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Consensus Guidelines: Preface

The International Consensus Group for Hematology Review is pleased to publish the attached guideline:

Suggested Criteria for Action Following Automated CBC and WBC Differential Analysis

Berend Houwen MD, PhD the founder of ISLH, who passed away recently, recognized the long-standing need for generally accepted guidelines
(“rules”) which could be applied to criteria for review of CBC and differential results from automated hematology analyzers and he addressed it
in a visionary manner. He invited twenty experts to a meeting to discuss the issues and agree upon the most appropriate criteria. Beckman
Coulter Inc. generously provided an educational grant to fund this meeting and to provide financial assistance for the development of guidelines.
Dr. Houwen gathered together hematology laboratorians who represented six countries and seventeen laboratories that were foremost in the
use of review criteria. The laboratories included those servicing tertiary care hospitals, oncology hospitals, community hospitals, childrens’
hospitals, and doctors’ offices. For almost three full days, each parameter of the CBC was discussed in depth and consensus was reached
regarding rules for the situations which should trigger a review of automated cell counter results potentially leading to further testing or blood
smear review.

Each laboratory agreed to test these rules in their own facilities. Approximately 1000 samples were to be collected and tested according to a
detailed protocol at each site. These samples were to represent the lab’s usual testing population. Of those 1000 samples, 200 were to be
“repeat” samples in order to test the Delta Rules. A manual blood smear review of all samples was also to be performed, with a manual
differential when indicated. Fifteen laboratories responded, providing results from a total of 13,298 patient samples for data analysis.

The Steering Committee for the International Consensus Group discussed extensively what constituted a positive finding on a peripheral smear.
Once again, consensus was reached by agreement of the participating laboratories. The samples were then analyzed and truth tables
established according to these criteria.

At the recommendation of Dr. Berend Houwen, the International Consensus Group for Hematology Review is placing the Consensus Rules in the
public domain in the hopes that our experience may enhance your own laboratory rules for review of automated analyzer results. The
information on this website includes the rules for review, definitions of delta terms, definitions of what constituted a positive smear finding in
this study, a consensus rules results “truth table”, contact information for steering committee members, and a list of participating hospitals and
laboratories. We thank each of the participating laboratories for taking the time to help determine the rules for this study, collecting and
providing the data, reviewing the data analysis for their individual laboratories, and reviewing the attached material prior to publication on this
website.

This material will be submitted in expanded form for journal publication within the next few months. Journal reference information will be posted
on this website as soon as available.

We encourage laboratorians to explore the application of these rules in their own laboratories and to share their findings with the Consensus
Group. Before activating any or all of these rules in your labs for clinical purposes, the Consensus Group strongly advocates testing of each rule
in your own setting to verify the results with your patient population. If anyone would like to perform a formal study similar to that performed
by the consensus participating laboratories, please contact a member of the steering committee for protocol information and guidance.

The International Hematology Consensus Group would like to extend their appreciation to Beckman Coulter, Inc. for their unrestricted
educational grant which allowed our group to come together to formulate and to test these rules. These rules are dedicated to the memory of
Dr. Berend Houwen: it was his foresight that recognized the need for these rules; it was his vision that an international consensus group was the
best means to address the need; it was his initiative that formed the group and; and it was his leadership and wisdom that guided the group in
it’s work.

Sincerely,
The Steering Committee
International Consensus Group

Consensus Guidelines: Delta Definitions

Delta checks: Delta checks operate to reduce hematological testing by recognizing previously detected validated abnormalities.

Delta limits: The delta limit for a particular test is the amount by which the most recent automated analyzer test result may differ from a
previous test result before triggering smear review or some other action to validate the analyzer result. Delta limits should be established for
each laboratory by taking into account physiological considerations as well as the characteristics of the automated analyzer used in that
laboratory.

Delta pass and delta fail: Delta pass occurs when the result of the most recent automated analyzer test does not differ by more than the delta
limit from the result of the previous test. Delta fail is when the result of the most recent test differs by more than the predefined delta limit from
the previous test result.

