Evaluation of errors related to surgical pathology specimens of different hospital departments with a patient safety approach: a case study in Iran

Patient safety is a strategic priority for senior managers of the health system. Managers should pay special attention to the evaluation of safety culture in healthcare organizations, especially hospitals to promote patient safety [1]. The patient safety culture in the hospital is inappropriate and requires urgent intervention [2]. Promoting patient safety culture can effectively reduce the medical errors and address concerns related to the lack of safety in health systems by recognizing the factors causing errors [2, 3].

Surgical specimen collection is a routine process occuring daily in hospitals [4], and various errors can occur in each of the three stages of the specimen management process. They are pre-analysis (from the operating room to the pathology), analysis (from receiving in pathology to analysis), and post-analysis (from analysis to reporting results) [5].

One primary concern of patient safety is the errors related to managing surgical specimens, especially in the pre-analysis stage [5]. Most surgical specimen errors happen in the pre-analysis stage, which can be prevented [6]. Misuse surgical specimens increases the risk of preventable harm through delayed treatment, incorrect treatment selection, or misdiagnosis [4].

The errors that are attributed to the pre-analytical phase are mismatch of specimen form and request [4, 6,7,8,9], incorrect patient identification [6,7,8, 10], unlabeled specimens [4, 6,7,8]; Incorrect number of specimens [6], incorrect order entry [7], incorrect specimen identification [7], incorrect laterality on specimen label [6, 10], incorrect specimen in the container [7], missing specimen(s) [11], incorrect fixator or holder [11] and delay in transporting to incorrect destination, and incorrect method of transporting [11].

The problem areas analysis shows that patient identification is a crucial issue. Most errors occur in the labeling of test tubes (45.4%) and analysis forms or request sheets (33%) [12]. Mislabeling laboratory specimens creates problems in the overall process of laboratory medicine diagnosis and can cause fatal patient harm [12]. Therefore, the ISO standard specifies the need to evaluate, monitor, and improve all procedures and processes in the pre-analysis phase, which includes the test request phase and specimen collection [13]. Therefore, identifying errors and reducing them in the pre-analytical stage is necessary to ensure cost-effectiveness, patient satisfaction, and high-quality laboratory services [14].

Analyzing these error reports and the complexity of the specimen collection process poses significant challenges for healthcare professionals. Although the rate of these errors can be used as one index of patient safety for patients undergoing surgery, the rate of these errors has been studied very little. This study aims to identify errors related to pathology specimens in the Ghaem healthcare center at the Mashhad University of Medical Sciences.

Methods

The current study is descriptive and analytical research conducted cross-sectionally in 2021 in one of the largest healthcare centers in the country’s northeast. The information sources of this study included all the pathology request forms completed in different hospitals departments and sent to the pathology laboratory for the diagnostic process. In this study, sampling was not done, and the study was done on the basis of a census sampling.

We identified errors related to pathology specimens from the difference between the information recorded in the pathology request form and the information on the specimen label sent to the pathology laboratory. For this purpose, after obtaining the permission to conduct the research, we sent the checklist for identifying the errors of the pathology specimens to the pathology unit in Ghaem healthcare center and collected the information and analyzed in six months. We classified errors based on error type and specimen location. We identified the type of error through any inconsistency between the information recorded on the application form and the specimen label. For example, the error of the unlabeled specimen refers to the unlabeled specimens, the wrong side error is paired specimens such as eyes and ears, and the errors related to the location of the specimen include the location of the tissue, which includes breast, skin, etc.

We used Makary’s standard checklist to collect information [15]. Face and content validity were used to measure the validity of the checklist. We provided the initial checklist to 5 professors and pathologists to reach a consensus on the checklist (face validity). We also used the content validity index and CVR calculation to measure content validity. For this purpose, a checklist with a measurement format was designed and completed with 30 experts’ opinions. The retest method was used to measure the reliability of the checklist. We analyzed the results using statistical indices, descriptive statistics, and Fisher’s exact test using SPSS software version 21.

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