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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 6  |  Issue : 3  |  Page : 102-106

An evaluation of the errors occurring in pathology and microbiology laboratories of a tertiary care teaching hospital and their root cause analyses


1 Department of Pathology, IQ City Medical College, Durgapur, West Bengal, India
2 Department of Microbiology, IQ City Medical College, Durgapur, West Bengal, India

Date of Submission14-Jun-2019
Date of Acceptance14-Aug-2019
Date of Web Publication27-Nov-2019

Correspondence Address:
Dr. Dipmala Das
Department of Microbiology, IQ City Medical College, Sovapur, Bijra, Durgapur - 713 206, West Bengal.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jhrr.jhrr_38_19

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  Abstract 

Background: Clinical laboratory testing is an important part of health-care services. Medical laboratories play a pivotal role in the health-care system and the decision-making of clinical doctors about their patients. In the era of consumer protection, everyone is aware of and tries to ensure quality health-care services to all. However, medical errors may sometimes cause undesirable consequences to patients. Therefore, it is important to know the types of errors occurring in laboratories in order to formulate strategies to prevent these. Although literature reporting errors in biochemistry laboratory is available, the literature pertaining to pathology and microbiology laboratories is very limited. Aims: This was a cross-sectional study done in pathology and microbiology laboratories of a tertiary care teaching hospital. Our study aimed to find different errors in these departments and also perform root cause analyses of these errors. Materials and Methods: The study was conducted for a period of 3 months. All the requisition forms, specimens, entered reports, and certified reports were scrutinized, and any error observed as per predefined categories was recorded. Errors that were noticed by laboratory personnel, laboratory doctors, clinicians, and nurses in the wards were included in this study. Each error was documented, and root cause analysis of the same was also done. Data were compiled on Microsoft excel worksheets (Microsoft Office Excel 2007, Redwoods, WA, USA) analyzed with GraphPad Prism 5 (GraphPad Software Inc., CA, USA). Chi-square test was applied to compare categorical data. Results: Among a total of 21,746 tests, a number of errors recorded were 304 (1.4%). The most common errors observed were preanalytical (64.5%), followed by postanalytical (18.1%) and analytical (17.4%). Conclusion: An error detection program must be in place, and it has to be acknowledged in order to ensure patients’ safety. Adequate measures must be adopted to reduce errors in laboratory.

Keywords: Errors, Pathology and microbiology laboratories, Root cause analysis


How to cite this article:
Roy AD, Das D. An evaluation of the errors occurring in pathology and microbiology laboratories of a tertiary care teaching hospital and their root cause analyses. J Health Res Rev 2019;6:102-6

How to cite this URL:
Roy AD, Das D. An evaluation of the errors occurring in pathology and microbiology laboratories of a tertiary care teaching hospital and their root cause analyses. J Health Res Rev [serial online] 2019 [cited 2019 Dec 10];6:102-6. Available from: http://www.jhrr.org/text.asp?2019/6/3/102/271841


  Introduction Top


Clinical laboratory testing is an essential element in the delivery of health-care services.[1] Medical laboratories play a pivotal role in the health-care system and the decision-making of clinical doctors about their patients. Any error in laboratory reporting can have a tremendous effect on patients’ safety.[2]

The dependence of patient management on laboratory data highlights the need for ensuring the quality of these services.[3],[4] Laboratory medicine must set high-quality standards in order to deliver quality patient care. Regulation of quality in the health-care sector is based on accreditation, certification, quality monitoring, patients’ rights, standard operation processes, and standards of health-care quality.

Many quality indicators are continuously monitored and analyzed in order to allocate resources and improve services.[5]

However, improvement of laboratory performance does not automatically indicate a reduction in the number of errors, both analytical and organizational. Even certification or accreditation processes focus attention more on the general performance of the laboratory than on events such as errors. As there is no universally accepted definition for laboratory error, most of the studies are done in clinical biochemistry laboratories emphasizing on analytical errors.[1],[6]

Moreover, in the days of automation in laboratory, quality of many tests in pathology and microbiology still depends on the skills and proficiency of individuals.

