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1.
This study evaluated the types and frequencies of pre-examination errors recorded in the chemical pathology laboratory at the University Hospital of the West Indies, Jamaica. This was a retrospective analysis of errors recorded over a three year period. Data analysis was done on an average of 519,084 samples collected and tested per year. Samples included blood, urine, stool and other fluids. Pre-examination errors were identified and recorded following visual inspection of the samples and corresponding request forms by laboratory staff, then subsequently by the Senior Medical Technologist. Errors were generally classified as inappropriate sample (58 %), inappropriate form (23.4 %), inappropriate sample volume (9.3 %) and inappropriate sample tube (9.3 %). Over 90 % of recorded pre-examination errors were related to blood samples while urine samples accounted for 6.8 % error. Pre-examination errors were lower at this study location than elsewhere. Measures aimed at reducing instances of these errors are recommended for improved laboratory quality output.  相似文献   

2.
Preanalytical steps are the major sources of error in clinical laboratory. The analytical errors can be corrected by quality control procedures but there is a need for stringent quality checks in preanalytical area as these processes are done outside the laboratory. Sigma value depicts the performance of laboratory and its quality measures. Hence in the present study six sigma and Pareto principle was applied to preanalytical quality indicators to evaluate the clinical biochemistry laboratory performance. This observational study was carried out for a period of 1 year from November 2015–2016. A total of 1,44,208 samples and 54,265 test requisition forms were screened for preanalytical errors like missing patient information, sample collection details in forms and hemolysed, lipemic, inappropriate, insufficient samples and total number of errors were calculated and converted into defects per million and sigma scale. Pareto`s chart was drawn using total number of errors and cumulative percentage. In 75% test requisition forms diagnosis was not mentioned and sigma value of 0.9 was obtained and for other errors like sample receiving time, stat and type of sample sigma values were 2.9, 2.6, and 2.8 respectively. For insufficient sample and improper ratio of blood to anticoagulant sigma value was 4.3. Pareto`s chart depicts out of 80% of errors in requisition forms, 20% is contributed by missing information like diagnosis. The development of quality indicators, application of six sigma and Pareto`s principle are quality measures by which not only preanalytical, the total testing process can be improved.  相似文献   

3.
Proficiency of laboratory services is the mainstay in clinical medicine in providing error free diagnostic results. The efficiency of the laboratory needs to be evaluated as per standard international criterion. The quality indicators of the different phases of total testing process are considered the fundamental measurable tool for evaluation of laboratory performance. In order to optimize the laboratory’s proficiency and accreditate it as per international standard in our newly established lab, the study was conducted to evaluate the frequency of errors incurred by laboratory and nonlaboratory professionals during the whole testing process. Retrospective analysis was done for data received from April 2016 to Dec 2016 in our lab. Total number of samples received was 61,674, out of which 43200 samples could be analyzed for quality indicators. Total numbers of tests processed in these samples were 172,800. In the study samples, 26.5% errors were due to pre-analytical factors whereas 9.4% of errors were contributed by analytical phase and 18% by post-analytical phase. Inappropriateness of test requisition was observed to be the major attributing determinant for pre-analytical errors. Instrumentation efficiency in form of frequent breakdown (~7%), greatly affected the proficiency of analytical phase in our lab. 12% of post-analytical errors were ascribed by excessive turn-around-time. However, timeliness of critical value call out and reporting for STAT samples revealed high proficiency up to 97%. High error rates were observed in pre–pre- and pre-analytical phases that also accorded for high error frequency in post analytical phase. This emphasizes urgent need to formulate guidelines for processing all steps of total testing process and initiate strategic measures for reducing risk of errors and increasing patient safety.  相似文献   

