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CAP Laboratory Improvement Programs

Clinical Consequences of Specimen Rejection


A College of American Pathologists Q-Probes Analysis of 78 Clinical Laboratories
Donald S. Karcher, MD; Christopher M. Lehman, MD

 Context.—Clinical laboratory specimens may be rejected Results.—Specimen rejection led to a (1) high rate of
as unsuitable for analysis for a variety of reasons and specimen recollection, (2) delay in result availability
specimen rejection may have significant clinical conse- (median of 65 minutes), and (3) high rate of specimen/
quences. test abandonment. Longer test result delay was associated
Objective.—To quantify the clinical consequences of with higher hospital bed size; and higher test abandon-
specimen rejection and determine the impact of laborato- ment rate, with failure of the laboratory to request
ries’ policies and practices on these consequences. specimen recollection. Relabeling of incorrectly labeled
Design.—Participants prospectively reviewed consecu- specimens was found to be of little benefit and was
tive blood and urine specimens submitted to the chemistry associated with a substantial percentage of subsequently
and/or hematology laboratories to identify rejected spec-
mislabeled specimens.
imens. For each rejected specimen, the patient’s age,
specimen type, testing priority, rejection reason, time from Conclusions.—Specimen rejection has significant clini-
specimen receipt to receipt of recollected/relabeled cal consequences, including patient discomfort, significant
specimen, recollection method, and test result time were delay in result availability, and high rate of specimen/test
recorded. Specimen/test abandonment was determined by abandonment. Allowing routine relabeling of incorrectly
failure to recollect or relabel a rejected specimen. Each labeled specimens is a dangerous practice, with little
laboratory’s policy regarding relabeling of incorrectly measureable benefit and with an increased risk to patient
labeled specimens was recorded, along with how many safety.
relabeled specimens were subsequently discovered to be (Arch Pathol Lab Med. 2014;138:1003–1008; doi:
mislabeled. 10.5858/arpa.2013-0331-CP)

S pecimens submitted to the clinical laboratory may be


rejected as unsuitable for analysis for a variety of
reasons, including inaccurate or inadequate labeling of the
excessive iatrogenic blood loss. Specimen rejection and the
need for specimen recollection or correction also ultimately
lead to a delay in specimen analysis and the availability of
specimen and defects in specimen quality or quantity. test results and may lead to abandonment of the test(s)
Specimens submitted to the chemistry and hematology requested. The prolonged turnaround time is clinically most
laboratories are typically rejected at an approximate mean significant for tests ordered with a stat testing priority, but
rate of 1.0% or less of all specimens submitted, with the rate similar delays may also impact routine and other nonstat
usually higher for inpatients and patients in the emergency tests.
department than for outpatients.1–4 This study was designed to quantify the effect of
Specimen rejection may have significant consequences for laboratory specimen rejection on the need to recollect
patients and their clinical management. Patients whose specimens, the delay in test result availability, and the rate
specimens are rejected are frequently subjected to repeated of test abandonment, and to determine the impact on test
specimen collection, resulting in inconvenience, the dis- result availability of the (1) reason for specimen rejection, (2)
comfort of repeated phlebotomy or other collection proce- detection method used for mislabeled specimens, and (3)
dures, and/or the potential need for blood transfusion due to the laboratory’s policy regarding resolution of improperly
labeled specimens. In addition, an attempt was made to
measure the accuracy of relabeling of incorrectly labeled
Accepted for publication October 7, 2013. specimens, if allowed by the laboratory.
From the Department of Pathology, The George Washington
University Medical Center, Washington, DC (Dr Karcher); and the MATERIALS AND METHODS
Department of Pathology, University of Utah School of Medicine,
Salt Lake City (Dr Lehman). Study Design
The authors have no relevant financial interest in the products or
companies described in this article. Participants prospectively reviewed consecutive blood and urine
Reprints: Donald S. Karcher, MD, Department of Pathology, The specimens submitted to the central chemistry and/or hematology
George Washington University Medical Center, 2100 W Pennsylva- (including coagulation) laboratory sections to identify specimens
nia Ave, NW, 5th Floor, Suite 5027, Washington, DC 20037 (e-mail: that were rejected for any reason. This process was conducted on
dkarcher@mfa.gwu.edu). all laboratory shifts until 80 rejected specimens that fit the study
Arch Pathol Lab Med—Vol 138, August 2014 Specimen Rejection—Karcher & Lehman 1003
Table 1. Definitions of Terms Provided to Participants
Test accession: A test order that resulted in a unique laboratory accession number.
