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1.

Introduction

Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown.

Materials and methods:

A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients’ samples in both devices.

Results:

27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein.

Conclusions:

A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results.  相似文献   

2.

Introduction

Extremely high glucose concentrations have been shown to interfere with creatinine assays especially with Jaffe method in peritoneal dialysate. Because diabetes is the fastest growing chronic disease in the world, laboratories study with varying glucose concentrations. We investigated whether different levels of glucose spiked in serum interfere with 21 routine chemistry and thyroid assays at glucose concentrations between 17-51 mmol/L.

Materials and methods

Baseline (group I) serum pool with glucose concentration of 5.55 (5.44-5.61) mmol/L was prepared from patient sera. Spiking with 20% dextrose solution, sample groups were obtained with glucose concentrations: 17.09, 34.52, and 50.95 mmol/L (group II, III, IV, respectively). Total of 21 biochemistry analytes and thyroid tests were studied on Abbott c8000 and i2000sr with commercial reagents. Bias from baseline value was checked statistically and clinically.

Results

Creatinine increased significantly by 8.74%, 31.66%, 55.31% at groups II, III, IV, respectively with P values of < 0.001. At the median glucose concentration of 50.95 mmol/L, calcium, albumin, chloride and FT4 biased significantly clinically (-0.85%, 1.63%, 0.65%, 7.4% with P values 0.138, 0.214, 0.004, < 0.001, respectively). Remaining assays were free of interference.

Conclusion

Among the numerous biochemical parameters studied, only a few parameters are affected by dramatically increased glucose concentration. The creatinine measurements obtained in human sera with the Jaffe alkaline method at high glucose concentrations should be interpreted with caution. Other tests that were affected with extremely high glucose concentrations were calcium, albumin, chloride and FT4, hence results should be taken into consideration in patients with poor diabetic control.Key words: assay interference, glucose interference, preanalytical phase, creatinine, Jaffe kinetic assay, thyroid function tests  相似文献   

3.

Introduction:

ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009.

Materials and methods:

Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods – from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009.

Results:

For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023).

Conclusion:

Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that ISO15189 contributed to quality improvement of accredited laboratories.  相似文献   

4.

Introduction

Early identification and management of chronic kidney disease (CKD) is highly cost-effective and can reduce the risk of kidney failure progression and cardiovascular disease. In 2014, the Joint Croatian Working Group (JCWG) for laboratory diagnostic of CKD on the behalf of Croatian society of medical biochemistry and laboratory medicine (CSMBLM) and Croatian chamber of medical biochemists (CCMB) conducted a survey across Croatian medical-biochemistry laboratories to assess the current practice in this area of laboratory medicine. The aim of this study was to present the data collected through the survey and to give insight about laboratory diagnostics of chronic kidney disease in Croatia.

Materials and methods

An invitation to participate in the survey was sent to all Croatian medical-biochemistry laboratories (N = 196). The questionnaire was designed in a form of questions and statements, with possible multiple answers, comprising 24 questions.

Results

The response rate was 80/196 (40.8%). 39 answers were from primary medical-biochemistry laboratories. 31/78 (0.40) laboratories measure creatinine with non-standardized method (uncompensated Jaffe method). 58/78 (0.74) of laboratories that measure creatinine do not report eGFR values. Similar number of laboratories (58/80, 0.73) do not measure urine albumin or protein.

Conclusions

There is a large heterogeneity among Croatian laboratories regarding measuring methods, reporting units and reference intervals (cut-off values), both for creatinine and urine albumin or protein. The two key prerequisites for CKD screening, automatic reporting of eGFR and albuminuria or proteinuria assessment, are not implemented nationwide. There is a need for harmonization in laboratory diagnostics of CKD in Croatia.Key words: survey, chronic kidney disease, estimated glomerular filtration rate (eGFR), albuminuria, proteinuria, creatinine, harmonization  相似文献   

5.

Introduction

Poor harmonization of critical results management is present in various laboratories and countries, including Croatia. We aimed to investigate procedures used in critical results reporting in Croatian medical biochemistry laboratories (MBLs).