4.
Quality can be defined as the ability of a product or service to satisfy the needs and expectations of the customer. Laboratories are more focusing on technical and analytical quality for reliability and accuracy of test results. Patients and clinicians however are interested in rapid, reliable and efficient service from laboratory. Turn around time (TAT), the timeliness with which laboratory personnel deliver test results, is one of the most noticeable signs of laboratory service and is often used as a key performance indicator of laboratory performance. This study is aims to provide clue for laboratory TAT monitoring and root cause analysis. In a 2 year period a total of 75,499 specimens of outdoor patient department were monitor, of this a total of 4,142 specimens exceeded TAT. With consistent efforts to monitor, root cause analysis and corrective measures, we are able to decreased the specimens exceeding TAT from 7–8 to 3.7 %. Though it is difficult task to monitor TAT with the help of laboratory information system, real time documentation and authentic data retrievable, along with identification of causes for delays and its remedial measures, improve laboratory TAT and thus patient satisfaction.  相似文献   

5.
Advances in instrument technology and automation have simplified tasks in laboratory diagnostics reducing errors during analysis thereby improving the quality of test results. However studies show that most laboratory errors occur in the pre-analytical phase. In view of the paucity of studies examining pre-analytical errors, we examined a total of 1513 request forms received at our laboratory during a 3 month period. The forms were scrutinized for the presence of specific parameters to assess the pre-analytical errors affecting the laboratory results. No diagnosis was provided on 61.20% of forms. Type of specimen was not mentioned in 61.60% of the forms and 89.25% of all forms were illegible. Critical results were encountered in 17.30% of patients, and of these 76.60% were not communicated due to incomplete forms. Thus, by following standard operating procedures vigorously from patient preparation to sample processing the laboratory results can be significantly improved without any extra cost.  相似文献   

6.
Quality in laboratory has huge impact on diagnosis and patient management as 80–90% of all diagnosis is made on the basis of laboratory tests. Monitoring of quality indicators covering the critical areas of pre-analytical, analytical and post-analytical phases like sample misidentification, sample rejection, random and systemic errors, critical value reporting and TATs have a significant impact on performance of laboratory. This study was conducted in diagnostic laboratories receiving approximately 42,562 samples for clinical chemistry, hematology and serology. The list of quality indicators was developed for the steps of total testing process for which errors are frequent and improvements are possible. The trend was observed for all the QI before and after sensitisation of the staff over the period of 12 months. Incomplete test requisition form received in the lab was the most poor quality indicator observed (7.89%), followed by sample rejection rate (4.91%). Most significant improvement was found in pre- and post-analytical phase after sensitisation of staff but did not have much impact on analytical phase. Use of quality indicators to assess and monitor the quality system of the clinical laboratory services is extremely valuable tool in keeping the total testing process under control in a systematic and transparent way.  相似文献   

7.
Acute coronary syndrome (ACS) is a term for a range of clinical signs and symptoms suggestive of myocardial ischemia. It results in functional and structural changes and ultimately releasing protein from injured cardiomyocytes. These cardiac markers play a major role in diagnosis and prognosis of ACS. This study aims to assess the efficacy of heart type fatty acid binding protein (h-FABP) as a marker for ACS along with the routinely used hs-TropT. In our observational study, plasma h-FABP (cut-off 6.32 ng/ml) and routinely done hs-Trop T (cutoff 0.1 and 0.014 ng/ml) were estimated by immunometric laboratory assays in 88 patients with acute chest pain. Based on the clinical and laboratory test findings the patients were grouped into ACS (n = 41) and non-ACS (n = 47). The diagnostic sensitivity, specificity, NPV, PPV and ROC curve at 95 % CI were determined. Sensitivity of hs-TropT (0.1 ng/ml), hs-TropT (0.014 ng/ml) and h-FABP were 53, 86 and 78 % respectively and specificity for the same were 98, 73 and 70 % respectively. Sensitivity, specificity and NPV calculated for a cut-off combination of hs-TropT 0.014 ng/ml and h-FABP was 100, 51 and 100 % respectively. These results were substantiated by ROC analysis. Measurement of plasma h-FABP and hs-TropT together on admission appears to be more precise predictor of ACS rather than either hs-Trop T or h-FABP.  相似文献   

