7th May 2014

TABLE OF CONTENTS
I- INTRODUCTION........................................................................................................................................................................................................... 3

II- QCP INSTRUMENTS, CONTROL PRODUCTS AND PEER GROUPS ................................................................................................................................ 4

II-1- HEMATOLOGY INSTRUMENTS & CONTROL PRODUCTS .................................................................................................................................... 4

II-2- HEMATOLOGY PEER GROUPS ....................................................................................................................................................................... 5
II-3- HEMATOLOGY PARAMETERS ........................................................................................................................................................................ 6
II-4- CLINICAL CHEMISTRY INSTRUMENT & CONTROL PRODUCTS ......................................................................................................................... 10
II-5- CLINICAL CHEMISTRY PEER GROUPS ........................................................................................................................................................... 11
II-6- CLINICAL CHEMISTRY PARAMETERS ........................................................................................................................................................... 12

III- HOW TO USE QCP .................................................................................................................................................................................................... 17

III-1- WEBSITE ADDRESS ................................................................................................................................................................................... 17

III-2- SIGN IN ................................................................................................................................................................................................... 18

III-3- ENROLL.................................................................................................................................................................................................... 19

III-4- INSTRUMENTS ......................................................................................................................................................................................... 21

III-4-1- Registration of an instrument .................................................................................................................................................. 22
III-4-2- Levels and Parameters ........................................................................................................................................................... 22
III-4-3- Registration of additional instrument(s) ................................................................................................................................... 24
III-4-4- Update the instrument information ......................................................................................................................................... 26

III-5- SUBMIT RESULTS ..................................................................................................................................................................................... 26

III-5-1- DETAIL DATA page ................................................................................................................................................................ 29
III-5-1-A- Manual input of daily results ................................................................................................................................ 29
III-5-1-B- Upload data from an external device .................................................................................................................... 31
III-5-2- SUMMARY DATA page ............................................................................................................................................................ 38

III-6- EDITING/MODIFYING/DELETING SUBMITTED RESULTS ................................................................................................................................ 40

III-7- STATISTICAL REPORTS ............................................................................................................................................................................. 41

III-7-1- Obtain the Statistical Reports .................................................................................................................................................. 41

III-7-2- Description of the Statistical Reports ........................................................................................................................................ 42
III-7-2-1- All Peer Comparison ............................................................................................................................................ 43
III-7-2-2- All Peer History................................................................................................................................................... 44
III-7-2-3- Levey-Jennings Charts ........................................................................................................................................ 45
III-7-2-4- Levey-Jennings Charts Detailed ............................................................................................................................ 46
III-7-2-5- Performance Index ............................................................................................................................................. 47
III-7-2-6- Performances, Comparisons and uncertainties ....................................................................................................... 48
III-7-2-7- History uncertainties ........................................................................................................................................... 50
III-7-2-8- Other Instrument Groups .................................................................................................................................... 51
III-7-2-9- Certificate .......................................................................................................................................................... 52

III-8- SPECIFIC REPORTS .................................................................................................................................................................................. 52

III-8-1- Activity/Data sent report ........................................................................................................................................ 53
III-8-2- QCP Alert report .................................................................................................................................................... 54
III-8-3- User Issue report................................................................................................................................................... 54

III-9- SPECIFIC PEER GROUPS ............................................................................................................................................................................ 55

III-9-1- Creation of a Specific Peer Group ............................................................................................................................ 55
III-9-2- Status of a Specific Peer Group ............................................................................................................................... 57
III-9-3- Modification/Update of a Specific Peer Group ........................................................................................................... 58

III-10- MAIN USER & USERS................................................................................................................................................................................ 59

III-10-1- Create MAIN USER ............................................................................................................................................... 59
III-10-2- Setup additional user(s) & Assign instrument(s) ..................................................................................................... 59
III-10-3- Delete users ........................................................................................................................................................ 65

III-11- INACTIVATION OF AN INSTRUMENT ......................................................................................................................................................... 65

IV- OTHER ONLINE FUNCTIONS .................................................................................................................................................................................... 66

IV-1- OTHER FUNCTIONS IN THE SIGN IN PAGE ................................................................................................................................................... 66

IV-2- OTHER FUNCTIONS IN THE USERS PAGE ..................................................................................................................................................... 67
IV-3- OTHER FUNCTION IN THE REPORTS PAGE ................................................................................................................................................... 68
IV-4- OTHER FUNCTIONS IN ALL PAGES ............................................................................................................................................................... 69

V- SCHEDULE ................................................................................................................................................................................................................ 70

V-1- QC DATA SUBMISSION ................................................................................................................................................................................ 70

V-2- STATISTICAL REPORTS ............................................................................................................................................................................... 70

VI- GLOSSARY ....................................................................................................................................................................................... 71

2
 I- INTRODUCTION

Clinical Laboratories are encouraged by regulatory and accreditation organizations to participate in Interlaboratory Comparison
Surveys (Proficiency Testing) for the assessment of the analytical performance of their in vitro diagnostic analyzers (ISO/CEI
43-1 guide).

To help laboratories participate in this quality process, HORIBA Medical enhances the service:

ABX Quality Control Program or QCP is an Online Interlaboratory Comparison Program dedicated to all Hematology & Clinical
Chemistry analyzers of HORIBA Medical.

By submitting Internal Quality Control results online to QCP, a participating laboratory can obtain real time peer group statistical
reports.

IMPORTANT

- Participation in QCP requires the exclusive use of HORIBA Medical instruments, reagents and control products

- For enrollment fees and conditions of participation, please contact your Local Representative

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 II- QCP INSTRUMENTS, CONTROL PRODUCTS AND PEER GROUPS

II-1- HEMATOLOGY INSTRUMENTS & CONTROL PRODUCTS

The following hematology instruments and control products are offered in QCP:

INSTRUMENTS and CONTROLS

Control Products ABX Pentra 120 ABX Pentra 80 ABX Pentra 60 ABX Micros series
series series series

Pentra DX Nexus Pentra XLR ABX Pentra 60C+ ABX Micros ABC Vet

ABX Pentra DX120 ABX Pentra XL80 ABX Pentra 60 ABX Micros 45

Pentra DF Nexus ABX Pentra 80 Pentra ES 60 ABX Micros 60

ABX Pentra DF120 Pentra MS 60 ABX Micros CRP

ABX Minotrol Retic
ABX Minotrol CRP
ABX Minotrol 16
ABX Difftrol

ABX Erytrol

ABX Pentra 120 Retic ABX Micros CRP 200

ABX Pentra 120 ABX Micros ES60

ABX Micros ESV

Microsemi CRP

Pentra MS CRP

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II-2- HEMATOLOGY PEER GROUPS

QCP uses 10 Hematology peer groups for statistical reports:

Each group is constituted of different instruments of the same Series and same Product Control.

It is an important point, because there is no comparison possible between instruments of a different Series or Control Product.