Rejected specimen: A specimen that was found for any reason to be unsuitable for analysis before initiation of testing or a specimen
found, before or after completion of testing, to be mislabeled or otherwise inappropriate as a result of comparison of the specimen
label to the requisition form or electronic test order, or comparison of the current test results to previous laboratory results for the
same patient (delta check analysis) or to the patient’s clinical status.
Improperly labeled specimen: A specimen that was (1) unlabeled, (2) incompletely labeled (does not include the minimum information
required by institutional guidelines), (3) labeled with information not in adequate agreement with the accompanying requisition form
or electronic test order, or (4) mislabeled (ie, found to not be from the intended patient, by any method of detection).
Inappropriate or inadequate specimen: A specimen found to be unsuitable for analysis as a result of (1) hemolysis, (2) unintended
clotting, (3) inadequate quantity, (4) inappropriate anticoagulant and/or collection container, (5) improper method of collection, (6)
excessive time from collection to receipt in the laboratory, or (7) inappropriate storage conditions before receipt in the laboratory.
Laboratory check of specimen label (‘‘lab check’’): Means of detecting mislabeled specimens by laboratory personnel proactively
comparing the specimen label to the accompanying requisition form or electronic test order.
Delta check: Means of detecting mislabeled specimens by laboratory personnel and/or the laboratory information system comparing
test results to previous results for the same patient.
Laboratory correlation with clinical picture (‘‘clinical picture–lab’’): Means of detecting mislabeled specimens by laboratory personnel
proactively comparing test results to the patient’s clinical picture.
Feedback from patient’s clinical care team (‘‘feedback from caregiver’’): Detection of a mislabeled specimen by feedback received
from the patient’s clinical care team indicating that the test result(s) is(are) inappropriate for the patient’s clinical picture. Note:
Although this would occur after initial test result(s) had already been reported, this was still considered ‘‘rejection’’ of the original
specimen and included in the study.
Corrected specimen: A specimen found to be improperly labeled and then allowed to be relabeled correctly without requiring
recollection.
Recollected specimen: A specimen recollected in direct response to rejection of a specimen previously collected for the same test(s).
Note: For the purposes of this study, any specimen recollected more than 6 hours after a specimen was rejected was not considered
to be in direct response to the previous rejection and was excluded.
Abandoned specimen: When a specimen was rejected and neither a recollected nor relabeled specimen was received within 6 hours
of the time of rejection, the original specimen/test was considered to be abandoned.
Laboratory-abandoned specimen: Specimen abandoned (see ‘‘Abandoned specimen’’ above) when the laboratory did not request a
recollected or relabeled specimen.
Provider-abandoned specimen: Specimen abandoned (see ‘‘Abandoned specimen’’ above) when the provider did not provide a
recollected or relabeled specimen after having been requested to do so by the laboratory.

inclusion criteria were identified or until 6 weeks elapsed, patient (wrong specimen in container). Median processing delay
whichever came first. Definitions of terms provided to participants was defined as the interval between the original and recollected/
are listed in Table 1. relabeled specimen receipt times.
Specimens included in the study were those received from Individual associations between the first 4 performance indica-
inpatients and emergency department patients older than 6 months tors with demographic and practice variables were tested by using
for on-site analysis. The following specimen types were excluded Kruskal-Wallis tests for discrete-valued independent variables and
from the study: point-of-care, blood bank, bone marrow, regression analysis for the continuous independent variables. The 2
specimens received in the form of pre-prepared smears, and abandoned rates were skewed so a log transformation was used for
specimens submitted for highly specialized testing (ie, flow the regression-based analyses.
cytometry, molecular DNA/RNA, cytogenetic analysis). Variables with significant associations for the individual associ-
Participants provided the total number of chemistry and ations (P , .10) were then included in a forward selection
hematology accessions separately for the study period. For each multivariate regression model. A significance level of .05 was used
rejected specimen included in the study, the following information for the final multivariate models. All analyses were run by using
was recorded: patient age, specimen type, laboratory testing SAS 9.1 (SAS Institute, Cary, North Carolina).
