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Are laboratory tests
always needed?
Frequency and causes of
laboratory
overuse in a hospital
setting
Clinical Biochemistry
https://doi.org/10.1016/j.clinbiochem.2018.01.024
0009-9120/ © 2018 The Canadian Society of
Clinical Chemists. Published by Elsevier Inc. All
rights reserved.
Dr. Hossamaaldin Bahaa Alzawawi
Clinical Pathologist – Chemist
Clinical Chemistry Unit
Introduction
“Most clinical decisions in
modern healthcare are
facilitated by, or rely on,
data generated by
laboratory medicine
investigations.”
TOWI(Importance)
Importance of
the laboratory
in the health
service
Importance of the laboratory in
the health service
• “Clinical information not being
forwarded to the lab,
• The increasing lack of human
resources, laboratories are often
forced to mainly focus on
analyzing tests, ordered by
clinicians rather than assisting in
test selection and result
interpretation.”
TOD(Defects)
Current defect in
laboratory operation
and practice, their
causes and results.
Current defect in laboratory
operation and practice are
caused by:
“However, these tasks are
essential parts of the expertise
or of the added value that a
laboratory physician should
provide in various healthcare
settings, a practice that would
be very well accepted by
clinicians.”
T
R
(Role)
Role of the laboratory
physicians
Role of the laboratory
physicians
“In a comprehensive meta-analysis Zhi et al. report
that over- and under-utilization proportions of in
vitro diagnostics tests may be as high as 20.6% and
44.8%, respectively.”
L
Result in defective
laboratory utilization
(Lack)
Lack of medical education regarding
laboratory medicine has a negative
impact on laboratory practice and is
responsible for a defective lab practice Current warning status of
laboratory misutilization
“Therefore, clinicians frequently fall short of specific
expertise comparable to that of a laboratory
specialist in taking clinical information as well as in
pre-, intra- and post-analytical issues of laboratory
results into reliable interpretative consideration.
Since primary care physicians are often uncertain
about the appropriate test to order or its proper
interpretation, there is a reasonable risk that
laboratory tests may be ordered inappropriately.”
Login
b
A D
Major effect of laboratory test
ordering malpractice on patient
safety in the health service
“Patient safety may hence be jeopardized by
delayed or missed diagnoses. Gandhi et al.
investigated 307 closed malpractice claims, in
which patients alleged a missed or delayed
diagnosis in the ambulatory setting, reporting
that 59% of these diagnostic errors generated
some kind of harm to the patients, including
1. failure to order an appropriate diagnostic
test,
2. derangement of appropriate follow-up and
3. incorrect interpretation of diagnostic tests.
These failures were mostly due to
misjudgment, lack of vigilance, memory or
knowledge.”
Purpose
(Study Aims and Objectives)
Purpose (Study Aims and Objectives)
• Addressing increasing concerns about inappropriate overutilization of
laboratory resources
• Estimate how many of the ordered tests are effectively used to deliver
patient care
• Detection of whether or not these numbers may differ between samples
sources (wards, outpatients, surgery, etc.) or between sample priority
(urgent vs. routine).
• Evaluate possible reasons for potentially inappropriate utilization of
laboratory resources.
Methodology
(Materials and Methods)
Methodology (Materials and Methods)
A. Study place, time, and time
This study, which took place in the University Hospital of Salzburg (Austria), ………..., laboratory data
from all patients treated in the local hospital in 2015 were evaluated retrospectively.
B. Study data gathering methodology (study performing steps)
1. Type of method used in the gathering of sample cancellation data and the cause of the cancellation
“The laboratory information system (LIS) was searched to identify test results, which have been
cancelled due to preanalytical non-conformities.”
