Laboratory Management 2

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Management of Delta Check In

Laboratory

Osman Sianipar

Department of Clinical Pathology and Laboratory


Medicine Universitas Gadjah Mada/Dr. Sardjito Hospital
Yogyakarta

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Clasic parameters of Quality Control

Control of specimen acquisition

Control of method

Control of instrument

Control of reagents

Control of data distribution


Am J Clin Pathol. 1974, 62: 707–712
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History
Lindberg alluded to Delta checking when he suggested that there
were limits (fluctuations) in hemoglobins or hematocrits
Method Inform Med., 1967, 6:97-107

Nosanchuk and Gottmann introduced Cum and delta check as a


systematic approach to quality control
Am J Clin Pathol.1974;62(5):707-712

Ladenson introduced a computer-based system of quality control


where patients were placed as their own controls to detect
laboratory error and called it as delta check system
Clin Chem.1975;21(11):1648-1653
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Laboratory Error
Steps Type of error Rates
(%)
Pre- Inappropriate test request, Order entry error, 46-68
analytical Misidentification of patient, Container inappropriate,
Sample collection & transport inadequate, Inadequate
sample/anticoagulant volume ratio, Insuffiicient
sample volume, Sorting & routing errors, Labelling
error
Analytical Equipment malfunction, sample mix-ups/interference, 7 - 13
undetected failure in QC, Procedure not follow
Post Failure in reporting, errorneous validation of analytical 18.5 - 47
analytical data, inproper data entry

Clin. Chem. 2002, 48, 691–698


Labmedicine, 2012, 43(2): 41-44
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Delta Check
• Can be expressed as the absolute or the
percent difference between two consecutive
results
• Can be an absolute limit
• Can be percent delta: the difference between
the larger result and the smaller result divided
by the smaller result.
• Time interval is flexible. Most hospital
laboratories choose 24 or 48 hours
http://www.clinlabnavigator.com/delta-check.html

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A 36 yo woman, probable Pneumonia
Date 9/17 9/18 9/17
Time drawn 8 pm 7 am Re-check
WBC 6.800 4.300 4.000
RBC : M: 5.4 ± 0.8/cmm 4.7 4.9 4.9
F : 4.8 ± 0.6/cmm
Hemoglobin 15.1 13.1 13.1
Hematokrit 46 40 41
MCV 78 – 94 µ3 98 81 81
MCH 27-32 µµg 32 26 26
MCHC 32-36% 33 33 32

Explanation: wrong sample recorded Am J Clin Pathol. 1974, 62: 707–712


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> 60% > 60%

Date/time of results for 03/09/2015 03/09/2015 03/09/2015


Patient @ 18:40 @ 23:10 @ 23:50
Creatinine 1.67mg/dL (↑) 0.35 mg/dL (↓) 1.83 mg/dL (↑)
Reference interval: 0.52 – [147.7 µmol/L] [31.0 µmol/L] [161.8 µmol/L]
1.04 mg/dL [45.6–92.0
µmol/L]
Potassium 5.0 mmol/L 1.2 mmol/L (↓) 4.9 mmol/L
Reference interval: 3.4–5.3
mmol/L
Urea Nitrogen 90 mg/dL (↑) 21 mg/dL 88 mg/dL (↑)
Reference interval: 7–30 [32.1 mmol/L] [7.5 mmol/L] [31.4 mmol/L]
mg/dL [2.5 –10.7 mmol/L]

Gruenberg et al., Clinical Biochemistry 2018 ( in press)


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Causes of discrepant results
• Pre-analytical variations
– Patient misidentification
– Specimen related issues
– Post- collection
• Analytical variations
– Instrument
– Methods
• Biological variations
– Rhythmic changes
– Lifespan
– Treatment

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Limits used to signal a delta check alert

• Derived from Biological Variation


– Sources of variation in laboratory measurements
– Biological variation
– Reference change values (RCV)
• Derived from Patient Data
– The empirical approach
– Delta check limits derived from the distribution of delta
values in the patient population
• Time interval between specimens, rate checks,
and clinically significant change
– Used in LIS

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Index of Individuality (II)
Index of individuality (II) = (CVI2 + CVA2)1/2/CVG

If CVA < CVI, then the formula can be simplified

Index of individuality (II) = CVI /CVG

II ≥ 1.4 ---→ low


II ≤ 0.6 ---→ high
CVA = Analytical or day to day coefficient of variation
CVI = Intra-individual coefficient of variation
CVG = inter-individual coefficient of variation
J Avian Med Surg., 2014, 28(2): 118 - 126
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Reference change value (RCV)