8.
In the clinical laboratory setting, interferences can be a significant source of laboratory errors with potential to cause serious harm for the patient. After hemolysis, lipemia is the most frequent endogenous interference that can influence results of various laboratory methods by several mechanisms. The most common preanalytical cause of lipemic samples is inadequate time of blood sampling after the meal or parenteral administration of synthetic lipid emulsions. Although the best way of detecting the degree of lipemia is measuring lipemic index on analytical platforms, laboratory experts should be aware of its problems, like false positive results and lack of standardization between manufacturers. Unlike for other interferences, lipemia can be removed and measurement can be done in a clear sample. However, a protocol for removing lipids from the sample has to be chosen carefully, since it is dependent on the analytes that have to be determined. Investigation of lipemia interference is an obligation of manufacturers of laboratory reagents; however, several literature findings report lack of verification of the declared data. Moreover, the acceptance criteria currently used by the most manufacturers are not based on biological variation and need to be revised. Written procedures for detection of lipemia, removing lipemia interference and reporting results from lipemic samples should be available to laboratory staff in order to standardize the procedure, reduce errors and increase patient safety.  相似文献   

9.
Aim of this study was to evaluate the role of Myeloperoxidase (MPO) and high sensitive Troponin T in the early diagnosis of acute coronary syndrome (ACS). This was a cross sectional study that comprised of 120 individuals of which 75 were cases and 45 healthy controls. On the basis of clinical history and 12 lead electrocardiogram initial diagnosis of ACS was made in the cases. MPO and high sensitive Troponin T (hs-cTnT) was measured in all the individuals. Levels of MPO were significantly higher in patients of ACS as compared to those in control group [medians: 15.40 (95 % CI 11.06–20.84) vs 5.84 (95 % CI 5.50–6.44)]. By taking the cut off as >11.87 U/mL for MPO, its sensitivity was 87 % (95 % CI 73.7–95.1), specificity was 97.3 % (95 % CI 90.6–99.7), positive predictive value was 94.6 % and negative predictive value was 92.6 %. Positive likelihood ratio was 33.0 while negative likelihood ratio was 0.13, whereas the corresponding values in case of hs-cTnT were 95.6 % (95 % CI 85.2–99.5), 61.3 % (95 % CI 49.5–72.6), 59.7 %, 95.8 %, 2.47 and 0.07 by taking cut off as >14 pg/ml. The area under the ROC curves (AUC) of MPO and hscTnT at 0–6 h were 0.971 (95 % CI 0.92–0.99, P < 0.001) and 0.797 (95 % CI 0.71–0.86, P < 0.001) respectively. The logistic model combining the two markers yielded sensitivity, specificity, positive predictive value and negative predictive value of 95.7, 97.3, 98.2 and 93.7 % respectively. It was concluded that MPO and hs-cTnT may be useful tools for risk stratification of ACS and can be used together with better accuracy in the early diagnosis of ACS.  相似文献   

10.
There is a substantial amount of public concern about patient safety, as, according to estimates from major studies, hundreds of thousands die in hospitals each year all over the developed world as a result of medical errors that could have been prevented. Unprecedented research commissioned by the EU has found that almost one out of every four families has experienced a serious medical error. Greek citizens concerning about serious medical errors in the hospital environment, were at the top of the list. Greek Ombudsman's report on medical errors has raised the debate among health policy makers as to the appropriate response to the problem. Proposals range from the implementation of nationwide mandatory reporting with public release of performance data, to voluntary reporting and quality-assurance efforts that protect the confidentiality of error-related data. Any successful safety program will first require a national effort to make significant investments in information systems, along with providing an environment and education that enables to contribute to an active quality improvement process. In this paper we propose the development and implementation of Medical Error Reporting Information System (MERIS), in order to identify, collect, analyse and report medical errors and patient adverse events, as a tool for enhancing patient safety and health care quality. We also describe the necessary organisational structure and the infrastructure environment of the system and the barriers to its successful implementation.  相似文献   

