Implementation_Manaul_XS_Series_MKT-30-1009

Implementation Manual

Sysmex® XS-Series Automated Hematology Systems
Document Number: MKT-30-1009
November 2008

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com



© 2006, 2007, 2008 Sysmex America, Inc. All rights reserved.
The contents of this manual, including all graphics and/or photographs are the property of
Sysmex America, Inc. Information in this document is subject to change without notice. Sysmex is
not liable for technical or editorial errors or omissions contained herein.
No part of this document may be reproduced or transmitted in any form or by any means,
electronic or mechanical, for any purpose, without the express written permission of Sysmex
America, Inc.
Sysmex is a registered trademark of Sysmex Corporation.

This manual was created by Sysmex America, Inc. Questions/comments regarding the content of
this manual can be directed to:

Sysmex America, Inc.
Attention: Marketing Communications
One Nelson C. White Parkway
Mundelein, IL 60060 USA
Document Number: MKT-30-1009

No part of this publication may be reproduced in any form or by any means without prior written permission.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com



Table of Contents

Section 1 Introduction

ƒ What’s in the XS-Series Implementation Manual?
ƒ Your Sysmex Contacts
ƒ Sysmex Support Personnel
ƒ Overview of Installation and Implementation Phases
ƒ Implementation Activity Checklist

Section 2 Instrument Settings

Section 3 Q-Flag Information

ƒ Customer Bulletin 61-1066 – Q-Flag Optimization
ƒ Q-Flag Implementation/Adjustment Documentation
ƒ Customer Bulletin 61-1036 – Q-Flag Optimization Protocol

Section 4 Quality Control Implementation

ƒ Insight ™ Enrollment Forms
ƒ QC Settings
ƒ Instructions for setting up L-J file and X-barM file
ƒ e-CHECK/e-CHECK(XS) ™ Suggested QC File Limits
ƒ Suggested X-barM QC File Limits
ƒ Customer Calibration Procedure

Section 5 Calibration Verification

ƒ Calibration Procedure

Section 6 Survey Sample

Section 7 Validation Protocols

ƒ Reportable Range (Verification of Linearity Studies)
ƒ Carryover
ƒ Correlation
ƒ Sensitivity
ƒ Reference Range (Reference Only)
ƒ Stability Study (Reference Only)
ƒ Mixing Study (Reference Only)

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

Table of Contents

(continued)

Section 8 Training Tools and Checklist

ƒ Training Checklist
ƒ Review Activity
ƒ Written Review
ƒ Written Review Answer Key
ƒ Maintenance Log Sheet

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

Introduction

What’s in the XS-Series Implementation Manual?

The purpose of this Implementation Manual is to outline the installation process and
provide procedures for common evaluation studies when introducing a new hematology
analyzer to the laboratory. Use the sections contained within this guide to perform and
document the studies that demonstrate the performance characteristics of your new
XS-Series analyzer.

Section 1 Introduction

This section describes the installation and implementation process and introduces you
to the Sysmex personnel who work with you throughout the process.

Section 2 Instrument Settings

Settings in the XS-Series Information Processing Unit (IPU) are customized to reflect the
laboratory’s preferences for printing, flagging, analysis ordering, etc. The setting options
are discussed in the User’s Guide and during On-Site Training. Your Health System
Application Specialist (HSAS) can assist with selecting and entering your preferences.
Once the settings have been entered, a printout of your customized settings can be
inserted in this section, and the settings can also be backed up unto the USB flash drive
provided with the mouse pad.

Section 3 Q-Flag Information

The Qualitative Flag (Q-Flag) optimization is a unique functionality of the X-Series
analyzer, which allows the customer to tailor their review rate to their specific review
criteria. This HSAS will discuss this option with the customer during the implementation
of their new analyzer.

Section 4 QC Implementation

To ensure instrument performance during the implementation phase and beyond, this
section outlines establishing a Quality Control program on the analyzer. This section
includes procedures for establishing analyzer specific ranges, and suggested starting
limits for commercial control files and the X-barM patient moving averages file.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 1: Introduction
Document Number: MKT-30-1009 November 2008 Page 1 of 8

Section 5 Validation Protocols

The HSAS is to verify that the analyzer meets manufacturer’s performance claims by
performing the following studies:

• Reportable Range (Verification of Linearity Studies)

• Carryover

It is the customer’s responsibility to perform additional studies, following the
requirements of their accrediting agency. The following protocols are provided:

• Correlation (HSAS assists)

• Sensitivity

• Reference Range

• Stability

• Mixing Studies

Typically, evaluation studies are performed on new analyzers to verify and document
satisfactory instrument performance according to the manufacturer’s requirements. It is
up to the laboratory to perform more extensive studies if they deem it necessary to
satisfy requirements over and above what is contained in these protocols. Data
summaries and raw data from these studies can be organized in this section of the
binder for future reference. Protocols for Correlation Studies, Sensitivity Studies,
Reference Range Verification, Stability, and Mixing Studies are also included in this
section.

With careful planning, procedures for some of the studies may be performed
concurrently. Data collected for correlation can also be used for sensitivity and reference
range verification. Samples with high values can be used for the linearity and carryover
procedures. Involving new operators in evaluation studies can speed the data gathering
as well as maximize their understanding of their new analyzer. Read through the
protocols and discuss the evaluation plan with your HSAS.

Section 6 Training Tools and Checklist

Training of the laboratory personnel is critical to the success of implementing any new
process or instrument. To begin the transition to the XS-Series, Key Operators must
review the e-learning tool on the XS-Series analyzer prior to the HSAS on-site visit.
These Key Operators work with the HSAS to be further trained on the analyzer. This
section contains a training checklist to customize the training for each individual, a
written review and review activity to assist in learning transfer, and Quick Guides to be
used as reference when operating the XS-Series.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 1: Introduction
Document Number: MKT-30-1009 November 2008 Page 2 of 8

Sysmex Contacts
1-800-379-7639

Health System Account Manager (HSAM)
________________________________________________

Health System Application Specialist (HSAS)
________________________________________________

Sysmex Technical Assistance Center
1-888-8Sysmex (1-888-879-7639)
24 hours, 7 days a week

Field Service Representative (FSR)
________________________________________________

Sysmex Customer Care Center

1-800-462-1262

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 1: Introduction
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XS-Series Implementation Manual Section 1: Introduction
Document Number: MKT-30-1009 November 2008 Page 4 of 8

Sysmex Support Personnel

Welcome to Sysmex America, Inc.

The installation of your clinical system and your laboratory’s transition to the Sysmex
family of products and services set the foundation of our partnership. We are committed
to working with your team to satisfy regulatory requirements and to ensure each member
of your organization feels confident in the operation and performance of your new
system. From delivery of your system to the tailored installation protocol and initial
stages of laboratory implementation, we provide personal and professional support to
meet your needs. In order to familiarize your laboratory with all the key personnel you
have met or will be meeting over the next few months, a description of the members of
your local Sysmex Team and Mundelein support network follows.

Health System Account Manager (HSAM)

The HSAM has extensive experience in the health care industry, and solid expertise in
workflow analysis and finance. The HSAM is equipped to make system
recommendations customized to meet your specific workflow and business needs.
These specialized sales representatives work in conjunction with your local HSAS to
assure your current system meets your growing needs.