To the best of our knowledge, no study has been done till date to identify errors in different sections (hematology, histology, cytology, clinical pathology, bacteriology, serology, and mycology) of pathology and microbiology laboratories. Therefore, the objectives of our study were to identify laboratory errors in preanalytical, analytical, and postanalytical phases in these sections of laboratory. We also aimed to hypothesize that there is no significant impact of these errors on the final health outcome of patients. Another purpose of our study was also to develop plans to minimize laboratory errors.


  Materials and Methods Top


This cross-sectional study was conducted in pathology and microbiology laboratories of a tertiary care teaching hospital in West Bardhaman district of West Bengal for a period of 3 months from June 1, 2018, to August 31, 2018. The laboratory is a state-of-the-art laboratory which runs 24h throughout the year. The sections in pathology laboratory are hematology, cytology, clinical pathology, and histopathology and in microbiology laboratory are bacteriology, serology, and mycology.

In the microbiology section of the laboratory, automated identification and sensitivity instrument was not available, and sensitivity reporting was done by manual Kirby–Bauer method according to the Clinical and Laboratory Standards Institute guideline 2018.[7]

Data collection

All the requisition forms, specimens, entered reports, and certified reports were scrutinized, and any error was recorded. Any error that was recorded or noticed by laboratory personnel, laboratory doctors, clinicians, and nurses in the wards was included in this study. For 3 months, physicians and nurses were requested to pay careful attention to all test results. Types of errors were recorded as per the table mentioned by Hammerling in her article.[8]

Statistical analysis

Collected data were compiled on Microsoft excel worksheets (Microsoft Office Excel 2007, Redwoods, WA, USA). Statistical evaluation was done using a simple percentage distribution. Data were analyzed with GraphPad Prism 5 (GraphPad Software Inc., CA, USA). Chi-square test was applied to compare categorical data. P < 0.05 was considered statistically significant.


  Results Top


Among a total of 21,746 tests, a number of errors recorded were 304 (1.4%). The number and percentage of errors in different sections are depicted in [Table 1]. The highest percentage of errors was observed in the hematology section (2%) [Table 1]. The distribution of errors in different phases in various sections is depicted in [Table 2]. Various errors in preanalytical, analytical, and postanalytical phases are mentioned in [Table 3]. The most common errors observed were preanalytical (64.5%), followed by postanalytical (18.1%) and analytical (17.4%). Laboratory doctors spotted most number of errors (43.8%) [Table 4]. Impact of errors on a patient is presented in [Figure 1]. In our study, we observed that there is no significant impact of these laboratory errors on patients’ health outcome (P < 0.05). Fortunately, 274 (90%) of the patients were not affected by these laboratory errors [Figure 1]. Root cause analyses of the errors were done, and failure of quality indicators (25.3%) and transcriptional errors (24.7%) were the most common causes of these errors [Table 5].
Table 1: Number and percentage of errors in different sections

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Table 2: Distribution of errors in different phases in various sections

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Table 3: Types and percentage of different errors in preanalytical, analytical, and postanalytical phase

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Table 4: Percentage of errors noted/documented by various groups (n=304)

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Figure 1: Pictorial representation of impact of errors on patients

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Table 5: Root cause analysis of various errors (n=304)

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  Discussion Top


There are only a few studies evaluating the types of errors in laboratory tests. Most of these types of studies were done in the clinical biochemistry laboratory.[1],[8] In our study, we attempted to evaluate errors in pathology and microbiology sections of laboratory medicine.

Most medical laboratories play a pivotal role in the diagnosis and management of patients as approximately 60%–70% of medical decisions related to diagnosis and treatment depend on different test results. Laboratory errors have a reported frequency of 0.012%–0.6% of all test results.[9] In a study by Plebani among a total of 40,490 analyses, 189 laboratory mistakes were identified contributing a relative frequency of 0.47%. The distribution of errors was as follows: preanalytical 68.2%, analytical 13.3%, and postanalytical 18.5%.[10] In our study, we observed a higher percentage of errors (1.4%). A total of 304 errors were noted out of 21,746 analyses. Similar to the study,[10] in our study, the most common errors observed were preanalytical (64.5%), followed by postanalytical (18.1%) and analytical (17.4%).

