Delta Checks for Random Error
Detection in Hematology Tests
Berend Houwen, MD, PhD, and David Duffin, PEng, PhD
We developed a computerized algorithm
for real-time hematology delta checks,
comparisons between current and pre-
vious patient automated blood cell
counts. Delta checking is restricted to an
arbitrarily set maximum ofseven days
and uses linear as well as variable-rate
nonlineardiscriminantfunctions.!wo
delta levels were used—one for intralabo-
ratory use and one requiring interaction
with the referring unit or physician. The
delta checks are useful for (1) random er-
ror detection mainly using a combina-
tion oftwo RBC parameters, mean cor-
puscular volume (MCV) and mean cor-
puscular hemoglobin (MCH), that re-
main stable over time; (2) warning for sig-
nificant clinical changes in hemoglobin,
MCV, WBC, and/or platelets; and (3) the
elimination ofmanual checks on abnor-
mal RBC morphology, WBC counts, and
for platelet counts in specimens with re-
peatedly abnormal values.
From the Department of Laboratory Medicine,
Foothills Hospital and Department of Pathology,
University of Calgary (Dr. Houwen), and Sharecom
Industries Ltd (Dr Duffin), Calgary, Alberta, Cana-
da. Berend Houwen is currently visiting professor
at Duke University Medical Center, Box 2929,
Durham, NC 27710.
410 Laboratory Medicine June 1989
Q uality control systems help ensure
the reliability of laboratory re-
sults provided to the clinician.
Their use commonly constitutes 10% or
more of the total laboratory workload.
While quality control procedures are
used primarily to detect instrument
inaccuracy and imprecision and to en-
sure day-to-day consistency, they are
often ineffective in detecting low-fre-
quency random errors. Not only can
random errors be caused by intermit-
tent instrument malfunction or reagent
problems, but they can be caused by
preanalytical and postanalytical errors.
Examples of preanalytical errors are in-
correct specimen collection, common
in patients with intravenous catheters,*.2
improper specimen handling; incorrect
specimen labeling; or misidentification
of the patient. Postanalytical errors in-
clude failure to correct test values for
dilution, transcription errors, and mis-
interpretation of test results. Literature
data on the frequency of preanalytical
and postanalytical errors are scarce. On
the basis of our series of 2,500 samples,
we believe that transcription errors oc-
cur at a rate of approximately 1 per 500
samples or more. Given the stability and
accuracy of currently available hema-
tology analyzers, it seems reasonable to
assume that random errors are most fre-
quently caused by preanalytical and
postanalytical problems rather than by
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instrument or reagent problems.
The occurrence of random errors is a
significant problem.3.4 Depending on the
degree of automation in the laboratory,
we estimate that the frequency of random
errors in most laboratories exceeds 1 per
200 to 500 samples. It is therefore reason-
able to develop systems that will assist in
detecting random errors. The use of a pa-
tient's own data in a delta-checking algo-
rithm is particularly suitable for such a
purpose,5-' as random errors caused by
most preanalytical or postanalytical prob-
lems often result in changes in one or
more parameters tested and cannot be ad-
equately explained by changes in the pa-
tient's clinical condition. Such changes
will be easily detected by a comparison,
or "delta check," of current sample re-
sults with one or more previous test re-
sults from the same patient.
Delta checking for sample identity will
be most powerful if parameters are chos-
en to be stable over the elapsed time peri-
od. For instance, it is clinically unlikely
that the mean corpusclar volume (MCV)
of a patient's red blood cells would
change from 96 to 84 fL in four days, even
though both values themselves are within
the reference range foran adult. Such a
change should raise doubt about the
specimen's identity and/or integrity, and
the referring unit orphysician should be
contacted about the clinical events that
have involved this patient.
 Several delta check systems have been
described for selected chemistry tests, us-
ing single or multivariate discriminant
analysis.915 In some instances these sys- %
tems also involve a "rate" check, which 40-
takes into account the time elapsed be-
tween the current and the most recent 30- .0)
.(3)
previous sample.5.' The use of time inter-
vals between samples permits delta 20- ,°(2)
checking of parameters that may not re- O
0
main constant overtime, although it re- o
• • o
mains dubious whether such parameters 10- •o o
.(4) o# . 0
• • ft
can be used for establishing sample identi- *» •• •»0_ o A?
••,li\&*j,tJL Is..' '•?£ — 5 *
fication.
Among the disadvantages of delta 60 70 80 90 100 120
checking is its relatively low specificity, MCV (fL)
resulting in a high flagging rate.5*11-12 We
will show that this can be avoided by
choosing delta levels appropriate per pa- Fig 1. The delta percentage is indicated on the vertical axis and is plotted against the highest of the two re-
rameter. One of the other major limita- sults compared (RH), on the horizontal axis. Two delta levels are indicated: level A, ranging from 3% to 4%,

