A study of pre-analytical errors in the clinical biochemistry laboratory at Victoria hospital, BMCRI, Bangalore

To categorize and calculate the percentage error of pre-analytical variables in the clinical biochemistry laboratory. Prospective observational study conducted for two months with documenting the frequency and type of pre-analytical errors occurring in venous samples. The total errors recorded were 1.31%. Insufficient volume followed by haemolysis amounted to a major proportion of errors. Continuous pre-analytical phase evaluation and taking corrective measures to make this phase error-free, have to be done.

The Implementation of Clinical Laboratory Quality Indicators in the Era of the COVID-19 Pandemic

The use of quality indicators (QIs) and risk assessment are valuable tools for maintaining the quality of laboratory tests. Both are requirements of ISO 15189: 2012 and are usually based on standard statistical and empirical data. In this chapter, the authors focus on evaluating clinical laboratory quality indicators in the era of the COVID-19 pandemic. The goal is to pose and discuss, based on the authors' experience, the quality evaluation and risk assessment through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. QIs were evaluated using the Six Sigma method. Moreover, FMEA risk analysis was performed, and the degree of risk priority was assessed using the Pareto method. The results show that in the analytical phase, the laboratory's performance is satisfactory, while the pre-and post-analytical phases need further preventive/corrective actions.

Assessment of Failure Risks in Laboratories During the Pandemic

Clinical laboratories produce test results that support the diagnosis, prognosis, and patient treatment. Test results must be relevant, accurate, and reliable for patient care. International bibliographic data estimate that approximately 62.0% of the errors made in clinical laboratories are due to errors during the pre-analytical stage. This chapter presents a failure modes and effects analysis (FMEA) to analyze potential failure risks within the pre-analytical phase and classify them according to severity and likelihood. FMEA allows molecular laboratories to lower costs and drive better outcomes through high-quality nucleic acid extraction, sensitive detection, and accurate quantification. RT-PCR technology continues to be the gold standard for the clinical detection of SARS-CoV-2 RNA in individuals suspected of COVID-19. It is essential to use highly sensitive assays to detect active infections and reduce the likelihood of false-negative results.

Checklist to select contract Research Organization for early phase Bioavailability/Bioequivalence Clinical Studies in Healthy Adult Human Volunteers

Nowadays health agencies of regulated markets are becoming stringent regarding the bio-studies. So clinical/contract research organization (CRO) need to be selected carefully after their detailed assessment. As per requirement of bio-study CRO should be assessed with the study specific checklist of questions before awarding the bio-study. Questions related to various services of study like: Clinic phase, analytical phase, Pharmacokinetic and statistical phase, ethics approval, QA/QC, record handing etc. and related to CRO capabilities are discussed here with their relevance to conclude the abilities of CRO for successful execution of bio-study. Hence, this paper focuses all possible questions which need to be assessed before selection of CRO mainly for Bioavailability/Bioequivalence (BABE) study in healthy adult volunteers. Properly selected CRO will help for smooth execution of study and quality report and subsequently, hassle-free approval of dossier submitted to regulatory agency.

Establishing pre-analytical requirements and maximizing peptide recovery in the analytical phase for mass spectrometric quantification of amyloid-β peptides 1–42 and 1–40 in CSF

Objectives Amyloid-β (Aβ) peptides in cerebrospinal fluid (CSF), including Aβ42 (residues 1–42) and Aβ40 (residues 1–40), are utilized as biomarkers in the diagnostic workup of Alzheimer’s disease. Careful consideration has been given to the pre-analytical and analytical factors associated with measurement of these peptides via immunoassays; however, far less information is available for mass spectrometric methods. As such, we performed a comprehensive evaluation of pre-analytical and analytical factors specific to Aβ quantification using mass spectrometry. Methods Using our quantitative mass spectrometry assay for Aβ42 and Aβ40 in CSF, we investigated the potential for interference from hemolysate, bilirubin, lipids, and anti-Aβ-antibodies. We also optimized the composition of the calibrator surrogate matrix and Aβ recovery during and after solid phase extraction (SPE). Results There was no interreference observed with total protein up to 12 g/L, hemolysate up to 10% (v/v), bilirubin up to 0.5% (v/v), intralipid up to 1% (v/v), or anti-Aβ-antibodies at expected therapeutic concentrations. For hemolysate, bilirubin and lipids, visual CSF contamination thresholds were established. In the analytical phase, Aβ recovery was increased by ∼50% via SPE solvent modifications and by over 150% via modification of the SPE collection plate, which also extended analyte stability in the autosampler. Conclusions Attention to mass spectrometric-specific pre-analytical and analytical considerations improved analytical sensitivity and reproducibility, as well as, established CSF specimen acceptance and rejection criteria for use by the clinical laboratory.