Rajalakshmi et al. studied about preanalytical errors in hematology laboratory and observed 0.3% preanalytical errors.[11] In our study, we observed 1.4% preanalytical errors (142 errors in 10,424 tests) in the hematology section. Arul et al. observed a 0.43% preanalytical error in their study.[12] In our study also, 90% of errors did not have any effect on patients’ outcome. Similarly, another study mentioned that about 85.7% of total errors were of nonsignificant implication on patients’ health.[2] Most of the laboratory mistakes (74%) did not affect patients’ outcome.[9]

In contrast, another study by Plebani mentioned that risk of adverse events and inappropriate care due to laboratory errors ranges from 2.7% to 12%, while in a larger percentage of cases (24.4%–30%), the laboratory error translates into a patient care problem.[13]

In our study, the most common errors observed were preanalytical (64.5%), followed by postanalytical (18.1%) and analytical (17.4%). Bonini et al. mentioned in their studies that most of the errors occurred in the pre- or postanalytical phases, whereas a minority (13%–32% according to the studies) occurred in the analytical portion.[6]

In our study, we observed that in histopathology and bacteriology, postanalytic and analytical errors were more than preanalytical errors. This could be due to involvement of manual work and skill of technicians in these sections of laboratory medicine. Moreover, interpretation of reports also depends on knowledge and experience of the laboratory doctors.[14]

The highest percentage of errors was documented in hematology (2%), followed by cytology and histopathology (1.7%). To the best of our knowledge, no studies are done to find errors in hematology, cytology, and histopathology separately.

The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories, and currently, available evidence demonstrates that the pre- and postanalytical steps of the total testing process are more error-prone than the analytical phase. In particular, most errors are identified in pre–preanalytic and post–postanalytic steps outside the walls of the laboratory and beyond its control.[13] In our study also, we observed that 22% of errors were noted by clinicians and nurses and 3.9% by patients beyond the boundary walls of laboratory. Maximum (43.8%) errors were noted by laboratory doctors in our study.

The awareness of current nature of laboratory testing-associated errors, in particular the link between appropriateness in test or ordering and result interpretation/utilization, and their potential in addressing diagnostic errors, should herald a change in the old paradigm which was focused only on errors detected within laboratory walls. In order to translate the concept of “patient-centered care” from theory to practice, it is of the utmost importance to investigate, and improve upon, not only those procedures and processes performed under the direct control of the clinical laboratory but also the initial and final steps of the testing cycle that are usually managed by other healthcare personnel. Projects aiming to improve quality and patient safety must, therefore, be based on a total quality perspective, in particular the accreditation of clinical laboratory services according to the International Standard ISO 15189:2012.[15],[16]

Most of the preanalytical errors were beyond the control of laboratory. However, we should emphasize the prevention and minimization of errors in analytical and postanalytical phases. After analyzing various data of our study, we can develop few strategies to prevent errors in different phases in various sections.

  1. Avoiding manual transcription of data


  2. Implementation of internal quality and external quality assurance scheme


  3. Training and skill development of technical staff and laboratory doctors


  4. Monitoring and documentation of errors and root cause analyses


  5. Accreditation of various tests by the National Accreditation Board for Testing and Calibration.


As stated by Leape et al.,[17] naming, blaming, shaming, and punishing have not worked in addressing and decreasing errors.

On the contrary, the new look has focused research on how people, individually, as groups and as organizations, make safety. This needs training, education, and culture.

Sandhu et al. also emphasized that intervention that enhances communication and collaboration between laboratory and health-care professionals, training and education of specimen collection staff, audit and feedback of labeling errors, and implementation of new technologies and strategies can reduce laboratory errors tremendously.[18]

Salinas et al. discussed in details the causes behind request inappropriateness, reasons to reduce such inefficiency, strategies to correct it, and a practical pathway to design and establish them to identify and correct the problem and to monitor success after interventions.[19]


  Conclusion Top


To the best of our knowledge, this is the first study to evaluate errors in different sections of pathology and microbiology laboratories in three phases of errors. Implementing proper technologies for error detection and correction of errors is a key tool for changing and improving upon every day clinical practice. In laboratory medicine process analysis, the recording/documentation of all procedures and processes according to quality standards, particularly ISO 15189:2012 which has been specifically developed for medical laboratories, is important for minimizing errors in laboratory.