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tions of delta checking has been the ex-
treme labor intensity when not per-
formed on a computerized system.
We describe in this report a computer-
ized on-line, real-time delta check system
for five parameters of the automated
blood cell count (ABC), using an arbi-
trary maximum time interval of seven
days between current and most recent
previous sample. Although the system
was designed primarily for random er-
ror detection, other applications in-
clude reporting of clinically significant
changes and the elimination of manual
checks on repeatedly abnormal results.
The entire software that includes the
delta check algorithms for the different
ABC parameters, all autoverification
procedures and, when indicated, the
comments to be included in thefinalre-
port, is integrated in the hematology
laboratory computer system. A sepa-
rate, on-line real-time, on-demand delta
check system is available at any time for
authorized staff working on a patient
sample.
and level B, ranging from 5% to 7%. The open circles indicate artificial data, most of which are included in
Table I. The closed circles represent patient data: (1) represents a change from 91 to 118 fL, or a delta of
30%; (2) shows an MCV change from 73 to 62 fL, or a delta of 18%; (3) shows a drop from 86 to 68 fL, or a
delta of 27%; and (4) shows a rise in MCV from 78 to 84 fL, or a delta of 8%. Data (1) and (2) represent sam-
ple identification problems, (3) a clerical error, and (4) a posttransfusional state, respectively.
View, Calif) and uses on-line data acquisi- error is suspected (Figs 1-4). If no delta
tion and handling. The system serves the check problem is encountered and if the
two hematology laboratories of the Foot- test results are within preset laboratory
hills Hospital, a 1,000-bed teaching and flagging criteria, the results are automati-
tertiary care facility, and the adjacent cally vertified and reported. Figure 5
Tom Baker Cancer Center. Approxi- shows the approach used to interpret del-
mately 600 samples for ABC are received ta checks.
per day, and approximately 60% of these Delta check results for all parameters
samples have a recent enough previous are calculated with the following
test result for delta checking. formula: RH - RLI/RL X 100%, where
The following parameters are checked: RL indicates the lowest test result and RH
hemoglobin (Hgb), MCV, mean corpus- indicates the highest result. This method
cular hemoglobin (MCH), and the plate- is different from the commonly used
let and WBC count. A complete delta equation: IRj — R2I/R2, where R, repre-
check for all hematological parameters is sents the current and R2 the previous re-
available at any time on any sample in a sult.58 If two tests results (R) are obtained
patient'sfileand is accessible through the on different occasions from the same pa-
patientfileor during the analysis of a pa- tient, for example, one platelet count of
tient specimen. Activation of the auto- 40 X 109/Landanotherplatelet count of
mated delta check leads to a statement on 80 X 109/L, then the delta percentage ac-

M
aterials and Methods
The hematology laboratory
computer data management
system was developed in-house in 1982
and has been expanded in modules. The
delta check software has been integrated
into the hematology laboratory data
management system (CALM™ Software,
Sharecom Industries Ltd, Calgary, Alber-
ta). The system can operate on a Micro-
vax™ Computer (Digital Equipment Cor-
poration, Boston) or a Macintosh™ mi-
croprocessor (Apple Inc, Mountain
the CRT as well as in the intralaboratory
report regarding the problem encoun-
tered, eg, "delta Hgb failed," and the pro-
hibition of the vertification of the test re-
sult until the delta check problem is re-
solved.
Two levels of flagging are applied. The
first level indicated by an "A" reflects a
clinically significant but medically plausi-
ble change from the previous test result. A
delta check result outside level "B" is not
likely to be caused by a medical cause, at
least not within seven days, and a random
cording to thefirstformula will be 100,
regardless of the order in which the re-
sults were obtained. If the second
formula is used, the outcome of the delta
percentage is determined by the order in
which results are obtained. If thefirstre-
sult (Rt) shows a platelet count of 40 X
109/L and the second result (R2) shows a
platelet count of 80 X 109/L, then the
delta percentage will be 50. However, if
the results are obtained in reverse order,
the delta percentage will be 100. Exam-
ples of changes in parameter levels and

