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Quality improvement in clinical laboratories is crucial to ensure accurate and reliable test results. With increasing awareness of the potential adverse effects of errors in laboratory practice on patient outcomes, the need for continual improvement of laboratory services cannot be overemphasized. A literature search was conducted on PubMed and a web of science core collection between October and February 2021 to evaluate the scientific literature quality of clinical laboratory quality improvement; only peer-reviewed articles written in English that met quality improvement criteria were included. A structured template was used to extract data, and the papers were rated on a scale of 0–16 using the Quality Improvement Minimum Quality Criteria Set (QI-MQCS). Out of 776 studies, 726 were evaluated for clinical laboratory literature quality analysis. Studies were analyzed according to the quality improvement and control methods and interventions, such as training, education, task force, and observation. Results showed that the average score of QI-MQCS for quality improvement papers from 1981–2000 was 2.5, while from 2001–2020, it was 6.8, indicating continuous high-quality improvement in the clinical laboratory sector. However, there is still room to establish a proper system to judge the quality of clinical laboratory literature and improve accreditation programs within the sector.
Keywords: performance evaluation, total quality management, analytical quality, QI-MQCSThe robustness of the healthcare system relies upon the clinical laboratory because all the clinical decisions taken on patients by physicians mainly depend upon the clinical lab reports. (1,2) About 70–75% of medical diagnoses are obtained via clinical laboratory reports, making laboratory service quality directly impact healthcare quality. (3,4) Laboratory findings should be precise as possible, also at the same instance; all laboratory operations must be reliable with timely reporting resulting in a beneficial clinical setting. (5) Negligence during laboratory operations, including processing, assessing, and reporting, can cause severe consequences, including complications, lack of adequate treatment, and delay in correct and timely diagnosis, leading to unnecessary treatment and diagnostic testing. (6–8) A clinical laboratory is a complex set of cultures that include several activity steps, and many people make it unique and saucerful. The comprehensive set of these complex operations occurring during a testing process is called the path of the workflow. (9) The workflow path in a clinical laboratory initializes with the patient and finishes with reporting and comprehending the results. In any clinical lab setting, it is presumed that mistakes will be made in this process due to the high volume of samples, the limited number of staff, and the different steps implicated in the testing process. (10,11) Errors at any stage of the total testing process (TTP) can result in inaccurate laboratory outcomes. To guarantee the quality of the results, a reliable method for determining errors within the TTP is required. (12)
The term “quality” in the healthcare context has been properly defined by the Institute of Medicine (IOM). (13) It defines “quality of care as the extent to which health services for individuals and populations increase the probability of desired health outcomes and conform with current professional knowledge.” More recently, quality has been characterized as “doing the right things for the right people, at the right time and doing them right the first time.” In recent years, quality may entail different domains; there appears to be a consensus emerging that quality involves safety, effectiveness, appropriateness, responsiveness or patient-centered care, equity or access, and efficiency.
In the context of laboratory medicine, high-quality diagnostic testing (such as for patient safety) is often achieved through the application of standardized processes. Standardization helps to guarantee the accuracy and reproducibility of test outcomes and their appropriate application to the correct patient and also helps to ensure that the results are accurate. The accreditation agencies guarantee crucial points for standardization in laboratory medicine. There are several authorized CLIA accreditation agencies like the College of American Pathologists (CAP), Joint Commission (JCIA), Accreditation Commission for Health Care, Inc (ACHC), and American Association for Laboratory Accreditation, accreditation, which significantly influences quality improvement (QI) in medical laboratory. However, the international organization of standardization ISO is a non-governmental organization that offers a general framework for all procedural sections up to reporting results. Over the years, the establishment and maturity of each agency have brought significant improvement in the medical laboratory sector. The most crucial accreditation is ISO 15189 among all others because ISO 15189 fixates more on laboratory management systems and processes, e.g., The ISO 15189 standard includes requirements linked to the entire testing process, including pre-examination (i.e., pre-analytics), examination (i.e., analytics), and post-examination (i.e., post-analytics). These requirements include developing and implementing standard operating procedures, validation processes, staff training, internal and external quality control (EQC) measures, laboratory setup, and other aspects. In contrast, the other CLIA-approved laboratory accreditation program concentrates more on technical procedures implicated in testing, e.g., policy statement, certification standards, archive standards, and adequate laboratory testing.
Several systematic analyses have been published on the quality and management of clinical laboratories, but none focus particularly on the overall QI of medical laboratories (Supplemental Table 1*). This leaves a dent in our understanding of QI in clinical laboratory settings. (14,15) Regardless of the number of QIs in a medical laboratory context, the high-quality collective QI systematic review is insufficient, which limits our understating of this field and requires further advancement of QI reporting in the clinical laboratory.
This study sought to comprehensively review and evaluate published literature on QI in clinical laboratories. The goal was to provide researchers and professionals with a thorough overview of the present knowledge on quality control (QC) and improvement in medical laboratories. Furthermore, the study sought to determine areas for potential future research and developments in the field of QI in this setting.
A systematic review is a technique for objectively summarizing prior research through a systematic and replicable process. (16) This review followed a three-stage design suggested by Tranfield et al. 2003. (16,17) During the planning stage, the choice of databases and keywords and the inclusion and exclusion criteria for selecting contextual articles were identified. The preferred reporting items for systematic reviews and Meta-analyses flow chart (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes) was employed to illustrate selecting articles for inclusion in the final sample.
To guarantee comprehensive coverage of the literature, multiple databases were applied in the bibliometric analysis. (18,19) In this research, the Web of Science (WOS) core collection and PubMed were chosen for their significance to management and medical research. Three keywords were used to determine relevant articles: “quality control” in any of its forms, terms linked to quality processes such as “quality systems,” “quality improvement,” or “quality management,” and “clinical laboratory” to narrow the focus to the healthcare sector using different databases and these keywords helped to guarantee a comprehensive search of the literature on QC and improvement in clinical laboratories. (20)
The present analysis specializes in clinical laboratory QC and improvement research published between 1981 and 2021. To be added, the publication must be a research article and be written in English, with at least a title and summary available. Conference proceedings, letters, notes, reviews, editorials, summaries, and other types of publications were removed from the analysis.
Before undertaking the study, we standardized the data to enhance the conformity of the results. We standardized the spelling of the author’s names and the formatting of journal affiliations and other data. We also revised to ensure that citations for each article were not counted multiple times when using both databases. Two authors worked independently to mitigate the risk of errors. Only articles that both reviewers agreed upon were included in the review, as displayed in Fig. 1 .