Implementation of a Risk Management Model to Identify and Prevent Preanalytical Errors in Medical Laboratories (original) (raw)
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Identifying Errors Involving Clinical Laboratory: A 1 Year Study
International Journal of Health Sciences and Research, 2014
OBJECTIVE: It is a known fact that in modern day, laboratory diagnosis is the cornerstone of health care system. It is seen that pre and post analytical phases in a testing cycle contribute majority of the laboratory errors. This study was conducted to recognize the errors that occurs in the three phases of the testing cycle and for improvement in the areas where required. METHODS: The present study was conducted during the period 2012-13 in the central laboratory in M.G.M. Hospital and Medical College. During a 12 month period 97,618 samples were monitored for major pre analytical, analytical and post analytical errors RESULTS: From the study it was documented that total errors were 14,149 of which pre-analytical were 9,867 (69.7%), analytical were 751 (5.3%) and post-analytical were 3,531 (25%). CONCLUSION: Our study showed that most of the errors pre-analytical either during sampling or preparation for analysis. The continuous improvement of the phases of testing cycle seems to b...
Biochemia Medica
Introduction: The presence of errors in the preanalytical phase is a thoroughly studied problem. A strategy to increase their source detection might be the use of the Healthcare Failure Mode and Effects Analysis (HFMEA). The aim of this study is improving the capacity of identifying sources of error during the preanalytical period in samples provided by primary care clinics (PCC) with the use of the HFMEA as a tool in the laboratories of two tertiary hospitals. Materials and methods: A HFMEA was carried out in each laboratory, by means of the creation of groups of experts with similar characteristics (doctors and nurses from PCC and laboratory, support staff, and laboratory technicians). The Risk Priority Number (RPN) was calculated. Results: Items with elevated RPN were presented in both centers. The highest RPN were in LAB1: "two request notes for a patient" and "the segregation of oncology urgent samples" (both with 384), while in LAB2 was "the lack of information in patients with oral glucose overload test" (RPN 576). Considering the different steps in the preanalytical phase, LAB1 paid attention in sampling, samples reception and the programming in the Laboratory Information System, while LAB2 paid attention in the request form, the appointment system, sampling procedures, transport and reception. Conclusion: The laboratories prioritized the problems differently. However, both centers offer solutions to these possible sources of error. We proposed improvement actions that can be resolved easily, with a low cost for the system, mainly to schedule a specific formative programme and a deep revision of the existing protocols.
Introduction: Laboratory tests are important to diagnose the diseases, to monitor the progress and to see the response to the treatment of patients. Pre-analytical variables include specimen collection, timing, transportation & handling of the sample processing. Methodology: The data were obtained from Biochemistry Central Laboratory, Descriptive Cross Sectional study design was used and data were entered in excel and analysed by using Epi-info Software version 3.4.3. Descriptive statistics like frequencies and percentages were calculated. Results: The total number of samples received by the laboratory for a period of two months was 7333 and analyzed for pre-analytical errors in those samples. The most common pre-analytical error was wrong ordering which is 16.73% & followed by hemolysed sample, insufficient quantity, mixed with saline, empty tubes and the least one was mismatched samples. Conclusion: Quality improvement in the pre-analytical phase helps laboratories to deliver more timely and accurate test results for clinicians.
Pre-analytical errors in the clinical laboratory and how to minimize them
Since evidence based medicine (EBM) is now become the main principle guiding clinical practice and is being followed universally the role of laboratory medicine in EBM needs not to be over-emphasized. So it is the need of the hour to ensure that the best evidence on testing is made available through the help of the laboratory to the clinician. This would result in making the best decision based on test results which would lead to increased probability of improved health outcomes. So it is necessary for the laboratory to maintain the strictest quality possible. Here we would see the steps of pre-analytical phase and the various points at which error can arise and how to mitigate them. The present study was carried out in our hospital central laboratory and data were collected and analyzed. Pre-analytical phase is most important in testing process and involves variables that are not under the control of the laboratory. So much care needs to be taken to deeply scrutinize this step of analysis and keep a tab on errors arising in it.
Preanalytic Error Rates for the Central Laboratory of a Large-scale Public Hospital in Turkey
Journal of Pharmacy and Pharmacology 4 (2016) 318-321, 2016
The pre and post analytical phase in a testing cycle contributes up to 93% of total laboratory errors. However, pre-analytical phase is primarily responsible for errors. Hence, it is of precise importance for the laboratory to study error occurrence rates during the testing cycle and implement a quality improvement plan to release an accurate result. The present study was conducted during the period Jan-Nov 2014 in the Central Clinical Lab in Osmaniye State Hospital, Turkey. During period of 11 months, 626897 samples were monitored for major preanalytical problems at the receiving counter of the Central Clinical Laboratory. Among all preanalytic laboratory errors, 35.4% of the errors were associated with clotted sample, 25.5% errors with inadequate sample, and 25.3% errors with hemolysed sample in the laboratory. Assessment considering the departments showed that emergency unit had the highest error rates (hemolysis: 52.5%, lipemic: 42.9%, damaged: 34.6%, clotted: 34.2%, inadequate: 26.8%, wrong material: 17.6%, wrong barcode: 16.7%). There was significant difference among the departments in terms of preanalytic errors (p < 0.001). Based on these observations, major preanalytic errors are of great concern and needs corrective approach via proper educational programs to related personals. If this area is ignored, that can lead to negative patient outcome. However, a better specimen quality and patient satisfaction are achieved with the high quality personal-based education regarding pre-analytical errors.