Laboratory Medicine June 1989 411

 the accompanying delta percentages are
given in Tables I—III. (2)*
The delta check system was developed *(3)
%
on a database consisting of data from 254 80-
samples received from patients in the he-
matology/oncology unit, the intensive -
care unit, and the surgery unit. These units *(4)

were selected because of an expected 60-

high frequency of abnormal test results,
as well as of expected significant changes / * \ °
in results. A number of test results were " (1) / \
"mixed up" on purpose for each of the o
40-
parameters in order to challenge the val- o
idity of the delta limits chosen.
B
Delta check levels for MCV and MCH ' •• • v
were determined by two linear discrimi- 20- •
,'' • •• * * • . • ft
nants—at slopes from 3% to 4% and
from 5% to 7%, respectively (Fig 1). The ,-*-(B)
.' * * * V « I " r"*'.l 'l'A • • - — -(A)
delta levels as well as the slope were chos-
•

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en arbitrarily, but based on the results
from our database. Variable-rate delta
limits were developed for Hgb, platelets,
and WBC due to the wide range in delta
check results. Delta checks for Hgb used
a combination of a linear discriminant for
delta level A and a mathematical function
described as a bell-shaped curve for level
B (Fig 2). The delta checks for platelets
used a combination of two different in-
verse hyperbolic equations16 for levels A
and B (Fig 3). Delta checks for WBC for
both A and B levels used similar hyper-
bolic equations (Fig 4). In all instances of
linear as well as variable-rate delta checks,
the results were always plotted against RH
the higher of the two test results, in order
to enhance sensitivity.
esults
i i i i ^~ I ^ I r i i i
60 80 100 120 140 160
HEMOGLOBIN (g/L)
Fig 2. The data points were obtained in the same way as in Fig 1: solid circles represent patient data, and
open circles represent artificial data (Table II). The changes in data forsamples (1) to (4) were as follows:
(1) Hgb from 54 to 36 g/L, delta 50%; (2) Hgb from 48 to 88 g/L, delta 92%; (3) Hgb from 58 to 108 g/L,
delta 86%; and (4) Hgb from 122 to 73 g/L, delta 67%. Sample (2) represented a collection error, while
samples (1) and (3) were obtained from transfused patients, and sample (4) was obtained from a patient with
massive hemorrhages.
cated. Before the change is reported the shows examples of the ap proach we took
technologist is required to check the sam- toward decision making based on delta
ple's identity by checking the sample label checks.
for patient name, hospital number, sam- Approximately 60% of the 400 to 600
ple number, collection date and time as samples received daily had previous re-
well as RBC "fingerprinting" (see below). sults to allow a delta checc. Of these 250
The test result should also be checked by to 350 samples, only 20% were reviewed
reanalysis, preferably by an alternative by technologists, and the: emainder were
method. If the sample identity was veri- within limits. The reviews for either MCV
fied and abnormal results are confirmed, or MCH for exceeding de lta level A con-

R The delta check results and the del-

ta limits A and B for the individual
parameters are shown in Figs 1 through 4.
The percentage delta result is always plot-
ted against the highest of the two test re-
sults (RH) on the y axis. As expected, the
data for MCV (Fig 1) and MCH (data not
shown) are narrowly distributed. The dis-
persion of Hgb, platelets, and WBC is
much greater, with clusters occurring in
characteristic areas. All delta checks flag-
ging limits were tested on current patient
data and were modified if the flagging
rate was too high. The delta check limits
were well in excess of method impreci-
sion and were compared to an arbitrary
clinically relevant change.
Delta flagging limits were used as fol-
lows: if the delta exceeds limit A but is less
than B, a clinically relevant change is indi-
the result is reported.
A delta check result outside the second
limit B indicates a major change in a test
result and is unlikely to have been caused
by a change in the patient condition. The
sample identity should be checked and
the test results verified by reanalysis. If no
errors are discovered, the technologist
should contact the patient's nursing unit
or referring physician for any clinical in-
formation that might explain the change
(eg, bleeding, surgery, transfusion of RBC
or platelets, etc). If there is no explana-
tion, the sample should be recollected. If
the sample identity cannot be confirmed,
recollection should be suggested to the
nursing unit. If the nursing unit or physi-
cian insists on reporting the result in ques-
tion, the result should be reported, but
with an appropriate comment. Table IV
sisted of approximately 60% of all flagged
specimens. Flagged result > for Hgb and
platelets were about equa I, while WBC
reviews were uncommon, largely because
of the limits chosen.
In approximately 1 per 3,000 samples
were delta check results consistent with a
failure in sample identity. Chart review
and other follow-up investigations usual-
ly indicated a probable sample mix-up.
^ ^ omment
It is unfortunate that clinically rele-
V- - vant changes in laboratory test re-
sults are often poorly defined. Physicians
may interpret changes in tests as signifi-
cant, when, in reality, they are close to
the performance limits. On the other
hand, changes in a patient's test results
that are due to random error must be rec-