Field Service Representative (FSR)

The Field Service Representatives (FSR) at Sysmex are dedicated professionals
devoted to providing their customers with the highest quality of service in the industry.
Acting as your personal consultants, the FSR provides analysis and recommendations
for your total laboratory environment. To begin, the pre-installation site inspection assists
your laboratory in a smooth installation process. Preventative maintenance calls are
designed to maximize uptime and are conveniently scheduled to minimize interruption of
workflow. The Field Service Team is a group of professionals committed to providing
consistent high quality services to the people we value most… our customers. We strive
to reach our goal to be the “best in the business”; so that we can help you to be the “best
in your business”.

Health System Application Specialist (HSAS)

The Health System Application Specialist (HSAS) at Sysmex are devoted laboratory
professionals who are certified Medical Technologists. They have extensive experience
in the field of clinical laboratory medicine and understand the first hand challenges that
you face everyday. The HSAS works with your Key Operators to conduct system
performance verification according to the Sysmex implementation protocol for your new
system. This protocol includes Reference Range Verification (Linearity Studies) and
Carryover Studies. Additional protocols are provided for your information. The HSAS will
use the ‘Train the Trainer’ concept when training your staff. This means that the HSAS
will work closely with the key operator by providing training tools and assistance for three
(3) training sessions. This provides an excellent opportunity to reinforce training with
your Key Operators. After the initial implementation of your system, your HSAS is
available as a technical resource to answer questions, assist in additional training and
with applications issues.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 1: Introduction
Document Number: MKT-30-1009 November 2008 Page 5 of 8

Technical Assistance Center 1-888-8Sysmex (1-888-879-7639)

The Sysmex service organization and company philosophy have always been one of
“service before sales”. Our service commitment to you encompasses both in-house and
field support. In-house technical support, customer service and field sales and service
teams are all available to provide you the most comprehensive support network in our
industry. Knowledgeable Technical Assistant Center Specialists are available by phone
24 hours a day, 365 days a year to assist in troubleshooting hematology and urinalysis
systems. Computerized tracking of inquiries allows routine review of calls to readily
identify recurrent problems and initiate solutions. Automated dispatching of field service
representatives enables prompt diagnosis and recommendation of solutions. Automated
update of troubleshooting resolutions provides immediate access to the most current
documentation.

Our strong commitment to service and partnership guarantees that you will enjoy a level
of support unsurpassed in today’s healthcare industry.

Customer Care Center 1-800-462-1262

The Sysmex Customer Care team consists of highly trained Customer Care
Representatives, dedicated to providing superior service to our Sysmex customers. They
are available to assist in ordering reagents and controls for your Sysmex
instrumentation. Our staff is committed to exceeding your expectations and continually
strives to improve and seek new opportunities to better serve our customer’s needs

today and in the future. Visit our website www.sysmexusa.com/usa for additional

information.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 1: Introduction
Document Number: MKT-30-1009 November 2008 Page 6 of 8

The installation of your new Sysmex Hematology
System takes place in three (3) phases:

Phase 1 Pre-Implementation Meeting

The Pre-Implementation meeting occurs before delivery of your new Sysmex Instrument.
The purpose of this meeting is to provide your laboratory with information and set
expectations regarding both the installation and implementation process, including the
expected timeline.

The participants from your local Sysmex team can include your HSAM, HSAS, FSR and
Product Manager. Guidelines for interfacing the system with your host computer are
established during the sales process; however, a key IT/Interface contact should be
identified to prevent delays in going “live” with the new analyzer if the interface for the
analyzer is unavailable during installation. We strongly suggest that all key personnel
from your laboratory participate to assist us in ensuring all questions, time lines and
implementation issues are addressed.

Prior to the shipment of your analyzer, you will be notified by Sysmex and provided with
an email address and URL with instructions to access the Sysmex Customer Resource
Center for e-learning. Once the XS courses are successfully completed, you will be
notified by Sysmex to determine an installation date. All staff members are encouraged
to complete these pre-training modules prior to arrival of the HSAS.

Phase 2 Installation and Implementation

Your FSR performs the hardware installation, mechanical checks, precision check and
calibration of the instrument. Once the instrument is operational the HSAS assists you
with the implementation. Copies of all service orders and certificates of calibration can
be located in the service manual. Once the instrument is operational the HSAS assists
you with the implementation.

A. Implementation Activities include:

¾ Selecting and entering IPU and Controller Settings, and Interpretive Program
Message Settings.

¾ Setting up QC files and entering Interim Limits.

¾ Using RANGE CHECK-X™, a commercial linearity product to verify directly
measured CBC and reticulocyte parameters.
• RANGE CHECK-X is provided as part of the installation kit.

¾ Assistance with Correlation and Sensitivity Tables using CLSI/NCCLS
guidelines.
• Studies are performed against the primary system being replaced.
• Performed with laboratory personnel assistance as training reinforcement.
• Data analysis is provided by Sysmex America, Inc.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 1: Introduction
Document Number: MKT-30-1009 November 2008 Page 7 of 8

Implementation Activities (continued)

Any changes or additions to the implementation protocol should have been previously
discussed with your HSAS and authorized by the HSAS Manager.

B. On-Site Training – the training on the XS system is a two-phased approach:
1. Customers must review e-learning modules on the Sysmex website prior to
the HSAS on-site visit. The training will prepare the operator for the
implementation process.

2. The HSAS will provide up to three additional on-site training sessions for the
Key Operator and other key staff, with the ‘Train the Trainer’ concept. Your
HSAS will contact you to schedule these sessions. Training tools such as
in-service outlines and competency checks with answer keys will be provided.

Phase 3 Post-Implementation

Your HSAM, FSR and HSAS continue to support your laboratory via on-site visits or
phone follow-up to assure that all issues are addressed.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 1: Introduction
Document Number: MKT-30-1009 November 2008 Page 8 of 8

Document Number 61-1066
03/2006

Q-Flag Optimization

Sysmex® XE-Series, XT-Series and SE-Series
Automated Hematology Analyzers

Introduction
The Sysmex Interpretive Program (IP) provides flagging of specimens based on
comprehensive analysis of particle counts, size distributions and scattergrams. The
IP messages categorize specimens as Negative (needing no further review) or Positive
(abnormal), and goes further to flag potential abnormalities detected in the count,
morphology or differential on Positive specimens.

“Abnormal” flags appear when the sample is abnormal based on count criteria
determined by the operator or by abnormal scattergram appearance. “Suspect” flags
alert the operator to the possibility that the sample is abnormal and directs the review to
a suspected cause of the abnormality.

“Suspect” flags use the Q-Flag system to flag abnormal morphology using trigger points
expressed on an arbitrary 0-300 scale. The default trigger point on all flags is 100, but
may be modified to optimize the flagging to the laboratory’s manual differential review
criteria. Q-Flag trigger points do not have a linear relationship with the number of
abnormal cells seen on microscopic review, but indicates the probability of the flag’s
evidence based on a combination of formulas.

Concept of Clinical laboratories establish their review criteria using instrument flags to
Q-Flag balance their tolerance for risk of non-detection with reduction of the manual
Optimization review rate. The flagging criteria for the Sysmex XE and SE-Series analyzers
are based on the CLSI/NCCLS H20-A guidelines for smear review. These
guidelines may seem too sensitive for some laboratory patient populations.
Adjustment of Q-Flags trigger points enable each laboratory to optimize their
instrument’s flagging based on their individual manual review criteria.

