis on the pre and post-analytic phases of testing, thus improving process error identification
- Over half of global survey participants revealed that their IQCP identified unacceptable risk(s) in their test system, thereby creating a more robust process
- Of the labs whose IQCP’s were inspected in the USA, 96.3% were deemed adequate by the relevant regulatory bodyies
- Identification of errors can lead to additional personnel training, thereby increasing the knowledge and expertise of laboratory staff
Negative Opinions of IQCP
- Due to the length of time taken to create a single IQCP, coupled with the additional expense, several survey participants found that the benefits of IQCP did not justify using so many resources in its implementation
- Many labs raised concerns regarding the availability of guidance in developing an IQCP. Participants complained that useful guidelines were not provided quickly enough, and labs had to rush their IQCP implementation.
- Several survey participants felt as though there was widespread confusion over IQCP. Participants highlighted that the volume of questions from laboratory professionals proves that IQCP was not introduced by regulatory bodies in an organized or effective manner
- Some labs surveyed voiced the opinion that IQCP evaluation needs to be more standardized, and that inspections can either be too lenient or too stringent.
ISO 15189:2012 requirements
As with any new system, feedback is important for further refinement. IQCP appears to be a step in the right direction for the advancement of laboratory QC. According to Westgard’s survey1, only around 30% of US respondents were satisfied, showing that labs still feel improvements need to be made. Inspectoral standardization, or more concise, straightforward guidelines on IQCP implementation could be potential improvements for regulatory bodies to consider.
We would love to know your thoughts on the subject. Send us an email at acusera@randox.com.
References:
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Westgard QC. (2016).2016 IQCP Users Survey. Available: https://www.westgard.com/iqcp-user-survey-comments.htm. Last accessed 25-Oct-16.
Liquid HbA1c Quality Control
Conveniently supplied liquid ready-to-use the Liquid HbA1c control is ideally suited to both clinical laboratories and POCT helping to significantly reduce preparation time. With a stability of 30 days waste and costs are also kept to a minimum.
Features & Benefits
- Liquid ready-to-use
- Human based whole blood
- Assayed target values
- Convenient bi-level pack covering clinically relevant decision levels
- Stable to expiry date at 2°C – 8°C
- Open vial stability of 30 days at 2°C – 8°C
Description Size Analytes Cat No
Liquid HbA1c Control 2 x 2 x 0.5 ml 1 HA10155
Liquid HbA1c Control Level 1 6 x 1 ml 1 HA10224
Liquid HbA1c Control Level 2 6 x 1 ml 1 HA10225
Analytes
HbA1c (Haemoglobin A1c)
Does Your QC Cover Clinically Relevant Ranges?
Following recommendations from recognized institutions such as ISO and CLIA, more laboratories are using third party controls than ever before. However, great care should be taken when choosing which third party control to use. A number of factors should be considered, and primarily among these is whether the control challenges the complete Clinical Range and the Medical Decision Levels. ISO 15189:2012 states that ‘The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made’.
Measuring the Complete Clinical Range
It is important to assess the full clinical range of an assay i.e. the range between the lowest and highest results which can be reliably reported. In order to make sure a laboratory instrument is working across the full clinical range, a QC which covers low, normal and elevated concentrations must be used.
Question: “If the full clinical range isn’t covered by QC, how will we know whether patient results which fall outside the range of quality controls are accurately reported?”
What are Medical Decision Levels?
Medical Decision Levels (MDL) are the analyte values at which medical professionals can determine whether a patient may be suffering from a certain condition. The MDL is determined by a consensus of medical professionals and clinical research. Patients’ test results are compared to the MDL and appropriate diagnoses or medical interventions can be made.
For example, the MDL of Glucose can indicate a certain diabetic status:
| Analyte | Medical Decision Level | Diagnostic Status |
| Glucose (fasting) | <100 mg/dL | Non-Diabetic |
| 100–125 mg/dL | Pre-Diabetic | |
| >125 mg/dL | Diabetic |
Competitor QC
Many QC manufacturers ‘cut corners’ in an attempt to keep costs down, which often results in the sale of controls which do not cover the complete clinical range or vital medical decision levels. Below is an example of the Glucose concentrations present in a competitor control:
Competitor Chemistry Control Level 1 – 68 mg/dL
Competitor Chemistry Control Level 2 – 134 mg/dL
Competitor Chemistry Control Level 3 – 386 mg/dL
In the examples above, the competitor’s level 1 control covers the non-diabetic MDL, but the level 2 control is not within the ‘Pre-Diabetic’ decision range. The level 3 control is also much higher than can be expected for an elevated diabetic patient result (200 mg/dL or more).