Effect of Pre-Analytical Errors in Laboratory Testing Facilities: the Way Forward
Texila International Journal of Public Health, 2023
Pre-analytical errors contribute a significant proportion of errors of all major sources of mistakes made in laboratory testing processes and are responsible for several patient safety risks. It contributes to wrong therapeutic interventions, irrelevant follow up laboratory investigations and diagnostic delays, which impact negatively on the economy and laboratory effectiveness of health services. Pre-analytical phase is directly related to the procedure of specimen collection and is mostly out of the direct control of the laboratory; further, most pre-analytical errors are related to human factors. The aim of the study is to determine the nature and the occurrence of pre-analytical errors and recommendations on possible measures to reduce these errors. A total of 300 specimens were randomly sampled from a study population of 600 patients and analyzed for pre-analytical errors. One hundred and eighty-four (184) samples were found unsuitable for further processing accounting for 1.9% of all samples analyzed for pre-analytical errors and sample rejection. Rejections were due to following reasons: hemolysis 21.7 % (40) wrong tubes 19 % (35); clotted blood 17% (32); inappropriate timing of collection 15.7% (29); mislabeled specimens 15.2% (28); insufficient specimen quantity 6.5 % (12) and lipemic specimens 4.3% (8). The overall percentage of rejection was 1.9% and the substantial numbers of the rejected specimens were re-tested. Efforts aimed to reduce the rates of rejected samples can improve the quality of laboratory-based health care response.
Quality Management of the Pre-Analytical Phase Errors: Monitoring and Way Forward
Texila International Journal of Public Health, 2023
Inadequate quality management during laboratory analysis can increase errors, specimen rejection, and economic resources wastages. A laboratory quality management system (QMS) helps to streamline and coordinate all the processes and operations within the lab, ensuring that each step is well planned, controlled, and correctly performed. Quality management ensures that results are accurate, reliable, and obtained under a traceable process that can easily detect errors. The study aimed to investigate quality practice among laboratory workers during pre-analytical phase activities. Unexpected deviation from quality procedures consequently compromise laboratory test results, leading to patient mismanagement and patient safety risks. Analysis of results showed that 97.1% (340 respondents) were knowledgeable on quality management of pre-analytical phase, and 2.9% (10 respondents) were not. 99.1% (347respondents) agreed to availability of quality management materials and 0.9% (3 respondents) had no resources. 4.6% (16 respondents) do not practice quality management system at pre-analytical phase and 94.5% (334 respondents) practiced quality improvements. 3.4% (12 respondents) agreed that quality improvement is the responsibility of phlebotomist and field staff. 96.6% (338 respondents) agreed that quality management is the responsibility of everyone at the facility. There was maximum knowledge of quality management at the facility. Availability of quality management resources at the facility was standard. The practice of quality management was below standard. Facility requires training in quality management. It is recommended that quality management system be integrated into the curriculum of school of health technology to guide graduates at work.
Approach to pre-analytical errors in a public health laboratory
Turkish Journal of Biochemistry, 2017
Background and objective:We aimed to investigate the effect of “training about the pre-analytical phase” and “technological arrangements in laboratory information systems (LISs) and tube barcoding system”, on decreasing PEs.Materials and methods:PEs in 2013 and 2014 were obtained from the LIS retrospectively in order to evaluate the effect of improvements. Ten quality indicators (QIs) described for pre-analytical phase were calculated. We compared QIs of the “improved year” with the past year. Four quality specification criteria were defined as “unacceptable”, “minimum”, “desirable” and “optimum” for each quality indicator.Results:There was a reduction in all types of PEs related to the improvement strategies. When QIs were considered as quality specifications (QSs), QI-14 (number of samples damaged in transport) and QI-16 (samples improperly stored) were “unacceptable”, QI-8 (samples lost-not received) and QI-12 (samples with insufficient sample volume) were “minimum” and QI-9 (sam...
International Journal of Emerging Trends in Health Sciences, 2023
The clinical laboratory is an important stakeholder in the patient management process with a direct impact on patient care by providing evidence and data for diagnosis and treatment. Identifying reliable quality indicators in clinical laboratories is an important step in enabling users to measure the quality of laboratory service. Any error in the pre-analytical process affects other processes and jeopardizes patient safety. This study aimed to examine the number of specimen rejections in clinical laboratories, their reasons, and their range according to the departments. The study was a descriptive retrospective study. The population of the study consisted of samples rejected from the Biochemistry Laboratory of a teaching and research hospital in 2021. Data were analyzed using percentage and frequency analysis. The study recommends that practices to minimize errors in the pre-analytical process should be carried out urgently by the management and a training plan for sample collection should established.
Management of errors in a clinical laboratory
Clinical laboratories focus their attention on quality control methods. However, such quality control cannot be assured by merely focusing on analytical aspects as both pre-analytical and post-analytical phases must be considered as well. This article analyses the causes of errors occurring in clinical laboratories by evaluating literature data and statistics from the " AMES " poly-diagnostic centre in Naples.