Q-Flag Optimization: The guidelines for Q-Flag optimization were derived from
historical data that was collected from SE-Series and X-Series instrument users that
have performed Q-Flag studies over the past 6 or 7 years. There were approximately 40
hospitals and reference labs that submitted Q-Flag data for analysis.

Each laboratory collected approximately 100 samples that were positive for the suspect
flag that they wished to adjust the corresponding Q-Flag. Manual differentials were
performed, according to CLSI/NCCLS document H20A, for all samples that were
collected. Using a special Q-Flag spreadsheet and instrument printouts, sensitivity truth
tables were established. A cut-off Q-Flag trigger point was determined by finding the
highest Q-Flag level that eliminates the most false positives flags yet does not create
any false negative flags.

Page 1 of 2

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Document Number 61-1066
03/2006

Q-Flag Optimization

Sysmex® XE-Series, XT-Series and SE-Series
Automated Hematology Analyzers

Conclusion:
Based on the analysis of the historical Q-Flag data that was collected, the chart below
lists the recommended Q-Flag adjustments for the hospital and reference lab settings. If
you wish to adjust other flags, or feel these adjustments are not in line with your patient
population, please refer to Customer Bulletin 61-1036. This bulletin provides guidelines
for performing y our own Q-Flag study.

Recommended Q-Flag Settings

Q-Flag Hospital Reference Lab
Settings Settings
Blast? 100
100 100
Immature Gran? 100 100
Left Shift? 100 160
Atypical Lympho? 150 160
ABN Lympho/L-Blasts? 130 100
NRBC? 100 100
RBC Lyse resistance? 100 100
RBC Agglutination? 100 100
Turbidity/HGB Interference? 100 100
Iron Deficiency? 100 100
HGB Defect? 100 100
Fragments? 100 150
PLT Clumps? 150 150
PLT Clumps (S)? 150

References 1. Sysmex XE-2100 IPU Operator’s Manual, Sysmex Corporation, Kobe, Japan.
2. Sysmex SE-9500 Operator’s Manual, Sysmex Corporation, Kobe, Japan, May

1999, Chapter 4.
3. Reference Leukocyte Differential Count (Proportional) and Evaluation of

Instrumental Methods. Approved Standard H20-A. National Committee for
Clinical Laboratory Standards, Villanova, PA, 1992.
4. Goossens, W, et al.: Optimisation of the Flagging Criteria on the Sysmex
SE-9500. Sysmex J Int, 10 (1) : 18-20, 2000.
5. Scientific Bulletin No. 9501 TOA Medical Electronics-Europe, GmbH, 24-Aug-
95, 1-8. Weber N, et al.: Performance Evaluation of Hematology Analyzers:
An Outline for Clinical Laboratory Testing. Sysmex J Int, 5 (2): 103-113, 1995.
Koepke, J., ed. Differential Leukocyte Counting. Skokie, IL, College of
American Pathologists, 1977: 39-45.

Page 2 of 2

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Q-Flag Implementation/Adjustment Documentation

Instructions:

After you have discussed the advantages of the Sysmex Q-Flag system with your
Sysmex Health Systems Account Manager/Specialist, please complete the
information listed below. This information will be used as documentation of how the
Sysmex Q-Flags are set on your analyzer. This document should be filled out at
implementation, or if Q-Flag settings are changed after installation.

Facility Name & Address: Sysmex Analyzer Model and Serial Number

______________________ _______________________________

______________________

______________________

______________________

_____ We have chosen to use the Sysmex flagging system with the Q-Flags set at
_____ factory default values.

_____ We have chosen to optimize the Q-Flag setting during our Sysmex instrument
_____
evaluation. The Q-Flag settings for Hospital Settings or Reference Lab Settings

were agreed upon. (circle one)

We currently have a Sysmex SE-Series analyzer with the Q-Flags adjusted.
We would like to use our current settings.

We have performed our own Q-Flag study to determine our own customized
Q-Flag settings. We have been given Customer Bulletin 61-1036, Q-Flag
Optimization Protocol: Data Collection Guidelines to use as a guide.

Documentation of Q-Flag Setting

Flag Original Setting New Setting

________________________________________________ ______________
Sysmex Health Systems Application Manager/Specialist/FSR Date

________________________________________________ ______________
Laboratory Representative Date

Sysmex America, Inc. www.sysmex.com

One Nelson C. White Parkway, Mundelein, IL 60060
Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639)

Documentation of Q-Flag Setting

Q-Flag Hospital Reference Lab
Settings Settings
Blast? 100
Immature Gran? 100 100
Left Shift? 100 100
Atypical Lympho? 100 160
ABN Lympho/L-Blasts? 150 160
NRBC? 130 100
RBC Lyse resistance? 100 100
RBC Agglutination? 100 100
Turbidity/HGB Interference? 100 100
Iron Deficiency? 100 100
HGB Defect? 100 100
Fragments? 100 100
PLT Clumps? 100 150
PLT Clumps (S)? 150 150
150

Sysmex America, Inc. www.sysmex.com

One Nelson C. White Parkway, Mundelein, IL 60060
Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639)

Document Number 61-1036
02/2007

Q-Flag Adjustment

Attention:

• Q-Flag adjustment is a 2 step process.

• See Customer Bulletin 61-1066, Q-Flag Optimization, first.

• If further optimization is needed, proceed to this Customer
Bulletin 61-1036, Q-Flag Optimization Protocol: Data Collection
Guidelines.

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Document Number 61-1036
02/2007

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Document Number 61-1036
02/2007

Q-Flag Optimization Protocol: Data Collection Guidelines

Sysmex® X-Series (XS-Series, XE-Series, XT-Series) and SE-Series
Automated Hematology Analyzers

Introduction
The Sysmex Interpretive Program (IP) provides flagging of specimens based on
comprehensive analysis of particle counts, size distributions and scattergrams. The
IP messages categorize specimens as Negative (needing no further review) or Positive
(abnormal), and goes further to flag potential abnormalities detected in the count,
morphology or differential on Positive specimens.

“Abnormal” flags appear when the sample is abnormal based on count criteria
determined by the operator or by abnormal scattergram appearance. “Suspect” flags
alert the operator to the possibility that the sample is abnormal and directs the review to
a suspected cause of the abnormality.

“Suspect” flags use the Q-Flag system to flag abnormal morphology using trigger points
expressed on an arbitrary 0-300 scale. The default trigger point on all flags is 100, but
may be modified to optimize the flagging to the laboratory’s manual differential review
criteria. Q-Flag trigger points do not have a linear relationship with the number of
abnormal cells seen on microscopic review, but indicates the probability of the flag’s
evidence based on a combination of formulas.

Concept of Clinical laboratories establish their review criteria using instrument flags to
Q-Flag balance their tolerance for risk of non-detection with reduction of the
Optimization manual review rate. The flagging criteria for the Sysmex XE and SE Series
analyzers are based on the CLSI/NCCLS H20-A guidelines for smear
review. These guidelines may seem too sensitive for some laboratory
patient populations.

Adjustment of Q-Flags trigger points enable each laboratory to optimize
their instrument’s flagging based on their individual manual review criteria.
Use the following protocol to determine appropriate Q-Flag settings to
optimize the laboratory’s review rate based on your patient population.

Process Outline
Below is an outline of the five stages in the Q-Flag optimization. Stage 4 is performed
with the assistance of the Health Systems Account Specialist (HSAS), and Stage 5 is
performed by the operator after new Q-Flag settings are entered into the analyzer
software.