Hematology product Controls

ABX ABX Minotrol
Series Hematology ABX Minotrol Retic ABX Erytrol
Instruments ABX Difftrol Minotrol 16 CRP
3 Levels
3 Levels 3 Levels 3 Levels 3 Levels

ABX Pentra
120
ABX Pentra Difftrol - Minotrol 16
DF120 Pentra 120 -Pentra 120
Pentra DF DX,DF DX,DF
ABX Pentra Nexus Pentra Pentra
120 ABX Pentra DX,DF DX,DF
120 Retic Nexus Nexus Minotrol
Pentra DX Group Group Retic Erytrol
Nexus Pentra 120 Pentra 120
retic,DX DX, Pentra
ABX Pentra Pentra DX DX Nexus
DX 120 Nexus,Pentra Group
Pentra XLR XLR
Difftrol - Minotrol 16 Group
ABX Pentra Pentra 80, - Pentra 80,
80 ABX Pentra XL80, XLR XL80, XLR
XL80 Group Group
ABX Pentra
80
ABX Pentra Difftrol - Minotrol 16
60C+ ABX Pentra - ABX
ABX Pentra 60, 60C+, Pentra 60,
ABX Pentra 60 Pentra 60C+,
60 Pentra ES60 ES60 Pentra
Group ES60
Group
Pentra MS60

ABX Micros
ABC Vet

ABX Micros
45
ABX Micros
ES60
ABX Micros
ABX Micros ESV
ABX Micros Minotrol 16
CRP 200 - Micros
ABX Micros series
60 analyzers
ABX Micros Group
CRP Minotrol
Microsemi CRP
CRP Group
Pentra MS
CRP

II-3- HEMATOLOGY PARAMETERS

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 Hematology Control Product: ABX Difftrol
Ex. : Lot PX034

Hematology Parameters
Hematology Instrument
Abbreviation Description Units

103/mm3
WBC White Blood Cells 109/L

106/mm3 1012/L
RBC Red Blood Cells 106/µL
g/dL
HGB Hemoglobin g/L
mmol/L
%
HCT Hematocrit
L/L
µm3
MCV Mean Corpuscular Volume
fL
pg
MCH Mean Corpuscular Hemoglobin
fmol
ABX Pentra 60
g/dL
ABX Pentra 60 C+
MCHC Mean Corpuscular Hemoglobin Concentration g/L
ABX Pentra ES 60
mmol/L
Pentra MS 60
Pentra MS CRP RDW Red Cell Distribution Width %

Pentra XLR PLT Platelets 103/mm3 109/L

ABX Pentra 80
ABX Pentra XL80 µm3
MPV Mean Platelet Volume
fL
Pentra DX Nexus
LYM % Lymphocytes Percentage %
Pentra DF Nexus
ABX Pentra DX120
ABX Pentra DF120 LYM # Lymphocytes Absolute Number #
ABX Pentra 120
ABX Pentra 120 Retic MON % Monocytes Percentage %

MON # Monocytes Absolute Number #

NEU % Neutrophils Percentage %

NEU # Neutrophils Absolute Number #

EOS % Eosinophils Percentage %

EOS # Eosinophils Absolute Number #

BAS % Basophils Percentage %

BAS # Basophils Absolute Number #

6
 Hematology Control Product : ABX Minotrol 16
Ex. : Lot MX034

Hematology Parameters
Hematology Instrument
Abbreviation Description Units

ABX Micros ABC Vet 103/mm3

WBC White Blood Cells 109/L
ABX Micros 45
ABX Micros 60 106/mm3
ABX Micros CRP RBC Red Blood Cells 1012/L
106/µL
ABX Micros CRP 200
ABX Micros ES60 g/dL
ABX Micros ESV HGB Hemoglobin g/L
Microsemi CRP mmol/L
%
HCT Hematocrit
ABX Pentra 60 * L/L
ABX Pentra 60 C+ * µm3
MCV Mean Corpuscular Volume
ABX Pentra ES 60 fL
Pentra MS 60 pg
MCH Mean Corpuscular Hemoglobin
Pentra MS CRP fmol
g/dL
Pentra XLR MCHC Mean Corpuscular Hemoglobin Concentration g/L
ABX Pentra 80 * mmol/L
ABX Pentra XL80 *
RDW Red Cell Distribution Width %
Pentra DX Nexus
103/mm3
Pentra DF Nexus PLT Platelets
109/L
ABX Pentra DX120 *
ABX Pentra DF120 *
ABX Pentra 120 *
ABX Pentra 120 Retic * µm3
MPV Mean Platelet Volume
fL

* CBC parameters only

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 Hematology Control Product : ABX Minotrol CRP
Ex. : Lot MC014

Hematology Parameters
Hematology Instrument
Abbreviation Description Units

103/mm3
WBC White Blood Cells 109/L

106/mm3 1012/L
RBC Red Blood Cells 106/µL
g/dL
HGB Hemoglobin g/L
mmol/L
%
HCT Hematocrit
L/L
µm3
MCV Mean Corpuscular Volume
fL
pg
MCH Mean Corpuscular Hemoglobin
fmol
ABX Micros ABC Vet g/dL
ABX Micros 45 MCHC Mean Corpuscular Hemoglobin Concentration g/L
ABX Micros 60 mmol/L
ABX Micros CRP
ABX Micros CRP 200 RDW Red Cell Distribution Width %
ABX Micros ES60
ABX Micros ESV PLT Platelets 103/mm3 109/L
Microsemi CRP
µm3
Pentra MS CRP MPV Mean Platelet Volume
fL

LYM % Lymphocytes Percentage %

LYM # Lymphocytes Absolute Number #

MON % Monocytes Percentage %

MON # Monocytes Absolute Number #

GRA % Granulocytes Percentage %

GRA # Granulocytes Absolute Number #

mg/dL
CRP C Reactive Protein
mg/L

8
 Hematology Control Product : ABX Minotrol Retic
Ex. : Lot RX034

Hematology Parameters
Hematology Instrument
Abbreviation Description Units

RETIC % Reticulocyte Percentage %

#
Pentra DX Nexus RETIC # Reticulocyte Absolute Number
106/µL
ABX Pentra DX120
ABX Pentra 120 Retic MFI Mean Fluorescence Index %
Pentra XLR
RBC Red Blood Cells 106/µL

Number of channels of the maxi. peak of

PIC Chan
the mature RBC

Hematology Control Product : ABX Erytrol

Ex. : Lot NX034

Hematology Parameters
Hematology Instrument
Abbreviation Abbreviation Units

103/mm3
WBC White Blood Cells
109/L

103/mm3
CWBC Corrected White Blood Cells
Pentra DX Nexus 109/L
ABX Pentra DX120
ERB % Erythroblast Percentage %

ERB # Erythroblast Absolute Number #

ESR - (With temperature correction)

Hematology Parameters
Hematology Instrument
Abbreviation Abbreviation Units

Auto compact StaRRsed

Inversa 24 ML SR (VS) Sedimentation rate mm/h

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II-4- CLINICAL CHEMISTRY INSTRUMENT & CONTROL PRODUCTS

The following clinical chemistry instrument and control products are offered in QCP:

INSTRUMENT

ABX Pentra 400 / Pentra C400 / Pentra C200

CONTROL PRODUCTS

1. ABX Pentra N Control

2. ABX Pentra P Control
3. ABX Pentra Urine Control
4. ABX Pentra Immuno I Control
5. ABX Pentra Immuno II Control
6. ABX Pentra CK Control
7. ABX Pentra Low CRP Control
8. ABX Pentra Micro ALB control L/H
9. ABX Pentra Protein Control
10. ABX Pentra CO2 Control
11. CO2 Control (USA only)

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II-5- CLINICAL CHEMISTRY PEER GROUPS

QCP uses 10 Clinical Chemistry peer groups for statistical reports:

