Tabatabaee et al.

Patient Safety in Surgery (2023) 17:8 Patient Safety in Surgery

https://doi.org/10.1186/s13037-023-00360-1

RESEARCH Open Access

Evaluation of errors related to surgical

pathology specimens of different hospital
departments with a patient safety approach:
a case study in Iran
Seyed Saeed Tabatabaee1,2, Vahid Ghavami3, Rohollah Kalhor4, Mohammad Amerzadeh4 and
Hadi Zomorrodi-Niat2,5*

Abstract
Background Most surgical specimen errors occur in the pre-analysis stage, which can be prevented. This study aims
to identify errors related to surgical pathology specimens in one of the most comprehensive healthcare centers in
Northeast Iran.
Methods The present study is descriptive and analytical research conducted cross-sectionally in 2021 at Ghaem
healthcare center in the Mashhad University of Medical Sciences on the basis of a census sampling. We used a
standard checklist to collect information. Professors and pathologists evaluated the validity and reliability of the
checklist using Cronbach’s alpha calculation method of 0.89. We analyzed the results using statistical indices, SPSS 21
software, and the chi-square test.
Results Out of 5617 pathology specimens studied, we detected 646 errors. The highest number of errors is the
mismatch of the specimen with the label (219 cases; 3.9%) and the non-compliance of the patient’s profile in the
specimen sent with the label (129 cases; 2.3%), and the lowest errors are the inappropriate volume of the fixator(24
cases; 0.4%), and they accounted for insufficient sample size (25 cases; 0.4%). Based on Fisher’s exact test results, there
was a significant difference between the proportion of errors in different departments and months.
Conclusion Considering the frequency of labeling errors in the stage before the analysis in the pathology
department, the use of barcode imprinted in specimen containers, the removal of the paper request for pathology,
the use of radio frequency chip technology, the use of the rechecking system and improving communication in
different departments can be effective in reducing these errors.
Keywords Patient safety, Labeling error, Pathology specimen, Hospital, Preanalytical error

3
*Correspondence: Department of Biostatistics, School of Health, Mashhad University of
Hadi Zomorrodi-Niat Medical Sciences, Mashhad, Iran
4
zomorrodinh1@mums.ac.ir Social Determinants of Health Research Center, Research Institute for
1
Social Determinants of Health Research Center, Mashhad University of Prevention of Non-Communicable Diseases, Qazvin University of Medical
Medical Sciences, Mashhad, Iran Sciences, Qazvin, Iran
2 5
Department of Health Economics and Management Sciences, School of Student Research Committee, Mashhad University of Medical Sciences,
Health, Mashhad University of Medical Sciences, Mashhad, Iran Mashhad, Iran

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Tabatabaee et al. Patient Safety in Surgery (2023) 17:8 Page 2 of 5