11.
Serum thyroglobulin (Tg) and thyroid stimulating hormone (TSH) measurements have evolved as important analytes for monitoring the prognosis of patients with differentiated thyroid cancer, post-thyroidectomy. Individual analyte immunoassay is the current practice in clinical pathology, but the simultaneous assay for all relevant analytes for a given disease, can reduce assay costs, improve patient compliance and give the clinician more information for an unequivocal diagnosis. Microarray immunoassay (MI) can achieve this goal and, hence, we have developed and validated a immuno-radiometric MI for quantitation of serum TSH and Tg by using highly micro-porous polycarbonate (PC) track-etched membranes (TEM) to immobilize the monoclonal anti-TSH and polyclonal anti-Tg antibodies in ~1 mm diameter spots. Non-competitive immunoassays were performed using mixture of 125I labeled monoclonal anti-TSH and anti-Tg antibodies. Phosphorimager was used to quantify the bound radioactivity. TSH and Tg were detected with detection limit of 0.07 µIU/ml and 0.13 ng/ml respectively, which is lower than the clinically required cut-off level. The assay showed: acceptable intra-assay precision within 20 % and recovery in the range of 76–111.2 %. MI compared well with the established immunoradiometric assay (IRMA) with r = 0.98, p < 0.01 (n = 41). No cross-reactivity was seen between the immobilized antibodies. Although two hormones are addressed in this report, MI using PC TEM and isotopic/non-isotopic tracers has the potential for highly automated multiplexed analysis.  相似文献   

12.
Hemophagocytic lymphohistiocytosis (HLH) is an inflammatory condition that may run a rapid fatal course and calls for prompt diagnosis. Early intervention with steroids and other immunosuppressive drugs can contain the disease process and favours positive outcome. Ferritin ≥500 ng/ml is a HLH diagnostic criterion. We evaluated the diagnostic potential of admission ferritin, in children with HLH. Pediatric patients of a referral teaching hospital from Feb 2010–Oct 2013 having been investigated for ferritin on admission were included. HLH was confirmed when patients had clinical features and met 5/8 diagnostic criteria of the revised 2004 HLH guidelines. Ferritin was estimated on Cobas e411 by electrochemiluminiscence, with a measuring range of 0.5–2000 ng/ml. Dilutions were made when linearity exceeded and absolute values were reported. 905 on-admission ferritin investigations were reviewed out of which 346 values ≥500 ng/ml. Hyperferritinemia was seen in HLH/MAS (macrophage activation syndrome) [HLH group, median age 4 year 4 month, 59% male] and in systemic lupus erythematosus, sepsis, juvenile idiopathic arthritis, impending HLH, haemolytic anemias and malignancy [non-HLH group, median age 4 year 6 month, 60% male]. Of 346, 72 cases of hyperferritinemia were diagnosed with secondary HLH while one patient had primary HLH. 13/73 patients expired. The median ferritin level of the HLH group was significantly higher [6556 (2402–11,734) ng/ml] compared to non-HLH group [median 1175 (943–2000) ng/ml] (p < 0.0001). Receiver operator characteristics curve analysis revealed optimal admission ferritin of 3120 ng/ml as the cut-off with sensitivity of 70% and specificity of 88.9% for HLH diagnosis, exceeding the currently prescribed cut-off of 500 ng/ml. Hyperferritinemia below 3120 ng/ml has higher negative predictive value to rule out secondary HLH on admission in the study population of children predominantly diagnosed with infection associated HLH than the prescribed cut-off as per the 2004 guidelines. This may prove to be beneficial to alert physicians for prompt intervention which considerably decreases mortality in this often fatal condition.  相似文献   

13.

Introduction

Preanalytical control and monitoring continue to be an important issue for clinical laboratory professionals. The aim of the study was to evaluate a monitoring system of preanalytical errors regarding not suitable samples for analysis, based on different indicators; to compare such indicators in different phlebotomy centres; and finally to evaluate a single synthetic preanalytical indicator that may be included in the balanced scorecard management system (BSC).

Materials and methods

We collected individual and global preanalytical errors in haematology, coagulation, chemistry, and urine samples analysis. We also analyzed a synthetic indicator that represents the sum of all types of preanalytical errors, expressed in a sigma level. We studied the evolution of those indicators over time and compared indicator results by way of the comparison of proportions and Chi-square.

Results

There was a decrease in the number of errors along the years (P < 0.001). This pattern was confirmed in primary care patients, inpatients and outpatients. In blood samples, fewer errors occurred in outpatients, followed by inpatients.