2. Type of the method used in gathering staff associated performance data
“clinicians and the nursing staff of the local hospital were surveyed to collect information about their
arbitrary perception about the burden of test re-ordering after initial cancellation,”
Methodology (Materials and Methods)
C. Statistical analysis tools used in the study
1. Tool used in assessing laboratory samples provided information
“Statistical analyses of retrospective data were limited to frequency and distribution analyses, and
were performed with Microsoft Excel 2016 (IBM, Armonk, USA).”
2. Tool used in assessing human provided information
“Survey results were analyzed using SPSS Statistics V.24 (IBM).”
D. Ethical approval requirement
“According to the local ethics committee this study does not need approval since it was observational (i.e.,
non-experimental) and was undertaken retrospectively, in the context of investigations requested for
routine clinical practice. ………………… The study was conducted according to the Declaration of Helsinki”
Methodology
(Study Population)
Methodology (Study Population)
Characteristics of the samples’ population
I. Study sampling selection criteria
1. Cause of test cancellation
• Test cancellation due to preanalytical non-conformity, including sample hemolysis for biochemical tests and
underfilled blood tubes for hematological specimens
2. Time span after test cancellation that being used to consider the specimen eligible to role in the study (why?)
• We then evaluated the number of deleted test results that were re-ordered within one week. This number was
considered as a surrogate marker of whether the results of cancelled tests would have been clinically
necessary.
3. Classification criteria for the period spend to reorder the deleted test.
• In those cases where the tests were re-ordered, we evaluated if the order was placed (i) within 24 h, (ii) after
24 h but within one week or (iii) after one week upon cancellation of the primary order.
Methodology (Study Population)
Characteristics of the samples’ population
II. Selection of sample type to include within the study.
1. Sample type and selection and the rational behind it
• “As sample hemolysis is the most predominant preanalytical error leading to test cancellation in our laboratory
as well as in many other facilities worldwide, we decided to focus on parameters measured from serum/plasma,
which are (i) more frequently ordered and (ii) more vulnerable to hemolysis.”
2. Type of parameter selected to be analyzed from the sample.
• Thereby, the following index parameters were selected: potassium (K), lactate dehydrogenase (LD) and aspartate
aminotransferase (AST). Additionally, we collected data about APTT and prothrombin time/International
Normalized Ratio (PT/INR) orders,
3. Sample source and situation subgrouping and the rationale behind it.
• “Subgroup analyses were performed to identify potential associations between outcomes and wards (in-patient, out-
patient, emergency department, intensive care, pediatrics, surgery, internal medicine) or sample type (routine or
urgent).”
4. Exclusion criteria for subgrouping
• “Subgroups with less than 50 cases were excluded from the subanalysis”
Methodology (Study Population)
Characteristics of the staff population
I. Type of staff being involved in the study
• “clinicians and the nursing staff of the local hospital were surveyed”
II. What are staff being assessed for?
1. Burden of test reorder after cancellation
• “arbitrary perception about the burden of test re-ordering after initial cancellation, asking the question “How often do you think
cancelled tests are reordered at your ward?”.”
2. The root cause of failed reorder of a test after test cancellation
• “In order to investigate the root causes for failed re-orders after test cancellation, we asked the question “What are the reasons for not
reordering a test after its cancellation?”, providing five possible reasons for its explanation. Participants were asked to declare if any of
these occur often, sometimes, rarely or never at their ward.”
3. Additional commentary section (why?)
• “Whenever the possible answer options did not appropriately reflect the setting or if they felt motivated to provide additional
information, participants were allowed to leave a free comment.”
Results
Retrospective data analysis
Results
Retrospective data analysis
1. Total number of assayed test.
2. Overall cancellation rate due to sample hemolysis or underfilled
tube
3. Cancellation rate for individual selected analyte of K, LD, AST, APTT
and PT/INR respectively (what does it reflect regarding cancellation
process)
Results
Retrospective data analysis
• Reordering rate for the
cancellated tests of K, LD, AST,
APTT and PT/INR respectively
1. Within 24 hours
2. Between 24 hours and 1
week
3. After 1 week.
4. Not requested cancellated
test rate.