Positive delta and negative delta: Positive delta occurs when the result of the most recent test differs in a positive direction from the result of
the previous test i.e. it is larger, irrespective of whether the delta limit has been exceeded. Negative delta is when the result of the most recent
test differs in a negative direction from the result of the previous test i.e. it is smaller.

Actions related to delta checks: The International Consensus Group did not set delta limits, leaving those to the individual laboraotory. However
the group did suggest specific actions for situations where delta limits set by the individual laboratory are exceeded.

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Consensus Guidelines: Positive Smear Findings

Below is the listing of criteria used to determine a positive smear finding for the study of suggested criteria for action following automated CBC
and WBC differential analysis.

1. Morphology
a. RBC morphology at either 2+ / Moderate or greater. The only exception is Malaria, where any finding will be considered a positive finding.
b. PLT morphology (giant platelets) at either 2+ / Moderate or greater.
c. Platelet Clumps at > rare / occasional
d. Dohle bodies at either 2+ / Moderate or greater
e. Toxic granulation at either 2+ / Moderate or greater
f. Vacuoles at either 2+ / Moderate or greater

2. Abnormal Cell Types

a. Blast > 1
b. Meta >2
c. Myelo / Promyelocyte > 1
d. Atypical Lymphs > 5
e. NRBC > 1
f. Plasma Cells > 1

Consensus Guidelines: Rules

Rule
Parameter Primary and/or Secondary and/or Tertiary and/or fourth Action 1 Action 2 Action 3
#
First
1 Neonate Slide Review
sample
WBC, RBC,
Exceeds Dilute sample and
2 HGB, PLT,
linearity rerun
Retics
Lower
than Lab
3 WBC, PLT verified Follow lab SOP
instrument
linearity
If persists,
perform
WBC, RBC, Check sample for Rerun
4 Vote Out alternate
HGB, PLT clot sample
counting
method
<4.0 OR >
5 WBC and first time Slide Review
30.0
<4.0 OR > within 3
6 WBC and delta failed and Slide Review
30.0 days
<100 OR
7 PLT and first time Slide Review
>1000
Delta
8 PLT Any value and Slide Review
Check Fail
<7g/dl or
> 2g/dl
above Verify
upper sample
9 HGB and first time Slide Review
reference integrity if
range for indicated
age and
sex
<75fl or > specimen
10 MCV 105fl and first time and is < 24 Slide Review
(Adult) hours old
Request
fresh Report with
sample if comment if
specimen Slide Review for
NO fresh
11 MCV >105 fl and adult and is >24 macrocytic
macrocytic sample is
hrs old associated changes
associated not
changes available
seen
specimen
Verify sample
12 MCV Any value and delta fails and is <24
integrity/identity
hours old
13 MCHC >=2 units Check for lipemia,
above hemolysis, RBC
upper limit

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of agglutination,
reference spherocytes.
range
Investigate possible
normal/high IV contamination or
14 MCHC <30 and
MCV other sample
specific cause.
15 RDW >22 and first time Slide Review
DIFFERENTIAL
No diff or Manual Diff and
16
incomplete diff Slide Review
<1.0 or >
17 Neut # and first time Slide Review
20.0
>5.0
(adult) or
18 Lymph # and first time Slide Review
>7.0 (<12
yrs old)
>1.5
(Adult) or
19 Mono # and first time Slide Review
>3.0 (<12
yrs old)
20 Eos # >2.0 and first time Slide Review
21 Baso # >0.5 and first time Slide Review
22 NRBC # any value and first time Slide Review
RETICS
Retic Absolute
23 >0.100 and first time Slide Review
#
SUSPECT FLAGS
Suspect flag
24 (except Flag + and first time and adult Slide Review
ImmG/Band)
25 Suspect flag Flag + and first time and child Slide Review
If persists, Slide
WBC Check sample
review review with
26 unreliability Flag + any integrity and rerun
instrument manual diff
Flag sample
output if indicated
27 RBC fragment Flag + any Slide Review
28 Dimorphic RBC Flag + and first time Slide Review
Validate by eg. Review
lab SOP smear for
Lyse resistant Review WBC
29 Flag + any (consider abnormal
RBC histogram/cytogram
incorrect RBC
retic count) morphology
Slide If clumps
Check sample for review persist,
30 PLT clump flag any count
clots (PLT follow lab
estimate) SOP
PLT &
MPV flags
31 Platelet Flags Slide Review
except plt
clumps
Immature
32 granulocyte Flag + and first time Slide Review
flag
Immature previous positive
33 granulocyte Flag + and confirmed and delta fail Slide Review
flag result for WBC
34 Left shift flag Flag + Follow lab SOP
Atypical/Variant
35 Flag + and first time Slide Review
lymphs
previous positive
Atypical/Variant
36 Flag + and confirmed and delta fail Slide Review
lymphs
result for WBC
37 Blast flag Flag + and first time Slide Review
delta
previous pass or within
38 Blast flag Flag + and confirmed and negative and 3-7 Follow lab SOP
result delta for days
WBC
39 Blast flag Flag + and previous and positive Slide Review
confirmed delta fail

