Clinical Biochemistry Laboratory Research Articles

A Retrospective Database Analysis to Investigate if Electrolytes in Venous Blood are Equivalent to the Levels in Arterial Blood.

In a critically ill patient, when an arterial blood sample is processed on an arterial blood gas (ABG) analyzer, it also measures electrolytes apart from analyzing the blood gases. The turnaround time for ABG analysis is way too less compared to the conventional electrolyte analysis with a serum sample. This study intends to investigate whether values of electrolytes estimated in arterial blood can substitute the routinely practiced method. This is a retrospective cross-sectional study. The source of data is patients' reports of serum electrolytes and ABG analysis from the Clinical Biochemistry laboratory, CIMS Teaching Hospital, Chamarajanagar between January and June 2021. The electrolytes report of 200 patients from whom both arterial and venous blood samples were sent to the Clinical Biochemistry laboratory on the same day and at the same time for analysis were selected. The data was compiled, compared, and correlated using a suitable statistical tool. The mean and standard deviation of sodium (135.62 ± 5.20 in venous vs 134.08 ± 8.49 in arterial blood), potassium (4.20 ± 0.64 vs 3.80 ± 0.75), and chloride (102.28 ± 4.99 vs 96.33 ± 8.11) were observed. However, when the concordance correlation coefficient and Bland-Altman plot analysis were made there was no agreement between electrolytes analyzed on serum in an autoanalyzer with that of ABG analyzer. We conclude that the electrolytes measured by a conventional autoanalyzer on a serum sample cannot be replaced by values analyzed on a blood gas analyzer. Devaki RN, Kasargod P, Roopa Urs AN, Chandrika N. A Retrospective Database Analysis to Investigate if Electrolytes in Venous Blood are Equivalent to the Levels in Arterial Blood. Indian J Crit Care Med 2024;28(5):442-446.

Label-free voltammetric screening of human blood serum

The current study presents a comprehensive voltammetric investigation into the direct analysis of untreated human blood serum in a phosphate buffer at an unmodified, graphite electrode by means of voltammetry. By employing advanced square-wave voltammetry at an edge plane pyrolytic graphite electrode (EPPGE), the basic principles were established for developing a sensitive, fast, simple, and label-free method for the simultaneous screening of uric acid, bilirubin, and albumin analytes that are present in human blood serum and are quite essential for rapid medical diagnostics. The electrochemical protocol utilizes the specific structural patterns of the EPPGE, the inherent redox and adsorption properties of the analysed analytes, and the sensitivity and rapidity of the employed advanced voltammetric technique. The methodology has been successfully applied for quantification of the considered analytes in a series of samples of human blood serum and was compared with the standard methods used in a clinical biochemical laboratory. This novel method represents a significant advancement towards the development of point-of-care devices aimed at swiftly and simultaneously quantifying uric acid, bilirubin, and albumin levels in human serum.

Design of an Insulin Tracer Protein-Based Biosensor for Insulin Determination

Aim: The regulation of blood glucose levels is controlled by insulin, which is produced by the pancreatic beta system. Inadequate synthesis of beta insulin, results in elevated glucose levels, a condition known as diabetes, which can lead to various chronic health issues. In recent times, the diagnosis of diabetes, particularly type 1, has shifted towards the direct measurement of insulin levels. To facilitate this, an immunosensor was created to enable rapid and sensitive examination of insulin levels, with the goal of improving the quality for life for diabetic patients. Material and Method: For this purpose, an insulin tracer protein based biosensor was designed for the determination of insulin at all solutions. For determination of insulin, electrobiochemical analyses were performed. Optimisation and characterisation studies were performed using differential pulse voltammetry. The performance of bioelectrochemical system was analysed by Receiver Operating Characteristic method. Results: The insulin biosensor cyclic woltammogram was obtained between -0,1 and 0,6 V potantial. At 0,45 V was found as the anodic peak side for determination the insulin. Optimisation and characterisation studies performed at 0,45 V with differential pulse voltammetry. Conclusion: The study successfully identified stable and easy-to-use insulin concentrations, indicating the potential of the newly developed immunosensor for applications in clinical biochemistry laboratories.