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Document Number 61-1036
02/2007

Q-Flag Optimization Protocol: Data Collection Guidelines

Sysmex® X-Series (XS-Series, XE-Series, XT-Series) and SE-Series
Automated Hematology Analyzers

Stage Description
1. Instrument Installation
The instrument is installed by the Sysmex Field Service
2. Instrument Representative (FSR) according to procedures described in the
Performance Verification instrument service manual. These procedures include:

3. Q-Flag Data Collection • Verifying blank readings and background counts are
within the specified range.

• Verifying Diff and IMI* scattergrams of background
analyses are free of “dots” that represent particles.
(*XE and SE -Series only)

• Sensitivity adjustments and count calibration.
• Optical alignment. (X-Series) If it has been greater

than 1 year since the instrument was installed and
performance studies performed or if any major
instrument component has been replaced, it is
recommended that instrument calibration and
sensitivities be verified by the FSR. This can be
assessed from PM documentation or a recent service
call.

The manufacturer suggests the instrument be in routine use for
at least 6-8 weeks to assess the flagging and quality control
performance before deciding whether to optimize Q-Flags.
If the laboratory chooses to optimize Q-Flags, the operator:

• Verifies Quality Control and X bar M (Xm), if used, are
within expected ranges.

• Reviews at least one Inter-laboratory Quality
Assessment Program report (Insight) for satisfactory
performance.

The operator collects instrument and manual differential data
from 100 samples. Half of the samples will be “negative” and
half “positive” for the abnormality represented by the flag
targeted for adjustment.

4. Q-Flag Adjustment The operator decides, with the assistance of the Health
5. Q-Flag Validation Systems Account Specialist (HSAS), the new Q-Flag trigger
points. The HSAS enters the new Q-Flag trigger settings into
the instrument software.

The operator collects data from 100 samples to repeat
sensitivity statistics to ensure the new Q-Flag settings satisfy
laboratory demands for clinical sensitivity and manual review
rate.

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ONE NELSON C. WHITE PARKWAY, MUNDELEIN, IL 60060
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Document Number 61-1036
02/2007

Q-Flag Optimization Protocol: Data Collection Guidelines

Sysmex® X-Series (XS-Series, XE-Series, XT-Series) and SE-Series
Automated Hematology Analyzers

Procedure
Follow the steps below to collect the necessary data for Q-Flag optimization. Once
sufficient data is collected, the HSAS can assist with selecting and entering new Q-Flag
trigger points.

Review QC
• Verify commercial quality control and Xm (if used) is within the laboratory’s
expected ranges.

• Review Inter-laboratory Quality Assessment Program reports (Insight). If
quality control review indicates an instrument problem, consult your FSR.

Note: If it is greater than 1 year of installation and validation studies, sensitivities and
calibration should be verified by the FSR.

Define Criteria
• Define your criteria for abnormal samples that require manual review
(Manual Review Criteria Worksheet).

• Adjustment of Q-Flags can only be effective if a single set of manual review
criteria is used. Populations that include aged and fresh specimens would be
flagged using the same Q-Flag trigger levels, thus should be evaluated with the
same manual review criteria.

Specimen Criteria
• Data for Q-Flag optimization can be collected as part of a daily routine until
the volume of data suggested is available for interpretation. Collection log
sheets at the end of this procedure can aid in this process.

• Collect at least 100 specimens that are flagged by the analyzer for the flag
targeted for adjustment. More samples would improve the confidence in the
Q-Flag trigger point selected from the study data.

− The aim is to collect 50 that are “positive” and 50 that are “negative” by
manual review criteria for the abnormality represented by the flag.

− “Positive” samples should represent the full range of expression of the
abnormality targeted for Q-Flag adjustment. Focus on collecting positive
samples that are triggered in the range of 100-200 where optimized
Q-Flag trigger points are likely to be set. Positive samples that are
triggered at the top of the Q-Flag range (300) are not as useful when
determining optimal trigger points.

− Ideally half of the “positive” samples should display the targeted flag
alone, and half should display the targeted flag in combination with other
flags.

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ONE NELSON C. WHITE PARKWAY, MUNDELEIN, IL 60060
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Document Number 61-1036
02/2007

Q-Flag Optimization Protocol: Data Collection Guidelines

Sysmex® X-Series (XS-Series, XE-Series, XT-Series) and SE-Series
Automated Hematology Analyzers

Instrument
• Analyze specimens on the Sysmex instrument according to laboratory defined
Analysis protocol. Typically, samples are best analyzed fresh, or within 6
hours of collection.

• Print results from all samples that display the targeted flag by itself or in
combination with other flags. (Refer to Specimen Criteria)

• Label the printout with a consecutive sequence number for easy identification.

• Print Q-Flag trigger levels on each sample.

• Staple instrument results and Q-Flag printouts together.

Blood Film • Prepare three wedge-type films as soon as possible for each sample
Preparation and stain according to laboratory defined protocol.

• Label each slide with the assigned consecutive sequence number and
“A”, “B” or “C”. The “A” and “B” slides are for each technologist
performing the manual differential. The “C” slide is for the referee
should it be necessary.

Differentials • Perform differentials evaluating 400 cells according to CLSI/NCCLS
H20-A protocol. Normal lab practice of performing 100-cell differentials
is not sufficiently sensitive to justify Q-Flag adjustment.

• Differentials should be performed by any or all persons who routinely
review smears.

• For each specimen, two reviewers will perform 200-cell differentials
using the smears labeled “A” and “B”.

• Reviewers performing the differentials should not review any instrument
printouts prior to performing the differentials to prevent unintentional
bias of results.

• Each reviewer will divide the 200-cell differential by 2 to get the average
and record the differentials.

• The referee compares both 200-cell differentials for agreement. If there
are significant differences between the two counts, the referee performs
a 200-cell differential and averages the counts that most closely agree.

• Save all smears until optimization procedure is completed.

Manual Review • Using the Manual Review Criteria Worksheet and the averaged 400-cell
Judge against differentials determine whether each sample would be judged as
Criteria “negative” or “positive.”

• Record the manual review judgment of “positive” or “negative” on the
instrument printouts. The “positives” represent True Positives (TP), the
“negatives” represent False Positives (FP).

Page 6 of 10

ONE NELSON C. WHITE PARKWAY, MUNDELEIN, IL 60060
1-800-3SYSMEX (800-379-7639)

Document Number 61-1036
02/2007

Q-Flag Optimization Protocol: Data Collection Guidelines

Sysmex® X-Series (XS-Series, XE-Series, XT-Series) and SE-Series
Automated Hematology Analyzers

References

1. Sysmex XE-2100 IPU Operator’s Manual, Sysmex Corporation, Kobe, Japan,
May 2002, Chapter 3.

2. Sysmex XE-2100 Main Unit Operator’s Manual, Sysmex Corporation, Kobe, Japan,
July 2002, Chapter 1.

3. Sysmex XT-2000i/XT-1800i Instructions for Use, Sysmex Corporation, Kobe, Japan,
August 2002, Chapter 16.

4. Sysmex SE-9500 Operator’s Manual, Sysmex Corporation, Kobe, Japan, May 1999,
Chapter 4.

5. Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental
Methods. Approved Standard H20-A. National Committee for Clinical Laboratory
Standards, Villanova, PA, 1992.