section, test priority, time of specimen receipt and time of specimen
rejection, rejection reason, detection method used for rejection due RESULTS
to improper labeling, whether or not a recollected or relabeled
specimen was requested by the laboratory, time of recollected/ Table 2 lists the characteristics of the 78 institutions
relabeled request, time of recollected/relabeled specimen receipt, submitting data for this study. A total of 4794 rejected
recollection method for blood and urine specimens, if applicable, specimens were identified from 2 054 702 accessions. Most
and result time. of the participating institutions (94%) are located in the
Participants were also asked to provide information regarding United States, with the remaining in Saudi Arabia (2),
their laboratory’s policies and practices in the following areas: Canada, Jordan, and Spain. Of the participating institutions,
presence of a detailed written policy regarding the detection and/or 39% are teaching hospitals and 27% have pathology
handling of rejected specimens, method(s) used to detect residency training programs.
improperly labeled specimens, whether or not improperly labeled Table 3 illustrates the distribution of 4 of the 5
blood and/or urine specimens are allowed to be relabeled, and the
performance indicators among participants. The overall
nature of recommendation(s) made to providers when a specimen
is rejected.
specimen rejection rate was 0.2%, with the 90th percentile
at 0.1%, median at 0.3%, and 10th percentile at 1.5%. The
Statistical Analysis overall median specimen processing delay due to specimen
Five performance indicators were calculated for this study: rejection was 65 minutes, with a median of 54 minutes for
specimen rejection rate, median processing delay, percentage of stat specimens and 88 minutes for nonstat specimens. Of
laboratory-abandoned specimens, percentage of provider-aban- the 4794 rejected specimens, 537 (11.2%) were abandoned
doned specimens (see Table 1), and percentage of relabeled by either the laboratory not requesting a recollected or
specimens subsequently determined to not be from the intended relabeled specimen (laboratory abandoned) or by the
1004 Arch Pathol Lab Med—Vol 138, August 2014 Specimen Rejection—Karcher & Lehman
Table 2. Institution Characteristics Table 4. Information Relating to the Rejected
Specimens Included in This Studya
Count Percentage
Occupied bed size Count Percentage
0–150 27 37.5 Patient age, y
151–300 22 30.6 0–10 304 6.3
301–450 14 19.4 11–20 180 3.7
451–600 5 6.9 21–40 645 13.3
.600 4 5.6 41–60 1286 26.5
Institution location 61–80 1679 34.7
81–100 751 15.5
City 40 54.1
Rural 17 23.0 Specimen type
Suburban 16 21.6 Blood 4674 96.5
Federal installation 1 1.4 Urine 170 3.5
Government affiliation Laboratory testing location
Nongovernmental 60 82.2 Chemistry 2462 50.9
Governmental, nonfederal 8 11.0 Hematology 2374 49.1
Governmental, federal 5 6.8
Test priority
Institution type Stat 2542 52.7
Voluntary, nonprofit hospital 47 64.4 Nonstat 2192 45.5
County hospital 5 6.8 Not applicable 85 1.8
Nongovernmental, university hospital 5 6.8
Rejection reason
Proprietary hospital 5 6.8
Veterans hospital 3 4.1 Inappropriate/inadequate specimen 4445 92.4
State acute hospital 2 2.7 Improperly labeled 367 7.6
Children’s hospital 1 1.4 Improper labeling detection method
Department of Defense 1 1.4 Laboratory check 268 73.6
Governmental, nonfederal university 1 1.4 Feedback from caregiver 36 9.9
hospital
Delta check 33 9.1
Indian Health Service 1 1.4 Clinical picture–laboratory 12 3.3
Private, independent laboratory 1 1.4 Not applicable 8 2.2
System/integrated delivery network 1 1.4 Other 7 1.9
Response to specimen rejection
provider or caregiver team not complying with the Recollected specimen 4206 87.7
Abandoned specimen (neither 537 11.2
laboratory request (provider abandoned). The median recollected nor relabeled/corrected)
laboratory abandonment rate was 1.3%. The median Relabeled/corrected specimen 51 1.1
provider abandonment rate was 5%. Nonstat and urine Blood recollection method
specimens were significantly more likely to be abandoned, Phlebotomy 3151 86.8
with approximately equal likelihood for laboratory- and Line draw 479 13.2
provider-abandoned specimens. Urine recollection method
Table 4 details information relating to the rejected Urine cup 69 86.3
specimens. A substantial majority (96.5%) of rejected Catheterization 11 13.8
specimens were blood, with essentially equal numbers of a
See Table 1 for definition of terms.