Internal quality control in a clinical biochemistry laboratory: Management of non-conformities on the general chemistry automate DXC800

Internal quality control in a clinical biochemistry laboratory: Management of non-conformities on the general chemistry automate DXC800

Application of the six sigma approach in the clinical biochemistry laboratory

Application of the six sigma approach in the clinical biochemistry laboratory

Internal quality control in a clinical biochemistry laboratory: Management of non-conformities on the general chemistry automate DxC800

Internal quality control in a clinical biochemistry laboratory: Management of non-conformities on the general chemistry automate DxC800

Critical test result management at Danish hospital laboratories: a national survey

Critical test results in clinical laboratories are crucial for timely patient care, serving as indicators of potentially life-threatening conditions. Despite their importance, a notable heterogeneity in management practices exists globally. This study investigates the current practices of managing critical results at Danish clinical biochemistry laboratories and identifies areas prone for improvement. A comprehensive online survey was distributed to all 21 Danish clinical biochemistry laboratories regarding their critical result management, including documentation practices, critical limit selection, and quality assurance measures. A total of 17 laboratories (81%) responded. The answers revealed a generally uniform approach to managing critical results, with all laboratories having 24-h reporting, local instructions and using the telephone as communication channel. However, variations were noted in documentation practices and critical limit selection. Notably, 23.5% of the laboratories reported that one out of every ten critical results was not reported, indicating a significant risk of delayed critical results. This is further complicated by the limited use of predefined timeframes for reporting and also, only few laboratories actively monitored response times. The findings emphasize the need for more standardized documentation and evaluation practices to align with international standards and to enhance patient safety. While the laboratories showed a commitment to standardized procedures, the study emphasizes the necessity of a National or Nordic guideline to supplement the ISO 15189:2022. This study is a step towards optimizing critical result management, not only in Danish clinical biochemistry laboratories but also across various laboratory specialties, thereby improving overall laboratory quality, efficiency, and patient safety.

Pre-Analytical Error in Biochemistry Laboratory

An observational study was done for a period of 6 months from 1st January, 2023 to 30th June, 2023 in the clinical biochemistry laboratory at GCS Medical College, Hospital and Research Centre. The study delved into pre-analytical errors within clinical biochemistry laboratories, focusing on error types, their prevalence, and potential impact. The study aimed to identify and quantify errors occurring in the pre-analytical phase, spanning from sample collection to report generation. Among the recorded errors (n=50), the most frequent was insufficient sample volume, signifying a pressing concern. Another prevalent error was Tests Not Mentioned or Add-on Testing, accounting for 26% of all errors, potentially disrupting workflow. The research also highlighted additional errors, including hemolysis, clotted samples, contamination from infusion routes, and lipemic samples. The study underscored the significance of addressing these errors to ensure accurate and reliable test results, thereby enhancing patient care. Overall, it provided valuable insights into the landscape of pre-analytical errors in clinical biochemistry, emphasizing the need for improved procedures, enhanced training, and effective communication to enhance the quality and precision of laboratory testing and, ultimately, patient care.

SIX SIGMA METRICS: INDICATOR OF QUALITY ASSURANCE FOR CLINICAL BIOCHEMSITRY

Introduction: In present scenario Quality is the important aspect of laboratory practices. Mostly internal and external quality control are utilized to maintain quality in laboratory. Quality assurance of laboratory services is the need of present time in health care which require Quality Planning, Quality Control (QC), Quality Assessment (QA) and Quality Improvement . Aims & Objectives: 1. To quantify the defects and errors in analytical phase of laboratory testing by sigma metrics and to represent the calculated sigma value. 2. Application of six sigma test in laboratory with the IQC and EQAS to maintain quality laboratory services. Methodology: Study was conducted at Clinical Biochemistry Laboratory, GMC Akola. We run IQC samples on daily basis and EQAS samples are running on monthly basis. Retrospectively we utilized data of IQC and EQAS from January to October 2023 for 16 Biochemical Analytes. Sigma metrics for each parameter was calculated. Result: The sigma metrics for IQC indicated that 1 out of 16 analytes qualified six sigma quality performance. Of these 15 analytes performance with sigma metrics was beteween three and six. We found different sigma value like more than6 for only HDL cholesterol and more than 3 for Amylase, Total Bilirunbin, Creatinine, Cholesterol, Glucose, Phosphorus, total Protein , SGPT , TG, UA, Urea, SGOT, which is among the acceptable range of performance. Conclusion: In our study sigma value was highest for HDL cholesterol and other 15 analytes show sigma value between 3 to 6 which is acceptable range. Sigma analysis is a continuous procedure and by taking the help of method decision chart we can improve on decision on making in clinical chemistry laboratory regarding optimising QC procedure.