6. Goossens, W, et al.: Optimisation of the Flagging Criteria on the Sysmex SE9500.
Sysmex J Int, 10 (1): 18-20, 2000.

7. Scientific Bulletin No. 9501 TOA Medical Electronics-Europe, GmbH, 24-Aug-95, 1-8.

8. Weber N, et al.: Performance Evaluation of Hematology Analyzers: An Outline for
Clinical Laboratory Testing. Sysmex J Int, 5 (2) : 103-113, 1995.

9. Koepke, J., ed. Differential Leukocyte Counting. Skokie, IL, College of American
Pathologists, 1977: 39-45.

Page 7 of 10

ONE NELSON C. WHITE PARKWAY, MUNDELEIN, IL 60060
1-800-3SYSMEX (800-379-7639)

Document Number 61-1036
02/2007

Q-Flag Optimization Protocol: Data Collection Guidelines

Sysmex® X-Series (XS-Series, XE-Series, XT-Series) and SE-Series
Automated Hematology Analyzers

Abnormal Manual Review Criteria Worksheet
Manual
Review Using your manual differential and morphology criteria for blood film
Criteria review, define what findings are considered abnormal or “positive”.
For example, a laboratory may define a sample as abnormal for their
population when greater than 10% Atypical Lymphs are present,
where other laboratories may consider > 5% to be abnormal.
Use the table below to quantify the criteria for abnormal samples in
your laboratory.

Differential/Morphology Sample is abnormal when:

Atypical Lymphs
Band/Stab neutrophils
Metamyelocytes
Myelocytes
Promyelocytes
Blasts
NRBC
Abnormal PLT morphology
Abnormal RBC Morphology
Other:
Other:

Page 8 of 10

ONE NELSON C. WHITE PARKWAY, MUNDELEIN, IL 60060
1-800-3SYSMEX (800-379-7639)

Document Number 61-1036
02/2007

Q-Flag Log Sheet

Log Sheet Instructions
Check off or record the specimen ID# in the open spaces for those samples chosen for
the Q-Flag Optimization study. For this study, collect all samples that display this flag
“_____________________________” by itself or in combination with other flags. Ideally
half of the samples should display the targeted flag alone, and half should display the
targeted flag in combination with other flags. Focus on collecting positive samples that
are triggered in the range of 100-200 where optimized Q-Flag trigger points are likely to
be set.

• Print results and Q-Flags for each specimen and staple printouts together.

• Print the assigned consecutive number on the printouts.

• Prepare three smears and perform two 200-cell differentials on each of two slides.

1 26
2 27
3 28
4 29
5 30
6 31
7 32
8 33
9 34
10 35
11 36
12 37
13 38
14 39
15 40
16 41
17 42
18 43
19 44
20 45
21 46
22 47
23 48
24 49
25 50

Page 9 of 10

ONE NELSON C. WHITE PARKWAY, MUNDELEIN, IL 60060
1-800-3SYSMEX (800-379-7639)

Document Number 61-1036
02/2007

Q-Flag Log Sheet

Log Sheet Instructions
Check off or record the specimen ID# in the open spaces for those samples chosen for
the Q-Flag Optimization study. For this study, collect all samples that display this flag
“_____________________________” by itself or in combination with other flags. Ideally
half of the samples should display the targeted flag alone, and half should display the
targeted flag in combination with other flags. Focus on collecting positive samples that
are triggered in the range of 100-200 where optimized Q-Flag trigger points are likely to
be set.

• Print results and Q-Flags for each specimen and staple printouts together.

• Print the assigned consecutive number on the printouts.

• Prepare three smears and perform two 200-cell differentials on each of two slides.

51 76
52 77
53 78
54 79
55 80
56 81
57 82
58 83
59 84
60 85
61 86
62 87
63 88
64 89
65 90
66 91
67 92
68 93
69 94
70 95
71 96
72 97
73 98
74 99
75 100

Page 10 of 10

ONE NELSON C. WHITE PARKWAY, MUNDELEIN, IL 60060
1-800-3SYSMEX (800-379-7639)

Existing/Current Insight™ Customer
Analyzer Enrollment Form

Complete the information requested below. If your current customer information is
correct, you need only complete the lines marked REQUIRED. Fax this form to
847-367-2897 or e-mail to [email protected].

Date
Four Digit Sysmex Insight
Customer Number (REQUIRED)

Facility Name (REQUIRED)

Department

Address Line 1

Address Line 2

City

State or Province

Zip and Country (if outside U.S.)

Fax Number

Primary Contact Name

Primary Contact E-mail Address

Primary Contact Phone

Secondary Contact Name

Secondary Contact E-mail Address

Secondary Contact Phone
Analyzer Model & Serial Number
(REQUIRED)
Analyzer Model & Serial Number

(REQUIRED)

Analyzer Model & Serial Number

(REQUIRED)

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 1 of 12

This Page Left Blank Intentionally.

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XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 2 of 12

New Insight Customer Analyzer Enrollment Form

Complete the information requested below. Fax this form to 847-367-2897 or e-mail to
[email protected].

Date

Facility Name

Department

Address Line 1

Address Line 2

City

State or Province

Zip and Country (if outside U.S.)

Fax Number

Primary Contact Name

Primary Contact E-mail Address

Primary Contact Phone

Secondary Contact Name

Secondary Contact E-mail Address

Secondary Contact Phone
Analyzer Model & Serial Number
(REQUIRED)

Analyzer Model & Serial Number
(REQUIRED)
Analyzer Model & Serial Number
(REQUIRED)

HSAS Name (if available)

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XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 3 of 12

This Page Left Blank Intentionally.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 4 of 12

e-CHECK™/e-CHECK(XS)™

Information Regarding Use of Suggested QC File Limits

o These limits are based on the best data available as of April 2006. These values
were derived from the performance of a limited number of XS-Series analyzers
running a limited number of lots of e-CHECK/e-CHECK(XS) control. As analyzer
performance data is compiled on additional lots of e-CHECK by the Insight™
program, these limits will be recalculated and updates will be made available.

o Suggested QC file limits must be used on analyzers with accurate calibration,
using control file Target Values that have been set to analyzer-specific and lot-
specific values.

When all two (2) control levels are analyzed per run and the 13s control rule (any
one control file exceeds limit) is used to reject a run, these limits can be expected
to provide reasonably sensitive error detection for primary parameters, while
keeping the probability of false rejection low.

o Control results that exceed these limits may represent atypical performance.
This can be due to control handling, increased analytic imprecision and/or
occasional random error. The root cause can also be an error in setting the
control Target/Limit Value, a normal drift in control parameter values (e.g. MCV,
DIFF-Y), a change in calibration (primary and/or mode-to-mode), or a defective
detector/reagent system.

o To perform meaningful statistical QC, each laboratory should establish analyzer-
specific control limits. Sysmex recommends control limits based on cumulative
CV% values from at least three (3) e-CHECK/e-CHECK(XS) lots, where the
analyzer and control performance were typical and stable. This creates control
limits that represent the laboratory’s process capability.

o For more information, contact your HSAS or Technical Assistance Center at
1-888-879-7639.

Note: Two (2) levels of control (Level 2 and Level 3) are provided as part of the
Installation Kit.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 5 of 12

e-CHECK™/e-CHECK(XS)™

Suggested e-CHECK/e-CHECK(XS) QC File Limits

The limits provided below are to be used on the XS-Series analyzers. These limits are
only for use in the interim where the laboratory is collecting control data to establish
analyzer-specific control limits (for reportable parameters only). Limits provided here
represent three (3) times the average analyzer’s cumulative CV% (equivalent to 3
Standard Deviation Limits).