Results
Retrospective data analysis
• Total number of assayed test.
• Overall cancellation rate.
• Cancellated tests reordering rate
1. Maximum reordering rate timing
2. What does it reflect?
Fig. 2. Time course of re-orders after initial test cancellation. K – Potassium;
LD – Lactate dehydrogenase; AST – Aspartate-Aminotransferase; APTT –
activated partial thromboplastin time; PZ/INR – Prothrombin
time/International normalized Ratio.
Results
Survey Analysis Procedure
Results
Survey Analysis Procedure
• Total number of staff being surveyed
• Percentage of staff responded to the
survey to the total staff population
• Percentage of the responder groups
• Formation of subgrouping for the staff
being surveyed
• Regarding
• Categorization of free to answer
comments
Results
Survey Analysis Procedure
• Subgrouping of the specific
question
1. “how often do you think
cancelled tests are re-ordered
at your ward”
2. “what are the reason for not
re-ordering a test after its
cancellation?”Fig. 3. Percentages of answers to the survey question, “How often do
you think cancelled tests are re-ordered at your ward?” ED –
Emergency Department.
Results
Survey Analysis Procedure
• Subgrouping of the cause of not
redoing a cancelled tests
• What are theses major subgroup
• What do it show
• What are the reflection deducted
from this analysis
• What do you think about
• Outpatient
• Pediatrics
Fig. 4. Percentages of answers to the survey question, “What are the reasons for not re-ordering
a test after its cancellation?”. Multiple responses were allowed. Routine Panel=Tests are part of
a routine panel, but not all requested parameters are necessary for patient care. Obsolete=Tests
are no longer needed after cancellation since results of other tests within the same laboratory
report are sufficient for clinical management. Short stay=Patients remain in the ward for a short
time, so that retesting was unfeasible. Erroneous order=Tests are erroneously ordered. Patient
comfort=We decide to spare the patient additional phlebotomy. ED – Emergency Department.
Discussion
Discussion
• Selected chemistry and hematology order rate
• Within 24 hour (what do these results reflect?)
• After 1 week or not at all (what do these result reflect?)
• Difficulty in assessing laboratory inappropriate utilization
• Overall estimated laboratory over utilization (what do these results reflect?)
• Cause of variation in the cancelled sample reorder rate
• Cause of high reorder rate of the cancelled specimen in critical care unit.
• Cause of low reorder rate of cancelled specimen in ward units.
• Cause of lowest reorder rate of the cancelled specimen in the outpatient clinic sittings
• Case of lack of discrepancy ratio between (urgent) and (routine) samples
• The impact of false urgency of outpatient tests orders
• Hypothetical conclusion regarding the relationship between reorder timing and test importance
Discussion
• Staff awareness
• Regarding laboratory test overutilization
• Regarding health system real tests needs
• Regarding the cause of test request overutilization
• Cause of test order request to be laboratory resources overutilization
• Reason that “patient discomfort” be a common reason for not repeating test
• Main source of this selection (which ward)
• Real case for preferring the selection to be overused
• How fake use of this selection being discovered
Discussion
• Other reason of erroneous test order
• Doing test through another modality
• Ordering test irrespective of the treating physician or attending nurse
• Cause of loss of the essence of laboratory operation
• Lack of clinical information (the power of bioinformatics)
• Lack of a mandatory laboratory resource (consulting physician)
Discussion
• The importance of laboratory consulting physician
• Causes that mandate tests advices in the clinical sittings
• Mortality as result of deficiency in laboratory consultation
• Suggested strategies to overcome laboratory overutilization
• The negative impact of laboratory malpractice on the health service
Discussion
• Advantage of this study over other done studies.
• Limitation of this study.
Closing Remarks
Closing Remark
“In essence, this means implementing efforts for achieving the best
possible analytical performance with a patient-centered strategy, thus
encompassing ordering the right test, in the right patient, at the right
time.”