Materials and methods

An anonymous questionnaire, consisting of 24 questions/statements, related to critical results reporting procedures, was send to managers of MBLs in Croatia. Participants were asked to declare the frequency of performing procedures and degree of agreement with statements about critical values reporting using a Likert scale. Total score and mean scores for corresponding separate statements divided according to health care setting were calculated and compared.

Results

Responses from 111 Croatian laboratories (48%) were analyzed. General practice laboratories (GPLs) more often re-analyzed the sample before reporting the critical result in comparison with the hospital laboratories (HLs) (score: 4.86 (4.75-4.96) vs. 4.49 (4.25-4.72); P = 0.001) and more often reported the critical value exclusively to the responsible physician compared to HLs (4.46 (4.29-4.64) vs. 3.76 (3.48-4.03), P < 0.001). High total score (4.69 (4.56-4.82)) was observed for selection of the critical results list issued by the Croatian Chamber of Medical Biochemistry (CCMB) indicating a high harmonization level for this aspect of critical result management. Low total scores were observed for the statements regarding data recording and documentation of critical result notification.

Conclusions

Differences in practices about critical results reporting between HLs and GPLs were found. The homogeneity of least favorable responses detected for data recording and documentation of critical results notification reflects the lack of specific national recommendations.Key words: critical results, laboratory testing, quality indicators, survey, post-analytical phase  相似文献   

6.

Introduction:

The aim of this survey study was to assess the current practices and policies in use related to the various steps in the blood gas testing process, across hospital laboratories in Croatia.

Materials and methods:

First questionnaire was sent by email to all medical biochemistry laboratories (N = 104) within general, specialized and clinical hospitals and university hospital centres to identify laboratories which perform blood gas analysis. Second questionnaire with detailed questions about sample collection, analysis and quality control procedures, was sent only to 47 laboratories identified by the first survey. Questionnaire was designed as combination of questions and statements with Likert scale. Third questionnaire was sent to all participating laboratories (N=47) for additional clarification for either indeterminate or unclear answers.

Results:

Blood gas analysis is performed in 47/104 hospital laboratories in Croatia. In 25/41 (0.61) of the laboratories capillary blood gas sampling is the preferred sample type for adult patient population, whereas arterial blood sample is preferentially used in only 5/44 laboratories (0.11). Blood sampling and sample processing for capillary samples is done almost always by laboratory technicians (36/41 and 37/44, respectively), whereas arterial blood sampling is almost always done by the physician (24/29) and only rarely by a nurse (5/28). Sample acceptance criteria and sample analysis are in accordance with international recommendations for majority of laboratories. 43/44 laboratories participate in the national EQA program. POCT analyzers are installed outside of the laboratory in 20/47 (0.43) institutions. Laboratory staff is responsible for education and training of ward personnel, quality control and instrument maintenance in only 12/22, 11/20 and 9/20 institutions, respectively.

Conclusions:

Practices related to collection and analysis for blood gases in Croatia are not standardised and vary substantially between laboratories. POCT analyzers are not under the direct supervision by laboratory personnel in a large proportion of surveyed institutions. Collective efforts should be made to harmonize and improve policies and procedures related to blood gas testing in Croatian laboratories.  相似文献   

7.

Introduction:

Optimal storage of serum specimens in central laboratories for a long period for multicenter reference interval studies, or epidemiologic studies remains to be determined. We aimed to examine the analytical stability of chemistry analytes following numerous freeze-thaw and long term storage.

Materials and methods:

Serum samples were obtained from 15 patients. Following baseline measurement, sera of each subject were aliquoted and stored at −20 °C for two experiments. A group of sera were kept frozen for up to 1, 2 and 3 months and then analyzed for stability. The other experiment consisted of one to ten times of freeze and thaw cycles. Total of 17 chemistry analytes were assayed at each time point. The results were compared with those obtained from the initial analysis of fresh samples. Median or mean changes from baseline (T0) concentrations were evaluated both statistically and clinically according to the desirable bias.