Prior to Establishing Analyzer Specific Limits

Parameter Level 1 Level 2 Level 3
Limit% Limit% Limit%
RBC
HGB 4.5 4.4 4.3
HCT 6.5 4.1 4.2
MCV 6.2 5.9 5.8
MCH 4.6 4.3 4.3
MCHC 6.5 5.0 4.8
PLT 7.2 5.4 5.3
RDW-SD 18.7 11.6 10.9
RDW-CV 5.3 5.3 5.5
MPV 4.6 3.8 3.4
WBC-C 9.3 4.6 3.6
WBC-D 11.1 9.6 8.8
NEUT% 11.1 9.6 8.8
LYMPH% 9.6 12.8 8.0
MONO% 13.2 9.0 7.1
EO% 60.0 40.0 20.0
BASO% 25.0 24.0 25.0
NEUT# 34.8 26.0 28.0
LYMPH# 14.4 16.0 9.8
MONO# 17.1 13.3 11.0
EO# 60.0 43.0 21.9
BASO# 25.9 23.7 26.0
36.2 27.0 28.0

Note: Only two (2) levels of controls (L 2 & L 3) are provided as part of the Installation Kit. Level 1
is optional and may be ordered from the Customer Care Center at 1-800-462-1262.

Detector Control Parameter (DCP) For the following parameters,
use 999 as the Limit Percent.
Detector Level 1 Level 2 Level 3
Limit% Limit% Limit% PDW
PLCR
DIFF-X 999 999 999 PCT

DIFF-Y 999 999 999

FSC-X 999 999 999

Shaded parameters are Detector Control Parameters (DCP),

these values are never changed.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 6 of 12

Quality Control

Quality Control is performed to monitor instrument performance. Control material with
known values and charts with appropriate limits alert the operator to potential systematic
problems. Quality control protocol is established according to the laboratory’s policy,
accrediting agency requirements and instrument manufacturer recommendations. Below
are instructions for preparing commercial control files, patient control files and the
X-barM patient moving averages file.

A. Establish Commercial Control Files using e-CHECK/e-CHECK(XS)

1. Enter the lot information for each level of the lot e-CHECK/e-CHECK(XS)
control using the manual method.
a. Select ‘QC Files’ from the Main Menu or F5 from keyboard.
b. Click the appropriate file number (1-20).
c. Click F9 or ‘Input’ icon. QC dialog box appears.
d. Select appropriate Control Level from ‘Material’ dropdown box.
e. Manually enter lot number from QC vial or assay sheet.

Note: Cannot use handheld barcode reader to scan the lot number.

f. Select expiration date dropdown box to display calendar. Click on
appropriate expiration date in the calendar as stated from QC vial or
assay sheet.

g. Manually enter the suggested QC file limits supplied in this section.
h. Verify information has been input correctly.
i. Click on the RBC parameter, press the [CTRL]; [Shift]; [End];

simultaneously or click and drag to highlight all parameters.
j. Click on Variable Target (used to establish mean for new lot number

of control).
k. Select [OK].
l. Perform Steps ‘a’ through ‘k’ for remaining levels of control

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 7 of 12

A. Establish Commercial Control Files using e-CHECK/e-CHECK(XS) (cont’d).

2. Establishing Laboratory Specific Ranges
a. Parallel test new controls by analyzing two (2) or three (3) levels of control
for a minimum of twice per day for five (5) days.
b. Analyze each control level once and compare to assay sheet.
Comparison is required for the first point only, as instrument compares
subsequent results to ongoing means.
c. The results of the New Lot number may be compared to the Current Lot
number by selecting F11 and then selecting the appropriate file.

3. Autosetting Target Values
a. Select QC files from the Main Menu or F5 on the keyboard.

b. Double-click the appropriate file number (1-20).

c. Set the range of data to calculate statistics by clicking on the green cursor
and dragging to the left until all the points have been selected, or press
[CTRL]; [A]; to select all data.

d. Observe Mean, SD, and CV displayed in the right data column.

e. Select F9 or ‘Input’ icon.

f. Click on RBC parameter, then press [CTRL]; [Shift]; [End]
simultaneously or click and drag to highlight parameters.

g. Click Autosetting. Confirm that only the Target is selected. Deselect Limit
if indicated.

h. Click [OK]. Target values will now be displayed.

i. Verify that the targets that have been established, fall within the range on
the assay sheet. If values are not within range, contact the Sysmex
Technical Assistance Center at 1-888-879-7639 for further assistance.

j. Click [OK] to close and save.

k. Repeat steps ‘a’ through ‘j’ for each level of control.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 8 of 12

B. Establishing Historical Limit % for Commercial Controls

Background

Sysmex suggests that each laboratory base its control limits on three (3)
times its analyzer’s cumulative CV% from at least three (3) control lots where
analyzer performance was stable and precision was acceptable.

The three (3) CV limits are recommended as they represent the analyzer’s
statistical process capability. Using 3 CV limits with three (3) control levels
should provide error detection that meets most laboratory’s medical quality
requirements while minimizing false run rejection.

Calculate CV

The Insight Analyzer Cumulative Report includes the CV values for each lot.
Use cumulative values from three (3) lots. The Cumulative CV values are the
coefficient of variation calculated from all data points submitted from your
analyzer for a given lot.

Procedure

After approximately eight months (three lots) of collecting and submitting
control data, there should be three (3) complete lots of Cumulative CV
values. Use the Cumulative CV data to calculate control limits as follows:

ƒ Add the Cumulative CV values from three (3) control lots. The 3 CV is
calculated within a parameter and control level.

o Include only Cumulate CV values from those lots in which analyzer
performance was known to be stable and where precision was
acceptable.

o In very little data was submitted for a lot, the Cumulative CV may not
be reliable.

o It is okay to exclude some parameters from lots with performance
problems. Update the limits on those parameters that you can. The
parameters with problems can be calculated later when the
performance problems have been resolved.

ƒ Replace the previously entered Suggested QC Limit Range% values with
your analyzer-specific control limits.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 9 of 12

XS-Series Suggested X-barM QC File Limits

The limits below are to be used in the X-barM control file (CBC and DIFF) on the
XS-Series analyzer. These limits are based on three (3) times the maximum CV values
obtained in our X-barM study of XS-Series analyzers. Where there is no data to work
from, the suggested limits provided are “999”. These wide limits should allow the
analyzer to run without X-barM Limit Errors while the laboratory is collecting patient data
to establish limits specific to their patient population and analyzer.

Suggested XS-Series, X-barM File Limits

Parameter Limit% Parameter Limit%
WBC 42.0 DIFF-X 999
RBC 21.0 DIFF-Y 999
HGB 22.2 FSC-X 999
HCT 21.3
MCV 4.6
MCH 5.3
MCHC 3.4
PLT 28.1
RDW-SD 9.3
RDW-CV 8.0
MPV 2.5
NEUT% 19.5
LYMPH% 53.0
MONO% 26.6
EO% 64.3
BASO% 72.6
NEUT# 55.0
LYMPH# 40.8
MONO# 43.0
EO# 60.0
BASO# 66.4

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 10 of 12

B. Establish the X-barM Control Program

The X-barM control program collects batches of patient results and uses a
‘weighted average’ algorithm described by Dr. Brian Bull, to smooth and trim the
data.