Development and Optimization of a SPME-GC-FID Method for Ethanol Detection

A solid-phase microextraction (SPME) injection gas chromatography was validated with the flame ionization detection method (GC-FID) using a capillary column to detect ethanol. The method was used to determine ethanol in fluids with biomedical, clinical, and forensic importance, including water, phosphate-buffered saline (PBS), and artificial sweat. The strategy produced good peak resolution and showed a linear correlation between the concentration and peak areas for ethanol in all matrices. The inter- and intra-day precisions of the method were below 15.5% and 6.5%, respectively, varying according to the matrix. The method achieved detection limits below 1.3 mg/L, varying according to the matrix. Lower limits were obtained for the aqueous solution (0.22 mg/L), followed by the PBS solution (0.96 mg/L), and finally, the sweat solution (1.29 mg/L). This method is easy to perform and suitable for use in routine clinical biochemistry and forensic laboratories, allowing ethanol detection at lower concentrations using lower temperature and time of extraction, when compared with other studies.

Comparative and stability study of glucose concentrations measured in both sodium fluoride and serum separator tubes

IntroductionSodium fluoride/potassium oxalate (NaF/KOx) tubes has been regarded as the gold-standard tubes for glucose analysis. Even though their ineffectiveness in immediately inhibiting glycolysis has been reported in several studies especially in the first 1–4h, they are still used in our clinical biochemistry laboratory for glucose measurement. However, in its absence, only serum separator tubes are employed for glucose measurement. We aim to determine whether serum separator tubes (SSTs) can replace NaF/KOx tubes for laboratory measurement of blood glucose and to assess the stability of glucose concentrations for 3 days period. Methods and findingsNaF/KOx tube type was the reference method while SSTs type was the candidate method for glucose measurement. A total of 50 paired samples collected separately in NaF/KOx tubes and SSTs from healthy adult participants in the Gambia Adults Reference Intervals Study (GARIS) project were used as the project sample size. Following blood collection and separation, the glucose concentration was measured within 2 h, and at 24h, 42h and 72h time-points. Our data analysis showed no significant difference in the mean glucose concentrations between the reference tube and candidate tube types (Mean difference = 0.06 mmol/L; P = 0.38) recorded in the different timepoints. Using growth trajectory and mixed effects model, the study data further showed no significant change in the glucose concentrations (p = 0.25) for three days period. ConclusionsThe study confirms that SSTs can produce similar glucose results when employed in the absence of NaF/KOx tubes. Besides, the glucose concentrations were stable in both tubes for three days when the samples were separated within 2 h and refrigerated in 2–8°C.

Analysis of SARS-CoV-2 antibody seroprevalence in Northern Ireland during 2020–2021

BackgroundWith the spread of SARS-CoV-2 impacting upon public health directly and socioeconomically, further information was required to inform policy decisions designed to limit virus spread during the pandemic. This study sought to contribute to serosurveillance work within Northern Ireland to track SARS-CoV-2 progression and guide health strategy. MethodsSera/plasma samples from clinical biochemistry laboratories were analysed for anti-SARS-CoV-2 antibodies. Samples were assessed using an Elecsys anti-SARS-CoV-2 or anti-SARS-CoV-2 S ECLIA (Roche) on an automated cobas e 801 analyser. Samples were also assessed via an anti-SARS-CoV-2 ELISA (Euroimmun). A subset of samples assessed via the Elecsys anti-SARS-CoV-2 ECLIA were subsequently analysed in an ACE2 pseudoneutralisation assay using a V-PLEX SARS-CoV-2 Panel 7 for IgG and ACE2 (Meso Scale Diagnostics). ResultsAcross three testing rounds (June–July 2020, November–December 2020 and June–July 2021 (rounds 1–3 respectively)), 4844 residual sera/plasma specimens were assayed for anti-SARS-CoV-2 antibodies. Seropositivity rates increased across the study, peaking at 11.6 % (95 % CI 10.4 %–13.0 %) during round 3. Varying trends in SARS-CoV-2 seropositivity were noted based on demographic factors. For instance, highest rates of seropositivity shifted from older to younger demographics across the study period. In round 3, Alpha (B.1.1.7) variant neutralising antibodies were most frequently detected across age groups, with median concentration of anti-spike protein antibodies elevated in 50–69 year olds and anti-S1 RBD antibodies elevated in 70+ year olds, relative to other age groups. ConclusionsWith seropositivity rates of <15 % across the assessment period, it can be concluded that the significant proportion of the Northern Ireland population had not yet naturally contracted the virus by mid-2021.