Background related to pathology specimens in the Ghaem healthcare

Patient safety is a strategic priority for senior managers of center at the Mashhad University of Medical Sciences.
the health system. Managers should pay special attention
to the evaluation of safety culture in healthcare organi- Methods
zations, especially hospitals to promote patient safety [1]. The current study is descriptive and analytical research
The patient safety culture in the hospital is inappropriate conducted cross-sectionally in 2021 in one of the largest
and requires urgent intervention [2]. Promoting patient healthcare centers in the country’s northeast. The infor-
safety culture can effectively reduce the medical errors mation sources of this study included all the pathology
and address concerns related to the lack of safety in request forms completed in different hospitals depart-
health systems by recognizing the factors causing errors ments and sent to the pathology laboratory for the diag-
[2, 3]. nostic process. In this study, sampling was not done, and
Surgical specimen collection is a routine process occur- the study was done on the basis of a census sampling.
ing daily in hospitals [4], and various errors can occur in We identified errors related to pathology specimens
each of the three stages of the specimen management from the difference between the information recorded in
process. They are pre-analysis (from the operating room the pathology request form and the information on the
to the pathology), analysis (from receiving in pathology specimen label sent to the pathology laboratory. For this
to analysis), and post-analysis (from analysis to reporting purpose, after obtaining the permission to conduct the
results) [5]. research, we sent the checklist for identifying the errors
One primary concern of patient safety is the errors of the pathology specimens to the pathology unit in
related to managing surgical specimens, especially in the Ghaem healthcare center and collected the information
pre-analysis stage [5]. Most surgical specimen errors hap- and analyzed in six months. We classified errors based on
pen in the pre-analysis stage, which can be prevented [6]. error type and specimen location. We identified the type
Misuse surgical specimens increases the risk of prevent- of error through any inconsistency between the informa-
able harm through delayed treatment, incorrect treat- tion recorded on the application form and the specimen
ment selection, or misdiagnosis [4]. label. For example, the error of the unlabeled specimen
The errors that are attributed to the pre-analytical refers to the unlabeled specimens, the wrong side error
phase are mismatch of specimen form and request [4, is paired specimens such as eyes and ears, and the errors
6–9], incorrect patient identification [6–8, 10], unla- related to the location of the specimen include the loca-
beled specimens [4, 6–8]; Incorrect number of speci- tion of the tissue, which includes breast, skin, etc.
mens [6], incorrect order entry [7], incorrect specimen We used Makary’s standard checklist to collect infor-
identification [7], incorrect laterality on specimen label mation [15]. Face and content validity were used to mea-
[6, 10], incorrect specimen in the container [7], missing sure the validity of the checklist. We provided the initial
specimen(s) [11], incorrect fixator or holder [11] and checklist to 5 professors and pathologists to reach a
delay in transporting to incorrect destination, and incor- consensus on the checklist (face validity). We also used
rect method of transporting [11]. the content validity index and CVR calculation to mea-
The problem areas analysis shows that patient identifi- sure content validity. For this purpose, a checklist with a
cation is a crucial issue. Most errors occur in the label- measurement format was designed and completed with
ing of test tubes (45.4%) and analysis forms or request 30 experts’ opinions. The retest method was used to
sheets (33%) [12]. Mislabeling laboratory specimens cre- measure the reliability of the checklist. We analyzed the
ates problems in the overall process of laboratory medi- results using statistical indices, descriptive statistics, and
cine diagnosis and can cause fatal patient harm [12]. Fisher’s exact test using SPSS software version 21.
Therefore, the ISO standard specifies the need to evalu-
ate, monitor, and improve all procedures and processes Results
in the pre-analysis phase, which includes the test request We studied 5617 pathology specimens, of which 4971
phase and specimen collection [13]. Therefore, identify- (88.5%) specimens did not have any errors, and the error
ing errors and reducing them in the pre-analytical stage of “non-matching of the specimen with the label.
is necessary to ensure cost-effectiveness, patient satisfac- ” with 219 (3.9%) had the highest number of errors. The
tion, and high-quality laboratory services [14]. details of the distribution of error types are reported in
Analyzing these error reports and the complexity of Table 1.
the specimen collection process poses significant chal- Among the pathology specimens sent from different
lenges for healthcare professionals. Although the rate of departments, the highest error ratio was related to surgi-
these errors can be used as one index of patient safety for cal departments with 17.6% and the lowest was related to
patients undergoing surgery, the rate of these errors has operating rooms with 9.9% (Table 2).
been studied very little. This study aims to identify errors
Tabatabaee et al. Patient Safety in Surgery (2023) 17:8 Page 3 of 5