Results:

Of the analytes studied, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine kinase (CK), gamma-glutamyl transferase (GGT), direct bilirubin, glucose, creatinine, cholesterol, triglycerides, high density lipoprotein (HDL) were stable in all conditions. Blood urea nitrogen (BUN), uric acid, total protein, albumin, total bilirubin, calcium, lactate dehydrogenase (LD) were changed significantly (P < 0.005).

Conclusions:

As a result, common clinical chemistry analytes, with considering the variability of unstable analytes, showed adequote stability after 3 months of storage in sera at −20 °C, or up to ten times of freeze-thaw cycle. All the same, such analysis can only be performed for exceptional cases, and this should be taken into account while planning studies.  相似文献   

8.

Introduction

This pilot study aimed to investigate the use of personal protective equipment (PPE) and compliance to the code of conduct (rules defined in institutional, governmental and professional guidelines) among laboratory technicians in Croatian medical laboratories. In addition, we explored the differences in compliance between participants of different age groups, laboratory ownership and accreditation status.

Materials and methods

An anonymous and voluntary survey with 15 questions was conducted among Croatian medical laboratory technicians (N = 217). The questions were divided into two groups: demographic characteristics and the use of PPE. The questions of the second part were graded according to the Likert scale (1-4) and an overall score, shown as median and range (min-max), was calculated for each participant. Differences between the overall scores were tested for each group of participants.

Results

The majority of participants always wear protective clothes at work, 38.7% of them always wear gloves in daily routine, more than 30.0% consume food and almost half of them drink beverages at workplace. A significantly lower overall score was found for participants working in public compared to private laboratories (36 (16-40) vs. 40 (31-40), P < 0.001). There were no statistically significant differences in overall scores for participants of different age groups (P = 0.456) and laboratory accreditation status (P = 0.081).

Conclusion

A considerable percentage of laboratory technicians in Croatian medical laboratories do not comply with safety measures. Lack of compliance is observed in all personnel regardless laboratory accreditation and participants’ age. However, those working in private laboratories adhere more to the code of conduct.Key words: survey, compliance, laboratory technician, universal safety measures, total quality management, clinical laboratory services  相似文献   

9.
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10.

Introduction

In vitro human diagnostic (IVD) company recalls are a common practice aimed to either minimize a potential error or eliminate an existing failure. In this case report, we aim to provide a critical analysis of a recent IVD recall and to provide a practical framework about what to do when an IVD company recalls product(s) based on the International Organization for Standardization - ISO 15189:2012 standard.

Case report

In 2014, Abbott Laboratories® (Green Oaks, IL) published an urgent field safety notice regarding a product recall (Architect Intact parathyroid hormone (PTH) Assay List Number 8K25) with immediate action required. The IVD company explained the reasons for the recall as follows: i) Abbott has confirmed that a performance shift in the Architect Intact PTH assay has the potential to generate falsely elevated results on patient samples; ii) results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. This issue may also impact established Architect Intact PTH reference ranges; iii) the magnitude of shift averages approximately 13% to 45%; iv) Abbott Architect Intact PTH controls do not detect the shift; and v) all current reagent, calibrator, and control inventory are impacted. The recall could have resulted in ~40,000 inaccurate laboratory tests reported by 18 laboratories from Italy (Lombardy region).

Conclusion

IVD company recalls have a serious impact on the patient safety and require a thorough investigation and responsible approach to minimize the possible damage. Medical laboratories accredited according to the ISO 15189 standard have procedures in place to manage such situations and ensure that patient safety is maintained when such recalls are issued.Key words: clinical laboratory techniques, patient safety, laboratory variability, reference standards, quality control, parathyroid hormone  相似文献   

11.

Introduction

The emergency laboratory in Hacettepe University Hospitals receives specimens from emergency departments (EDs), inpatient services and intensive care units (ICUs). The samples are accepted according to the rejection criteria of the laboratory. In this study, we aimed to evaluate the sample rejection ratios according to the types of pre-preanalytical errors and collection areas.

Materials and methods

The samples sent to the emergency laboratory were recorded during 12 months between January to December, 2013 in which 453,171 samples were received and 27,067 specimens were rejected.