The Evaluation of the Quality Performance of Biochemical Analytes in Clinical Biochemistry Laboratory Using Six Sigma Matrices.

Introduction This study was conducted to assess the analytical performance of biochemical tests using Six Sigma methodology and to assess the underlying causes of unsatisfied performance ofanalytes with a sigma value of less than 4 using quality goal index (QGI) and root cause analysis (RCA). Methodology Daily data for internal quality control (IQC) for both level 1 (L1) and level 2 (L2) and monthly data for external quality assessment for a period of six months were recorded. The coefficient of variation (CV), bias, and total allowable error (TEa) were calculated to analyze the sigma (σ) values for 19 biochemical analytes. Quality goal index (QGI) analysis was done to analyze impressions and inaccuracies in analyte performance having a sigma value of less than 4. Root cause analysis (RCA) was done to evaluate the possible causes that can improve quality performance. Results Creatinine and high-density lipoprotein (HDL) had sigma metrics of ≤2.0, and chloride, aspartate aminotransferase (AST), and alkaline phosphatase (ALP) had sigma values between 2 and 3. Glucose, total protein (TP), phosphate (Phos), and potassium had sigma values between 4 and 5 in level 1 QC. Sigma grading for level 2 quality control (QC) also gave similar results. For analytes with σ < 4, QGI analysis exposed inaccuracy or imprecision issues and identified errors such as the reconstitution of IQC, storage temperature, and air bubbles while processing the QC, being common causes of poor performance. Conclusion Six Sigma approach is helpful for quality assurance and identifying areas for improvement.Assessing Six Sigma metrics should be a routine practice to decide the frequency of QC run and to detect errors in analysis.

The current status of lipoprotein (a) measurement in clinical biochemistry laboratories in the UK: Results of a 2021 national survey.

Lipoprotein(a) (Lp(a)) is now established as a causal risk factor for cardiovascular disease (CVD) and accurate laboratory measurement is of pivotal importance in reducing Lp(a) associated risk. The consensus statement by HEART UK in 2019 included recommendations to improve standardisation of clinical laboratory measurement and reporting of Lp(a). A 16 question, electronic audit survey was circulated to 190 accredited clinical biochemistry laboratories to assess the adoption of these recommendations in the UK. Responses were received from 65 of 190 laboratories (34%). Only 5 (8%) did not offer Lp(a) measurement. Of those providing the test, 23% (n = 14) offered an in-house service (IHS), the remaining laboratories (77%; n = 46) used an external referral service (ERS). The majority (10 of 14 or 71%) of IHS laboratories responded with details of their method, stating whether it minimised sensitivity to the effect of Lp(a) isoform size and used calibrators certified for traceability to the WHO/IFCC reference material, however, only a minority ERS laboratories (13 of the 46 or 28%) were able to specify the method used by their referral laboratory. Of the laboratories who specified their reporting units, 6 of 10 IHS and 7 of 23 ERS laboratories reported in nmol/L. Among the 60 laboratories who responded, the HEART UK recommendations appear to have been adopted in full by only 3 IHS laboratories. Further efforts are needed to standardise the measurement and reporting of Lp(a) so that results and interpretation are comparable across clinical biochemistry laboratories in the UK.

Preanalitik Hataların Altı Sigma Metodu ve Pareto Prensibi Analizi ile Değerlendirilmesi

Aim: In this study, we aimed to evaluate the preanalytical errors over a five year period using the Six Sigma methodology and Pareto Principle in the clinical biochemistry laboratory. Methods: Five-year sample rejection data between January 2015 and December 2019 in the clinical biochemistry laboratory were analyzed and classified according to the reasons for rejection. Six Sigma levels for the total and each preanalytical error were calculated with Westgard online formula. Preanalytical errors were evaluated according to their frequencies ranks and percentages with Pareto's principle. Results: The overall rate of five-year total critical preanalytical errors was 1.91% and the sigma level was 3.6. According to Pareto's chart, the three most common errors among the five-year preanalytical rejections were clotted sample (42.49%, sigma value:4), insufficient sample (23.53%, sigma value:4.2), and wrong container (8.01%, sigma value:4.5). Conclusion: Six Sigma is a quality management methodology used to evaluate laboratory performance processes according to universal quality criteria. Calculated sigma values of preanalytical errors in our laboratory were within the acceptable range. However, planned regulatory activities for frequently observed preanalytical errors should be a laboratory management strategy to reduce these error rates and improve our laboratory performance.