Laboratory PHYSICIANS are
solely responsible for
conducting successful
laboratory operations and
practices.

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Are laboratory tests always needed frequency and causes of laboratory overuse in hospital setting 3.1

  • 1. Are laboratory tests always needed? Frequency and causes of laboratory overuse in a hospital setting Clinical Biochemistry https://doi.org/10.1016/j.clinbiochem.2018.01.024 0009-9120/ © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. Dr. Hossamaaldin Bahaa Alzawawi Clinical Pathologist – Chemist Clinical Chemistry Unit
  • 3. “Most clinical decisions in modern healthcare are facilitated by, or rely on, data generated by laboratory medicine investigations.” TOWI(Importance) Importance of the laboratory in the health service Importance of the laboratory in the health service
  • 4. • “Clinical information not being forwarded to the lab, • The increasing lack of human resources, laboratories are often forced to mainly focus on analyzing tests, ordered by clinicians rather than assisting in test selection and result interpretation.” TOD(Defects) Current defect in laboratory operation and practice, their causes and results. Current defect in laboratory operation and practice are caused by:
  • 5. “However, these tasks are essential parts of the expertise or of the added value that a laboratory physician should provide in various healthcare settings, a practice that would be very well accepted by clinicians.” T R (Role) Role of the laboratory physicians Role of the laboratory physicians
  • 6. “In a comprehensive meta-analysis Zhi et al. report that over- and under-utilization proportions of in vitro diagnostics tests may be as high as 20.6% and 44.8%, respectively.” L Result in defective laboratory utilization (Lack) Lack of medical education regarding laboratory medicine has a negative impact on laboratory practice and is responsible for a defective lab practice Current warning status of laboratory misutilization “Therefore, clinicians frequently fall short of specific expertise comparable to that of a laboratory specialist in taking clinical information as well as in pre-, intra- and post-analytical issues of laboratory results into reliable interpretative consideration. Since primary care physicians are often uncertain about the appropriate test to order or its proper interpretation, there is a reasonable risk that laboratory tests may be ordered inappropriately.”
  • 7. Login b A D Major effect of laboratory test ordering malpractice on patient safety in the health service “Patient safety may hence be jeopardized by delayed or missed diagnoses. Gandhi et al. investigated 307 closed malpractice claims, in which patients alleged a missed or delayed diagnosis in the ambulatory setting, reporting that 59% of these diagnostic errors generated some kind of harm to the patients, including 1. failure to order an appropriate diagnostic test, 2. derangement of appropriate follow-up and 3. incorrect interpretation of diagnostic tests. These failures were mostly due to misjudgment, lack of vigilance, memory or knowledge.”
  • 9. Purpose (Study Aims and Objectives) • Addressing increasing concerns about inappropriate overutilization of laboratory resources • Estimate how many of the ordered tests are effectively used to deliver patient care • Detection of whether or not these numbers may differ between samples sources (wards, outpatients, surgery, etc.) or between sample priority (urgent vs. routine). • Evaluate possible reasons for potentially inappropriate utilization of laboratory resources.