Clinical Chemistry Instrument

Clinical Chemistry Controls Levels ABX Pentra 400 / pentra C400 / pentra C 200

ABX Pentra N Control None

N/P Control
ABX Pentra P Control None

Urine Control
ABX Pentra Urine Control Low / High

ABX Pentra Immuno I Control Low / High Immuno I Control

ABX Pentra Immuno II Control Low / High

Immuno II Control

ABX Pentra CK Control None CK Control

ABX Pentra Low CRP Control None Low CRP Control

ABX Pentra Micro-Albumin Control Low / High Micro ALB Control

ABX Pentra Protein Control Low / High Protein Control

CO2 Control
ABX Pentra CO2 Control None

CO2 Control (USA only) Level1 / Level2 CO2 Control

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II-6- CLINICAL CHEMISTRY PARAMETERS

ABX Pentra N Control & ABX Pentra P Control

Parameters - 1/2

QCP Code Methodology Signification Units

µmol/L
ALB Bromocresol green Albumin g/L
g/dL

U/L
ALP IFCC Alkaline Phosphatase
µkat/L

IFCC
U/L
ALT (UV without pyridoxal Alanine Aminotransferase
µkat/L
phosphate)

U/L
AMY EPS-G7 Amylase
µkat/L

IFCC
U/L
AST (UV without pyridoxal Aspartate Aminotransferase
µkat/L
phosphate)

mmol/L
BUN GLDH (UV technique) Blood Urea Nitrogen
mg/dL

mmol/L
mg/dL
CA OCP Calcium
mEq/L (mval/L)
g/L
mmol/L
mg/dL
CA-AS Arsenazo Calcium arsenazo
mEq/L (mval/L)

µmol/L
mg/L
CREA-ENZ Enzymatic creatinine Enzymatic creatinine
mg/dL
mmol/L
µmol/L
mg/L
CREA_RB Jaffe/Alkaline Picrate Creatinine jaffe rate blank
mg/dL
mmol/L
µmol/L
mg/L
CREA3 Jaffe/Alkaline Picrate Creatinine Jaffe
mg/dL
mmol/L
mmol/L
CHOL SRM909 Chol.Esterase/Oxidase Cholesterol g/L
mg/dL
mmol/L
g/L
CHOL AK Chol.Esterase/Oxidase Cholesterol Abell-Kendal
mg/dL

U/L
CK IFCC/DGKC Creatine Kinase
µkat/L

mmol/L
Cl-E Direct Potentiometry Chloride mg/dL
mEq/L (mval/L)

µmol/L
DBIL DCA Direct Bilirubin mg/L
mg/dL

µmol/L
FE Ferene Iron mg/L
µg/dL

SZASZ Carboxilated U/L

GGT Gamma Glutamyltransferase
substrate µkat/L

12
 ABX Pentra N Control & ABX Pentra P Control

Parameters - 2/2

QCP Code Methodology Signification Units

mmol/L
GLUK Hexokinase Glucose Hexokinase g/L
mg/dL

mmol/L
GLUP Trinder Glucose PAP g/L
mg/dL

mmol/L
HDL Polyanions/Detergent HDL Cholesterol, Direct g/L
mg/dL

mmol/L
K-E Direct Potentiometry Potassium mg/dL
mEq/L (mval/L)

mmol/L
Lactate oxidase /
LACT Lactic Acid mg/L
Peroxidase
mg/dL

U/L
LDH DGKC DGKC Lactate Dehydrogenase DGKC
µkat/L

LDH IFCC IFCC Lactate Dehydrogenase IFCC U/L

µkat/L

mmol/L
Detergent/
LDL LDL Cholesterol, Direct g/L
Chol.Esterase/ Oxidase
mg/dL

U/L
LIP Colorimetric Lipase
µkat/L

mmol/L
mg/dL
MG Xylidyl Blue Magnesium
mEq/L (mval/L)
g/L
mmol/L
Na-E Direct Potentiometry Sodium mg/dL
mEq/L (mval/L)
mmol/L
Ammonium Molybdate mg/L
PHOS Phosphorus
UV mg/dL
g/L
µmol/L
TBIL DCA Total Bilirubin mg/L
mg/dL

g/L
TP100 Biuret Total Protein CP
g/dL

g/L
TP300 Biuret Total Protein CP
g/dL

mmol/L
TRIG PAP Triglycerides g/L
mg/dL

µmol/L
UA Uricase/Peroxidase Uric Acid mg/L
mg/dL

mmol/L
UREA GLDH (UV technique) Urea g/L
mg/dL

13
 ABX Pentra Urine Control Parameters

QCP Code Methodology Signification Units

U/L
AMY EPS-G7 Amylase
µkat/L

mmol/L
mg/dL
CA-OCP OCP Calcium
mEq/L (mval/L)
g/L
µmol/L
mg/L
CREA-ENZ Enzymatic creatinine Creatinine enzymatic
mg/dL
mmol/L
mmol/L
GLUP Trinder Glucose PAP g/L
mg/dL
mmol/L
Ammonium Molybdate mg/L
PHOS Phosphorus
UV mg/dL
g/L
g/L
TPU Pyrogalol red Urinary Proteins mg/L
mg/dL

mmol/L
UREA GLDH (UV technique) Urea g/L
mg/dL

µmol/L
UA Uricase/Peroxidase Uric Acid mg/L
mg/dL

mmol/L
CA-AS Arsenazo Calcium arsenazo mg/dL
mEq/L (mval/L)

mmol/L
CHOL AK Chol. Esterase/oxydase Cholesterol Abell-Kendal g/L
mg/dL

14
 ABX Pentra Immuno I Control

QCP Code Methodology Signification Units

mg/L
CRP 2 Latex TIA C – Reactive Protein mg/dL

RF Latex TIA Rheumatoid Factor IU/mL

ASO Latex TIA Anti - Streptolysin O IU/mL

ABX Pentra Immuno II Control

QCP Code Methodology Signification Units

ng/mL
MYO Latex TIA Myoglobin µg/L
µg/dL

ng/mL
FERR Latex TIA Ferritin µg/dL

ABX Pentra CK Control

QCP Code Methodology Signification Units

U/L
CK IFCC/DGKC Creatinine Kinase NAC
µkat/L

U/L
CK-MB Immunology method Creatinine Kinase MB
µkat/L

ABX Pentra Low CRP Control

QCP Code Methodology Signification Units

CRP 2 Latex TIA C – Reactive Protein mg/L

ABX Pentra Micro – Albumin Control

QCP Code Methodology Signification Units

M ALB mg/L
TIA Micro-Albumin
AlbT-U mg/dL

15
 ABX Pentra Protein Control

QCP Code Methodology Signification Units

g/L
ALB 2 TIA Albumin
g/dL

ABX Pentra CO2 Control

QCP Code Methodology Signification Units

CO2 UV Enzymatic Bicarbonate mmol/L

CO2 Control (USA only)

QCP Code Methodology Signification Units

CO2-US UV Enzymatic Bicarbonate mmol/L

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 III- HOW TO USE QCP

III-1- WEBSITE ADDRESS

To use QCP go to the following internet address:

http://qcp.horiba-abx.com

Contextual Help for each page is also available online by clicking QCP Help in the upper right of the page.

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III-2- SIGN IN

If you have already enrolled in QCP or have received an email saying you are enrolled, enter your email and password, and
click SIGN IN or press ENTER.

You will be able to submit results for your registered instruments and view your statistical reports as soon as your instrument(s)
have been activated by HORIBA Medical.

18
III-3- ENROLL

First time QCP users will need to register an email address and password by clicking ENROLL.

IMPORTANT

According to your location, you may have been enrolled by your local HORIBA Medical Representative.
For more information, please contact your local HORIBA Medical Representative.