Table 1 Distribution of errors in pathology specimens Discussion

Type of error Number Percentage This study aimed to identify errors related to pathology
Without error 4971 88.5 specimens in one of the largest healthcare centers in Iran
Not-matching of the specimen with the 219 3.9 northeast. This study focused on the pre-analysis stage
label
(transferring information from the doctor to the nurse,
Not-compliance of the patient’s profile in 129 2.3
the specimen
labeling, packaging, and transferring the specimen).
sent with the label Since it has been less investigated in other studies and
Not-mentioning the full demographic 93 1.7 due to the lack of supervision in this stage, differences in
information of the patient on the label or the way specimens are labeled and transported can be a
incorrect information valuable source of patient harm.
Not-mentioning the specifications of the 76 1.4 The overall labeling errors in the studied hospital is
technician completing the label
11.5%. On average, for every 1000 pathology specimens
Not mentioning the patent history 51 0.9
sent from different departments of the hospital, 115
Not mentioning the location of the 29 0.5
errors occur, and this number of errors raises signifi-
specimen
Insufficient specimen 25 0.4
cant risks for the patient safety. Jesica et al. identified 234
Inappropriate volume of fixator 24 0.4
errors (6.8%) in a review of 33,962 pathology specimens,
Total 5617 100.0
ten errors per 1000 specimens [16]. A review of 8288
pathology specimens identified 5.8% errors per 1000
specimens [17]. Bülbüloğlu et al. identified a 0.32% speci-
Based on Fisher’s exact test, the percentage of errors in men error in a 21,078 pathology specimens [18]. Nakhleh
different sections was significantly different (p < 0.001). and Zarbo, in a review of over one million surgical
Regarding the status of errors in different months, we pathology specimens from 417 institutions around the
observed the highest percentage of errors in the first world, concluded that the error in the identification of
quarter (Table 3). Also, based on Fisher’s exact test, a sig- pathology specimens occurs in 6% of the specimens [19].
nificant relationship between month and error rate was Makary et al. identified 4.3 errors per 1000 examined
observed (P < 0.001). specimens [15]. The present study’s increase in pathology
Regarding the status of errors by insurance, the high- errors compared to similar studies is due to the lack of
est percentage of errors was related to the uninsured, error prevention methods in the studied hospital.
and the lowest was related to other insurances (Table 4). The results showed that the error of non-matching
Based on Fisher’s exact test, the percentage of pathol- the specimen with the label 219 (3.9%) has the highest
ogy error was significantly different in different types of error rate among the errors. After that, the highest error
insurance (p = 0.005). is related to the non-compliance of the patient’s profile
in the specimen with the label at 129 (2.3%). In a study

Table 2 The status of pathology errors by different department

The department Without Percentage Error Percentage Total Percentage
errors
Operating rooms 2872 90.12% 315 9.88% 3187 100%
Surgical departments 530 82.43% 113 17.57% 643 100%
Maternity 749 86.89% 113 13.11% 862 100%
Non-surgical 397 88.81% 50 11.19% 447 100%
Endoscopy 210 87.50% 30 12.50% 240 100%
Intensive Care Units 213 89.50% 25 10.50% 238 100%
Total 4971 88.50% 646 11.50% 5617 100%

Table 3 The pathology errors in different months

Months Without error Percentage without error Error Percentage error Total Percentage
April 775 84.61% 141 15.39% 916 100%
May 847 85.73% 141 14.27% 988 100%
June 1081 84.12% 204 15.88% 1285 100%
July 1165 91.37% 110 8.63% 1275 100%
August 500 95.79% 22 4.21% 522 100%
September 603 95.56% 28 4.44% 631 100%
Total 4971 88.50 646 11.50% 5617 100%
Tabatabaee et al. Patient Safety in Surgery (2023) 17:8 Page 4 of 5

