IJMB

Journal of the American Veterinary Medical Association, 2013

A ll clinicians expect that the results obtained from the diagnostic tests they perform on their patients are accurate and precise, so that correct clinical decisions can be made to manage their patients. Obtaining results that are inaccurate or imprecise can lead to incorrect diagnoses, inappropriate courses of action, and, potentially, patient harm. These expectations apply to in-clinic biochemistry analyzer systems, which have proliferated in general veterinary practice over the past decade. However, despite the popularity of these analyzers, quality-assurance programs and QC systems have been largely neglected in general veterinary practice, with most clinicians relying on manufacturers' claims and occasional calibration of equipment to ensure diagnostic test quality. Quality assurance is an implied concept inherent in every consumer' s purchase of a product or service. Many of the initial quality-assurance procedures came from the manufacturing sector and were the result of the need to produce products that were cost effective and did not fail. 1 Quality-assurance systems were then discussed and applied over time in human diagnostic laboratories beginning in the 1950s 2 and subsequently implemented in veterinary laboratories. These programs have changed and evolved along with new procedures, statistical concepts, and evaluations of system Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing

Journal of Nepal Medical Association

Introduction: Clinical laboratory holds a central position in patient care, thus, ensuring accurate laboratory test results is a necessity. Internal quality control ensures day-to-day laboratory consistency. However, unless practised, laboratory quality systems cannot be achieved. This depends on the efforts and commitment of laboratory personnel for its implementation. Hence, the aim of this study was to find out the knowledge of internal quality control for laboratory tests among laboratory personnel working in the Department of Biochemistry in a tertiary care centre. Methods: This was a descriptive cross-sectional study conducted from 1 July 2022 to 30 August 2022 after receiving ethical approval from Institutional Review Committee (Reference number: 2341/022). Semi-structured questionnaire was used to assess knowledge on internal quality control. Three non-respondents were excluded. The operational definition of the knowledge domain was set before finalizing the questionnaire. T...

Clinical Chemistry and Laboratory Medicine (CCLM)

Objectives The trueness and precision of clinical laboratory results are ensured through total quality management systems (TQM), which primarily include internal quality control (IQC) practices. However, quality practices vary globally. To understand the current global state of IQC practice and IQC management in relation to TQM the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC member countries on IQC practices and management. Methods The survey included 16 questions regarding IQC and laboratory TQM practices and was distributed to IFCC full and affiliate member countries (n=110). A total of 46 (41.8 %) responses were received from all regions except North America. Results Of the responding countries, 78.3 % (n=36) had legislative regulations or accreditation requirements governing medical laboratory quality standards. However, implementation was not mandatory in 46.7 % (n=21) ...

IP innovative publication pvt. ltd, 2019

Abstract Introduction: Laboratory bias can occur during the pre-examination, examination and post-examination stages. The appropriate laboratory practice has the great impact on health care system, more than 70% patient management mainly depend on laboratory test result. Current scenario shows huge importance of the laboratory errors and its negative impact on patient treatment outcomes. Quality improvement program main aim is to evaluate the total system performance and provide appropriate protocol to improve that performance. Therefore in this study we recorded the errors occurred in pre-examination. Aim: The aim of this study was to access the importance of quality improvement program in clinical diagnostic laboratory to reduce or eliminate the diagnostic error. Materials and Methods: The present study was conducted in King Fahad Hofuf Hospital Al-Assah (KSA) clinical biochemistry laboratory during a period of 2 years from March 2016 to June 2018. A total of 458,786 tests were performed on 147,746 outpatients and inpatients. Results: A total of 4, 58,786 tests were performed in 1, 47,746 patients during the overall study period. The overall bias was recorded 4.35%. Out of total bias pre-examination bias was 3.15%, examination error was 0.2% and post-examination bias was 1% respectively. During 2 years study period no significant increase (P= 0.9) of total examination bias were found. Conclusion: As laboratory scientist professionals, we need to acquire proper strategies to maintain the quality in diagnostic laboratory and concern with the physicians provide effective health care service to the patients. We recommend regular assessments in all the laboratories to assure the quality in the health sector.

IOSR Journal of Dental and Medical Sciences, 2016

Introduction: Quality indicators (QIs) are fundamental tools enabling users to quantify the quality of laboratory services. Pre-analytical errors account for more than 70% of the total number of laboratory errors. Objective: To quantify performancein the pre analytical phase of testing in Clinical Biochemistry Laboratory, using quality indicators and compare our results with those in the literature to assess the quality of our laboratory services.

2016

Background & Objective: The errors associated with the total testing process in laboratory, affecting clinical decision making, may occur at the pre-analytical, analytical and post-analytical phase. This study is aimed at finding out the types and frequencies of errors recorded and recommending the corrective measures in pre analytical phase, which accounts for preventable errors significantly. Materials & Methods: This was a retrospective analysis of errors observed and recorded over 3 months period in clinical biochemistry laboratory at SMIMER hospital, Surat. Data analysis was done on an average of 12680 samples collected and tested. Samples included blood, urine and other fluids. Pre-analytical errors were identified and recorded subsequent to visual inspection of the samples and corresponding request forms by laboratory staff. Results: Pre-analytical errors were classified as A) inappropriate form (28.24%), B) inappropriate sample (3.52%), C) inappropriate transport (22.16%) and D) inappropriate centrifugation (7.29%). For category A, high error rate for date and time of sample collection (99.97%), provisional diagnosis (99.92%) and physician's detail (100%) were observed. For category B, error rate for insufficient sample volume was 26.38%. For category C, error rate for date and time of sample receipt was 100%. Pre-analytical error rate was highest for samples received from outpatient department (18.37%) and for urine sample (18.61%) comparatively. Conclusion: Pre-examination errors were high at this study location. Measures aimed at reducing the same and exposure to accreditation are recommended for improved laboratory quality output.