Future challenge on probiotics uses from fermented milk on the endocrine disorder in human

More than fifty different probiotics have been identified with different structures and modes of action. This study aimed to offer an overview of the evidence on the clinical microbiology activity of the probiotics group derived from fermented milk. We conducted a framework for reporting probiotics activity using the MICRO (Microbiology Investigation Criteria for Reporting Objectively) checklist. Two electronic databases (Pubmed and EMBASE) were used to conduct this study. The initial search discovered 22 references (Pubmed 8 and EMBASE 16). We included human study, clinical trial study, English written, and full articles in this review. Of all these original articles, only six articles were included in the review. These included articles reported the testing phase on the pre-analytical and analytical phases. This review found that probiotics such as Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp lactis BB-12 are beneficial in humans’ endocrine disorder therapy. This activity includes maintaining serum insulin levels in pregnant women and reducing weight in healthy obese men and women. Thus, probiotics, with their several features, may advance their candidacy as therapeutic agents. However, there is more effort to do. For example, finishing the analytical phase, especially on quality assurance and avoiding bias.

A Customized Tool of Incident Reporting for the Detection of Nonconformances at a Single IVF Center: Development, Application, and Efficacy

In IVF centers, risk assessment applies to complex processes potentially accounting for adverse events and reactions that undergo well-established legislative oversight, and nonconformances (NCs), that lack of established tracking systems. NCs account for an integral part of the quality management system, so that their documentation is important. The study evaluated the performance of a customized tool for incident reporting (IR) to track and characterize NCs in a public IVF center. IVF operators used the IVF-customized IR tool to record NCs at the moment of detection or subsequently, and in a time-saving manner during daily practice. From February 2015 to February 2020, 635 NCs were reported leading to the implementation of 10 operative instructions and 3 procedures with corrective strategies. NCs referred to the IVF laboratory were the most numerically meaningful (454/635, 71.5%). The majority (352/454, 77.5%) accounted for NCs related to procedures of sample management; considering the analytical phase as all the procedures involving sample treatment, the intra-analytical phase (176/352, 50%) has always been more subject to NCs compared to pre- (102/352, 29%) and postanalytical (74/352, 21%) phases. Our experience showed that the IVF-customized IR tool is suitable for application in IVF with regard to NC reports and documentation, as it identifies the most vulnerable steps of treatments. It manages NCs over the time, but it requires a contextual understanding of its application in order to avoid NC underestimates that could negatively influence the safety and quality aspects of IVF treatments.

A Blumgart-Anastomosis Based Half-Invagination Pancreaticoenterostomy With Better Applicability to Laparoscopy and Lower Incidence of Pancreatic Leakage