On the ENROLL page, complete the online form for your laboratory.

To move from one field to another you can use the TAB key.

The bold fields are required fields.

Click on View HORIBA Medical Terms and Conditions to read about the terms and conditions.

Before clicking SUBMIT, you will have to check: “I accept the Terms and Conditions”

19
IMPORTANT

According to your location, you may have been enrolled by your local HORIBA Medical Representative.
For more information, please contact your local HORIBA Medical Representative.

NOTE

 The person who registers the information in the ENROLL page, or, the person who has been enrolled by the local HORIBA
Medical Representative will be identified by QCP as the MAIN USER [see III-9 MAIN USER & USERS]. In this example, Dr
Jacques Meyer is the MAIN USER.
 Registration information can be updated by the MAIN USER at any time on the USERS page.
 The MAIN USER may also setup any number of additional users and assign them instruments [see III-9-2- Setup additional
user(s) & Assign instrument(s)]

20
III-4- INSTRUMENTS

After you have clicked SUBMIT on the ENROLL page, a welcome message will be displayed at the top of the INSTRUMENTS
page.

At the same moment, you will be sent by email your password to access QCP. You will be able to change this password in the
USERS page after you have signed in QCP.

You will need to complete this page for each instrument & control product combination.

To move from one field to another you can use the TAB key

III-4-1- Registration of an instrument

One instrument can be registered with several control products.

Each instrument & control product combination will require a separate registration with a unique “Instrument Name” for each
combination, such as the name “PDX120-Difftrol” for the combination ABX Pentra DX120 & ABX DIFFTROL.

You are free to choose the name you want for the field “Instrument Name”, but you will need a unique name for each
combination of instrument & control product.

21
You will enter:
- Instrument Name
- Instrument Model
- Serial Number
- Control Product

IMPORTANT

The correct SERIAL NUMBER is mandatory for appropriate functioning of the QCP system. Please, make sure it is the exact
serial number displayed at the back of the instrument.

Once the Control Product is selected from the dropdown box, the corresponding Levels and Parameters will appear.

III-4-2- Levels and Parameters

After registering your instrument & control product combination, you will select the following elements:

- Levels to report
- Method of calibration (Standard or Instrument Correlation)
- A Unit for each Parameter (All the parameters are selected by default; you may hide one or several by deselecting the
corresponding check button)
- Reagent
- Calibration product

Click SUBMIT.

22
A message in blue will appear at the top of the page after you submit this information:

“You may now enter Detail Data and Summary Data. Once you receive an email saying your instrument has been activated by
HORIBA Medical you will be able to View Reports”

At this point, you may submit QC results which will be stored in the QCP system, but without being included in the peer group.
Once you receive an email saying your instrument has been activated by HORIBA Medical and the field on the INSTRUMENTS
STATUS changes from “PENDING” to “ACTIVE”, your data will be included in the peer group and you will have access to
statistical reports.

23
III-4-3- Registration of additional instrument(s)

To register each new instrument & control product combination, the above steps must be followed [see III-4-1- Registration of
an instrument, III-4-2- Levels and Parameters]

You will be able to register as many combinations of instrument & control product as needed.

Already registered instruments will be displayed in the instrument dropdown box.

24
For each new combination instrument & control product that you add and submit, a message in blue will appear at the top of
the page:

“You may now enter Detail Data and Summary Data. Once you receive an email saying your instrument has been activated by
HORIBA Medical you will be able to View Reports”

At this point, you may submit QC results which will be stored in the QCP system, but without being included in the peer group.
Once you receive an email saying your instrument has been activated by HORIBA Medical and the field on the INSTRUMENTS
STATUS changes from “PENDING” to “ACTIVE”, your data will be included in the peer group and you will have access to
statistical reports.
25
III-4-4- Update the instrument information

A MAIN USER [see III-9 MAIN USER & USERS] may change all but the instrument model, the control product and the serial
number for an instrument:

- Select the Instrument Name from the dropdown box

- Make the changes in the appropriate fields
- Click SUBMIT

III-5- SUBMIT RESULTS

There are 2 pages for submitting results:

1/ DETAIL DATA page

 Upload data from an external device.
 Manual input of daily results.

2/ SUMMARY DATA page

Manual input of summary results

26
NOTE
At the beginning of the month you will have the option to enter data on BOTH the SUMMARY and DETAIL pages.
Once you enter data on one of these two pages you will not be allowed to enter data for the same Month/Lot/Level on the
other page.

Example
1) If you enter data on the DETAIL DATA page for 2013/10 PX034 Low, then 2013/10 PX034 Low will not appear as an option
on the SUMMARY DATA page for the same instrument.
2) 2013/10 PX034 Normal and 2013/10 PX034 Low High would appear as options on both the DETAIL DATA and SUMMARY
DATA pages until data was entered by the customer for Normal or High.

NOTES ABOUT SUBMITTING RESULTS

1/ Data entry errors or out of range values will appear in red.

Pointing the cursor on a red value will display the target values and the ranges expected for the parameter that has a red value.

27
2/ Any comments you enter will reach HORIBA Medical and will be taken into account for the statistical processing of the results
you submitted.

3/ “*” beside the “Lot/Level” means data has already been entered and stored as a run for this particular Year/Month/Lot/Level.

28
4/ You may enter data for a prior or current month.

You can choose to receive the current month’s reports by email. You will need to view prior months’ reports using the REPORTS
page in QCP.

5/ QCP is able to process values with commas and decimal points.

III-5-1- DETAIL DATA page

III-5-1-A- Manual input of daily results

Click on DETAIL DATA and follow these steps to enter daily results for each parameter:

Step 1
Select Instrument Name

Step 2
Select the Year/Month/Lot/Level

Step 3
Enter date
Enter time (not required but this helps to identify multiple runs)
Enter your data (QC daily results for each parameter)
To move from one field to another you can use the TAB key.

Step 4
Click SUBMIT

29
Your submitted data will appear as a new run along with a message in blue at the top of the page.

30
III-5-1-B- Upload data from an external device

III-5-1-B-a- External device plugged in the ABX Pentra ML

The hematology instruments may be connected to our external data management: ABX Pentra ML (Multi-Link).

This configuration allows the export of QC data of one instrument, one control lot and three levels with USB key which will allow
the automatic upload of QC results into QCP (via the USB key) without any manual input.

ABX Micros 45
ABX Micros ES60
ABX Pentra 60
Pentra DX Nexus ABX Pentra XL80

ABX Micros ESV60 ABX Micros ABC Vet

ABX Pentra 60C+ *
ABX Pentra DF120

ABX Pentra 80
ABX Micros CRP ABX Micros CRP200

Pentra ES60

ABX Pentra DX120

ABX Micros 60 MicrosEmi CRP

Pentra MS 60

Pentra XLR
ABX Pentra 120 * Pentra MS CRP
ABX Pentra 120 Retic *

High Range Mid Range Low Range

QC QC
EIGHT STATISTICAL
values values
REPORTS
IN REAL TIME

USB Key
ABX Pentra ML QCP website
http://qcp.horiba-abx.com

*: If used without the ABX Pentra ML, these analyzers have the ability to export QC results to an external device for an upload
into QCP: From version 2.4.1 for ABX Pentra 60C+ / From version 4.8.0 (JCMV2) for ABX Pentra 120 Retic and ABX Pentra 120
- [see III-5-1-B-b- External device plugged directly in the instrument]
31
Click on DETAIL DATA and follow these steps to upload daily results for each parameter:

Step 1
Select Instrument Name

Step 2
Click the BROWSE button
Select the file that contains the results you want to submit for one control lot.