Results

Rejection ratios was 2.5% for biochemistry tests, 3.2% for complete blood count (CBC), 9.8% for blood gases, 9.2% for urine analysis, 13.3% for coagulation tests, 12.8% for therapeutic drug monitoring, 3.5% for cardiac markers and 12% for hormone tests. The most frequent rejection reasons were fibrin clots (28%) and inadequate volume (9%) for biochemical tests. Clotted samples (35%) and inadequate volume (13%) were the major causes for coagulation tests, blood gas analyses and CBC. The ratio of rejected specimens was higher in the EDs (40%) compared to ICUs (30%) and inpatient services (28%). The highest rejection ratio was observed in neurology ICU (14%) among the ICUs and internal medicine inpatient service (10%) within inpatient clinics.

Conclusions

We detected an overall specimen rejection rate of 6% in emergency laboratory. By documentation of rejected samples and periodic training of healthcare personnel, we expect to decrease sample rejection ratios below 2%, improve total quality management of the emergency laboratory and promote patient safety.Key words: clinical laboratory services, total quality management, patient safety, preanalytical phase, preanalytical error  相似文献   

12.

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   

13.

Introduction

The study was performed to compare and analyze the inter-departmental variability in the request of rarely requested laboratory tests in primary care, as opposed to other more common and highly requested tests.

Materials and methods

Data from production statistics for the year 2012 from 76 Spanish laboratories was used. The number of antinuclear antibodies, antistreptolysin O, creatinine, cyclic citrullinated peptide antibodies, deaminated peptide gliadine IgA antibodies, glucose, protein electrophoresis, rheumatoid factor, transglutaminase IgA antibodies, urinalysis and uric acid tests requested was collected. The number of test requests per 1000 inhabitants was calculated. In order to explore the variability the coefficient of quartile dispersion was calculated.

Results

The smallest variation was seen for creatinine, glucose, uric acid and urinalysis; the most requested tests. The tests that were least requested showed the greatest variability.

Conclusion

Our study shows through a very simplified approach, in a population close to twenty million inhabitants, how in primary care, the variability in the request of laboratory tests is inversely proportional to the request rate.Key words: primary care, laboratory proficiency testing, clinical laboratory services, test requesting, preanalytical phase  相似文献   

14.

Background:

The ultra-large von Willebrand factor (vWF) multimers are very active and must be degraded by ADAMTS13 for optimal activity. A severe functional deficiency of ADAMTS13 has been associated with thrombotic thrombocytopenic purpura. The correct interpretation of patient vWF and ADAMTS13 plasma levels requires an understanding of the biological variation associated with these analytes. In the present paper, we aimed to determine the biological variation of ADAMTS13 and vWF in human adults.

Materials and methods:

Blood samples were collected weekly from 19 healthy subjects for 5 consecutive weeks. vWF activity and antigenicity were determined using aggregometric and immunoturbidimetric methods. ADAMTS13 antigenicity and activity were determined by ELISA.

Results:

The within-subject biological variations for vWF activity and antigenicity were 8.06% and 14.37%, respectively, while the between-subject biological variations were 18.5% and 22.59%, respectively. The index of individuality for vWF activity was 0.44, while vWF antigenicity was 0.64. Similarly, ADAMTS13 activity and antigenicity within-subject biological variations were 12.73% and 9.75%, respectively, while between-subject biological variations were 9.63% and 6.28%, respectively. The ADAMTS13 indexes of individuality were 1.32 and 1.55, respectively.

Conclusion:

We report high biological variation and individuality in vWF antigenicity and activity levels. However, ADAMTS13 antigenicity and activity displayed high biological variation, but low individuality. Thus, population-based reference intervals may be useful for monitoring ADAMTS13 antigenicity and activity, but not for vWF, which displays high individuality. These findings should be considered when determining the reference interval and other clinical variables associated with ADAMTS13 and vWF levels.  相似文献   

15.

Introduction

The educational program for health care personnel is important for reducing preanalytical errors and improving quality of laboratory test results. The aim of our study was to assess the level of knowledge on preanalytical phase in population of biomedicine students through a cross-sectional survey.