412 Laboratory Medicine June 1989

 As is pointed out previously, even the
method of the calculation of the delta
\ i check is important. The commonly used
formula5-8 for delta checks—current mi-
I 1 o nus previous result divided by the pre-
% •
1 •• 1 vious result—will lead to different per-
300- •
• 1
1 1
5 centages for patients in whom a parame-
• 1. • \
* 1 1 ter increases as compared to those in
1 \ o
200- o whom a parameter decreases.5 In terms of
o accuracy in determining a change, howev-
o
er, it seemed to us that the delta or the dif-
.*•»• \ \ ° o o
100- ferences should not be skewed one way
or the other. Our alternate formula elimi-
80-
... ••>* v.) o
nates such a bias and yields equal delta
checks, regardless of the direction of the
parameter change.
60-
a
On Another problem is caused by a poten-
* ". * A • (3)° (4). o .° tially highflaggingrate, as has been re-
A A
4a • * .\ • o ported for chemistry results of patients
with renal failure, diabetic ketoacidosis,

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• • . • A •• *

or shock.10-12 This illustrates the failure of

20- • A thefixedlinear limit approach for tests
with a wide range of values. For auto-
™—1™—1 1 1— - T * — 1 1-*-1 T WA " ^ ^ *—1-*— mated blood results, platelet counts,
40 80 120 160 200 300 400 500 600 700 WBC, and Hgb have such wide ranges in
PLATELETS (109/L) contrast to the narrowly distributed
MCV and MCH. We found that the vari-
Fig 3. The data points were obtained as outlined in Fig 1. Solid circles represent patient data, and open cir- able-rate discriminant functions were su-
cles represent artificial data (most of which are included in Table III). Open triangles represent clinically
suspicions data, in which thefinalconclusion was that in all but two patients the results were caused by the
perior for platelet and WBC delta checks
medical condition of the patients. The platelet counts for samples (1) to (4) were as follows: (1) 73 and and resulted in more meaningful flagging.
130X 10»/L, delta 77%; (2) 305 and 179X 10»/L, delta 70%; (3) 300 and 190X 10»/L, delta 58%; (4) 222 For Hgb it was necessary to develop a
and 350X 10'/L, delta 58%. In sample (1), the probable cause was collection error, sample (2) discloses a rather complex mathematical function
sample mix-up, and samples (3) and (4) show hemorrhagic conditions.
described as a bell-shaped curve. Other-
wise, the delta checks would only have
alerted laboratory staff to Hgb changes
ognized before the test results are re- ty control procedures helps assure accura- caused by either blood loss or blood
ported. cy and precision, and while retesting of transfusion. The majority of those
The common laboratory practice of in- abnormal test results may detect intermit- changes are still documented and result in
vestigating patient specimen results that tent analytical failure, there are no widely an automatic comment: "note change in
exceed certain limits provides only lim- applied quality control mechanisms other Hgb," but do not require the interaction
ited assurance of a truly pathological re- than delta checking for solving the major- of laboratory staff. The delta results out-
sult. An abnormal result is usually con- ity of causes of preanalytical and postana- side the bell-shaped limit, however, are
firmed by repeating the test, preferably, lytical error. In principle, delta checking is subject to technologist interaction, be-
by an independent method, and while this an excellent method for random error de- cause the magnitude of the change may
will not detect problems such as sample tection, but it is flawed. It has been argued reflect nonmedical causes such as im-
mix-up, it may uncover a random error that delta checking may be inappropriate proper sample collection or sample mix-
caused by intermittent instrument mal- when material is obtained from patients up. For an indication of the significance
function or reagent problem. who are being actively treated, for fear of of changes in Hgb levels see Table II.
Another approach to demonstrating detecting solely changes representing the A high false-positive flagging rate for
this type of error requires that the result is result of clinical intervention.17 However, delta checks is a common problem.10-12
part of a combination of interdependent these clinical changes are unlikely to af- Ideally, delta checking shouldflagonly
parameters. Inconsistencies in such a set fect all hematological parameters at the samples with a random error, and perhaps
of results can be detected by correlating a same rate. If delta check algorithms em- give a different type of warning for clini-
test result with those obtained for the ploy parameters that have little tendency cally relevant, but true changes. All too
other parameters, a technique that has for change over a limited period of time, easily, a delta check system will require
been successfully applied to anion gap de- such as MC V or MCH, a delta check may the laboratory staff to follow-up and
tection and for the creatinine/urea nitro- be used to successfully establish sample check numerousflaggedsamples that
gen ratio.7-9 identity, regardless of clinical events such represent clinical change but not random
While the operational stability of cur- as surgery, giving birth or even after a error. Because of this, delta checking may
rent instrumentation coupled with quali- number of blood transfusions. cause more trouble in the laboratory than