NOTE

The file shall contain data for a single QC Month. If the file contains data for more than one QC month, QCP will put
the runs in the QC Month that contains the most number of runs. Thus, you should only export data that you want
loaded into the current QC Month.

Example
If you start running the control when you receive it on June 28th and then continue to run it through July 31st (or even
into the first few days of August) you will have more runs in July than either June or August. QCP will automatically
know that ALL of this data should be loaded for the July QCP month. You should take care to NOT include this data
again when you load your data for August (if you are still using the same lot).

Click UPLOAD FILE

32
Your submitted data will appear as a new run along with a message in blue at the top of the page.

33
IMPORTANT

Do not change the name of the files that have been exported from the instrument to an external device.

34
NOTES ABOUT UPLOADING DATA

1/ In case data is loaded at the very beginning or end of a lot’s date range (period of lot validity / stability or shelf life), QCP will
handle the dates following this rule:

- The [first valid QC Month] 1 will be used if the data is [prior to the first valid QC Month] 1’ for the lot being uploaded.
- The [last valid QC Month] 2 will be used if the data is [after the last valid QC Month] 2’ for the lot being uploaded.

Example
Control = ABX Difftrol
Lot = PX034
Validity = July and August

1 = [first valid QC Month] = JULY 2 = [last valid QC Month] = AUGUST

1’ = [prior to the first valid QC Month] = JUNE 2’ = [after the last valid QC Month] = SEPTEMBER

2/ If a parameter value is missing (blank) from a loaded run, QCP will not issue any sort of message. If all of the values in a run
were missing (blank), QCP will issue a message such as: “There is 1 run with no values that was not loaded”.

3/ If the runs have the same date, time and values, the duplicate run will be ignored by QCP.

4/ If the runs have the same date and time but different values, both runs will be entered in QCP and a message will alert you
about the similar runs : “There is 1 run with a date and time identical to another run with different values”. In this case you
may want to remove one of the runs if they are duplicates

5/ If the external device contains 10 runs of different days (day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day
10), QCP uploads the 10 runs from the 10 days all at once (one upload). After the upload of the 10 runs, the run from day 1
will appear along with any messages from the upload. You will need to select another run from the Run dropdown box to see
the additional runs.

Later if this external device is uploaded again with QCP data for additional days, QCP will only add the new runs because of rule
number 3 above. This allows you to easily upload your data weekly or even daily if you wish.

35
III-5-1-B-b- External device plugged directly in the instrument

The following instruments have the ability to export QC results to an external device which will allow the automatic upload of
QC results into QCP (via the external device) without any manual input.
- ABX Pentra 60C+ - version 2.4.1
- ABX Pentra 60
- Pentra ES60

- ABX Pentra 120 Retic – version 4.8.0

- ABX Pentra 120 – version 4.8.0
- Pentra DX Nexus
- Pentra DF Nexus
- ABX Pentra DX120
- ABX Pentra DF120
* Condition: JCMV2, since P120 n°1282, Oct 2003.

Click on DETAIL DATA and follow these steps to upload daily results for each parameter:

Step 1
Select Instrument Name

Step 2
Click the BROWSE button
Select the file that contains the results you want to submit for one control lot.

NOTE

The file shall contain data for a single QC Month. If the file contains data for more than one QC month, QCP will put
the runs in the QC Month that contains the most number of runs. Thus, you should only export data that you want
loaded into the current QC Month.

Example
If you start running the control when you receive it on June 28th and then continue to run it through July 31st (or even
into the first few days of August) you will have more runs in July than either June or August. QCP will automatically
know that ALL of this data should be loaded for the July QCP month. You should take care to NOT include this data
again when you load your data for August (if you are still using the same lot).

Click UPLOAD FILE

36
Your submitted data will appear as a new run along with a message in blue at the top of the page.

IMPORTANT

Do not change the name of the files that have been exported from the instrument to an external device.

NOTES ABOUT UPLOADING DATA

1/ In case data is loaded at the very beginning or end of a lot’s date range (period of lot validity / stability or shelf life), QCP will
handle the dates following this rule:

- The [first valid QC Month] 1 will be used if the data is [prior to the first valid QC Month] 1’ for the lot being uploaded.
- The [last valid QC Month] 2 will be used if the data is [after the last valid QC Month] 2’ for the lot being uploaded.

Example
Control = ABX Difftrol
Lot = PX034
Validity = July and August

1 = [first valid QC Month] = JULY 2 = [last valid QC Month] = AUGUST

1’ = [prior to the first valid QC Month] = JUNE 2’ = [after the last valid QC Month] = SEPTEMBER

2/ If a parameter value is missing (blank) from a loaded run, QCP will not issue any sort of message. If all of the values in a run
were missing (blank), QCP will issue a message such as: “There is 1 run with no values that was not loaded”.

3/ If the runs have the same date, time and values, the duplicate run will be ignored by QCP.

4/ If the runs have the same date and time but different values, both runs will be entered in QCP and a message will alert you
about the similar runs : “There is 1 run with a date and time identical to another run with different values”. In this case you
may want to remove one of the runs if they are duplicates

5/ If the external device contains 10 runs of different days (day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day
10), QCP uploads the 10 runs from the 10 days all at once (one upload). After the upload of the 10 runs, the run from day 1
will appear along with any messages from the upload. You will need to select another run from the Run dropdown box to see
the additional runs.

Later if this external device is uploaded again with QCP data for additional days, QCP will only add the new runs because of rule
number 3 above. This allows you to easily upload your data weekly or even daily if you wish.
37
III-5-2- SUMMARY DATA page

After you have printed out your final QC results from the instrument for that month, click on SUMMARY DATA and follow these
steps to enter summary results for each parameter:

Step 1
Select Instrument Name

Step 2
Select the Year/Month/Lot/Level

Step 3
Enter Number of results, Mean, and SD for each parameter.
To move from one field to another you can use the TAB key.

Step 4
Click SUBMIT

38
NOTE

You may enter your summary data throughout the month

Just edit any previously entered results and type over (replace) the previously entered results.

This would allow for peer group comparisons during the month

Your submitted data will appear with a message in blue at the top of the page.

39
III-6- EDITING/MODIFYING/DELETING SUBMITTED RESULTS

The submitted results are saved online for a 24 month period.

Follow these steps to edit/modify/delete the submitted daily/summary results:

Step 1
Click on DETAIL DATA page / SUMMARY DATA page

Step 2
Select Instrument Name

Step 3
Select the Year/Month/Lot/Level

Step 4
Select the Run/date/time (only for DETAIL DATA page)

Step 5
Click SUBMIT.
The results will be displayed.

Step 6
Select the result next to the parameter you want to modify/delete

Step 7
To delete: Press the delete key on your keyboard to remove the result
To modify: Type the value you want in the place of the selected result

Step 8
Click SUBMIT to record your change

 You will instantly see a blue message at the top of the page informing you that QCP has updated your data.

 The statistical reports will automatically include your changes.

NOTE

From the DETAIL DATA page:

- It is possible to delete an ENTIRE RUN, by selecting the “Run/date/time” and clicking DELETE RUN.

From the SUMMARY DATA page:

- It is possible to delete QC data of month / lot / level, by selecting the “Year/Month/Lot/Level” and clicking DELETE.