chemistry and hematology specimens. The reason for most
rejected specimens (92.4%) was inappropriate/inadequate
specimen. The remaining 7.6% were rejected owing to tory review (‘‘lab check’’), 9.9% by feedback from caregiver,
improper labeling. Regarding specimens found to be and 9.1% by delta check (see Table 1). Most rejected
improperly labeled, most (73.6%) were detected by labora- specimens (87.7%) were ultimately recollected, 1.1% were
relabeled/corrected, and 11.2% were abandoned (neither
recollected nor relabeled/corrected).
Table 3. Distribution of Performance Indicators The first 4 performance indicators were tested for
All Institutions Percentiles associations with institutional demographic and laboratory
policy variables. A P value of less than .05 was considered
Median
N 10th 25th (50th) 75th 90th statistically significant. Institutional and/or laboratory policy
relationships were found with 3 of the first 4 performance
Rate of specimen 77 1.5 0.6 0.3 0.2 0.1
rejection, %
indicators. No relationships were found with the rate of
Median specimen 72 93.0 80.8 65.5 51.5 41.0 specimen rejection. The significant associations, detailed in
processing delay, Table 5, were as follows: longer specimen processing delays
min tended to occur in institutions with higher occupied bed
Laboratory-abandoned 73 31.3 11.3 1.3 0.0 0.0 size; higher rates of laboratory-abandoned specimens
specimens, %
Provider-abandoned 72 23.8 14.0 5.0 0.0 0.0 tended to occur in laboratories that communicate to the
specimens following patient’s caregiver that the specimen is rejected without
laboratory request providing any direction for specimen replacement; and
for correction/ higher rates of provider-abandoned specimens tended to
recollection, % occur in institutions that train pathology residents/fellows or
Arch Pathol Lab Med—Vol 138, August 2014 Specimen Rejection—Karcher & Lehman 1005
Table 5. Statistically Significant Relationships Between 3 Performance Indicators
and Demographic or Practice Variables
No. of Institutions 10th Percentile Median 90th Percentile
Median specimen processing delay, min
Occupied bed size (P ¼ .005)
0–150 27 33 51 84
151–300 22 55 71 83
301–450 14 55 67 111
.450 9 51 91 263
Rejected specimens abandoned by laboratory, %
Laboratory only communicates that the specimen is rejected when reporting a rejected specimen to the patient’s caregiver (P ¼ .01)
Yes 21 0.0 10.0 47.5
No 49 0.0 1.3 24.4
Rejected specimens abandoned by provider, %
Laboratory trains pathology residents/fellows (P ¼ .007)
Yes 20 0.0 15.0 44.8
No 51 0.0 3.8 14.1
Laboratory allows any improperly labeled chemistry or hematology blood specimen to be relabeled without requiring the specimen
to be recollected (P ¼ .01)
Yes 30 0.0 0.0 18.3
No 40 0.0 6.9 31.1

that do not allow improperly labeled chemistry or hema- the past several years designated accurate patient identifi-
tology blood specimens to be relabeled without requiring cation as one of its national patient safety goals.