Materials and methods

A survey was sent to students on penultimate and final year of Faculty of Pharmacy and Biochemistry – study of medical biochemistry (FPB), Faculty of Veterinary Medicine (FVM) and School of Medicine (SM), University of Zagreb, Croatia, using the web tool SurveyMonkey. Survey was composed of demographics and 14 statements regarding the preanalytical phase of laboratory testing. Comparison of frequencies and proportions of correct answers was done with Fisher’s exact test and test of comparison of proportions, respectively.

Results

Study included 135 participants, median age 24 (23-40) years. Students from FPB had higher proportion of correct answers (86%) compared to students from other biomedical faculties 62%, P < 0.001. Students from FPB were more conscious of the importance of specimen mixing (P = 0.027), prevalence of preanalytical errors (P = 0.001), impact of hemolysis (P = 0.032) and lipemia interferences (P = 0.010), proper choice of anticoagulants (P = 0.001), transport conditions for ammonia sample (P < 0.001) and order of draw during blood specimen collection (P < 0.001), in comparison with students from SM and FVM.

Conclusions

Students from FPB are more conscious of the importance of preanalytical phase of testing in comparison with their colleagues from other biomedical faculties. No difference in knowledge between penultimate and final year of the same faculty was found.Key words: survey, education, preanalytical phase  相似文献   

16.

Introduction

The collected and shipped blood samples are exposed to a various extra-analytical factors prior to analysis. The aim of the study was to determine the stability of analytes in serum gel tubes and plain tubes exposed to a range of storage temperatures and times after centrifugation.

Materials and methods:

Fifteen healthy volunteers were recruited and venous blood was collected into four tubes, two with and two without gel separator. Analyzing the baseline samples in 30 min, all were stored at 4ºC or 24ºC for 6, 12, 18, 24, 30, 36, 48 and 72 hours and 1 week. Sixteen biochemical anaytes were measured on each sample. Variations remained under the desirable bias considered as clinically insignificant.

Results:

On day three, most analytes remained stable including albumin, protein, creatinine, cholesterol, triglycerides, gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT), creatine kinase (CK), lactate dehydrogenase (LD) regardless of tube types. Glucose concentration decreased markedly (P = 0.001) beginning from the first hours of storage in plain serum. The stability maximized for the analytes including glucose, total bilirubin, urea nitrogen (BUN), uric acid stored at 4 ºC in gel tubes. Aspartate aminotransferase (AST) activity increased significantly (P = 0.002) up to 48-h, however bias was not significant clinically. High density lipoprotein (HDL) concentration was stable in gel tubes at 24 ºC, in plain tubes at 4 ºC stored up to 36-h.

Conclusion:

Serum gel or non-gel tubes might be used interchangeably for 11 analytes chilled or at 24 ºC, whereas some restrictions must be applied for glucose, AST, BUN, HDL, and uric acid.  相似文献   

17.

Introduction

We aimed to determine the number of repeated cholesterol (RC) tests and the ratio of unnecessary-repeated cholesterol (URC) tests among patients admitted to Pamukkale University Hospital (Denizli, Turkey) and provide solutions to avoid URC testing.

Materials and methods

Total cholesterol (T-cholesterol) tests (N = 86,817) between June 2014 and May 2015 were evaluated. The tests performed more than once per patient were determined as RC test (N = 28,811). RC test with an interval shorter than 4 weeks were determined as URC test (N = 3968) according to the shortest retest interval stated in ACC/AHA blood cholesterol guideline. RC testing included internal medicine, surgery and paediatric outpatients and inpatients. Reference change value (RCV) of total cholesterol was calculated.

Results

The 33.1% of the T-cholesterol tests were RC tests (N = 28,811), 13.7% of them were URC tests (N = 3968). Our RCV value was 25%. The percentage change between consecutive tests was less than RCV in 86.1% (N = 3418) of URC tests. URC tests were performed more frequently in patients with desirable total cholesterol value (P < 0.001).

Conclusion

There is a significant part of repeated T-cholesterol tests requested in our hospital. URC test requests can be evaluated by laboratories and the obtained data should be shared with clinicians. Laboratories can calculate RCV for the tests they performed and report this value with the test result. To prevent from URC tests, a warning plug-in can be added to hospital information software in accordance with guidelines to prevent from URC test requests.Key words: unnecessary repeated cholesterol test, cholesterol retest interval, reference change value, laboratory costs, preanalytical phase, test requesting  相似文献   

18.