40
III-7- STATISTICAL REPORTS

Statistical Reports are available to view online anytime after data is submitted to QCP. Final Statistical Reports for a
Month/Lot/Level will be available for viewing about the 15th of the month following the month the data is collected.

III-7-1- Obtain the Statistical Reports

To obtain the statistical reports click on REPORTS. Once in the REPORTS page, follow the steps below:

Step 1
Select Instrument Name

Step 2
Select Year/Month/Lot

Step 3
Select World, Country, and /or Specific Peer Group(s) if created [see III-8 SPECIFIC PEER GROUPS]

Step 4
Select the reports you want (All Peer Comparison, Performance Index, Levey-Jennings Charts, Levey-Jennings Charts Detailed,
All Peer History, Other Instrument Groups)

Step 5
Select a Delivery method for your FINAL MONTHLY REPORTS.

Step 6
Click SET AS DEFAULTS to have QCP remember your choices the next time you visit the REPORTS page.
Next visit, you will only have to do Step 1 - Step 2 - Step 7.

Step 7
Click VIEW REPORTS

41
NOTE

1/ For Levey-Jennings Charts and Levey-Jennings Charts Detailed any peer group selections are ignored [see III-7-2-3- Levey-
Jennings Charts, III-7-2-4- Levey-Jennings Charts Detailed]

2/ All months with target data for the user’s instrument and control product in QCP are listed in the QC Month dropdown on the
REPORTS page. This allows users to view reports with their own data as well as reports with their peer data.

III-7-2- Description of the Statistical Reports

By submitting your Internal Quality Control results on the QCP website, it will be possible to obtain real time statistical reports
which compare your results with those of your peer group.

QCP offers the following statistical reports:

1. All Peer Comparison

2. Performance index
3. Performances, Comparisons and uncertainties
4. Levey-Jennings Charts
5. Levey-Jennings Charts Detailed
6. History of uncertainties
7. All Peer History
8. Other Instrument Groups

42
III-7-2-1- All Peer Comparison

This report enables you to compare your Lab results to World, Country and Specific Peer Groups using the same control
product, lot and level on similar instruments. Each parameter, in each level of the control product, is shown with the
following data for your Lab and the World, Country and Specific Peer Groups.

 Number of results reporting by lab

 Instruments Reporting (number of reporting Peers) Each point could be divided in three levels:
 Mean - Lab : user value.
 SD - United states : country level value.
 2SD - World : value from which the comparison should
 CV be made (lab/world).
 SDI (Relative Accuracy) = (Your Mean – Group Mean) / Group SD
 PI (Relative Precision) = Your CV / Group CV In addition to these user data, there is another value:
- Target : assay value (best theoretical value).
Any errors will be noted near the bottom of the report.
Investigate rejected data, and data beyond the +/- 2 SD, to determine any cause for the unexpected results.

43
III-7-2-2- All Peer History

This report enables you to compare your lab results to World, Country and Specific Peer Groups using the same control
product, lot and level on similar instruments, for the last 12 months.

Each parameter, in each level of the control product is shown with the following data for your Lab, Specific, Country and
World Peer Groups, for the last 12 months.

 Instruments Reporting (number of reporting Peers)

 Mean
 SD
 2SD
 CV
 SDI (Relative Accuracy) = (Your Mean – Group Mean) / Group SD
 PI (Relative Precision) = Your CV / Group CV

44
III-7-2-3- Levey-Jennings Charts

This report shows a separate Levey-Jennings Chart for each parameter and level of the control product.

Visually check your instrument's precision by comparing how far your plotted daily results vary from your overall mean for
the month.

 The x-axis or abscissa shows the days of the month.

 The y-axis or ordinate shows +/- 1SD, +/- 2SD, +/-3SD.
 The central line is your Lab Mean.

45
III-7-2-4- Levey-Jennings Charts Detailed

This more detailed version of a Levey-Jennings Chart allows for the values from multiple runs on a day to be shown
individually.

Visually check your instrument’s precision by comparing how far your plotted daily results vary from your overall mean for
the month.

 The y-axis or ordinate on the right shows the Target value

 The y-axis or ordinate on the left shows your Lab Mean with +/- 1SD, +/- 2SD, +/-3SD.
 The x-axis or abscissa shows the days of the month.

Out of range values will appear in red next to the date in the table below the graph.

46
NOTE

The Levey-Jennings Charts Detailed has room for 39 days of data.

The first date in the graph will be the date of the earliest run the user enters for a QC month.

The dates could start at the end of one month, cycle through an entire month, and end with the beginning of a third
month.

III-7-2-5- Performance Index

This graphical representation shows the position of each parameter in each level of the control product.

 The y-axis or ordinate shows PI

 The x-axis or abscissa shows SDI
 The Peer Group Position is shown with a black circle
 The Ideal Position (SDI = PI = 0) is shown with a black diamond
 L, N and H represent the position of the parameter in the Levels Low, Normal and High, respectively.

Check for World or Country results in the left part of the page header. Multiple sets of graphs can appear in this report
depending on the peer groups selected.

The Low, Normal and High values are positioned in function of the Peer Group Position.

47
 Example :
Low value : in the ideal zone. It’s the correct area to
achieve.

Normal value : within an acceptable area. The result

could be better.

High value : positioned in the unacceptable zone, the

value is not correct.

III-7-2-6- Performances, Comparisons and uncertainties

This kind of report shows different indicators which are compared to the group.

- Performance index values (precisions)

Compared within a graphic visualization
- Z-score (accuracy)
-
- Variation coefficient (CV)
- Standard deviation
- Uncertainty
- Sigma indicator (gap between actual and required performances)
- Mean Lab/Group

Concerning the Normal and High HCT, we can see the symbol : That means that these values are beyond the
satisfying limit (which is equal to 1).

Indeed, the precision value on the HCT N/H are, respectively, 1.04 and 1.03.

48
 Practical examples:

QCP Alert : The QCP alert will appear when the value of Accuracy and Precision will be 2< or >2. The LQM will find these
alerts in the QCP alerts reports (see manual further).

Precision: Accuracy:
- Tube mixing to improve values - Not correct accuracy (MCV L/N), PLT N/H, NEU H, MON N/H)
- The MON N/H values are unacceptable
(lower precision on PLT level N and H)

Precision: Accuracy:
- Incredible precision exclusively on Low HGB (Check individual values). - Multiples wrong values (WBC L, LYM H, GRA H)

Accuracy:
Precision:
- Totally bad, absolutely unacceptable values. Total lack of quality.
- Wrong values (HCT L, MCV N/H, PLT H, GRA #L, GRA%L)

49
 III-7-2- 7- History of uncertainties

Tables and graphics that present an historic of the “Performances, Comparisons and uncertainties report” :

Summary of
statistical
data Over year tendency Over year tendency
Precision: 6 Sigma: Theoretical performance to achieve.
Global improvement of the precision over Sigma objective: Performance of the Peer Group: slight downward trend.
the year. Your sigma: Ratio between actual and required performances: improvement of
Accuracy: performances over the year, but without achieving the theoretical performance
Shift of accuracy from positive to negative (6 sigma).
value, still remaining in acceptable limits.

 Mean : Presentation of the history of means from the lab and the group. This way it is easy to compare the both all
over the year.

 SD : Standard deviation

 Bias : Average expressed in number of standard deviation.

 Performance index (PI) : PI = CVI = CVLab / CVPeer Group

 Standard deviation index (SDI) : “Relative standard deviation”.