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result for WBC
If positive,
enumerate
NRBC
40 NRBC flag Flag + Slide Review count,
correct
WBC if
appropriate
Repeat if
Abnormal Look at instrument If persists,
41 Retics aspiration
pattern output review slide
problem

Consensus Guidelines: Truth Table

Delta checks: Delta checks operate to reduce hematological testing by recognizing previously

Number Percentage

True Positive 1483 11.20%

False Positive 2476 18.60%

True Negative 8953 67.30%

False Negative 386 2.90%

Total number of samples 13298

Consensus Guidelines: Participating Laboratories

Last Name First Name Company/Institute Country Phone E-mail
PWB0280
Barnes Patrick Barnes Jewish Hospital US 314-362-5048
@bjc.org
rhonda.becker
Becker Rhonda University of California, Davis Medical Center US 916-734-3475
@ucdmc.ucdavis.edu
auscorpmarketin
Fawcett Terry Biospecifix Australia 61-3-9890-8498
@ozemail.com.au
bfernandes
Fernandes Bernard Mt Sinai Hospital, Dept. of Pathology & Lab Medicine Canada 416-586-4462
@mtsinai.on.ca
Houwen Berend Beckman Coulter, Inc.
lkemerer
Kemerer Linda Grant/Riverside Methodist Hospitals US 614-566-5686
@ohiohealth.com
jamieson.bette
Jamieson Bette The Children's Hospital, Dept. of Pathology US 303-861-6252
@tchden.org
JohnstlM
Johnstone Lynn Health Alliance Laboratories US 513-585-1410
@healthall.com
samuel.machin
Machin Samuel University College Hospital, Dept. of Haematology UK (44)20 7380 9884
@ucl.ac.uk
stefhem
McFadden Stefanie Laboratory Consultant US 614-579-5999
@aol.com
kready
Ready Kirk Chinook Health Region, Corp. Office Canada 403-382-6093
@mail.chr.ab.ca
d.rosenfeld
Rosenfeld David Liverpool Hospital Australia (61) 2 98 28 51 67
@unsw.edu.au
ramon.simon
Simon Ramon Beckman Coulter Eurocenter S.A. Switzerland 41-22-994-08-08
@beckman.com
elkin.simson
Simson Elkin Mt Sinai Hospital US 212-659-8181
@mssm.edu
soppa.vicky
Soppa Vicky Mayo Foundation, Hematopathology US 507-284-3198
@mayo.edu
msuter
Suter Michael OML Laboratories US 541-687-2134, x 8182
@omlabs.com

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Villarubia Jesus Hospital Ramon y Cajal Spain 34 91 336 8224 jvillarrubia.hrc
@salud.madrid.org
dwall
Wall Debbie Dynacare Laboratories, Dynacare Northwest, Inc. US 206-215-3945
@dynacare.com
jeri.walters
Walters Jeri Sinai Samaritan Medical Center, East Campus US 414-328-7920
@aurora.org

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