Reporting LDL cholesterol results by clinical biochemistry laboratories in Czechia and Slovakia to improve the detection rate of familial hypercholesterolemia.

This survey aims to assess the implementation of recommendations from the European Atherosclerosis Society (EAS) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) by clinical biochemistry laboratories in Czechia and Slovakia in their policies for reporting low-density lipoprotein cholesterol (LDL-C) concentrations. The web-based survey was distributed to all 383 Czech and Slovak clinical biochemistry laboratories that measure lipids by external quality assessment provider SEKK. A total of 17 single-answer questions were included. The questionnaire was focused on the detection and decision points in familial hypercholesterolemia (FH). All survey answers were taken into account. The laboratories followed the EFLM and EAS guidelines when they reported an interpretative comment considering FH diagnosis in adults. A total of 203 (53%) laboratories answered. Only 5% of laboratories added interpretative comments considering FH diagnosis when LDL-C concentrations are above 5.0 mmol/L in adults, and 3% of laboratories added interpretative comments considering FH diagnosis when LDL-C concentrations are above 4.0 mmol/L in children. Only 7% of laboratories reported goals for all cardiovascular risk categories (low, moderate, high, very high). Non-HDL cholesterol concentrations were calculated by 74% of responders. A significant number (51%) of participants did not measure apolipoprotein B, and 59% of laboratories did not measure lipoprotein(a). Only a small portion of laboratories from Czechia and Slovakia reported high LDL-C results with interpretative comments considering FH diagnosis in adults, the laboratories did not follow the guidelines.

B-022 Technical Evaluation of Urine Chemistry Testing on the Beckman DxC700AU Chemistry Analyzer

Abstract Background The Singapore General Hospitals’ clinical biochemistry laboratory constantly reviews and optimizes its automated chemistry testing through workflow enhancements and advancement of technology. The laboratory had evaluated 11 urine chemistry analytes on a standalone Beckman Coulter DxC700AU in view of upgrading its existing Beckman Coulter AU680. Methods The laboratory evaluated the following urine chemistry analytes: urea, sodium, potassium, chloride, creatinine, total protein, calcium, inorganic phosphate, magnesium, amylase and uric acid. The parameters evaluated were: linearity, limit of detection (LOD), carryover, imprecision and patient comparison against the AU680. Linearity was verified by analyzing Validate-It linearity materials in triplicate, and assessed by generating linearity statistics using Analyze-It v2.03. LOD was verified by analyzing 20 replicates of a blank matrix (saline) and 20 replicates of a patient specimen with concentrations near the LOD. Carryover was verified by sequentially analyzing a low concentration sample in triplicates followed by a high concentration sample in duplicates and lastly the same low concentration sample in duplicates. Imprecision was performed in triplicates across 5 days using quality control material from Bio-Rad, and assessed against the vendor’s imprecision claims. Patient comparison was performed using 60 to 80 samples for each analyte between the DxC700AU and the AU680. Passing Bablok Regression, Spearman Correlation and Altman-Bland Bias Plots was generated using the Analyze-It program. Results All analytes were verified to be linear within their respective AMRs; all linearity material recovered within ±10% of its expected target value. LOD was assessed to be satisfactory and below the lower limit of measurement. No significant carryover was observed for any analyte. Total imprecision for all the analytes were generally &amp;lt;4.8%. Passing Bablok Regressions, where X is the AU680 and Y is the DxC700AU, generated slopes ranging between 0.98X and 1.04X with constants ranging between -1.13 and 31.18. The large constants were partly due to analytes with large AMR (e.g. creatinine and uric acid urine). Altman-Bland Bias Plots presented bias ranging between −3.6% to 1.7% for different analytes. All analytes had excellent correlation between the 2 analyzers with R values of 1.0. Conclusion The performance characteristics of the DxC700AU in analyzing urine chemistries was found to be acceptable and highly comparable to the AU680. The upgrade of the AU680 to DxC700AU was seamless in view of excellent comparability in assay performances. Although the DxC700AU was expected to be the technological successor to the AU680, the quality-of-life improvements of the analyzer were the highlights of the DxC700AU. Improvements included a large clear LED indicator that highlights the status of the instrument and on-the-fly loading of reagent kits. Future improvements that the laboratory is looking forward to is the removal of the need to manually load specimens onto the instrument by connecting the standalone equipment onto its total laboratory automation track.