SDI = Z-score = (XLab – XPeer Group ) / SDPeer Group
The accuracy has been evaluated by calculating a "Z-score" which expresses the number of standard deviation separating
the laboratory result from the average of the comparison group (ISO/FDIS 13528).

 Uncertainty :
- U1 = SDRepro : Standard deviation on the reproductibility
- U2 = Uncertainty# / 3 : Uncertainty attributable to uncertainty. (Uncertainty# = (m – V) ; m: mean of standard
deviation ; V: expected target value)
- Uc =  (U1²+U2²) : Combined uncertainty
- U = 2Uc : Expanded uncertainty

 Sigma :
Your sigma : (TEa% – Bias%) / CV (Difference between actual and required performance)
Sigma objective : (TEa%) /0.5 * CV%

- TEa : Total error allowable.

- Bias% : Average expressed in number of standard deviation.

50
III-7-2- 8- Other Instrument Groups

This report shows the results of Other Instruments Groups (different than your instrument), using the same control
product, the same lot and level as your instrument.

For each parameter and, level of the control product, the following data is shown:

 Instruments Reporting (number of reporting Peers)

 Mean
 CV
 SDI (Relative Accuracy) = (Your Mean – Group Mean) / Group SD

This report shows the World and Country groups of the different instruments.

51
III-7-2- 9- Certificate

It is now possible to get a certification about this interlaboratory comparison process. On this certificate is mentioned the
user, loboratory and instrument name and the type of control.
Is also indicated in which period the lab has contributed at this comparison program.
The signature of the QCP Marketing Product Manager, Philippe Milian, come to certify this contribution.

III-8- SPECIFIC REPORTS

It is possible to have access to another kind of report, specifically to the Local Quality Manager (LQM) and Distributor Quality
Manager (DQM):

52
 III-8-1 Activity/Data sent reports

This report present the number of data sends by registered instrument and country.

Instrument description

Instrument SN Model Control

Main User Institution Status 201307 201308 201309 201310 201311 201312 201401 201402

SELAL 704PC7049|ABX
Amanh Pentra 60C+|ABX #N/A #N/A #N/A #N/A #N/A #N/A #N/A #N/A
amanh@e-bio.fr Active DIFFTROL

608 ver 1432|ABX

Pentra 120 Retic|ABX 1 1 1 1 1 2 2 1
ana21@yahoo.fr ANA Active DIFFTROL

601PDX0230|ABX
audrey.bout@labo Pentra DX 120|ABX 1 1 1 1 1 1 1 1
-caudry.fr PORTE Active DIFFTROL

None data sent about the

Pentra 60C+/ABX DIFFTROL.
53
 The activity data sent report is visible for the local managers (CQM/LQM/DQM). This way, they are able to see if customers
are actually using the registered instruments.

If it is not the case, the local manager can act on the registration to prevent the customer to pay a non-used service.

Automatic Deactivation Policy:

An instrument which is non used while 4 months, will be automatically deactivated from the database.
This happens for all users already registered for more than 6 months.

III-8-2 QCP Alerts Report

This report allow to easily see every SDI and PI exceeded values by user for each parameter. Either positive (>2) or
negative (<-2) excess. (see the example below):

III-8-3 User Issue Report

This report display the activation status for each enrolled instrument (pending activation or inactivation) and customers that
have enrolled without requesting any reports or notification email.

54
III-9- SPECIFIC PEER GROUPS

A SPECIFIC PEER GROUP is a special grouping of similar instruments determined by a MAIN USER.

Only the MAIN USER may create any number of SPECIFIC PEER GROUPS.

III-9-1- Creation of a Specific Peer Group

To create a specific peer group, click SPECIFIC PEERS in the REPORTS page.

55
The INVITE SPECIFIC PEERS page will be displayed :

Step 1
Select the Instrument Name

Step 2
Select New Peer Group

Step 3
Name the specific peer group.
There will be a name set by default: “Group Number / Institution Name of the user creating the Specific Peer”

Step 4
Complete the table with the information of users you would like to invite to form a Specific Peer Group.
- Email (required)
- Institution (optional)
- Address (optional)

Step 5
Click SUBMIT to send the invitation.

Step 6
The invited users will receive an email instructing them how to accept or decline your invitation on their REPORTS
page.
There will be a place on the invitees REPORTS page to Accept or Decline the invitation.
The Status field will let you know if a peer has Accepted or Declined your invitation.

56
The list of all specific groups that are created will be in the REPORT page below the World and the Country peer
groups.

It will be possible to check or uncheck these specific peer groups and to obtain the ALL PEER COMPARISON report, the
ALL PEER HISTORY report and the PERFORMANCE INDEX that contains the results of the World, Country, Specific peer
group(s) if selected, as well the results of your instrument, for comparison.

III-9-2- Status of a Specific Peer Group

The status of each invited peer will be displayed as follows:

 Accepted: the invited peer has accepted your invitation to form a specific peer group
 Declined: the invited peer has declined your invitation to form a specific peer group
 No instrument: the invited peer does not have the instrument for which you created the specific peer group
 Unidentified: If the email address entered does not match a user in QCP

57
III-9-3- Modification/Update of a Specific Peer Group

The MAIN USER can modify/update the created specific peer groups, by selecting the specific peer group in the
dropdown box to edit it.

Then, the following actions may be done:

1/ Complete the information about the institution and the address, and click SUBMIT.

2/ Add or remove peers (members) to or from the Specific Peer Group at any time.

 To add a new member, add his email address and click SUBMIT, an invitation email will be sent
to that user.

 To remove a member, erase his email address and click SUBMIT.

The deleted member will no longer see this specific peer group on their REPORTS page.

3/ Change the name of an already created specific peer group. The members of this group will get an
automatic notification by email with the new name. The specific peer group will appear in their REPORTS
page with the new name.

4/ Delete an entire Specific Peer Group with the DELETE GROUP button in the INVITE SPECIFIC PEERS page.

NOTE

1. The specific peer groups are not limited to one month

2. Specific peer groups with less than 6 peers will receive a warning message in the ALL PEER COMPARISON report
saying : “A minimum of 6 Instruments reporting provides better comparative results”

3. An instrument may be a member of any number of Specific Peer Groups at a time.

58
III-10- MAIN USER & USERS

III-10-1- Create MAIN USER

The MAIN USER enrolls to create an account, or, is enrolled by the local HORIBA Medical Representative, registers each
instrument & control product combination, creates additional users with restricted access to instruments, invites specific peers
and inactivates instruments.

The procedure for creating a MAIN USER account is explained above [see III-3- ENROLL, III-4- INSTRUMENTS]

III-10-2- Setup additional user(s) & Assign instrument(s)

The MAIN USER who first registered the information in the ENROLL and INSTRUMENTS pages is able to set any number of
additional users with restricted access to instruments, by following the steps below:

Step 1
Sign onto the MAIN USER account

Step 2
Click on the USERS link to get to the USERS Page

Step 3
Select NEW USER from the drop-down (this will already be selected.)
QCP will default many of the fields from the MAIN USER account.

59
Step 4

 Enter the email address and the password for the additional user (twice)

 Enter the First and Last Names of the additional user

 Using the checkboxes, select the Instruments that this user has access to.

In this example, the MAIN USER Dr Jacques Meyer has checked the instrument “P60C-DIFF-Jacques” for the
additional user Ms Sarah Doe.

60
Step 5
The remaining required fields should have default information.
Check this information and make changes as needed.
Step 6
Click SUBMIT

Step 7
You will see a message in blue to confirm that the additional user has been enrolled, and to inform you that
an information email is sent to this additional user.