Background The Blumgart anastomosis has been established as one of the safest anastomoses for pancreas remnant reconstruction, with low rates of postoperative pancreatic fistula (POPF) and postoperative complications. However, how to make laparoscopic pancreaticoenterostomy easier and safer is still a subject to be discussed. Methods Data of patients undergoing laparoscopic pancreaticoduodenectomy from April 2014 to December 2019 were retrospectively analyzed. Results 20 cases of half-invagination anastomosis (Group HI) and 26 cases of Cattell-warren anastomosis (Group CW) were included. Intraoperative blood loss, Operative time and Postoperative drainage tube placement time of Group HI was significantly less than those of Group CW. Patients of Clavien-Dindo grade III and above in Group HI was significantly less than Control Group. Group Incidence of POPF in Group HI was significantly lower than that in Group CW. No high-risk group emerged during Fistula risk score analytical phase, and the highest risk of moderate-risk group was pancreatic leakage. Respectively, incidence of pancreatic leakage in Group HI and Group CW was 7.7% and 46.67%, while incidence of Group HI was significantly lower than that in the Group CW. Conclusions The Blumgart-anastomosis based half-invagination pancreaticoenterostomy with better applicability to laparoscopy can effectively reduce the incidence of postoperative pancreatic leakage.

PRACTICALAPPLICATION OF SIX SIGMA DMAIC METHODOLOGY IN EVALUATION OF PRE-ANALYTICAL QUALITY INDICATORS IN LABORATORY SETTINGS

The Six Sigma is a global management methodology that empowers clinical laboratories by better understanding of the quality in their laboratories and helps in improving quality and subsequently reducing laboratory costs. The objective of this prospective study was to practically apply Six Sigma on pre-analytical quality indicators i.e. pre-analytical phase errors of “Total Testing Process” in laboratory at PGIMER Satellite Centre, Sangrur (Punjab). In this study Six Sigma DMAIC ( Dene, Measure, Analyse, Improvement and Control) methodology was applied on routine Outpatient Department (OPD) samples received in hematology and biochemistry laboratory from May, 2020 to July, 2020 after institutional ethical committee permission. Pre-analytical phase errors were taken as pre-analytical quality indicators and were broadly classied in to requisition form and sampling errors. Sigma values and frequencies were calculated using Westgard formula present online at (www. westgard.com > six sigma calculators) for pre-analytical phase errors. After that Improvement phase of DMAIC methodology was done by training of laboratory technicians or personell involved in pre-analytical phase by audio-visual aids. Six Sigma values were calculated again after improvement phase. A total of 787 requisition forms and 1105 samples were studied before improvement phase and 889 requisition forms and 1400 samples were studied after improvement phase. Before improvement phase, overall requisition form errors were working at 2.9 sigma and sampling process was working at 3.1 sigma but after improvement phase, requisition form errors were working at 3.3 sigma and sampling process was working at 3.5 sigma. Before and after improvement phase the sample rejection rate in laboratory improved from 1.90% to 0.93% highlighting the benecial concept of six sigma in laboratory in pre-analytical phase leading to increased clinicians and patients'satisfaction and prevents unusual delaying of reports.

Assessing Quality Indicators for the COVID-19 RTPCR in a Molecular Laboratory

A quality indicator is a tool that enables the user to quantify the quality of a selected aspect of care by comparing it with a set benchmark. The objective of this study was to review quality indicators for COVID-19 molecular testing at S.S. Institute of Medical Sciences and Research Centre and to compare with the predefined quality indicators in order to improve the performance of the molecular laboratory and to initiate the corrective and preventive measures. Over the period of one year we assessed different quality indicators collected from the molecular laboratory of a tertiary care hospital in Central Karnataka which has processed 36000 throat swabs for the diagnosis of COVID-19. Twelve quality indicators under pre-analytical, analytical and post analytical stage were assessed for the quality by referring it with the select criteria. Missing test request form / specimen (1.36/1000) was the most common inconsistency observed during the assessment of pre-analytical indicators followed by specimen inadequacy (0.194/1000), duplicate specimen referral forms (SRF) generated in ICMR portal (0.277/1000) and color change in the viral transport medium. In analytical phase, non-conformity with QC was seen in 2.83/1000 samples. In post analytical phase, excessive turnaround time was seen in 0.75/1000 samples followed by revised reports due to transcription error (0.38/1000) and duplicate reports (0.13/1000). The results of assessment of quality indicators in the molecular laboratory explicitly supports that laboratory could keep the incidence of errors to the minimum level by following proper corrective and preventive measures. Thus, catering quality laboratory services during devastated COVID pandemic year.