One of the limitations of our study was that we could not get full cooperation from all the clinicians as well as nursing staffs regarding reporting of errors observed by them. Failure to follow up all test results with wrong value or interpretation and impact of these errors on patients’ safety was another limitation.

Another crucial step is to create a culture among all staff in which the existence of risk is acknowledged and injury prevention is recognized as everyone’s responsibility. We will try to implement the strategies designed and measure the outcome in our laboratory.

Acknowledgments

We would like to thank the nursing staff and the clinicians who helped us in data collection.

Ethical policy and institutional review board statement

The study was conducted after getting clearance from the Institutional Ethics Committee (IQMC/IEC/LTR/17/02/280).

Data availability statement

Data are available in the article and supplementary materials.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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Ambachew S, Adane K, Worede A, Melak T, Asmelash D, Damtie S, et al. Errors in the total testing process in the clinical chemistry laboratory at the university of gondar hospital, northwest ethiopia. Ethiop J Health Sci 2018;28:235-44.  Back to cited text no. 1
    
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Miligy DA. Laboratory errors and patient safety. Int J Health Care Qual Assur 2015;28:2-10.  Back to cited text no. 2
    
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Shahangian S, Snyder SR. Laboratory medicine quality indicators: a review of the literature. Am J Clin Pathol 2009;131:418-31.  Back to cited text no. 3
    
4.
Chawla R. Evaluating laboratory performance with quality indicators. Labmedicine 2010;41:297-300.  Back to cited text no. 4
    
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Weiner BJ, Alexander JA, Shortell SM, Baker LC, Becker M, Geppert JJ. Quality improvement implementation and hospital performance on quality indicators. Health Serv Res 2006;41:307-34.  Back to cited text no. 5
    
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Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691-8.  Back to cited text no. 6
    
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Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing. 28th Informational Supplement. CLSI Document M100-S28. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.  Back to cited text no. 7
    
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Hammerling JA. A review of medical errors in laboratory diagnostics and where we are today. Lab Med 2012;43:41-4.  Back to cited text no. 8
    
9.
Agarwal R. Measurement of errors in clinical laboratories. Indian J Clin Biochem 2013;28:227-34.  Back to cited text no. 9
    
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Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem 1997;43:1348-51.  Back to cited text no. 10
    
11.
Rajalakshmi V, Muthukrishnan R, Rajeswari K, Selvakumar S. Identification of the types of pre analytical errors in a haematology laboratory: 1 year study at ESIC hospital. Trop J Pathol Microbiol 2017;3;272-5.  Back to cited text no. 11
    
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Arul P, Pushparaj M, Pandian K, Chennimalai L, Rajendran K, Selvaraj E, et al. Prevalence and types of preanalytical error in hematology laboratory of a tertiary care hospital in south india. J Lab Physicians 2018;10:237-40.  Back to cited text no. 12
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Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 2006;44:750-9.  Back to cited text no. 13
    
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Al-faraeh W, Ababeneh MF. The detection and prevention of errors in clinical laboratory. Int J Sci Res Publ 2018;8:480-5.  Back to cited text no. 14
    
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International Organization for Standardization. ISO 15189: Medical Laboratories Requirements for Quality and Competence and the Search for Valuable Quality Indicators (QIs) for all Phases of the Testing Process. Geneva, Switzerland: International Organization for Standardization; 2012.  Back to cited text no. 15
    
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Plebani M. Diagnostic errors and laboratory medicine - causes and strategies. Ejifcc 2015;26:7-14.  Back to cited text no. 16
    
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Leape LL, Woods DD, Hatlie MJ, Kizer KW, Schroeder SA, Lundberg GD. Promoting patient safety by preventing medical error. Jama 1998;280:1444-7.  Back to cited text no. 17
    
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Sandhu P, Bandyopadhyay K, Ernst DJ, Hunt W, Taylor TH Jr, Birch R, et al. Effectiveness of laboratory practices to reducing patient misidentification due to specimen labeling errors at the time of specimen collection in healthcare settings: LMBP™ systematic review. J Appl Lab Med 2017;2:244-58.  Back to cited text no. 18
    
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Salinas M, Flores E, López-Garrigó M, Salinas CL. Laboratory test inappropriateness: Lessons revisited and clarified in seven questions. J Lab Precis Med 2018;3:1-14.  Back to cited text no. 19
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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