NOTE
The additional user (Ms Sarah Doe in this example) who is enrolled by the MAIN USER (Dr Jacques Meyer in
this example) will receive by email a password to sign in to QCP. The additional user may change this
password in the USERS page.

61
 In the USERS page, if the MAIN USER (Dr Jacques Meyer in this example) selects in the User dropdown box the additional
user (Ms Sarah Doe in this example), the information and the instrument of this additional user will be displayed.

62
When the additional user signs in to QCP :

 Only his/her email will appear in the USER dropdown box

 Only the instrument that the MAIN USER has assigned to her/him will be available in the
INSTRUMENT page

63
IMPORTANT

If a new instrument is added, the MAIN USER will need to edit each user that needs to access that instrument and check the
instrument and click SUBMIT.

All of the laboratories instruments are always listed for a MAIN USER.

In this example, the MAIN USER is Dr Jacques Meyer: Two instruments are enrolled in QCP for his laboratory.

64
III-10-3- Delete users

The MAIN USER can use the following procedure to delete a user.

Step 1
Go to the USERS Page

Step 2
Select the user you want to delete from the drop-down

Step 3
Click DELETE

Step 4
Wait for QCP to return with the verification message.

IMPORTANT

All the users under a MAIN USER need to be deleted before a MAIN USER can be deleted.

III-11- INACTIVATION OF AN INSTRUMENT

The MAIN USER may inactivate an instrument by clicking INACTIVATE in the INSTRUMENTS page, after selecting the name of
the instrument to inactivate.

Before you remove the instrument by inactivation, HORIBA Medical strongly recommends that you review your contract with
your local representative before making this change.

65
 IV- OTHER ONLINE FUNCTIONS

IV-1- OTHER FUNCTIONS IN THE SIGN IN PAGE

1/ Forgot your Password

A new password will arrive by email by clicking on FORGOT YOUR PASSWORD, completing the information required
and clicking SUBMIT

2/ More info
Learn about browser settings, browsers supported and download a PDF reader for viewing reports by clicking on MORE
INFO.

66
IV-2- OTHER FUNCTIONS IN THE USERS PAGE

1/ Preferred Language
You can choose your preferred language, simply by choosing the language in the dropdown box.
Once you sign in, the pages of QCP will always appear with your preferred language.

2/ Date Format
You can choose the date format that will be used in the DETAIL DATA page, and that will be displayed in the statistical
reports.

3/ Time Format
You can choose the time format that will be used in the DETAIL DATA page, and that will be displayed in the statistical
reports.

67
IV-3- OTHER FUNCTION IN THE REPORTS PAGE

Clicking on QCP Concept will give you a glossary of terms to help explain the concepts used in the statistical reports.

68
IV-4- OTHER FUNCTIONS IN ALL PAGES

1/ Submit Inquiry
You may submit any inquiry by clicking on SUBMIT INQUIRY, completing the fields and clicking the SUBMIT INQUIRY
button.

2/ Brochure
You may View and Print the QCP brochure by clicking on BROCHURE.

3/ FAQ
You can review the most Frequently Asked Questions by clicking on FAQ.

4/ QCP Help
Contextual help is available by clicking on QCP Help.

5/ Select Language

Y
ou can select your language in the dropdown box.

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 V- SCHEDULE

V-1- QC DATA SUBMISSION

The cut-off date each month for QC data submission is the 6th of the month following the month of data collection in order to
be included in the Final Monthly Report. Data for that month may still be submitted after that time. QCP will automatically
recalculate the peer results to include your data and your report may be obtained online once any required review by QCP is
done.

V-2- STATISTICAL REPORTS

 The Preliminary Reports are available in real time, immediately after QC data submission.

 The Final Monthly Reports are available about the 15th of the month following the month of data collection.

NOTE

 Submitted QC data and Statistical Reports are available online for a 24 month period.

 If the user has missed the 6th of the month cut-off date, it is still possible to submit the data for dates before the 6th of the
month.

 The user can make corrections to the data entered for a prior month.

- If corrections are made to a prior month, the new reports are valid when the corrections made do not have errors
that need to be reviewed by Horiba Medical.

- When the corrections made do have errors that need to be reviewed by Horiba Medical, the new reports are
preliminary until the errors are reviewed for the peer group.

Final Monthly
Reports

Available about the

15th of the month

Participant Lab Preliminary Reports

in Real Time
 Submit QC results
 Receive statistical reports Available throughout the
month, immediately after QC
data submission
Submit QC results

Cut-off : 6th of the month

QCP

 Process submitted QC results

 Emit statistical reports

QCP WORKFLOW

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 VI- GLOSSARY

TERM DESCRIPTION

Standard Deviation x 2. 95% of all results in a normal population fall within 2 SDs of the mean. Therefore, + or - 2 SD is
2SD
considered an acceptable laboratory standard.

Exclusive smart “multilink” concept that allows up to 3 ABX Pentra hematology analyzers to be connected to the same validation
ABX Pentra ML
station. For more information please go to Horiba Medical website : http://www.horiba.com/fr/medical/

Accuracy Closeness to the true value or the measure of truth for a result.

A material that is used to adjust the instrument that is based on or traceable to a reference preparation or material, and whose
Calibration Product
values are determined by acceptable reference methods.

Materials that are solutions of chemically stabilized red cells, white cells and/or analogs, and platelets. The most important
Control Product characteristics of control materials are their stability and physical similarity to real patient samples. They are used to monitor the
performance of an instrument or procedure.

Country Peer Group Group of all the peers in your country.

Coefficient of Variation: The Standard Deviation expressed as a percentage of the mean. The smaller the CV, the more precise is the
analytic method.
CV SD
%CV   100
Mean
Instruments Reporting Number of reporting peers

The mathematical average for a group of data points.

N

Mean x
i 1
i
x
N
Number of results Number of results entered per parameter per level

Peer An instrument from a group of similar instrument types, using the same control product of the same lot and level.
Peer Group Group of similar instrument types, using the same control product of the same lot and level.
Precision Index: The ratio of a Lab's CV to the Group CV. PI is a measure of Relative Precision. A PI value between 0 and + 2
defines acceptable performance.
PI Your %CV
PI 
Group%CV
Precision Reproducibility of replicate analyses.

Reports published before the end of a data collection month will be marked as Preliminary
In QCP any report that has errors or data pending review will be marked “Preliminary.” Also, any report generated before the 15th
Preliminary Report
of the following month would be marked “Preliminary.” Final reports will not be marked with any designation. The date and time the
report was generated is always at the bottom of the report.

Rejected Data outside the target limits for the control product used is rejected.

Run Set of internal quality control results of different parameters collected the same date and time from an instrument
Standard Deviation: A measure of the dispersion of a group of values around a mean, expressed in the units being measured.

SD
SD 
 xi  x  
2

N 1
Standard Deviation Index: The number of Group Standard Deviations by which a Lab's Mean differs from the Group Mean.
SDI is a measure of Relative Accuracy.
Accuracy indicates how close Your Mean is to the Group Mean.
An SDI value between - 2 and + 2 defines acceptable performance.
SDI
Your Mean  Group Mean
SDI 
Group SD
Shift An abrupt change in the pattern of data points on a plot, graph, or chart of data points.
Target value A peer group specific value published on the assay sheet of the control product.
Trend A gradual change in the pattern of data points on a plot, graph, or chart of data points.
World Peer Group Group of all the peers in the world.

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