Conclusion

We present a practical and effective methodology to monitor unsuitable sample preanalytical errors. The synthetic indicator results summarize overall preanalytical sample errors, and can be used as part of BSC management system.Key words: Preanalytical phase, errors in laboratory medicine, balanced scorecard, patient safety  相似文献   

14.
Prostate specific antigen (PSA) has long been used as a biological marker for prostatic cancer. Recent studies have demonstrated that PSA synthesis can be induced by steroid hormones in several tissues of women. Menstrual cycle is regulated by the cyclic variation of estradiol and progesterone. This study was undertaken in order to study the correlation of serum PSA to both these corpus luteal hormones. 110 serum samples and 10 saliva samples were collected from healthy women aged 18–45 years of age having normal menstrual cycles. Active PSA DSL-9700 ultrasensitive kit with detection limit 0.001 ng/ml was used to analyze PSA. 38.2 % of all serum samples and 10 % of saliva samples had detectable concentrations of PSA. The serum PSA was highest during mid follicular phase (between 4th and 8th days of cycle). Variation in PSA levels seemed to follow the variations in progesterone with a lag period of 12–14 days, but did not appear to bear any relationship with the estradiol levels.  相似文献   

15.
Hepcidin is a 25-amino acid peptide hormone produced by hepatocytes and plays a key role in body iron metabolism. Hepcidin deficiency is the cause of iron overload in hereditary hemochromatosis, iron-loading anemia, and its excess is associated with anemia of inflammation, chronic disease and iron deficiency anemia (IDA). The aims of this study was to evaluate HAMP gene mutation, namely IVS2 + 1(–G) (c.148–150 + 1del) and Gly71 Asp (c.212G > A (rs104894696) association with iron status in IDA conditions. Our study participants were 500 IDA patients and 550 age and sex-matched healthy controls. Hepcidin, ferritin and CRP analysis was done by ELISA method while ESR analysis was done according to Wintrobe method. CBC analysis was done by auto-analyzer. Two mutations in the HAMP genes were analysed by PCR RFLP method. Among the IDA patients, 7 were heterozygous for Met50del IVS2 + 1(–G) mutation. Nine IDA patients were heterozygous for G71D G–A mutation and homozygous were not identified in both mutations.Controls were showing heterozygous frequency 1.8 and 2.1% of Met50del IVS2 + 1(–G) and G71D G–A mutations respectively. Mutation of HAMP (Met50del IVS2 + 1(–G) and G71D G–A) were clinically associated with IDA and act as modulator of disease.  相似文献   

16.
Genitourinary tuberculosis is a disease of the genitourinary system which includes the entire urinary tract and reproductive system. Genital tuberculosis is an important cause of female infertility, especially in developing nations like India. In the present study, a total of 257 clinical specimens comprising of endometrial biopsy (109), endometrial curetting (42), menstrual blood (8), semen (17), placenta (11) and urine (70) were collected from patients and subjected for PCR, Culture and AFB detection. The endometrial biopsy, endometrial curetting, menstrual blood, semen, placenta, urine showed 30.2, 45.2,12.5, 5.8, 27.2, 31.4 %, positivity rate for tuberculosis by PCR, 7.3, 9.5, 25.0, 0, 9, 8.5 % by culture and 1.8, 2.3, 0, 0, 0, 2.8 % respectively by AFB smear. Being a novel, rapid technique, PCR is the method of choice for rapid diagnosis and management of genitourinary tuberculosis shared with the other concerned tests. This study reveals that genital tuberculosis can occur in any age group, however, the majority of patients were from reproductive age (nearly 75 % of them were from 20–45 years of age) group.  相似文献   