https://www.ijhsr.org/IJHSR_Vol.11_Issue.2_Feb2021/IJHSR-Abstract.023.html, 2021

Objective: Pre-analytical errors have been the commonest source of error in the total testing process. Errors of this nature prove to be a burden for the laboratory, misleading for clinicians, disturbing for management of patient, and a serious issue for the hospital administration as sample rejection leads to loss of critical time and adds to the cost of patient care. The aim of the study is to determine the incidence and types of pre-analytical errors leading to sample rejection. Materials & Method: A prospective observational study was conducted over a period of two months in the Dept. of Laboratory Medicine in a teaching hospital for biochemistry investigations with an aim to determine the incidence and types of pre-analytical errors leading to sample rejection using six sigma metrics and to generate preventive and corrective actions to achieve higher quality laboratory reports. Sigma value for each error was identified and the defects per million (DPM) yield of the process were calculated. Results: Of the total 19,002 samples received, 401 (2.11%) were rejected due to pre-analytical problems. Level of sample rejection was unsatisfactory with a sigma metric of 3.6. A larger proportion of errors (73.3%) occurred at the time of sample collection as opposed to errors related to patient identification factors (26.6%). The commonest pre-analytical error was detected to be hemolysis (64.0%). Conclusion: Pre-analytical errors, although preventable, still remains a major cause of poor quality test results and wastage of resources. By standardization and monitoring the steps involved in obtaining a sample, the pre-analytical errors will greatly reduce. Competent administrative bodies teaming up with laboratory physicians can bring a positive change in patient care. Awareness amongst health care providers cannot be overemphasized.

IP innovative publication pvt. ltd, 2019

Abstract Introduction and Objective: In laboratory, the errors related to the total testing process, affecting clinical decision making, may occur in all the phases. Quality Indicators are fundamental tool to assess the laboratory performance. The aim of this study is to observe the error types and rates for analytical and post analytical phase inorder to assess laboratory performance and rectify them. In addition to acrreditate laboratory as per international standards, it would also help to improve patient care and safety. Materials and Methods: For a period of one year, errors were observed, recorded and analyzed at clinical Biochemistry laboratory, SMIMER, Surat by this retrospective study. Data analysis of total 907611 tests carried out on 317212 samples was done. Analytical and post analytical errors were identified; recorded and analysed taking into consideration certain related Quality Indicators. Results: For analytical phase and post analytical phase error rates recorded were 7.51% and 8.57% of total samples respectively while it was observed to be as high as 46.71% and 53.28% respectively against total errors encountered for the phases. Highest (45.9%) error rate of analytical phase error was due to tests not in conformance with External Quality Assurance - Proficiency Testing scheme in a previously treated cause. 17.52% of post analytical phase error was due to low rate of critical call outs to clinicians. No records were maintained pertaining to (1) delayed delivery of reports due to insufficient reagents, (2) critical values call out time (min) and (3) staff training events. Also the laboratory was not equipped with Laboratory Informatics System. Conclusion: Quality Indicators based high error rates warrant active intervention and strict supervision of both the phases of TTP under study. Strategic measures should be initiated to minimize the risk of errors. Ultimately it would be useful for betterment of patient care and safety. Keywords: Total testing process, Errors in analytical and post analytical phase, Quality indicators, Rectification measures, Laboratory medicine.

JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH

Introduction: The analytical phase of the total testing process is the one in which the clinical biochemist can directly intervene to improve the quality of tests reporting. The sigma metrics and Operational Process Specification (OPSpec) chart can specify to which category the laboratory belongs. Aim: To apply sigma metrics to analytical process of testing, do the root cause analysis and apply the corrective measures according to Westgard Rules to improve laboratory performance towards the quality assurances. Materials and Methods: This was a retrospective-prospective study carried out in a clinical laboratory of MKCG Medical College and Hospital, Berhampur, Odisha, India, from July 2020 to March 2021. A retrospective secondary data analysis of six months duration was carried out in a clinical chemistry laboratory with a follow-up prospective study for three months. During this period, 16 analytes were tabulated to analyse the Internal Quality Control (IQC). External Quality Contro...

Asian Journal of Medical Sciences

Background: Pre-analytical phase is the major source of errors in a clinical biochemistry laboratory. Aims and Objectives: The study aims to determine the quality of laboratory performance in the pre-analytical phase using quality indicators (QI) specified by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Laboratory Errors and Patient Safety and sigma metric scale for both the inpatient and outpatient samples received in the clinical biochemistry laboratory. Materials and Methods: All samples and requisition forms received in the laboratory were examined before analysis. The percentages of the seven QI were calculated. The frequency, percentage, and defects per million rates of each pre-analytical error were calculated. Sigma value was obtained using an online sigma calculator. The laboratory performance was then categorized by the IFCC-based performance levels and sigma-based values. Results: Out of 30,546 samples received during ...