  • 11. Methodology (Materials and Methods) A. Study place, time, and time This study, which took place in the University Hospital of Salzburg (Austria), ………..., laboratory data from all patients treated in the local hospital in 2015 were evaluated retrospectively. B. Study data gathering methodology (study performing steps) 1. Type of method used in the gathering of sample cancellation data and the cause of the cancellation “The laboratory information system (LIS) was searched to identify test results, which have been cancelled due to preanalytical non-conformities.” 2. Type of the method used in gathering staff associated performance data “clinicians and the nursing staff of the local hospital were surveyed to collect information about their arbitrary perception about the burden of test re-ordering after initial cancellation,”
  • 12. Methodology (Materials and Methods) C. Statistical analysis tools used in the study 1. Tool used in assessing laboratory samples provided information “Statistical analyses of retrospective data were limited to frequency and distribution analyses, and were performed with Microsoft Excel 2016 (IBM, Armonk, USA).” 2. Tool used in assessing human provided information “Survey results were analyzed using SPSS Statistics V.24 (IBM).” D. Ethical approval requirement “According to the local ethics committee this study does not need approval since it was observational (i.e., non-experimental) and was undertaken retrospectively, in the context of investigations requested for routine clinical practice. ………………… The study was conducted according to the Declaration of Helsinki”
  • 14. Methodology (Study Population) Characteristics of the samples’ population I. Study sampling selection criteria 1. Cause of test cancellation • Test cancellation due to preanalytical non-conformity, including sample hemolysis for biochemical tests and underfilled blood tubes for hematological specimens 2. Time span after test cancellation that being used to consider the specimen eligible to role in the study (why?) • We then evaluated the number of deleted test results that were re-ordered within one week. This number was considered as a surrogate marker of whether the results of cancelled tests would have been clinically necessary. 3. Classification criteria for the period spend to reorder the deleted test. • In those cases where the tests were re-ordered, we evaluated if the order was placed (i) within 24 h, (ii) after 24 h but within one week or (iii) after one week upon cancellation of the primary order.
  • 15. Methodology (Study Population) Characteristics of the samples’ population II. Selection of sample type to include within the study. 1. Sample type and selection and the rational behind it • “As sample hemolysis is the most predominant preanalytical error leading to test cancellation in our laboratory as well as in many other facilities worldwide, we decided to focus on parameters measured from serum/plasma, which are (i) more frequently ordered and (ii) more vulnerable to hemolysis.” 2. Type of parameter selected to be analyzed from the sample. • Thereby, the following index parameters were selected: potassium (K), lactate dehydrogenase (LD) and aspartate aminotransferase (AST). Additionally, we collected data about APTT and prothrombin time/International Normalized Ratio (PT/INR) orders, 3. Sample source and situation subgrouping and the rationale behind it. • “Subgroup analyses were performed to identify potential associations between outcomes and wards (in-patient, out- patient, emergency department, intensive care, pediatrics, surgery, internal medicine) or sample type (routine or urgent).” 4. Exclusion criteria for subgrouping • “Subgroups with less than 50 cases were excluded from the subanalysis”
  • 16. Methodology (Study Population) Characteristics of the staff population I. Type of staff being involved in the study • “clinicians and the nursing staff of the local hospital were surveyed” II. What are staff being assessed for? 1. Burden of test reorder after cancellation • “arbitrary perception about the burden of test re-ordering after initial cancellation, asking the question “How often do you think cancelled tests are reordered at your ward?”.” 2. The root cause of failed reorder of a test after test cancellation • “In order to investigate the root causes for failed re-orders after test cancellation, we asked the question “What are the reasons for not reordering a test after its cancellation?”, providing five possible reasons for its explanation. Participants were asked to declare if any of these occur often, sometimes, rarely or never at their ward.” 3. Additional commentary section (why?) • “Whenever the possible answer options did not appropriately reflect the setting or if they felt motivated to provide additional information, participants were allowed to leave a free comment.”
  • 18. Results Retrospective data analysis 1. Total number of assayed test. 2. Overall cancellation rate due to sample hemolysis or underfilled tube 3. Cancellation rate for individual selected analyte of K, LD, AST, APTT and PT/INR respectively (what does it reflect regarding cancellation process)
  • 19. Results Retrospective data analysis • Reordering rate for the cancellated tests of K, LD, AST, APTT and PT/INR respectively 1. Within 24 hours 2. Between 24 hours and 1 week 3. After 1 week. 4. Not requested cancellated test rate.