17.
During post-analytical phase, critical value notification to responsible caregiver in a timely manner has potential to improve patient safety which requires cooperative efforts between laboratory personnel and caregivers. It is widely accepted by hospital accreditors that ineffective notification can lead to diagnostic errors that potentially harm patients and are preventable. The objective of the study was to assess the variables affecting critical value notification, their role in affecting it’s quality and approaches to improve it. In the present study 1,187 critical values were analysed in the Clinical Chemistry Laboratory catering to tertiary care hospital for neuropsychiatric diseases. During 25 months of study period, we evaluated critical value notification with respect to clinical care area, caregiver to whom it was notified and timeliness of notification. During the study period (25 months), the laboratory obtained 1,279 critical values in clinical chemistry. The analytes most commonly notified were sodium and potassium (20.97 & 20.8 % of total critical results). Analysis of critical value notification versus area of care showed that critical value notification was high in ICU and emergency area followed by inpatients and 64.61 % critical values were notified between 30 and 120 min after receiving the samples. It was found that failure to notify the responsible caregiver in timely manner represent an important patient safety issue and may lead to diagnostic errors. The major area of concern are notification of critical value for outpatient samples, incompleteness of test requisition forms regarding illegible writing, lack of information of treating physician and location of test ordering and difficulty in contacting the responsible caregiver.  相似文献   

18.
Pre analytical process of extraction for accurate detection of organic acids is a crucial step in diagnosis of organic acidemias by GCMS analysis. This process is accomplished either by solid phase extraction (SPE) or by liquid–liquid extraction (LLE). Both extraction procedures are used in different metabolic laboratories all over the world. In this study we compared these two extraction procedures in respect of precision, accuracy, percent recovery of metabolites, number of metabolites isolated, time and cost in a resource constraint setup. We observed that the mean recovery from SPE was 84.1 % and by LLE it was 77.4 % (p value <0.05). Moreover, the average number of metabolites isolated by SPE and LLE was 161.8 ± 18.6 and 140.1 ± 20.4 respectively. The processing cost of LLE was economical. In a cost constraint setting using LLE may be the practical option if used for organic acid analysis.  相似文献   

19.
The association between methylenetetrahydrofolate reductase (MTHFR) C677T polymorphism and susceptibility to Alzheimers disease (AD) was controversial in previous studies. The present meta-analysis was designed to investigate the association of MTHFR C677T polymorphism with AD. Nine studies were identified by search of PubMed, Google Scholar, Elsevier, Springer Link databases, up to January 2013. Odds ratios (ORs) with corresponding 95 % confidence interval (CI) were calculated using fixed effects model or random effects model. All statistical analysis was done by Mix version 1.7. MTHFR C677T polymorphism had a significant association with susceptibility to AD in all genetic models (for T vs C: OR 1.29, 95 % CI 1.15–1.44, p < 0.0001; for TT + CT vs CC: OR 1.38, 95 % CI 1.16–1.364, p = 0.0002; for TT vs CC: OR 1.60, 95 % CI 1.25–2.04, p = 0.0001; for CT vs CC: OR 1.28, 95 % CI 1.1–1.53, p < 0.008; for TT vs CT + CC: OR 1.37, 95 % CI 1.12–1.67, p = 0.002). Results from present meta-analysis supported that the MTHFR C677T polymorphism was associated with an increased risk of AD in Asian population.  相似文献   

20.
Clinical reference intervals among Indian population are poorly defined. Therefore, there is an urgent need to establish local clinical laboratory reference intervals for healthy Indian population. The present study aimed to identify the 95 % reference interval for hematological and biochemical parameters in apparently healthy Indian population. We undertook a multicentric cross-sectional study conducted at Apollo Hospitals Educational and Research Foundation across India. Of which 10,665 reference individuals identified as healthy by physicians. The 95 % of the reference distribution was estimated using 2.5th and 97.5th percentile reference limits. The 95 % reference intervals for hemoglobin (Males: 12.3–17 g/dL; Females: 9.9–14.3 g/dL), platelet count (Males: 1.3–3.8; Females: 1.3–4.2 Lakhs/µL), erythrocyte sedimentation rate (Males: 2–22; Females: 4–55 mm/h), serum uric acid in males: 3.5–8.2 mg/dL, gamma glutamyl transferase (Males: 13–61 U/L), fasting blood glucose (Males: 78–110 mg/dL), total cholesterol (Males: 115–254 mg/dL), low density lipoprotein (Males: 60–176 mg/dL) and triglycerides (Males: 55–267 mg/dL, Females: 52–207 mg/dL) were different from currently used reference values. Additionally need for gender based partitioning were observed for triglycerides and gamma glutamyl transferase. The observed findings are of clinical significance and it needs to be validated with additional community based studies.  相似文献   

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