Table 4 Pathology errors according to insurance types

Type of insurance without error Percentage without error Error Percentage of total error Total Percentage
The uninsured 152 81.28% 35 18.72% 187 100%
Health insurance 3125 88.08% 423 11.92% 3548 100%
Social Security Insurance 1504 89.79% 171 10.21% 1675 100%
Other insurances 190 91.79% 17 8.21% 207 100%
Total 4971 88.50% 646 11.50% 5617 100%

by Syndman et al., after extensive analysis of laboratory to the uninsured, and the lowest was related to other
reports in 30 healthcare organizations, they found that insurances. This shows that the departments’ staff have
laboratory events before analysis were the most com- been more sensitive to sampling and preventing labeling
mon (81%) errors. The top three examples of errors were errors due to the careful monitoring of insurance experts
unlabeled specimens (18.7%), wrongly labeled specimens to confirm patients’ files with insurance.
(16.3%), and improper collection (13.2%) [20]. In the
study of Makary et al., in the evaluation of 21,351 surgical Conclusion
specimens, 11 cases (0.05%) of inappropriate label errors The quality control without accepting the possibility
were discovered, which led to assigning the specimen to of error is impossible. Incorrect labeling of pathology
the wrong patient [15]. Francis et al. examined over 8000 specimens is a significant source of medical errors cause
containers containing pathology specimens and identi- harm to the patient. The percentage of labeling errors
fied 0.09% wrong labels [21]. In Tabatabai et al.’s study, the in the pre-analysis stage in the pathology department of
most common errors were non-recording the patient’s the studied healthcare center was high, which necessi-
age (9%), not registering the patient’s father name (9%), tates the use of preventive risk assessment strategies to
and not recording the number of biopsy specimens (9%) identify weak points. Investing in continuous training of
[22]. Its difference with this study is in the type of data employees with an emphasis on patient safety, improve-
collection form. The lack of continuous training of per- ment initiatives such as simplifying processes, using
sonnel and the lack of sufficient supervision caused barcode technology in specimen containers, eliminating
this type of error to be high in the studied hospital. The paper pathology request forms, using radio frequency
results showed that using two patient identification codes chip technology, using recheck systems, and improv-
simultaneously reduced such errors [8]. Therefore, the ing communication in operating rooms, such as using a
simultaneous use of two identification codes for patients surgical checklist to increase team communication and
can significantly reduce the errors related to not register- improve team culture, can reduce the number of errors in
ing the identification code or incorrect registering the labeling surgical specimens.
identification code of the patients.
The status of department errors showed that even Rigor of study
though most cases of pathology sampling were in oper- This is the first kind of study conducted at Mashhad Uni-
ating rooms, the lowest detected error was in operating versity of Medical Sciences. Nonetheless, we had some
rooms at 9.9%. Despite the third place in the number of limitations. The most important one was conducting
specimens taken, the surgery department had the highest a study in one hospital. We also did not include private
number of errors with 17.57%. The reason for this could hospitals in our study.
be the greater sensitivity (ability or training) of operat-
Acknowledgements
ing room personnel for specimen preparation. There are We would like to express our deepest gratitude to all the managers and staff
ways to reduce errors. The writing technique is rereading who sincerely contributed to this article.
that the nurse can use to communicate with the doctor
Author contributions
during surgery [5]. The results of one study showed that SST and HZ conceived the study. SST supervised all evaluation phases and
the use of a pathology specimen management protocol revised the manuscript. VGH and RK were advisors in methodology and
in the operating room reduced the rate of adverse events contributed to the intellectual development of the manuscript. MA, RK and HZ
collected and conducted primary data analysis. All authors read and approved
from 0.3226% (68 of 21,078) to 0.032% (6 of 18,706) after the final version of the manuscript.
the protocol systematized the surgical pathology speci-
men management process [18]. The pathology depart- Funding
No applicable.
ment can quickly identify mislabeled specimens using a
simple screening process. This quality control method Data Availability
is a meager cost and has a high acceptance rate, which The datasets used and/or analyzed during the current study available from
the corresponding author on reasonable request. The entire dataset is in Farsi
makes patient safety more effective. Regarding the status language. The Data can be available in English language for the readers and
of errors by insurance, the highest percentage was related make available from the corresponding author on reasonable request.
Tabatabaee et al. Patient Safety in Surgery (2023) 17:8 Page 5 of 5

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