Introduction:

Serum blood collection tubes with separator gel are widely used by many laboratories for chemistry analyses. We describe a case of a primary blood collection tube filled with blood sample and a floating separator gel.

Materials and methods:

The blood sample was collected from a 51 years old female in intensive care unit with the diagnosis of pneumonia into a BD Vacutainer SST tube (Becton Dickinson, NJ, USA) containing serum separator gel and conveyed to the core laboratory of Marmara University Hospital within 30 minutes from collection. Sample was immediately centrifuged at room temperature at 1500 × g for 10 minutes.

Results:

The analyses revealed a highly increased total protein concentration of 145 g/L (reference interval 64–83 g/L). The nephelometric analyses showed an elevated serum IgG concentration of 108 g/L (reference interval 6.5–16 g/L) and IgG lambda monoclonal band was determined by serum immunofixation electrophoresis.

Conclusion:

Limitation of the separator gel tubes in patients with a high plasma density and its possible effects on test results and laboratory costs should be remembered. The clinical diagnosis stated in the information system should also reveal known comorbid conditions besides the apparent admission reason. This information would avoid resampling, additional testing, and communication efforts with the clinicians.  相似文献   

19.

Introduction:

We hypothesized that patients are poorly informed about proper procedure for 24-hour urine specimen collection and its relevance in determination of biochemical analytes, despite availability of leaflets and webpage with instruction for collection. The aim of this survey was to question outpatients how well are they informed about procedure of 24-hour urine specimen collection.

Materials and methods:

The survey with 10 questions was done in outpatient laboratory of University Department of Chemistry, Medical School University Hospital Sestre Milosrdnice, Zagreb, Croatia. The study included 59 patients with collected 24-hour urine sample who have consented to participate in the survey.

Results:

Out of 59 participants, most of them (0.97) were older than 40 years. Internet was not recognized as a source of information (1/59). Almost one third of the patients have changed their drinking habits to collect more urine volume. Although most of the patients (0.60) were aware that the bottle of water is the best choice for the container, almost half of them were collected urine samples in the plastic soft drink bottle. Laboratory staff and physicians often have given information about proper collection procedure, but that information was insufficient.

Conclusions:

Patients are usually not aware of importance of proper preanalytical procedure for collecting urine specimen and how improper collection could affect results of requested tests. Education of outpatients, general practitioners and laboratory staff is needed in order to improve sample quality and trueness of results.  相似文献   

20.

Introduction

Glycosylated hemoglobin (HbA1c) concentrations measured in clinical chemistry laboratories show large differences between their interlaboratory reported values. Laboratory measurements of quality performance should be based on quantitative data. The sigma metrics model provides an objective method for the assessment of current HbA1c assays and is useful in quality management planning. The aim of our study was to evaluate the analytical performance of the MQ-2000 PT HbA1c analyzer test results in the context of our operating conditions on the sigma scale.

Materials and methods

The coefficient of variation was determined from the calculated mean and standard deviation evaluated from internal quality control (QC) (N = 168 days) (Shanghai Huachen Biological Reagent Co. Ltd, China) data, and records of external quality data (KBUDEK, İstanbul, Turkey) measured in the period from May to November 2013 were used to determine the bias. The resulting data and total allowable error rate (TEA = 10%) from the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) were used to calculate the sigma level.

Results

The calculated coefficient of variations (CVs) at the two levels, normal (QC1 = 36.6 ± 2.38 mmol/mol) and pathological (QC2 = 84.7 ± 2.68 mmol/mol), were 6.5% and 3.1%, respectively. The average bias between the external QC and MQ-2000 PT during the study period was 4.3%. The calculated average sigma value was 1.19.

Conclusions

The MQ-2000 PT HbA1c is a new analyser in the market; there is need for improvement and the method should be controlled with greater attention to ensure quality.Key words: diabetes mellitus, hemoglobin A1c protein, human, chromatography, high pressure liquid chromatography  相似文献   

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