  • 20. Results Retrospective data analysis • Total number of assayed test. • Overall cancellation rate. • Cancellated tests reordering rate 1. Maximum reordering rate timing 2. What does it reflect? Fig. 2. Time course of re-orders after initial test cancellation. K – Potassium; LD – Lactate dehydrogenase; AST – Aspartate-Aminotransferase; APTT – activated partial thromboplastin time; PZ/INR – Prothrombin time/International normalized Ratio.
  • 22. Results Survey Analysis Procedure • Total number of staff being surveyed • Percentage of staff responded to the survey to the total staff population • Percentage of the responder groups • Formation of subgrouping for the staff being surveyed • Regarding • Categorization of free to answer comments
  • 23. Results Survey Analysis Procedure • Subgrouping of the specific question 1. “how often do you think cancelled tests are re-ordered at your ward” 2. “what are the reason for not re-ordering a test after its cancellation?”Fig. 3. Percentages of answers to the survey question, “How often do you think cancelled tests are re-ordered at your ward?” ED – Emergency Department.
  • 24. Results Survey Analysis Procedure • Subgrouping of the cause of not redoing a cancelled tests • What are theses major subgroup • What do it show • What are the reflection deducted from this analysis • What do you think about • Outpatient • Pediatrics Fig. 4. Percentages of answers to the survey question, “What are the reasons for not re-ordering a test after its cancellation?”. Multiple responses were allowed. Routine Panel=Tests are part of a routine panel, but not all requested parameters are necessary for patient care. Obsolete=Tests are no longer needed after cancellation since results of other tests within the same laboratory report are sufficient for clinical management. Short stay=Patients remain in the ward for a short time, so that retesting was unfeasible. Erroneous order=Tests are erroneously ordered. Patient comfort=We decide to spare the patient additional phlebotomy. ED – Emergency Department.
  • 26. Discussion • Selected chemistry and hematology order rate • Within 24 hour (what do these results reflect?) • After 1 week or not at all (what do these result reflect?) • Difficulty in assessing laboratory inappropriate utilization • Overall estimated laboratory over utilization (what do these results reflect?) • Cause of variation in the cancelled sample reorder rate • Cause of high reorder rate of the cancelled specimen in critical care unit. • Cause of low reorder rate of cancelled specimen in ward units. • Cause of lowest reorder rate of the cancelled specimen in the outpatient clinic sittings • Case of lack of discrepancy ratio between (urgent) and (routine) samples • The impact of false urgency of outpatient tests orders • Hypothetical conclusion regarding the relationship between reorder timing and test importance
  • 27. Discussion • Staff awareness • Regarding laboratory test overutilization • Regarding health system real tests needs • Regarding the cause of test request overutilization • Cause of test order request to be laboratory resources overutilization • Reason that “patient discomfort” be a common reason for not repeating test • Main source of this selection (which ward) • Real case for preferring the selection to be overused • How fake use of this selection being discovered
  • 28. Discussion • Other reason of erroneous test order • Doing test through another modality • Ordering test irrespective of the treating physician or attending nurse • Cause of loss of the essence of laboratory operation • Lack of clinical information (the power of bioinformatics) • Lack of a mandatory laboratory resource (consulting physician)
  • 29. Discussion • The importance of laboratory consulting physician • Causes that mandate tests advices in the clinical sittings • Mortality as result of deficiency in laboratory consultation • Suggested strategies to overcome laboratory overutilization • The negative impact of laboratory malpractice on the health service
  • 30. Discussion • Advantage of this study over other done studies. • Limitation of this study.
  • 32. Closing Remark “In essence, this means implementing efforts for achieving the best possible analytical performance with a patient-centered strategy, thus encompassing ordering the right test, in the right patient, at the right time.”
  • 33. Laboratory PHYSICIANS are solely responsible for conducting successful laboratory operations and practices.

Editor's Notes

  1. Cancellation reflect number of total sample analysis not a percentage of the cancelled sample
  2. There are two subgroups: first for responder specialty type, second for responder specialty location