RCV = 1.414 X Zscore X [CVA2 + CVI2]1/2


CVA = analytical coeficient of variation
CVI = intra-individual biological coeficient of variation
individual
Z score 95% CI =1.96
Z score 99% CI = 2.58
Z score 99.9% CI = 3.29

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Delta check limits based on RCV (%)

Clinica Chimica Acta., 2016, 463: 18 - 21


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Clinically significant change
• PSA velocity
– > 2.0 ng/mL/year (> 2.0 μg/L/year)
– Stated in terms of rate checks
– Monitored on outpatients
• Rate of Troponin rise indicative of an acute coronary
event
– Various suggestions in the literature range from a 20% to a
50% rise from the previous result
– Stated in terms of absolute or percentage absolute terms
without specifying the time interval between specimens
– Monitored on inpatients

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Delta Check Limit
• The allowable difference between consecutive
results for a specific analyte on the same
patient within a certain time interval.
• Should be set so that true changes in patient
test results are not flagged but improbable
changes are flagged as delta check failures.
• Should be based upon the total expected
variation, which include biological and
analytical variation
http://www.clinlabnavigator.com/delta-check.html

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Delta check parameters
1. WBC change > 25%
2. RBC change > 25%
3. Hb change > 1 gr or 1%
4. Hct change > 3%
5. MCV change > 2 u3
6. MCH change 2 pg
7. MCHC change 2%
8. Segs or lymphs change by 25%
9. Bands change by more than 100%
10. Monos change by more than 100%
11. Eos change by more than 100%
Am J Clin Pathol. 1974, 62: 707–712
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Single Parameter Check
• Anytime technologist has a question
• Unusual morphology: atypia, immaturity
• WBC < 3.000 or > 18.000
• MCV < 75 or > 105
• MCH > 32
• MCHC > 36
• Reticulocyte > 5%
• Low or high platelet estimates
• When techs rechecking disagree
Am J Clin Pathol. 1974, 62: 707–712
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Delta Limit Time Frame
Analyte
Sodium 8 meq/L 30 hours
Chloride 8 meq/L 30 hours
Potassium 20% 30 hours
Carbon Dioxide 10 meq/L 30 hours
Creatinine 1.0 mg/dL 30 hours Recommended
BUN 20 mg/dL 30 hours parameter for delta
Calcium 2.0 mg/dL 30 hours check in clinical
Magnesium 1.0 mg/dL 30 hours chemistry
Phosphorus 2.0 mg/dL 30 hours
Albumin 1.5 mg/dL 30 hours
Total protein 2.0 mg/dL 30 hours
http://www.clinlabnavigator.com/delta-check.html
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Recommended parameter for delta
check in hematology
• Delta checks should be applied to parameters that show
the least short-term biological variation
• MCV and MCHC are extremely stable in a patient over a
short interval, such as 24 hours
• The diurnal biological coefficient of variation in MCV is
only 0.5%.
• In emergency cases, such as hemorrhage, MCV and
MCHC do not change significantly since the reticulocyte
response does not begin for two to three days.

http://www.clinlabnavigator.com/delta-check.html
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Recommended parameter for delta
check in hematology
• MCHC has the added benefit of detecting instrument
malfunction because it is calculated from hemoglobin,
MCV and RBC count
• Suggested delta check limits for MCV and MCHC are +/-
5 fl and +/-5.0 g/dL, respectively
• Delta checks are not recommended for other
hematology parameters including hemoglobin,
hematocrit, RBC count, WBC count or platelet count.

http://www.clinlabnavigator.com/delta-check.html
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Delta Check Etiology

1968 1973
Explained by patient 94% 98%
pathophysiology, therapy or
natural course of disease
Unexplained 1% 1%
Laboratory-induced 5% < 1%

Am J Clin Pathol. 1974, 62: 707–712


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Delta check for blood group

AJTS, 2017, 11(1): 18-21


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Summary
• Delta check: comparing current patient values
to previous ones
• It is a systematic approach in addition to
quality control in order to improve quality of
care and patient safety and also to reduce
laboratory error
• It needs delta check limit for analysis

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Summary
• The laboratory parameters which have the
lowest biological variation
• It is also can be applied for nominal data

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