the specimen to be recollected. This study clearly documents the consequences of
Table 6 summarizes responses received from participants laboratory specimen defects and resulting specimen rejec-
regarding their policies and practices related to detection tion. Prospective analysis performed by 78 institutions of a
and resolution of rejected specimens. Of the participating total of 2 054 702 specimen accessions revealed an overall
laboratories, 45% reported that they allow improperly specimen rejection rate of 0.2%. This is generally in line with
labeled blood specimens (see Table 1) to be relabeled the rate reported in past studies of specimen rejection,1–4
(among these, 85% when incompletely labeled, 59% when which have typically shown rates of less than 0.3% and up
mislabeled, and 38% when unlabeled). Likewise, 37% allow to 0.75%, with lower rejection rates reported in more recent
improperly labeled urine specimens to be relabeled (among studies.3,4
these, 89% when incompletely labeled, 57% when misla- The first and most direct consequence of specimen
beled, and 36% when unlabeled). Regarding the laboratories rejection is the need to collect a new specimen from the
that allow relabeling of specimens and the relabeled patient. In this study, 86.8% of rejected blood specimens led
specimens included in this study, the following were found: to repeated phlebotomy. Likewise, 13.8% of rejected urine
(1) These laboratories reported no better performance specimens required recatheterization of the patient to collect
regarding specimen processing delay, but a slightly lower a new urine sample. Both of these repeated procedures are
rate of provider-abandoned specimens (see Table 5); (2) of associated with inconvenience and discomfort for the
the 51 improperly labeled specimens that were relabeled, 20 patient, and both introduce the potential for patient
specimens (39%) were subsequently discovered to not be complications.
from the intended patient (wrong specimen in container). Another well-known consequence of specimen rejection
Of the 6 laboratories that reported the 20 relabeled is a delay in the performance and reporting of the results of
the ordered tests. In this study, the median specimen
specimens with ‘‘wrong specimen in container,’’ 4 allowed
processing delay was 65 minutes, with a range of 41 minutes
relabeling of unlabeled blood and/or urine specimens, and 2
(90th percentile) to 93 minutes (10th percentile). The
stated that they did not allow relabeling of any improperly
median processing delay was longer for tests with routine
labeled specimens (ie, there was an apparent breach of
priority (88 minutes) but was still 54 minutes for stat tests.
policy). Among the 51 improperly labeled specimens
This indicates that delays in availability of urgent and
allowed to be relabeled, there was no statistically significant sometimes critical test results of nearly a full hour are
difference in the rate of relabeling between stat and routine commonly seen when stat specimens must be rejected. An
test priorities. interesting association with even longer specimen process-
ing delay (median ¼ 91 minutes) was hospital occupied bed
COMMENT
size, specifically with bed size of greater than 450 beds. No
Defects in laboratory specimens that result in specimen definite explanation for this association was apparent;
rejection are a cause of inconvenience and discomfort to however, this may be a function of the greater complexity
patients, lead to a delay in the availability of often critical of very large hospitals, which could contribute to less
laboratory results, and, if the methods used to detect effective communication among patient care staff members
specimen defects are not effective, may also represent a and slower response time to special requests, such as for
major compromise of patient safety. To address the potential recollection of a rejected laboratory specimen. Although not
harm to patients from misidentification, including mislabel- specifically assessed in this study, longer delays in test result
ing of laboratory specimens, the Joint Commission5 has for availability in the largest hospitals, where the clinical acuity
1006 Arch Pathol Lab Med—Vol 138, August 2014 Specimen Rejection—Karcher & Lehman
Table 6. Laboratory Policies and Practices Relating to Rejected Specimens
Count Percentage
Does your laboratory have a detailed written policy/procedure regarding the detection and/or handling of the following?a (N ¼ 74)
Improperly labeled (including mislabeled) specimens 73 98.6
Inappropriate/inadequate specimens 71 95.9
Neither 0 0.0
What methods are used by your laboratory to detect improperly labeled (including mislabeled) specimens?a (N ¼ 75)
Laboratory check of specimen label 74 98.7
Delta check 68 90.7
Feedback from patient’s clinical care team 60 80.0
Laboratory correlation with the clinical picture 42 56.0
If you indicated ‘‘delta check’’ above, which method is used in your laboratory to perform delta checks?
Automated/preprogrammed comparison using laboratory information system 48 70.6
Both manual and automated comparison 17 25.0
Manual comparison by laboratory personnel 3 4.4
Does your laboratory allow any improperly labeled blood specimens submitted to the central chemistry or hematology laboratories to be
relabeled correctly without requiring the specimen to be recollected?
Yes 34 45.3
No 41 54.7
If blood specimens are allowed to be relabeled correctly, for which of the following circumstances?a (N ¼ 34)
Incompletely labeled specimens 29 85.3
Mislabeled specimens 20 58.8
Unlabeled specimens 13 38.2
Does your laboratory allow any improperly labeled urine specimens submitted to the central chemistry or hematology laboratories to be
relabeled correctly without requiring the specimen to be recollected?