1. Select the batch size for the CBC, DIFF.
a. CBC and DIFF. The common batch size is 20; however, your HSAS will
discuss the appropriate batch size depending on daily volume.

2. Manually enter the Suggested File Limits for X-barM.
3. Use the Variable Target function during data collection.

a. Click the ‘QC’ icon from the Menu window or Tool bar.
b. Click the [X-barM].
c. Click [Target/Limit].
d. Click [Variable Target], then [OK].
4. Auto-set Targets, and establish a 3 CV% limit once at least 200 data points
are collected over multiple reagent lots and at least 1 month (preferably a few
months).
5. Maintenance of the X-barM file.
a. Exclude known groups of abnormal samples that would plot points that

represent a shift in population, not a shift in instrument performance.
b. Remove points plotted during times where the instrument was proven to

be out of control or unstable according to e-CHECK/e-CHECK(XS)
commercial control data.

C. Saving QC Data for Insight Program:

1. Select QC Files from Main Menu or F5.

2. Highlight the appropriate file to save to Insight format (1-20).
3. Select Insight F12.
4. Use flash drive when prompted.
5. Verify the lot number and level in the ‘File Name’ box. Click [Save].
6. Repeat Steps 2-5 for remaining levels.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 11 of 12

D. Submit QAP Data to Insight Program:

1. Access Sysmex website via www.sysmex.com

2. Click the Go to Insight icon

3. Log on: User name: Input four digits of Insight Account No.
Password: Enter four-digit Insight Account Number, immediately followed by
the five digits of the facility zip code.

4. Press [Enter].

5. Your name and institution displays. Click Submit QC from the list on the left.

6. Select the type of data to be submitted: Data Disk Upload or flash drive.

7. Select XS analyzer from the drop down menu. Click browse to select
appropriate drive for USB flash drive.

8. Click on one of the three (3) QC files. Click [Open]. Confirm QC lot number in
the File example A:\QC-XXXX0804.ins

9. Click [Submit].

10. Click [Submit more Files] and repeat for other files.

11. Click [Review Report] to view submitted data.

12. Click [Close]; click [Log out].

References

1. Sysmex XS-1000i/XS-800i User’s Guide, Sysmex Corporation, Kobe, Japan, February, 2006.
2. Sysmex America, Inc., Mundelein, IL. e-CHECK Hematology Control Assay Sheet for Sysmex

XE-Series Analyzers, Rev. 1, 28-Nov-00.
3. Sysmex America, Inc., Mundelein, IL. e-CHECK Insight User Manual, Rev. 1.0d, 8-November-00.

4. Sysmex America, Inc., Mundelein, IL. e-CHECK Insight User Manual, Appendix A, Xm Quality

Control, Version 1.0a, 14-September-00.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 4: Quality Control
Document Number: MKT-30-1009 November 2008 Page 12 of 12

XS Calibration Verification – Optional

The XS-1000i will be installed by trained Sysmex personnel and calibrated to
manufacturer’s specifications. To meet regulatory or certifying agency standards you will
periodically need to verify instrument calibration. Calibration is required at installation,
and then calibration is verified at least daily with QC material. Some governing
bodies recommend (usually at six [6] month intervals) that calibration be checked using
manufacturer’s recommended procedures. The following process is also covered in
Section 8 of the User’s Guide.

This section covers procedures necessary to verify calibration of the instrument for WBC
(white blood cell count), RBC (red blood cell count), HGB (hemoglobin), HCT
(hematocrit) and PLT (platelet count). WBC differential parameters are calibrated during
the installation and are monitored as part of routine QC. They do not need to be
calibrated in your laboratory.

Suggested Calibration Verification Events

• Controls begin to reflect unusual trends or are outside acceptable limits and cannot be
corrected by maintenance or troubleshooting with the Technical Assistance Center.

• The laboratory’s internal procedures require periodic calibration verification.

• The Sysmex Technical Assistance Center or Service Representative has advised
verification and adjustment.

• Regulatory or certifying agencies require periodic verification.

• The calibration verification procedure check requires the repeat analysis (11 times)
of a fresh human blood sample for a precision study and the analysis of 6 samples of
SCS-1000 to conduct the calibration verification and/or adjustment. Please allow sufficient
time, reagent and sample material to complete the process.

Preparation

• Perform routine maintenance ensuring the transducer aperture is clean.

• Review QC files (all levels) for unusual trends in either direction. Proceed only if no unusual
trends are noted. If unusual trends are noted, contact Sysmex Technical Assistance.

• Ensure sufficient volume of reagent to complete 20 sampling analyses (includes reserve
for any additional sample runs).

• Perform a background check and ensure the values fall within the following ranges

•: Parameter Range

WBC-C 3
WBC-D
< 0.10 × 10 /µL

RBC 6

< 0.02 × 10 /µL

HGB < 0.1 g/dL

3

PLT < 10 × 10 /µL

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 5: Calibration Verification

Document Number: MKT-30-1009 November 2008 Page 1 of 10

Precision Check

One sample of fresh normal whole blood should be used for the precision check.
The sample should be analyzed within six hours of collection and stored at room
temperature. Observe the following recommendations when selecting blood for precision
check purposes.
Note: Do not use the sample which has been judged POSITIVE. The sample should be

collected from a person who is not on medication. The sample should be
morphologically and numerically normal.

Parameter Range

WBC 4-10 × 103/µL
RBC 3.8-5.5 × 106/µL

PLT 160-440 × 103/µL

1. Lipemic, icteric, and hemolyzed specimens must be avoided.

2. The anticoagulant should be the proper type and in proportion with the sample.

3. The volume of whole blood per sample should be greater than 2 ml (smaller
volumes may indicate poor sample collection and increase the risk of hemolysis
or have incorrect anticoagulant proportions).

4. Do not use the control blood for precision check. The system program for the
precision check is designed to analyze human blood.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

XS-Series Implementation Manual Section 5: Calibration Verification

Document Number: MKT-30-1009 November 2008 Page 2 of 10

Executing the Precision Check Program

1. Click the Controller button on the Menu screen. The Controller Menu will be
displayed.

2. Double-click the Precision Check icon in the Controller Menu. The Precision Check
Window will appear.

Analyzed Data The analysis results of a precision check are displayed. Mean The mean
value of the analysis data, excluding the data of the first sample analysis, is displayed. SD
The SD value of the analysis data, excluding the data of the first analysis, is displayed.
CV (%)The CV value of the analysis data, excluding the data of the first sample analysis,
is displayed. After the analysis of the 11th sample, CV values are displayed in red if they
exceed the Precision Limit (%).
Precision Limit (%) Acceptable precision limit is displayed.
Analysis A closed tube specimen is analyzed 11 times in the manual mode. After the
analysis, the results are displayed on the Analyzed Data. After the first sample analysis,
the Mean, SD, and CV (%) values are automatically calculated and displayed each time an
analysis is completed.
Note: The discrete test panel at the time of the precision check is automatically set for

CBC. To perform the precision check, 10 or more replicates of a sample with
normal data analyzed without error are required.

After the 11th cycle of analysis is completed, check that the CV (%) value is below
the Precision Limit (%) and it is not displayed in red.

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Document Number: MKT-30-1009 November 2008 Page 3 of 10

Executing the Precision Check Program (continued)

3. Complete the Precision Check by ensuring that the CV (%) values of all parameters
are below the Precision Limit (%), then click [OK] or [Cancel].