Laboratory Medicine June 1989 413

 improvement. This may best be illus-
% trated by our own frustrating experience
300 • • • with implementing the delta check sys-
tem. The initial procedure took into ac-
count method imprecision, but did not
200 - *\ ' •
N. " *. require testing the delta check on our da-
* N. • tabase nor plotting of the data. The initial,
100 • *\ • linear delta limit for MCV of 2.0% was far
too conservative for clinical use and re-
*\ • #
B sulted in a high number offlaggedspeci-
80 mens, although theflagginglimit was set
f
% • well in excess of method imprecision for
\ * this parameter (CV 1.1% for Coulter
60 •
S+V, and 2.1% for Sysmex/TOA
•• E-5000, for references see CAP survey18).
40
• •••. x • *<
Jr.
Application of a limit of three times the
coefficient of variation for the specific pa-
rameter as suggested by Lacher and Don-
20 ——!i • nelly5 did not improve the results signifi-
A
cantly. On review, most of the flagged

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- • • • • • • specimens did not reveal a problem with
2 4 6 8 10" 20 40 60 80
sample identification, which had been the
Fig 4. The data points were obtained as outlined in Fig 1. Solid circles represent patient data. There is a clus- major purpose for using delta checking
ter of data points between a WBC of 10 to 20X lO'/L caused by febrile conditions. The delta check system for MCV. In other words, a change from
for WBC is used mainly for intralaboratory use on very low or high counts. Delta level A has been disabled anMCVof84to87fL,oradeltaof3.6%,
because of a high and unusableflaggingrate. may represent a clinical change, or instru-
ment imprecision, but it does not indicate
sample mix-up. This was further illus-
trated by analyzing the results from sam-
OVERVIEW OF DECISION ALGORITHM ples repeated on a daily basis on the same
FOR VERIFYING PLATELET TEST RESULTS individuals: the coefficient of variation
for repeated specimens often well ex-
Instrument Results ceeded the CV for repeated tests on the
same specimen. Similar observations have
been made for the WBC differential.19
Within Laboratory Flagging Outside Laboratory Ragging This made it necessary to develop two
Criteria Criteria delta limits, one forflagginga clinically
relevant change, and one for checking the
Delta Check specimen's identity.
Tables I-IH illustrate the application of
Within Delta Outside A, OutsdeB Within Delta Outside A, Outside B two separate levels of delta checking, as
Check A and B Within B Check A and B Within B well as of variable-rate delta levels. For
example, an increase in a platelet count of
50 X109/L, which is clinically hardly rele-
Action
vant if the initial count is 480 X10 9 /L re-
sults in a delta check of 10%. This is with-
None Check PLT Check Sample None Check PLT Check Sample in delta limit A and the result is accepted.
on Film ID and PLT on Rim ID and PLT On the other hand, if the initial platelet
on Film on Rim count is very low, for example 15 X10 9 /
L, the same increment of 50 X10 9 /L
would result in a large delta of 333%. This
Final Results
is outside delta limit A but within limit B
and requires the technologist to rerun the
Verified If Confirmed, Held Until Verified If Confirmed, Held Until specimen and to perform a platelet check
Verified, and Confirmed Verified, and Confirmed onfilm.If confirmed, the report would
Reported by Clinical Reported by Clinical contain the following message: "note
Information Information change in platelet count" but would
otherwise be accepted. If the platelet
Fig 5. Algorithm for verifying platelet results. A delta is calculated and compared with the A and B limits. count would drop by 50 X10 9 /L from an
The comparison leads to an action andfinalresults. initial count of 100X 10'/L, the resulting

414 Laboratory Medicine June 1989

 the particular purpose of the delta check,
Table 1: Effect of Adding Increments of M C V ie, patient identity, laboratory use, or clin-
ical flags. We were almost invariably too
Initial
% cautious in applying delta limits and had
MCV, fL +3 a % +6 a + 9 fL %
to adjust individual limits. However,
60 638 5 668 10 698 15 since these results are based mainly on an
70 73* 4 768 9 79B 13 in-patient population, it may well be pos-
80 83* 4 868 8 898 n
sible that different delta limits are re-
90 93 3 968 7 99B 10
quired in an outpatient population that
100 103 3 106* 6 1098 9
does not undergo interventions such as
110 113 3 116* 5 119B 8
surgery or cancer chemotherapy.
"Expressed as absolute values and delta percentage If delta exceeds either limit A or B, the new value It is of vital importance that the mean-
is noted with an A or B. ing of a positive delta check is clear to the
operator. Therefore, if a positive delta re-
sult is not decisive, ie, if a distinction can-
not be made between a sample identifica-
Table II: Effect of Adding Increments of Hemoglobin*
tion problem or a clinically relevant
Initial Hgb change, then the system will confuse the
g/L + 10 g/L % + 20 g/L % + 30 g/L % + 40 g/L % operator, and the delta flag may not lead
to appropriate action. We have tried to