Randox QC
Due to the superior manufacturing process used by Randox, QC target values are consistently within the MDL of tests. For example, the Glucose concentrations present in our Liquid Assayed Chemistry Premium Plus control are:
Level 1 – 57 mg/dL
Level 2 – 114 mg/dL
Level 3 – 236 mg/dL
The MDL for Glucose is covered by the Randox control, meaning laboratory professionals can be confident that patient results will be accurately interpreted.
Immunoassay Medical Decision Levels
Controls which cover the MDL can reduce the number of Quality Controls required by laboratories. For example, Randox Acusera Lyophilised Immunoassay Controls contain particularly low levels of TSH, Ferritin and Vitamin B12 in the Level 1 control, eliminating the need for an additional control at extra expense:
| Analyte | Medical Decision Level | Randox Level 1 IA Control | Competitor Level 1 IA Control |
| TSH | 0.1 or 0.27 uU/mL | 0.15uU/mL | 0.37 uU/mL |
| Vitamin B12 | 190 pmol/L | 174 pmol/L | 327 pmol/L |
| Ferritin | 12 ng/mL | 11.1 ng/mL | 49.6 ng/mL |
In this example the competitor offers an anaemia control with lower levels of TSH, Vitamin B12 and Ferritin at an additional cost. With Randox Acusera QC, only one control is required for anemia monitoring and detection.
Demand for external support driving growth of EQA
“In Vitro Diagnostics (IVD) Quality Controls Market” recently published by Markets and Markets has highlighted an overall significant growth within the Quality Control Market. Further growth is anticipated in the coming years with the Markets and Markets report estimating that the IVD QC market will be worth $979 million.
One area that is currently experiencing growth within this sector is the EQA segment, which Markets and Markets estimates to command a 6.6% share of the overall IVD market. The report is crediting growth within this segment to you, the customer, stating “…various end users or customers of IVD quality control products mostly prefer external support to run their quality control activities. For this, market players are largely focusing on providing external quality assurance (EQA) support”. As such companies such as Randox are being approached to provide EQA for a range of small, independent laboratories and large laboratory chains alike.
What other factors have contributed to this growth?
The adoption of ISO15189 and other similar standards is becoming mandatory in many countries, as discussed in a previous blog post. Accreditation highlights the accuracy and reliability of the patient results being released. ISO15189 states that “The laboratory shall participate in interlaboratory comparisons such as those organised by external quality assessment or proficiency testing schemes”. Therefore laboratory managers are employing EQA programmes in their laboratory to meet such requirements. EQA also enables laboratories to meet other accreditation requirements such as peer comparison and clinically relevant testing.
Selecting the right EQA for you
When selecting the right EQA scheme for your laboratory there are a number of considerations to be made; sample frequency, peer group numbers, report format, report turnaround and so on. According to a survey conducted by Randox Quality Control 55% of respondents listed sample frequency as the most important feature to be considered when selecting an EQA scheme. Sample frequency is an ongoing debate regarding EQA. However, schemes with frequent reporting will allow you to easily pinpoint when an error occurred and implement corrective actions with minimal disruption. Also making the top three key factors in this survey were; quality samples and peer group numbers.
What can Randox Quality Control offer?
As the largest international EQA scheme available on the market RIQAS offers laboratories around the world assurance that the results they are releasing are accurate and reliable. With more than 40,000 participant in 124 countries and 32 flexible programmes we are certain that the external support we offer for your quality control activities will provide you with the upmost confidence in your laboratory’s performance. Furthermore with our programmes accepted by national and international accreditation bodies worldwide employing RIQAS can help you gain accredited status providing your end users with peace of mind. With other benefits such as programme consolidation, rapid report turnaround, easy to read at-a-glance reporting and the ability to register up to 5 instruments per programme at no extra cost why don’t you contact us today and find out how we can support your quality control activity?
To request a visit from a QC consultant contact us via acusera@randox.com
Microalbumin Calibrator
Dedicated Microalbumin calibrator designed for use with Microalbumin assays on a wide range of clinical analysers. 6 levels are provided in a liquid ready-to-use format making it both easy and convenient to use.
Features & Benefits
- Liquid ready-to-use
- 100% human serum
- Stable to expiry date at 2oC – 8oC
- Once opened stable to expiry date at 2oC – 8oC
| Description | Size | Analytes | Cat No | |
|---|---|---|---|---|
| Microalbumin Calibrator Series | 6 x 2ml | 1 | MA1567 | |
Analytes
- Microalbumin