OK Saves the numerical data, as well as the Mean, SD, and CV,
Cancel for all precision check parameters, and then closes the
Precision Check window.

Displays the Cancel Confirmation dialog box.

Confirm by selecting [OK] which saves the precision check
results, and closes the Cancel Confirmation dialog box and
the Precision Check window.

Choosing [Cancel] closes the Cancel Confirmation dialog
box, and returns to the Precision Check window giving the
operator an opportunity to recheck the precision values and
avoid inadvertently closing the dialogue box.

Printing Precision Check Values

Sysmex recommends keeping hard copy printouts for inspector reviews. While in the
“Precision Check List” program, select “File” and click “Print”. This will print the screen
for the precision check.
1. To print the data from the precision check, select data to be output from the

Precision Check List.

2. Select and click an instrument you wish to use from the “Report” menu to start
output. Ledger (LP) sends data to connected line printer.

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XS-Series Implementation Manual Section 5: Calibration Verification

Document Number: MKT-30-1009 November 2008 Page 4 of 10

Calibration Verification

Six (6) samples of the data analyzed with SCS-1000 are used for calculating new
compensation value and for performing calibration verification.
1. Click the Controller button on the Menu screen. The Controller Menu will be

displayed.

2. Double-click the Calibrator Calibration icon in the Controller Menu. The Calibrator
Calibration window will appear.

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XS-Series Implementation Manual Section 5: Calibration Verification

Document Number: MKT-30-1009 November 2008 Page 5 of 10

Calibration Verification (continued)

Max Range The maximum allowable value of the Range Value is
Mean Value displayed.
Delta Percent
The mean value of the analysis data, excluding the
Acceptable Limit data of the first sample analyzed, is displayed.
Service Limit
( Assay Target - Mean Value ) / Mean Value x 100(%)
Current Compensation Rate is calculated and displayed.
New Compensation Rate
If the Delta Percent is at or below the “Acceptable
Limit,” it appears with no background color.

If the Delta Percent exceeds the “Acceptable Limit,” but
is at or below the “Service Limit,” it appears with a
yellow background.

If Delta Percent exceeds the “Service Limit,” it appears
with a red background.

When the Delta percent exceeds “Acceptable Limit”,
the parameter needs calibration. Calibration is not
necessary when the Delta Percent is less than this limit
value.

If the Delta Percent exceeds this limit, technical
assistance may be necessary and your instrument
system needs service. Calibration cannot be completed
because the system recognizes an unusually high
change in compensation rates.

Current calibration value, which was obtained in the
previous calibration procedure.

New calibration value calculated from the calibrator
analysis using the following formula; Assay Target ×
Current Calibration Mean Value.

3. Calibration Program – Setting (Entering Assay Target Values). To perform calibrator
calibration program, you must enter the Assay Target values provided with the
Sysmex SCS-1000 Calibrator product. Verify that the assay sheet matches the Lot #
of calibrator.

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XS-Series Implementation Manual Section 5: Calibration Verification

Document Number: MKT-30-1009 November 2008 Page 6 of 10

Calibration Verification (continued)

4. Click the Assay Target on the Calibrator Calibration window. The Assay Target
dialog box will appear. Enter the values from the assay sheet into the respective
boxes in the dialogue box.

OK Confirms the entered assay target values, and closes the
Cancel dialog box.
The entered assay target values are displayed under “Assay
Target” on the Calibrator Calibration window. The “Max
Range” value is calculated and displayed.

Cancels change to the entered assay target values, and
closes the dialog box.

5. Calibration Program – Analyze samples. Proper handling of the calibrator is crucial to
accurate calibration verification. See the package insert of the SCS-1000 Calibrator
for handling information.

6. Analyze the calibrator 6 to 10 times in open-sampling manual mode. After analysis is
complete, the analysis results are displayed under ‘Analyzed Data’. The Range
Value, Mean Value, Delta Percent, and New Compensation Rate values are
calculated and displayed.

Note: The discrete test panel at the time of the calibrator calibration is automatically
set to CBC (no Diff). To perform calibrator calibration, five (5) or more
samples must be analyzed with normal data analyzed and completed without
error. The analysis data for the first sample is omitted from calculations. The
second and subsequent samples are used for calculation calibration factors

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XS-Series Implementation Manual Section 5: Calibration Verification

Document Number: MKT-30-1009 November 2008 Page 7 of 10

A. Calibration Verification (continued)

7. Calibration Program – Exe. Cal. (Execute Calibration) Calibration value can be
updated when the new calibration value of all calibration parameters are displayed.

8. Click the [Accept] on the calibrator calibration window, and the New Compensation
Rate dialog box will open.

9. To cancel calibrator calibration and cancel update of the calibration value, click
[Cancel] on the Calibrator Calibration window. The Cancel Confirmation dialog box
will appear. Click [OK] or [Cancel].

OK Cancels changes to the analysis data, and closes the
Cancel Cancel Confirmation dialog box and the Calibrator
Calibration window

Closes the Cancel Confirmation dialog box, and returns to
the Calibrator Calibration window.

Note: In the cases below, parameter names and compensation rates appear in gray. In
these cases, calibration cannot be performed.
• New Compensation Rate < 80 New Compensation Rate > 120 (Current
Compensation Rate – New Compensation Rate) > 5 Range Value > Max Range
Delta Percent > Service Limit Take corrective action by referring to Chapter 10:
Troubleshooting, and analyze a fresh vial of the calibrator again. If the same
situation persists, contact a Sysmex technical representative.

• In the case below, a check mark is automatically placed in the check box when
the dialog box appears. Acceptable Limit < Delta Percent < Service Limit.

• In the case below, a check mark is not placed in the check box when the dialog
box appears. Delta Percent < Acceptable Limit.

The check box for the parameter which needs calibration will be checked automatically,
and New Compensation Rate is displayed.
10. Changing the check mark in the check box to select the parameter to perform the

calibration. Execution of the calibration of the parameter checked in the check box
will change into new compensation rate. The parameter without check mark will not
change even if you perform a calibration.

11. Click [OK] or [Cancel] in the New Compensation Rate dialog box.

OK Applies the new compensation rate to the instrument,
makes an addition to the calibration history, and closes
Cancel the New Compensation Rate dialog box
a.
Discards changes to the new compensation rate, and
closes the New Compensation Rate dialog box.

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XS-Series Implementation Manual Section 5: Calibration Verification

Document Number: MKT-30-1009 November 2008 Page 8 of 10

Calibration Verification (continued)

12. Use another fresh vial of the calibrator, verify the calibration by repeating the
procedures described in Steps 2 and 3 of Section 8.10. If Delta Percent appears
with no background color, the system is calibrated correctly.

13. Sysmex recommends keeping hard copy printouts for inspector reviews. To obtain a
hard copy of the screen, go into ‘File’ and click [Print]. You must be in “Calibration
History” program in order to do this.

14. LP printing of data selected in the Calibration history can be carried out.

15. Select a data to be output from the Calibrator Calibration History screen.

16. Select and click an instrument you wish to use from the ‘Report’ menu to start output.
Ledger(LP) sends data to connected line printer.

One Nelson C. White Parkway, Mundelein, IL 60060 Phone 847-996-4500 · 1-800-3SYSMEX (1-800-379-7639) www.sysmex.com

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This Page Left Blank Intentionally.

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