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B
50 60* 20 70* 40 808 60 90 80 avoid such situations by using a combina-
70 80 14 90* 29 100* 43 110B 57
tion of delta checks for sample identifica-
90 100 11 110* 22 120* 30 140B 40
100 110 10 120* 1308 140B
tion purposes, which we called the speci-
20 30 40
120 130 8 140* 17 1508 25 1608 33
men's fingerprint (Table IV). We chose as
parameters forfingerprintingonly MCV
•Expressed <is absolute values and delta percentage. If delta exceeds either limit A or B, the new value and MCH, applying linear but variable-
is noted with an A or B. rate delta limits. The addition of a third
parameter, such as MCHC, would only
have made the program more compli-
cated without significant advantages.
Table III: Effect of Adding Increments of Platelet Counts*
Moreover, this parameter would have
Initial Pit, been an inappropriate choice because of
10»/L +25 % +50 % +100 % +250 % its limited variability from one patient
specimen to another, and therefore
5 30* 500 55A 1,000 1058 2,000 255" 5,000 would have had poor sensitivity to detect
15 45* 166 65* 333 1158 667 265s 1,669
random error. Narrow delta limits for
30 55 83 80* 167 1308 333 2808 833
1608 3108
Hgb and/orplatelet results, however,
60 85 42 110" 83 167 417
120 145 21 170* 42 220 s 83 3708 208
would have made checking for sample
240 265 10 290* 21 340* 42 490B 104 identification far too sensitive. We tried
480 505 5 530 10 580* 21 730* 52 to avoid overflagging by using only rela-
tively stable parameters for checking the
•Expressed as absolute values and delta percentage. If delta exceeds either limit A or B, the new value specimen identification. The nonlinear,
is noted with an A or B.
variable delta check limits on parameters
such as Hgb, platelets, and WBC were
mainly to be used for detection of clini-
delta of 100% would be outside limit B, ized that the variability of those results, as cally relevant change and for random er-
which, if confirmed, would render the re- well as of those obtained from purely ror detection only, when the changes be-
sult unacceptable without further clinical clinical data, was far greater than ex- came excessive.
information. The algorithm we devel- pected. This resulted in delta limits that The approach we chose to delta check-
oped thus represents a differential ap- had seemed initially far too wide, and it ing, as illustrated in Tables I through III,
proach to a parameter change in absolute made us realize thatfixed,linear discrimi- and in Figs 1 through 4, shows the robust-
terms. Depending on the parameter value nants or combinations of various fixed ness of a percentage delta check when
at which the change occurs, the delta linear discriminant levels were not going combined with nonlinear and variable-
check can result in a pass without further to be effective for the majority of our ap- rate limits.
action, a pass following further action, plications. The plots as shown in Figs 1-4 Our data over the past 2Vi years have
and a fail to accept the result if clinical in- have assisted us significantly in develop- shown a low incidence of sample identifi-
formation explains the change insuffi- ing the algorithms described in this study. cation problems of approximately
ciently. Once the allowable limits for delta check- 1 /3,000, or less than 0.03%. This is in part
When plotting the percentage of delta ing had been chosen, we subsequently due to the method of detection: samples
results obtained on our database, we real- tested these limits on clinical material for with values for MCV and MCH and

Laboratory Medicine June 1989 415

 Table IV: Examples of Decision Making Based on Delta Check Results and Further Investigations

RANDOM ERROR MODE

Establishing Sample Identity or RBC Finger Printing

The sample identity is confirmed if both MCV and MCH are within limit A and platelets are at least within limit B.

• The sample identity cannot be established if either MCV or MCH are outside limit B, or if both are outside limit A, but within limit B.

CLINICAL USAGE MODE

Establishing Clinically Relevant Change

• A change in Hgb within limit B but outside limit A, while the sample identity is intact, would result in an automatic comment on the report: "note
change in Hgb." A change in platelet count outside limit A but within limit B while both MCV and MCH are within limit A would result in a "delta
fail Pit count," followed by a check of the platelet count by the technologist, and if confirmed by a comment on the report: "note change in
platelet count." If the platelet count had been within limit A, then the result would have been verified without further checks regardless of the
acutal platelet count.