Yes 28 37.3
No 47 62.7
If urine specimens are allowed to be relabeled correctly, for which of the following circumstances?a (N ¼ 28)
Incompletely labeled specimens 25 89.3
Mislabeled specimens 16 57.1
Unlabeled specimens 10 35.7
When your laboratory reports a rejected chemistry or hematology specimen to a patient’s caregiver, what may be communicated to the
caregiver?a (N ¼ 74)
The specimen is rejected 23 31.1
The specimen is rejected, please recollect 69 93.2
The specimen is rejected, please come to laboratory to correct labeling defect 20 27.0
Were any relabeled specimens encountered in this study subsequently discovered, by any means, to not be from the intended patient?
Yes 6 9.0
No 61 91.0
If any relabeled specimens in this study were subsequently discovered to not be from the intended patient, how many were there?
1 2 33.3
4 2 33.3
5 2 33.3
a
Multiple responses allowed.

of patients is often higher, may have an even greater with nonstat priority may be a simple function of lower
negative impact on patient safety and on the delivery of care clinical urgency and a decision to wait for the next routine
to a larger number of critically ill patients. phlebotomy session or next urine collection opportunity to
An additional significant consequence of laboratory recollect a rejected specimen. Higher overall abandonment
specimen rejection is abandonment of the ordered test(s). of urine specimens is likely a reflection of the difficulty in
Such abandonment may occur when the laboratory fails to having patients produce urine samples on demand or in
request recollection or relabeling/correction of a defective recollecting catheter urine specimens. Another association
specimen (laboratory abandonment) or when the provider with higher specimen abandonment, this time by the
or patient care team fails to comply with such a request provider, was institutions that train pathology residents/
(provider abandonment). The overall specimen abandon- fellows. Similar to the longer specimen processing delay
ment rate in this study was 11.2%, meaning that these seen in the largest hospitals, the higher rate of provider
patients received no result(s) for the test(s) originally specimen abandonment may be related to the complexity
ordered. The laboratory abandonment rate was lower and communication challenges typical in academic medical
(median rate ¼ 1.3%) than when the provider abandoned centers.
the specimen (median rate ¼ 5%), but still significant. A troubling finding in this study was the very high rate of
Specimen abandonment rates were significantly higher for mislabeled specimens that were the result of allowing
all nonstat tests and for urine specimens. The association providers and other patient care team members to relabel
Arch Pathol Lab Med—Vol 138, August 2014 Specimen Rejection—Karcher & Lehman 1007
specimens that were received in the laboratory improperly tests and a situation potentially made worse in large and/or
labeled. Of the participating institutions, 45% allow teaching hospitals, where a higher number of critically ill
relabeling of blood specimens and 37% allow relabeling of patients typically receive care. Specimen rejection also leads
urine specimens. Among the institutions allowing specimen to frequent abandonment of the test(s) originally ordered,
relabeling, this was reported to be allowed at higher rates more so with nonstat tests and urine specimens. Finally, the
for incompletely labeled specimens, but 59% and 38% of practice of allowing relabeling of improperly labeled
participating institutions allow correction of mislabeled or specimens is associated with little clinical benefit but
unlabeled blood specimens, respectively. Among these introduces a significant likelihood of specimen mislabeling
institutions, the percentage allowing correction of misla- and potential harm to the patient. If laboratories choose to
beled or unlabeled urine specimens was similar (57% and allow relabeling of blood and urine specimens, they should
36%, respectively). When asked to indicate how many construct their policy thoughtfully, considering the relative
relabeled specimens ultimately turned out to not be from risks and benefits, and perhaps restrict relabeling to
the intended patient (ie, wrong specimen in container), correction of only the simplest labeling defects. The policy
respondents reported that 39% of such specimens had this should also address relabeling of specimens that either
outcome. Though this may represent a slight overestimate cannot be recollected (eg, surgical pathology specimens), or
of the true risk of a ‘‘wrong specimen in container’’ that cannot be recollected without potential harm to the
collection event (since multiple blood tubes may have been patient (eg, cerebrospinal fluid or other body cavity fluid
collected at the same time, but given different accession specimens, bone marrow aspirate/biopsy specimens).
numbers and thus considered separate events), the inci-
dence of ‘‘wrong blood in container’’ in this study is clearly References
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