Positive direct antiglobulin tests in cancer patients on immune checkpoint inhibitors: A case series from India.

Tumour cells activate immune checkpoints such as programmed death receptor-1 (PD-1) and cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) signalling pathways to inhibit T lymphocyte activation and thus escape from immune surveillance. Immune checkpoint inhibitors (ICPis) reactivate T lymphocytes to recognize cancer cells by blocking CTLA-4 or PD-1. Autoimmune haemolytic anaemia is a rare, but often severe, complication of ICPis. Therefore, we performed a retrospective clinical case review, including serologic, haematology, and biochemistry laboratory results, of three patients who developed autoantibodies to erythrocytes following treatment with pembrolizumab, an anti-PD-1 inhibitor. Serologic testing of blood samples from these patients showed their red cells were positive for direct antiglobulin test (DAT+for IgG in two cases and IgG with C3d in one case). Antibody detection test was negative. No patient had clinical and laboratory features of haemolysis. There were no additional immune-related adverse events. IgG antibodies coating red cells were neither IgG1 nor IgG3 in class and elution was found negative in all. In conclusion, immunohaematology laboratories should be aware of the possibility of erythroid autoantibodies and their nature in cancer patients receiving ICPis. The result of a positive DAT should be interpreted carefully in these patients to exclude other possible causes of anaemia.

Assessment of cardio-vascular disease risk in diabetic population of Northern India

: Type 2 Diabetes mellitus (DM) is a chronic metabolic disorder. India has 72.9 million people living with diabetes (8.8%). The Cardio Vascular Disease (CVD) risk increases in patients with Type 2 diabetes. The Non-HDL-C level includes cholesterol carried in several atherogenic lipoproteins. The estimation of non-HDL-C may provide a better means to follow these patients toward their treatment goals. The study compares the level of non-HDL-C in non diabetic, pre-diabetic and diabetes patients and their occurrence of dyslipidemia. : The study group included 1418 patients and were grouped as – Non diabetic, pre-diabetic and Diabetic, having age group of 20 to 85 years. The Male:Female ratio was 1.9:1. Their blood samples were analysed in Clinical Biochemistry Laboratory on automated chemistry analyzer with quality checks.: The Non Diabetic group (HbA1c&amp;#60;5.7%) had 564 patients having Non-HDL-C 127.85±1.79 mg/dl; the Pre-Diabetic group (HbA1c-5.7-6.4%) had 316 patients with Non-HDL-C 132.37±2.35 mg/dl and Diabetic group (HbA1c &amp;#62;6.4%) had 538 patients and its non HDL-C was 148±4.27 mg/dl. : This study showed the groups, pre-diabetic and diabetic, had Non-HDL-C &amp;#62;130mg/dl. An increase in Non-HDL-C levels is associated with increased risk of CVD according to Adult Treatment Panel (ATP) III guidelines.

Impact of developing and implementing nonconformance management system at clinical biochemistry laboratory section of tertiary care hospital run by Government of Gujarat, India

In the era of evidence based medicine, laboratories are in implied need of providing quality services to their stakeholders. Development and implementation of NMS is the most important for laboratory preparing for accreditation. The aim of the study is to supplement the knowledge and to provide guidance about development of NMS in accordance with the accreditation requirements. The study was conducted at clinical biochemistry section of NCHSLS, Gujarat, India. Total of 85 NCs retrieved from the nonconformance record for the period of Oct 2011 to Sep 2013. They were analyzed for sources. Analysis was done to know whether they belong to management or technical requirements. Frequency and percentage-wise analysis of NCs related to various procedures of total testing process was also done and RCA for some of the NCs were done using 5 why’s or Fish bone technique.Majority of NCs are related to IQC (60%), External audit (14%) and EQAS (12%).Major NCs occurred in analytical and post analytical procedures and were related to the technical requirements (87%) pertaining to laboratory equipment (35%) and quality of examination procedures (20%).Development and implementation of NMS, is very useful for identification, record and RCA of NCs. NMS, helps to identify the area of QMS in need of attention as well suggest the corrective and preventive actions. It guides, decision making for developing a robust QMS system. Moreover, correct method of RCA is important in comprehensive evaluation of cause and prevention of the NCs.