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LABORATORY USAGE MODE
Laboratory Usage Examples

• MCV abnormal but within delta check limits: accept and do not perform red cell morphology check. The computer system will verify
automatically.

• Platelets are abnormally low but within delta check limits: accept and do not perform manual platelet count or platelet check on film. The
computer system will autoverify, and the result is'reported.

• Platelets are low, no delta check sample available. Check sample identification; if ok check sample for problems such as clots, clumping; if none
are detected, rerun and perform manual platelet count or check platelets on film. If platelet counts concur, verify the result and report the result.

• Platelets are outside delta check level A. Check sample identification; if ok, check for sample problems such as clots, if not detected, rerun,
perform manual platelet count or platelet check on film. If the counts concur, verify and report the result. The following comment will be printed
automatically on the report form: "note change in platelet count."

• Platelets are outside delta check level B, check results as above; if the results concur and no sample problems are detected, contact referring unit
or physician for clinical information. If no satisfactory explanation is obtained, suggest that the sample be recollected. Results are reported only if
this is specifically requested with a statement: "delta check for platelets failed, recollection of sample is suggested."

platelets within delta limits will not be de-
tected as having sample identification
problems, since Hgb and WBC changes,
unless extreme, will usually be ascribed to
medically caused changes without further
checking. The small number of specimen
identification problems in our laboratory
is much lower than we expected and than
quoted in the literature,12 possibly be-
cause the majority of causes for preana-
lytic or postanalytic errors already may
have been eliminated by an extensive
"random error prevention" program.
This program includes a bar-code label
system, with labels constituting an inte-
gral part of the requisition form (R.L.
Crayn, Crayn Laboratory Forms; Calgary,
Alberta, Canada). The labels are affixed
on the sample at the site of collection and
are also used throughout all sample han-
dling and sample splitting (eg, preparation
of bloodfilms,reticulocyte preparations,
ESRs, etc) in the laboratory. All work sta-
tions are equipped with a bar code reader,
while the cell counters used in the labora-
tory (Coulter S+V, STKR, Sysmex E-
5000) are equipped with bar code readers
and are on line with the laboratory com-
puter system. Transcription errors are fur-
ther reduced by on-line, real-time differ-
ential counting on the computer termi-
nal's modified numerical keypad and by
limiting transcription of data to a mini-
mum, for example, in the case of nonau-
tomated procedures such as entry of ESR
data. All these measures contribute to re-
duce the incidence of preanalytical and
postanalytical errors.
Chart review in cases of sample identi-
fication problems has brought to light
that the majority of such problems have
been caused by specimen mix-up or other
problems through mistakes at the site of
sample collection, usually by staff other
than the blood procurement team. The
detection of such errors prior to release of
results or of verification is important, be-
cause it often involves critically ill pa-
tients, in whom blood is drawn from in-
dwelling intravenous catheters, and on
whose test results immediate medical de-
cisions may depend. In these patients an
identification mix-up or improperly col-
lected sample may delay or, possibly
worse, change treatment-related deci-
sions. Without a delta check system in the
laboratory there is little chance that a ran-
dom error will be detected before the re-
port is sent out. The error may or may not
be noted by the clinician, but it is hoped
that it will cause recollection and repeat
of testing. Such random errors, however,

416 Laboratory Medicine June 1989

create a situation of little trust in the labo-
ratory results.
While the flagging of a clinically rele-
vant change in Hgb, platelet count, or
WBC may not seem of great importance,
it is an indication of the laboratory's com-
mitment to quality toward the clinical
user at a time when clinicians often feel
that machines have taken over the labora-
tory, and that the human involvement is
lacking. Ironically, it is human involve-
ment that has been one of the major
causes of preanalytical and postanalytical
errors, and in fact, of the majority of er-
rors in test results.
The impact of delta checking on our
laboratory practices has been significant.
As in most laboratories, written criteria
for samples with abnormal test results re-
quired that those results be confirmed by
repeating the test or by applying a differ-
ent method, usually a manual one. This
leads to a situation where red cell mor-
phology review or manual platelet checks
have to be performed every time a sample
from the same patient with microcytosis
or thrombocytopenia is processed. In
smaller laboratories, such patients are of-
ten known to the laboratory staff and un-
necessary work can be avoided, but in
larger laboratories this is not possible on a
routine basis. Automated delta checking
offers a good solution, for instance by au-
toverifying those results that are within
delta checking limits. In fact, automated
delta checking eliminates the need to han-
dle abnormal test results differently from
normal results (Fig 5). This means that a
sample with a low platelet count will not
require manual checks if the results are
within delta check limits. This is an ad-
vantage particularly for repeated samples
on patients with hematological malignan-
cies where significant labor savings can be
achieved by eliminating needless manual
counting or checking, and perhaps even
more important, where the turnaround
time for results can be reduced by elimi-
nating the time-consuming step of manu-
al checking.
Delta checking can be an important
tool to reduce the chances of results with
a random error to be reported, to im-
prove the quality of reported results, and
to reduce turnaround time and labor
costs. It should be realized, however, that
this can only be achieved if delta checking
is performed on computerized systems
without delaying the reporting of non-
flagged results. The labor costs of manual
delta checking are prohibitive, and it is
highly questionable whether humans will
sustain prolonged periods of such a repet-
itive clerical task without making mis-
takes. If results have to be transcribed in
order to be delta checked, the procedure
almost defeats its own purpose, and if del-
ta checking significantly delays reporting
of results there also may be a significant
loss of the potential benefits of a delta
check system. It is necessary to select pa-
rameters and delta limits carefully and not
to choose too many for the purposes re-
quired, in order to avoid overflagging. We
have shown that automated, real-time,
on-line delta checking can be performed
on a relatively small computer system at
low cost and with good clinical results •
Acknowledgments
The authors wish to thank Dr John A. Koepke for
helpful discussions and advice on this paper, and
Brenda Croucher, MT, for assistance in the devel-
opment of the delta checking system.
References
1. Read DC, Viera H, Arkin C: Effect of drawing
blood specimens proximal to an in-place but dis-
continued intravenous solution. Am J Clin Pathol
1988;90:702-706.
2. Watson KR, O'Kell RT, Joyce JT: Data regard-
ing blood drawing sites in patients receiving intra-
venous fluids. Am J Clin Pathol 1983;79:119-121.
3. Koepke JA: Clerical errors in surveys. Patholo-
gist 1971;25:193-194.
4. Cembrowski GS: Use of patient data for quality
control. Clin Lab Med 1986;6:715-733.
5. Lacher DA and Donnelly DP: Rate and delta
checks compared for selected chemistry tests. Clin
Chem 1988;34:1966-1970.
6. Nosanchuk JS, Gottman AW: CUMS and delta
checks. AmJClin Pathol 1974;62:707-712.
7. Whitehurst P, Di Silvo TV, Gaydzag B: Evalua-
tion of discrepancies in patients' results—an aspect
of computer-assisted quality control. Clin Chem
1975;21:87-92.
8. Ladenson JH: Patients as their own controls: use
of the computer to identify "laboratory error."
Clin Chem 1975;21:1648-1653.
9. Wheeler LA, Sheiner LB: Delta check tables for
the Technicon SMA 6 continuous flow analyzer.
Clin Chem 197703:216-219.
10. Sher PP: An evaluation of the detection capac-
ity of a computer-assisted real-time delta check
Downloaded from http://labmed.oxfordjournals.org/ by guest on March 22, 2016
system. Clin Chem 1979;25:870-872.
11. Sheiner LB, Wheeler LA, Moore J K: The per-
formance of delta check methods. Clin Chem
1979;25:2034-2037.
12. Wheeler LA, Sheiner LB: A clinical evaluation
of various delta check methods. Clin Chem
1981;27:5-9.
13. Iizuka Y, Kume H, Kitamura M: Multivariate
delta check method for detecting specimen mix-
up. Clin Chem 198208:2244-2248.
14. Harris EK, Yasaka T: On the calculation of a
"reference range" for comparing two consecutive
measurements. Clin Chem 1983;29:25-30.
15. Furutani H, Kitazoe Y, Yamamoto K, et al:
Evaluation of the "Mahalanobis generalized dis-
tance" method of quality control: Monitoring sys-
tem of multivariate data. AmJClin Pathol 1984;
81:329-336.
16. Burden RL, FairesJD: Numerical Analysis, ed
3. Prindle, Weberand Schmidt, 1985.
17. Cavill I: Internal quality control—quantitative
assays, in Lewis SM, Verwilghen RL (eds): Quality
Assessment in Haematology, London, Bailliere
Tindall,1988.
18. CAP Survey, 1987. Skokie, 111, College of
American Pathologists.
19. Statland BE, Winkel P: Physiological variability
of leukocytes in healthy subjects, in Koepke JA
(ed): Differential Leukocyte Counting. Skokie 111,
College of American Pathologists, 1977.
Laboratory Medicine June 1989 417